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Enhancing Human Resources and Use of Appropriate Technologies for Maternal and Perinatal Survival in Sub-Saharan Africa (ETATMBA) David Ellard, Version 1, 07.11.13 ETATMBA Project Research Protocol: Tanzania

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Page 1: ETATMBA Project Research Protocol: Tanzania · Web viewMaternal mortality and morbidity associated with pregnancy remain major challenges to improving health in Africa. Six hundred

Enhancing Human Resources and Use of Appropriate Technologies for Maternal and Perinatal Survival in Sub-Saharan Africa (ETATMBA)

David Ellard, Version 1, 07.11.13

ETATMBA Project Research Protocol: Tanzania

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Table of Contents

Background....................................................................................................................................3

Aims of the study...........................................................................................................................4

Broad aims..................................................................................................................................4

Specific aims..............................................................................................................................5

Methods..........................................................................................................................................5

Design.........................................................................................................................................5

Outcomes....................................................................................................................................5

Research team.............................................................................................................................5

Participants.................................................................................................................................5

Procedure........................................................................................................................................6

Interviews...................................................................................................................................6

Quantitative data.........................................................................................................................7

Data analysis...................................................................................................................................7

Qualitative Data Analysis...........................................................................................................7

Quantitative Analysis.................................................................................................................8

Ethical considerations.....................................................................................................................8

Information and consent forms......................................................................................................9

Letter............................................................................................................................................17

Draft Emails.................................................................................................................................18

References....................................................................................................................................19

Interview schedules......................................................................................................................20

Interview Schedule for ETATMBA trainees (Draft)...............................................................20

For those who have been trained by the NPCs (Draft):...........................................................21

For the District Medical Officers (Draft):................................................................................21

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BackgroundMaternal mortality and morbidity associated with pregnancy remain major challenges to improving health in Africa. Six hundred thousand women die every year as a result of complications from pregnancy and childbirth and most are preventable. 1 Human resources and the effective service delivery of appropriate sustainable technologies have been identified as key areas that need support if this global inequity in health is to be improved. The Millennium Development Goals 4 and 5 of reducing maternal mortality and perinatal death can only be achieved by developing and evaluating innovative transferable and sustainable solutions through collaboration between African and International partnerships.

Maternal mortality in most of sub-Saharan Africa remains obstinately high 2 in Tanzania, for example, the maternal mortality rate in 2008 was 449/100,000 compared to the UK 8/100,000. 3 Whereas there has been a steady decline in maternal mortality in Europe over the past 60 years, in Africa even long periods of stability and increases in health spending have had little apparent effect in some countries. 4 The UN has set a target for maternal case fatality rate of less than 1%. Skilled health personnel attend less than 50% of women in low-income countries, yet life-threatening complications that require emergency care will arise for around 15%. 4 Perinatal mortality is 12 times higher than maternal mortality and accounts for seven million deaths: about three million babies are stillborn and four million die in the neonatal period. Much of this loss is preventable. 2, 4, 5 The major causes of the almost four million neonatal deaths in low-income countries in or around the first week of life are infection, pre-term birth and asphyxia. 5

There is a need for alternative strategies as Models of healthcare like those that have developed in Europe, based on highly trained medical specialists, using complex technology, are unlikely to be practical or sustainable in sub-Saharan Africa. There is much evidence to support a different model of service provision in Africa, whereby the relatively scarce resource of medical obstetric specialists are focused to train and support a service mainly provided by healthcare staff other than doctors, e.g. non-physician clinicians (NPCs), assistant medical officers, clinical officers, midwives and outreach community health-workers. In this model, the medically trained specialist obstetricians, mainly operating in large centres and capital cities, can focus their attention on management of difficult clinical cases and on providing support, leadership and training for NPCs. In sub-Saharan Africa, due to training and retention difficulties, there are only 5 doctors per 100,000 people. 1 Many women in rural and urban communities in Africa give birth without any trained assistance for their pregnancy and childbirth. Programmes of training for health-workers to provide safe outreach community healthcare are being developed but these need to be systematic, transferable, and able to be scaled up to meet the needs of these woman across Africa. A health delivery model of non-physician clinicians (NPCs) and with support and supervision of the physician specialist obstetricians would be an affordable and sustainable system for these communities.

