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Current dose-finding designs for phase I clinical trials can correctly select the MTD in a range of 30–80% depending on various conditions based on a sample of 30 subjects. However, there is still an unmet nee...
Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that requ...
Qualitative longitudinal research (QLR) comprises qualitative studies, with repeated data collection, that focus on the temporality (e.g., time and change) of a phenomenon. The use of QLR is increasing in heal...
By substituting the general ‘susceptibility factor’ concept for the conventional ‘gene’ concept in the case-only approach for gene-environment interaction, the case-only approach can also be used in environmen...
The Symptom Checklist (SCL) developed by the Health Behaviour in School-aged Children (HBSC) study is a non-clinical measure of psychosomatic complaints (e.g., headache and feeling low) that has been used in n...
Men are often viewed as a difficult group to recruit for psychological research, including in psycho-oncology. Whilst research has demonstrated the effectiveness of small monetary incentives for encouraging re...
In the context of the COVID-19 pandemic, social science research has required recruiting many prospective participants. Many researchers have explicitly taken advantage of widespread public interest in COVID-1...
Missing data are ubiquitous in randomised controlled trials. Although sensitivity analyses for different missing data mechanisms (missing at random vs. missing not at random) are widely recommended, they are r...
Participant recruitment is one of the main challenges in research. It is suggested that including researcher photographs might increase participation rates, but empirical evidence is lacking. This study within...
Previous studies support cultural tailoring of recruitment materials as a strategy to promote the enrollment of minoritized groups in clinical trials. However, there is a lack of guidance for research teams to...
Increasing attention is being given to assessing treatment effect heterogeneity among individuals belonging to qualitatively different latent subgroups. Inference routinely proceeds by first partitioning the i...
The Posttraumatic growth inventory (PTGI) aims to assess the positive psychological changes that individuals can perceive after a traumatic life event such as a cancer diagnosis. Several French translations of...
Prostate cancer is a very prevalent disease in men. Patients are monitored regularly during and after treatment with repeated assessment of prostate-specific antigen (PSA) levels. Prognosis of localised prosta...
Null Hypothesis Significance Testing (NHST) has been well criticised over the years yet remains a pillar of statistical inference. Although NHST is well described in terms of statistical models, most textbooks...
The ARena study (Sustainable Reduction of Antimicrobial Resistance in German Ambulatory Care) is a three-arm, cluster randomized trial to evaluate a multifaceted implementation program in a German primary care...
A sample size justification is required for all studies and should give the minimum number of subjects to be recruited for the study to achieve its primary objective. The aim of this review is to describe samp...
Many studies rely on self-reported height and weight. While a substantial body of literature exists on misreporting of height and weight, little exists on improving accuracy. The aim of this study was to deter...
One of the most important formats to disseminate the evidence in health to different populations are Cochrane Plain Language Summaries (PLSs). PLSs should be written in a simplified language, easily understand...
Risk-prediction tools allow classifying individuals into risk groups based on risk thresholds. Such risk categorization is often used to inform screening schemes by offering screening only to individuals at in...
We provide an overview of Bayesian estimation, hypothesis testing, and model-averaging and illustrate how they benefit parametric survival analysis. We contrast the Bayesian framework to the currently dominant...
Public health research frequently relies on collaborations with community-based organizations, and these partnerships can be essential to the success of a project. However, while public health ethics and overs...
Previous research has demonstrated that individual risk of mental illness is associated with individual, co-resident, and household risk factors. However, modelling the overall effect of these risk factors pre...
A classic methodology used in evaluating the impact of health policy interventions is interrupted time-series (ITS) analysis, applying a quasi-experimental design that uses both pre- and post-policy data witho...
Systematic reviews that synthesize safety outcomes pose challenges (e.g. rare events), which raise questions for grading the strength of the body of evidence. This is maybe one reason why in many potentially i...
One critical variable in the time series analysis is the change point, which is the point where an abrupt change occurs in chronologically ordered observations. Existing parametric models for change point dete...
