bmj open · (vena saphena magna, vena saphena parva, and vena poplitea). the diagnosis is...

For peer review only

Structured wound management through a national quality

registry reduces healing time and antibiotic treatment

Journal: BMJ Open

Manuscript ID: bmjopen-2013-003091

Article Type: Research

Date Submitted by the Author: 22-Apr-2013

Complete List of Authors: Öien, Rut; Blekinge Wound Healing Center, Blekinge Centre of Competence Forssell, Henrik; Blekinge Centre of Competence,

<b>Primary Subject Heading</b>:

Medical management

Secondary Subject Heading: Diagnostics, General practice / Family practice, Medical management

Keywords: WOUND MANAGEMENT, GENERAL MEDICINE (see Internal Medicine), Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Structured wound management through a national quality registry reduces

healing time and antibiotic treatment

Rut F Öien, 1,2 Henrik W Forssell 2

Rut F Öien, M.D., PhD, General Practitioner

Henrik W Forssell, M.D., PhD, Associate Professor

1 Blekinge Wound Healing Centre, Karlskrona, Sweden

2 Blekinge Centre of Competence, Karlskrona, Sweden

Correspondence to

Dr Rut F Öien

[email protected]

Blekinge Wound Healing Centre

Blekinge Centre of Competence,

S- 371 41 Karlskrona

Sweden

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ABSTRACT

Objectives: To investigate changes in ulcer healing time and antibiotic treatment in Sweden

following the introduction of a national quality registry in 2009.

Design: A statistical analysis of data from the Swedish Registry of Ulcer Treatment (RUT)

concerning healing time and antibiotic treatment for patients with hard-to-heal ulcers in

Sweden between 2009 and 2012.

Setting: RUT is a national web-based quality registry used to structure wound management

by registering patients with hard-to-heal leg, foot, and pressure ulcers. Registration includes

variables such as gender, age, diagnosis, healing time, antibiotic treatment, and ulcer duration

and size.

Population: Every patient with a hard-to-heal ulcer registered in RUT between 2009 and

2012 (n=1268).

Main outcome measures: The statistical analysis was performed using version 12.1 of the

Stata software package (StataCorp LP, College Station, Texas, USA). Healing time was

assessed with Kaplan-Meier analysis and adjustment was made for ulcer size. A log-rank test

was used for equality of survivor functions.

Results: Basic data from the adjusted registry in December 2012 (n=1268) showed a median

age of 80 years (mean age 77.5 years), ranging from 11 to 103 years. The median healing

time, adjusted for ulcer size, was 146 days (21 weeks) for all ulcers in 2009 and 63 days (9

weeks) for all ulcers in 2012 (p=0.001). Considering all years between 2009 and 2012,

antibiotic treatment for patients with hard-to-heal ulcers was reduced from 71% before

registration to 29% after registration to ulcer healing (p=0.001).

Conclusions: Healing time and antibiotic treatment both decreased significantly during the

three years after the introduction of RUT.

Results from RUT, a national quality registry

Key words: Hard-to-heal ulcers, ulcer assessment, diagnosis, ulcer care, ulcer healing,

antibiotic treatment, RUT (Registry of Ulcer Treatment)

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ARTICLE SUMMARY

Article focus

▪ The aim of the study was to statistically analyse the data from the Swedish Registry of Ulcer

Treatment (RUT) in order to detect any differences in healing time and antibiotic treatment

between 2009 and 2012.

Key messages

▪ Median healing time for all ulcers (adjusted for ulcer size) decreased significantly between

2009 and 2012.

▪ Median healing time for venous ulcers (adjusted for ulcer size) decreased significantly

between 2009 and 2012.

▪ The proportion of patients receiving antibiotic treatment before registration was significantly

higher than the proportion of patients receiving such treatment between registration and to

ulcer healing.

Strengths and limitations of this study

▪The data cover every patient registered in RUT during the years 2009 to 2012.

▪ RUT is used throughout Sweden and covers wound management in primary care,

community care, private care, and in-patient hospital care.

▪ RUT provides a reliable diagnosis, adequate strategies for ulcer care, and a structured

follow-up of ulcer healing.

▪ One limitation is that RUT is still in the process of being implemented, which means that in

some areas of Sweden every patient with a hard-to-heal ulcer is registered, while in other

areas only some patients are registered.

INTRODUCTION

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Wound management consumes time and money, and is a source of reduced quality of life for

the affected patients.1-3 A large proportion of patients with hard-to-heal ulcers are treated with

oral antibiotics (68–78%), 1,4-6 mostly because of problems with clinically assessing an ulcer

infection6,7 but also because of a lack of continuity of medical care.8

To address these difficulties, the Swedish Registry of Ulcer Treatment (RUT)9 was

introduced in May 2009. RUT (www.rikssar.se) is a national web-based quality register for

hard-to-heal ulcers developed to meet the demands of modern ulcer care in providing reliable

diagnosis, adequate strategies for ulcer care, and a structured follow-up of ulcer healing.

The aim of this study was to statistically analyse the data from RUT for the years 2009 and

2012 concerning healing time and antibiotic treatment for patients with hard-to-heal ulcers in

Sweden.

National registries

In recent decades, a system of national quality registries has been established in the Swedish

health and medical services, 10 covering different areas of medicine. There are currently 73

registries, which receive central funding from the Swedish Association of Local Authorities

and Regions (www.skl.se). Data from the registries are used for optimising medical care in

areas such as diabetes mellitus, dementia, and hard-to-heal ulcers.

Research in wound management Blekinge County is a Swedish county with 150,000

inhabitants and health care professionals with 25 years’ experience of quality improvement

and clinical research within the field of wound management.1,11 This tradition of research

resulted in the establishment of Blekinge Wound Healing Centre (BWHC) in 2003. BWHC is

a GP-led, primary care based specialist centre covering the treatment and follow-up of the

majority of ulcer patients in the whole county. It offers a structured team management of ulcer

care with emphasis on diagnosis, documentation, and treatment. The GP in charge of the

centre is the first author of this study (RFÖ).

The experience of our daily practice made it obvious that there is a need for a structured

programme for wound management; this was the reason behind the development of RUT, a

web-based quality registry for hard-to-heal ulcers. This approach has made RUT a useful tool

in daily clinical practice throughout Sweden since it became operational on 1st May 2009.

METHODOLOGY

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Study population and variables

Patients with a hard-to-heal leg, foot, or pressure ulcers are registered on two occasions. The

first registration, assessment of the ulcer diagnosis, is to guarantee optimal treatment. The

second registration is at follow-up; that is, at the point where the ulcer has healed or a

negative clinical event such as amputation or death has occurred. Every patient with a non-

healed ulcer remains in the registry until the ulcer is healed, no matter how long the healing

time.

At the first registration the following variables are recorded: social security number,

gender, age, date of diagnosis, profession or former profession, smoking habits, civil status,

number of children, mobility, exercise habits, and body mass index. The patient’s social

security number is linked and matched to the population statistics at the Council for Official

Statistics of Sweden.

