Publications by authors named "Hemkens L"

This paper reviews the scientific evidence on new anti-amyloid monoclonal antibodies for treating Alzheimer's disease as a case study for improving scientific evidence communication. We introduce five guidelines condensed from the biomedical evidence literature but adapted to the short format of science communication in e.g.

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Background: This systematic review evaluates the effect of audit and feedback (A&F) interventions targeting antibiotic prescribing in primary care and examines factors that may explain the variation in effectiveness.

Methods: Randomized controlled trials (RCTs) involving A&F interventions targeting antibiotic prescribing in primary care were included in the systematic review. Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and ClinicalTrials.

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Conducting systematic reviews of clinical trials is arduous and resource consuming. One potential solution is to design databases that are continuously and automatically populated with clinical trial data from harmonised and structured datasets. We aimed to map publicly available, continuously updated, topic-specific databases of randomised clinical trials (RCTs).

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Article Synopsis
  • * Out of 50 Cochrane Reviews analyzed, only 48% provided clear outcome definitions for the time-to-event analyses, and critical trial characteristics related to these analyses were often missing or inaccurately reported.
  • * The inconsistencies in reporting and methods at both the trial and review levels hinder the reliability of meta-analyses on time-to-event outcomes, suggesting a need for improved standards in research reporting.
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Objective: To investigate the longitudinal dynamics of serum glial fibrillary acidic protein (sGFAP) and serum neurofilament light chain (sNfL) levels in people with multiple sclerosis (pwMS) under B-cell depleting therapy (BCDT) and their capacity to prognosticate future progression independent of relapse activity (PIRA) events.

Methods: A total of 362 pwMS (1,480 samples) starting BCDT in the Swiss Multiple Sclerosis (MS) Cohort were included. sGFAP levels in 2,861 control persons (4,943 samples) provided normative data to calculate adjusted Z scores.

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Background And Objectives: Over half a century ago, the terms "pragmatic" and "explanatory" were introduced to biomedicine by Schwartz and Lellouch, presenting two distinct conceptual approaches to trial design. Today, we frequently say that there are pragmatic trials and there are explanatory trials. Pragmatic trials inform decision-making in practice, and explanatory trials aim to understand the mechanism of an intervention.

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Article Synopsis
  • The study critiques the GRADE system for evaluating the certainty of scientific evidence, highlighting its inability to accurately assess treatment effects compared to a simpler linear tallying method.
  • Researchers explored the relationship between odds ratios from meta-analyses before and after updates, finding that stable estimates suggest higher certainty when CoE is high.
  • Results showed a clear linear drop in the likelihood of obtaining 'true' treatment effect estimates as CoE ratings decrease, indicating that more robust evidence correlates with higher quality ratings.
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  • The study assesses the effectiveness of large language models (LLMs) in evaluating scientific research reports and systematic reviews compared to human raters, using established criteria like PRISMA, AMSTAR, and PRECIS-2.
  • Five LLMs were tested across a total of 168 systematic reviews and clinical trials, revealing that while individual LLMs showed lower accuracy (ranging from 38% to 74%), combined LLM ratings improved that accuracy significantly.
  • The most accurate results came from human and AI collaboration, which achieved accuracies between 80% and 96%, suggesting that integrating human judgment with AI technology enhances the appraisal process more than either can do alone.
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Background: Treatment decisions for persons with relapsing-remitting multiple sclerosis (RRMS) rely on clinical and radiological disease activity, the benefit-harm profile of drug therapy, and preferences of patients and physicians. However, there is limited evidence to support evidence-based personalized decision-making on how to adapt disease-modifying therapy treatments targeting no evidence of disease activity, while achieving better patient-relevant outcomes, fewer adverse events, and improved care. Serum neurofilament light chain (sNfL) is a sensitive measure of disease activity that captures and prognosticates disease worsening in RRMS.

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Objective: To evaluate the personal protective effects of wearing versus not wearing surgical face masks in public spaces on self-reported respiratory symptoms over a 14 day period.

Design: Pragmatic randomised superiority trial.

Setting: Norway.

