Building an evidence base for chronic illness management: the example of chronic wounds

1
Building an evidence base for chronic illness
management the example of chronic wounds

• Nicky Cullum RGN
• Department of Health Sciences

2
Context

• Ageing western population
• Increasing numbers of people living with chronic
  illness
• Increasing demand for health care
• Meeting demand huge challenge from financial and
  workforce perspectives

3
Huge contribution of nursing and nurses to
chronic illness management

• Nurses play a key role in the care and management
  of the care of people with chronic ill health
• Can be role substitution (see Temmink et al, JAN
  2000)
• Can be a new role care coordination, case
  management etc
• Often combination with the emphasis on care
  rather than cure living with

4
Examples of nursing roles in chronic illness
management

• Nurse specialists in diabetes, Parkinsons
  disease, COPD, rheumatology, asthma, wound care
  etc etc
• Increasing emphasis on role of nurse specialists
  in implementing evidence based health
  care/evidence based decision making

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Key Question

• Does research evidence, relevant for the nursing
  role in chronic illness management, exist?
• Is there an evidence base?

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What is evidence based health care?

• The consideration of relevant, valid, research
  evidence when making health care decisions
• NOT evidence driven or dictated but evidence
  informed
• The nature of the research evidence depends on
  the nature of the decision/uncertainty
• NOT solely concerned with RCTs though it is for
  questions of effectiveness

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Is the evidence base fit for purpose?
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Evidence in context

• Chronic disease research historically
  under-funded
• Complexity (interventions and co-morbidities)
  methodologically challenging
• Nursing research still young, under-developed
  and under-resourced
• Nurses less likely to have research training in
  epidemiological and health services research
  methods
• Exemplar of chronic wounds

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Chronic wounds

• Leg ulcers (mainly venous disease, also arterial
  and mixed aetiology)
• Diabetic foot ulcers
• Pressure ulcers
• Chronic, non-healing surgical wounds
• In many parts of the world management of people
  with chronic wounds almost wholly a nursing
  responsibility
• Common and costly

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Imagine it is 1990
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Problem of leg ulcers

• The UK Department of Health knew that the
  management of people with leg ulcers was a major
  proportion of community nurse workload
• They did not know how much
• They did not know what care nurses were
  delivering
• They did not know if it was effective
• Commissioned a systematic review

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Traditional reviews not fit for purpose

• Mulrow reviewed 50 reviews in 4 major medical
  journals from 1985 1986
• used 8 explicit quality criteria to assess the
  reviews
• no review met 8 criteria
• one met 6 32 met 4/5 17 met 3/8
• only one review had clear methods
• Mulrow concluded that current medical reviews do
  not routinely use scientific methods to identify,
  assess and synthesise information
• Mulrow CD. The medical review article state of
  the science. Ann Intern Med 1987 106485-8.

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Death after heart attack
Cumulative Year RCTs Pts 1960 1965
1970 1975 1980 1985 1990
Odds Ratio
2
1
0.5
1 23 2 65 3 149 4 316 7 1793 10 2544 11 2651 15 33
11 17 3929 23 5767 27 6125 33 6571 43
21059 54 22051 70 48154
l
l
l
l
l
l
p l
l
l
l
l
l
p l
l
l
p l
Favours treatment Favours control
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Death after heart attack
Textbook Recommendations Rout Specif Exp NOT
Cumulative Year RCTs Pts 1960 1965
1970 1975 1980 1985 1990
Odds Ratio
2
1
0.5
1 23 2 65 3 149 4 316 7 1793 10 2544 11 2651 15 33
11 17 3929 23 5767 27 6125 33 6571 43
21059 54 22051 70 48154
l
21 5 10 2 8 7 8 12 4 3 1 1
l
l
l
1 1 2 8 7 2
l
l
p l
l
l
1 1 1 2 8 1
l
l
l
p l
5 15 6
l
l
p l
Favours treatment Favours control
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Systematic reviews

• Are driven by a focused, answerable question
• Have a pre-specified, scientific method
• Strive to minimise bias at all stages
• Aim to be comprehensive (all relevant research
  included)
• Base their conclusions on the amount and validity
  of the evidence

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UK Department of Health commissioned a systematic
review of leg ulcer care in March 1990

• Objectives
• to critically review the research underpinning
  the nursing management of leg ulcers in the
  community and
• develop a research agenda to inform and improve
  nursing practice

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Clinical question driven review

• What is the underlying pathology of leg
  ulceration?
• How many people affected?
• Do we know risk factors and early warning signs?
• Effective prevention?
• Recurrence rates?
• Interventions to reduce recurrence?
• What methods of treatment are used?
• Which treatments are effective?
• What are the adverse effects of leg ulcer
  treatment?

• Can adverse effects be reduced?
• What is a nursing assessment of a leg ulcer
  patient?
• How is care delivered and where?
• What proportion of community nursing workload is
  leg ulcer management?
• What is the impact of leg ulceration on the
  patient?
• What outcomes should be measured?

