Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially prompt collaboration. Evidence documenting the existence of selective reporting and excessive duplication of reviews on the same or similar topics is accumulating and many calls have been made in support of the documentation and public availability of review protocols. Several efforts have emerged in recent years to rectify these problems, including development of an international register for prospective reviews (PROSPERO) and launch of the first open access journal dedicated to the exclusive publication of systematic review products, including protocols (BioMed Central's Systematic Reviews). Furthering these efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international group of experts has created a guideline to improve the transparency, accuracy, completeness, and frequency of documented systematic review and meta-analysis protocols--PRISMA-P (for protocols) 2015. The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol.This PRISMA-P 2015 Explanation and Elaboration paper provides readers with a full understanding of and evidence about the necessity of each item as well as a model example from an existing published protocol. This paper should be read together with the PRISMA-P 2015 statement. Systematic review authors and assessors are strongly encouraged to make use of PRISMA-P when drafting and appraising review protocols.

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Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.

Importance Primary care clinicians find managing chronic pain challenging. Evidence of long-term efficacy of opioids for chronic pain is limited. Opioid use is associated with serious risks, including opioid use disorder and overdose. Objective To provide recommendations about opioid prescribing for primary care clinicians treating adult patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care. Process The Centers for Disease Control and Prevention (CDC) updated a 2014 systematic review on effectiveness and risks of opioids and conducted a supplemental review on benefits and harms, values and preferences, and costs. CDC used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to assess evidence type and determine the recommendation category. Evidence Synthesis Evidence consisted of observational studies or randomized clinical trials with notable limitations, characterized as low quality using GRADE methodology. Meta-analysis was not attempted due to the limited number of studies, variability in study designs and clinical heterogeneity, and methodological shortcomings of studies. No study evaluated long-term (≥1 year) benefit of opioids for chronic pain. Opioids were associated with increased risks, including opioid use disorder, overdose, and death, with dose-dependent effects. Recommendations There are 12 recommendations. Of primary importance, nonopioid therapy is preferred for treatment of chronic pain. Opioids should be used only when benefits for pain and function are expected to outweigh risks. Before starting opioids, clinicians should establish treatment goals with patients and consider how opioids will be discontinued if benefits do not outweigh risks. When opioids are used, clinicians should prescribe the lowest effective dosage, carefully reassess benefits and risks when considering increasing dosage to 50 morphine milligram equivalents or more per day, and avoid concurrent opioids and benzodiazepines whenever possible. Clinicians should evaluate benefits and harms of continued opioid therapy with patients every 3 months or more frequently and review prescription drug monitoring program data, when available, for high-risk combinations or dosages. For patients with opioid use disorder, clinicians should offer or arrange evidence-based treatment, such as medication-assisted treatment with buprenorphine or methadone. Conclusions and Relevance The guideline is intended to improve communication about benefits and risks of opioids for chronic pain, improve safety and effectiveness of pain treatment, and reduce risks associated with long-term opioid therapy.

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CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016

Dementia prevention, intervention, and care

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CDC guideline for prescribing opioids for chronic pain

The TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) Statement includes a 22-item checklist, which aims to improve the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. This explanation and elaboration document describes the rationale; clarifies the meaning of each item; and discusses why transparent reporting is important, with a view to assessing risk of bias and clinical usefulness of the prediction model. Each checklist item of the TRIPOD Statement is explained in detail and accompanied by published examples of good reporting. The document also provides a valuable reference of issues to consider when designing, conducting, and analyzing prediction model studies. To aid the editorial process and help peer reviewers and, ultimately, readers and systematic reviewers of prediction model studies, it is recommended that authors include a completed checklist in their submission. The TRIPOD checklist can also be downloaded from www.tripod-statement.org.

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Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration.

Previous work has identified 6 important areas to consider when evaluating validity and bias in studies of prognostic factors: participation, attrition, prognostic factor measurement, confounding measurement and account, outcome measurement, and analysis and reporting. This article describes the Quality In Prognosis Studies tool, which includes questions related to these areas that can inform judgments of risk of bias in prognostic research.A working group comprising epidemiologists, statisticians, and clinicians developed the tool as they considered prognosis studies of low back pain. Forty-three groups reviewing studies addressing prognosis in other topic areas used the tool and provided feedback. Most reviewers (74%) reported that reaching consensus on judgments was easy. Median completion time per study was 20 minutes; interrater agreement (κ statistic) reported by 9 review teams varied from 0.56 to 0.82 (median, 0.75). Some reviewers reported challenges making judgments across prompting items, which were addressed by providing comprehensive guidance and examples. The refined Quality In Prognosis Studies tool may be useful to assess the risk of bias in studies of prognostic factors.

