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4. A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols

Author

Schönenberger, Christof Manuel, Griessbach, Alexandra, Taji Heravi, Ala, Gryaznov, Dmitry, Gloy, Viktoria L., Lohner, Szimonetta, Klatte, Katharina, Ghosh, Nilabh, Lee, Hopin, Mansouri, Anita, Marian, Ioana R., Saccilotto, Ramon, Nury, Edris, Busse, Jason W., von Niederhäusern, Belinda, Mertz, Dominik, Blümle, Anette, Odutayo, Ayodele, Hopewell, Sally, Speich, Benjamin, and Briel, Matthias

Published
2022
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18. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis – a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis

Author

Stanton, Tasha R., Braithwaite, Felicity A., Butler, David, Moseley, G. Lorimer, Hill, Catherine, Milte, Rachel, Ratcliffe, Julie, Maher, Carol, Tomkins-Lane, Christy, Pulling, Brian W., MacIntyre, Erin, Esterman, Adrian, Stanford, Ty, Lee, Hopin, Fraysse, Francois, Metcalf, Ben, Mouatt, Brendan, and Bennell, Kim

Published
2021
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23. Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Author

Hansford, Harrison J., primary, Cashin, Aidan G., additional, Jones, Matthew D., additional, Swanson, Sonja A., additional, Islam, Nazrul, additional, Douglas, Susan R. G., additional, Rizzo, Rodrigo R. N., additional, Devonshire, Jack J., additional, Williams, Sam A., additional, Dahabreh, Issa J., additional, Dickerman, Barbra A., additional, Egger, Matthias, additional, Garcia-Albeniz, Xabier, additional, Golub, Robert M., additional, Lodi, Sara, additional, Moreno-Betancur, Margarita, additional, Pearson, Sallie-Anne, additional, Schneeweiss, Sebastian, additional, Sterne, Jonathan A. C., additional, Sharp, Melissa K., additional, Stuart, Elizabeth A., additional, Hernán, Miguel A., additional, Lee, Hopin, additional, and McAuley, James H., additional

Published
2023
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24. Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Author

Hansford, Harrison J, primary, Cashin, Aidan G, additional, Jones, Matthew D, additional, Swanson, Sonja A, additional, Islam, Nazrul, additional, Dahabreh, Issa J, additional, Dickerman, Barbra A, additional, Egger, Matthias, additional, Garcia-Albeniz, Xavier, additional, Golub, Robert M, additional, Lodi, Sara, additional, Moreno-Betancur, Margarita, additional, Pearson, Sallie-Anne, additional, Schneeweiss, Sebastian, additional, Sterne, Jonathan, additional, Sharp, Melissa K, additional, Stuart, Elizabeth A, additional, Hernan, Miguel A, additional, Lee, Hopin, additional, and McAuley, James H, additional

Published
2023
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25. Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

Author

Speich, Benjamin, Gryaznov, Dmitry, Busse, Jason W., Gloy, Viktoria L., Lohner, Szimonetta, Klatte, Katharina, Taji Heravi, Ala, Ghosh, Nilabh, Lee, Hopin, Mansouri, Anita, Marian, Ioana R., Saccilotto, Ramon, Nury, Edris, Kasenda, Benjamin, Ojeda-Ruiz, Elena, Schandelmaier, Stefan, Tomonaga, Yuki, Amstutz, Alain, Pauli-Magnus, Christiane, Bischoff, Karin, Wollmann, Katharina, Rehner, Laura, Meerpohl, Joerg J., Nordmann, Alain, Wong, Jacqueline, Chow, Ngai, Hong, Patrick Jiho, Mc Cord - De Iaco, Kimberly, Sricharoenchai, Sirintip, Agarwal, Arnav, Schwenkglenks, Matthias, Hemkens, Lars G., von Elm, Erik, Copsey, Bethan, Griessbach, Alexandra N., Schönenberger, Christof, Mertz, Dominik, Blümle, Anette, von Niederhäusern, Belinda, Hopewell, Sally, Odutayo, Ayodele, and Briel, Matthias

Subjects
Medical research -- Methods -- Management, Medicine, Experimental -- Methods -- Management, Clinical trials -- Methods -- Management -- Statistics, Company business management, Biological sciences
Abstract

Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. Conclusions We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research., Author(s): Benjamin Speich 1,2,*, Dmitry Gryaznov 1, Jason W. Busse 3,4, Viktoria L. Gloy 1, Szimonetta Lohner 5,6, Katharina Klatte 7, Ala Taji Heravi 1,8, Nilabh Ghosh 1, Hopin Lee [...]

