Evidence map›Paper›PMID 37598153›Full record

SynthesisBMC medical research methodology2023

Sample size requirements are not being considered in studies developing prediction models for binary outcomes: a systematic review.

Paula Dhiman, Jie Ma, Cathy Qi, Garrett Bullock, Jamie C Sergeant, Richard D Riley, Gary S Collins

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical research methodology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Paula DhimanCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK. paula.dhiman@csm.ox.ac.uk.
Jie MaCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK.
Cathy QiPopulation Data Science, Faculty of Medicine, Health and Life Science, Swansea University Medical School, Swansea University, Singleton Park, Swansea, SA2 8PP, UK.
Garrett BullockDepartment of Orthopaedic Surgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Jamie C SergeantCentre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PL, UK.
Richard D RileyInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, B15 2TT, Birmingham, UK.
Gary S CollinsCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK.

Funding

Cancer Research UK 27294Cancer Research UK C49297/A27294Cancer Research UK PRCPJT-Nov21\100021Department of Health
6 · The paper itself

Abstract

backgroundHaving an appropriate sample size is important when developing a clinical prediction model. We aimed to review how sample size is considered in studies developing a prediction model for a binary outcome.

methodsWe searched PubMed for studies published between 01/07/2020 and 30/07/2020 and reviewed the sample size calculations used to develop the prediction models. Using the available information, we calculated the minimum sample size that would be needed to estimate overall risk and minimise overfitting in each study and summarised the difference between the calculated and used sample size.

resultsA total of 119 studies were included, of which nine studies provided sample size justification (8%). The recommended minimum sample size could be calculated for 94 studies: 73% (95% CI: 63-82%) used sample sizes lower than required to estimate overall risk and minimise overfitting including 26% studies that used sample sizes lower than required to estimate overall risk only. A similar number of studies did not meet the ≥ 10EPV criteria (75%, 95% CI: 66-84%). The median deficit of the number of events used to develop a model was 75 [IQR: 234 lower to 7 higher]) which reduced to 63 if the total available data (before any data splitting) was used [IQR:225 lower to 7 higher]. Studies that met the minimum required sample size had a median c-statistic of 0.84 (IQR:0.80 to 0.9) and studies where the minimum sample size was not met had a median c-statistic of 0.83 (IQR: 0.75 to 0.9). Studies that met the ≥ 10 EPP criteria had a median c-statistic of 0.80 (IQR: 0.73 to 0.84).

conclusionsPrediction models are often developed with no sample size calculation, as a consequence many are too small to precisely estimate the overall risk. We encourage researchers to justify, perform and report sample size calculations when developing a prediction model.

Indexed as

Models, StatisticalResearch PersonnelHumansPrognosisPubMedMethodologyPrediction modelSample size

Identifiers

PMID37598153
PMCPMC10439652

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.