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Objective: The objective of this systematic review is to describe existing literature pertaining to the use of non-pharmacological interventions (NPIs) for the management of primary or secondary Raynaud’s Phenomenon (RP) compared to placebo. Methods: The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched from their inception to the present for randomized controlled trials and clinical trials for studies assessing the therapeutic effects NPIs in primary or secondary RP. The studies were screened, and data were extracted by two reviewers. The major outcomes assessed included frequency (per week) and duration (minutes) of attacks and pain. Results: We found 23 parallel or crossover RCTs, 5 of which were not discussed in this review. The categories of NPIs included acupuncture and other needling techniques (n=4), temperature biofeedback (n=4), lasers and electrotherapy (n=5), exercise therapy (n=2), gas therapy (n=1), therapeutic gloves (n=1), and ischemic preconditioning (n=1). Most studies demonstrated trends towards therapeutic benefit; however, there was substantial heterogeneity amongst the studies. Laser therapy had the most consistent evidence; 60% and 75% of the studies reported significant improvements in frequency of attacks per week and pain. Acupuncture therapies had minimal statistically significant benefits and the data for temperature biofeedback were inconsistent and of low quality. Exercise therapy is more recently being explored showing a marked therapeutic benefit for pain. Conclusion: The evidence is limited and inconsistent; however, the studies demonstrated a trend towards therapeutic benefits, with laser and electrotherapy having the most consistent evidence. Further high-quality and multi-center RCTs are required.

There is increasing recognition of the need for researchers to collect and report data that can illuminate health inequities. In pain research, routinely collecting equity-relevant data has the potential to inform about the generalisability of findings; whether the intervention has differential effects across strata of society; or it could be used to guide population targeting for clinical studies. Developing clarity and consensus on what data should be collected and how to collect it is required to prompt researchers to further consider equity issues in the planning, conduct, interpretation, and reporting of research. The overarching aim of the ‘Identifying Social Factors that Stratify Health Opportunities and Outcomes’ (ISSHOOs) in pain research project is to provide researchers in the pain field with recommendations to guide the routine collection of equity-relevant data. The design of this project is consistent with the methods outlined in the ‘Guidance for Developers of Health Research Reporting Guidelines’ and involves 4 stages: (i) Scoping review; (ii) Delphi Study; (iii) Consensus Meeting; and (iv) Focus Groups. This stakeholder-engaged project will produce a minimum dataset that has global, expert consensus. Results will be disseminated along with explanation and elaboration as a crucial step towards facilitating future action to address avoidable disparities in pain outcomes.

Abstract Background Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes. Our objectives are to: A. Identify, map, and synthesize qualitative and quantitative findings related to engagement in evidence syntheses B. Explore how engagement in evidence synthesis promotes health equity C. Develop equity-oriented guidance on methods for conducting, evaluating, and reporting engagement in evidence syntheses Methods Our diverse, international team will develop guidance for engagement with collaborators and partners throughout multiple sequential steps using an integrated knowledge translation approach: 1. Reviews. We will co-produce 1 scoping review, 3 systematic reviews and 1 evidence map focusing on (a) methods, (b) barriers and facilitators, (c) conflict of interest considerations, (d) impacts, and (e) equity considerations of engagement in evidence synthesis. 2. Methods study, interviews, and survey. We will contextualise the findings of step 1 by assessing a sample of evidence syntheses reporting on engagement with collaborators and partners and through conducting interviews with collaborators and partners who have been involved in producing evidence syntheses. We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3. Consensus. The guidance checklists will be co-produced and finalised at a consensus meeting with collaborators and partners. 4. Dissemination. We will develop a dissemination plan with our collaborators and partners and work collaboratively to improve adoption of our guidance by key organizations. Conclusion Our international team will develop guidance for collaborator and partner engagement in health care evidence syntheses. Incorporating partnership values and expectations may result in better uptake, potentially reducing health inequities.

Abstract Background Juvenile idiopathic arthritis (JIA) is a common pediatric rheumatic condition and is associated with symptoms such as joint pain that can negatively impact health-related quality of life. To effectively manage pain in JIA, young people, their families, and health care providers (HCPs) should be supported to discuss pain management options and make a shared decision. However, pain is often under-recognized, and pain management discussions are not optimal. No studies have explored decision-making needs for pain management in JIA using a shared decision making (SDM) model. We sought to explore families’ decision-making needs with respect to pain management among young people with JIA, parents/caregivers, and HCPs. Methods We conducted semi-structured virtual or face-to-face individual interviews with young people with JIA 8–18 years of age, parents/caregivers and HCPs using a qualitative descriptive study design. We recruited participants online across Canada and the United States, from a hospital and from a quality improvement network. We used interview guides based on the Ottawa Decision Support Framework to assess decision-making needs. We audiotaped, transcribed verbatim and analyzed interviews using thematic analysis. Results A total of 12 young people (n = 6 children and n = 6 adolescents), 13 parents/caregivers and 11 HCPs participated in interviews. Pediatric HCPs were comprised of rheumatologists (n = 4), physical therapists (n = 3), rheumatology nurses (n = 2) and occupational therapists (n = 2). The following themes were identified: (1) need to assess pain in an accurate manner; (2) need to address pain in pediatric rheumatology consultations; (3) need for information on pain management options, especially nonpharmacological approaches; (4) importance of effectiveness, safety and ease of use of treatments; (5) need to discuss young people/families’ values and preferences for pain management options; and the (6) need for decision support. Themes were similar for young people, parents/caregivers and HCPs, although their respective importance varied. Conclusions Findings suggest a need for evidence-based information and communication about pain management options, which would be addressed by decision support interventions and HCP training in pain and SDM. Work is underway to develop such interventions and implement them into practice to improve pain management in JIA and in turn lead to better health outcomes.

Summary: Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain mechanisms and treatments. Existing pain-related COS often focus on specific conditions, which can hamper data harmonization across various pain states. Methods: Our objective was to develop four overarching COS of domains/subdomains (i.e., what to measure) that transcend pain conditions within different pain categories. We hosted a meeting to assess the need for these four COS in pain research and clinical practice. Potential COS domains/subdomains were identified via a systematic literature review (SLR), meeting attendees, and Delphi participants. We conducted an online, three step Delphi process to reach a consensus on domains to be included in the four final COS. Survey respondents were identified from the SLR and pain-related social networks, including multidisciplinary health care professionals, researchers, and people with lived experience (PWLE) of pain. Advisory boards consisting of COS experts and PWLE provided advice throughout the process. Findings: Domains in final COS were generally related to aspects of pain, quality of life, and physical function/activity limitations, with some differences among pain categories. This effort was the first to generate four separate, overarching COS to encourage international data harmonization within and across different pain categories. Interpretation: The adoption of the COS in research and clinical practice will facilitate comparisons and data integration around the world and across pain studies to optimize resources, expedite therapeutic discovery, and improve pain care. Funding: Innovative Medicines Initiative 2 Join Undertaking; European Union Horizon 2020 research innovation program, European Federation of Pharmaceutical Industries and Associations (EFPIA) provided funding for IMI-PainCare. RDT acknowledges grants from Esteve and TEVA.

