Machine learning models for abstract screening task - A systematic literature review application for health economics and outcome research.

OBJECTIVE: Systematic literature reviews (SLRs) are critical for life-science research. However, the manual selection and retrieval of relevant publications can be a time-consuming process. This study aims to (1) develop two disease-specific annotated corpora, one for human papillomavirus (HPV) associated diseases and the other for pneumococcal-associated pediatric diseases (PAPD), and (2) optimize machine- and deep-learning models to facilitate automation of the SLR abstract screening. METHODS: This study constructed two disease-specific SLR screening corpora for HPV and PAPD, which contained citation metadata and corresponding abstracts. Performance was evaluated using precision, recall, accuracy, and F1-score of multiple combinations of machine- and deep-learning algorithms and features such as keywords and MeSH terms. RESULTS AND CONCLUSIONS: The HPV corpus contained 1697 entries, with 538 relevant and 1159 irrelevant articles. The PAPD corpus included 2865 entries, with 711 relevant and 2154 irrelevant articles. Adding additional features beyond title and abstract improved the performance (measured in Accuracy) of machine learning models by 3% for HPV corpus and 2% for PAPD corpus. Transformer-based deep learning models that consistently outperformed conventional machine learning algorithms, highlighting the strength of domain-specific pre-trained language models for SLR abstract screening. This study provides a foundation for the development of more intelligent SLR systems.

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

INTRODUCTION: Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved. METHODS AND ANALYSIS: A COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance. ETHICS AND DISSEMINATION: Ethical approval for the consensus process will be obtained from the Queen's University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely. REGISTRATION: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).

Cross-cultural adaptation and psychometric validation of point-of-care outcome assessment tools in Chinese palliative care clinical practice.

BACKGROUND: A standardized national approach to routinely assessing palliative care patients helps improve patient outcomes. However, a quality improvement program-based on person centered outcomes within palliative care is lacking in Mainland China. The well-established Australian Palliative Care Outcome Collaboration (PCOC) national model improves palliative care quality. This study aimed to culturally adapt and validate three measures that form part of the PCOC program for palliative care clinical practice in China: The PCOC Symptom Assessment Scale (PCOC SAS), Palliative Care Problem Severity Scale (PCPSS), Palliative Care Phase. METHODS: A study was conducted on cross-cultural adaptation and validation of PCOC SAS, PCPSS and Palliative Care Phase, involving translation methods, cognitive interviewing, and psychometric testing through paired assessments. RESULTS: Cross-cultural adaptation highlighted the need to strengthen the link between the patient's care plan and the outcome measures to improve outcomes, and the concept of distress in PCOC SAS. Analysis of 368 paired assessments (n = 135 inpatients, 22 clinicians) demonstrated that the PCOC SAS and PCPSS had good and acceptable coherence (Cronbach's a = 0.85, 0.75 respectively). Palliative Care Phase detected patients' urgent needs. PCOC SAS and PCPSS showed fair discriminant and concurrent validity. Inter-rater reliability was fair for Palliative Care Phase (k = 0.31) and PCPSS (k = 0.23-0.30), except for PCPSS-pain, which was moderate (k = 0.53). CONCLUSIONS: The Chinese version of PCOC SAS, PCPSS, and Palliative Care Phase can be used to assess outcomes as part of routine clinical practice in Mainland China. Comprehensive clinical education regarding the assessment tools is necessary to help improve the inter-rater reliability.

The use of routinely collected healthcare records for outcome assessment in clinical trials: a UK perspective.

The use of routinely collected electronic healthcare records (EHR) for outcome assessment in clinical trials has been described as a 'disruptive' new technique more than a decade ago. Despite this potential, significant methodological issues and regulatory barriers have hampered the progress in this area. This article discusses the key considerations that trialists should take into account when incorporating EHR into their trials. These include considerations of the clinical relevance of the outcome, data timeliness and quality, ethical and regulatory issues, and some practical considerations for clinical trials units. In addition, this article describes the benefits of using EHR which include cost, reduced trial burden for participants and staff, follow up efficiencies, and improved health economic evaluation procedures. We also describe the major regulatory and start up costs of using EHR in clinical trials. This article focuses on the UK specific EHR landscape in clinical trials and would help researchers and trials units considering the use of this method of outcome data collection in their next trial. If the issues described are mitigated, this method will be a formidable tool for conducting pragmatic clinical trials.

