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  • Psychotropic medication non-adherence and its associated factors among patients with major psychiatric disorders: a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2020-01-16
    Agumasie Semahegn; Kwasi Torpey; Adom Manu; Nega Assefa; Gezahegn Tesfaye; Augustine Ankomah

    Major psychiatric disorders are growing public health concern that attributed 14% of the global burden of diseases. The management of major psychiatric disorders is challenging mainly due to medication non-adherence. However, there is a paucity of summarized evidence on the prevalence of psychotropic medication non-adherence and associated factors. Therefore, we aimed to summarize existing primary studies’ finding to determine the pooled prevalence and factors associated with psychotropic medication non-adherence. A total of 4504 studies written in English until December 31, 2017, were searched from the main databases (n = 3125) (PubMed (MEDLINE), Embase, CINAHL, PsycINFO, and Web of Science) and other relevant sources (mainly from Google Scholar, n = 1379). Study selection, screening, and data extraction were carried out independently by two authors. Observational studies that had been conducted among adult patients (18 years and older) with major psychiatric disorders were eligible for the selection process. Critical appraisal of the included studies was carried out using the Newcastle Ottawa Scale. Systematic synthesis of the studies was carried out to summarize factors associated with psychotropic medication non-adherence. Meta-analysis was carried using Stata 14. Random effects model was used to compute the pooled prevalence, and sub-group analysis at 95% confidence interval. Forty-six studies were included in the systematic review. Of these, 35 studies (schizophrenia (n = 9), depressive (n = 16), and bipolar (n = 10) disorders) were included in the meta-analysis. Overall, 49% of major psychiatric disorder patients were non-adherent to their psychotropic medication. Of these, psychotropic medication non-adherence for schizophrenia, major depressive disorders, and bipolar disorders were 56%, 50%, and 44%, respectively. Individual patient’s behaviors, lack of social support, clinical or treatment and illness-related, and health system factors influenced psychotropic medication non-adherence. Psychotropic medication non-adherence was high. It was influenced by various factors operating at different levels. Therefore, comprehensive intervention strategies should be designed to address factors associated with psychotropic medication non-adherence. PROSPERO CRD42017067436

    更新日期:2020-01-17
  • Maternal and birth cohort studies in the Gulf Cooperation Council countries: a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2020-01-16
    Rami H. Al-Rifai; Nasloon Ali; Esther T. Barigye; Amal H. I. Al Haddad; Fatima Al-Maskari; Tom Loney; Luai A. Ahmed

    We systematically reviewed and chronicled exposures and outcomes measured in the maternal and birth cohort studies in the Gulf Cooperation Council (GCC) countries and quantitatively summarized the weighted effect estimates between maternal obesity and (1) cesarean section (CS) and (2) fetal macrosomia. We searched MEDLINE-PubMed, Embase, Cochrane Library, Scopus, and Web of Science electronic databases up to 30 June 2019. We considered all maternal and birth cohort studies conducted in the six GCC countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and United Arab Emirates (UAE)). We categorized cohort studies on the basis of the exposure(s) (anthropometric, environmental, medical, maternal/reproductive, perinatal, or socioeconomic) and outcome(s) (maternal or birth) being measured. Adjusted weighted effect estimates, in the form of relative risks, between maternal obesity and CS and fetal macrosomia were generated using a random-effects model. Of 3502 citations, 81 published cohort studies were included. One cohort study was in Bahrain, eight in Kuwait, seven in Qatar, six in Oman, 52 in Saudi Arabia, and seven in the UAE. Majority of the exposures studied were maternal/reproductive (65.2%) or medical (39.5%). Birth and maternal outcomes were reported in 82.7% and in 74.1% of the cohort studies, respectively. In Saudi Arabia, babies born to obese women were at a higher risk of macrosomia (adjusted relative risk (aRR), 1.15; 95% confidence interval (CI), 1.10–1.20; I2 = 50%) or cesarean section (aRR, 1.21; 95% CI, 1.15–1.26; I2 = 62.0%). Several cohort studies were only descriptive without reporting the magnitude of the effect estimate between the assessed exposures and outcomes. Cohort studies in the GCC have predominantly focused on reproductive and medical exposures. Obese pregnant women are at an increased risk of undergoing CS delivery or macrosomic births. Longer-term studies that explore a wider range of environmental and biological exposures and outcomes relevant to the GCC region are needed. PROSPERO CRD42017068910

    更新日期:2020-01-16
  • Engaging older adults in self-management talk in healthcare encounters: a systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2020-01-16
    Michael T. Lawless; Phoebe Drioli-Phillips; Mandy M. Archibald; Alison L. Kitson

    Clinical practice guidelines for the management of complex chronic conditions in older adults encourage healthcare providers to engage patients in shared decision-making about self-management goals and actions. Yet, healthcare decision-making and communication for this population can pose significant challenges. As a result, healthcare professionals may struggle to help patients define and prioritise their values, goals, and preferences in ways that are clinically and personally meaningful, incorporating physical functioning and quality of life, when faced with numerous diagnostic and treatment alternatives. The aim of this systematic review is to locate and synthesise a body of fine-grained observational research on communication between professionals, older adults, and carers regarding self-management in audio/audio-visually recorded naturalistic interactions. The paper describes a systematic review of the published conversation analytic and discourse analytic research, using an aggregative thematic approach and following the PRISMA-P guidelines. This review will include studies reporting on adult patients (female or male) aged ≥ 60 years whose consultations are conducted in English in any healthcare setting and stakeholders involved in their care, e.g. general practitioners, nurses, allied health professionals, and family carers. We will search nine electronic databases and the grey literature and two independent reviewers will screen titles and abstracts to identify potential studies. Discrepancies will be resolved via consultation with the review team. The methodological quality of the final set of included studies will be appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research and a detailed description of the characteristics of the included studies using a customised template. This is the first systematic review to date to locate and synthesise the conversation analytic research on how healthcare professionals raise and pursue talk about self-management with older adults in routine clinical interactions. Amalgamating these findings will enable the identification of effective and potentially trainable communication practices for engaging older adults in healthcare decision-making about the self-management goals and actions that enable the greatest possible health and quality of life in older adulthood. PROSPERO CRD42019139376

    更新日期:2020-01-16
  • Uncontrolled hypertension among patients with comorbidities in sub-Saharan Africa: protocol for a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2020-01-16
    Shukri F. Mohamed; Olalekan A. Uthman; Rishi Caleyachetty; Ivy Chumo; Martin K. Mutua; Gershim Asiki; Paramjit Gill

    Uncontrolled hypertension is the most important risk factor and leading cause of cardiovascular diseases. It is predicted that the number of people with hypertension will increase, and a large proportion of this increase will occur in developing countries. The highest prevalence of uncontrolled hypertension is reported in sub-Saharan Africa, and treatment for hypertension is unacceptably low. Hypertension commonly co-exists with comorbidities and this is associated with poorer health outcomes for patients. This review aims to estimate the prevalence of uncontrolled hypertension among patients with comorbidities in sub-Saharan Africa. All published and unpublished studies on the prevalence of uncontrolled hypertension among patients with comorbidities in sub-Saharan Africa will be included. MEDLINE via OVID, Embase, and Web of Science will be searched to identify all relevant articles published from January 2000 to June 2019. Experts in the field will be contacted for unpublished literature, and Open SIGLE will be reviewed for relevant information. No language restriction will be imposed. Two reviewers will select, screen, extract data, and assess the risk of bias while a third reviewer will arbitrate the disagreements. A meta-analysis will be performed on variables that are similar across the included studies. Proportions will be stabilized before estimates are pooled using a random effects model. The presence of publication bias will be assessed using Egger’s test and visual inspection of the funnel plots. This systematic and meta-analysis review protocol will be reported in accordance with the PRISMA-P protocol guidelines. Results will be stratified by country, comorbidity, and geographic region. This systematic review and meta-analysis is expected to quantify the magnitude of uncontrolled hypertension among patients with certain comorbid conditions in sub-Saharan Africa to guide policies and interventions. This review is registered in PROSPERO International Prospective Register of Systematic reviews CRD42019108218.

    更新日期:2020-01-16
  • Inter-rater reliability and concurrent validity of ROBINS-I: protocol for a cross-sectional study
    Syst. Rev. (IF 0) Pub Date : 2020-01-13
    Maya M. Jeyaraman; Rasheda Rabbani; Nameer Al-Yousif; Reid C. Robson; Leslie Copstein; Jun Xia; Michelle Pollock; Samer Mansour; Mohammed T. Ansari; Andrea C. Tricco; Ahmed M. Abou-Setta

    The Cochrane Bias Methods Group recently developed the “Risk of Bias (ROB) in Non-randomized Studies of Interventions” (ROBINS-I) tool to assess ROB for non-randomized studies of interventions (NRSI). It is important to establish consistency in its application and interpretation across review teams. In addition, it is important to understand if specialized training and guidance will improve the reliability of the results of the assessments. Therefore, the objective of this cross-sectional study is to establish the inter-rater reliability (IRR), inter-consensus reliability (ICR), and concurrent validity of ROBINS-I. Furthermore, as this is a relatively new tool, it is important to understand the barriers to using this tool (e.g., time to conduct assessments and reach consensus—evaluator burden). Reviewers from four participating centers will appraise the ROB of a sample of NRSI publications using the ROBINS-I tool in two stages. For IRR and ICR, two pairs of reviewers will assess the ROB for each NRSI publication. In the first stage, reviewers will assess the ROB without any formal guidance. In the second stage, reviewers will be provided customized training and guidance. At each stage, each pair of reviewers will resolve conflicts and arrive at a consensus. To calculate the IRR and ICR, we will use Gwet’s AC1 statistic. For concurrent validity, reviewers will appraise a sample of NRSI publications using both the New-castle Ottawa Scale (NOS) and ROBINS-I. We will analyze the concordance between the two tools for similar domains and for the overall judgments using Kendall’s tau coefficient. To measure the evaluator burden, we will assess the time taken to apply the ROBINS-I (without and with guidance), and the NOS. To assess the impact of customized training and guidance on the evaluator burden, we will use the generalized linear models. We will use Microsoft Excel and SAS 9.4 to manage and analyze study data, respectively. The quality of evidence from systematic reviews that include NRS depends partly on the study-level ROB assessments. The findings of this study will contribute to an improved understanding of the ROBINS-I tool and how best to use it.

    更新日期:2020-01-14
  • A systematic review protocol on small/kiddie cigarette packaging size and its impact on smoking
    Syst. Rev. (IF 0) Pub Date : 2020-01-13
    Halizah Mat Rifin; Wan Shakira Rodzlan Hasani; Miaw Yn Jane Ling; Tania Gayle Robert Lourdes; Thamil Arasu Saminathan; Nur Liana Ab Majid; Ahzairin Ahmad; Hasimah Ismail; Muhammad Fadhli Mohd Yusoff

    Small/kiddie cigarette packs consist of less than 20 cigarette sticks. Kiddie packs were recently proposed to be reintroduced by the tobacco industry with an excuse to prevent consumers from buying illicit cigarettes. By reintroducing kiddie packs, cigarettes will inevitably be more affordable and this would appeal to lower-income consumers especially teens. In this systematic review, we aimed to identify the impact of kiddie packs on smoking, specifically on smoking initiation, the urge/tendency to buy cigarettes and attempts to reduce cigarette consumption. This systematic review will be based on the review of original articles on the impact of kiddie packs on smoking. There is no restriction on the publication dates. The Cochrane Central Register of Controlled Trials, PubMed, EMBASE, Web of Science and Scopus will be searched to retrieve potential original articles. Additional records identified through other sources: Google Scholar, as well as Journal of Substance Use and Tobacco Control, are also to be searched. These will include original articles in any language which included all study designs (randomised controlled trials, quasi experimental and experimental studies, observational cross-sectional and cohort studies) comparing kiddie packs with regular cigarette packs. The primary outcomes of interest will be initiation of smoking and urge/tendency to buy cigarettes in the general population and attempts to reduce cigarette consumption among current smokers. Secondary outcomes will be the prevalence of smoking using kiddie packs among the current smokers. This systematic review will provide evidence to support the impact of kiddie packs on smoking in terms of smoking initiation, smoking prevalence, urge/tendency to purchase cigarettes and attempts to reduce cigarette consumption. The findings from this review could be helpful to policymakers in regulating kiddie packs to control the consumption of tobacco. PROSPERO CRD42018102325

    更新日期:2020-01-14
  • Essential items for reporting of scaling studies of health interventions (SUCCEED): protocol for a systematic review and Delphi process
    Syst. Rev. (IF 0) Pub Date : 2020-01-11
    Amédé Gogovor; Hervé Tchala Vignon Zomahoun; Ali Ben Charif; Robert K. D. McLean; David Moher; Andrew Milat; Luke Wolfenden; Karina Prévost; Emmanuelle Aubin; Paula Rochon; Giraud Ekanmian; Jasmine Sawadogo; Nathalie Rheault; France Légaré

    The lack of a reporting guideline for scaling of evidence-based practices (EBPs) studies has prompted the registration of the Standards for reporting studies assessing the impact of scaling strategies of EBPs (SUCCEED) with EQUATOR Network. The development of SUCCEED will be guided by the following main steps recommended for developing health research reporting guidelines. Executive Committee. We established a committee composed of members of the core research team and of an advisory group. Systematic review. The protocol was registered with the Open Science Framework on 29 November 2019 (https://osf.io/vcwfx/). We will include reporting guidelines or other reports that may include items relevant to studies assessing the impact of scaling strategies. We will search the following electronic databases: EMBASE, PsycINFO, Cochrane Library, CINAHL, Web of Science, from inception. In addition, we will systematically search websites of EQUATOR and other relevant organizations. Experts in the field of reporting guidelines will also be contacted. Study selection and data extraction will be conducted independently by two reviewers. A narrative analysis will be conducted to compile a list of items for the Delphi exercise. Consensus process. We will invite panelists with expertise in: development of relevant reporting guidelines, methodologists, content experts, patient/member of the public, implementers, journal editors, and funders. We anticipated that three rounds of web-based Delphi consensus will be needed for an acceptable degree of agreement. We will use a 9-point scale (1 = extremely irrelevant to 9 = extremely relevant). Participants’ response will be categorized as irrelevant (1–3), equivocal (4–6) and relevant (7–9). For each item, the consensus is reached if at least 80% of the participants’ votes fall within the same category. The list of items from the final round will be discussed at face-to-face consensus meeting. Guideline validation. Participants will be authors of scaling studies. We will collect quantitative (questionnaire) and qualitative (semi-structured interview) data. Descriptive analyses will be conducted on quantitative data and constant comparative techniques on qualitative data. Essential items for reporting scaling studies will contribute to better reporting of scaling studies and facilitate the transparency and scaling of evidence-based health interventions.

