Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study† ‡.
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SUBMITTER: Duffy JMN
PROVIDER: S-EPMC7744157 | 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.
| S-EPMC8817512 | biostudies-literature
Project description:ObjectiveTo develop a core outcome set for international burn research.DesignDevelopment and international consensus, from April 2017 to November 2019.MethodsCandidate outcomes were identified from systematic reviews and stakeholder interviews. Through a Delphi survey, international clinicians, researchers, and UK patients prioritised outcomes. Anonymised feedback aimed to achieve consensus. Pre-defined criteria for retaining outcomes were agreed. A consensus meeting with voting was held to finalise the core outcome set.ResultsData source examination identified 1021 unique outcomes grouped into 88 candidate outcomes. Stakeholders in round 1 of the survey, included 668 health professionals from 77 countries (18% from low or low middle income countries) and 126 UK patients or carers. After round 1, one outcome was discarded, and 13 new outcomes added. After round 2, 69 items were discarded, leaving 31 outcomes for the consensus meeting. Outcome merging and voting, in two rounds, with prespecified thresholds agreed seven core outcomes: death, specified complications, ability to do daily tasks, wound healing, neuropathic pain and itch, psychological wellbeing, and return to school or work.ConclusionsThis core outcome set caters for global burn research, and future trials are recommended to include measures of these outcomes.
| S-EPMC9978679 | biostudies-literature
Project description:Heterogeneity of descriptors and outcomes measured and reported in sedentary behaviour (SB) research hinder the meta-analysis of data and accumulation of evidence. The objective of the Core Research Outcomes for Sedentary Behaviour Interventions (CROSBI) consensus study was to identify and validate, a core outcome set (COS) to report (what, how, when to measure) in interventional sedentary behaviour studies. Outcomes, extracted from a systematic literature review, were categorized into domains and data items (COS v0.0). International experts (n = 5) provided feedback and identified additional items, which were incorporated into COS v0.1. A two round online Delphi survey was conducted to seek consensus from a wider stakeholder group and outcomes that achieved consensus in the second round COS (v0.2), were ratified by the expert panel. The final COS (v1.0) contains 53 data items across 12 domains, relating to demographics, device details, wear-time criteria, wear-time measures, posture-related measures, sedentary breaks, sedentary bouts and physical activity. Notably, results indicate that sedentary behaviour outcomes should be measured by devices that include an inclinometry or postural function. The proposed standardised COS is available openly to enhance the accumulation of pooled evidence in future sedentary behaviour intervention research and practice.
| S-EPMC9367894 | 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:BackgroundSurgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field.MethodsStage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized.ResultsSome 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events.ConclusionA COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.
| S-EPMC10364901 | biostudies-literature
Project description:BackgroundCore outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent.Methods and findingsIn recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set-STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas.ConclusionsWith many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users.
| S-EPMC5068732 | 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:AimTo develop a core set of outcome domains to be measured in clinical studies on lower limb orthopaedic surgery for ambulant children with cerebral palsy (CP) that represents the priorities of an international multi-stakeholder group (children, parent/carers, and health professionals).MethodPotential outcome domains were identified through literature review and qualitative interviews with key stakeholders. These were scored in an international two-round Delphi survey, using a 9-point Likert scale. A final consensus meeting with key stakeholders agreed on the most important outcome domains and refined the core outcome set (COS).ResultsOne hundred and sixty-one health professionals and 36 individuals with CP and their parents/carers rated 21 of 41 outcomes as important in the Delphi survey. The final consensus group agreed 19 outcomes within eight domains to be included in the final COS: pain and fatigue, lower limb structure, motor function, mobility (daily life activities), gait-related outcomes, physical activity, independence, and quality of life.InterpretationA COS for lower limb orthopaedic surgery for children with CP was developed. Incorporating this in the design of future clinical studies will provide a more holistic assessment of the impact of treatment while allowing meaningful comparisons and future synthesis of results from primary studies.What this paper addsEight core outcome domains were identified as important to measure in future clinical research. Key stakeholders perceived pain, balance and fall, and independence as very important outcomes. Six contextual factors were identified as essential in surgical decision-making.
| S-EPMC10084115 | biostudies-literature
Project description:BackgroundInvasive off- or on-pump cardiac surgery (elective and emergency procedures, excluding transplants are routinely performed to treat complications of ischaemic heart disease. Randomised controlled trials (RCT) evaluate the effectiveness of treatments in the setting of cardiac surgery. However, the impact of RCTs is weakened by heterogeneity in outcome measuring and reporting, which hinders comparison across trials. Core outcome sets (COS, a set of outcomes that should be measured and reported, as a minimum, in clinical trials for a specific clinical field) help reduce this problem. In light of the above, we developed a COS for cardiac surgery effectiveness trials.MethodsPotential core outcomes were identified a priori by analysing data on 371 RCTs of 58,253 patients. We reached consensus on core outcomes in an international three-round eDelphi exercise. Outcomes for which at least 60% of the participants chose the response option "no" and less than 20% chose the response option "yes" were excluded.ResultsEighty-six participants from 23 different countries involving adult cardiac patients, cardiac surgeons, anaesthesiologists, nursing staff and researchers contributed to this eDelphi. The panel reached consensus on four core outcomes: 1) Measure of mortality, 2) Measure of quality of life, 3) Measure of hospitalisation and 4) Measure of cerebrovascular complication to be included in adult cardiac surgery trials.ConclusionThis study used robust research methodology to develop a minimum core outcome set for clinical trials evaluating the effectiveness of treatments in the setting of cardiac surgery. As a next step, appropriate outcome measurement instruments have to be selected.
| S-EPMC5667757 | biostudies-literature