The impact of blinding on estimated treatment effects in randomized clinical trials on acupuncture: A meta-epidemiological study.

OBJECTIVE: To evaluate the sole impact of blinding patients and outcome assessors in acupuncture randomized controlled trials (RCTs) on treatment effects while considering the type of outcome measures. METHODS: We searched databases for the meta-analyses on acupuncture with both blinded and non-blinded RCTs. Mixed-effects meta-regression models estimated the average ratio of odds ratios (ROR) and differences in standardized mean differences (dSMD) for non-blinded RCTs versus blinded mixed-effects meta-regression model. RESULTS: The study included 96 meta-analyses (1012 trials). The average ROR for lack of patient blinding was 1.08 (95% confidence intervals 0.79-1.49) in 18 meta-analyses with binary patient-reported outcomes. The average ROR for lack of outcome assessor blinding was 0.98 (0.77-1.24) in 43 meta-analyses with binary subjective outcomes. The average dSMD was -0.38 (-0.96 to 0.20) in 10 meta-analyses with continuous patient-reported outcomes. The average dSMD was -0.13 (-0.45 to 0.18) in 25 meta-analyses with continuous subjective outcomes. The results of the subgroup analysis were consistent with the primary analysis findings. CONCLUSIONS: Blinding of participants and outcome assessors does not significantly influence acupuncture treatment efficacy. It underscores the practical difficulties of blinding in acupuncture RCTs and the necessity to distinguish between trials with and without successful blinding to understand treatment expectations' effects. Enhancing blinding procedures' quality and assessment in future research is crucial for improving RCTs' internal validity and reliability.

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

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

Developing a core outcome set for the health outcomes for children and adults with congenital oesophageal atresia and/or tracheo-oesophageal fistula: OCELOT task group study protocol.

INTRODUCTION: Heterogeneity in reported outcomes of infants with oesophageal atresia (OA) with or without tracheo-oesophageal fistula (TOF) prevents effective data pooling. Core outcome sets (COS) have been developed for many conditions to standardise outcome reporting, facilitate meta-analysis and improve the relevance of research for patients and families. Our aim is to develop an internationally-agreed, comprehensive COS for OA-TOF, relevant from birth through to transition and adulthood. METHODS AND ANALYSIS: A long list of outcomes will be generated using (1) a systematic review of existing studies on OA-TOF and (2) qualitative research with children (patients), adults (patients) and families involving focus groups, semistructured interviews and self-reported outcome activity packs. A two-phase Delphi survey will then be completed by four key stakeholder groups: (1) patients (paediatric and adult); (2) families; (3) healthcare professionals; and (4) researchers. Phase I will include stakeholders individually rating the importance and relevance of each long-listed outcome using a 9-point Likert scale, with the option to suggest additional outcomes not already included. During phase II, stakeholders will review summarised results from phase I relative to their own initial score and then will be asked to rescore the outcome based on this information. Responses from phase II will be summarised using descriptive statistics and a predefined definition of consensus for inclusion or exclusion of outcomes. Following the Delphi process, stakeholder experts will be invited to review data at a consensus meeting and agree on a COS for OA-TOF. ETHICS AND DISSEMINATION: Ethical approval was sought through the Health Research Authority via the Integrated Research Application System, registration no. 297026. However, approval was deemed not to be required, so study sponsorship and oversight were provided by Alder Hey Children's NHS Foundation Trust. The study has been prospectively registered with the COMET Initiative. The study will be published in an open access forum.

Limited English Proficiency and Outcomes in the Intensive Care Unit: An Integrated Review.

