Outcome Measurement Instruments Research Articles

An international core outcome set for primary progressive aphasia (COS-PPA): Consensus-based recommendations for communication interventions across research and clinical settings.

Interventions to treat speech-language difficulties in primary progressive aphasia (PPA) often use word accuracy as a highly comparable outcome. However, there are more constructs of importance to people with PPA that have received less attention. Following Core Outcome Set Standards for Development Recommendations (COSSTAD), this study comprised: Stage 1 - systematic review to identify measures; Stage 2 - consensus groups to identify important outcome constructs for people with PPA (n=82) and care partners (n=91); Stage 3 - e-Delphi consensus with 57 researchers. The systematic review identified 84 Outcome Measurement Instruments. Core outcome constructs identified included: (1) Participate in conversations with family and friends, (2) get words out, (3) be more fluent, (4) convey a message by any means, and (5) understand what others are saying. Researchers were unable to reach a consensus on measurement instruments. Further work is required to develop appropriate measurement instruments that address all core outcome constructs important to key stakeholders. We introduce new symptom-led perspectives on primary progressive aphasia (PPA). The focus is on non-fluent/agrammatic (nfvPPA) and semantic (svPPA) variants. Foregrounding of early and non-verbal features of PPA and clinical trajectories is featured. We introduce a symptom-led staging scheme for PPA. We propose a prototype for a functional impairment scale, the PPA Progression Planning Aid.

Cross-cultural adaptation and validation of a French version of the perceived personal control questionnaire as an outcome measure instrument for genetic counseling.

The perceived personal control (PPC) questionnaire serves as an instrument to assess the concept of PPC, which refers to a person's perception of their ability to achieve positive outcomes while avoiding the negative effects of a given situation. Developed and used as a patient-reported outcome measure (PROM) in genetic counseling, the PPC questionnaire has been translated and validated in several languages, but not in French. The aim of this study was to cross-culturally adapt and validate a French version of the PPC questionnaire to evaluate genetic counseling services for hereditary breast and ovarian cancer (HBOC). After the translation into French, cognitive interviews were conducted with nine participants who had attended genetic counseling for HBOC to examine the adequacy of this French version and to verify participants' understanding of the questionnaire items. Cognitive interview data suggested that slight modifications should be made to four of the nine items and that it would be beneficial to add a short introduction to ensure that participants' interpretation corresponded to the intended meaning. Psychometric validation was then conducted with 99 participants who had also attended genetic counseling for HBOC. Counselees completed the questionnaire before and after their genetic consultation. The acceptability of the questionnaire was demonstrated by the presence of few missing items. The original three-factor solution was not confirmed by our exploratory factor analysis, suggesting that the questionnaire should be used as a one-dimensional instrument. The internal consistency of the questionnaire was high, with Cronbach's alpha of 0.89 before genetic counseling and 0.88 after. The significant increase in PPC scores before and after genetic counseling supports the responsiveness of the questionnaire. Convergent validity was confirmed by positive association with counselees' satisfaction with genetic counseling. These properties suggest the French PPC questionnaire is a valuable instrument for use as a PROM in genetic counseling research.

What aspects of outcome measurement instruments are important to parents and caregivers in child health trials: Survey protocol

Background Trials of interventions to prevent illness and/or improve health outcomes in children play a crucial role in the advancement of paediatric healthcare, research, and policy. It is important for researchers and trialists involved in such trials to understand factors which are important to parents/caregivers when deciding to participate and provide data about their child. There is little evidence to date surrounding the impact of outcome measurement instruments (OMIs) on parents/caregivers’ decisions about participation and provision of data in trials. The aim of this project is to examine what characteristics of OMIs are important in parents/caregivers’ decisions to engage with and participate in trials of interventions to prevent childhood illness and/or improve child health outcomes. Methods An online cross-sectional survey is being conducted. Survey recruitment began July 2024 and will be completed in October 2024. Parents/caregivers are eligible to participate if they have at least one child up to 12 years of age; there are no restrictions based on factors such as gender or nationality. Survey participants are being recruited using convenience sampling via social media, parenting websites, and online forums. This survey includes questions about parents/caregivers’ preferences for how, when, where, and with whom data is collected in child health research, as well as the types of OMIs parents/caregivers would be most comfortable using. Data will be analysed using descriptive statistics. Conclusions Findings from this study will address the current gap in knowledge related to preferences of parents/caregivers in how data are collected in trials of interventions to improve health outcomes in children. Study findings will inform trialists in the design and conduct of child health research in the future. Implementation of study findings in future trials can also improve experiences of children and their caregivers engaged in research and enhance the quality and quantity of data being collected.

