Set Of Outcomes Research Articles

Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study.

Tension-type headache (TTH) is the most common type of headache and the second most common health-related complaint among children and adults. Traditional Chinese medicine (TCM) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence-such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data-has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings. This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM. The COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings. The protocol has been registered in PROSPERO, with the review commencing on October 1, 2024, and anticipated results by November 15, 2024. The systematic reviews will be finalized, followed by the Delphi survey and consensus conference in late 2024 and early 2025. The COS findings will be reported per COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application. This study is necessary as developing a COS for future TCM clinical studies in the treatment of TTH can maximize the value of data from individual trials and provide high-quality research evidence. Core Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p. PRR1-10.2196/63481.

Lessons Learned from the INTEGRATE-Pain Delphi Process to Develop Core Outcome Sets (COS) across the Pain Continuum.

Lessons Learned from the INTEGRATE-Pain Delphi Process to Develop Core Outcome Sets (COS) across the Pain Continuum.

Effectiveness of educational interventions for improving healthcare professionals' information literacy: A systematic review.

It is unclear which educational interventions effectively improve healthcare professionals' information literacy. We aimed to evaluate the effectiveness of educational interventions for improving the formulation of answerable clinical questions and the search skills of healthcare professionals. We followed the Cochrane methodology and reported according to the PRISMA statement. The following databases from inception to November 2022: MEDLINE, Cochrane CENTRAL, EMBASE, Web of Science, CINAHL, and Google Scholar search engine, were searched. Randomised controlled trials and crossover trials on any educational interventions were included. Studies on search tools that are obsolete were excluded. Ten studies that mainly compared the effectiveness of lectures and bedside education to lectures or no intervention for searching of PubMed and/or MEDLINE, were included. There was evidence for improved attitude towards the intervention favouring lecture with self-directed learning over lecture, bedside education, and computer-assisted self-directed learning (RR: 1.14; 95% CI 1.06-1.23; N = 2 studies; 1064 participants; I2 = 0%; moderate certainty evidence). There were limited findings on the knowledge, skills, satisfaction, and behaviour outcomes. Future research should include a wider set of outcomes, be reported better and explore the use of digital technology for delivery of educational interventions. Further research should entail well-designed trials with relevant outcomes evaluating novel digital-based educational interventions.

Aquatic exercise interventions in the treatment of musculoskeletal upper extremity disorders: A scoping review.

To identify literature on aquatic exercise therapy used to manage upper extremity musculoskeletal disorders and identify key concepts, intervention components, and gaps in the evidence base. The comprehensive search included MEDLINE (Ovid), CINAHL (EBSCOHost), Embase (Ovid), CENTRAL (Cochrane Central Register of Controlled Trials) databases and grey literature sources. JBI Scoping review methodology guided this review through protocol development, searching, screening, data extraction and analysis. Study Selection included: Participants - Adults with upper extremity musculoskeletal disorders; Concept - Aquatic based exercise therapy; Context - any setting in any very highly developed nation. The search identified 5045 sources with 68 studies included in the final synthesis. Findings outlined shoulder problems were the most reported upper extremity condition treated (n = 78) especially following rotator cuff repair (n = 17), followed by the hand and wrist (n = 9), and elbow (n = 6). Range of movement (n = 36) and resistance exercises (n = 17) were the most common interventions reported for aquatic therapy, however compliance with reporting guidance across included studies was poor. Sixteen health domains were identified with range of movement (n = 21) and pain (n = 20) the most common, and 62 outcome measures were reported related to the identified domains. Qualitative aspects of aquatic interventions were evaluated in two papers. There is a need for more primary experimental and qualitative studies related to the upper extremity and aquatic therapy. Improved reporting quality of aquatic therapy exercise intervention is required as is the need to establish specific core outcome sets and domains in this area.

Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study

IntroductionNeonatal death exerts long-lasting impact on parents’ mental health, finances and relationships, and the wider family. There is national and international momentum to evaluate interventions to support parents after the...