Background. Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages.Objectives. This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports.Article design and setting. Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers.Results and conclusion. This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.Source. This article is a translation of the original paper «CARE guidelines for case reports: explanation and elaboration document» in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia). Present translation was first published in Digital Diagnostics. doi: 10.17816/DD105291. It is published with minor changes related to the literary editing of the translation itself. Keywords: case report; case study; EQUATOR network; health research reporting guidelines; CARE guideline; timelines; N-of-1 For citation: Riley David S., Barber Melissa S., Kienle Gunver S., Aronson Jeffrey K., von Schoen-Angerer Tido, Tugwell Peter, Kiene Helmut, Helfand Mark, Altman Douglas G., Sox Harold, Werthmann Paul G., Moher David, Rison Richard A., Shamseer Larissa, Koch Christian A., Sun Gordon H., Hanaway Patrick, Sudak Nancy L., Kaszkin-Bettag Marietta, Carpenter James E., Gagnier Joel J. CARE Guidelines for Case Reports: Explanation and Elaboration Document. Translation into Russian. Voprosy sovremennoi pediatrii — Current Pediatrics. 2023;22(2):88–108. (In Russ). doi: https://doi.org/10.15690/vsp.v22i2.2540

Abstract Background The prioritisation of updating published systematic reviews of interventions is vital to prevent research waste and ensure relevance to stakeholders. The consideration of health equity in reviews is also important to ensure interventions will not exacerbate the existing inequities of the disadvantaged if universally implemented. This study aimed to pilot a priority setting exercise based on systematic reviews of interventions published in the Cochrane Library, to identify and prioritise reviews to be updated with a focus on health equity. Methods We conducted a priority setting exercise with a group of 13 international stakeholders. We identified Cochrane reviews of interventions that showed a reduction in mortality, had at least one Summary of Findings table and that focused on one of 42 conditions with a high global burden of disease from the 2019 WHO Global Burden of Disease report. This included 21 conditions used as indicators of success of the United Nations Universal Health Coverage in attaining the Sustainable Development Goals. Stakeholders prioritised reviews that were relevant to disadvantaged populations, or to characteristics of potential disadvantage within the general population. Results After searching for Cochrane reviews of interventions within 42 conditions, we identified 359 reviews that assessed mortality and included at least one Summary of Findings table. These pertained to 29 of the 42 conditions; 13 priority conditions had no reviews with the outcome mortality. Reducing the list to only reviews showing a clinically important reduction in mortality left 33 reviews. Stakeholders ranked these reviews in order of priority to be updated with a focus on health equity. Conclusions This project developed and implemented a methodology to set priorities for updating systematic reviews spanning multiple health topics with a health equity focus. It prioritised reviews that reduce overall mortality, are relevant to disadvantaged populations, and focus on conditions with a high global burden of disease. This approach to the prioritisation of systematic reviews of interventions that reduce mortality provides a template that can be extended to reducing morbidity, and the combination of mortality and morbidity as represented in Disability-Adjusted Life Years and Quality-Adjusted Life Years.

Abstract Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.

Abstract Background Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. Methods We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. Discussion Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Abstract Background Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). Methods COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. Conclusions This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. Trial registration This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081

Background Adverse social determinants of health give rise to individual-level social needs that have the potential to negatively impact health. Screening patients to identify unmet social needs is becoming more widespread. A review of the content of currently available screening tools is warranted. The aim of this scoping review was to determine what social needs categories are included in published Social Needs Screening Tools that have been developed for use in primary care settings, and how these social needs are screened. Methods We pre-registered the study on the Open Science Framework (https://osf.io/dqan2/). We searched MEDLINE and Embase from 01/01/2010 to 3/05/2022 to identify eligible studies reporting tools designed for use in primary healthcare settings. Two reviewers independently screened studies, a single reviewer extracted data. We summarised the characteristics of included studies descriptively and calculated the number of studies that collected data relevant to specific social needs categories. We identified sub-categories to classify the types of questions relevant to each of the main categories. Results We identified 420 unique citations, and 27 were included. Nine additional studies were retrieved by searching for tools that were used or referred to in excluded studies. Questions relating to food insecurity and the physical environment in which a person lives were the most frequently included items (92–94% of tools), followed by questions relating to economic stability and aspects of social and community context (81%). Seventy-five percent of the screening tools included items that evaluated five or more social needs categories (mean 6.5; standard deviation 1.75). One study reported that the tool had been ‘validated’; 16 reported ‘partial’ validation; 12 reported that the tool was ‘not validated’ and seven studies did not report validation processes or outcomes.

BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 20112012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. ARTICLE DESIGN AND SETTING: Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. RESULTS AND CONCLUSION: This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports. SOURCE: This article is a translation of the original paper CARE guidelines for case reports: explanation and elaboration document in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia).

Abstract Background Research on adherence interventions in rheumatology is limited by methodological issues, particularly heterogeneous outcomes. We aimed to describe researchers’ experiences with conducting interventional studies targeting medication adherence in rheumatology and their perspectives on establishing core outcomes. Methods Semi-structured interviews using audio conference were conducted with researchers who had conducted an adherence study of any design in the past 10 years. Data collection and thematic analysis were performed iteratively, until saturation. Results We interviewed 13 researchers, most of whom worked in academia and specialized in epidemiology and/or health services research. We identified three themes: 1) improving measurement of adherence (considering all phases of adherence, using appropriate and relevant measures, and establishing clinically meaningful thresholds); 2) challenges in designing and appraising adherence intervention studies (considering the confusion over a plethora of outcomes, difficulties with powering studies to demonstrate meaningful changes, and suboptimal descriptions of adherence interventions in published studies); and 3) advancing outcome assessment in adherence intervention studies (capturing rationale for developing a core domain set as well as recommendations and anticipated challenges by participants). Conclusions Uniquely gathering perspectives from international adherence researchers, our findings led to researcher-informed recommendations for improving adherence research including specifying the targeted adherence phase in designing interventions and studies and providing a glossary of terms to promote consistency in reporting. We also identified recommendations for developing a core domain set for interventional studies targeting medication adherence including involvement of patients, clinicians, and other stakeholders and methodological and practical considerations to establish rigor and support uptake.

Abstract Objective Osteoarthritis generates substantial health and socioeconomic burden, which is particularly marked in marginalized groups. It is imperative that practitioners have ready access to summaries of evidence-based interventions for osteoarthritis that incorporate equity considerations. Summaries of systematic reviews can provide this. The present study surveyed experts to prioritize a selection ofinterventions, from which equity focused summaries will be generated. Specifically, the prioritized interventions will be developed into Cochrane Evidence4Equity (E4E) summaries. Methods Twenty-seven systematic reviews of OA interventions were found. From these, twenty-nine non-surgical treatments for osteoarthritis were identified, based on statistically significant findings for desired outcome variables or adverse events. Key findings from these studies were summarised and provided to 9 experts in the field of osteoarthritis.. Expert participants were asked to rate interventions based on feasibility, health system effects, universality, impact on inequities, and priority for translation into equity based E4E summaries. Expert participants were also encouraged to make comments to provide context for each rating. Free text responses were coded inductively and grouped into subthemes and themes. Results Expert participants rated the intervention home land-based exercise for knee OA highest for priority for translation into an E4E summaries, followed by the interventions individual land-based exercise for knee OA, class land-based exercise for knee OA, exercise for hand OA and land-based exercise for hip OA. Upon qualitative analysis of the expert participants’ comments, fifteen subthemes were identified and grouped into three overall themes: (1) this intervention or an aspect of this intervention is unnecessary or unsafe; (2) this intervention or an aspect of this intervention may increase health inequities; and (3) experts noted difficulties completing rating exercise. Conclusion The list of priority interventions and corresponding expert commentary generated information that will be used to direct and support knowledge translation efforts.

