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2017 Volume 53 Number 2

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Health Technology Assessment ❙ The future of HTA in hospitals: Evidences from the EU Research Project “Adopting

Hospital Based Health Technology Assessment in EU” (AdHopHTA)

❙ Improving value for money invested in technologies through hospital-based health technology assessment: A Turkish example

❙ Health Technology Assessment in the Hospital Authority of Hong Kong – to support doctors, protect patients, and enhance accountability to the public

❙ Hospital-Based Health Technology Assessment: Experience in an Italian University Hospital

❙ Health Technology Assessment: Implementation challenges in Lebanon

❙ Experiences of Health Technology Assessment Units in Finnish Hospitals

❙ ‘Be There’ Without Being There: An Innovative Approach to Achieve JCI Reaccreditation through Virtual/Video Survey (Hybrid)

❙ “Economic Evaluation applied to the hospital setting” Experience of the Ezkerraldea Enkarterri Cruces Integrated Healthcare Organisation (Basque Country)

World Hospitals and Health ServicesThe Official Journal of the International Hospital Federation

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Contents

World Hospitals and Health Services – Health Technology Assessment Vol. 53 No. 2 1

Contents volume 53 number 2

Editorial StaffExecutive Editor: Eric de Roodenbeke, PhD Desk Editor: Marianne Corazon E. Bacani

External Advisory BoardAlexander S Preker Chair of the Advisory Board, Health Invest-ment & Financing CorporationCharles Evans, International Health Services Group Juan Pablo Uribe, Fundación Santa Fe de BogotaMark Pearson, Head of Health Division (OECD)

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The International Hospital Federation (IHF) is an independent non-political and not for profit membership organization promoting better Health for all through well managed and efficient health care facilities delivering safe and high quality to all those that need it. The opinions expressed in this journal are not necessarily those of the International Hospital Federation or Nexo Corporation.

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03 Editorial

Health Technology Assessment

04 The future of HTA in hospitals: Evidences from the EU Research Project “Adopting Hospital Based Health Technology Assessment in EU” (AdHopHTA)

Americo Cicchetti, Ph. D, Laura Sampietro-Colom, MD, Kristian Kidholm, Ph. D.

12 Improving value for money invested in technologies through hospital-based health technology assessment: A Turkish example

Assoc. Prof. Dr. Rabia Kahveci, Prof. Dr. Nurullah Zengin, Emine Ozer Kucuk, Msc, Phd

15 Health Technology Assessment in the Hospital Authority of Hong Kong – to support doctors, protect patients, and enhance accountability to the public Dr Shao-Haei Liu

18 Hospital-Based Health Technology Assessment: Experience in an Italian University HospitalMarco Marchetti, Irene Urbina, Americo Cicchetti

22 Health Technology Assessment: Implementation challenges in LebanonRiad Farah, B.E, Chtm

25 Experiences of Health Technology Assessment Units in Finnish HospitalsRisto P. Roine, Md. Ph. D., Miia Turpeinen, Md. Ph. D., Tuija S. Ikonen, Md. Ph. D.

28 ‘Be There’ Without Being There: An Innovative Approach to Achieve JCI Reaccreditation through Virtual/Video Survey (Hybrid)Salma Jaffer, Rozina Roshan, Khairunnisa Ismail

34 “Economic Evaluation applied to the hospital setting” Experience of the Ezkerraldea Enkarterri Cruces Integrated Healthcare Organisation (Basque Country)Mª Teresa Acaiturri Ayesta, Iker Ustarroz Aguirre, Elisa Gómez Inhiesto

Reference

39 Language abstracts

47 IHF events calendar

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Editorial

World Hospitals and Health Services – Health Technology Assessment Vol. 53 No. 2Joint Commission International® (JCI) is a division of Joint Commission Resources, Inc.®, a wholly controlled not-for-profit affiliate of The Joint Commission. JCI provides leadership in international health care accreditation and quality improvement.

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3

Health Technology Assessment: The two Edged Sword

The WHO defines health technology assessment (HTA) as “the systematic evaluation of properties, effects, and/or im-pacts of health technology …. a multidisciplinary process

to evaluate the social, economic, organizational and ethical is-sues of a health intervention or health technology.” It defines health technology as the “application of organized knowledge and skills in the form of devices, medicines, vaccines, proce-dures and systems developed to solve a health problem and improve quality of lives.”

In this issue of the World Hospitals and Health Services (WHHS) Journal, the contributing authors look at the different ways in which HTA can contribute to informed policy decision making in the health sector, including advantages and some caveats.

Countries throughout the world spend from under 2 percent (low income countries) to over 5 percent (OECD countries) of total health expenditure on medical devices and diagnostics, and somewhere in the range of 10 to 20 percent on pharmaceuticals and vaccines. Given that many countries outside the OECD import technology in foreign currencies, spending on health technology sometimes constitutes a substantial part of the non-staff health care budget in developed countries.

As indicated by many of the contributing authors in this issue of the Journal, good HTA can therefore significantly contribute towards improving not only care quality but also financial sustainability in the health sector. In a 2015 WHO survey on HTA among member states (111 of 145 responded to the survey), most countries reported having a formal process for systematically compiling, analyzing and synthesizing relevant information and scientific evidence to support health care policy decision making. Countries used HTA for different purposes depending on their income level, but most countries gathered the information for planning and budgeting purposes. Surprisingly however, fewer than half of the countries with a formal process had legislative requirements for the consideration of analysis results.

Critics of HTA often claim that HTA is often devised by anti-technology bureaucrats and policy researchers who do not

have a full grasp of the underlying scientific sophistication of technologies under assessment, or the commercial challenges and costs of translating bench research from the lab to something that benefits patients. Most of the major breakthroughs in medicine in during the past Century have occurred through entrepreneurs developing new drug, vaccines, medical devices and diagnostic equipment.

In the case of medical devices and diagnostic equipment (less so in the case of pharmaceuticals and vaccines), the cost and effectiveness of a new technological development may have as much to do with the operator’s clinical judgment and skills as with the soundness of the underlying technology. Advanced and cutting-edge devices or diagnostic equipment will be of little value unless used by a skilled specialist. Similarly, a mediocre new technology may achieve good outcomes if used by an exceptional operator. The selection and high performance training of staff that will use new technology is an important factor to consider in any HTA.

This raises the so-called Collingridge Dilemma: on the one hand, impacts of new technologies cannot be easily predicted until the technology is extensively developed and widely used; on the other hand, control or change of a technology is difficult as soon as it is widely used.

It is now estimated that the development of a new block buster drug can take 12 to 15 years and cost up to US$2 to 3 million before earning the first dollar in sales. Without brave entrepreneurship (putting money up front), many of the 20th century’s major advances would still be sitting on the shelves of university laboratories, depriving patients of the impressive potential benefits from research in the life-sciences.

Hospitals are often real life laboratories where new technology is developed, tested and eventually introduced into patient care. The International Hospital Federation supports the development of new and innovative technologies that contribute to patient care. At the same it is committed to working with its members, national agencies and researchers to find the right balance between the recent explosion in new innovations and the need for HTA to ensure that such advances lead to better quality of care.

ERIC DE ROODENBEKECEOINTERNATIONAL HOSPITAL FEDERATION

ALEXANDER S. PREKERPRESIDENT AND CEO HEALTH INVESTMENT & FINANCING CORPORATION


World Hospitals and Health Services – Health Technology Assessment Vol. 53 No. 24

The future of HTA in hospitals: Evidences from the EU Research Project “Adopting Hospital Based Health Technology Assessment in EU” (AdHopHTA)

ABSTRACT: Health Technology Assessment (HTA) has been increasingly used in decision-making processes at national, regional, and international levels over the past 40 years. However, a large number of good-value innovative Health Technologies (HTs) never reaches clinical practice while, in many instances, others with no significant added value actually do. This situation can result in ineffective and inefficient resource allocation which has an impact on the health of the populations and equitable access to healthcare in public healthcare systems under financial pressure.A way of overcoming this problem is by approaching HTA at hospital level, notably because hospitals are the main entry level for innovative HTs. The adoption of the HTA logic as support for managerial, together with clinical decision making at hospital level, has been labelled “hospital based health technology assessment” (HB-HTA). In 2013, the European Commission funded a 3-year FP7 project (AdHopHTA) with the aim of creating pragmatic knowledge, useful to fostering the use of the HTA approach for managing health technologies in European hospitals. A consortium was set up, consisting of 10 institutions under the coordination of Hospital Clinic de Barcelona – Fundacio CLINIC per a la Recerca Biomedica (FCRB) , to perform a critical analysis of existing hospital-based HTA initiatives, and develop new methods, instruments and processes for the evaluation of technology in hospital settings.Over 385 hospital managers from 20 different countries have collaborated in this research which has shed light upon decision-making approaches used in EU hospitals for the adoption of different medical technologies, as well as the development of new tools to foster the adoption of the HTA approach in hospital processes.

Introduction and Background. HTA plays a key role in promoting the spread of HTs, thus optimizing the sustainability of health care systems. The use of HTA as a part of the decision-mak-

ing process at national, regional, and international levels has evolved considerably over the past 35 years. Traditionally, HTA has focused on informing policy making at a macro level. In the ‘80s, health care systems in developed countries established agencies to produce scientific information and address health care policies. At this stage HTA WHO (67th WHO Assembly, May 2014) considered HTA as the way to ensuring universal cover-

age for healthcare systems worldwide under tremendous eco-nomic and financial pressure.

Since hospitals, especially university and teaching hospitals, are often the first entry points for new and innovative interventions, in recent years small HB-HTA units have been established, mostly within hospitals, to support decisions at local and institutional levels. HB-HTA consists of the implementation of health technology assessment processes and methods at hospital level.

The contextualisation of HTA within a specific hospital requires

KRISTIAN KIDHOLM, PH.D.HEAD OF RESEARCH, CENTER FOR INNOVATIVE MEDICAL TECHNOLOGY, ODENSE UNIVERSITY ASSOCIATE PROFESSOR, HEALTH ECONOMICS, UNIVERSITY OF SOUTHERN DENMARK. SCIENTIFIC COORDINATOR AT THE HTA-UNIT AT ODENSE UNIVERSITY HOSPITAL.

AMERICO CICCHETTI, PH. DPROFESSOR, HEALTHCARE MANAGEMENT, UNIVERSITÀ CATTOLICA DEL SACRO CUOREDIRECTOR, POST GRADUATE SCHOOL OF HEALTH ECONOMICS AND MANAGEMENTCHIEF OF RESEARCH, HEALTH TECHNOLOGY ASSESSMENT UNIT AND BIOMEDICAL ENGINEERING DIRECTOR, HEALTH TECHNOLOGY ASSESSMENT INTERNATIONAL. PRESIDENT, ITALIAN SOCIETY OF HEALTH TECHNOLOGY ASSESSMENT.

LAURA SAMPIETRO-COLOM, MDDEPUTY DIRECTORINNOVATION AND HEAD OF THE HEALTH TECHNOLOGY ASSESSMENT (HTA) UNITHOSPITAL CLINIC OF BARCELONA



consideration of its unique characteristics within the assessment process, including the choice of an available comparator and the hospital’s specific organisational structure.

Hospital-based HTA can either be performed by a team of professionals working at the hospital, or by an external team of professionals.

Hospital-based Health Technology Assessment (HB-HTA) means performing HTA activities tailored to the hospital context to inform managerial decisions on different types of health technologies. It includes processes and meth-ods used to produce HTA reports in and for hospitals.Definition developed by the partners of the AdHopHTA project (AdHopHTA Handbook; Sampietro-Colom et al, 2015)1

Different motivations can explain the widespread adoption of HTA methods and tools at hospital level (Cicchetti et al, 2008; Sampietro-Colom, Martin, 2017).

Firstly, hospitals require contextualised assistance on how to make sound investment decisions on innovations that should be: tailored to their specific contexts (e.g. organisation of care), focused on the HTs of their strategic interest (financial growth, focus of healthcare services, etc.) and adjusted to their timing (faster answers).

Secondly, hospitals are increasingly acting under budget constraints and economic pressure as a result of the tendency in many healthcare systems to foster micro-economic efficiency to achieve financial equilibrium at system level. Consequently, hospital managers are looking for advanced managerial tools, based on economic-rational approaches which are also acceptable in medical contexts.

Lastly, healthcare systems are increasingly recognising HB-HTA development as the most effective way of translating HTA results from clinical research and national/regional organisations into clinical practice, increasing the impact of relevant investments on HTAs performed at institutional level.

Examples of HTA use at hospital level have been reported since the eighties, when CEDIT was established within the Assistance Publique Hopitaux de Paris. We have learnt that HB-HTA can be performed within varying degrees of organisational complexity. It can exist through a unit with permanent full-time HTA professionals, or even a network of part-time clinicians, planned and assigned regularly to assessment duties.

In order to better understand what we should actually mean by HB-HTA, it could be useful to focus on what it is not. Based on the analysis of the AdhopHTA project, the following activities cannot be considered as pure HB-HTA, in light of the definition of HB-HTA, although they are important steps towards actual HB-HTA:

❙ Use of national or regional (or other hospitals) HTA reports without proper adaptation to a hospital’s own setting and where clinical leaders act as promoters;

❙ Drawing up of recommendations on health technologies by a committee of clinicians without basic understanding of HTA methods and/or comprehensive information as

1 The AdHopHTA project has received funding from the European Union Seventh Framework Programme for Research (2007-2013) under grant agreement No 305018.

required by international HTA standards; ❙ Completion of a checklist of questions to assess health

technologies in hospitals without using the quality standards required for any HTA process;

❙ Assessing health technologies solely from a bioengineering or organisations-of-care viewpoint;

❙ Using evidence to inform procurement processes.

Aims of the AdHopHTA ProjectMain aims of the projectEven though several HB-HTA initiatives have emerged

in Europe, they have never been examined systematically, resulting in limited possibilities for learning said heterogeneous experiences. In order to fill this gap, the AdHopHTA (Adopting hospital-based Health Technology Assessment in the EU) research project was funded by the European Commission under the 7th Framework Programme (Grant Agreement 305018).

Strategic aims of the project include: ❙ production of a critical analysis of current formally

established hospital based HTA initiatives; ❙ provision of a set of principles for best practices in

hospital-based HTA; ❙ definition of a framework to establish collaboration

among current hospital-based HTA initiatives and deploy it to other interested EU hospitals;

❙ promotion of collaboration and coordination for hospital HTA initiatives with HTA National/Regional organisations.

In order to reach these strategic aims, AdHopHTA partners have adopted a research approach useful to producing pragmatic knowledge for a more widespread adoption of the HTA approach to support decision-making in European (and non European) hospitals health technologies.

The aim of the project was to reach specific goals: ❙ Systematic characterisation of innovation uptaking

in hospitals, analysis of information needs and of organisational models of hospital-based HTA units.

❙ Mapping current European trends of coordination between National/Regional HTA and Hospital-based HTA programmes and the analysis of coordination and collaboration patterns;

❙ Building a framework of best practices in HTA and reviewing accompanying EU policies;

❙ Developing principles for HB- HTA best practices and a toolkit for its deployment;

❙ Networking and communication on AdHopHTA and its products and development of a repository for hospital based HTA products.

Methods in the AdhopHTA projectA number of different studies using different scientific methods

were carried out by the AdHopHTA Consortium as part of the project. A total of six literature reviews were conducted (Ølholm et al. 2015).

107 Face-to-face, structured interviews were conducted with 53 hospital managers from nine European countries. Focus during the interview was on the hospital managers’ need for information about new treatments for decision-making (Kidholm et al., 2015).



A large web-based questionnaire survey with a sample of 339 hospital healthcare professionals was conducted. The questionnaire focused on hospital managers’ need for information about new treatments, for decision-making purposes. 163 respondents from Spain, Italy, Turkey, Switzerland, Austria, Estonia, Denmark, Finland and Norway participated in the survey.

A case series study was also carried out including 40 cases regarding the description of adoption processes of different kinds of medical technologies (drugs, medical devices, medical equipment, surgical procedures) in teaching and non-teaching hospitals.

In addition, a Delphi process, one focus group study and a validation workshop was carried out. In total 385 hospital managers from 20 countries provided their input, 345 were external to the AdHopHTA consortium.

Main resultsThe activities performed by consortium members as well

as collaboration with external reviewers has produced both informative and practical outputs.

The main informative outputs, outlined in the AdohopHTA Handbook (Sampietro-Colom et al., 2015), are:

❙ The current status of decision-making of health technology management in hospitals and clear definition of the role of HB-HTA units;

❙ Analysis of the organisational models of HB-HTA units; ❙ Analysis of the health technology assessment process

in hospitals with HB-HTA units and the characteristics of produced reports;

❙ Analysis of collaborative experiences for HB-HTA with national or regional HTA agencies.

The project also produced some practical tools that can be used to foster the adoption of the HTA approach in hospitals. Among these pragmatic outputs, we include:

❙ Guiding principles for good practices in HB-HTA and related toolkit;

❙ The AdHopHTA Mini-HTA Template; ❙ The mini-HTA quality checklist; ❙ A database of HB-HTA reports (AdHopHTA Database).

Informative outputs: the AdHopHTA Handbook table of contents The vast majority of results of the AdhopHTA project have

been summarized in a “Handbook”. This contains the results of the literature analysis, various surveys, and the analysis of multiple case studies (Sampietro-Colom et al., 2015).

Current status of decision-making in the management of health technology in hospitals and the role of HB-HTA units

Decision-making processes for the adoption of new technologies were analysed based on 34 different case studies. The process varies from hospital to hospital, and differs according to the type of technology under consideration (equipment, medical devices or drugs) and on the existence or otherwise of an HB-HTA unit. Hospitals with an HB-HTA unit seem to have a better organised and more efficient health technology adoption process. In particular, the presence of an HTA function reduces variability in adoption process length: in the case of medical devices, the length between the request and the adoption varies

from 5 to 12 months in those hospitals with an HB-HTA function, and from 1 to 60 months in hospitals without.

Organisational models of HB-HTA units There is no “one-size fits all” model to look at when setting up

an HB-HTA unit. The way an HB-HTA unit is framed, organised and run depends on the characteristics of hospital context and values, and is influenced by the culture of professionals working in the specific healthcare system. 7 in-depth case studies were analysed to create a taxonomy of models of HB-HTA functions, based on two different relevant variables: the level of interaction with national-regional level HTA bodies, as well as the level of organizational structuring and function maturity2:

❙ Independent group; these units operate within the hospital as an “independent group” to provide support for management decisions in a fairly informal way;

❙ Integrated-essential HB-HTA unit; these are small-sized units with a limited number of staff members, but which are able to involve many other actors and “allies” in their activities;

❙ Stand-alone HB-HTA units; units with usually highly formalised and specialised procedures, acting internally within hospitals and not strongly influenced by national or regional HTA organisations (currently the most frequent model in Europe).

❙ Integrated-specialised HB-HTA units; the functions of the HB-HTA unit are influenced by formal collaboration with the national or regional HTA agency. In general, the involvement of HB-HTA units in the technology adoption process is considered advisable, and HTA-based recommendations are closely followed by hospital decision-makers.

The health technology assessment process in hospitals with HB-HTA units

Based on 34 case studies, the project looked at the process and outputs produced by HB-HTA functions. The analysis showed how crucial it is to ensure that HTA reports are “fit-for- purpose” and meet end-user needs and expectations. In the case of HB-HTA, these users are hospital decision-makers. Hospital decision-makers require information on the clinical effectiveness, budget impact, safety, organisational and strategic aspects of the technologies they consider for adoption (Kidholm et al., 2016). This information can be provided at different levels of comprehensiveness. Correct timing is even more important in relation to the subsequent decision. Moreover, ensuring the quality of information is crucial; to this end, the project provides a quality checklist for HB-HTA reports along with results of the quality analysis of a sample of HTA reports from AdHopHTA partners’ countries. These are available from the AdHopHTA homepage. The following are some of the main observations from the analysis:

❙ There is no one type of HB-HTA report. The reports range from almost full HTA reports to simpler checklists of questions, without a deep level of detail;

2 List of Case Studies. Hospital Clinic de Barcelona (HCB/FCRB); Ankara Numune Training and Research Hospital (ANH); University Hospital of Lausanne (CHUV); Hospital District of Helsinki and Uusimaa (HUS); Odense University Hospital (OUH); Policlinico universitario “A. Gemelli”, Università Cattolica del Sacro Cuore (UCSC); Auckland City Hospital (ACH) located in the Auckland District Health Board in New Zealand.



❙ The overall quality of the reports evaluated is moderate, with room for improvement;

❙ The higher the quality score of an HB-HTA report, the greater the volume and amount of staff-effort required to produce it.

Collaborative experiences for HB-HTA with national or regional HTA agencies

A specific section of the study was dedicated to reviewing the experiences of interactions and collaboration between hospital national or regional levels in HTA. Analysis results indicate they are mostly informal in nature, despite the fact that formal organisation is deemed necessary by most. More formal relations between hospital level and national-regional levels were reported in Norway, Finland and Italy (“A. Gemelli” University Hospital), Spain (Basque country). Informal interactions were reported with Spain (Catalonia), Austria, Switzerland, Turkey, Denmark, Italy (Emilia Romagna Region). In general, the effectiveness of the interaction is perceived as a critical point, with huge space for improving the general impact of HTA on clinical practice in the real world.

Pragmatic outputsGuiding principles for good practices in HB-HTA and related

toolkitGuiding Principles were defined to guarantee good practices

for those hospitals wishing to implement or use HTA as well as for those wishing to improve their current work on HB-HTA (Sampietro-Colom et al., 2016). The 15 guiding principles for good practices in HB-HTA are grouped under 4 dimensions: the assessment process, unit framework (in particular: leadership, strategy and partnerships), resources needed by the unit, and the impact of the unit’s work.

