Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

He, Jinzhang; Morales, Daniel R.; Guthrie, Bruce

doi:10.1186/s13063-020-4139-0

Cited by 147Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsEthics in Clinical Research

Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

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He, Jinzhang, Morales, Daniel R., Guthrie, Bruce·2020·Trials

DOI 10.1186/s13063-020-4139-0PMC PMC7045589

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Abstract

Background: The generalisability of randomized controlled trials (RCTs) can be uncertain because the impact of exclusion criteria is rarely quantified. The aim of this study was to systematically review studies examining the percentage of clinical populations with a physical health condition who would be excluded by RCTs of treatments for that condition. Methods: Medline and Embase were searched from inception to Feb 11th 2018. Two reviewers independently completed screening, full-text review, data extraction and risk-of-bias assessment. The primary outcome was the percentage of patients in the clinical population who would have been excluded from each examined trial. Subgroup analyses examined exclusion by population setting, publication date and funding source. Results: Titles/abstracts (20,754) were screened, and 50 studies were included which reported exclusion rates from 305 trials of treatments in 31 physical conditions. Estimated rates of exclusion from trials varied from 0% to 100%, and the median exclusion rate was 77.1% of patients (interquartile range 55.5% to 89.0% exclusion). Median exclusion rates for trials in common chronic conditions were high, including hypertension 83.0%, type 2 diabetes 81.7%, chronic obstructive pulmonary disease 84.3%, and asthma 96.0%. The most commonly applied exclusion criteria related to age, co-morbidity and co-prescribing, whereas more implicit criteria relating to life expectancy or functional status were not typically examined. There was no evidence that exclusion varied by the nature of the clinical population in which exclusion was evaluated or trial funding source. There was no statistically significant change in exclusion rates in more recent compared with older trials. Conclusions: The majority of trials of treatments for physical conditions examined excluded the majority of patients with the condition being treated. Almost a quarter of the trials studied excluded over 90% of patients, more than half of trials excluded at least three quarters of patients, and four out of five trials excluded at least half of patients. A limitation is that most studies applied only a subset of eligibility criteria, so exclusion rates are likely under-estimated. Exclusion from trials of older people and people with co-morbidity and co-prescribing is increasingly untenable given population aging and increasing multimorbidity. Trial registration: PROSPERO registration CRD42016042282 .

