What to measure in biliary atresia research: study protocol for developing a core outcome set.
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ABSTRACT: Aim
Extrahepatic biliary atresia is a rare disorder. This creates challenges in the quality and quantity of research conducted. This issue is exacerbated by the potential heterogeneity in the reported outcomes in research examining the management of biliary atresia. A core outcome set is required to standardise reporting on the management of biliary atresia in research, facilitate systematic reviews that include outcomes of greatest importance to patients and clinicians, and to evaluate the quality of the existing evidence base on the management of biliary atresia.Methods
A list of all potential outcomes will be developed through a systematic review of the literature. This list will be refined through a three-stage Delphi approach, involving key stakeholders in the management of biliary atresia. This will include patients and their parents, clinicians, nurses and allied health professionals. In this way, outcomes will be prioritised into a set of consensus core outcomes.Conclusion
The development of a core outcome set in biliary atresia management is needed to guide future research and assist in evaluating the quality of existing research.Ethics and dissemination
Ethical approval has been granted by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC), Ref: HREC/20/QCHQ/62448. Results of the study will be published in an open access format.
SUBMITTER: Maguire C
PROVIDER: S-EPMC8362727 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC7744160 | biostudies-literature
Project description:BackgroundAntimicrobial resistance is both a global public health and patient safety problem driven by overprescribing of antibiotic and other antimicrobial drugs. To conserve the effectiveness of antibiotics for future generations, antibiotic stewardship approaches to using them only where appropriate and necessary are advocated. Dentistry accounts for about 10% of antibiotic prescriptions across global healthcare, with 80% not in accordance with guidance in some countries. Core outcome sets enable the results of studies to be compared in order to maximise the value which can be derived from them. The aim of this study is to develop an international consensus on a core outcome set for dental antibiotic stewardship.MethodsConsensus on outcomes which are critical for inclusion in the core outcome set for dental antibiotic stewardship will be sought through two rounds of a Delphi survey (using the DelphiManager online system) followed by a final online consensus meeting. Thirty participants will be recruited to the Delphi Panel from across three stakeholder groups: ten dentists, ten academics and ten adults experienced with dental antibiotics as either a patient or parent/carer of a patient who has been prescribed them. Consensus will be achieved if more than 70% of the panel agree that an outcome is critical, with at least one from each stakeholder group in agreement. A long-list of candidate core outcomes has been developed from previously published studies with additions recommended by the steering group. The steering group will oversee development of the core outcome set and includes people from around the world with experience of dental antibiotics: clinicians, researchers and people with experience of being prescribed dental antibiotics and/or surviving an antibiotic resistant infection.DiscussionTo date, few studies of dental antibiotic stewardship have been published. Internationally, dental antibiotic guidelines and patterns of use vary widely, so a core outcome set is particularly important to facilitate meaningful comparisons between studies. This core outcome set will encompass antibiotic prescribing for both therapeutic indications, such as for people with acute infections, and for prophylactic indications, such as the prevention of distant site infections (like infective endocarditis) following dental procedures.
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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:BackgroundCurrent data on critical illness during pregnancy are insufficient for evidence-based decision making. Core outcome sets are promoted to improve reporting of outcomes important to decision makers. We aim to develop a Core Outcome Set for research on critically ill obstetric patients (COSCO study).MethodsWe will perform a systematic review of studies on critical illness in pregnancy and focus groups or interviews with women who were critically ill while being pregnant. These data will inform an international Delphi survey where stakeholders will rank proposed outcomes. Selected outcomes will be brought forward to a consensus meeting where core outcomes will be defined. We will then complete a second consensus process to define measures for each core outcome.ConclusionThe Core Outcome Set on Critically ill Obstetric patients study aims to develop a set of core outcomes to be part of all studies on critically ill obstetric patients. Implementation of this core outcome set will help improve future research efforts.Trial registration: This study is registered on the COMET-initiative website (COS #916). This systematic review is registered on PROSPERO (CRD #42017071944).