Details are also taken regarding the nurse responsible for ulcer care; whether the ulcer is

recurrent, new, or traumatic; current or earlier concomitant diseases; current medication with

particular interest in analgesics and antibiotics; and ulcer-related pain. The patient history

focuses on the following variables: deep vein thrombosis (DVT), varicose veins, arterial or

venous surgery, history of recurrent leg ulcers, and ulcer localisation (foot, leg, or sacrum/hip;

and lateral or medial). Ulcer size is measured by digital planimeter (Visitrak®) and the

number of ulcers is noted.

The patient’s arterial circulation is assessed by palpating the arteria dorsalis pedis and

arteria tibialis posterior and measuring the ankle-brachial pressure index with a hand-held

Doppler. The Doppler is also used for measuring deep or superficial venous insufficiency

(vena saphena magna, vena saphena parva, and vena poplitea).

The diagnosis is determined from these variables together with the clinical examination.

The following ulcer diagnoses are used: venous ulcer, arterial ulcer, venous-arterial ulcer,

diabetic foot ulcer, pressure ulcer, traumatic ulcer, ulcer due to inflammatory vessel diseases

such as vasculitis, and other diagnosis (for example pyoderma gangrenosum). The strategy for

wound management includes dressings, care for the skin surrounding the ulcer, and treatment

for oedema. A photo gallery is linked to the registry for visualization of the healing process.

The second registration (at follow-up) includes date of healing, healing time, estimated

number of weekly dressing changes throughout healing, compression therapy, treatment with

antibiotics, pain relief, the most frequently used dressing material, and whether advice was

given on smoking cessation, exercise, and diet. Adverse events are also recorded at follow-up:

amputation, venous or arterial surgery, and death.

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Registration can be done at any time, and follow-up can be carried out when all the

mandatory variables are registered. Each unit has access only to data on its own patients; this

can be retrieved online at any time, and used to compare the unit’s quality of wound

management with that of the whole country.

Data analysis from RUT

The statistical analysis was performed using version 12.1 of the Stata software package

(StataCorp LP, College Station, Texas, USA). Continuous variables were expressed as mean

values (S.D.) and compared using two-sample Student’s t-tests. Group comparisons for

categorical variables were performed with Pearson’s chi square tests. Healing time was


was used for equality of survivor functions. P < 0.05 was considered statistically significant.

RESULTS

Healing time

Basic data from the adjusted registry in December 2012 (n=1268) showed a median age of 80

years (mean age 77.5 years), ranging from 11 to 103 years.

The majority of the patients were women (60%). The median ulcer duration was 12 weeks

(mean 117 weeks), ranging from 1 to 2400 weeks, and the median ulcer size at inclusion in

RUT was 3 cm2 (mean 12 cm2), ranging from 0.05 cm2 to 600 cm2.

Figure 1 illustrates the median healing time, adjusted for ulcer size, from 2009 to 2012.

The median healing time was 146 days (21 weeks) for all ulcers in 2009 and 63 days (9

weeks) for all ulcers in 2012 (p=0.001).

Negative pressure wound therapy was introduced to the European market in 1997, and has

been used in Swedish primary health care since 2006. This technique was used in only 1.3%

of all cases during the study period.

Figure 2 illustrates the median healing time for venous ulcers, adjusted for ulcer size, from

2009 to 2012. The median healing time for these ulcers was 120 days (17 weeks) in 2009 and

69 days (10 weeks) in 2012 (p=0.001). Compression therapy was used in 87.3% of venous

ulcers in 2009 and 88.9% in 2012. In some areas of Sweden, every venous ulcer (100%) was

treated with compression therapy both in 2009 and 2012.

Antibiotic treatment

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Figure 3 illustrates antibiotic treatment from 2009 to 2012. In 2009, 76% of patients were

treated with antibiotics before registration, and 24% were treated after registration to ulcer

healing. In 2012, the corresponding figures were 73% before registration and 27% between

registration and healing. These differences were significant in both years (p=0.001).

Considering all years between 2009 and 2012, antibiotic treatment for patients with hard-to-

heal ulcers in the registry nationwide was reduced from 71% before registration to 29% after

registration to ulcer healing (p=0.001).

DISCUSSION

The principal finding in this study was the significantly reduced healing time for hard-to-heal

ulcers registered in RUT, the Swedish national quality registry; from 146 days (21 weeks) in

2009 to 63 days (9 weeks) in 2012. During this period, no new techniques and no innovative

new dressings were introduced for wound management on the Swedish market. Negative

pressure wound therapy was used in less than 2% of all cases, but has now become a more

widespread mode of treatment in clinical practice. There was some development of services,

such as the introduction of smaller wound healing centres based on the BWHC model.

Healing time is the one important endpoint in wound management.12 Earlier researchers

found a median healing time of 20-43 weeks when following patients through a period of 12

months.12 Some researchers noted a healing rate of 83% at 30 weeks,13 while others reported

that 62/90 (69%) of venous leg ulcers healed within 12 weeks.14 Moffatt et al.15 found that

70% of venous ulcers healed after 48 weeks of treatment; they also noted that much of the

evidence on healing rates is drawn from the results of randomized controlled trials. These

trials typically achieve 24-week healing rates in excess of 60%, but may not reflect the

complex issues faced in clinical practice.15

The significantly reduced healing time in our study seems to depend on the use of a

structured wound management, based on accurate diagnosis and thereby optimal treatment

and follow-up; all these factors are found in RUT.

Another important finding in the present study was the low rate (24-27%) of antibiotic

treatment administered to patients between registration and ulcer healing; that is, to patients

with a diagnosis and adequate treatment. This can be compared with earlier findings of 68–

78%1,5 for patients in primary care. Considering the years between 2009 and 2012, antibiotic

treatment for patients with hard-to-heal ulcers in the registry nationwide was reduced from

71% before registration to 29% between registration and ulcer healing (p=0.001).

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Antimicrobial therapy for local ulcer infection became more firmly established between

2009 and 2012, which could be one explanation for the reduced antibiotic treatment. This

issue is addressed in an ongoing research study within the frame of RUT.

A further explanation for the low rate of antibiotic treatment and reduced healing time

could be that RUT focuses on a stable doctor-patient relationship. Previous research has

shown the advantages of a structured organization in leg ulcer care.16,17 Petursson found that

lack of continuity of medical care was the main reason for general practitioners to prescribe

antibiotics in a “non-pharmacological” manner.8

The ulcer patient’s right to receive optimal treatment has been limited in recent decades,

due to lack of diagnosis and low continuity of ulcer care.1,18-20 Dressing changes over weeks,

months, and even years have been carried out, often without a proper diagnosis.1 It is well

known that understanding the aetiology of leg ulceration is a prerequisite for a systematic

clinical assessment as a base for appropriate wound management.13,14,21 RUT meets these

requirements.

Data must be collected in a uniform manner to capture the scale of the wound care, as

pointed out in previous studies.21 The conventional approach is to record details of all major

resources consumed (clinician time, dressings, antibiotics, analgesics, investigations, hospital

admissions, and surgical interventions) at each patient contact over the period from first

presentation to wound healing.21 RUT contains all these details.

The health care system requires information on the burden of care in order to inform

decisions on the needs of the population and the allocation of appropriate resources.15

RUT comprises a structured and practical methodology which can be used at any level in the

health care system.

The nationwide implementation of the RUT quality registry has not yet been fully achieved.

One area for future research is to investigate differences in the results of ulcer care between

areas in Sweden where RUT is used and areas where it is not used.

