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Pragmatic trials of pain therapies: a systematic review of methods.

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Abstract

Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic trials of pain therapies to examine methods, identify common challenges, and areas for improvement. Seven databases were searched for pragmatic randomised controlled clinical trials that assessed pain treatment in a clinical population of adults reporting pain. All screening steps and data extractions were performed twice. Data were synthesised descriptively, and correlation analyses between prespecified trial features and PRECIS-2 (PRagmatic-Explanatory Continuum Indicator Summary 2) ratings and attrition were performed. Protocol registration: PROSPERO-ID CRD42020178954. Of 57 included trials, only 21% assessed pharmacological interventions, the remainder physical, surgical, psychological, or self-management pain therapies. Three-quarters of the trials were comparative effectiveness designs, often conducted in multiple centres (median: 5; Q1/3: 1, 9.25) and with a median sample size of 234 patients at randomization (Q1/3: 135.5; 363.5). Although most trials recruited patients with chronic pain, reporting of pain duration was poor and not well described. Reporting was comprehensive for most general items, while often deficient for specific pragmatic aspects. Average ratings for pragmatism were highest for treatment adherence flexibility and clinical relevance of outcome measures. They were lowest for patient recruitment methods and extent of follow-up measurements and appointments. Current practice in pragmatic trials of pain treatments can be improved in areas such as patient recruitment and reporting of methods, analysis, and interpretation of data. These improvements will facilitate translatability to other real-world settings-the purpose of pragmatic trials.

SUBMITTER: Hohenschurz-Schmidt D

PROVIDER: S-EPMC8675058 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To assess the pragmatism of published critical care randomized controlled trials self-described as pragmatic using a validated tool.Data sourcesMedical Literature Analysis and Retrieval Online database and PubMed interface from inception to November 1, 2021.Study selectionWe performed a systematic search of randomized controlled trials evaluating interventions for critically ill adults that self-identified as pragmatic in title or abstract.Data extractionReviewers independently performed study selection and data extraction in duplicate; discrepancies were resolved by consensus. Pragmatism was assessed independently in duplicate by trained reviewers using the Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2), a validated tool designed to represent how explanatory/pragmatic a trial is on the pragmatic to explanatory continuum. Trials were scored in nine domains on a 5-point continuum (from 1 = very explanatory to 5 = very pragmatic). Discrepancies of greater than 2 points were adjudicated by consensus discussion.Data synthesisThe search resulted in 284 studies; 56 met eligibility criteria. Forty-one of the trials had a discrepancy in at least one domain that required consensus discussion, most commonly in domains of eligibility and follow-up. Twelve studies (21.4%) were scored as "overall pragmatic," defined as score of greater than 4 in five domains provided the scores in the remaining domains were three. The overall PRECIS-2 score of self-identified pragmatic studies increased from 1995 to 2021 suggesting increasing pragmatism over time. Pragmatic trials were more likely to have a waiver of informed consent (p = 0.05).ConclusionsThe number and pragmatism of self-identified pragmatic trials have increased, particularly in the past decade. However, less than one-quarter of these trials that use the term pragmatic in title or abstract were retrospectively rated as pragmatic. Our results support the concept that trials are designed on a spectrum of pragmatic to explanatory. Advances in the design and reporting of critical care trials are needed to ensure their real-world applicability.

