Core Outcome Measures In Effectiveness Trials Research Articles

Surgical Handover Core Outcome Measures (SH-CORE): a protocol for the development of a core outcome set for trials in surgical handover

BackgroundSurgical handover is associated with a significant risk of care failures. Existing research displays methodological deficiencies and little consensus on the outcomes that should be used to evaluate interventions in this area. This paper reports a protocol to develop a core outcome set (COS) to support standardisation, comparability, and evidence synthesis in future studies of surgical handover between doctors.MethodsThis study adheres to the Core Outcome Measures in Effectiveness Trials (COMET) initiative guidance for COS development, including the COS-Standards for Development (COS-STAD) and Reporting (COS-STAR) recommendations. It has been registered prospectively on the COMET database and will be led by an international steering group that includes surgical healthcare professionals, researchers, and patient and public partners. An initial list of reported outcomes was generated through a systematic review of interventions to improve surgical handover (PROSPERO: CRD42022363198). Findings of a qualitative evidence synthesis of patient and public perspectives on handover will augment this list, followed by a real-time Delphi survey involving all stakeholder groups. Each Delphi participant will then be invited to take part in at least one online consensus meeting to finalise the COS.Ethics and disseminationThis study was approved by the Royal College of Surgeons in Ireland (RCSI) Research Ethics Committee (202309015, 7th November 2023). Results will be presented at surgical scientific meetings and submitted to a peer-reviewed journal. A plain English summary will be disseminated through national websites and social media. The authors aim to integrate the COS into the handover curriculum of the Irish national surgical training body and ensure it is shared internationally with other postgraduate surgical training programmes. Collaborators will be encouraged to share the findings with relevant national health service functions and national bodies.DiscussionThis study will represent the first published COS for interventions to improve surgical handover, the first use of a real-time Delphi survey in a surgical context, and will support the generation of better-quality evidence to inform best practice.Trial registrationCore Outcome Measures in Effectiveness Trials (COMET) initiative 2675. http://www.comet-initiative.org/Studies/Details/2675.

Diagnostic criteria and core outcome set development for necrotising otitis externa: the COSNOE Delphi consensus study.

Evidence for necrotising otitis externa (NOE) diagnosis and management is limited, and outcome reporting is heterogeneous. International best practice guidelines were used to develop consensus diagnostic criteria and a core outcome set (COS). The study was pre-registered on the Core Outcome Measures in Effectiveness Trials (COMET) database. Systematic literature review identified candidate items. Patient-centred items were identified via a qualitative study. Items and their definitions were refined by multidisciplinary stakeholders in a two-round Delphi exercise and subsequent consensus meeting. The final COS incorporates 36 items within 12 themes: Signs and symptoms; Pain; Advanced Disease Indicators; Complications; Survival; Antibiotic regimes and side effects; Patient comorbidities; Non-antibiotic treatments; Patient compliance; Duration and cessation of treatment; Relapse and readmission; Multidisciplinary team management.Consensus diagnostic criteria include 12 items within 6 themes: Signs and symptoms (oedema, otorrhoea, granulation); Pain (otalgia, nocturnal otalgia); Investigations (microbiology [does not have to be positive], histology [malignancy excluded], positive CT and MRI); Persistent symptoms despite local and/or systemic treatment for at least two weeks; At least one risk factor for impaired immune response; Indicators of advanced disease (not obligatory but mut be reported when present at diagnosis). Stakeholders were unanimous that there is no role for secondary, graded, or optional diagnostic items. The consensus meeting identified themes for future research. The adoption of consensus-defined diagnostic criteria and COS facilitates standardised research reporting and robust data synthesis. Inclusion of patient and professional perspectives ensures best practice stakeholder engagement.

Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: the PRECEDENT project

IntroductionNeoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored...