Much work has been done to assess the efficiency of training NPCs (assistant medical officers, clinical officers and specialist midwives) in the skills of clinical decision-making and surgical

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intervention. 1, 6 Training skilled attendants to prevent, detect and manage major obstetric complications, including undertaking emergency caesarean surgery in complicated deliveries is arguably the single most important factor in preventing maternal deaths and protecting the human rights of women. 1, 6-8 To be effective NPCs need appropriate equipment, drugs and technology essential for managing obstetric complications in rural or deprived communities.

Task shifting from physicians to non-physicians appears to be both safe and effective in countries that have organised and supported the extension of their maternal care in this way. 1, 6-10 Major surveys consistently show that extra training and support can achieve task shifting and improve maternal and fetal mortality and morbidity in the areas where these schemes have been piloted. 6-8 Most of the maternal population in sub-Saharan Africa lives outside the major cities and for these women there remain major challenges to effective maternal care. Solutions must include outreach of effective care to this population. In addition to lack of available trained manpower, factors that have been identified as contributing to the higher maternal and perinatal mortality include poor availability of relatively cheap drugs and simple technologies for managing post-partum haemorrhage (PPH). For example, shortages of immediately available blood, lack of access to senior advice on 24/7 basis, access to facilities and staff for emergency Caesareans, and delays and inadequacies in the safe transport to hospital when complications arise. There can also be a problem in recognising complications early enough for effective action (for example; breech, transverse lie, placenta praevia, pre-eclampsia and anaemia). Early detection of these could be improved with training and simple technologies. It is estimated that 75% of maternal deaths and more than 60% of perinatal deaths are caused by eight major conditions. For the mother the five major killers are post-partum haemorrhage, sepsis, hypertensive disorders of pregnancy, obstructed labour, and unsafe abortion and the three major causes of perinatal child death are low birth-weight, birth asphyxia, and infection. 6, 11

Enhancing Training and Appropriate Technologies for Mothers and Babies in Africa (ETATMBA) is European Commission Framework 7 funded collaboration between the University of Malawi, the Malawi Ministry of Health, the University of Warwick (UK), the Karolinska Institute (Sweden) and Ifakara Health Institute in Tanzania (UK). The aim of the project is to provide training in advanced obstetrics, neonatal care and leadership to 50 NPCs in both Malawi and Tanzania (called assistant medical officers (AMOs) in Tanzania) and to evaluate its impact. In Malawi the evaluation is being conducted as a randomised controlled trial and is not part of this application as it already has approval. 12 This application is for an evaluation of the Tanzanian part of the project.

Aims of the study

Broad aimsThe main aims of this study are to evaluate the impact on health outcomes (e.g. maternal and perinatal morbidity and mortality) of the training in the facilities where the trainees are based and to explore perceptions of the training from a range of stakeholders.

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Specific aimsTo explore changes in maternal and perinatal mortality (pragmatically defined in this study as fresh stillbirths and neonatal deaths before discharge from the health care facility) comparing data from before the training was implemented and an endpoint not less than a year after the trainees completed their training.

Methods

DesignThe study is mixed methods with a retrospective before and after comparison of the quantitative data and a qualitative evaluation (interviews) exploring the perceptions of the programme from a number of stakeholders including the trainees, their district medical officers, colleagues whom they have cascaded ETAMBA skills to and trainers.

OutcomesThe primary outcome for the study is early neonatal mortality (only includes deaths that occur before discharge) in the district.

Secondary outcomes include:• Perinatal mortality (defined as fresh stillbirths and neonatal deaths before discharge

from the health care facility)• Maternal death rates (case specific);• Recorded data (e.g. still births, Post-partum Haemorrhage, C-Section, Eclampsia,

Sepsis, Neonatal resuscitation);• Availability of resources (e.g. are drugs/blood available);• Use of available resources (e.g. are drugs being used).

