Developing a core outcome set for future infertility research: an international consensus development study† ‡.
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SUBMITTER: Duffy JMN
PROVIDER: S-EPMC7744160 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC7744157 | biostudies-literature
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| S-EPMC7744161 | 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.
| S-EPMC8817512 | biostudies-literature
Project description:BACKGROUND:Cauda Equina Syndrome (CES) is an emergency condition that requires acute intervention and can lead to permanent neurological deficit in working age adults. A Core Outcome Set (COS) is the minimum set of outcomes that should be reported by a research study within a specific disease area. There is significant heterogeneity in outcome reporting for CES, which does not allow data synthesis between studies. The hypothesis is that a COS for CES can be developed for future research studies using patients and healthcare professionals (HCPs) as key stakeholders. METHODS AND FINDINGS:Qualitative semi-structured interviews with CES patients were audio-recorded, transcribed and analysed using NVivo to identify the outcomes of importance. These were combined with the outcomes obtained from a published systematic literature review of CES patients. The outcomes were grouped into a list of 37, for rating through two rounds of an international Delphi survey according to pre-set criteria. The Delphi survey had an overall response rate of 63% and included 172 participants (104 patients, 68 HCPs) from 14 countries who completed both rounds. Thirteen outcomes reached consensus at the end of the Delphi survey and there was no attrition bias detected. The results were discussed at an international consensus meeting attended by 34 key stakeholders (16 patients and 18 HCPs) from 8 countries. A further three outcomes were agreed to be included. There was no selection bias detected at the consensus meeting. There are 16 outcomes in total in the CESCOS. DISCUSSION:This is the first study in the literature that has determined the core outcomes in CES using a transparent international consensus process involving healthcare professionals and CES patients as key stakeholders. This COS is recommended as the most important outcomes to be reported in any research study investigating CES outcomes and will allow evidence synthesis in CES.
| S-EPMC6953762 | biostudies-literature
Project description:ObjectivesA core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to achieve consensus on core outcomes. International input is important to achieve global COS uptake. We aimed to investigate participant representation in international Delphi surveys, with reference to the inclusion of patients and participants from low and middle income countries as stakeholders (LMICs).DesignSystematic review.Data sourcesEMBASE, Medline, Web of Science, COMET database and hand-searching.Eligibility criteriaProtocols and studies describing Delphi surveys used to develop an international COS for trial reporting, published between 1 January 2017 and 6 June 2019.Data extraction and synthesisDelphi participants were grouped as patients or healthcare professionals (HCPs). Participants were considered international if their country of origin was different to that of the first or senior author. Data extraction included participant numbers, country of origin, country income group and whether Delphi surveys were translated. We analysed the impact these factors had on outcome prioritisation.ResultsOf 90 included studies, 69% (n=62) were completed and 31% (n=28) were protocols. Studies recruited more HCPs than patients (median 60 (IQR 30-113) vs 30 (IQR 14-66) participants, respectively). A higher percentage of HCPs was international compared with patients (57% (IQR 37-78) vs 20% (IQR 0-68)). Only 31% (n=28) studies recruited participants from LMICs. Regarding recruitment from LMICs, patients were under-represented (16% studies; n=8) compared with HCPs (22%; n=28). Few (7%; n=6) studies translated Delphi surveys. Only 3% studies (n=3) analysed Delphi responses by geographical location; all found differences in outcome prioritisation.ConclusionsThere is a disproportionately lower inclusion of international patients, compared with HCPs, in COS-development Delphi surveys, particularly within LMICs. Future international Delphi surveys should consider exploring for geographical and income-based differences in outcome prioritisation.Prospero registration numberCRD42019138519.
| S-EPMC7684826 | 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:AimExtrahepatic 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.MethodsA 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.ConclusionThe 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 disseminationEthical 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.
| S-EPMC8362727 | biostudies-literature
Project description:OBJECTIVE:To develop a core metric set to monitor the quality of maternity care. DESIGN:Delphi process followed by a face-to-face consensus meeting. SETTING:English maternity units. POPULATION:Three representative expert panels: service designers, providers and users. MAIN OUTCOME MEASURES:Maternity care metrics judged important by participants. METHODS:Participants were asked to complete a two-phase Delphi process, scoring metrics from existing local maternity dashboards. A consensus meeting discussed the results and re-scored the metrics. RESULTS:In all, 125 distinct metrics across six domains were identified from existing dashboards. Following the consensus meeting, 14 metrics met the inclusion criteria for the final core set: smoking rate at booking; rate of birth without intervention; caesarean section delivery rate in Robson group 1 women; caesarean section delivery rate in Robson group 2 women; caesarean section delivery rate in Robson group 5 women; third- and fourth-degree tear rate among women delivering vaginally; rate of postpartum haemorrhage of ?1500 ml; rate of successful vaginal birth after a single previous caesarean section; smoking rate at delivery; proportion of babies born at term with an Apgar score <7 at 5 minutes; proportion of babies born at term admitted to the neonatal intensive care unit; proportion of babies readmitted to hospital at <30 days of age; breastfeeding initiation rate; and breastfeeding rate at 6-8 weeks. CONCLUSIONS:Core outcome set methodology can be used to incorporate the views of key stakeholders in developing a core metric set to monitor the quality of care in maternity units, thus enabling improvement. TWEETABLE ABSTRACT:Achieving consensus on core metrics for monitoring the quality of maternity care.
| S-EPMC6220866 | biostudies-literature
Project description:ObjectiveTypically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).DesignA two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.ResultsThere was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.ConclusionInternational and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.
| S-EPMC8634270 | biostudies-literature
Project description:PURPOSE:Cryptoglandular anal fistula is a disorder with an incidence of around 1 per 5,000 people per year in European countries. Many studies have been conducted to evaluate the effectiveness of interventions for anal fistula. However, there is considerable heterogeneity in the outcomes assessed and reported in these studies. This limits research quality and complicates evidence synthesis. A solution for heterogeneity in outcome reporting is the development of a Core Outcome Set (COS). This paper describes the protocol for the development of a European COS for Anal Fistula (AFCOS). METHODS:The first step will be a systematic review of the literature to identify potential outcomes that may be included in the COS. Patient interviews will be conducted in The United Kingdom and The Netherlands to ensure that both clinician-important and patient-important outcomes are captured. The outcomes will be categorized using the COMET taxonomy and taken forward to a Delphi consensus exercise. In up to three web-based Delphi surveys the outcomes will be prioritized by patients, clinicians (surgeons, gastroenterologists, and radiologists), and (clinical) researchers. The responses will be summarized and reported anonymously in subsequent round(s) facilitating convergence to a consensus opinion. The final COS will be decided during a face-to-face consensus meeting with patients, clinicians, and (clinical) researchers. DISCUSSION:This study protocol describes the development of a European COS for anal fistula to improve research quality, evidence synthesis, and patient care.
| S-EPMC7079265 | biostudies-literature