Some practical tools related to the 15 guiding principles are available On the AdHopHTA website (www.adhophta.eu), for those willing to implement an HB-HTA function. The toolkit provides both answers to frequently asked questions and tools (such as forms or checklists) for practically developing an HB-HTA unit and carrying out the assessment of new HTs.

AdHopHTA Mini-HTA Template The AdHopHTA Mini-HTA Template provides a model to

collect the information needed to carry out the assessment of a new technology in a hospital setting. The template is structured as a list of questions (32) grouped in 5 sections to be answered for a comprehensive collection of information to support managerial decision-making regarding the adoption of a specific technology3.

A database of HB-HTA reports (AdHopHTA Database)The AdHopHTA Database includes assessments performed

by 8 HB-HTA units and is intended to be the seed for an expanded database which will include the work of more HB-HTA units in Europe. Currently it contains 269 abstracts in English, with extensive information regarding methodology and results.

3 Structure of the AdHopHTA Mini-HTA Template. Question 1: Summary; Question 2-7: Basic in-formation; Question 8-13: General methodological aspects & reporting; Question 14-27: Results within domains; Question 28-32: Discussion, conclusion and recommendations (Source: www.adhophta.eu).

Abstracts also contain author contact details.

Final Considerations: Towards an HTA ecosystemThe prominent position of HTA on the EU health agenda

is firmly established as a result of the long history of support from Member States and the EU. However, until now, European coordination efforts in HTA have basically involved national and regional organisations without specific consideration of the hospital level. HB-HTA initiatives are a better answer to hospital decision needs regarding health technologies, and represent a bridge to a more effective transfer of HTA results from national or regional levels to the hospital context. Improved collaboration and involvement of HB-HTA units within the European HTA scientific and professional network would result in a more comprehensive approach across the different health system levels.

In general, the development of HB-HTA seems to be related to a process of progressive opening of HTA to the clinical and managerial worlds within healthcare systems. HTA should not be perceived as something intelligible for “insiders only”, rather it should become a fundamental part of clinical work and an organizational process to be mastered by hospital managers as well as many other key healthcare professionals. Moreover, with the 2014/24/EU Directive on Public Procurement which enforces hospital procurement based on the most advantageous economic tender, collaboration with HB_HTA professionals will be needed more than ever.

HB-HTA can provide an enormous contribution towards delivering valuable medicine in healthcare systems worldwide, increasing the appropriateness of resource use and making (public and private) systems sustainable. Currently, HB-HTA seems capable of producing “local value”: this has been confirmed within the AdHopHTA project as well as in a recent comparative analysis of 31 HTA hospital functions around the world (Cicchetti et al, 2017). In order to translate “local value” into greater global impact, HB-HTA functions should be interacting and integrating along the HTA “supply chain”, contributing to international, national, regional and provincial HTA efforts, offering unique knowledge about the impact of healthcare technologies on “local contexts”. In this manner, the role of HB-HTA functions could evolve and embrace two different “missions”: on the one hand, hospital HTA functions could continue to operate as they mainly did up to now, integrating globally produced reviews of clinical research and HTAs with local evidence, experiences, resources and data to provide intelligent support for managerial and clinical decisions. On the other hand, they should be asked to share locally produced evidence with international, national and regional HTA bodies (and networks such as EuNetHTA) and regulatory bodies (such as EMA or CADTH) supporting adaptive / progressive drug licensing models that are under experimentation worldwide, or complementing the task that National/Regional HTA agencies are performing around medical devices.

In this fashion, HB-HTA functions could assume a clear positioning and role within the global “HTA eco-system” which is requiredto fully manage the life cycle of health technologies. This should be done by extracting maximum value from the tremendous economic efforts of countries worldwide in facing future challenges of healthcare systems.

http://www.adhophta.eu





Table 1. The AdHopHTA Consortium

1.2.3.4.5.6.7.8.9.10.

Hospital Clinic de Barcelona – Fundació CLINIC per a la Recerca Biomedica (FCRB), Spain – CoordinatorCenter for Research in Healthcare Innovation Management (CRHIM), IESE Business School, SpainOdense University Hospital (OUH), DenmarkCentre Hospitalier Universitaire Vaudois (CHUV), SwitzerlandUniversity of Helsinki and Helsinki University Hospital (HUS), FinlandTartu University Hospital (TUH), EstoniaUniversita Cattolica del Sacro Cuore (UCSC) – University Hospital “A. Gemelli“, Rome, ItalyLudwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), AustriaAnkara Numune Training and Research Hospital (ANH), TurkeyNorwegian Knowledge Centre for the Health Services (NOKC), Norway

Table 2. Most frequently encountered differences between standard HTA carried out at a national or regional level and at hospitals.

Characteristics National or regional agency Hospital

Assessment process

Type of technologies assessed

• Drugs• Medical equipment• Medical devices• Diagnostic tests

• Drugs*• Medical equipment• Medical devices• Diagnostic tests• Organizational technologies

Scope of HTAThe comparator is the “gold standard” or the most extensively used technology in the country

The comparator is normally the technology that is being used in the hospital (current standard practice)

Most frequently required information (criteria)

• Description of HT and technical characteristics

• Health problem and current use of the HT• Clinical effectiveness• Safety aspects• Ethical, organizational, social and legal

aspects• Cost and economic evaluation (societal

and hospital point of view)

• Health problem and current use of the HT• Clinical effectiveness• Safety aspects• Organizational aspects• Political and strategic aspects• Cost and economic evaluation (hospital

point of view)

Perspective of the health economic assessment section

Cost-effectiveness with a societal perspective and using average costs

Differential cost analysis process, budget impact analysis, cost-effectiveness using hospital perspective (i.e. actual costs for hospital)

Primary target audience of the assessment

Policy-makers, healthcare payers Hospital and clinical managers

Type of decision which HTA assessment is going to support

Payment, coverage, reimbursementAcquisition/investment, strategic alliances, collaborative public-private research, disinvestment

Relevant stakeholders involvedHealthcare payers, representatives of clinicians, patients

Clinician asking for the HT, manager, nurses$, bioengineers$, planners$

Follow-up process Hardly ever Seldom

HTA reportFull HTA review, more frequently rapid reviews

Hospital HTA (e.g. using mini-HTA, rapid review, full HTA review)

Timescale of assessment 12-24 months 1-6 months (average = 3)

Performance of the assessment

Most frequently:• Scientists at national or regional HTA

agency • University scientists commissioned for the

purpose

Most frequently:• Scientists at HB-HTA unit• Clinicians trained in HTA assisted by

scientists at HB-HTA unit• Scientists at national or regional HTA

agency working for the hospital• Clinicians trained in HTA assisted by

university scientists

Initiators of the assessment Policy makers, healthcare payers Clinicians



Characteristics National or regional agency Hospital

Leadership & Strategy & Partnerships

Leaders Civil servants or contracted by the national or regional agency, with different levels of experience and training

Fully or partly dedicated professionals contracted by the hospital, mostly trained in HTA and with long experience

Mission, vision and values Providing high-quality evidence to inform decision-making by national health services

Managerial support for decision-making, assessing health technologies for clinical practice

Priority setting of HTs to evaluateEstablished by policy makers or healthcare payers at national (ministry of health) or regional level

Established by clinical leaders and hospital managers

Partnerships and networksFormal partners of established networks from national or regional HTA agencies and international organizations

Informal contacts between hospitals at local, regional, national and/or international level

Resources

Financing• Mainly by government (national or

regional)

• Mainly by external sources (e.g. competitive grants, contracts with other organizations)

• Rarely by internal sources (from the hospital’s budget)

Profiles and skills (more frequent)

• Medical doctors• Epidemiologists• Economists, statisticians• Social workers, ethicists

• Medical doctors• Epidemiologists, public health

specialists• Economists

Results & Impact

Capacity of local adaptationLimited (high degree of adaptation to local needs required)

Frequently total

Impact measurement (benefits / outcomes to end-users)

• Usually end-point outcomes (health & social impact); require significant funds

• Costly and difficult to prove direct cause-effect relationship

• Usually end-point outcomes (health & social impact); require significant funds


• Usually intermediate outcomes (e.g. satisfaction with the HB-HTA unit and its assessments, net present savings or avoided loss from adopting/not adopting HTs). Impact measurement for specific, recommended HTs


Customers’ resultsLevel of use and adoption of recommendations

Level of use and adoption by hospital managers and clinicians (usefulness in decision-making, satisfaction with HB-HTA function)

Impact on society Difficult to assess Difficult to assess

Source: Sampietro-Colom L., et al 2015. The AdHopHTA handbook: a handbook of hospital-based Health Technology Assessment (HB-HTA): Pages 24-25.

* In EU countries, there are pharmacy committees in hospitals responsible for analysing drugs due for introduction into hospitals; hospitals usually focus on other technologies, although this may vary from country to country.

$ If needed according to type of HT being assessed.

Table 3. Most frequent characteristics of an HB-HTA function

Characteristics of HB-HTA Micro-trends in organization and performance of HB-HTA units

Mission (how it is defined by the HB-HTA unit)

a) Managerial support for decision-making (in this case, the hospital management body is committed to taking the assessment results into consideration in its decision-making process)

b) Assessing health technologies (in this case, there is no formal commitment to integrating assessment results in the final decision-making process)



Position in the hospital's organizational structure

a) CMO (Chief Medical Officer) (most)b) CEO c) Quality and Research Directorated) Research and Innovation Directorate

Funding source (public)

a) External (e.g. competitive grants, contract with other organizations) – most casesb) Internal (from hospital budget) (in most cases there is little funding support from the hospital budget)

Role of HB-HTA in the decision-making

a) Advisory – most casesb) Mandatory

Role after the assessment

a) None – most casesb) Procurement (acquisition) phase – few casesc) Implementation of recommendation – few cases

Background of professionals in the unit

a) Clinicians, health economists, public health – most casesb) The same as a) plus nurses, bioengineers, and other allied health professionals

Careers opportunities

a) Formal (specific plans for development) – noneb) Informal (e.g. ad-hoc conferences, courses, etc.) – most cases

Staff dedication in the HB-HTA unit

a) Part time – most casesb) Full time

Dissemination of the activities performed by HB-HTA unit

a) Internal (clinical rounds, word of mouth, information send to clinical departments, broadcast email, presentation at the hospital board meeting)

b) External (media, national journals, newsletters, websites, courses, events and conferences)

Prioritization of health technologies for assessment

a) Based on specific criteria – few casesb) First-in-first assessed – most cases

Types of assessed health technologies (in order of frequency)

a) Medical devicesb) Medical equipmentc) Diagnostic testsd) Procedures (clinical and organizational) and drugs

Assessment performance

a) By professionals in the HB-HTA unit involving closely clinicians and hospital managersb) Shared between clinicians (e.g. literature review) and the HB-HTA unit (e.g. economic analysis +

supervision of work by clinicians)c) By clinicians supported and supervised by the HTA unit

Scopea) PICO (patient, intervention, comparator, outcome) – all cases b) Type Comparator: gold standard and technology available at hospital

Recommendations included

a) Yes – most casesb) No, just results (e.g. clinical or economic) of the assessment are presented.

Role of HB-HTA in the decision-making

a) Advisory – alwaysb) Mandatory – never

Impact of recommendations on the final decision

a) High – most casesb) Low

Assurance of transparency during the assessment

a) Internal reviews – oftenb) Step–by–step, explicit (e.g. published or shown to clinician)c) External review – less frequent

System/approaches to assure independence of assessment

a) Informal – mostb) Systematic

Dissemination of the HB-HTA product/assessment

a) Internal (e.g. Intranet-database: complete assessment, abstracts or summaries of the assessment) – most cases

b) External (e.g. database open to other hospitals) – few cases

Measurement of impact of HB-HTA unit

a) None – most casesb) Non-systematic – few casesc) Systematic – never

Source: Sampietro-Colom L., et al 2015. The AdHopHTA handbook: a handbook of hospital-based Health Technology Assessment (HB-HTA): Page 63-64.



References

Sampietro-Colom L, Lach K, Cicchetti A, Kidholm K, Pasternack I, Fure B, Rosenmöller M, Wild C, Kahveci R, Wasserfallen JB, Kiivet RA, et al. 2015. The AdHopHTA handbook: a handbook of hospital-based Health Technology Assessment (HB-HTA). Public deliverable; The AdHopHTA Project (FP7/2007-13 grant agreement nr 305018). Available from: http://www.adhophta.eu/handbook.

Cicchetti A, Marchetti M, Di Bidino R, Coiro M. 2008. Hospital based health technology assessment world-wide survey. Hospital based health technology assessment Sub-Interest Group. 2008. Health Technology Assessment International (HTAi).

World Health Organization. 2014. WHO resolutions and decisions, WHA67.23. Health intervention and technology assessment in support of universal health coverage. 24th May 2014. Geneva, World Health Organization.

Sampietro-Colom, L. et al. 2016. “Guiding Principles for good practices in hospital-based health technology assessment units”. International Journal of Technology Assessment in Health Care, Volume 31, Issue 6 January 2015, pp. 457-465.

Kidholm, K. et al. 2016. “Hospital managers’ need for information in decision-making – An interview study in nine European countries”. Health Policy , Volume 119 , Issue 11 , 1424 – 1432.

Sampietro-Colom, L., Martin, J. (Eds.), 2017. Hospital-Based Health Technology Assessment: The Next Frontier for Health Technology Assessment, Springer, New York.

Halmesmäki E, Pasternack I, Roine R. 2016. “Hospital-based health technology assessment (HTA) in Finland: a case study on collaboration between hospitals and the national HTA unit”. Health Res Policy Syst. Apr 5;14:25.

Cicchetti, A., et al. 2015. “Organizational Models of Hospital Based HTA: Empirical Evidence from Adhophta European Project”. Value in Health 18.7: A560-A561.

Oelholm, Anne Mette, K. K. Kidholm, and M. Birk-Olsen. “Quality assessment of Hospital-Based HTA.” The European Journal of Public Health 25.s uppl 3: ckv172-044.

Ølholm, Anne Mette, et al. 2015. “HOSPITAL MANAGERS’NEED FOR INFORMATION ON HEALTH TECHNOLOGY INVESTMENTS.” International journal of technology assessment in health care 31.06: 414-425.

Cicchetti A., Sampietro-Colom L., Martin J., Marchetti M. 2017. “Hospital based HTA in 30 organizations world-wide: what lessons learnt?” In Sampietro L. Martin J. (Eds) Hospital-Based Health Technology Assessment: The Next Frontier for Health Technology Assessment, Springer New York.

BIOGRAPHIES

Americo Cicchetti, Ph.D. is Professor of Healthcare Management at Universita Cattolica del Sacro Cuore, Faculty of Economics, Rome. He is also Director of the Post Graduate School of Health Economics and Management. In addition, Cicchetti is a Chief of Research in the Health Technology Assessment Unit and of Biomedical Engineering at the “A. Gemelli” University Hospital. Lastly, he is Director of Health Technology Assessment International and the President of the Italian Society of Health Technology Assessment.

Kristian Kidholm, Ph.D. is Head of Research at the Center for Innovative Medical Technology, Odense University Hospital, Denmark. He is also Associate Professor in Health Economics at the University of Southern Denmark. Moreover, Kidholm is a Scientific Coordinator at the HTA-Unit at Odense University Hospital.

Laura Sampietro-Colom, MD is the Deputy Director of Innovation and Head of the Health Technology Assessment (HTA) Unit at the Hospital Clinic of Barcelona. She has over 20 years of experience in evaluative research, and during all these years, her work has focused on advising decision-makers on the designing of strategies and policies for covering health technologies.

http://www.adhophta.eu/handbook



Improving value for money invested in technologies through hospital-based health technology assessment: A Turkish example

The What is Health Technology Assessment?In health systems throughout the world, HTA plays an essential role

in supporting decision-making. HTA is a research-based, practice-oriented assessment of relevant available knowledge on both the direct and intended consequences of health technologies, as well as indirect and unintended consequences, in the short and long term (1). Health technologies include pharmaceuticals, devices, diagnostics, procedures and other clinical, public health and organizational interventions.

It is well known that new health technologies contribute significantly to the rise in health care costs, despite not always yielding high clinical outcomes. Safety is also a concern, since there is always an associated risk with any health technology (2). HTA addresses the clinical impact of health technology, including effectiveness and safety, but also economic, organizational, social, legal, and ethical impacts, considering the specific healthcare context as well as available alternatives. The scope and methods of HTA may be adapted to the needs of a particular health system, however HTA processes and methods should always be transparent, systematic and rigorous (3).

At national level, HTA might be used to inform the design of effective and efficient policies regarding the introduction and allocation of resources in a specific nation or region (2). However, at a macro level,

HTA is not always available (or available in appropriate content and recommendations) when a hospital manager needs to make a decision pertaining to the allocation of resources or introduction of technologies in the hospital’s unique context. Therefore HTA is needed at hospital level to inform local decisions on the uptake or disinvestment of health technologies.

Hospital-based Health Technology Assessment (HB-HTA)There is increasing pressure to adopt innovative and expensive

technologies due to public expectations of a better and healthier quality of life. Hospitals are the main entry point for health technologies. However, hospital managers are aware that not all innovative technologies will provide us with the best care within our budget. Therefore we need a process where decision makers are able to obtain accurate and context-based information on the value of technologies. In this way, they can adopt a rationalized decision-making process about which technologies to invest in and to maximize the value generated from each dollar the hospital spends (4). HB-HTA perfectly serves this purpose.

HB-HTA consists of the implementation of HTA activities “in” or “for” hospitals, which includes processes and methods of organising and

ABSTRACT: Ankara Numune Training and Research Hospital (ANH) has saved over 2 million Euros in three years with just two projects, simply by using Health Technology Assessment (HTA) methods and principles at hospital level. HTA is a research-based, practice-oriented assessment of relevant available knowledge on both the direct and intended consequences of health technologies as well as indirect and unintended consequences, in the short and long term. Hospital-Based HTA (HB-HTA) means performing HTA activities tailored to the hospital context, to inform managerial decisions on different types of health Technologies. HB-HTA is essential to achieving better value for money spent by the hospital, and has been adopted by many hospitals around the globe. There are available methods and tools for performing HB-HTA. ANH has been the first to invest in HTA in Turkey, with a proven impact which transcends borders. Ankara Numune Training and Research Hospital (ANH) has saved over 2 million Euros in three years with just two projects, simply by using Health Technology Assessment (HTA) methods and principles at hospital level. This has had a positive impact on the hospital management and the HTA team. The hospital sets an excellent example on how decisions pertaining to technology use can be rationalized by investing in Hospital-Based HTA (HB-HTA), which clearly facilitates the systematic use of scientific evidence to support hospital managerial decisions on technologies.

EMINE OZER KUCUK, MSC, PHDNURSE, ANKARA NUMUNE TRAINING AND RESEARCH HOSPITAL HEALTH TECHNOLOGY ASSESSMENT UNIT (ANHTA)TURKEY

ASSOC. PROF. DR. RABIA KAHVECICHAIR, ANKARA NUMUNE TRAINING AND RESEARCH HOSPITAL HEALTH TECHNOLOGY ASSESSMENT UNIT (ANHTA)TURKEY

PROF. DR. NURULLAH ZENGINCHIEF EXECUTIVE OFFICER,ANKARA NUMUNE TRAINING AND RESEARCH HOSPITALTURKEY

Improving value for money invested in technologies through hospital-based health technology assessment: A Turkish example


carrying out HTA at hospital level with a multidisciplinary, systematic and evidence-based approach. HB-HTA means performing HTA activities tailored to the hospital context to inform managerial decisions on different types of health technologies (5).

Promotion of HB-HTA at international levelHTA was first established in the USA in the 1970’s and today many

countries all over the world have national HTA structures. The umbrella society for these agencies is the International Network of Agencies for HTA (INAHTA), whereas Health Technology Assessment International (HTAi) is the reference society for all HTA-related professionals and facilities at a global level. HB-HTA has been developed since the 1990’s and today successful examples can be found in many European countries including, but not limited to, Spain, Italy, Switzerland, France, Turkey, as well as Canada, Australia and other parts of the world. AdHopHTA (Adopting Hospital Based HTA in European Union) constitutes a major scientific contribution to HB-HTA in Europe, producing a collection of information and tools for HB-HTA best practices.

Health Technology Assessment International (HTAi): The global platform for HTA

HTAi is a scientific and professional society for all stakeholders engaged in HTA. HTAi’s mission is to support and promote the development, communication, understanding and use of HTA around the world, as a scientifically based and multi-disciplinary means of informing decision-making regarding the use of effective technologies and efficient use of resources in health care. HTAi has 82 organizational members and over 2500 individual members from 65 countries. The HTAi Interest Group on HB-HTA was established in 2006 to provide an area for members of HTAi who are developers and users of HTA in hospital settings, to share information, insights, and work on collaborative projects. HTAi holds an annual meetings each year, hosts a global policy forum as well as regional forums in Asia and Latin America, encouraging members to reflect on emerging HTA topics under interest groups. The society also has an official journal “International Journal of Technology Assessment in Health Care (IJTAHC)” (6).

AdHopHTA: a European Project on Hospital Based Health Technology Assessment

AdHopHTA, Adopting Hospital Based HTA in European Union (EU), is an EU-funded research Project (2012-2015). AdHopHTA aimed to strengthen the availability and impact of sound HTA results in hospital settings. The Project concluded with three products for improving the practice of hospital-based HTA, three pragmatic knowledge and implementation tools: Handbook, Toolkit and Database (7).

