Gestational diabetes prevention and treatment: a protocol for developing core outcome sets.
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ABSTRACT:
SUBMITTER: Egan AM
PROVIDER: S-EPMC6887023 | biostudies-literature | 2019 Nov
REPOSITORIES: biostudies-literature
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Gestational diabetes prevention and treatment: a protocol for developing core outcome sets.
Egan Aoife Maria AM Dunne Fidelma P FP Biesty Linda M LM Bogdanet Delia D Crowther Caroline C Dempsey Eugene E Thangaratinam Shakila S Devane Declan D Fhelelboom Narjes N
BMJ open 20191114 11
<h4>Introduction</h4>Selective reporting bias, inconsistency in the chosen outcomes between trials and irrelevance of the chosen outcomes for women, limit the efficiency and value of research for prevention and treatment of gestational diabetes mellitus (GDM). One way to address these challenges is to develop core outcome sets (COSs).<h4>Methods and analysis</h4>The aim of this manuscript is to present a protocol for a study to develop COSs for GDM prevention and treatment. This is a three-phase ...[more]
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Project description:AIMS/HYPOTHESIS:The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS:We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS:Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION:This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION:This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.
| S-EPMC7228989 | biostudies-literature
Project description:IntroductionCore outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set.Methods and analysisWe will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a 'realist synthesis review' to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set.Ethics and disseminationThe review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators.
| S-EPMC5724145 | biostudies-literature
Project description:BackgroundPregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM.MethodsThe study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group.DiscussionThis paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups.Trial registrationThis COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative ( http://www.comet-initiative.org/studies/details/1425 ) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549 ).
| S-EPMC7730783 | biostudies-literature
Project description:Introduction'Core outcome sets' are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations and so on) consider the important outcomes in the management or prevention of a condition. This paper describes the rationale and design for the development of Core Outcome Sets for Miscarriage Trials.Methods and analysisSystematic reviews, interviews and focus groups with patients and their partners will be conducted to identify potential core outcomes that will be introduced into a modified Delphi survey. To ensure all key stakeholders are included, patients, partners, clinicians, charities and researchers will be invited to take part in the modified Delphi survey. There will be three rounds of scoring and rescoring during the Delphi survey to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions.Ethics and disseminationThe use of core outcome sets allows results from different studies to be compared and combined, thereby reducing inconsistency and aiding interpretation of study findings. It also means research is more likely to report relevant outcomes and so can reduce reporting bias. Understanding which outcomes are important to patients has the potential to act as a driver to improve both the quality and cost-effectiveness of miscarriage services.
| S-EPMC5701979 | biostudies-literature
Project description:Synthesis of effects of infant feeding interventions to prevent childhood obesity is limited by outcome measurement and reporting heterogeneity. Core outcome sets (COSs) represent standardised approaches to outcome selection and reporting. The aim of this review is to identify feeding outcomes used in infant feeding studies to inform an infant feeding COS for obesity prevention interventions. The databases EMBASE, Medline, CINAHL, CENTRAL, and PsycINFO searched from inception to February 2017. Studies eligible for inclusion must examine any infant feeding outcome in children ?1 year. Feeding outcomes include those measured using self-report and/or observational methods and include dietary intake, parent-child interaction, and parental beliefs, among others. Data were extracted using a standardised data extraction form. Outcomes were assigned to outcome domains using an inductive, iterative process with a multidisciplinary team. We identified 82 unique outcomes, representing nine outcome domains. Outcome domains were "breast and formula feeding," "introduction of solids," "parent feeding practices and styles," "parent knowledge and beliefs," "practical feeding," "food environment," "dietary intake," "perceptions of infant behaviour and preferences," and "child weight outcomes." Heterogeneity in definition and frequency of outcomes was noted in reviewed studies. "Introduction of solids" (59.5%) and "breastfeeding duration" (55.5%) were the most frequently reported outcomes. Infant feeding studies focus predominantly on consumption of milks and solids and infant weight. Less focus is given to modifiable parental and environmental factors. An infant feeding COS can minimise heterogeneity in selection and reporting of infant feeding outcomes for childhood obesity prevention interventions.
| S-EPMC7199036 | biostudies-literature
Project description:BackgroundGestational diabetes mellitus (GDM) increases the risk of adverse short- and long-term outcomes, including development of type 2 diabetes. The US Diabetes Prevention Program demonstrates this risk can be halved with an intensive health behavior change intervention in women with pre-diabetes averaging 12?years since a GDM pregnancy. In recent years, the number of studies looking at changing the behaviors of women with previous GDM closer to the time of delivery has steadily grown, but reported outcomes vary and most studies are not long enough or large enough to examine incident diabetes. This initiative aims to develop a core outcome set (COS) for interventions seeking to prevent diabetes after pregnancy (DAP) in both women with prior GDM and their families.MethodsThe COS-DAP project will use established COS methodology, in four stages: (1) a systematic literature review of DAP prevention intervention studies following GDM; (2) discussion and cataloguing of outcomes measured and implementation components at an investigator meeting; (3) a two-round online Delphi survey aimed at prioritizing the identified outcomes; and (4) a consensus meeting with key stakeholders to review, discuss, and refine suitable COS measures, using nominal group technique.DiscussionCOS-DAP aims to develop a COS for health behavior change interventions to prevent DAP. The COS is expected to enhance opportunities for comparison of future studies and allow for better synthesis of the effects. The inclusion of multiple stakeholder perspectives will increase the final COSs applicability and relevance.Trial registrationComet Initiative, COMET 1083; PROSPERO, CRD42018084853 . Registered in prospero on 03/01/2018.