INTRODUCTION: Language barriers place patients at risk of substandard care. Hospitalized patients with limited English proficiency (LEP) face unique challenges, especially in the intensive care unit (ICU). The purpose of this review is to critique and synthesize quantitative evidence on LEP and ICU outcomes. METHODOLOGY: Quantitative studies published in English between 1999 and 2022 were queried using intentional terminology. RESULTS: Searches yielded 138 results, with 12 meeting inclusion criteria. The analysis resulted in the extrapolation of five themes pertinent to outcomes of ICU patients or families with LEP: (a) knowledge deficit relating to conditions and care; (b) lack of language-appropriate care; (c) alienation from care process; (d) decreased confidence and ownership of care; and (e) relationship to clinical quality indicators. DISCUSSION: Outcomes associated with LEP were largely negative and revealed unmet needs for ICU patients with LEP. More research is needed to improve linguistically and culturally congruent care in the ICU.

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

INTRODUCTION: Current clinical trials on swallowing disorders (dysphagia) in Parkinson's disease (PD) apply a high variety of outcomes and different outcome measures making comparative effectiveness research challenging. Furthermore, views of patients and dysphagia clinicians when selecting trial outcomes have not been considered in the past, thus study results may have little importance to them. This study aims to develop an agreed standardised Core Outcome Set for Dysphagia Interventions in Parkinson's disease (COS-DIP), systematically measured and reported as a minimum for all clinical trials. It will also comprise guidance on outcome definitions, outcome measures and time points of measurement. METHODS AND ANALYSIS: The COS-DIP development will comprise five stages following established methodology: (1) a recent scoping review on all applied outcomes, their definitions, methods and time points of measurement in clinical trials in dysphagia in PD, (2) online surveys and focus groups with clinicians, patients, caregivers and family members to identify outcomes that are important to them, (3) an identified list of outcomes based on results of stage 1 and 2, (4) three round online Delphi survey with up to 200 key stakeholders to determine core outcomes and (5) two online consensus meetings with up to 40 representative key stakeholders to agree on all outcomes, definitions, methods and time points of measurement in the final COS-DIP. ETHICS AND DISSEMINATION: Full ethical approval was obtained from the Research Ethics Committee, School of Linguistic, Speech and Communication Sciences, Trinity College Dublin, on 15 May 2023 (HT27). Dissemination of the COS-DIP will be enhanced through presentations at (inter-) national conferences and through peer-reviewed, open access publications of related manuscripts. Lay and professional information sheets and infographics will be circulated through relevant patient and professional organisations and networks. TRIAL REGISTRATION NUMBER: The COS-DIP study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database on 24 September 2021 (www.comet-initiative.org/Studies/Details/1942).

Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol.

INTRODUCTION: The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. 'PelvEx-Beating the empty pelvis syndrome' aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome. METHODS AND ANALYSIS: A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting. ETHICS AND DISSEMINATION: The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome. TRIAL REGISTRATION NUMBER: NCT05683795.

Core Descriptor Sets for Rectal Prolapse Outcomes Research Using a Modified Delphi Consensus.