The methodological quality of systematic reviews regarding the Core Outcome Set (COS) development

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) working group proposed core outcome sets (COS) to address the heterogeneity in outcome measures in clinical studies. According to the recommendations of COMET, performing systematic reviews (SRs) usually was the first step for COS development. However, the SRs that serve as a basis for COS are not specifically appraised by organizations such as COMET regarding their quality. Here, we investigated the status of SRs related to development of COS and evaluated their methodological quality.MethodsWe conducted a search on PubMed to identify SRs related to COS development published from inception to May 2022. We qualitatively summarized the disease included in SR topics, and the studies included in the SRs. We evaluated the methodological quality of the SRs using AMSTAR 2.0 and compared the overall quality of SRs with and without protocols using the Mann-Whitney U test.ResultsWe included 175 SRs from 23 different countries or regions, and they mainly focused on five diseases: musculoskeletal system or connective tissue disease (n = 19, 10.86%), injury, poisoning, or certain other consequences of external causes (n = 18, 10.29%), digestive system disease (n = 16, 9.14%), nervous system disease (n = 15, 8.57%), and genitourinary system disease (n = 15, 8.57%). Although 88.00% of SRs included randomized controlled trials (RCTs), only a few SRs (23.38%) employed appropriate tools to assess the risk of bias in RCTs. The assessment results on the basis of AMSTAR 2.0 indicated that most SRs (93.71%) were rated as ‘’critically low’’ to ‘’low’’ in terms of overall confidence. The overall confidence of SRs with protocols was significantly higher than that without protocols (P <.001). Compared to the SRs with protocols on Core Outcome Measures in Effectiveness Trials (COMET), SRs with protocols on PROSPERO were of better overall confidence (P = .017).ConclusionThe overall quality of published SRs regarding COS development was poor. Our findings emphasize the need for researchers to carefully select the disease topic and strictly adhere to the requirements of optimal methodology when conducting a SR for the establishment of a COS.

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

BackgroundOutcome assessment in perioperative exercise trials for lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This heterogeneity hinders the synthesis of evidence. To address this issue, a core outcome set, an agreed-upon standardized set of outcomes to be measured and reported, is required to reduce heterogeneity among outcome measurements. This study protocol describes the methodology, aiming to develop a core outcome set for perioperative exercise intervention trials for lung cancer in clinical practice.MethodsThe project will follow the standard methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, which is divided into four steps. Stage I: Conducting a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains. Stage II: Conducting semi-structured interviews to obtain important outcomes for patients. Stage III: Choosing the most important outcomes by conducting two rounds of the Delphi exercise. Stage IV: Achieving a consensus in a face-to-face meeting to discuss the final core outcome set.DiscussionThis is the first project identified for the core outcome set of perioperative exercise trials in lung cancer, which will enhance the quality, comparability, and usability of future trials and positively impact perioperative exercise and the care of patients with lung cancer.Trials registrationCore Outcome Measurement in Effectiveness Trials (COMET) Initiative database registration: https://www.comet-initiative.org/Studies/Details/2091

Protocol of a scoping review of outcome domains in dermatology

IntroductionCore outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide,...

Development of a Core Outcome Set for Dysphagia Interventions in Parkinson’s disease (COS-DIP): study protocol

IntroductionCurrent clinical trials on swallowing disorders (dysphagia) in Parkinson’s disease (PD) apply a high variety of outcomes and different outcome measures making comparative effectiveness research challenging. Furthermore, views of patients...

Protocol for the development of a Core Outcome Set (COS) for Adolescents and Young Adults (AYAs) with cancer

BackgroundAdolescents and young adults (AYAs) with cancer, defined as individuals aged 15–39 years at initial cancer diagnosis, form a unique population; they face age-specific issues as they transition to adulthood. This paper presents the protocol for the development of a core outcome set (COS) for AYAs with cancer.MethodsThe methodological standards from the Core Outcome Measures in Effectiveness Trials (COMET) and the International Consortium for Health Outcomes Measurement (ICHOM) for COS development will guide the development of the COS for AYAs with cancer. The project will consist of the following phases: (1) define the scope of the COS; (2) establish the need for a COS in this field (3) assemble an international, multi-stakeholder working group; (4) develop a detailed protocol; (5) determine “what to measure” (i.e., outcomes); (6) determine “how to measure” (i.e., measures); and (7) determine “case-mix” variables.ConclusionsThe development of a COS for AYAs with cancer will facilitate the implementation of efficient and relevant standards for data collection, both for clinical trials and in routine healthcare, thereby increasing the usefulness of these data to improve the value of the care given to these underserved young cancer patients.

