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ObjectivesThere are multiple instruments for measuring multimorbidity. The main objective of this systematic review was to provide a list of instruments that are suitable for use in studies aiming to measure the association of a specific outcome with different levels of multimorbidity as the main independent variable in community-dwelling individuals. The secondary objective was to provide details of the requirements, strengths and limitations of these instruments, and the chosen outcomes.MethodsWe conducted the review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO registration number: CRD42018105297). We searched MEDLINE, Embase and CINAHL electronic databases published in English and manually searched the Journal of Comorbidity between 1 January 2010 and 23 October 2020 inclusive. Studies also had to select adult patients from primary care or general population and had at least one specified outcome variable. Two authors screened the titles, abstracts and full texts independently. Disagreements were resolved with a third author. The modified Newcastle-Ottawa Scale was used for quality assessment.ResultsNinety-six studies were identified, with 69 of them rated to have a low risk of bias. In total, 33 unique instruments were described. Disease Count and weighted indices like Charlson Comorbidity Index were commonly used. Other approaches included pharmaceutical-based instruments. Disease Count was the common instrument used for measuring all three essential core outcomes of multimorbidity research: mortality, mental health and quality of life. There was a rise in the development of novel weighted indices by using prognostic models. The data obtained for measuring multimorbidity were from sources including medical records, patient self-reports and large administrative databases.ConclusionsWe listed the details of 33 instruments for measuring the level of multimorbidity as a resource for investigators interested in the measurement of multimorbidity for its association with or prediction of a specific outcome.

PurposeThe Applied Public-Private Research enabling OsteoArthritis Clinical Headway (APPROACH) consortium intends to prospectively describe in detail, preselected patients with knee osteoarthritis (OA), using conventional and novel clinical, imaging, and biochemical markers, to support OA drug development.ParticipantsAPPROACH is a prospective cohort study including 297 patients with tibiofemoral OA, according to the American College of Rheumatology classification criteria. Patients were (pre)selected from existing cohorts using machine learning models, developed on data from the CHECK cohort, to display a high likelihood of radiographic joint space width (JSW) loss and/or knee pain progression.Findings to dateSelection appeared logistically feasible and baseline characteristics of the cohort demonstrated an OA population with more severe disease: age 66.5 (SD 7.1) vs 68.1 (7.7) years, min-JSW 2.5 (1.3) vs 2.1 (1.0) mm and Knee injury and Osteoarthritis Outcome Score pain 31.3 (19.7) vs 17.7 (14.6), except for age, all: p<0.001, for selected versus excluded patients, respectively. Based on the selection model, this cohort has a predicted higher chance of progression.Future plansPatients will visit the hospital again at 6, 12 and 24 months for physical examination, pain and general health questionnaires, collection of blood and urine, MRI scans, radiographs of knees and hands, CT scan of the knee, low radiation whole-body CT, HandScan, motion analysis and performance-based tests.After two years, data will show whether those patients with the highest probabilities for progression experienced disease progression as compared to those wit lower probabilities (model validation) and whether phenotypes/endotypes can be identified and predicted to facilitate targeted drug therapy.Trial registration numberNCT03883568

IntroductionParticipation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.Methods and analysisGuided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.Ethics and disseminationEthical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