BACKGROUND: There is wide variation in prolapse care. OBJECTIVE: To determine core descriptor sets for rectal prolapse to enhance outcomes research. DESIGN: Descriptors for patients undergoing rectal prolapse surgery were generated through a systematic review and expert opinion. Stakeholders were recruited internationally via listserv and social media. Experts were encouraged to consider the minimum descriptors that could be considered during clinical care, and descriptors were grouped into core descriptor sets. Consensus was defined as greater than 70% agreement. SETTING: A 3-round Delphi process using a 9-point Likert scale based on expert results was distributed via survey. The final interactive meeting used a polling platform. PARTICIPANTS: The Pelvic Floor Disorders Consortium interdisciplinary group convened to advance the clinical care of pelvic floor disorders. MAIN OUTCOME MEASURES: To achieve expert consensus for core descriptor sets for rectal prolapse using a modified Delphi method. RESULTS: A total of 206 providers participated, with survey response rates of 82% and 88%, respectively. Responders were from North America (56%), Europe (29%), and Latin America, Asia, Australia, New Zealand, and Africa (15%). Ninety-one percent of participants identified as colorectal surgeons and 80% reported >5 years of experience (35% reported >15 years). Fifty-seven attendees participated in the final meeting and voted on core descriptor sets. Ninety-three percent of participants agreed that descriptors such as age, BMI, frailty, nutrition, and the American Society of Anesthesiology score correlated to physiologic status. One hundred percent of participants agreed to include baseline bowel function. One hundred percent of participants reported willingness to complete a synoptic operative report. Follow-up intervals 1, 3, and 5 years after surgery (76%) with a collection of recurrence and functional outcomes at those time periods reached an agreement. LIMITATIONS: Individual bias, self-identification of experts, and paucity of knowledge related to rectal prolapse. CONCLUSIONS: This represents the first steps toward international consensus to unify language and data collection processes for rectal prolapse. See Video Abstract . CONJUNTOS DE DESCRIPTORES BSICOS PARA LA INVESTIGACIN DE RESULTADOS DE PROLAPSO RECTAL MEDIANTE UN CONSENSO DELPHI MODIFICADO: ANTECEDENTES:Existe una amplia variación en la atención del prolapso.OBJETIVO:Determinar conjuntos de descriptores básicos para el prolapso rectal para mejorar los resultados de la investigación.DISEÑO:Los descriptores para pacientes sometidos a cirugía de prolapso rectal se generaron a través de una revisión sistemática y la opinión de expertos. Las partes interesadas fueron reclutadas internacionalmente a través de listas de servicio y redes sociales. Se animó a los expertos a considerar los descriptores mínimos que podrían considerarse durante la atención clínica, y los descriptores se agruparon en conjuntos de descriptores básicos. El consenso se definió como > 70% de acuerdo.AJUSTE:Se distribuyó mediante encuesta un proceso Delphi de tres rondas que utiliza una escala Likert de 9 puntos basada en resultados de expertos. La reunión interactiva final utilizó una plataforma de votación.PARTICIPANTES:El grupo interdisciplinario del Consorcio de Trastornos del Suelo Pélvico se reunió para avanzar en la atención clínica de los trastornos del suelo pélvico.MEDIDAS PRINCIPALES DE RESULTADOS:Lograr el consenso de expertos para los conjuntos de descriptores básicos para el prolapso rectal utilizando un método Delphi modificado.RESULTADOS:Participaron 206 proveedores con tasas de respuesta a la encuesta del 82% y 88% respectivamente. Los encuestados procedían de América del Norte (56%), Europa (29%) y América Latina, Asia, Australia, Nueva Zelanda y África (15%). El noventa y uno por ciento se identificó como cirujanos colorrectales y el 80% reportó más de 5 años de experiencia (35% > 15 años). Cincuenta y siete asistentes participaron en la reunión final y votaron sobre conjuntos de descriptores básicos. El noventa y tres por ciento estuvo de acuerdo en que descriptores como edad, índice de masa corporal, fragilidad, nutrición y puntuación de la Sociedad Estadounidense de Anestesiología se correlacionaban con el estado fisiológico. El cien por ciento estuvo de acuerdo en incluir la función intestinal inicial. El 100% refirió disposición para realizar un informe operativo sinóptico. Los intervalos de seguimiento 1,3,5 años después de la cirugía (76%) con un conjunto de recurrencias y los resultados funcionales en esos períodos de tiempo coincidieron.LIMITACIONES:Sesgo individual, autoidentificación de los expertos y escasez de conocimientos relacionados con el prolapso rectal.CONCLUSIONES:Esto representa los primeros pasos hacia un consenso internacional para unificar el lenguaje y los procesos de recolección de datos para el prolapso rectal. (Traducción-Yesenia Rojas-Khalil ).

Clinical utility and validity testing of a co-designed outcome measure for hand burn injuries.