The aim of the AdHopHTA Handbook is to provide information and knowledge for decision-making for technology management at hospital level, through the implementation and use of HB-HTA. The AdHopHTA Toolkit provides practical guidance on setting up and effectively running an HB-HTA unit. The toolkit provides both answers to frequently asked questions and tools for practically developing an HB-HTA unit and carrying out the assessment of new health technologies. The AdHopHTA Database includes all assessments performed by 8 HB-HTA units and is intended to be the seed for an expanded database which will include the work of more HB-HTA units in Europe.

The AdHopHTA consortium brought together the expertise of ten

partners from nine countries: Spain, Denmark, Switzerland, Finland, Estonia, Italy, Austria, Turkey and Norway. ANH participation in the project has been an excellent experience, an invaluable opportunity to contribute to HB-HTA promotion in Europe, learn about experiences from other hospitals in Europe and transfer this knowledge to the Turkish context, but most importantly, to be involved in a consortium that has developed the most extensive HB-HTA resource set at a global level. The Project has also provided an empirically founded set of principles for best practice in hospital-based HTA (8).

ANHTA: Ankara Numune Training and Research Hospital Health Technology Assessment Unit

ANH has been in service since 1881. It is considered as the reference hospital in Turkey with a mission to provide high qualified health care services to individuals, with experienced teams and necessary modern technologies. ANH has a 1200 bed capacity and almost 5000 staff members: of which 1000 physicians. With its high technology use, reference hospital status, modern equipment and highly qualified health care staff, ANH has an excellent reputation in Turkey and considerable influence on medical practice and health policy.

ANHTA was established in February 2012 and is the first HB-HTA unit in Turkey. ANH launched HB-HTA programme as a part of the hospital strategy of moving towards higher levels of quality in healthcare provision. Although some other hospitals have also been interested in related concepts, to date there is no evidence for multidisciplinary and structured progress as required for HTA. ANHTA unit is tasked with evaluating technologies prioritized and assigned to the unit by the CEO in medical, economic, ethical, legal, social and organizational aspects, and submitting reports to management. The unit aims to support hospital managers in evidence-based investment or disinvestment decisions regarding health technology use in the hospital. From the start, we decided to run our assessments under three sub-headings: investment, disinvestment and rationalization of use of existing technologies.

Although we started with a small group of professionals, over time human resources involvement was bolstered. Currently we have two full-time physicians, two full time nurses with PhD degrees, two part time physicians and a part time economist/administrator. The staff is supported by continuous training on HTA methods. HTA unit members are selected from the hospital staff with a background in evidence-based medicine and HTA-related fields, and who have an interest in improving efficiency in the hospital.

To date we have published almost 50 publications, including 2 books, 7 HTA reports, 5 activity reports, 8 book chapters, 7 articles and 20 abstracts in conferences. The team has organized two international conferences and two national conferences, in addition to several training sessions involving academics, government staff and industry members. We were a partner of the AdHopHTA Project and an organizational member of HTAi. We have guided many hospitals in the country on HB-HTA. The initial achievement in ANHTA was the publication of guidance on HB-HTA, where the reader can find the definition, aims and information on the place in management of HTA and HB-HTA. The same guidance also involves “ANHTA mini-HTA”, which was developed after extensive work based on adaptation of examples of Spain and Denmark within the Turkish context. This guide has been prepared to help those who will conduct new HTAs.

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Impact of ANHTAWe assessed the impact of our initial projects. The first two projects

helped to rationalise drug and laboratory use in the hospital, resulting in a saving of 2,242,464 Euros over three years. Both projects also helped hospitals to focus on the “correct use of current technologies”. The Bone Bank project was our first HTA for investment purposes and was a pilot to improve Turkish version of mini-HTA. We recommended against investment and specifically it was established that if implemented, the Bone Bank would have generated a loss of 104,221 Euros over the next ten years.

ANHTA projects have increased awareness and promoted evidence-informed decision-making in the hospital, involved relevant clinicians in the process, thus bolstering acceptability of the management decisions by clinics, enabled the improvement of multi-disciplinary work in the hospital, helped close the gap between managers and clinicians, facilitated understanding of the local facts and reinforced HTA culture in the hospital.

The reports were recommended for use in other hospitals and the impact has transcended ANH. The amount of savings was recognized by the main reimbursement organization in Turkey (SGK) as well as the Ministry of Health. Many hospitals have contacted ANHTA to request training and more information on HTA methods.

What is next? ANHTA is recognized by the hospital administration as a function

producing timely assessments, using transparent methodology. Over time the methods used, impact, appreciation received from the managers and clinicians, as well as career opportunities have all bolstered ANHTA team motivation. Success is evident in terms of impact at hospital as well as national level. This opens the door for collaborations with other hospitals elsewhere.

HB-HTA is essential to achieving better value for the money spent by the hospital, and managers worldwide are increasingly aware of this. Demand for HB-HTA is likely to increase as fiscal restraints tighten, health technology options multiply, and patients’ expectations continue to rise (9). Given that it is not possible to invest in everything, we have to make choices and HTA can help us prioritize investment areas.

ANHTA, has several advantages as a training and research hospital. We believe there is a huge potential for us to apply our knowledge and skills on HTA to work together with our clinicians to innovate technologies and enhance successful technology transfer. The HTA process might inform us on knowledge gaps that could become potential research areas. ANHTA can shape the research agenda and improve knowledge translation, while identifying potential topics to be covered by researchers and residents. As a reference hospital with a high technology demand, we have the opportunity to align our activities with procurement processes. This could strategically improve our outcomes if we invest in HTA-informed procurement to ensure the technologies chosen for procurement represent the best value for money.

We need to benefit from the experience of other, locally or internationally. We are also keen to help others to develop their capacity and understand the real-life application of methods and potential impact of HTA on hospitals.

HB-HTA will also face challenges in the future. The pace for technology introductions will be high and HTA team will need to make timely recommendations. We will need to improve our capacity and methods as well as our skills and resources, in order to keep up with

developments in the field of evidence-based medicine, introduced technologies, changes in public expectations, resources and pressures faced by our manager. This new era will require a greater degree of engagement with stakeholders, whether decision makers, industry or patients.

In any case, HB-HTA is here to stay, helping us to make rational investment decisions. We need to find ways to understand and invest in developing HTA in our hospitals.

BIOGRAPHIES

Assoc. Prof. Dr. Rabia Kahveci is the founding and current Chair of Ankara Numune Training and Research Hospital Health Technology Assessment Unit (ANHTA). She is also the Board Director of HTAi, Chair of HTAi Developing Countries Interest Group and Chair of Eurasian HTA Initiative.

Emine Özer works as MSc, PhD is a nurse in Ankara Numune Training and Research Hospital Health Technology Assessment Unit (ANHTA) since 2012.

Prof. Dr. Nurullah Zengin is the Chief Executive Officer of Ankara Numune Training and Research Hospital and is a medical oncologist by background.

References1. HTA Glossary (2014) Health Technology Assessment International

(HTAi). Available from: http://htaglossary.net. Accessed 6th March 2017

2. Sampietro-Colom L, Martin J. Hospital Based Health Technology Assessment: The next frontier. In: Sampietro-Colom L, Martin J (editors). Hospital Based Health Technology Assessment: The next frontier for health technology assessment. pp. 3-11. Springer International Publishing Switzerland 2016. ISBN 978-3-319-39203-5

3. http://www.htai.org/htai/what-is-hta.html Accessed 6th March 2017

4. Craig AU, Kendall W, Brennan PJ (2010) Hospital-based comparative effectiveness centers: translating research into practice to improve the quality, safety, and value of patient care. J Gen Intern Med 25(12):1352–1355

5. Sampietro-Colom L, Lach K, Cicchetti A, Kidholm K, Pasternack I, Fure B, Rosenmoller M, Wild C, Kahveci R, Wasserfallen JB, Kiivet RA, et al. The AdHopHTA Handbook: a handbook of Hospital Based Health Technology Asssessment (HB-HTA); Public deliverable; The AdHopHTA Project (FP7/2007-13 grant agreement nr 305018); 2015. Available from http://www.adhophta.eu/handbook

6. www.htai.org Accessed 6th march 2017

7. www.adhophta.eu Accessed 6th march 2017

8. Sampietro-Colom L, Lach K, Pasternack I, Wasserfallen JB, Cicchetti A, Marchetti M, Kidholm K, Arentz-Hansen H, Rosenmoller M, Wild C, Kahveci R, Margus Ulst. Guiding Principles For Good Practices In Hospital-Based Health Technology Assessment Units. International Journal of Technology Assessment in Health Care, 31:6 (2015), 457–465.

9. Martin J, Sampietro-Colom L. Looking to the Future of Hospital-Based HTA: The next frontier. In: Sampietro-Colom L, Martin J (editors). Hospital Based Health Technology Assessment: The next frontier for health technology assessment. pp. 387-397. Springer International Publishing Switzerland 2016. ISBN 978-3-319-39203-5

http://htaglossary.net

http://www.htai.org/htai/what-is-hta.html



http://www.htai.org


Health Technology Assessment in the Hospital Authority of Hong Kong – to support doctors, protect patients, and enhance accountability to the public



Introduction. Modern healthcare is technology-laden. While technology advancement has resulted in previously unimaginable health gains, it has become increasingly complex, with inherent risks. The Hospital Authority (HA) of Hong Kong heralds quality and safety as top priorities in the planning and running of its patient-centered services. It is important to balance the risks and benefits of introducing new procedures/technologies, while continuing to modernize HA to improve the quality of patient care.

HA is a statutory body responsible for managing Hong Kong’s public hospitals services since December 1991. As of March 2017, there are 42 public hospitals and institutions, 47 Specialist Out-patient Clinics, and 73 General Out-patient Clinics in HA, organized into seven hospital clusters according to geographic distribution.

A robust health technology assessment (HTA) mechanism,

the Hospital Authority Mechanism for the Safe Introduction of New Procedures/Technology (HAMSINP) was set up in HA in 2001 to support evidence-based decision-making in the adoption of new health technology. HTA in HA does not directly link to budget allocation or reimbursement. The proposition of an explicit peer review process aims to support doctors, protect patients, and enhance HA accountability to the public.

Health Technology Assessment Rapid developments in medical research have resulted in

the proliferation of new health technology. HTA is a systematic evaluation of the properties, effects and/or impacts of health technology, which can be applied to clinical procedures and interventions, medical equipment, medical devices, diagnostics, pharmaceuticals, and other public health and

ABSTRACT: The management of emerging technology and new interventions by means of explicit reviews is a global trend in healthcare organizations. Health technology assessment (HTA) acts as a “bridge” between evidence and policy making, providing the Hospital Authority (HA) of Hong Kong with accessible, usable and evidence-based information to guide decision-making about the appropriate use of technology and rational allocation of resources. A robust HTA mechanism has been set up in HA aiming to ensure patient safety through rigorous peer reviews of safety and efficacy data on new interventional procedures/technology introduced within the HA service. An evidence-based and risk-stratified approach is adopted to address the issues of safety and efficacy. It is important to balance the risks and benefits of introducing new procedures/technology, while continuing to modernize HA to improve the quality of patient care.The HTA process is transparent and key stakeholders are engaged in the assessment process and implementation, with a view to achieving synergies through sharing knowledge and experience across clinical specialties and hospitals. Moreover, in order to ensure the competence of professional staff, keep up with technological change in HA, enhance patient safety and follow the requirements of the Australian Council on Healthcare Standards on hospital accreditation, HA has also established a framework for credentialing and defining scope of practice. Quality assurance activities will be conducted continuously and regularly.

DR SHAO-HAEI LIU DEPUTIZING DIRECTOR (QUALITY AND SAFETY), QUALITY AND SAFETY DIVISION, HOSPITAL AUTHORITY, HONG KONG SPECIAL ADMINISTRATIVE REGION, CHINA

15



organizational interventions. The scope and methods of HTA may be adapted to the needs of a particular health system, but in all cases HTA processes and methods should be transparent, systematic and rigorous.

As for other health systems throughout the world, HTA acts as a “bridge” between evidence and policy making and plays an essential role in supporting HA with accessible, usable and evidence-based information to guide decision making about the appropriate use of technology and rational allocation of resources.

HA establishes the Central Technology Office (CTO) under the Quality and Safety Division at HA Head Office (HAHO) to coordinate and align cross-departmental issues concerning new interventional procedures and health technology management using a risk-stratified approach. A mechanism is in place to review the safety and efficacy of new procedures and technologies before introduction to the HA service, to ensure that they are safe and better than, or equal to, the existing practice.

Risk AssessmentHA implemented HAMSINP with the aim of ensuring

patient safety through rigorous peer reviews of safety and efficacy data on new interventional procedures/technology introduced to the HA service. An evidence-based and risk-stratified approach is adopted to address the issues of safety and efficacy. Factors to be taken into consideration include the adequacy of evidence, safety concerns, practicability and implementation issues, such as inclusion and exclusion criteria for patient selection, the availability of expertise, training and credentialing requirements, readiness in devising informed consent forms and implications for other departments. Reference is also made to the current development status in overseas countries, such as recommendations and guidelines issued by their expert committees or licensing registration authorities. In addition, HA solicits input from external consultants to better understand overseas trend and practices if needed.

The level of HTA corresponds to risk implication and the extent of deviation from existing practice or technology used. For new health technology and procedures that are new to HA and of significant risk, a review group consisting of a panel of experts from different specialty backgrounds is be formed to conduct the HTA. For the introduction of new health technology and procedures representing significant change compared to existing practice, or with unknown or potentially significant risk implications , expedited HTA reviews is performed.

Stakeholder Engagement – CliniciansProfessional deliberations and reviews on new and

debatable medical technology will enhance transparency and the improved management of the introduction of new clinical practices and technology within the HA system. Clinicians contribute by providing evidence about their experiences and preferences and direct participation in the assessment process. Clinical governance is the system and

collective measures through which healthcare organizations are accountable for continuously assuring and improving the quality and standards of their services. In this respect, HA has established a clinical governance structure under which clinical specialty leaders form Coordinating Committees (COCs) identify and address clinical risks.

When assessing risk implication, it is important to compare the new health technology and procedure to the existing practice in HA. In categorizing the risk associated with incremental changes, COCs have to exercise clinical judgment over factors such as the degree of technology invasiveness, the nature and extent of deviation from existing practice and approach, degree of uncertainty and potential hazards, volume and quality of evidence available, as well as local experience, etc..

A procedure which has become established for treating one condition may be adopted for another. Sometimes, the likelihood of similar benefits and risks seems obvious, but frequently that is not the case. Examples include the use of ablative procedures for different types of conditions in different parts of the body—for example high intensity focused ultrasound (HIFU). Full reviews involving a panel of multi-specialties expert review group were conducted for HIFU for uterine fibroids, a benign condition. Apart from assessing the adequacy of evidence and procedure classification, the review group also helped generate recommendations for the implementation of this procedure in HA. On the other hand, expedited reviews were conducted by clinical experts of the relevant COC for the introduction of HIFU for advanced renal tumors in which effective and curable treatment is limited.

Engagement of the COCs in sharing local experience of using new and evolving health technology amongst peers can speed up the learning curve of clinicians involved. When necessary, outcome monitoring through conducting clinical audits or reviews and evaluation by COCs is recommended. This is also important in supporting deliberation on further adoption in HA.

Moreover, HAMSINP is a multi-disciplinary process. HA will continue engaging and empowering more COCs to form technology advisory groups entrusted with conducting expedited HTA reviews. To this end, standardized tools and forms have been developed by HAHO to facilitate the review process.

Stakeholder Engagement – at Hospital and Cluster LevelTo build a culture that supports the capturing and sharing

of knowledge and to enhance transparency and equity access, HAHO disseminates completed HTA reviews to all hospitals through their clusters’ dedicated healthcare technology management governance structure. These platforms provide an oversight on the introduction of new health technology and procedures in respective clusters through conducting peer reviews, matching credentialing requirements, and carrying out follow-up reviews.

ImplementationRecommendations are made to ensure safe implementation

16



of a new procedure. The most frequent recommendations made regard patient selection, who should do the procedure, consent (provide patients with explicit information about the known and uncertain risks and benefits of the procedure) and the need to audit the outcomes. For specific high-risk procedures, submission of clinical data on all patients undergoing the procedure to a registry is recommended over a period of time.

Moreover, CTO involves stakeholders in key parts of health technology assessment and implementation, aiming to achieve synergies through sharing knowledge and experience across clinical specialties and hospitals. Tertiary or teaching hospitals in particular, may have unique contexts and priorities for specialized services. Common benchmarking criteria should be developed and adopted to rationalize competing needs across hospitals, clusters and major service lines. The technology positioning between different types of hospitals and within a cluster should be appropriately delineated as the basis for identifying and quantifying the largest gaps between desired and actual technology adoption at cluster and hospital levels. This is to maintain the overall standard of care across HA and to minimize variations between hospitals and clusters while addressing their diversified needs.

HA is establishing a mechanism for the development of highly specialized services and advanced technology among hospital clusters for uniform and consistent service provision, equity and even training opportunities.

CredentialingTo ensure professional staff keep up with technological

change in HA and enhance patient safety, and to follow the requirements of the Australian Council on Healthcare Standards on hospital accreditation, the Department of Quality and Standards at HAHO has also established a framework of credentialing and defining scope of practice.

The system was an activity credentialing selective and risk-based opportunities. The criteria to fulfill the scope of practice for the particular activity is set by the respective specialty or discipline, according to which standards and requirements for training, facilities and support will be defined. For each procedure or activity to be credentialed, criteria are based on the qualifications, relevant experience as well as competence and performance of healthcare professionals. A two-tier governance structure of Central and Cluster Credentialing Committees has been established, which defines the two levels of credentialing activities in HA and clusters along with the development of a vetting mechanism of HA credentialing activities.

Furthermore, clinical management teams will continue to conduct quality assurance activities regularly, such as mortality and morbidity meetings and clinical audits, to ensure that investigation and intervention, if needed, are conducted appropriately in timely manner.

ConclusionModern healthcare is under increasing pressure to keep

up with rapid advancements in technology. It is important for HA to ensure patient safety and balance the risks and benefits inherent to the introduction of new health technologies and procedures, while continuing to modernize HA to improve the quality of patient care.

A HTA mechanism adopting evidence-based and risk-stratified approach has been established in HA for the introduction, dissemination, maintenance and evaluation for safety and further adoption. The HTA process is transparent and key stakeholders are engaged in the process.

AnnexThe procedure flow for a HAMSINP full review is illustrated

at annex.

BIOGRAPHIE

Dr Liu was the Medical Superintendent of Tuen Mun Hospital from 1990 - 1992 and commissioned the regional hospital. In 1993 - 1995, he was the Chief Executive of Ruttonjee Hospital for the implementation of new management initiatives. He is a senior executive manager at the Hospital Authority Head Office, with exterior experience in various coordinating senior improvement programs. His portfolio includes Accident & Emergency Service, Intensive Care Service, Trauma Centers, Isolation Facilities, Major Incident Control Center, Toxicology and Critical Incident Psychology Service. He is now the Deputizing Director of Quality and Safety, overseeing standards, patient safety, incidents reporting and technology development.

AcknowledgementThe author thanks Dr Rebecca Lam, Chief Manager

(Clinical Effectiveness and Technology Management), Quality and Safety Division of HA, and Dr Wing Yee So, Chief Manager (Quality and Standards), Quality and Safety Division of HA, for their contributions in this article.

17

ReferencesAustralian Council on Healthcare Standards. Available from: http://www.achs.org.au/

Hospital Authority, Hong Kong. Available from: http://www.ha.org.hk

Royal Australasian College of Surgeons. Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S). Available from: http://www.surgeons.org/for-health-professionals/audits-and-surgical-research/asernip-s

World Health Organization. Health technology assessment. Available from: http://www.who.int/medical_devices/assessment/en/

http://www.achs.org.au/

http://www.ha.org.hk

http://www.ha.org.hk

http://www.surgeons.org/for-health-professionals/audits-and-surgical-research/asernip-s



http://www.who.int/medical_devices/assessment/en/

http://www.who.int/medical_devices/assessment/en/



Hospital-Based Health Technology Assessment: Experience in an Italian University Hospital

Introduction.Health Technology Assessment (HTA) is a multidisciplinary

field of research which evaluates and summarizes data on clinical, economic, organizational, social and ethical issues related to the use of health technologies (HTs) in a systematic, transparent, unbiased, and robust manner [1]. The aim of HTA is to support decision-makers in health care systems by providing explicit evidence-based information correlated to a specific context, to ultimately achieve the appropriate utilization of HTs and an efficient allocation of resources.

HTA originally targeted the macro level, i.e., national and other levels of health care decision-making in decentralized health care systems. HTA performed locally for the support of managerial decisions within specific health care institutions (meso level) is known as Hospital-based HTA (HB-HTA) [2], a tool that has gained recognition as a method for informing decisions regarding acquisition, implementation or the discontinuation of HTs [3].

Few Italian hospitals perform HB-HTA in Italy. One of the first to adopt HB-HTA was the Fondazione Policlinico Universitario ‘Agostino Gemelli’ in Rome, a private teaching hospital that established an HTA Unit in 2001[4]. This paper synthesizes the Gemelli Teaching Hospital’s experience with the implementation

of HB-HTA.

