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The article focuses on a meta-epidemiologic study which analyses how primary outcomes are adjusted in randomized controlled trials and how the choices can change the significance of the results. It differentiates unadjusted and adjusted models of the primary outcome on the level of nominal statistical significance. It informs about the selection criteria for studies which shows that controlled trials are published in biomedical journals and addresses that protocols are retrieved from trial registries, design papers, and directly from the authors during clinical trials. It also presents a flow diagram for199 evaluated trials.

The authors discuss whether reviewers be credited as authors because sometimes they contribute more to research than some authors do. Author also states that in some cases reviewers suggest modifications to design and text, which improves the paper and sometimes reviewers' recommendations to accept the paper for publication qualifies as final approval. In the author's opinion, greater transparency demands that reviewers receive credit and shoulder the responsibility for their work.

The author focuses on the need of reporting about deaths in clinical trials. He says that is has been observed that deaths in clinical trials are sometimes omitted and there is little direct evidence of this. He mentions that the U.S. Food and Drug Administration (FDA) reviews had compared the antidiabetes drugs repaglinide and nateglinide with sulfonylurea drugs and the sulfonylurea drugs had been approved before the FDA started to publish reviews online. He also says that in 50 trials, nine percent of patients in the repaglinide arm and nine percent patients in the glibenclamide arm experienced hypoglycaemia.

The article reports a study which was conducted to determine the percentage of available data for continuous primary outcomes presented in randomised trials published in high impact factor medical journals. The results revealed that when adjusted for the number of patients in the trial, studies report a median 3.5 percent of the available data for the best reported primary outcome. This indicates that only a small fraction of the available data is reported.

A call for the papers that are unpublished years after completion due to distorted representation or other reasons is presented.

The article focuses on the Consolidated Standards of Reporting Trials (CONSORT) statement that was developed to improve the reporting of randomised controlled trials. The statement includes a checklist of items that should be included in the trial report. It was first published in 1996 and was revised in 2001 with a further update in 2010. The standard CONSORT statement focuses on reporting parallel group randomised controlled trials in which individual participants are randomly assigned to study groups. An updated guidance on the reporting of cluster randomised trials based on the 2010 revision of the CONSORT statement and the 2008 CONSORT extension for the reporting of abstracts is provided. It is suggested that routine use of this guidance should lead to improved quality of reporting.

STUDY QUESTION: What is the extent of non-publication or delayed publication of registered randomized trials on vaccines, and what are the potential determinants of delay to publication? SUMMARY ANSWER: Most trials on vaccines are published eventually or the results are posted in ClinicalTrials.gov, but delays of several years to publication are common. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: A growing body of evidence indicates that an important proportion of results from randomized controlled trials remains unpublished, or is published after major delay; however, only two studies focused on vaccines. The amount of randomized evidence on vaccines that remains unpublished may be lower than that for other medical specialties, but actions are still required to ensure timely public dissemination of trial data in published reports that can be easily linked to the codes for trial registration. [ABSTRACT FROM AUTHOR]

The article reports on the defense made by Aneez Esmail, a British authority on racial discrimination, of his paper that revealed the possibility of a bias in the membership examination of the Royal College of General Practitioners.

STUDY QUESTION: What are the rates of early discontinuation and non-publication of surgical randomised controlled trials? SUMMARY ANSWER: One in five surgical randomised controlled trials is discontinued early, and one in three completed trials remains unpublished at a median time of 4.9 years from study completion to publication search. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Non-publication of randomised controlled trials is common and raises ethical concerns for trial participants, while providing no benefit for the wider community. Considerable resource wastage exists in the conduct of modern surgical trials, through early termination due to insufficient recruitment and non-publication after completion, and investigators are frequently not contactable for additional information. [ABSTRACT FROM AUTHOR]