    更新日期:2020-01-13
  • Sexual dysfunction and satisfaction in obsessive compulsive disorder: protocol for a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2020-01-09
    Andrea Pozza; David Veale; Donatella Marazziti; Jaime Delgadillo; Umberto Albert; Giacomo Grassi; Davide Prestia; Davide Dèttore

    Obsessive compulsive disorder (OCD) is a chronic mental health condition recognized as one of the most serious causes of disability and impaired quality of life. In the literature, there is no review about sexual dysfunction and satisfaction in OCD. The current paper presents the protocol for a systematic review and meta-analysis aimed to summarize data (1) comparing the presence of sexual dysfunction between groups with OCD and non-clinical groups, (2) investigating prevalence of each one of the sexual dysfunctions in patients with OCD, (3) comparing risk for sexual dysfunction in OCD groups with the prevalence in control groups, (4) comparing sexual satisfaction between OCD groups and non-clinical groups, and (5) investigating moderators of sexual dysfunction in OCD groups as compared with control groups. Gender, age, marital status, OCD symptom severity and subtypes, comorbid depressive disorders, comorbid anxiety disorders, concurrent psychiatric medications, comorbid general medical disease, and study quality will be investigated as moderators. The protocol is reported according to PRISMA-P guidelines. The search will be conducted by independent reviewers during the second week of December 2019 by using electronic databases (Scopus, PubMed, EMBASE, PsycINFO, CINAHL, and the Cochrane Library), by contacting the authors of the included studies to identify further data, by examining the references of the included studies, and by handsearching conference proceedings and theses/doctoral dissertations. The study quality will be independently evaluated using the Newcastle-Ottawa Quality Assessment Scale. Random-effect meta-analyses will be computed. If there is insufficient data for a specific outcome, only a systematic review will be performed. This review may support clinical practice highlighting the importance of the assessment of sexuality in patients with OCD and suggesting the use of therapeutic strategies dedicated to sexuality in this clinical population with the aim of improving patients’ quality of life. Potential limitations will regard the heterogeneity of the studies in terms of the instruments used to assess sexual dysfunction/satisfaction and of the definitions used to conceptualize sexual dysfunction. Prospero CRD42019132264

    更新日期:2020-01-11
  • Assessing the completeness and comparability of outcomes in systematic reviews addressing food security: protocol for a methodological study
    Syst. Rev. (IF 0) Pub Date : 2020-01-09
    Solange Durão; Marianne Visser; Tamara Kredo; Ian J. Saldanha

    Systematic reviews should specify all outcomes at the protocol stage. Pre-specification helps prevent outcome choice from being influenced by knowledge of included study results. Completely specified outcomes comprise five elements: (1) domain (title), (2) specific measurement (technique/instrument), (3) specific metric (data format for analysis), (4) method of aggregation (how group data are summarised), and (5) time points. This study aims to assess the completeness of outcome pre-specification in systematic reviews of interventions to improve food security, specifically food availability, in low- and middle-income countries, as well as to assess the comparability of outcome elements across reviews reporting the same outcome domains. We will examine systematic reviews from an ongoing overview of systematic reviews, which assessed the effects of interventions addressing food insecurity through improving food production, access, or utilisation compared with no intervention or a different intervention, on nutrition outcomes. We will examine the original protocols; if unavailable, we will examine the “Methods” section of the systematic reviews’ most recent version. One investigator will identify and group all outcome domains that the authors of the included protocols intended to measure in the systematic review and a second investigator will verify the domains. For outcome domains reported in at least 25% of protocols, one author will extract data using a pre-specified form and a second author will verify the data. We will use descriptive statistics to report the number, types, and degree of specification of outcomes in included protocols. We will assess the extent of completeness of outcome pre-specification based on the number of outcome elements (out of five). We will assess comparability of outcome domains through examining how individual elements are described across SRs reporting the same outcome domains. Our findings will contribute to understanding about the best approach to pre-specify outcomes for systematic reviews and primary research in the field of food security.

    更新日期:2020-01-11
  • A systematic review protocol examining workplace interventions that aim to improve employee health and wellbeing in male-dominated industries
    Syst. Rev. (IF 0) Pub Date : 2020-01-09
    Paige M. Hulls; Rebecca C. Richmond; Richard M. Martin; Frank de Vocht

    The workplace environment potentially provides access to a large population who are employed, and it is an employer's responsibility to provide appropriate conditions for its employees. Whilst the aetiology of cardiovascular disease is multifactorial, it is generally acknowledged that working conditions, gender and age are involved in its development. Male-dominated industries (comprising > 70% male workers, e.g., agriculture, construction, manufacturing, mining, transport and technology) have a higher prevalence of health risk behaviours than other population subgroups. Working in a gender-dominated industry can impact an employee's health and wellbeing, particularly for the opposite sex. This systematic review examines workplace interventions that address the health and wellbeing of employees in male-dominated industries. We will include randomised controlled trials and studies with non-randomised intervention groups. The interventions must aim to improve employee physical and/or mental health and wellbeing implemented in the workplace in male-dominated industries. There will be no limits on date. The following electronic databases will be searched for published studies: Web of Science, Embed, MedLine, PsycInfo and the Cochrane Database. The search strategy will include free-text terms and MeSH vocabulary, including ‘male-dominated industries’, ‘workplace interventions’, ‘occupational stress’, ‘mental health’, ‘cardiovascular disease’, ‘blood pressure’, ‘body mass index’ and ‘exercise’. Two authors will independently select, review and extract data from studies that meet the inclusion criteria. The Cochrane's Risk of Bias tool will be used to assess risk of bias. We will perform structured summaries of the included studies and, if possible, conduct meta-analyses or construct an Albatross plot. There are an increasing number of interventions designed to improve employee health and wellbeing in the workplace, but no prior review that systematically evaluates their effectiveness. A systematic review is required to prioritise the future implementation of those interventions found to be most effective. PROSPERO CRD42019161283

    更新日期:2020-01-11
  • Mapping the evidence on health equity considerations in economic evaluations of health interventions: a scoping review protocol
    Syst. Rev. (IF 0) Pub Date : 2020-01-08
    Hafizah Besar Sa’aid; Sharon Mathew; Marina Richardson; Joanna M. Bielecki; Beate Sander

    Equity in health has become an important policy agenda around the world, prompting health economists to advance methods to enable the inclusion of equity in economic evaluations. Among the methods that have been proposed to explicitly include equity are the weighting analysis, equity impact analysis, and equity trade-off analysis. This is a new development and a comprehensive overview of trends and concepts of health equity in economic evaluations is lacking. Thus, our objective is to map the current state of the literature with respect to how health equity is considered in economic evaluations of health interventions reported in the academic and gray literature. We will conduct a scoping review to identify and map evidence on how health equity is considered in economic evaluations of health interventions. We will search relevant electronic, gray literature and key journals. We developed a search strategy using text words and Medical Subject Headings terms related to health equity and economic evaluations of health interventions. Articles retrieved will be uploaded to reference manager software for screening and data extraction. Two reviewers will independently screen the articles based on their titles and abstracts for inclusion, and then will independently screen a full text to ascertain final inclusion. A simple numerical count will be used to quantify the data and a content analysis will be conducted to present the narrative; that is, a thematic summary of the data collected. The results of this scoping review will provide a comprehensive overview of the current evidence on how health equity is considered in economic evaluations of health interventions and its research gaps. It will also provide key information to decision-makers and policy-makers to understand ways to include health equity into the prioritization of health interventions when aiming for a more equitable distribution of health resources. This protocol was registered with Open Science Framework (OSF) Registry on August 14, 2019 (https://osf.io/9my2z/registrations).

    更新日期:2020-01-08
  • Systematic review and meta-analysis protocol for efficacy and safety of Momordica charantia L. on animal models of type 2 diabetes mellitus
    Syst. Rev. (IF 0) Pub Date : 2020-01-08
    Emanuel L. Peter; Andrew G. Mtewa; Prakash B. Nagendrappa; Anita Kaligirwa; Crispin Duncan Sesaazi

    Studies on several preclinical models of type 2 diabetes mellitus have been conducted to establish the hypoglycemic activity of Momordica charantia L. Concerned with appropriateness of these models, we designed a systematic review to establish the efficacy and safety of M. charantia L. in preclinical models of type 2 diabetes mellitus. Review authors will search without language restriction in MEDLINE/PubMed, Web of Science, Embase, Scopus, and CINAHL databases through April 2019. Search filters will be applied to enhance search efficiency. The authors will search for gray literature in Google and Google Scholar, OpenGrey, and ProQuest Dissertations & Theses. Two authors will evaluate full texts, extract data, and asses risk of bias independently. The review will include randomized or non-randomized studies that assessed the efficacy or safety of M. charantia L. with vehicle control group. The primary endpoint will be fasting blood glucose level. We will use Egger’s test to assess publication biases. Chi-square test and I2 will be used to assess heterogeneity in effect size of the primary outcome. Using RevMan software version 5.3, the authors will perform a meta-analysis of quantitative data. The strength of evidence will be rated as high, moderate, low, or very low using GRADE framework for animal studies. This systematic review will potentially improve research practice by identifying risks of bias and design features that compromise translatability and contribute to evidence-based clinical trial design. PROSPERO CRD42019119181

    更新日期:2020-01-08
  • Health education programs for improving men’s engagement with health services in low- to middle-income countries: a scoping review protocol
    Syst. Rev. (IF 0) Pub Date : 2020-01-07
    Tafadzwa Dzinamarira; Desmond Kuupiel; Tivani Phosa Mashamba-Thompson

    Health education programs (HEPs) have been documented to increase individuals’ awareness toward their health and improve health outcomes. Given the reported poor health seeking behavior among men in low- to middle-income countries (LMICs), it is crucial for HEPs to be targeted toward men in order to improve health outcomes. Here, we outline a protocol for a scoping review aimed at mapping literature on HEPs for men in LMICs in order to reveal gaps to guide future research and practice. We will conduct a scoping review with guidance from the Arksey and O’Malley framework (Journal of Social Research Methodology 8(1):19–32, 2005), further enhanced by Levac et al. (Implementation Science 5(1):69, 2010). We will conduct a comprehensive keyword search for relevant studies presenting evidence on HEP for men in LMICs from PubMed, Google Scholar, EBSCOhost, and WEB of Science databases. In addition, we will search for relevant gray literature, dissertations, and theses from university repositories as well as international organizations such as the World Health Organization (WHO). We will include articles reporting evidence on health education programs for men in LMICs and published between January 2000 and March 2019. We will employ NVIVO version 12 software package to extract the relevant outcomes from the included articles using content thematic analysis. We will conduct quality appraisal of the included articles using the mixed methods appraisal tool (MMAT) 2018 version. We anticipate to find relevant studies reporting on health education programs for men in LMICs. The findings of this review will guide further implementation research on health education programs for men in LMICs. The results of the proposed scoping review will be disseminated electronically, in print, and through conference presentation as well as key stakeholder meetings.

    更新日期:2020-01-07
  • Interactions of clinical relevance associated with concurrent administration of prescription drug and food or medicinal plants: a systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2020-01-06
    Adriana Orellana-Paucar; Daniela Vintimilla-Rojas

    An inadequate combination of prescription drugs with food or medicinal plants could cause adverse effects in patients or produce negative therapeutic results. Therefore, this generic systematic review protocol aims to identify and synthesize the literature on clinical characteristics and safety issues of these types of pharmacological interactions occurring in children, adolescents, adults, pregnant/lactating women, and older adults. This generic protocol follows the stated guidelines from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement. A literature search will be performed in PubMed, Scopus, and Virtual Health Library (VHL) electronic databases from 1960 till present for studies reporting clinical characteristics and safety issues associated with pharmacological interactions occurring between prescription drugs and food or medicinal plants in participants from birth-age to ≥ 65-year-old, including pregnant/lactating women. Lateral searching will be carried out in PubMed via related citation. Two reviewers will carry out an independent evaluation of eligible studies as well as the corresponding data extraction of the selected ones. Subsequently, the methodological quality evaluation of the selected articles will be completed using the corresponding Joanna Briggs Institute Checklists. Moreover, the quality of evidence will be graded according to the criteria of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group. Quantitative research in humans comprising clinical trials and clinical, comparative and, observational studies will be included. The main outcomes of this protocol involve reported potential food-drug and herb-drug interactions, associated safety issues, and adverse reactions along with the generic name of the prescribed drug and the scientific name of the food and medicinal plants involved in these types of pharmacological interactions. Finally, findings extracted from the selected studies will be summarized in a narrative synthesis. This generic systematic review protocol seeks to synthesize and critically evaluate current knowledge besides to identify any comprehension gaps in the concurrent administration of prescription drugs with food and herbs. By achieving a better understanding of this topic, this information will allow healthcare professionals to develop useful strategies to recognize, manage, and prevent these types of pharmacological interactions at different age stages, including pregnant/lactating women. PROSPERO CRD42018117308

    更新日期:2020-01-06
  • Mapping evidence on women’s knowledge and practice of breast self-examination in sub-Saharan Africa: a scoping review protocol
    Syst. Rev. (IF 0) Pub Date : 2020-01-06
    Roseline H. Udoh; Monica Ansu-Mensah; Mohammed Tahiru; Vitalis Bawontuo; Desmond Kuupiel

    Globally, breast cancer is the most common malignant condition in women. Breast self-examination practice following correct procedure potentially can lead to early detection of breast abnormalities. We propose to systematically chart literature and examine the scope of evidence on women’s knowledge and practice of breast self-examination in sub-Saharan Africa (SSA). Our scoping review methods will be guided by the framework proposed by Arksey and O'Malley, Levac et al. and Joanna Briggs Institute guidelines. Literature searches will be conducted in the following electronic databases (from 2008 onwards): PubMed/MEDLINE, Scopus, Web of Science, CINAHL, PsycINFO and Health Sources. Grey literature will be identified through searching dissertation databases, Google Scholar and governmental databases. Two reviewers will screen all citations and full-text articles We will abstract data, organise them into themes and sub-themes, summarise them and report the results using a narrative synthesis. The study methodological quality (or bias) will be appraised using a mixed-method appraisal tool. The findings from the scoping review will contribute to obtain an understanding of the women’s knowledge and practice of breast self-examination in sub-Saharan Africa, and will likely reveal the depth of evidence helping to identify gaps for future research. Results will be published in a peer-reviewed journal. Implications for clinical practice and health policy will be discussed.

