Completion and Publication Rates of Randomized Controlled Trials in Surgery: An Empirical Study.

OBJECTIVE: To investigate the prevalence of discontinuation and nonpublication of surgical versus medical randomized controlled trials (RCTs) and to explore risk factors for discontinuation and nonpublication of surgical RCTs. BACKGROUND: Trial discontinuation has significant scientific, ethical, and economic implications. To date, the prevalence of discontinuation of surgical RCTs is unknown. METHODS: All RCT protocols approved between 2000 and 2003 by 6 ethics committees in Canada, Germany, and Switzerland were screened. Baseline characteristics were collected and, if published, full reports retrieved. Risk factors for early discontinuation for slow recruitment and nonpublication were explored using multivariable logistic regression analyses. RESULTS: In total, 863 RCT protocols involving adult patients were identified, 127 in surgery (15%) and 736 in medicine (85%). Surgical trials were discontinued for any reason more often than medical trials [43% vs 27%, risk difference 16% (95% confidence interval [CI]: 5%-26%); P = 0.001] and more often discontinued for slow recruitment [18% vs 11%, risk difference 8% (95% CI: 0.1%-16%); P = 0.020]. The percentage of trials not published as full journal article was similar in surgical and medical trials (44% vs 40%, risk difference 4% (95% CI: -5% to 14%); P = 0.373). Discontinuation of surgical trials was a strong risk factor for nonpublication (odds ratio = 4.18, 95% CI: 1.45-12.06; P = 0.008). CONCLUSIONS: Discontinuation and nonpublication rates were substantial in surgical RCTs and trial discontinuation was strongly associated with nonpublication. These findings need to be taken into account when interpreting surgical literature. Surgical trialists should consider feasibility studies before embarking on full-scale trials.

Nutritional behaviour and beliefs of ski-mountaineers: a semi-quantitative and qualitative study.

BACKGROUND: Endurance athletes are advised to optimize nutrition prior to races. Little is known about actual athletes' beliefs, knowledge and nutritional behaviour. We monitored nutritional behaviour of amateur ski-mountaineering athletes during 4 days prior to a major competition to compare it with official recommendations and with the athletes' beliefs. METHODS: Participants to the two routes of the 'Patrouille des Glaciers' were recruited (A, 26 km, ascent 1881 m, descent 2341 m, max altitude 3160 m; Z, 53 km, ascent 3994 m, descent 4090 m, max altitude 3650 m). Dietary intake diaries of 40 athletes (21 A, 19 Z) were analysed for energy, carbohydrate, fat, protein and liquid; ten were interviewed about their pre-race nutritional beliefs and behaviour. RESULTS: Despite belief that pre-race carbohydrate, energy and fluid intake should be increased, energy consumption was 2416 ± 696 (mean ± SD) kcal · day(-1), 83 ± 17 % of recommended intake, carbohydrate intake was only 46 ± 13 % of minimal recommended (10 g · kg(-1) · day(-1)) and fluid intake only 2.7 ± 1.0 l · day(-1). CONCLUSIONS: Our sample of endurance athletes did not comply with pre-race nutritional recommendations despite elementary knowledge and belief to be compliant. In these athletes a clear and reflective nutritional strategy was lacking. This suggests a potential for improving knowledge and compliance with recommendations. Alternatively, some recommendations may be unrealistic.

Challenges to patient-centred care in a general internal medicine context: findings from an exploratory study

Introduction. If we are to promote more patient-centred approaches in care delivery, we have to better characterize the situations in which being patient-centred is difficult to achieve. Data from professionals in health and social care are important because they are the people charged with operationalizing patient-centred care (PCC) in their daily practice. However, empirical accounts from frontline care providers are still lacking, and it is important to gather experiences not only from doctors but also from the other care providers. Indeed, experiences from different professions can help inform our understanding of patient care, which is expected to be both patient-centred and collaborative. Methods. This study was based on the following research question: What factors make the provision of PCC difficult to achieve? Sample and setting. A purposeful sampling technique was used, allowing for a series of choices about the participants and their professional affiliation. Because patient-centredness is the focus, 3 professions appeared to be of special interest: general internists, nurses and social workers. The study was undertaken in the General Internal Medicine Division of a teaching hospital located in a North American context. Data Collection. To answer the research question, a methodological approach based on a theory called phenomenology was chosen. Accordingly, semi-structured interviews were used since they generate understanding of the meanings different individuals have of their lived world. Interviews with 8 physicians, 10 nurses and 10 social workers were eventually conducted. Data analysis. An inductive thematic analysis was employed to make sense of the interview data. Results. The thematic analysis allowed identifying various types of challenges to PCC. Although most of the challenges were perceived by all three groups of professionals, they were perceived to a different degree across the professions, which likely reflected the scope of practice of each profession. The challenges and their distribution across the professions are illustrated in Table 1. Examples of challenges are provided in Table 2. Discussion. There is a tension between what is supposed to be done - what stands in the philosophy of patient -centredness - and what is currently done - the real life with all the challenges to PCC. According to some participants' accounts, PCC clearly risks becoming a mere illusion for health care professionals on which too great pressures are imposed.

Myocardial blood flow quantification by Rb-82 cardiac PET/CT: A detailed reproducibility study between two semi-automatic analysis programs.

BACKGROUND: Several analysis software packages for myocardial blood flow (MBF) quantification from cardiac PET studies exist, but they have not been compared using concordance analysis, which can characterize precision and bias separately. Reproducible measurements are needed for quantification to fully develop its clinical potential. METHODS: Fifty-one patients underwent dynamic Rb-82 PET at rest and during adenosine stress. Data were processed with PMOD and FlowQuant (Lortie model). MBF and myocardial flow reserve (MFR) polar maps were quantified and analyzed using a 17-segment model. Comparisons used Pearson's correlation ρ (measuring precision), Bland and Altman limit-of-agreement and Lin's concordance correlation ρc = ρ·C b (C b measuring systematic bias). RESULTS: Lin's concordance and Pearson's correlation values were very similar, suggesting no systematic bias between software packages with an excellent precision ρ for MBF (ρ = 0.97, ρc = 0.96, C b = 0.99) and good precision for MFR (ρ = 0.83, ρc = 0.76, C b = 0.92). On a per-segment basis, no mean bias was observed on Bland-Altman plots, although PMOD provided slightly higher values than FlowQuant at higher MBF and MFR values (P < .0001). CONCLUSIONS: Concordance between software packages was excellent for MBF and MFR, despite higher values by PMOD at higher MBF values. Both software packages can be used interchangeably for quantification in daily practice of Rb-82 cardiac PET.