Another further research issue concerns the mapping of all pressure ulcers, such as ulcers

in younger patients with neurological diseases and in palliative care patients. RUT is an

appropriate basis for such a study, as it has a special section for pressure ulcers.

As of March 2013, the registry includes 1438 patients. The role of the registry manager

and the steering group is to show staff how data from the registry can be used to improve

ulcer care. We focus on documentation, treatment, education, research, and economic

analyses to guarantee improvement of health outcomes nationwide. Our ultimate aim is to

introduce RUT internationally.

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CONCLUSION

The findings from this study illustrate the immediate impact of RUT, concerning significantly

reduced healing time from 146 days (21 weeks) in 2009 to 63 days (9 weeks) in 2012.

Antibiotic treatment was reduced from 71% before registration to 29% between registration

and ulcer healing. They also demonstrate the potential for improved wound management,

when using a national quality registry for structured ulcer care.

Contributors

RFÖ led the research project and played the major role in the research design.

HWF contributed to the data analysis and assisted in the research design and interpretation of

the results.

Proper English provided language editing services.

Funding

This study was partly funded by the Council of Sciences in Blekinge County.

Competing interests None.

Ethics approval

The Lund Ethical Review Board has approved of this study concerning data from a quality

registry.

Provenance and peer review This study has not been externally peer reviewed.

Data sharing statement No additional data are available.

Acknowledgement This study was performed in the interests of the steering group for the

Swedish Registry of Ulcer Treatment (RUT).

REFERENCES

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1. Öien RF, Håkansson A, Ovhed I , Hansen BU . Wound management for 287 patients with

chronic leg ulcers demands 12 full-time nurses. Leg ulcer epidemiology and care in a well-

defined population in Southern Sweden . Scand J Prim Health Care 2000;18:220–5.

2. Lindholm C, Bjellerup M, Christensen OB, Zederfeldt B. Quality of life in chronic leg

ulcer patients: An assessment according to the Nottingham Health Profile . Acta Derm

Venereol 1993;73:440–3.

3. Anon. Evidence-based prescribing of advanced wound dressings for chronic wounds in

primary care. MeRec Bulletin 2010;1:1–7.

4. Wiström J, Lindholm C, Melhus A, et al . Infections and treatment in chronic leg ulcers:

The use of antibiotics is too excessive, restrictive prescription is recommended.

Lakartidningen.1999 ;6:96:42–6 [in Swedish].

5. André M, Eriksson M, Odenholt I. Treatment of patients with skin and soft tissue

infections: Results from the STRAMA survey of diagnoses and prescriptions among general

practitioners. Lakartidningen 2006;103:3165–7 [in Swedish].

6. Öien RF, Åkesson N. Bacterial cultures, rapid strep test, and antibiotic treatment in infected

hard-to-heal ulcers in primary care. Scand J Prim Health Care, 2012;30:254–258.

7. European Wound Management Association (EWMA) Position document: Management of

wound infection. London: MEP;2006.

8. Petursson P. G Ps’ reasons for “ non-pharmacological” prescribing of antibiotics: A

phenomenological study. Scand J Prim Health Care 2005;23:120-5.

9. Öien RF. R UT (Register of Ulcer Treatment) – a winning concept for both patients and the

health care sector. EWMA J 2009; 9:41–4.

10. Lundström M (ed.), Albrecht S, Serring I, Svensson K, Wendel E. Handbook for

establishing quality registries. EyeNet Sweden, Karlskrona, Sweden 2005.

ISBN 91-631- 8585-7.

11. Öien RF, Ragnarson Tennvall G. Accurate diagnosis and effective treatment of leg ulcer

reduce prevalence, care time and costs. J Wound Care 2006;15:259-62.

12. Morrell CJ, Walters SJ, Dixon S, et al. Cost effectiveness of community leg ulcer clinics:

randomised controlled trial. BMJ 1998 May 16;316(7143):1487-91.

13. Rybak Z, Franks PJ, Krasowski G, et al. Strategy for the treatment of chronic leg wounds:

a new model in Poland. Int Angiol 2012 Dec;31(6):550-6.

14. Hjerppe A, Saarinen JP, Venermo MA, et al. Prolonged healing of venous leg ulcers: the

role of venous reflux, ulcer characteristics and mobility. J Wound Care. 2010

Nov;19(11):474, 476, 478 passim.

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15. Moffatt CJ, Doherty DC, Smithdale R, Franks PJ. Clinical predictors of leg ulcer healing.

Br J Dermatol. 2010 Jan;162(1):51-8. doi: 10.1111/j.1365-2133.2009.09397.x. Epub 2009 Jul

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16. Moffatt CJ, Franks PJ, Oldroyd M, et al. Community clinics for leg ulcers and impact on

healing. BMJ 1992;305:1389–92.

17. Kjaer ML, Sorensen LT, Karlsmark T, et al. Evaluation of the quality of venous leg ulcer

care given in a multidisciplinary specialist centre. J Wound Care 2005 Apr;14(4):145-50

18. Törnvall E, Wilhelmsson S. Quality of nursing care from the perspective of patients with

leg ulcers. J Wound Care. 2010 Sep;19(9):388–95



7.

20. Edwards H, Finlayson K, Courtney M et al. Health service pathways for patients with

chronic leg ulcers: identifying effective pathways for facilitation of evidence based wound

care. BMC Health Serv Res. 2013 Mar 8;13:86. doi: 10.1186/1472-6963-13-86.

21. Harding K, Posnett J, Vowden K. A new methodology for costing wound care.

Int Wound J. 2012 Dec 13. doi: 10.1111/iwj.12006.

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Figure 1. Ulcer healing time, 2009-2012. Figures adjusted for ulcer size.

0.00

0.25

0.50

0.75

1.00

% ulcer healing

0 100 200 300 400 500 600 700 800Days

2009 2010 2011 2012

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Figure 2.Venous ulcer healing time, 2009-2012. Figures adjusted for ulcer size.

0.00

0.25

0.50

0.75

1.00

% ulcer healing

0 100 200 300 400 500 600 700 800Days

2009 2010 2011 2012

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Figure 3. Antibiotic treatment before registration in RUT for the years 2009, 2010, 2011, and

2012, compared with antibiotic treatment between registration and ulcer healing for the same

years.

76

64

75 73

24

36

25 27

0

10

20

30

40

50

60

70

80

90

100

2009 2010 2011 2012

Before registration

After registration to ulcer healing

%

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STROBE Statement—Checklist of items that should be included in reports of cohort studies

Structured wound management through a national quality registry reduces healing time and

antibiotic treatment

Title and abstract

Introduction

Background/rationale

Objectives

Methods

Study design

Setting

Participants

Variables

Data sources/

measurement

Bias

Study size

Quantitative variables

Statistical methods

Results

Participants

Descriptive data

Outcome data

Main results

Other analyses

Discussion

Key results

Item

No

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

Recommendation

We have followed the recommendation

We have explained the scientific background in Introduction

We have stated the prespecified hypotheses

The key elements of study design are presented early in the

paper

The setting, locations, and relevant dates, including periods of

recruitment,

exposure, follow-up, and data collection are described

The eligibility criteria, and the sources and methods of selection

of participants. are described and methods of follow-up

All outcomes, exposures, predictors, potential confounders, and

effect modifiers are clearly defined.

