Mary Madden

Alienating evidence based medicine vs. innovative medical device marketing: A report on the evidence debate at a Wounds conference

Wound care management is one of the largest segments of the UK medical technology sector with a turnover exceeding £1bn in 2009 (BIS, 2010). Using data derived from participant observation, this article examines the antagonistic relationship expressed by wound care clinicians towards evidence based medicine in the context of the 2010 United Kingdom (UK) Wounds UK conference/trade show, where evidence based medicine is positioned in opposition to clinical knowledge, as an obstacle to innovation and as a remover of solutions rather than a provider of them. The article is written in the context of the trend towards increasing marketization and privatization in the UK National Health Service (NHS).

Funding source and the quality of reports of chronic wounds trials: 2004 to 2011

BackgroundCritical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality.MethodsA systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed.ResultsA total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered.ConclusionsThis overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.

Exploring the challenge of health research priority setting in partnership: reflections on the methodology used by the James Lind Alliance Pressure Ulcer Priority Setting Partnership

Plain English SummaryThe James Lind Alliance (JLA) brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs) to identify and prioritise shared uncertainties about the effects of treatment. The JLA emerged from the evidence-informed healthcare movement to address a concern that the research being carried out on treatment effectiveness is not that of most importance to patients and health professionals. In the JLA PSPs, ‘hard’ evidence-informed ideals meet ‘soft’ participatory practices. This article explores the challenges of putting co-production methods into practice by reflecting on the methods used by the JLA Pressure Ulcer PSP (JLAPUP). The JLA principles are transparency, inclusivity and avoiding waste in research. This means paying the same close critical attention to how PSPs are designed and run, as is desired in the health research which the JLA seeks to influence. JLAPUP showed that it was possible to work in partnership in a field where patients are often elderly, immobile, unrepresented and particularly unwell, many of whom are living with more than one long term condition. However, for those unfamiliar with it, ‘uncertainty’ was a difficult term to get to grips with. Also, it was harder for some people than others to take part and to have their voices heard and understood. In keeping with other PSPs, JLAPUP found that the nature and quality of research into pressure ulcer prevention and treatment did not reflect the priorities of those who took part.AbstractᅟBackgroundStudies identifying a mismatch between the priorities of academics and clinicians and those of people with direct experience of a health condition pose a challenge to the assumption that professional researchers can represent the interests of patients and the public in setting priorities for health research. The James Lind Alliance (JLA) brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs) to identify and prioritise shared uncertainties about the effects of treatment. There is no formal evaluation yet to examine the different approaches used by individual PSPs and the impact these methods have on the quality of the partnership and subsequent outputs. There is no gold standard method for health research topic identification and priority setting and reporting on public involvement in this area is predominantly descriptive rather than evaluative.Methods and FindingsThe JLA Pressure Ulcer PSP (JLAPUP) was developed and worked between 2009 and 2013 to identify and prioritise the top 10 ‘uncertainties’, or ‘unanswered questions’, about the effects of pressure ulcer interventions. JLAPUP identified a mismatch between the nature and quality of RCTs in pressure ulcer prevention and treatment and the kind of research evidence desired by patients or service users, carers and health professionals. Results and methods have been reported fully elsewhere. The consultative and deliberative methods used to establish health research priorities in PSPs are fundamentally interpretive. PSPs are therefore an arena in which ‘hard’ evidence-informed ideals meet ‘soft’ participatory practices. This article provides an account of the challenges faced in one particular PSP. We explain the rationale for the approaches taken, difficulties faced and the limitations at each stage, because these aspects are particularly under-reported. The JLAPUP case is used to identify possible areas for evaluation and reporting across PSPs.ConclusionEngaging people with very different health and life experiences in the complexities of health science based discussions of uncertainty is challenging. This is particularly the case when engaging groups routinely excluded from participating in health research, for example, older people with multiple comorbidities. The JLA principles of transparency, inclusivity and avoiding waste in research require paying close critical attention to PSP methodology, including full evaluation and reporting of PSP processes and outcomes. Assessing the impact of PSPs is contingent on the decision making processes of commissioners and funders.