BackgroundThe Italian National Health System (NHS) is a public

health care system funded primarily by taxes which provides universal coverage and comprehensive health care. Regions and Autonomous Provinces are responsible for the delivery of health services through a network of health care management organizations (local health units), along with public and private accredited health care providers. The latter are reimbursed for health services provided (through DRG –diagnosis related groups– system for inpatients, and reimbursement tariffs for outpatient procedures) [5]. Additionally, in order to meet public health objectives, the National Outcomes Program (Piano Nazionale Esiti [6]) was established in 2005 by the Italian National Agency for Regional Health Services (AGENAS) and the Ministry of Health to serve as an auditing instrument utilizing indicators on outcomes, processes and volumes in various clinical areas which can be employed by each Region to manage resources while promoting quality, appropriateness and equity.

NHS drug coverage decisions depend on the National Government through the Italian Medicines Agency (AIFA), while,

ABSTRACT:The main purpose of the Health Technology Assessment and Innovation Unit of the Gemelli Teaching Hospital is to advise directives in decision-making processes concerning the introduction and disinvestment of health technologies, and ultimately ensure that these are appropriately selected and used. This paper synthesizes the experience of this Rome-based University Hospital with the implementation of Hospital-Based Health Technology Assessment.

AMERICO CICCHETTIDIRECTOR, GRADUATE SCHOOL OF HEALTH ECONOMICS AND MANAGEMENTUNIVERSITÀ CATTOLICA DEL SACRO CUORE, ITALY

MARCO MARCHETTIDIRECTOR, ITALIAN NATIONAL CENTER FOR HEALTH TECHNOLOGY ASSESSMENTNATIONAL INSTITUTE OF HEALTH (ISS), ITALY

IRENE URBINAHEALTH TECHNOLOGY ASSESSMENT ANALYST AND RESEARCHERHEALTH TECHNOLOGY ASSESSMENT AND INNOVATION UNITFONDAZIONE POLICLINICO UNIVERSITARIO ‘AGOSTINO GEMELLI’, ITALY



at the hospital level, Drug and Therapeutics Committees (DTCs) select those medications that shall be added to each hospital drug formulary (HDF).

On the other hand, hospitals are able to make their own investment decisions regarding medical devices; however, consultation with the public payer (i.e., the regional government) is required when considering the acquisition of high cost capital equipment requiring extra public funds or when applying specific regulations.

The Gemelli Teaching Hospital is a highly complex private health care institution located in Rome, Italy, with a 1,547 bed capacity. The hospital, in operation since 1968, is affiliated to the Universita Cattolica del Sacro Cuore (the largest private university in Italy), and serves the Italian NHS.

StructureThe HTA Unit, now called the HTA and Innovation Unit

(Unita di Valutazione delle Tecnologie e Innovazione-UVT), was formally established at the Gemelli Teaching Hospital in the year 2001 to support informed decision-making in the selection of technologies at hospital level. Currently, the Unit is positioned in the hospital organizational chart under the Clinical Governance Directorate [Fig 1].

The main purpose of the UVT is to advise hospital directives in the decision-making processes, with reference to the introduction and disinvestment of health technologies, and ultimately to ensure that these are appropriately selected and used.

The multidisciplinary staff of the UVT includes a medical doctor specialized in public health (executive director of the Unit), a biomedical engineer (executive), two health economists, a health

economist specialized in biostatistics, and a clinician trained in HTA. The Unit’s scientific direction is in charge of the director of the Graduate School of Health Economics and Management (ALTEMS), a faculty of the Universita Cattolica del Sacro Cuore. Other academic staff and researchers from ALTEMS and from the Ethics Department of the University participate in selected projects led by the UVT.

The organizational model of the UVT can be categorized as “stand-alone”, i.e., a “unit with usually highly formalized and specialized procedures, acting internally within hospitals and not strongly influenced by national or regional HTA organizations (currently the most frequent model in Europe)” [7,8].

ActivitiesHealth Technology Appraisal and managerial support for decision-making

In the Gemelli University Hospital, the UVT appraises technologies such as pharmaceuticals, medical devices, biomedical technologies, diagnostic tests and organizational procedures. The appraisal process for each category of technologies has been formalized in internal procedures comprising all dimensions of HTA and involving several Units of the hospital.

The Unit receives requests for the introduction of a new technology directly submitted by clinicians. Prioritization criteria assessment include the order of receipt of requests, the relevance of the health care process into which the HT would be introduced, the expected amount of work needed for each evaluation, and the proportion of assessments requested by each clinical department. Upon receiving a request and in cooperation with other hospital Units (Hospital Pharmacy, Purchasing and Logistics Department, Management and Controlling Unit, Hospital Technical Services Department, etc.), the UVT conducts a rapid technology appraisal, taking into account published clinical evidence

and economic analysis, clinicians’ inputs, and internal data on comparators in use in the hospital.

The principal products of the UVT are rapid HTA reports developed using a systematic methodology containing all HTA dimensions, although ethical, legal, and social dimensions are included only when required. These reports serve as a tool for different administrative procedures, including purchasing, and can support dialogues between clinicians and the administration,

Fig. 1: gemelli HoSpital organizational cHart (not extenSive)



increasing transparency and consistency. Such documents contain the following sections:

❙ research/management question ❙ technical description of the health technology and

current use ❙ legal requirements and regulatory approval status ❙ review of clinical evidence ❙ review of alternative devices/therapies available ❙ economic and organizational impact analysis ❙ conclusions and recommendationsResults of the HTA process are presented on a monthly basis

to the hospital DTC (Commissione per la Farmacoterapia e i Dispostivi Medici - COFT-DM), which discusses and decides on the matter at hand, based on the presentation and the analysis of clinical needs and budget constraints.

The disclosure of the unit’s HTA reports is mostly limited to interested stakeholders. Some of these documents are shared with the HTA community through journals, courses, events, conferences, and the AdHopHTA database of HB-HTA reports [9] [see section International Collaboration below].

Additional projects in which the UVT takes part include, among others, internal guidelines for the appropriate use of new drugs (e.g. biosimilar drugs), assessment of drugs of the same class (e.g. new oral anticoagulants) to enhance appropriateness and to optimize the HDF, and new drugs expenditure monitoring.

Health Technology ManagementThe UVT also collaborates with other hospital units, such

as Purchases and Logistics and the Technical Office [Fig 1], in the performance of the following HT management (HTM) activities: needs assessment of medical devices, medical device procurement (acquisition), medical equipment inventory management, medical equipment maintenance, supervision of external service providers, user training, etc.

Recently, the Unit led the project for the reorganization of the hospital’s core clinical laboratory, coordinating all steps of the process, from tendering to user training.

Research and trainingIn collaboration with ALTEMS, the UVT also conducts research

projects and training activities in specific areas of interest, which have resulted in collaborations with national and international agencies and institutions.

National collaborationThe UVT of the Gemelli Hospital has been collaborating with

other hospitals in the Lazio region and with the regional HTA Agency (ASP Lazio) since 2009, and its successor, the regional HTA unit, since 2013; it also has a longstanding collaboration with the Italian Medicines Agency (AIFA). Recently the Unit produced a handbook on HB-HTA distributed nationally [10], in collaboration with the National Society of Hospital Pharmacy (SIFO).

The Unit participates in the Italian Health Policy Forum since 2010, formally linked to the Policy Forum established at Health Technology Assessment International (HTAi). The UVT staff are

also involved in national projects and collaborations, among which the Italian HTA Society (SIHTA) and the Italian Health Policy Forum, linked to the Policy Forum established at Health Technology Assessment International (HTAi).

International collaborationThe UVT is a member of the European Network for HTA

EUnetHTA, and the international networks HTAi and INAHTA. The executive director and the scientific director of the UVT co-chair the HB-HTA Interest Subgroup of HTAi.

The UVT also participated in the AdHopHTA project [8], a EU funded initiative that developed three products for improving the practice of HB-HTA: a database of HB-HTA reports, a handbook, and a toolkit for setting-up and running a HB-HTA Unit. UVT has been also a co-founder of the Ulysses Program (International Master’s Program in Health Technology Assessment and Management).

ImpactTo illustrate the impact of the activities of the UVTI, the

productivity of the UVT for 2016 as well as the results of the ultimate decision made by the CMO, based on the Unit’s analysis, are presented in Figure 2; during this year, 33 drugs and 44 medical devices were evaluated.

In the same year, HTM activities led by the UVT enabled the proper allocation of a budget of 13.3 million Euros for the acquisition of biomedical and surgical instruments, after receiving acquisition requests of over 40 million Euros.

ConclusionIn the case of the Italian NHS, economic constraints, the

increasing impact of payment by health outcome performance, and established competition between health care institutions determine growing economic and social pressures to offer the best possible services while managing a limited budget. Decentralization of HTA activities responds to this issue, as the HB-HTA approach allows transparent, unbiased, evidence-informed and consistent decision-making processes on the foundations of evidence-based medicine with outputs tailored to the specific hospital context.

The success of the HTA and Innovation Unit can be attributed to: hospital administration’s strong commitment, the use of robust and transparent methodologies, the integration of the HTA process in the operational line, and timeliness.

Potential opportunities for optimizing the operation of the

Fig. 2: Summary oF deciSionS made by tHe coFt-dm in 2016



Unit could arise with further collaboration with other HB-HTA Units and HTA organizations at regional or national level, in the context of an integrated HTA ecosystem [8]. The creation of such a network would result in: i) improved integration of HTA activities with health care national and regional health planning; and ii) reduced duplication of work, as well as the optimization of activities performed within each institution. In fact, HTA documents could be shared, and HB-HTA Units could act more as users and less as doers, applying common evidence to each particular context. Such an effort could potentially enhance patient safety, equity in access to HTs, innovation and clinical research [11].

BIOGRAPHIES

Marco Marchetti, MD is the Director of the National Center for HTA of the Italian National Institute of Health (ISS) since January 2017. From 2001, he was the Director of the HTA and Innovation Unit of the Fondazione Policlinico Universitario ‘Agostino Gemelli’ and European Director of the International Master Program in HTA and Management (Ulysses Program). He also co-chairs the HB-HTA Interest Subgroups of HTAi. He has published more than 150 papers on HTA.

Prof. Americo Cicchetti is a Professor of Management at the Catholic University of the Sacred Heart, Faculty of Economics. He is the scientific director of the HTA and Innovation Unit of the Fondazione Policlinico Universitario ‘Agostino Gemelli’, Director of the Masters Program in Health Care Management at the Catholic University, and member of the Scientific Committee of the International Masters Program in Health Technology Assessment and Management (Ulysses Program). He is currently the President and founder of the Italian Society of HTA and Executive Director of Health Technology Assessment International.

Irene Urbina, DMD MSc is currently a researcher and analyst at the HTA and Innovation Unit of the Fondazione Policlinico Universitario ‘Agostino Gemelli’. Her research interests include evidence-based practice, HTA, evidence-informed health policy and global health.

Other authors:

Lorenzo Leogrande, Executive of the Clinical Engineer at the Health Technology Assessment and Innovation Unit, Fondazione Policlinico Universitario ‘Agostino Gemelli’, Rome, Italy. President of the Italian Association of Clinical Engineers (AIIC).

Marco Oradei, Health Economist at the Health Technology Assessment and Innovation Unit, Fondazione Policlinico Universitario ‘Agostino Gemelli’, Rome, Italy.

Rossella Di Bidino, Health Economist and Statistician at the Health Technology Assessment and Innovation Unit, Fondazione Policlinico Universitario ‘Agostino Gemelli’, Rome, Italy.

Carmen Furno, Health Economist at the Health Technology Assessment and Innovation Unit, Fondazione Policlinico Universitario ‘Agostino Gemelli’, Rome, Italy.

Pierluigi Granone, Chief Clinical Governance Officer, Fondazione Policlinico Universitario ‘Agostino Gemelli’, Rome, Italy.

Andrea Cambieri, Chief Medical Officer, Fondazione Policlinico Universitario ‘Agostino Gemelli’, Rome, Italy.

References1. European Network for Health Technology Assessment

(EUnetHTA). http://www.eunethta.net/. Accessed on 02/2017.

2. Sampietro-Colom L, Martin J. 2016. “Hospital-Based Health Technology Assessment: The Next Frontier.” In Hospital-Based Health Technology Assessment: The Next Frontier, ed. Sampietro-Colom L, Martin J, 3-11. Springer International Publishing.

3. Gagnon MP. Hospital-Based Health Technology Assessment: Developments to Date. PharmacoEconomics (2014) 32:819–824

4. Catananti C, Cicchetti A, Marchetti M. Hospital-based health technology assessment: The experience of Agostino Gemelli University Hospital’s HTA Unit. Ital J Public Health. 2005; 3:23-28.

5. Giorgetti R. 2016. Legislazione e organizzazione del servizio sanitario. Maggioli Editore.

6. Programma Nazionale Esiti. http://95.110.213.190/PNEedizione16_p/index.php. Accessed on 02/2017.

7. Cicchetti A, Sampietro-Colom L, Martin J, Marchetti M. Hospital based HTA in 25 organizations world-wide: what lessons learnt? In “Hospital –based Health Technology Assessment”, Editor: Sampietro-Colom L., Martin J. Springer Edition, New York, January 17, 2017.

8. Sampietro-Colom L, Lach K, Cicchetti A, Kidholm K, Pasternack I, Fure B, Rosenmöller M, Wild C, Kahveci R, Wasserfallen JB, Kiivet RA, et al. The AdHopHTA handbook: a handbook of hospital-based Health Technology Assessment (HB-HTA); Public deliverable; The AdHopHTA Project (FP7/2007-13 grant agreement nr 305018); 2015. Available from: http://www.adhophta.eu/handbook

9. AdHopHTA Database. http://intranet.adhophta.eu/. Accessed on 02/2017.

10. Marchetti M, Cicchetti A. La valutazione delle tecnologie sanitarie una guida pratica per le Aziende Sanitarie della Societa Italiana di Farmacia Ospedaliera e dei Servizi Farmaceutici delle Aziende Sanitarie (SIFO). 2015.

11. Halmesmäki E, Pasternack I, and Roine R. Hospital-based health technology assessment (HTA) in Finland: a case study on collaboration between hospitals and the national HTA unit. Health Res Policy Syst. 2016; 14: 25.

http://www.eunethta.net/

http://95.110.213.190/PNEedizione16_p/index.php

http://95.110.213.190/PNEedizione16_p/index.php



http://intranet.adhophta.eu/



Health Technology Assessment: Implementation challenges in Lebanon

Introduction. The adoption of latest Healthcare Technology is one of the main boosters of Hospital budgets. The WHO report (20102) (Resolution WHA67.23) indicated that “40% of spending

on health is being wasted and that there is, therefore, an urgent need … to enhance the rational use of health technology”. Incred-ibly, it is reported that developing countries spend more on health-care technology than industrial ones. HTA is essential for countries which have limited resources and rely on shared expertise from advanced nations, as a bridge between patient needs and deci-sion-making. As a technology consumer, Lebanon carries a huge expenditure burden at national level. There is a gap between ad-vanced medical procedures carried out at private hospitals, and the governmental endorsement of healthcare technologies. On the other hand, the Government is in the process of executing a na-tional campaign for the implementation of HTA and meeting WHO expectations.

Definition of HTAAccording to the WHO, “Health Technology Assessment is

the systematic evaluation of properties, effects and/or impacts of health technologies and interventions. The approach is used to in-form policy and decision-making in health care, especially on how best to allocate limited funds to health interventions and technol-ogies”. It is categorized as one of the six basic pillars for health systems, along with leadership/governance, financing, human re-sources, information, and delivery. Health technology assessment has been instrumental in efforts to achieve one of the WHO’s ob-

jectives, which is to ensure improved access, quality and use of medical products and technologies (WHO, 2011).

The WHO defines health technology “as the application of or-ganized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”. Technology is frequently perceived as merely related to medical equipment and yet, inter-national usage of this word touches other branches of healthcare related devices/items, mainly medicine, implants, catheters and more…

HTA programs in Europe are recognized as important for ad-vancement in the quality of health care delivered to the public. (Garrido, Kristensen, Nielsen & Busse, 2008). “Health Technolo-gy Assessment (HTA) is a way of assessing the ways science & technology are used in healthcare and disease prevention. It cov-ers medical, social, economic, and ethical issues. It provides poli-cy-makers with objective information, so they can formulate health policies that are safe, effective, patient-focused and cost-effective” (ec.europa.eu).

The adoption of HTA activities is also present in developing countries (WHO, 2013; Kriza et al, 2014). In resource-poor coun-tries, the use of health technologies could perhaps be determined in the absence of evidence-based information, however this would lead to the use of technologies which do not address healthcare needs within a certain context, thus resulting in the inefficient use of resources (Chalkidou, Levine & Dillon, 2010; Kriza et al, 2014). Contrary to popular belief; the fewer the resources, the greater

ABSTRACT: The adoption of latest Healthcare Technology is one of the main boosters of Hospital budgets. The WHO report (20102) indicated that “40% of healthcare spending is being wasted and there is an urgent need to enhance the rational use of health technology”. It is reported that developing countries spend more on healthcare technology than industrial ones. This makes HTA a necessity for countries which have limited resources and rely on shared expertise from advanced countries. In line with this, Lebanon carries a huge expenditure burden at national level. There is actually a gap between advanced medical procedures carried out at private hospitals, and endorsement. On the other hand, the Government is in the process of executing a national HT implementation campaign and faces numerous challenges. However, there are a couple of private Lebanese hospitals which have prepared a HTA infrastructure, through the implementation of an in-house HTM programs.

RIAD FARAH, B.E, CHTMMEDICAL ENGINEERING MANAGERSAINT GEORGE HOSPITAL- LEBANONUNIVERSITY MEDICAL CENTER

Health Technology Assessment: Implementation challenges in Lebanon


the need for establishing a national system that supports deci-sion makers. The use of HTA contributes to investment decisions, needs prioritization and organizational impacts of new and emerg-ing technologies, striking a balance between equity, quality health-care and efficiency.

Statistical Information on the Lebanese Healthcare sectorLet us gauge the size of the healthcare sector in Lebanon com-

pared to others: there are a total of 180 hospitals in Lebanon, 84% of which (151) are private, and only 16% (29) are governmental. This sector is clearly dominated by the private industry. In total there are 11,400 beds,88% in private and only 12% in govern-mental hospitals. On average there are 700,000 admissions per year (Haroun 2014). Lebanon is relatively well-off, with good num-bers of highly educated individuals. There are 12,827 Physicians and 10,079 registered Nurses serving the Lebanese population which is estimated at 3.5 Million. The proportion of physicians at the service of the Lebanese population stands at around 3.54 phy-sicians/1,000 person, and the density of available beds is around 3.5beds/1,000 person, relatively acceptable compared to other 3rd world countries. Private facilities often embrace state-of-the-art technologies, with governmental hospitals trailing behind most of the time. In contrast, around two thirds of endorsement comes from the public insurance sector, which has been slow in adopting latest techniques. Public insurers start covering new technological procedures after a period of incubation and only after technology has proven itself on the market for a period of time. After learn-ing the advantages of new techniques, most of the times patients don’t wait for public adoption and start paying from their own pockets. Only then does public endorsement kick-in, with the ac-ceptance of a proven new technique.

Challenges in HTA implementation in LebanonThe World Health Assembly resolution WHA67.23 requested to

“assess the status of health intervention and technology assess-ment in Member States in terms of methodology, human resourc-es and institutional capacity, governance…” and to provide tech-nical support to Member States to strengthen capacity for Health Technology Assessment (HTA). The objectives were: to evaluate the use of HTA principles, develop a database of national HTA fo-cal points, establish HTA Country profiles, raise awareness, foster knowledge and encourage the practice of health technology as-sessment and its uses in evidence-based decision-making. At the 2014 conference in Lebanon, the WHO presented HTA and HTM requirements at national level and requested the Lebanese Ministry of Health to adopt necessary measures for implementation.

Subsequently, the Lebanese Ministry of Public Health MOH en-dorsed a national HTA implementation program. This will eventual-ly ensure the practice of proper and safe technology for patients at the least reasonable cost. Survey 13464/4/2017 was launched in all hospitals to gauge readiness. We anticipate that this campaign will be very challenging, and there will be lots of obstacles, some of which are listed here below:

❙ The capacity to access and assess public health, economic, medical outcomes; the organizational implications of health interventions and technologies is inadequate in Lebanon, as in most developing countries, resulting in inadequate

information for guiding rational policy and professional decisions. Limited healthcare data is available at national level and also fails to cover health technology.

❙ There is no unified national nomenclature of medical equipment technology. Each hospital describes technologies in a different manner, making it cumbersome if not impossible for the Ministry of Health and the Syndicate of Hospitals to de-code and scrutinize the data.

❙ Private Lebanese hospitals are more progressive than governmental facilities, and have greater financial freedom for the adoption of latest technologies. Therefore private hospitals are more prepared to adopt HTM and HTA and have actually started setting up a mechanism to ensure compliance with HTA and HTM requirements.

❙ There are only 12 university hospitals (around 7%) capable of in-housing a good research program among Physicians, Clinical engineers and Administrative officers to drive a proper technology assessment for the best benefit of patients, and reduce technology expenditure to meet needs without over-spending.

❙ As recommended by the WHO, assessment is conducted by interdisciplinary groups using explicit analytical frameworks along with the depiction of clinical, epidemiological, health-economic as well as other information and methodologies. Setting up the infrastructure for consolidated work by several entities is an arduous task due to the involvement of different backgrounds and expertise, sometimes speaking different languages (Engineering, Medical, or Financial), always characterized by different priorities.

❙ University hospitals have to design a mechanism and an efficient organizational structure which requires research evidence to support well-defined policy decisions. Solid commitment from key decision makers is required, particularly from top management, to integrate HTA findings and recommendations into decision-making. This functional structure type can vary from a committee to a large-scale organization, and depends directly on the availability of qualified human and financial resources.