Our project partner in Tanzania (Ifakara Health Institute) routinely collects all of the outcomes above along with a multitude of other health outcomes and indicators the data is anonymous pooled data (not patient identifiable).

Research teamThe primary data collection team will consist of two local research assistants based at the Ifakara health institute, Dar Es Salaam, Tanzania. Both of the research assistants are experienced researchers. The principal investigator at the Ifakara health institute provides local support with management/oversight provided by David Ellard at Warwick.

ParticipantsDuring late 2010 and 2011 approximately 50 Assistant medical officers (AMOs) were recruited from districts across Tanzania and invited to join the ETATMBA training programme. Whilst there has been some attrition (e.g. withdrawn from the training), the remaining trainees represent the sample from which we will invite participation in interviews. We will invite all to participate. In addition, we will identify a number of facilities where trainees are working and invite the district medical officer and cascadees to be involved in interviews (Cascadee – a nurse, midwife, AMO

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whom our ETATMBA AMO have shared their ETATMBA skills and knowledge with). We will also invite a number (two or three) of the local faculty, who delivered the training, to give interviews.

Procedure

InterviewsA letter of invitation including an information sheet and a copy of a consent form will be sent via email to all trainees from the Ifakara health institute. Similarly, the researchers will identify the facilities where trainees are based and email letters and information to the district medical officer. This letter will have two purposes the first to inform them about our research in general and secondly to invite them to participate. A copy of the consent form will be included for information. The information will ask the participant to respond to the email if they require more information but also to express a wish to take part and asked to return a signed consent form. The research team In Ifakara will manage responses and make appointments at mutually agreeable times to conduct interviews. The information will state that if there is no response within two weeks of the first mail a single reminder will be sent.

Tanzania is a very large country and road access is at times problematic. Whilst face-to-face interviews are our first option we are aware we may lack resources and time to travel to the remotest districts. However, internet access, whilst not perfect does have good countrywide coverage so we will also offer a more structured interview exploring key area but allowing free text, which can be completed by the participant in their own time and emailed back to the team.

We can only identify cascadees once we have spoken to the trainees the number and spread of these is unknown. The researchers will be visiting some of the facilities, probably those not too far away; during these visits they may identify a cascadee and be able to invite them for an interview (providing them with information and consenting them if willing). Our sample of cascadees may be limited but available resources (funding for lots of travel) and a project endpoint of July 2014 limit us.

The researchers will identify local faculty trainers who provided the training and will also invite them to be interviewed

Interviews will be conducted at a time and place agreeable to all concerned and they will not interfere with the day-to-day work of the trainees, Medical officers, cascadees or their facility. All interviewees will provide informed consent. We aim to have all interviews completed by the end of February 2014.

The researchers in Ifakara will conduct all interviews in English. English is actually the third language in Tanzania but it is commonly spoken and all of the trainees have good levels of English. Indeed the training was delivered in English.

There are no formal inclusion exclusion criteria for this evaluation as we are targeting specific populations. Those outside these groups will not be invited.

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Quantitative dataThe research assistants will identify the facilities in which trainees are working and extract the study variables from the Ifakara database and create an ETATMBA database. Baseline data will be data for the facility for the year 2011. The follow-up data will be the same variables for the year 2013. The team will run basic checks on this data and carry out data cleaning. It is important to note that this is secondary analysis of anonymous (pooled and not patient identifiable) existing data which belongs to Ifakara Health institute (a project partner who have provided confirmation of local ethical review of the ETATMBA project).

Data analysis

Qualitative Data AnalysisInterviews will be digitally recorded, subject to permission of each participant, and where appropriate, will be transcribed verbatim. The recordings will be stored in a secure digital environment and only members of the research team will have access to them. Participants will not be identified and a code number will identify transcripts. Subsequent written material will use pseudonyms, for participants, and at the end of the study, recordings will be erased. Data will be analysed using the Framework method. This approach is described by Ritchie and Spencer 13 and Pope et al., 14 and is broadly as follows:

• Data familiarisation: reading of complete interview transcripts, listening to original audio-recordings and use of field notes;

• Identifying a thematic framework: key issues, concepts and themes are identified and an index of codes developed;