Beware Zombies and Unicorns: Toward Critical Patient and Public Involvement in Health Research in a Neoliberal Context

Patient and Public Involvement (PPI) in UK National Health Service (NHS) research has become an imperative in policy and practice. However, lack of clarity on what PPI is (or might be) has given rise to a poorly monitored, complex field of activity, variously framed by the expectations of policy makers, funders, host organisations, researchers, health professionals, individual recruits, volunteers, activists and third sector organisations. The normative shift towards PPI has taken place within a neoliberal policy context, the implications of which needs to be explicitly considered, particularly after the Brexit referendum which has left policy makers and researchers wondering how to better appeal to a distrustful public subjected to ‘post-truth’ and ‘dog whistle’ politics. This commentary examines the prospects for a more critical approach to PPI which addresses context, is evidence-informed and mindful of persistent inequalities in health outcomes, at a time when models of PPI in NHS health research tend to be conceptually vague, derived from limited clinical and managerial settings, and centred on a construction of the abstract, rational, compliant and self-managing patient or lay-person.

The ghost of Nora Batty: A qualitative exploration of the impact of footwear, bandaging and hosiery interventions in chronic wound care

Objective To explore the impact of footwear, bandaging and hosiery interventions in the everyday lives of women and men undergoing treatment for chronic, complex wounds in a city in England, UK. Methods This study draws on data generated in semi-structured interviews with patients exploring outcomes and impacts of undergoing treatment for leg and foot ulcers undertaken as part of a UK National Institute for Health Research funded study. Footwear, bandaging and hosiery are explored here as aspects of material culture, not only in functional terms as a treatment supporting or hindering healing but also as part of the means by which people receiving treatment for two of the most common complex, chronic wounds, leg ulcers and foot ulcers, negotiate and understand their embodied selves in everyday life. Findings Physical and social discomfort associated with interventions can lead to ambivalence about effectiveness. Not being able to dress appropriately impacts on the ability of people to feel comfortable and take part in special occasions and everyday events. In this context, the removal of bandaging or refusal to wear support hosiery which may be viewed as ‘non-compliance’ by a health professional may feel like a strategy of self-care or self-preservation from a patient perspective. Discussion The study of material culture explores how inanimate objects work and how they are worked with in carrying out social functions, regulating social relations and giving symbolic meaning to human activity. The interviews show some of the ways in which footwear, hosiery and bandaging play a role in controlling the boundaries between the private (wounded and potentially socially unacceptable smelly, leaky, embodied), self and the public presentation of self.

Access and multi-centre research

This paper reports a seldom considered but very important practical aspect of research: access to respondents in multi-centre research. The advantages of multi-centre research are often balanced by extra difficulties in negotiating access to the research subjects. Using the example of a multi-centre pilot study of breast cancer.1 this article reviews various structures barring researchers’ access, and considers reasons for these barriers. The consequent costs to research in time, resources and staff continuity are discussed, and ways of addressing problems of access are suggested.

Using genre literature and video in homelessness research: A feminist sociological experiment in insurrectional textuality

Abstract It is a truism that research does not occur outside of the life which researches and that ‘things happen’ which impact constantly on the development of thinking, knowing, theorising and writing/ making (Oates, 1992). Such things for me include reading novels, watching films and listening to music. Here I discuss the use of a literary feminist gothic style and the interjection of video excerpts and montages/mashups into a written academic text as a means of exploring the source, affect and dis/crediting of knowledges about homelessness at a time when British neo-liberal capitalism was on the rise.

Put more trust in the trustworthy and less in the untrustworthy to improve judgement of medicines

The Academy of Medical Sciences recommends involving patients, carers, and the public in research as a means of tackling concerns about the erosion of public trust, overmedication, and conflicts of interest.1 Patient and public involvement, …

Engaging civil society with health research

The move to an open access model in contemporary health research raises questions about the role of the scientific journal and its engagement with civil society in shaping the research agenda, as well as highlighting tensions between the public interest in science and doing science that is in the

Articulating Otherness A Methodological Adventure in Gothic Intertextuality

This article is inspired both by the radical feminist work of Daly and the post/modern possibilities of deconstruction. The author adopts a monstrous textual form to show and warn fellow voyagers in the academic mode of production that challenging exclusion and assimilation involves thinking beyond existing forms and going beyond “methodolatory”. Shelley’s Frankenstein provides the basis for a feminist gothic approach that emphasizes research as a written, passionate, and embodied process with consequences for the researcher and the researched. The article asserts the narrative inevitability of intertextuality, examines the gendering of knowledge, and presents a discursive challenge to the subject/object binary.