Core Outcome Measures Research Articles

Establishing a peritoneal dialysis technique survival core outcome measure: A standardised outcomes in nephrology-peritoneal dialysis consensus workshop report

Background Technique survival, also reported with negative connotations as technique failure or transfer from peritoneal dialysis to haemodialysis, has been identified by patients, caregivers and health professionals as a critically important outcome to be reported in all trials. However, there is wide variation in how peritoneal dialysis technique survival is defined, measured and reported, leading to difficulty in comparing or consolidating results. Methods We conducted an online international consensus workshop to establish a core outcome measure of technique survival. Discussions were analysed thematically. Results Fifty-five participants including 14 patients and caregivers from 13 countries took part in facilitated breakout discussions using video-conferencing. The following themes were identified: capturing important aspects of the outcome (requiring a core event to define the outcome, distinguishing temporary from permanent events, recognising heterogeneous experiences of transfers), adopting appropriate neutral nomenclature (conveying with clarity, avoiding negative connotations), and ensuring feasibility and applicability (capturing data relevant to clinical and research settings, ease of adoption). The suggested definitions for the core outcome measure were ‘the event of a transfer to haemodialysis’, or ‘discontinuation of peritoneal dialysis’. Applying the principles described within the workshop, defining the outcome measure as a ‘transfer to haemodialysis’ was preferable. Conclusions It is proposed that the core outcome of technique survival is redefined as ‘transfer to haemodialysis’ and that its components are standardised using simple, neutral terminology Components considered important by stakeholders included recording the reasons for transfer from peritoneal dialysis, and focussing on permanent events whilst ensuring the outcome remains easy to implement.

Patient-centred composite scores as tools for assesment of response to biological therapy for paediatric and adult severe asthma.

We have previously developed Core Outcome Measures sets for Severe Asthma (COMSA) by multi-stakeholder consensus. There are no patient-centred tools to quantify response to biologics for severe asthma. We aimed to develop paediatric and adult CompOsite iNdexes For Response in asthMa (CONFiRM) incorporating clinical parameters and patient-reported quality of life (QoL). International expert healthcare professionals (HCPs) and patients with severe asthma were invited to: 1) develop consensus levels of clinically relevant changes for each outcome measure within COMSA; 2) use multicriteria decision analysis to develop the CONFiRM scores and 3) assess their internal validity. A separate group of HCPs evaluated CONFiRM's external validity. Five levels of change for each COMSA outcome were agreed. Severe exacerbations and maintenance oral corticosteroids use were rated as most important in determining both paediatric and adult CONFiRM scores. There was strong agreement between HCPs and patients, although patients assigned greater importance to QoL. The CONFiRM score quantified response to a biological from -31 (deterioration) to 69 (best possible response). Paediatric and adult CONFiRMs had good discriminative ability for a sufficient (AUC≥0.92) and a substantial (AUC≥0.95) response to biologics. Both CONFiRMs demonstrated excellent external validity (Spearman correlation coefficients 0.9 and 0.8 for paediatric and adult respectively (p<0.0001)). We have developed novel patient-centred paediatric and adult CONFiRMs which include QoL measures. CONFiRMs should allow a more holistic understanding of response for the patient and a standardised assessment of the effectiveness of biologics between studies. Further research is needed to prospectively validate CONFiRM scores.

Developing a core outcome set for Netherton syndrome: An international multi-stakeholder e-Delphi consensus study.

