Decision makers in public health practice and policy rely on access to trustworthy, relevant, synthesized evidence. The second edition of the Cochrane Handbook for Systematic Reviews of Interventions ...('the Handbook') reflects a major revision in guidance for authors of systematic reviews, incorporating a decade of methodological development and a number of significant changes to previous recommendations. This paper aims to highlight new guidance that addresses a number of key methodological challenges for authors of systematic reviews in public health.
The revised Handbook includes guidance on framing public health research questions for synthesis, considering equity, intervention complexity, risk of bias assessment and synthesis methods other than meta-analysis. Reviews of public health interventions frequently encounter the types of methodological complexity addressed in this new guidance.
We hope that readers will find that the Cochrane Handbook includes detailed and thoughtful guidance on both conceptualizing and executing systematic reviews relevant to public health questions. Considering the available methods guidance will, we hope, provide support for authors of public health reviews to tackle the challenges they encounter, strengthen their analysis and provide useful answers to the important questions asked by stakeholders and users of public health evidence.
To examine the specification and use of summary and statistical synthesis methods, focusing on synthesis methods other than meta-analysis.
We coded the specification and use of summary and synthesis ...methods in 100 randomly sampled systematic reviews (SRs) of public health and health systems interventions published in 2018 from the Health Evidence and Health Systems Evidence databases.
Sixty of the 100 SRs used other synthesis methods for some (27/100) or all syntheses (33/100). Of these, 54/60 used vote counting: three based on direction of effect, 36 on statistical significance, and 15 were unclear. Eight SRs summarized effect estimates (for example, using medians). Seventeen SRs used the term ‘narrative synthesis’ (or equivalent) without describing methods; in practice 15 of these used vote counting. 58/100 SRs used meta-analysis. In SRs providing a rationale for not proceeding with meta-analysis, the most common reason was due to diversity in study characteristics (33/39).
Statistical synthesis methods other than meta-analysis are commonly used, but few SRs describe the methods. Improved description of methods is required to allow users to appropriately interpret findings, critique methods used and verify the results. Greater awareness of the serious limitations of vote counting based on statistical significance is required.
Social prescribing (SP) enables healthcare professionals to link patients with non-medical interventions available in the community to address underlying socioeconomic and behavioural determinants. ...We synthesised the evidence to understand the effectiveness of SP for chronic disease prevention.
A systematic literature search was conducted using five databases and two registries. Eligible studies included randomised controlled trials of SP among community-dwelling adults recruited from primary care or community setting, investigating any chronic disease risk factors defined by the WHO (behavioural factors: smoking, physical inactivity, unhealthy diet and excessive alcohol consumption; metabolic factors: raised blood pressure, overweight/obesity, hyperlipidaemia and hyperglycaemia). Random effect meta-analyses were performed at two time points: completion of intervention and follow-up after trial.
We identified nine reports from eight trials totalling 4621 participants. All studies evaluated SP exercise interventions which were highly heterogeneous regarding the content, duration, frequency and length of follow-up. Majority of studies had some concerns for risk of bias. Meta-analysis revealed that SP likely increased physical activity (completion: mean difference (MD) 21 min/week, 95% CI 3 to 39, I
=0%; follow-up ≤12 months: MD 19 min/week, 95% CI 8 to 29, I
=0%). However, SP may not improve markers of adiposity, blood pressure, glucose and serum lipid. There were no eligible studies that primarily target unhealthy diet, smoking and excessive alcohol drinking behaviours.
SP exercise interventions probably increased physical activity slightly; however, no benefits were observed for metabolic factors. Determining whether SP is effective in modifying the determinants of chronic diseases and promotes sustainable healthy behaviours is limited by the current evidence of quantification and uncertainty, warranting further rigorous studies.
CRD42022346687.
To examine the characteristics of population, intervention and outcome groups and the extent to which they were completely reported for each synthesis in a sample of systematic reviews (SRs) of ...interventions.
We coded groups that were intended (or used) for comparisons in 100 randomly sampled SRs of public health and health systems interventions published in 2018 from the Health Evidence and Health Systems Evidence databases.
Authors commonly used population, intervention and outcome groups to structure comparisons, but these groups were often incompletely reported. For example, of 41 SRs that identified and/or used intervention groups for comparisons, 29 (71%) identified the groups in their methods description before reporting of the results (e.g., in the Background or Methods), 12 (29%) defined the groups in enough detail to replicate decisions about which included studies were eligible for each synthesis, 6 (15%) provided a rationale, and 24 (59%) stated that the groups would be used for comparisons. Sixteen (39%) SRs used intervention groups in their synthesis without any mention in the methods. Reporting for population, outcome and methodological groups was similarly incomplete.
Complete reporting of the groups used for synthesis would improve transparency and replicability of reviews, and help ensure that the synthesis is not driven by what is reported in the included studies. Although concerted effort is needed to improve reporting, this should lead to more focused and useful reviews for decision-makers.
