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BMC Medical Research Methodology

James H Rimmer, Cassandra Herman, Brooks Wingo, Kevin Fontaine, Tapan Mehta
BACKGROUND: Hybrid research designs targeting adults with neurologic disability are critical for improving the efficiency of models that can identify, track and intervene on identified health issues. METHODS: Our Russian doll framework encompasses three study phases. Phase 1 involves prospectively following a cohort of participants with disability to examine the relationships between rates of health and functional deficits (e.g., pain, fatigue, deconditioning), functional measures (e...
March 14, 2018: BMC Medical Research Methodology
Keri L Calkins, Chelsea E Canan, Richard D Moore, Catherine R Lesko, Bryan Lau
BACKGROUND: Restricted mean survival time (RMST) is an underutilized estimand in time-to-event analyses. Herein, we highlight its strengths by comparing time to (1) all-cause mortality and (2) initiation of antiretroviral therapy (ART) for HIV-infected persons who inject drugs (PWID) and persons who do not inject drugs. METHODS: RMST to death was determined by integrating the Kaplan-Meier survival curve to 5 years of follow-up. To account for the competing risks of death and loss-to-clinic when estimating time to ART, we calculated RMST to ART initiation by estimating the area between the survival curve for ART initiation and the cumulative incidence curve for death or loss-to-clinic...
March 9, 2018: BMC Medical Research Methodology
Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A Berkley, Gail Davey
BACKGROUND: We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials. METHODS: We explain in detail the preparation for the trial, its setting in northern Ethiopia, the identification and selection of patients (inclusion and exclusion criterion, identifying and screening of patients at home, enrollment of patients at the health centres and health posts), and randomisation...
March 7, 2018: BMC Medical Research Methodology
Christopher J Weir, Isabella Butcher, Valentina Assi, Stephanie C Lewis, Gordon D Murray, Peter Langhorne, Marian C Brady
BACKGROUND: Rigorous, informative meta-analyses rely on availability of appropriate summary statistics or individual participant data. For continuous outcomes, especially those with naturally skewed distributions, summary information on the mean or variability often goes unreported. While full reporting of original trial data is the ideal, we sought to identify methods for handling unreported mean or variability summary statistics in meta-analysis. METHODS: We undertook two systematic literature reviews to identify methodological approaches used to deal with missing mean or variability summary statistics...
March 7, 2018: BMC Medical Research Methodology
Jared L Katzman, Uri Shaham, Alexander Cloninger, Jonathan Bates, Tingting Jiang, Yuval Kluger
BACKGROUND: Medical practitioners use survival models to explore and understand the relationships between patients' covariates (e.g. clinical and genetic features) and the effectiveness of various treatment options. Standard survival models like the linear Cox proportional hazards model require extensive feature engineering or prior medical knowledge to model treatment interaction at an individual level. While nonlinear survival methods, such as neural networks and survival forests, can inherently model these high-level interaction terms, they have yet to be shown as effective treatment recommender systems...
February 26, 2018: BMC Medical Research Methodology
G Manzini, T J Ettrich, M Kremer, M Kornmann, D Henne-Bruns, D A Eikema, P Schlattmann, L C de Wreede
BACKGROUND: Standard survival analysis fails to give insight into what happens to a patient after a first outcome event (like first relapse of a disease). Multi-state models are a useful tool for analyzing survival data when different treatments and results (intermediate events) can occur. Aim of this study was to implement a multi-state model on data of patients with rectal cancer to illustrate the advantages of multi-state analysis in comparison to standard survival analysis. METHODS: We re-analyzed data from the RCT FOGT-2 study by using a multi-state model...
February 13, 2018: BMC Medical Research Methodology
Sarah R Haile, Beniamino Guerra, Joan B Soriano, Milo A Puhan
Following publication of the original article [1], a member of the writing group reported that his name is misspelt. The paper should appear in Pubmed under "Ter Riet G", bot as "Riet GT".
February 12, 2018: BMC Medical Research Methodology
Sharon O'Brien, Sally Wilson, Fenella J Gill, Elizabeth Cotterell, Meredith L Borland, Edward Oakley, Stuart R Dalziel
BACKGROUND: 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. METHOD: An adaption of the nine steps recommended by the National Health and Medical Research Council (NHMRC) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology were utilised...
February 12, 2018: BMC Medical Research Methodology
Michael Pearce, Siew Wan Hee, Jason Madan, Martin Posch, Simon Day, Frank Miller, Sarah Zohar, Nigel Stallard
BACKGROUND: Most confirmatory randomised controlled clinical trials (RCTs) are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a given significance level, usually 2.5% for a one-sided test. Approval of the experimental treatment by regulatory agencies is then based on the result of such a significance test with other information to balance the risk of adverse events against the benefit of the treatment to future patients. In the setting of a rare disease, recruiting sufficient patients to achieve conventional error rates for clinically reasonable effect sizes may be infeasible, suggesting that the decision-making process should reflect the size of the target population...