• Indexing: whereby the index generated through identification of the thematic framework is applied to all data;

• Charting: a summary of each passage of text is transferred into a chart to allow more overall and abstract consideration of index codes across the data set and by each individual;

• Mapping and interpretation: understanding the meaning of key themes, dimensions and broad overall picture of the data and identifying and understanding the typical associations between themes and dimensions;

• The charting process provides an opportunity to code data from numerous vantage points, by demographic factors, such as gender or age, by personality characteristics, such as looking specifically at people who are highly anxious compared to those who are not, or by medical aspects, such as those with diabetes compared to those without.

The charting process provides an opportunity to code data from numerous vantage points, by demographic factors, such as gender or age, by personality characteristics, such as looking specifically at people who are highly anxious compared to those who are not, or by medical aspects, such as those with a particular condition compared to those without.

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The computer package NVivo 10 will be used to facilitate this process. Researcher bias will be minimised through regular crosschecking of data and findings by the members of Research Team. In addition, transcripts will be returned to participants (where possible) providing them with the opportunity to check the transcripts for accuracy and authenticity and to offer any subsequent reflections. Quotes will be used as exemplars of key points in the writing up of these data.

Quantitative AnalysisDescriptive and summary statistics will produced for the two years, change scores will be produced, and appropriate paired statistics carried out. Significance will be set at 5%.

Ethical considerationsHospitals/health facilities will be provided with full information about the ETATMBA training and its evaluation. Researchers will be respectful of the needs of the hospitals and make appropriate arrangements to visit and carry out interviews.

No patient identifiable data will be collected during this study. Indeed, the quantitative data is pooled anonymous data that is collected by our project partner the Ifakara Health Institute.

The safety of the researcher also needs to be considered. In this trial researchers will possibly be travelling across Tanzania into rural/remote districts and into major population centres. The local researchers employed on the project are Tanzanian nationals giving them a slight advantage as they have local knowledge however, all of the researchers on the ground will employ a system of informing a central point about their movements with reasonable ‘check-in’ times. Mobile phones will be provided for this. Should a researcher not check in, the office would investigate and if necessary inform appropriate authorities. As mobile access may be variable across the country, some leeway will have to be allowed for. Transport and drivers are being employed on the study to move people that will add another level of security. UK based researcher (DE), visiting Tanzania, if going out into the field, to supervise project related activity will always be accompanied by a local researcher or driver.

Data will be stored on a secure computer system at Ifakara and uploaded to Warwick via a secure link. Data archived at the end of the study securely stored for 10 years.

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Information and consent formsTrainee Information sheet, Version 1, 07.11.2013

Participant information sheetEnhancing Human Resources and Use of Appropriate Technologies for

Maternal and Perinatal Survival in Sub-Saharan Africa (ETATMBA)

You are being invited to take part in a research project evaluating the impact of the ETATMBA training programme. Its aim is to improve skills and knowledge across the districts and to improve hospital outcomes like neonatal, perinatal and maternal mortality. You are one of the Assistant Medical officers who received this training. This research study will evaluate how effective the training programme has been. Researchers from the Ifakara Health Institute (Tanzania) and The University of Warwick in the UK are conducting the study. Before you decide whether you would like to take part it is important for you to understand what this process will involve. Please take time to read the following information carefully. Talk to others about the study if you wish.

What is the purpose of this research?

We want to know how the training you have been given has changed your practice and how you have been able to share your new skills and knowledge with other officers in your district. We will also be looking to see if these changes in knowledge, skills and practice make a difference to neonatal, perinatal and maternal mortality in your districts.

Why have I been asked to take part?

Approximately fifty assistant medical officers were recruited to the training programme from across Tanzania. We are inviting all recruits to participate in the research.

Do I have to take part?

No. It is up to you to decide whether or not you wish to take part. If you do, you will be asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect you in any way.

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What do I have to do?

You are invited to an interview the interview will be about 30 to 40 minutes in length and in many cases will be face-to-face. However, I am sure you appreciate that the country is very large and travel can at times be problematic so in some cases we may have to ask you to complete a structured interview which we would provide electronically via email.