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Clinical trials often lack generalizability to complex patients who often fail to qualify for trials.
“First, clinical trials often lack generalizability 4 to complex patients who often fail to qualify for trials.5,6”
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Reporting on patient’s body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review
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Operationalizing the GRADE-equity criterion to inform guideline recommendations: application to a medical cannabis guideline
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Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK
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Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: Guidelines from the International Society for Nutritional Psychiatry Research
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Conceptualizing, operationalizing, and utilizing equity, diversity, and inclusion in clinical trials: a scoping review
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Brentuximab vedotin in the treatment of paediatric patients with relapsed or refractory Hodgkin's lymphoma: Results of a real‐life study
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Acute and Long-Term Outcomes of ST-Elevation Myocardial Infarction in Cancer Patients, a ‘Real World’ Analysis with 175,000 Patients
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Assessing trial representativeness using serious adverse events: an observational analysis using aggregate and individual-level data from clinical trials and routine healthcare data
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Treatment-related Adverse Events, Including Fatal Toxicities, in Patients With Extensive-stage Small-cell Lung Cancer Receiving Adjuvant Programmed Cell Death 1/Programmed Cell Death Ligand 1 Inhibitors: A Meta-analysis and Trial Sequential Analysis of Randomized Controlled Trials
de Moraes, F. C. A., Lôbo, A. D. O. M., Sano, V. K. T., Kelly, F. A., & Burbano, R. M. R. (2024) · Clinical Oncology · doi:10.1016/j.clon.2024.06.056 · Cited by 10 · see citing works
Long-term outcomes of vedolizumab in inflammatory bowel disease: the Swedish prospective multicentre SVEAH extension study
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Investigator-initiated Randomized Controlled Trials in Infectious Diseases: Better Value for Money for Registration Trials of New Antimicrobials
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Does the frailty index applied to randomised controlled trials really measure frailty?
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Limited access to liver transplantation and TIPS despite high mortality, healthcare resource use and costs of cirrhosis in Germany
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COVID-19, community trials, and inclusion
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Impact of primary, specialist, and hospital care data on disease frequency estimates in older adults in Sweden
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Mapping Comorbidities in Patients With Low Back Pain—A Systematic Review
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Eligibility for psychedelic therapy: Clinical trial medical exclusion criteria and their implications for hospital practice
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The implications of competing risks and direct treatment disutility in cardiovascular disease and osteoporotic fracture: risk prediction and cost effectiveness analysis
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Trial Forge Guidance 3: Randomised trials and how to recruit and retain individuals from ethnic minority groups– practical guidance to support better practicePreprint
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Essential New Complexity-Based Themes for Patient-Centered Diagnosis and Treatment of Dementia and Predementia in Older People: Multimorbidity and Multilevel Phenomenology
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Effectiveness of telerehabilitation-based mckenzie method versus manual therapy in low-back pain management: a randomised controlled trial
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Proxy Decision-Making for Clinical Research in Nursing Home Residents with Dementia: A Qualitative Analysis
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Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders
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Are health status and treatment burden associated with non-response bias in patients with chronic spinal pain? A Prospective Cohort Study
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Making “inclusion” more than a buzzword: A critical interpretive synthesis of literature about recruiting seldom-heard groups in health research
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Prevalence of multimorbidity and its impact on survival in people with motor neuron disease
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Commentary on ‘Exclusion rates in randomized trials of treatments for physical conditions: a systematic review’
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Comparing stroke rehabilitation inpatients and clinical trials eligibility criteria: A secondary chart review analysis revealing that most patients could have been excluded from rehabilitation trials based on comorbidity status
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Representation and outcomes of individuals with major depression in routine care who are ineligible for randomized controlled trials: a nationwide register‐based study
Hamina, A., Pinzón-Espinosa, J., Taipale, H. T., Schneider‐Thoma, J., Radua, J., Efthimiou, O., Cardoner, N., Correll, C. U., Fusar‐Poli, P., Mittendorfer-Rutz, E., et al. (2026) · World Psychiatry · doi:10.1002/wps.70013 · Cited by 5 · see citing works