❙ Smaller hospitals and committees with limited resources must build on knowledge produced elsewhere and contextualize it.

❙ The engineering of a well-defined awareness campaign is equally important in explaining HTA and aligning all visions and expectations. HTM managers or Clinical Engineers in all hospitals can play a vital role in implementing HTA programs.

❙ Hospitals are invited to achieve a new level of coordination, vital to all, and participate at the lowest possible level for sharing information at national level.

❙ While the Lebanese Ministry of Public Health (MOH) is establishing a national system of HTA, this must be accompanied by appropriate legislative and institutional frameworks, as well as human and financial resources in hospitals to translate the findings of these assessments into effective decision making.

❙ Parallel to all of the above, some Lebanese hospitals have practically built on years of cooperation, based on personal

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contacts rather than national requirements, resulting in an environment including a wide spectrum of private hospitals, a proper networking infrastructure for technology information exchange, the joint benefit of capacity building and the adoption of best practices. This shall pave the road for the MOH to implement HTA easily in some private hospitals.

Experience in Implementing HTM in LebanonHealth Technology Management (HTM) is a vital health technol-

ogy tool for proper technology implementation to the best benefit of patients, based on scientific evidence. It is a pre-requisite for HTA and should be developed in parallel with the latter. Implement-ing HTA without proper HTM technology management is similar to travelling without carrying a suitable suitcase for the journey.

There are a couple of private hospitals in Lebanon with well-es-tablished HTM programs which are ready to support HTA when-ever launched. The HTM implementation plan at Saint George Hospital, one of the biggest private hospitals in Lebanon, started with obtaining HTM certification from an international association called the AAMI Credentials Institute (ACI). This was then followed by acknowledging literature offered both by the World Health Or-ganization (WHO) and Association for the Advancement of Medical Instrumentation (AAMI). These guidance books provided vital sup-port for HTM implementation. We referred to WHO HTA “Health Technology Assessment of Medical Devices” and HTM “Intro-duction to Medical Equipment Inventory Management”, “Medical Equipment Maintenance Programme Overview”, and “Comput-erized Maintenance Management System”, which are all public-ly available on the WHO website. We equally relied on the AAMI publication “A practicum for Health Technology Management” book which describes several tools for the proper implementation of an HTM program. Some of these projects are: planning, needs assessment, evaluation, benchmarking, comparison, purchasing, standardization, safety, training, basics of Incidents investigation, inventory management, maintenance (corrective and preventive), Failure Mode and Effect Analysis, Reliability Centered Maintenance, computerized maintenance management system, Replacement/Repair logical algorithm, project management, facility manage-ment, wireless spectrum management, customer satisfaction, end of life and when to depose.

After equipping ourselves with said references, we brain-stormed, obtained the commitment of the entire medical engi-neering team and performed a gap analysis comparing our current status with HTM requirements. This resulted in an exhaustive table of steps to be done. The entire team’s commitment was crucial for the success of HTM implementation. Benchmarking with key performance indicators from more developed countries was also crucial for success.

Just to mention few examples, the adoption of RCM and FMEA techniques saved the hospital around 30% of unnecessary preven-tive maintenance hours. The Repair/Replace algorithm is adopted by the hospital purchasing committee as a tool to decide whether to repair or replace a medical device.

ConclusionHTA is internationally considered as a strategic managerial

method to ensure proper technology is considered with patient needs in focus. It reduces unnecessary expenditure, saves costs, and therefore results in the efficient allocation of resources. Leb-anon has joined the HTA wave, adopted WHO resolutions, and through the Ministry of Public Health, started the HTA long journey of its implementation. Some Lebanese University Medical Centers are more prepared than other hospitals for HTA adoption. The project has been started, and we all believe that HTA is essential for countries like Lebanon, with limited resources.

ReferencesWorld Health Organization WHO. Health Technology Assessment of Medical Devices. Internet available at: http://www.who.int/entity/health-technology-assessment/en/index.html

World Health Organization WHO. Introduction to Medical Equipment Inventory Management. Internet available at: http://whqlibdoc.who.int/publications/2011/9789241501392_eng.pdf?ua=1

World Health Organization WHO. Medical Equipment Maintenance Programme Overview. Internet available at: http://whqlibdoc.who.int/publications/2011/9789241501538_eng.pdf?ua=1

World Health Organization WHO. Computerized Maintenance Management System. Internet available at: http://whqlibdoc.who.int/publications/2011/9789241501415_eng.pdf?ua=1

World Health Organization WHO (2013). First Inter-country meeting on Health Technology Assessment: A Tool for evidence informed decision making in health. WHO-EM.

World Health Organization WHO. Assembly Resolution WHA67.23. available at: http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R23-en.pdf?ua=1

Association for the Advancement Medical Instrumentation AAMI. (2015). A Practicum for Health Technology Management. Available at: www.aami.org

Ammar. Ministry of Public Health. (2017). Capacity assessment campaign for launching Technology Assessment in Lebanon. National Project. Lebanon.

Akoum (2014).” National Strategy for Regulation Assessment and Management of Medical Technologies in Lebanon”. WHO / Ministry of Public Health conference. Lebanon.

Garrido, M.V. et al (2008); Health Technology Assessment and Health Policy Making in Europe: Current Status, challenges, and potential. European Observatory on Health Systems and Policies.

Kriza et al (2014). A systematic review of Health Technology Assessment tools in sub-Saharan Africa: methodological issues and implications. Health research policy and systems.2:66.

Chalkidou, K. et al (2013). Health Technology Assessment in universal health coverage. The Lancet. Vol 386.

Haroun, S. (2014). Presentation at the Syndicate of Hospitals in Lebanon.

24

http://www.who.int/entity/health-technology-assessment/en/index.html

http://www.who.int/entity/health-technology-assessment/en/index.html

http://whqlibdoc.who.int/publications/2011/9789241501392_eng.pdf?ua=1






http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R23-en.pdf?ua=1

http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R23-en.pdf?ua=1

http://www.aami.org

Experiences of Health Technology Assessment Units in Finnish Hospitals



Introduction. Between 1995 and 2016 Health Technology Assess-ment (HTA) - related work in Finland was supported and coordinated by the national Finnish HTA agency, Finohta, which promoted as-

sessment research and acted as a national clearing-house, collecting, analyzing, synthesizing, and disseminating information on HTA studies provided by other HTA-organizations worldwide (1-2).

Although the concept of HTA was marketed among clinicians, and a network of 65 hospital-based specialists was formed to distribute information about HTA work (1), it soon became evident that this was not sufficient to incorporate HTA into hospital decision making. The main reasons for the unsatisfactory implementation of HTA appeared to be an immature HTA culture among clinicians and hospital managers, and the lack of formal requirements to demonstrate safety, effectiveness, and cost-effectiveness before the adoption of new technologies.

With the aim of improving hospital decision making and introducing the rigorous assessment of new technologies therein, Finohta followed the examples of many other countries and together with 20 Finnish hospital districts, started to develop a nation-wide approach for the managed uptake of new technologies into Finnish hospitals. The ensuing new Managed Uptake of Medical Methods (MUMM) program started in December 2005, to offer critically appraised information for decisions concerning the uptake of new technologies in specialized care (2-4). Furthermore, the program encouraged healthcare decision-makers to

commit to evidence-based practices (5). Systematic MUMM reviews were intended to provide essential evidence on the effectiveness and costs of new technologies for hospital decision makers.

To maximize the uptake of the information offered by the MUMM program, the Chief Medical Officers of all hospital districts were invited to form the Board of the program. The Board chose the topics and gave guidance on the uptake of assessed technologies. The assessments were performed by a small group of clinical and methodological experts and were published in the Finnish Medical Journal after peer-review (5). The program produced 51 systematic reviews based on which 58 recommendations were given.

The members of the Board were expected to be key-players in the dissemination and implementation of recommendations in their hospital districts. However, as decision making in Finnish health care is decentralized, and the recommendations were not binding, the hospitals could freely decide whether to follow the recommendations or not.

Although the impact of the MUMM program was not systematically studied, there are indications that recommendations have been followed, at least to a certain degree. For instance, a study based on quantitative data reported that the number of patients treated with six out of seven technologies with a positive recommendation had markedly increased. The scene was more mixed regarding technologies with a more restrictive recommendation, as 40 percent of

ABSTRACT: Despite a national program for the Managed Uptake of Medical Methods (MUMM), the role of health technology assessment (HTA) in Finnish hospitals has been limited, and the value of rigorous assessment in the acquisition of new technologies is insufficiently recognized. Management by information only does not always appear to lead to the implementation of MUMM recommendations, consequently, more powerful steering mechanisms and mandatory compliance with recommendations may be needed. Savings required from its host organization recently led to the closing of the national HTA office, Finohta, and the MUMM-program, which may further reduce adherence to evidence-based decision making. Currently, the main actors in the HTA field are the Finnish Medicines Agency (Fimea) and the five university hospitals. Given the scarcity of resources reserved for technology assessment, there is a high risk that HTA activities in Finland will further decline unless national coordination of HTA is rapidly re-established.

TUIJA S. IKONEN, MD. PH.D.CHIEF PHYSICIANHOSPITAL DISTRICT OF SOUTHWEST FINLAND

RISTO P. ROINE, MD. PH.D.PROFESSOR, UNIVERSITY OF EASTERN FINLANDCHIEF PHYSICIANPOHJOIS-SAVO HOSPITAL DISTRICT AND HELSNKI AND UUSIMAA HOSPITAL DISTRICT

MIIA TURPEINEN, MD. PH.D.CHIEF PHYSICIAN OULU UNIVERSITY HOSPITAL AND UNIVERSITY OF OULU



them showed increased use despite the recommendation to limit their use (6). In the largest hospital district, the Hospital District of Helsinki and Uusimaa, MUMM recommendations appeared to be followed fairly well according to a recent study (7).

Even if the MUMM program had already existed for several years and produced a fair number of systematic assessments and recommendations, interviews with Finnish health care decision makers, as part of the EU-funded “Adopting Hospital Based Health Technology Assessment” (AdHopHTA, www.adhophta.eu) project in 2013, revealed that the program was still poorly known and underutilized in hospitals (8). This was probably because the results of MUMM reviews were not systematically required in the clinics’ purchasing decisions. Furthermore, the fairly slow assessment process, often exceeding a year, was identified as a major barrier of the MUMM program in a world in which news about potentially useful new technologies rapidly reaches both the clinicians and the public eager to use them as soon as possible.

Exposition Formal HTA activity in Finnish hospitals before their involvement

in the MUMM program was more or less non-existent. In 2001 the Helsinki University Hospital was the first hospital in Finland to establish a chief medical officer post for the assessment of health care effectiveness. However, HTA-related work was not considered a priority in the hospital. In spite of the efforts of the MUMM program, it soon became evident that the penetration of its results at hospital level was suboptimal, raising the question whether HTA should also, or even preferably, take place at hospital level. This was also supported by a new Health Care Act in 2011 which required the agreement of five specific catchment areas formed around the five university hospitals on the principles for adopting new practices and technologies in their respective areas.

To comply with the new requirements, the university hospital specific catchment areas have mandated that new technologies shall be introduced and justified using a mini-HTA form (9). Although subsequent decision making differs from one catchment area to another, the basic principle is that for the technology to be adopted, there needs to be sufficient evidence on effectiveness and cost-effectiveness presented by the mini-HTA approach. If evidence is not clear-cut, most of the catchment areas have special assessment groups which can perform rapid assessments, to systematically collect more comprehensive evidence. Technologies requiring more detailed assessment were intended to proceed to the MUMM program.

For example, when evidence presented by the mini-HTA approach in the Helsinki University hospital specific catchment area is considered sufficient (the most common situation), the decision maker (usually the clinical director of a specialty), can independently make the decision concerning the adoption of new technology. If there are reservations concerning effectiveness, safety or cost-effectiveness, the decision maker can request one of two assessment groups (medication group or other technologies group) to review the case. Both groups consist of approximately ten members (mostly representing the medical profession) which review available information and may also perform a rapid and systematic review to gather more evidence before giving a recommendation. To date there has not been any explicit funding for assessment work, therefore group members perform assessments on top of their other hospital duties. There is no health economic expertise in either of the assessment groups, therefore assessments of new

technologies focus mainly on effectiveness. While there is a formal requirement to use the mini-HTA approach

for every decision for cases with annual budget impact exceeding 50 000 Euros, current assessments are still sporadic, at least in the case of new procedures or technologies, and the technology assessment group has received only occasional requests, some of which regarded experimental procedures that are difficult to assess via HTA methodology. The drug assessment group has been more active and has assessed several new drugs since 2003. However, assessments have been mainly informal in nature and based on discussions with clinical experts, concerning the clinical value of the new drug. The drug assessment group has had a more formally established role since 2015.

In the other four specific catchment areas of Finland, HTA procedures concerning drug assessments are very much the same, with slight local variations. For instance, in the Tampere University hospital area, all new drugs are evaluated using the mini-HTA approach and a short literature review, after which an expert panel decides whether to include the drug in the hospital drug formulary and which patient groups to offer the drug to. In the Oulu University hospital area, the mini-HTA approach is utilized in all new drug and technology acquisitions with a yearly budget impact of over 35 000 Euros. In addition to drugs, only a few other technologies have been evaluated yearly. Some evaluations have focused on organizational aspects, such as how rehabilitation should be organized.

In the Turku University hospital, the hospital-based HTA methodology has been piloted for the purchasing of equipment and supplies as well as for investment planning. Purchase proposals are usually evaluated by small groups of professionals and, when a costlier technology is under consideration, a rapid assessment and literature review may also be performed. To date, the most extensive assessment was undertaken to support the planning of investments for novel diagnostic and teaching units at the university hospital. The hospital board nominated a working group to assess all investment proposals for devices, equipment and furniture. Depending on the level of expenditure, all proposals were assessed by one of the following processes: 1) Proposals over 250 000 Euros were evaluated by 3-5 person expert groups using multi-domain assessment, adapting hospital based HTA-principles 2) Proposals between 50 000 and 250 000 Euros were returned to the units for mini-HTA-assessment 3) Proposals below 50 000 Euros were prioritized to cut expenditure by at least 25 %, with particular emphasis on the synergistic use of devices and equipment among units. As a result, expert groups suggested significant reductions, including the withdrawal of an MRI-unit; adjustments to specifications and proposals were made, resulting in a 3.8 million reduction in investment proposals. After encouraging results of hospital based HTA application to budget planning and investment proposals, hospital based HTA was accepted in the Turku University hospital as a tool for the annual planning of investments exceeding 100 000 Euros.

So far, all assessment groups in the five specific catchment areas have been conducting assessments independently, but there have been discussions on enhancement to avoid multiple work. To harmonize decisions concerning the uptake of new hospital drugs in Finnish hospitals, the Ministry of Social Affairs and Health is carrying out an implementation program for rational pharmacotherapy, including the evaluation of the therapeutic and economic value of medicines. In parallel, the Finnish Medicines Agency Fimea has started to produce timely assessments on some hospital medicines, with the intention of having results available for hospital decision makers the moment a new




drug enters the market. The usefulness of this approach remains to be established, but it is hoped that it will lead to the introduction of new medications with equal indications and restrictions in different parts of the country.

Current situationFinland is planning a major health care reform which aims to integrate

primary care, secondary care, and social care into 18 districts. At the same time the provision of health care services, which so far have been mainly organized by the not-for-profit public sector, will be opened to competition so that private providers may play a greater role in the future. Funding will still mostly be tax-based and come from the state, at least in the beginning. A long-term option is that the districts will be able to levy taxes themselves to fund the provision of services to the citizens.

The health care reform is expected to produce major savings over the next years, and most of the country’s planning efforts have focused on the organization and management of healthcare and social services in the new system as of January 1st, 2019. In addition, plans to broaden traditionally restricted individual freedom of choice among health care and social care providers have received much attention, whereas requirements concerning the effectiveness and cost-effectiveness of health care services and health technologies, appear to be partially forgotten. This is reflected in the fact that Finohta and the MUMM program have been closed down in 2016, due to financial saving constraints of its host organization, the National Institute for Health and Welfare. The aforementioned development raises concerns that future competition among service providers may lead to the acquisition of new technologies with little regard to HTA principles.

ConclusionsThe role of HTA in Finland has been limited, and the value of rigorous

assessment in the acquisition of new technologies is insufficiently recognized. Furthermore, recommendations made, for instance by the MUMM Board, have not been binding, in all likelihood undermining HTA. Guidance by information does not appear to be sufficient, and more powerful steering mechanisms may be needed. The closing down of Finohta and the national MUMM program may further reduce adherence to evidence based decision making. Currently, the main actors in the HTA field are the Finnish Medicines Agency Fimea and the five university hospital catchment areas. Given the scarcity of technology assessment resources in all catchment areas, there is a high risk that HTA activities in Finland will further decline unless national coordination of HTA is rapidly re-established.

BIOGRAPHIES

Risto Roine is currently professor of patient safety at the University of Eastern Finland and part-time chief physician at both the Kuopio and Helsinki University hospitals. He has twenty years of experience in both national and international health technology assessment projects.

Tuija S. Ikonen is the chief medical officer for health technology assessment in the Hospital District of Southwest Finland, adjunct professor of health care administration in Turku University and adjunct professor of surgery in Helsinki University. She is a former Senior Medical Officer of Finohta and has 10 years of experience in HTA.

Miia Turpeinen has a specialist degree in clinical pharmacology and she is the chief medical officer for health technology assessment at the Northern Ostrobothnia Hospital District and adjunct professor of drug research at the University of Oulu. She has expertise, especially in evaluation of clinical and cost-effectiveness of medicines and is currently serving as a member of a governmental committee on rational pharmacotherapy.

Other authors

Anna-Kaisa Parkkila, MD. Ph.D.Chief physicianTampere University Hospital

Kimmo Mattila, Md. Ph.D. Chief physcianHelsinki and Uusimaa Hopistal District

References

1. Lauslahti K, Roine R, Semberg V, Kekomäki M, Konttinen M, Karp P. Health technology assessment in Finland. Int J Technol Assess Health Care. 2000;16:382-99.

2. Mäkelä M, Roine RP. Health technology assessment in Finland. Int J Technol Assess Health Care. 2009;25 Suppl 1:102-7.

3. Kaila M. Managed uptake of medical methods. Impakti - Finohta newsletter 2/2007: 12-13.http://finohta.stakes.fi/NR/rdonlyres/2872CE40-7E60-400C-9CAD-FC1466378B11/0/impakti2007_2.pdf.

4. Kaila M. “Managed Uptake of Medical Methods”. Health Policy Monitor, April 2008. Available at http://hpm.org/fi/a11/2.pdf.

5. MUMM program. https://www.thl.fi/fi/web/thlfi-en/research-and-expertwork/projects-and-programmes/mumm-programme.

6. Ikonen T, Rautiainen H, Räsänen P, Sihvo S, Roine RP. HALO-suositusten käyttöönoton seurannassa on haasteita [Adherence to national Managed Uptake of Medical Methods programme guidelines on uptake of new technologies in secondary health care in Finland]. Suomen Lääkärilehti (Finnish Medical Journal) 2014;42:2713-2721. In Finnish with English summary.

7. Karma P, Roine R, Simonen O, Isolahti E. [Are practice guidelines being followed in specialized care?]. Duodecim. 2015;131:1467-74. In Finnish with English abstract.

8. Halmesmäki E, Pasternack I, Roine RP. Hospital based health technology assessment (HTA) in Finland. A case study on collaboration between hospitals and the national HTA unit. Health Res Policy Syst 2016;14:25.

9. DACEHTA. Introduction to Mini-HTA – a management and decision support tool for the hospital service. Danish Centre for Evaluation and Health Technology Assessment, 2005. http://sundhedsstyrelsen.dk/publ/publ2005/cemtv/mini_mtv/introduction_mini_hta.pdf.

http://finohta.stakes.fi/NR/rdonlyres/2872CE40-7E60-400C-9CAD-FC1466378B11/0/impakti2007_2.pdf



http://hpm.org/fi/a11/2.pdf

http://hpm.org/fi/a11/2.pdf

https://www.thl.fi/fi/web/thlfi-en/research-and-expertwork/projects-and-programmes/mumm-programme



http://sundhedsstyrelsen.dk/publ/publ2005/cemtv/mini_mtv/introduction_mini_hta.pdf

http://sundhedsstyrelsen.dk/publ/publ2005/cemtv/mini_mtv/introduction_mini_hta.pdf

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To find out more about our services, please call our team on

020 3411 1868www.hcahealthcareuk.co.uk

Giving patients the care they deserve

“Economic Evaluation applied to the hospital setting” Experience of the Ezkerraldea Enkarterri Cruces Integrated Healthcare Organisation (Basque Country)


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To find out more about our services, please call our team on

020 3411 1868www.hcahealthcareuk.co.uk

Giving patients the care they deserve “Economic Evaluation applied to the hospital

setting” Experience of the Ezkerraldea Enkarterri Cruces Integrated Healthcare Organisation (Basque Country)

ABSTRACT: Economic Evaluation (EE) methodology is a discipline that has been used in Spain for more than 30 years. Despite being almost exclusively applied by Healthcare Technology Assessment (HTA) agencies, it can also be found in hospitals aiming to incorporate innovative technologies for diagnostic, therapeutic or surgical treatments or organisational innovation. In this context, we at the Ezkerraldea Enkarterri Cruces Integrated Healthcare Organisation (OSI EEC) are working in the area of sustainability as a strategic added value for patients which has forced us to delve deeper into the concept of cost-effectiveness. It requires us to measure the health outcomes obtained and the resources used to achieve them. That is why we have implemented the HTA methodology and are systematising its use as a management tool in the hospital setting in order to ensure that new healthcare technology is introduced based on cost-effectiveness criteria.