Netherton syndrome (NS; OMIM#256500) is a rare and severe disorder of epidermal maturation and keratinization caused by pathogenic variants in the serine protease inhibitor Kazal type 5 (SPINK5), leading to severe skin barrier impairment. Although effective treatment is crucial for NS patients, there is a lack of knowledge on what the best treatment options are for these patients. Large heterogeneity in reported outcomes and measurement instruments hinders accurate comparison of treatment results across studies and the development of a treatment guideline. Therefore, we aimed to develop a core outcome set (COS) for NS that can be used in clinical care and research. This study was performed in accordance with the recommendations of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. After identification of outcomes through a literature search and classification based on the International Classification of Functioning and taxonomies published by the COMET initiative, discussion groups were organized at the 2nd International Netherton Congress 2022 to finalize the provisional outcome list. Through a 2-round e-Delphi, 41 stakeholders (patients and family members, professionals, and representatives of industry) from 14 countries rated the importance of the outcomes using a 9-point Likert scale. An online consensus meeting attended by 14 stakeholders finalized the COS. The core outcome set for NS comprised 21 outcomes in 10 domains. These included four 'skin' outcomes, two 'sensation' outcomes, two 'side-effects of treatment' outcomes, one 'vitality' outcome, one 'emotional functioning' outcome, two 'physical development' outcomes, two 'nutrition' outcomes, two 'infections' outcomes, two 'allergies' outcomes, and three 'assessment results' outcomes. In this study, consensus was reached on 21 outcomes to be included in the COS for NS. The selection of outcomes in the COS underlines that NS not only affects the skin, but is a disease requiring a broad multidisciplinary approach in clinical care and research. International implementation of this COS will lead to more uniform reporting, thereby enabling comparison of study results, which may facilitate future treatment guideline development. The next step is to further conceptually define the outcomes and reach consensus on how the measure these.

Reported outcomes in studies of intermittent claudication - first step toward a core outcome set: systematic review.

This review aimed to compile an exhaustive list of all outcome measures and identify different characteristics of the outcomes reported in studies of intermittent claudication as the first step in developing a core outcome set for intermittent claudication. Medline and Embase were searched for all studies including individuals with intermittent claudication and reporting ≥1 outcome from January 2015 to August 2024. Abstract, full text screening and data extraction were performed by two investigators independently. All reported outcome measures were extracted verbatim and categorized by Dodd's domains (Core Outcome Measures in Effectiveness Trials registration: COMIC Study, 1590; https://www.comet-initiative.org/Studies/Details/1590). 4985 studies were screened and 408 were included. A total of 541 unique outcomes across 25 Dodd's domains were identified. Ankle-brachial pressure index was the most frequently reported outcome. Among the 541 unique outcomes, 386 outcomes were only reported once. Only 38.9% of the studies exclusively included patients with intermittent claudication. Patient-reported outcomes were reported in 36.2% of studies. There were wide variations in the definition of commonly used outcome measures (for example, major adverse limb event and primary patency) across different studies. There is substantial heterogeneity in reported outcomes in studies of intermittent claudication. Most reported outcomes are clinical/physiology oriented rather than patient centred. Development of a core outcome set for intermittent claudication is vital to improve and standardize reporting in future research.

Methodological considerations in calculating the minimal clinically important change score for the core outcome measures index (COMI): insights from a large single-centre spine surgery registry.

The Minimal Clinically Important Change (MCIC) is used in conjunction with Patient-Reported Outcome Measures (PROMs) to determine the clinical relevance of changes in health status. MCIC measures a change within the same person or group over time. This study aims to evaluate the variability in computing MCIC for the Core Outcome Measure Index (COMI) using different methods. Data from a spine centre in Switzerland were used to evaluate variations in MCIC for the COMI score. Distribution-based and anchor-based methods (predictive and nonpredictive) were applied. Bayesian bootstrap estimated confidence intervals. From 27,003 cases, 9821 met the inclusion criteria. Distribution-based methods yielded MCIC values from 0.4 to 1.4. Anchor-based methods showed more variability, with MCIC values from 1.5 to 4.9. Predictive anchor-based methods also provided variable MCIC values for improvement (0.3-2.4), with high sensitivity and specificity. MCIC calculation methods produce varying values, emphasizing careful method selection. Distribution-based methods likely measure minimal detectable change, while non-predictive anchor-based methods can yield high MCIC values due to group averaging. Predictive anchor-based methods offer more stable and clinically relevant MCIC values for improvement but are affected by prevalence and reliability corrections.

A study of impulsivity as a predictor of problematic internet use in university students with disabilities.

The role played by impulsivity in problematic internet use (PIU) is the object of much debate among researchers. Some studies emphasize its importance, while others suggest mental distress or personality traits may be more crucial. More research into the issue is clearly needed-especially in at-risk populations like people with disabilities. The objectives of this study were therefore to investigate the relationship between PIU and impulsivity among university students with disabilities, and to develop a specific predictive model for this group that would include psychological and life-functioning variables. A cross-sectional design was used with a sample of 240 Spanish university students with disabilities from seven universities. Several instruments were used for data collection: a sociodemographic questionnaire, the Internet Addiction Test (IAT), the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), and NEO-FFI-R. The results indicated that impulsivity is significantly correlated with PIU, as indeed it also is with other factors like conscientiousness and social functioning problems. The study's regression model explained nearly 50% of PIU variance, with impulsivity, personality traits, wellness and health indicators, and social media usage as predictive variables. This suggests that interventions should consider these psychological and lifestyle variables as a means of mitigating PIU risks in students with disabilities. The findings identify a need for further longitudinal studies to understand the causality and develop targeted prevention strategies.

