The DOI matches its Crossref record; 26 of the 27 references it cites were found in a registry or an index.
Investigating the veracity of a sample of divergent published trial data in spinal pain
Open accessAbstract
Evidence-based medicine is replete with studies assessing quality and bias, but few evaluating research integrity or trustworthiness. A recent Cochrane review of psychological interventions for chronic pain identified trials with a shared lead author with highly divergent results. We sought to systematically identify all similar trials from this author to explore their risk of bias, governance procedures, and trustworthiness. We searched OVID MEDLINE, EMBASE, CENTRAL, and PEDro from 2010 to December 22, 2021 for trials. We contacted the authors requesting details of trial registration, ethical approval, protocol, and access to the trial data for verification. We used the Cochrane risk-of-bias tool and the Cochrane Pregnancy and Childbirth group's Trustworthiness Screening Tool to guide systematic exploration of trustworthiness. Ten trials were included: 9 compared cognitive behavioural therapy and physical exercise to usual care, exercise alone, or physiotherapy and 1 compared 2 brief cognitive behavioural therapy programmes. Eight trials reported results divergent from the evidence base. Assessment of risk of bias and participant characteristics identified no substantial concerns. Responses from the lead author did not satisfactorily explain this divergence. Trustworthiness screening identified concerns about research governance, data plausibility at baseline, the results, and apparent data duplication. We discuss the findings within the context of methods for establishing the trustworthiness of research findings generally. Important concerns regarding the trustworthiness of these trials reduce our confidence in them. They should probably not be used to inform the results and conclusions of systematic reviews, in clinical training, policy documents, or any relevant instruction regarding adult chronic pain management.
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In the citing paper
“Many problematic studies appear to frequently describe perfectly sound methods [8”
From Assessing the feasibility and impact of clinical trial trustworthiness checks via an application to Cochrane Reviews: Stage 2 of the INSPECT-SR project (2025) · cites this paper as [8]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Identical numbers allocated to each group in the absence of a block approach to randomization are considered as cause for concern. 22”
From Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis (2023) · cites this paper as [22]
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“Risk of bias tools are not designed to identify problems of this nature, nor do they appear to be successful in doing so (9, 10).”
From INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials (2025) · cites this paper as [10]
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“Examples of potentially problematic trials threatening the integrity of systematic reviews can be found across a diverse range of clinical areas (3, 10, 28).”
From INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials (2025) · cites this paper as [10]
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3 retracted
Monticone, M., Ferrante, S., Rocca, B., Baiardi, P., Farra, F. D., & Foti, C. (2013) · The Clinical Journal of Pain · doi:10.1097/ajp.0b013e31827fef7e · Cited by 124
RetractedMonticone, M., Ambrosini, E., Rocca, B., Cazzaniga, D., Liquori, V., Pedrocchi, A., & Vernon, H. (2017) · Clinical Rehabilitation · doi:10.1177/0269215516651979 · Cited by 45
RetractedMonticone, M., AMBROSINI, E., Portoghese, I., & ROCCA, B. (2021) · European Journal of Physical and Rehabilitation Medicine · doi:10.23736/s1973-9087.21.06696-x · Cited by 11
RetractedFanelli, D. (2009) · PLoS ONE · doi:10.1371/journal.pone.0005738 · Cited by 1,911
Psychological therapies for the management of chronic pain (excluding headache) in adults
Williams, A. C. D. C., Eccleston, C., & Morley, S. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007407.pub3 · Cited by 1,634
Self-citationPsychological therapies for the management of chronic pain (excluding headache) in adults
Williams, A. C. D. C., Fisher, E., Hearn, L., & Eccleston, C. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007407.pub4 · Cited by 605
Self-citationMoore, R. A., Moore, O. A., Derry, S., Peloso, P. M., Gammaitoni, A. R., & Wang, H. (2010) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2009.107805 · Cited by 279
Expect analgesic failure; pursue analgesic success
Moore, A., Derry, S., Eccleston, C., & Kalso, E. (2013) · BMJ · doi:10.1136/bmj.f2690 · Cited by 271
Self-citationThe analysis of 168 randomised controlled trials to test data integrity
Carlisle, J. B. (2012) · Anaesthesia · doi:10.1111/j.1365-2044.2012.07128.x · Cited by 255
Carlisle, J. B. (2017) · Anaesthesia · doi:10.1111/anae.13938 · Cited by 229
Research works printed but not linked: 3
- Adam, 2012, Japanese PONV researcher probed in sweeping research fraud case, Anesthesiol News, 7
- Monticone, 2020, Multimodal exercises integrated with cognitive-behavioural therapy improve disability of patients with failed back surgery syndrome: a randomized controlled trial with one-year follow-up, Disabil Rehabil, 27, 1
- Smith, 2021, Time to assume that health research is fraudulent until proven otherwise?, BMJ Opin
Cited by
Sorted by citations
Weibel, S., Popp, M., Reis, S., Skoetz, N., Garner, P., & Sydenham, E. (2023) · Research Synthesis Methods · doi:10.1002/jrsm.1599 · Cited by 93
Moore, A., Fisher, E., & Eccleston, C. (2022) · British Journal of Anaesthesia · doi:10.1016/j.bja.2022.09.030 · Cited by 51
Self-citationJenkins, H. J., Corrêa, L. A., Brown, B. T., Ferreira, G. E., Nim, C. G., Aspinall, S. L., Wareham, D. M., Choi, J., Maher, C. G., & Hancock, M. J. (2025) · The Lancet Rheumatology · doi:10.1016/s2665-9913(25)00064-5 · Cited by 38
Farrell, S. F., Edmunds, D., Fletcher, J., Martine, H., Mohamed, H., Liimatainen, J., & Sterling, M. M. (2023) · PAIN Reports · doi:10.1097/pr9.0000000000001076 · Cited by 27
Bidonde, J., Fisher, E., Perrot, S., Moore, R. A., Bell, R. F., Makri, S., & Häuser, W. (2023) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2023.152248 · Cited by 27
Self-citation
Metadata
- Authors
- O'Connell, N. E., Moore, R. A., Stewart, G., Fisher, E., Hearn, L., Eccleston, C., & Williams, A. C. D. C.
- Affiliations
- Brunel University of London (GB)
- Newton Ferrers, Plymouth, United Kingdom
- Newcastle University (GB)
- University of Bath (GB)
- University of Oxford (GB)
- University College London (GB)
- Corresponding author
- O'Connell, Neil E.
- ORCID
- Venue
- Pain
- Published
- 2022-04-25
- Volume
- 164
- Issue
- 1
- Pages
- 72-83
- ISSN
- 0304-3959 (ISSN-L)
- 1872-6623
- OpenAlex
- W4224309368
- Cited by
- 36
- References
- 27
- Citations by year
- 2026: 1 · 2025: 11 · 2024: 8 · 2023: 10 · 2022: 6
- FWCI
- 5.29
- Type
- journal article
- Language
- en
- Open access
- green
- discovery.ucl.ac.uk
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Brunel University Research Archive (BURA) (Brunel University London) (submittedVersion, cc-by-nc)
- Pure (University of Bath) (submittedVersion, other-oa)
- Funders
- Versus Arthritis
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Education › Academic integrity and plagiarism
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Keywords
- research integrity, trustworthiness, research governance, data duplication, risk of bias, cognitive behavioral therapy, chronic pain, spinal pain, clinical trial registration
- MeSH terms
- Systematic Reviews as Topic, Adult, Cognition, Female, Humans, Pilot Projects, Pregnancy, Cognitive Behavioral Therapy, Neck Pain, Chronic Pain
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