    更新日期:2020-01-06
  • Reducing meat consumption by appealing to animal welfare: protocol for a meta-analysis and theoretical review
    Syst. Rev. (IF 0) Pub Date : 2020-01-06
    Maya B. Mathur; Thomas N. Robinson; David B. Reichling; Christopher D. Gardner; Janice Nadler; Paul A. Bain; Jacob Peacock

    Reducing meat consumption may improve human health, curb environmental damage and greenhouse gas emissions, and limit the large-scale suffering of animals raised in factory farms. Previous work has begun to develop interventions to reduce individual meat consumption, often by appealing directly to individual health motivations. However, research on nutritional behavior change suggests that interventions additionally linking behavior to ethical values, identity formation, and existing social movements may be particularly effective and longer-lasting. Regarding meat consumption, preliminary evidence and psychological theory suggest that appeals related to animal welfare may have considerable potential to effectively leverage these elements of human psychology. We aim to conduct a systematic review and quantitative meta-analysis evaluating the effectiveness of animal welfare-related appeals on actual or intended meat consumption or purchasing. Our investigation will critically synthesize the current state of knowledge regarding psychological mechanisms of intervening on individual meat consumption and empirically identify the psychological characteristics underlying the most effective animal welfare-based interventions. We will systematically search eight academic databases and extensively search unpublished grey literature. We will include studies that assess interventions intended to reduce meat consumption or purchase through the mention or portrayal of animal welfare, that measure outcomes related to meat consumption or purchase, and that have a control condition. Eligible studies may recruit from any human population, be written in any language, and be published or released any time. We will meta-analyze the studies, reporting the pooled point estimate and additional metrics that describe the distribution of potentially heterogeneous effects. We will assess studies’ risk of bias and conduct sensitivity analyses for publication bias. We describe possible follow-up analyses to investigate hypothesized moderators of intervention effectiveness. The findings of the proposed systematic review and meta-analysis, including any identified methodological limitations of the existing literature, could inform the design of successful evidence-based interventions with broad potential to improve human, animal, and environmental well-being. The protocol was preregistered via the Open Science Framework (https://osf.io/d3y56/registrations).

    更新日期:2020-01-06
  • Measuring women’s experiences of maternity care: protocol for a systematic review of self-report survey instruments
    Syst. Rev. (IF 0) Pub Date : 2020-01-06
    Claire Beecher; Richard Greene; Laura O’Dwyer; Ethel Ryan; Mark White; Michelle Beattie; Declan Devane

    The use of survey instruments to measure women’s experiences of their maternity care is regarded internationally as an indicator of the quality of care received. To ensure the credibility of the data arising from these instruments, the methodological quality of development must be high. This paper reports the protocol for a systematic review of self-report instruments used to measure women’s experiences of their maternity care. Citation databases CINAHL, Ovid MEDLINE and EMBASE will be searched from 2002 to 2018 using keywords including women, experience, maternity care, questionnaires, surveys, and self-report. Citations will be screened by two reviewers, in two rounds, for inclusion as per predetermined inclusion and exclusion criteria. Data extraction forms will be populated with data, extracted from each study, to evaluate the methodological quality of each survey instrument and the criteria for good measurement properties using quality criteria. Data will also be extracted to categorise the items included in each survey instrument. A combination of a structured narrative synthesis and quantitate summaries in tabular format will allow for recommendations to be made on the use, adaptation and development of future survey instruments. The value of survey instruments that evaluate women’s experiences of their maternity care, as a marker of quality care, has been recognised internationally with many countries employing the use of such instruments to inform policy and practice. The development of these instruments must be methodologically sound and the instrument itself fit for the purpose and context in which it is used. This protocol describes the methods that will be used to complete a systematic review that will serve as a guide for choosing the most appropriate existing instruments to use or adapt so that they are fit for purpose, in addition to informing the development of new instruments. PROSPERO CRD42018105325

    更新日期:2020-01-06
  • Effectiveness of remineralising agents in prevention and treatment of orthodontically induced white spot lesions: a protocol for a systematic review incorporating network meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-29
    Huimin Hu; Chong Feng; Zhaowei Jiang; Lufei Wang; Sonu Shrestha; Xiaoming Su; Yu Shu; Long Ge; Wenli Lai; Fang Hua; Hu Long

    White spot lesions (WSLs) are common adverse effects in fixed orthodontic treatment. Remineralising agents are widely used to prevent WSLs formation and are the first-line treatment for existing WSLs. Previous systematic reviews have evaluated the effectiveness of remineralisation agents in the management of WSLs. However, their conclusions were contradictory. The objective of this study will be to compare the effectiveness and safety of current remineralising agents used in the management of WSLs in patients treated with fixed orthodontic appliances in any orthodontic setting. Literature searches will be conducted in several electronic databases (from inception onwards): MEDLINE (via Ovid), Scopus, Embase, the Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL), among others. Grey literature will be identified through searching clinical trials registries. Randomised controlled trials that compared the effectiveness of different remineralisation agents in the prevention and treatment of WSLs will be included. Two researchers will independently screen all citations, full-text articles, and abstract data. The study risk bias will be appraised using an appropriate tool. The primary outcomes will be WSLs incidence and severity of WSLs. Secondary outcomes will be subjective measures of WSLs and adverse effects. The mean difference (MD) and relative risk (RR) with corresponding 95% confidence intervals (CI) will be chosen as effect measures for continuous and binary outcomes, respectively. If feasible, fixed and random-effects pairwise meta-analyses and frequentist network meta-analyses will be conducted where appropriate. This network meta-analysis will compare the effectiveness of remineralising agents in the prevention and treatment of orthodontically induced WSLs. By integrating the evidence from direct and indirect comparisons and ranking all evaluated interventions, our findings have the potential to help clinicians make more accurate treatment decisions. PROSPERO CRD42019116852, registered on March 15, 2019

    更新日期:2019-12-30
  • Case report: a rapid review approach used by the UK National Screening Committee to inform recommendations on general population screening for vasa praevia
    Syst. Rev. (IF 0) Pub Date : 2019-12-29
    Saoirse Leonard; Amy Buchanan-Hughes; Anna Bobrowska; Cristina Visintin; John Marshall

    The UK National Screening Committee (UK NSC) reviews evidence about existing or potential population screening programmes using rapid review products called evidence summaries. We provide a case report as an example of how rapid reviews are developed within the UK NSC’s process, consider how the quality of rapid reviews should be assessed and ask whether the rapid review was an appropriate tool to inform the UK NSC’s decision-making process. We present the rapid review approach taken by the commissioner and the reviewers to develop an evidence summary for vasa praevia (VP), which the UK NSC reappraised as part of its 3-yearly cycle for conditions where screening is currently not recommended. We apply the AMSTAR 2 quality appraisal checklist for systematic reviews, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and a published checklist of items to consider with a rapid review approach. As UK NSC evidence summaries do not include meta-analyses, any related AMSTAR 2 or PRISMA checklist items were considered inapplicable. The evidence summary was available within the required timelines and highlighted little change from the previous review in terms of key evidence gaps relating to the epidemiology of VP, the screening test and the management pathway. Therefore, the UK NSC concluded that there was insufficient evidence to support a change in its previous recommendation against screening. The evidence summary scored moderately against the applicable AMSTAR 2 and PRISMA checklist items. Against the published checklist of items to consider with a rapid review approach, the evidence summary performed well. In this case report, the use of a rapid review as part of the UK NSC’s process enabled a pragmatic approach to assessing the overall volume, quality and direction of literature on key questions relating to the viability of a population screening programme for VP. Based on our assessments of this single evidence summary, systematic review quality appraisal tools may undervalue rapid reviews. The validity of the methods used in this case report, as well as the wider generalisability of our insights relating to rapid review practice, reporting and quality assessment, requires analysis of a larger sample of rapid reviews.

    更新日期:2019-12-30
  • Pharmacologic and surgical therapies for patients with Meniere’s disease: a protocol for a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-30
    Nadera Ahmadzai; Wei Cheng; Dianna Wolfe; Jamie Bonaparte; David Schramm; Elizabeth Fitzpatrick; Vincent Lin; Becky Skidmore; Leila Esmaeilisaraji; Shaun Kilty; Brian Hutton

    Hearing loss is one of the leading causes of disability in Canada and worldwide, with more than one million Canadians enduring a hearing-related disability. Meniere’s disease (MD) is a chronic condition of the inner ear, manifesting as a triad of disabling symptoms, including attacks of vertigo, fluctuating sensorineural hearing loss (SNHL), and tinnitus. Impacts on quality of life are severe, particularly with respect to restrictions in social participation and physical activity, fatigue, and reduced capacity to work. Anxiety and other psychological disorders may result from the restrictions imposed on life, the constant uncertainty of vertigo attacks, and fluctuating SNHL, with neuroses and depression affecting 40 to 60% of sufferers of intractable MD. There is a need to establish the benefits of previously studied interventions with greater certainty. The planned systematic review and meta-analyses/network meta-analyses (NMAs) will assess the relative effects of competing pharmacologic and surgical interventions for management of MD in adults. An experienced medical information specialist in consultation with the review team will develop the electronic search strategies. We will search various databases including MEDLINE, Embase, and the Cochrane Library with no date or language restrictions for published literature, and key clinical trial registries for in-progress and completed trials. Screening of the literature will be performed by two reviewers independently using pre-specified eligibility criteria, and quality of the included studies will be assessed using the Cochrane Risk of Bias tool. We will resolve disagreements through consensus or third-party adjudication. When applicable, meta-analyses and NMAs will be pursued to compare interventions in terms of their effects on outcomes, including frequency and severity of vertigo, occurrence and intensity of tinnitus, changes in hearing and speech recognition, quality of life, and harms. Separate analyses exploring the effects of pharmacologic and surgical approaches will be performed. Our planned systematic review will provide informative evaluations of existing treatments for management of Meniere’s disease. The findings will inform practitioners as to the relative benefits and harms of the existing competing interventions for MD, offer optimal clinical treatment strategies, identify evidence gaps, and determine promising therapies for evaluation in future trials. PROSPERO CRD42019119129

    更新日期:2019-12-30
  • Magnetic resonance spectroscopy across chronic pain disorders: a systematic review protocol synthesising anatomical and metabolite findings in chronic pain patients
    Syst. Rev. (IF 0) Pub Date : 2019-12-27
    Kirk J. Levins; Thomas Drago; Elena Roman; Anna Martin; Roisin King; Paul Murphy; Hugh Gallagher; Denis Barry; Erik O’Hanlon; Darren William Roddy

    Chronic pain is pain greater than 3 months duration that may result from disease, trauma, surgery, or unknown origin. The overlap between the psychological, behavioural, and management aspects of pain suggest that limbic brain neurochemistry plays a role in chronic pain pathology. Proton magnetic resonance spectroscopy (1H-MRS) can evaluate in vivo brain metabolites including creatine, N-acetylaspartate, myo-inositol, choline, glutamate, glutamine, and gamma-aminobutyric acid in chronic pain; however, a comprehensive systemic review of metabolite expression patterns across all brain areas has yet to be performed. Online databases including PubMed/MEDLINE, Google Scholar, EMBASE, the Cochrane Library, OVID, and PsycINFO will be searched for articles relating to 1H-MRS and chronic pain. Study inclusion criteria will include ages of between 18 and 65 years with a definite diagnosis of chronic pain, no comorbidities, clearly stated brain volumes of interest, and imaging protocols, with comparisons to healthy controls. Two reviewers will extract data relating to volumes of interest, metabolites, study participant demographics, diagnostic method and pain scores, treatments and duration of treatment, scanner information, 1H-MRS acquisition protocols, and spectral processing software. Where possible, volumes of interest will be reassigned as regions of interest consistent with known regional anatomical and functional properties to increase the power and relevance of the analysis. Statistical analyses will then be conducted using STATA. A central common pathway may exist for chronic pain due to the behavioural manifestations and management similarities between its different types. The goal of this systemic review is to generate a comprehensive neurochemical theory of chronic pain in different brain compartments. This study is registered with PROSPERO CRD42018112640.

    更新日期:2019-12-27
  • A protocol for systematic review of Plantago major L. effectiveness in accelerating wound-healing in animal models
    Syst. Rev. (IF 0) Pub Date : 2019-12-23
    Fernanda de Cássia Israel Cardoso; Priscila Peruzzo Apolinário; Jéssica da Silva Cunha Breder; Thalita Paranhos; Henrique Ceretta Oliveira; Ariane Dini Polidoro; Ana Railka Souza Oliveira Kumakura; Maria Helena Melo Lima

    Studies have indicated that Plantago major L. (P. major) has therapeutic properties, such as anti-inflammatory, antioxidant, antifungal, immunostimulatory, and tissue regeneration. This plant species is assumed to provide potent tissue repair and healing in treatments of skin wound injuries, but the understanding of its effectiveness is still unclear. The systematic review proposed herein aims to assess effectiveness of P. major for wound healing in animal models. We will conduct database searches in BVS, PubMed, Scopus, Web of Science, CINAHL, and CABDirect. Reviewers will independently evaluate titles, abstracts, and full-text articles retrieved from databases to identify potentially eligible studies. Relevant articles will be assessed for risk of bias and quality. The database searches will include analysis of wound healing rate through macroscopic evaluation, photo images, or calculation of the wound area retraction until the wound closure. Relevant data will be compiled for the capability and effectiveness of P. major treatments in accelerating wound healing. Random effects meta-analysis models will be employed to compare among groups based on outcome variables from studies reporting sufficient high-quality data. Results of this systematic review will be presented in a narrative synthesis form. They will provide a summary and clear understanding of the relevant current questions and evidences directly related to P. major effective tissue repair and healing. Outcomes of this systematic review will contribute with important information that could benefit future research efforts and potential applicability in humans. PROSPERO CRD42019121962

    更新日期:2019-12-25
  • Preferred Reporting Items for Overviews of Reviews (PRIOR): a protocol for development of a reporting guideline for overviews of reviews of healthcare interventions
    Syst. Rev. (IF 0) Pub Date : 2019-12-23
    Michelle Pollock; Ricardo M. Fernandes; Dawid Pieper; Andrea C. Tricco; Michelle Gates; Allison Gates; Lisa Hartling

    Overviews of reviews (i.e., overviews) compile information from multiple systematic reviews to provide a single synthesis of relevant evidence for healthcare decision-making. Despite their increasing popularity, there are currently no systematically developed reporting guidelines for overviews. This is problematic because the reporting of published overviews varies considerably and is often substandard. Our objective is to use explicit, systematic, and transparent methods to develop an evidence-based and agreement-based reporting guideline for overviews of reviews of healthcare interventions (PRIOR, Preferred Reporting Items for Overviews of Reviews). We will develop the PRIOR reporting guideline in four stages, using established methods for developing reporting guidelines in health research. First, we will establish an international and multidisciplinary expert advisory board that will oversee the conduct of the project and provide methodological support. Second, we will use the results of comprehensive literature reviews to develop a list of prospective checklist items for the reporting guideline. Third, we will use a modified Delphi exercise to achieve a high level of expert agreement on the list of items to be included in the PRIOR reporting guideline. We will identify and recruit a group of up to 100 international experts who will provide input into the guideline in three Delphi rounds: the first two rounds will occur via online survey, and the third round will occur during a smaller (8 to 10 participants) in-person meeting that will use a nominal group technique. Fourth, we will produce and publish the PRIOR reporting guideline. A systematically developed reporting guideline for overviews could help to improve the accuracy, completeness, and transparency of overviews. This, in turn, could help maximize the value and impact of overviews by allowing more efficient interpretation and use of their research findings.