Cross-cultural adaptation of the Czech version of the core outcome measures index for low back and neck pain.

The Core Outcome Measures Index (COMI) is a short, multidimensional instrument translated into several languages that covers five domains recommended in the assessment of outcome in patients with low-back and neck pain. The purpose of this study was to cross-culturally adapt the COMI from English to Czech language and to test the face and construct validity and reproducibility of its results in patients with low-back and neck pain. Participants (n = 125) were included from primary and secondary care. The participants reported moderate pain and disability levels. All participants filled in the COMI forms before and after surgery. Descriptive statistics, Wilcoxon paired test, Crombach's alpha, principal component analysis and information entropy calculation were used. The instrument was successfully forward and back-translated. It can be seen that the questionnaire applied as part of our intervention study produces answers with a sufficient degree of variability and with a satisfactory degree of representation of extreme values. It can be also seen that the questionnaire can diagnose an objectively occurring change associated with the surgeon within the intervention procedure. Our other findings support the idea of ​​a possible reduction in the number of questions that measure the same latent variable. Our investigations also showed that it is possible to reduce the range of the point scale of the perception of pain to 5 degrees of intensity and thus unify the range with the other questions. The Czech COMI shows acceptable properties and is thus suitable to use as a short instrument for measuring important domains in patients with low-back and neck pain.

Acupuncture’s Emergence as A Promising Non-Pharmacological Therapy for Appetite Management in Cancer Chemotherapy

Objective The primary objective of this investigation was to assess the impact of acupuncture intervention and explore the intricacies of acupoint selection as a therapeutic strategy for chemotherapy-induced Anorexia (CIA). Method Eight electronic databases were searched to identify relevant studies on the use of acupuncture for the treatment of CIA to conduct a comprehensive meta-analysis. Following this, the Apriori algorithm, correlation analysis, and cluster analysis were performed to identify correlations between the selection of acupoints. Results Acupuncture significantly reduced the incidence of anorexia (RR = 0.76, 95%CI: 0.65, 0.90; I 2=63%; p = 0.001; n = 503) and anorexia score (SMD=-0.33, 95%CI: −0.53, −0.14; I 2=22%; p = 0.0008; n = 419), as well as preserved body mass (MD = 2.70, 95%CI: 1.08, 4.32; I 2=0%; p = 0.001; n = 187) and enhanced physical strength (MD = 4.23, 95%CI: 1.90, 6.55; I 2=58%; p = 0.0004; n = 377). Moreover, subgroup analysis highlighted its efficacy in managing anorexia associated with non-gastrointestinal tumors and mitigating the severity of cisplatin-induced anorexia. Meanwhile, Zusanli (ST36), Neiguan (PC6), Tianshu (ST25), Zhongwan (RN12), and Qihai (RN6) were identified as crucial acupoints in CIA management. Conclusion Acupuncture holds promise as a potential non-pharmacological approach for managing anorexia during cancer chemotherapy. To provide robust evidence of its effectiveness, well-designed Randomized Controlled Trials (RCTs) with larger participant cohorts, and consistent core outcome measures are essential.

Surgical decisions on implant-related parameters can enhance knowledge transfer for glenoid bone grafting in primary reverse shoulder arthroplasty: a scoping review of heterogeneity sources.