INTRODUCTION: A new outcome measure for hand burn injuries was co-designed within a Participatory Action Research framework with expert clinicians and individuals with hand burn injuries. The outcome measure reviews activities which are commonly interrupted post hand burn injuries and includes 18 activities. OBJECTIVE: The aim of this study was to establish the clinical utility, face, and content validity of the newly developed outcome measure. METHODS: Three constructs of interest were examined using study specific questionnaires from the perspectives of clinicians and individuals with hand burn injuries. Clinicians working in burns centres around Australia and New Zealand and individuals attending a burn centre within one tertiary hospital trialled the outcome measure. Upon testing the outcome measure each participant completed the questionnaire. RESULTS: Twenty individuals with hand burn injuries and eight clinicians trialled the outcome measure. There was 85% agreement from individuals and 100% agreement from clinicians for face validity. Content validity was tested across the domains of relevance and clarity. Individuals rated all activities and clinicians rated 16 activities as relevant. Clarity of activities was high for both participant groups (>75% agreement). Clinical utility (measured in the domains of appropriateness, accessibility, practicability, and acceptability) was high, 95% of individuals reported agreement for practicability and 100% agreement for acceptability. Clinicians reported agreement of > 87.5% for appropriateness, accessibility, practicability, and acceptability. CONCLUSION: The results demonstrated agreement for clinical utility, face, and content validity of the co-design outcome measure for hand burn injuries. Further validity and reliability testing is planned, including Rasch analysis.

Evaluation of clinical oral care outcomes according to nursing outcomes classification.

PURPOSE: This research was planned to follow the healing process of the oral mucosa in patients in intensive care with an "Impaired Oral Mucous Membrane Integrity" nursing diagnosis based on the "NOC (1100) Oral Health Assessment" outcome criteria. METHOD: This study, which was planned in a methodological and descriptive type of research, was carried out with 50 patients who were hospitalized in the intensive care clinic of a state hospital between June and December 2022, with a nursing diagnosis of "Impaired Oral Mucous Membrane Integrity." Data were collected using a Patient Information Form and the "NOC (1100) Oral Health Evaluation Scale" for the nursing outcomes classification. In the analysis of the data descriptive statistical methods, Pearson correlation test, Friedman test as well as Cohen's kappa test were used to evaluate the agreement between two independent observers. FINDINGS: In the study, content validity index value of the NOC scale was calculated to be 0.90. The examination of the participants' mean scores on the NOC (1100) Oral Health Assessment Scale showed that there were statistically significant differences in terms of the repeated evaluations, except for the NOC indicators of "Oral mucosal integrity," "Gum integrity," and "Tooth integrity" (p < 0.01). No statistically significant correlation was found between the mean NOC scale scores of the patients according to the variables of age, body mass index, mechanical ventilation time, and length of stay in the intensive care unit (p > 0.05). CONCLUSIONS: The findings showed that the Turkish version of NOC (1100) Oral Health Assessment Scale was a valid tool for monitoring the healing process of the oral mucosa in patients in intensive care. IMPLICATIONS OF NURSING PRACTICE: With the use of NOC (1100) Oral Health Assessment Scale, a common language will be formed in the evaluation for monitoring the healing process of the oral mucosa in nursing care.

Developing a set of patient-centered outcomes for routine use in endometriosis: An international Delphi study.

INTRODUCTION: There is large variation in individual patient care for endometriosis. A uniform approach to measure outcomes could be incorporated into routine clinical practice to personalize and monitor treatments and potentially improve the quality of care. The aim of this study is to identify a group of patient-centered outcomes for use in routine endometriosis care which are relevant to all patient profiles. MATERIAL AND METHODS: By means of a modified two-round Delphi study with international representation including healthcare professionals, researchers and patient representatives (51 participants, 16 countries) we developed a set of patient-centered measurements. The participants evaluated 47 Patient Reported Outcome Measures (PROMs) and 30 Clinician Reported Outcome Measures (CROMs) regarding their feasibility and relevance for their use in routine endometriosis care. After the two rounds of quotation, meetings of the experts were convened to participate in a final discussion to finalize the consensus of the final set of included measures. RESULTS: The final set of patient-centered outcomes includes six PROMs (measuring symptomatic impact, pain, work productivity and quality of life) and 10 CROMs (measuring clinical, imaging and surgical indicators). A supplementary list of outcomes was added to include important dimensions that were considered essential by the expert panel but are not relevant to all patients. In addition the need for development of specific tools (PROMs) measuring the psychological impact and the impact in sexual activity of endometriosis was highlighted. CONCLUSIONS: We have developed a set of patient-centered outcomes measures in endometriosis care. The selected outcomes comprise the common features for all patients suffering from endometriosis. adapted for use in routine practice. The list of outcomes has been adapted for use in routine practice from which clinicians can chose, depending on their needs.