| S-EPMC6134347 | biostudies-literature
Project description:BackgroundThere is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals.ObjectiveDevelop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases.MethodsMixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting.ParticipantsKey stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers.ResultsThe literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss.ConclusionsImplementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions.RegistrationCOMET Database: http://www.comet-initiative.org/studies/details/265?result=true.
| S-EPMC8297801 | biostudies-literature
Project description:IntroductionRandomized trials evaluating interventions for stress urinary incontinence (SUI) have been using variable outcome measures, reporting a variety of outcomes. Alongside this variation across studies, outcome-reporting flaws contribute to a limited use of research to inform clinical practice. The development and use of core outcome sets (COSs) in future trials would ensure that outcomes important to different stakeholders and primarily women with SUI are reported more consistently and comprehensively.MethodsAn international steering group including healthcare professionals, researchers, and women with urinary incontinence will guide the development of this COS. Potential outcomes will be identified through comprehensive literature reviews. These outcomes will be entered into an international, multiperspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and women with urinary incontinence, will be invited to participate. The modified Delphi method encourages stakeholder group convergence toward collective agreement, also referred as consensus, core outcomes.DiscussionDissemination and implementation of the resulting COS within an international context will be promoted and reviewed. Embedding the COS for SUI within future clinical trials, systematic reviews and clinical practice guidelines could make a significant contribution to advancing the value of research in informing clinical practice, enhancing patient care and improving outcomes. The infrastructure created by developing a COS for SUI could be leveraged in other settings, for example, selecting research priorities and clinical practice guideline development.
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Project description:BACKGROUND:Selective fetal growth restriction in monochorionic twin pregnancies is associated with an increased risk of perinatal mortality and morbidity and represents a clinical dilemma. Interventions include expectant management with early preterm delivery if there are signs of fetal compromise, selective termination of the compromised twin, fetoscopic laser coagulation of the communicating placental vessels or termination of the whole pregnancy. Previous studies evaluating interventions have reported many different outcomes and outcome measures. Such variation makes comparing, contrasting, and combining results challenging, limiting ongoing research on this uncommon condition to inform clinical practice. We aim to produce, disseminate, and implement a core outcome set for selective fetal growth restriction research in monochorionic twin pregnancies. METHODS:An international steering group, including professionals, researchers, and lay experts, has been established to oversee the development of this core outcome set. The methods have been guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. Potential core outcomes will be developed by undertaking a systematic review of studies evaluating interventions for selective fetal growth restriction in monochorionic twin pregnancies. Potential core outcomes will be entered into a three-round Delphi survey and key stakeholders including clinical professionals, researchers, and lay experts will be invited to participate. Repeated reflection and rescoring of individual outcomes should encourage group and individual stakeholder convergence towards consensus outcomes which will be entered into a modified Nominal Group Technique to finalize the core outcome set. Once core outcomes have been agreed, we will establish standardized definitions and recommend high-quality measurement instruments for each outcome. DISCUSSION:The development, dissemination, and implementation of a core outcome set for selective fetal growth restriction should ensure that future research protocols select, collect, and report outcomes and outcome measures in a standardized manner. Data synthesis will be possible on a broad level and rigorous implementation should advance the quality of research studies and their effective use in order to guide clinical practice, improve patient care, maternal, short-term perinatal outcomes, and long-term neurodevelopmental outcomes. TRIAL REGISTRATION:Core Outcome Measures in Effectiveness Trials (COMET) registration number: 998. International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42018092697 . 18th April 2018.