| S-EPMC6311057 | biostudies-literature
Project description:BackgroundIt is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The relationship between outcomes chosen for comparative effectiveness research, outcomes used in decision-making in routine care, and outcome data recorded in electronic health records (EHR) is also poorly understood. The COMET Initiative (http://www.comet-initiative.org/. Accessed 3 Apr 2020) supports and encourages the development and use of 'core outcome sets' (COS), which represent the minimum set of patient health outcomes that should be measured and reported for a specific condition. There is growing interest in identifying how COS might fit into the different stages of the healthcare research and delivery ecosystem, and whether inclusion in the EHR might facilitate this.MethodsWe sought to determine the degree of overlap between outcomes within COS for research and routine care, EMA, FDA and NICE guidelines, NICE quality statements/indicators, EHR and a point-of-care randomised clinical trial, using type 2 diabetes (T2D) as a case study.ResultsThere is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR.ConclusionsThis case study has demonstrated the potential for efficient research and value-based healthcare when the EHR can include COS for both research and care, where the COS comprises outcomes of importance to all relevant stakeholders. However, this concordance may not hold more generally, as the focus on patient-centred outcomes may well be greater in T2D than in other conditions. Work is ongoing to examine other clinical areas, in order to highlight any current inefficiencies when health outcomes in research and healthcare do not agree with core outcomes identified by patients, clinicians and other key stakeholders.
| S-EPMC7318375 | biostudies-literature
Project description:Diabetes prevention intervention studies in women with previous gestational diabetes have increased, but no consensus exists on core outcomes to support comparisons and synthesis of findings. We aimed to systematically catalogue outcomes in diabetes after pregnancy prevention interventions with the goal of developing a core outcome set. Embase, Medline, Cochrane Library, Cochrane Pregnancy and Childbirth Trials Register, and CINAHL were searched from inception to October 2017. Post-partum lifestyle and diabetes screening intervention studies in women with previous gestational diabetes and/or their families were eligible. No limits were placed on intervention type, duration, or location. Two authors independently screened and performed data extraction on outcomes, measurement tools, and relevant study characteristics. We analysed data from 38 studies (29 randomised controlled trials and 9 pre-post intervention evaluations) comprising 12,509 participants. Most publications (80%) occurred between the years 2012 and 2017. Among 172 outcomes, we identified 36 outcome groups and classified them under three domains: health status (body weight, body composition, diabetes risk, cardiometabolic risk, diabetes development, mental health, pregnancy outcomes, and fitness), health behaviours (dietary, physical activity, diabetes screening, behaviour change, and breastfeeding), and intervention processes (implementation). The health status domain contained the most commonly reported outcomes, but measurement tools were very heterogeneous. Despite the recent explosion in diabetes after pregnancy prevention studies, large variation in outcomes and measurement methods exists. Research is needed to define a core outcome set to standardise diabetes after pregnancy prevention interventions. The core outcome set should engage a wide group of stakeholders to identify impactful indicators for future trials.
| S-EPMC7296791 | biostudies-literature
Project description:This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice.A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients.Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions.
| S-EPMC5537457 | biostudies-other
Project description:IntroductionRecognition that child maltreatment (CM) and domestic violence and abuse (DVA) are common and have serious and long-term adverse health consequences has resulted in policies and programmes to ensure that services respond to and safeguard children and their families. However, high-quality evidence about how services can effectively intervene is scant. The value of the current evidence base is limited partly because of the variety of outcomes and measures used in evaluative studies. One way of addressing this limitation is to develop a core outcome set (COS) which is measured and reported as a minimum standard in the context of trials and other types of evaluative research. The study described in this protocol aims to develop two discrete COSs for use in future evaluation of psychosocial interventions aimed at improving outcomes for children and families at risk or with experience of (1) CM or (2) DVA.Methods and analysisA two-phase mixed methods design: (1) rapid reviews of evidence, stakeholder workshops and semistructured interviews with adult survivors of CM/DVA and parents of children who have experienced CM/DVA and (2) a three panel adapted E-Delphi Study and consensus meeting. This study protocol adheres to reporting guidance for COS protocols and has been registered on the Core Outcome Measures for Effectiveness Trials (COMET) database.Ethics and disseminationWe will disseminate our findings through peer-reviewed and open access publications, the COMET website and presentations at international conferences. We will engage with research networks, journal editors and funding agencies to promote awareness of the CM-COS and DVA-COS. We will work with advisory and survivor and public involvement groups to coproduce a range of survivor, policy and practice facing outputs.Approval for this study has been granted by the Research Ethics Committee at University College London.
| S-EPMC8383853 | biostudies-literature