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Clinical question driven review

• What is the underlying pathology of leg
  ulceration?
• How many people affected?
• Do we know risk factors and early warning signs?
• Effective prevention?
• Recurrence rates?
• Interventions to reduce recurrence?
• What methods of treatment are used?
• Which treatments are effective?
• What are the adverse effects of leg ulcer
  treatment?

• Can adverse effects be reduced?
• What is a nursing assessment of a leg ulcer
  patient?
• How is care delivered and where?
• What proportion of community nursing workload is
  leg ulcer management?
• What is the impact of leg ulceration on the
  patient?
• What outcomes should be measured?
• CLEAR ANSWER
• SOME ANSWERS
• UNCLEAR

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Pressure ulcer systematic review 1995

• Evidence for the accuracy of risk prediction
  scales is confusing not clear whether better
  than clinical judgement
• Effects of manual repositioning not adequately
  studied
• Most available equipment not reliably evaluated
• More RCTs and economic evaluations required

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an evidence desert
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Developing a research agenda for chronic wounds
Primary Research
Evidence Synthesis
Implementation into Practice
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UK NHS Research and Development Programme

• Funded a suite of systematic reviews in wound
  care beginning in 1997

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(No Transcript)
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Cochrane Wounds Group

• Cochrane Collaboration was established 1993
• an international not-for-profit and independent
  organization that produces and disseminates
  systematic reviews of healthcare interventions
• the major product of the Collaboration is the
  Cochrane Database of Systematic Reviews which is
  published quarterly as part of The Cochrane
  Library.
• The Cochrane Wounds Group was established 1995
• 56 systematic reviews published to date with a
  further 57 reviews in production

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Examples of completed Cochrane reviews

• Antibiotics and antiseptics for mammalian bites
• Antimicrobial drugs for treating MRSA
  colonisation
• Compression for venous leg ulcers
• Hyperbaric oxygen therapy for chronic wounds
• Patient education for preventing diabetic foot
  ulceration
• Pin site care for preventing infections
  associated with external bone fixators and pins
• Support surfaces for pressure ulcer prevention
• Tissue adhesives for closure of surgical
  incisions
• Wound drainage after incisional hernia repair

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The changing landscape 1990 - 2008

• 1994 One systematic review in wound care
• 2008
• 133 Cochrane Reviews
• 176 non-Cochrane systematic reviews
• Huge amount of primary research completed in
  response to evidence gaps identified in Cochrane
  reviews

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From evidence synthesis to evidence creation
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RCTs only provide part of the picture
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We need to know more than is treatment x
effective? the patient perspective

• How do patients feel about larval therapy?
• Are patients comfortable on alternating pressure
  mattresses?
• What is the effect of pressure ulceration on
  patients quality of life?

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We need to know more than is treatment x
effective? the service perspective

• How do nursing staff feel about using larval
  therapy?
• Were alternating pressure mattresses and overlays
  used appropriately?
• Would a costly trial of topical negative pressure
  be an efficient use of health service resources?
  (would the value of the information be greater
  than the cost?)
• Do staff use the results of research in practice,
  and if not, why not?

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Methodological Research
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Real progress RCTs Published by Year (PubMed
Clinical Queries)
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Long way to go

• 40 out of 42 (95) recommendations in the UK
  national (NICE) pressure ulcer guidelines based
  on opinion, consensus or case reports
• 32 out of 45 (71) recommendations in the UK leg
  ulcer guidelines based on level III evidence

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Further improvements needed

• Ensuring the patient voice in establishing the
  research agenda
• Research capacity shortage (eg, insufficient
  nurse researchers with epidemiological skills)
• Research agenda based on the value of the
  information likely to accrue

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Whose research questions? (Tallon et al, Lancet
2000)

• Research funding does not reflect burden of
  disease
• Funding sources vested interests publication
  bias consumer pressure
• When studied in osteoarthritis showed that
  evidence base dominated by pharmaceutical (59)
  and surgical (26) studies
• Patients, doctors and physiotherapists want more
  research on knee replacement, physiotherapy,
  education and advice

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The need for epidemiological methods

• Epidemiology is the study of the distribution and
  determinants of health in the population
• Answers questions about causes of ill health
  prognosis effects of treatments
• Some education in epidemiological methods and the
  interpretation of epidemiological studies
  fundamental to evidence based health care
• If nurses not epidemiologically literate they are
  not likely to ask important questions or answer
  them with the most appropriate methods

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and finally

• Increasingly research funders are turning to
  health economics to help judgements of whether a
  particular research study is likely to be an
  efficient investment of funding
• The value of the information that the study will
  provide is an important consideration (see work
  by Claxton and others)
• Knowledge of the impact on quality of life of
  chronic disease and therapies essential