A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus.

Disease outbreaks significantly affect maternal and neonatal health. Variability in reporting health outcomes hinder evidence generation. We aimed to develop a core outcome set (COS) for maternal and neonatal health research and surveillance during emerging and ongoing epidemic threats and to agree on outcomes' definitions. We conducted a systematic review of observational and experimental studies related to epidemics to identify outcomes, and a four-stage modified-Delphi consensus. 150 international stakeholders participated in online surveys, and 24 representatives in consensus meetings. The panels were diverse, with balanced representation of professional background, gender, and geography, including civil society representatives. Outcome were included if≥80% of participants scored them as critically important and ≤10% rated them as not important. The final COS includes seven main maternal outcomes-pregnancy outcome, maternal death, suspected symptomatic infection, confirmed infection, severe disease, preterm delivery, mode of birth; seven complementary maternal outcomes-antepartum haemorrhage, postpartum haemorrhage, hypertensive disorders of pregnancy, maternal sepsis, admission to intensive care unit/special units, respiratory support, depression and anxiety; 11 main neonatal outcomes-neonatal death, neonatal suspected symptomatic infection, confirmed infection, severe disease, vertical transmission, low birth weight, prematurity, congenital disorder, respiratory support, skin-to-skin contact, breastfeeding; and, four complementary neonatal outcomes-admission to neonatal intensive care unit/special units, respiratory failure, birth asphyxia, sepsis. This COS could contribute to standardize maternal and neonatal outcomes selection and reporting in observational and experimental studies, facilitating efficient data comparison and timely evidence-based decision-making in the context of ongoing and emerging epidemic threats. Bill & Melinda Gates Foundation (grant INV-041181) and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (HQHRP2422779).

Outcome measurement instruments for adult brachial plexus injury: a systematic review of development and measurement properties

Purpose To review candidate outcome measurement instruments (OMIs) for the core outcome set (COS) for brachial plexus injury (BPI) and identify those with the strongest measurement properties. Methods We conducted a PRISMA-compliant systematic review to identify studies on the measurement properties of domain-specific OMIs for adult BPI. OMIs with adequate content validity were further evaluated. Two independent reviewers assessed the methodological quality of each study using the COSMIN Risk of Bias checklist and assessed overall quality using a modified GRADE approach. Results Nineteen development/validation studies concerning nine OMIs were identified. The Brachial Assessment Tool (BrAT) and the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) (both measuring carrying out daily routine) had sufficient content validity to proceed to full evaluation. The BrAT had moderate quality evidence to support its psychometric properties. The IMBPIQ needs further research to evidence structural validity and internal consistency. The Brief Pain Inventory has strong psychometric properties in other populations and is recommended for the core measurement set (CMS) for chronic pain. Conclusions The BrAT and the Brief Pain Inventory are recommended for inclusion in the BPI CMS. Further consensus work is needed to identify the most appropriate OMI for voluntary movement. Systematic Review Registration: PROSPERO (CRD42022307564).

Outcomes used to measure the clinical application of neonatal palliative and/or end-of-life care in neonatal settings: a systematic review.

Standardised reporting of outcomes in neonatal palliative and/or end-of-life care would facilitate comparison of practice and lead to more informed decisions about practice. We systematically reviewed evidence evaluating outcomes currently used to characterise the clinical provision of palliative and/or end-of-life care in neonatal settings. A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was undertaken using Ovid Medline, Ovid Embase, OVID PsycINFO, OVID MIDIRIS and EBSCOhost CINAHL. No date or language restrictions were used. Studies were included if they measured or reported outcomes related to the clinical practice of neonatal palliative care in a neonatal unit. Of 7998 records identified through database searching, 20 articles were included. Identified studies were retrospective chart reviews. No studies used standardised outcomes and all used proxy outcome measures. Results were organised according to the WHO domains of paediatric palliative care. All studies (n=20) reported documentation of physical symptoms and functional status (physical domain); six documented parental emotional and support needs (psychological domain); four reported sibling support and wider family presence (social and cultural domain), and three reported support from spiritual services (spiritual domain). Despite neonatal death accounting for the largest category of child death under 5 years of age, there are no standardised outcomes from which to characterise or develop clinical practice. Developing a core outcome set for neonatal palliative and end-of-life care would ensure that services can be compared using reliably collected and collated data and help advance care in this area.

Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology

Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology

Psychedelic-assisted treatment for substance use disorder: A narrative systematic review.

This is the first systematic review of the extant literature on all major psychedelic-assisted treatment for alcohol use disorder (AUD), tobacco use disorder (TUD) and other substance use disorders (SUD). We aimed to summarise the evidence for efficacy of psychedelic-assisted treatment for AUD, TUD, and SUD; to evaluate its quality; and to offer recommendations for research. This was a prospectively registered narrative systematic review of open-label, randomised controlled trials (RCT), and observational studies of d-lysergic acid diethylamide (LSD), mescaline, psilocybin, ayahuasca, ketamine, ibogaine and 3,4-methylenedioxymethamphetamine (MDMA). Eligible studies had SUD outcome measures including craving, substance use, relapse, and remission. Study quality was evaluated using the Cochrane Collaboration Risk of Bias (RoB), and Cochrane Collaboration RoB in Non-randomised Studies of Interventions tool. Certainty of evidence for RCTs was judged using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool. 37 studies (2035 participants) were reviewed: LSD (14; n = 1047); mescaline (1; n = 7); psilocybin (4; n = 135); ayahuasca (3; n = 101); ketamine (10; n = 579); ibogaine (5; n = 166); and MDMA (1; n = 14). There were no serious adverse events reported in any study. A two-centre, placebo-controlled, phase 2 superiority RCT of psilocybin for AUD, and a two-centre, double-blind, four-arm, placebo-controlled phase 2 RCT of ketamine for AUD yielded the best evidence of efficacy. Progression support to a phase 3 trials was secured from an open-label phase 2 study of psilocybin for TUD and nine phase 2 RCTs of ketamine for AUD, cannabis use disorder, cocaine use disorder, and opioid use disorder (all nine with high-RoB and low-GRADE evidence certainty). Psilocybin-assisted treatment for alcohol use disorder appears to have the best evidence of efficacy among all major psychedelic-assisted treatments for alcohol, tobacco, and other substance use disorders. Future research of psychedelic-assisted treatment should report all safety events; screen for person-level characteristics indicating that psychedelic-assisted substance use disorders treatment is contraindicated; strive to mitigate blinding of participants to interventions; use factorial designs for drug and psychotherapy randomised controlled trials; and build consensus for a field-specific Core Outcome Set.

Development of a Core Outcome Set for Endodontics (COS-ENDO). Part 4: COS-ENDO for Studies of Vital Pulp Therapy in Permanent Teeth.

Methodological heterogeneity and reporting bias complicate interpreting endodontic outcomes. Supported by the American Association of Endodontists (AAE) and its Foundation, this study developed the Core Outcome Set for Endodontics (COS-ENDO) to standardize reporting for studies of Nonsurgical Root Canal Treatment/Retreatment, Surgical Endodontics, Vital Pulp Therapy, Apexification, and Regenerative Endodontics. This manuscript, Part 4 of a 5-part series, focuses on COS-ENDO for Vital Pulp Therapy, while other parts address the remaining treatments. Outcomes were identified through a scoping review and a web-based survey of AAE practicing members. In a two-round Delphi survey, clinicians, patients, and researchers rated outcomes on a 9-point scale. Ratings were assessed against consensus criteria, and a virtual meeting finalized COS-ENDO. Of the 97 invited participants to Round 1, 77 registered, and 73 (24 Academicians/Researchers, 26 Clinicians, and 23 Patients or their parents/caregivers) assessed 46 outcomes, with 17 excluded. The remaining outcomes-4 achieving consensus for inclusion and 25 lacking consensus-advanced to Round 2 for re-rating by 70 participants. This resulted in 10 outcomes achieving consensus for inclusion, and 19 lacking consensus. In the final meeting, 16 participants finalized the COS-ENDO for Vital Pulp Therapy studies, including Tooth survival, Pain, Signs of infection, Radiographic evidence of maintained periradicular health, Continued root development, Success, Functional tooth, Need for further intervention, and Adverse events/Complications. COS-ENDO is an important step in standardizing outcome reporting in endodontics, ensuring consistent reporting and enhancing research utility. Further efforts are needed to establish optimal measurement methods.