Mª TERESA ACAITURRI AYESTADEPUTY DIRECTOR OF ECONOMIC EVALUATION, OSI EZKERRALDEA ENKARTERRI CRUCES

Introduction The two basic principles of economics are “scarcity”

and “choice”. Needs always outweigh available resources, especially in these recent years of severe economic crisis. It is perhaps for this reason that the concept of opportunity cost is increasingly mentioned in decision-making, not least in the healthcare sector.

In this sector, there is an absence of a culture grounded in evaluation, transparency, the sharing and comparison of results both in a healthcare and an economic context, making it difficult to systematically evaluate the performance of decisions.

Fortunately however, organisations are increasingly committed to patient management as well as the principles

of sound governance, accountability and sustainability of the healthcare system.

However sustainability requires efficiency, which means achieving the highest possible quality with available resources. We are not only talking about costs, but also about the relationship between costs and health outcomes.

Why Economic Evaluation in the Hospital?We are a healthcare services organisation that is

a member of Osakidetza, the Basque Country Health Authority, which is dependent on the Health Department of the Basque Government

We are an Integrated Healthcare Organisation belonging to Osakidetza, the public healthcare system of the Basque

29

ELISA GÓMEZ INHIESTOECONOMIC, FINANCIAL AND GENERAL SER-VICES DIRECTOR, OSI EZKERRALDEA ENKAR-TERRI CRUCES

IKER USTARROZ AGUIRREECONOMIC EVALUATION UNIT, OSI EZKERRAL-DEA ENKARTERRI CRUCES


Country (Spain), consisting of the Cruces University Hospital and 29 Primary Healthcare Centres, all providing healthcare to citizens in our relevant geographical areas. We also attend to patients from other areas for highly specialised services. 6,000 professionals work in our Organisation which disposed of a budget that amounted to EUR 489 million in 2016.

We have a commitment to responsibility for the proper use of resources, which forces us to face new management challenges, such as how the incorporation of new healthcare technologies should take into account cost-effectiveness. The EE methodology is vital for obtaining such information.

Drummond defines Economic Evaluation as “the comparative analysis of alternative courses of action in terms of both their costs and consequences in order to assist in policy decision-making” [1].

The relationship between used resources (costs) and consequent outcomes obtained (effectiveness) for any intervention carried out is what we define as efficiency.

In the healthcare field, EE is used as a tool to aid decision-making. This tool makes it possible to:

1. Understand the efficiency of new healthcare technologies with respect to existing options.

2. Choose and manage technological needs by ensuring that investment is made in useful innovations.

3. Maximise health gains with available resources.The application of EE has historically been reserved

for Healthcare Technology Assessment Agencies. These agencies are tasked with creating evidence to assist in decision-making on whether or not to invest in healthcare technologies.

The Agencies are involved in macro-level decision-making, along with the healthcare authorities and National Health Services, and usually provide reports to support decision-making at this level.

On the other hand, micro-level decision-making is the

responsibility of healthcare professionals who make choices on a daily basis about treatments to be administered to patients.

It is in Hospitals, which constitute the meso level, along with Primary Care and Social Healthcare Centres, where the incorporation of high-impact technologies is constantly taking place, in terms of equipment, new healthcare services or new healthcare materials.

That is why we have set ourselves the strategic challenge of implementing EE methodology and systematising its use as a management tool, to ensure that technologies are incorporated based on cost-effectiveness and transparency criteria.

At present, hospital managers are increasingly aware of the usefulness of the Healthcare Technology Assessment (HTA) approach as a management and decision-making aid. The number of university hospitals that carry out HTA has increased since the 2008 global survey on hospital-based HTA. In 2013, 22 hospitals were identified that had an HTA unit in place to support decision-making [2]. By 2016, over 30 hospitals that incorporate HTA into their organisation had been identified. These hospitals are mainly located in North America and Europe [3].

In 2012, AdHopHTA was launched, a European project led by the Hospital Clinic of Barcelona, with the aim of promoting and standardising a hospital-based HTA methodology, identifying barriers and creating a network of hospitals to share good practices. This project encompasses hospitals, research and teaching centres and has validated a technology assessment reporting template (mini-HTA) [4].

How we work at the OSI Ezkerraldea Enkarterri CrucesWe work in the area of sustainability as a strategic added

value for patients, forcing us to delve deeper into the concept of cost-effectiveness. It requires us to measure the health outcomes obtained and the resources used to achieve them.

In 2013, Cruces University Hospital defined and approved the strategic project “Implementing the Economic Evaluation methodology”, led by the Economic Evaluation Sub-Department, which intended to systematise the evaluation of the acquisition of new technology necessary for the provision of healthcare, through the use of cost/effectiveness criteria.

The degree of project progress is measured by quantitative indicators such as the number of reports issued, the number of projects evaluated and training sessions held.

The organisational model chosen is the networking of the OSI EEC professionals themselves, who make up the evaluation teams created on an ad hoc basis for each of the EE studies to be carried out.

The teams are made up of professionals with different profiles: clinicians, economists, researchers and managers. The evaluation teams are coordinated by the Economic Evaluation Unit (EEU), which is responsible for generating and managing the documentation and information necessary for drawing up evaluation reports.

30



The EEU was created in late 2014 following the evaluation methodology proposed by the AdHopHTA project and the standardised Mini-HTA reporting template.

Likewise, the procedure to be followed depending on the type of technology incorporation to be evaluated has been standardised.

❙ Technology Incorporation Applications regarding healthcare material are sent to the Procurement Commission via a web platform (SIT) available to clinicians, which facilitates application management, analysis by the Commission and online notification of the decision to the applicant. The Commission determines in which cases it is necessary to request an EE study of the proposed technological incorporation, generally taking into account the economic impact or the guarantee of clinical safety. This evaluation may be requested before its incorporation or after a trial period. Applications should include a justification of the application, information on efficiency and effectiveness, economic, environmental and organisational requirements, etc.

❙ If the application refers to a New Services Portfolio, the evaluation report request will come from the OSI’s Healthcare Department (Medical Department, Nursing Department or Integration Department), who, in view of the requests made by the healthcare services/units or on the basis of the needs of the OSI EEC itself, will use the report as an additional decision-making tool.

The project also concerns methodology dissemination, which is why the OSI organises training and dissemination days with the aim of spreading the EE culture among professionals. To date, 5 training days have been organised, attended by a total of 204 participants.

Training Days (Attendees)

“Pharmacoeconomics applied to decision-making”

72

“Introduction to Health Economics” 21

“Selection and purchase of healthcare technologies in the hospital setting: the role of economic evaluations”

31

“Economic Evaluation applied to the hospital setting”

35

“Clinical and healthcare service evaluation in the hospital setting: from macro to micro”

45

The EEU issues different reporting templates depending on what information is needed on the technology to be evaluated or its characteristics. Complete EE reports are issued for the incorporation of a new services portfolio,

while cost-effectiveness or budgetary impact reports are produced for new healthcare materials.

What have we done so far?Since the creation of the EEU, five reports on the incorporation

of a new services portfolio have been issued following the methodology proposed by the AdHopHTA project. The Mini-HTA reporting template requires submission of the minimum information necessary to issue a recommendation on the evaluated technology and consists of five dimensions:

1. Summary2. Basic information: parties involved, objective and

scope, which are delineated under the TICO (Technology, Indication, Comparison and Outcome) approach

3. Methodological aspects4. Outcomes within the area of interest 5. Discussion, conclusion and recommendations

New Service Portfolio Applications Years

Endoscopic submucosal dissection versus open

surgery [Work team: Gastroenterology Department,

General Surgery Department, Medical Department,

Medical Sub-department of Medical Services,

Economic Department, Research Unit, Economic

Evaluation Unit]

2015

Deep brain stimulation for obsessive-compulsive

disorder in refractory patients [Work team:

Neurosurgery Department, Psychiatry Department,

Medical Department, Medical Sub-department

of Surgical Services, Economic Department,

Research Unit, Economic Evaluation Unit]

2015

Image-guided prostate biopsy for the detection of

prostate cancer

[Work team: Urology Department, Medical

Department, Medical Sub-department of Surgical

Services, Economic Department, Research Unit,

Economic Evaluation Unit]

2015

Transbronchial cryobiopsy for the diagnosis of

interstitial lung disease [Work team: Pulmonology

Department, Thoracic Surgery Department,


of Medical Services, Economic Department,


2016

Cytoreductive surgery and hyperthermic

intraperitoneal chemotherapy in the treatment of

peritoneal carcinomatosis [Work team: General

Surgery Department, Oncology Department,


of Surgical Services, Economic Department,


2017

31


Nine reports on new healthcare materials have also been issued. The situation and status of the reports (Not Started, Ongoing, Completed) and the economic impact of authorised materials is monitored in the OSI EEC’s Economic Scorecard.

The Report resulting from the study includes evaluation team recommendations and is checked by external experts before being sent to Management. Following its analysis, Management makes a decision and, in the interests of transparency, the EE reports are published on the OSI EEC Intranet.

We are currently working on evaluating projects such as the creation of a centralised unit for the insertion of venous catheters, or the preparation of EE reports on equipment which has been scheduled for incorporation. In addition, the EEU supports Research Projects like “Analysis and improvement of the suitability of scheduled abdominal aortic aneurysm surgery”, Innovative Projects coordinated by the Innovation EEU like “Traceability of blood products QTA Tracer System” or Health Outcomes Measurement Projects (International Consortium for Health Outcomes Measurement - ICHOM).

Studies are always performed from the Organisation’s perspective and as a result, we consider direct costs and those costs associated with disease management, i.e. the cost of hospitalisations, consultations, surgical treatments, pharmacy, diagnostic tests, etc. This information comes from the OSI EEC’s Economic Information System, which is developed up to a cost per patient level and ensures a comprehensive and reliable cost database, while also enabling us to contextualise economic studies in our environment.

At the same time as the methodology was implemented, in 2014, the “Management per patient” strategic project,

led by the OSI EEC’s Economic and Financial Department, was designed and approved to obtain an individualised cost per patient. The measurement of costs of the entire healthcare circuit is key to understanding the value given to patients, by comparing the health outcomes obtained with the healthcare to the resources used to achieve them.

This Management per Patient system helps to identify the variability of existing clinical practice, identify avoidable costs, provide sound information both for management and for research projects or scientific production and,

above all, provide individualised and contextualised information that is not based on mere estimates.

ConclusionsThe use of the EE methodology provides important

information for decision-making. Its regular use in Hospitals should be systematised so that the incorporation of technologies is based on cost-effectiveness criteria and is carried out with transparency.

In order to achieve this, it is essential to have detailed and real information on costs and outcomes, contextualised in our environment, to formulate reliable and relevant conclusions.

It is necessary to work in a network with a multidisciplinary team of internal employees capable of suggesting different approaches from all necessary different perspectives, both from a clinical and economic point of view. Collaboration between Hospitals committed to this approach is also important.

EE is the tool that enables us to understand our value contribution to the patient, by comparing the health outcomes obtained with the resources used to achieve them [5].

32



Reference1) Drummond M, O’Brien B, Sculpher M, Stoddart G, Torrance

G. Methods for the Economic Evaluation of Health Care Programmes. 3rd Edition. Oxford: Oxford Medical Publications; 2005.

2) Martelli, N; Lelong, AS; Prognon, P; Pineau, J. Hospital-based health technology assessment for innovative medical devices in university hospitals and the role of hospital pharmacists: learning from international experience. International Journal of Technology Assessment in Health Care, 29:2 (2013), 185-191.

3) L. Sampietro-Colom, J. Martin. 2016. Hospital-based Health Technology Assessment. Switzerland: Springer International Publishing

4) http://www.adhophta.eu/

5) Porter, Michael E., and Thomas H. Lee. “The Strategy That Will Fix Health Care.” Harvard Business Review 91, no. 10 (October 2013): 50–70.

BIOGRAPHIES

M. Teresa Acaiturri Ayesta has a degree in Economics from the University of the Basque Country, a Master’s in Advanced Studies in Cost Accounting, European Communities and Audit and Management Control from the Technical University of Madrid, and is a University Expert in Pharmacoeconomics. M. Teresa is currently the Deputy Director of Economic Evaluation at the OSI Ezkerraldea Enkarterri Cruces, a position she has held since 2013. She has previously served as Head of Financial Accounting and Analytical Accounting at Galdakao Hospital.

Elisa Gómez Inhiesto has a degree in Economics from the University of the Basque Country, a Master’s in Business Management from the University of Deusto, a Diploma in the Calculation of Hospital Costs from the Technical University of Valencia and a Specialist Diploma in Health Economics, Pharmacoeconomics and the Healthcare System from the University of Deusto.

She is currently the Economic, Financial and General Services Director at the OSI Ezkerraldea Enkarterri Cruces, a position she has held since 2012. She has previously served as Economic Assistant Manager of University of the Basque Country and as Economic and Financial Director at Galdakao Hospital.

Iker Ustárroz Aguirre has a degree in Economics from the Public University of Navarre (2011) and a Master’s Degree in Health Economics and Pharmacoeconomics from Pompeu

Fabra University (2015).Iker currently works in the Economic Evaluation Unit at

the OSI Ezkerraldea Enkarterri Cruces, a position he has held since 2014. Previously, he has worked as a researcher within a project on temporary disability in Navarre, as well as working in the banking and pharmaceutical sector.

http://www.adhophta.eu/



‘Be There’ Without Being There: An Innovative Approach to Achieve JCI Reaccreditation through Virtual/Video Survey (Hybrid)

Introduction. Aga Khan University Hospital Karachi (AKUH, K) is a 650-bed tertiary care teaching hospital which was es-tablished in 1985 as one of Pakistan’s first private university

hospitals committed to delivering safe and quality healthcare services. AKUH is the first hospital in Pakistan to achieve this milestone. The AKUH quality journey began with the introduc-tion of Continuous Quality Improvement (CQI) methodologies and the obtainment of ISO 9001 Quality Management System certification in 2000. In 2006, AKUH, K became the first hospital in Pakistan to be awarded Joint Commission International (JCI) Accreditation for hospital standards. Triennial surveys are carried out by the JCI accreditation surveyors during an onsite visit.

In 2012, reaccreditation became a challenge for Pakistan due to security reasons. Considering these unavoidable circumstances, a unique and innovative approach of virtual/

video surveying was proposed. AKUH took on this challenge and assured the JCIA central office that all measures would be taken to ensure auditors could see what they wanted to see, just like during an onsite audit.

A unique approach to innovationAKUH, K has taken pride in maintaining JCI accreditation

since 2006. The challenge started in 2012 when JCI Surveyors could not visit Pakistan for the scheduled second triennial survey of AKUH, K for security reasons, in August 2012. In order to overcome this challenge, AKUH, K and JCI leaders jointly agreed to test out some innovative solutions for assessing compliance with JCI accreditation standards. After extensive discussion between the two organizations, the concept of a “Video Survey” was agreed upon as an effective alternative for testing. AKUH,

ABSTRACT: In 2006, Aga Khan University Hospital (AKUH) became the first ever hospital in Pakistan to receive Joint Commission International (JCI) Accreditation. To maintain certification status, triennial surveys are carried out by JCI auditors by means of an onsite visit. In 2009, AKUH successfully passed the 1st triennial survey; however, in 2012 reaccreditation became a challenge for Pakistan for security reasons. Considering these unavoidable circumstances, a unique and innovative approach of virtual/video surveying was proposed. It was a big challenge for AKUH, nevertheless with ongoing negotiation with JCI executives it was agreed to take a chance and conduct the JCI survey using video technology for the first time ever. Advanced technology was made available and tested, becoming the eyes and ears of surveyors sitting in a different time zone. Specially designed mobile workstation with high definition camera, laptop, headphone, microphone and speaker were introduced. This new and innovative approach was very much appreciated by the JCIA as they were able to execute the same audit agenda, view documents, medication, patient care areas, interview patients and staff during the virtual survey just like during an onsite survey.

KHAIRUNNISA ISMAILASSISTANT MANAGERCLIFTON MEDICAL SERVICESPAKISTAN

SALMA JAFFERCHIEF NURSING OFFICERAGA KHAN UNIVERSITY HOSPITALPAKISTAN

ROZINA ROSHANQUALITY MANAGER PATIENT SAFETY AND INFECTION CONTROLAGA KHAN UNIVERSITY HOSPITALPAKISTAN



K accepted the challenge and considered this as a window of opportunity to demonstrate the organization’s dedication to quality improvement through the effective use of Information technology.

Given JCI’s enthusiasm for developing a new and innovative survey process and AKUH, K’s commitment to maintaining JCI accreditation, the challenge was embraced as an opportunity and both organizations agreed to pilot this innovative method of surveying at AKUH, K. Advanced technology, compatible enough to become eyes and ears of the surveyors sitting in a different time zone was made available and tested. Specially designed mobile workstation with a high definition camera, laptop, headphone, microphone and speaker were introduced. This new and innovative approach was very much appreciated by the JCI as they were able view all documents, medications, patient care areas etc. They were even able to interview patients and staff as though were physically present.

Video Survey Planning Framework Determined to maintain JCI accreditation, AKUH, K opted

for a management by objective (MBO) model for the timely completion of its target, as depicted in figure 1. The entire process of readiness assessment was to be carried out over 5 months. To meet the deadline, an existing Quality Core Group (QCG) and an IT Team was activated to carefully test each step, process feedback, adjust resources, in order to improve outcomes and maintain the momentum towards excellence. This activity was guided and monitored by AKUH, K and JCI leaders.

I. PlanningDuring August 2012, the AKUH, K team began initial planning,

led by the Regional CEO, JCI coordinator, Manager, IT AKUH, K and JCI Accreditation Program leadership. Detailed video survey planning meetings took place between AKUH, K and JCI with focus on all aspects of pre-survey, survey and post-survey activities and procedures. Needs analysis was a key component of the planning process. AKUH, K staff was willing to accept the task but was uncertain of how it would be executed. Typical physical surveys with personal interactions were being

substituted by a mechanical trolley carrying a laptop, a speaker and a camera. A key to success was continuous communication and timely updates. The following components were considered vital, as illustrated in Figure 2:

I.a Staff Awareness and trainingExtensive education and training was given to healthcare

teams via e-mails, hands-on trainings, mock surveys and quality grand round presentations, with focus on JCI preparation and updates. These activities helped different teams to overcome initial hesitation with web-cam interaction, through answering questions, explaining processes and sharing documentation. Divisional/departmental heads, managers, unit based teams and Quality Core Groups played a vital role in accelerating acceptance among staff and mentally preparing them for an emergent “video survey” methodology.

I.b IT Infrastructure up-gradingVideo surveying was a major challenge for IT support at

both ends. In fact, IT support was classified a critical success factor for effective survey execution. It started with the process of evaluating AKUH, K’s video conferencing facility and internet availability in each and every hospital location, required for an un-interrupted Video Survey via Webex1. 3-4 trolleys fitted with a laptop, a video camera and speakers were required to perform the video survey across all patient care settings and other support service areas throughout the hospital. The Video survey also required a room with an internet connection that would enable video discussion involving larger groups of staff for sessions pertaining to SQE, Infection Control, FMS and Leadership etc. In order to organize a video document review session, all requested documents were scanned and uploaded using the iShare2 application.

I.c Preparing Escort TeamsPortable trolleys were designed to be the eyes and ears of

the 03 JCI surveyors based in Chicago. To escort these trolleys to the desired locations during the JCI Video Survey, internal teams comprising of 3 nursing, three physicians and three administrator staff were constituted. Before the actual survey, said teams performed a mock video survey with a full survey

Figure 1: virtual Survey-mbo FrameworK

Figure 2: vital planning componentS



agenda to test the system and train staff. Surveyors sitting in Chicago used these trolleys with the help of escorts in Karachi to visit any location and ask questions directed at the faculty and staff member, through the eye of a camera.

I.d Document Management Documents were shared before the commencement of

the video survey, giving surveyors adequate time for review before starting the tracers and interviews with staff and faculty. Documents included various policies and procedures, organizational plans, institutional indicators (managerial, clinical and library of measures), data related to clinical practice guidelines and clinical pathways, SQE related information, evidence of compliance and other requested data and policies. Documents to be reviewed during the tracers were either reviewed live, focusing through the mobile camera on the trolley, or scanned immediately and shared via iShare2 with the respective surveyor.

II. Testing Wi-Fi connections, sound quality, screen resolution, iShare

document retrieval, staff preparedness and other logistics were verified, covering almost every detail of the scope mentioned in JCI application. This enabled the IT team to plan an up-gradation of services pertaining to specific areas. Said internal testing exercise revealed many areas which had poor or no WiFi coverage. Additional IT needs were identified, such as the modification of trolleys, speaker and high resolution cameras and outsourcing of Wi-Fi service, for uninterrupted and enhanced quality. An IT control room was equipped to co-ordinate video coverage. Once detailed planning was formalized and resources were identified, testing was carried out prior to the actual survey. Mobile phones were supplied to the escorts to ensure uninterrupted communication with surveyors in case of WebEx connection failure due to the lack of Wi-Fi coverage.

III. Mock Virtual/Video SurveyDry runs were carried out to test the logistics and staff

preparedness. AKUH, K developed a Mock Audit schedule replicating the final JCI survey to avoid any last moment glitches.