Abstract Background There is a need for the development of comprehensive, global, evidence‐based guidance for stakeholder engagement in guideline development. Stakeholders are any individual or group who is responsible for or affected by health‐ and healthcare‐related decisions. This includes patients, the public, providers of health care and policymakers for example. As part of the guidance development process, Multi‐Stakeholder Engagement (MuSE) Consortium set out to conduct four concurrent systematic reviews to summarise the evidence on: (1) existing guidance for stakeholder engagement in guideline development, (2) barriers and facilitators to stakeholder engagement in guideline development, (3) managing conflicts of interest in stakeholder engagement in guideline development and (4) measuring the impact of stakeholder engagement in guideline development. This protocol addresses the second systematic review in the series. Objectives The objective of this review is to identify and synthesise the existing evidence on barriers and facilitators to stakeholder engagement in health guideline development. We will address this objective through two research questions: (1) What are the barriers to multi‐stakeholder engagement in health guideline development across any of the 18 steps of the GIN‐McMaster checklist? (2) What are the facilitators to multi‐stakeholder engagement in health guideline development across any of the 18 steps of the GIN‐McMaster checklist? Search Methods A comprehensive search strategy will be developed and peer‐reviewed in consultation with a medical librarian. We will search the following databases: MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, PsycInfo, Scopus, and Sociological Abstracts. To identify grey literature, we will search the websites of agencies who actively engage stakeholder groups such as the AHRQ, Canadian Institutes of Health Research (CIHR) Strategy for Patient‐Oriented Research (SPOR), INVOLVE, the National Institute for Health and Care Excellence (NICE) and the PCORI. We will also search the websites of guideline‐producing agencies, such as the American Academy of Pediatrics, Australia's National Health Medical Research Council (NHMRC) and the WHO. We will invite members of the team to suggest grey literature sources and we plan to broaden the search by soliciting suggestions via social media, such as Twitter. Selection Criteria We will include empirical qualitative and mixed‐method primary research studies which qualitatively report on the barriers or facilitators to stakeholder engagement in health guideline development. The population of interest is stakeholders in health guideline development. Building on previous work, we have identified 13 types of stakeholders whose input can enhance the relevance and uptake of guidelines: Patients, caregivers and patient advocates; Public; Providers of health care; Payers of health services; Payers of research; Policy makers; Program managers; Product makers; Purchasers; Principal investigators and their research teams; and Peer‐review editors/publishers. Eligible studies must describe stakeholder engagement at any of the following steps of the GIN‐McMaster Checklist for Guideline Development. Data Collection and Analysis All identified citations from electronic databases will be imported into Covidence software for screening and selection. Documents identified through our grey literature search will be managed and screened using an Excel spreadsheet. A two‐part study selection process will be used for all identified citations: (1) a title and abstract review and (2) full‐text review. At each stage, teams of two review authors will independently assess all potential studies in duplicate using a priori inclusion and exclusion criteria. Data will be extracted by two review authors independently and in duplicate according to a standardised data extraction form. Main Results The results of this review will be used to inform the development of guidance for multi‐stakeholder engagement in guideline development and implementation. This guidance will be official GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group guidance. The GRADE system is internationally recognised as a standard for guideline development. The findings of this review will assist organisations who develop healthcare, public health and health policy guidelines, such as the World Health Organization, to involve multiple stakeholders in the guideline development process to ensure the development of relevant, high quality and transparent guidelines.

Abstract This is the protocol for a Campbell systematic review. The objectives are as follows: to identify, describe, and summarize existing guidance and methods for multistakeholder engagement throughout the health guideline development process.

Abstract This is the protocol for a Campbell systematic review. The overall objective of this study is to gather and summarize the existing literature on conflict of interest issues when engaging stakeholders in guideline development.

Abstract Background Investigations of transparency, reproducibility and replicability in science have been directed largely at individual studies. It is just as critical to explore these issues in syntheses of studies, such as systematic reviews, given their influence on decision-making and future research. We aim to explore various aspects relating to the transparency, reproducibility and replicability of several components of systematic reviews with meta-analysis of the effects of health, social, behavioural and educational interventions. Methods The REPRISE (REProducibility and Replicability In Syntheses of Evidence) project consists of four studies. We will evaluate the completeness of reporting and sharing of review data, analytic code and other materials in a random sample of 300 systematic reviews of interventions published in 2020 (Study 1). We will survey authors of systematic reviews to explore their views on sharing review data, analytic code and other materials and their understanding of and opinions about replication of systematic reviews (Study 2). We will then evaluate the extent of variation in results when we (a) independently reproduce meta-analyses using the same computational steps and analytic code (if available) as used in the original review (Study 3), and (b) crowdsource teams of systematic reviewers to independently replicate a subset of methods (searches for studies, selection of studies for inclusion, collection of outcome data, and synthesis of results) in a sample of the original reviews; 30 reviews will be replicated by 1 team each and 2 reviews will be replicated by 15 teams (Study 4). Discussion The REPRISE project takes a systematic approach to determine how reliable systematic reviews of interventions are. We anticipate that results of the REPRISE project will inform strategies to improve the conduct and reporting of future systematic reviews.

Introduction Health inequities are defined as unfair and avoidable differences in health between groups within a population. Most health research is conducted through observational studies, which are able to offer real-world insights about etiology, healthcare policy/programme effectiveness and the impacts of socioeconomic factors. However, most published reports of observational studies do not address how their findings relate to health equity. Our team seeks to develop equity-relevant reporting guidance as an extension of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. This scoping review will inform the development of candidate items for the STROBE-Equity extension. We will operationalise equity-seeking populations using the PROGRESS-Plus framework of sociodemographic factors. As part of a parallel stream of the STROBE-Equity project, the relevance of candidate guideline items to Indigenous research will be led by Indigenous coinvestigators on the team.Methods and analysis We will follow the Joanna Briggs Institute method for conducting scoping reviews. We will evaluate the extent to which the identified guidance supports or refutes our preliminary candidate items for reporting equity in observational studies. These candidate items were developed based on items from equity-reporting guidelines for randomised trials and systematic reviews, developed by members of this team. We will consult with our knowledge users, patients/public partners and Indigenous research steering committee to invite suggestions for relevant guidance documents and interpretation of findings. If the identified guidance suggests the need for additional candidate items, they will be developed through inductive thematic analysis.Ethics and dissemination We will follow a principled approach that promotes ethical codevelopment with our community partners, based on principles of cultural safety, authentic partnerships, addressing colonial structures in knowledge production and the shared ownership, interpretation, and dissemination of research. All products of this research will be published as open access.

Summary: Clinicians, patients, policy makers, funders, programme managers, regulators, and science communities invest considerable amounts of time and energy in influencing or making decisions at various levels, using systematic reviews, health technology assessments, guideline recommendations, coverage decisions, selection of essential medicines and diagnostics, quality assurance and improvement schemes, and policy and evidence briefs. The criteria and methods that these actors use in their work differ (eg, the role economic analysis has in decision making), but these methods frequently overlap and exist together. Under the aegis of WHO, we have brought together representatives of different areas to reconcile how the evidence that influences decisions is used across multiple health system decision levels. We describe the overlap and differences in decision-making criteria between different actors in the health sector to provide bridging opportunities through a unifying broad framework that we call theory of everything. Although decision-making activities respond to system needs, processes are often poorly coordinated, both globally and on a country level. A decision made in isolation from other decisions on the same topic could cause misleading, unnecessary, or conflicted inputs to the health system and, therefore, confusion and resource waste.

Abstract The Assessment of SpondyloArthritis international Society (ASAS) has defined core sets for (i) symptom-modifying anti-rheumatic drugs (SM-ARD), (ii) clinical record keeping, and (iii) disease-controlling anti-rheumatic therapy (DC-ART). These include the following domains for all three core sets: “physical function,” “pain,” “spinal mobility,” “spinal stiffness,” and “patient’s global assessment” (PGA). The core set for clinical record keeping further includes the domains “peripheral joints/entheses” and “acute phase reactants,” and the core set for DC-ART further includes the domains “fatigue” and “spine radiographs/hip radiographs.” The Outcome Measures in Rheumatology (OMERACT) endorsed the core sets in 1998. Using empirical evidence from axSpA trials, we investigated the efficacy (i.e., net benefit) according to the ASAS/OMERACT core outcome set for axSpA across all interventions tested in trials included in subsequent Cochrane reviews. For all continuous scales, we combined data using the standardized mean difference (SMD) to meta-analyze outcomes involving the same domains. Also, through meta-regression analysis, we examined the effect of the separate SMD measures (independent variables) on the primary endpoint (log [OR], dependent variable) across all trials. Based on 11 eligible Cochrane reviews, from these, 85 articles were screened; we included 43 trials with 63 randomized comparisons. Mean (SD) number of ASAS/OMERACT core outcome domains measured for SM-ARD/physical therapy trials was 4.2 (1.7). Six trials assessed all proposed domains. Mean (SD) for number of core outcome domains for DC-ART trials was 5.8 (1.7). No trials assessed all nine domains. Eight trials (16%) were judged to have inadequate (i.e., high risk of) selective outcome reporting bias. The most responsible core domains for achieving success in meeting the primary objective per trial were pain, OR (95% CI) 5.19 (2.28, 11.77), and PGA, OR (95% CI) 1.87 (1.14, 3.07). In conclusion, selective outcome reporting (and “missing data”) should be reduced by encouraging the use of the endorsed ASAS/OMERACT outcome domains in clinical trials. Overall outcome reporting was good for SM-ARD/physical therapy trials and poor for DC-ART trials. Our findings suggest that both PGA and pain provide a valuable holistic construct for the assessment of improvement beyond more objective measures of spinal inflammation.