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Objectives: To quantify the strength of statistical evidence of randomized controlled trials (RCTs) for novel cancer drugs approved by the Food and Drug Administration in the last 2 decades.

Study Design And Setting: We used data on overall survival (OS), progression-free survival, and tumor response for novel cancer drugs approved for the first time by the Food and Drug Administration between January 2000 and December 2020. We assessed strength of statistical evidence by calculating Bayes factors (BFs) for all available endpoints, and we pooled evidence using Bayesian fixed-effect meta-analysis for indications approved based on 2 RCTs.

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Objectives: Trials within Cohorts (TwiCs) is a pragmatic design approach that may overcome frequent challenges of traditional randomized trials such as slow recruitment, burdensome consent procedures, or limited external validity. This scoping review aims to identify all randomized controlled trials using the TwiCs design and to summarize their design characteristics, ways to obtain informed consent, output, reported challenges and mitigation strategies.

Study Design And Setting: Systematic search of Medline, Embase, Cochrane, trial registries and citation tracking up to December 2022.

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Article Synopsis
  • Consensus statements are important in medicine and public health, but not all use solid evidence to support their claims.
  • Some statements rely on expert panels, which can be biased if many members share the same opinions or interests, especially without a thorough review of evidence.
  • A recent case about COVID-19 showed that many panel members had strong connections to groups pushing for strict COVID measures without revealing these biases, highlighting the need for clear conflicts of interest to ensure trustworthiness.
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Rationale: Novel therapeutic approaches are needed in stroke recovery. Whether pharmacological therapies are beneficial for enhancing stroke recovery is unclear. Dopamine is a neurotransmitter involved in motor learning, reward, and brain plasticity.

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Objectives: To assess to what extent the overall quality of evidence indicates changes to observe intervention effect estimates when new data become available.

Methods: We conducted a meta-epidemiological study. We obtained evidence from meta-analyses of randomized trials of Cochrane reviews addressing the same health-care question that was updated with inclusion of additional data between January 2016 and May 2021.

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Background: Increasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis (PwMS).

Methods: Randomized trials assessing approved DMTs in PwMS with results for at least one outcome referred to as "quality of life" were searched in PubMed and ClinicalTrials.

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Background: Technological devices such as smartphones, wearables and virtual assistants enable health data collection, serving as digital alternatives to conventional biomarkers. We aimed to provide a systematic overview of emerging literature on 'digital biomarkers,' covering definitions, features and citations in biomedical research.

Methods: We analysed all articles in PubMed that used 'digital biomarker(s)' in title or abstract, considering any study involving humans and any review, editorial, perspective or opinion-based articles up to 8 March 2023.

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Introduction: Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective: To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

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Background: Smoking cessation is challenging, despite making use of established smoking cessation therapies. Preclinical studies and one clinical pilot study suggest the antidiabetic drug glucagon-like peptide-1 (GLP-1) analogue to modulate addictive behaviours and nicotine craving. Previously, we reported the short-term results of a randomised, double-blind, placebo-controlled trial.

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Article Synopsis
  • Pragmatic trials are gaining importance in multiple sclerosis research as they provide real-world evidence about treatment choices.
  • A systematic review identified 48 pragmatic trials published between 1967 and 2022, mostly involving small sample sizes and focusing primarily on supportive care rather than drug interventions.
  • The findings suggest a lack of widespread use of routine data in these trials, highlighting a significant opportunity to improve the quality of evidence in MS treatment through more comprehensive, pragmatic study designs.
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Objectives: Evidence-based research (EBR) is the systematic and transparent use of prior research to inform a new study so that it answers questions that matter in a valid, efficient, and accessible manner. This study surveyed experts about existing (e.g.

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Background: Clinical trial registries allow assessment of deviations of published trials from their protocol, which may indicate a considerable risk of bias. However, since entries in many registries can be updated at any time, deviations may go unnoticed. We aimed to assess the frequency of changes to primary outcomes in different historical versions of registry entries, and how often they would go unnoticed if only deviations between published trial reports and the most recent registry entry are assessed.

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