{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T15:18:28Z","timestamp":1772205508676,"version":"3.50.1"},"reference-count":41,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"unspecified","delay-in-days":26,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004543","name":"China Scholarship Council","doi-asserted-by":"publisher","award":["202108330084"],"award-info":[{"award-number":["202108330084"]}],"id":[{"id":"10.13039\/501100004543","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,11]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We planned to conduct an individual participant data meta-analysis (IPD-MA) to investigate the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) compared with placebo in patients with (sub)acute low back pain (LBP). This report describes the challenges encountered in conducting this IPD-MA and their implications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A systematic review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources<\/jats:title>\n                    <jats:p>Medline ALL, Embase and the Cochrane Central Register of Controlled Trials were searched through January 2024.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Eligibility criteria<\/jats:title>\n                    <jats:p>We included randomised clinical trials (RCTs) from the Cochrane review on NSAIDs for (sub)acute LBP and trials identified through the aforementioned data sources. We compared NSAIDs (regardless of administration route) to placebo on effectiveness outcomes. Our primary outcomes were pain intensity, physical functioning and health-related quality of life at 1-, 3- and 12-week follow-ups, with secondary outcomes including adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data extraction and synthesis<\/jats:title>\n                    <jats:p>Two independent reviewers screened and included eligible studies. Risk of bias (RoB) was assessed using the Cochrane RoB tool 2. Original authors of included RCTs were contacted based on a hierarchy: Corresponding &gt; First &gt; Last &gt; Other authors via email, social media or institution. For contributors, we requested their study protocol, codebook and IPD, and provided our data-sharing agreement and transfer protocol. One-stage IPD-MA was planned with a generalised linear mixed model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 10 RCTs. Seven authors responded, but only one author agreed to share IPD. Data were unavailable or lost due to the age of the trials, dissolution of research departments, lack of records by sponsoring companies, market withdrawal of the studied drug, or contractual restrictions on data sharing. Two RCTs had a \u2018low\u2019 overall RoB, four had \u2018some concerns\u2019 and four had \u2018high\u2019. With only one IPD set obtained, the planned IPD-MA could not be conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This IPD-MA on NSAIDs for (sub)acute LBP could not be completed due to challenges in data acquisition. In future IPD research, researchers should focus on clearer rationale, recent RCTs, improved data-sharing and storing practices.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-102349","type":"journal-article","created":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T14:40:31Z","timestamp":1772203231000},"page":"e102349","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Challenges in conducting an individual participant data meta-analysis of non-steroidal anti-inflammatory drugs for patients with (sub)acute low back pain: a systematic review and report on data availability"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9553-6518","authenticated-orcid":false,"given":"Yanyan","family":"Fu","sequence":"first","affiliation":[{"name":"Department of General Practice, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annemarie","family":"de Zoete","sequence":"additional","affiliation":[{"name":"Department of General Practice, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1054-2327","authenticated-orcid":false,"given":"Simon Dyrl\u00f8v","family":"Madsen","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1258-5125","authenticated-orcid":false,"given":"Christina","family":"Abdel Shaheed","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health, The University of Sydney School of Public Health, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bart","family":"Koes","sequence":"additional","affiliation":[{"name":"Department of General Practice, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"},{"name":"Research Unit of General Practice, Department of Public Health & Center for Muscle and Joint Health, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2350-9945","authenticated-orcid":false,"given":"Alessandro","family":"Chiarotto","sequence":"additional","affiliation":[{"name":"Department of General Practice, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,2,27]]},"reference":[{"key":"2026022706401912000_16.2.e102349.