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Prognostic models are abundant in the medical literature yet their use in practice seems limited. In this article, the third in the PROGRESS series, the authors review how such models are developed and validated, and then address how prognostic models are assessed for their impact on practice and patient outcomes, illustrating these ideas with examples.

Prognostic factor research aims to identify factors associated with subsequent clinical outcome in people with a particular disease or health condition. In this article, the second in the PROGRESS series, the authors discuss the role of prognostic factors in current clinical practice, randomised trials, and developing new interventions, and explain why and how prognostic factor research should be improved.

Background In order to address the opioid crisis in North America, many regions have adopted preventative strategies, such as prescription drug monitoring programs (PDMPs). PDMPs aim to increase patient safety by certifying that opioids are prescribed in appropriate quantities. We aimed to synthesize the literature on changes in opioid-related harms and consequences, an important measure of PDMP effectiveness. Methods We completed a systematic review. We conducted a narrative synthesis of opioid-related harms and consequences from PDMP implementation. Outcomes were grouped into categories by theme: opioid dependence, opioid-related care outcomes, opioid-related adverse events, and opioid-related legal and crime outcomes. Results We included a total of 22 studies (49 PDMPs) in our review. Two studies reported on illicit and problematic use but found no significant associations with PDMP status. Eight studies examined the association between PDMP status and opioid-related care outcomes, of which two found that treatment admissions for prescriptions opioids were lower in states with PDMP programs ( p  < 0.05). Of the thirteen studies that reported on opioid-related adverse events, two found significant ( p  < 0.001 and p < 0.05) but conflicting results with one finding a decrease in opioid-related overdose deaths after PDMP implementation and the other an increase. Lastly, two studies found no statistically significant association between PDMP status and opioid-related legal and crime outcomes (crime rates, identification of potential dealers, and diversion). Conclusion Our study found limited evidence to support overall associations between PDMPs and reductions in opioid-related consequences. However, this should not detract from the value of PDMPs’ larger role of improving opioid prescribing.

Background Adoption of low back pain guidelines is a well-documented problem. Information to guide the development of behaviour change interventions is needed. The review is the first to synthesise the evidence regarding physicians’ barriers to providing evidence-based care for LBP using the Theoretical Domains Framework (TDF). Using the TDF allowed us to map specific physician-reported barriers to individual guideline recommendations. Therefore, the results can provide direction to future interventions to increase physician compliance with evidence-based care for LBP. Methods We searched the literature for qualitative studies from inception to July 2018. Two authors independently screened titles, abstracts, and full texts for eligibility and extracted data on study characteristics, reporting quality, and methodological rigour. Guided by a TDF coding manual, two reviewers independently coded the individual study themes using NVivo. After coding, we assessed confidence in the findings using the GRADE-CERQual approach. Results Fourteen studies ( n  = 318 physicians) from 9 countries reported barriers to adopting one of the 5 guideline-recommended behaviours regarding in-clinic diagnostic assessments (9 studies, n  = 198), advice on activity (7 studies, n  = 194), medication prescription (2 studies, n  = 39), imaging referrals (11 studies, n  = 270), and treatment/specialist referrals (8 studies, n  = 193). Imaging behaviour is influenced by (1) social influence — fr om patients requesting an image or wanting a diagnosis ( n  = 252, 9 studies), (2) beliefs about consequence— physicians believe that providing a scan will reassure patients ( n  = 175, 6 studies), and (3) environmental context and resources— physicians report a lack of time to have a conversation with patients about diagnosis and why a scan is not needed ( n  = 179, 6 studies). Referrals to conservative care is influenced by environmental context and resources —long wait-times or a complete lack of access to adjunct services prevented physicians from referring to these services ( n  = 82, 5 studies). Conclusions Physicians face numerous barriers to providing evidence-based LBP care which we have mapped onto 7 TDF domains. Two to five TDF domains are involved in determining physician behaviour, confirming the complexity of this problem. This is important as interventions often target a single domain where multiple domains are involved. Interventions designed to address all the domains involved while considering context-specific factors may prove most successful in increasing guideline adoption. Registration PROSPERO 2017, CRD42017070703

Theory is often recommended as a framework for guiding hypothesized mechanisms of treatment effect. However, there is limited guidance about how to use theory in intervention development. We conducted a systematic review to provide an exemplar review evaluating the extent to which use of theory is identified and incorporated within existing interventions. We searched electronic databases PubMed, PsycINFO, CENTRAL, and EMBASE from inception to May 2014. We searched clinicaltrials.gov for registered protocols, reference lists of relevant systematic reviews and included studies, and conducted a citation search in Web of Science. We included peer-reviewed publications of interventions that referenced the social cognitive theory of self-regulation as a framework for interventions to manage chronic health conditions. Two reviewers independently assessed articles for eligibility. We contacted all authors of included studies for information detailing intervention content. We describe how often theory mechanisms were addressed by interventions, and report intervention characteristics used to address theory. Of 202 articles that reported using the social cognitive theory of self-regulation, 52% failed to incorporate self-monitoring, a main theory component, and were therefore excluded. We included 35 interventions that adequately used the theory framework. Intervention characteristics were often poorly reported in peer-reviewed publications, 21 of 35 interventions incorporated characteristics that addressed each of the main theory components. Each intervention addressed, on average, six of eight self-monitoring mechanisms, two of five self-judgement mechanisms, and one of three self-evaluation mechanisms. The self-monitoring mechanisms 'Feedback' and 'Consistency' were addressed by all interventions, whereas the self-evaluation mechanisms 'Self-incentives' and 'External rewards' were addressed by six and four interventions, respectively. The present review establishes that systematic review is a feasible method of identifying use of theory as a conceptual framework for existing interventions. We identified the social cognitive theory of self-regulation as a feasible framework to guide intervention development for chronic health conditions.

