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The randomized controlled study is the gold-standard research method in biomedicine. In contrast, the validity of a (nonrandomized) observational study is often questioned because of unknown/unmeasured factors...
Analyzing time-to-onset of adverse drug reactions from treatment exposure contributes to meeting pharmacovigilance objectives, i.e. identification and prevention. Post-marketing data are available from reporting ...
The editors of BMC Medical Research Methodology would like to thank all our reviewers who have contributed their time to the journal in Volume 13 (2013).
A major aim of the i2b2 (informatics for integrating biology and the bedside) clinical data informatics framework aims to create an efficient structure within which patients can be identified for clinical and ...
The Canadian Community Health Survey (CCHS) is a cross-sectional survey that has collected information on health determinants, health status and the utilization of the health system in Canada since 2001. Sever...
In biomedical research, response variables are often encountered which have bounded support on the open unit interval - (0,1). Traditionally, researchers have attempted to estimate covariate effects on these t...
The Erratum to this article has been published in BMC Medical Research Methodology 2016 16:152
Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised...
Sensitivity analyses are an important tool for understanding the extent to which the results of randomised trials depend upon the assumptions of the analysis. There is currently no guidance governing the choic...
Recruiting the required number of participants is vital to the success of clinical research and yet many studies fail to achieve their expected recruitment rate. Increasing research participation is a key agen...
Recent studies have suggested that patients treated in research-active institutions have better outcomes than patients treated in research-inactive institutions. However, little attention has been paid to expl...
Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients ...
Electronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that...
Tracing mail survey responses is useful for the management of reminders but may cause concerns about anonymity among prospective participants. We examined the impact of numbering return envelopes on the partic...
The discriminative ability of a risk model is often measured by Harrell’s concordance-index (c-index). The c-index estimates for two randomly chosen subjects the probability that the model predicts a higher ri...
The original article was published in BMC Medical Research Methodology 2013 13:10
Borg developed scales for rating pain and perceived exertion in adults that have also been used in pediatric populations. Models describing functional relationships between perceived exertion and work capacity...
Risk prediction models estimate the risk of developing future outcomes for individuals based on one or more underlying characteristics (predictors). We review how researchers develop and validate risk predicti...
Large-scale public health interventions with rapid scale-up are increasingly being implemented worldwide. Such implementation allows for a large target population to be reached in a short period of time. But w...
To assess concordance between Medicare claims and Surveillance, Epidemiology, and End Results (SEER) reports of incident BM among prostate cancer (PCa) patients. The prevalence and consequences of bone metasta...
Accrual to Cancer Control and Supportive Care (CCL) studies can be challenging. Our objective was to identify facilitators and perceived barriers to successful Children’s Oncology Group (COG) CCL accrual from ...
The UK leads the world in recruitment of patients to cancer clinical trials, with a six-fold increase in recruitment during 2001–2010. However, there are large variations across cancer centres. This paper deta...
Designs and analyses of clinical trials with a time-to-event outcome almost invariably rely on the hazard ratio to estimate the treatment effect and implicitly, therefore, on the proportional hazards assumptio...
Fetal ultrasound scanning is considered vital for routine antenatal care with first trimester scans recommended for accurate estimation of gestational age (GA). A reliable estimate of gestational age is key in...
Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates. This exploratory randomized controlled trial tested this pro...
One of the biggest challenges for population health studies is the recruitment of participants. Questions that investigators have asked are “who volunteers for studies?” and “does recruitment method influence ...
Diagnostic problems in clinical trials are sometimes ordinal. For example, colon tumor staging was performed according to the TNM classification. However, clinical data are limited by markedly small sample siz...
Increasingly, network meta-analysis (NMA) of published survival data are based on parametric survival curves as opposed to reported hazard ratios to avoid relying on the proportional hazards assumption. If a B...
Methodological development of joint models of longitudinal and survival data has been rapid in recent years; however, their full potential in applied settings are yet to be fully explored. We describe a novel ...
Recruiting deaf and hard-of-hearing participants, particularly sign language-users, for genetics health service research is challenging due to communication barriers, mistrust toward genetics, and researchers’...
Multiple imputation (MI) is becoming increasingly popular as a strategy for handling missing data, but there is a scarcity of tools for checking the adequacy of imputation models. The Kolmogorov-Smirnov (KS) t...
Additive risk models are necessary for understanding the joint effects of exposures on individual and population disease risk. Yet technical challenges have limited the consideration of additive risk models in...
The High-Dimensional Propensity Score (hd-PS) algorithm can select and adjust for baseline confounders of treatment-outcome associations in pharmacoepidemiologic studies that use healthcare claims data. How hd...
Reference management software programs enable researchers to more easily organize and manage large volumes of references typically identified during the production of systematic reviews. The purpose of this st...
Accurately characterizing a drug’s safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants’ reports of medical histories, adverse events (AEs), and concomitant medic...
Randomised controlled trials are becoming increasingly costly and time-consuming. In 2011, Royston and colleagues proposed a particular class of multi-arm multi-stage (MAMS) designs intended to speed up the ev...
The way in which maternity care is provided affects perinatal outcomes for pregnant adolescents; including the likelihood of preterm birth. The study purpose was to assess the feasibility of recruiting pregnan...
There is little or no information available on the impact of funding by the food industry on trial outcomes and methodological quality of synbiotics, probiotics and prebiotics research in infants. The objectiv...
Assessing health effects from background exposure to air pollution is often hampered by the sparseness of pollution monitoring networks. However, regional atmospheric chemistry-transport models (CTMs) can prov...
Patient registries represent a well-established methodology for prospective data collection with a wide array of applications for clinical research and health care administration. An examination and synthesis ...
Controversies are common in medicine. Some arise when the conclusions of research publications directly contradict each other, creating uncertainty for frontline clinicians.
Comparison of outcomes between populations or centres may be confounded by any casemix differences and standardisation is carried out to avoid this. However, when the casemix adjustment models are large and co...
The benefits of stroke unit care in terms of reducing death, dependency and institutional care were demonstrated in a 2009 Cochrane review carried out by the Stroke Unit Trialists’ Collaboration.
Recent research indicates a high recall in Google Scholar searches for systematic reviews. These reports raised high expectations of Google Scholar as a unified and easy to use search interface. However, studi...
International clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in ...
A common characteristic of environmental epidemiology is the multi-dimensional aspect of exposure patterns, frequently reduced to a cumulative exposure for simplicity of analysis. By adopting a flexible Bayesi...
In multicenter studies, center-specific variations in measurements may arise for various reasons, such as low interrater reliability, differences in equipment, deviations from the protocol, sociocultural chara...
Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended pe...
The Current Opioid Misuse Measure (COMM) is a self-report questionnaire designed to help identify aberrant drug-related behavior in respondents who have been prescribed opioids for chronic pain. The full-lengt...
The development and evaluation of complex interventions in healthcare has obtained increased awareness. The Medical Research Council’s (MRC) framework for the development and evaluation of complex intervention...
Data processing contributes a non-trivial proportion to total research costs, but documentation of these costs is rare. This paper employed a priori cost tracking for three posture assessment methods (self-report...
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