Sources of data and details of methods of

assessment (measurement) for each variable of are given.

Since we have taken all patients in the registry, we considered it

not necessary to discuss sources of bias

We have described the results for every patient in the registry

during 2009 to 2012

No groupings were chosen

Statistics are thoroughly described for every moment

This section is written according to the check-list

Since we followed every patient to healing there are no missing

data for each variable of interest

The numbers of outcome events or summary measures over time

are reported

We have used the 95% confidence interval

We do not have any subgroups

key results with reference to study objectives have been

summarised

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Limitations

Interpretation

Generalisability

Other information

Funding

19

20

21

22

limitations of the study are discussed

An overall interpretation of results considering objectives,

limitations are being discussed. No similar studies have been

undertaken.

The generalisability (external validity) of the study results are

only mentioned,

This study was partly funded by the Council of Sciences in

Blekinge County.

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The Registry of Ulcer Treatment shows reduced healing time and antibiotic treatment – an improvement project in

the national quality registries in Sweden

Journal: BMJ Open

Manuscript ID: bmjopen-2013-003091.R1


Date Submitted by the Author: 14-Jun-2013



Medical management






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The Registry of Ulcer Treatment shows reduced healing time and antibiotic

treatment – an improvement project in the national quality registries in

Sweden

Rut F Öien,1,2 Henrik W Forssell2

Rut F Öien, MD, PhD, General Practitioner, Registry Manager of RUT (Registry of Ulcer

Treatment)

Henrik W Forssell, MD, PhD, Associate Professor

1Blekinge Wound Healing Centre, Karlskrona, Sweden 2Blekinge Centre of Competence, Karlskrona, Sweden

Correspondence to:

Dr Rut F Öien


Blekinge Centre of Competence

S-371 41 Karlskrona

Sweden

Phone: +46 706 687202

E-mail: [email protected]

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ABSTRACT


following the introduction of the Registry of Ulcer Treatment (RUT), a national quality

registry, in 2009.

Design: Statistical analysis was performed of RUT data concerning healing time and

antibiotic treatment for patients with hard-to-heal ulcers in Sweden between 2009 and 2012.

Setting: The RUT is a national web-based quality registry used to capture areas of

improvement in ulcer care and to structure wound management by registering patients with

hard-to-heal leg, foot and pressure ulcers. Registration includes variables such as gender, age,

diagnosis, healing time, antibiotic treatment and ulcer duration and size.

Population: Every patient with a hard-to-heal ulcer registered with the RUT between 2009

and 2012 (n=1,417) was included.

Main outcome measures: Statistical analyses were performed using Stata version 12.1.

Healing time was assessed with Kaplan-Meier analysis and adjustment was made for ulcer

size. A log-rank test was used for equality of survivor functions.

Results: According to the adjusted registry in December 2012, patients’ median age was 80

(mean 77.5, range 11–103) years. The median healing time for all ulcers, adjusted for ulcer

size, was 146 days (21 weeks) in 2009 and 63 days (9 weeks) in 2012 (p=0.001). Considering

all years between 2009 and 2012, antibiotic treatment for patients with hard-to-heal ulcers

was reduced from 71% before registration to 29% after registration to ulcer healing

(p=0.001).

Conclusions: Healing time and antibiotic treatment both decreased significantly during the 3

years after launch of the RUT.

Key words: hard-to-heal ulcers, ulcer assessment, diagnosis, ulcer care, ulcer healing,

antibiotics, RUT, pressure ulcer, topical antimicrobial treatment

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ARTICLE SUMMARY

Article focus

▪ The aim of this study was to analyse the data from the Swedish Registry of Ulcer Treatment

(RUT) to detect any differences in healing time and antibiotic treatment between 2009 and

2012.

Key messages

▪ Median healing time for all ulcers (adjusted for ulcer size) decreased significantly from 146

days in 2009 to 63 days in 2012.

▪ Median healing time for venous ulcers (adjusted for ulcer size) decreased significantly from

120 days in 2009 to 69 days in 2012.

▪ Antibiotic treatment for patients with hard-to-heal ulcers was reduced from 71% before

registration to 29% when using the RUT.


Strengths

▪ The data cover every patient registered with the RUT during 2009–2012.

▪ The RUT covers wound management in primary care, community care, private care and in-

patient hospital care throughout Sweden.

▪ The RUT provides a reliable diagnosis, adequate strategies for ulcer care, and a structured


Limitations

▪ One limitation is that the RUT is still in the process of being implemented, which means that

in some areas of Sweden every patient with a hard-to-heal ulcer is registered, while

registration of patients in other areas is only partial.

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INTRODUCTION

Wound management not only consumes time and money, but ulcers and their treatment

reduce quality of life for affected patients.1–3

Patients with hard-to-heal ulcers have long been considered a neglected patient population.

Many are treated without diagnosis, and consequently receive suboptimal ulcer care. Overuse

of oral antibiotics in these patients (68–78%)1,4–6 is mostly due to absence of diagnosis or

inadequate clinical assessment of ulcer infections.6,7 The lack of continuity in ulcer care and

also the lack of team-working between health professionals in this field has further

contributed to antibiotic overuse.8 In Sweden, lack of national guidelines for medical ulcer

care has had a negative impact on wound management.

Structured wound management based on accurate diagnosis leads to effective treatment

and, consequently, decreased prevalence, care time and costs.9 For this reason, the Swedish

Registry of Ulcer Treatment (RUT)10 was started in May 2009. Its purpose is to assess

physician diagnoses of ulcers, give medical staff a structured check list for optimal treatment

and identify areas of improvement in wound management.

The focus of this study was to investigate whether ulcer healing time and antibiotic

treatment have been affected by the registry. We aimed to analyse data from the RUT from

the time the registry was introduced nationally (2009) to 2012.

National registries


health and medical services,11 covering different areas of medicine. There are currently 73

registries which receive central funding (www.skl.se).

The ambition of the Swedish national quality registries is to gather data on diagnoses and

symptoms, interventions and treatment outcomes in order to give a continuous, systematic

evaluation of medical practice.

The majority of the Swedish national quality registries have been developed by physicians

with special interest in a research field in order to bring about quality improvement to health

care for a specific medical problem.

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The Registry of Ulcer Treatment - RUT

Health care professionals in Blekinge have for the past 25 years focused on quality

improvement and clinical research within the field of wound management.1,9 This tradition of

research linked to clinical practice led to the establishment of the Blekinge Wound Healing

Centre (BWHC) in 2003. The BWHC is a general practitioner (GP)-led, primary care-based

specialist centre covering the treatment and follow-up of the majority of ulcer patients across

the county (150, 000 inhabitants). It offers a structured team management of ulcer care with

emphasis on diagnosis, documentation and treatment. The GP in charge of the centre is the

first author of this study (R.F.Ö.).

The experience of our daily practice combined with research results soon made it obvious

that there was a need for a structured programme for wound management to guarantee

optimal treatment. The RUT was started in Blekinge County by Rut F Öien, the registry

manager, who has developed and launched the registry.

The RUT was the first national registry in primary care. It is web-based and the

participating units use the registry as a check list for ulcer assessment and a base for quality

improvement in their units.