Handheld point-of-care devices for snakebite coagulopathy: a scoping review.

Venom induced consumption coagulopathy (VICC) is a common complication of snakebite that is associated with hypofibrinogenaemia, bleeding, disability, and death. In remote tropical settings, where most snakebites occur, the 20-minute whole blood clotting test is used to diagnose VICC. Point-of-care (POC) coagulation devices could provide an accessible means of detecting VICC that is better standardised, quantifiable, and more accurate. In this scoping review, the mechanistic reasons that previously studied POC devices have failed in VICC are considered, and evidence-based recommendations are made to prioritise certain devices for clinical validation studies. Four small studies have evaluated a POC international normalised ratio (INR) device in patients with Australian Elapid, Daboia russelii and Echis carinatus envenoming. All of these studies used POC INR devices that rely on a thrombin substrate endpoint, which, unlike laboratory-based INR measurement, is known to underestimate INR in patients with hypofibrinogenaemia. Seventeen commercially available POC devices for measuring INR, activated clotting time (ACT), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer, and fibrin(ogen) degradation products (FDP) have been reviewed. POC INR devices that detect fibrin clot formation, as well as a novel POC device that quantifies fibrinogen were identified, that show promise for use in patients with VICC. These devices could support more accurate allocation of antivenom, reduce the time to antivenom administration, and provide improved clinical trial outcome measurement instruments. There is an urgent need for these promising POC coagulation devices to be validated in prospective clinical snakebite studies.

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.

Measuring successful conversations in couples with and without aphasia: A scoping review.

Aphasia impacts communication and relationships. While counselling is increasingly recognised as a component of the speech-language therapy role, the success of conversation partner training is typically measured in terms of communication alone. This scoping review aimed to describe how successful conversation is currently measured with couples-with and without aphasia, to inform the development of an ecologically valid measure for couples with aphasia. The scoping review was reported in alignment with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extensions for Scoping Reviews (PRISMA-SCR). MEDLINE, EMBASE, CINAHL and PsycINFO databases were searched for conversation treatment studies for couples with and without aphasia. Patient-reported outcome measures (PROMs) were extracted from included studies and screened against the three-tier model of situated language to shortlist those that measure everyday communication. Items within shortlisted PROMs were further described using the refined International Classification of Functioning, Disability and Health linking rules. Following screening and full-text review, 46 studies were included, consisting of 24 studies conducted with couples with aphasia and 22 studies conducted with couples without aphasia. For couples with aphasia, 13 PROMs were identified that measured everyday communication. Of these, 23% were dyadic (i.e., measured from the perspectives of both members of the couple); however, they usually only appraised the communication behaviours of the person with aphasia. For couples without aphasia, eight PROMs were identified that measured everyday communication; all were dyadic and measured both attitudes and communication behaviours of both partners. Conversation relies on the interaction of two people, and success in conversation is best rated by those having the conversation. The use of PROMs is recommended as part of person and relationship-centred practice; however, there is currently no validated PROM for conversation in aphasia that considers the perspectives and behaviours of both the person with aphasia and their communication partner. The PROM items identified in this study will form the basis of future research to develop a PROM for couples' conversations in aphasia. What is already known on the subject Communication partner training (CPT) for couples, where one person has aphasia, can improve conversation skills and enhance relationships. Clinician-rated measures, such as conversation analysis, have been used to measure the outcomes of CPT. However, there is a lack of person-centred or self-rated outcome measurement instruments. that is, patient-reported outcome measures (PROMs) for couples' conversations in aphasia. What this paper adds to existing knowledge We have identified outcome measurement instruments used in conversation treatment studies for couples with and without aphasia. We found that most PROMs used in aphasia treatment studies were not dyadic, that is, they did not include the self-report of both communication partners. In contrast, the PROMs used with couples without aphasia were dyadic and contained items that measured a more complex range of both partners' emotions, behaviours and attitudes. What are the potential or actual clinical implications of this work? This study provides insights into the content and characteristics of PROMs for couples' conversation therapy and may assist clinicians in selecting outcome measurement instruments in their practice.

