Cost-effectiveness of bariatric surgery and non-surgical weight management programmes for adults with severe obesity: a decision analysis model.

OBJECTIVES: To determine the most cost-effective weight management programmes (WMPs) for adults, in England with severe obesity (BMI ≥ 35 kg/m2), who are more at risk of obesity related diseases. METHODS: An economic evaluation of five different WMPs: 1) low intensity (WMP1); 2) very low calorie diets (VLCD) added to WMP1; 3) moderate intensity (WMP2); 4) high intensity (Look AHEAD); and 5) Roux-en-Y gastric bypass (RYGB) surgery, all compared to a baseline scenario representing no WMP. We also compare a VLCD added to WMP1 vs. WMP1 alone. A microsimulation decision analysis model was used to extrapolate the impact of changes in BMI, obtained from a systematic review and meta-analysis of randomised controlled trials (RCTs) of WMPs and bariatric surgery, on long-term risks of obesity related disease, costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) measured as incremental cost per QALY gained over a 30-year time horizon from a UK National Health Service (NHS) perspective. Sensitivity analyses explored the impact of long-term weight regain assumptions on results. RESULTS: RYGB was the most costly intervention but also generated the lowest incidence of obesity related disease and hence the highest QALY gains. Base case ICERs for WMP1, a VLCD added to WMP1, WMP2, Look AHEAD, and RYGB compared to no WMP were £557, £6628, £1540, £23,725 and £10,126 per QALY gained respectively. Adding a VLCD to WMP1 generated an ICER of over £121,000 per QALY compared to WMP1 alone. Sensitivity analysis found that all ICERs were sensitive to the modelled base case, five year post intervention cessation, weight regain assumption. CONCLUSIONS: RYGB surgery was the most effective and cost-effective use of scarce NHS funding resources. However, where fixed healthcare budgets or patient preferences exclude surgery as an option, a standard 12 week behavioural WMP (WMP1) was the next most cost-effective intervention.

Communicating good care: a qualitative study of what people with urological cancer value in interactions with health care providers.

PURPOSE: Communication with health care providers is important to help meet cancer patients' information and support needs. It can significantly affect the extent to which patients feel cared for, respected and involved, and it can influence a range of cancer care processes and outcomes. This paper presents findings from a study which explored urological cancer patients' experiences of care, focussing on insights into what they appeared to value in their interactions with health care providers and why. METHOD: In-depth interviews were undertaken with 20 men and 6 women with different types of urological cancer at a range of times since diagnosis. Interviews were audio-recorded, transcribed and thematically analysed using an established interpretive approach. RESULTS: Patients valued being treated as someone who mattered and was worthy of care; being recognised and responded to as an individual; and experiencing support for autonomy/agency. Reasons for their valuations related to the implications of communicative interactions for the ways patients thought health professionals related to them 'as persons'. Our findings highlight the value of relational aspects of communication for: indicating to patients what clinicians think of their worth; facilitating individualised care; and enabling patients to contribute to their own care. CONCLUSIONS: Efforts to improve health care provider-patient communication should attend not only to the transfer of information about the condition and its management but to the range of features of interactions that can signal to people how health care providers relate to them as persons.

Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.

OBJECTIVE: To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. DESIGN: Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. DATA SOURCES: A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. RESULTS: There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. CONCLUSION: The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

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.

Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study).