Abstract Background The randomized controlled trial (RCT) is considered the gold standard study design to inform decisions about the effectiveness of interventions. However, a common limitation is inadequate reporting of the applicability of the intervention and trial results for people who are “socially disadvantaged” and this can affect policy-makers’ decisions. We previously developed a framework for identifying health-equity-relevant trials, along with a reporting guideline for transparent reporting. In this study, we provide a descriptive assessment of health-equity considerations in 200 randomly sampled equity-relevant trials. Methods We developed a search strategy to identify health-equity-relevant trials published between 2013 and 2015. We randomly sorted the 4316 records identified by the search and screened studies until 100 individually randomized (RCTs) and 100 cluster randomized controlled trials (CRTs) were identified. We developed and pilot-tested a data extraction form based on our initial work, to inform the development of our reporting guideline for equity-relevant randomized trials. Results In total, 39 trials (20%) were conducted in a low- and middle-income country and 157 trials (79%) in a high-income country focused on socially disadvantaged populations (78% CRTs, 79% RCTs). Seventy-four trials (37%) reported a subgroup analysis across a population characteristic associated with disadvantage (25% CRT, 49% RCTs), with 19% of included studies reporting subgroup analyses across sex, 9% across race/ethnicity/culture, and 4% across socioeconomic status. No subgroup analyses were reported for place of residence, occupation, religion, education, or social capital. One hundred and forty-one trials (71%) discussed the applicability of their results to one or more socially disadvantaged populations (68% of CRT, 73% of RCT). Discussion In this set of trials, selected for their relevance to health equity, data that were disaggregated for socially disadvantaged populations were rarely reported. We found that even when the data are available, opportunities to analyze health-equity considerations are frequently missed. The recently published equity extension of the Consolidated Reporting Standards for Randomized Trials (CONSORT-Equity) may help improve delineation of hypotheses related to socially disadvantaged populations, and transparency and completeness of reporting of health-equity considerations in RCTs. This study can serve as a baseline assessment of the reporting of equity considerations.

Abstract Background Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. Methods This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. Discussion We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.

Abstract Background Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods We searched nine commonly used databases (e.g., EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient-reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g., abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n = 28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, although they also stressed goals under-reported in clinical trials. Conclusions There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. Trial registration PROSPERO, CRD42013006507.

Abstract Background Everyone has the right to achieve the standard of health and well-being. Migrants are considered as vulnerable populations due to the lack of access to health services and financial protection in health. Several interventions have been developed to improve migrant population health, but little is known about whether these interventions have considered the issue of equity as part of their outcome measurement. Objective To assess the evidence of health interventions in addressing inequity among migrants. Methods We adopted a two-stage searching approach to ensure the feasibility of this review. First, reviews of interventions for migrants were searched from five databases: PubMed, Cochrane, CINAHL, PsycINFO, and EMBASE until June 2017. Second, full articles included in the identified reviews were retrieved. Primary studies included in the identified reviews were then evaluated as to whether they met the following criteria: experimental studies which include equity aspects as part of their outcome measurement, based on equity attributes defined by PROGRESS-Plus factors (place of residence, race/ethnicity, occupation, gender, religion, education, socio-economic status, social capital, and others). We analysed the information extracted from the selected articles based on the PRISMA-Equity guidelines and the PROGRESS-Plus factors. Results Forty-nine reviews involving 1145 primary studies met the first-stage inclusion criteria. After exclusion of 764 studies, the remaining 381 experimental studies were assessed. Thirteen out of 381 experimental studies (3.41%) were found to include equity attributes as part of their outcome measurement. However, although some associations were found none of the included studies demonstrated the effect of the intervention on reducing inequity. All studies were conducted in high-income countries. The interventions included individual directed, community education and peer navigator-related interventions. Conclusions Current evidence reveals that there is a paucity of studies assessing equity attributes of health interventions developed for migrant populations. This indicates that equity has not been receiving attention in these studies of migrant populations. More attention to equity-focused outcome assessment is needed to help policy-makers to consider all relevant outcomes for sound decision making concerning migrants.

Introduction Pregnant and postpartum women face major psychological stressors that put them at higher risk of developing common mental disorders, such as depression and anxiety. Yet, their limited access to and uptake of traditional mental health care is inequitable, especially during the COVID-19 pandemic. Mobile interventions emerged as a potential solution to this discontinued healthcare access, but more knowledge is needed about their effectiveness and impact on health equity. This equity-focused systematic review examined the effectiveness and equity impact of mobile interventions targeting common mental disorders among pregnant and postpartum women. Methods and results We systematically searched MEDLINE, EMBASE, PsychINFO and 3 other databases, from date of database inception and until January 2021, for experimental studies on mobile interventions targeting pregnant and postpartum women. We used pooled and narrative synthesis methods to analyze effectiveness and equity data, critically appraised the methodological rigour of included studies using Cochrane tools, and assessed the certainty of evidence using the GRADE approach. Our search identified 6148 records, of which 18 randomized and non-randomized controlled trials were included. Mobile interventions had a clinically important impact on reducing the occurrence of depression (OR = 0.51 [95% CI 0.41 to 0.64]; absolute risk reduction RD: 7.14% [95% CI 4.92 to 9.36]; pConclusion As the COVID-19 pandemic has increased the need for virtual mental health care, mobile interventions show promise in preventing and managing common mental disorders among pregnant and postpartum women. Such interventions carry the potential to address health inequity but more rigorous research that examines patients’ intersecting social identities is needed.

Introduction Methodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool—the MethodologIcal STudy reportIng Checklist—to harmonise naming conventions and improve the reporting of methodological studies.Methods and analysis We will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies.Ethics and dissemination The consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites.Registration We have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).

Abstract This is a protocol for a co‐registered Cochrane and Campbell Review (Methodology). The objectives are as follows: To identify, describe and assess methods for: when to replicate a systematic review; how to replicate a systematic review.

BACKGROUND:Substance use is disproportionately high among people who are homeless or vulnerably housed. We performed a systematic overview of reviews examining the effects of selected harm reduction and pharmacological interventions on the health and social well-being of people who use substances, with a focus on homeless populations. METHODS AND FINDINGS:We searched MEDLINE, EMBASE, PsycINFO, Joanna Briggs Institute EBP, Cochrane Database of Systematic Reviews and DARE for systematic reviews from inception to August 2019. We conducted a grey literature search and hand searched reference lists. We selected reviews that synthesized evidence on supervised consumption facilities, managed alcohol programs and pharmacological interventions for opioid use disorders. We abstracted data specific to homeless or vulnerably housed populations. We assessed certainty of the evidence using the GRADE approach. Our search identified 483 citations and 30 systematic reviews met all inclusion criteria, capturing the results from 442 primary studies. This included three reviews on supervised consumption facilities, 24 on pharmacological interventions, and three on managed alcohol programs. Supervised consumption facilities decreased lethal overdoses and other high risk behaviours without any significant harm, and improved access to care. Pharmaceutical interventions reduced mortality, morbidity, and substance use, but the impact on retention in treatment, mental illness and access to care was variable. Managed alcohol programs reduced or stabilized alcohol consumption. Few studies on managed alcohol programs reported deaths. CONCLUSIONS:Substance use is a common chronic condition impacting homeless populations. Supervised consumption facilities reduce overdose and improve access to care, while pharmacological interventions may play a role in reducing harms and addressing other morbidity. High quality evidence on managed alcohol programs is limited.