Face-to-face interviews will be at a time and place agreeable to all and will be audio recorded and transcribed. You will have the opportunity to review the transcription if you would like too.

The interviewer will ask you to talk about your experiences of the training and how you have or if you have changed your practice as a result of the training we will ask you to give specific examples to support what you say. We are also interested in talking to people who you may have cascaded ETAMBA training too and we will ask you if you could identify these people so we can invite them to be interviewed.

If I take part now will I have to take part again?

No. This is a one-off reflective interview asking you to comment on your whole ETATMBA experience (from the training to current date).

Who will know that I am taking part?

The only people who will know that you are taking part are the research team and your district medical officer who will be aware that you are involved in the training programme and that you are being invited to participate in the research.

What will you do with the findings?

All findings will be completely anonymised and presented in the study report to our funders. They will also be used in academic publications and presentations at academic and professional conferences. We will make sure that all the information is anonymous and that you cannot be identified from the data.

What are the other possible risks of taking part?

We do not foresee any risks to you in taking part in this study.

What are the possible benefits of taking part?

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We hope that your increased knowledge and skills start to bring about improvements in terms of neonatal and maternal mortality in your districts. Your feedback about the course will help us to make improvements for future students.

Will my details be kept confidential?

Yes. We will follow ethical and legal practice and all information about you will be stored securely. Contact details will be stored separate from transcripts which will be only be identified by a unique code.

How will records from the study be stored?

All paper records from the study will be stored in a locked cabinet in a locked office. All information stored on a computer will require a password to view the information and will only be accessed by authorised personnel.

Who is funding this study?

This study is funded by The European Commission, CORDIS, Seventh Framework Programme (FP7).

Who has reviewed this study?

This study has been reviewed and given favourable opinions by Tanzania ethics (Add reference), the Biomedical and Scientific Research Ethics Committee (BSREC), The University of Warwick UK (Add Reference).

What happens if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact number below). If you remain unhappy and wish to complain formally, you can do this. Details can be obtained from the Ifakara Health Institute, P.OBox 783733, Dar es Salaam.

Contact DetailsGodfrey Mbaruku,Deputy Chief Executive DirectorIfakara Health Institute,P.OBox 783733,

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Dar es Salaam.Cell: +255784492129.

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Colleagues’ information sheet (Version 1, 07.11.13)

Participant information sheetEnhancing Human Resources and Use of Appropriate Technologies for Maternal

and Perinatal Survival in Sub-Saharan Africa (ETATMBA)

You are being invited to take part in a research project evaluating the impact of the ETATMBA training programme. ETATMBA is an advanced skills and leadership training programme being delivered to 50 assistant medical officers (AMOs) across Tanzania with the aim of improving skills and knowledge across the districts and improving hospital outcomes like neonatal, perinatal and maternal mortality. This research study will evaluate how effective the training programme has been. Researchers from the Ifakara Health Institute (Tanzania) and The University of Warwick in the UK are conducting the study. Before you decide whether you would like to take part it is important for you to understand what this process will involve. Please take time to read the following information carefully. Talk to others about the study if you wish.

What is the purpose of this evaluation?

We want to know how well the AMOs have passed on the training they have received to colleagues, and how the training they have given as advanced leaders is received and implemented.

Why have I been asked to take part?

AMOs in your health facility are involved in this programme. We would like to interview a number of people whom they have trained and we also would like to interview the District Medical Officer and the District Nursing Officer. If you have received training from one of these AMOs they have identified you during an interview. If you are a District Medical Officer you are being invited because of your managerial roles in the district.

Do I have to take part?

No. It is up to you to decide whether or not you wish to take part. If you do, you will be asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect you in any way.

What do I have to do?

Ref. CASINFO

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Colleagues’ information sheet (Version 1, 07.11.13)

If you decide that you would like to take part then the researcher will conduct an interview with you, asking you about your thoughts and experiences of the training and how it has fitted into your health facility. This interview should take no longer than an 30-40 minutes. . However, I am sure you appreciate, that the country is very large and travel can at times be problematic so in some cases we may have to ask you to complete a structured interview which we would provide electronically via email.