Objective: This study retroactively investigated the search methods used in the 2019 Hayden et al. study, one of the first systematic reviews of prognostic factors that was published in the Cochrane Library. The review was designed to address recognized weaknesses in reviews of prognosis by using multiple supplementary search methods in addition to traditional electronic database searching.Methods: The authors used four approaches to comprehensively assess aspects of systematic review literature searching for prognostic factor studies: (1) comparison of search recall of broad versus focused electronic search strategies, (2) linking of search methods of origin for eligible studies, (3) analysis of impact of supplementary search methods on meta-analysis conclusions, and (4) analysis of prognosis filter performance.Results: The review’s focused electronic search strategy resulted in a 91% reduction in recall, compared to a broader version. Had the team relied on the focused search strategy without using supplementary search methods, they would have missed 23 of 58 eligible studies that were indexed in MEDLINE; additionally, the number of included studies in 2 of the review’s primary outcome meta-analyses would have changed. Using a broader strategy without supplementary searches would still have missed 5 studies. The prognosis filter used in the review demonstrated the highest sensitivity of any of the filters tested.Conclusions: Our study results support recommendations for supplementary search methods made by prominent systematic review methodologists. Leaving out any supplemental search methods would have resulted in missed studies, and these omissions would not have been prevented by using a broader search strategy or any of the other prognosis filters tested.

Exercise therapy encompasses a heterogeneous group of interventions. There continues to be uncertainty about the most effective exercise approach in chronic low back pain. To identify particular exercise intervention characteristics that decrease pain and improve function in adults with nonspecific chronic low back pain. MEDLINE, EMBASE, PsychInfo, CINAHL, and Cochrane Library databases to October 2004 and citation searches and bibliographic reviews of previous systematic reviews. Randomized, controlled trials evaluating exercise therapy in populations with chronic (>12 weeks duration) low back pain. Two reviewers independently extracted data on exercise intervention characteristics: program design (individually designed or standard program), delivery type (independent home exercises, group, or individual supervision), dose or intensity (hours of intervention time), and inclusion of additional conservative interventions. 43 trials of 72 exercise treatment and 31 comparison groups were included. Bayesian multivariable random-effects meta-regression found improved pain scores for individually designed programs (5.4 points [95% credible interval (CrI), 1.3 to 9.5 points]), supervised home exercise (6.1 points [CrI, -0.2 to 12.4 points]), group (4.8 points [CrI, 0.2 to 9.4 points]), and individually supervised programs (5.9 points [CrI, 2.1 to 9.8 points]) compared with home exercises only. High-dose exercise programs fared better than low-dose exercise programs (1.8 points [CrI, -2.1 to 5.5 points]). Interventions that included additional conservative care were better (5.1 points [CrI, 1.8 to 8.4 points]). A model including these most effective intervention characteristics would be expected to demonstrate important improvement in pain (18.1 points [CrI, 11.1 to 25.0 points] compared with no treatment and 13.0 points [CrI, 6.0 to 19.9 points] compared with other conservative treatment) and small improvement in function (5.5 points [CrI, 0.5 to 10.5 points] compared with no treatment and 2.7 points [CrI, -1.7 to 7.1 points] compared with other conservative treatment). Stretching and strengthening demonstrated the largest improvement over comparisons. Limitations of the literature, including low-quality studies with heterogeneous outcome measures and inconsistent and poor reporting; publication bias. Exercise therapy that consists of individually designed programs, including stretching or strengthening, and is delivered with supervision may improve pain and function in chronic nonspecific low back pain. Strategies should be used to encourage adherence. Future studies should test this multivariable model and further assess specific patient-level characteristics and exercise types.