Background
The World Health Organization (WHO) recommends undertaking 150 minutes of moderate‐intensity physical activity per week, but most people do not. Workplaces present opportunities to ...influence behaviour and encourage physical activity, as well as other aspects of a healthy lifestyle. A pedometer is an inexpensive device that encourages physical activity by providing feedback on daily steps, although pedometers are now being largely replaced by more sophisticated devices such as accelerometers and Smartphone apps. For this reason, this is the final update of this review.
Objectives
To assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving long‐term health outcomes.
Search methods
We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Occupational Safety and Health (OSH) UPDATE, Web of Science, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform from the earliest record to December 2016. We also consulted the reference lists of included studies and contacted study authors to identify additional records. We updated this search in May 2019, but these results have not yet been incorporated. One more study, previously identified as an ongoing study, was placed in 'Studies awaiting classification'.
Selection criteria
We included randomised controlled trials (RCTs) of workplace interventions with a pedometer component for employed adults, compared to no or minimal interventions, or to alternative physical activity interventions. We excluded athletes and interventions using accelerometers. The primary outcome was physical activity. Studies were excluded if physical activity was not measured.
Data collection and analysis
We used standard methodological procedures expected by Cochrane. When studies presented more than one physical activity measure, we used a pre‐specified list of preferred measures to select one measure and up to three time points for analysis. When possible, follow‐up measures were taken after completion of the intervention to identify lasting effects once the intervention had ceased. Given the diversity of measures found, we used ratios of means (RoMs) as standardised effect measures for physical activity.
Main results
We included 14 studies, recruiting a total of 4762 participants. These studies were conducted in various high‐income countries and in diverse workplaces (from offices to physical workplaces). Participants included both healthy populations and those at risk of chronic disease (e.g. through inactivity or overweight), with a mean age of 41 years. All studies used multi‐component health promotion interventions. Eleven studies used minimal intervention controls, and four used alternative physical activity interventions. Intervention duration ranged from one week to two years, and follow‐up after completion of the intervention ranged from three to ten months.
Most studies and outcomes were rated at overall unclear or high risk of bias, and only one study was rated at low risk of bias. The most frequent concerns were absence of blinding and high rates of attrition.
When pedometer interventions are compared to minimal interventions at follow‐up points at least one month after completion of the intervention, pedometers may have no effect on physical activity (6 studies; very low‐certainty evidence; no meta‐analysis due to very high heterogeneity), but the effect is very uncertain. Pedometers may have effects on sedentary behaviour and on quality of life (mental health component), but these effects were very uncertain (1 study; very low‐certainty evidence).
Pedometer interventions may slightly reduce anthropometry (body mass index (BMI) ‐0.64, 95% confidence interval (CI) ‐1.45 to 0.18; 3 studies; low‐certainty evidence). Pedometer interventions probably had little to no effect on blood pressure (systolic: ‐0.08 mmHg, 95% CI ‐3.26 to 3.11; 2 studies; moderate‐certainty evidence) and may have reduced adverse effects (such as injuries; from 24 to 10 per 100 people in populations experiencing relatively frequent events; odds ratio (OR) 0.50, 95% CI 0.30 to 0.84; low‐certainty evidence). No studies compared biochemical measures or disease risk scores at follow‐up after completion of the intervention versus a minimal intervention.
Comparison of pedometer interventions to alternative physical activity interventions at follow‐up points at least one month after completion of the intervention revealed that pedometers may have an effect on physical activity, but the effect is very uncertain (1 study; very low‐certainty evidence). Sedentary behaviour, anthropometry (BMI or waist circumference), blood pressure (systolic or diastolic), biochemistry (low‐density lipoprotein (LDL) cholesterol, total cholesterol, or triglycerides), disease risk scores, quality of life (mental or physical health components), and adverse effects at follow‐up after completion of the intervention were not compared to an alternative physical activity intervention.
Some positive effects were observed immediately at completion of the intervention periods, but these effects were not consistent, and overall certainty of evidence was insufficient to assess the effectiveness of workplace pedometer interventions.
Authors' conclusions
Exercise interventions can have positive effects on employee physical activity and health, although current evidence is insufficient to suggest that a pedometer‐based intervention would be more effective than other options. It is important to note that over the past decade, technological advancement in accelerometers as commercial products, often freely available in Smartphones, has in many ways rendered the use of pedometers outdated. Future studies aiming to test the impact of either pedometers or accelerometers would likely find any control arm highly contaminated. Decision‐makers considering allocating resources to large‐scale programmes of this kind should be cautious about the expected benefits of incorporating a pedometer and should note that these effects may not be sustained over the longer term.
Future studies should be designed to identify the effective components of multi‐component interventions, although pedometers may not be given the highest priority (especially considering the increased availability of accelerometers). Approaches to increase the sustainability of intervention effects and behaviours over a longer term should be considered, as should more consistent measures of physical activity and health outcomes.