BACKGROUND:Individuals who are homeless or vulnerably housed are at an increased risk for mental illness, other morbidities and premature death. Standard case management interventions as well as more intensive models with practitioner support, such as assertive community treatment, critical time interventions, and intensive case management, may improve healthcare navigation and outcomes. However, the definitions of these models as well as the fidelity and adaptations in real world interventions are highly variable. We conducted a systematic review to examine the effectiveness and cost-effectiveness of case management interventions on health and social outcomes for homeless populations. METHODS AND FINDINGS:We searched Medline, Embase and 7 other electronic databases for trials on case management or care coordination, from the inception of these databases to July 2019. We sought outcomes on housing stability, mental health, quality of life, substance use, hospitalization, income and employment, and cost-effectiveness. We calculated pooled random effects estimates and assessed the certainty of the evidence using the GRADE approach. Our search identified 13,811 citations; and 56 primary studies met our full inclusion criteria. Standard case management had both limited and short-term effects on substance use and housing outcomes and showed potential to increase hostility and depression. Intensive case management substantially reduced the number of days spent homeless (SMD -0.22 95% CI -0.40 to -0.03), as well as substance and alcohol use. Critical time interventions and assertive community treatment were found to have a protective effect in terms of rehospitalizations and a promising effect on housing stability. Assertive community treatment was found to be cost-effective compared to standard case management. CONCLUSIONS:Case management approaches were found to improve some if not all of the health and social outcomes that were examined in this study. The important factors were likely delivery intensity, the number and type of caseloads, hospital versus community programs and varying levels of participant needs. More research is needed to fully understand how to continue to obtain the increased benefits inherent in intensive case management, even in community settings where feasibility considerations lead to larger caseloads and less-intensive follow-up.

BACKGROUND:Homelessness is one of the most disabling and precarious living conditions. The objective of this Delphi consensus study was to identify priority needs and at-risk population subgroups among homeless and vulnerably housed people to guide the development of a more responsive and person-centred clinical practice guideline. METHODS:We used a literature review and expert working group to produce an initial list of needs and at-risk subgroups of homeless and vulnerably housed populations. We then followed a modified Delphi consensus method, asking expert health professionals, using electronic surveys, and persons with lived experience of homelessness, using oral surveys, to prioritize needs and at-risk sub-populations across Canada. Criteria for ranking included potential for impact, extent of inequities and burden of illness. We set ratings of ≥ 60% to determine consensus over three rounds of surveys. FINDINGS:Eighty four health professionals and 76 persons with lived experience of homelessness participated from across Canada, achieving an overall 73% response rate. The participants identified priority needs including mental health and addiction care, facilitating access to permanent housing, facilitating access to income support and case management/care coordination. Participants also ranked specific homeless sub-populations in need of additional research including: Indigenous Peoples (First Nations, Métis, and Inuit); youth, women and families; people with acquired brain injury, intellectual or physical disabilities; and refugees and other migrants. INTERPRETATION:The inclusion of the perspectives of both expert health professionals and people with lived experience of homelessness provided validity in identifying real-world needs to guide systematic reviews in four key areas according to priority needs, as well as launch a number of working groups to explore how to adapt interventions for specific at-risk populations, to create evidence-based guidelines.

Abstract Background Randomized controlled trials (“randomized trials”) can provide evidence to assess the equity impact of an intervention. Decision makers need to know about equity impacts of healthcare interventions so that people get healthcare that is best for them. To better understand the equity impacts of healthcare interventions, a range of people who were potentially the ultimate users of research results were involved in a six-phase project to extend the CONsolidated Standards Of Reporting Trials Statement for health equity (“CONSORT-Equity 2017”). We identified these “knowledge users” as: patients and healthcare researchers, decision makers and providers. This paper reports on one project phase: specifically, a qualitative study designed to integrate the expertise of knowledge users. The experiences and perspectives of knowledge users provided many insights about the reporting of health equity issues in randomized trials. This paper describes key informant interviews with knowledge users that contribute to a better understanding of the effects of an intervention on health equity. Additionally, the paper shows how these insights were used to develop CONSORT-Equity 2017. Methods A qualitative study that used the framework analysis method was conducted in collaboration with an international study executive and advisory board team. In-depth semi-structured interviews were conducted with a purposive sample of key informants who: consider the research ethics of, fund, conduct, participate in, publish, or use research evidence generated in randomized trials. Transcripts were coded and analyzed using the seven-stage framework analysis method, and data reported to reflect knowledge user suggestions to develop CONSORT-Equity 2017. Results Thirteen key informants, of which three were patients, chose to participate in interviews. Seven themes emerged: “Differentiate the type of trial”, “Prompts for health equity”, “Ethics matter”, “Describe unique research strategies”, “Clarity of reporting”, “Implications of equity for sampling and analysis”, “Think beyond the immediate trial”. The interviews provided direction for the extension of 16 CONSORT-Equity 2017 items. Conclusions Key informant interviews were used to identify new concepts that were not generated in our other studies and to develop CONSORT-Equity 2017. We encourage the use of key informant interviews in guideline development to obtain and include the real-life expertise of knowledge users.

Abstract Background Soil transmitted (or intestinal) helminths and schistosomes affect millions of children worldwide. Objectives To use individual participant data network meta‐analysis (NMA) to explore the effects of different types and frequency of deworming drugs on anaemia, cognition and growth across potential effect modifiers. Search Methods We developed a search strategy with an information scientist to search MEDLINE, CINAHL, LILACS, Embase, the Cochrane Library, Econlit, Internet Documents in Economics Access Service (IDEAS), Public Affairs Information Service (PAIS), Social Services Abstracts, Global Health CABI and CAB Abstracts up to March 27, 2018. We also searched grey literature, websites, contacted authors and screened references of relevant systematic reviews. Selection Criteria We included randomised and quasirandomised deworming trials in children for deworming compared to placebo or other interventions with data on baseline infection. Data Collection and Analysis We conducted NMA with individual participant data (IPD), using a frequentist approach for random‐effects NMA. The covariates were: age, sex, weight, height, haemoglobin and infection intensity. The effect estimate chosen was the mean difference for the continuous outcome of interest. Results We received data from 19 randomized controlled trials with 31,945 participants. Overall risk of bias was low. There were no statistically significant subgroup effects across any of the potential effect modifiers. However, analyses showed that there may be greater effects on weight for moderate to heavily infected children (very low certainty evidence). Authors' Conclusions This analysis reinforces the case against mass deworming at a population‐level, finding little effect on nutritional status or cognition. However, children with heavier intensity infections may benefit more. We urge the global community to adopt calls to make data available in open repositories to facilitate IPD analyses such as this, which aim to assess effects for the most vulnerable individuals.

Abstract Background The importance of sex and gender considerations in research is being increasingly recognized. Evidence indicates that sex and gender can influence intervention effectiveness. We assessed the extent to which sex/gender is reported and analyzed in Campbell and Cochrane systematic reviews. Methods We screened all the systematic reviews in the Campbell Library (n = 137) and a sample of systematic reviews from 2016 to 2017 in the Cochrane Library (n = 674). We documented the frequency of sex/gender terms used in each section of the reviews. Results We excluded 5 Cochrane reviews because they were withdrawn or published and updated within the same time period as well as 4 Campbell reviews and 114 Cochrane reviews which only included studies focused on a single sex. Our analysis includes 133 Campbell reviews and 555 Cochrane reviews. We assessed reporting of sex/gender considerations for each section of the systematic review (Abstract, Background, Methods, Results, Discussion). In the methods section, 83% of Cochrane reviews (95% CI 80–86%) and 51% of Campbell reviews (95% CI 42–59%) reported on sex/gender. In the results section, less than 30% of reviews reported on sex/gender. Of these, 37% (95% CI 29–45%) of Campbell and 75% (95% CI 68–82%) of Cochrane reviews provided a descriptive report of sex/gender and 63% (95% CI 55–71%) of Campbell reviews and 25% (95% CI 18–32%) of Cochrane reviews reported analytic approaches for exploring sex/gender, such as subgroup analyses, exploring heterogeneity, or presenting disaggregated data by sex/gender. Conclusion Our study indicates that sex/gender reporting in Campbell and Cochrane reviews is inadequate.

Abstract Background Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) – Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology. Methods/design This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology. Discussion Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.

