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Background: The mobile device diffusion has increasingly highlighted the opportunity to collect patient-reported outcomes (PROs) through electronic patient-reported outcomes measurements (ePROMs) during the clinical routine. Despite the ePROMs promises and advantages, the equivalence when a PRO measure is moved from the original paper-and-pencil to the electronic version is still little investigated. This study aims at evaluating equivalence between PROMs and ePROMs self-administration in people with multiple sclerosis (PwMS); in addition, preference of self-administration type was evaluated. Methods: The Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) were selected for the equivalence test. The app ABOUTCOME was developed through a user-centered design approach to administer the questionnaires on tablet. Both paper-and-pencil and electronic versions were randomly self-administered. Intrarater reliability between both versions was evaluated through the intraclass correlation coefficient (ICC, excellent for values ≥ 0.75). Results: Fifty PwMS (35 females) participated to the study (mean age: 54.7±11.0 years, disease course: 27 relapsing-remitting and 23 progressive; mean EDSS: 4.7±1.9; mean disease duration: 13.3±9.5 years). No statistically significant differences were found for the means total scores of MAM-36 (p = 0.61) and FSS (p = 0.78). The ICC value for MAM-36 and FSS was excellent (0.98 and 0.94, respectively). Most of participants preferred the tablet version (84%). Conclusion: The results of the study provide evidence about the equivalence between the paper-and-pencil and electronic versions of PROs administration. In addition, PwMS prefer electronic methods rather than paper because the information can be provided more efficiently and accurately. The results could be easily extended to other MS PROs. [ABSTRACT FROM AUTHOR]

Background: The Inventory of Physical Activity Barriers (IPAB) assesses physical activity participation barriers. Development, refinement, and psychometric evaluation of the IPAB occurred via an electronic format. However, various circumstances may require using a pen-and-paper format. As instrument formats are not always interchangeable, the authors aimed to establish whether 2 different formats (electronic and pen and paper) can be used interchangeably for the IPAB. Methods: This randomized crossover study included 66 community-dwelling adults aged 50 years and older (mean age = 73 [SD = 7.6]). Half the sample completed the electronic format of the IPAB first and the pen-and-paper format second, and the other half completed them in reverse order. Tests of equivalence and a Bland–Altman plot were performed. Results: The intraclass correlation coefficient between formats was.94, and kappa was.68. The mean difference between the 2 administration forms of the IPAB was 0.002 (P =.96). Both administration formats had high internal consistency (Cronbach alpha =.92 and.93) and illustrated construct validity (P ≤.001 for both administration formats). Conclusion: Pen-and-paper and electronic formats of the IPAB are equivalent and, thus, can be used interchangeably among non-Hispanic whites who are highly educated. The format should be used consistently if completing preintervention and postintervention evaluations or comparing scores. [ABSTRACT FROM AUTHOR]

Pen-on-paper pain drawing are an easily administered self-reported measure that enables patients to report the spatial distribution of their pain. The digitalization of pain drawings has facilitated the extraction of quantitative metrics, such as pain extent and location. This study aimed to assess the reliability of pen-on-paper pain drawing analysis conducted by an automated pain-spot recognition algorithm using various scanning procedures. One hundred pain drawings, completed by patients experiencing somatic pain, were repeatedly scanned using diverse technologies and devices. Seven datasets were created, enabling reliability assessments including inter-device, inter-scanner, inter-mobile, inter-software, intra- and inter-operator. Subsequently, the automated pain-spot recognition algorithm estimated pain extent and location values for each digitized pain drawing. The relative reliability of pain extent analysis was determined using the intraclass correlation coefficient, while absolute reliability was evaluated through the standard error of measurement and minimum detectable change. The reliability of pain location analysis was computed using the Jaccard similarity index. The reliability analysis of pain extent consistently yielded intraclass correlation coefficient values above 0.90 for all scanning procedures, with standard error of measurement ranging from 0.03% to 0.13% and minimum detectable change from 0.08% to 0.38%. The mean Jaccard index scores across all dataset comparisons exceeded 0.90. The analysis of pen-on-paper pain drawings demonstrated excellent reliability, suggesting that the automated pain-spot recognition algorithm is unaffected by scanning procedures. These findings support the algorithm's applicability in both research and clinical practice. [ABSTRACT FROM AUTHOR]

Background and Aims: Accurate assessment of patient‐reported oropharyngeal dysphagia (OPD) is essential to guide appropriate management and evaluate response. The Sydney Swallow Questionnaire (SSQ) is a paper‐based 17‐item inventory developed and validated to objectively detect risk of OPD. An easy‐to‐use electronic version with digital output has significant potential in streamlining patient assessment. This study aims to develop and validate an electronic version of the SSQ (eSSQ) against the original paper version. Method: The English‐based paper SSQ was adapted on the online REDcap (Research Electronic Data Capture) platform to be accessible on computer and mobile devices. Patients with OPD and asymptomatic controls completed both electronic and paper versions in randomized order. Patients with stable symptoms then repeated the eSSQ after ≥14 days for test–retest reliability. Paper‐based and eSSQs were also collected from an independent cohort for external validation. Agreement of total scores between both versions and eSSQ test–retest reliability were calculated using two‐way mixed‐effects intra‐class correlation coefficient (ICC). Results: 47 dysphagic patients, 32 controls, and 31 patients from an external validation cohort were recruited. The most common underlying etiology was head and neck cancer. Mean eSSQ total score was 789 in dysphagic patients, and 68 in controls. eSSQ had excellent agreement with paper SSQ in total scores among all participants, with ICC 0.97 (95% CI [0.93, 0.98]) in controls, 0.97 (95% CI [0.94, 0.98]) in dysphagic patients and 0.96 (95% CI [0.92, 0.98]) in validation cohort. Test–retest reliability was also excellent (ICC 0.96, 95% CI [0.90, 0.98]). Conclusion: The newly developed eSSQ shows excellent agreement with the paper version and test–retest reliability. Future applications of its use may allow for more efficient and accessible patient assessment. [ABSTRACT FROM AUTHOR]

Background and Purpose: Patient-Reported Measured Outcomes (PROMs) are essential to gain a full understanding of a patient's condition, and in spine surgery, these questionnaires are of help when tailoring a surgical strategy. Electronic registries allow for a systematic collection and storage of PROMs, making them readily available for clinical and research purposes. This study aimed to investigate the reliability between the electronic and paper form of ODI (Oswestry Disability Index), SF-36 (Short Form Health Survey 36) and COMI-back (Core Outcome Measures Index for the back) questionnaires. Methods: A prospective analysis was performed of ODI, SF-36 and COMI-back questionnaires collected in paper and electronic format in two patients' groups: Pre-Operatively (PO) or at follow-up (FU). All patients, in both groups, completed the three questionnaires in paper and electronic form. The correlation between both methods was assessed with the Intraclass Correlation Coefficients (ICC). Results: The data from 100 non-consecutive, volunteer patients with a mean age of 55.6 ± 15.0 years were analysed. For all of the three PROMs, the reliability between paper and electronic questionnaires results was excellent (ICC: ODI = 0.96; COMI = 0.98; SF36-MCS = 0.98; SF36-PCS = 0.98. For all p < 0.001). Conclusions: This study proved an excellent reliability between the electronic and paper versions of ODI, SF-36 and COMI-back questionnaires collected using a spine registry. This validation paves the way for stronger widespread use of electronic PROMs. They offer numerous advantages in terms of accessibility, storage, and data analysis compared to paper questionnaires. [ABSTRACT FROM AUTHOR]

Background: Harmful Alcohol use is frequent among opioid dependents patients undergoing agonist maintenance treatment. The objective assessment of harmful alcohol use can be done using laboratory measures of serum biomarkers. For community-based patients, there is often a requirement of an alternative method due to lack of onsite laboratory services. The aim of the study was to examine filter paper as a matrix to measure serum biomarkers of harmful alcohol use. Methods: The initial phase involved standardization of the filter-paper-based assay. Conditions were optimised for extraction and estimation of alcohol biomarkers (Aspartate Aminotransferase; AST, Alanine Aminotransferase; ALT, Gamma Glutamyl transferase; GGT and Carbohydrate Deficient Transferrin; CDT) from the filter paper. For clinical validation, serum samples were collected from community clinics. Biomarker levels obtained from both the methods were correlated using linear regression analysis. Limits of agreement between the two methods was estimated using the Intraclass Correlation Coefficient (ICC). Results: The extraction of enzymes (AST, ALT and GGT) from filter paper was carried out using the substrate buffer available with the reagent kit (Randox, UK). CDT was readily extracted from filter paper using deionised water. Serum biomarker levels measured from samples collected from community clinics correlated well with filter paper extracted levels (ICC 0.97-0.99). More than 90% of alcohol biomarker levels were recovered from the filter paper matrix using this method. Conclusion: Filter paper has the potential to be used as a matrix to objectively measure alcohol biomarkers among opioid-dependent patients from community settings lacking onsite laboratory facilities. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to determine the validity and reliability of the electronic Compassion Competence Scale (e-CCS). Methods: A cross-sectional, randomized, two-period crossover design was used. Nursing students from four South Korean universities were surveyed between June 2017 and April 2018. The participants were randomly assigned to one of three groups-paper/paper, electronic/electronic, and paper/electronic or electronic/paper-and a test-retest procedure was implemented. The reliability and validity of the e-CCS were evaluated using linear weighted kappa coefficients and intraclass correlation coefficients (ICCs). Internal consistency reliability was verified using linear weighted kappa coefficients and ICCs. Pearson's correlation coefficients between the initial test and retest scores were all statistically significant. Results: The newly developed e-CCS was found to have good reliability and validity. We suggest that future research should increase sample heterogeneity by recruiting diverse age groups, nurses working in different nursing fields, and students from multiple colleges. Conclusion: This electronic instrument will help determine the differences in the level of compassion competence and devise interventions to improve compassion competence in nurses and nursing students. Further studies on enhancing compassion competence among nurses and nursing students may rely on the use of this electronic format. [ABSTRACT FROM AUTHOR]

