Developing a placebo-controlled trial in surgery:issues of design, acceptability and feasibility

BACKGROUND: Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. METHODS: Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed). RESULTS: There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot.Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. CONCLUSIONS: Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented. TRIAL REGISTRATION NUMBER: The trial was assigned ISRCTN02328576 through http://controlled-trials.com/ in June 2006. The first patient was randomised to the pilot in July 2007

Responses to gestational weight management guidance: a thematic analysis of comments made by women in online parenting forums

Background: The National Institute for Health and Clinical Excellence (NICE) published guidance on weight management in pregnancy in July 2010[1], and this received considerable press coverage across a range of media. This offered an opportunity to examine how gestational weight management guidance was received by UK women. Methods: A thematic analysis was conducted of 400 posts made in UK-based parenting internet forums in the week following the publication of the NICE guidance. This allowed us to examine the naturally occurring comments from 202 women who posted about the guidance on public forums. Results: Three main themes were identified and explored: i) Perceived control/responsibility ii) Risk perception iii) Confused messages. Conclusions: Women differed in their perceptions of the level of control that they had over being overweight with some feeling responsible and motivated to maintain a healthy lifestyle. Others felt there were multiple factors influencing their weight issues beyond their control. There were reports of feeling guilty about the impact of weight on the growing baby and experiencing significant obesity stigma from the public and health professionals. Information about the risks of overweight and obesity in pregnancy were difficult messages for women to hear, and for health professionals to deliver. Women reported being confused by the messages that they received. Health messages need to be delivered sensitively to women, and health professionals need support and training to do this. Risk information should always be accompanied with clear advice and support to help women to manage their weight in pregnancy. Keywords: internet-mediated research, gestational weight gain, parenting forums, NICE, women, views, risk perception</p

Acceptability and feasibility of weight management programmes for adults with severe obesity: A qualitative systematic review

OBJECTIVES:To improve our understanding of the acceptability of behavioural weight management programmes (WMPs) for adults with severe obesity. DESIGN:A systematic review of qualitative evidence. DATA SOURCES:Medline, Embase, PsycINFO, CINAHL, SCI, SSCI and CAB abstracts were searched from 1964 to May 2017. ELIGIBILITY CRITERIA:Papers that contained qualitative data from adults with body mass index (BMI) ≥35 kg/m2 (and/or the views of providers involved in their care) and considered issues about weight management. DATA EXTRACTION AND SYNTHESIS:Two reviewers read and systematically extracted data from the included papers which were compared, and contrasted according to emerging issues and themes. Papers were appraised for methodological rigour and theoretical relevance using Toye's proposed criteria for quality in relation to meta-ethnography. RESULTS:33 papers met our inclusion criteria from seven countries published 2007-2017. Findings were presented from a total of 644 participants and 153 programme providers. Participants described being attracted to programmes that were perceived to be novel or exciting, as well as being endorsed by their healthcare provider. The sense of belonging to a group who shared similar issues, and who had similar physiques and personalities, was particularly important and seemed to foster a strong group identity and related accountability. Group-based activities were enjoyed by many and participants preferred WMPs with more intensive support. However, some described struggling with physical activities (due to a range of physical comorbidities) and not everyone enjoyed group interaction with others (sometimes due to various mental health comorbidities). Although the mean BMI reported across the papers ranged from 36.8 to 44.7 kg/m2, no quotes from participants in any of the included papers were linked to specific detail regarding BMI status. CONCLUSIONS:Although group-based interventions were favoured, people with severe obesity might be especially vulnerable to physical and mental comorbidities which could inhibit engagement with certain intervention components