    更新日期:2019-12-23
  • Rehabilitation approaches for children living with HIV in sub-Saharan Africa: a protocol for scoping review
    Syst. Rev. (IF 0) Pub Date : 2019-12-23
    Stacy Maddocks; Saul Cobbing; Jill Hanass-Hancock; Verusia Chetty

    A large number of children living with chronic conditions such as HIV experience impairments and disabilities. Current sub-Saharan African healthcare systems are challenged with paediatric care that does not integrate rehabilitation into management of chronic diseases such as HIV. Furthermore, little attention is paid to societal inclusion, community engagement and educational needs of these children. Integration of paediatric care and rehabilitation in a holistic approach can help to overcome the challenges associated with living disabilities. This scoping review proposes a synthesis of existing evidence on rehabilitation intervention strategies to increase functioning and to address disability-related barriers in children living with HIV and disability in sub-Saharan Africa. A scoping review will be conducted to systematically map evidence on rehabilitation intervention for children living with HIV in sub-Saharan Africa. Studies in sub-Saharan Africa from December 2012 to 2019 on rehabilitation interventions for children aged 5 to 10 years living with HIV will be included in the review. Peer-reviewed primary studies, as well as grey literature, will be identified from electronic databases including Google Scholar; PubMed; Medline; CINAHL and Cochrane. The search strings using keywords such as “HIV”, “impairment”, “disability”, “neurocognitive impairment”, “behavioural”, “rehabilitation” and “intervention” will be conducted using Boolean logic. Two groups of independent reviewers will conduct all title, abstract and full article screening. The study selection process will be mapped using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. A predesigned data-charting table will supplement the extraction of data. NVIVO software will aide in the thematic analysis of the data. The information from studies will be discussed in relation to the research questions using a critical narrative to explore the emergent themes. The quality of studies will be appraised using the mixed method appraisal tool. The scoping review will provide a baseline of evidence on rehabilitation interventions for children living with HIV in sub-Saharan Africa. The scoping review will inform healthcare providers, scholars and policy developers about the current use of rehabilitation interventions and what gaps need to be addressed with further research and intervention development. OSF Center for Open Science: https://osf.io/ed7zb/

    更新日期:2019-12-23
  • The Systematic Review Data Repository (SRDR): descriptive characteristics of publicly available data and opportunities for research
    Syst. Rev. (IF 0) Pub Date : 2019-12-20
    Ian J. Saldanha; Bryant T. Smith; Evangelia Ntzani; Jens Jap; Ethan M. Balk; Joseph Lau

    Conducting systematic reviews (“reviews”) requires a great deal of effort and resources. Making data extracted during reviews available publicly could offer many benefits, including reducing unnecessary duplication of effort, standardizing data, supporting analyses to address secondary research questions, and facilitating methodologic research. Funded by the US Agency for Healthcare Research and Quality (AHRQ), the Systematic Review Data Repository (SRDR) is a free, web-based, open-source, data management and archival platform for reviews. Our specific objectives in this paper are to describe (1) the current extent of usage of SRDR and (2) the characteristics of all projects with publicly available data on the SRDR website. We examined all projects with data made publicly available through SRDR as of November 12, 2019. We extracted information about the characteristics of these projects. Two investigators extracted and verified the data. SRDR has had 2552 individual user accounts belonging to users from 80 countries. Since SRDR’s launch in 2012, data have been made available publicly for 152 of the 735 projects in SRDR (21%), at a rate of 24.5 projects per year, on average. Most projects are in clinical fields (144/152 projects; 95%); most have evaluated interventions (therapeutic or preventive) (109/152; 72%). The most frequent health areas addressed are mental and behavioral disorders (31/152; 20%) and diseases of the eye and ocular adnexa (23/152; 15%). Two-thirds of the projects (104/152; 67%) were funded by AHRQ, and one-sixth (23/152; 15%) are Cochrane reviews. The 152 projects each address a median of 3 research questions (IQR 1–5) and include a median of 70 studies (IQR 20–130). Until we arrive at a future in which the systematic review and broader research communities are comfortable with the accuracy of automated data extraction, re-use of data extracted by humans has the potential to help reduce redundancy and costs. The 152 projects with publicly available data through SRDR, and the more than 15,000 studies therein, are freely available to researchers and the general public who might be working on similar reviews or updates of reviews or who want access to the data for decision-making, meta-research, or other purposes.

    更新日期:2019-12-21
  • Respiratory syncytial virus prophylaxis for prevention of recurrent childhood wheeze and asthma: a protocol for a systematic review
    Syst. Rev. (IF 0) Pub Date : 2019-12-19
    Lauren Alexandra Quinn; Michael D. Shields; Helen E. Groves

    Lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) has been associated with greater risk of recurrent wheezing and subsequent asthma. However, it is still unclear whether this association is causal or not. RSV-specific monoclonal antibodies have been shown to reduce RSV-related hospitalisations in high-risk infants, i.e. those born pre-term, but the longer term follow-up has given conflicting evidence for the prevention of recurrent wheeze or asthma. We aim to perform a systematic review and meta-analysis to determine whether or not prophylaxis with a monoclonal antibody for prevention of RSV-bronchiolitis reduces the risk of subsequent recurrent wheeze or asthma. If so, this would support the hypothesis that the association between RSV and recurrent wheeze and/or asthma is causative. To identify relevant studies, we will search a number of databases including Medline, Embase, PubMed and Web of Science and will also manually look for unpublished data by contacting the manufacturers of monoclonal antibodies. The intervention being investigated is RSV-specific monoclonal antibody prophylaxis, and the outcome being measured is recurrent wheeze and/or asthma. Studies will be screened according to inclusion/exclusion criteria, to include primary studies of any study design type. Eligible studies will then be evaluated for quality and assessed for bias independently by three reviewers using the ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) approach. The results of the studies will be extracted into 2 × 2 outcome tables, and a meta-analysis will be carried out to produce forest plots based on relative risk. Heterogeneity will be assessed using the I2 statistic. The statistical software we will use is StatsDirect. This review will aid in determining if the relationship between RSV and asthma development is a causal one, by showing the effect (if any) of RSV prophylaxis on subsequent recurrent wheeze/asthma. If this study shows RSV prophylaxis to have no effect on the outcome of recurrent wheeze/asthma, the question of causality remains.

    更新日期:2019-12-20
  • The scale of neurodegeneration in moderate-to-severe traumatic brain injury: a systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-18
    Bhanu Sharma; Alana T. Changoor; Leanne Monteiro; Brenda Colella; Robin E. A. Green

    Our understanding of recovery after moderate-to-severe traumatic brain injury (TBI) has shifted. Until recently, it was presumed that following a period of acute neurological vulnerability, the brain remained stable in the chronic stages of injury. However, recent research has shown neurodegeneration in the chronic stages of moderate-to-severe TBI, challenging the assumption of neurological stability. While there is extensive evidence that neurodegeneration occurs, debate remains regarding the scale and timing. This systematic review will evaluate the scale and timelines of neurodegeneration in adult patients with moderate-to-severe TBI. Literature searches will be conducted in six electronic databases (from inception onwards), including MEDLINE, EMBASE, PsycINFO, CINAHL, SportDiscus, and Cochrane Central Register of Controlled Trials. We will include observational studies that examine neurodegenerative changes within a single sample of TBI patients or studies that compare neuroimaging outcomes between TBI patients and healthy controls. Our primary outcome is structural neuroimaging, and our secondary outcome is diffusion tensor imaging for detection of post-injury white matter changes. All screening, data extraction, and study quality appraisal will be performed independently by the same two study members. It is expected that a narrative summary of the literature will be produced. If feasible, we will conduct a random-effects meta-analysis. However, given the expected heterogeneity between studies (with respect to, for example, timing of imaging, regions imaged) we do not expect to perform a meta-analysis; rather, a narrative synthesis of our findings is expected to be performed. Understanding the scale and timelines of neurodegeneration in moderate-to-severe TBI (as well as which brain areas are most vulnerable to chronic declines) can inform intervention research designed to offset such changes. This may help improve patient outcome following moderate-to-severe TBI and, in turn, reduce the burden of the injury. PROSPERO CRD42019117548

    更新日期:2019-12-19
  • The impact of inclusion, dose and duration of pyrazinamide (PZA) on efficacy and safety outcomes in tuberculosis: systematic review and meta-analysis protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-17
    James D. Millard; Elizabeth A. Mackay; Laura J. Bonnett; Geraint R. Davies

    Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735

    更新日期:2019-12-18
  • Adding exercise to usual care in patients with hypertension, type 2 diabetes mellitus and/or cardiovascular disease: a protocol for a systematic review with meta-analysis and trial sequential analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-17
    Anupa Rijal; Emil Eik Nielsen; Bianca Hemmingsen; Dinesh Neupane; Peter Haulund Gæde; Michael Hecht Olsen; Janus Christian Jakobsen

    Hypertension, type 2 diabetes mellitus and cardiovascular disease are among the leading causes of mortality globally. Exercise is one of the commonly recommended interventions/preventions for hypertension, type 2 diabetes mellitus and cardiovascular disease. However, the previous reviews have shown conflicting evidence on the effects of exercise. Our objective is to assess the beneficial and harmful effects of adding exercise to usual care for people with hypertension, type 2 diabetes mellitus and/or cardiovascular disease. This protocol for a systematic review was undertaken using the recommendations of The Cochrane Collaboration, the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) and the eight-step assessment procedure suggested by Jakobsen et al. We plan to include all relevant randomised clinical trials and cluster-randomised trials assessing the effects of adding exercise to usual care for people with hypertension, type 2 diabetes mellitus and/or cardiovascular disease. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded on Web of Science, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Science Journal Database (VIP) and BIOSIS. We will systematically assess the risks of random errors using Trial Sequential Analysis as well as risks of bias of all included trials. We will create a ‘Summary of Findings’ table in which we will present our primary and secondary outcomes, and we will assess the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). The present systematic review will have the potential to aid patients, clinicians and decision-makers recommending exercise and thereby, benefit patients with hypertension, type 2 diabetes mellitus and/or cardiovascular disease. PROSPERO CRD42019142313

    更新日期:2019-12-18
  • Etiologic workup in cases of cryptogenic stroke: protocol for a systematic review and comparison of international clinical practice guidelines
    Syst. Rev. (IF 0) Pub Date : 2019-12-17
    Emma P. Bray; Naoimh E. McMahon; Munirah Bangee; A. Hakam Al-Khalidi; Valerio Benedetto; Umesh Chauhan; Andrew J. Clegg; Rachel F. Georgiou; Josephine Gibson; Deirdre A. Lane; Gregory Y. H. Lip; Elizabeth Lightbody; Alakendu Sekhar; Kausik Chatterjee; Caroline L. Watkins

    Stroke is a leading cause of death and disability worldwide. Identifying the aetiology of ischaemic stroke is essential in order to initiate appropriate and timely secondary prevention measures to reduce the risk of recurrence. For the majority of ischaemic strokes, the aetiology can be readily identified, but in at least 30% of cases, the exact aetiology cannot be determined using existing investigative protocols. Such strokes are classed as ‘cryptogenic’ or as a stroke of unknown origin. However, there exists substantial variation in clinical practice when investigating cases of seemingly cryptogenic stroke, often reflecting local service availability and the preferences of treating clinicians. This variation in practice is compounded by the lack of international consensus as to the optimum level and timing of investigations required following a stroke. To address this gap, we aim to systematically review and compare recommendations in evidence-based clinical practice guidelines (CPGs) that relate to the assessment and investigation of the aetiology of ischaemic stroke, and any subsequent diagnosis of cryptogenic stroke. We will search for CPGs using electronic databases (MEDLINE, Health Management Information Consortium (HMIC), EMBASE, and CINAHL), relevant websites and search engines (e.g. guideline specific websites, governmental, charitable, and professional practice organisations) and hand-searching of bibliographies and reference lists. Two reviewers will independently screen titles, abstracts and CPGs using a pre-defined relevance criteria form. From each included CPG, we will extract definitions and terms for cryptogenic stroke; recommendations related to assessment and investigation of the aetiology of stroke, including the grade of recommendations and underpinning evidence. The quality of the included CPGs will be assessed using the AGREE II (Appraisal of Guidelines for Research and Evaluation) tool. Recommendations across the CPGs will be summarised descriptively highlighting areas of convergence and divergence between CPGs. To our knowledge, this will be the first review to systematically compare recommendations of international CPGs on investigating the aetiology of ischaemic stroke. The findings will allow for a better understanding of international perspectives on the optimum level of investigations required following a stroke and thus contribute to achieving greater international consensus on best practice in this important and complex area. PROSPERO CRD42019127822.