The purpose of the present scoping review is to identify sources of heterogeneity in reporting domains that have the potential to improve surgical decision-making in reverse shoulder arthroplasty associated with glenoid bone grafting. A scoping review was conducted according to the JBI and PRISMA ScR guidelines. Articles covering glenoid bone grafting at the time of reverse shoulder replacement, published between 2012 and 2022 in MEDLINE, Scopus, Epistemonikos, Web of Science, and Cochrane Database of Systematic Reviews, were searched. Reporting of core outcome measures, as well as prosthesis-related variables, rehabilitation protocols, radiographic evaluation methods, and bone graft incorporation assessments, were collected. For the final analysis, a total of 14 articles were considered. There were 649 operated shoulders with a mean patient age of 72 years, ranging from 48 to 85 years. Analysis of preoperative ranges of motion and patient-reported outcome measures revealed increased heterogeneity in patient selection between studies. Reporting of implant-related parameters was the most inconsistent. Rehabilitation protocols were scarcely reported. Assessment of graft incorporation and radiographic evaluation of choice revealed that there is no consistent method or measurement and the clinical relevance of radiolucent lines at the graft-glenoid bone interface is unclear. Addressing implant-related reporting gaps has the highest potential to improve surgical decision-making and provide orthopedic surgeons with a more comprehensive understanding of published results on glenoid bone grafting at the time of primary reverse shoulder arthroplasty.

Core outcome set for studies evaluating interventions to prevent or treat delirium in long-term care older residents: international key stakeholder informed consensus study.

Trials of interventions to prevent or treat delirium in older adults resident in long-term care settings (LTC) report heterogenous outcomes, hampering the identification of effective management strategies for this important condition. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in this population. We used a rigorous COS development process including qualitative interviews with family members and staff with experience of delirium in LTC; a modified two-round Delphi survey; and virtual consensus meetings using nominal group technique. The study was registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (https://www.comet-initiative.org/studies/details/796). Item generation identified 22 delirium-specific outcomes and 32 other outcomes from 18 qualitative interviews. When combined with outcomes identified in our earlier systematic review, and following an item reduction step, this gave 43 outcomes that advanced to the formal consensus processes. These involved 169 participants from 12 countries, and included healthcare professionals (121, 72%), researchers (24, 14%), and family members/people with experience of delirium (24, 14%). Six outcomes were identified as essential to include in all trials of interventions for delirium in LTC, and were therefore included in the COS. These are: 'delirium occurrence'; 'delirium related distress'; 'delirium severity'; 'cognition including memory', 'admission to hospital' and 'mortality'. This COS, endorsed by the American Delirium Society and the European and Australasian Delirium Associations, is recommended for use in future clinical trials evaluating delirium prevention or treatment interventions for older adults residing in LTC.

Effectiveness of psychological workplace counseling for South Korean employees: A longitudinal study

Purpose: This study aimed to determine the effectiveness of psychological workplace counseling for South Korean employees.Methods: Psychological counseling sessions were conducted for 93 employees from 11 companies that signed a contract for psychological counseling services with the Workplace Mental Health Institute, Kangbuk Samsung Hospital. Each 50-minute session was tailored to the individual needs of the clients. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) counseling effectiveness assessment scale was administered before and after the counseling. A paired t-test was used to compare the mean scores before and after the sessions, and an analysis of variance (ANOVA) was performed, followed by a Scheffe post hoc analysis.Results: In the overall sample, the mean CORE-OM scores before and after counseling showed a significant decrease from 1.343 to 0.883, with improvements observed in all four sub-domains. ANOVA showed that the group with more than 11 sessions showed greater change in scores than the group with four sessions or fewer. The reliable change index scores showed that 38% of the employees demonstrated a reliable change, and the groups with eight or more sessions exhibited greater change than the group with fewer than eight sessions.Conclusion: Among South Korean employees who received workplace counseling services, both the mean total score of the CORE-OM and the mean scores of the four sub-domains decreased after counseling. In addition, the effectiveness of counseling significantly increased as the total number of sessions increased.

Examining the Development of Peer Attachment Based on Parental Attachment, and Collaborative Impacts on Mental Health among Japanese Youth

This study aimed at confirming the factor structure of the Japanese version of Inventory of Parent and Peer Attachment (IPPA) for peers. Furthermore, it examined whether or not peer attachment is significantly influenced by father and/or mother attachment, and to see whether father and mother attachment affects mental health directly and/or indirectly via peer attachment for each gender among Japanese youth. The targets of this study were 433 (men: 149, women: 284) Japanese college students who completed every item of the Japanese version of father, mother, and peer IPPAs, as well as Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) to evaluate their mental health. Confirmatory Factor Analysis (CFA) was conducted to confirm the factor structure of the Japanese version of peer IPPA. Structural Equation Modelling (SEM) was utilized to see whether or not peer attachment is significantly influenced by father and/or mother attachment, and whether or not peer attachment mediates between parental IPPA and mental health. A bi-factor model, constituted by one general factor and three specific factors forming the original IPPA developed by Armsden &amp; Greenberg (1989), was supported by excluding one item from the specific factor Alienation. SEM revealed that the mental health of both male and female respondents was significantly influenced by peer attachment. Among males, its platform was built by attachment only to the father, whereas among females, it was built by both father and mother attachment.

