Evidence Of Content Validity Research Articles

Cognitive interviewing for assessing the content validity of older-person specific outcome measures for quality assessment and economic evaluation: a scoping review.

Older people (aged ≥ 65years) are significant users of health and social care systems. However, many outcome measures for quality assessment and economic evaluation lack content validation for this population. Cognitive interviews are a key approach for generating content validity evidence. This systematic scoping review aimed to synthesise evidence on cognitive interviewing practices with older adults, including those with cognitive impairment and dementia, to determine the content validity of outcome measures used with these populations in health and social care settings. A search was conducted across five databases, and results were uploaded to Covidence review management software. Two researchers performed screening and data extraction using a custom template. The initial search identified 8814 articles. After removing duplicates and conducting title and abstract screening, 105 articles remained. Full-text screening excluded 86 references, resulting in 19 included articles. Studies utilised various cognitive interviewing approaches, predominantly concurrent think-aloud combined with verbal probing. Inductive analysis based on Tourangeau's four-stage response model was commonly used for analysing verbal protocol data. Only one in four included studies indicated any allowances to alleviate cognitive burden for older participants. There was limited involvement of older people with cognitive impairment and dementia, but studies including these populations reported several modifications enhancing meaningful inclusion.

Content Validity for a 3D-Printed Model for Simulation-Based Training of Basic Epistaxis Management

Introduction Hands-on training of basic epistaxis management is often minimal during pregraduate medical training. The objective was to develop and gather structured content validity evidence for a 3D-printed model for simulation-based training and assessment of technical skills in basic epistaxis management. Methods A simulator for epistaxis management training was built based on publicly available 3D-print files with addition of tubing to mimic anterior bleeding. Ten otorhinolaryngologists evaluated the model after performing nasal cavity inspection and insertion and insufflation of a nasal tamponade device. Content validity evidence was collected following Messick's framework. Results Two content experts contributed to define features in the iterative building process. In the structured evaluation of the model, experienced clinicians found the appearance of the outer nose and the resistance when insufflating a nasal tamponade device into the nasal cavity satisfying (mean score of 3.9 and 4.7 out of 5, respectively), whereas the nasal cavity was found to be a bit too spacious compared with typical real-life conditions. Conclusions A 3D-printed simulator for simulation-based training of basic epistaxis management was successfully built. Content validity was gathered, and overall, content experts found the model to adequately represent the technical skills challenges for training novices such as medical students and junior doctors.

Development and Validation of the Decisions to use Opioids Measure

BackgroundMillions experience inadequately managed acute pain each year. Opioids are an important tool for managing pain; however, recent reductions in opioid prescriptions have exacerbated preexisting challenges in pain management. Moreover, patient expectations and desires for pain management may drive additional opioid use. There is an important need to characterize patient motivations for using opioids in order to develop promising interventions. The aim of this study was to develop the Decisions To use Opioids (DTO) measure. MethodsWe used an exploratory sequential mixed methods design to create items for the DTO measure. Qualitative data from patient interviews and focus groups informed the development of items for the DTO. We evaluated the content validity of candidate items with nine experts using the content validity index (CVI) and conceptual significance. Face validity was assessed via cognitive interviews with five emergency department (ED) participants who experienced acute pain. ResultsWe generated an initial pool of 52 items. Expert ratings provided evidence of content validity on 40 items, as indicated by an item CVI score of 0.83 or higher. Nine items with CVI scores of <0.83 were retained and revised due to the conceptual significance. The remaining three items were discarded. ConclusionsThis study provided evidence of content and face validity of the DTO measure for ED patients. Further psychometric evaluation is needed to gather data regarding the DTO's internal consistency, construct validity, and criterion validity.

Measurement properties of patient-reported outcome measures for women with dysmenorrhea: A systematic review.