    更新日期:2019-12-18
  • Recovery rate and determinants of severe acute malnutrition children treatment in Ethiopia: a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-13
    Kassahun Gebeyehu Yazew; Chanyalew Worku Kassahun; Amare Wondim Ewnetie; Habtamu Kerebih Mekonen; Endalamaw Salilew Abagez

    Severe acute malnutrition affects more than 20 million children. Africa is pointed out as a region where the problem is highly prevalent. There were individual studies on the recovery rate and its determinants among children with severe acute malnutrition in Ethiopia. But, there is no national pooled estimate. Therefore, this systematic review and meta-analysis aimed to estimate the recovery rate and determinants among children with severe acute malnutrition admitted to the therapeutic feeding unit in Ethiopia. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline was followed in this study. Studies were accessed through electronic web-based search from PubMed, Cochrane Library, Google Scholar, and EMBASE. The statistical analysis was conducted using STATA version-11 software. The pooled prevalence was estimated with 95% confidence intervals using a random-effects model. A total of 12 studies were included with 2658 participants in the analysis. The overall pooled estimated recovery rate among children with severe acute malnutrition admitted to the inpatient therapeutic feeding unit in Ethiopia was 72.02 % (CI, 64.83, 79.22%). In the subgroup analysis, the highest estimate (80.29%) was observed in studies conducted in Oromia regional state, while 68.63% was observed in studies Southern Nation Nationality of people region 68.63%. Children who had no congestive heart failure were 4.88 times (OR, 4.88; 95% CI, 2.246, 10.586) more likely to recover than their counterparts. The recovery rate among severe acute malnourished children on the therapeutic feeding unit in Ethiopia lied within the international minimum sphere. Hence, health care providers shall strengthen the management of severe acute malnutrition and management other co-morbidities like congestive heart failure. PROSPERO CRD42019119124

    更新日期:2019-12-17
  • The effectiveness of psychological interventions for fatigue in cancer survivors: systematic review of randomised controlled trials
    Syst. Rev. (IF 0) Pub Date : 2019-12-13
    T. K. Corbett; A. Groarke; D. Devane; E. Carr; J. C. Walsh; B. E. McGuire

    Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. This systematic review evaluated the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. We searched relevant online databases and sources of grey literature. Randomised controlled trials (RCTs) evaluating psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, were included. Two review authors extracted data independently from the selected studies and assessed the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Thirty-three psychological interventions were identified. The sample size of the included studies varied between 28 and 409, with 4525 participants overall. Twenty-three of the included studies reported a significant effect of the interventions on reducing fatigue in cancer survivors. Most interventions focused on psychoeducation, mindfulness, cognitive or behaviour therapy-oriented strategies. However, studies differed widely in terms of measurement tools used to assess fatigue, mode, duration and frequency of the intervention delivery. This review showed some tentative support for psychological interventions for fatigue after cancer treatment. However, as the RCTs were heterogeneous in nature and the number of high-quality studies was limited, definitive conclusions are not yet possible. With the growing need for stage-specific research in cancer, this review sought to inform current practice and to summarise the existing evidence base of randomised controlled trials in the area. PROSPERO registration number: CRD42014015219.

    更新日期:2019-12-17
  • Feasibility and acceptability of living systematic reviews: results from a mixed-methods evaluation
    Syst. Rev. (IF 0) Pub Date : 2019-12-14
    Tanya Millard; Anneliese Synnot; Julian Elliott; Sally Green; Steve McDonald; Tari Turner

    Living systematic reviews (LSRs) offer an approach to keeping high-quality evidence synthesis continually up to date, so the most recent, relevant and reliable evidence can be used to inform policy and practice, resulting in improved quality of care and patient health outcomes. However, they require modifications to authoring and editorial processes and pose technical and publishing challenges. Several teams within Cochrane and the international Living Evidence Network have been piloting living systematic reviews. We conducted a mixed-methods evaluation with participants involved in six LSRs (three Cochrane and three non-Cochrane). Up to three semi-structured interviews were conducted with 27 participants involved with one or more of the pilot LSRs. Interviews explored participants’ experiences contributing to the LSR, barriers and facilitators to their conduct and opportunities for future development. Pilot team members also completed monthly surveys capturing time for key tasks and the number of citations screened for each review. Across the pilot LSRs, search frequency was monthly to three-monthly, with some using tools such as machine learning and Cochrane Crowd to screen searches. Varied approaches were used to communicate updates to readers. The number of citations screened varied widely between the reviews, from three to 300 citations per month. The amount of time spent per month by the author team on each review also varied from 5 min to 32 h. Participants were enthusiastic to be involved in the LSR pilot. They highlighted the importance of a motivated and well-organised team; the value of technology enablers to improve workflow efficiencies; the need to establish reliable and efficient processes to sustain living reviews; and the potential for saving time and effort in the long run. Participants highlighted challenges with the current publication processes, managing ongoing workload and the lack of resources to support LSRs in the long term. Findings to date support feasibility and acceptability of LSR production. There are challenges that need to be addressed for living systematic reviews to be sustainable and have maximum value. The findings from this study will be used in discussions with the Cochrane community, key decision makers and people more broadly concerned with LSRs to identify and develop priorities for scale-up.

    更新日期:2019-12-17
  • Prevalence of lifetime substances use among students in Ethiopia: a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-14
    Hirbo Shore Roba; Addisu Shunu Beyene; Asnake Ararsa Irenso; Berhe Gebremichael

    The use of substances is a growing concern in Ethiopia, and their impacts on younger generation have been a concern of different professionals. Even though students are at high-risk of substance abuse, there is lack of comprehensive evidence for policy decision on substance use among students. Therefore, the aim of this systematic review and meta-analysis was to estimate the prevalence of common substances among students in Ethiopia. A comprehensive literature searches were done from biomedical databases: PubMed/Medline, African Journal Online, HINARI, Science Direct, and Google Scholar for article published until Dcember 31, 2017, and Addis Ababa Uiversity’s electronic library search of unpublished thesis and dissertations. Two authors autonomously selected studies, extracted data, and evaluated quality of studies. The prevalence of lifetime substances use was estimated using the random effects model. Q and I2 statistics were computed to measure the extents of heterogeneity. A total 676 study articles were identified from electronic databases, and 28 of them were included in meta-analysis. The analysis revealed that the lifetime prevalence of any substance use was 52.5% (95% CI 42.4–62.4%), khat 24.7% (95% CI 21.8–27.7%), alcohol 46.2% (95% CI 40.3–52.2%), and smoking cigarette 14.7% (95% CI 11.3–18.5%). Significant heterogeneity was observed but there was no significant publication bias. The lifetime prevalence of khat, alcohol, and cigarette smoking among high school vs university students was 22.5% (95% CI 15.2–30.7%) vs 25.1% (95% CI 21.9–28.5%), 41.4% (95% CI 22.1–62.1%) vs 47.8% (95% CI 39.9–55.7%), and 21.5% (95% CI 12.6–32.1%) vs 12.9% (95% CI 10.1–16.0%), respectively. This meta-analysis highlighted the extent of lifetime prevalence of any substance, khat, alcohol, and cigarettes smoking among students in Ethiopia. Significant percent of high school students have exposed to substances. Policy makers should devise and implement strictly binding regulation to curb widespread of substances around educational institution premises at national level. Priority should be given to intervention strategies that help delay first use of substance to prevent problems later in life. Besides, the problem warrants regular national-level educational institutions based studies focusing on the magnitude, trajectory, and consequences of substance use among students. Systematic review registration: PROSPERO CRD42018082635

    更新日期:2019-12-17
  • Lifestyle interventions to maternal weight loss after birth: a systematic review
    Syst. Rev. (IF 0) Pub Date : 2019-12-16
    Pernille Kjaergaard Christiansen; Mette Maria Skjøth; Mette Juel Rothmann; Christina Anne Vinter; Ronald Francis Lamont; Eva Draborg

    Over the past decades, there has been an increase in overweight and obesity in women of childbearing age, as well as the general population. Overweight and obesity are related to a later, increased risk of type 2 diabetes and cardiovascular diseases. Increasing weight between pregnancies has a negative impact on the development of the fetus in a subsequent pregnancy. It is also related to long-term obesity and overweight for the woman. Accordingly, weight control in women of the childbearing age is important for both women and their offspring. Information and communication technology (ICT) has become an integrated part of many peoples’ lives, and it has the potential to prevent disease. In this systematic review, we summarize the evidence from randomized controlled trials to compare effects of different ICT-based interventions to support postpartum women to achieve weight loss. A systematic search was performed in PubMed, Embase, PsycInfo, CINAHL, Web of Science, Scopus, and Cochrane, searching on terms, such as postpartum, weight loss, telemedicine, and randomized controlled trials. Two independent researchers undertook study selection and data extraction. Results were reported narratively. The systematic review only included studies that were randomized controlled trials. Eight studies were included in the systematic review. All of them were characterized by applying one or more ICT components to assist postpartum women in weight control, and had weight loss as an outcome measure. A significant difference was found in weight loss between control group and intervention group in the majority of the studies. However, five of the studies had a relatively short follow-up period (40 days to 16 weeks), six of the studies had a relatively small sample size (18 to 66 women), and half of the studies indicated challenges with adherence to the interventions over time. ICT-based interventions can support postpartum women to achieve a healthy lifestyle and weight control. Future studies should focus on larger sample sizes, longer follow-up periods, and adherence to the interventions. PROSPERO CRD42018080731

    更新日期:2019-12-17
  • Mapping evidence on access to healthcare information by women of reproductive age in low-and-middle-income countries: scoping review protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-16
    Joyce T. Shatilwe; Tivani P. Mashamba-Thompson

    Research shows that there are inadequate interventions in resource-limited settings that could enable women of reproductive age to access and use health services in those settings. The main objective of this scoping review is to map the evidence on access to healthcare information by women of reproductive age in LMICs. The primary search will include Google Scholar, Science Direct, PubMed, EBSCOhost (Academic search complete, CINAHL with full text, MEDLINE with full text, MEDLINE), Emerald, Embase, CDSR, PsycINFO, published and peer review journals, organisational projects, conference papers, reference list, grey literature sources, as well as reports related to this objective will be included in the study. Identified keywords will be used to search articles from the studies. The articles and abstracts will be screened by two independent reviewers (JS and TPMT). Inclusion and exclusion criteria will be considered to guide the screening. A thematic content analysis will be used to present the narrative account of the reviews, using NVivo computer software (version 11). The scoping review will focus on women of reproductive age in LMICs. We anticipate finding relevant literature on the interventions aimed at accessing health care services in LMICs. The study findings will help reveal research gaps to guide future research. Not registered with PROSPERO (not needed). This scoping review was not registered.

    更新日期:2019-12-17
  • Methods and efficacy of extracellular vesicles derived from mesenchymal stromal cells in animal models of disease: a preclinical systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-12
    Alvin Tieu; Mitchell Slobodian; Dean A. Fergusson; Joshua Montroy; Dylan Burger; Duncan J. Stewart; Risa Shorr; David S. Allan; Manoj M. Lalu

    Over the past decade, mesenchymal stromal cells have been increasingly investigated for their therapeutic potential in several different illnesses. However, cell therapy can be limited by potentially serious adverse events including cell embolus formation and tumorigenesis. Importantly, the protective effects of mesenchymal stromal cells are largely mediated by paracrine mechanisms including release of extracellular vesicles. This systematic review intends to synthesize the current knowledge of mesenchymal stromal cell-derived extracellular vesicles as a therapeutic option for preclinical models of disease, inflammation, or injury. A systematic literature search of MEDLINE, Embase, and BIOSIS databases will be conducted. Interventional preclinical in vivo studies using extracellular vesicles derived from any tissue source of mesenchymal stromal cells will be included. Studies will be screened by abstract, and full-text by two independent reviewers. Eligible studies will undergo data extraction with subcategorization into domains based on disease. Methods utilized for extracellular vesicle characterization and isolation will be collected, as well as information on interventional traits, such as tissue source of mesenchymal stromal cells, dosage regimen, and vesicle modifications. Reported outcomes will be collected to determine which diseases studied may be impacted most from treatment with mesenchymal stromal cell-derived extracellular vesicles. This systematic review will summarize preclinical studies investigating the therapeutic efficacy of both small and large extracellular vesicles derived by mesenchymal stromal cells. Extracellular vesicles represent a possibility to harness the benefits of mesenchymal stromal cells with added benefits of reduced manufacturing costs and an improved safety profile. Hence, there has been an exponential increase in interest for developing this cell-free therapy with hundreds of preclinical studies published to date. However, a vast amount of heterogeneity between groups relates to methods of extracellular vesicle isolation, characterization, and study design. This review will capture this heterogeneity and identify the most commonly used and optimal approaches to evaluate mesenchymal stromal cell-derived extracellular vesicle treatment. A meta-analysis of outcomes within each disease domain will help elucidate which fields of research demonstrate promise for developing extracellular vesicles as a novel cell-free therapy. Summarizing this robust information on extracellular vesicles as an intervention can provide guidance for designing preclinical studies with hopes of future clinical translation.

    更新日期:2019-12-13
  • The comparative efficacy and risk of harms of the intravenous and subcutaneous formulations of trastuzumab in patients with HER2-positive breast cancer: a rapid review
    Syst. Rev. (IF 0) Pub Date : 2019-12-11
    Miriam Van den Nest; Anna Glechner; Maria Gold; Gerald Gartlehner

    Trastuzumab is a monoclonal antibody for patients with HER2 (human epidermal growth factor receptor 2)-positive breast cancer, which is added to regular treatment and reduces mortality. Originally, trastuzumab had to be administered intravenously (IV) over 30 min every 3 weeks for 1 year. Since 2012, a formulation for the subcutaneous (SC) administration of trastuzumab has been available, which has not yet been approved in the USA. Advocates claim that the SC formulation saves time and money, despite higher costs. The purpose of this study is to review existing literature concerning the comparative efficacy and risk of harms of trastuzumab IV and SC concerning patient-relevant health outcomes. We conducted searches in the Cochrane Library and MEDLINE for articles published through May 2018 in English or German. In addition, we searched ClinicalTrials.gov to identify unpublished studies. We dually reviewed the abstracts and full-text articles based on a priori defined inclusion criteria, rated the risk of bias of included studies, and assessed the strength of the evidence for each outcome of interest. Because data was insufficient for quantitative synthesis, we summarized results narratively. We identified three RCTs (randomized controlled trials) meeting our eligibility criteria, which included data on 1003 patients. We found moderate evidence for similar event rates (20.05% vs. 18%, HR (hazard ratio) 0.88, CI 95% = 0.62–1.27), and mortality rates (10% vs. 8%, HR 0.76, CI 95% = 0.44–1.32) after 1.7 years for patients receiving trastuzumab IV and for patients receiving SC. Results remained similar after 3.3 years, though evidence lacked strength due to a high dropout rate. All trials reported more adverse events among the SC group than in the IV group. Evidence for these findings was of moderate strength. Nevertheless, more than 85% of the patients preferred trastuzumab SC over IV. Results concerning serious adverse events appeared to be heterogeneous. Results of studies indicate similar efficacy between the two routes of administration. The higher rates of adverse events for SC administration were mainly attributable to injection site–related events. The clinical decision of whether to administer trastuzumab SC or IV requires the consideration of several factors and should be determined individually.