Cross-Cultural Adaptation and Validation of the Traditional Chinese Version of the Core Outcome Measures Index for People with Low Back Pain in Hong Kong

Cross-Cultural Adaptation and Validation of the Traditional Chinese Version of the Core Outcome Measures Index for People with Low Back Pain in Hong Kong

External validation of the smartphone-based 6-minute walking test in patients with degenerative lumbar disorders undergoing epidural steroid injection

BackgroundThe 6-minute walking test (6WT) has previously shown to be reliable and valid outcome measure in patients undergoing surgery for degenerative lumbar disorders (DLD). A role of 6WT in conservatively treated patients undergoing epidural steroid injection (ESI) remains unclear. MethodsAbout 50 patients with DLD, scheduled for ESI were assessed by the smartphone-based 6WT and common paper-based patient-reported outcome measures (PROMs), including the Core Outcome Measures Index [COMI] back, Oswestry Disability Index (ODI) and Short Form Survey (SF-12). Pearson correlation coefficient (PCC) was used to define the relationship between 6WT and PROMs. Reliability of the 6WT was determined by intraclass correlation coefficient (ICC). Age- and sex-adjusted objective functional impairment (OFI) z-scores were calculated for each patient. ResultsA total of 50 patients (mean age 52 years, SD 13; 25% female), including 35 patients (70%) with lumbar disc herniation and 15 patients (30%) with lumbar spinal stenosis were included. The mean 6-minute walking distance (6WD) was 454.1 m (SD 89.1); the age- and sex-adjusted mean OFI z-score was −2.1 (SD 4.0). A total of 17 (34%) patients had mild, 8 (16%) moderate, and 4 (8%) severe OFI, while 21 (42%) had 6WT results within the normal population range (no OFI). The PCCs between the 6WD and VAS back pain were r=−0.30, ODI r=−0.43, COMI back r=−0.36, and PCS-12 r=0.51 (all p<.05). The ICC of the 6WT was β=0.92. ConclusionsThis external validation in a patient cohort with DLD, which was managed conservatively, confirms the reliability and content validity of the 6WT with similar PCCs with PROMs compared to the original surgical cohort. The results confirm the 6WT as a valid and useful tool for assessing OFI in patients with DLD and a broad range of functional restrictions in an outpatient setting.

Impact of incidental dural tears on postoperative outcomes in patients undergoing cervical spine surgery: a multicenter retrospective cohort study

BACKGROUND CONTEXTIncidental dural tear (DT) during cervical spine surgery is a feared complication. However, its impact on patient-reported outcomes (PROs) remains unclear. PURPOSETo determine the influence of DTs on PROs 1 year after cervical spine surgery. STUDY DESIGNRetrospective cohort. PATIENT SAMPLEPatients undergoing elective cervical spine surgery for cervical spondylosis, ossification of the posterior longitudinal ligament (OPLL), and cervical disc herniation. OUTCOME MEASURESAnalysis included patients’ characteristics, perioperative complications, and PROs both preoperatively and at 1 year postoperatively. METHODSThis study enrolled consecutive patients who underwent elective cervical spine surgery at 13 high-volume spine centers. All patients were required to complete questionnaires both preoperatively and 1 year postoperatively, which included PROs such as numerical rating scales of pain or dysesthesia for each part of the body, Neck Disability Index NDI, and Core Outcome Measures Index. Patients were divided into 2 groups based on the presence (DT+) or absence (DT-) of dural injury. Comparisons were made regarding patient background, perioperative complications, and pre and postoperative PROs. Propensity score matching was also utilized to adjust for patient background, and further comparisons were made regarding complication rates and PROs. RESULTSOut of 2,704 patients, dural tears were identified in 97 (3.6%) cases. The DT+ group had a significantly higher proportion of fixation surgeries, upper cervical surgeries, OPLL, and revision surgeries. Perioperative complications were significantly higher in the DT+ group, including intraoperative nerve damage, postoperative paralysis, surgical site infections (SSI), and cerebrovascular complications. Outcomes collected from 2,163 patients (79.9%) revealed significantly more severe neck and upper limb pain in the DT+ group. After propensity score matching, significant differences persisted in postoperative paralysis and SSI in the DT+ group, but no significant differences were observed in PROs. CONCLUSIONSPatients with dural tears showed nearly equivalent postoperative outcomes at 1 year following cervical spine surgery compared to those without dural tears. However, the incidence of perioperative complications was higher, emphasizing the need for careful management.