Dysmenorrhea, or menstrual pain, is a subjective experience, and can only be assessed by patient-reported outcomes. These instruments should be reliable, valid and responsive. To identify and critically appraise the available evidence for the measurement properties of specific patient-reported outcome measures used for dysmenorrhea. The PRISMA statement was used to report this systematic review. Databases searched were PubMed, SCOPUS, CINAHL, Web of Science, ScienceDirect and Google Scholar (April 2021; updated on February 2023). Original studies with primary data collection, with no restriction on language and publication date that reported psychometric properties of one or more dysmenorrhea-related patient-reported outcome measure. The literature searches, selection of studies, data extraction and assessment of the risk of bias were performed independently by two reviewers and followed the COSMIN guidelines. Thirty studies were analysed in this review, and 19 patient-reported outcome measures were evaluated. The instruments varied in relation to the measured construct and measurement properties (validity, reliability and responsiveness). The methodological quality of the studies and the quality of evidence of the patient-reported outcome measures were variable. Among the 13 studies that reported the development of patient-reported outcome measures, most had inadequate methodological quality, and the overall rating was insufficient or inconsistent. The Dysmenorrhea Symptom Interference (DSI) scale was the only identified patient-reported outcome measure that has the potential to be recommended because of its sufficient rating combined with moderate quality of evidence for content validity. Future studies should further evaluate the measurement properties of the existing patient-reported outcome measures, or develop new patient-reported outcome measures following the COSMIN methodology. Not applicable as this is a systematic review. PROSPERO protocol: CRD42021244410. Registration on April 22, 2021.

Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS).

Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome(PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS. The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719). Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items). The 9-item HEIS is the first CHE-specific PROmeasure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes. NCT03683719.

Development and evaluation of a questionnaire to capture environmental and occupational inhalational exposures in adults with fibrotic interstitial lung disease

BackgroundIdentification of exposures in patients with interstitial lung diseases (ILDs) is essential for diagnosis and management and can be facilitated through the use of exposure questionnaires. However, for most ILDs, a patient-focused questionnaire is lacking. Cognitive interviewing is a methodology used to evaluate sources of understanding and misunderstanding in a questionnaire and to provide evidence of content validity. We developed and refined a new exposure questionnaire for patients with fibrotic ILDs by using cognitive interviewing to establish its understandability and content validity.MethodsAn exposure assessment questionnaire was developed by a multidisciplinary team. Cognitive interviews with 24 patients with fibrosing ILDs were conducted by trained interviewers over the phone or Zoom using a semi-structured interview guide. The questionnaire was amended based on the interviewers’ interpretation of sources of misunderstanding. The revised questionnaire was tested in a second round of cognitive interviews with a different group of 24 patients.ResultsAmong the 48 patients who completed interviews, mean age was 61 years, 58.3% were male and 75.0% were white. Based on the first round of cognitive interviews, the multidisciplinary team modified the questions, organization, and instructions of the questionnaire to facilitate recall, adjust for exposures that were frequently misunderstood or required clarification, and focus on clinically relevant exposures. The revised questionnaire performed well in the second round of interviews.ConclusionAn exposure questionnaire, developed with input from patients, can be used to assess clinically relevant exposures in adults with fibrosing ILDs. This is the first questionnaire for all types of fibrosing ILD to have undergone content validation.

Virtual simulation for teaching cardiology in nursing: a scoping review protocol

IntroductionVirtual simulation (VS) can be an effective learning strategy in the context of nursing education on cardiovascular disease; however, its use in teaching cardiology in nursing is less studied. The...

Development and Validation of a Game for Older Adults on Lifestyles and Frailty.

Games are a promising strategy for rehabilitating older adults. The effect of games on promoting healthy lifestyles and preventing frailty remains uncertain. This article aims to describe the process of development and validation of the game "Bem-me-quer para a saúde"® to promote the acquisition of healthy lifestyles and prevent frailty in over 65-year-olds. This study comprised three distinct phases, spanning from December 2023 to June 2024. The first phase comprised a thorough review of the scientific literature on the frailty and lifestyles of older adults, a second phase of game design, and a third phase of content and semantic validation conducted by specialized nurses and older adults. After revising literature, this study utilized an e-Delphi with a panel of 14 specialist nurses who underwent two rounds of evaluation. The "Bem-me-quer para a saúde"® game includes a puzzle board with 54 pieces and 30 educational cards. In the final phase, we evaluated the game on a cohort of 50 older adults, highlighting its reflective, interactive, and educational aspects. The game presented sufficient evidence of content validity and relevance to clinical practice. We should conduct additional research to evaluate its impact on lifestyle modification and frailty prevention.