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)30480-X"},{"key":"2026022706401912000_16.2.e102349.2","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(24)00757-8"},{"key":"2026022706401912000_16.2.e102349.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00733-9"},{"key":"2026022706401912000_16.2.e102349.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32279-7"},{"key":"2026022706401912000_16.2.e102349.5","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000000351"},{"key":"2026022706401912000_16.2.e102349.6","article-title":"Low back pain (acute)","volume":"2011","author":"McIntosh","year":"2011","journal-title":"BMJ Clin Evid"},{"key":"2026022706401912000_16.2.e102349.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.jphys.2019.04.010"},{"key":"2026022706401912000_16.2.e102349.8","doi-asserted-by":"publisher","DOI":"10.1007\/s00586-018-5673-2"},{"key":"2026022706401912000_16.2.e102349.9","article-title":"Non-steroidal anti-inflammatory drugs for acute low back pain","volume":"4","author":"van der Gaag","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"key":"2026022706401912000_16.2.e102349.10","doi-asserted-by":"crossref","DOI":"10.1186\/s12874-020-00964-6","article-title":"Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide","volume":"20","author":"Ventresca","year":"2020","journal-title":"BMC Med Res Methodol"},{"key":"2026022706401912000_16.2.e102349.11","doi-asserted-by":"crossref","unstructured":"Tierney JF , Riley RD , Rydzewska LHM , et al . Running an IPD meta-analysis project. In: Individual participant data meta\u2010analysis. 2021: 45\u201380.","DOI":"10.1002\/9781119333784.ch4"},{"key":"2026022706401912000_16.2.e102349.12","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.c221","article-title":"Meta-analysis of individual participant data: rationale, conduct, and reporting","volume":"340","author":"Riley","year":"2010","journal-title":"BMJ"},{"key":"2026022706401912000_16.2.e102349.13","doi-asserted-by":"crossref","unstructured":"Riley RD , Fisher DJ . Using IPD meta-analysis to examine interactions between treatment effect and participant-level covariates. In: Individual participant data meta\u2010analysis. 2021: 163\u201398.","DOI":"10.1002\/9781119333784.ch7"},{"key":"2026022706401912000_16.2.e102349.14","doi-asserted-by":"crossref","first-page":"705","DOI":"10.1016\/j.euf.2023.10.012","article-title":"Challenges In Performing An Individual Participant-level Data Meta-analysis","volume":"9","author":"van der Worp","year":"2023","journal-title":"Eur Urol Focus"},{"key":"2026022706401912000_16.2.e102349.15","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1016\/j.jclinepi.2021.05.007","article-title":"PRIME-IPD SERIES Part 1. The PRIME-IPD tool promoted verification and standardization of study datasets retrieved for IPD meta-analysis","volume":"136","author":"Dewidar","year":"2021","journal-title":"J Clin Epidemiol"},{"key":"2026022706401912000_16.2.e102349.16","doi-asserted-by":"crossref","DOI":"10.1016\/j.mex.2024.102713","article-title":"Moderators of treatment effect of non-steroidal anti-inflammatory drugs for patients with (sub) acute low back pain: Protocol for a systematic review with individual participant data meta-analysis","volume":"12","author":"Fu","year":"2024","journal-title":"MethodsX"},{"key":"2026022706401912000_16.2.e102349.17","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.3656"},{"key":"2026022706401912000_16.2.e102349.18","doi-asserted-by":"publisher","DOI":"10.1007\/s00586-015-3892-3"},{"key":"2026022706401912000_16.2.e102349.19","first-page":"28","article-title":"Efficacy of various forms of conservative treatment in low back pain: a comparative study","volume":"6","author":"Postacchini","year":"1988","journal-title":"Neuro-Orthopedics"},{"key":"2026022706401912000_16.2.e102349.20","first-page":"204","article-title":"Parenteral dipyrone versus diclofenac and placebo in patients with acute lumbago or sciatic pain: randomized observer-blind multicenter study","volume":"32","author":"Babej-D\u00f6lle","year":"1994","journal-title":"Int J Clin Pharmacol Ther"},{"key":"2026022706401912000_16.2.e102349.21","doi-asserted-by":"crossref","first-page":"1012","DOI":"10.1097\/00007632-200205150-00003","article-title":"Continuous Low-Level Heat Wrap Therapy Provides More Efficacy Than Ibuprofen and Acetaminophen for Acute Low Back Pain","volume":"27","author":"Nadler","year":"2002","journal-title":"Spine (Phila Pa 1986)"},{"key":"2026022706401912000_16.2.e102349.22","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61686-9"},{"key":"2026022706401912000_16.2.e102349.23","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/33.1.74"},{"key":"2026022706401912000_16.2.e102349.24","doi-asserted-by":"crossref","first-page":"540","DOI":"10.1097\/BRS.0b013e318275d09c","article-title":"Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo","volume":"38","author":"von