Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics

Thorn, Beverly E.; Eyer, Joshua C.; Dyke, Benjamin P. Van; Torres, Calia A.; Burns, John W.; Kim, Minjung; Newman, Andrea K.; Campbell, Lisa C.; Anderson, Brian; Block, Phoebe; Bobrow, Bentley J.; Brooks, Regina; Burton, Toya T.; Cheavens, Jennifer S.; DeMonte, C.; Demonte, William; Edwards, Crystal S.; Jeong, Minjeong; Mulla, Mazheruddin M.; Penn, Terence; Smith, Laura; Tucker, Deborah H.

doi:10.7326/m17-0972

Cited by 63 publications

(61 citation statements)

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“…To investigate the compliance of the submitting authors and the journal editors with the ICMJE recommendations, the full text content of these trials publications was screened and only 2.8% (8/286) of the authors explained the reason for delayed registration of the trial—that is, registering the trial retrospectively after the enrolment of the first participant. Reasons for delayed registration were lack of awareness or error of omission in five papers, that the registration process took longer than anticipated in two papers, and that in one paper the feasibility of recruitment was to be tested before registration 6869707172737475. Appendix M provides details of this analysis.…”

Section: Resultsmentioning

confidence: 99%

“…Based on the authors’ explanations, some were committed to register their trial prospectively but the registration was not completed until during, or after, enrolment because of an extended revision process with the registry or attempts being made to validate the feasibly of recruitment before registration 6869…”

Section: Resultsmentioning

confidence: 99%

“…The ICMJE and WHO recommendations do not allow for any grace period for prospective registration (ie, a trial is considered to have been registered prospectively if it was registered after enrolment within a defined period). Based on the analysis of authors’ explanations for delayed registration, two of the eight studies emphasised that the registration occurred during the enrolment process and before the collection of any outcome data 6869. We identified four other studies that reported prospective trial registration and considered a trial registration as prospective up to two months after enrolment, and in one study even up to the date of primary endpoint ascertainment (see supplementary appendix O) 23383940.…”

Section: Discussionmentioning

confidence: 99%

“…We suspect that this eight week delay might be driven by trial record registration, revision, and ethical approvals in multisite trials. These delays are likely to be beyond the control of investigators 6880. Therefore, our findings would support the notion of perhaps including a grace period of between three weeks and two months to the existing ICMJE definition of prospective trial registration.…”

Section: Discussionmentioning

confidence: 99%

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Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Al-Durra

Nolan

Seto

et al. 2020

BMJ

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Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. Design Cross sectional analysis. Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. Results This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated. Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Al-Durra

Nolan

Seto

et al. 2020

BMJ

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“…As PCORI-funded studies continue to publish their findings, the opportunities for continued work relevant to general internal medicine and health services research are clear. Recently published findings include interventions to reduce harmful medical errors in the hospital, 6 to improve pain management 7 and address opioid overprescribing, 8 and improve emergency care for patients with chest pain. 9 JGIM has published many papers supported by PCORI funding, including original investigations of clinical interventions, 10,11 systematic reviews of key clinical topics, 12,13 and overviews of methodological approaches.…”

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confidence: 99%

The Future of the Patient-Centered Outcomes Research Institute (PCORI)

Fischer

Asch

2019

J GEN INTERN MED

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Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain

Gordon²,

et al. 2022

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IMPORTANCE Chronic back pain (CBP) is a leading cause of disability, and treatment is often ineffective. Approximately 85% of cases are primary CBP, for which peripheral etiology cannot be identified, and maintenance factors include fear, avoidance, and beliefs that pain indicates injury.OBJECTIVE To test whether a psychological treatment (pain reprocessing therapy [PRT]) aiming to shift patients' beliefs about the causes and threat value of pain provides substantial and durable pain relief from primary CBP and to investigate treatment mechanisms. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial with longitudinal functional magnetic resonance imaging (fMRI) and 1-year follow-up assessment was conducted in a university research setting from November 2017 to August 2018, with 1-year follow-up completed by November 2019. Clinical and fMRI data were analyzed from January 2019 to August 2020. The study compared PRT with an open-label placebo treatment and with usual care in a community sample. INTERVENTIONS Participants randomized to PRT participated in 1 telehealth session with a physician and 8 psychological treatment sessions over 4 weeks. Treatment aimed to help patients reconceptualize their pain as due to nondangerous brain activity rather than peripheral tissue injury, using a combination of cognitive, somatic, and exposure-based techniques. Participants randomized to placebo received an open-label subcutaneous saline injection in the back; participants randomized to usual care continued their routine, ongoing care. MAIN OUTCOMES AND MEASURES One-week mean back pain intensity score (0 to 10) at posttreatment, pain beliefs, and fMRI measures of evoked pain and resting connectivity. RESULTS At baseline, 151 adults (54% female; mean [SD] age, 41.1 [15.6] years) reported mean (SD) pain of low to moderate severity (mean [SD] pain intensity, 4.10 [1.26] of 10; mean [SD] disability, 23.34 [10.12] of 100) and mean (SD) pain duration of 10.0 (8.9) years. Large group differences in pain were observed at posttreatment, with a mean (SD) pain score of 1.18 (1.24) in the PRT group, 2.84 (1.64) in the placebo group, and 3.13 (1.45) in the usual care group. Hedges g was −1.14 for PRT vs placebo and −1.74 for PRT vs usual care (P < .001). Of 151 total participants, 33 of 50 participants (66%) randomized to PRT were pain-free or nearly pain-free at posttreatment (reporting a pain intensity score of 0 or 1 of 10), compared with 10 of 51 participants (20%) randomized to placebo and 5 of 50 participants (10%) randomized to usual care. Treatment effects were maintained at 1-year follow-up, with a mean (SD) pain score of 1.51 (1.59) in the PRT group, 2.79 (1.78) in the placebo group, and 3.00 (1.77) in the usual care group. Hedges g was −0.70 for PRT vs placebo (P = .001) and −1.05 for PRT vs usual care (P < .001) at 1-year follow-up. Longitudinal fMRI showed (1) reduced responses to evoked back pain in the anterior midcingulate and the anterior prefrontal cortex for PRT vs placebo;(2) reduced responses in the anterio...

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Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics

Abstract: Patient-Centered Outcomes Research Institute.

Cited by 63 publications

References 32 publications

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

The Future of the Patient-Centered Outcomes Research Institute (PCORI)

Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain

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