Developing a Core Outcome Set for Cytoreductive Surgery for Colorectal Cancer with Peritoneal Metastases: A Mixed-Method Study Protocol

As the number of centres offering cytoreductive surgery (CRS) for colorectal cancer with peritoneal metastases (CPMs) is increasing worldwide, research is focused on establishing better patient selection and ensuring that new techniques have positive impacts on survival. However, high-impact comparative research in this field is limited by the heterogeneity of outcome measurement and reporting. Additionally, as there are comparatively few randomised controlled trials reporting comprehensive patient-reported outcomes, it is possible that key stakeholders such as patients and carers are underrepresented in the current literature. A core outcome set (COS) for CRS with or without intraperitoneal chemotherapy for the treatment of CPMs, supported by clinicians and patients, will promote homogenous comparison across trials and optimise the utility of research findings. We have established a comprehensive protocol based on the Core Outcome Measures in Effectiveness Trials (COMETs) method to facilitate this. A systematic review will identify all the outcomes reported in the literature, whereas a semi-structured interview will identify outcomes considered important by patients and carers. The identified outcomes will populate an international Delhi survey, distributed to patients, carers, surgeons, oncologists, nurses, and allied health clinicians. Outcomes reaching international consensus of importance will be further discussed in a face-to-face workshop between patients, carers, and clinicians. This process will inform the development of a final COS for CRS for patients with CPMs.

Development of the Core Outcome Set for Psychiatric Pharmacists

AbstractObjectiveThe American Association of Psychiatric Pharmacists (AAPP) sought to develop a consensus‐based set of outcomes and measures to standardize psychiatric pharmacy practice and research. The measures in this Core Outcome Set for Psychiatric Pharmacists (COS‐PP) are designed to study the impact of psychiatric pharmacists caring for individuals living with psychiatric disorders.MethodsThe COS‐PP was developed using guidelines from the Core Outcome Measures in Effectiveness Trials (COMET) initiative. A committee systematically reviewed a catalog of 194 articles and 40 posters that referenced psychiatric disorders, patient‐level outcomes, and pharmacist interventions. From these initial 234 resources, 554 combinations of outcomes and measures were identified. Additional papers, guidelines, and feedback from experts increased the number to 592 combined outcomes and measures. The principal investigator consolidated the list to 46 potential outcomes. AAPP members were invited to complete a survey rating the 46 potential outcomes on five key factors: comprehensive, attributable to pharmacy, feasible, scientifically sound, and usable. These survey results were provided to the 18 Board‐Certified Psychiatric Pharmacists participating in a summit examining the potential outcomes and measures gleaned from literature review. Through discussion and refinement, consensus was achieved on the final COS‐PP.ResultsThe final COS‐PP included 21 outcomes, 14 of which included at least 1 measure (84 total measures). The outcomes were grouped according to the quadruple health care aims: better care, reduced healthcare costs, improved patient experience, and improved clinician well‐being.ConclusionsCOS‐PP will help define psychiatric pharmacists' support of the interdisciplinary team in addressing the quadruple health care aims. Using standardized outcomes across practice sites will allow aggregation of data on the impact of psychiatric pharmacists on patient care.

