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Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants’ views and experiences of trial interventions and related quality of life. Purely ...
Configural, metric, and scalar measurement invariance have been indicators of bias-free statistical cross-group comparisons, although they are difficult to verify in the data. Low comparability of translated q...
Healthcare, as with other sectors, has undergone progressive digitalization, generating an ever-increasing wealth of data that enables research and the analysis of patient movement. This can help to evaluate t...
Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst partic...
Epidemiological surveys offer essential data on adolescent substance use. Nevertheless, the precision of these self-report-based surveys often faces mistrust from researchers and the public. We evaluate the ef...
Random Forests are a powerful and frequently applied Machine Learning tool. The permutation variable importance (VIMP) has been proposed to improve the explainability of such a pure prediction model. It descri...
Health and social care interventions are often complex and can be decomposed into multiple components. Multicomponent interventions are often evaluated in randomised controlled trials. Across trials, intervent...
Intensive care unit (ICU) length of stay (LOS) and the risk adjusted equivalent (RALOS) have been used as quality metrics. The latter measures entail either ratio or difference formulations or ICU random effec...
Stepped-wedge cluster randomized trials (SWCRTs) are a type of cluster-randomized trial in which clusters are randomized to cross-over to the active intervention sequentially at regular intervals during the st...
Patterns of survey response and the characteristics associated with response over time in longitudinal studies are important to discern for the development of tailored retention efforts aimed at minimizing res...
Non-experimental studies (also known as observational studies) are valuable for estimating the effects of various medical interventions, but are notoriously difficult to evaluate because the methods used in no...
The original article was published in BMC Medical Research Methodology 2023 23:50
The original article was published in BMC Medical Research Methodology 2023 23:154
Studies have suggested that agreement between administrative health data and self-report for asthma status ranges from fair to good, but few studies benefited from administrative health data over a long period...
Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can potentially be stopped early, therefore, it ...
Alzheimer’s disease and related dementia (ADRD) are characterized by multiple and progressive anatomo-clinical changes including accumulation of abnormal proteins in the brain, brain atrophy and severe cogniti...
Symptoms reported following the administration of investigational drugs play an important role in decisions for registration and treatment guidelines. However, symptoms are subjective, and interview methods to...
Real-world observational data are an important source of evidence on the treatment effectiveness for patients hospitalized with coronavirus disease 2019 (COVID-19). However, observational studies evaluating tr...
Rare superficial vascular anomalies represent a wide range of diseases. Their management is difficult given the broad spectrum and the lack of clinical trials assessing treatment efficacy. A randomized clinica...
Implementation outcomes, including acceptability, are of critical importance in both implementation research and practice. The gold standard measure of acceptability, Acceptability of Intervention Measure (AIM...
The original article was published in BMC Medical Research Methodology 2023 23:81
Novel precision medicine therapeutics target increasingly granular, genomically-defined populations. Rare sub-groups make it challenging to study within a clinical trial or single real-world data (RWD) source;...
A multiple dependent state sampling plan (MDSSP) is designed when the lifetimes of the variables follow New Lomax Rayleigh Distribution (NLRD). The decision to accept or reject a lot in the proposed methodolog...
The aggregation of a series of N-of-1 trials presents an innovative and efficient study design, as an alternative to traditional randomized clinical trials. Challenges for the statistical analysis arise when t...
The Naive Bayes (NB) classifier is a powerful supervised algorithm widely used in Machine Learning (ML). However, its effectiveness relies on a strict assumption of conditional independence, which is often vio...
Cancer, a complex and deadly health concern today, is characterized by forming potentially malignant tumors or cancer cells. The dynamic interaction between these cells and their environment is crucial to the ...
Having an appropriate sample size is important when developing a clinical prediction model. We aimed to review how sample size is considered in studies developing a prediction model for a binary outcome.
Machine learning models promise to support diagnostic predictions, but may not perform well in new settings. Selecting the best model for a new setting without available data is challenging. We aimed to invest...
When conducting randomised controlled trials is impractical, an alternative is to carry out an observational study. However, making valid causal inferences from observational data is challenging because of the...
The current Evidence-Based-Medicine (EBM) approach is generally based on data coming from Randomized Clinical Trials or and, epidemiological observational studies. However, the past few years, with the explosi...
Declining response proportions in surveys have been observed internationally. Improving response proportions is important for the generalizability of the outcome. The aim of this study was to examine the poten...
The non-inferiority test is a reasonable approach to assessing a new treatment in a three-arm trial. The three-arm trial consists of a placebo, reference, and an experimental treatment. The non-inferiority is ...
Bayesian models have been applied throughout the Covid-19 pandemic especially to model time series of case counts or deaths. Fewer examples exist of spatio-temporal modeling, even though the spatial spread of ...
Longitudinal matching can mitigate confounding in observational, real-world studies of time-dependent treatments. To date, these methods have required iterative, manual re-specifications to achieve covariate b...
Electronic health records (EHRs) are widely accepted to enhance the health care quality, patient monitoring, and early prevention of various diseases, even when there is incomplete or missing information in them.
Historically, a priori power and sample size calculations have not been routinely performed cost-effectiveness analyses (CEA), partly because the absence of published cost and effectiveness correlation and var...
The Targeted Learning roadmap provides a systematic guide for generating and evaluating real-world evidence (RWE). From a regulatory perspective, RWE arises from diverse sources such as randomized controlled t...
Epidemiologic and medical studies often rely on evaluators to obtain measurements of exposures or outcomes for study participants, and valid estimates of associations depends on the quality of data. Even thoug...
The original article was published in BMC Medical Research Methodology 2023 23:166
The main objective of this study is to evaluate the methodological quality and reporting quality of living systematic reviews (LSRs) on Coronavirus disease 2019 (COVID-19), while the secondary objective is to ...
Care pathways are increasingly being used to enhance the quality of care and optimize the use of resources for health care. Nevertheless, recommendations regarding the sequence of care are mostly based on cons...
The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical...
Efficient measurement of the receipt of cancer screening has been attempted with electronic health records (EHRs), but EHRs are commonly implemented within a single health care setting. However, health informa...
COVID-19 brought enormous challenges to public health surveillance and underscored the importance of developing and maintaining robust systems for accurate surveillance. As public health data collection effort...
In a potential epidemic of an emerging infection, representative population-based serologic studies are required to determine the extent of immunity to the infectious agent, either from natural infection or va...
Machine learning (ML) methods to build prediction models starting from electrocardiogram (ECG) signals are an emerging research field. The aim of the present study is to investigate the performances of two ML ...
Safety is an essential part of the evaluation of new medications and competing risks that occur in most clinical trials are a well identified challenge in the analysis of adverse events. Two statistical framew...
Medication adherence is usually defined as the extent of the agreement between the medication regimen agreed to by patients with their healthcare provider and the real-world implementation. Proactive identific...
Frailty, neurodegeneration and geriatric syndromes cause a significant impact at the clinical, social, and economic level, mainly in the context of the aging world. Recently, Information and Communication Tech...
The Correction to this article has been published in BMC Medical Research Methodology 2023 23:176
Measuring the performance of models that predict individualized treatment effect is challenging because the outcomes of two alternative treatments are inherently unobservable in one patient. The C-for-benefit ...
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