Impact of Gender-Specific Physiological activities on Bone Density and Spinal Alignment Post-Spinal Stabilization Surgery Affecting Quality of Life

Background: The rate of spinal stabilization surgery has increased in recent years among both males and females due to ineffective activities impacting their quality of life, work-disability, and social-disability. Aim: This study aimed to determine the impact of such activities on bone density and spinal alignment after spinal stabilization surgery within the context of Bursa, Turkey. Method: A sample of 450 patients, who had undergone spinal surgery, was included, 210 of which were females and 240 were males. These patients had suffered from different ailments including spinal stenosis, degenerative spondylolisthesis and disc herniation. In order to attain the required outcomes, Core Outcome Measures Index (COMI) was measured before and after (one year) operation. This test measured various positive and negative outcomes post-spinal stabilization surgery including improvement in degree of pain and back function, quality of life, degree of work-disability and social-disability, over a period of 12-months. Patients' satisfaction level with therapy was also measured using a 5-point Likert scale while parametric statistics provided the relationship among variables. Results: The results obtained show that females with all pathologies had worse COMI scores significantly (p &lt; 0.05) as compared to males. However, no significant differences were observed after the operation within the context of gender (p &gt; 0.05). However, 72% of females and 71% of males received minimal clinically important change (MCIC) score of 2.2 for COMI. Hence, gender showed insignificant relationship with MCIC, since females did not show any significant satisfaction level as compared to males concerning their post-operative health outcomes. Conclusion: The study recommends to emphasize on improving therapeutic and surgical measures aiming at attaining significant satisfaction levels after surgery.

Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis.

Localized cutaneous leishmaniasis (LCL) is a chronic ulcerating disease. A literature review identified inconsistencies in clinical trials. The aims of this study were to reach a consensus on the most important domains to measure when assessing LCL, agree on parameters to measure the domains, and develop a tool representing a Core Outcome Set (COS), for use in clinical assessment of LCL. A literature review was conducted to identify any existing COS for LCL embracing agreed Outcome Domains, i.e. what to measure and any Outcome Measurement Instruments (OMIs). As no COS was available, potential outcome domains for assessment of LCL were identified through an international collaborative approach using e-consultations and virtual discussions with expert stakeholders (n = 20) from geographically different LCL endemic countries. Subsequent judgmental validation process included a face-to-face multidisciplinary stakeholders' meeting adopting the Nominal Group Technique. A final consensual agreement on outcome domains and items required to measure these domains was established. "Clinical Cure" was defined as the ideal overall "General Concept". The five Core Outcome Domains included Signs capturing clinical morphology, diameter, and induration of an index lesion with the aid of a palpability score, Treatment Efficacy assessing percentage change in size of the lesion and re-epithelialization compared to baseline, Treatment Impact which included an investigator and patient visual analogue score, and Clinical Sequelae rating pigment change, atrophic and hypertrophic/keloid scars. It was agreed that two open-ended questions should be included to capture some aspects of Health-Related Quality of Life as a means of capturing a patient-focused approach. LeishCOM_LCL was generated to reflect a COS for LCL. This captured demographic details, agreed outcome domains and measures to assess these domains. Validation of LeishCOM_LCL will be reported in a separate paper. Development of a Patient Reported Outcome Measure will be considered in the future.