This review summarizes the evidence from six randomized controlled trials that judged the effectiveness of systematic review summaries on policymakers' decision making, or the most effective ways to present evidence summaries to increase policymakers' use of the evidence. This review included six randomized controlled studies. A randomized controlled study is one in which the participants are divided randomly (by chance) into separate groups to compare different treatments or other interventions. This method of dividing people into groups means that the groups will be similar and that the effects of the treatments they receive will be compared more fairly. At the time the study is done, it is not known which treatment is the better one. The researchers who did these studies invited people from Europe, North America, South America, Africa, and Asia to take part in them. Two studies looked at “policy briefs,” one study looked at an “evidence summary,” two looked at a “summary of findings table,” and one compared a “summary of findings table” to an evidence summary. None of these studies looked at how policymakers directly used evidence from systematic reviews in their decision making, but two studies found that there was little to no difference in how they used the summaries. The studies relied on reports from decision makers. These studies included questions such as, “Is this summary easy to understand?” Some of the studies looked at users' knowledge, understanding, beliefs, or how credible (trustworthy) they believed the summaries to be. There was little to no difference in the studies that looked at these outcomes. Study participants rated the graded entry format higher for usability than the full systematic review. The graded entry format allows the reader to select how much information they want to read. The study participants felt that all evidence summary formats were easier to understand than full systematic reviews. Plain language summary Policy briefs make systematic reviews easier to understand but little evidence of impact on use of study findings It is likely that evidence summaries are easier to understand than complete systematic reviews. Whether these summaries increase the use of evidence from systematic reviews in policymaking is not clear. What is this review about? Systematic reviews are long and technical documents that may be hard for policymakers to use when making decisions. Evidence summaries are short documents that describe research findings in systematic reviews. These summaries may simplify the use of systematic reviews. Other names for evidence reviews are policy briefs, evidence briefs, summaries of findings, or plain language summaries. The goal of this review was to learn whether evidence summaries help policymakers use evidence from systematic reviews. This review also aimed to identify the best ways to present the evidence summary to increase the use of evidence. What is the aim of this review? This review summarizes the evidence from six randomized controlled trials that judged the effectiveness of systematic review summaries on policymakers' decision making, or the most effective ways to present evidence summaries to increase policymakers' use of the evidence. What are the main findings of this review? This review included six randomized controlled studies. A randomized controlled study is one in which the participants are divided randomly (by chance) into separate groups to compare different treatments or other interventions. This method of dividing people into groups means that the groups will be similar and that the effects of the treatments they receive will be compared more fairly. At the time the study is done, it is not known which treatment is the better one. The researchers who did these studies invited people from Europe, North America, South America, Africa, and Asia to take part in them. Two studies looked at “policy briefs,” one study looked at an “evidence summary,” two looked at a “summary of findings table,” and one compared a “summary of findings table” to an evidence summary. None of these studies looked at how policymakers directly used evidence from systematic reviews in their decision making, but two studies found that there was little to no difference in how they used the summaries. The studies relied on reports from decision makers. These studies included questions such as, “Is this summary easy to understand?” Some of the studies looked at users' knowledge, understanding, beliefs, or how credible (trustworthy) they believed the summaries to be. There was little to no difference in the studies that looked at these outcomes. Study participants rated the graded entry format higher for usability than the full systematic review. The graded entry format allows the reader to select how much information they want to read.. The study participants felt that all evidence summary formats were easier to understand than full systematic reviews. What do the findings of this review mean? Our review suggests that evidence summaries help policymakers to better understand the findings presented in systematic reviews. In short, evidence summaries should be developed to make it easier for policymakers to understand the evidence presented in systematic reviews. However, right now there is very little evidence on the best way to present systematic review evidence to policymakers. How up to date is this review? The authors of this review searched for studies through June 2016. Executive summary/Abstract Background Systematic reviews are important for decision makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which makes them hard to use for decision‐making. Strategies to promote the use of evidence to decision makers are required, and evidence summaries have been suggested as a facilitator. Evidence summaries include policy briefs, briefing papers, briefing notes, evidence briefs, abstracts, summary of findings tables, and plain language summaries. There are many organizations developing and disseminating systematic review evidence summaries for different populations or subsets of decision makers. However, evidence on the usefulness and effectiveness of systematic review summaries is lacking. We present an overview of the available evidence on systematic review evidence summaries. Objectives This systematic review aimed to 1) assess the effectiveness of evidence summaries on policy‐makers' use of the evidence and 2) identify the most effective summary components for increasing policy‐makers' use of the evidence. Search methods We searched several online databases (Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Global Health Library, Popline, Africa‐wide, Public Affairs Information Services, Worldwide Political Science Abstracts, Web of Science, and DfiD), websites of research groups and organizations which produce evidence summaries, and reference lists of included summaries and related systematic reviews. These databases were searched in March‐April, 2016. Selection criteria Eligible studies included randomised controlled trials (RCTs), non‐randomised controlled trials (NRCTs), controlled before‐after (CBA) studies, and interrupted time series (ITS) studies. We included studies of policymakers at all levels as well as health system managers. We included studies examining any type of “evidence summary”, “policy brief”, or other product derived from systematic reviews that presented evidence in a summarized form. These interventions could be compared to active comparators (e.g. other summary formats) or no intervention. The primary outcomes were: 1) use of systematic review summaries decision‐making (e.g. self‐reported use of the evidence in policy‐making, decision‐making) and 2) policymaker understanding, knowledge, and/or beliefs (e.g. changes in knowledge scores about the topic included in the summary). We also assessed perceived relevance, credibility, usefulness, understandability, and desirability (e.g. format) of the summaries. Results Our database search combined with our grey literature search yielded 10,113 references after removal of duplicates. From these, 54 were reviewed in full text and we included 6 studies (reported in 7 papers, 1661 participants) as well as protocols from 2 ongoing studies. Two studies assessed the use of evidence summaries in decision‐making and found little to no difference in effect. There was also little to no difference in effect for knowledge, understanding or beliefs (4 studies) and perceived usefulness or usability (3 studies). Summary of Findings tables and graded entry summaries were perceived as slightly easier to understand compared to complete systematic reviews. Two studies assessed formatting changes and found that for Summary of Findings tables, certain elements, such as reporting study event rates and absolute differences were preferred as well as avoiding the use of footnotes. No studies assessed adverse effects. The risks of bias in these studies were mainly assessed as unclear or low however, two studies were assessed as high risk of bias for incomplete outcome data due to very high rates of attrition. Authors' conclusions Evidence summaries may be easier to understand than complete systematic reviews. However, their ability to increase the use of systematic review evidence in policymaking is unclear.

Abstract Background A focus on equity in health can be seen in many global development goals and reports, research and international declarations. With the development of a relevant framework and methods, the Campbell and Cochrane Equity Methods Group has encouraged the application of an ‘equity lens’ to systematic reviews, and many organizations publish reviews intended to address health equity. The purpose of the Evidence for Equity (E4E) project was to conduct a priority-setting exercise and apply an equity lens by developing a knowledge translation product comprising summaries of systematic reviews from the Cochrane Library. E4E translates evidence from systematic reviews into ‘friendly front end’ summaries for policy makers. Methods The following topic areas with high burdens of disease globally, were selected for the pilot: diabetes/obesity, HIV/AIDS, malaria, nutrition, and mental health/depression. For each topic area, a “stakeholder panel” was assembled that included policymakers and researchers. A systematic search of Cochrane reviews was conducted for each area to identify equity-relevant interventions with a meaningful impact. Panel chairs developed a rating sheet which was used by all panels to rank the importance of these interventions by: 1) Ease of Implementation; 2) Health System Requirements; 3)Universality/Generalizability/Share of Burden; and 4) Impact on Inequities/Effect on equity. The ratings of panel members were averaged for each intervention and criterion, and interventions were ordered according to the average overall ratings. Results Stakeholder panels identified the top 10 interventions from their respective topic areas. The evidence on these interventions is being summarized with an equity focus and the results posted online, at http://methods.cochrane.org/equity/e4e-series . Conclusions This method provides an explicit approach to setting priorities by systematic review groups and funders for providing decision makers with evidence for the most important equity-relevant interventions.