'A Meaningful Difference, but Not Ultimately the Difference I Would Want': A Mixed-Methods Approach to Explore and Benchmark Clinically Meaningful Changes in Aphasia Recovery.

Outcome measurement instruments (OMIs) are used to gauge the effects of treatment. In post-stroke aphasia rehabilitation, benchmarks for meaningful change are needed to support the interpretation of patient outcomes. This study is part of a research programme to establish minimal important change (MIC) values (the smallest change above which patients perceive themselves as importantly changed) for core OMIs. As a first step in this process, the views of people with aphasia and clinicians were explored, and consensus was sought on a threshold for clinically meaningful change. Sequential mixed-methods design was employed. Participants included people with post-stroke aphasia and speech pathologists. People with aphasia were purposively sampled based on time post-stroke, age and gender, whereas speech pathologists were sampled according to their work setting (hospital or community). Each participant attended a focus group followed by a consensus workshop with a survey component. Within the focus groups, experiences and methods for measuring meaningful change during aphasia recovery were explored. Qualitative data were transcribed and analysed using reflexive thematic analysis. In the consensus workshop, participants voted on thresholds for meaningful change in core outcome constructs of language, communication, emotional well-being and quality of life, using a six-point rating scale (much worse, slightly worse, no change, slightly improved, much improved and completely recovered). Consensus was defined a priori as 70% agreement. Voting results were reported using descriptive statistics. Five people with aphasia (n = 4, > 6 months after stroke; n = 5, < 65 years; n = 3, males) and eight speech pathologists (n = 4, hospital setting; n = 4, community setting) participated in one of four focus groups (duration: 92-112 min). Four themes were identified describing meaningful change as follows: (1) different for every single person; (2) small continuous improvements; (3) measured by progress towards personally relevant goals; and (4) influenced by personal factors. 'Slightly improved' was agreed as the threshold of MIC on the anchor-rating scale (75%-92%) within 6 months of stroke, whereas after 6 months there was a trend towards supporting 'much improved' (36%-66%). Our mixed-methods research with people with aphasia and speech pathologists provides novel evidence to inform the definition of MIC in aphasia rehabilitation. Future research will aim to establish MIC values for core OMIs. This work is the result of engagement between people with lived experience of post-stroke aphasia, including people with aphasia, family members, clinicians and researchers. Engagement across the research cycle was sought to ensure that the research tasks were acceptable and easily understood by participants and that the outcomes of the study were relevant to the aphasia community. This engagement included the co-development of a plain English summary of the results. Advisors were remunerated in accordance with Health Consumers Queensland guidelines. Interview guides for clinicians were piloted by speech pathologists working in aphasia rehabilitation.

Selection of outcome measurement instruments for a core outcome set for trials aimed at improving appropriate polypharmacy in older people in primary care: a Delphi consensus study.

Despite developing a polypharmacy core outcome set (COS) in primary care, it is not clear how these outcomes should be measured. To select outcome measurement instruments (OMIs) for a COS targeting appropriate polypharmacy in older patients in primary care. Following the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, OMIs were identified from a Cochrane review focusing on appropriate polypharmacy. The quality of OMIs was assessed using a published checklist. Subsequently, two rounds of Delphi questionnaires were conducted via the SoGoSurvey® platform, engaging stakeholders (researchers, clinicians and journal editors specialising in geriatric primary care) to achieve consensus on OMIs using a scale encompassing "agree", "disagree", or "unsure". Consensus was achieved if 70% or more participants chose "agree" and 15% or fewer chose "disagree." The quality of 20 OMIs identified from the Cochrane review was evaluated. Seven OMIs were selected based on meeting the COSMIN guideline's minimum requirements. Out of 188 potential participants, 57 (30.3%) consented to participate. Rounds 1 and 2 of Delphi exercises were completed by 50 respondents, achieving agreement on three OMIs: 'number of serious adverse drug reactions (ADRs)' (98%), 'number of deaths' (76%), and 'number of patients who fell' (70%) for measuring 'serious ADRs,' 'mortality,' and 'falls,' respectively. No agreement was reached for 'medication appropriateness,' 'medication side-effects,' 'quality of life,' and 'medication regimen complexity.' OMIs were selected for a limited number of outcomes in the polypharmacy COS. Future research should identify suitable OMIs for the remaining four outcomes.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024

