Development of a core outcome set for physiotherapy trials in adults with bronchiectasis (the COS-PHyBE study): A Delphi study and consensus meeting.

Background: Physiotherapy is recommended for bronchiectasis management, but there is disparity in evidence supporting its use. This is partly because of inconsistency and poor reporting of outcomes in available studies. A Core Outcome Set (COS) may improve trial consistency and decrease reporting bias. This study aimed to develop a COS for physiotherapy clinical trials in adults with bronchiectasis. Methods: A comprehensive list of outcomes was developed using a systematic review and qualitative semi-structured interviews with patients with bronchiectasis and physiotherapists.An international two-round online Delphi survey was conducted. Outcomes scored 7-9 (crucial) by ≥ 70 % of participants and 1-3 (not that important) by ≤ 15 % of participants from each stakeholder in the Likert scale were nominated for inclusion in the COS. Nominated outcomes and those considered crucial by only one of the stakeholders' groups were further discussed and voted in an international consensus meeting. Results: A list of 137 outcomes was generated; 104 from literature and 33 from interviews. A Delphi survey containing 59 outcomes was completed by 171 participants from 20 countries. After the consensus meeting, representatives agreed on seven outcomes: health-related quality of life, respiratory symptoms, physical functioning, emotional and psychological functioning, fatigue, adherence to treatment, and functional exercise capacity. Conclusion: A minimum set of seven outcomes are recommended to be included as measurements in future trials evaluating physiotherapy interventions for bronchiectasis.

Systematic Review of Outcome Reporting for Interventions to Treat Patients with Acute Lower Limb Ischaemia.

OBJECTIVE: Inconsistencies in outcome data of therapeutic strategies for acute lower limb ischaemia (ALI) have hindered the synthesis of findings. A core outcome set (COS) may offer a solution to this problem by defining a minimum set of outcomes that are considered essential to all stakeholders involved. The first step in developing a COS is to review the previously reported outcomes on various treatment strategies for ALI. DATA SOURCES: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched from inception to August 2023. REVIEW METHODS: This systematic review was conducted in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative framework, adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was pre-registered with PROSPERO (CRD42022320073). Abstracts were independently screened by two authors for full text review. All outcomes and their definitions were extracted from selected papers. Outcomes with different terminologies were then categorised into an "agreed outcome term". The list of agreed outcomes was given a standardised outcome domain and core area using a 38 item standardised taxonomy. RESULTS: Of 6 184 articles identified, 176 relevant studies were included, yielding 1 325 verbatim outcomes. After deduplication, 72 unique verbatim outcomes were categorised into five broad outcome domains. Outcomes considered key to the evaluation of treatment of ALI were further categorised as delivery of care (19.4%), vascular outcomes (13.8%), and adverse events (12.5%). The three most frequently reported agreed outcomes were amputation (14.1%), mortality (12.3%), and general bleeding (11.6%). CONCLUSION: This systematic review provides an overview of currently reported outcomes in the literature of interventions for ALI. After categorisation into agreed outcome terms, 72 outcomes were identified that can be used in the development of a COS.

OMERACT systemic lupus erythematosus domain survey.

BACKGROUND: Since the development of the OMERACT Systemic Lupus Erythematosus (SLE) Core Outcome Set (COS) in 1998, many new SLE domains have been identified and measures developed, creating a need to update the SLE COS. To revisit the 1998 SLE COS and research agenda domains, and generate new candidate domains, we conducted this study of patients with SLE and collaborators. OBJECTIVE: (1) To evaluate existing candidate SLE domains for inclusion in the SLE COS. (2) To generate additional candidate SLE domains for COS consideration. (3) To engage SLE collaborators, including patients, in developing the updated SLE COS. METHODS: The OMERACT SLE Working Group's steering committee developed a survey to assess the importance of candidate SLE domains and generate additional domains for consideration towards the SLE COS. Patients with SLE followed at the University of Toronto Lupus Clinic (patient group) and members of the OMERACT SLE Working Group (collaborator group) were invited to complete the survey between August 2022 and February 2023. RESULTS: A total of 175 patients were invited and 100 completed the survey. Of 178 collaborators invited, 145 completed the survey. Patients tended to prioritize life-impact domains while collaborators prioritized clinical domains. Both patients and collaborators recommended additional domains to those included in the 1998 SLE COS and research agenda. CONCLUSION: The domain inclusion and importance results demonstrate that patients and collaborators prioritize different domains, so capturing the perspectives of both groups is essential to ensure a holistic assessment of SLE. The results of the study identify domains that already have a high level of agreement for potential inclusion in the SLE COS, domains that require further explanation, and novel domains that warrant consideration.