Face-to-face interviews will be at a time and place agreeable to all and will be audio recorded and transcribed. You will have the opportunity to review the transcription if you would like too.

If I take part now will I have to take part again?

No. this is a one-off interview.

Who will know that I am taking part?

The only people who will know that you are taking part are the research team.

What will you do with the findings?

All findings will be completely anonymised and presented in the study report to our funders. They will also be used in academic publications and presentations at academic and professional conferences. We will make sure that all the information is anonymous and that you cannot be identified from the data.

What are the other possible risks of taking part?

We do not foresee any risks to your health in taking part in this study.

What are the possible benefits of taking part?

Whilst there may not be any direct benefits to you, we hope that the information we gather can help in understanding whether such programmes may be of benefit in the future.

Will my details be kept confidential?

Ref. CASINFO

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Colleagues’ information sheet (Version 1, 07.11.13)

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence.

How will records from the study be stored?

All paper records from the study will be stored in a locked cabinet in a locked office. All information stored on a computer will require a password to view the information and will only be accessed by authorised personnel.

Who is funding this study?

This study is funded by The European Commission, CORDIS, Seventh Framework Programme (FP7).

Who has reviewed this study?

This study has been reviewed and given favourable opinions by Tanzania ethics (Add reference), the Biomedical and Scientific Research Ethics Committee (BSREC), The University of Warwick UK (Add Reference).

What happens if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact number below). If you remain unhappy and wish to complain formally, you can do this. Details can be obtained from the Ifakara Health Institute, P.OBox 783733, Dar es Salaam.

Contact DetailsGodfrey Mbaruku,Deputy Chief Executive DirectorIfakara Health Institute,P.OBox 783733,Dar es Salaam.Cell: +255784492129.

Ref. CASINFO

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Version 2, Date 17/08/11

CONSENT FORM (TRAINEES)

Enhancing Human Resources and Use of Appropriate Technologies for Maternal and Perinatal Survival in Sub-Saharan Africa (ETATMBA)

Study Number: _________________________

Please initial boxI confirm that I have read and understand the information sheet dated 07.11.131, version 1 for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily

I understand that I will be asked questions about my experience of the ETATMBA training and of implementing it in my health facility

I understand that this interview will be tape recorded and later typed up in full

I understand that brief, anonymous, extracts from the interview may be reproduced in academic presentations and academic and non-academic publications

I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my legal rights being affected

I agree to take part in the above study

Name Signature Date

______________________ _________________________ ____________

Researcher’s Name Researcher’s Signature Date

______________________ _________________________ _____________

Copies: 1 for participant, 1 for investigator (original)

Ref. NPCCFinterv

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Version 2, 17/08/11

CONSENT FORM (COLLEAGUES)

Enhancing Human Resources and Use of Appropriate Technologies for Maternal and Perinatal Survival in Sub-Saharan Africa (ETATMBA)

Study Number: _________________________

Please initial boxI confirm that I have read and understand the information sheet dated 07.11.13, version 1 for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily

I understand that I will be asked questions about my experience of the ETATMBA training and how it is being implementing it in my district

I understand that this interview will be tape recorded and later typed up in full

I understand that brief, anonymous, extracts from the interview may be reproduced in academic presentations and academic and non-academic publications

I agree to take part in the above study

Name Signature Date

______________________ _________________________ ____________

Researcher’s Name Researcher’s Signature Date

______________________ _________________________ _____________

Copies: 1 for participant, 1 for investigator (original)

Ref. CASCFinterv

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District Medical Officer Letter, Version 2, 17/08/11

Letter Ifakara headed paper and send by Ifakara as an email attachment:

Enhancing Human Resources and Use of Appropriate Technologies for Maternal and Perinatal Survival in Sub-Saharan Africa (ETATMBA)

Dear

We are writing to you to inform you about a research study (ETATMBA) that is taking place in some districts of Tanzania. This study is funded by The European Commission, CORDIS, Seventh Framework Programme (FP7) and is a collaboration between the Ifakara Health Institute Tanzania) and The University of Warwick in the UK. Approximately 50 assistant medical officers (AMOs) were invited to undergo the training from various districts across Tanzania.