Published
2022
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28. Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation

Author

Fioratti, Iuri, Saragiotto, Bruno T., Reis, Felipe J. J., Miyamoto, Gisela C., Lee, Hopin, Yamato, Tiê P., Fandim, Junior V., Dear, Blake, Maher, Chris G., and Costa, Leonardo O. P.

Published
2020
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30. Mechanisms of education and graded sensorimotor retraining in people with chronic low back pain: a mediation analysis.

Author

Cashin, Aidan G., Lee, Hopin, Wand, Benedict M., Bagg, Matthew K., O’Hagan, Edel T., Rizzo, Rodrigo R. N., Stanton, Tasha R., Moseley, G. Lorimer, and McAuley, James H.

Subjects
*CHRONIC pain, *CONTROL (Psychology), *PAIN catastrophizing, *ATTENTION control, *PAIN management, *BACKACHE
Abstract

An improved understanding of the biopsychosocial influences that contribute to and maintain pain has promoted the development of new efficacious treatments for chronic low back pain (CLBP). This study aimed to investigate the mechanisms of a new treatment—education and graded sensorimotor retraining—on pain and disability. We conducted a preplanned causal mediation analysis of a randomized clinical trial which allocated 276 participants with CLBP to 12 weekly clinical sessions of education and graded sensorimotor retraining (n = 138) or a sham and attention control (n = 138). Outcomes were pain intensity and disability, both assessed at 18 weeks. Hypothesized mediators included tactile acuity, motor coordination, back self-perception, beliefs about the consequences of back pain, kinesiophobia, pain self-efficacy, and pain catastrophizing, all assessed at the end of treatment (12 weeks). Four of 7 mechanisms (57%) mediated the intervention effect on pain; the largest mediated effects were for beliefs about back pain consequences (−0.96 [−1.47 to −0.64]), pain catastrophizing (−0.49 [−0.61 to −0.24]), and pain self-efficacy (−0.37 [−0.66 to −0.22]). Five of 7 mechanisms (71%) mediated the intervention effect on disability; the largest mediated effects were for beliefs about back pain consequences (−1.66 [−2.62 to −0.87]), pain catastrophizing (−1.06 [−1.79 to −0.53]), and pain self-efficacy (−0.84 [−1.89 to −0.45]). When all 7 mechanisms were considered simultaneously, the joint mediation effect explained most of the intervention effect for both pain and disability. Optimizing interventions to target beliefs about the consequences of back pain, pain catastrophizing, and pain self-efficacy is likely to lead to improved outcomes for people with CLBP. [ABSTRACT FROM AUTHOR]

Published
2023
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33. Mechanisms of vocational interventions for return to work from musculoskeletal conditions: a mediation analysis of the MI-NAV trial

Author

Cashin, Aidan G, primary, Øiestad, Britt Elin, additional, Aanesen, Fiona, additional, Storheim, Kjersti, additional, Tingulstad, Alexander, additional, Rysstad, Tarjei Langseth, additional, Lee, Hopin, additional, McAuley, James H, additional, Sowden, Gail, additional, Wynne-Jones, Gwenllian, additional, Tveter, Anne Therese, additional, and Grotle, Margreth, additional

Published
2023
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34. Pharmacological treatments for low back pain in adults: an overview of Cochrane Reviews

Author

Cashin, Aidan G., Wand, Benedict M., O'Connell, Neil E., Lee, Hopin, Rizzo, Rodrigo R.N., Bagg, Matthew K., O'Hagan, Edel, Maher, Christopher G., Furlan, Andrea D., van Tulder, Maurits W., McAuley, James H., Cashin, Aidan G., Wand, Benedict M., O'Connell, Neil E., Lee, Hopin, Rizzo, Rodrigo R.N., Bagg, Matthew K., O'Hagan, Edel, Maher, Christopher G., Furlan, Andrea D., van Tulder, Maurits W., and McAuley, James H.

Abstract

BACKGROUND: Pharmacological interventions are the most used treatment for low back pain (LBP). Use of evidence from systematic reviews of the effects of pharmacological interventions for LBP published in the Cochrane Library, is limited by lack of a comprehensive overview.OBJECTIVES: To summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non-specific LBP.METHODS: The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non-specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.MAIN RESULTS: Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There is high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub-acute LBP and five reviews included participants with chronic LBP. Acute LBP Paracetamol There was high-certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI -0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33). NSAIDs There was moderate-certainty

Published
2023
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40. Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study

Author

Gardener, Antoni D., Hick, Ellen J., Jacklin, Chloe, Tan, Gifford, Cashin, Aidan G., Lee, Hopin, Nunan, David, Toomey, Elaine, and Richards, Georgia C.