Background: Several cross-sectional studies have investigated the incidence of urinary Congo-red dye positivity in women with preeclampsia (PE), compared to unaffected pregnancies, and reported very high sensitivity and low false positive rate in the diagnosis of PE. Objective: To determine the performance of the urinary Congo-red dot paper test at 35–37 weeks’ gestation in the prediction of delivery with PE at ≤2 and >2 weeks after assessment. Methods: This was a prospective observational study in women attending for a routine hospital visit at 35+0 to 36+6 weeks’ gestation in a maternity hospital in England. Urine samples were collected and the Congo-red dot paper test was used to assess the degree of Congo-red dye positivity. The test uses a scoring system from 1 to 8 and the higher the score the greater the degree of Congo-red dye positivity. We examined and compared the degree of Congo-red dye positivity in the groups that delivered with PE at ≤2 and >2 weeks with those that remained normotensive. Reproducibility was assessed by examining the inter- and intra-observer reliability of scoring on stored images with the researchers blinded to previous results. Results: The study population of 2140 women included 46 (2.1%) that subsequently developed PE (2.1%). The urinary Congo-red dot test was positive in 8.3% (1/12) and 2.9% (1/34) that delivered with PE at ≤2 and >2 weeks from assessment and in 0.2% (4/2094) of the unaffected pregnancies when the cutoff for Congo-red dye positivity was ≥5. The respective values when the cutoff used was ≥3 were 66.7%, 23.5%, and 16.5%, respectively. The intraclass correlation coefficient for the inter-observer reliability was 0.926 (95% CI 0.890–0.953, p<.0001) and Cohen's kappa coefficient for the intra-observer reliability was 0.904, p<.0001. Conclusions: The performance of the urinary Congo-red dot paper test at 35–37 weeks’ gestation in the prediction of PE is very poor. [ABSTRACT FROM AUTHOR]

Background: The Integrated Palliative Care Outcome Scale (IPOS) validly and reliably measures symptoms and concerns of those receiving palliative care. Aim: To determine the equivalence of the paper version with an electronic version of the IPOS (eIPOS). Design: Multicentre randomised crossover trial (NCT03879668) with a within-subject comparison of the two modes (washout period 30 min). Setting/Participants: Convenience sample of specialist inpatient and palliative home care patients aged over 18 years with cancer and non-cancer conditions was recruited. Scores were compared using intraclass correlation coefficients (ICC), Bland-Altman plots and via a mixed-effects analysis of variance. Results: Fifty patients were randomised to complete paper-electronic (n = 24) and electronic-paper (n = 26) IPOS with median age 69 years (range 24–95), 56% male, 16% non-cancer. The ICCs showed very high concordance for the total score (ICC 0.99, 95% CI 0.98–1.00), lowest ICCs being observed for symptoms 'Appetite loss' and 'Drowsiness' (ICC 0.95, 95% CI 0.92–0.97). Nine of seventeen items had ICCs above 0.98, as did all subscales. No statistically significant mode, order, age, and interaction effects were observed for IPOS total score and subscales, except for 'Communication' (Fmode = 5.9, p = 0.019). Fifty-eight percent preferred the electronic version. In the group 75+ years, 53% preferred the paper version. Only three entries in the free-text main problems differed between the versions. Conclusion: The very high equivalence in scores and free text between the IPOS and the eIPOS demonstrates that eIPOS is feasible and reliable in an older palliative population. [ABSTRACT FROM AUTHOR]

Peer review is a key gatekeeper for academic journals, attempting to block inadequate submissions or correcting them to a publishable standard, as well as improving those that are already satisfactory. The three key aspects of research quality are rigour, significance, and originality but no prior study has assessed whether journal reviewers are ever able to judge these effectively. In response, this article compares reviewer scores for these aspects for theoretical articles in the SciPost Physics journal. It also compares them with Italian research assessment exercise physics reviewer agreement scores. SciPost Physics theoretical articles give a nearly ideal case: a theoretical aspect of a mature science, for which suitable reviewers might comprehend the entire paper. Nevertheless, intraclass correlations between the first two reviewers for the three core quality scores were similar and moderate, 0.36 (originality), 0.39 (significance), and 0.40 (rigour), so there is no aspect that different reviewers are consistent about. Differences tended to be small, with 86% of scores agreeing or differing by 1 on a 6-point scale. Individual reviewers were most likely to give similar scores for significance and originality (Spearman 0.63), and least likely to for originality and validity (Spearman 0.38). Whilst a lack of norm referencing is probably the biggest reason for differences between reviewers, others include differing background knowledge, understanding, and beliefs about valid assumptions. The moderate agreement between reviewers on the core aspects of scientific quality, including rigour, in a nearly ideal case is concerning for the security of the wider academic record. [ABSTRACT FROM AUTHOR]

Background: Sport-related concussion is a public concern with between 1.6 and 3.8 million sport- and recreationrelated injuries occurring annually. An estimated 65% to 90% of concussed athletes show oculomotor disruption such as difficulty with saccades, accommodation, smooth pursuit, and fixation. A rapid number-naming saccade test, the King-Devick (K-D) test, has shown promising results as part of a multifaceted concussion assessment tool. Purpose: The purpose of the current study was to evaluate the two versions of the K-D in collegiate aged (18-24) athletes to determine the agreement between versions. A secondary purpose was to investigate the association of K-D scores with sport, sex, use of glasses or contacts, and age of the athlete. Study design: Descriptive laboratory study. Methods: Division 1 NCAA collegiate athletes across ten sports were recruited to participate in baseline concussion assessments at the beginning of their respective athletic season. Correlations and multivariable logistic regression analyses were used to investigate the association of K-D scores with sex and age. Results: One-hundred and nine athletes (69 males, 40 females; mean age =20.40±1.38 years) were baseline tested. There was excellent agreement (ICC=0.93, 95% CI: 0.90, 0.95) between the paper and computer version. Preseason K-D scores were statistically different (r2=0.873, p<0.05) with athletes scoring a mean of 37.58 seconds on the paper version (95% CI, 36.21, 38.96) and athletes scoring a mean of 41.48 seconds for the computerized tablet version (95% CI, 40.17, 42.91). There were no significant differences in sex, sport, or use of glasses noted for both versions. Age differences were identified; eighteen-year-old athletes took statistically longer than their peers for both K-D versions. Pairwise comparisons showed statistically significant differences between 18-year olds up to the age of 21-year-olds (p<0.05) for the computer version and statistically significant differences between 18-year olds up to 22-year-olds (p<0.05) for the paper version. Conclusion: This study supports the use of either version of the K-D test as a potential part of a multifaceted concussion assessment. The age of the athlete influences scores and therefore a K-D baseline should be repeated annually for collegiate athletes. Clinicians should not substitute K-D versions (computer vs. paper) in comparing baseline to a post-concussion K-D score as the scores are quite different. [ABSTRACT FROM AUTHOR]

The Dimensional Anhedonia Rating Scale (DARS) is a novel questionnaire to assess anhedonia of recent validation. In this work, we aim to study the equivalence between the traditional paper-and-pencil and the digital format of DARS. Sixty-nine patients filled the DARS in a paper-based and digital versions. We assessed differences between formats (Wilcoxon test), validity of the scales [Kappa and intraclass correlation coefficients (ICCs)], and reliability (Cronbach's alpha and Guttman's coefficient). We calculated the comparative fit index and the root mean squared error (RMSE) associated with the proposed one-factor structure. Total scores were higher for paper-based format. Significant differences between both formats were found for three items. The weighted Kappa coefficient was approximately 0.40 for most of the items. Internal consistency was greater than 0.94, and the ICC for the digital version was 0.95 and 0.94 for the paper-and-pencil version (F = 16.7, p < 0.001). Comparative Adjustment Index was 0.97 for the digital DARS and 0.97 for the paper-and-pencil DARS, and RMSE was 0.11 for the digital DARS and 0.10 for the paper-and-pencil DARS. We concluded that the digital DARS is consistent in many respects with the paper-and-pencil questionnaire, but equivalence with this format cannot be assumed without caution. [ABSTRACT FROM AUTHOR]