The training is in advanced obstetrics and paediatrics and was aimed at giving the trainees new knowledge, practice skills and advanced leadership skills. They are expected to cascade this knowledge out to other clinical officers and midwives in their health facility. Facilities in your district have ETATMBA trainees within them. It is our hope that the increased knowledge and skills that they have obtained start to bring about improvements in terms of neonatal and maternal mortality Tanzania.

We are now planning to evaluate the impact of the training and this will involve inviting the trainees to be interviewed about their experiences. We would also like to invite you to share your thought about this training programme with us in an interview. You will see that information is included with this letter. In addition, the AMOs as noted above expected to cascade the ETATMBA training to local colleagues. We hope to identify some of these cascadees from interviews with the trainees; once we do, we will approach them and invite them for an interview.

Where possible we would like to do the interviews face-to-face and this will involve us visiting your facility. You will be notified in advance of these visits and appointments to interview the trainees and yourself will be made so far as possible not to disrupt the service.

This study has been reviewed and given favourable opinions by the Tanzanian Research Ethics Committee (Add reference), the Biomedical and Scientific Research Ethics Committee (BSREC), The University of Warwick UK (Add Reference).

If you have any questions please do not hesitate to contact us.

Kind Regards

Godfrey Mbaruku,Deputy Chief Executive DirectorIfakara Health Institute,P.OBox 783733,Dar es Salaam.Cell:+255784492129

Ref. DMOl

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19

Draft EmailsEmail to Trainees (Which will have information sheet and consent form attached)

Dear

You recently completed the Enhancing Training and Appropriate Technologies for Mothers and Babies in Africa (ETATMBA) training programme and you have now returned to your district. <Add dates of training>

The ETATMBA team are now looking to evaluate the impact of the training and we would very much like your help with this.

Attached you will find an information sheet which we would like you to read and a copy of the consent form.

If you are willing to participate or you would like more information please respond to this email and the team will be in contact with you. If you would like to be part of this evaluation, please also return a signed consent form.

Note: if we do not here from you in two weeks from the date this mail was sent a single reminder email will be sent out.

Thank you in anticipationKind RegardsThe ETATMBA Research team

Email to District Medical officer (Which will have information sheet and consent form attached)

DearPlease find attached information about the Enhancing Training and Appropriate Technologies for Mothers and Babies in Africa (ETATMBA) training that has been going on across Tanzania for the last few years. A number of trainees from this are based in health facilities in your district.

The purpose of this mail is two-fold the first is to provide you with information about ETATMBA and the second is to invite you to participate in the evaluation of the project. Attached you will find an information sheet which we would like you to read and a copy of the consent form.

If you are willing to participate or you would like more information please respond to this email and the team will be in contact with you. If you would like to be part of this evaluation, please also return a signed consent form.

Note: if we do not here from you in two weeks from the date this mail was sent a single reminder email will be sent out.

Thank you in anticipation

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Kind RegardsThe ETATMBA Research team

References1. Bergstrom S. Who will do the caesareans when there is no doctor? Finding creative solutions

to the human resource crisis. BJOG : an international journal of obstetrics and gynaecology 2005;112(9):1168-9.

2. Hill K, Thomas K, AbouZahr C, Walker N, Say L, Inoue M, et al. Estimates of maternal mortality worldwide between 1990 and 2005: an assessment of available data. Lancet 2007;370(9595):1311-9.

3. Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, et al. Maternal mortality for 181 countries, 1980–2008: a systematic analysis of progress towards Millennium Development Goal 5. The Lancet 2010;375(9726):1609-23.

4. Graham W, Hussein J. The right to count. Lancet 2004;363(9402):67-8.5. Bryce J, Boschi-Pinto C, Shibuya K, Black RE. WHO estimates of the causes of death in

children. Lancet 2005;365(9465):1147-52.6. McCord C, Mbaruku G, Pereira C, Nzabuhakwa C, Bergstrom S. The quality of emergency

obstetrical surgery by assistant medical officers in Tanzanian district hospitals. Health Aff (Millwood) 2009;28(5):w876-85.