Subjects
42 Health sciences, public health, statistics and research methods, Health sciences, epidemiology, NON-CLINICAL, journalology, FOS: Health sciences
Abstract

Objectives To audit the transparent and open science standards ofhealth and medical sciences journal policies and explore the impact of the COVID-19 pandemic. Design Repeat cross-sectional study. Setting 19 journals listed in Google Scholar’s Top Publications for health and medical sciences. Participants Blood, Cell, Circulation, European Heart Journal, Gastroenterology, Journal of Clinical Oncology, Journal of the American College of Cardiology, Nature Genetics, Nature Medicine, Nature Neuroscience, Neuron, PLoS ONE, Proceedings of the National Academy of Sciences, Science Translational Medicine, The British Medical Journal, The Journal of the American Medical Association, The Lancet, The Lancet Oncology, and The New England Journal of Medicine Main outcome measures We used the Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) to evaluate journals standards. Results TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2–12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4–12) in May 2021, but overall, scores were very low at both time points. Journal policies scored highest for their adherence to data transparency and scored lowest for preregistration of study protocols and analysis plans and the submission of replication studies. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n = 16) and during (95%; n = 18) the COVID-19 pandemic. Conclusions The COVID-19 pandemic has highlighted the importance of practising open science. However, requirements for open science practices in audited policies were overall low, which may impede progress in health and medical research. As key stakeholders in disseminating research, journals should promote a research culture of greater transparency and more robust open science practices.

Published
2023
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41. Supplementary Tables from Estimating the effect of COVID-19 on trial design characteristics: a registered report

Author

Smith, James A., DeVito, Nicholas, Lee, Hopin, Tiplady, Catherine, Abhari, Roxanna E., and Kartsonaki, Christiana

Abstract

There have been reports of poor-quality research during the COVID-19 pandemic. This registered report assessed design characteristics of registered clinical trials for COVID-19 compared to non-COVID-19 trials to empirically explore the design of clinical research during a pandemic and how it compares to research conducted in non-pandemic times. We did a retrospective cohort study with a 1 : 1 ratio of interventional COVID-19 registrations to non-COVID-19 registrations, with four trial design outcomes: use of control arm, randomization, blinding and prospective registration. Logistic regression was used to estimate the odds ratio of investigating COVID-19 versus not COVID-19 and estimate direct and total effects of investigating COVID-19 for each outcome. The primary analysis showed a positive direct and total effect of COVID-19 on the use of control arms and randomization. It showed a negative direct effect of COVID-19 on blinding but no evidence of a total effect. There was no evidence of an effect on prospective registration. Taken together with secondary and sensitivity analyses, our findings are inconclusive but point towards a higher prevalence of key design characteristics in COVID-19 trials versus controls. The findings do not support much existing COVID-19 research quality literature, which generally suggests that COVID-19 led to a reduction in quality. Limitations included some data quality issues, minor deviations from the pre-registered plan and the fact that trial registrations were analysed which may not accurately reflect study design and conduct. Following in-principle acceptance, the approved stage 1 version of this manuscript was pre-registered on the Open Science Framework at https://doi.org/10.17605/OSF.IO/5YAEB. This pre-registration was performed prior to data analysis.

Published
2023
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42. Mediation analysis of the Healthy Lifestyle Program (HeLP) for low back pain study

Author

Gleadhill, Connor, Davidson, Simon, Cashin, Aidan, Kamper, Steven, Robson, Emma, da Silva, Priscilla, Lee, Hopin, McAuley, James, and Williams, Christopher

Subjects
Randomised controlled trial, Mediation analysis, Low back pain, Lifestyle factors, Causal inference
Abstract

This is a mediation analysis statistical plan for the HeLP for low back pain study.

Published
2022
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50. Transparency and open science standards in the policies of medical and health science journals

Author

Lee, Hopin, Richards, Georgia, Nunan, David, Gardener, Antoni, Tan, Yi, Hick, Ellie, and Jacklin, Chloe

Subjects
ComputingMilieux_COMPUTERSANDEDUCATION, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

An evaluation of the policies of health and medical science journals with respect to transparency and open science standards

Published
2022
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