, J. M. (2010). What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychology & Health, 25(10), pp. 1229-1245. doi: 10.1080 This is the unspecified version of the paper.This version of the publication may differ from the final published version. Permanent 2What is an adequate sample size? Operationalising data saturation for theory-based interview studies AbstractIn interview studies, sample size is often justified by interviewing participants until reaching "data saturation". However, there is no agreed method of establishing this. We propose principles for deciding saturation in theory-based interview studies (where conceptual categories are pre-established by existing theory). First, specify a minimum sample size for initial analysis (initial analysis sample). Second, specify how many more interviews will be conducted without new ideas emerging (stopping criterion). We demonstrate these principles in two studies, based on Theory of Planned Behaviour, designed to identify three belief categories (Behavioural, Normative, Control), using an initial analysis sample of 10 and stopping criterion of 3. Study 1 (retrospective analysis of existing data) identified 84 shared beliefs of 14 general medical practitioners about managing patients with sore throat without prescribing antibiotics. The criterion for saturation was achieved for Normative beliefs but not for other beliefs or study-wise saturation. In Study 2 (prospective analysis), 17 relatives of people with Paget's disease of the bone reported 44 shared beliefs about taking genetic testing. Study-wise data saturation was achieved at interview 17. We propose specification of these principles for reporting data saturation in theory-based interview studies. The principles may be adaptable for other types of studies.

Objective To assess whether weight loss interventions for adults with obesity affect all cause, cardiovascular, and cancer mortality, cardiovascular disease, cancer, and body weight. Design Systematic review and meta-analysis of randomised controlled trials (RCTs) using random effects, estimating risk ratios, and mean differences. Heterogeneity investigated using Cochran’s Q and I2 statistics. Quality of evidence assessed by GRADE criteria. Data sources Medline, Embase, the Cochrane Central Register of Controlled Trials, and full texts in our trials’ registry for data not evident in databases. Authors were contacted for unpublished data. Eligibility criteria for selecting studies RCTs of dietary interventions targeting weight loss, with or without exercise advice or programmes, for adults with obesity and follow-up ≥1 year. Results 54 RCTs with 30 206 participants were identified. All but one trial evaluated low fat, weight reducing diets. For the primary outcome, high quality evidence showed that weight loss interventions decrease all cause mortality (34 trials, 685 events; risk ratio 0.82, 95% confidence interval 0.71 to 0.95), with six fewer deaths per 1000 participants (95% confidence interval two to 10). For other primary outcomes moderate quality evidence showed an effect on cardiovascular mortality (eight trials, 134 events; risk ratio 0.93, 95% confidence interval 0.67 to 1.31), and very low quality evidence showed an effect on cancer mortality (eight trials, 34 events; risk ratio 0.58, 95% confidence interval 0.30 to 1.11). Twenty four trials (15 176 participants) reported high quality evidence on participants developing new cardiovascular events (1043 events; risk ratio 0.93, 95% confidence interval 0.83 to 1.04). Nineteen trials (6330 participants) provided very low quality evidence on participants developing new cancers (103 events; risk ratio 0.92, 95% confidence interval 0.63 to 1.36). Conclusions Weight reducing diets, usually low in fat and saturated fat, with or without exercise advice or programmes, may reduce premature all cause mortality in adults with obesity. Systematic review registration PROSPERO CRD42016033217.

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Background: Robot-assisted laparoscopic prostatectomy is increasingly used compared to a standard laparoscopic technique but it remains uncertain whether potential benefits offset higher costs.Objective: To determine cost-effectiveness of robotic prostatectomy.Design, Setting, Participants: Care pathway description and model-based cost-utility analysis. We studied men with localised prostate cancer able to undergo either robotic or laparoscopic prostatectomy for cure. Data Sources:We used data from a meta-analysis, other published literature, and costs from United Kingdom (UK) National Health Service (NHS) and commercial sources.Outcome Measurements and Statistical Analysis: Care received by men for ten years following radical prostatectomy was modelled. Clinical events, their effect on quality of life, and associated costs were synthesised assuming 200 procedures were performed annually. Results and Limitations: Over ten years robotic prostatectomy was on average [95% confidence interval] £1412 (€1595) [£1304 (€1473) to £1516 (€1713)] more costly than laparoscopic prostatectomybut more effective with mean (95% confidence interval) gain in quality adjusted life years (QALY) of 0.08 (0.01 to 0.15). The incremental cost-effectiveness ratio (ICER) was £18,329 (€20,708) with an 80% probability that robotic prostatectomy was cost-effective at a threshold of £30,000 (€33,894)/QALY. The ICER was sensitive to the throughput of cases and the relative positive margin rate favouring robotic prostatectomy. Conclusions:Higher costs of robotic prostatectomy may be offset by modest health gain resulting from lower risk of early harms and positive margin provided more than 150 cases are performed each year.Considerable uncertainty persists in the absence of directly comparative randomised data.

