ArticlePain medicine (Malden, Mass.)2024
Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans.
Qilu Yu, Steven Z George, Tassos C Kyriakides, Daniel I Rhon, Benjamin J Morasco, James Dziura, Julie M Fritz, Mary Geda, Peter Peduzzi, Cynthia R Long
Abstract read
In one paragraphArticle in Pain medicine (Malden, Mass.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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What it found
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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 registryThe 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 literatureWho cites it
0 citing papers in PubMed.
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4 · The recordCorrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what moneyAuthors and funding
10 authors.
Qilu YuOffice of Clinical & Regulatory Affairs, National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0003-2641-3535 Steven Z GeorgeDepartments of Orthopedic Surgery and Population Health Sciences and Duke Clinical Research Institute, Duke University, Durham, NC 27701, United States.ORCID 0000-0003-4988-9421 Tassos C KyriakidesVA Cooperative Studies Program Coordinating Center, West Haven, CT, United States, Department of Biostatistics and Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT 06516, United States.
Daniel I RhonDepartment of Rehabilitation Medicine, F. Edward Hébert School of Medicine, Uniformed Services University, Bethesda, MD 20814, United States.ORCID 0000-0002-4320-990X Benjamin J MorascoCenter to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, OR 97239, United States.ORCID 0009-0003-0106-5105 James DziuraDepartment of Emergency Medicine, School of Medicine, Department of Biostatistics and Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT 06520, United States.
Julie M FritzDepartment of Physical Therapy & Athletic Training, College of Health, University of Utah, Salt Lake City, UT 84112, United States.ORCID 0000-0002-3599-1057 Mary GedaDepartment of Internal Medicine, School of Medicine, Yale University, New Haven, CT 06520, United States.
Peter PeduzziPain Management Collaboratory Coordinating Center, Yale University, New Haven, CT 06520, United States.
Cynthia R LongPalmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA 52803, United States.
Funding
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9MPain Management Collaboratory Coordinating Center (PMC3)U24AT009769 · NCCIH · YALE UNIVERSITY · PI WILLIAM C BECKER, Alicia Heapy · 2017 to 2026
$16.4MChiropractic Care for Veterans: A Pragmatic Randomized Trial Addressing Dose Effects for cLBPUH3AT009761 · NCCIH · PALMER COLLEGE OF CHIROPRACTIC · PI GOERTZ, CHRISTINE MARIE, LONG, CYNTHIA R · 2019 to 2024
$7.2MAIM BACK UH3 TransitionUH3AT009790 · NCCIH · DUKE UNIVERSITY · PI GEORGE, STEVEN Z, HASTINGS, SUSAN NICOLE · 2020 to 2023
$6.4MSMART Stepped Care Management for Low Back Pain in Military Health SystemUH3AT009763 · NCCIH · UNIVERSITY OF UTAH · PI FRITZ, JULIE M, RHON, DAN · 2019 to 2022
$6.2MTele-Collaborative Outreach to Rural Patients with Chronic Pain: The CORPs TrialUH3AT012257 · NCCIH · OREGON HEALTH & SCIENCE UNIVERSITY · PI LOVEJOY, TRAVIS IAN, MORASCO, BENJAMIN J · 2023 to 2025
$5.2MImproving Veteran Access To Integrated Management of Chronic Back PainUG3AT009790 · NCCIH · DUKE UNIVERSITY · PI GEORGE, STEVEN Z, HASTINGS, SUSAN NICOLE · 2017 to 2019
$1.9MChiropractic Care for Veterans: A Pragmatic Randomized Trial Addressing Dose Effects for cLBPUG3AT009761 · NCCIH · PALMER COLLEGE OF CHIROPRACTIC · PI GOERTZ, CHRISTINE MARIE, LONG, CYNTHIA R · 2017 to 2018
$1.7MSMART Stepped Care Management for Low Back Pain in Military Health SystemUG3AT009763 · NCCIH · UNIVERSITY OF UTAH · PI FRITZ, JULIE M, RHON, DAN · 2017 to 2018
$1.3MTele-Collaborative Outreach to Rural Patients with Chronic Pain: The CORPs TrialUG3AT012257 · NCCIH · OREGON HEALTH & SCIENCE UNIVERSITY · PI LOVEJOY, TRAVIS IAN, MORASCO, BENJAMIN J. · 2022 to 2022
$731kNCATS NIH HHS UL1 TR001863NCCIH NIH HHS U24 AT009769NCCIH NIH HHS UG3 AT009761NCCIH NIH HHS UG3 AT009763NCCIH NIH HHS UG3 AT009790NCCIH NIH HHS UG3 AT012257NCCIH NIH HHS UH3 AT009761NCCIH NIH HHS UH3 AT009763NCCIH NIH HHS UH3 AT009790NCCIH NIH HHS UH3 AT012257NIH HHS U24AT009769
6 · The paper itselfAbstract
backgroundBest practices for clinical trials stipulate that statistical analysis plans (SAPs) need to be finalized before initiation of any analysis. However, there is limited guidance about when changes to SAPs are acceptable and how these changes should be incorporated into the research plan with appropriate documentation.
methodsWe conducted a survey of 12 pragmatic clinical trials (PCTs) in the Pain Management Collaboratory that evaluated nonpharmacological interventions for pain to assess the following SAP information: (1) location of statistical analysis details, (2) types of statistical analyses planned, (3) sponsor requirements, (4) templates used for development, (5) publication plan, (6) changes since trial launch, (7) process of documenting changes, and (8) process of updating the trial registry.
resultsAll 12 PCTs provided details of their SAPs for the primary outcomes in the institutional review board-approved trial protocol; 8 included plans for secondary outcomes, and 6 included plans for tertiary/exploratory outcomes. Most PCTs made SAP changes after trial initiation, many as a result of COVID-19-related issues. Eleven of the PCTs were actively recruiting participants. Changes were made to sample size, study design, study arms, and analytical methods, all before the data lock/unblinding. In all cases, justification for the changes was documented in the trial protocol or SAP, signed off by the trial biostatistician and principal investigator, and reviewed/approved by an institutional review board, data and safety monitoring board, or sponsor.
conclusionsWe recommend that SAP changes can be acceptable up to the time of data lock/unblinding. To maintain full transparency and necessary rigor, clear documentation of such changes should include details, rationale, date(s) such changes were implemented, and evidence of approval by relevant oversight bodies.
Indexed as
Pain ManagementCOVID-19Data Interpretation, StatisticalHumansPragmatic Clinical Trials as TopicResearch DesignCOVID-19nonpharmacological interventionspragmatic clinical trialsrandomized clinical trialsstatistical analysis plans
Identifiers
PMID39514871
PMCPMC11548855
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