Study Design: Cross-sectional study.Objective: To investigate the equivalence of electronic and paper version of self-report questionnaires for the assessment of disability, pain, fear of movement, depression, and physical activity of patients with chronic low back pain (LBP).Summary Of Background Data: Paper and electronic versions of self-report questionnaires are commonly used for assessment of patients with LBP. However, the equivalence of self-report questionnaires commonly used for assessment of patients with chronic LBP remains unclear.Methods: Seventy-nine individuals with chronic LBP seeking physiotherapy care were recruited. Participants attended the clinic twice with an interval of 1 week and completed the self-reported questionnaires in a random order. The following questionnaires were administered: Roland Morris Disability Questionnaire (RMDQ); 11-point numerical rating scale (NRS); Tampa Scale for Kinesiophobia (TSK); Center for Epidemiological Studies-Depression (CES-D), and Baecke Habitual Physical Activity Questionnaire (BPAQ). To investigate the equivalence between the two questionnaire versions, intraclass correlation coefficient with 95% confidence interval and Bland-Altman plotting was used.Results: The paper and electronic versions of the RMDQ, TSK, and CES-D showed good reliability and the showed moderate reliability. In contrast, the NRS showed poor reliability between the electronic and paper versions.Conclusion: Our findings support that the electronic version of the RMDQ, TSK, CES-D, and BPAQ can be administered in clinical and research settings for assessment of patients with chronic LBP. Nevertheless, electronic version of the NRS for assessment of pain intensity should not be used interchangeably in clinical practice in patients with chronic LBP.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background: Patient reported outcome measures (PROMs) provide valuable insight on patients' well-being and facilitates communication between healthcare providers and their patients. The increased integration of the technology within the healthcare setting presents the opportunity to collect PROMs electronically, rather than on paper. The Childhood Health Assessment Questionnaire (CHAQ) and Quality of My Life (QoML) are common PROMs collected from pediatric rheumatology patients. The objectives of this study are to (a) determine the equivalence of the paper and electronic forms (e-form) of CHAQ and QoML questionnaires; (b) identify potential benefits and barriers associated with using an e-form to capture PROMs; and (c) gather feedback on user experience. Methods: Participants completed both a paper and an e-form of the questionnaires in a randomized order, following which they completed a feedback survey. Agreement of the scores between the forms were statistically analyzed using the intraclass correlation coefficient (ICC) (95 % Confidence Interval (CI)) and bias was assessed using a Bland-Altman plot. Completion and processing times of the forms were compared using mean and median measures. Quantitative analysis was performed to assess user experience ratings, while comments were qualitatively analyzed to identify important themes. Results: 196 patients participated in this project. Scores on the forms had high ICC agreement > 0.9. New patients took longer than returning patients to complete the forms. Overall, the e-form was completed and processed in a shorter amount of time than the paper form. 83 % of survey respondents indicated that they either preferred the e-form or had no preference. Approximately 10 % of respondents suggested improvements to improve the user interface. Conclusions: E-forms collect comparable information in an efficient manner to paper forms. Given that patients and caregivers indicated they preferred completing PROMs in this manner, we will implement their suggested changes and incorporate e-forms as standard practice for PROMs collection in our pediatric rheumatology clinic. [ABSTRACT FROM AUTHOR]

Purpose: Smartphone-based questionnaires have advantages compared with their paper versions, but there is a lack of consistent research on depressive disorder questionnaires. This study aimed to assess the equivalence between the paper and smartphone versions of the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) and Patient Health Questionnaire-9 (PHQ-9) for patients with depressive disorders in psychiatric hospitals in China. Patients and Methods: This was a randomized crossover study of 110 depressed patients recruited from the outpatient department of Beijing Anding Hospital from March 2016 to September 2018. Group 1 completed both the QIDS-SR16 and PHQ-9 in paper format and then completed the smartphone version 1– 2 h later. Group 2 completed the scales in the reverse order. Reliability was evaluated using intraclass correlation coefficients (ICCs) with 95% confidence intervals (CI). The expected ICC was 0.9 (α=0.05). Results: The overall ICC score of the QIDS-SR16 paper and smartphone versions was 0.904 (95% CI: 0.861– 0.934), and the ICCs of each item ranged from 0.769 to 0.923. The overall ICC score of the PHQ-9 paper and smartphone versions was 0.951 (95% CI: 0.929– 0.967), and the ICCs of each item ranged from 0.779 to 0.914. Conclusion: This study demonstrated the equivalence of the paper and smartphone versions of the PHQ-9 and QIDS-SR16 in depressed patients in China. [ABSTRACT FROM AUTHOR]

The Physical Activity Neighborhood Environment Scale (PANES) has been used internationally; however, PANES properties have not been assessed in all geographical contexts. Our objectives were to assess the reliability and validity of an online and paper version of the PANES in Canadian adults. Reliability was estimated using intraclass correlation coefficients (ICC), percent of overall agreement (p0) and Cohen's Kappa coefficient (κ). Lower 95% confidence interval (CI) ICC ranged from 0.10 to 0.70. Lower 95%CI for κ statistics ranged from −0.20 to 0.64 and p0 ranged from 80.1% to 95.7%. Cronbach's alpha coefficients (α) estimated internal consistency of the PANES (α = 0.58 for the paper version and α = 0.55 for the online version). Mean scores for the PANES Built Environment Index (BEI) significantly differed by neighborhood street pattern (p <.05). The PANES administrated via paper or online provides reliable overall agreement and valid estimates of the self-reported neighborhood built environment supportiveness of physical activity. [ABSTRACT FROM AUTHOR]

Patient-reported outcome measures (PROMs) have gained considerable interest in health care moving beyond traditional outcome measures of morbidity and mortality. In breast cancer surgery, women's' perceptions of appearance, function and quality of life have become increasingly important. The BREAST-Q questionnaire is a validated PROM for use in cosmetic and reconstructive breast surgery in clinical practice. The objective of this study was to validate the Spanish electronic version of the BREAST-Q questionnaire, to verify the measurement equivalence of digital and paper versions and to identify the possible disadvantages and advantages of implementing this new tool. The study population included 113 patients undergoing breast cancer survey at a single hospital in Barcelona (Spain) who were able to complete both the electronic and paper versions of the preoperative module of the BREAST-Q questionnaire. The intraclass correlation coefficient (ICC) in the four domains of the questionnaire between the two versions of the questionnaire was >0.9, with a weighted kappa of >0.74 at item level. The reliability of the internal consistency was also excellent, with Cronbach's alpha coefficient of >0.70 in all domains. Age was a limiting factor for the delivery of the electronic version of BREAST-Q, with 69 years of age as the cut-off point to obtain reliable results. The interchangeability of the electronic and paper versions of the BREAST-Q questionnaire facilitates implementation of this instrument in routine surgical oncological practice. [ABSTRACT FROM AUTHOR]

Introduction: Freezing of gait, a common PD motor symptom, could increase the risk of falling. This study aimed to investigate the clinimetric attributes of the Freezing of Gait Questionnaire (FOGQ) for people with Parkinson disease in the "off" state. Methods: A total of 115 patients with Parkinson disease (PD; mean age, 60.25 years) were included. Acceptability, internal consistency (by the Cronbach alpha, and test-retest by Intraclass Correlation [ICC]), and reliability of the Persian-translated version of the FOGQ were examined. Dimensionality was estimated by Exploratory Factor Analysis (EFA). Fall efficacy scale-international, unified Parkinson disease rating scale-II, Berg balance scale, functional reach test, and Parkinson disease questionnaire-39 were applied to determine the convergent validity. Diagnostic accuracy for obtaining optimal cutoff point, separating faller and non-faller groups, was analyzed by Receiver Operating Characteristics (ROC) curve analysis and Area Under the Curve (AUC). All tests were carried out in an "off" state. Results: The Cronbach alpha was high (a=0.92). The test-retest showed high reliability (ICC=0.89). The FOGQ was unidimensional according to the EFA and had acceptable convergent validity with moderate to high correlation with other clinical scales. The optimal cutoff point to discriminate fallers from non-fallers during the "off" state was 9/10, with an AUC of 0.92. Conclusion: Our results suggest that the FOGQ has appropriate reliability, validity, and discriminative ability for measuring FOG in patients with PD during the "off" state. [ABSTRACT FROM AUTHOR]

Introduction: Administering patient-reported outcome measures (PROMs) by text message may improve response rate in hard-to-reach populations. This study explored cultural acceptability of PROMs and compared measurement equivalence of the EQ-5D-3L administered on paper and by text message in a rural South African setting.Materials and Methods: Participants with upper or lower limb orthopaedic pathology were recruited. The EQ-5D was administered first on paper and then by text message after 24 h and 7 days. Differences in mean scores for paper and text message versions of the EQ-5D were evaluated. Test-retest reliability between text message versions was evaluated using Intraclass Correlation Coefficients (ICCs).Results: 147 participants completed a paper EQ-5D. Response rates were 67% at 24 h and 58% at 7 days. There were no differences in means between paper and text message responses for the EQ-5D Index (p = 0.95) or EQ-5D VAS (p = 0.26). There was acceptable agreement between the paper and 24-h text message EQ-5D Index (0.84; 95% Confidence Interval (CI) 0.78-0.89) and EQ-5D VAS (0.73; 95% CI 0.64-0.82) and acceptable agreement between the 24-h and 7-day text message EQ-Index (0.72; CI 0.62-0.82) and EQ-VAS (0.72; CI 0.62-0.82). Non-responder traits were increasing age, Xhosa as first language and lower educational levels.Conclusions: Text messaging is equivalent to paper-based measurement of EQ-5D in this setting and is thus a viable tool for responders. Non-responders had similar socioeconomic characteristics and attrition rates to traditional modes of administration. The EQ-5D by text message offers potential clinical and research uses in hard-to-reach populations. [ABSTRACT FROM AUTHOR]