Involving different stakeholders in prioritising outcomes to assess healthcare systems response for type 1 diabetes management: Using co-creation approaches in Peru.

BACKGROUND: Engaging diverse stakeholders in developing core outcome sets (COSs) can produce more meaningful metrics as well as research responsive to patient needs. The most common COS prioritisation method, Delphi surveys, has limitations related to selection bias and participant understanding, while qualitative methods like group discussions are less frequently used. This study aims to test a co-creation approach to COS development for type 1 diabetes (T1DM) in Peru. METHODS: Using a co-creation approach, we aimed to prioritise outcomes for T1DM management in Peru, incorporating perspectives from people with T1DM, caregivers, healthcare professionals, and decision-makers. A set of outcomes were previously identified through a systematic review and qualitative evidence synthesis. Through qualitative descriptive methods, including in-person workshops, each group of stakeholders contributed to the ranking of outcomes. Decision-makers also discussed the feasibility of measuring these outcomes within the Peruvian healthcare system. RESULTS: While priorities varied among participant groups, all underscored the significance of monitoring healthcare system functionality over mortality. Participants recognized the interconnected nature of healthcare system performance, clinical outcomes, self-management, and quality of life. When combining the rankings from all the groups, metrics related to economic impact on the individual and structural support, policies promoting health, and protecting those living with T1DM were deemed more important in comparison to measuring clinical outcomes. CONCLUSION: We present the first COS for T1DM focused on low-and-middle-income countries and show aspects of care that are relevant in this setting. Diverse prioritisation among participant groups underscores the need of inclusive decision-making processes. By incorporating varied perspectives, healthcare systems can better address patient needs and enhance overall care quality.

Inclusion of harm outcomes in Core Outcome Sets requires careful consideration.

OBJECTIVE: The objective of this study was to determine the proportion of all published core outcome set (COS) studies that include an adverse event or harm outcome, to determine the proportion of individual versus pooled harms, and to investigate characteristics that influence their inclusion. METHODS: We examined the extent to which a sample of 100 published COS studies (from January 2021 to January 2023) include both pooled and individual harms in the final COS. One investigator extracted the information from the COS studies, which was cross-checked against previous COS investigational research, and where possible verified with COS authors or a pharmacologist. Using QualtricsTM, we conducted a personalised online survey of developers of the 100 COS to ask them about the importance, their experiences, and methodological approaches for dealing with harms within their COS development studies. RESULTS: One hundred COS were identified from 91 separate COS studies, the majority of which considered most of the minimum standards for development. Two-thirds (65%) of the COS included at least one harm outcome. In total, 1104 core outcomes were identified across the 100 COS, of which 184 (17%) were harm outcomes (154 individual vs. 56 pooled). Individual harms were more likely to be included in a final COS if they were developed for single treatment interventions (50%) compared to those being developed for multi-treatment modalities (39%). Some COS developers adopted outcome frameworks as part of their COS development process to facilitate the inclusion of harm outcomes in their final COS. A third (33%) of respondents felt that harm outcomes should be included in all COS but over half (56%) thought this would be dependent on some aspect of the scope of the COS and improved methodology and awareness of how to deal with harm outcomes in the COS development process. CONCLUSION: Harm outcomes are already included in many COS either as individual or pooled harms. It is evident that there are some challenges with regards to both the methodology and necessity to include harms within a COS (pooled or individual. COS developers should carefully consider the need to include important harms outcomes in relation to the scope of the COS that they are developing.