Assessing Bias in Studies of Prognostic Factors

In examining how researchers assess the quality of individual studies in systematic reviews about prognosis, the authors found that appraisal of the quality of the article, a necessary step in syst...

Evaluation of the quality of prognosis studies in systematic reviews.

Objective To determine the empirical evidence for deficits in working memory (WM) processes in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Method Exploratory meta-analytic procedures were used to investigate whether children with ADHD exhibit WM impairments. Twenty-six empirical research studies published from 1997 to December, 2003 (subsequent to a previous review) met our inclusion criteria. WM measures were categorized according to both modality (verbal, spatial) and type of processing required (storage versus storage/manipulation). Results Children with ADHD exhibited deficits in multiple components of WM that were independent of comorbidity with language learning disorders and weaknesses in general intellectual ability. Overall effect sizes for spatial storage (effect size=0.85, CI=0.62 − 1.08) and spatial central executive WM (effect size=1.06, confidence interval=0.72-1.39) were greater than those obtained for verbal storage (effect size=0.47, confidence interval=0.36-0.59) and verbal central executive WM (effect size=0.43, confidence interval=0.24-0.62). Conclusion: Evidence of WM impairments in children with ADHD supports recent theoretical models implicating WM processes in ADHD. Future research is needed to more clearly delineate the nature, severity, and specificity of the impairments to ADHD.

A Meta-Analysis of Working Memory Impairments in Children With Attention-Deficit/Hyperactivity Disorder

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

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Prognosis Research Strategy (PROGRESS) 3: prognostic model research.

Background
Exercise therapy is widely used as an intervention in low-back pain.

Objectives
To evaluate the effectiveness of exercise therapy in adult non-specific acute, subacute and chronic low-back pain versus no treatment and other conservative treatments.

Search methods
The Cochrane Central Register of Controlled Trials (Issue 3, 2004), MEDLINE, EMBASE, PsychInfo, CINAHL databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews.

Selection criteria
Randomized controlled trials evaluating exercise therapy for adult non-specific low-back pain and measuring pain, function, return-to-work/absenteeism, and/or global improvement outcomes.

Data collection and analysis
Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short, intermediate, and long-term follow-up.

Main results
Sixty-one randomized controlled trials (6390 participants) met inclusion criteria: acute (11), subacute (6) and chronic (43) low-back pain (1 unclear). Evidence was found of effectiveness in chronic populations relative to comparisons at all follow-up periods; pooled mean improvement was 7.3 points (95% CI, 3.7 to 10.9) for pain (out of 100), 2.5 points (1.0 to 3.9) for function (out of 100) at earliest follow-up. In studies investigating patients (i.e. presenting to healthcare providers) mean improvement was 13.3 points (5.5 to 21.1) for pain, 6.9 (2.2 to 11.7) for function, representing significantly greater improvement over studies where participants included those recruited from a general population (e.g. with advertisements). There is some evidence of effectiveness of graded-activity exercise program in subacute low-back pain in occupational settings, though the evidence for other types of exercise therapy in other populations is inconsistent. There was evidence of equal effectiveness relative to comparisons in acute populations [pain: 0.03 points (95% CI, -1.3 to 1.4)].

Limitations: This review largely reflects limitations of the literature, including low quality studies with heterogeneous outcome measures, inconsistent and poor reporting, and possibility of publication bias.

Authors' conclusions
Exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low-back pain, particularly in healthcare populations. In subacute low-back pain there is some evidence that a graded activity program improves absenteeism outcomes, though evidence for other types of exercise is unclear. In acute low-back pain, exercise therapy is as effective as either no treatment or other conservative treatments.

Jill A. Hayden

Papers

Assessing Bias in Studies of Prognostic Factors

Evaluation of the quality of prognosis studies in systematic reviews.

A Meta-Analysis of Working Memory Impairments in Children With Attention-Deficit/Hyperactivity Disorder

Prognosis Research Strategy (PROGRESS) 3: prognostic model research.

Exercise therapy for treatment of non-specific low back pain.