PurposeAlthough comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.MethodsThe development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.ResultsFrom the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts.ConclusionPRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application.NoteIn order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024

PurposeAlthough comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.MethodsThe development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.ResultsFrom the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts.ConclusionPRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application.NoteIn order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024

PurposeAlthough comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.MethodsThe development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.ResultsFrom the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts.ConclusionPRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application.NoteIn order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Comment on "PRISMA-COSMIN guidance for reporting systematic reviews of outcome measurement instruments".

Comment on "PRISMA-COSMIN guidance for reporting systematic reviews of outcome measurement instruments".

Development of a core domain set for ankle osteoarthritis: An international consensus study of patients and health professionals

ObjectivesTo develop an internationally agreed-upon core domain set for ankle osteoarthritis (OA). MethodsIn a three-part Delphi process, a group of multidisciplinary health professionals with expertise in ankle OA and people with ankle OA responded to online questionnaires. The questionnaires proposed a list of 29 candidate domains derived from a systematic review of ankle OA research, and interviews with people with ankle OA and health professionals. Consensus was defined a priori as ≥70% agreement in people with ankle OA and health professionals whether a domain should or should not be included in a core domain set. ResultsA total of 100 people (75 health professionals and 25 people with ankle OA) from 18 countries (4 continents) participated in this study. Five domains reached consensus for inclusion in a core domain set for ankle OA – pain severity, health-related quality of life, function, disability and ankle range of motion. Twenty-one candidate domains reached agreement not to be included in the core domain set, and three domains remained undecided (ankle instability, physical capacity, and mental health). ConclusionThis international consensus study, which included people with ankle OA and health professionals, has established a core domain set for ankle OA with five domains that should be measured and reported in all ankle OA trials – pain severity, health-related quality of life, function, disability and ankle range of motion. This core domain set will guide the reporting of outcomes in clinical trials on ankle OA. Future research should determine which outcome measurement instruments should be used to measure each of the core domains.

Calculation of the minimum clinically important difference (MCID) using different methodologies: case study and practical guide

IntroductionEstablishing thresholds of change that are actually meaningful for the patient in an outcome measurement instrument is paramount. This concept is called the minimum clinically important difference (MCID). We summarize available MCID calculation methods relevant to spine surgery, and outline key considerations, followed by a step-by-step working example of how MCID can be calculated, using publicly available data, to enable the readers to follow the calculations themselves.MethodsThirteen MCID calculations methods were summarized, including anchor-based methods, distribution-based methods, Reliable Change Index, 30% Reduction from Baseline, Social Comparison Approach and the Delphi method. All methods, except the latter two, were used to calculate MCID for improvement of Zurich Claudication Questionnaire (ZCQ) Symptom Severity of patients with lumbar spinal stenosis. Numeric Rating Scale for Leg Pain and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire Walking Ability domain were used as anchors.ResultsThe MCID for improvement of ZCQ Symptom Severity ranged from 0.8 to 5.1. On average, distribution-based methods yielded lower MCID values, than anchor-based methods. The percentage of patients who achieved the calculated MCID threshold ranged from 9.5% to 61.9%.ConclusionsMCID calculations are encouraged in spinal research to evaluate treatment success. Anchor-based methods, relying on scales assessing patient preferences, continue to be the “gold-standard” with receiver operating characteristic curve approach being optimal. In their absence, the minimum detectable change approach is acceptable. The provided explanation and step-by-step example of MCID calculations with statistical code and publicly available data can act as guidance in planning future MCID calculation studies.