What to Measure in Aneurysmal Subarachnoid Haemorrhage Research-An International Delphi Survey.

Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating condition with high mortality and morbidity. The outcome measures used in aSAH clinical research vary making it challenging to compare and combine different studies. Additionally, there may be a mismatch between the outcomes prioritized by patients, caregivers, and health care providers and those selected by researchers. We conducted an international, online, multiple round Delphi study to develop consensus on domains (where a domain is a health concept or aspect) prioritized by key stakeholders including those with lived experience of aSAH, health care providers, and researchers, funders, or industry professionals. One hundred seventy-five people participated in the survey, 59% of whom had lived experience of aSAH. Over three rounds, 32 domains reached the consensus threshold pre-defined as 70% of participants rating the domain as being critically important. During the fourth round, participants ranked the importance of each of these 32 domains. The top ten domains ranked highest to lowest were (1) Cognition and executive function, (2) Aneurysm obliteration, (3) Cerebral infarction, (4) Functional outcomes including ability to walk, (5) Delayed cerebral ischemia, (6) The overall quality of life as reported by the SAH survivor, (7) Changes to emotions or mood (including depression), (8) The basic activities of daily living, (9) Vasospasm, and (10) ICU complications. Our findings confirm that there is a mismatch between domains prioritized by stakeholders and outcomes used in clinical research. Our future work aims to address this mismatch through the development of a core outcome set in aSAH research.

Glottic insufficiency caused by vocal fold atrophy with or without sulcus: systematic review of outcome measurements.

PURPOSE: Identifying outcome measurements instruments (OMIs) to evaluate treatment efficacy in patients with vocal fold atrophy and/or sulcus. METHODS: Systematic review of records published before March 2021 by searching Pubmed and EMBASE. Included studies reported on adults (> 18 year) with dysphonia caused by glottic insufficiency due to vocal fold atrophy with or without sulcus, who were enrolled into a randomized controlled trial, a non-randomized controlled trial, a case-controlled study or a cohort study. All included studies described an intervention with at least one outcome measurement. RESULTS: A total of 5456 studies were identified. After removing duplicates, screening title and abstract and full text screening of selected records, 34 publications were included in final analysis. From these 50 separate OMIs were recorded and categorized according to the ELS protocol by DeJonckere et al. (Eur Arch Otorhinolaryngol 258: 77-82, 2001). With most OMIs being used in multiple studies the total number of OMIs reported was 265. Nineteen (19) individual OMIs accounted for 80% of reports. The most frequently used OMIs according to category were: VHI and VHI-10 (subjective evaluation); G of GRBAS (perceptual evaluation); F0, Jitter and Shimmer (acoustic evaluation); MPT and MFR (aerodynamic evaluation) and glottic closure and mucosal wave (endoscopic evaluation). Of these OMIs VHI had a high percentage of significance of 90%. CONCLUSION: This systematic review identifies the most used OMIs in patients with glottic incompetency due to vocal fold atrophy and/or sulcus as a step toward defining a Core Outcome Set (COS) for this population. PROSPERO REGISTRATION: 238274.

A Systematic Review of Reported Outcomes in Randomized Controlled Trials Targeting Early Interventions in Moderate-to-Severe Traumatic Brain Injury.

Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Randomized controlled trials (RCTs) are the cornerstone to evaluate the efficacy of an intervention. To assess the methodology of clinical research, we performed a systematic review that evaluated the different outcomes used in RCTs targeting the early phase of moderate-to-severe adult TBI from 1983 to October 31, 2023. We extracted each outcome and organized them according to the COMET and OMERACT framework (core area, broad domains, target domains, and finally outcomes). A total of 190 RCTs were included, including 52,010 participants. A total of 557 outcomes were reported and classified between the following core areas: pathophysiological manifestations [169 RCTs (88.9%)], life impact [117 RCTs (61.6%)], death [94 RCTs (49.5%)], resource use [72 RCTs (37.9%)], and adverse events [41 RCTs (21.6%)]. We identified 29 broad domains and 89 target domains. Among target domains, physical functioning [111 (58.4%)], mortality [94 (49.5%)], intracranial pressure target domain [68 (35.8%)], and hemodynamics [53 (27.9%)] were the most frequent. Outcomes were mostly clinician-reported [177 (93.2%)], while patient-reported outcomes were rarely reported [11 (5.8%)]. In our review, there was significant heterogeneity in the choice of end-points in TBI clinical research. There is an urgent need for consensus and homogeneity to improve the quality of clinical research in this area.