Development of a Core Outcome Set in Endodontics (COS-ENDO). Part 2: COS-ENDO for Studies of Nonsurgical Root Canal Treatment and Retreatment in Permanent Teeth.

Methodological heterogeneity and reporting bias complicate interpreting endodontic outcomes. Supported by the American Association of Endodontists (AAE) and its Foundation, this study developed the Core Outcome Set in Endodontics (COS-ENDO) to standardize reporting for studies of Nonsurgical Root Canal Treatment/Retreatment, Surgical Endodontics, Vital Pulp Therapy, Apexification, and Regenerative Endodontics. This manuscript, Part 2 of a 5-part series, focuses on COS-ENDO for Nonsurgical Root Canal Treatment/Retreatment, while other parts address the remaining treatments. Outcomes were identified through scoping reviews, a qualitative study with patients, and a web-based survey of AAE practicing members. In a two-round Delphi survey, clinicians, patients, and researchers rated outcomes on a 9-point scale. Ratings were assessed against consensus criteria, and a virtual meeting finalized COS-ENDO. Of the 97 invited participants to Round 1, 77 registered, and 73 (24 Academicians/Researchers, 26 Clinicians, and 23 Patients (or their parents/caregivers) assessed 39 outcomes, with 18 excluded. The remaining outcomes-7 achieving consensus for inclusion and 14 lacking consensus-advanced to Round 2 for re-rating by 70 participants. This resulted in 9 outcomes achieving consensus for inclusion, and 12 lacking consensus. In the final meeting, 16 participants finalized the COS-ENDO for Nonsurgical Root Canal Treatment/Retreatment, including Tooth survival, Pain, Signs of infection, Radiographic evidence of periradicular healing, Success, Functional tooth, Need for further intervention, and Adverse events/Complications. COS-ENDO is an important step in standardizing outcome reporting in endodontics, ensuring consistent reporting and enhancing research utility. Further efforts are needed to establish optimal measurement methods.

Development of a Core Outcome Set for Endodontics (COS-ENDO). Part 3: COS-ENDO for Studies of Surgical Endodontics in Permanent Teeth.

Methodological heterogeneity and reporting bias complicate interpreting endodontic outcomes. Supported by the American Association of Endodontists (AAE) and its Foundation, this study developed the Core Outcome Set in Endodontics (COS-ENDO) to standardize reporting for studies of Nonsurgical Root Canal Treatment/Retreatment, Surgical Endodontics, Vital Pulp Therapy, Apexification, and Regenerative Endodontics. This manuscript, Part 3 of a 5-part series, focuses on COS-ENDO for Surgical Endodontics, while other parts address the remaining treatments. Outcomes were identified through a scoping review, a qualitative study with patients, and a web-based survey of AAE practicing members. In a two-round Delphi survey, clinicians, patients, and researchers rated outcomes on a 9-point scale. Ratings were assessed against consensus criteria, and a virtual meeting finalized COS-ENDO. Of the 97 invited participants to Round 1, 77 registered, and 73 (24 Academicians/Researchers, 26 Clinicians, and 23 Patients or their parents/caregivers) assessed 46 outcomes, with 17 excluded. The remaining outcomes-7 achieving consensus for inclusion and 22 lacking consensus-advanced to Round 2 for re-rating by 70 participants. This resulted in 1 outcome achieving consensus for exclusion, 10 for inclusion, and 18 lacking consensus. In the final meeting, 16 participants finalized the COS-ENDO for Surgical Endodontics, including Tooth survival, Pain, Signs of infection, Radiographic evidence of periradicular healing, Success, Functional tooth, Need for further intervention, and Adverse events/Complications. COS-ENDO is an important step in standardizing outcome reporting in endodontics, ensuring consistent reporting and enhancing research utility. Further efforts are needed to establish optimal measurement methods.