How well can the clinician appraise the patient's perception of the severity and impact of their back problem?

PURPOSE: A main concern of patients with back problems is pain and its impact on function and quality of life. These are subjective phenomena, and should be probed during the clinical consultation so that the physician can ascertain the extent of the problem. This study evaluated the agreement between clinicians' and patients' independent ratings of patient status on the Core Outcome Measures Index (COMI). METHODS: This was an analysis of the data from 5 spine specialists and 108 patients, in two centres. Prior to the consultation, the patient completed the COMI. After the consultation, the clinician (blind to the patient's version) also completed a COMI. Concordance was assessed by % agreement, Kappa values, Bland-Altman plots, Spearman rank, Intraclass Correlation Coefficients and comparisons of mean values, as appropriate. RESULTS: Agreement regarding the "main problem" (back pain, leg/buttock pain, sensory disturbances, other) was 83%, Kappa = 0.70 (95%CI 0.58-0.81). Moderate/strong correlations were found between the doctors' and patients' COMI-item ratings (0.48-0.74; p < 0.0001), although compared with the patients' ratings the doctors systematically underestimated absolute values for leg pain (p = 0.002) and dissatisfaction with symptom state (p = 0.002), and overestimated how much the patient's function was impaired (p = 0.029). CONCLUSION: The doctors were able to ascertain the location of the main problem and the multidimensional outcome score with good accuracy, but some individual domains were systematically underestimated (pain, symptom-specific well-being) or overestimated (impairment of function). More detailed/direct questioning on these domains during the consultation might deliver a better appreciation of the impact of the back problem on the patient's daily life.

Core outcomes in nerve surgery: development of a core outcome set for ulnar neuropathy at the elbow.

OBJECTIVE: Ulnar neuropathy at the elbow (UNE) is common, affecting 1%-6% of the population. Despite this, there remains a lack of consensus regarding optimal treatment. This is primarily due to the difficulty one encounters when trying to assess the literature. Outcomes are inconsistently reported, which makes comparing studies or developing meta-analyses difficult or even impossible. Thus, there is a need for a core outcome set (COS) for UNE (COS-UNE) to help address this problem. The objective of this study was to utilize a modified Delphi method to develop COS-UNE. METHODS: A 5-stage approach was utilized to develop COS-UNE: stage 1, consortium development; 2, literature review to identify potential outcome measures; 3, Delphi survey to develop consensus on outcomes for inclusion; 4, Delphi survey to develop definitions; and 5, consensus meeting to finalize the COS and definitions. The study followed the Core Outcome Set-STAndards for Development (COS-STAD) recommendations. RESULTS: The Core Outcomes in Nerve Surgery (COINS) Consortium comprised 21 participants, all neurological surgeons representing 11 countries. The final COS-UNE consisted of 22 data points/outcomes covering the domains of demographic characteristics, diagnostics, patient-reported outcomes, motor/sensory outcomes, and complications. Appropriate instruments, methods of testing, and definitions were set. The consensus minimum duration of follow-up was 6 months, with the consensus optimal timepoints for assessment identified as preoperatively and 3, 6, and 12 months postoperatively. CONCLUSIONS: The authors identified consensus data points/outcomes and also provided definitions and specific scales to be utilized to help ensure that clinicians are consistent in their reporting across studies on UNE. This COS should serve as a minimum set of data to be collected in all future neurosurgical studies on UNE. The authors hope that clinicians evaluating ulnar neuropathy will incorporate this COS into routine practice and that future studies will consider this COS in the design phase.