Combination of palbociclib with adjuvant endocrine therapy for treatment of hormone receptor‑positive and human epidermal growth factor receptor 2‑negative metastatic breast cancer: An experience at two cancer centers in Saudi Arabia
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A Comparison of Neighborhood Socioeconomic Deprivation Measures and the Association with Survival among Black and White Women with Endometrial Cancer
Gottschlich, A., Robinson, J. R. M., Ruterbusch, J. J., Burchett, K., Adams, R. M., Washington, A., Coté, M. L., Schwartz, A. G., Purrington, K. S., & Wilson, M. R. (2025) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-24-1833 · Cited by 5 · see citing works
International Systematic Review of Utility Values Associated with Cardiovascular Disease and Reflections on Selecting Evidence for a UK Decision-Analytic Model
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Does weight management research for adults with severe obesity represent them? Analysis of systematic review data
Robertson, C., Aceves-Martins, M., Cruickshank, M., Imamura, M., & Avenell, A. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-054459 · Cited by 7 · see citing works
A systematic review of flurbiprofen 8.75 mg dose and risk of adverse events (excluding haemorrhagic) resulting from drug-drug interactions
Evans, A., Roy, D., Dhanda, S., Lane, S., Coutinho, G., Kulasekaran, A., Miller-Shakesby, D. M., Ramamoorthi, N., & Shakir, S. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1107185 · Cited by 4 · see citing works
Pharmacologic Treatment of Hypertension in Older Adults
Todd, O. M., Knight, M., Jacobs, J. A., Derington, C. G., Sheppard, J. P., & Bress, A. P. (2024) · Clinics in Geriatric Medicine · doi:10.1016/j.cger.2024.04.004 · Cited by 4 · see citing works
Multicomponent rehabilitation to improve independence and functioning in elderly patients with common age-associated diseases: a scoping review
Baritello, O., Taxis, T., Stein, H., Luizink-Dogan, M., Völler, H., & Salzwedel, A. (2025) · BMJ Open · doi:10.1136/bmjopen-2023-083733 · Cited by 3 · see citing works
Considerations of older adults with multimorbidity when facing healthcare choices: A qualitative systematic review
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Disease progression in patients with systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS)
Morand, E. F., Furie, R. A., Aringer, M., Arnaud, L., PESCHKEN, C. A., Hoi, A. Y.-B., Lee, K. W., Hedberg, J., Eén, T. G., Tummala, R., et al. (2025) · Lara D. Veeken · doi:10.1093/rheumatology/keaf599 · Cited by 3 · see citing works
Ceftazidime/avibactam and ceftolozane/tazobactam for severe paediatric infections: A systematic review, meta-analysis, and evidence map
Pimenta-de-Souza, P., Ramos-Silva, A., Sandes, V. S., Portella, P., Gouvêa, T., Fernández-Llimós, F., & Elisangela Costa, L. I. M. A. (2026) · International Journal of Antimicrobial Agents · doi:10.1016/j.ijantimicag.2025.107710 · Cited by 3 · see citing works
Do the Few Dictate Care for the Many? Revascularisation Considerations That Go Beyond the Guidelines
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Protocol for the development and validation of a Core Set for exercise-based rehabilitation of adults with multiple long-term conditions (multimorbidity) based on the World Health Organization’s International Classification of Functioning, Disability, and Health (ICF) framework
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Misuse of Guidelines Could Disadvantage and Harm Patients
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Trastuzumab in early curative breast cancer: A target trial emulation benchmarked against two randomized clinical trials
Voelskow, V., García‐Albéniz, X., Berglund, A., Feychting, M., Kurth, T., & Matthews, A. (2025) · PLoS Medicine · doi:10.1371/journal.pmed.1004661 · Cited by 2 · see citing works
Effectiveness of ixekizumab in 709 real-world patients with axial spondyloarthritis and psoriatic arthritis: a nationwide cohort study
Jensen, K. Y., Grøn, K. L., Hetland, M. L., & Glintborg, B. (2025) · RMD Open · doi:10.1136/rmdopen-2025-005806 · Cited by 2 · see citing works
How much is too much? A methodological investigation of the literature on alcohol consumption and health
Castriota, S., Frumento, P., & Suppressa, F. (2025) · Journal of Wine Economics · doi:10.1017/jwe.2025.10077 · Cited by 2 · see citing works
Challenges and Perspectives in Treating Individuals With Musculoskeletal Disorders and Comorbidity: A Systematic Literature Review With a Descriptive Thematic Synthesis
Rømer, L. C., Gandløse, J. S., Andreasen, J., Skou, S. T., & Palsson, T. S. (2025) · Scandinavian Journal of Caring Sciences · doi:10.1111/scs.70130 · Cited by 2 · see citing works
Assessing the representativeness of trials of Sodium-glucose Cotransporter-2 inhibitors in type 2 diabetes: a comparison of individual-level trial data and people newly prescribed treatment in a Welsh routine care database
Hanlon, P., Wightman, H., Sullivan, M. K., Lees, J. S., Butterly, E. W., Wei, L., McChrystal, R., Whalley, E., Almazam, S. A., Alsallumi, K., et al. (2025) · BMC Medicine · doi:10.1186/s12916-025-04492-2 · Cited by 2 · see citing works
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Tailored interventions to prevent functional decline after a Sentinel Fall presenting to the Emergency Department (iSeFallED) – protocol for a pragmatic mixed-methods implementation study
Zieschang, T., Himmelmann, L., Schmidt, N. M., Speckmann, E.-M., Feld, L., Klenk, J., Laurentius, T., Boerner, K., Diekmann, R., Hein, A., et al. (2026) · BMC Geriatrics · doi:10.1186/s12877-025-06943-0 · Cited by 2 · see citing works
Short Versus Longer Antibiotic Duration for Community-Acquired Pneumonia
Doumat, G., Ratz, D., Horowitz, J. K., Gandhi, T. N., Petty, L. A., Malani, A. N., Osterholzer, D., Misra, P., GUPTA, A. K. D., Flanders, S. A., et al. (2026) · Annals of Internal Medicine · doi:10.7326/annals-25-03538 · Cited by 2 · see citing works
Low-density lipoprotein cholesterol response to statins according to comorbidities and co-medications: A population-based study
