ArticleBMC medicine2019
Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis.
Article in BMC medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 9 syntheses or guidelines pooled it, 99 citations in OpenAlex.
- Cardiovascular disease and amyloidosis in phase III multiple myeloma trials: a systematic review of eligibility, screening and event reporting.Open heart · 2026Pooled it
- Prevalence and representation of comorbidities and multimorbidity in randomised controlled trials in sepsis or septic shock: a systematic review.Critical care (London, England) · 2026Pooled it
- Multimorbidity and analgesic-related harms: a systematic review.British journal of anaesthesia · 2025Pooled it
- A systematic review and meta-analysis of the effect of intravitreal VEGF inhibitors on cardiorenal outcomes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023Pooled it
- Frailty in randomised controlled trials for dementia or mild cognitive impairment measured via the frailty index: prevalence and prediction of serious adverse events and attrition.Alzheimer's research & therapy · 2023Pooled it
- Treatment effect modification due to comorbidity: Individual participant data meta-analyses of 120 randomised controlled trials.PLoS medicine · 2023Pooled it
- Lipid-Lowering Trials Are Not Representative of Patients Managed in Clinical Practice: A Systematic Review and Meta-Analysis of Exclusion Criteria.Journal of the American Heart Association · 2023Pooled it
- Comorbidity and health-related quality of life in people with a chronic medical condition in randomised clinical trials: An individual participant data meta-analysis.PLoS medicine · 2023Pooled it
- Pooled it
- Associations of Multimorbidity With Stroke Severity, Subtype, Premorbid Disability, and Early Mortality: Oxford Vascular Study.Neurology · 2023Trial
- Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability.BMC medicine · 2022Trial
- Myoprotective Fat-Loss Phenotypes in Obesity-Associated Type 2 Diabetes: A 12-Month Real-World Cohort Study of Metformin-Based Treatment Regimens.Clinics and practice · 2026Article
- Real-world outcomes and toxicities of CAR-T in relapsed/refractory follicular lymphoma: a multicenter cohort study.Blood advances · 2026Article
- Exploring Patient Perspectives on the Use of Artificial Intelligence to Inform Joint Decision-Making for Patients With Multiple Conditions in Primary Care in the United Kingdom: Qualitative Study.Journal of medical Internet research · 2026Article
- Person-Centered Multimorbidity Care in UK Primary Care: Identifying Changes to Practice.Annals of family medicine · 2026Article
- Global, regional, and national burden of bone and joint infections, 1990-2021: a comprehensive analysis of trends, pathogens, and antimicrobial resistance.Frontiers in cellular and infection microbiology · 2026Article
- Sex-specific transcriptome similarity networks elucidate comorbidity relationships.Communications medicine · 2025Article
- Endocrine therapies and mortality risk in postmenopausal women with breast cancer: benchmarking an observational analysis against a randomized trial.American journal of epidemiology · 2025Observational
- Real-World Studies and Randomized Controlled Trials: A Podcast Discussion of the Relative Strengths and Limitations of These Complementary Designs for Cancer Research.Oncology and therapy · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundClinicians are less likely to prescribe guideline-recommended treatments to people with multimorbidity than to people with a single condition. Doubts as to the applicability of clinical trials of drug treatments (the gold standard for evidence-based medicine) when people have co-existing diseases (comorbidity) may underlie this apparent reluctance. Therefore, for a range of index conditions, we measured the comorbidity among participants in clinical trials of novel drug therapies and compared this to the comorbidity among patients in the community.
methodsData from industry-sponsored phase 3/4 multicentre trials of novel drug therapies for chronic medical conditions were identified from two repositories: Clinical Study Data Request and the Yale University Open Data Access project. We identified 116 trials (n = 122,969 participants) for 22 index conditions. Community patients were identified from a nationally representative sample of 2.3 million patients in Wales, UK. Twenty-one comorbidities were identified from medication use based on pre-specified definitions. We assessed the prevalence of each comorbidity and the total number of comorbidities (level of multimorbidity), for each trial and in community patients.
resultsIn the trials, the commonest comorbidities in order of declining prevalence were chronic pain, cardiovascular disease, arthritis, affective disorders, acid-related disorders, asthma/COPD and diabetes. These conditions were also common in community-based patients. Mean comorbidity count for trial participants was approximately half that seen in community-based patients. Nonetheless, a substantial proportion of trial participants had a high degree of multimorbidity. For example, in asthma and psoriasis trials, 10-15% of participants had ≥ 3 conditions overall, while in osteoporosis and chronic obstructive pulmonary disease trials 40-60% of participants had ≥ 3 conditions overall.
conclusionsComorbidity and multimorbidity are less common in trials than in community populations with the same index condition. Comorbidity and multimorbidity are, nevertheless, common in trials. This suggests that standard, industry-funded clinical trials are an underused resource for investigating treatment effects in people with comorbidity and multimorbidity.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.