Development of a Core Outcome Set in Endodontics (COS-ENDO): Part 1 - General Methods for Developing COS-ENDO for Studies of Nonsurgical Root Canal Treatment, Retreatment, Surgical Endodontics, Vital Pulp Therapy, Apexification, and Regenerative Endodontics in Permanent Teeth.

Methodological heterogeneity and reporting bias complicate interpreting endodontic outcomes. Supported by the American Association of Endodontists (AAE) and its Foundation, this study developed the Core Outcome Set in Endodontics (COS-ENDO) to standardize reporting for studies of Nonsurgical Root Canal Treatment/Retreatment, Surgical Endodontics, Vital Pulp Therapy, Apexification, and Regenerative Endodontics. This manuscript, the first in a 5-part series, outlines the methods for developing COS-ENDO, with detailed findings for each treatment presented in subsequent parts. Outcomes were identified through scoping reviews, a qualitative study with patients, and a web-based survey of AAE practicing members. In a two-round Delphi survey, clinicians, patients, and researchers rated outcomes on a 9-point scale. Ratings were assessed against consensus criteria, and a virtual meeting finalized COS-ENDO. Of the 97 invited participants to Round 1, 77 (79%) registered, and 73 (95%) completed the survey, including 24 Academicians/Researchers, 26 Clinicians, and 23 Patients (or their caregivers/parents). They rated 64 outcomes, totaling 182 occurrences across treatments: 39 for Nonsurgical Root Canal Treatment/Retreatment, 46 for Surgical Endodontics, 46 for Vital Pulp Therapy, and 51 for Apexification/Regenerative Endodontics. The outcomes that achieved consensus for inclusion and those lacking consensus (either for inclusion or exclusion) advanced to Round 2 for re-rating by 70 participants. During the final consensus meeting, 16 participants discussed the outcomes and finalized the COS-ENDO. COS-ENDO is an important step toward standardizing outcome reporting in endodontics. Its implementation will ensure consistent reporting, enhancing research utility and evidence synthesis. Further efforts are needed to establish optimal measurement methods.

Development of a Core Outcome Set for Endodontics (COS-ENDO). Part 5: COS-ENDO for Studies of Apexification and Regenerative Endodontics in Permanent Teeth.

Methodological heterogeneity and reporting bias complicate interpreting endodontic outcomes. Supported by the American Association of Endodontists (AAE) and its Foundation, this study developed the Core Outcome Set in Endodontics (COS-ENDO) to standardize reporting for studies of Nonsurgical Root Canal Treatment/Retreatment, Surgical Endodontics, Vital Pulp Therapy, Apexification, and Regenerative Endodontics. This manuscript, the last in a 5-part series, focuses on COS-ENDO for Apexification and Regenerative Endodontics, while other parts address the remaining treatments. Outcomes were identified through scoping reviews and a web-based survey of AAE practicing members. In a two-round Delphi survey, clinicians, patients, and researchers rated outcomes on a 9-point scale. Ratings were assessed against consensus criteria, and a virtual meeting finalized COS-ENDO. Of the 97 invited participants to Round 1, 77 registered, and 73 (24 Academicians/Researchers, 26 Clinicians, and 23 Patients or their parents/caregivers) assessed 51 outcomes, with 18 excluded. The remaining outcomes-7 achieving consensus for inclusion and 26 lacking consensus-advanced to Round 2 for re-rating by 70 participants. This resulted in 14 outcome achieving consensus for inclusion, and 19 lacking consensus. In the final meeting, 16 participants finalized the COS-ENDO for Apexification and Regenerative Endodontics, including Tooth survival, Pain, Signs of infection, Radiographic evidence of periradicular healing, Continued root development, Success, Functional tooth, Need for further intervention, and Adverse events/Complications. COS-ENDO is an important step in standardizing outcome reporting in endodontics, ensuring consistent reporting and enhancing research utility. Further efforts are needed to establish optimal measurement methods.

