Bmc Med Res Methodol
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Bmc Med Res Methodol · Feb 2018
The management of children with bronchiolitis in the Australasian hospital setting: development of a clinical practice guideline.
Bronchiolitis is the commonest respiratory infection in children less than 12 months and cause of hospitalisation in infants under 6 months of age in Australasia. Unfortunately there is substantial variation in management, despite high levels of supporting evidence. This paper reports on the process, strengths and challenges of the hybrid approach used to develop the first Australasian management guideline relevant to the local population. ⋯ Developing evidence-based clinical guidelines is a complex process with considerable challenges. Challenges included having committee members located over two countries and five time zones, large volume of literature and variation of member's knowledge of grading of evidence and recommendations. The GRADE and NHMRC processes provided a systematic and transparent approach ensuring a final structure including bedside interface, and a descriptive summary of the evidence base and tables for each key statement. Involvement of stakeholders who will ultimately be end-users as members of the GDC provided valuable knowledge. Lessons learnt during this guideline development process provide valuable insight for those planning development of evidence-based guidelines.
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Bmc Med Res Methodol · Feb 2018
Using an onset-anchored Bayesian hierarchical model to improve predictions for amyotrophic lateral sclerosis disease progression.
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a rare disease with extreme between-subject variability, especially with respect to rate of disease progression. This makes modelling a subject's disease progression, which is measured by the ALS Functional Rating Scale (ALSFRS), very difficult. Consider the problem of predicting a subject's ALSFRS score at 9 or 12 months after a given time-point. ⋯ Augmenting patient data with an additional artificial data-point, or onset anchor, can drastically improve predictive modelling in ALS by reducing the variability of estimated parameters at the cost of a slight increase in bias. This onset-anchored model is extremely useful if predictions are desired directly after a single baseline measure (such as at the first day of a clinical trial), a feat that would be very difficult without the onset-anchor. This approach could be useful in modelling other diseases that have bounded progression scales (e.g. Parkinson's disease, Huntington's disease, or inclusion-body myositis). It is our hope that this model can be used by clinicians and statisticians to improve the efficacy of clinical trials and aid in finding treatments for ALS.
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Bmc Med Res Methodol · Jan 2018
Randomized Controlled TrialStudying medical communication with video vignettes: a randomized study on how variations in video-vignette introduction format and camera focus influence analogue patients' engagement.
Video vignettes are used to test the effects of physicians' communication on patient outcomes. Methodological choices in video-vignette development may have far-stretching consequences for participants' engagement with the video, and thus the ecological validity of this design. To supplement the scant evidence in this field, this study tested how variations in video-vignette introduction format and camera focus influence participants' engagement with a video vignette showing a bad news consultation. ⋯ Our findings imply that using an audiovisual introduction combined with alternating camera focus depicting patient's emotions results in the highest levels of emotional engagement in analogue patients. This evidence can inform methodological decisions during the development of video vignettes, and thereby enhance the ecological validity of future video-vignettes studies.
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Bmc Med Res Methodol · Jan 2018
Getting messier with TIDieR: embracing context and complexity in intervention reporting.
The Template for Intervention Description and Replication (TIDieR) checklist and guide was developed by an international team of experts to promote full and accurate description of trial interventions. It is now widely used in health research. The aim of this paper is to describe the experience of using TIDieR outside of trials, in a range of applied health research contexts, and make recommendations on its usefulness in such settings. ⋯ We found TIDieR to be a useful tool for applied research outside the context of clinical trials and we suggest four revisions or additions to the original TIDieR which would enable it to better capture these complexities in applied health research: An additional item, 'voice' conveys who was involved in preparing the TIDieR template, such as researchers, service users or service deliverers. An additional item, 'stage of implementation' conveys what stage the intervention has reached, using a continuum of implementation research suggested by the World Health Organisation. A new column, 'modification' reminds authors to describe modifications to any item in the checklist. An extension of the 'how well' item encourages researchers to describe how contextual factors affected intervention delivery.
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Bmc Med Res Methodol · Jan 2018
Comparative StudyA systematic review of comparisons between protocols or registrations and full reports in primary biomedical research.
Prospective study protocols and registrations can play a significant role in reducing incomplete or selective reporting of primary biomedical research, because they are pre-specified blueprints which are available for the evaluation of, and comparison with, full reports. However, inconsistencies between protocols or registrations and full reports have been frequently documented. In this systematic review, which forms part of our series on the state of reporting of primary biomedical, we aimed to survey the existing evidence of inconsistencies between protocols or registrations (i.e., what was planned to be done and/or what was actually done) and full reports (i.e., what was reported in the literature); this was based on findings from systematic reviews and surveys in the literature. ⋯ We found that inconsistent reporting between protocols or registrations and full reports of primary biomedical research is frequent, prevalent and suboptimal. We also identified methodological issues such as the need for consensus on measuring inconsistency across sources for trial reports, and more studies evaluating transparency and reproducibility in reporting all aspects of study design and analysis. A joint effort involving authors, journals, sponsors, regulators and research ethics committees is required to solve this problem.