Toward a core outcome set for faecal incontinence-A systematic review of outcomes reported in the literature.

AIM: Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient's quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a core outcome set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. Through several steps outlined by COMET 'what' to measure will be determined prior to determining 'how' to measure these outcomes. This systematic review aims to identify 'what' outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI. METHOD: Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development. RESULTS: A total of 109 studies were included, which revealed 51 unique outcomes classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1-11). The most commonly reported outcomes were "severity of FI" (83%), "quality of life" (64%), "number of FI episodes" (40%), "anorectal motor function" (39%), and "frequency of bowel movements" (16%). CONCLUSION: This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasizes the need for standardizing outcome reporting which can be established through the creation of a COS.

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

BACKGROUND: Surgical 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. METHODS: This 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 DISSEMINATION: This 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. DISCUSSION: This 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 REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) initiative 2675.  http://www.comet-initiative.org/Studies/Details/2675 .

Developing a core outcome set for acetabular fractures: a systematic review protocol.

BACKGROUND: Clinical trials investigating acetabular fractures are heterogeneous in their investigated outcomes and their corresponding measurements. Standardization may facilitate comparability and pooling of research results, which would lead to an increase in knowledge about the optimal treatment of acetabular fractures, resulting in long-term evidence-based treatment decisions and improvements in patient care. The aim of this systematic review is to identify the reported outcomes and their measurements from studies on treatments for acetabular fractures to develop a core outcome set which contains the most relevant outcome measures to be included in future studies. METHODS: Studies published in English and German including patients aged 16 years and older, with a surgically treated acetabular fracture, will be included. Studies with nonsurgical treatment, pathologic fractures, polytraumatized patients, and patients younger than 16 years of age will be excluded because other outcomes may be of interest in these cases. Any prospective and retrospective study will be included. Systematic reviews will be excluded, but their included studies will be screened for eligibility. The literature will be searched on MEDLINE, CENTRAL, Web of Science, ClinicalTrials.gov, and WHO ICTRP. Risk of selective reporting of outcomes will be assessed using the Outcome Reporting Bias in Trials classification system. Heterogeneously defined outcomes that measure the same outcome will be grouped and subsequently categorized into outcome domains using the taxonomy of the Core Outcome Measures in Effectiveness Trials Initiative. DISCUSSION: It is expected that a high number of studies will be included, and many outcomes will be identified using different definitions and measurement instruments. A limitation of this systematic review is that only previously investigated outcomes will be detected, thus disregarding potentially relevant outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022357644.

Development of the Korean Medicine Core Outcome Set for Facial Palsy: herbal medicine treatment of patients with facial palsy in primary clinics.

Introduction: Facial palsy (FP) significantly affects the quality of life of patients and poses a treatment challenge in primary healthcare settings. This study aimed to develop a Korean medicine (KM) core outcome set (COS) for FP, with a focus on evaluating the effectiveness of herbal medicine (HM) treatments in KM primary clinics. Methods: Outcomes and effect modifiers related to FP treatments were initially identified through related review articles. Subsequently, experts in the field took part in three rounds of modified Delphi consensus exercises to refine and prioritize these outcomes and effect modifiers. Additionally, primary KM clinicians were involved in a Delphi consensus round to assess the suitability and feasibility of the proposed COS in real-world clinical settings. Results: The initial review of related literature identified 44 relevant studies, resulting in an initial selection of 23 outcomes and 10 effect modifiers. The expert consensus process refined these to 8 key outcomes and 6 effect modifiers, which established the foundation of the COS-FP-KM. Subsequently, primary KM clinicians confirmed the practicality and applicability of the COS, endorsing its suitability for use in KM primary clinics. Conclusion: The COS-FP-KM establishes a standardized approach for assessing HM treatment effectiveness in FP patients in KM primary clinics. The COS-FP-KM encourages consistent outcome reporting and enhances patient care quality. Future work should aim to integrate broader stakeholder perspectives to refine and validate the COS further.