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Project description:IntroductionChronic heart failure (CHF) is a serious and advanced stage of various cardiovascular diseases and portends poor prognosis. An increase in clinical studies has reported the effectiveness of traditional Chinese medicine (TCM). For example, intravenous Chinese medicine can significantly improve cardiac function and biomarkers in patients with CHF. However, there exists inconsistency, lack of practicality and unclear reporting of outcomes in these clinical trials causing difficulty in the comparison of results across similar studies during data synthesis. A core outcome set (COS) can help in the standardisation of outcomes reported across studies from the same healthcare area. The aim of this study is to develop a COS on TCM for CHF (COS-TCM-CHF) to reduce heterogeneity in reporting and improve quality assessment in clinical trials to support data synthesis in addressing the effectiveness of TCM treatment.Methods and analysisThis study will include constructing an outcome pool which will identify potential outcomes through systematic reviews of TCM randomised clinical trials, two clinical registry databases, semi-structured interviews of patients and the clinicians' questionnaire. According to the characteristics of TCM and a taxonomy recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, all outcomes in the outcome pool will be classified into different domains. A preliminary list of outcomes which will then be used in the Delphi survey is generated using a certain criteria based on the length of the pool. The Delphi survey will include two rounds with seven key stakeholder groups to select candidate items for a consensus meeting. A final COS-TCM-CHF will be developed at a face-to-face consensus meeting involving representatives from the different stakeholders.Ethics and disseminationEthical approval of this study has been granted by Evidence-based Medicine Centre of Tianjin University of Traditional Chinese Medicine Research Ethics Committee (TJUTCMEC201200002). We will disseminate our research findings of the final COS on the website of Chinese Clinical Trials for Core Outcome Set, with open access publications and present at international conferences to reach a wide range of knowledge users.Trial registration numberhttp://www.comet-initiative.org/studies/details/1486.
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Project description:BACKGROUND:Oral healthcare service provision for dependent older adults is often poor. For dental services to provide more responsive and equitable care, evidence-based approaches are needed. To facilitate future research, the development and application of a core outcome set would be beneficial. The aim of this study is to develop a core outcome set for oral health services research involving dependent older adults. METHODS:A multi-step process involving consensus methods and including key stakeholders will be undertaken. This will involve identifying potentially relevant outcomes through a systematic review of previous studies examining the effectiveness of strategies to prevent oral disease in dependent older adults, combined with semi-structured interviews with key stakeholders. Stakeholders will include dependent older adults, family members, carers, care-home managers, health professionals, researchers, dental commissioners and policymakers. To condense and prioritise the long list of outcomes generated by the systematic review and semi-structured interviews, a Delphi survey consisting of several rounds with key stakeholders, as mentioned above, will be undertaken. The 9-point Likert scale proposed by the GRADE Working Group will facilitate this consensus process. Following the Delphi survey, a face-to-face consensus meeting with key stakeholders will be conducted where the stakeholders will anonymously vote and decide on what outcomes should be included in the finalised core outcome set. DISCUSSION:Developing a core set of outcomes that are clinically and patient-centred will help improve the design, conduct and reporting of oral health services research involving dependent older adults, and ultimately strengthen the evidence base for high-quality oral health care for dependent older adults. TRIAL REGISTRATION:The study was registered with the COMET initiative on 9 January 2018 http://www.cometinitiative.org/studies/details/1081?result=true .
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Project description:IntroductionPrimary school-based physical activity interventions, such as The Daily Mile initiative, have the potential to increase children's physical activity levels over time, which is associated with a variety of health benefits. Comparing interventions or combining results of several studies of a single intervention is challenging because previous studies have examined different outcomes or used different measures that are not feasible or relevant for researchers in school settings. The development and implementation of a core outcome set (COS) for primary school-based physical activity interventions would ensure outcomes important to those involved in implementing and evaluating interventions are standardised.Methods and analysisOur aim is to develop a COS for studies of school-based physical activity interventions. We will achieve this by undertaking a four-stage process:(1) identify a list of outcomes assessed in studies through a systematic review of international literature; (2) establish domains from these outcomes to produce questionnaire items; (3) prioritise outcomes through a two-stage Delphi survey with four key stakeholder groups (researchers, public health professionals, educators and parents), where stakeholders rate the importance of each outcome on a 9-point Likert scale (consensus that the outcomes should be included in the COS will be determined as 70% or more of all stakeholders scoring the outcome 7%-9% and 15% or less scoring 1 to 3); (4) achieve consensus on a final COS in face-to-face meetings with a sample of stakeholders and primary school children.Ethics and disseminationWe have received ethical approval from Imperial College London (ref: 19IC5428). The results of this study will be disseminated via conference presentations/public health meetings, peer-reviewed publications and through appropriate media channels.Trial registration numberCore Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1322.
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