Background: Computerized methods to analyze pain drawings (PDs) have been developed and may aid to measure the pain area more precisely. Objective: The aim of this study was to verify whether examiners can reproduce the patient's PDs with acceptable reliability. Methods: This was an intra‐rater and inter‐rater reliability study. The protocol consisted of 4 steps: (1) scanning of paper PDs; (2) sharing the digitalized PD images between examiners; (3) reproducing the PD images in the sketching application; and (4) calculating the pain area in pixels and percentages. We calculated intraclass correlation coefficients (ICCs; 2,1), the standard error of the measurement (SEM), and the smallest detectable difference (SDD). Results: Reliability was tested using 31 PDs from 17 patients in our database (11 female [64.7%], mean age: 53.23 ± 11.57 years). Intra‐rater reliability varied from ICC (2,1) = 0.991 (95% confidence interval [CI] = 0.982 to 0.996; SEM = 3,432.45; SDD = 162.39 pixels; P < 0.001) to ICC (2,1) = 0.992 (95% CI = 0.978 to 0.997; SEM = 3,412.96; SDD = 161.93 pixels; P < 0.001). Inter‐rater reliability for the measurement between all examiners was considered excellent (ICC [2,1] = 0.976; 95% CI = 0.956 to 0.987; SEM =8,580.75; SDD = 256.76 pixels; P < 0.001), being higher between Examiners A and C (ICC [2,1] = 0.970; 95% CI = 0.936 to 0.986; SEM = 6,453.34; SDD = 222.67 pixels; P < 0.001). Conclusion: Our results show that intra‐ and inter‐rater reliabilities were excellent when an examiner reproduced the paper PDs into digitalized PDs. This process gives clinicians and researchers the opportunity to analyze pain extent more precisely using a computerized method. [ABSTRACT FROM AUTHOR]

Introduction: Sensory Gating Inventory (SGI) measures behavioral aspects of Sensory Gating (SG), which filters irrelevant sensory inputs into the higher cortex. It modifies sensitivity to sensory stimuli. Abnormal SG leads to overloading of information in the brain and its subsequent dysfunction. Electrophysiological techniques cannot assess the behavioral aspects of SG. We aimed to design the Persian version of SGI with high validity and reliability. Methods: After a forward and then backward translation of the original SGI, we assessed the content validity and construct validity of the Persian version. A total of 405 participants filled the Persian version of SGI. To assess test-retest reliability, 100 participants filled the inventory again 7-10 days later. The content validity ratio and index, as well as confirmatory factor analysis, were computed, too. Finally, the Cronbach's alpha, Cohen's kappa, and intraclass correlation coefficients were calculated. Results: The content validity ratios of all items of the inventory were more than 60%, which means that they were necessary according to the experts' opinions. Confirmatory factor analysis confirmed the fitness of the 4-factor structure of the original Inventory. The test- retest reliability using the intraclass correlation coefficient and Cronbach's alpha coefficients were also high for the four subscales. The Cohen's kappa coefficients revealed moderate to substantial level of agreement between the first and second scores for all items. Conclusion: The Persian version of SGI has good and acceptable psychometric properties. It can be used as a valid and reliable tool for studying behavioral aspects of SG in Persian speaking population. [ABSTRACT FROM AUTHOR]

Objective: The Swedish Rheumatology Quality Register has implemented an internet-based method (PER) for registering patient-recorded outcome measures. The aim of this study was to compare the agreement between visual analogue scales (VASs) reported via PER and clinic-based reporting using paper forms. Methods: In a cross-sectional study (70 patients), the results of 79 registrations of VASs for global health, pain, and fatigue from PER were compared with corresponding clinic-based paper registrations. For patients with polyarthritis, 28-joint count Disease Activity Scores (DAS28) were computed. Patients with axial disease also completed Bath Ankylosing Spondylitis Disease Activity Index and Functional Index (BASDAI and BASFI) questionnaires. Mean differences and intraclass correlation coefficients (ICCs) were calculated. Agreement was visualized using Bland-Altman plots. Results: No statistically significant differences in VASs were found comparing PER and paper forms for VAS Global, VAS Pain, and VAS Fatigue (p = 0.295, 0.463, and 0.288, respectively). ICCs for VAS Global, Pain, and Fatigue ranged from 0.889 to 0.952, indicating excellent agreement. Bland-Altman plots for VAS did not show any proportional bias. The mean difference for DAS28 calculated by VASs from paper vs PER was -0.02 (n = 65, p = 0.660), and the mean difference for BASDAI was 0.04 (n = 11, p = 0.742). ICCs for DAS28 and BASDAI were 0.962 and 0.985, respectively. Of the participating patients, 60% preferred PER. Conclusion: Internet-based reporting for patient-reported outcomes in a clinical setting resulted in similar data for VASs and corresponding disease activity scores to clinic-based reporting on paper forms. [ABSTRACT FROM AUTHOR]

Background The use of patient-reported outcome measures in electronic format has been increasing. However, these formats are usually not validated or compared with the original paper-based formats, so there is no evidence that they are completed in the same way. Objectives To compare the conventional paper version with a web-based application ( iPad®) version of the Dermatology Life Quality Index ( DLQI) to assess equivalence of scores. Methods The study employed a randomized crossover design using a within-subjects comparison of the two formats of the questionnaire. International Society for Pharmacoeconomics and Outcomes Research ( ISPOR) guidelines were followed. Participants aged over 18 years with any confirmed skin condition were recruited from a teaching hospital dermatology outpatient clinic. Expected intraclass correlation coefficient ( ICC) was 0·9 (α = 0·05). Results A total of 104 patients were recruited, median age 53·5 years (interquartile range 37·3-67·8; 43% male). The ICC showed high concordance between the total DLQI scores from paper and iPad versions ( ICC 0·98; 95% confidence interval 0·97-0·99). Patients took a median of 78 s to complete the electronic version and 73 s for paper ( P = 0·008): 76% preferred the electronic version and perceived completion to take a shorter time. Conclusions There is high concordance and thus equivalence between the iPad and paper versions of the DLQI, with an ICC of 0·98, and a clear patient preference for the iPad version. [ABSTRACT FROM AUTHOR]

Background: Gas‐related symptoms (GRS) are common in the general population (GPop) and among patients with disorders of gut‐brain interactions but there is no patient‐reported outcome evaluating these symptoms and their impact on daily life. We have previously developed a 43‐item intestinal gas questionnaire (IGQ). The aim of the present study is to perform a psychometric validation of this instrument. Methods: Participants (119 from the GPop and 186 irritable bowel syndrome (IBS) patients) were recruited from 3 countries (UK, Spain, France). IBS patients fulfilled ROME IV criteria with an IBS severity score between 150 and 300. Participants completed the IGQ, the functional Digestive Disorders Quality of Life (FDDQL), and the EQ‐5D. A subgroup (n = 90) repeated the IGQ completion after 7 days on paper or electronically. Results: From the original IGQ questionnaire, 26 items were deleted because of poor performance. Confirmatory factorial analysis on the remaining 17 items (7 symptom and 10 impact items) yielded a 6‐factor structure accounting for 67% of the variance for bloating (6 items), flatulence (3), belching (2), bad breath (2), stomach rumbling (2), and difficult gas evacuation (2). Global score (0‐100) was worse among IBS vs GPop (40 ± 15 vs 33 ± 17; p = 0.0016). At the second visit, the intraclass correlation coefficient of IGQ scores was between 0.71 and 0.86 (n = 67) for test‐retest reliability and 0.61‐0.87 (n = 64) for equivalence between electronic and paper versions of IGQ. Conclusion: The IGQ available in paper and electronic versions in 3 languages is a robust instrument for capturing and measuring GRS and their impact on daily life. [ABSTRACT FROM AUTHOR]

Objective: To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patient reported outcome measures (PROMs) in studies conducted subsequent to those included in Gwaltney et al's 2008 review.Methods: A systematic literature review of PROM equivalence studies conducted between 2007 and 2013 identified 1,997 records from which 72 studies met pre-defined inclusion/exclusion criteria. PRO data from each study were extracted, in terms of both correlation coefficients (ICCs, Spearman and Pearson correlations, Kappa statistics) and mean differences (standardized by the standard deviation, SD, and the response scale range). Pooled estimates of correlation and mean difference were estimated. The modifying effects of mode of administration, year of publication, study design, time interval between administrations, mean age of participants and publication type were examined.Results: Four hundred thirty-five individual correlations were extracted, these correlations being highly variable (I2 = 93.8) but showing generally good equivalence, with ICCs ranging from 0.65 to 0.99 and the pooled correlation coefficient being 0.88 (95% CI 0.87 to 0.88). Standardised mean differences for 307 studies were small and less variable (I2 = 33.5) with a pooled standardised mean difference of 0.037 (95% CI 0.031 to 0.042). Average administration mode/platform-specific correlations from 56 studies (61 estimates) had a pooled estimate of 0.88 (95% CI 0.86 to 0.90) and were still highly variable (I2 = 92.1). Similarly, average platform-specific ICCs from 39 studies (42 estimates) had a pooled estimate of 0.90 (95% CI 0.88 to 0.92) with an I2 of 91.5. After excluding 20 studies with outlying correlation coefficients (≥3SD from the mean), the I2 was 54.4, with the equivalence still high, the overall pooled correlation coefficient being 0.88 (95% CI 0.87 to 0.88). Agreement was found to be greater in more recent studies (p < 0.001), in randomized studies compared with non-randomised studies (p < 0.001), in studies with a shorter interval (<1 day) (p < 0.001), and in respondents of mean age 28 to 55 compared with those either younger or older (p < 0.001). In terms of mode/platform, paper vs Interactive Voice Response System (IVRS) comparisons had the lowest pooled agreement and paper vs tablet/touch screen the highest (p < 0.001).Conclusion: The present study supports the conclusion of Gwaltney's previous meta-analysis showing that PROMs administered on paper are quantitatively comparable with measures administered on an electronic device. It also confirms the ISPOR Taskforce´s conclusion that quantitative equivalence studies are not required for migrations with minor change only. This finding should be reassuring to investigators, regulators and sponsors using questionnaires on electronic devicesafter migration using best practices. Although there is data indicating that migrations with moderate changes produce equivalent instrument versions, hence do not require quantitative equivalence studies, additional work is necessary to establish this. Furthermore, there is the need to standardize migration practices and reporting practices (i.e. include copies of tested instrument versions and screenshots) so that clear recommendations regarding equivalence testing can be made in the future.raising questions about the necessity of conducting equivalence testing moving forward. [ABSTRACT FROM AUTHOR]