Using patient and care partner experiences to confirm outcomes of relevance for inclusion in a core outcome set for trials of physical rehabilitation in critical illness: A qualitative interview study.

BACKGROUND: Incorporating the perspectives of patients and care partners is crucial in the development of core outcome sets. One effective approach for achieving this involvement is by seeking input to refine the outcomes for consensus. The objectives of the study were to: i) to determine patient and care partner views on outcomes that should be measured in trials of physical rehabilitation interventions across the critical illness recovery continuum; (ii) to map these views with a pre-established list of thirty outcomes for potential inclusion in a core outcome set for these trials; and (iii) to identify any new outcomes that could be considered for inclusion. METHODS: A qualitative semistructured telephone interview study was conducted with a convenience sample of post-critical illness patients and care partners, as part of core outcome set development work. Anonymised interview transcripts were analysed using a framework approach, and exemplary narrative quotes from participants were reported used to illustrate outcome reporting. FINDINGS: Fourteen participants were recruited (male:female ratio = 8:6, age range [minimum-maximum]: 50-80 years, 13 former patients, one spouse). Time since intensive care unit discharge ranged from less than 1 year to 10 years at the time of interview. Participants described a range of outcomes that could be measured in trials of physical rehabilitation after critical illness that mapped closely with the pre-established list. No new outcomes were introduced by participants during the interviews. Experiences described by participants commonly reflected outcomes related to physical ability and performance, functional level, activities of daily living, and emotional and mental wellbeing. Participants spoke to how the different outcomes directly impacted their day-to-day lives and highlighted their priorities centred around resumption of tasks and activities that had value to them at personal, functional, and societal level. CONCLUSION: Qualitative interviews confirmed the relevance of existing outcomes for potential inclusion in a core outcome set for trials of physical rehabilitation interventions across the critical illness recovery continuum. The added significance of our findings is to provide real-world meaning to these outcomes. REGISTRATION: COMET Initiative, ID288, https://www.comet-initiative.org/studies/details/288.

Outcomes of interventions in neonatal sepsis: A systematic review of qualitative research.

BACKGROUND: While a systematic review exists detailing neonatal sepsis outcomes from clinical trials, there remains an absence of a qualitative systematic review capturing the perspectives of key stakeholders. OBJECTIVES: Our aim is to identify outcomes from qualitative research on any intervention to prevent or improve the outcomes of neonatal sepsis that are important to parents, other family members, healthcare providers, policymakers, and researchers as a part of the development of a core outcome set (COS) for neonatal sepsis. SEARCH STRATEGY: A literature search was carried out using MEDLINE, EMBASE, CINAHL, and PsycInfo databases. SELECTION CRITERIA: Publications describing qualitative data relating to neonatal sepsis outcomes were included. DATA COLLECTION AND ANALYSIS: Drawing on the concepts of thematic synthesis, texts related to outcomes were coded and grouped. These outcomes were then mapped to the domain headings of an existing model. MAIN RESULTS: Out of 6777 records screened, six studies were included. Overall, 19 outcomes were extracted from the included studies. The most frequently reported outcomes were those in the domains related to parents, healthcare workers and individual organ systemas such as gastrointestinal system. The remaining outcomes were classified under the headings of general outcomes, miscellaneous outcomes, survival, and infection. CONCLUSIONS: The outcomes identified in this review are different from those reported in neonatal sepsis clinical trials, thus highlighting the importance of incorporating qualitative studies into COS development to encapsulate all relevant stakeholders' perspectives.