Heymann","year":"2013","journal-title":"Spine (Phila Pa 1986)"},{"key":"2026022706401912000_16.2.e102349.25","doi-asserted-by":"crossref","first-page":"375","DOI":"10.5414\/CPP41375","article-title":"Relief of acute low back pain with diclofenac-K 12.5 mg tablets: a flexible dose, ibuprofen 200 mg and placebo-controlled clinical trial","volume":"41","author":"Dreiser","year":"2003","journal-title":"Int J Clin Pharmacol Ther"},{"key":"2026022706401912000_16.2.e102349.26","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1097\/00007632-198706000-00010","article-title":"Treatment of Acute Low-back Pain with Piroxicam: Results of a Double-blind Placebo-controlled Trial","volume":"12","author":"Amlie","year":"1987","journal-title":"Spine (Phila Pa 1986)"},{"key":"2026022706401912000_16.2.e102349.27","first-page":"95","article-title":"A double blind, placebo controlled study of piroxicam in the management of acute musculoskeletal disorders","volume":"7","author":"Lacey","year":"1984","journal-title":"Eur J Rheumatol Inflamm"},{"key":"2026022706401912000_16.2.e102349.28","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1007\/s40122-020-00161-9","article-title":"Efficacy and Safety of Diclofenac\u2009+\u2009Capsaicin Gel in Patients with Acute Back\/Neck Pain: A Multicenter Randomized Controlled Study","volume":"9","author":"Predel","year":"2020","journal-title":"Pain Ther"},{"key":"2026022706401912000_16.2.e102349.29","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3165"},{"key":"2026022706401912000_16.2.e102349.30","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1007\/978-1-0716-1566-9_16","article-title":"Practical Considerations and Challenges When Conducting an Individual Participant Data (IPD) Meta-Analysis","volume":"2345","author":"Nevitt","year":"2022","journal-title":"Methods Mol Biol"},{"key":"2026022706401912000_16.2.e102349.31","doi-asserted-by":"crossref","unstructured":"Stewart LA , Riley RD , Tierney JF . Planning and initiating an IPD meta-analysis project. In: Individual participant data meta\u2010analysis. 2021: 21\u201343.","DOI":"10.1002\/9781119333784.ch3"},{"key":"2026022706401912000_16.2.e102349.32","doi-asserted-by":"publisher","DOI":"10.1177\/0163278702025001006"},{"key":"2026022706401912000_16.2.e102349.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.cub.2013.11.014"},{"key":"2026022706401912000_16.2.e102349.34","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2018.10.006"},{"key":"2026022706401912000_16.2.e102349.35","doi-asserted-by":"crossref","DOI":"10.1093\/jlb\/lsaa055","article-title":"International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an \u201cadequate\u201d level of protection","volume":"7","author":"Bradford","year":"2020","journal-title":"J Law Biosci"},{"key":"2026022706401912000_16.2.e102349.36","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pcbi.1010879","article-title":"Ten (not so) simple rules for clinical trial data-sharing","volume":"19","author":"Pellen","year":"2023","journal-title":"PLoS Comput Biol"},{"key":"2026022706401912000_16.2.e102349.37","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-021-05787-4","article-title":"Sharing individual participant data: through a systematic reviewer lens","volume":"23","author":"Rydzewska","year":"2022","journal-title":"Trials"},{"key":"2026022706401912000_16.2.e102349.38","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-019-3253-3","article-title":"Evaluation of repositories for sharing individual-participant data from clinical studies","volume":"20","author":"Banzi","year":"2019","journal-title":"Trials"},{"key":"2026022706401912000_16.2.e102349.39","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2017-018647","article-title":"Sharing and reuse of individual participant data from clinical trials: principles and recommendations","volume":"7","author":"Ohmann","year":"2017","journal-title":"BMJ Open"},{"key":"2026022706401912000_16.2.e102349.40","doi-asserted-by":"crossref","unstructured":"Eisenstein E , Zozus MN , Sanns W . Beyond EDC. J Soc Clin Data Manag 2021;1. doi:10.47912\/jscdm.33","DOI":"10.47912\/jscdm.33"},{"key":"2026022706401912000_16.2.e102349.41","doi-asserted-by":"crossref","first-page":"24","DOI":"10.29173\/iq904","article-title":"Research Data Repositories: Review of Current Features, Gap Analysis, and Recommendations for Minimum Requirements","volume":"39","author":"Austin","year":"2016","journal-title":"IQ"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-102349","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T14:40:35Z","timestamp":1772203235000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-102349"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":41,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,2,27]]},"published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1136\/bmjopen-2025-102349"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-102349","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2]]}}}