This was carried out by a senior team of physicians, nurses and administrators sitting on one side of the hospital, who acted as surveyors from Chicago; escorts were assigned to each trolley to be taken to patient care areas. The main objectives of the video mock survey were:

❙ to assess hospital preparation for video mock survey by testing the Wi-Fi connectivity, sound quality, screen resolution, iShare document retrieval systems

❙ to ensure staff and faculty familiarization with the video survey and

❙ to plan for the final JCIA video survey from the lessons learnt.

❙ to assess overall compliance against the JCI accreditation standards for hospitals, 4th Edition.

Following activities/audits were carried out in a manner that gave the staff actual audit feeling as it would be done in final JCI accreditation survey:

III.a Patient TracersDuring patient tracers in various patient care areas nursing,

medical and allied health staffs involved in care were interviewed for various patient care processes. Surveyors requested to scan documents from the patient MR files, WebEx enabled staff to share the requested hospital policies and procedures, medical staff privileges, eMAR, medication review process, staff competencies list etc. with surveyors. Surveyors also interviewed a few patients/ family members etc. Inclusion of off-site survey locations were also ensured, located 16-18

Figure 3: portable trolleyS witH a laptop, SpeaKerS, camera and wiFi

Figure 4: mocK Survey auditorS on diStant and auditing our clinical areaS proceSSeS



kilometers away from the main facility.

III.b Facility Tour Apart from the patient tracer facility tour carried out

by the administrator surveyor to ensure compliance with facility management system standards during the actual JCI accreditation audit, other activities were also carried out during the mock survey. Various inpatient, outpatient, diagnostic patient care areas and support services were physically inspected and staff were interviewed. Demonstration by staff on the use of fire alarms, fire extinguishers, location of Spill kit, Emergency Eye Wash and Body Shower stations were also seen through cameras. On-screen review of necessary records e.g. Quality Checks in CSSD, Refrigerator Temperature Log Sheets, staff training record, indications on various panels and maintenance control room monitoring board also took place. Almost all hospital locations were included in the facility tour, excluding rooftops.

III.c System Tracer and Other activities As per JCI accreditation auditing methodology, a number of

system tracers and other sessions were conducted through video conferencing. These included infection control, medication management, leadership, quality program, supply chain, organ transplant team interviews and document review etc., with the help of a video conferencing facility. Finally, leadership exit meeting took place in auditorium where all hospital leadership and management staff assembled, and the surveyors communicated key findings of the survey.

IV. Final Virtual/Video Survey The time arrived for the final JCI Video Survey. This was a

5-day survey from 0700- 1300 Hours Pakistan Standard Time (PST) (2100-0300 Hours Chicago Time). Due to the time difference, the surveyors could not start the survey at the hospital before 0700, therefore surveyors planned to utilize two hours for pre-survey activities each day, to make it an eight hours survey time per day. The video JCI accreditation survey team comprised of Physician Surveyor and Team Leader, Nurse Surveyor, Administrator Surveyor. In addition, there were two JCI executive leaders present to observe and evaluate this unique unprecedented methodology.

The survey was conducted in accordance with the standard survey agenda as it is done for onsite surveys. This survey was no different from any regular JCI triennial survey, except that surveyors were present on the screen of the laptop. As per agenda, JCI team started survey proceedings at 0700 hours (PST) in a video meeting with the survey coordinator, escorts and IT support staff. Survey activities included patient tracers, Systems Tracers, facility tour and other sessions as per plan. Figure 6 Learning from previous audits, a slight change was implemented in 2015, with the introduction of hybrid methodology according to which six JCIA surveyors carried out the audit: three virtually and three locally trained. A transition was made from virtual surveying to hybrid surveying.

Figure 5: Final virtual/video Survey

Final Video Survey: JCIA Surveyors sitting in Chicago and Auditing AKUH, Karachi.

Challenges and Limitations The JCI accreditation survey was a huge challenge for AKUH, K.

It involved the intensive use of a technology-enabling environment, compatible enough for the surveyors to carry out an assessment while sitting thousands of miles away in a different time zone. This was a defying moment for our IT colleagues, who were challenged to come up with interim solutions with multiple alternate plans to counter unanticipated events during the survey. Some challenges were encountered during the survey, which were skillfully overcome using alternative strategies, to execute the virtual JCI survey in its true letter and spirit. These challenges mainly include camera and locations coverage, internet degradation, unavailability of cellular services, staff engagement, and technological expertise.

ConclusionThe innovative and unique approach proved to be successful in

achieving recertification and maintaining the status of certification. For the first time in history of JCIA a virtual/video audit was conducted in 2013 & using Hybrid methodology in 2015. The JCIA Executive Director congratulated AKUH, K for developing a best



References

1 Webex is an application sharing and conferencing service that is widely used for presentations, demos, training and support from WebEx Communications, Inc., Santa Clara, CA (www.webex.com). Everything that the presenters see and manipulate on their computers can be viewed by everyone in the conference. Participants can also give “remote control” to others for demonstration or support purposes. WebEx uses either an Active X control or Java applet in the computer at each end of the conference, and installation for new attendees is automatic. Meetings can be instantly set up or scheduled, and voice is handled by voice over IP (VoIP) or traditional PSTN conference calling. Founded in 1996, the company became a wholly owned subsidiary of Cisco in 2007.

2 iShare is a browser-based, cross-platform file sharing facility provided by Apple Inc. Separate profiles are created and maintained for each member and each is provided with a customizable file sharing space. It works as a file server where different types of files can be uploaded by any member, which can be viewed by other members in real time, subject to access permission.

practice example in surveying methodology. This revolutionary style has heralded an innovation in survey methodology and AKU is the pioneer of launching this matchless technique for conducting audits at a distance. We suggest that such a detailed video survey should be acknowledged as an equivalent to a regular on-site survey as this successful venture has opened up new horizons.

BIOGRAPHIES

Salma Jaffer is a Chief Nursing Officer (CNO) at Aga Khan University Hospital, Karachi (AKUH, K). She is also a Joint Commission International Surveyor. She holds RN, RM, BScN, MScN Degrees along with Certified Six Sigma Green Belt, and is a Certified Professional in Healthcare Quality (CPHQ), as awarded by the Healthcare Quality Certification Commission. She has over 30 years of experience in healthcare and expertise in healthcare quality, executive management, accreditation preparation and survey process, performance improvement & patient safety.

Rozina Roshan is Quality, Patient Safety and Infection control Manager at Aga Khan University Hospital, Karachi (AKUH, K). She has RN, BScN, MScN Degrees along with Certified Six Sigma Green Belt and has around 20 years of experience of working at AKUH. She is also a lead auditor for ISO 9001:2008 Quality Management Systems and Internal lead Auditor for Joint Commission International Accreditation (JCIA) standards for hospitals.

Khairunnisa Ismail has a Master’s degree in Hospital & Health Management and is a Six Sigma Green Belt holder. She has over 12 years of experience in hospital planning, operations, quality & safety, financial counseling & assistance for patients and Service delivery with excellence and a patient centric approach. Currently she is Assistant Manager atClifton

Medical Services, AKUH, K and is part of the AKUH,K Internal Audit team for quality and patient safety as a volunteer.

ACKNOWLEDGEMENTSMembers of Quality Core Group at Aga Khan University

Hospital Karachi: Dr. Safdar, Kagazwala, Waqar Mirza, Noman Rajani, Ehsan Ali & Salimah Taufiq.

Figure 6: Jcia SurveyorS in clinical areaS interviewing StaFF, viewing documentS and auditing proceSSeS

http://www.webex.com

Reference


L’avenir de l’HTA dans les hôpitaux : Resultats du projet de recherche de l’UE « Adoption d’une evaluation des technologies medicales en milieu hos-pitalier dans l’UE » (AdHopHTA)

L’evaluation des technologies medicales (HTA en anglais) a ete de plus en plus utilisee dans les processus decisionnels aux ni-veaux national, regional et international au cours des 40 dernières annees. Cependant, un grand nombre de technologies medicales innovantes (HTs) caracterisees par un bon rapport qualite-prix n’est jamais utilise dans la pratique clinique alors que, dans de nombreux cas, d’autres n’ont en fait aucune valeur ajoutee significative. Cette situation peut entraîner une allocation inefficace des ressources qui a un impact sur la sante des populations et sur un accès equitable aux soins de sante dans les systèmes de sante publique sous pres-sion financière.

Une façon de surmonter ce problème est d’avoir une approche de l’HTA a l’echelle de l’hôpital, notamment parce que les hôpitaux sont le principal niveau d’entree pour les technologies medicales innovantes. L’adoption de la logique HTA en tant qu’aide a la ges-tion, ainsi qu’a la prise de decision clinique a l’echelle de l’hôpital, a ete intitulee « evaluation des technologies medicales en milieu hospitalier » (HB-HTA).

En 2013, la Commission europeenne a finance le projet triennal FP7 (AdHopHTA) visant a creer des connaissances pragmatiques, utiles pour favoriser le recours a l’approche HTA pour la gestion des technologies medicales dans les hôpitaux europeens. Un consor-tium a ete mis en place, compose de 10 institutions sous la coor-dination de l’Hôpital Clinic de Barcelone - Fundació CLINIC per a la Recerca Biomedica (FCRB)1 , pour effectuer une analyse critique des initiatives HTA existantes en milieu hospitalier et developper de nouvelles methodes, instruments et processus d’evaluation des technologies dans les hôpitaux.

Plus de 385 responsables d’hôpitaux de 20 pays differents ont collabore a ce projet de recherche qui a mis en lumière les ap-proches de prise de decision utilisees dans les hôpitaux de l’UE pour l’adoption de differentes technologies medicales, ainsi que le developpement de nouveaux outils pour favoriser l’adoption de l’approche HTA dans les processus hospitaliers.

Ameliorer l’optimisation des ressources investies dans les technologies grâce à une evaluation des technologies medicales en milieu hospitalier : Un exemple turc

L’hôpital Numune d’Ankara (ANH) a economise plus de 2 mil-lions d’euros en trois ans avec seulement deux projets, tout simple-ment en utilisant des methodes et des principes d’evaluation des

1 Le projet AdHopHTA a reçu un financement du septième programme-cadre de recherche de l’Union européenne (2007-2013) dans le cadre de l’accord de subvention n° 305018.

technologies medicales (HTA) a l’echelle de l’hôpital. HTA est une methode d’evaluation basee sur la recherche et axee sur la pratique des connaissances pertinentes disponibles en ce qui concerne les consequences directes et prevues des technologies medicales ainsi que les consequences indirectes et non voulues, a court et a long terme. L’approche HTA en milieu hospitalier (HB-HTA) signifie mettre en œuvre des activites HTA adaptees au contexte hospita-lier, pour informer sur les decisions des responsables relatives aux differents types de technologies medicales. L’approche HB-HTA est essentielle pour obtenir un meilleur rapport qualite-prix depense par l’hôpital et a ete adopte par de nombreux hôpitaux du monde entier Il existe des methodes et des outils pour mettre en œuvre l’ap-proche HB-HTA. L’ANH a ete le premier a investir dans l’approche HTA en Turquie, avec un impact avere qui transcende les frontières.

L’hôpital Numune d’Ankara (ANH) a economise plus de 2 millions d’euros en trois ans avec seulement deux projets, tout simplement en utilisant des methodes et des principes d’evaluation des techno-logies medicales (HTA) a l’echelle de l’hôpital. Cela a eu un impact positif sur la gestion de l’hôpital et l’equipe HTA. L’hôpital donne un excellent exemple de la façon dont les decisions relatives a l’utili-sation des technologies peuvent être rationalisees en investissant dans l’approche HTA en milieu hospitalier (HB-HTA), ce qui facilite clairement l’utilisation systematique de preuves scientifiques pour appuyer les decisions des responsables des hôpitaux en ce qui concerne les technologies.

Évaluation des technologie medicales dans l’administration hospitalière de Hong Kong - Pour aider les medecins, proteger les patients et ameliorer la responsabilite publique

La gestion des technologies emergentes et les nouvelles inter-ventions au moyen d’examens explicites est une tendance mon-diale dans les organisations des soins de sante. L’evaluation des technologies medicales (HTA) agit comme un « pont » entre les resultats et les politiques, en fournissant a l’administration l’hos-pitalière de Hong Kong des informations accessibles, utilisables et fondees sur des preuves pour guider la prise de decision sur l’uti-lisation appropriee des technologies et l’allocation rationnelle des ressources.

Un mecanisme HTA solide a ete mis en place dans le cadre de l’approche HA afin de garantir la securite des patients grâce a des analyses rigoureuses par des pairs des donnees de securite et d’efficacite relatives aux nouvelles procedures d’intervention/tech-nologies introduites dans le service HA. Une approche fondee sur des donnees probantes et stratifiees est adoptee pour resoudre les problèmes de securite et d’efficacite. Il est important d’equilibrer les risques et les avantages de l’introduction de nouvelles procedures/

IHF Recognition Awards for 2016 Volume 53 Number 2

Résumés en Français

Reference


technologies tout en continuant a moderniser l’HA pour ameliorer la qualite des soins fournis aux patients.

Le processus de l’HTA est transparent et les intervenants cles participent au procedures d’evaluation et a leur mise en œuvre, en vue d’obtenir des synergies en partageant les connaissances et l’experience dans les secteurs cliniques et les hôpitaux. De plus, afin de garantir la competence du personnel de specialistes, de suivre l’evolution des technologies dans le cadre de l’approche HA, d’ameliorer la securite des patients et de suivre les exigences du Conseil australien sur les normes de sante en matière d’accredita-tion hospitalière, HA a egalement etabli un referentiel pour l’accredi-tation et la definition du champ de pratique. Les activites de contrôle de la qualite seront menees de manière continue et regulière.

Évaluation des technologies medicales en milieu hospitalier : Experience dans un C.H.U italien

Le principal objectif de l’unite d’evaluation et d’innovation des technologies medicales du C.H.U Gemelli est d’informer sur les di-rectives dans les processus decisionnels concernant l’introduction et le desinvestissement des technologies medicales et, en fin de compte, de veiller a ce qu’elles soient selectionnees et utilisees de manière appropriee. Cet article constitue une synthèse de l’expe-rience de cet hôpital universitaire base a Rome dans la mise en œuvre de l’evaluation des technologies medicales en milieu hos-pitalier.

Évaluation des technologies medicales : Defis de la mise en œuvre au LibanL’adoption des dernières technologies medicales est l’un des

principaux elements stimulants des budgets des hôpitaux. Le rap-port de l’OMS (20102) a precise que « 40 % des depenses de sante sont gaspillees et qu’il est urgent d’ameliorer l’utilisation rationnelle des technologies medicales ». Il est rapporte que les pays en voie de developpement depensent davantage dans les technologies medi-cales que ceux industriels. Cela fait de l’approche HTA une neces-site pour les pays qui ont des ressources limitees et qui s’appuient sur l’expertise partagee de pays avances. Conformement a cela, le Liban porte sur ses epaules un enorme fardeau de depenses au niveau national. Il existe actuellement un ecart entre les procedures medicales avancees menees dans les hôpitaux prives et l’appro-bation. D’autre part, le gouvernement est en train de mener une campagne nationale pour la mise en œuvre de l’approche HT et fait face a de nombreux defis. Cependant, quelques hôpitaux prives libanais ont mise en place une infrastructure HTA, a travers la mise en place de programmes HTM internes.

Experiences des unites d’evaluation des technologies medicales dans les hôpitaux finlandais

Malgre un programme national d’adoption coordonnee de me-thodes medicales (MUMM), le rôle de l’evaluation des technologies medicales (HTA) dans les hôpitaux finlandais a ete limite, et la valeur d’une evaluation rigoureuse dans l’acquisition de nouvelles tech-nologies n’est pas suffisamment reconnue. La gestion par l’infor-mation ne semble pas toujours conduire a la mise en œuvre des recommandations MUMM, par consequent, des mecanismes de pilotage plus puissants et une mise en conformite obligatoire aux recommandations peuvent être necessaires. Les economies exi-gees par son organisation hôte ont recemment conduit a la fer-

meture du bureau national de l’HTA, de Finohta et a la fin du pro-gramme MUMM, ce qui pourrait reduire davantage l’adhesion a la prise de decision fondee sur des donnees probantes À l’heure actuelle, les principaux acteurs ayant adopte l’approche HTA sont l’Agence finlandaise des medicaments (FiMeA) et les cinq hôpitaux universitaires. Compte tenu de la rarete des ressources reservees a l’evaluation des technologies, il existe un risque eleve que les activi-tes de l’HTA en Finlande diminueront encore, a moins que la coor-dination nationale de l’HTA ne soit rapidement retablie.

Etre là-bas » sans être là-bas : Une approche innovante pour re-obtenir l’agrement JCI par le biais d’un sondage virtuel/video (hybride)

En 2006, l’hôpital universitaire Aga Khan (AKUH) est devenu le premier hôpital au Pakistan a obtenir l’agrement de la Joint Com-mission International (JCI). Pour garder la certification, des etudes triennales sont effectuees par des auditeurs JCI en effectuant une visite sur place. En 2009, AKUH a passe avec succès la 1ère etude triennale ; cependant, en 2012, le re-agrement est devenu un defi pour le Pakistan pour des raisons de securite. Compte tenu de ces circonstances inevitables, une approche unique et innovante de prospection virtuelle/video a ete proposee. C’etait un grand defi pour AKUH, mais avec la negociation en cours avec les cadres de JCI, il a ete convenu de prendre un risque et de realiser l’etude JCI en utilisant la technologie video pour la toute première fois. La technologie avancee a ete mise a disposition et testee, devenant les yeux et les oreilles des inspecteurs travaillant avec un fuseau horaire different. Un poste de travail mobile specialement conçu avec camera haute definition, ordinateur portable, casque, micro-phone et haut-parleur a ete mis en place. Cette approche nouvelle et innovante a ete très appreciee par le JCIA car ils ont pu realiser le même programme d’audit, examiner des documents, les traite-ments, les centres de soins des patients, parler avec ces derniers ainsi qu’avec le personnel durant l’etude virtuelle exactement de la même manière qu’une etude sur place.

« Évaluation economique appliquee au milieu hospitalier » Experience de l’organisation sanitaire integree Ezkerraldea Enkarterri Cruces (pays basque)

La methode d’evaluation economique (EE) est une discipline qui est utilisee en Espagne depuis plus de 30 ans. En depit du fait qu’elle n’est presque utilisee que par les agences d’evaluation des technologies medicales (HTA), on y a egalement recours dans les hôpitaux voulant integrer des technologies novatrices pour les trai-tements diagnostiques, therapeutiques ou chirurgicaux ou l’innova-tion organisationnelle.

Dans ce contexte, nous, les membres de l’organisation sani-taire integree Ezkerraldea Enkarterri Cruces (OSI EEC), travaillons dans le domaine du developpement durable, et nous le conside-rons comme une valeur ajoutee strategique pour les patients, ce qui nous a forces a approfondir le concept de coût-efficacite. Cela nous oblige a mesurer les resultats obtenus au niveau sanitaire et les ressources utilisees pour les obtenir.

C’est pourquoi nous avons mis en œuvre la methode HTA et que nous systematisons son utilisation comme outil de gestion en milieu hospitalier afin de s’assurer que les nouvelles technologies medicales sont mises en place en se basant sur le rapport coût-efficacite.

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Resumen en Español

El futuro de la ETS en los hospitales: evidencias del proyecto de investiga-cion de la UE “Adopcion de la Evaluacion de las Tecnologias Sanitarias a Escala Hospitalaria en la UE” (AdHopHTA, por sus siglas en ingles)

La Evaluación de Tecnologias Sanitarias (ETS) se ha estado utili-zando cada vez más en los procesos de toma de decisión a escala nacional, regional e internacional durante los últimos 40 años. Sin embargo, una gran cantidad de Tecnologias Sanitarias innovadoras interesantes nunca llegan a la práctica clinica, mientras que, en mu-chos casos, otras tecnologias sin un valor añadido significativo si logran hacerlo. Esta situación puede dar como resultado una asig-nación de recursos poco efectiva e ineficiente que tiene un impacto en la salud de la población y en el acceso equitativo a la salud en los sistemas de salud pública con dificultades financieras.

Una manera de superar este problema es el enfoque de la ETS a escala hospitalaria, fundamentalmente, porque los hospitales son la principal puerta de acceso para las tecnologias sanitarias inno-vadoras. La adopción de la lógica de la ETS como apoyo para la dirección, junto con la toma de decisión clinica a escala hospitala-ria, se ha denominado “evaluación de las tecnologias sanitarias a escala hospitalaria” (HB-HTA, por sus siglas en ingles).

En 2013, la Comisión Europea financió un proyecto trienal FP7 (AdHopHTA) con el objeto de crear conocimiento práctico y útil para fomentar el uso del enfoque de la ETS para gestionar las tecnolo-gias sanitarias en los hospitales europeos. Se creó un consorcio, compuesto por 10 instituciones bajo la coordinación del Hospital Clinic de Barcelona – Fundació CLINIC per a la Recerca Biomedica (FCRB)1, para llevar a cabo un análisis critico de las iniciativas de ETS a escala hospitalaria ya existentes y desarrollar nuevos meto-dos, instrumentos y procesos para la evaluación de la tecnologia en las instalaciones hospitalarias.

Más de 385 directores de hospitales de 20 paises diferentes han colaborado en esta investigación, que ha contribuido a comprender mejor los enfoques para la toma de decisión de los hospitales de la UE para la adopción de tecnologias medicas diferentes, como tam-bien el desarrollo de nuevas herramientas para alentar la adopción del enfoque de la ETS en los procesos hospitalarios.