Project description:PurposeWalking and mind-body therapies (MBTs) are commonly recommended to relieve pain and improve function in patients with chronic low back pain (CLBP). The purpose of this study was to compare the effectiveness of walking and MBTs in CLBP.MethodsWe included randomized controlled trials (RCTs) comparing walking or MBTs to any other intervention or control in adults with CLBP. Studies were identified through PubMed, Cochrane Library, PsycINFO, Scopus, and ScienceDirect databases. The research was limited to studies published in English and French between January 2008 and December 2018. Two reviewers independently selected the studies, extracted data, and assessed studies quality using the Physiotherapy Evidence Database (PEDro) scale. Statistical analyses were performed under a random-effects model. We analyzed pain and activity limitation, with the calculation of standardized mean differences and 95% confidence intervals for the different treatment effects.ResultsThirty one randomized controlled trials involving 3193 participants were analyzed. Walking was as effective as control interventions in the short-term and slightly superior in the intermediate term with respect to pain (Standardized mean differences (SMD) = -0.34; 95% CI, -0.65 to -0.03; P = .03) and activity limitation (SMD = -0.30; 95% CI, -0.50 to -0.10; P = .003). In contrast, yoga was more effective than control interventions in the short term in terms of pain (SMD = -1.47; 95% CI, -2.26 to -0.68; P = .0003) and activity limitation (SMD = -1.17; 95% CI, -1.80 to -0.55; P = .0002). Yoga was no longer superior to the control interventions for pain at the 6-month follow-up.ConclusionMBTs, especially yoga, seem to be more effective in the short term, and walking seems to be more effective in the intermediate term, for the relief of pain and activity limitation in patients with CLBP. A combination of walking and MBTs fits the biopsychosocial model and might be valuable therapy for CLBP throughout follow-up due to combined effects.

Project description:Importance:Mind-body therapies (MBTs) are emerging as potential tools for addressing the opioid crisis. Knowing whether mind-body therapies may benefit patients treated with opioids for acute, procedural, and chronic pain conditions may be useful for prescribers, payers, policy makers, and patients. Objective:To evaluate the association of MBTs with pain and opioid dose reduction in a diverse adult population with clinical pain. Data Sources:For this systematic review and meta-analysis, the MEDLINE, Embase, Emcare, CINAHL, PsycINFO, and Cochrane Library databases were searched for English-language randomized clinical trials and systematic reviews from date of inception to March 2018. Search logic included (pain OR analgesia OR opioids) AND mind-body therapies. The gray literature, ClinicalTrials.gov, and relevant bibliographies were also searched. Study Selection:Randomized clinical trials that evaluated the use of MBTs for symptom management in adults also prescribed opioids for clinical pain. Data Extraction and Synthesis:Independent reviewers screened citations, extracted data, and assessed risk of bias. Meta-analyses were conducted using standardized mean differences in pain and opioid dose to obtain aggregate estimates of effect size with 95% CIs. Main Outcomes and Measures:The primary outcome was pain intensity. The secondary outcomes were opioid dose, opioid misuse, opioid craving, disability, or function. Results:Of 4212 citations reviewed, 60 reports with 6404 participants were included in the meta-analysis. Overall, MBTs were associated with pain reduction (Cohen d?=?-0.51; 95% CI, -0.76 to -0.26) and reduced opioid dose (Cohen d?=?-0.26; 95% CI, -0.44 to -0.08). Studies tested meditation (n?=?5), hypnosis (n?=?25), relaxation (n?=?14), guided imagery (n?=?7), therapeutic suggestion (n?=?6), and cognitive behavioral therapy (n?=?7) interventions. Moderate to large effect size improvements in pain outcomes were found for meditation (Cohen d?=?-0.70), hypnosis (Cohen d?=?-0.54), suggestion (Cohen d?=?-0.68), and cognitive behavioral therapy (Cohen d?=?-0.43) but not for other MBTs. Although most meditation (n?=?4 [80%]), cognitive-behavioral therapy (n?=?4 [57%]), and hypnosis (n?=?12 [63%]) studies found improved opioid-related outcomes, fewer studies of suggestion, guided imagery, and relaxation reported such improvements. Most MBT studies used active or placebo controls and were judged to be at low risk of bias. Conclusions and Relevance:The findings suggest that MBTs are associated with moderate improvements in pain and small reductions in opioid dose and may be associated with therapeutic benefits for opioid-related problems, such as opioid craving and misuse. Future studies should carefully quantify opioid dosing variables to determine the association of mind-body therapies with opioid-related outcomes.

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Pragmatic trials of pain therapies: a systematic review of methods.

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