Thirst Distress Scale for Patients With Heart Failure: Cross-Cultural Adaptation and Preliminary Psychometric Assessment in Brazil.

Background and Purpose: Thirst-related distress in individuals with heart failure (HF) is associated with exacerbated symptoms. This study aimed to culturally adapt the Thirst Distress Scale for Patients with Heart Failure (TDS-HF) for Brazil and assess the content validity of the adapted version. Methods: The TDS-HF was translated, back-translated, and evaluated for linguistic equivalence, clarity, relevance, and pertinence by seven professional experts. The adapted TDS-HF was administered to 40 patients with HF, who provided feedback on its understandability. Results: The adaptation achieved satisfactory evidence of linguistic equivalence and content validity, with a total content validity coefficient of 0.95. The patients understood the translated version effectively. Conclusion: The Brazilian TDS-HF maintains linguistic equivalence to the original version and demonstrates satisfactory evidence of content validity. Further psychometric testing is deemed necessary for implementation.

Design and Validation of the Scientific-Research Skills Questionnaire for Basic Education Teachers

One teacher skill that has allowed for progress and development in pedagogy is that of scientific research, but there is very little attention to its measurement in basic education. The aim of the study was to design and validate a questionnaire of teachers' scientific-research skills and to compare them according to socio-demographic variables. The design was psychometric and descriptive-comparative with the participation of 736 Peruvian teachers. The results indicate that the instrument has evidence of content validity with a concordance &gt; 0.7 among the 9 judges. The exploratory factor analysis (EFA) exposed 25 items and 3 dimensions that explained 81.1% of the total variance (KMO &gt; 0.7, Bartlett &lt; 0.05) and was confirmed by adequate fit indices (X2/df = 4.648, p &lt; 0.001, SRMR=0.036, RMSEA=0.099, TLI, CFI and GFI &gt;0.95). The values obtained for convergent validity (AVE &gt; 0.5), discriminant validity (√AVE &gt; r) and internal consistency (αordinal and ωordinal &gt; 0.7) exceeded the minimum expected values. In addition, it was found that there are moderate and significant differences in the skills of problematisation and research theorisation, research contrastation and scientific communication according to teaching levels in favour of secondary school teachers and in academic training with higher scores in teachers with a doctorate degree (p &lt; 0.05; ɛ̂ &gt; 0.25). In conclusion, the questionnaire has adequate evidence of validity and reliability, and there are differences in teachers' abilities according to teaching and training levels.

Adaptation of the Cognitive Screening Test (Triagem Cognitiva – TRIACOG) for computer-mediated assessments: TRIACOG-Online

This study aims to present the adaptation, evidence of content validity and results of a pilot study of the Cognitive Screening Test - Online (TRIACOG-Online) in a clinical sample of patients after stroke. The process comprised four stages: 1) Adaptation of the instructions, stimulus and responses; 2) Seven experts analyzed the equivalence between the previous printed version and the online version; 3) A pilot study was carried out with seven adults who had experienced a stroke in order to check the comprehension and feasibility of the items; and 4) The development of the final version of TRIACOG-Online. Expert validity testing of the questionnaire yielded a content validity index (CVI) of 100% for correspondence and construct in 13 items, and a CVI of 87.71% in four items. In the pilot study, problems related to the internet led to the decision to use a single section form. No difficulties were observed in carrying out the tasks and understanding the instructions. Participants reported being able to adequately visualize the stimuli and remain motivated to complete the tasks presented. It was shown that TRIACOG-Online evaluated the same constructs as the pencil-and-paper version, can be used in remote neuropsychological assessments and face-to-face settings.