Interrater reliability, aka intercoder reliability, is defined as true agreement between raters, aka coders, without chance agreement. It is used across many disciplines including medical and health research t...
Retention (participants completing a trial) is a persistent, and often under-studied, challenge within clinical trials. Research on retention has focussed on understanding the actions of participants who decid...
Restrictions in systematic reviews (SRs) can lead to bias and may affect conclusions. Therefore, it is important to report whether and which restrictions were used. This study aims to examine the use of restri...
An increasing number of large-scale multi-modal research initiatives has been conducted in the typically developing population, e.g. Dev. Cogn. Neur. 32:43-54, 2018; PLoS Med. 12(3):e1001779, 2015; Elam and Van E...
Platform trials can evaluate the efficacy of several experimental treatments compared to a control. The number of experimental treatments is not fixed, as arms may be added or removed as the trial progresses. ...
Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical research studies relying on secondary use data. Yet, the quality of data collected using...
When interested in a time-to-event outcome, competing events that prevent the occurrence of the event of interest may be present. In the presence of competing events, various estimands have been suggested for ...
The use of routine data will be essential in future healthcare research. Therefore, harmonizing procedure codes is a first step to facilitate this approach as international research endeavour. An example for t...
Meaningfully interpreting patient-reported outcomes (PRO) results from randomized clinical trials requires that the PRO scores obtained in the trial have the same meaning across patients and previous applicati...
Depression is common in the human immunodeficiency virus (HIV)-hepatitis C virus (HCV) co-infected population. Demographic, behavioural, and clinical data collected in research settings may be of help in ident...
Cluster randomised trials (CRTs) are often designed with a small number of clusters, but it is not clear which analysis methods are optimal when the outcome is binary. This simulation study aimed to determine ...
In response to the COVID-19 pandemic many clinical studies have been initiated leading to the need for efficient ways to track and analyze study results. We expanded our previous project that tracked registere...
To identify and describe the use of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for rating the certainty of systematic reviews (SRs) evidence published in urology an...
To measure the specific effectiveness of a given treatment in a randomised controlled trial, the intervention and control groups have to be similar in all factors not distinctive to the experimental treatment....
The Correction to this article has been published in BMC Medical Research Methodology 2023 23:48
Diagnosing urinary tract infections (UTIs) in children in the emergency department (ED) is challenging due to the variable clinical presentations and difficulties in obtaining a urine sample free from contamin...
Anchored covariate-adjusted indirect comparisons inform reimbursement decisions where there are no head-to-head trials between the treatments of interest, there is a common comparator arm shared by the studies...
The Correction to this article has been published in BMC Medical Research Methodology 2022 22:280
The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial is aimed at addressing the urgent need to find effective treatments for patients hospitalised with suspected or confirmed COVID-19. The trial has ...
Long-term prophylactic therapy is considered the standard of care for hemophilia A patients. This study models the long-term clinical and cost outcomes of two factor VIII (FVIII) products using a pharmacokinet...
For the development of prognostic models, after multiple imputation, variable selection is advised to be applied from the pooled model. The aim of this study is to evaluate by using a simulation study and prac...
Adolescent pregnancies and sexually-transmitted infections continue to impact 15 – 19-year-olds across the globe. The lack of sexual reproductive health information (SRH) in resource-limited settings due to cu...
Models, theories, and frameworks (MTFs) provide the foundation for a cumulative science of implementation, reflecting a shared, evolving understanding of various facets of implementation. One under-represented...
Hospital length of stay (LOS) is a key indicator of hospital care management efficiency, cost of care, and hospital planning. Hospital LOS is often used as a measure of a post-medical procedure outcome, as a g...
The original article was published in BMC Medical Research Methodology 2021 21:277
Although books and articles guiding the methods of sample size calculation for prevalence studies are available, we aim to guide, assist and report sample size calculation using the present calculators.
Estimations of causal effects from observational data are subject to various sources of bias. One method for adjusting for the residual biases in the estimation of treatment effects is through the use of negat...
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