IntroductionRapid, robust and continually updated evidence synthesis is required to inform management of COVID-19 in pregnant and postpartum women and to keep pace with the emerging evidence during the pandemic.Methods and analysisWe plan to undertake a living systematic review to assess the prevalence, clinical manifestations, risk factors, rates of maternal and perinatal complications, potential for mother-to-child transmission, accuracy of diagnostic tests and effectiveness of treatment for COVID-19 in pregnant and postpartum women (including after miscarriage or abortion). We will search Medline, Embase, WHO COVID-19 database, preprint servers, the China National Knowledge Infrastructure system and Wanfang databases from 1 December 2019. We will supplement our search with studies mapped by Cochrane Fertility and Gynaecology group, Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), COVID-19 study repositories, reference lists and social media blogs. The search will be updated every week and not be restricted by language. We will include observational cohort (≥10 participants) and randomised studies reporting on prevalence of COVID-19 in pregnant and postpartum women, the rates of clinical manifestations and outcomes, risk factors in pregnant and postpartum women alone or in comparison with non-pregnant women with COVID-19 or pregnant women without COVID-19 and studies on tests and treatments for COVID-19. We will additionally include case reports and series with evidence on mother-to-child transmission of SARS-CoV-2 in utero, intrapartum or postpartum. We will appraise the quality of the included studies using appropriate tools to assess the risk of bias. At least two independent reviewers will undertake study selection, quality assessment and data extraction every 2 weeks. We will synthesise the findings using quantitative random effects meta-analysis and report OR or proportions with 95% CIs and prediction intervals. Case reports and series will be reported as qualitative narrative synthesis. Heterogeneity will be reported as I2 and τ2 statistics.Ethics and disseminationEthical approval is not required as this is a synthesis of primary data. Regular updates of the results will be published on a dedicated website (https://www.birmingham.ac.uk/research/who-collaborating-centre/pregcov/index.aspx) and disseminated through publications, social media and webinars.PROSPERO registration numberCRD42020178076.

IntroductionMany systematic reviews and meta-analyses (SRs/MAs) have evaluated the efficacy of biologic therapies for severe asthma. However, the overall quality of these SRs/MAs is unclear, which may influence the selection of biologics and lead to misleading clinical decisions. This umbrella review aims to objectively evaluate the overall quality of these SRs/MAs and reassess the efficacy of biologic therapies for severe asthma. Thus, this study will provide reliable evidence for clinical practice.Methods and analysisA systematic search will be performed in PubMed, Embase, Cochrane Library, Web of Science, Scopus and conference abstracts up to 1 March 2025. Literature screening and data extraction will be conducted according to predefined inclusion and exclusion criteria. We will evaluate the reporting quality, methodological quality and evidence quality of these SRs/MAs using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement, PRISMA for Network Meta-Analysis 2015 checklist, A MeaSurement Tool to Assess Systematic Reviews 2, Cochrane Risk of Bias 1.0 and Grading of Recommendations Assessment, Development and Evaluation system. Additionally, the re-analysis of outcomes will be performed using R software (V.4.3.3).Ethics and disseminationSince this umbrella review will use publicly available data, ethics approval is not required. The results of this study will be disseminated through publication in a peer-reviewed journal.PROSPERO registration numberCRD42024607393.

IntroductionScaling up evidence-based practices (EBPs) in family planning (FP), as recommended by the WHO, has increasingly been accepted by global health actors as core to their mission, goals and activities. National policies, strategies, guidance, training materials, political commitment and donor support exist in many countries to adopt and scale up a range of EBPs, including postpregnancy FP, task sharing for FP and the promotion of social and behaviour change (SBC) for FP. While there has been some success in implementing these practices, coverage remains inadequate in many countries. To gain a better understanding of the factors that may be hindering the sustained scale-up of these interventions, WHO has developed an assessment protocol to systematically identify the health systems’ ‘bottlenecks’ to implementation and to then identify solutions and develop strategies to address them.Methods and analysisA mixed method approach that includes document review, secondary data analysis (from surveys, service delivery data and case studies) and key informant interviews with policymakers, programme managers, health providers and community groups will be used to identify bottlenecks. This will be followed by a workshop to prioritise bottlenecks and characterise their root causes. Finally, solutions for the root causes of prioritised bottlenecks will be proposed. The protocol is structured in a modular format, with separate modules on postpregnancy FP, task sharing and SBC. Assessment themes and questions are informed by a wide body of literature on the three programmatic components, as well as studies on health policy implementation and scale-up.Ethics and disseminationThe protocol was exempt from ethical review by the WHO ethics committee. The findings of the bottleneck analysis will be presented at local, national and international conferences and disseminated through peer-reviewed publications and webinars.

