Patient involvement in complex evidence syntheses provides valuable background experience and may supplement clinical findings

Article type
Authors
Brazzelli M1, Montgomery I2, Imamura M1, Hudson J1, Javanbakht M3, Moloney E3, Wallace S4, MacLennan G5, Vale L6, Craig D6
1Health Services Research Unit, University of Aberdeen
2Patient and Public Involvement Lay Representative
3Health Economics Group, Institute of Health & Society, Newcastle University
4Cochrane Incontinence Group, Institute of Health & Society, Newcastle University
5Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen
6Evidence Synthesis Group, Institute of Health & Society, Newcastle University
Abstract
Background:
Public involvement in evidence syntheses and health technology assessments (HTAs) is essential. However, the degree of involvement and how this is reflected in the published reports still varies widely. We describe our experience of involving a member of the public in a complex NIHR HTA assessing the clinical and cost-effectiveness of surgical treatments for women with stress urinary incontinence (ESTER). Surgical interventions for stress urinary incontinence (SUI) have changed over the last decade with less invasive mesh techniques available to women. However, recent concerns regarding supposed severe adverse effects from mesh procedures have caused anxiety in women and uncertainty for clinicians and decision-makers.

Methods:
This was an evidence synthesis and economic decision model, with a value of information analysis. We compared nine surgical interventions for the treatment of SUI. We assessed primary outcomes (cure and improvement rates) in a network meta-analysis (NMA). We analysed data on adverse events, when possible, using pair-wise meta-analyses. The Advisory Group for this project included, among others, patient representatives. In particular, one patient representative was involved as project advisor and formal grant holder, integral to shaping the initial proposal and scope. She contributed to all phases of the research process and attended both Project and Advisory Group meetings.

Results:
Data from 175 RCTs were included in the effectiveness review. The NMA results (121 RCTs) indicated that traditional slings and retropubic mid-urethral slings (MUS) were most likely to cure or improve SUI. Retropubic MUS were also the most cost-effective option. Data for adverse events were limited. Our patient representative helped identify patient-centred issues, guided the direction of work and selection of outcomes, informed the economic modelling and provided perspectives on the advocacy against mesh use. This allowed a fuller contextualisation of the clinical findings. She provided comments on the report and wrote the plain language summary.

Conclusions:
Involving members of the public in complex evidence syntheses can be challenging. Our experience demonstrated that the contribution of a patient representative improved our findings by providing invaluable insight and information that was otherwise unavailable.