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DEBATE-statistical analysis plans for observational studies

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Hiemstra, Bart ; Keus, Frederik ; Wetterslev, Jørn ; Gluud, Christian ; van der Horst, Iwan C C. / DEBATE-statistical analysis plans for observational studies. In: BMC Medical Research Methodology. 2019 ; Vol. 19, No. 1. pp. 233.

Bibtex

@article{5f20c60ac57848aca67f17a612672207,
title = "DEBATE-statistical analysis plans for observational studies",
abstract = "BACKGROUND: All 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.CONCLUSION: With 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.",
author = "Bart Hiemstra and Frederik Keus and J{\o}rn Wetterslev and Christian Gluud and {van der Horst}, {Iwan C C}",
year = "2019",
month = dec,
day = "9",
doi = "10.1186/s12874-019-0879-5",
language = "English",
volume = "19",
pages = "233",
journal = "BMC Medical Research Methodology",
issn = "1471-2288",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - DEBATE-statistical analysis plans for observational studies

AU - Hiemstra, Bart

AU - Keus, Frederik

AU - Wetterslev, Jørn

AU - Gluud, Christian

AU - van der Horst, Iwan C C

PY - 2019/12/9

Y1 - 2019/12/9

N2 - BACKGROUND: All 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.CONCLUSION: With 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.

AB - BACKGROUND: All 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.CONCLUSION: With 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.

UR - http://www.scopus.com/inward/record.url?scp=85076343356&partnerID=8YFLogxK

U2 - 10.1186/s12874-019-0879-5

DO - 10.1186/s12874-019-0879-5

M3 - Journal article

C2 - 31818263

VL - 19

SP - 233

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

SN - 1471-2288

IS - 1

M1 - 233

ER -

ID: 58626638