7. Chilopora G, Pereira C, Kamwendo F, Chimbiri A, Malunga E, Bergstrom S. Postoperative outcome of caesarean sections and other major emergency obstetric surgery by clinical officers and medical officers in Malawi. Human resources for health 2007;5:17.

8. Pereira C, Cumbi A, Malalane R, Vaz F, McCord C, Bacci A, et al. Meeting the need for emergency obstetric care in Mozambique: work performance and histories of medical doctors and assistant medical officers trained for surgery. BJOG : an international journal of obstetrics and gynaecology 2007;114(12):1530-3.

9. Mullan F, Frehywot S. Non-physician clinicians in 47 sub-Saharan African countries. Lancet 2007;370(9605):2158-63.

10. Pereira C, Bugalho A, Bergstrom S, Vaz F, Cotiro M. A comparative study of caesarean deliveries by assistant medical officers and obstetricians in Mozambique. British journal of obstetrics and gynaecology 1996;103(6):508-12.

11. Graham W, Cairns J, Bhattacharya S, Bullough C, Quayyum Z, Rogo K. Maternal and Perinatal Conditions In: Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, et al., editors. Disease Control Priorities in Developing Countries (2nd edition)2006. p. 499-530.

12. Ellard D, Simkiss D, Quenby S, Davies D, Kandala NB, Kamwendo F, et al. The impact of training non-physician clinicians in Malawi on maternal and perinatal mortality: a cluster randomised controlled evaluation of the enhancing training and appropriate technologies for mothers and babies in Africa (ETATMBA) project. BMC pregnancy and childbirth 2012;12(1):116.

13. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, Burgess R, editors. Analysing Qualitative Data. London: Routledge; 1994.

14. Pope C, Mays N. Qualitative Research: Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ 1995;311(6996):42-5.

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Interview schedules

Interview Schedule for ETATMBA trainees (Draft) Introduction

“My name is… I am a researcher working on the evaluation of the ETAMBA project. “

“Thank you for agreeing to participate in this follow-up interview. You have been given information about this evaluation, had the chance to ask questions and signed a consent form. I would like to remind you that you can withdraw from this evaluation at any time and it will not affect you in any way. Today, in this interview, I would like you to reflect on the whole of the course (to date) excluding this current module so from “year” (2010/2011, try to know when the interviewee attended first course). I would like to ask you about the ETATMBA training and how the training has impacted on your practice. Can you please confirm for the recording that you understand this and are willing to continue?”

What have you likes about training?

What have you not liked?

Prompts (note: only use if this information does not come out of general question): What about the teaching?

What about the style or form of teaching?

Picking up on teaching/teaching style: In the teaching what was new to you?

What have you learnt from the training?

Prompts: An example would be?

How has your practice changed since the you started the ETATMBA training?

Prompt: For each/any changes what aspects of the training brought about the change?

An example would be?

Think about the last few months; are there things you have done differently compared to before?

Have you made any innovations?

Prompts: Any new ways of solving a problem?

An example would be?

Have the people around you changed their practice?

Prompts: An example would be?

Here is a list of skills which have been taught on the training please give examples of when you have used these? (we will provide a flash card for this listing the skills taught)

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Tell me about your audits?

Prompts: How have these changed practice?

An example would be?

Tell me about the leadership training you have received to date?

Prompts: How has this changed practice?

An example would be?

Tell me about this current module

Prompts: thoughts on teaching on this module (will be limited as for some it will only be first day)

Any questions or comments you would like to make that we have not covered with regard to the ETATMBA training and its implementation?

End of interview

For those who have been trained by the NPCs (Draft):• What was taught• Experience of the training• Whether and how this has been put into practice• What they liked or disliked about the training

Note get real examples

For the District Medical Officers (Draft):• Interviews will cover how the training has been implemented in the district

Have they any evidence of training being implemented?

ETATMBA Tanzania Protocol v.1, 07.11.13