Purpose: To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration.Methods: Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1-6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7-8 completed the survey twice, either by Web or by IVRS. The 20-item survey, including the MSKCC Bowel Function Instrument (BFI), the LASA Quality of Life (QOL) scale, and the Subjective Significance Questionnaire (SSQ) adapted to bowel function, was completed from home on consecutive days. Mode equivalence was assessed by comparison of mean scores across modes and intraclass correlation coefficients (ICCs) and was compared to the test-retest reliability of Web and IVRS.Results: Of 170 patients, 157 completed at least one survey and were included in analysis. Patients had mean age 56 (SD = 11), 53% were male, 81% white, 53% colon, and 47% rectal cancer; 78% completed all assigned surveys. Mean scores for BFI total score, BFI subscale scores, LASA QOL, and adapted SSQ varied by mode by less than one-third of a score point. ICCs across mode were: BFI total score (Web-paper = 0.96, Web-IVRS = 0.97, paper-IVRS = 0.97); BFI subscales (range = 0.88-0.98); LASA QOL (Web-paper = 0.98, Web-IVRS = 0.78, paper-IVRS = 0.80); and SSQ (Web-paper = 0.92, Web-IVRS = 0.86, paper-IVRS = 0.79).Conclusions: Mode equivalence was demonstrated for the BFI total score, BFI subscales, LASA QOL, and adapted SSQ, supporting the use of multiple modes of PRO data capture in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Glycosylated haemoglobin (HbA1c) measurement is used to diagnose and to guide treatment of diabetes mellitus. Within-subject variability in measured HbA1c affects its clinical utility and interpretation, but no comprehensive systematic review has described within-subject variability. Methods: A systematic review and meta-analysis was performed of within-subject variability of HbA1c. Multiple databases were searched from inception to November 2022 for follow-up studies of any design in adults or children, with repeated measures of HbA1c or glycosylated haemoglobin. Title and abstract screening was performed in duplicate, full text screening and data extraction by one reviewer and verified by a second. Risk of bias of included papers was assessed using a modified consensus-based standards for the selection of health measurement Instruments (COSMIN) tool. Intraclass correlation coefficient (ICC) results were pooled with a meta-analysis and coefficient of variation (CV) results were described by median and range. Results: Of 2675 studies identified, 111 met the inclusion criteria. Twenty-five studies reported variability data in healthy patients, 19 in patients with type 1 diabetes and 59 in patients with type 2 diabetes. Median within-subject coefficient of variation (CV) was 0.070 (IQR 0.034 to.09). For healthy subjects the median CV for HbA1c % was 0.017 (IQR 0.013 to 0.022), for patients with type 1 diabetes 0.084 (IQR 0.067 to 0.89) and for type 2 diabetes 0.083 (IQR 0.06 to 0.10). CV increased with mean population HbA1c. Limitations: Assessment of variability was not the main aim of many of the included studies and some relevant papers may have been missed. Many included papers had few participants or few repeated measurements. Conclusions: Within-subject variability of HbA1c is higher for patients with than without diabetes and increases with mean population HbA1c. This may confound observed relationships between HbA1c variability and health outcomes. Because of its importance in clinical decision-making there is a need for better estimates and understanding of factors associated with of HbA1c variability. [ABSTRACT FROM AUTHOR]

The Trail Making Test (TMT) was adapted for the iPad by Parker-O'Brien, which uses the 2004 Tombaugh norms. This study investigated the equivalency of this electronic test by (a) examining the test-retest reliability of the iPad-TMT, and (b) calculating the concurrent validity between the two versions. The sample included 77 healthy adults. Reliability was assessed by Pearson product-moment correlation and intraclass correlation coefficient, while validity was assessed by MANOVA. Results indicate that Part A of the iPad-TMT did not demonstrate adequate test-retest reliability over 1 week (r = 0.15-0.70); Part B demonstrated adequate test-retest reliability in the majority of groups (r = 0.33-0.80). Conversely, Part A of the electronic TMT demonstrated adequate concurrent validity, whereas Part B did not; however, validity in Part A has minimal significance without adequate reliability. Handedness had a significant effect on performance, with left-handers performing slower on the electronic TMT Part A (p < .05) and the traditional TMT Part B (p < .05). Clinicians should use caution when using electronic versions of traditional tests, as they may assess different constructs. New norms should be developed. The role of handedness on TMT performance should be further assessed. [ABSTRACT FROM AUTHOR]

Background: Accurate quantification of pain in a clinical setting is vital. The use of an electronic pain scale enables data to be collected, analyzed, and utilized much faster compared with traditional paper-based scales. The advancement of smart technology in pediatric and adult pain evaluation may offer opportunities to introduce easy-to-use and reliable pain assessment methods within different clinical settings. If promptly introduced within different pediatric and adult pain clinic services, validated and easily accessible mobile health pain apps may lead to early pain detection, promoting improvement in patient's quality of life and leading to potentially less time off from school or work.Objective: This cross-sectional observational study aimed to investigate the interchangeability of an electronic visual analog scale (eVAS) app with a traditional paper visual analog scale (pVAS) among Australian children, adolescents, and adults for pain evaluation.Methods: Healthy participants (age range 10-75 years) were recruited from a sporting club and a secondary school in Melbourne (Australia). The data collection process involved application of pressure (8.5 kg/cm2) from a Wagner Force Dial FDK 20 to the midpoint of the thumb. The pressure was applied twice with a 5-minute interval. At each pressure application, participants were asked to randomly record their pain perception using the "eVAS" accessible via the "Interactive Clinics" app and the traditional pVAS. Statistical analysis was conducted to determine intermethod and intramethod reliabilities.Results: Overall, 109 healthy participants were recruited. Adults (mean age 42.43 years, SD 14.50 years) had excellent reliability, with an intraclass correlation coefficient (ICC) of 0.94 (95% CI 0.91-0.96). Children and adolescents (mean age 13.91 years, SD 2.89 years) had moderate-to-good intermethod and intramethod reliabilities, with an ICC of 0.80 (95% CI 0.70-0.87) and average ICC of 0.80 (95% CI 0.69-0.87), respectively.Conclusions: The eVAS app appears to be interchangeable compared with the traditional pVAS among children, adolescents, and adults. This pain evaluation method may offer new opportunities to introduce user-friendly and validated pain assessment apps for patients, clinicians, and allied health professionals. [ABSTRACT FROM AUTHOR]

Objective: Patient‐reported outcomes (PROs) can provide critical information concerning the impact of a disease on an individual. Mobile technology to collect PRO data in an electronic format (ePRO) allows for frequent assessment in the person's regular environment. The goal of this study was to assess the compliance with a phone application (app) and validate ePRO information in individuals with systemic lupus erythematosus (SLE). Methods: A smartphone app that collects ePRO data from various clinical instruments was developed. Information was collected by both an ePRO and a paper‐administered instrument as part of a multicenter randomized interventional clinical trial of patients meeting American College of Rheumatology (ACR) criteria for the classification of SLE. To determine agreement between PRO information collected in the different formats, intraclass correlation coefficients (ICCs), paired Student's t tests, and Bland–Altman plots were evaluated. Compliance and Cronbach's alpha were also assessed as a measure of survey reliability. Results: For the 62 subjects from diverse ancestral backgrounds, compliance with ePRO completion was high (more than 75%). Cronbach alpha values for PROs indicated moderate to high survey reliability. The vast majority (73.4%) of ICC values were indicative of good to excellent reliability between measurement methods. Bland–Altman plots verified method agreement, and 87% of pairwise t tests yielded an insignificant difference between information collected with the different administration methods. Conclusion: The excellent compliance and the high level of consistency between data collected by paper and that collected by electronic methods indicate that the app provides a reliable means of cataloging real‐time changes in PROs in SLE patients. [ABSTRACT FROM AUTHOR]