STUDY QUESTION: Does pelvic floor muscle training lead to a greater change in bladder, bowel, and pelvic floor symptoms than watchful waiting in women aged 55 years or over with symptomatic mild pelvic organ prolapse recruited from primary care? SUMMARY ANSWER: Change in bladder, bowel, and pelvic floor symptoms differed significantly between pelvic floor muscle training and watchful waiting, but the clinical relevance of this difference remains unclear. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Pelvic floor muscle training seems to be effective in relieving symptoms of prolapse in women with an advanced stage pelvic organ prolapse. This is the first study to investigate the effects of pelvic floor muscle training in a primary care population of women with symptomatic mild pelvic organ prolapse. [ABSTRACT FROM AUTHOR]

STUDY QUESTION Does thrombolytic therapy for acute ischaemic stroke have a similar time dependent benefit/risk ratio in clinical practice to that seen in pooled analyses of randomised clinical trials? SUMMARY ANSWER In patients with acute ischaemic stroke treated with thrombolytic therapy in routine clinical practice, the time dependent odds ratios for mortality and favourable early outcome are close to the values found in a pooled analysis of randomised clinical trials. WHAT IS KNOWN AND WHAT THIS PAPER ADDS Pooled analysis of randomised clinical trials of recombinant tissue plasminogen activator in patients with stroke has shown a time related decreasing benefit/risk ratio with increasing time between onset of stroke and treatment up to 4.5 hours. In an unselected cohort of patients with acute ischaemic stroke in clinical practice, there was also a clear association between shorter onset to treatment with thrombolytic therapy and better functional outcome, suggesting a similar magnitude to that observed in clinical trials. [ABSTRACT FROM AUTHOR]

The author discusses how the process of revalidation being promoted by the General Medical Council is not really of much use in enhancing the current appraisal processes for doctors in Great Britain. He describes some of the risks of revalidation including just adding to paper work without any results, and high costs. The main concern is that revalidation is pretending to do what it cannot in terms of actual evaluation of the knowledge and performance of doctors.

The article analyzes the acceptability of the refusal of the academic investigators who led the CHEST trial, which compared saline and hydroxyethyl starch (HES) to replace lost blood volume in critically ill patients, to share their data. Topics discussed include the investigators' concern on who could do the analyses, the confidence showed by key investigator John Myburgh, on the trial's conclusions, and the problems that have reportedly been found out in their handling of adverse event data. INSETS: THE GREAT COLLOIDS VERSUS CRYSTALLOIDS DEBATE;MIRROR IMAGES--THE STORY OF THE 6S TRIAL.

The article focuses on a study which evaluates trustworthiness of statements related to randomised controlled trials about subgroup prespecifications in journal publications. The study reveals existence of discrepancies between the planning and reporting of subgroup analyses in randomised controlled trials, and states that published statements are not trustworthy.

The article discusses the results of a study that examined the role of quality measurement in the inappropriate use of screening for colorectal cancer. Topics discussed include stability of screening use from age 50 to 75 with abrupt decline in use after 75 and the likelihood that a 75-year-old man with poor health will undergo screening than a 76-year-old in good health.

The article discusses a randomised controlled trial to identify patients who may benefit from an endovascular strategy. Eligible patients with a clinical diagnosis of ruptured aneurysm were recruited at 29 vascular centers in Great Britain and one Canadian centre. It indicates that women appeared to benefit more than men from an endovascular strategy although there was no convincing differences with respect to Hardman index or age.

A letter to the editor is presented in response to the article "Study Raises Concerns Over Racial Discrimination in MRCGP Exam," by Z. Kmietowicz in the 2013 issue.

The article focuses on a study on the reduction of angina and stroke in high risk patients by the antihypertensive drug valsartan. It states that the European Cardiology Society has referred to the critical problems concerning data in the study. It mentions that the Japanese government will investigate research practices and will develop guidance to maintain ethical standards. It discusses an interim report by the Jikei committee of Japan on medical records.

The author reflects on the drug beta (β) blockers and states that the use of certain β blockers in the patients with heart failure has enhanced their quality and health of life. Researchers Chatterjee and colleagues performed a network meta-analysis of trials for a linked paper to elucidate different β blockers and its benefits and tolerability among heart patients. They concluded that β blockers reveal a class effect rather than an individual drug effect among the patients with heart failure.