Abstract Background Scientific editors are responsible for deciding which articles to publish in their journals. However, we have not found documentation of their required knowledge, skills, and characteristics, or the existence of any formal core competencies for this role. Methods We describe the development of a minimum set of core competencies for scientific editors of biomedical journals. Results The 14 key core competencies are divided into three major areas, and each competency has a list of associated elements or descriptions of more specific knowledge, skills, and characteristics that contribute to its fulfillment. Conclusions We believe that these core competencies are a baseline of the knowledge, skills, and characteristics needed to perform competently the duties of a scientific editor at a biomedical journal.

Abstract Background It has been hypothesized that adaptation of health practice guidelines to the local setting is expected to improve their uptake and implementation while cutting on required resources. We recently adapted the published American College of Rheumatology (ACR) Rheumatoid Arthritis (RA) treatment guideline to the Eastern Mediterranean Region (EMR). The objective of this paper is to describe the process used for the adaptation of the 2015 ACR guideline on the treatment of RA for the EMR. Methods We used the GRADE-Adolopment methodology for the guideline adaptation process. We describe in detail how adolopment enhanced the efficiency of the following steps of the guideline adaptation process: (1) groups and roles, (2) selecting guideline topics, (3) identifying and training guideline panelists, (4) prioritizing questions and outcomes, (5) identifying, updating or conducting systematic reviews, (6) preparing GRADE evidence tables and EtD frameworks, (7) formulating and grading strength of recommendations, (8) using the GRADEpro-GDT software. Results The adolopment process took 6 months from January to June 2016 with a project coordinator dedicating 40% of her time, and the two co-chairs dedicating 5% and 10% of their times respectively. In addition, a research assistant worked 60% of her time over the last 3 months of the project. We held our face-to-face panel meeting in Qatar. Our literature update included five newly published trials. The certainty of the evidence of three of the eight recommendations changed: one from moderate to very low and two from low to very low. The factors that justified a very low certainty of the evidence in the three recommendations were: serious risk of bias and very serious imprecision. The strength of five of the recommendations changed from strong to conditional. The factors that justified the conditional strength of these 5 recommendations were: cost (n = 5 [100%]), impact on health equities (n = 4 [80%]), the balance of benefits and harms (n = 1 [20%]) and acceptability (n = 1 [20%]). Conclusion This project confirmed the feasibility of GRADE-Adolopment. It also highlighted the value of collaboration with the organization that had originally developed the treatment guideline. We discuss the implications for both guideline adaptation and future research to advance the field.

Abstract Health research has documented disparities in health and health outcomes within and between populations. When these disparities are unfair and avoidable they may be referred to as health inequities. Few trials attend to factors related to health inequities, and there is limited understanding about how to build consideration of health inequities into trials. Due consideration of health inequities is important to inform the design, conduct and reporting of trials so that research can build evidence to more effectively address health inequities and importantly, ensure that inequities are not aggravated. In this paper, we discuss approaches to integrating health equity-considerations in randomized trials by using the PROGRESS Plus framework (Place of residence, Race/ethnicity/culture/language, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and “Plus” that includes other context specific factors) and cover: (i) formulation of research questions, (ii) two specific scenarios relevant to trials about health equity and (iii) describe how the PROGRESS Plus characteristics may influence trial design, conduct and analyses. This guidance is intended to support trialists designing equity-relevant trials and lead to better design, conduct, analyses and reporting, by addressing two main issues: how to avoid aggravating inequity among research participants and how to produce information that is useful to decision-makers who are concerned with health inequities.

Abstract Background Health interventions fall along a spectrum from simple to more complex. There is wide interest in methods for reviewing ‘complex interventions’, but few transparent approaches for assessing intervention complexity in systematic reviews. Such assessments may assist review authors in, for example, systematically describing interventions and developing logic models. This paper describes the development and application of the intervention Complexity Assessment Tool for Systematic Reviews (iCAT_SR), a new tool to assess and categorise levels of intervention complexity in systematic reviews. Methods We developed the iCAT_SR by adapting and extending an existing complexity assessment tool for randomized trials. We undertook this adaptation using a consensus approach in which possible complexity dimensions were circulated for feedback to a panel of methodologists with expertise in complex interventions and systematic reviews. Based on these inputs, we developed a draft version of the tool. We then invited a second round of feedback from the panel and a wider group of systematic reviewers. This informed further refinement of the tool. Results The tool comprises ten dimensions: (1) the number of active components in the intervention; (2) the number of behaviours of recipients to which the intervention is directed; (3) the range and number of organizational levels targeted by the intervention; (4) the degree of tailoring intended or flexibility permitted across sites or individuals in applying or implementing the intervention; (5) the level of skill required by those delivering the intervention; (6) the level of skill required by those receiving the intervention; (7) the degree of interaction between intervention components; (8) the degree to which the effects of the intervention are context dependent; (9) the degree to which the effects of the interventions are changed by recipient or provider factors; (10) and the nature of the causal pathway between intervention and outcome. Dimensions 1–6 are considered ‘core’ dimensions. Dimensions 7–10 are optional and may not be useful for all interventions. Conclusions The iCAT_SR tool facilitates more in-depth, systematic assessment of the complexity of interventions in systematic reviews and can assist in undertaking reviews and interpreting review findings. Further testing of the tool is now needed.

[This corrects the article DOI: 10.1371/journal.pone.0208251.].