February 8, 2018: BMC Medical Research Methodology
Katja Petrowski, Sören Kliem, Michael Sadler, Alicia E Meuret, Thomas Ritz, Elmar Brähler
BACKGROUND: Demands placed on individuals in occupational and social settings, as well as imbalances in personal traits and resources, can lead to chronic stress. The Trier Inventory for Chronic Stress (TICS) measures chronic stress while incorporating domain-specific aspects, and has been found to be a highly reliable and valid research tool. The aims of the present study were to confirm the German version TICS factorial structure in an English translation of the instrument (TICS-E) and to report its psychometric properties...
February 6, 2018: BMC Medical Research Methodology
Alex G Karanevich, Jeffrey M Statland, Byron J Gajewski, Jianghua He
BACKGROUND: 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. METHODS: We obtained ALS subject data from the Pooled Resource Open-Access ALS Clinical Trials Database, a collection of data from various ALS clinical trials...
February 6, 2018: BMC Medical Research Methodology
Geneviève Lefebvre, Mariia Samoilenko
Following publication of the original article [1], the authors reported that the following four references in Table 2 are incorrect.
January 29, 2018: BMC Medical Research Methodology
Thomas Forkmann, Tobias Teismann, Jana-Sophie Stenzel, Heide Glaesmer, Derek de Beurs
BACKGROUND: Defeat and entrapment have been shown to be of central relevance to the development of different disorders. However, it remains unclear whether they represent two distinct constructs or one overall latent variable. One reason for the unclarity is that traditional factor analytic techniques have trouble estimating the right number of clusters in highly correlated data. In this study, we applied a novel approach based on network analysis that can deal with correlated data to establish whether defeat and entrapment are best thought of as one or multiple constructs...
January 25, 2018: BMC Medical Research Methodology
Leonie N C Visser, Nadine Bol, Marij A Hillen, Mathilde G E Verdam, Hanneke C J M de Haes, Julia C M van Weert, Ellen M A Smets
BACKGROUND: 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...
January 19, 2018: BMC Medical Research Methodology
Ulrike Pötschger, Harald Heinzl, Maria Grazia Valsecchi, Martina Mittlböck
BACKGROUND: Investigating the impact of a time-dependent intervention on the probability of long-term survival is statistically challenging. A typical example is stem-cell transplantation performed after successful donor identification from registered donors. Here, a suggested simple analysis based on the exogenous donor availability status according to registered donors would allow the estimation and comparison of survival probabilities. As donor search is usually ceased after a patient's event, donor availability status is incompletely observed, so that this simple comparison is not possible and the waiting time to donor identification needs to be addressed in the analysis to avoid bias...
January 19, 2018: BMC Medical Research Methodology
Soyeon Cheon, Hi-Joon Park, Younbyoung Chae, Hyangsook Lee
BACKGROUND: While full disclosure of information on placebo control in participant information leaflets (PILs) in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes...
January 18, 2018: BMC Medical Research Methodology
Sarah Cotterill, Sarah Knowles, Anne-Marie Martindale, Rebecca Elvey, Susan Howard, Nia Coupe, Paul Wilson, Michael Spence
BACKGROUND: 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. MAIN BODY: We used the TIDieR template for intervention description in six applied health research projects...
January 18, 2018: BMC Medical Research Methodology
Dale J Cooper, Brigitte E Scammell, Mark E Batt, Debbie Palmer
BACKGROUND: The impracticalities and comparative expense of carrying out a clinical assessment is an obstacle in many large epidemiological studies. The purpose of this study was to develop and validate a series of electronic self-reported line drawing instruments based on the modified Beighton scoring system for the assessment of self-reported generalised joint hypermobility. METHODS: Five sets of line drawings were created to depict the 9-point Beighton score criteria...
January 17, 2018: BMC Medical Research Methodology
Meryl Dahan, Caroline Scemama, Raphael Porcher, David J Biau
BACKGROUND: This article corresponds to a literature review and analyze how heterogeneity of treatment (HTE) is reported and addressed in cohort studies and to evaluate the use of the different measures to HTE analysis. METHODS: prospective cohort studies, in English language, measuring the effect of a treatment (pharmacological, interventional, or other) published among 119 core clinical journals (defined by the National Library of Medicine) in the last 16 years were selected in the following data source: Medline...
January 12, 2018: BMC Medical Research Methodology
Guowei Li, Luciana P F Abbade, Ikunna Nwosu, Yanling Jin, Alvin Leenus, Muhammad Maaz, Mei Wang, Meha Bhatt, Laura Zielinski, Nitika Sanger, Bianca Bantoto, Candice Luo, Ieta Shams, Hamnah Shahid, Yaping Chang, Guangwen Sun, Lawrence Mbuagbaw, Zainab Samaan, Mitchell A H Levine, Jonathan D Adachi, Lehana Thabane
BACKGROUND: 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...
January 11, 2018: BMC Medical Research Methodology
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