Factors influencing use and choice of Core Outcome Sets and outcome measurement instruments in trials of interventions to prevent childhood obesity: A survey protocol

Background Two core outcome sets for childhood obesity prevention have been developed; standardised sets of outcome measurement instruments for these core outcome sets are currently being developed. Core outcome sets and standardised measurement sets can reduce heterogeneity and improve evidence syntheses for trials of interventions to prevent childhood obesity and/or interventions to improve child health behaviours related to childhood obesity. Such benefits are only realised if core outcome sets and standardised measurement sets are used in trials. The aims of this study are 1) to examine trialists’ awareness and attitudes towards the two existing core outcome sets and factors influencing their use; 2) to explore the characteristics of outcome measurement instruments that trialists currently use; and 3) to better understand how trialists choose outcome measurement instruments and the factors that influence those choices. Methods A cross-sectional online survey will be conducted with researchers involved in the design and/or conduct of trials of interventions to prevent childhood obesity and/or to improve child health behaviours related to childhood obesity, in children aged 0 to 5 years (trialists). Trialists will be recruited using purposive sampling, and will complete a 22-item survey examining trialist characteristics, awareness of the existing core outcome sets, factors influencing use of the existing core outcome sets, characteristics of measurement instruments, how trialists choose measurement instruments, and factors influencing choice of measurement instrument. Quantitative data will be analysed descriptively; responses to open-ended questions will be analysed using qualitative content analysis. Conclusions Findings from this study will inform approaches to maximising use of core outcome sets and standardised measurement sets for childhood obesity prevention. Use of standardised approaches to what and how outcomes are measured in this area will reduce heterogeneity and research waste and enhance evidence syntheses to better determine intervention effects.

The development of a Core Outcome Set for clinical trials targeting interventions aiming to improve adherence to appropriate polypharmacy in older people – A Delphi consensus study

Abstract Introduction Older people encounter challenges when taking polypharmacy. Different interventions have been applied to improve adherence to polypharmacy. However, there are few high-quality studies, and little consideration has been given to the outcomes selected to measure the effectiveness of interventions.[1] To produce high-quality studies and accurately report adherence-related outcomes, developing a Core Outcome Set (COS) is important.[2] A COS is the minimum number of outcomes that should be reported and measured in future trials in a specific health field to reduce outcomes’ inconsistencies across trials.[2] Aim This study aimed to develop a COS for use in clinical trials aiming at improving adherence to appropriate polypharmacy in older patients. Methods A list of outcomes related to adherence to polypharmacy (n=13) was compiled from previous semi-structured interviews with stakeholders. The Delphi panel consisted of experts in adherence, polypharmacy and gerontology, including journal editors, academics, non-National Health Service doctors, nurses and pharmacists who were identified by searching researchers’ publication profiles using Google Scholar and Scopus. Senior editors and editor-in-chief of peer-reviewed journals were identified by searching journal information. Public members were identified by searching for contact emails of staff members in public charities/organisations representing older people’s healthcare needs (e.g. AgeUK). Additionally, identified participants received invitation emails asking them to forward the email to other participants and experts who might be interested in this study (i.e. snowball sampling). The 13 outcomes were distributed in three online Delphi questionnaires between February and April 2023 using an online SoGoSurvey® platform. All outcomes were rated according to their degree of importance using a nine-point Likert scale (1 to 3 = unimportant; 4 to 6 = important but not critical; 7 to 9 = critical). Following each round, response rates and the distribution of scores were calculated to classify outcomes into ‘consensus in’, ‘consensus out’ and ‘no consensus’. An outcome was considered very important if ≥80% of participants scored it as ‘critical’ and ≤15% scored it as ‘unimportant’. Results The Delphi panel (Round 1, n=57; Round 2, n=53; Round 3, n=50) comprised different professionals, including 38 academics, 23 pharmacists, 12 doctors, six journal editors, three nurses and four public members, some of whom had multiple roles, e.g. doctor and academic. Participants were distributed over four continents, mostly from Europe (n=39). Both Australia and America had identical representation (n=8), while two participants represented Asia. Consensus was reached following the third round on seven outcomes, namely: medication adherence across multiple medications (100.0%), treatment burden (96.2%), health-related quality of life (96.2%), healthcare utilisation (83.0%), adverse events and side effects (83.0%), patient-carer satisfaction (82%), and cost-effectiveness (81.1%). Conclusion Seven outcomes were considered of critical importance to stakeholders. This study is the first to develop a COS for interventions targeting adherence to appropriate polypharmacy in older patients. However, most of our participants were academics and pharmacists from Europe, whilst other participant categories and continents were less well-represented. A future nominal group technique study will be conducted to discuss the results obtained from previous Delphi questionnaires, followed by selecting the appropriate outcome measurement instruments to measure these outcomes.