Table of contents S1 Criteria for exercises selection in subjects with low back pain Alessandro Aina S2 Recent advances in pathophysiology and treatment of myofascial trigger points Marco Barbero S3 Rehabilitation of scapular dyskinesia Barbara Cagnie S4 Musculoskeletal rehabilitation in subjects affected by neurological disorders Elena Castelli S5 Which examination tests suggest the best candidates for manual therapy Chad Cook S6 Case study: the role of the measurements for the identification of targets and guidance of the treatment Silvano Ferrari S7 Assessment of joint mobility: state of the art Andrea Foglia, Paolo Bizzarri S8 Core stabilization exercises in the treatment of urinary incontinence Donatella Giraudo S9 Preventing surgical subacromial decompression through rotator cuff rehabilitation Chris Littlewood S10 Methodological aspects of Clinical Prediction Rules in the rehabilitation of Low Back Pain Paolo Pillastrini S11 Interpretability of outcome measures in musculoskeletal rehabilitation Daniele Piscitelli S12 Conservative treatment of the misalignment of the spine: state of the art and perspectives Michele Romano S13 Balance training in subjects with musculoskeletal disorders Andrea Tettamanti S14 Dosage of manual therapy: principles for clinical practice Carla Vanti S15 Are there speed limits in post-surgery lower limb rehabilitation? Stefano Vercelli S16 Classification of predominant neuropathic, nociceptive or central sensation pain Lennard Voogt P1 A wearable proprioceptive stabilizer (Equistasi®) for rehabilitation of balance disorders in multiple sclerosis patients: preliminary results of a randomized, double-blind, versus placebo controlled study Aceto Maria, Spina Emanuele, Paone Paolo, Silvestre Francesco, Carotenuto Antonio, Cerillo Ilaria, Orefice Giuseppe P2 Effect of repeated neck retraction movements on strength and EMG activity of the upper limbs, range of motion and cervical posture Bassi Raffaele, Fiorito Serena, Aina Alessandro P3 Hamstring injuries: clinical assessment or image evaluation? Bonfanti M., Pasquetti M. P4 Effectiveness of the physical therapy treatment on pelvic floor muscles in pelvic girdle pain. A literature review Bortolami Arianna, Pillastrini Paolo, Vanti Carla P5 Scapulo-humeral muscles electromiographic activity during the elevation movement of the upper limb in subjects with rotator cuff lesion Brioschi D, Vitali M, Pedretti A, Fraschini G, Tettamanti A P6 Mechanical low back pain: secular trend and intervention topics of randomized controlled trials Castellini G, Gianola S, Bonovas S, Banfi G, Moja L P7 Quality of reporting in rehabilitation interventions for low back pain: a review of published randomised controlled trials Greta Castellini, Silvia Gianola, Pamela Frigerio, Michela Agostini, Rosa Bolotta, Davide Corbetta, Monica Gasparini, Paolo Gozzer, Erica Guariento, Linda Li, Valentina Pecoraro, Valeria Sirtori, Andrea Turolla, Andreano A, Lorenzo Moja P8 Power analysis and sample size reporting in rehabilitation of low back pain: review of randomized controlled trials included in Cochrane systematic review Castellini G, Gianola S, Bonovas S, Moja L P9 A core outcome set for clinical trials in non-specific low back pain Alessandro Chiarotto, Caroline B. Terwee, Maarten Boers, Raymond W. Ostelo P10 Roland & Morris Disability Questionnaire and Oswestry Disability Index: which has better measurement properties? A systematic review and meta-analysis Alessandro Chiarotto, Lara J. Maxwell, Caroline B. Terwee, George A. Wells, Peter Tugwell, Raymond W. Ostelo P11 Prevalence of myofascial trigger points in spinal pain disorders: systematic review and meta-analysis Alessandro Chiarotto, Ron Clijsen, Cesar Fernandez-de-las-Penas, Marco Barbero P12 Post-surgical scar rating scales in physiotherapy: a systematic review Ciceri Matteo, Rossetti Sara, Vercelli Stefano P13 Efficacy of action observation pre-operative training in functional recovery after hip and knee prosthesis Cislaghi M, Penone G, Marinelli G, Rezzan G, Melegati G, Gatti R P14 The use of Kinesio Taping in the treatment of hematomas: can we distinguish fancy from the effects? Colombo Claudio, Tolosa Francesca, Andrea Moriondo, Vercelli Stefano P15 Who is able to perform explicit motor imagery after stroke? Stefano Doronzio, Matteo Paci P16 Responsiveness of the Bridge tests in Symptomatic Lumbar Spondylolisthesis Silvano Ferrari, Carla Vanti, Marco Monticone P17 The relationship between number of sessions and clinical results in lumbar symptomatic spondylolisthesis Silvano Ferrari, Carla Vanti, Marco Monticone P18 Conservative treatments for upper extremity tendinopathies in occupational medicine: narrative review Garzonio Fabiola, Zanetta Anna, Bargeri Serena, Cerone Giorgia, Sartorio Francesco P19 The time-related effect of roller-massager on extensibility of the hamstring muscles Filippo Ghirlanda, Alessandro Schneebeli, Corrado Cescon, Marco Barbero P20 Effect of two different exercise programs on pain, disability and quality of life in people with subacute and chronic nonspecific neck pain Gioia G, Faccendini S, Aina A, Tettamanti A P21 A bridge between clinical practice and research: how health professionals can study literature and learn on the job Granzotto G, Coppola L, Gava I, Frassinelli M, Gattinoni F P22 Walking capacity improves after neuromotor physiotherapy in stroke patients Lorenzo Guidotti, Marco Postiglione, Bruna Lombardi, Matteo Paci P23 Intra and inter-session reliability of the angle between pain onset and submaximal pain during upper limb neurodynamics test 1: a study in healty individuals Diego Leoni, Davide Storer, Roberto Gatti, Michele Egloff, Marco Barbero P24 Effects of an AO-MI training on balance task in patients affected by multiple sclerosis Magno Tiziano, Tettamanti Andrea P25 Outcomes of treatment with neuromuscular stimulator for chronic anterior knee pain: a clinical case Daniele Maremmani, Sebastiano Cencini, Giuseppe Plebani P26 Consistency in locating pressure stimuli over the lumbar spine on a digital body chart: a comparison between chronic low back pain patients and healthy subjects Federica Moresi, Marco Barbero, Matteo Isnardi, Alberto Gallace, Corrado Cescon, Roberto Gatti P27 Malignant Cord Compression in the thoraco-lumbar spine. Early signs and symptoms in the differential diagnosis of low back pain Moretti N, Maselli, Testa M. P28 End growth results of exercise treatment to avoid bracing in adolescents with idiopathic scoliosis: a prospective cohort controlled study Stefano Negrini, Sabrina Donzelli, Francesco Saveri, Alessandra Negrini, Silvana Parzini, Michele Romano, Fabio Zaina P29 Reliability of the Ashworth scale and its modified versions: systematic review and meta-analysis Leonardo Nesi, Francesco Ferrarello, Valeria Anna Maria Bianchi, Matteo Paci P30 Differences in motor recovery between upper and lower limbs in stroke subtypes Matteo Paci, Luca Nannetti, Bruna Lombardi P31 Influence of clinical experience on the reliability of the Salford Gait Tool Giuditta Mini, Mariangela Marchettini, Francesco Ferrarello, Matteo Paci P32 A somatosensory discrimination training induces brain functional changes in healthy young subjects Fabio Piccolo, Federica Agosta, Elisabetta Sarasso, Paola Adamo, Federico Temporiti, Andrea Falini, Roberto Gatti, Massimo Filippi P33 Effects of dynamic tilt-table with integrated robotic stepping associated with functional electrical stimulation: a cross-over study Daniele Piscitelli, Roberto Meroni, Leonardo Pellicciari, Marco A. Mondelli, Thomas Favaron, Cesare G. Cerri, Enrico A. Tallarita P34 Manual therapy techniques in the treatment of whiplash and its associated disorders: a systematic review Ravizzotti Elisa, Vercelli Stefano P35 The Patient and Observer Scar Assessment Scale (POSAS) as a screening tool for early detection of pathologic post-surgical scars in physiotherapy Rossetti Sara, Ciceri Matteo, Vercelli Stefano P36 The anatomical basis of genetic dystonia: a multimodal MRI study Elisabetta Sarasso, Federica Agosta, Aleksandra Tomić, Silvia Basaia, Nataša Dragašević, Marina Svetel, Massimiliano Copetti, Vladimir S. Kostic, Massimo Filippi P37 The relative inclination of the end vertebrae of a scoliotic single curve can influence the results of the conservative treatment? A pilot study Francesco Saveri, Michele Romano, Matteo Mastrantonio, Alessandra Negrini, Fabio Zaina, Negrini Stefano P38 Physiotherapy for myofascial pain syndromes: reported methodological quality of randomized controlled trials indexed in the PEDro database Alessandro Schneebeli, Greta Castellini, Valentina Redaelli, Emiliano Soldini, Marco Barbero P39 Is the patellar pubic percussion test useful to diagnose only femur fractures or something else? Two case reports Segat M, Casonato O, Margelli M, Pillon S. P40 Effectiveness of new rehab method for MDI Spunton V, Fenini R, Garofalo R, Conti M P41 Toe walking and autism: cross-sectional study on clinical presentation patterns and correlation with language delay Valagussa G, Balatti V, Trentin L, Melli S, Norsi M, and Grossi E P42 Active Kyphosis Value (AKV): a new test for the evaluation of the kyphotisation mobility of the thoracic spine Massimiliano Vanossi, Francesco Saveri, Michele Romano P43 Pain Drawing and psychological distress in low back pain - systematic review and meta-analysis Carla Vanti, Sara Taioli, Ivan Gardenghi, Lucia Bertozzi, Anna Rosso, Antonio Romeo, Paolo Pillastrini P44 Responsiveness of the Oswestry Disability Index in symptomatic lumbar spondylolisthesis Carla Vanti, Silvano Ferrari, Martina Ruggeri, Marco Monticone P45 The relationship between instability tests, pain and disability in non-specific low back pain Carla Vanti, Bellini Filippo, Cristina Conti, Federica Faresin, Martina Ruggeri, Raffaella Piccarreta, Silvano Ferrari P46 Smartphone applications (apps) for physical therapists: a review Villanova Luca, Vercelli Stefano P47 A randomized controlled pilot trial of hand robotic training compared with a sensory-motor training program in post stroke patients Violini Claudia, Cenci Marco Joseph, Delconte Carmen, Pisano Fabrizio P48 Critical Illness PolyNeuroMyopathy (CIPNM): chance for a good prognosis Youssef S, Montesano M, Picardi M, De Giampaulis P, Corbo M, Pisani L. P49 The EdUReP approach plus manual therapy for the management of insertional Achilles tendinopathy: a case study Zanetta Anna, Garzonio Fabiola, Ruella Carolina, Sartorio Francesco