Patient-reported outcome measures for medication treatment satisfaction: a systematic review of measure development and measurement properties

BackgroundMedication Treatment Satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs) for M-TS are valid, reliable, responsive, and interpretable remains unclear. To assess the measurement properties of existing PROMs for M-TS and to highlight research gaps.MethodsUsing PubMed, Embase (Ovid), Cochrane library (Ovid), IPA (Ovid), PsycINFO, Patient-Reported Outcome and Quality of Life Questionnaires biomedical databases, and four Chinese databases, we performed a systematic search for studies addressing the development and validation of PROMs for M-TS. Based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, pairs of reviewers independently assessed the measurement properties of the PROMs and rated the quality of evidence on the measurement properties of each PROM. (The Open Science Framework registration: https://doi.org/10.17605/OSF.IO/8S5ZM).ResultsThis review identified 69 PROMs for M-TS in 114 studies (four generic, 32 disease-specific, and 33 drug-specific) of which 60 were intended for adults. All provided limited or no information regarding interpretability. Most demonstrated appropriate construct validity including convergent validity (39/69) and discriminative or known-groups validity (40/69) (high to moderate quality of evidence). Only a few provided evidence of sufficient content validity (8/69), structural validity (13/69), and internal consistency (11/69). Of 38 PROMs reporting test–retest reliability, results in 24 provided evidence of satisfactory test–retest reliability (18 with high to moderate, 6 with low to very low quality of evidence). Few PROMs reported responsiveness (16/69). Two generic PROMs (Treatment Satisfaction Questionnaire for Medication initial Version 1.4, TSQM-1.4; Treatment Satisfaction with Medicines Questionnaire, SATMED-Q) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory validity and reliability.ConclusionsMost existing PROMs for M-TS require further exploration of measurement properties. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.

Escala de Invalidación Emocional Percibida (PIES): Análisis psicométrico de la primera versión en español en adultos peruanos

Perceived emotion invalidation is a construct that is currently relevant due to its implications on mental health domains. The aim of this study was to linguistically adapt and to analyze the psychometric properties of the first Spanish-version of the Perceived Invalidation of Emotion Scale (PIES). This test was translated and reviewed by 10 experts to guarantee evidence of content validity. Confirmatory factor analysis verified the original two-dimensional proposal of the model. The study involved 411 adults (77.6% women, 22.4% men) with a mean age of 25.52 years (SD=6.64). Evidence of convergent and concurrent validity were found by associating scores with theoretically related constructs. In addition, the scores for both dimensions showed adequate levels of internal consistency. It is concluded that PIES complies with current psychometric standards and can be used in Peruvian samples similar to the one in this study.

Development and validation of the theatre team tool (TTT): A clinical debriefing tool for multidisciplinary theatre teams

Clinical debriefing (CD) after unanticipated clinical events benefits staff, teams, patients and systems. Use of a structured tool may help overcome barriers to implementation, however, there is not presently a validated CD tool for theatre teams. We aimed to design and validate a CD tool for multidisciplinary theatre teams.The initial stages of development involved prototype design using underlying theory and literature, including review of pre-existing CD tools. Content validity evidence was sought from subject matter experts to calculate Item- and Scale-Content Validity Indices (I-CVI; S-CVI) of the tool. Face validity evidence was sought from wider theatre team members to evaluate clarity, relevance, difficulty and sensitivity of the tool. The final stage of development involved integration of these findings to deliver the final version of the CD tool, which was named the “Theatre Team Tool”: “TTT” or “Triple T” as a shorthand.The tool contains simple instructions on how to conduct a CD. A novel design aspect is that it gives options to debrief with either intention to ‘learn’ or ‘manage’ according to the required impact. All sections of the tool achieved an I-CVI greater than the recommended cut-off value. The S-CVI for the full tool was within the acceptable range. The tool scored highly on all face validity measurements.This is the first validated CD tool designed specifically for use by multidisciplinary theatre teams which enables the debriefing to be flexibly tailored to the required intention. Future work should focus on maximizing successful implementation. Making the TTT widely available to facilitate CD could have significant benefits for theatre teams and their patients.