Core outcomes measures in dental computer vision studies (DentalCOMS)

ObjectivesTo improve reporting and comparability as well as to reduce bias in dental computer vision studies, we aimed to develop a Core Outcome Measures Set (COMS) for this field. The COMS was derived consensus based as part of the WHO/ITU/WIPO Global Initiative AI for Health (WHO/ITU/WIPO AI4H). MethodsWe first assessed existing guidance documents of diagnostic accuracy studies and conducted interviews with experts in the field. The resulting list of outcome measures was mapped against computer vision modeling tasks, clinical fields and reporting levels. The resulting systematization focused on providing relevant outcome measures whilst retaining details for meta-research and technical replication, displaying recommendations towards (1) levels of reporting for different clinical fields and tasks, and (2) outcome measures. The COMS was consented using a 2-staged e-Delphi, with 26 participants from various IADR groups, the WHO/ITU/WIPO AI4H, ADEA and AAOMFR. ResultsWe assigned agreed levels of reporting to different computer vision tasks. We agreed that human expert assessment and diagnostic accuracy considerations are the only feasible method to achieve clinically meaningful evaluation levels. Studies should at least report on eight core outcome measures: confusion matrix, accuracy, sensitivity, specificity, precision, F-1 score, area-under-the-receiver-operating-characteristic-curve, and area-under-the-precision-recall-curve. ConclusionDental researchers should aim to report computer vision studies along the outlined COMS. Reviewers and editors may consider the defined COMS when assessing studies, and authors are recommended to justify when not employing the COMS. Clinical significanceComparing and synthesizing dental computer vision studies is hampered by the variety of reported outcome measures. Adherence to the defined COMS is expected to increase comparability across studies, enable synthesis, and reduce selective reporting.

Clinical Utility of the CORE-OM and CORE-10

This study explores the clinical utility of the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM), and the Clinical Outcomes in Routine Evaluation–10 (CORE-10). This is an exploratory, naturalistic longitudinal study conducted in two psychotherapy services that offer training for psychology students in Ecuador. These services provide affordable and free short-term psychotherapy based on a constructivist approach. In total, 259 adult clients presenting non-severe mental disorders and symptoms and/or relational problems were included, 147 were women (57%); ages ranged from 18 to 66 with mean 28.70 years. At first contact we collected socio-demographic data and responses to the Clinical Outcomes in Routine Evaluation- Outcome Measure, Outcome Questionnaire-45.2 and the Schwartz Outcome Scale-10-E. Data were analyzed with statistical estimation using bootstrap 95% confidence intervals to assess clinical utility and psychometric adequacy of the measures for similar services and clients. The measures showed good acceptability and adequate internal consistency, similar to findings from the United Kingdom and Spain. There were strong correlations between all scale scores of the CORE-OM except for risk. Adequate convergent validity was found for the CORE-OM with the other two measures. There were no significant gender, age, or education effects for initial scores. Comparing help-seeking and non-help-seeking populations, large effect sizes were found for the CORE-OM total, non-risk, and risk scores, and medium effect size for the CORE-10 scores. Cut-off scores for the CORE-OM and CORE-10 were 1.26 and 1.51, respectively. The measures showed sensitivity to change with large effect sizes for all scores, except for risk, which shows a medium effect size. The CORE-OM and CORE-10 are suitable for clinimetric use, the former for broad assessment of psychological state and the latter for tracking changes in psychotherapy. Recommendations are made for assessment structure designs and data interpretation for routine use particularly in Latin America.

The Eczema Area and Severity Index: An update of progress and challenges in its measurement of atopic dermatitis after 20 years of use.

The Eczema Area and Severity Index is an investigator-assessed instrument reporting clinical signs of atopic dermatitis. The instrument is extensively validated in both adult and paediatric populations and recommended as a core outcome measure to assess clinical signs by the Harmonising Outcome Measures for Eczema initiative in clinical trials and was recently recommended as an option to measure signs in clinical practice. Here, we review the validation of the instrument using standard assessment criteria, explore controversies and challenges to its universal applicability and highlight future electronic adaptations. We find that the instrument demonstrates adequate performance in the measurement properties recommended by the COnsensus-based Standards for the selection of health Measurement INstruments initiative for instruments reporting clinical signs, is clinically interpretable, and is suitable for all atopic dermatitis severities. Some validation gaps remain. Information reporting on its performance in diverse populations, with emphasis on deeply pigmented skin, is promising though limited. Technological adaptations are demonstrating promising initial validation results and may facilitate remote and/or automated assessments assisting clinical care and decentralized clinical trials in the future. We find no strong evidence limiting its use in trials or clinical practice although questions pertaining to the effect of investigator training remain. We recommend that the Eczema Area and Severity Index be used in all interventional atopic dermatitis trials and be considered alongside other recommended clinical practice severity instruments.