That data must be collected in a uniform manner to capture the scale of wound care has

been previously pointed out.12 The conventional approach is to record details of ulcer care

such as treatment strategies, dressings, antibiotics, analgesics, investigations, hospital

admissions and surgical interventions at each patient contact over the period from first

presentation to wound healing.12 These details are noted in the patient’s medical record for

decision support for the individual patient.

Registration in the RUT is usually done at the first patient contact, and follow-up can be

carried out when all the mandatory variables are registered. Each unit has access only to data

on its own patients; these can be retrieved online at any time, and used to compare the unit’s

quality of wound management with that across the country. By using accumulated data for the

whole country, areas of improvement can be highlighted.

To capture the situation of patients with pressure ulcers, the registry has during the study

period further developed the special pressure ulcer section. To cover community units where

these patients are mostly treated, we have established cooperation with another Swedish

national quality registry on pressure ulcer prevention. This could in the future give a more

accurate picture of pressure ulcer prevention linked to either pressure ulcer healing or

negative clinical events, such as death.

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Registering with the RUT has been mandatory in Blekinge County since 2012 and today

some of the larger national dermatological departments are likewise obliged to register with

the RUT.

METHODOLOGY


During the study period we had frequent meetings with the participating units, at which nurses

and physicians evaluated the RUT. Having had access to the structure of the registry, they

commented on how the registry had made a difference in their approach to wound

management. Their new focus was on adequate diagnosis, continuity of care by nominating a

responsible ulcer nurse for every patient and follow-up to ulcer healing. The shorter time to

healing recorded was an acknowledgment of their effort to introduce improved wound

management.

Another area of improvement was the reduction in antibiotic treatment. Since the variable

antibiotic treatment before and after registration is mandatory, the participants’ attention was

drawn to antibiotic use and participants acknowledged the reduction in oral antibiotic

treatment for their patients as a success for their unit and an improvement of the patients’

quality of life.

During the study period 160 patients were registered in 2009, 348 patients in 2010, 400 in

2011 and 509 in 2012, making a total of 1,417 patients nationwide by 2012.

The RUT registers patients with hard-to-heal leg, foot or pressure ulcers on two occasions.

The first registration, assessment of the ulcer diagnosis, is to guarantee optimal treatment. The



healed ulcer remains in the registry until follow-up is completed.






To guarantee continuity of care there is a mandatory variable containing the name of the

nurse responsible for ulcer care, facilitating follow-up of every patient to complete ulcer

healing. This nurse is often the person responsible for registering the patient with the RUT.

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Other details taken include whether the ulcer is new or recurrent; current or earlier

concomitant diseases; current medication, especially asking for analgesics and antibiotics; and

ulcer-related pain. The patient history focuses on the following variables: deep vein

thrombosis (DVT), varicose veins, arterial or venous surgery, history of recurrent leg ulcers,

and ulcer localization (foot, leg or sacrum/hip; and lateral or medial). Ulcer size is measured

by digital planimeter (Visitrak®, manufactured in the United Kingdom for

Smith & Nephew Medical Limited, Hull HU3 2BN) and the number of ulcers is noted.



Doppler, (manufactured by Histolab,Gothenburg, Sweden). The Doppler is also used for

measuring deep or superficial venous insufficiency (vena saphena magna, vena saphena

parva and vena poplitea).

The diagnosis is determined from these variables, in combination with the clinical

examination. The following ulcer diagnoses are used: venous ulcer, arterial ulcer, venous-

arterial ulcer, diabetic foot ulcer, pressure ulcer, traumatic ulcer, ulcer due to inflammatory

vessel diseases such as vasculitis, and other diagnoses (for example pyoderma gangrenosum).

The strategy for wound management includes dressings, care for the skin surrounding the

ulcer, and treatment for oedema. A photo gallery is linked to the registry for visualization of

the healing process.




given on smoking cessation, exercise and diet. Adverse events are also recorded: e.g.


Data analysis

The statistical analysis was performed using Stata version 12.1 (StataCorp LP, College

Station, TX, USA). Continuous variables were expressed as mean values (± standard

deviation (SD)) and compared using two-sample Student’s t-tests. Group comparisons for

categorical variables were performed using Pearson’s chi-square tests. Healing time was


was used for equality of survivor functions. P<0.05 was considered statistically significant.

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Ethical approval

The Lund Ethical Review Board considered the study to be a valuable quality improvement

study, so no further ethical approval was required.

RESULTS

Healing time

Basic data from the adjusted registry in December 2012 showed a population (n=1,417) with

a median age of 80 years (mean age 77.5 years), ranging from 11 to 103 years.


(mean 117 weeks), ranging from 1 week to 46 years, and the median ulcer size at inclusion in

the RUT was 3 cm2 (mean 12 cm2, range 0.05–600 cm2).

The participating units covered primary care (50%), community care (4%), hospital care

(22%), wound healing centres (22%) and private caregivers (2%). Patients from Blekinge

County constituted 39% of all patients.




Negative pressure wound therapy was introduced in Europe in 1997, and has been used in

Swedish primary health care since 2006. During the study period, this technique was used in

only 1.3% of cases.

Figure 2 gives the median healing time for venous ulcers, adjusted for ulcer size, from




treated with compression therapy both in 2009 and in 2012.



treated with antibiotics before registration, compared with 24% after registration. In 2012, the

corresponding figures were 73% before and 27% after registration. These differences were

significant in both years (p=0.001).

Considering all years between 2009 and 2012, antibiotic treatment for patients with hard-

to-heal ulcers in the registry nationwide was reduced from 71% before registration to 29%

after registration (p=0.001).

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DISCUSSION


ulcers registered with the RUT, from 146 days (21 weeks) in 2009 to 63 days (9 weeks) in

2012. This reduction in healing time seems to be due to structured wound management, based

on accurate diagnosis, continuity of care by nominating a responsible ulcer nurse for every

patient and follow-up to healing, all of which factors were facilitated by the RUT.

Although topical antimicrobial therapy for local ulcer infection, such as iodine, silver,

honey and polyhexamethylene biguanide (PHMB), has become more firmly established, no

further innovative dressings or devices were introduced for wound management on the

Swedish market during the study period. Negative pressure wound therapy was used in less

than 1.5% of all cases during the study, but is now more widespread in clinical practice. There

was some development of services, such as the introduction of smaller wound healing centres

based on the BWHC model.


found a median healing time of 20–43 weeks when following patients through a period of 12

months.13 Some researchers have noted a healing rate of 83% at 30 weeks,14 while others have

reported that 62/90 (69%) of venous leg ulcers healed within 12 weeks.15 Moffatt et al.16

found that 70% of venous ulcers healed after 48 weeks of treatment; they also noted that

much of the evidence on healing rates is drawn from the results of randomized controlled

trials. These trials typically achieve 24-week healing rates in excess of 60%, but may not

reflect the complex issues faced in clinical practice.16

Another important finding in the present study was the low proportion of patients (24-

27%) given antibiotics between registration and ulcer healing; that is, in patients with a

diagnosis and adequate treatment. This can be compared with earlier findings of 68–78%1,5

for patients in primary care. Between 2009 and 2012, antibiotic treatment for patients with

hard-to-heal ulcers in the registry nationwide was reduced from 71% before registration to

29% between registration and ulcer healing (p=0.001).