OBJECTIVES: To ascertain the acceptability of a randomised controlled trial comparing arthroscopic lavage with a placebo-surgical procedure for the management of osteoarthritis of the knee; and to assess the practical feasibility of mounting such a multicentre placebo-controlled trial. DESIGN: Mixed methods study including: focus groups with surgeons and anaesthetists; focus groups and interviews with potential participants; interviews with chairpersons of UK Multicentre Research Ethics Committees (MRECs); surveys of surgeons and anaesthetists; and a two-centre, three-arm pilot. SETTING: UK secondary care. PARTICIPANTS: Members of the British Association of Surgeons of the Knee and members of the British Society of Orthopaedic Anaesthetists took part in the focus groups and surveys. Surgeons and anaesthetists from two regional centres in the UK also contributed to focus groups, as did patients from consultant lists in two UK regional centres, and members of Arthritis Care. Chairpersons of six UK MRECs were interviewed. Participants were eligible for the pilot if they were adults (18 years or older) with radiological evidence of osteoarthritis of the knee who might be considered for arthroscopic lavage, and were fit for general anaesthetic (defined by the American Society of Anaesthesiologists grades 1 and 2), and able to give informed consent. INTERVENTIONS: Participants in the pilot study were randomised to arthrosocopic lavage (with or without debridement at the clinical discretion of the surgeon); placebo surgery; or non-operative management with specialist reassessment. MAIN OUTCOME MEASURES: The acceptability and feasibility of mounting a placebo-controlled trial for the evaluation of knee arthroscopic lavage. RESULTS: There was broad acceptance across all stakeholder groups of the need to find out more about the effectiveness of arthroscopic lavage. Despite this there was variation in opinion within all the groups about how researchers should approach this and whether or not it would be acceptable to investigate using placebo surgery. Within the health professional groups, there tended to be a split between those who were strongly opposed to the inclusion of a placebo surgery arm and those who were more in favour. For prospective trial participants who had osteoarthritis of the knee, the acceptability of the trial was discussed from a more individual perspective - reflecting on their personal reasons for or against participating. The majority of this group said they would consider taking part. The pilot study showed that, in principle, a placebo-controlled trial could be conducted. It showed that patients were willing to participate in a trial which would involve a placebo-surgical arm and that it was possible to undertake placebo surgery successfully and to blind patients to their allocation - although once patients knew their allocation, some patients allocated to surgery became more concerned about the possibility of undergoing placebo surgery, and withdrew. The experience of the pilot, however, showed that, despite full MREC approval, the study required major discussion and negotiation before local clinical approvals could be obtained. The fact that ethics approval had been granted did not mean that clinicians would automatically accept that the process was ethical. CONCLUSIONS: The study showed that, in principle, a placebo-controlled trial of arthroscopic lavage could be conducted in the UK, albeit with difficulty. Against the background of falling use of arthroscopic lavage the decision was, therefore, taken not to proceed to full-scale trial for this procedure. The study showed that for some health professionals the use of placebo surgery can never be justified. It highlighted the importance of the surgeon-anaesthetist relationship in this context and how acceptance of the trial design by both parties is essential to successful participation. It also highlighted the importance of informed consent for trial participants and the strength and influence of individuals' ethical perspectives in addition to collective ethics provided by MRECs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02328576.

Women's perceptions of decision-making about hysterectomy.

OBJECTIVE: To explore women's views of decision-making relating to hysterectomy. DESIGN: Structured questionnaire and in-depth interview surveys. SETTING: A teaching hospital and a district general hospital in northeast Scotland. SAMPLE: Women scheduled for hysterectomy for benign menstrual problems. METHODS: Pre-operative questionnaires were sent to a consecutive sample of women booked for hysterectomy. A purposive sample was interviewed post-operatively. MAIN OUTCOME MEASURES: Women's experiences of, and satisfaction with, information provision, communication and decision-making processes; the relationship between views of decision-making processes and decisions made. RESULTS: One hundred and four women (66%) returned questionnaires. Most responded positively to structured questions about the process by which the decision to have a hysterectomy was reached. Almost all (97%) reported satisfaction with the decision made. Twenty women were interviewed post-operatively. A number, including some who had responded positively on the questionnaire, described aspects of the decision-making process that were suboptimal. Women's perceptions of the decision-making process, including the way their doctors communicated with them, did impinge on their views of the course of action selected. Some women had residual doubts about the appropriateness of hysterectomy. CONCLUSIONS: In a significant minority of women, there are important shortcomings in current patterns of information provision and communication relating to decision-making. These are unlikely to be picked up by conventional structured patient feedback surveys. Further efforts are required to ensure that women are adequately informed and involved in decisions about gynaecological treatments.