Corn, G., Lund, M., Andersson, N. W., Dohlmann, T. L., Hlatky, M. A., Wohlfahrt, J., & Melbye, M. (2024) · American Heart Journal · doi:10.1016/j.ahj.2024.04.018 · Cited by 2 · see citing works
Patient- vs organ-based prognostic tools for older patients in critical care units
Hochleitner, M., Pickert, L., Nolting, N. A., Affeldt, A. M., Becker, I., Benzing, T. R., Kochanek, M., & Polidori, M. C. (2024) · Medizinische Klinik - Intensivmedizin und Notfallmedizin · doi:10.1007/s00063-024-01179-z · Cited by 2 · see citing works
A Digital Tool for Clinical Evidence–Driven Guideline Development by Studying Properties of Trial Eligible and Ineligible Populations: Development and Usability Study
Mumtaz, S., McMinn, M., Cole, C., Gao, C., Hall, C., Guignard‐Duff, M., Huang, H., McAllister, D., Morales, D. R., Jefferson, E., et al. (2024) · Journal of Medical Internet Research · doi:10.2196/52385 · Cited by 2 · see citing works
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Screening log: Challenges in community patient recruitment for gynecologic oncology clinical trials
Ratnaparkhi, R., Doolittle, G. C., Krebill, H. M., Springer, M. A., Calhoun, E. A., Jewell, A., & Mudaranthakam, D. P. (2024) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2024.101379 · Cited by 2 · see citing works
Effect Modification by Obesity on Nonsurgical Periodontal Treatment
Krall, E. A., McDonough, R., Singhal, A., García, R. I., & Jurasic, M. M. (2024) · JDR Clinical & Translational Research · doi:10.1177/23800844241276863 · Cited by 2 · see citing works
Influence of study characteristics on harm estimates from randomised controlled trials in patients with inflammatory arthritis receiving biological or synthetic antirheumatic drugs: a meta-epidemiological study
Berg, J. I., Nielsen, S. M., Malm, E., Ioannidis, J. P. A., Furst, D. E., Smolen, J. S., Taylor, P. C., Kristensen, L. E., Tarp, S., Ellingsen, T., et al. (2024) · Annals of the Rheumatic Diseases · doi:10.1136/ard-2024-226129 · Cited by 2 · see citing works
Inequities in Research and Publication: A Call for Equity, Diversity, and Inclusion
Bajpai, D., Wijewickrama, E. S., Anand, U., Chaudhury, A. R., & Sandal, S. (2025) · Advances in Kidney Disease and Health · doi:10.1053/j.akdh.2025.03.003 · Cited by 2 · see citing works
Impacts of Eligibility Criteria on Trial Participants' Age in Alzheimer's Disease Clinical Trials.
Chen, A., Li, Q., He, X., Jaffee, M. S., Hogan, W. R., Wang, F., Guo, Y. M., & Bian, J. (2022) · PubMed Central · Cited by 2 · see citing works
Diabetes in Old Age: Particularities and Specifics
Weber, P., Weberová, D., & Meluzínová, H. (2023) · IntechOpen eBooks · doi:10.5772/intechopen.1002479 · Cited by 2 · see citing works
Supplementing systematic review findings with healthcare system data: pilot projects from the Agency for Healthcare Research and Quality Evidence-based Practice Center program
Holmer, H. K., Iyer, S., Fiordalisi, C. V., Kuhn, E., Forte, M. L., Murad, M. H., Wang, Z., Tsou, A. Y., Michel, J. J., & Umscheid, C. A. (2024) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2024.111484 · Cited by 2 · see citing works
Testing an informatics consulting service for systematic bias using negative control reference setsPreprint
Jackson, M., Gombar, S., Manickam, R., Brown, R., Tekumalla, R., Ballentine, P., & Low, Y. (2024) · Research Square · doi:10.21203/rs.3.rs-3694681/v1 · Cited by 2 · see citing works
Unified Protocol for the transdiagnostic treatment of emotional disorders in people with post COVID-19 condition: study protocol for a multiple baseline n-of-1 trial
Martínez-Borba, V., Martínez-García, L., Peris-Baquero, Ó., Osma, J., & del Corral-Beamonte, E. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1160692 · Cited by 1 · see citing works
“Co-prescribing is one of the most common exclusion criteria in clinical trials for physical conditions (He et al., 2020).”
Background
Pragmatic Clinical Studies: An Emerging Clinical Research Discipline for Improving Evidence-Based Practice of Cardiovascular Diseases in Asia
Zhao, D. H., & Yao, C. (2022) · Korean Circulation Journal · doi:10.4070/kcj.2022.0100 · Cited by 1 · see citing works
UK Stakeholder Perspectives on Surrogate Endpoints in Cancer, and the Potential for UK Real-World Datasets to Validate Their Use in Decision-Making
Baldwin, D., Carmichael, J., Cook, G., Navani, N., Peach, J., Slater, R., Wheatstone, P., Wilkins, J., Allen-Delingpole, N., Kerr, C., et al. (2024) · Cancer Management and Research · doi:10.2147/cmar.s441359 · Cited by 1 · see citing works
Characteristics, treatment patterns and survival of patients with high-risk early hormone receptor-positive breast cancer in French real-world settings: an exploratory study of the CANTO cohort
Giugliano, F., Bertaut, A., Blanc, J., Martin, A., Gaudin, C., Fournier, M., Kieffer, A., Sauterey, B., Levy, C., Campone, M., et al. (2024) · ESMO Open · doi:10.1016/j.esmoop.2024.103994 · Cited by 1 · see citing works
Use of the chronic illness research recruitment taxonomy to evaluate recruitment strategies in an eHealth feasibility study.
Austin, R. C., Husebø, A. M. L., Wathne, H. B., Storm, M., Urstad, K. H., Morken, I. M., & Karlsen, B. (2024) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2024.101420 · Cited by 1 · see citing works
Enhancing evidence-based care using trial emulation in electronic health records: real-world effects of empagliflozin in people with type 2 diabetes
Ryan, D., Keogh, R. H., Williamson, E., Lumbers, R. T., Diaz‐Ordaz, K., Shah, A. D., & Bidulka, P. (2026) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2025-005672 · Cited by 1 · see citing works
Shaping the future of clinical trials through strategic foresight
Lee, S., McIntyre, J., Robertson, T., Kallsen, K., Bauer, M., Berardi, R., Boisvert-Huneault, C., Clerisme-Beaty, E. M., Denton, C. P., Fakra, É., et al. (2026) · Clinical Trials · doi:10.1177/17407745251414680 · Cited by 1 · see citing works