KeywordsWeight loss, weight maintenance, men and women, systematic review 3 AcknowledgementsThis review is one of a series of systematic reviews for the ROMEO project (Review Of MEn and Conflict of interestThe authors have no conflict of interests to declare. Contribution of authorsCR drafted the manuscript under the supervision of AA. FS developed and ran the electronic literature search. CR and AA conducted the eligibility screening, data extraction and quality assessment. All authors contributed to the study design and manuscript preparation. 5 AbstractWe systematically reviewed the randomised controlled trial (RCT) evidence for long-term (>12 months) weight management interventions for obese men in contrast to women to help understand whether programmes should be designed differently for men.We searched 11 databases up to October 2014. Twenty-two RCTs reported data separately for men and women in weight loss or weight maintenance interventions.We found men were under-represented in RCTs of weight loss interventions open to both sexes. Men comprised 36% of participants (4771 from 13,305 participants). Despite this, men were 11% (95% CI 8% to 14%, p<0.001) more likely to be trial completers compared to women. The trials did not report service user consultation and none were designed to investigate whether men and women responded differently to given interventions. Our meta-analysis of 13 trials showed no significant difference in weight loss between men and women, either for weight loss in kg ( p=0.90) or percentage weight loss (p=0.78), although men tended to lose more weight with intensive low fat reducing diets, with or without meal replacements, and structured physical activity/exercise programmes than women.Orlistat was less beneficial for men for weight maintenance. Individual support and tailoring appeared more helpful for men than women.We found evidence that men and women respond differently to, and have different preferences for, varying types of weight management programme. We suggest that it is important to understand men's views on weight loss, as this is likely to also improve the uptake and effectiveness of programmes for men.

BackgroundFor people with localised prostate cancer, active treatments are effective but have significant side effects. Minimally invasive treatments that destroy (or ablate) either the entire gland or the part of the prostate with cancer may be as effective and cause less side effects at an acceptable cost. Such therapies include cryotherapy, high-intensity focused ultrasound (HIFU) and brachytherapy, among others.ObjectivesThis study aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localised prostate cancer, and compared with RP for salvage treatment of localised prostate cancer which has recurred after initial treatment with EBRT.Data sourcesMEDLINE (1946 to March week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (29 March 2013), EMBASE (1974 to week 13, 2013), Bioscience Information Service (BIOSIS) (1956 to 1 April 2013), Science Citation Index (1970 to 1 April 2013), Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2013), Cochrane Database of Systematic Reviews (CDSR) (issue 3, 2013), Database of Abstracts of Reviews of Effects (DARE) (inception to March 2013) and Health Technology Assessment (HTA) (inception to March 2013) databases were searched. Costs were obtained from NHS sources.Review methodsEvidence was drawn from randomised controlled trials (RCTs) and non-RCTs, and from case series for the ablative procedures only, in people with localised prostate cancer. For primary therapy, the ablative therapies were cryotherapy, HIFU, brachytherapy and other ablative therapies. The comparators were AS, RP and EBRT. For salvage therapy, the ablative therapies were cryotherapy and HIFU. The comparator was RP. Outcomes were cancer related, adverse effects (functional and procedural) and quality of life. Two reviewers extracted data and carried out quality assessment. Meta-analysis used a Bayesian indirect mixed-treatment comparison. Data were incorporated into an individual simulation Markov model to estimate cost-effectiveness.ResultsThe searches identified 121 studies for inclusion in the review of patients undergoing primary treatment and nine studies for the review of salvage treatment. Cryotherapy [3995 patients; 14 case series, 1 RCT and 4 non-randomised comparative studies (NRCSs)], HIFU (4000 patients; 20 case series, 1 NRCS) and brachytherapy (26,129 patients; 2 RCTs, 38 NRCSs) studies provided limited data for meta-analyses. All studies were considered at high risk of bias. There was no robust evidence that mortality (4-year survival 93% for cryotherapy, 99% for HIFU, 91% for EBRT) or other cancer-specific outcomes differed between treatments. For functional and quality-of-life outcomes, the paucity of data prevented any definitive conclusions from being made, although data on incontinence rates and erectile dysfunction for all ablative procedures were generally numerically lower than for non-ablative procedures. The safety profiles were comparable with existing treatments. Studies reporting the use of focal cryotherapy suggested that incontinence rates may be better than for whole-gland treatment. Data on AS, salvage treatment and other ablative therapies were too limited. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. The probabilistic sensitivity analyses suggest that a number of ablative techniques are worthy of further research.LimitationsThe main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction.ConclusionsThe findings indicate that there is insufficient evidence to form any clear recommendations on the use of ablative therapies in order to influence current clinical practice. Research efforts in the use of ablative therapies in the management of prostate cancer should now be concentrated on the performance of RCTs and the generation of standardised outcomes.Study registrationThis study is registered as PROSPERO CRD42012002461.FundingThe National Institute for Health Research Health Technology Assessment programme.