Interventions for providers to promote a patient-centred approach in clinical consultations.

BACKGROUND: Communication problems in health care may arise as a result of health care providers focusing on diseases and their management, rather than people, their lives and their health problems. Patient-centred approaches to care are increasingly advocated by consumers and clinicians and incorporated into training for health care providers. The effects of interventions that aim to promote patient-centred care need to be evaluated. OBJECTIVES: To assess the effects of interventions for health care providers that aim to promote patient-centred approaches in clinical consultations. SEARCH STRATEGY: We searched Medline (1966 - Dec 1999); Health Star (1975 - Dec 1999); PsycLit (1887- Dec 1999); Cinahl (1982 - Dec 1999); Embase (1985-Dec 1999) and the bibliographies of studies assessed for inclusion. SELECTION CRITERIA: Randomised controlled trials, controlled clinical trials, controlled before and after studies, and interrupted time series studies of interventions for health care providers that promote patient-centred care in clinical consultations. Patient-centred care was defined as a philosophy of care that encourages: (a) shared control of the consultation, decisions about interventions or management of the health problems with the patient, and/or (b) a focus in the consultation on the patient as a whole person who has individual preferences situated within social contexts (in contrast to a focus in the consultation on a body part or disease). The participants were health care providers, including those in training. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data onto a standard form and assessed study quality for each study. We extracted all outcomes other than health care providers' knowledge, attitudes and intentions. MAIN RESULTS: 17 studies met the inclusion criteria. These studies display considerable heterogeneity in terms of the interventions themselves, the health problems or health concerns on which the interventions focused, the comparisons made and the outcomes assessed. All included studies used training for health care providers as an element of the intervention. Ten studies evaluated training for providers only, while the remaining studies utilised multi-faceted interventions where training for providers was one of several components. The health care providers were mainly primary care physicians (general practitioners or family doctors) practising in community or hospital outpatient settings. In two studies, the providers also included nurses. There is fairly strong evidence to suggest that some interventions to promote patient-centred care in clinical consultations may lead to significant increases in the patient centredness of consultation processes. 12 of the 14 studies that assessed consultation processes showed improvements in some of these outcomes. There is also some evidence that training health care providers in patient-centred approaches may impact positively on patient satisfaction with care. Of the eleven studies that assessed patient satisfaction, six demonstrated significant differences in favour of the intervention group on one or more measures. Few studies examined health care behaviour or health status outcomes. REVIEWER'S CONCLUSIONS: Interventions to promote patient-centred care within clinical consultations may significantly increase the patient centredness of care. However, there is limited and mixed evidence on the effects of such interventions on patient health care behaviours or health status; or on whether these interventions might be applicable to providers other than physicians. Further research is needed in these areas.

Decisions about treatment: interpretations of two measures of control by women having a hysterectomy.

A number of authors have developed sets of role descriptions that have been used to classify patients' roles in decisions about their health care as either active, collaborative or passive. We explored the validity of two such measures. Twenty women who had recently had a hysterectomy described their experiences of treatment decision-making in their own words and picked role descriptions from the Control Preferences Scale (Degner, Sloan, J. Clin. Epidemiol. 45 (1992) 941) and Patient Preferences for Control measure (Bradley et al.. Fam. Med. 28 (1996) 496), both phrased in the past tense to assess roles played. The women explained why they had picked particular role descriptions. We compared the women's selections from the two measures and considered the relationship between their narrative descriptions and the role descriptors they picked. Several women found it hard to find an appropriate role description among those they were offered. Some picked apparently conflicting statements from the two measures. The role classifications that would be made on the basis of the women's chosen role descriptions did not always seem appropriate when compared with their narrative descriptions of how treatment decisions were reached. Women gave a range of explanations for choosing the role descriptors that they did, and some women who picked different role descriptions gave similar explanations for doing so. These findings suggest that there are problems with the validity of some currently used measures of patients' participation in health care decision-making. Researchers need to pay more attention to the key features of participation in decision-making and develop measures that can distinguish between these.