    更新日期:2019-12-11
  • Psychometric properties of the Jefferson Scale of Empathy: a COSMIN systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-10
    Brett Williams; Bronwyn Beovich

    Empathy is an important characteristic to possess for healthcare professionals. It has been found to improve communication between professionals and patients and to improve clinical health outcomes. The Jefferson Scale of Empathy (JSE) was developed to measure this quality and has been used extensively, and psychometrically appraised, with a variety of cohorts and in different cultural environments. However, no study has been undertaken to systematically examine the methodological quality of studies which have assessed psychometric factors of the JSE. This systematic review will examine the quality of published papers that have reported on psychometric factors of the JSE. A systematic review of studies which report on the psychometric properties of the JSE will be conducted. We will use a predefined search strategy to identify studies meeting the following eligibility criteria: original data is reported on for at least one of the psychometric measurement properties described in the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist, examines the JSE in a healthcare cohort (using the student, physician or health profession versions of the JSE), and is published from January 2001 and in the English language. Conference abstracts, editorials and grey literature will be excluded. Six electronic databases (Medline, EMBASE, PsychInfo, PubMed, Web of Science and CINAHL) will be systematically searched for articles meeting these criteria and studies will be assessed for eligibility by two review authors. The methodological quality of included papers will be examined using the COSMIN Risk of Bias checklist. A narrative description of the findings will be presented along with summary tables. Recommendations for use of the JSE with various cohorts and circumstances will be offered which may inform future research in this field. PROSPERO CRD42018111412

    更新日期:2019-12-11
  • Benefits and harms of medical cannabis: a scoping review of systematic reviews
    Syst. Rev. (IF 0) Pub Date : 2019-12-10
    Misty Pratt; Adrienne Stevens; Micere Thuku; Claire Butler; Becky Skidmore; L. Susan Wieland; Mark Clemons; Salmaan Kanji; Brian Hutton

    There has been increased interest in the role of cannabis for treating medical conditions. The availability of different cannabis-based products can make the side effects of exposure unpredictable. We sought to conduct a scoping review of systematic reviews assessing benefits and harms of cannabis-based medicines for any condition. A protocol was followed throughout the conduct of this scoping review. A protocol-guided scoping review conduct. Searches of bibliographic databases (e.g., MEDLINE®, Embase, PsycINFO, the Cochrane Library) and gray literature were performed. Two people selected and charted data from systematic reviews. Categorizations emerged during data synthesis. The reporting of results from systematic reviews was performed at a high level appropriate for a scoping review. After screening 1975 citations, 72 systematic reviews were included. The reviews covered many conditions, the most common being pain management. Several reviews focused on management of pain as a symptom of conditions such as multiple sclerosis (MS), injury, and cancer. After pain, the most common symptoms treated were spasticity in MS, movement disturbances, nausea/vomiting, and mental health symptoms. An assessment of review findings lends to the understanding that, although in a small number of reviews results showed a benefit for reducing pain, the analysis approach and reporting in other reviews was sub-optimal, making it difficult to know how consistent findings are when considering pain in general. Adverse effects were reported in most reviews comparing cannabis with placebo (49/59, 83%) and in 20/24 (83%) of the reviews comparing cannabis to active drugs. Minor adverse effects (e.g., drowsiness, dizziness) were common and reported in over half of the reviews. Serious harms were not as common, but were reported in 21/59 (36%) reviews that reported on adverse effects. Overall, safety data was generally reported study-by-study, with few reviews synthesizing data. Only one review was rated as high quality, while the remaining were rated of moderate (n = 36) or low/critically low (n = 35) quality. Results from the included reviews were mixed, with most reporting an inability to draw conclusions due to inconsistent findings and a lack of rigorous evidence. Mild harms were frequently reported, and it is possible the harms of cannabis-based medicines may outweigh benefits. The protocol for this scoping review was posted in the Open Access (https://ruor.uottawa.ca/handle/10393/37247).

    更新日期:2019-12-11
  • Nurses’ perspectives on human rights when coercion is used in psychiatry: a systematic review protocol of qualitative evidence
    Syst. Rev. (IF 0) Pub Date : 2019-12-09
    Pierre Pariseau-Legault; Sandrine Vallée-Ouimet; Marie-Hélène Goulet; Jean-Daniel Jacob

    The World Health Organization describes the perpetuation of human rights violations against people with mental health problems as a global emergency. Despite this observation, recent studies suggest that coercive measures, such as seclusion, restraints, involuntary hospitalization, or involuntary treatment, are steadily or increasingly being used without proof of their effectiveness. In nursing, several literature reviews have focused on understanding nurses’ perspectives on the use of seclusion and restraints. Although many studies describe the ethical dilemmas faced by nurses in this context, to this date, their perspectives on patient’s rights when a broad variety of coercive measures are used are not well understood. The aim of this review is to produce a qualitative synthesis of how human rights are actually integrated into psychiatric and mental health nursing practice in the context of coercive work. Noblit and Hare’s meta-ethnographic approach will be used to conduct this systematic review. The search will be conducted in CINAHL, Medline, PsycINFO, ERIC, and Scopus databases, using the PICo model (Population, phenomenon of Interest, Context) and a combination of keywords and descriptors. It will be complemented by a manual search of non-indexed articles, gray literature, and other applicable data sources, such as human rights related documents. Qualitative and mixed-method study designs will be included in this review. Empirical and peer-reviewed articles published between 2008 and 2019 will be selected. Articles will be evaluated independently by two reviewers to determine their inclusion against eligibility criteria. The quality of the selected papers will then be independently evaluated by two reviewers, using the Joanna Briggs Institute’s Checklist for Qualitative Research. Data extraction and content analysis will focus on first- and second-order constructs, that is, the extraction of research participants’ narratives and their interpretation. This review will provide a synthesis of how psychiatric and mental health nurses integrate human rights principles into their practice, as well as it will identify research gaps in this area. The results of this review will then provide qualitative evidence to better understand how nurses can contribute to the recognition, protection, and advocate for human rights in a psychiatric context. PROSPERO, CRD42019116862

    更新日期:2019-12-09
  • Effectiveness of physical activity promotion and exercise referral in primary care: protocol for a systematic review and meta-analysis of randomised controlled trials
    Syst. Rev. (IF 0) Pub Date : 2019-12-05
    Jean-Pierre Laake; Joanna Fleming

    Physical inactivity is the fourth leading risk factor for global mortality. Reducing sedentary behaviour and increasing physical activity are efficacious for improving many physical and mental health conditions including cardiovascular disease, type 2 diabetes and depression. Reducing sedentary behaviour and increasing physical activity can also be effective at reducing obesity; however, sedentary behaviour and reduced physical activity are also associated with mortality independently. Despite this, most adults in the UK do not currently meet the UK Chief Medical Officers’ guidelines for weekly physical activity. As most adults visit their general practitioner at least once a year, the primary care consultation provides a unique opportunity to deliver exercise referral or physical activity promotion interventions. This is a protocol for a systematic review of randomised controlled trials for the effectiveness of physical activity promotion and referral in primary care. A comprehensive literature search of Embase, MEDLINE (Ovid), Web of Science (Core Collection), Scopus, CINAHL, PsycINFO, and The Cochrane Library (CENTRAL) will be conducted for studies with a minimum follow-up of 12 months that report physical activity as an outcome measure (by either self-report or objective measures) including an intention to treat analysis. The authors will screen papers, first by title and abstract and then by full text, independently assess studies for inclusion, appraise risk of bias and extract data. The quality of the evidence will be assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluations) approach. The primary outcome will be participation in physical activity at 12 months. Pooled effects will be calculated using random effects models. Results will be submitted for publication in a peer-reviewed journal and for presentation at UK national primary care conferences. This systematic review and meta-analyses will summarise the evidence for the effectiveness of physical activity promotion and referral as interventions for improving physical activity, as well as whether studies using objective measures of physical activity have similar effects to those studies using self-report measures. This knowledge has importance for primary care clinicians, patients and, given the focus of the recent NHS long-term plan on preventive medicine, those making policy decisions. The protocol is registered with PROSPERO the international prospective register of systematic reviews, ID CRD42019130831

    更新日期:2019-12-05
  • Do wastewater treatment plants increase antibiotic resistant bacteria or genes in the environment? Protocol for a systematic review
    Syst. Rev. (IF 0) Pub Date : 2019-12-05
    Daloha Rodríguez-Molina; Petra Mang; Heike Schmitt; Mariana Carmen Chifiriuc; Katja Radon; Laura Wengenroth

    Antibiotic resistance is a global public health threat. Water from human activities is collected at wastewater treatment plants where processes often do not sufficiently neutralize antibiotic resistant bacteria and genes, which are further shed into the local environment. This protocol outlines the steps to conduct a systematic review based on the Population, Exposure, Comparator and Outcome (PECO) framework, aiming at answering the question “Are antimicrobial-resistant enterobacteriaceae and antimicrobial resistance genes present (O) in air and water samples (P) taken either near or downstream or downwind or down-gradient from wastewater treatment plants (E), as compared to air and water samples taken either further away or upstream or upwind or up-gradient from such wastewater treatment plant (C)?” Presence of antimicrobial-resistant bacteria and genes will be quantitatively measured by extracting their prevalence or concentration, depending on the reviewed study. We will search PubMed, EMBASE, the Cochrane database and Web of Science for original articles published from 1 Jan 2000 to 3 Sep 2018 with language restriction. Articles will undergo a relevance and a design screening process. Data from eligible articles will be extracted by two independent reviewers. Further, we will perform a risk of bias assessment using a decision matrix. We will synthesize and present results in narrative and tabular form and will perform a meta-analysis if heterogeneity of results allows it. Antibiotic resistance in environmental samples around wastewater treatment plants may pose a risk of exposure to workers and nearby residents. Results from the systematic review outlined in this protocol will allow to estimate the extend of exposure, to inform policy making and help to design future studies.

    更新日期:2019-12-05
  • Effect of implementation interventions on nurses’ behaviour in clinical practice: a systematic review, meta-analysis and meta-regression protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-05
    Guillaume Fontaine; Sylvie Cossette; Marc-André Maheu-Cadotte; Marie-France Deschênes; Geneviève Rouleau; Andréane Lavallée; Catherine Pépin; Ariane Ballard; Gabrielle Chicoine; Alexandra Lapierre; Patrick Lavoie; Jérémie Blondin; Tanya Mailhot

    Practitioner-level implementation interventions such as audit and feedback, communities of practice, and local opinion leaders have shown potential to change nurses’ behaviour in clinical practice and improve patients’ health. However, their effectiveness remains unclear. Moreover, we have a paucity of data regarding the use of theory in implementation studies with nurses, the causal processes—i.e. mechanisms of action—targeted by interventions to change nurses’ behaviour in clinical practice, and the constituent components—i.e. behaviour change techniques—included in interventions. Thus, our objectives are threefold: (1) to examine the effectiveness of practitioner-level implementation interventions in changing nurses’ behaviour in clinical practice; (2) to identify, in included studies, the type and degree of theory use, the mechanisms of action targeted by interventions and the behaviour change techniques constituting interventions and (3) to examine whether intervention effectiveness is associated with the use of theory or with specific mechanisms of action and behaviour change techniques. We will conduct a systematic review based on the Cochrane Effective Practice and Organization of Care (EPOC) Group guidelines. We will search six databases (CINAHL, EMBASE, ERIC, PsycINFO, PubMed and Web of Science) with no time limitation for experimental and quasi-experimental studies that evaluated practitioner-level implementation interventions aiming to change nurses’ behaviour in clinical practice. We will also hand-search reference lists of included studies. We will perform screening, full-text review, risk of bias assessment, and data extraction independently with the Covidence systematic review software. We will assess the quality of evidence using the GRADEpro software. We will code included studies independently for theory use (Theory Coding Scheme), mechanisms of action (coding guidelines from Michie) and behaviour change techniques (Behaviour Change Technique Taxonomy v1) with QSR International’s NVivo qualitative data analysis software. Meta-analyses will be performed using the Review Manager (RevMan) software. Meta-regression analyses will be performed with IBM SPSS Statistics software. This review will inform knowledge users and researchers interested in designing, developing and evaluating implementation interventions to support nurses’ behaviour change in clinical practice. Results will provide key insights regarding which causal processes—i.e. mechanisms of action—should be targeted by these interventions, and which constituent components—i.e. behaviour change techniques—should be included in these interventions to increase their effectiveness. The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019130446).

    更新日期:2019-12-05
  • Antibiotic regimens for neonatal sepsis - a protocol for a systematic review with meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-05
    Steven Kwasi Korang; Sanam Safi; Christian Gluud; Ulrik Lausten-Thomsen; Janus C. Jakobsen

    Sepsis is a major cause of morbidity and mortality among neonates and infants. Antibiotics are a central part of the first line treatment for sepsis in neonatal intensive care units worldwide. However, the evidence on the clinical effects of the commonly used antibiotic regimens for sepsis in neonates remains scarce. This systematic review aims to assess the efficacy and harms of antibiotic regimens for neonatal sepsis. Electronic searches will be conducted in MEDLINE, Embase, The Cochrane Library, CINAHL, ZETOC and clinical trial registries (clinicaltrials.gov and ISRCTN). We will include randomised controlled trials of different antibiotic regimens for sepsis of neonates and infants. Eligible interventions will be any antibiotic regimen. Two reviewers will independently screen, select, and extract data. The methodological quality of individual studies will be appraised following Cochrane methodology. Primary outcomes will be ‘all-cause mortality’ and ‘serious adverse events’. Secondary outcomes will be ‘need for respiratory support’, ‘need for circulatory support’, ‘neurodevelopmental impairment’, ototoxicity, nephrotoxicity and necrotizing enterocolitis. We plan to perform a meta-analysis with trial sequential analysis. This is the study protocol for a systematic review on the effects of different antibiotic regimens for neonatal sepsis. The results of this systematic review intent to adequately inform stakeholders or health care professionals in the field of neonatal sepsis, and to aid appropriate development of treatment guidelines. PROSPERO reference number: CRD42019134300.