A systematic review on the influence of coagulopathy and immune activation on New Onset Atrial Fibrillation in patients with sepsis.

New Onset Atrial Fibrillation (NOAF) is the most common arrhythmia in intensive care. Complications of NOAF include thromboembolic events such as myocardial infarction and stroke, which contribute to a greater risk of mortality. Inflammatory and coagulation biomarkers in sepsis are thought to be associated with NOAF development. The aim of this systematic review and narrative synthesis is to identify inflammatory and coagulation biomarkers as predisposing risk factors for NOAF in sepsis. Three databases (Medline, Cochrane Library, and Scopus) were searched using a predefined search strategy. Inclusion / exclusion criteria were applied, and quality assessments were performed using the Newcastle Ottawa Scale (NOS). We identified 1776 articles; and 12 articles were included in this review. 8 articles were retrospective observational studies and 4 were prospective observational studies. There was considerable heterogeneity between studies regarding outcomes, methodological design, quality, definitions and reported biomarkers of interest. There is evidence that C-reactive protein (CRP) is associated with NOAF, with hazard ratios 3.33 (3.32-3.35) p = 0.001 and odds ratios of 1.011 (1.008-1.014) p<0.001. International Normalised Ratio (INR) and fibrinogen may be associated with NOAF with odds ratios reported as 1.837 (1.270-2.656) p = 0.001 and 1.535(1.232-1.914) p<0.001 respectively. Further research is required to confirm the association between inflammatory and coagulation biomarkers and the development of NOAF in sepsis. A broader evidence base will guide treatment strategies, improving the standard of care for patients who develop NOAF in sepsis. Furthermore, given the heterogeneity between studies consideration should be given to inclusion of immune biomarkers in future core outcome sets for trials investigating NOAF.

A meta-core outcome set for stillbirth prevention and bereavement care following stillbirth in LMIC

Study objectiveStillbirth is burdensome in low-income and middle-income countries (LMICs), especially in sub-Saharan Africa and South Asia. Currently, there are two core outcome sets (COS) for stillbirth (prevention and bereavement...

Core Patient-Centered Outcomes for Adolescents and Young Adults with Cancer: A Comprehensive Review of the Literature from the STRONG-AYA Project

Background: In adolescents and young adults (AYAs) with cancer, the importance of patient-centered research outcomes is increasingly acknowledged and there is a need for consensus on the most relevant outcomes. This review provides a comprehensive overview of outcomes relevant to AYAs with cancer in order to develop an AYA-specific core outcome set (COS) as part of the European project STRONG-AYA. Methods: A literature search was conducted to identify relevant articles in five databases. Each article was reviewed by two independent researchers, using Rayyan (an online tool) to screen articles by their title/abstract and then by their full text. Subsequently, the data were extracted using a predefined, tailored extraction framework. Results: In total, 17,301 articles were screened, of which 1631 were included in the analyses. Registry studies (52.9%) were the most used study type. Well-represented continents were North America (50.3%) and Europe (27.8%). Of the five core areas, functioning (47.0%) and epidemiology (44.9%) were covered most often, followed by physiological/clinical (42.4%), resource use (6.1%), and adverse events (4.5%). The outcome domains that were represented the most include mortality/survival (43.1%), delivery of care (23.4%), outcomes relating to neoplasms (22.7%), and emotional functioning/well-being (19.2%). Conclusions: This literature review provides a foundation for the development of an AYA-specific COS for improving the relevance and efficiency of measuring outcomes, the pooling of (international) research data, and the value of care for current and future AYAs with cancer. Finalization and refinement of the COS should be a priority for future research.

