Reaching a consensus and ranking research priorities in urinary incontinence

Authors

Brian S Buckley, PhD, MHSc, BA, is Cochrane fellow, Department of General Practice, National University of Ireland, Galway, and chair, Bladder and Bowel Foundation; Adrian M Grant, FRCPE, FRCOG, MFPH, DM, MA, MSc, BM, BCh, is professor of health services research, University of Aberdeen; Douglas G Tincello, FRCOG, MD, MBChB, is senior lecturer in urogynaecology, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary; Adrian Wagg, FRCP, MBBS, is consultant and senior lecturer in geriatric medicine, University College London; Lester Firkins is chair, James Lind Alliance, Oxford.

Research often neglects important gaps in existing evidence. As a result, every day clinicians and patients must make decisions about treatments and management strategies without reliable evidence about their effectiveness. This is as true of urinary incontinence as it is of any other field.

With the aim of influencing research priorities, the James Lind Alliance Priority Setting Partnership on Urinary Incontinence helped patients and clinicians to identify and then prioritise gaps in the evidence base that affect decisions on managing urinary incontinence (Buckley et al, 2009). Such gaps have been referred to as “unanswered research questions”, “treatment uncertainties” or even “therapeutic ignorance” (Buckley et al, 2009; Chalmers, 2008; 2004).

The James Lind Alliance is an organisation that aims to help patients and clinicians to work together in healthcare research. It is named after an 18th century Scottish naval surgeon, who conducted what was perhaps the first fully reported clinical trial, in which he compared various supposed treatments for scurvy among sailors and established the value of citrus fruits (Lind, 1753).
One of the alliance’s approaches is to facilitate partnerships of patient and clinician organisations in specific clinical areas to identify and prioritise research needs.

The partnership on urinary incontinence was proposed in 2007 by representatives of Incontact (now the Bladder and Bowel Foundation) and the Cochrane Incontinence Group, and completed its work in 2009. Its findings have recently been published in Neurourology and Urodynamics, the journal of the International Continence Society (Buckley et al, 2009).

The partnership

Very few projects of this type have been undertaken, so the partnership on urinary incontinence had to devise a methodology that would be systematic, transparent and inclusive, to ensure all potential stakeholder organisations could become involved.

In the first phase, UK clinician and patient organisations whose remit included urinary incontinence were identified and invited to become involved. Thirty organisations were identified and eight patient and 13 clinician groups agreed to participate. These included both large organisations, such as royal college related groups and national patient charities, and small ones, such as patient and clinician groups with specific clinical interests.

Participating organisations were required to ask their members to identify uncertainties which were of most concern to them. As a result of this, 417 submissions were received describing areas of uncertainty that regularly affected patients’ and clinicians’ ability to make decisions about management options in urinary incontinence. In addition, a further 131 unanswered research questions were identified in the recommendations of systematic reviews and clinical guidelines.

The examples of clinical uncertainty gathered in these ways were collated and refined: similar questions were combined while, in some cases, more than one were derived from a single submission; some were excluded because a systematic review that addressed them was identified; and each was re-written in PICO format (population, intervention, comparator, outcome) (Akobeng, 2005; Sackett et al, 2000).

The final database contained 226 uncertainties: 79 came from patients; 37 from clinicians; six from both patients and clinicians; two from both patients and research recommendations; and 102 from research recommendations alone.

Compiling the list

The resulting list was prioritised in two phases.

First, each participating organisation identified a shortlist of 10 questions through consultation with their membership. These were then combined to produce a shortlist of 29.

Second, at a workshop of patient and clinician organisation representatives, nominal group techniques were used to reach a consensus on a ranked “top 10” list of important clinical uncertainties. Prioritised uncertainties were verified by searching to ensure no up to date systematic reviews had been published which answered the questions.

The final prioritised list of clinical uncertainties has been published and reported to funding agencies, with the dual aims of acting as a catalyst for research design and funding applications and of informing funding decisions (Buckley et al, 2009). Of the top 10, five were originally submitted by clinicians, four by patients and one came from research recommendations.

The wide range of evidence needs included in the final list reflects the breadth of urinary incontinence as a clinical area. Every prioritised uncertainty relates to treatment and management strategies that can have profound effects on quality of life and rehabilitation of those affected and yet about which little evidence exists. The 10 prioritised research questions are outlined in Box 1.

Gaps in the evidence

There are gaps in the evidence relating to interventions that are widely used yet not thoroughly understood.

For example, pelvic floor muscle training is widely recommended as a treatment in many scenarios, yet uncertainty remains about which incontinence types it can treat best and which are the most effective exercise protocols in terms of outcomes, patient adherence and sustainability.

Urodynamic testing is commonly used in the care pathway for urinary incontinence, but it is not clear whether in all circumstances its effectiveness in informing treatment decisions justifies the expense, discomfort and small potential risk.

Intermittent catheterisation is the mainstay of management strategies in many situations where there are voiding problems, yet uncertainties exist around areas of its practice.

Two questions were combined on which regimens are most effective in preventing urinary tract infection, while the question of whether reusable catheters may be as acceptable and effective as disposable ones was also prioritised.

Other questions related to patterns of incontinence which, although commonly seen, have been inadequately addressed by research: optimal treatment and management strategies for “mixed” stress and urge incontinence; frequency and urgency in adults; and daytime urinary incontinence in children.

Others relate to specific surgical uncertainties. For example, suburethral tapes are a common operation for urodynamic stress incontinence in women, yet for the 10% whose operation fails, there is no robust comparative data to guide decision making between medical or surgical treatment, and about whether an abdominal procedure such as colposuspension or repeat suburethral tape insertion is the correct intervention. And should suburethral tapes be inserted at the same time as repairing a prolapse in women with coexisting pelvic organ prolapse and stress urinary incontinence?

One area of uncertainty that was highly placed by patients and clinicians alike related to access to care. Whether training for GPs in care pathways for urinary incontinence might improve referrals and, ultimately, outcomes probably reflects concerns that, while most of those affected who seek help do so from their family doctor, these clinicians may not be sufficiently trained to diagnose, treat and refer appropriately (Shaw et al, 2006; Grealish and O’Dowd, 1998).

Conclusion

This partnership demonstrates clinicians and patients can work together effectively and unanswered research questions of everyday importance can be identified and prioritised through consultation and consensus.

The results of this work have been published and reported to funding agencies such as the National Institute for Health Research and the Medical Research Council, which have signalled their intention to take into account the recommendations of James Lind Alliance Priority Setting Partnerships.

The 10 prioritised areas of clinical uncertainty reflect the heterogeneity of the patient group affected by incontinence and the wide range of treatment and management strategies available. They also reflect the uncertainty asfsociated with commonly recommended treatment and management options. It is hoped the work will lead to the design and funding of research that seeks to answer questions on areas of clinical uncertainty regarded important by clinicians and patients alike.

Dedication

We were very sorry to learn of the recent death of Jenny Henderson from the MS Trust, who gave a huge personal contribution to the project. This article is dedicated to her.

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