There is still a high rate of oral antibiotic treatment for patients outside the registry,

which may be explained by the fact that these patients do not receive continuity of care or

treatment by a specialized team, where topical antimicrobial treatment is the golden standard

when treating local ulcer infection.

The use of topical antimicrobial dressings could be one explanation for the reduction in

antibiotic treatment. This issue is being addressed in an on going research study within the

frame of the RUT.

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A further explanation for the recent low rate of antibiotic treatment and reduced healing

time could be that the RUT focuses on stable doctor-patient relationships. Previous research

has shown the advantages of a structured organization for leg ulcer care.17,18 Petursson argues

that lack of continuity in medical care is the main reason why GPs prescribe antibiotics in a

“non-pharmacological” manner.8


owing to lack of diagnosis and low continuity in ulcer care.1,19–21 Dressing changes over

weeks, months and even years have been carried out, often without a proper diagnosis.1 It is

well known that understanding the aetiology of leg ulceration is a prerequisite for a systematic

clinical assessment as a base for appropriate wound management.12,14,15 The RUT meets these

requirements.

A large proportion of the patient population (39%) in the registry was concentrated in

Blekinge County. This could be considered a bias as the registry was developed in Blekinge

County, from where it has spread to the whole country. That the majority of patients were

treated in primary care reflects the true situation in Sweden.


decisions on the needs of the population and the allocation of resources.16 The RUT comprises

a structured and practical methodology which can be used at any level in the health care

system.

Nationwide implementation of the RUT has not yet been fully achieved. One area for

future research is to investigate differences in the results of ulcer care between areas in

Sweden where the RUT is being used and areas where it is not used.


in younger patients with neurological diseases and in palliative care patients. The RUT is an


Since March 2013, the registry has included 1,438 patients. The role of the registry

manager and the steering group is to show staff how data from the registry can be used to

improve ulcer care. We focus on documentation, treatment, education, research, and

economic analyses to guarantee improvement of health outcomes nationwide. Our ultimate

aim is twofold: to serve as basis for national guidelines and for the registry to be implemented

internationally.

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CONCLUSION

The findings from this study illustrate the immediate impact of the RUT as an improvement

project within wound management, resulting in significantly reduced healing time from 146

days (21 weeks) in 2009 to 63 days (9 weeks) in 2012. Antibiotic treatment was reduced from

71% before registration to 29% between registration and ulcer healing. The results also

demonstrate the potential for improved wound management when using a national quality

registry for structured ulcer care.

Contributors

R.F.Ö. led the research project and played the main role in the research design.

H.W.F. contributed to the data analysis and assisted in the research design and interpretation

of results.

Funding

This study was partly funded by the Council of Sciences in Blekinge County, Sweden.

Competing interests

None.

Ethics approval


study, so no further ethical approval was required

Provenance and peer review

This study has not been externally peer-reviewed.

Data-sharing statement

No additional data are available.

Acknowledgement

This study was performed in the interests of the steering group for the Swedish Registry of

Ulcer Treatment (RUT).

REFERENCES

1. Öien RF, Håkansson A, Ovhed I , Hansen BU. Wound management for 287 patients with



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Venereol 1993;73:440–3.



4. Wiström J, Lindholm C, Melhus A, et al. Infections and treatment in chronic leg ulcers:










8. Petursson P. G Ps’ reasons for “non-pharmacological” prescribing of antibiotics: A




10. Öien RF. R UT (Register of Ulcer Treatment) – a winning concept for both patients and

the health care sector. EWMA J 2009; 9:41–4.



ISBN 91-631- 8585-7.


Int Wound J. 2012 Dec 13. doi: 10.1111/iwj.12006







Nov;19(11):474, 476, 478 passim.


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7.


healing. BMJ 1992;305:1389–92.







7.




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The Registry of Ulcer Treatment shows reduced healing time and antibiotic

treatment – an improvement project in the national quality registries in

Sweden



Treatment)



Correspondence to:

Dr Rut F Öien



S-371 41 Karlskrona

Sweden

Phone: +46 706 687202


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ABSTRACT



registry, in 2009.

Design: Statistical analysis was performed of RUT data concerning healing time and

antibiotic treatment for patients with hard-to-heal ulcers in Sweden between 2009 and 2012.















(p=0.001).





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ARTICLE SUMMARY

Article focus



2012.

Key messages




120 days in 2009 to 69 days in 2012.




Strengths






Limitations




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INTRODUCTION








contributed to antibiotic overuse.8 In Sweden, lack of national guidelines for medical ulcer

care has had a negative impact on wound management.

Structured wound management based on accurate diagnosis leads to effective treatment

and, consequently, decreased prevalence, care time and costs.9 For this reason, the Swedish







National registries




The ambition of the Swedish national quality registries is to gather data on diagnoses and

symptoms, interventions and treatment outcomes in order to give a continuous, systematic



with special interest in a research field in order to bring about quality improvement to health


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Health care professionals in Blekinge have for the past 25 years focused on quality



Centre (BWHC) in 2003. The BWHC is a general practitioner (GP)-led, primary care-based

specialist centre covering the treatment and follow-up of the majority of ulcer patients across

the county (150, 000 inhabitants). It offers a structured team management of ulcer care with

emphasis on diagnosis, documentation and treatment. The GP in charge of the centre is the

first author of this study (R.F.Ö.).




manager, who has developed and launched the registry.

The RUT was the first national registry in primary care. It is web-based and the



That data must be collected in a uniform manner to capture the scale of wound care has




presentation to wound healing.12 These details are noted in the patient’s medical record for

decision support for the individual patient.

Registration in the RUT is usually done at the first patient contact, and follow-up can be

carried out when all the mandatory variables are registered. Each unit has access only to data

on its own patients; these can be retrieved online at any time, and used to compare the unit’s

quality of wound management with that across the country. By using accumulated data for the

whole country, areas of improvement can be highlighted.

To capture the situation of patients with pressure ulcers, the registry has during the study

period further developed the special pressure ulcer section. To cover community units where

these patients are mostly treated, we have established cooperation with another Swedish

national quality registry on pressure ulcer prevention. This could in the future give a more

accurate picture of pressure ulcer prevention linked to either pressure ulcer healing or

negative clinical events, such as death.

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Registering with the RUT has been mandatory in Blekinge County since 2012 and today


the RUT.

METHODOLOGY



and physicians evaluated the RUT. Having had access to the structure of the registry, they

commented on how the registry had made a difference in their approach to wound

management. Their new focus was on adequate diagnosis, continuity of care by nominating a

responsible ulcer nurse for every patient and follow-up to ulcer healing. The shorter time to

healing recorded was an acknowledgment of their effort to introduce improved wound

management.


antibiotic treatment before and after registration is mandatory, the participants’ attention was

drawn to antibiotic use and participants acknowledged the reduction in oral antibiotic

treatment for their patients as a success for their unit and an improvement of the patients’

quality of life.

During the study period 160 patients were registered in 2009, 348 patients in 2010, 400 in















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concomitant diseases; current medication, especially asking for analgesics and antibiotics; and

ulcer-related pain. The patient history focuses on the following variables: deep vein

thrombosis (DVT), varicose veins, arterial or venous surgery, history of recurrent leg ulcers,

and ulcer localization (foot, leg or sacrum/hip; and lateral or medial). Ulcer size is measured

by digital planimeter (Visitrak®, manufactured in the United Kingdom for




Doppler, (manufactured by Histolab,Gothenburg, Sweden). The Doppler is also used for













given on smoking cessation, exercise and diet. Adverse events are also recorded: e.g.