"Now I Am Walking Toward Health": A Qualitative Study About the Outcomes of Physical Activity Participation That Matter to Older Adults.

BACKGROUND/OBJECTIVES: Randomized controlled trials that deliver physical activity interventions have demonstrated benefits for older adults across numerous health outcomes. However, too little attention has been directed to ensuring that such trials are measuring patient-relevant outcomes. To support outcome selection for future trials, the objective of this study was to understand what outcomes related to their physical activity participation older adults find important. METHODS: We conducted 12 semistructured interviews with adults aged 65 years and older and analyzed interview transcripts with a reflexive thematic analysis. RESULTS: Older adults desired diverse outcomes from their physical activity participation, ranging from generic (e.g., quality of life) to specific (e.g., leg strength). Relevant outcomes were classified under five themes: physical, clinical, social, psychological, and overarching, each with respective subthemes. CONCLUSIONS: The outcomes that older adults found important were plentiful and rooted in a desire to improve their quality of life. Some of the outcome themes have been reported frequently in past trials (e.g., physical), but others have not (e.g., social). Future researchers should be aware of, and responsive to, the priorities of older adults when designing trials and defining outcomes. Significance/Implications: This study will help to improve outcome selection for future trials of physical activity with older adults. In alignment with a patient-oriented research philosophy, this study will also ground future outcome selection in the priorities of older adults.

Core outcome Set for Cardio-oncology (COS-CO): development of a set of outcomes for the cardiovascular assessment and monitoring of cancer patients and survivors.

AIMS: There is an increasing awareness of the evidence-based selection of outcomes to be measured in clinical trials and clinical practice. Currently, there is no core outcome set (COS) for cardio-oncology, which may hinder the (inter)national comparison of the effectiveness of research and the quality of cardio-oncology care. The aim of this study is to develop a standard and pragmatic patient-centred outcome set to assess and monitor cancer patients and survivors at risk of or with cardiovascular diseases. METHODS & RESULTS: A list of outcome domains was generated through a review of registries and guidelines, and six patient interviews. The project team reviewed and refined the outcome domains prior to starting a two-round Delphi procedure conducted between January-June 2022. The panellists, including healthcare providers and researchers, were invited to rate the importance of the outcomes. 26 experts from 11 countries rated a list of 93 outcomes (round 1) and 63 outcomes (round 2) to gain consensus on a list of outcome measures, and of demographic factors, health status and treatment variables. The final COS includes 15 outcome measures, reflecting four core areas: life impact (n = 2), pathophysiological manifestations (n = 9), resource use/economic impact (n = 1), and mortality/survival (n = 3). Next, six demographic factors, 21 health status, three cardiovascular and nine cancer variables were included. CONCLUSION: This is the first international development of a COS for cardio-oncology. This set aims to facilitate (inter)national comparison in cardio-oncology care, using standardised parameters and meaningful patient-centred outcomes for research and quality of care assessments.

Analysis of outcome reporting in sciatic neuropathy studies: a systematic review of the literature.

PURPOSE: As a first step towards developing a core outcome set (COS) for sciatic neuropathy, the goal of the current study was to perform a systematic review of the literature to identify outcome measures that have been previously reported in studies on sciatic neuropathy. METHODS: A systematic review of the literature from 2000-2024 was performed utilizing PubMed and Medical Subject Headings (MeSH). Identified articles were screened according to study inclusion/exclusion criteria. Outcome measures reported in each included study were recorded and categorized into motor, sensory, pain, patient-reported outcomes, electrodiagnostic outcomes, imaging outcomes, and composite outcomes. Descriptive statistics were performed. RESULTS: A total of 1586 articles were initially identified, and 31 articles met criteria for inclusion and underwent analysis. The most common outcome domain was pain. A pain outcome was reported in 17 (63%) studies. A motor outcome was reported in 10 (37%) studies; 6 (22%) reported a sensory outcome; 1 (4%) reported a composite outcome; 4 (15%) reported an electrodiagnostic outcome; 5 (19%) reported a patient-reported outcome; 3 (11%) reported an imaging outcome. Across the included studies, 21 unique outcomes were reported. CONCLUSIONS: We have identified the outcome measures that have previously been utilized in studies on sciatic neuropathy. Previously used outcome measures fell into seven domains: motor outcomes, sensory outcomes, pain outcomes, patient-reported outcomes, electrodiagnostic outcomes, imaging outcomes, and composite outcomes. Pain outcomes were most commonly used across the included studies.