Background: The Ruff Figural Fluency Test (RFFT) is a valid but time-consuming and labour-intensive cognitive paper-and-pencil test. A digital RFFT was developed that can be conducted independently using an iPad and Apple Pencil and RFFT scores are computed automatically. We investigated the validity and reliability of this digital RFFT. Methods: We randomly allocated participants to the digital or paper-and-pencil RFFT. After the first test, the other test was performed immediately (cross-over). Participants were invited for a second digital RFFT 1 week later. For the digital RFFT, an (automatic) algorithm and two independent raters (criterion standard) assessed the number of unique designs (UD) and perseverative errors (PE). These raters also assessed the paper-and-pencil RFFT. We used Intraclass correlation coefficients (ICC), sensitivity, specificity, %-agreement, Kappa, and Bland–Altman plots. Results: We included 94 participants (mean (SD) age 39.9 (14.8), 73.4% follow-up). Mean (SD) UD and median (IQR) PE of the digital RFFT were 84.2 (26.0) and 4 (2–7.3), respectively. Agreement between manual and automatic scoring of the digital RFFT was high for UD (ICC = 0.99, 95% CI 0.98, 0.99, sensitivity = 0.98; specificity = 0.96) and PE (ICC = 0.99, 95% CI 0.98, 0.99; sensitivity = 0.90, specificity = 1.00), indicating excellent criterion validity. Small but significant differences in UD were found between the automatic and manual scoring (mean difference: − 1.12, 95% CI − 1.92, − 0.33). Digital and paper-and-pencil RFFT had moderate agreement for UD (ICC = 0.73, 95% CI 0.34, 0.87) and poor agreement for PE (ICC = 0.47, 95% CI 0.30, 0.62). Participants had fewer UD on the digital than paper-and-pencil RFFT (mean difference: − 7.09, 95% CI − 11.80, − 2.38). The number of UD on the digital RFFT was associated with higher education (Spearman's r = 0.43, p < 0.001), and younger age (Pearson's r = − 0.36, p < 0.001), showing its ability to discriminate between different age categories and levels of education. Test–retest reliability was moderate (ICC = 0.74, 95% CI 0.61, 0.83). Conclusions: The automatic scoring of the digital RFFT has good criterion and convergent validity. There was low agreement between the digital RFFT and paper-and-pencil RFFT and moderate test–retest reliability, which can be explained by learning effects. The digital RFFT is a valid and reliable instrument to measure executive cognitive function among the general population and is a feasible alternative to the paper-and-pencil RFFT in large-scale studies. However, its scores cannot be used interchangeably with the paper-and-pencil RFFT scores. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the precision, accuracy, and reliability of the common measurement methods for collecting comfort and reachability distances. Four measurement methods were applied in the study: real-life measurement, virtual reality (VR) simulation, the media method, and the paper-and-pencil test. Forty participants were recruited, who were required to determine their comfort and reachability distances when approached by, or actively approaching, confederates under the four methods. The relative error magnitude and mean absolute difference were used to evaluate the precision and accuracy of the methods, respectively. Then, intraclass correlation coefficients were applied to evaluate the reliability of the methods. The ANOVA results showed that the confederate's gender, method, and pattern all had significant effects on the comfort and reachability distances. The distance obtained by the paper-and-pencil test was the smallest, while the distance measured by the media method was larger. The real-life measurement had high reliability, but its precision performance was worse than that of both the VR simulation and the active media method. The VR simulation had the best precision and reliability, while the measurement value tended to be overestimated. The media method in the passive pattern showed the worst precision, accuracy, and reliability performance among the four methods. The active media method performed well except for accuracy when collecting distance data. The paper-and-pencil test showed erroneous results regarding the precision and reliability performance. These findings provide scientific reference suggestions for the selection of measuring methods for collecting comfort and reachability distances. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device).Methods: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire.Results: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference).Conclusions: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach. [ABSTRACT FROM AUTHOR]

Background: Patellofemoral pain (PFP) is often reported as a diffuse pain at the front of the knee during knee-loading activities. A patient's description of pain location and distribution is commonly drawn on paper by clinicians, which is difficult to quantify, report and compare within and between patients. One way of overcoming these potential limitations is to have the patient draw their pain regions using digital platforms, such as personal computer tablets. Objective: To assess the validity of using computer tablets to acquire a patient's knee pain drawings as compared to paper-based records in patients with PFP. Methods: Patients (N = 35) completed knee pain drawings on identical images (size and colour) of the knee as displayed on paper and a computer tablet. Pain area expressed as pixel density, was calculated as a percentage of the total drawable area for paper and digital records. Bland-Altman plots, intraclass correlation coefficient (ICC), Pearson's correlation coefficients and one-sample tests were used in data analysis. Results: No significant difference in pain area was found between the paper and digital records of mapping pain area (p = 0.98), with the mean difference = 0.002% (95% CI [-0.159-0.157%]). A very high agreement in pain area between paper and digital pain drawings (ICC = 0.966 (95% CI [0.93-0.98], F = 28.834, df = 31, p < 0.001). A strong linear correlation (R2 = 0.870) was found for pain area and the limits of agreement show less than ±1% difference between paper and digital drawings. Conclusion: Pain drawings as acquired using paper and computer tablet are equivalent in terms of total area of reported knee pain. The advantages of digital recording platforms, such as quantification and reporting of pain area, could be realized in both research and clinical settings. [ABSTRACT FROM AUTHOR]

Existing bladder-specific measures lack the ability to assess the full range of bladder health, from poor to optimal health. This study aimed to report evidence of validity of the self-administered, multidimensional bladder health scales and function indices for research in adult women. A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms in 7 clinical research centers. Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t -tests and 2-way mixed-effects intraclass correlation coefficient models. Chi-square, Fisher exact, or t -tests were used for mode comparisons. Convergent validity was evaluated using Pearson correlations with the external construct measures, and known-group validity was established with comparison of women known and unknown to be symptomatic of urinary conditions. The sample included 1072 participants. Factor analysis identified 10 scales, with Cronbach's alpha ranging from 0.74 to 0.94. Intraclass correlation coefficients of scales ranged from 0.55 to 0.94. Convergent validity of the 10 scales and 6 indices ranged from 0.52 to 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration. The paper and electronic forms of the bladder health scales and function indices are reliable and valid measures of bladder health for use in women's health research. [ABSTRACT FROM AUTHOR]

Aims: To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary). Methods: Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice‐daily phone notifications. Women were randomized to complete up to three consecutive 14‐day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test‐retest reliability was assessed with intraclass correlations (ICCs). Results: Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to‐strongly correlated for BMs per week (r =.61), urgency BMs per week (r =.76), FIE per week (r =.66), urgency FIE per week (r =.72). Test‐retest reliability was good (ICC =.81 BMs per week,.79 urgency BMs per week,.74 FIE per week, and.62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0–100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper. Conclusion: The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real‐time diary completion that obviated staff data entry. [ABSTRACT FROM AUTHOR]

Background: This study aimed to develop a Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) tablet application, "iCAMS," and examine equivalency between the original paper-based and the tablet-based assessments. Methods: This study enrolled 100 participants with physician-confirmed multiple sclerosis (MS). Interrater reliability, parallel forms reliability, and concurrent validity were evaluated by incorporating two test administrators in each session: one scoring participant responses with the original paper assessments and the other with iCAMS. Although the participant was exposed to the material only once, responses were recorded on both administration methods. In addition to the standard test procedures, each research assistant used a stopwatch to measure the amount of time required to administer and score each version of BICAMS. Results: Pearson correlation coefficients (r) revealed strong and significant correlations for all three tests. Excellent agreement was observed between iCAMS and paper versions of the BICAMS tests, with all intraclass correlation coefficients exceeding 0.93. The scores from all the cognitive tests were not statistically significantly different, indicating no proportional bias. Including scoring, administration of the iCAMS application saved approximately 10 minutes over the paper version. Conclusions: Preliminary findings suggest that the tablet application iCAMS is a reliable and fast method for administering BICAMS. [ABSTRACT FROM AUTHOR]

Purpose: Immediate transfer of patient-reported outcome measures (PROMs) for use in medical consultations is facilitated by electronic assessments. We aimed to describe the rationale and development of Eir version 3 (EirV3), a computer-based symptom assessment tool for cancer, with emphasis on content and user-friendliness. Methods: EirV3's specifications and content were developed through multiprofessional, stepwise, and iterative processes (from 2013 to 2016), with literature reviews on traditional and electronic assessment and classification methods, formative iterative usability tests with end-users, and assessment of patient preferences for paper versus electronic assessments. Results: EirV3 has the following two modules: Eir-Patient for PROMs registration on tablets and Eir-Doctor for presentation of PROMs in a user-friendly interface on computers. Eir-Patient starts with 19 common cancer symptoms followed by specific, in-depth questions for endorsed symptoms. The pain section includes a body map for pain location and intensity, whereas physical functioning, nutritional intake, and well-being are standard questions for all. Data are wirelessly transferred to Eir-Doctor. Symptoms with intensity scores ≥ 3 (on a 0 to 10 scale) are marked in red, with brighter colors corresponding to higher intensity, and supplemented with graphs displaying symptom development over time. Usability results showed that patients and health care providers found EirV3 to be intuitive, easy to use, and relevant. When comparing PROM assessments on paper versus tablets (n = 114), 19% of patients preferred paper, 41% preferred tablets, and 40% had no preference. Median intraclass correlation coefficient between paper and tablets (0.815) was excellent. Conclusion: Iterative test rounds followed by continuous improvements led to a user-friendly, applicable symptom assessment tool, EirV3, developed for and by end-users. EirV3 is undergoing international testing of clinical and cross-cultural adaptability. [ABSTRACT FROM AUTHOR]