Assessing the uptake of the type 1 diabetes core outcome set in randomized controlled trials: A Cross-Sectional study

AimsThis study analyzed uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in its use before and after its development in December 2017. MethodsOn June 26, 2023, ClinicalTrials.gov was systematically searched for T1D randomized controlled trials. The Core Outcome Measures in Effectiveness Trials (COMET) database provided a COS of eight key outcomes for analysis. Included trials were analyzed for COS uptake before and after its release in December 2017 in a masked, duplicate fashion by independent reviewers. We also calculated the proportion of trials that measured the complete COS and assessed the most frequently reported COS outcomes. ResultsOf 3,792 originally screened articles, 144 RCTs were included in the final sample. Following COS publication, its use steadily decreased. Within the COS, HbA1c and severe hypoglycemia were most frequently implemented as endpoints; other recommended outcomes were rarely used in the published trials. ConclusionDespite the 2017 T1D COS publication, use has decreased over time. This inconsistency negatively influences evidence-based practices and care. Educating researchers on COS and promoting uptake is crucial. Wider COS adoption in T1D trials could enhance clinical research overall. Further study of barriers and facilitators influencing uptake is essential to support consistent use and reporting.

Acute care models for older people living with frailty: a systematic review and taxonomy

BackgroundThe need to improve the acute care pathway to meet the care needs of older people living with frailty is a strategic priority for many healthcare systems. The optimal care model for this patient group is unclear.MethodsA systematic review was conducted to derive a taxonomy of acute care models for older people with acute medical illness and describe the outcomes used to assess their effectiveness. Care models providing time-limited episodes of care (up to 14 days) within 48 h of presentation to patients over the age of 65 with acute medical illness were included. Care models based in hospital and community settings were eligible.Searches were undertaken in Medline, Embase, CINAHL and Cochrane databases. Interventions were described and classified in detail using a modified version of the TIDIeR checklist for complex interventions. Outcomes were described and classified using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy. Risk of bias was assessed using RoB2 and ROBINS-I.ResultsThe inclusion criteria were met by 103 articles. Four classes of acute care model were identified, acute-bed based care, hospital at home, emergency department in-reach and care home models. The field is dominated by small single centre randomised and non-randomised studies. Most studies were judged to be at risk of bias. A range of outcome measures were reported with little consistency between studies. Evidence of effectiveness was limited.ConclusionAcute care models for older people living with frailty are heterogenous. The clinical effectiveness of these models cannot be conclusively established from the available evidence.Trial registrationPROSPERO registration (CRD42021279131).

What should be measured and reported in clinical trials for the treatment of patients with acute pancreatitis? A study protocol for establishing a core outcome set

IntroductionAcute pancreatitis (AP) is characterised by inflammation of the exocrine pancreas, which potentially leads to local complications and organ failure resulting in significant morbidity and mortality. A long-term follow-up by...

A core outcome set (COS) for dementia with Lewy bodies

AbstractBackgroundMethodological heterogeneity in the outcome measurements adopted in DLB trials impedes effective evidence synthesis, rigorous meta‐analysis, and clinical translation. We aimed to develop a Core Outcome Set (COS), an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical DLB trials.MethodWe adopted a multi‐faceted approach to COS development, adopting the principles of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. We conducted systematic reviews of outcomes used in intervention trials, qualitative studies, and health economic studies in DLB. A resulting shortlist of outcome measures formed the basis of an e‐Delphi consensus process, piloted among members of the study group, before it was administered in two rounds to clinicians, scientists, policy and third sector leads. Lay stakeholders, including people with DLB and their caregivers, also contributed to the e‐Delphi process. Consensus on inclusion was determined by at least 70% of respondents grading an outcome measure as “critical for inclusion” and less than 15% grading as “not important”. After appraisal of each outcome using Consensus‐based Standards for the selection of health Measurement Instruments (COSMIN) guidelines, a consensus meeting was conducted, in which all participants were invited to agree on final outcomes and rate each outcome on impact, relevance and clinical feasibility.ResultsThrough validated mechanisms we constructed a COS including measurements of motor, cognitive, neuropsychiatric, autonomic, health economic, health provision, and quality of life. A diverse group of international and intersectional stakeholders have lent approval to its use.ConclusionWe propose a COS; a benchmark which all DLB trials should meet. This standardised approach will could optimise research resources, facilitate multicentre collaboration, and minimize methodological bias.

