Building an evidence base for chronic illness management: the example of chronic wounds Nicky Cullum RGN Department of Health Sciences

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

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 …

Examples of nursing roles in chronic illness management Nurse specialists in diabetes, Parkinson’s 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

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

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

Is the evidence base “fit for purpose”?

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…

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

Imagine it is 1990 … Thatcher resigns! Ninja Turtles Baywatch was big! Nelson Mandela released

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

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; 106:485-8.

Death after heart attack Cumulative Year RCTs Pt s Odds Ratio Favours treatment Favours control p < 0.01 p < p <

Death after heart attack Cumulative Year RCTs Pt s Odds Ratio Favours treatment Favours control p < 0.01 p < p < Textbook Recommendations Rout Specif Exp NOT

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

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

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?

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

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

an evidence desert…

Implementation into Practice Primary Research Evidence Synthesis Developing a research agenda for chronic wounds

UK NHS Research and Development Programme Funded a suite of systematic reviews in wound care beginning in 1997

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 systematic reviews published to date with a further 57 reviews in production

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

The changing landscape: : 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

From evidence synthesis to evidence creation Are cheaper alternating pressure overlays as effective as alternating pressure mattresses? PRESSURE Trial 1972 participants Mattresses more cost effective Is the 4 layer compression bandage more effective than the short stretch bandage for healing venous leg ulcers? VenUS I 387 participants 4 layer bandage more clinically and cost effective Is larval therapy more effective than hydrogel in healing sloughy venous leg ulcers? VenUS II 200+ participants Is therapeutic ultrasound more effective than standard care alone in healing venous leg ulcers? VenUS III 300+ participants Is compression hosiery more effective than bandages in healing venous leg ulcers? VenUS IV

RCTs only provide part of the picture …

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?

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?

Describing the Problem epidemiology; the patient experience; social determinants of health and health care Methodological Research Evidence Synthesis Systematic reviews Meta analysis Mixed treatment comparisons Decision analytic modelling Value of information analysis Evaluating Interventions Large, multi-centre RCTs with economic evaluations Implementation into Practice A schema for nursing research in chronic disease management

Real progress: RCTs Published by Year (PubMed Clinical Queries)

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

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

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

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

… 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