Peer review is the backbone of modern science. F1000Prime is a postpublication peer review system of the biomedical literature (papers from medical and biological journals). This study is concerned with the interrater reliability and convergent validity of the peer recommendations formulated in the F1000Prime peer review system. The study is based on about 100,000 papers with recommendations from faculty members. Even if intersubjectivity plays a fundamental role in science, the analyses of the reliability of the F1000Prime peer review system show a rather low level of agreement between faculty members. This result is in agreement with most other studies that have been published on the journal peer review system. Logistic regression models are used to investigate the convergent validity of the F1000Prime peer review system. As the results show, the proportion of highly cited papers among those selected by the faculty members is significantly higher than expected. In addition, better recommendation scores are also associated with higher performing papers. [ABSTRACT FROM AUTHOR]

The Cumberland Ankle Instability Tool is a common patient reported outcome used to assess those with Chronic Ankle Instability. However, paper versions of the Cumberland Ankle Instability Tool have only been assessed for reliability purposes. The purpose of this study was to assess the agreement and reliability of a digital version of the Cumberland Ankle Instability Tool-Digital. Sixty-eight participants with a history of ankle sprain(s) were recruited to participate in this study. Participants completed a paper version of the Cumberland Ankle Instability Tool and a digital version then returned one week later and completed them again. Intraclass correlation coefficients (ICC) and Kappa coefficients were used to determine the agreement between the paper and digital versions as well as test-retest reliability between the two time periods. The digital version showed excellent reliability (ICC = 0.93, 95% CI: 0.89–0.96) with the paper version. The test-retest reliability between testing sessions was considered good (ICC = 0.86, 95% CI: 0.77–0.92). A majority of individual items on the digital version demonstrated substantial agreement (κ = 0.60–0.81) with the paper version. A digital version of the Cumberland Ankle Instability Tool demonstrated good to excellent psychometric properties. Clinicians who utilize a digital version as part of an electronic medical record system can utilize them confidently to accurately assess patients with Chronic Ankle Instability. Future studies may want to consider assessing a digital version with expanded clinical and research populations. The digital version of the Cumberland Ankle Instability Tool demonstrated adequate psychometric properties. The digital version of the Cumberland Ankle Instability Tool can be considered a reliable instrument for the assessment of Chronic Ankle Instability. A digital version of the Cumberland Ankle Instability Tool can provide automated scoring and quick administration for clinicians in a rehabilitation setting. [ABSTRACT FROM AUTHOR]

Background: Region-specific patient-reported outcomes (PROs) are commonly used in rehabilitation medicine. Digital versions of PROs may be implemented into electronic medical records and are also commonly used in research, but the validity of this method of administration (MOA) must be established. Purpose: To determine the agreement between and compare the test–retest reliability of a paper version (FAAM-P) and digital version (FAAM-D) of the Foot and Ankle Ability Measure (FAAM). Study Design: Randomized, nonblinded, crossover observational study. Methods: A total of 90 adults were randomized to complete the FAAM-P or FAAM-D first, and then completed the second MOA (first day [D1]). The FAAM-D was a digital adaptation of both FAAM-P subscales on Qualtrics. Identical test procedures were completed 1 week later (D2). Data were removed if a participant scored 100% on both MOA, reported injury between D1 and D2, or did not complete both MOA. Agreement was assessed on 46 participants between the 2 MOA using intraclass correlation coefficients (ICC) at D1. There was good-to-excellent test–retest reliability for the FAAM activities of daily living. Results: The authors observed good agreement between the FAAM-P and FAAM-D for the activities of daily living (ICC = .88) and sport scales (ICC = .87). Test–retest reliability was good-to-excellent for the FAAM activities of daily living (FAAM-P: ICC = .87; FAAM-D: ICC = .89) and sport (FAAM-P: ICC = .71; FAAM-D: ICC = .91). Conclusions: The MOA does not appear to affect the responses on the FAAM; however, the authors observed slightly higher reliability on the FAAM-D. The FAAM-D is sufficient to be used for generating practice-based evidence in rehabilitation medicine. [ABSTRACT FROM AUTHOR]

This paper prioritizes the effective factors for fostering the culture of paying taxes in Iran's economic enterprises. The statistical population includes academic instructors and experts in the field of taxation selected by the purposive sampling method. Finally, 15 university instructors and experts answered structured interview questions. The inclusion criteria were at least 10 years of study, instructing, or working in the field of tax affairs. Sampling continued until the theoretical saturation stage. Also, the Intraclass Correlation Coefficient (ICC)coefficient value consistency and absolute agreement were confirmed to determine the measurement tool's reliability. Super Decision software and the ANP network analysis process were used to prioritize criteria. The results of prioritization showed that criterion V1, namely "electronic infrastructure" is the most important and as a result the most important sub-criteria in presenting the model of fostering the culture of tax payment in Iranian economic enterprises. After that, the V3 criterion, namely "financial incentives" was placed as the second priority. The management ability and attitude, and compliance with tax laws were ranked third and fourth. [ABSTRACT FROM AUTHOR]

(1) Background: Marker-based 3D motion capture systems (MBS) are considered the gold standard in gait analysis. However, they have limitations for which markerless camera-based 3D motion capture systems (MCBS) could provide a solution. The aim of this systematic review and meta-analysis is to compare the accuracy, validity, and reliability of MCBS and MBS. (2) Methods: A total of 2047 papers were systematically searched according to PRISMA guidelines on 7 February 2024, in two different databases: Pubmed (1339) and WoS (708). The COSMIN-tool and EBRO guidelines were used to assess risk of bias and level of evidence. (3) Results: After full text screening, 22 papers were included. Spatiotemporal parameters showed overall good to excellent accuracy, validity, and reliability. For kinematic variables, hip and knee showed moderate to excellent agreement between the systems, while for the ankle joint, poor concurrent validity and reliability were measured. The accuracy and concurrent validity of walking speed were considered excellent in all cases, with only a small bias. The meta-analysis of the inter-rater reliability and concurrent validity of walking speed, step time, and step length resulted in a good-to-excellent intraclass correlation coefficient (ICC) (0.81; 0.98). (4) Discussion and conclusions: MCBS are comparable in terms of accuracy, concurrent validity, and reliability to MBS in spatiotemporal parameters. Additionally, kinematic parameters for hip and knee in the sagittal plane are considered most valid and reliable but lack valid and accurate measurement outcomes in transverse and frontal planes. Customization and standardization of methodological procedures are necessary for future research to adequately compare protocols in clinical settings, with more attention to patient populations. [ABSTRACT FROM AUTHOR]

Purpose: The Comprehensive assessment of Acceptance and Commitment Therapy (CompACT) is a 23-item questionnaire measuring psychological flexibility, a quality of life protective factor. An 18-item version was recently produced. We assessed validity and reliability of CompACT, and equivalence of paper and electronic (eCompACT) versions in people with multiple sclerosis (PwMS) in Italy, Germany and Spain. Methods: We used confirmatory factor analysis and assessed CompACT-23 and CompACT-18 measurement invariance between the three language versions. We assessed construct validity (Spearman's correlations) and internal consistency (Cronbach's alpha). Test–retest reliability (intraclass correlation coefficient, ICC) and equivalence of paper and eCompACT (ICC and linear regression model for repeated measures) were assessed in subsamples of PwMS. Results: A total of 725 PwMS completed the study. The three-factor structure of the CompACT-23 showed poor fit (RMSEA 0.07; CFI 0.82; SRMR 0.08), while the fit of the CompACT-18 was good (RMSEA 0.05; CFI 0.93; SRMR 0.05). Configural and partial metric invariance were confirmed, as well as partial scalar invariance (reached when five items were allowed to vary freely). The CompACT-18 showed good internal consistency (all alpha ≥ 0.78); and test–retest reliability (all ICCs ≥ 0.86). Equivalence between paper and eCompACT was excellent (all ICCs ≥ 0.86), with no mode, order, or interaction effects. Conclusion: Results support using the refined CompACT-18 as a three-factor measure of psychological flexibility in PwMS. Paper and eCompACT-18 versions are equivalent. CompACT-18 can be used cross-culturally, but sub-optimal scalar invariance suggests that direct comparison between the three language versions should be interpreted with caution. [ABSTRACT FROM AUTHOR]