Data analysis







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Ethical approval



RESULTS

Healing time














only 1.3% of cases.














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DISCUSSION












based on the BWHC model.


found a median healing time of 20–43 weeks when following patients through a period of 12















treatment by a specialized team, where topical antimicrobial treatment is the golden standard

when treating local ulcer infection.


antibiotic treatment. This issue is being addressed in an on going research study within the

frame of the RUT.

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requirements.


Blekinge County. This could be considered a bias as the registry was developed in Blekinge

County, from where it has spread to the whole country. That the majority of patients were





system.



Sweden where the RUT is being used and areas where it is not used.








aim is twofold: to serve as basis for national guidelines and for the registry to be implemented

internationally.

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CONCLUSION







Contributors



of results.

Funding


Competing interests

None.

Ethics approval







Acknowledgement



REFERENCES




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Venereol 1993;73:440–3.





















ISBN 91-631- 8585-7.









Nov;19(11):474, 476, 478 passim.


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7.


healing. BMJ 1992;305:1389–92.







7.




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0.00

0.25

0.50

0.75

1.00

% ulcer healing

0 100 200 300 400 500 600 700 800Days

2009 2010 2011 2012

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years.

76

64

75 73

24

36

25 27

0

10

20

30

40

50

60

70

80

90

100

2009 2010 2011 2012

Before registration


%

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0.00

0.25

0.50

0.75

1.00

% ulcer healing

0 100 200 300 400 500 600 700 800Days

2009 2010 2011 2012

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Title and abstract

Introduction


Objectives

Methods

Study design

Setting

Participants

Variables

Data sources/

measurement

Bias

Study size


Statistical methods

Results

Participants

Descriptive data

Outcome data

Main results

Other analyses

Discussion

Key results

Item

No

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

Recommendation





paper


recruitment,











during 2009 to 2012







are reported




summarised

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Limitations

Interpretation

Generalisability

Other information

Funding

19

20

21

22




undertaken.


only mentioned,


Blekinge County.

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Ulcer healing time and antibiotic treatment before and after the introduction of the Registry of Ulcer Treatment – an

improvement project in a national quality registry in Sweden

Journal: BMJ Open

Manuscript ID: bmjopen-2013-003091.R2


Date Submitted by the Author: 20-Jul-2013



Medical management






jopen.bmj.com

/B

MJ O


ugust 2013. Dow

nloaded from



Ulcer healing time and antibiotic treatment before and after the

introduction of the Registry of Ulcer Treatment – an improvement project

in a national quality registry in Sweden



Treatment)



Correspondence to:

Dr Rut F Öien



S-371 41 Karlskrona

Sweden

Phone: +46 706 687202


Page 1 of 31


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ABSTRACT



registry, in 2009.

Design: A statistical analysis of RUT data concerning healing time and antibiotic treatment

for patients with hard-to-heal ulcers in Sweden between 2009 and 2012.















(p=0.001).





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ARTICLE SUMMARY

Article focus



2012.

Key messages




120 days in 2009 to 69 days in 2012.




Strengths






Limitations




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INTRODUCTION








contributed to antibiotic overuse.8 In Sweden, the absence of national guidelines for medical

ulcer care has had a negative impact on wound management.

Structured wound management based on accurate diagnosis leads to effective treatment,

and consequently to decreased prevalence, care time and costs.9 For this reason, the Swedish







National registries




The ambition of the Swedish national quality registries is to gather data on diagnoses,

symptoms, interventions and treatment outcomes in order to give a continuous systematic



with special interest in a research field, in order to bring about quality improvement to health


Page 4 of 31


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For the past 25 years, health care professionals in Blekinge have focused on quality



Centre in 2003. This is a general practitioner (GP)-led, primary care-based specialist centre

covering the treatment and follow-up of the majority of ulcer patients across the county

(150,000 inhabitants). It offers a structured team management of ulcer care with emphasis on

diagnosis, documentation and treatment. The GP in charge of the centre is the first author of

this study (R.F.Ö.).




manager, who then developed the registry further and launched it nationwide.

The RUT was the first national registry in primary care. It is web-based, and the



The data must be collected in a uniform manner to capture the scale of wound care, as has




presentation to wound healing.12 These details are noted in the patient’s medical record to

support decisions regarding the care for that individual patient.

Registration in the RUT usually takes place at the first patient contact, and follow-up can

be carried out when all the mandatory variables are registered. Each unit has access only to

data on its own patients; these can be retrieved online at any time, and used to compare the

unit’s quality of wound management with that across the country. By using accumulated data

for the whole country, areas of improvement can be highlighted.

To capture the situation of patients with pressure ulcers, during the study period the

pressure ulcer section of the registry was further developed. To improve our coverage of

community units (where these patients are mostly treated), we have established cooperation

with another Swedish national quality registry on pressure ulcer prevention.

This could in the future give a more accurate picture of pressure ulcer prevention linked to

either pressure ulcer healing or negative clinical events, such as death.

Page 5 of 31


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Registering with the RUT has been mandatory in Blekinge County since 2012, and today


the RUT.

METHODOLOGY



and physicians provided feedback on the RUT. Having had access to the structure of the

registry, they commented on how the registry had made a difference in their approach to

wound management. Their new focus was on adequate diagnosis, continuity of care by

nominating a responsible ulcer nurse for every patient, and follow-up to ulcer healing. They

saw the documented shorter time to healing as an acknowledgment of their efforts to

introduce improved wound management.


for antibiotic treatment before and after registration is mandatory, the participants’ attention

was drawn to antibiotic use. They acknowledged the reduction in oral antibiotic treatment for

their patients as a success for their unit and an improvement of the patients’ quality of life.

During the study period, 160 patients were registered in 2009, 348 patients in 2010, 400 in
















concomitant diseases; current medication, particularly analgesics and antibiotics; and ulcer-

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related pain. The patient history focuses on the following variables: deep vein thrombosis,

varicose veins, arterial or venous surgery, history of recurrent leg ulcers, and ulcer

localization (foot, leg or sacrum/hip; and lateral or medial). Ulcer size is measured by digital

planimeter (Visitrak®, manufactured in the United Kingdom for




Doppler (manufactured by Histolab, Gothenburg, Sweden). The Doppler is also used for













given on smoking cessation, exercise and diet. Adverse events are also recorded, such as


Data analysis







Page 7 of 31


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Ethical approval



RESULTS

Healing time














only 1.3% of cases.














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DISCUSSION












based on the model of the Blekinge Wound Healing Centre.


found a median healing time of 20–43 weeks when following patients over a period of 12















treatment by a specialized team, where topical antimicrobial treatment is the gold standard for

treating local ulcer infection.


antibiotic treatment. This issue is being addressed in an ongoing research study within the

frame of the RUT.

Page 9 of 31


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requirements.


Blekinge County. This could be considered a bias, as the registry was developed in Blekinge

County before being expanded to the whole country. That the majority of patients were





system.



Sweden where the RUT is used and areas where it is not used.








aim is twofold: to serve as a basis for national guidelines, and for the registry to be

implemented internationally.