The GenderCOS project: study protocol for the development of two international Core Outcome Sets for genital gender affirming surgery

Background: Worldwide an increasing number of transgender and gender diverse individuals are requesting genital Gender Affirming Surgery (gGAS). For both masculinizing and feminizing gGAS various procedures and techniques are employed. Current literature on gGAS reports heterogeneous, non-standardized and often ill-defined outcomes. Presently, no consensus exists on what outcomes should be evaluated in order to assess the clinical results and the effectiveness of these procedures, which precludes development of evidence-based treatment guidelines. Aims: This international consensus study aims to develop Core Outcome Sets (COS) for both masculinizing and feminizing gGAS. These represent the minimum sets of outcomes recommended to be measured and reported in all clinical trials pertaining to gGAS. Methods: Two Core Outcome Sets for masculinizing and feminizing gGAS will be developed in parallel by following the Core Outcome Measures in Effectiveness Trials (COMET) guidelines. The stages of development for each set are: i) Identify outcomes measured and reported in previous research through a systematic review of the literature; ii) Identify outcomes suggested by transgender and gender diverse individuals during focus groups and interviews; iii) Combine and structure the outcomes into a preliminary outcome list; iv) Conduct e-Delphi surveys among stakeholders (i.e. professionals in transgender healthcare and transgender individuals) in which all potential outcomes will be rated on level of importance; and v) Decide on the final COS during an online consensus meeting. Discussion: This study will produce minimum, core sets of relevant outcomes for gGAS, through reaching international consensus with key stakeholders, including transgender individuals. Development of these COS will enable the measurement and reporting of relevant and standardized outcomes, facilitating continued scientific advancement of this field.

Development of a core outcome set for ventilation trials in neurocritical care patients with acute brain injury: protocol for a Delphi consensus study of international stakeholders

IntroductionThere is little consensus and high heterogeneity on the optimal set of relevant clinical outcomes in research studies regarding extubation in neurocritical care patients with brain injury undergoing mechanical ventilation....

Development of the national Dutch PEWS: the challenge against heterogeneity and implementation difficulties of PEWS in the Netherlands

BackgroundFor the early recognition of deteriorating patients several Pediatric Early Warning Score (PEWS) systems have been developed with the assumption that early detection can prevent further deterioration. Although PEWS are widely being used in hospitals in the Netherlands, there is no national consensus on which score to use and how to embed the score into a PEWS system. This resulted in a substantial heterogeneity of PEWS systems, of which many are unvalidated or self-designed. The primary objective of this study was to develop a pragmatic consensus-based PEWS system that can be utilized in all Dutch hospitals (University Medical Centers, teaching hospitals, and general hospitals).MethodsThis study is an iterative mixed-methods study. The methods from the Core Outcome Measures in Effectiveness Trials (COMET) initiative were used and consisted of two Delphi rounds, two inventories set out to all Dutch hospitals and a focus group session with parents. The study was guided by five expert meetings with different stakeholders and a final consensus meeting that resulted in a core PEWS set.ResultsThe first Delphi round was completed by 292 healthcare professionals, consisting of pediatric nurses and physicians. In the second Delphi round 217 healthcare professionals participated. Eventually, the core PEWS set was been developed comprising of the parameters work of breathing, respiratory rate, oxygen therapy, heart rate and capillary refill time, and AVPU (Alert, Verbal, Pain, and Unresponsive). In addition, risk stratification was added to the core set with standardized risk factors consisting of [1] worried signs from healthcare professionals and parents and [2] high-risk treatment, with the option to add applicable local defined risk factors. Lastly, the three categories of risk stratification were defined (standard, medium, and high risk) in combination with standardized actions of the professionals for each category.ConclusionThis study demonstrates a way to end a country’s struggle with PEWS heterogeneity by co-designing a national Dutch PEWS system. Currently, the power of the system is being investigated in a large multi-center study in the Netherlands.

