Concept: Evaluation methods
To examine the traditional diet-heart hypothesis through recovery and analysis of previously unpublished data from the Minnesota Coronary Experiment (MCE) and to put findings in the context of existing diet-heart randomized controlled trials through a systematic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.
Previous studies indicate that in published reports, trial results can be distorted by the use of “spin” (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment). We aimed to (1) evaluate the presence of “spin” in press releases and associated media coverage; and (2) evaluate whether findings of randomized controlled trials (RCTs) based on press releases and media coverage are misinterpreted.
To quantify risk of overall cancer across all levels of alcohol consumption among women and men separately, with a focus on light to moderate drinking and never smokers; and assess the influence of drinking patterns on overall cancer risk.
Efficacy and safety of the “mother’s kiss” technique: a systematic review of case reports and case series.
- CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
- Published almost 5 years ago
Foreign bodies lodged in the nasal cavity are a common problem in children, and their removal can be challenging. The published studies relating to the “mother’s kiss” all take the form of case reports and case series. We sought to assess the efficacy and safety of this technique.
Depression is common in primary care and clinicians are encouraged to screen their patients. Meta-analyses have evaluated the effectiveness of screening, but two author groups consistently reached completely opposite conclusions.
BACKGROUND: While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. METHODS: Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16), three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers) was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender). Usual experiences were categorised and discussed separately. RESULTS: Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022) and enhanced mood (p=.027). The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin group having minor digestive complaints. CONCLUSION: This represents the first documented qualitative investigation of participants' experience of chronic administration of a multivitamin. Results uncovered a range of subjective beneficial effects that are consistent with quantitative data from previously published randomised controlled trials examining the effects of multivitamins and B vitamin complexes on mood and well-being.Trial registration: Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) ACTRN12611000092998.
Individual participant data (IPD) meta-analyses that obtain “raw” data from studies rather than summary data typically adopt a “two-stage” approach to analysis whereby IPD within trials generate summary measures, which are combined using standard meta-analytical methods. Recently, a range of “one-stage” approaches which combine all individual participant data in a single meta-analysis have been suggested as providing a more powerful and flexible approach. However, they are more complex to implement and require statistical support. This study uses a dataset to compare “two-stage” and “one-stage” models of varying complexity, to ascertain whether results obtained from the approaches differ in a clinically meaningful way.
- Journal of the American Medical Informatics Association : JAMIA
- Published about 2 years ago
To develop and evaluate RobotReviewer, a machine learning (ML) system that automatically assesses bias in clinical trials. From a (PDF-formatted) trial report, the system should determine risks of bias for the domains defined by the Cochrane Risk of Bias (RoB) tool, and extract supporting text for these judgments.
Randomised controlled trials (RCTs) have reported conflicting results on whether extracorporeal shock wave therapy alleviates the pain of recalcitrant plantar fasciitis patients. We focused on high-energy extracorporeal shock wave therapy (HESWT) and aimed to assess the effectiveness and feasibility of HESWT versus placebo in the treatment of recalcitrant plantar fasciitis.
The impact case studies submitted by UK Higher Education Institutions to the Research Excellence Framework (REF) in 2014 provide a rich resource of text describing impact beyond academia and across all disciplines. Using text mining techniques and qualitative assessment, the 6,679 non-redacted case studies submitted were analysed and the impact described was found to be multidisciplinary, multi-impactful, and multinational. By digging deeper into the data, the health gains from health research in terms of Quality Adjusted Life Years was also estimated. Similar analyses are possible using these case studies, but will require the data to be ’re-purposed' from the original intention (i.e., for assessment purposes) for robust analysis.