A letter is presented with regards to how a lack of inquiry into the Wakefield case is actually a lost opportunity.

The article discusses the results of an observational study revealing the comparability of average associations with survival for cardiovascular drugs to those reported in randomised controlled trials and their variation for some drugs according to coexisting conditions. A table showing the adjusted hazard ratios of death in association with guideline recommended cardiovascular drugs for adults aged 65 or more with multiple chronic conditions is presented.

The editors propose the liberation of clinical trial data for the benefit of patients and for the prevention of harm and correction of misleading research. Among the cited threats posed by data sharing are patient confidentiality, data dredging, and rogue analysis by investigators. The author note the rising popularity of the use of administrative and electronic medical record (EMR) data and recommends steps for reactivation of dormant clinical trials.

OBJECTIVE To examine the traditional diet-heart hypothesis through recovery and analysis of previously unpublished data from the Minnesota Coronary Experiment (MCE) and to put findings in the context of existing diet-heart randomized controlled trials through a systematic review and meta-analysis. DESIGN The MCE (1968-73) is a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol. Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators. Further, a systematic review and meta-analyses of randomized controlled trials that lowered serum cholesterol by providing vegetable oil rich in linoleic acid in place of saturated fat without confounding by concomitant interventions was conducted. SETTING One nursing home and six state mental hospitals in Minnesota, United States. PARTICIPANTS Unpublished documents with completed analyses for the randomized cohort of 9423 women and men aged 20-97; longitudinal data on serum cholesterol for the 2355 participants exposed to the study diets for a year or more; 149 completed autopsy files. INTERVENTIONS Serum cholesterol lowering diet that replaced saturated fat with linoleic acid (from corn oil and corn oil polyunsaturated margarine). Control diet was high in saturated fat from animal fats, common margarines, and shortenings. MAIN OUTCOME MEASURES Death from all causes; association between changes in serum cholesterol and death; and coronary atherosclerosis and myocardial infarcts detected at autopsy. RESULTS The intervention group had significant reduction in serum cholesterol compared with controls (mean change from baseline-13.8% y-1.0%; P<0.001). Kaplan Meier graphs showed no mortality benefit for the intervention group in the full randomized cohort or for any prespecified subgroup. There was a 22% higher risk of death for each 30 mg/dL (0.78 mmol/L) reduction in serum cholesterol in covariate adjusted Cox regression models (hazard ratio 1.22, 95% confidence interval 1.14 to 1.32; P<0.001). There was no evidence of benefit in the intervention group for coronary atherosclerosis or myocardial infarcts. Systematic review identified five randomized controlled trials for inclusion (n=10 808). In meta-analyses, these cholesterol lowering interventions showed no evidence of benefit on mortality from coronary heart disease (1.13, 0.83 to 1.54) or all cause mortality (1.07, 0.90 to 1.27). CONCLUSIONS Available evidence from randomized controlled trials shows that replacement of saturated fat in the diet with linoleic acid effectively lowers serum cholesterol but does not support the hypothesis that this translates to a lower risk of death from coronary heart disease or all causes. Findings from the Minnesota Coronary Experiment add to growing evidence that incomplete publication has contributed to overestimation of the benefits of replacing saturated fat with vegetable oils rich in linoleic acid. [ABSTRACT FROM AUTHOR]

The article discusses research which investigated benefits and harms associated with the administration of arthroscopic knee surgery for elderly patients with knee pain and degenerative knee disease. Topics explored include the utilization of clinical data derived from related randomised controlled trials, the effectiveness of said treatment in addressing knee pain, and the adverse reactions recorded such as pulmonary embolism and infection.

The article presents a study that explored the effect of delirium on short term and long term outcomes in critically ill patients admitted to intensive care. The study compared outcome variables between critically ill patients in intensive care with delirium and without delirium, and reveals increased risk of death for these patients during their hospital admission, longer length of stay, and cognitive impairment after discharge.