Background Adults with severe obesity [body mass index (BMI) of ≥ 35 kg/m2] have an increased risk of comorbidities and psychological, social and economic consequences. Objectives Systematically review bariatric surgery, weight-management programmes (WMPs) and orlistat pharmacotherapy for adults with severe obesity, and evaluate the feasibility, acceptability, clinical effectiveness and cost-effectiveness of treatment. Data sources Electronic databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials and the NHS Economic Evaluation Database were searched (last searched in May 2017). Review methods Four systematic reviews evaluated clinical effectiveness, cost-effectiveness and qualitative evidence for adults with a BMI of ≥ 35 kg/m2. Data from meta-analyses populated a microsimulation model predicting costs, outcomes and cost-effectiveness of Roux-en-Y gastric bypass (RYGB) surgery and the most effective lifestyle WMPs over a 30-year time horizon from a NHS perspective, compared with current UK population obesity trends. Interventions were cost-effective if the additional cost of achieving a quality-adjusted life-year is < £20,000–30,000. Results A total of 131 randomised controlled trials (RCTs), 26 UK studies, 33 qualitative studies and 46 cost-effectiveness studies were included. From RCTs, RYGB produced the greatest long-term weight change [–20.23 kg, 95% confidence interval (CI) –23.75 to –16.71 kg, at 60 months]. WMPs with very low-calorie diets (VLCDs) produced the greatest weight loss at 12 months compared with no WMPs. Adding a VLCD to a WMP gave an additional mean weight change of –4.41 kg (95% CI –5.93 to –2.88 kg) at 12 months. The intensive Look AHEAD WMP produced mean long-term weight loss of 6% in people with type 2 diabetes mellitus (at a median of 9.6 years). The microsimulation model found that WMPs were generally cost-effective compared with population obesity trends. Long-term WMP weight regain was very uncertain, apart from Look AHEAD. The addition of a VLCD to a WMP was not cost-effective compared with a WMP alone. RYGB was cost-effective compared with no surgery and WMPs, but the model did not replicate long-term cost savings found in previous studies. Qualitative data suggested that participants could be attracted to take part in WMPs through endorsement by their health-care provider or through perceiving innovative activities, with WMPs being delivered to groups. Features improving long-term weight loss included having group support, additional behavioural support, a physical activity programme to attend, a prescribed calorie diet or a calorie deficit. Limitations Reviewed studies often lacked generalisability to UK settings in terms of participants and resources for implementation, and usually lacked long-term follow-up (particularly for complications for surgery), leading to unrealistic weight regain assumptions. The views of potential and actual users of services were rarely reported to contribute to service design. This study may have failed to identify unpublished UK evaluations. Dual, blinded numerical data extraction was not undertaken. Conclusions Roux-en-Y gastric bypass was costly to deliver, but it was the most cost-effective intervention. Adding a VLCD to a WMP was not cost-effective compared with a WMP alone. Most WMPs were cost-effective compared with current population obesity trends. Future work Improved reporting of WMPs is needed to allow replication, translation and further research. Qualitative research is needed with adults who are potential users of, or who fail to engage with or drop out from, WMPs. RCTs and economic evaluations in UK settings (e.g. Tier 3, commercial programmes or primary care) should evaluate VLCDs with long-term follow-up (≥ 5 years). Decision models should incorporate relevant costs, disease states and evidence-based weight regain assumptions. Study registration This study is registered as PROSPERO CRD42016040190. Funding The National Institute for Health Research Health Technology Assessment programme. The Health Services Research Unit and Health Economics Research Unit are core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.