IntroductionPoor oral health among older people is a global problem impacting on health and well-being. The economic cost to the health system is significant. An ageing population is intensifying the urgency for action. However, poor oral health, particularly for those in residential aged care facilities, continues to be highly resistant to resolution. The overall aims of this realist review are to: (A) explore and synthesise evidence on oral health interventions for older people in residential aged care facilities, (B) produce a causal theory on how contextual factors and mechanisms interact to produce outcomes, and (C) produce guidelines/policies to inform high-quality oral health interventions to improve older people’s oral health in residential aged care facilities.Methods and analysisThe review is guided by the RAMESES publication standards for realist synthesis. Participants include older people in residential aged care facilities, the aged care workforce, carers and families. Interventions include oral healthcare, oral health education, policy interventions and oral health promotion. The five-step realist review process of Pawson et al will guide the review: clarification of scope and development of initial framework, systematic searches, study appraisal and data extraction, synthesising evidence, drawing conclusions, and dissemination, implementation and evaluation. Expert input with key stakeholders will occur through a blog. Stakeholders will examine consistencies across studies and an explanatory causal theory will be developed to guide policy and practice.Ethics and disseminationFormal ethical approval was granted by the La Trobe University Ethics Committee HREC 20144. The developed theory will guide education, practice and policy decisions about interventions and the factors that impact on implementation. Using an integrated knowledge translation approach, traditional research outputs such as international conference presentations and publications will be supplemented with stakeholder forums, infographics, blogs, social media postings, webinars, podcasts and writing for web-based independent outlets.PROSPERO registration numberCRD42021155658.

IntroductionWith the wide adoption of the two-child policy in China since 2016, a large percentage of women with a history of caesarean delivery plan to have a second child. Accordingly, the rate of vaginal birth after caesarean (VBAC) delivery is increasing. Women attempting repeat VBAC may experience multiple morbidities, which is also one of the leading causes of maternal and perinatal mortality. However, it remains to be addressed how we evaluate factors for successful VBAC. This study aims to use a novel approach to identify a set of potential predictive factors for successful VBAC, especially for Chinese women, to be included in prediction models which can be most applicable to pregnant women in China. We plan to assess all potential predictive factors collected through a comprehensive literature review. Then the certainty of the evidence for the identified potential predictive factors will be assessed using the Grading of Recommendations Assessment, Development and Evaluation process. Finally, a two-round international Delphi survey will be conducted to determine the level of consensus.Methods and analysisThis study will apply a methodology through an evidence-based approach. A long list of potential predictive factors for successful VBAC will be extracted and identified through the following stages: First, an up-to-date systematic review of the published literature will be conducted to extract identified potential predictive factors for successful VBAC. Second, an online Delphi survey will be performed to achieve expert consensus on which factors should be included in future prediction models. The online questionnaires will be developed in the field of patient, maternal and fetal-related factors. A two-round international Delphi survey will be distributed to the expert panel in the field of perinatal medicine using Google Forms. Experts will be asked to score each factor using the 9-point Likert rating scale to establish potential predictive factors for the successful VBAC. The expert panel will determine on whether to include, potentially include or exclude predictive factors, based on a systematic review of clinical evidence and the Delphi method.Ethics and disseminationThe study was approved by the Institutional Review Board of the Jiaxing Maternity and Children Healthcare Hospital (approval number: 2019–79). The results of this study will be submitted to international peer-reviewed journals or conferences in perinatal medicine or obstetrics.

IntroductionDespite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based Expecting intervention (NCT02125149) with pregnant women with obesity in community settings.Methods and analysisWe will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted Expecting intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol).Ethics and disseminationThis study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals.Trial registration numberNCT04298125; Pre-results.