ArticleBMC medical research methodology2019
DEBATE-statistical analysis plans for observational studies.
Article in BMC medical research methodology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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
21 citing papers in PubMed.
- Childhood Sexual Abuse and Long-Term Risk of Self-Harm, Overdose, and Cardiovascular Disease.medRxiv : the preprint server for health sciences · 2026Article
- Predictors and prognostic value for in-hospital outcomes associated with postoperative anemia in cardiac surgery: a retrospective cohort study.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2026Article
- A Statistical Analysis Plan Template for Observational Studies: Promoting Quality and Rigor in Research.Journal of statistical theory and practice · 2025Article
- Multiplicity corrections in life sciences: challenges and consequences.International journal of epidemiology · 2025Article
- Using QALYs as an Outcome for Assessing Global Prediction Accuracy in Diabetes Simulation Models.Medical decision making : an international journal of the Society for Medical Decision Making · 2025Article
- Calcium supplementation during trauma resuscitation: a propensity score-matched analysis from the TraumaRegister DGUCritical care (London, England) · 2024Article
- Initial data analysis for longitudinal studies to build a solid foundation for reproducible analysis.PloS one · 2024Article
- ESMO Guidance for Reporting Oncology real-World evidence (GROW).ESMO real world data and digital oncology · 2023Article
- Effects of a single cash transfer on school re-enrollment during COVID-19 among vulnerable adolescent girls in Kenya: Randomized controlled trial.Economics of education review · 2023Article
- Infants' immunisations, their timing and the risk of allergic diseases (INITIAL): an observational prospective cohort study protocol.BMJ open · 2023Article
- Toward Open and Reproducible Epidemiology.American journal of epidemiology · 2023Article
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- Challenges and recommendations for high quality research using electronic health records.Frontiers in digital health · 2022Article
- Association Between Consumption of Fermented Food and Food-Derived Prebiotics With Cognitive Performance, Depressive, and Anxiety Symptoms in Psychiatrically Healthy Medical Students Under Psychological Stress: A Prospective Cohort Study.Frontiers in nutrition · 2022Article
- Observational
- A Cross-Sectional Study on Canine and Feline Anal Sac Disease.Animals : an open access journal from MDPI · 2021Article
- The Essential Medicinal Chemistry of Cannabidiol (CBD).Journal of medicinal chemistry · 2020Review
- Bridging research integrity and global health epidemiology (BRIDGE) guidelines: explanation and elaboration.BMJ global health · 2020Review
- 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
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAll clinical research benefits from transparency and validity. Transparency and validity of studies may increase by prospective registration of protocols and by publication of statistical analysis plans (SAPs) before data have been accessed to discern data-driven analyses from pre-planned analyses. MAIN MESSAGE: Like clinical trials, recommendations for SAPs for observational studies increase the transparency and validity of findings. We appraised the applicability of recently developed guidelines for the content of SAPs for clinical trials to SAPs for observational studies. Of the 32 items recommended for a SAP for a clinical trial, 30 items (94%) were identically applicable to a SAP for our observational study. Power estimations and adjustments for multiplicity are equally important in observational studies and clinical trials as both types of studies usually address multiple hypotheses. Only two clinical trial items (6%) regarding issues of randomisation and definition of adherence to the intervention did not seem applicable to observational studies. We suggest to include one new item specifically applicable to observational studies to be addressed in a SAP, describing how adjustment for possible confounders will be handled in the analyses.
conclusionWith only few amendments, the guidelines for SAP of a clinical trial can be applied to a SAP for an observational study. We suggest SAPs should be equally required for observational studies and clinical trials to increase their transparency and validity.
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.