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CONCLUSION







Contributors



of results.

Funding


Competing interests

None.

Ethics approval







Acknowledgements



REFERENCES




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Venereol 1993;73:440–3.





















ISBN 91-631- 8585-7.









Nov;19(11):474, 476, 478 passim.


Page 12 of 31


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7.


healing. BMJ 1992;305:1389–92.







7.




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BM


jopen-2013-003091 on 19 August 2013. D

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Ulcer healing time and antibiotic treatment before and after the

introduction of the Registry of Ulcer Treatment – an improvement project

in a national quality registry in Sweden



Treatment)



Correspondence to:

Dr Rut F Öien



S-371 41 Karlskrona

Sweden

Phone: +46 706 687202


Page 14 of 31


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BM


jopen-2013-003091 on 19 August 2013. D

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ABSTRACT



registry, in 2009.

Design: A statistical analysis of RUT data concerning healing time and antibiotic treatment

for patients with hard-to-heal ulcers in Sweden between 2009 and 2012.















(p=0.001).





Page 15 of 31


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ARTICLE SUMMARY

Article focus



2012.

Key messages




120 days in 2009 to 69 days in 2012.




Strengths






Limitations




Page 16 of 31


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INTRODUCTION








contributed to antibiotic overuse.8 In Sweden, the absence of national guidelines for medical

ulcer care has had a negative impact on wound management.

Structured wound management based on accurate diagnosis leads to effective treatment,

and consequently to decreased prevalence, care time and costs.9 For this reason, the Swedish







National registries




The ambition of the Swedish national quality registries is to gather data on diagnoses,

symptoms, interventions and treatment outcomes in order to give a continuous systematic



with special interest in a research field, in order to bring about quality improvement to health


Page 17 of 31


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123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


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j.com/

BM


jopen-2013-003091 on 19 August 2013. D

ownloaded from




For the past 25 years, health care professionals in Blekinge have focused on quality



Centre in 2003. This is a general practitioner (GP)-led, primary care-based specialist centre

covering the treatment and follow-up of the majority of ulcer patients across the county (150,

000 inhabitants). It offers a structured team management of ulcer care with emphasis on

diagnosis, documentation and treatment. The GP in charge of the centre is the first author of

this study (R.F.Ö.).




manager, who then developed the registry further and launched it nationwide.

The RUT was the first national registry in primary care. It is web-based, and the



The data must be collected in a uniform manner to capture the scale of wound care, as has




presentation to wound healing.12 These details are noted in the patient’s medical record to

support decisions regarding the care for that individual patient.

Registration in the RUT usually takes place at the first patient contact, and follow-up can

be carried out when all the mandatory variables are registered. Each unit has access only to

data on its own patients; these can be retrieved online at any time, and used to compare the

unit’s quality of wound management with that across the country. By using accumulated data

for the whole country, areas of improvement can be highlighted.

To capture the situation of patients with pressure ulcers, during the study period the

pressure ulcer section of the registry was further developed. To improve our coverage of

community units (where these patients are mostly treated), we have established cooperation

with another Swedish national quality registry on pressure ulcer prevention.

This could in the future give a more accurate picture of pressure ulcer prevention linked to

either pressure ulcer healing or negative clinical events, such as death.

Page 18 of 31


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123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


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j.com/

BM


jopen-2013-003091 on 19 August 2013. D

ownloaded from



Registering with the RUT has been mandatory in Blekinge County since 2012, and today


the RUT.

METHODOLOGY



and physicians provided feedback on the RUT. Having had access to the structure of the

registry, they commented on how the registry had made a difference in their approach to

wound management. Their new focus was on adequate diagnosis, continuity of care by

nominating a responsible ulcer nurse for every patient, and follow-up to ulcer healing. They

saw the documented shorter time to healing as an acknowledgment of their efforts to

introduce improved wound management.


for antibiotic treatment before and after registration is mandatory, the participants’ attention

was drawn to antibiotic use. They acknowledged the reduction in oral antibiotic treatment for

their patients as a success for their unit and an improvement of the patients’ quality of life.

During the study period, 160 patients were registered in 2009, 348 patients in 2010, 400 in
















concomitant diseases; current medication, particularly analgesics and antibiotics; and ulcer-

Page 19 of 31


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BM


jopen-2013-003091 on 19 August 2013. D

ownloaded from



related pain. The patient history focuses on the following variables: deep vein thrombosis,

varicose veins, arterial or venous surgery, history of recurrent leg ulcers, and ulcer

localization (foot, leg or sacrum/hip; and lateral or medial). Ulcer size is measured by digital

planimeter (Visitrak®, manufactured in the United Kingdom for




Doppler (manufactured by Histolab, Gothenburg, Sweden). The Doppler is also used for













given on smoking cessation, exercise and diet. Adverse events are also recorded, such as


Data analysis







Page 20 of 31


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Ethical approval



RESULTS

Healing time














only 1.3% of cases.














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BM


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DISCUSSION












based on the model of the Blekinge Wound Healing Centre.


found a median healing time of 20–43 weeks when following patients over a period of 12















treatment by a specialized team, where topical antimicrobial treatment is the gold standard for

treating local ulcer infection.


antibiotic treatment. This issue is being addressed in an ongoing research study within the

frame of the RUT.

Page 22 of 31


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BM


jopen-2013-003091 on 19 August 2013. D

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requirements.


Blekinge County. This could be considered a bias, as the registry was developed in Blekinge

County before being expanded to the whole country. That the majority of patients were





system.



Sweden where the RUT is used and areas where it is not used.








aim is twofold: to serve as a basis for national guidelines, and for the registry to be

implemented internationally.

Page 23 of 31


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CONCLUSION







Contributors



of results.

Funding


Competing interests

None.

Ethics approval







Acknowledgements



REFERENCES




Page 24 of 31


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Venereol 1993;73:440–3.





















ISBN 91-631- 8585-7.









Nov;19(11):474, 476, 478 passim.


Page 25 of 31


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7.


healing. BMJ 1992;305:1389–92.







7.




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0.00

0.25

0.50

0.75

1.00

% ulcer healing

0 100 200 300 400 500 600 700 800Days

2009 2010 2011 2012

Page 27 of 31


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0.00

0.25

0.50

0.75

1.00

% ulcer healing

0 100 200 300 400 500 600 700 800Days

2009 2010 2011 2012

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years.

76

64

75 73

24

36

25 27

0

10

20

30

40

50

60

70

80

90

100

2009 2010 2011 2012

Before registration


%

Page 29 of 31


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BM


jopen-2013-003091 on 19 August 2013. D

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Title and abstract

Introduction


Objectives

Methods

Study design

Setting

Participants

Variables

Data sources/

measurement

Bias

Study size


Statistical methods

Results

Participants

Descriptive data

Outcome data

Main results

Other analyses

Discussion

Key results

Item

No

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

Recommendation





paper


recruitment,











during 2009 to 2012







are reported




summarised

Page 30 of 31


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j.com/

BM


jopen-2013-003091 on 19 August 2013. D

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Limitations

Interpretation

Generalisability

Other information

Funding

19

20

21

22




undertaken.


only mentioned,


Blekinge County.

Page 31 of 31


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bmj open · (vena saphena magna, vena saphena parva, and vena poplitea). the diagnosis is...

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