Validation of Autism Stigma Knowledge – Questionnaire (ASK-Q) for Brazilian Portuguese

BackgroundLow levels of knowledge among health professionals about autism spectrum disorders (ASD) can impair the care provided to people with autism. In Brazil, there are still no validated instruments that assess the knowledge of pharmacy students and pharmacists regarding ASD. ObjectiveThis study aimed to carry out the cross-cultural adaptation of the Autism Stigma Knowledge Questionnaire (ASK-Q) into Brazilian Portuguese and to evaluate the evidence of content validity. MethodsThis study was conducted in two stages, as recommended in the literature. Stage 1 corresponded to cross-cultural adaptation carried out in six phases (translation of the ASK-Q, synthesis of the translations, evaluation by a committee of experts, evaluation by the target audience of pharmacy students and pharmacists, reverse translation, and evaluation by the author of the original instrument). Step 2 corresponds to the assessment of content validity evidence. ResultsThe instrument presented semantic, idiomatic, conceptual, and cultural equivalences, and the author considered the adaptation adequate. Content validity had an adequate coefficient (0.89). The ASK-Q was cross-culturally adapted to the Brazilian context according to the main theoretical framework. ConclusionsFuture studies will be conducted to evaluate other evidence for the validity of the ASK-Q-Brasil. These studies will be fundamental in assessing knowledge about ASD.

Development and Content Validation of a Nursing Clinical Simulation Scenario on Transfusion Reaction Management.

Blood transfusion is a life-saving procedure widely used in healthcare. However, complications such as transfusion reactions may occur. Knowledge of these reactions is essential for patient safety. Nurses play a crucial role in this process by identifying complications and adverse reactions early on. A lack of professional competence in blood transfusion can lead to errors and serious complications, such as death. The aim of this study was to present evidence of the content validity of a simulated clinical scenario on transfusion reactions for teaching and learning for nursing students. This methodological study was carried out in three phases: (1) development of the simulated scenario of a transfusion reaction; (2) analysis of evidence of content validity by experts (n = 11); and (3) determination of satisfaction and self-confidence in the use of the simulated scenario by the nursing students (n = 45). The Content Validity Index was 94%. After the scenario had been developed, the content was validated and approved by 100% of the experts. All the items in the simulated scenario obtained agreement scores above 0.90. The simulated scenario was validated in terms of content and can be used to teach the management of transfusion reactions.

Development and content validity of educational videos on self-management of fluid restriction and thirst for individuals with heart failure.

To create and evaluate the content validity of educational videos on self-management of fluid restriction and thirst for individuals with heart failure (HF). A psychometric study was conducted in three stages: (1) an integrative literature review to identify strategies for self-management of fluid restriction and thirst by individuals with HF; (2) creation of animated videos about strategies for self-management of fluid restriction and thirst; and (3) analysis of the content validity of the educational videos by 11 experts. For each criterion, the content validity ratio (CVR) was calculated; it was considered adequate when <0.636. Suggestions were evaluated by the researchers, and the videos were modified. Ten scripts and videos were created, averaging 30s each. The videos' contents were based on 11 studies retrieved from the review and one specialized website. The videos were evaluated by experts, and adjustments were made when CVR<0.636 and when allowed by the video production platform. Educational videos were developed and have satisfactory content validity evidence according to expert opinions. These videos are expected to be used as educational strategies in clinical practice to prevent episodes of decompensation due to excessive fluid volume.

Initial Validity Evidence for the American Board of Emergency Medicine Emergency Medical Services Certification Examination

Objectives The American Board of Emergency Medicine (ABEM) Emergency Medical Services Medicine (EMS) subspecialty was approved by the American Board of Medical Specialties on September 23, 2010. Subspecialty certification in EMS was contingent on two key elements—completing Accreditation Council for Graduate Medical Education (ACGME)-accredited EMS training and passing the subspecialty certification examination developed by ABEM. The first EMS certification examination was offered in October 2013. Meaningful certification requires rigorous assessment. In this instance, the EMS certification examination sought to embrace the tenets of validity, reliability, and fairness. For the purposes of this report, the sources of validity evidence were anchored on the EMS core content, the examination development process, and the association between fellowship training and passing the certification examination. Methods We chose to use validity evidence that included: 1) content validity (based on the EMS core content); 2) response processes (test items required intended cognitive processes); 3) internal structure supported by the internal relationships among items; 4) relations to other variables, specifically the association between examination performance and ACGME-accredited fellowship training; and 5) the consequences of testing. Results There is strong content validity evidence for the EMS examination based on the core content and its detailed development process. The core content and supporting job-task analysis was also used to define the examination blueprint. Internal structure support was evidenced by Cronbach’s coefficient alpha, which ranged from 0.82 to 0.92. Physicians who completed ACGME-accredited EMS fellowship training were more likely to pass the EMS certification examination (chi square, p < 0.0001; Cramér’s, V = 0.24). Finally, there were two sources of consequential validity evidence—use of test results to determine certification and use of the resulting certificate. Conclusions There is substantial and varied validity evidence to support the use of the EMS certifying examination in making summative decisions to award certification in EMS. Of note, there was a statistically significant association between ACGME-accredited fellowship training and passing the examination.