Qualitative study exploring which research outcomes best reflect women’s experiences of heavy menstrual bleeding: stakeholder involvement in development of a core outcome set

ObjectiveThis work contributed to the development of a core outcome set (COS) for heavy menstrual bleeding (HMB). The objective was to determine which research outcomes best reflect how HMB affects...

Development of an international core outcome set for treatment trials in necrotizing enterocolitis—a study protocol

AimNecrotizing enterocolitis (NEC) is the most lethal disease of the gastrointestinal tract of preterm infants. New and existing management strategies need clinical evaluation. Large heterogeneity exists in the selection, measurement, and reporting of outcome measures in NEC intervention studies. This hampers meta-analyses and the development of evidence-based management guidelines. We aim to develop a Core Outcome Set (COS) for NEC that includes the most relevant outcomes for patients and physicians, from moment of diagnosis into adulthood. This COS is designed for use in NEC treatment trials, in infants with confirmed NEC.MethodsThis study is designed according to COS-STAD (Core Outcome Set-STAndards for Development) recommendations and the COMET (Core Outcome Measures in Effectiveness Trials) Initiative Handbook. We obtained a waiver from the Ethics Review Board and prospectively registered this study with COMET (Study 1920). We will approach 125 clinicians and/or researchers from low-middle and high-income countries based on their scientific output (using SCIVAL, a bibliometric tool). Patients and parents will be approached through local patient organisations. Participants will be separated into three panels, to assess differences in priorities between former patients and parents (1. lay panel), clinicians and researchers involved in the neonatal period (2. neonatal panel) and after the neonatal period (3. post-neonatal panel). They will be presented with outcomes currently used in NEC research, identified through a systematic review, in a Delphi process. Eligible outcome domains are also identified from the patients and parents’ perspectives. Using a consensus process, including three online Delphi rounds and a final face-to-face consensus meeting, the COS will be finalised and include outcomes deemed essential to all stakeholders: health care professionals, parents and patients’ representatives. The final COS will be reported in accordance with the COS-Standards for reporting (COS-STAR) statement.ConclusionsDevelopment of an international COS will help to improve homogeneity of outcome measure reporting in NEC, will enable adequate and efficient comparison of treatment strategies, and will help the interpretation and implementation of clinical trial results. This will contribute to high-quality evidence regarding the best treatment strategy for NEC in preterm infants.

Social Prescribing Outcomes for Trials (SPOT): Protocol for a modified Delphi study on core outcomes.

This is a study protocol to co-create with knowledge users a core outcome set focused on middle-aged and older adults (40 years+) for use in social prescribing research. We will follow the Core Outcome Measures in Effectiveness Trials (COMET) guide and use modified Delphi methods, including collating outcomes reported in social prescribing publications, online surveys, and discussion with our team to finalize the core outcome set. We intentionally center this work on people who deliver and receive social prescribing and include methods to evaluate collaboration. Our three-part process includes: (1) identifying published systematic reviews on social prescribing for adults to extract reported outcomes; and (2) up to three rounds of online surveys to rate the importance of outcomes for social prescribing. For this part, we will invite people (n = 240) who represent the population experienced in social prescribing, including researchers, members of social prescribing organizations, and people who receive social prescribing and their caregivers. Finally, we will (3) convene a virtual team meeting to discuss and rank the findings and finalize the core outcome set and our knowledge mobilization plan. To our knowledge, this is the first study designed to use a modified Delphi method to co-create core outcomes for social prescribing. Development of a core outcome set contributes to improved knowledge synthesis via consistency in measures and terminology. We aim to develop guidance for future research, and specifically on the use of core outcomes for social prescribing at the person/patient, provider, program, and societal-level.