    更新日期:2019-12-05
  • Networked information technologies and patient safety: a protocol for a realist synthesis
    Syst. Rev. (IF 0) Pub Date : 2019-12-05
    Justin Keen; Joanne Greenhalgh; Rebecca Randell; Peter Gardner; Justin Waring; Roberta Longo; Jon Fistein; Maysam Abdulwahid; Natalie King; Judy Wright

    There is a widespread belief that information technologies will improve diagnosis, treatment and care. Evidence about their effectiveness in health care is, however, mixed. It is not clear why this is the case, given the remarkable advances in hardware and software over the last 20 years. This review focuses on interoperable information technologies, which governments are currently advocating and funding. These link organisations across a health economy, with a view to enabling health and care professionals to coordinate their work with one another and to access patient data wherever it is stored. Given the mixed evidence about information technologies in general, and current policies and funding, there is a need to establish the value of investments in this class of system. The aim of this review is to establish how, why and in what circumstances interoperable systems affect patient safety. A realist synthesis will be undertaken, to understand how and why inter-organisational systems reduce patients’ clinical risks, or fail to do so. The review will follow the steps in most published realist syntheses, including (1) clarifying the scope of the review and identifying candidate programme and mid-range theories to evaluate, (2) searching for evidence, (3) appraising primary studies in terms of their rigour and relevance and extracting evidence, (4) synthesising evidence, (5) identifying recommendations, based on assessment of the extent to which findings can be generalised to other settings. The findings of this realist synthesis will shed light on how and why an important class of systems, that span organisations in a health economy, will contribute to changes in patients’ clinical risks. We anticipate that the findings will be generalizable, in two ways. First, a refined mid-range theory will contribute to our understanding of the underlying mechanisms that, for a range of information technologies, lead to changes in clinical practices and hence patients’ risks (or not). Second, many governments are funding and implementing cross-organisational IT networks. The findings can inform policies on their design and implementation. PROSPERO CRD42017073004

    更新日期:2019-12-05
  • Reporting quality of Cochrane systematic reviews with Chinese herbal medicines
    Syst. Rev. (IF 0) Pub Date : 2019-12-03
    Xuan Zhang; Qi-Ying Aixinjueluo; Si-Yao Li; Lisa-L Song; Chung-Tai Lau; Ran Tan; Zhao-Xiang Bian

    Chinese herbal medicines (CHMs) are the major interventions of traditional Chinese medicine (TCM), which are typically administered as either single herbs or formulas. The Cochrane systematic reviews (SRs) of CHMs are essential references for evaluating the efficacy and safety of CHMs interventions; they are expected to be accurate and reliable. This study aimed to assess the reporting quality of these SRs, particularly whether necessary information related to CHM was adequately reported. The Cochrane Database was systematically searched for all SRs of CHM that were published up to 31 December 2017. The primary analysis was to assess their reporting quality based on 27-item of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and 9-item of CHM-related information designed according to TCM theory. Descriptive statistics were additionally used to analyze their baseline characteristics. A total of 109 Cochrane SRs of CHM were identified from 1999 to 2017. For 27-item of PRISMA, 26 had the reporting compliances higher than 50%, of which 11 were fully reporting (100%). However, for CHM-related information, 65 (59.6%) SRs did not report the specific name of the CHM in the title, 42 (38.5%) lacked TCM-related rationales in the introduction, 62 (56.9%) did not include CHM-related characteristics in the additional analyses, and 77 (70.6%) did not analyze CHM results in terms of TCM-related theories in the discussion. Of 97 SRs that included clinical trials, 38 (39.2%) did not provide the details of composition and dosage of CHMs, 85 (87.6%) did not report the CHM sources, 13 (13.4%) did not provide the dosage form, 95 (97.9%) lacked CHM quality control information, and 57 (58.8%) did not describe details of the controls. For 62 (72.9%) of 85 SRs that included meta-analysis, it was impossible to assess whether meta-analysis had been properly conducted due to inadequate reporting of CHM interventions. Although the Cochrane SRs of CHM showed reporting compliance with PRISMA checklist, their reporting quality needs improvement, especially about full reporting of CHM interventions and of TCM-related rationales. Reporting guideline of “PRISMA extension for CHM interventions” should be developed thus to improve their quality.

    更新日期:2019-12-04
  • Psychological intervention for universal prevention of antenatal and postnatal depression among pregnant women: protocol for a systematic review and meta-analysis
    Syst. Rev. (IF 0) Pub Date : 2019-12-01
    Naonori Yasuma; Zui Narita; Natsu Sasaki; Erika Obikane; Junpei Sekiya; Takuma Inagawa; Aiichiro Nakajima; Yuji Yamada; Ryuichi Yamazaki; Asami Matsunaga; Tomomi Saito; Kazuhiro Watanabe; Kotaro Imamura; Norito Kawakami; Daisuke Nishi

    Prevention of antenatal and postnatal depression is crucial, given its high prevalence and severe consequences. Although several systematic reviews and meta-analyses have examined the effects of psychological interventions on the population at risk for perinatal depression, few studies have focused on universal prevention and none have focused specifically on universal prevention in pregnancy. The aim of this study is to examine the effects of psychological interventions with a universal prevention focus on perinatal depression during pregnancy by performing a systematic review and meta-analysis based on both the latest articles and a broader literature search. The literature search will be conducted using the Cochrane Controlled Register of Trials (CENTRAL), Embase, PubMed and PsycINFO, from inception onwards. Randomized controlled trials that examined the association between psychological interventions and universal prevention of antenatal and postnatal depression among pregnant women will be included. Study selection, data collection, quality assessment, and statistical syntheses will be conducted following a priori defined methods in the protocol. The findings of this systematic review and meta-analysis will have both clinical and political importance in the context of perinatal mental health. In addition, this study will promote future studies and clarify the direction of research on universal prevention of perinatal depression. PROSPERO CRD42019118041

    更新日期:2019-12-02
  • The association of telomere length with substance use disorders: systematic review and meta-analysis protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-01
    Fernando Navarro-Mateu; María Rubio-Aparicio; Pedro Cayuela; Francisco-Javier Álvarez; Agustín Roca-Vega; María Dolores Chirlaque; María Luisa Cayuela; Mathilde Husky; Salvador Martínez; Julio Sánchez-Meca

    The present protocol was designed for a systematic review and meta-analysis aimed at determining the association of telomere length with substance use disorders with the exclusion of nicotine addiction, and to identify potential moderators of the effect of telomere length. Such methodological information may provide guidance to improve the quality of future research on this important topic. Potential studies will be identified through electronic databases (PubMed/MEDLINE, EMBASE, PsycINFO, and Web of Science) up from inception onwards. The inclusion criteria will include published or unpublished observational studies (cohort, case–control, and cross-sectional studies) reporting telomere length in adult patients with substance use disorder compared with a control group. Non-human studies or other study designs such as reviews, case-only, family-based, and/or population studies with only healthy participants will be excluded, as well as those focused solely on nicotine addiction. The main outcome will be telomere length in adults with substance use disorder (primary) and, specifically, in those with alcohol use disorder (secondary). Two investigators will independently evaluate the preselected studies for possible inclusion and will extract data following a standardized protocol. Disagreements will be resolved by consensus. The risk of bias of all included studies will be assessed using the Newcastle–Ottawa Quality Assessment Scale for non-randomized studies. Data will be converted into standardized mean differences as effect size index, and random-effects models will be used for the meta-analysis. Cochran’s Q statistic, I2 index, and visual inspection of the forest plot will be used to verify study heterogeneity. Subgroup analyses and meta-regressions will be conducted to ascertain heterogeneity. Several sensitivity analyses will be conducted to address the influence of potential confounding factors. Publication bias will be examined using the “funnel plot” method with Duval and Tweedie’s trim-and-fill method and Egger test. This systematic review will assess the association of telomere length with substance use disorders aside from nicotine addiction. PROSPERO registration number CRD42019119785

    更新日期:2019-12-02
  • Quality of life and well-being from the perspective of patients on opioid agonist maintenance treatment: study protocol for a systematic review of qualitative research and a scoping review of measures
    Syst. Rev. (IF 0) Pub Date : 2019-12-01
    Ivan Solà; Joan Trujols; Elisa Ribalta; Saul Alcaraz; Gemma Robleda; Clara Selva Olid; José Pérez de los Cobos

    Opioid agonist maintenance treatment (OAMT) is a first-line treatment for heroin dependence, but its effectiveness has been assessed primarily through clinical outcomes with a limited attention to patient perspectives. Despite the increased use of patient reported outcome measures their patient-centeredness is highly questionable. This is the protocol of a systematic review of qualitative research on how OAMT users construct the meaning of their quality of life and well-being and a scoping review of instruments that measure these domains. We will conduct a systematic review of qualitative research exploring the views of quality of life of patients on OAMT (registration number CRD42018086490). According pre-specified eligibility criteria, we will include studies from a comprehensive search of bibliographical databases from their inception. We will extract data from included studies and assess their risk of bias with the CASP appraisal criteria, and will implement a thematic analysis to generate a set of interpretative analytical themes ascertaining their confidence using the CERQual approach. We will implement similar methods to conduct a scoping review to assess to what extent the existing measures of these domains were focused on user’s views, assessing their validity using the COSMIN methodology, and summarizing their characteristics and level of patient centeredness. The findings from the reviews will contribute to obtain a genuine understanding of the perspective from users on OAMT regarding their perception of well-being and quality of life and will likely lead to greater patient centeredness when assessing such variables, which in turn may contribute to a more patient-centered care.

    更新日期:2019-12-02
  • Recruitment and retention of fathers with young children in early childhood health intervention research: a systematic review and meta-analysis protocol
    Syst. Rev. (IF 0) Pub Date : 2019-12-01
    Elizabeth M. Keys; Jill M. Norris; Emily E. Cameron; Katherine S. Bright; Lianne M. Tomfohr-Madsen; Karen M. Benzies

    Fathers are under-represented in research and programs addressing early childhood health and development. Recruiting fathers into these interventions can be hampered for multiple reasons, including recruitment and retention strategies that are not tailored for fathers. The primary aim of this systematic review and meta-analysis is to determine the effectiveness of recruitment and retention strategies used to include fathers of children (from conception to age 36 months) in intervention studies. The secondary aim is to investigate study-level factors that may influence recruitment and retention. We will conduct searches for scholarly peer-reviewed randomized controlled trials, quasi-experimental studies, and pre-post studies that recruited fathers using the following databases: MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), and CINAHL. English-language articles will be eligible if they recruited self-identified fathers of children from conception to age 36 months for health-promoting interventions that target healthy parents and children. Two reviewers will independently screen titles/abstracts and full texts for inclusion, as well as grading methodological quality. Recruitment and retention proportions will be calculated for each study. Where possible, we will calculate pooled proportional effects with 95% confidence intervals using random-effects models and conduct a meta-regression to examine the impact of potential modifiers of recruitment and retention. Findings from this review will help inform future intervention research with fathers to optimally recruit and retain participants. Identifying key factors should enable health researchers and program managers design and adapt interventions to increase the likelihood of increasing father engagement in early childhood health interventions. Researchers will be able to use this review to inform future research that addresses current evidence gaps for the recruitment and retention of fathers. This review will make recommendations for addressing key target areas to improve recruitment and retention of fathers in early childhood health research, ultimately leading to a body of evidence that captures the full potential of fathers for maximizing the health and wellbeing of their children. PROSPERO CRD42018081332.

    更新日期:2019-12-02
  • Weight loss interventions for Hispanic women in the USA: a protocol for a systematic review
    Syst. Rev. (IF 0) Pub Date : 2019-12-01
    Kristin E. Morrill; Melissa Lopez-Pentecost; Guadalupe Ballesteros; Jeanne L. Pfander; Melanie D. Hingle; Yann C. Klimentidis; Cynthia A. Thomson; David O. Garcia

    In the U.S., Hispanic women experience a disproportionate rate of obesity and obesity-related chronic diseases. At the same time, Hispanic women remain considerably underrepresented in behavioral weight loss interventions. The purpose of this review is to systematically evaluate the evidence related to the effectiveness of weight loss interventions among Hispanic women in the U.S. This review will identify elements of successful weight loss interventions as well as areas for future research. The following databases will be searched to identify all relevant articles (from inception onwards): PubMed, Embase, Scopus, Web of Science (Science Citation Index and Social Sciences Citation Index), PsycINFO, CINAHL, Chicano Database, SPORTDiscus, CAB Abstracts, and Google Scholar. We will include randomized controlled trials and quasi-experimental studies of adult women (> 18 years) from Hispanic/Latino background living in the United States. Eligible interventions will target weight-related behaviors (including diet, physical activity, behavior modification and/or their combinations). The review’s primary outcome will be weight change (expressed as change in lbs/kg or body mass index (BMI) (kg/m2)). Three reviewers will independently screen and select data and two will extract data. The methodological quality (or risk of bias) of individual studies will be appraised using the Effective Public Health Practice Project Quality Assessment Tool. A narrative synthesis will describe quality and content of the evidence. The aim of this systematic review is to critically examine existing weight loss interventions for Hispanic women in the U.S. and provide quality evidence for the effectiveness of these interventions on weight loss. Further, this review seeks to identify characteristics of effective interventions and suggest future directions for research efforts targeting weight loss in this population. This review will inform the development of future weight loss interventions for this population. PROSPERO CRD42019119094

    更新日期:2019-12-02
  • Prevalence and factors associated with poor mental health among healthcare professionals in low- and lower-middle-income countries: a systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2019-11-29
    Julia Lohmann; Denny John; Aso Dzay

    A healthy and productive health workforce is central to a well-functioning health system. However, health workers are at high risk of poor psychological wellbeing due to their particularly strenuous work demands. While mental health of health workers is a well-researched issue in high-income countries, research from low- and lower-middle-income countries (LLMIC) has begun to emerge only recently. The review aims to synthesize this body of research, specifically to assess the prevalence of mental health issues among health workers in LLMIC, to identify factors associated with good or poor mental health, and to highlight gaps in knowledge. We will perform a systematic search of the published English and French language literature (from inception onwards) in MEDLINE, EMBASE, and PsycINFO. Eligible for inclusion are observational studies (e.g., cross-sectional, case-control, or cohort) and control arms of randomized controlled trials reporting investigations on the nature, prevalence, and factors associated with mental health or psychological wellbeing among formally trained health professionals and health associate professionals delivering health services in formal healthcare facilities in LLMIC. The primary outcomes will be burnout, depression, and general psychological wellbeing. Secondary outcomes include other specific mental health diagnoses, as well as general psychological stress, distress and/or trauma if work-related and explicitly framed as a mental health issue. Two authors will independently examine the studies against the eligibility criteria in the stages of title, abstract, and full-text study selection, as well as assess the risk of bias in included studies using standard checklists depending on study design. Disagreements will be resolved in discussion with the third author. Data will be extracted from included studies using a predefined and piloted coding framework. Given the anticipated heterogeneity of studies, we do not expect to be able to conduct meta-analysis and plan to summarize the extracted data in narrative form. The framework method will be used to organize narrative data by subthemes and explore patterns. In assessing the prevalence of mental health issues among healthcare professionals in LLMIC and identifying factors associated with positive or poor mental health, the review aims to synthesize all possible available information for policy makers and health system managers on a potentially highly important but not yet much-discussed issue and to highlight gaps in currently available knowledge. International Prospective Register of Systematic Reviews PROSPERO (registration number CRD42019140036)