A systematic review of outcomes reported in studies to optimise the medication use of patients at hospital discharge

IntroductionCare transitions, specifically hospital discharge, hold a risk for drug-related problems and medication errors. Effective interventions that optimise medication use during and after transitions are needed, yet there is no standardisation of the outcomes. This literature review aimed at collecting outcomes from studies investigating how to optimise medication use of patients following hospital discharge, and to categorise them, as a first step in the development of a core outcome set.MethodsWe systematically reviewed quantitative and qualitative literature using Embase, PubMed, CINAHL and the EU Clinical Trial Register databases. Studies investigating the optimisation of medication use following hospital discharge were eligible. The quantitative literature review specifically included trials and protocols that evaluated the effect of an intervention for patients ≥ 65 years or multimorbid / polypharmacy patients, as they are at high risk of drug-related problems. The qualitative literature review focused on the patients' and healthcare professionals’ views. Outcomes were summarised into unique outcome terms and categorised using an adapted version of the OMERACT filter 2.0.ResultsThe review included 75 quantitative and 20 qualitative studies. The interventions investigated in the quantitative literature mostly had multiple components performed either pre- or post-discharge. Sixty percent of the qualitative studies addressed the views of healthcare professionals, 40% the views of patients, and only one study addressed both. A median of 5 outcomes (range 1–17) were reported in the quantitative studies. In total, 91 unique outcomes were identified from the quantitative or qualitative literature, or both (73, 12 and 6 outcomes, respectively). Outcomes were categorised into five domains: 'medication' (n = 32 outcomes), 'economic impact/resource use' (n = 26), 'life impact' (n = 16), 'pathophysiological manifestations' (n = 15) and 'death' (n = 2). The top 5 most frequently measured outcomes in quantitative studies were number of readmissions (n = 54/75, 72%), mortality (n = 30/75, 40%), number of emergency department visits (n = 26/75, 35%), number of outpatient physician visits (n = 12/75, 16%), and medication adherence (n = 12/75, 16%).Discussion and conclusionThis study identified a large number of different outcomes, especially in the domains medication and economic impact/resource use. This heterogeneity impedes the identification of effective interventions and confirms the need for a core outcome set.

A Core Outcome Set for Trials in CKD: Report of the Standardized Outcomes in Nephrology-Chronic Kidney Disease (SONG-CKD) Stakeholder Workshops.

Omitting outcomes of importance to patients with chronic kidney disease (CKD) and their caregivers from trials can impede decision-making based on patient-centered outcomes. As part of the global Standardized Outcomes in Nephrology - Chronic Kidney Disease (SONG-CKD) initiative, we aimed to establish a consensus-based set of core outcomes for trials in CKD (prior to the need for kidney replacement therapy). To finalize the proposed set of core outcomes that were identified through focus groups and an international Delphi survey, we convened two international stakeholder workshops in English and Spanish languages that involved 61 patients/caregivers and 75 health professionals from 18 countries. Participants were asked to discuss and endorse the potential core outcomes (mortality, kidney function, life participation, and cardiovascular disease), and to provide suggestions for implementing the core outcomes. The discussions were summarized into four themes: reflecting a comprehensive approach to health, facilitating patient empowerment in their own care, ensuring applicability to broad geographic areas and populations, and feasibility for implementation. Patients, caregivers, and health professionals agreed that mortality, kidney function, life participation and cardiovascular disease should be established as core outcomes for trials in CKD.