La mejora de la rentabilidad del dinero invertido en tecnologias a traves de la evaluacion de las tecnologias a escala hospitalaria: un ejemplo en Turquia

El Hospital de Formación e Investigación de Ankara Numune (ANH, por sus siglas en ingles) ha ahorrado más de 2 millones de euros en tres años con solo dos proyectos, simplemente utilizan-do los metodos y principios de la Evaluación de las Tecnologias

1 El proyecto AdHopHTA ha recibido financiación del Séptimo Programa Marco de Investigación de la Unión Europea (2007-2013) en virtud del acuerdo de subvención N.° 305018.

Sanitarias (ETS) a escala hospitalaria. La ETS es una evaluación basada en la investigación y orientada a la práctica del conoci-miento disponible pertinente tanto de las consecuencias directas y previstas, como tambien las indirectas y las imprevistas, a corto y largo plazo. La evaluación de las tecnologias sanitarias a escala hospitalaria (HB-HTA, por sus siglas en ingles) implica la realiza-ción de las actividades de ETS a medida del contexto hospitalario para informar las decisiones de dirección sobre los diferentes tipos de Tecnologias Sanitarias. La HB-HTA es esencial para lograr una mejor eficiencia del dinero invertido en el hospital y ha sido adop-tada por muchos hospitales en el mundo. Hay distintos metodos y herramientas para la realización de la HB-HTA. El ANH ha sido el primero en invertir en la ETS en Turquia, con un impacto probado que trasciende fronteras.

El Hospital de Formación e Investigación de Ankara Numune (ANH, por sus siglas en ingles) ha ahorrado más de 2 millones de euros en tres años con solo dos proyectos, simplemente utilizando los metodos y principios de la Evaluación de las Tecnologias Sanita-rias (ETS) a escala hospitalaria. Esto ha tenido un impacto positivo en la dirección del hospital y el equipo de la ETS. El hospital es un ejemplo excelente sobre cómo las decisiones relativas al uso de la tecnologia se puede racionalizar invirtiendo en la ETS a escala hos-pitalaria, lo que claramente facilita el uso sistemático de la evidencia cientifica para apoyar las decisiones de la dirección relativas a las tecnologias.

Evaluacion de las Tecnologias Sanitarias en el Hospital Authority de Hong Kong – apoyar a los medicos, proteger a los pacientes y mejorar la respon-sabilidad para con el público

La gestión de la tecnologia emergente y las nuevas intervencio-nes por medio de revisiones explicitas es una tendencia mundial en las organizaciones dedicadas al cuidado de la salud. La evaluación de las tecnologias sanitarias (ETS) actúa como un “puente” entre la evidencia cientifica y la formulación de politicas, aportando al Hos-pital Authority (HA) de Hong Kong una información accesible, utili-zable y con base empirica sobre el uso apropiado de la tecnologia y la asignación racional de los recursos.

Se ha creado un sólido mecanismo de ETS en el HA orientado a garantizar la seguridad del paciente a traves de rigurosas revisiones entre pares de los datos sobre la seguridad y la eficacia relativa a los procedimientos de intervención y la tecnologia introducidas en el servicio de HA. Se adopta un enfoque con base empirica y con estratificación de riesgos para abordar los problemas de seguridad y eficacia. Es importante equilibrar los riesgos y beneficios de la in-troducción de nuevos procedimientos/tecnologia, al tiempo que se moderniza el HA para mejorar la calidad del cuidado del paciente.

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El proceso de la ETS es transparente y los actores claves están comprometidos en el proceso de evaluación y puesta en marcha, con vistas a lograr sinergias mediante el conocimiento compartido y la experiencia a traves de las distintas especialidades clinicas y los diferentes hospitales. Además, para garantizar la competencia del equipo de profesionales, seguir el ritmo del cambio tecnológico en el HA, mejorar la seguridad de los pacientes y cumplir con los requisitos del Australian Council on Healthcare Standards relativos a la acreditación de los hospitales, el HA tambien ha establecido un marco de trabajo para la comprobación de credenciales y la defini-ción del alcance de la práctica. Se realizarán actividades de control de calidad de manera continua y regular.

La Evaluacion de las Tecnologias Sanitarias a Escala Hospitalaria: experien-cia en un hospital universitario italiano

El principal propósito de la Evaluación de las Tecnologias Sani-tarias y la Unidad de Innovación del Hospital Universitario Gemelli es asesorar a los directivos en los procesos de tomas de decisión concernientes a la introducción y desinversión de las tecnologias sanitarias y, en última instancia, garantizar que se seleccionen y uti-licen apropiadamente. Este estudio sintetiza la experiencia de este Hospital Universitario con sede en Roma con la puesta en marcha de la Evaluación de las Tecnologias Sanitarias a Escala Hospitalaria.

La Evaluacion de las Tecnologias Sanitarias: retos de su aplicacion en LibanoLa adopción de los últimos avances en tecnologia sanitaria es

uno de los principales potenciadores de los presupuestos hospita-larios. El informe de la OMS (20102) señaló que “el 40 % del gasto en salud se está desperdiciando y existe una necesidad urgente de mejorar el uso racional de la tecnologia sanitaria”. Se informó que los paises en desarrollo gastan más en tecnologia sanitaria que los paises industrializados. Por ello, la ETS se convierte en una nece-sidad para los paises que tienen recursos limitados y se basan en conocimientos compartidos de los paises avanzados. En conso-nancia con esto, Libano carga con un gran gasto sanitario nacional. En realidad, existe una brecha entre los avanzados procedimientos medicos efectuados en los hospitales privados, y el apoyo oficial. Por otro lado, el Gobierno se encuentra en proceso de ejecutar una campaña nacional de aplicación de las tecnologias sanitarias y enfrenta numerosos retos. Sin embargo, existen algunos hospitales privados libaneses que han preparado una infraestructura de ETS mediante la puesta en marcha de programas internos de gestión de las tecnologias sanitarias.

Experiencias de Evaluacion de las Tecnologias Sanitarias en hospitales de Finlandia

A pesar de la existencia de un programa para la Aceptación Administrada de los Metodos Medicos (MUMM, por sus siglas en ingles), el papel de la evaluación de las tecnologias sanitarias (ETS) en los hospitales de Finlandia ha sido limitado, y no está su-ficientemente reconocido el valor de una rigurosa evaluación en la adquisición de nuevas tecnologias. La gestión por información en si misma no siempre parece conducir a la puesta en marcha de las recomendaciones de MUMM, por lo tanto, podrian ser nece-sarios mecanismos de dirección y obligación de conformidad con recomendaciones. Los ahorros que requeria su organización sede ocasionaron recientemente el cierre de la oficina nacional de ETS,

Finohta, y el programa de MUMM, lo que puede reducir aun más el seguimiento de la toma de decisiones con base empirica. Ac-tualmente, los principales actores en el campo de la ETS son la Agencia Nacional Finlandesa de Medicamentos (FiMeA) y los cinco hospitales universitarios. Debido a la escasez de recursos reserva-dos para la evaluación de tecnologia, existe un alto riesgo de que las actividades de ETS en Finlandia disminuyan aun más, salvo que la coordinación nacional de ETS se restablezca rápidamente.

“Estar alli” sin estar alli:un enfoque innovador para obtener la reacreditacion de la JCI a traves de una entrevista virtual y en video (hibrida)

En 2006, el Hospital Universitario Aga Khan (AKUH, por sus si-glas en ingles) se convirtió en el primer hospital de la historia de Pa-kistán en recibir la acreditación de la Joint Commission International (JCI, por sus siglas en ingles). Para mantener el estatus de certifi-cación, los auditores de la JCI llevan a cabo entrevistas trienales mediante una visita in situ. En 2009, AKUH superó con exito la pri-mera entrevista trienal; sin embargo, en 2012, la reacreditación se convirtió en un gran reto para Pakistán por razones de seguridad. Considerando estas circunstancias inevitables, se propuso un en-foque único e innovador de realización de entrevistas virtuales y en video. Esto constituyó un gran reto para AKUH, sin embargo, con una negociación continuada con los ejecutivos de la JCI se acordó realizar un intento y llevar a cabo la entrevista de la JCI utilizando tecnologia de video por primera vez en absoluto. Se puso a dis-posición la tecnologia más avanzada y se la probó, convirtiendose asi en los ojos y oidos de los inspectores que se encontraban en una zona horaria diferente. Se instaló una estación de trabajo móvil especialmente diseñada, con cámara de alta definición, ordenador portátil, auriculares, micrófono y altavoz. Este enfoque nuevo e in-novador fue muy apreciado por la JCI, ya que pudieron ejecutar el mismo programa de auditoria, ver los documentos, la medicación, las zonas de cuidado de los pacientes, entrevistar a los pacientes y al personal durante la entrevista virtual, del mismo modo que du-rante una entrevista in situ.

“La evaluacion economica aplicada al ámbito hospitalario”La experiencia de la Organizacion Sanitaria Integrada Ezkerraldea Enkarte-rri Cruces (Pais Vasco)

La metodologia de Evaluación Económica (EE) es una disciplina que ha sido utilizada en España desde hace más de 30 años. A pesar de que ha sido aplicada casi exclusivamente por agencias de Evaluación de Tecnologia Sanitaria (ETS), tambien se la puede encontrar en hospitales que aspiran a incorporar tecnologias inno-vadoras para diagnóstico, tratamientos terapeuticos o quirúrgicos o innovaciones organizacionales.

En este contexto, en la Organización Sanitaria Integrada Ezke-rraldea Enkarterri Cruces (OSI EEC) nos encontramos trabajando en el área de la sostenibilidad como un valor añadido estrategico para los pacientes que nos ha obligado a profundizar más en el concepto de la rentabilidad. Debimos medir los resultados sanita-rios obtenidos y los recursos utilizados para alcanzarlos.

Por ello, utilizamos la metodologia de la ETS y estamos siste-matizando su uso como una herramienta de gestión en el entorno hospitalario para garantizar que las nuevas tecnologias sanitarias se introduzcan con criterios de rentabilidad.

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中文摘要

卫生技术评估在医院的未来发展之路：欧盟科研项目“欧盟采用基于医院的卫生技术评价”（AdHopHTA）的证据

过去40年来，卫生技术评估（HTA）被越来越多地应用到了国家、地区和国际的各级决策过程中。然而，大量有价值的卫生技术（HTs）却一直没有应用到临床实践，反而在多数情况下，那些没有明显附加值的卫生技术做到了这一点。这种情况可能会造成资源分配效率低下和不足，进而在财政压力下对人们的健康和公平享有公共保健系统的卫生保健服务造成影响。

克服这个问题的一个办法，是在医院层面探讨卫生技术评估，主要是因为医院是新卫生技术的主要进入层面。加上在医院一级进行临床决策，作为对管理进行支持而采取的卫生技术评估逻辑已被称为“基于医院的卫生技术评估”（HB-HTA）。

2 0 1 3 年，欧盟委员会资助了一个为期 3 年的 F P 7 项目（AdHopHTA），旨在积累务实的知识，从而有助于促进卫生技术评估在管理欧洲医院卫生技术方面的应用。他们成立了一个协会，由Hospital Clínic de Barcelona - Fundació CLINIC per a la Recerca Biomédica （FCRB）1 的10家机构组成，对现有基于医院的卫生技术评估项目进行批评分析，并开发新方法、手段和步骤来在医院环境中进行技术评估。

来自20个不同国家的385名医院管理人员合作参与了这项研究。它解释了欧盟医院为采用不同的医疗技术所采用的各种决策方法，以及为促进卫生技术评估方法在医院中的使用而开发新工具。

通过基于医院的卫生技术评估来提升技术投资资金的价值：土耳其的一个示例

该院（ANH）利用两个项目，仅通过在医院一级应用卫生技术评估（HTA）方法和原则，在三年间就节省了200多万欧元的资金。卫生技术评估是一项以研究为基础、以实践为导向的评估。它针对短期和长期的卫生技术的直接故意后果以及间接无意后果的相关知识进行评估。基于医院的卫生技术评估（HB-HTA）是指，采取根据医院环境而定制的卫生技术评估，来为管理决策提供不同类型的卫生技术。基于医院的卫生技术评估的重要性在于：使医院花费的金钱能有更高的价值。它已被全世界的许多医院的采用。基于医院的卫生技术评估有现成的方法和工具。安卡拉Numune培训和研究医院是土耳其第一家对卫生技术评估进行投资的医院。其影响力非同凡响。

该院（ANH）利用两个项目，仅通过在医院一级应用卫生技术评估（HTA）方法和原则，在三年间就节省了200多万欧元的资金。这对医院管理和卫生技术评估团队产生了积极的影响。该院树立了了一个很好的榜样，说明如何通过对基于医院的卫生技术评估（HB-HTA）进行投资，来使技术应用的相关决策合理。这明显简化了科学证据的系统利用，从而协助医院对技术所进行的管理决策。 1 Marchetti根据第305018号授权协议，AdHopHTA项目获得了欧盟第七期研发

计划（2007-2013）的资助。

香港医院管理局的卫生技术评估—— 支持医生、保护病人和增强公众责任感

通过明确的审查来管理新兴技术和新干预措施，是医疗机构中的全球化趋势。卫生技术评估（HTA）在证据与决策之间起到了“桥梁”的作用，为香港医院管理局（“医管局”）提供了便利、易于使用及有证据证明的信息来指导相关决策，从而进行适当的技术利用和理性的资源配置。

医管局制订了健全的卫生技术评估机制，旨在通过对引入医管局服务内的新干预程序/技术的安全和效能数据进行严格的同行评议来确保患者安全。它们还采用了通过证据证明和风险分层的方法来解决安全和效能的问题。很重要的一点是，在平衡所引入的新程序/新技术的风险和利益的同时，继续让医管局更现代化，从而提升患者卫生保健质量。

这一卫生技术评估流程完全透明，其主要利益相关者参与到评估和实施过程中，其目的是通过在临床专科和医院之间共享知识和经验来实现协同效应。此外，为确保专业人员的能力，紧跟医管局的技术变革，加强病人的安全，和遵循澳大利亚医疗保健标准委员会的要求，医管局还设立了实践范围认证和界定的框架。它们还将一直进行定期质检。

基于医院的卫生技术评估：一间意大利大学医院的经验Gemelli教学医院的卫生技术评估和创新部的主要目的，是

对卫生技术的引入和减少投资的相关决策过程提供指导方针，并最终确保能适当选择和使用卫生技术。本文综述了这间位于罗马的大学医院在实施基于医院的卫生技术评估中所取得的经验。

基于医院的卫生技术评估：在黎巴嫩实施所面临的挑战应用最新的医疗保健技术是医院预算的主要动力之一。世卫

组织报告（第20102号）表示，“40%的卫生保健费用被浪费，迫切需要更合理地使用卫生技术”。据悉，发展中国家在医疗技术方面的支出比工业化国家更高。这使得卫生技术评估成为了那些资源有限并且依靠发达国家进行专业技术分享的国家不可缺少的措施。相应地，黎巴嫩在国家层面上承担着巨额的支出负担。私立医院所提供的先进医疗程序，与它们保证的内容实际上有所差别。另一方面，政府正在开展全国卫生技术实施运动，并且还面临着无数的挑战。然而，也有几家黎巴嫩的私人医院通过实施内部卫生技术管理计划来准备好了卫生技术评估的基础设施。

芬兰医院卫生技术评估单位的经验尽管针对医疗方法的管制应用（MUMM）有国家计划，芬

兰医院卫生技术评估（HTA）的作用却很有限。在新技术获取方面所进行的严格评估，其价值得不到充分认可。通过信息来进行管理看上去似乎并不总会实施对MUMM所提出的建议，进而导致需要更强有力的指导机制和对建议的强制性合规。其

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主办单位所要求的费用节省，最近最终导致了国家卫生技术评估办公室Finohta和MUMM计划停摆。这可能会进一步降低对基于证据而进行决策的遵循。目前，卫生技术评估领域的主要参与方是芬兰药物管理局（FIMeA）和五所大学医院。鉴于技术评估的资源匮乏，除非能迅速地重新在国家层面对卫生技术评估进行协调，否则芬兰的卫生技术评估将有进一步减少的风险。

无需身临其境就能“伴随左右”：通过虚拟/视频调查（混合）实现JCI重新认证的新方法

2006年，阿加汗大学医院（AKUH）成为了巴基斯坦第一家获得联合委员会国际部（JCI）认证的医院。为维持其认证状态，JCI审核员将通过现场走访进行三年一度的调查。2009年，阿加汗大学医院地顺利通过了第一次三年一度的调查；然而，由于安全方面的原因，2012年的重新认证成为了巴基斯坦所面临的挑战。考虑到这些不可避免的情形，有人提出了一种独特的新方法——虚拟/视频调查。对于阿加汗大学医院来说，这是一项巨大的挑战。但是，经过与JCI主要负责人进行不断的协商，最终同意勉力一试，首次通过视频技术来进行JCI调查。院方提供了先进的技术并通过了测试。这项技术成为了身处另一个时区的调查人员的耳鼻喉舌。它使用了专门设计的移动工作站，并配备了高清摄像头、笔记本电脑、耳机、麦克风和扬声器。JCIA非常赞赏这种新方法，因为他们可以在虚拟调查期间进行与现场调查相同的审核议程，查看文件、药物、病人护理区，对病人和员工进行采访。

“经济评价在医院背景下的应用” Ezkerraldea Enkarterri Cruces 综合卫生组织（巴斯克国家）的经验

经济评价（EE）方法学是一门在西班牙使用了超过30年的学科。尽管几乎只有医疗技术评估（HTA）机构在使用EE，但它也在医院应用，其目的是将创新技术用于诊断、治疗或外科治疗或组织的创新。

在这方面, 我们正在Ezkerraldea Enkarterri Cruces综合卫生组织（OSI EEC）进行可持续性方面的研究，以期其为患者带来战略附加值。因此，我们在成本效益这一概念上进行了深入的探索。它要求我们衡量在卫生方面所取得的成果，以及实现这些目标所使用的资源。

因此，我们实施了HTA方法，并正在将其应用作为医院环境中的一项系统化的管理工具，以确保新医疗保健技术的引入符合成本效益的标准。

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Reference


IHF events calendar

For further details contact the: IHF Partnerships and Project, International Hospital Federation, 151 Route de Loëx, 1233 Bernex, Switzerland; E-Mail: [email protected] or visit the IHF website: https://www.ihf-fih.org

2017MEMBERS

AUSTRALIAJoint 2017 ACHSM/ACHS Asia-Pacific health leadership congressThe winds of change – adjust your sailsWed – Fri Sep 29, Hilton Sydney, 488 George Street, Sydney NSW 2000, AustraliaAustralasian College of Health Service Managementhttp://achsm.org.au/congress

BRAZIL5º CONAHP – (Congresso Nacional dos Hospitais Privados) Brazilian Private Hospitals ConferenceThe Hospital of Future: the future of hospitalsNovember 22 -24, Convention Center – Hotel Sheraton WTC - São Paulo, BrazilAssociação Nacional de Hospitais Privadoshttp://www.conahp.org.br

GERMANY European Hospital ConferenceNovember 16, Düsseldorf FairgroundsGerman Hospital Federationhttp://www.dkgev.de; www.deutscherkrankenhaustag.de; www.medica.de

German Hospital ConferenceNovember 13-16, Düsseldorf FairgroundsGerman Hospital Federationhttp://www.dkgev.de; www.deutscherkrankenhaustag.de; www.medica.de

SWITZERLANDH+ Congress 2017Humanity and Technology: Digital Dynamics without boundaries?November 8, Kursaal Bern, Kornhausstrasse 3, 3000 Bern, SwitzerlandH+ Les Hôpitaux de Suissewww.hplus-kongress.ch

2017IHF

41st World Hospital CongressNovember 7 – 9, Taipei, TaiwanFor more information, contact [email protected]

2018IHF

42nd World Hospital CongressOctober 9 – 11, Brisbane, AustraliaFor more information, contact [email protected]

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mailto:info%40ihf-fih.org?subject=

https://www.ihf-fih.org/

http://achsm.org.au/congress

http://www.conahp.org.br

http://www.dkgev.de

http://www.deutscherkrankenhaustag.de

http://www.medica.de

http://www.dkgev.de

http://www.deutscherkrankenhaustag.de

http://www.medica.de

http://www.hplus-kongress.ch

mailto:2017congress%40ihf-fih.org?subject=

mailto:2017congress%40ihf-fih.org?subject=

The 3-day congress will give you a chance to:

Discover best practices in leadership in hospital and healthcare management and delivery of services

Learn from top international level of presentation and recognition of outstanding healthcare practices

Participate to professional sessions and discussions on global healthcare challenges and opportunities

Take part to multidisciplinary exchange of knowledge, expertise and experiences

Network actively during numerous occasions

“Patient-friendly & Smarter Healthcare”November 7-9 | Taipei International Convention Center

For more information, please visit www.worldhospitalcongress.org

http://bit.ly/IHF2017Registration

Join health ministers, global healthcare leaders andhospital CEOs in Taipei, Taiwan

PLENARY SPEAKERS

Nancy Howell Agee USA

Prof. John Leong Chi-yanHong Kong

Dr. Deborah Cole Australia

Dr. Sidney Klajner Brazil

Dr. San-Cheng Chang Taiwan

PROGRAMME http://worldhospitalcongress.org/program/

HEALTHCARE VISITS http://worldhospitalcongress.org/program/healthcare-visits/

SOCIAL EVENTS http://worldhospitalcongress.org/social-events-2/

PRE & POST CONGRESS TOURS http://worldhospitalcongress.org/travel-accom-modation/pre-post-congress-tours-2/

Early bird deadline: July 31, 2017

QUICK LINKS