Jill Alison Hayden

The integrity of evidence synthesis is threatened by problematic randomised controlled trials, where there are serious concerns about the trustworthiness of the data or findings. Such concerns could be due to research misconduct, including fraud, or due to honest critical errors. If these trials are not detected, they may be inadvertently included in systematic reviews and guidelines, potentially distorting their results. To resolve this problem, the INSPECT-SR (Investigating Problematic Clinical Trials in Systematic Reviews) tool has been developed to assess the trustworthiness of randomised controlled trials. This tool will help researchers to identify and exclude problematic trials from systematic reviews. This article describes the development of INSPECT-SR and presents the tool and an associated guidance document.

Background/Objectives: Sleep seems to be associated with worse low back pain (LBP) outcomes in older adults; however, studies investigating the association of objective sleep with future changes in LBP outcomes are lacking. The objectives of this study are as follows: (a) to investigate the association between objectively measured sleep with changes in clinical outcomes in older adults with LBP receiving physical therapy care and (b) to examine the cross-sectional association between sleep and pain catastrophizing. Methods: This was a prospective cohort study. We recruited older adults (≥60 years old) with chronic LBP undergoing physical therapy treatment. At baseline, we assessed participants’ sleep (actigraphy for 10–14 days), pain intensity, disability, pain catastrophizing, and covariates. After 8 weeks, we reassessed pain intensity, disability, and self-perceived recovery. We ran linear regression models and Spearman coefficient tests. Results: Fifty-eight participants were included, and 51 completed follow-up assessments (60.8% women; mean age 70.1 ± 5.6 years). We found no associations between sleep quantity and efficiency with changes in pain intensity, disability, and self-perceived recovery after 8 weeks of physical therapy care. We found a correlation between sleep fragmentation and pain catastrophizing (r = .30; 95% confidence interval: [.03, .54]). Conclusion: Objective sleep quantity and efficiency may not be associated with changes in LBP outcomes after physical therapy care in older adults. Among the sleep domains evaluated, sleep fragmentation may be the sleep domain with the strongest association with pain catastrophizing. Significance/Implications: Objectively measured sleep might not be a prognostic factor for LBP improvement in older adults. Future studies should explore the association between sleep fragmentation and pain catastrophizing.

Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. Methods and analysis The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. Ethics and dissemination The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Sleep problems are common in individuals with low back pain (LBP) and sleep restriction seems to be associated with impaired pain processing. Our objective was to investigate whether sleep is associated with future LBP outcomes (i.e. pain intensity, disability, and recovery) in adults. We conducted a systematic review of prospective cohort studies and secondary analyses of randomized controlled trials (registration—PROSPERO CRD42022370781). In December 2022, we searched the MEDLINE, Embase, CINAHL, and PsycINFO databases. Fourteen studies, totaling 19 170 participants were included. Thirteen studies were rated as having high risk of bias (QUIPS tool). We used vote-counting and meta-analysis approaches to synthesize the data. We found associations between baseline sleep with future pain intensity, recovery, and between changes in sleep with changes in pain intensity, changes in disability, and recovery. We further synthesized outcomes as “overall LBP improvement” outcomes. Baseline poor sleep was moderately associated with non-improvement in LBP in the long-very long term (OR 1.55, 95% CI: 1.39 to 1.73; three studies providing unadjusted effect sizes), and non-improvement in sleep was largely associated with non-improvement in LBP in the short-moderate term (OR 3.45, 95% CI: 2.54 to 4.69; four studies providing unadjusted effect sizes). We found no association between baseline sleep with future disability and overall LBP improvement in the short-moderate term. Therefore, sleep may be a prognostic factor for pain intensity and recovery from LBP. All findings were supported by low to very low-quality evidence. Better-conducted studies are needed to strengthen our certainty about the evidence.