Dysphagia Screening in Brazilian Older Adults with Dementia: Content Development and Validation of a Questionnaire for Caregivers - RaDID-QC.

This study aims to develop and validate the content and response processes of a questionnaire intended for caregivers to screen for dysphagia in Brazilian older adults with dementia due to Alzheimer's disease and/or vascular dementia. The instrument items were developed in Brazilian Portuguese language based on the theoretical framework. A committee of speech-language-hearing therapists analyzed the relevance, objectivity, clarity, and understandability of the items with the Delphi method. The content validity index cutoff agreement score for experts' answers to validate each item in the questionnaire was 0.78; in the intraclass correlation coefficient, it was 0.75 for all items. For response process validity evidence, the questionnaire was applied to 30 caregivers of older adults with dementia, who judged the clarity and understandability of the items. Each item was validated when understood by at least 95% of participants. The first version of the instrument had 29 items. After two expert assessments, the last version had 24 items. The intraclass correlation coefficient was 0.85. Only one item needed semantic adjustments in the pre-test. The dysphagia screening instrument applied to caregivers of older adults with dementia was developed with adequate content and response process validity evidence, enabling adjustments in its construct. Future studies will analyze the remaining evidence of validity and reliability.

Validity of Cardiopulmonary Exercise Testing for Assessing Aerobic Capacity in Neuromuscular Diseases

ObjectivesTo determine the content validity of cardiopulmonary exercise testing (CPET) for assessing peak oxygen uptake (VO2peak) in neuromuscular diseases (NMD). DesignBaseline assessment of a randomized controlled trial. SettingAcademic hospital. ParticipantsEighty-six adults (age: 58.0±13.9 y) with Charcot-Marie-Tooth disease (n=35), postpolio syndrome (n=26), or other NMD (n=25). InterventionNot applicable. Main Outcome MeasuresWorkload, gas exchange variables, heart rate, and ratings of perceived exertion were measured during CPET on a cycle ergometer, supervised by an experienced trained assessor. Muscle strength of the knee extensors was assessed isometrically with a fixed dynamometer. Criteria for confirming maximal cardiorespiratory effort during CPET were established during 3 consensus meetings of an expert group. The percentage of participants meeting these criteria was assessed to quantify content validity. ResultsThe following criteria were established for maximal cardiorespiratory effort: a plateau in oxygen uptake (VO2plateau) as the primary criterion, or 2 of 3 secondary criteria: (1) peak respiratory exchange ratio (RERpeak) ≥1.10 (2), peak heart rate ≥85% of predicted maximal heart rate; and (3) peak rating of perceived exertion (RPEpeak) ≥17 on the 6-20 Borg scale. These criteria were attained by 71 participants (83%). VO2plateau, RERpeak ≥1.10, peak heart rate ≥85%, and RPEpeak ≥17 were attained by 31%, 73%, 69%, and 72% of the participants, respectively. Peak workload, VO2peak, and knee extension muscle strength were significantly higher, and body mass index was lower (all P<.05), in participants with maximal cardiorespiratory effort than other participants. ConclusionsMost people with NMD achieved maximal cardiorespiratory effort during CPET. This study provides high quality evidence of sufficient content validity of VO2peak as a maximal aerobic capacity measure. Content validity may be lower in more severely affected people with lower physical fitness.