Psychometric properties and domains covered by patient-reported outcome measures used in trials assessing interventions for chronic pain.

OBJECTIVES: To identify the patient-reported outcome measures (PROMs) used in clinical trials assessing interventions for chronic pain, describe their psychometric properties, and the clinical domains they cover. STUDY DESIGN AND SETTING: We identified phase 3 or 4 interventional trials: on adult participants (aged >18 years), registered in clinicaltrials.gov between January 1, 2021 and December 31, 2022, and which provided "chronic pain" as a keyword condition. We excluded diagnostic studies and phase 1 or 2 trials. In each trial, one reviewer extracted all outcomes registered and identified those captured using PROMs. For each PROM used in more than 1% of identified trials, two reviewers assessed whether it covered the six important clinical domains from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain, emotional functioning, physical functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition (eg, adherence to medication). Second, reviewers searched PubMed for both the initial publication and latest review reporting the psychometric properties of each PROM and assessed their content validity, structural validity, internal consistency, reliability, measurement error, hypotheses testing, criterion validity, and responsiveness using published criteria from the literature. RESULTS: In total, 596 trials assessing 4843 outcomes were included in the study (median sample size 60, interquartile range 40-100). Trials evaluated behavioral (22%), device-based (21%), and drug-based (10%) interventions. Of 495 unique PROMs, 55 were used in more than 1% trials (16 were generic pain measures; 8 were pain measures for specific diseases; and 30 were measures of other symptoms or consequences of pain). About 50% PROMs had more than 50% of psychometric properties rated as sufficient. Scales often focused on a single clinical domain. Only 25% trials measured at least three clinical domains from IMMPACT. CONCLUSION: Half of PROMs used in trials assessing interventions for chronic pain had sufficient psychometric properties for more than 50% of criteria assessed. Few PROMs assessed more than one important clinical domain. Only 25% of trials measured more than 3/6 clinical domains considered important by IMMPACT.

A review and analysis of outcomes in randomized clinical trials of plasma transfusion in patients with bleeding or for the prevention of bleeding: The BEST collaborative study.

BACKGROUND: Previous systematic reviews have revealed an inconsistency of outcome definitions as a major barrier in providing evidence-based guidance for the use of plasma transfusion to prevent or treat bleeding. We reviewed and analyzed outcomes in randomized controlled trials (RCTs) to provide a methodology for describing and classifying outcomes. STUDY DESIGN AND METHODS: RCTs involving transfusion of plasma published after 2000 were identified from a prior review (Yang 2012) and combined with an updated systematic literature search of multiple databases (July 1, 2011 to January 17, 2023). Inclusion of publications, data extraction, and risk of bias assessments were performed in duplicate. (PROSPERO registration number is: CRD42020158581). RESULTS: In total, 5579 citations were identified in the new systematic search and 22 were included. Six additional trials were identified from the previous review, resulting in a total of 28 trials: 23 therapeutic and five prophylactic studies. An increasing number of studies in the setting of major bleeding such as in cardiovascular surgery and trauma were identified. Eighty-seven outcomes were reported with a mean of 11 (min-max. 4-32) per study. There was substantial variation in outcomes used with a preponderance of surrogate measures for clinical effect such as laboratory parameters and blood usage. CONCLUSION: There is an expanding literature on plasma transfusion to inform guidelines. However, considerable heterogeneity of reported outcomes constrains comparisons. A core outcome set should be developed for plasma transfusion studies. Standardization of outcomes will motivate better study design, facilitate comparison, and improve clinical relevance for future trials of plasma transfusion.