Interrupted time series (ITS) studies are frequently used to examine the impact of population‐level interventions or exposures. Systematic reviews with meta‐analyses including ITS designs may inform ...public health and policy decision‐making. Re‐analysis of ITS may be required for inclusion in meta‐analysis. While publications of ITS rarely provide raw data for re‐analysis, graphs are often included, from which time series data can be digitally extracted. However, the accuracy of effect estimates calculated from data digitally extracted from ITS graphs is currently unknown. Forty‐three ITS with available datasets and time series graphs were included. Time series data from each graph was extracted by four researchers using digital data extraction software. Data extraction errors were analysed. Segmented linear regression models were fitted to the extracted and provided datasets, from which estimates of immediate level and slope change (and associated statistics) were calculated and compared across the datasets. Although there were some data extraction errors of time points, primarily due to complications in the original graphs, they did not translate into important differences in estimates of interruption effects (and associated statistics). Using digital data extraction to obtain data from ITS graphs should be considered in reviews including ITS. Including these studies in meta‐analyses, even with slight inaccuracy, is likely to outweigh the loss of information from non‐inclusion.
Background
Adhesive capsulitis (frozen shoulder or painful stiff shoulder) is characterised by spontaneous onset of shoulder pain accompanied by progressive stiffness and disability. It is usually ...self‐limiting but often has a prolonged course over two to three years.
Objectives
To determine the effectiveness and safety of arthrographic distension of the glenohumeral joint in the treatment of adults with adhesive capsulitis.
Search methods
We searched the Cochrane Musculoskeletal Review Group Register, CENTRAL, MEDLINE, CINAHL, and EMBASE to November 2006, unrestricted by date or language.
Selection criteria
We included randomised controlled trials and controlled clinical trials comparing arthrographic distension with placebo or other interventions.
Data collection and analysis
Two review authors independently assessed study quality and extracted data.
Main results
Five trials with 196 people were included. One three‐arm trial (47 participants) compared arthrographic distension using steroid and air to distension using air alone and to steroid injection alone. One trial (46 participants) compared arthrographic distension using steroid and saline to placebo. Two trials (45 and 22 participants) compared arthrographic distension using steroid to steroid injection alone. One trial (36 participants) compared arthrographic distension using steroid and saline plus physical therapy to physical therapy alone. Trials included similar study participants, but quality and reporting of data were variable. Only one trial was at low risk of bias. No meta‐analysis was performed.
The trial with low risk of bias demonstrated that distension with saline and steroid was better than placebo for pain (number needed to treat to benefit (NNTB) = 2), function (NNTB = 3) and range of movement at three weeks. This benefit was maintained at six and 12 weeks only for one of two scores measuring function (NNT = 3). A second trial with high risk of bias also reported that distension combined with physical therapy improved range of movement and median percent improvement in pain (but not pain score) at eight weeks compared to physical therapy alone. Three further trials, all at high risk of bias, reported conflicting, variable effects of arthrographic distension with steroid compared to distension alone, and arthrographic distension with steroid compared to intra‐articular steroid injection. The trials reported a small number of minor adverse effects, mainly pain during and after the procedure.
Authors' conclusions
There is "silver" level evidence that arthrographic distension with saline and steroid provides short‐term benefits in pain, range of movement and function in adhesive capsulitis. It is uncertain whether this is better than alternative interventions.
The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and ...conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability.
Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019.
Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map.
The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.
This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.
Introduction: Systematic reviews are used to synthesise research and inform decision making by clinicians, consumers and policy makers. The synthesis component of systematic reviews is often narrowly ...considered as the use of statistical methods to combine the results of studies, primarily meta-analysis. However, synthesis can be considered more broadly as a process beginning with: (i) defining the groupings of populations, interventions and outcomes to be compared (the 'PICO for each synthesis'); (ii) examining the characteristics of the available studies; and (iii) applying synthesis methods from among multiple options. To date, there has been limited examination of approaches used in reviews to define and group PICO characteristics and synthesis methods other than meta-analysis.
Objectives: To identify and describe current practice in systematic reviews in relation to structuring the PICO for each synthesis and methods for synthesis when meta-analysis is not used.
Methods: We will randomly sample 100 systematic reviews of the effects of public health and health systems interventions published in 2018 and indexed in the
Health Evidence and
Health Systems Evidence databases. Two authors will independently screen studies for eligibility. One author will extract data on approaches to grouping and defining populations, interventions and outcomes, and the rationale for the chosen groups; and the presentation and synthesis methods used (e.g. tabulation, visual displays, statistical synthesis methods such as combining P values, vote counting based on direction of effect). A second author will undertake independent data extraction for a subsample of reviews. Descriptive statistics will be used to summarise the findings. Specifically, we will compare approaches to grouping in reviews that primarily use meta-analysis versus those that do not.
Conclusion: This study will provide an understanding of current practice in two important aspects of the synthesis process, enabling future research to test the feasibility and impact of different methodological approaches.
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