Commentary on ‘Exclusion rates in randomized trials of treatments for physical conditions: a systematic review’
Ugalde, A., Kiss, N. K., Livingston, P. M., & Rankin, N. M. (2021) · Trials · doi:10.1186/s13063-021-05019-9 · Cited by 6 · see citing works
Additional file 1 of Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review
He, J., Morales, D., & Guthrie, B. (2020) · Figshare · doi:10.6084/m9.figshare.11906727
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Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals
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Threats to Applicability of Randomised Trials: Exclusions and Selective Participation
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Estimating the Applicability of Wound Care Randomized Controlled Trials to General Wound-Care Populations by Estimating the Percentage of Individuals Excluded from a Typical Wound-Care Population in Such Trials
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Authors: He, J., Morales, D. R., & Guthrie, B.
Affiliations: University of Dundee (GB)
University of Edinburgh (GB)
Corresponding author: Guthrie, Bruce
ORCID: Morales, Daniel R.
Guthrie, Bruce
Venue: Trials
Publisher: Springer Science and Business Media LLC
Published: 2020-02-26
Volume: 21
Issue: 1
Pages: 228-228
ISSN: 1745-6215 (ISSN-L)
DOI: 10.1186/s13063-020-4139-0
PMC: PMC7045589
OpenAlex: W3009768886
Cited by: 147
References: 37
Citations by year: 2026: 20 · 2025: 25 · 2024: 34 · 2023: 31 · 2022: 20 · 2021: 13 · 2020: 4
FWCI: 2.73
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Trials (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Discovery Research Portal (University of Dundee) (submittedVersion, cc-by)
Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders: Medical Research Scotland (Vac-965-2016)
Health Services and Delivery Research Programme (NIHR HS&DR 11/2003/27)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: exclusion rates, exclusion criteria, eligibility criteria, generalizability of trial results, physical health conditions, multimorbidity, older adults, co-prescribing, chronic disease, hypertension, type 2 diabetes, chronic obstructive pulmonary disease, asthma, trial funding, population aging
MeSH terms: Humans, Morbidity, Bias, Randomized Controlled Trials as Topic, Patient Selection

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Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

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