In a cluster-randomized trial (CRT), the number of participants enrolled often varies across clusters. This variation should be considered during both trial design and data analysis to ensure statistical performance goals are achieved. Most methodological literature on the CRT design has assumed equal cluster sizes. This scoping review focuses on methodology for unequal cluster size CRTs. EMBASE, Medline, Google Scholar, MathSciNet and Web of Science databases were searched to identify English-language articles reporting on methodology for unequal cluster size CRTs published until March 2021. We extracted data on the focus of the paper (power calculation, Type I error etc.), the type of CRT, the type and the range of parameter values investigated (number of clusters, mean cluster size, cluster size coefficient of variation, intra-cluster correlation coefficient, etc.), and the main conclusions. Seventy-nine of 5032 identified papers met the inclusion criteria. Papers primarily focused on the parallel-arm CRT (p-CRT, n = 60, 76%) and the stepped-wedge CRT (n = 14, 18%). Roughly 75% of the papers addressed trial design issues (sample size/power calculation) while 25% focused on analysis considerations (Type I error, bias, etc.). The ranges of parameter values explored varied substantially across different studies. Methods for accounting for unequal cluster sizes in the p-CRT have been investigated extensively for Gaussian and binary outcomes. Synthesizing the findings of these works is difficult as the magnitude of impact of the unequal cluster sizes varies substantially across the combinations and ranges of input parameters. Limited investigations have been done for other combinations of a CRT design by outcome type, particularly methodology involving binary outcomes—the most commonly used type of primary outcome in trials. The paucity of methodological papers outside of the p-CRT with Gaussian or binary outcomes highlights the need for further methodological development to fill the gaps. [ABSTRACT FROM AUTHOR]

Background: The only complete and validated tool for evaluating professional orchestra musicians is the English-language Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM) questionnaire, which, in recent years, has been translated, adapted, and validated in other languages. The aim of the study was to validate the online version of the Polish version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-P). Materials and Methods: The group included 182 professional musicians. The respondents were asked to complete the MPIIQM-P, BPI, and QuickDash questionnaires twice within an interval of 4 days. The questionnaires were created in the web form creator—Google Form. Results: The EFA analysis showed a two-factor structure of the questionnaire consisting of factor 1—pain intensity and factor 2—pain interference. The internal agreement of the factors identified in the EFA analysis was measured by the α Cronbach index reaching from 0.813 to 0.913. The intraclass correlation coefficient of both factors ranged from 0.276 to 0.583. The analysis of convergent and divergent validity between the subscales of the questionnaire value ranged from 0.414 to 0.925. Conclusions: The online version of the MPIIQM-P questionnaire is a valid and reliable tool for the assessment of musculoskeletal pain and interference. The online MPIIQM-P questionnaire maintains the psychometric properties previously defined for the paper version. [ABSTRACT FROM AUTHOR]

Purpose: Autistic camouflaging is a collection of strategies used to hide autistic characteristics. It can have serious consequences on autistic people's mental health and needs to be addressed and measured in clinical practice. The purpose of this study is to evaluate the psychometric properties of the French adaptation of the Camouflaging Autistic Traits Questionnaire. Methods: 1227 participants (744 autistic, 483 non-autistic) answered the French version of the CAT-Q in an online survey or on paper. Confirmatory factor analysis, measurement invariance testing, internal consistency analysis (McDonald's ω), and convergent validity with the DASS-21 depression subscale were conducted. Test-rest reliability was assessed on a sample of 22 autistic volunteers using intraclass correlation coefficient. Results: A good fit was found for the original three-factor structure as well as a good internal consistency, excellent test-retest reliability and highly significant convergent validity. Measurement invariance testing indicates however that the meaning behind items is different for autistic vs. non-autistic people. Conclusion: The French version of the CAT-Q can be used in clinical settings to assess camouflaging behaviors and intent to camouflage. Further research is needed to clarify the camouflage construct and whether reported measurement noninvariance are due to cultural differences or a true difference in what camouflaging might mean for non-autistic people. [ABSTRACT FROM AUTHOR]

Background: The majority of studies that explore changes in musculature following resistance training interventions or examine atrophy due to immobilization or sarcopenia use ultrasound imaging. While most studies assume acceptable to excellent reliability, there seems to be unawareness of the existing absolute measurement errors. As early as 1998, methodological research addressed a collective unawareness of the random measurement error and its practical indications. Referring to available methodological approaches, within this work, we point out the limited value of focusing on relative, correlation-based reliability indices for the interpretability in scientific research but also for clinical application by assessing 1,512 muscle thickness values from more than 400 ultrasound images. To account for intra- and inter-day repeatability, data were collected on two consecutive days within four testing sessions. Commonly-stated reliability values (ICC, CV, SEM and MDC) were calculated, while evidence-based agreement analyses were applied to provide the accompanied systematic and random measurement error. Results: While ICCs in the range of 0.832 to 0.998 are in accordance with the available literature, the mean absolute percentage error ranges from 1.34 to 20.38% and the mean systematic bias from 0.78 to 4.01 mm (all p ≤ 0.013), depending on the measurement time points chosen for data processing. Conclusions: In accordance with prior literature, a more cautious interpretation of relative reliability values should be based on included systematic and random absolute measurement scattering. Lastly, this paper discusses the rationale for including different measurement error statistics when determining the validity of pre-post changes, thus, accounting for the certainty of evidence. Key Points: • While reliability of a testing protocol is most often determined via relative reliability indices such as the intraclass correlation coefficient, further reliability values such as the systematic bias and the random error have been described as valuable for results interpretation. • This study used the most frequently employed procedure to determine muscle hypertrophy (ultrasound) as an example linking relative reliability values to absolute measurement errors under special consideration of appropriate calculation models using three scenarios (best case, worst case, stability). • Overall, 504 ultrasound images were examined showing excellent relative reliability, but the corresponding measurement errors suggest that caution must be exercised when interpreting pre-post settings in cases where the measurement error exceeds the expected changes. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study is to examine and evaluate the existing clinical practice guidelines and consensus statements regarding tracheostomy care for non‐mechanically ventilated patients. Methods: A systematic search of databases, and professional organisations was conducted from inception to 19 March 2023. Two appraisers evaluated each guideline using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) and the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Text and Opinion Papers. Results: No specific clinical guidelines exist on airway management in non‐mechanically ventilated patients. Of 6318 articles identified, we included 12 clinical practice guidelines, and 9 consensus statements, which were from China, the US, the UK, South Korea, Australia, France and Belgium. The AGREE II scores in six domains are (1) the scope and purpose, 70.30%; (2) stakeholder involvement, 37.61%; (3) rigor of development, 33.97%; (4) clarity of presentation, 68.16%; (5) applicability, 44.23% and (6) editorial independence, 40.06%. The overall quality of evidence was level B. The summarised recommendations for clinical practice encompass the following six areas: airway humidification, management of the trach cuff, management of inner cannula, tracheostoma care, tracheostomy suctioning and management and prevention of common post‐operative complications. Conclusions: The overall quality of the clinical guidelines on non‐ventilated tracheostomy care was moderate, and further improvements are needed in domains of stakeholder involvement, applicability, clarity of presentation and editorial independence. Recommendations on non‐ventilated tracheostomy care are often embedded in the guidelines on ventilated tracheostomy. Specific clinical guidelines are needed to provide a standardised approach to tracheostomy care for non‐ventilated patients. Relevance to clinical practice: Patients with non‐ventilated tracheostomy need specialised airway management. Improving patient outcomes requires standardised protocols, patient involvement, quality evaluation, and interdisciplinary approaches. No patient or public contribution: The study reviewed clinical practice guidelines and consensus statements, therefore patient or public input was not needed. [ABSTRACT FROM AUTHOR]

Accessible Summary: What is known on the subject?: Children and adolescents' mental health problems, such as autism spectrum disorder, anxiety disorder and attention‐deficit hyperactivity disorder, are a global public health concern, and nurses require advanced expertise and skills to properly care for this population.There is a gap between the required competencies and the actual skills and knowledge of CAMHN practitioners. Previous studies suggest that educational interventions for nurses are necessary to enhance the quality of care for children and adolescents with mental health problems. However, the corresponding evaluation indicators have not been verified, making it difficult to determine the most effective methods. What this paper adds to existing knowledge?: The present study developed the two‐factor (direct care for children and their family members and approach to the care environment) Clinical Competency Assessment Scale in Child and Adolescent Mental Health Nursing (CCAS‐CAMHN).We demonstrated that the assessment scale was reliable and valid, based on its adequate internal consistency and temporal stability, the acceptable range of its model‐fit indexes, and its good concurrent and divergent validity. What are the implications for practice?: The newly developed scale is useful for assessing nurses' competency and could help them identify their difficulties in CAMHN.The scale could contribute to the development of effective educational interventions to enhance the quality of care for children and adolescents with mental health problems. Introduction: Caring for children and adolescents with mental health problems, such as autism spectrum disorder, anxiety disorder and attention‐deficit hyperactivity disorder, requires expertise and skills. A quantitative clinical competency measurement tool in child and adolescent mental health nursing (CAMHN) is needed to evaluate the indicators of advanced expertise. Aim: The aim of this study was to develop a clinical competency assessment scale in CAMHN and evaluate its psychometric properties. Method: Scale items were derived from previous studies and adjusted based on cognitive interviews with five CAMHN experts. In total, 505 nurses in CAMHN from 29 hospitals in Japan participated in the self‐administered survey. The scale's construct validity, criterion‐related validity, internal consistency and test–retest reliability were assessed. Results: A two‐factor (direct care for children and their family members and approach to the care environment) scale was constructed. A secondary structural model showed that a two‐factor model fits best. The total score was significantly and positively correlated with excellence in nursing practice, amount of clinical experience and mental status. The overall scale exhibited good validity and reliability. Discussion: The scale is reliable and valid for assessing CAMHN clinical competency. Implications for Practice: The scale is useful for assessing nurses' competency and evaluating educational interventions' effectiveness for nurses. [ABSTRACT FROM AUTHOR]