    更新日期:2019-11-30
  • Diabetes drugs for nonalcoholic fatty liver disease: a systematic review
    Syst. Rev. (IF 0) Pub Date : 2019-11-29
    Ian Blazina; Shelley Selph

    Fatty liver is associated with obesity, type 2 diabetes, hyperlipidemia, hypertension, and metabolic syndrome. While there are no approved drugs for the treatment of nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis, strategies to ameliorate fatty liver often target these related diseases. We sought to determine if any medications approved by the US Food and Drug Administration to treat diabetes are helpful in reducing weight and improving steatohepatitis in patients with NAFLD. We conducted a systematic review of published and unpublished studies evaluating the comparative effectiveness and harms of diabetes medications for the treatment of NAFLD. We searched MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials through 3rd quarter, 2019 using terms for included drugs and indications. We screened 1591 citations and included 18 trials of diabetes drugs to treat NAFLD. Studies of metformin found no difference from placebo in steatosis, fibrosis, NAFLD activity score, or resolution of NASH. While weight and glucose control were improved with metformin, it did not substantially impact liver disease. Studies of pioglitazone in NASH patients found benefits in liver function, liver fat, and NASH resolution, though significant increases in weight may be cause for concern. Evidence for other thiazolinediones was more limited and had somewhat mixed results, but findings were generally consistent with those for pioglitazone: liver fat and function and glucose measures improved, but weight also increased. We found some evidence that liraglutide improves liver fat, liver function, and HbA1c and is effective at resolving NASH and reducing weight. Exenatide performed less well but also resulted in significant reductions in liver fat and weight. Consistent with existing clinical practice guidelines, which recommend lifestyle intervention and treatment for comorbidities related to fatty liver disease as first-line treatment, trial evidence supports the efficacy of some diabetes drugs (especially pioglitazone) in patients with NAFLD or NASH, though weight gain with some diabetes drugs may warrant caution. Larger trials are needed to better characterize the efficacy and harms of diabetes pharmacotherapy in these patients.

    更新日期:2019-11-30
  • Strategies and effects of promising school-based interventions to promote active school transportation by bicycle among children and adolescents: protocol for a systematic review
    Syst. Rev. (IF 0) Pub Date : 2019-11-29
    Dorothea M. I. Schönbach; Teatske M. Altenburg; Mai J. M. Chinapaw; Adilson Marques; Yolanda Demetriou

    Active school travel by bike may provide appropriate means to promote physical activity through commuting to and from school, expanding the mobility during leisure time, and integrating a lifelong positive behavior routine. However, bicycling seems to be a less common form of active school transport and declining cycling to school trends in some European countries have been observed. Therefore, effective interventions aiming at promoting biking to school are warranted. To gain a better understanding of effective programs, the systematic review will summarize strategies and effects of school-based interventions targeted on positively influencing active school travel by bicycle. The databases ERIC, PsycINFO, PSYNDEX, PubMed, Scopus, SPORTDiscus, SURF, and Web of Science will be searched utilizing a detailed search strategy according to “PICo”. Consequently, there will be no restriction regarding the outcomes measured in studies. For inclusion in the review, the identified primary studies (i.e. randomized and non-randomized controlled trials) should be published between 2000 and 2019 due to their current relevance, and written in English. The screening, data extraction, and appraisal of study quality as well as behavior change techniques will be undertaken by two independent researchers. To assess the methodological quality of every included study, the quality assessment tool “Effective Public Health Practice Project” for quantitative studies will be used. Behavior change techniques will be identified by utilizing the “BCT Taxonomy v1”. If data permits, meta-analyses for intervention effects will be conducted where appropriate. The planned systematic review can provide information about how bicycling is considered in school-based interventions as an effective strategy to promote active commuting to school among students. In this regard, the conclusions drawn from the review will establish a basis for researchers to plan and implement a comprehensive cycling intervention in the school setting. PROSPEROCRD42019125192

    更新日期:2019-11-30
  • Protocol for a systematic review and network meta-analysis of the management of new onset atrial fibrillation in critically unwell adult patients
    Syst. Rev. (IF 0) Pub Date : 2019-10-28
    Brian W. Johnston; Ruaraidh Hill; Rui Duarte; Chung Shen Chean; Danny F. McAuley; Bronagh Blackwood; Nathan Pace; Ingeborg D. Welters

    New onset atrial fibrillation is the most commonly encountered arrhythmia in critically unwell patients with a reported incidence of 4% to 29%. The occurrence of new onset atrial fibrillation may precipitate acute heart failure and lead to thromboembolic complications as well as being associated with increased in-hospital and in intensive care unit (ICU) mortality. Despite being common, much of our current knowledge regarding the treatment of new onset atrial fibrillation comes from patients with chronic atrial fibrillation or post cardiac surgery. It is unclear if management strategies in these patient cohorts can be applied to new onset atrial fibrillation in the general ICU. This protocol for a systematic review and network meta-analysis aims to address this uncertainty and define what is the most effective management strategy for the treatment of new onset atrial fibrillation (NOAF) in acutely unwell adult patients. In this systematic review and network meta-analysis, we plan to search electronic databases (Cochrane Central Register of Controlled Trials [CENTRAL], MEDLINE, EMBASE, Science Citation Index Expanded on Web of Science and relevant trial registries) for relevant randomised and non-randomised trials. Citations will be reviewed by title, abstract and full text by two independent reviewers and disagreement resolved by discussion and a third independent reviewer, if necessary. The Cochrane Risk of Bias tool will be used to assess risk of bias in randomised trials and the Risk of Bias in Nonrandomised Studies of Interventions (ROBINS-I) tool will be used for non-randomised studies. Statistical analysis will be carried out using R package meta and netmeta. We will first conduct a pairwise meta-analysis. If conditions for indirect comparison are satisfied and suitable data are available, we will conduct network meta-analysis using frequentist methodology. Treatments will be ranked according to efficacy with associated P-scores. We will assess the quality of the evidence in the pairwise using GRADE methodology and network meta-analysis comparisons in the CINeMA module in R package meta. Our review will be the first to assess direct and indirect evidence to assess the efficacy and rank the treatments available for new onset atrial fibrillation in critically unwell patients. Our review findings will be applicable to the care of people in a range of acute settings including, ICU, the emergency department and acute medical units. PROSPERO registry number: CRD42019121739.

    更新日期:2019-11-28
  • Measuring the impact of screening automation on meta-analyses of diagnostic test accuracy
    Syst. Rev. (IF 0) Pub Date : 2019-10-28
    Christopher R. Norman; Mariska M. G. Leeflang; Raphaël Porcher; Aurélie Névéol

    The large and increasing number of new studies published each year is making literature identification in systematic reviews ever more time-consuming and costly. Technological assistance has been suggested as an alternative to the conventional, manual study identification to mitigate the cost, but previous literature has mainly evaluated methods in terms of recall (search sensitivity) and workload reduction. There is a need to also evaluate whether screening prioritization methods leads to the same results and conclusions as exhaustive manual screening. In this study, we examined the impact of one screening prioritization method based on active learning on sensitivity and specificity estimates in systematic reviews of diagnostic test accuracy. We simulated the screening process in 48 Cochrane reviews of diagnostic test accuracy and re-run 400 meta-analyses based on a least 3 studies. We compared screening prioritization (with technological assistance) and screening in randomized order (standard practice without technology assistance). We examined if the screening could have been stopped before identifying all relevant studies while still producing reliable summary estimates. For all meta-analyses, we also examined the relationship between the number of relevant studies and the reliability of the final estimates. The main meta-analysis in each systematic review could have been performed after screening an average of 30% of the candidate articles (range 0.07 to 100%). No systematic review would have required screening more than 2308 studies, whereas manual screening would have required screening up to 43,363 studies. Despite an average 70% recall, the estimation error would have been 1.3% on average, compared to an average 2% estimation error expected when replicating summary estimate calculations. Screening prioritization coupled with stopping criteria in diagnostic test accuracy reviews can reliably detect when the screening process has identified a sufficient number of studies to perform the main meta-analysis with an accuracy within pre-specified tolerance limits. However, many of the systematic reviews did not identify a sufficient number of studies that the meta-analyses were accurate within a 2% limit even with exhaustive manual screening, i.e., using current practice.

    更新日期:2019-11-28
  • Risk of major bleeding during extended oral anticoagulation in patients with first unprovoked venous thromboembolism: a systematic review and meta-analysis protocol
    Syst. Rev. (IF 0) Pub Date : 2019-10-28
    Faizan Khan; Miriam Kimpton; Tobias Tritschler; Grégoire Le Gal; Brian Hutton; Dean A. Fergusson; Marc A. Rodger

    The optimal duration of anticoagulation after a first unprovoked venous thromboembolism (VTE) remains controversial. Deciding to stop or continue anticoagulant therapy indefinitely after completing 3 to 6 months of initial treatment requires balancing the long-term risk of recurrent VTE if anticoagulation is stopped against the long-term risk of major bleeding if anticoagulation is continued. However, knowledge of the long-term risk for major bleeding events during extended anticoagulation in this patient population is limited. We plan to conduct a systematic review and meta-analysis to quantify the risk for major bleeding events during extended oral anticoagulation in patients with first unprovoked VTE. Electronic databases including MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials will be systematically searched with the assistance of an information specialist (from inception to March 1, 2019) to identify randomized controlled trials and prospective cohort studies reporting major bleeding during extended oral anticoagulation in patients with first unprovoked VTE, who have completed at least 3 months of initial anticoagulant therapy. Study selection, risk of bias assessment, and data extraction will be performed independently by at least two investigators. The number of major bleeding events and person-years of follow-up will be used to calculate the rate (events per 100 person-years) with its 95% confidence interval for each study cohort, during clinically relevant time periods of extended anticoagulant therapy. Results will be pooled using random effect meta-analysis. The planned systematic review and meta-analysis will provide reliable estimates of the risk for major bleeding events during extended anticoagulation. This information will help inform patient prognosis and assist clinicians with balancing the risks and benefits of treatment to guide management of unprovoked VTE. PROSPERO CRD42019128597 .

    更新日期:2019-11-28
  • Impact of interventions on work-related outcomes for individuals with musculoskeletal injuries after road traffic crash: a systematic review protocol
    Syst. Rev. (IF 0) Pub Date : 2019-10-29
    Charlotte L. Brakenridge; Elise M. Gane; Esther J. Smits; Nicole E. Andrews; Venerina Johnston

    Musculoskeletal injuries are the most common non-fatal injury from road traffic crashes. Even when the injuries are mild, they can cause pain which can affect return to work rates and work ability post-crash. Workplace output losses are the biggest cost from traffic crash-related injuries. There is a need to identify effective interventions that can improve work-related outcomes (e.g. time to return to work, sick leave, and work ability) in this group and a need to understand the intervention components, external factors, and participant characteristics that may be associated with improvement. A systematic review will be conducted using seven databases and search terms related to road traffic crash, musculoskeletal injury, work-related outcomes, and study design. Intervention studies will be eligible if they report on at least one work-related outcome, include adults with a traffic crash-related musculoskeletal injury (e.g. fracture or whiplash), include a comparison group, and are written in English. Interventions can be medical, therapeutic, work-based, multicomponent, or other. Two researchers will independently screen titles and abstracts, review full texts for inclusion in the review, and perform the data extraction. The main outcomes of the review will be time until return to work and duration of sick leave. The results will be narratively described, with meta-analyses conducted where possible. This review will explore the effectiveness of interventions in individuals with traffic crash-related musculoskeletal injury on work-related outcomes and will act as a useful source for researchers, policy makers, and stakeholders when developing and implementing interventions in this group. PROSPERO CRD42018103746

    更新日期:2019-11-28
  • Interpersonal psychotherapy for perinatal women: a systematic review and meta-analysis protocol
    Syst. Rev. (IF 0) Pub Date : 2019-10-29
    Katherine S. Bright; Elyse M. Charrois; Muhammad Kashif Mughal; Abdul Wajid; Deborah McNeil; Scott Stuart; K. Alix Hayden; Dawn Kingston

    Interpersonal psychotherapy (IPT) is an intervention that has established efficacy in the prevention and treatment of depressive disorders. Previous systematic reviews have not evaluated the effectiveness of IPT on symptoms of stress, anxiety, depression, quality of life, relationship satisfaction/quality, social supports, and an improved psychological sense of well-being. There is limited data regarding factors that moderate and mediate the effectiveness of IPT including the timing of the intervention or the mode of delivery of IPT intervention. The objective of this systematic review and meta-analysis is to evaluate the effectiveness, feasibility, and acceptability of IPT interventions to treat perinatal psychological distress and to summarize the evidence on predictors, mediators, and moderators of IPT. We will include peer-reviewed studies that recruited perinatal women. The search strategy will involve the following databases: MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials (Ovid), CINAHL with Full Text (EBSCO), Social Work Abstracts (EBSCO), SocINDEX with Full Text (EBSCO), Academic Search Complete (EBSCO), Family & Society Studies Worldwide (EBSCO), Family Studies Abstracts (EBSCO), and Scopus. Study inclusion criteria include (1) randomized controlled trials, quasi-experimental studies, and pre-post studies that evaluated the effectiveness of IPT; (2) qualitative studies that evaluated feasibility and acceptability of IPT; (3) study sample included and analyzed perinatal women; and (4) publication language was English. Using pilot-tested screening and data extraction forms, two reviewers will independently review studies in three steps: (1) abstract/title screening, (2) full-text screening of potentially accepted studies, and (3) data extraction of accepted studies. Disagreements will be resolved by a third reviewer. Studies will be aggregated for meta-synthesis and meta-analysis should the data allow for this. Two independent reviewers will grade methodological quality. Findings from this review will inform future development and implementation of IPT intervention research for perinatal women. Identifying key factors of successful IPT interventions will inform intervention design and adaptation of IPT interventions to increase the likelihood that perinatal women will engage in and benefit from IPT interventions. This review will also identify key considerations for increasing the effectiveness of IPT interventions during the perinatal period. PROSPERO CRD42019114292

    更新日期:2019-11-28
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