To explore the relationships between the risk of bias and treatment effect estimates for exercise therapy interventions on pain intensity and physical functioning outcomes in randomized controlled trials (RCTs) involving patients with chronic low back pain. A cross-sectional meta-epidemiological study of the 230 RCTs (31,674 participants) in the 2021 ‘Exercise therapy for chronic low back pain’ Cochrane Review were included. Study design characteristics, sample size, prospective trial registration, flowchart information, interventions, and comparisons were extracted. Independent pairs of reviewers assessed the risk of bias using the Cochrane Risk of Bias 2 tool. The metaregression included 220 (pain intensity) and 203 (physical functioning) effect sizes. Unadjusted and adjusted metaregression models showed no significant associations between the bias domains and pain intensity effect sizes. Only domain ‘bias in the measurement of the outcome’ was significantly associated with physical functioning (standardized mean difference: −0.40, 95% confidence interval: −0.77 to −0.02) when adjusted for flowchart reported (yes/no), prospective trial registration, sample size, and comparator type. The risk of bias in the measurement of the outcome could lead to slight overestimates of the effect size for physical functioning. Clinicians should consider this when they read and assess RCT results in this field. We encourage metaresearchers to replicate our findings using a consistent approach for evaluating the risk of bias (i.e., the RoB 2 tool) in other musculoskeletal conditions and interventions to investigate their generalizability. •This study evaluated the risk of bias in 230 randomized controlled trials with the Cochrane Risk of Bias 2 tool.•We investigated associations between risk of bias and effect sizes of exercise therapy interventions on chronic low back pain.•The risk of bias in the outcome measurement could slight overestimate the effect size for physical functioning.•Future studies should assess whether these results generalise to other interventions and clinical conditions.

Exercise therapy is widely used as an intervention in low back pain. To evaluate the effectiveness of exercise therapy in adult nonspecific acute, subacute, and chronic low back pain versus no treatment and other conservative treatments. MEDLINE, EMBASE, PsychInfo, CINAHL, and Cochrane Library databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews. Randomized, controlled trials evaluating exercise therapy for adult nonspecific low back pain and measuring pain, function, return to work or absenteeism, and global improvement outcomes. Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short-, intermediate-, and long-term follow-up. 61 randomized, controlled trials (6390 participants) met inclusion criteria: acute (11 trials), subacute (6 trials), and chronic (43 trials) low back pain (1 trial was unclear). Evidence suggests that exercise therapy is effective in chronic back pain relative to comparisons at all follow-up periods. Pooled mean improvement (of 100 points) was 7.3 points (95% CI, 3.7 to 10.9 points) for pain and 2.5 points (CI, 1.0 to 3.9 points) for function at earliest follow-up. In studies investigating patients (people seeking care for back pain), mean improvement was 13.3 points (CI, 5.5 to 21.1 points) for pain and 6.9 points (CI, 2.2 to 11.7 points) for function, compared with studies where some participants had been recruited from a general population (for example, with advertisements). Some evidence suggests effectiveness of a graded-activity exercise program in subacute low back pain in occupational settings, although the evidence for other types of exercise therapy in other populations is inconsistent. In acute low back pain, exercise therapy and other programs were equally effective (pain, 0.03 point [CI, -1.3 to 1.4 points]). Limitations of the literature, including low-quality studies with heterogeneous outcome measures inconsistent and poor reporting, and possibility of publication bias. Exercise therapy seems to be slightly effective at decreasing pain and improving function in adults with chronic low back pain, particularly in health care populations. In subacute low back pain populations, some evidence suggests that a graded-activity program improves absenteeism outcomes, although evidence for other types of exercise is unclear. In acute low back pain populations, exercise therapy is as effective as either no treatment or other conservative treatments.

Introduction Persistent low back pain (LBP) is the leading cause of disability worldwide, and therapeutic exercise is recommended as a first-line treatment in international guidelines. The effects of exercise on clinical outcomes of pain and physical function are small to moderate, despite broader impacts on cardiovascular systems, biological health, mood, and emotional well-being. Therapeutic exercise prescription is defined as exercise that is prescribed by a clinician for a health-related treatment. It is unknown how therapeutic exercise prescription creates effects on outcomes of importance. Realist reviews explore how underlying mechanisms (M) may be active in the context (C) of certain situations, settings, or populations to create an intended or unintended outcome (O). Our objective is to explore and understand the mechanisms by which therapeutic exercise prescription changes outcomes for people with persistent LBP. Methods We will develop initial programme theories based on preliminary data from a previous systematic review and consensus workshop. These theories will be modified with input from a steering group (experts), a stakeholder group (people with lived experience of exercise for persistent LBP and clinicians), and a scoping search of the published literature. An information specialist will design and undertake an iterative search strategy. These will be used to create CMO configurations, which will be refined and tested using the literature. The realist review will be reported following RAMESES guidance. Discussion Realist reviews are uncommon in LBP research to date, yet those offer an opportunity to contrast with traditional methods of randomised controlled trials and systematic reviews and provide additional information regarding the contexts and mechanisms that may trigger certain outcomes. This can aid our understanding of the contextual features that may influence exercise prescription, such as for whom they are most effective, in what setting, how they are implemented and why. This realist synthesis will enhance our understanding of therapeutic exercise prescription to improve adherence and engagement and ultimately will provide clinically relevant recommendations regarding exercise prescription for those with persistent LBP. Systematic review registration The review has been registered with PROSPERO (CRD42017072023).