ArticleClinical epidemiology2019
Randomized clinical trials with run-in periods: frequency, characteristics and reporting.
Article in Clinical epidemiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06342024 (Effects of Pistachio Consumption on Inflammatory Markers and Lean Body Mass in Recreationally Active Women and Men), which is not on this map. Cited by 34 papers, 4 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.
Effects of Pistachio Consumption on Inflammatory Markers and Lean Body Mass in Recreationally Active Women and Men
Who cites it
34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Medication adherence during the run-in phase of clinical trials: A systematic review of methodological and reporting rigour.British journal of clinical pharmacology · 2025Pooled it
- Association of Single-blind Placebo Run-in Periods With the Placebo Response in Randomized Clinical Trials of Antidepressants: A Systematic Review and Meta-analysis.JAMA psychiatry · 2022Pooled it
- Improving rheumatoid arthritis comparative effectiveness research through causal inference principles: systematic review using a target trial emulation framework.Annals of the rheumatic diseases · 2020Pooled it
- Triple therapy for COPD: a crude analysis from a systematic review of the evidence.Therapeutic advances in respiratory diseasePooled it
- Value of the Run-In Period to Evaluate the Safety of Conventional Trypanocidal Treatment: A Subanalysis of a Colombian Randomized Clinical Trial.The American journal of tropical medicine and hygiene · 2026Trial
- Exercise and QUality Diet after Leukemia: A Randomized Weight Loss Trial among Adult Survivors of Childhood Leukemia in the Childhood Cancer Survivor Study.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2024Trial
- The efficacy of the TEACH e-Learning course at improving early childhood educators' physical activity and sedentary behaviour self-efficacy, knowledge, intentions, and perceived behavioural control: a randomized controlled trial.The international journal of behavioral nutrition and physical activity · 2024Trial
- Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial.Journal of medical Internet research · 2021Trial
- Closed-loop motor imagery brain-computer interface-assisted training for upper limb rehabilitation after subacute stroke: clinical and electroencephalographic outcomes from a randomized pilot trial.Frontiers in neurologyTrial
- Host-state biomarkers and clinical factors for stratification and optimization of cell therapy trials in chronic limb-threatening ischemia: A review.Regenerative therapy · 2026Review
- Article
- Acupuncture for irritable bowel syndrome comorbid with anxiety and depression: study protocol for a placebo run-in, randomized clinical trial.Frontiers in psychiatry · 2026Article
- Patterns of Oncological Clinical Trials in African Countries: A Scoping Review.Journal of cancer prevention · 2025Review
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- Uncertainty in the estimated effects of statin initiation on risk of dementia: using a multiverse analysis to assess sources of variability.European journal of epidemiology · 2025Article
- Run-in periods and treatment outcomes in asthma trials: A narrative review.Contemporary clinical trials communications · 2024Review
- Recommendations for Designing, Conducting, and Reporting Feeding Trials in Nutrition Research.Advances in nutrition (Bethesda, Md.) · 2024Review
- An Updated Review on the Role of Non-dihydropyridine Calcium Channel Blockers and Beta-blockers in Atrial Fibrillation and Acute Decompensated Heart Failure: Evidence and Gaps.Cardiovascular drugs and therapy · 2023Review
- Designs used in published therapeutic studies of rare superficial vascular anomalies: a systematic literature search.BMC medical research methodology · 2023Review
- Core protocol development for phase 2/3 clinical trials in the leukodystrophy vanishing white matter: a consensus statement by the VWM consortium and patient advocates.BMC neurology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRun-in periods are occasionally used in randomized clinical trials to exclude patients after inclusion, but before randomization. In theory, run-in periods increase the probability of detecting a potential treatment effect, at the cost of possibly affecting external and internal validity. Adequate reporting of exclusions during the run-in period is a prerequisite for judging the risk of compromised validity. Our study aims were to assess the proportion of randomized clinical trials with run-in periods, to characterize such trials and the types of run-in periods and to assess their reporting. MATERIALS AND
methodsThis was an observational study of 470 PubMed-indexed randomized controlled trial publications from 2014. We compared trials with and without run-in periods, described the types of run-in periods and evaluated the completeness of their reporting by noting whether publications stated the number of excluded patients, reasons for exclusion and baseline characteristics of the excluded patients.
resultsTwenty-five trials reported a run-in period (5%). These were larger than other trials (median number of randomized patients 217 vs 90,
conclusionApproximately 1 in 20 trials used run-in periods, though much more frequently in industry trials. Reporting of the run-in period was often incomplete, precluding a meaningful assessment of the impact of the run-in period on the validity of trial results. We suggest that current trials with run-in periods are interpreted with caution and that updates of reporting guidelines for randomized trials address the issue.
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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.