The Arabic psychosocial impact of assistive devices scale: Development, translation, and evaluation

ABSTRACT This paper describes the development, translation, and early evaluation of the Arabic Psychosocial Impact of Assistive Devices Scale (AR-PIADS), an outcome measure instrument for the subjective impact of Assistive Technology on a person with a disabilities’ quality of life. Developing the AR = PIADS instrument involved forward and backward translation by two independent teams of bilingual, Arabic-English speakers (n = 5) and a quality and usability review by a panel of people with disabilities (n = 18). The emergent version was evaluated with a group of experienced Arabic-speaking Assistive Technology users (n = 67) for its psychometric properties. Initial results demonstrate a favorable comparison for 16 of the 26 questionnaire items with scores recorded for the original, English language version. Internal consistency, measured using Cronbach’s alpha, yielded a range of 0.97–0.99 for AR-PIADS while the new instrument’s reliability was assessed using an intraclass correlation coefficient resulting in scores within the range of 0.86–0.97 for the overall instrument. Despite these positive results however, the translation process did highlight a number of challenges with language and cultural interpretation of the translated instrument. This suggests that further work is warranted to explore its utility in service provision.

Quality of Life Outcomes After Pediatric Otitis Media Surgery: A Systematic Review and Meta-Analysis.

Systematically review of literature characterizing health-related quality of life (HRQoL) impact of surgery in pediatric otitis media (OM) patients, and meta-analysis of studies using the OM-6 questionnaire. Pubmed, EMBASE, Cochrane Library, Scopus. A systematic review of literature of studies evaluating HRQoL outcomes for OM patients managed by surgery. Two investigators independently reviewed abstracts and full-length articles. Risk of bias was assessed using the MINORS criteria and Cochrane Risk of Bias 2 tool. The search yielded 1272 studies, 50 underwent full-text review and 23 met inclusion criteria. Non-randomized studies were of moderate to good quality, while randomized trials had a high risk of bias. Age ranged from 6 months to 15 years. Race and socioeconomic factors were inconsistently reported. There were 11 HRQoL outcome measure instruments of which four were disease-specific. Eleven studies used OM-6 and nine were included in the meta-analysis. Pooled analysis of five studies showed a mean OM-6 change of 1.79 (95% CI: 1.53-2.06; 95% PI: 0.92-2.67; I2 = 68%) 4-6 weeks after surgery; a mean change of 1.87 (95% CI: 1.15-2.58; 98%) after 6 months across two studies; and a mean change of 1.64 (1.02 to 2.27; -6.35 to 9.64; 98%) after 9-13 months across three studies. There is no consistency in HRQoL instruments used to evaluate pediatric OM surgery outcomes in current literature with few RCTs. Meta-analysis showed a clinically significant large improvement in HRQoL 4-6 weeks after tympanostomy tube placement. N/A Laryngoscope, 134:4176-4185, 2024.

Reliability and measurement error of a maximal voluntary toe plantarflexion measurement process

Despite the growing interest, information regarding the psychometric properties of maximal voluntary isometric toe plantarflexion force and rate of force development (RFD) is lacking. Hence, we investigate the test-retest reliability and measurement error of these outcome measurement instruments measured with a custom-built dynamometer. Twenty-six healthy adults participated in a crossed design with four sessions separated by 5–7 days. RFD was quantified using manual onset and calculating the impulse and the slope in the following time windows: 0–50 ms, 0–100 ms, 0–150 ms, 0–200 ms, 0–250 ms. We estimated the systematic bias of the mean, the intraclass correlation coefficient (ICC) and standard error of measurement (SEM) from the agreement and consistency models. The ICC and the SEM agreement for maximal voluntary isometric toe plantarflexion force along the perpendicular axis were respectively 0.87 (95%CI: 0.76, 0.93) and 27 N (22, 32), while along the resultant of the perpendicular and anterior posterior axis they were 0.85 (0.73, 0.92) and 29 N (23, 35). The results of the consistency model were similar as the estimated variance for session was closer to zero. A systematic bias of the mean between session 1 and 3 was found. For the RFD variables, the ICC agreement ranged from 0.35 to 0.65. The measurement process was found to be reliable to assess maximal voluntary isometric toe plantarflexion force but not RFD. However, a familiarization session is mandatory and these results need to be confirmed in less coordinated (e.g. aging population) individuals.

Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

IntroductionPeople with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum...