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Purpose: Management reasoning is a distinct subset of clinical reasoning. We sought to explore features to be considered when designing assessments of management reasoning. Methods: This is a hybrid empirical research study, narrative review, and expert perspective. In 2021, we reviewed and discussed 10 videos of simulated (staged) physician-patient encounters, actively seeking actions that offered insights into assessment of management reasoning. We analyzed our own observations in conjunction with literature on clinical reasoning assessment, using a constant comparative qualitative approach. Results: Distinguishing features of management reasoning that will influence its assessment include management scripts, shared decision-making, process knowledge, illness-specific knowledge, and tailoring of the encounter and management plan. Performance domains that merit special consideration include communication, integration of patient preferences, adherence to the management script, and prognostication. Additional facets of encounter variation include the clinical problem, clinical and nonclinical patient characteristics (including preferences, values, and resources), team/system characteristics, and encounter features. We cataloged several relevant assessment approaches including written/computer-based, simulation-based, and workplace-based modalities, and a variety of novel response formats. Conclusions: Assessment of management reasoning could be improved with attention to the performance domains, facets of variation, and variety of approaches herein identified. [ABSTRACT FROM AUTHOR]

Abstract Background The assessment of plaque indices may be time-consuming and error-prone. Simplification of these indices may increase their utility without compromising their validity. The aim of this study was to evaluate the validity of two simplified versions of the Marginal Plaque Index (MPI). Methods Two simplified versions of the MPI as well as the Plaque Control Record (PCR) were derived from full-scale MPI assessments in two studies with four age groups (N = 42 10-year-olds; N = 24 15 year-olds; N = 53 university students (18y-33y); N = 66 parents (32y-57y). Correlations with the Turesky modification of the Quigley-Hein Index (TQHI) and the Papillary Bleeding Index (PBI) were calculated. Results The indices derived from the MPI showed high convergence with each other (all r ≥ 0.94) and with the TQHI (r ≥ 0.80). The concurrent validity of the MPI with the PBI was equal to that of the TQHI in all age groups. The simplified versions of the MPI and the PCR show a lower convergent validity with the PBI than the MPI within parents (p

ABSTRACT Objectives: to analyze the psychometric properties of the ProQOL-BR instrument in hospital nursing professionals. Methods: a methodological study to validate the ProQOL-BR. Confirmatory factor analysis, assessment of local and global adjustment quality, Pearson hypothesis testing and Cronbach’s alpha internal consistency analysis were used. Results: a total of 490 professionals participated. The model presents adequate quality due to factor weights (λ≥ 0.40), acceptable overall fit quality and adequate chi-square ratio and degrees of freedom (χ2/g.1=2.51) for the parameters of CFI (0.923), GFI (0.902), TLI (0.914) and RMSEA (0.042). In terms of validity, it was shown to be adequate with CC=0.89. The internal consistency obtained by standardized Cronbach’s alpha was 0.761. Criterion validity was shown to be favorable with significant correlations (0.001). Conclusions: the instrument was validated regarding content, criteria and reliability. Three questions were removed from the original instrument, ProQOL-BR, leaving the final instrument with 25 questions.

Objective: The Temperament Evaluation of Memphis, Pisa, Paris, and San Diego -- Auto-questionnaire (TEMPS-A) assesses five affective temperaments and has been translated into 32 languages. A 35-item short version is available in Persian, but the complete version is not yet translated. This study aimed to assess the validity and reliability of the complete Persian version of the TEMPS-A in an Iranian population. Method: This descriptive study translated the TEMPS-A questionnaire from English to Persian using a standard forwardbackward method. The translation was evaluated for face and content validity by 10 psychiatry specialists, with quantitative content validity assessed through content validity ratio (CVR) and content validity index (CVI) calculations. The Persian TEMPS-A was completed twice, with a two-week interval, by 30 individuals out of the 319 medical staff of Imam Hossein Hospital in Tehran, Iran, who participated in the study, and its reliability was evaluated using Cronbach's alpha. The questionnaire was then distributed to the entire sample (n = 319) for the analysis of temperament frequencies and statistical indices by a statistician. Results: The Persian version of the TEMPS-A, consisting of 110 items across five factors (depressive, cyclothymic, hyperthymic, irritable, and anxious), demonstrated excellent reliability with Cronbach's alpha values of 0.910, 0.909, 0.911, 0.910, and 0.909, respectively. The questions related to cyclothymic and hyperthymic temperaments exhibited the highest and lowest correlation coefficients with the general scale, respectively. Most subscales in the Persian TEMPS-A version showed correlation coefficients ranging from 0.28 to 0.68. An ANOVA with Cochrane's test revealed a significant difference in the mean scores of the questionnaire items (P < 0.001), with a grand mean score of 1.73 across all questions. Conclusion: The Persian version of the TEMPS-A, consisting of 110 items, showed good internal consistency and a strong correlation with the original version. This suggests that it is suitable for use in temperament studies among the Iranian population. [ABSTRACT FROM AUTHOR]

Abstract Background Several instruments have been designed to assess the childbirth experience. The Childbirth Experience Questionnaire (CEQ) is one of the most widely used tools. There is an improved version of this instrument, the Childbirth Experience Questionnaire (CEQ 2.0), which has not been adapted or validated for use in Spain. The aim of present study is to adapt the CEQ 2.0 to the Spanish context and evaluate its psychometric properties. Methods This research was carried out in 2 stages. In the first stage, a methodological study was carried out in which the instrument was translated and back-translated, content validity was assessed by 10 experts (by calculating Aiken's V coefficient) and face validity was assessed in a sample of 30 postpartum women. In the second stage, a cross-sectional study was carried out to evaluate construct validity by using confirmatory factor analysis, reliability evaluation (internal consistency and temporal stability) and validation by known groups. Results In Stage 1, a Spanish version of the CEQ 2.0 (CEQ-E 2.0) was obtained with adequate face and content validity, with Aiken V scores greater than 0.70 for all items. A final sample of 500 women participated in Stage 2 of the study. The fit values for the obtained four-domain model were RMSEA = 0.038 [95% CI: 0.038–0.042], CFI = 0.989 [95% CI: 0.984–0.991], and GFI = 0.990 [95% CI: 0.982–0.991]. The overall Omega and Cronbach's Alpha coefficients were 0.872 [95% CI: 0.850–0.891] and 0.870 [95% CI: 0.849–0.890] respectively. A coefficient of intraclass correlation of 0.824 [95% CI: 0.314–0.936] (p ≤ 0.001) and a concordance coefficient of 0.694 [95% CI: 0.523–0.811] were obtained. Conclusions The Spanish version of CEQ 2.0 (CEQ-E 2.0), has adequate psychometric properties and is a valid, useful, and reliable instrument for assessing the childbirth experience in Spanish women.

The validation of evaluation instruments such as the Objective Structured Clinical Examination (OSCE) in healthcare education is crucial for precise clinical skills assessments, which are requisites for professional practice. This study aims to validate an OSCE designed specifically for physical therapy students enrolled in the electrophysical agents course. A non-experimental cross-sectional study included 167 fourth-year students (86 men, 79 women, average age 21 years ±1.3) at Andres Bello University. The OSCE, comprising five stations (S1-S5) assessing electrophysical agent applications, constituted 30% of the course grade. Stations evaluated generic skills, clinical reasoning, and practical abilities with checklists. Statistical Analysis KR-20 for internal consistency and exploratory factor analysis for construct validity, with the removal of criteria with low correlations and high eigenvalues to refine the instrument. Descriptive statistics indicated a non-normal score distribution (p<0.01) across stations. Notably, stations S1 (connective tissue flexibility) and S5 (equipment installation) exhibited notable performance. The KR-20 statistic showed that most stations had high (S2-S4) or very high (S1, S2) reliability. Analysis by domain revealed low internal consistency (<0.4) for generic and practical skills, specifically for S3 (drainage), S4 (strengthening), and S5 (equipment installation). Factor analysis identified underlying latent variables, particularly in S2, S3, and S4. Refinement led to the removal of 6,7, and 3 criteria from S1, S2-S4, and S5, respectively, resulting in improved reliability and construct validity in the instrument. The enhancements in validity and internal consistency, justifying the removal of the generic domain. [ABSTRACT FROM AUTHOR]

Background: Several instruments have been designed to assess the childbirth experience. The Childbirth Experience Questionnaire (CEQ) is one of the most widely used tools. There is an improved version of this instrument, the Childbirth Experience Questionnaire (CEQ 2.0), which has not been adapted or validated for use in Spain. The aim of present study is to adapt the CEQ 2.0 to the Spanish context and evaluate its psychometric properties. Methods: This research was carried out in 2 stages. In the first stage, a methodological study was carried out in which the instrument was translated and back-translated, content validity was assessed by 10 experts (by calculating Aiken's V coefficient) and face validity was assessed in a sample of 30 postpartum women. In the second stage, a cross-sectional study was carried out to evaluate construct validity by using confirmatory factor analysis, reliability evaluation (internal consistency and temporal stability) and validation by known groups. Results: In Stage 1, a Spanish version of the CEQ 2.0 (CEQ-E 2.0) was obtained with adequate face and content validity, with Aiken V scores greater than 0.70 for all items. A final sample of 500 women participated in Stage 2 of the study. The fit values for the obtained four-domain model were RMSEA = 0.038 [95% CI: 0.038–0.042], CFI = 0.989 [95% CI: 0.984–0.991], and GFI = 0.990 [95% CI: 0.982–0.991]. The overall Omega and Cronbach's Alpha coefficients were 0.872 [95% CI: 0.850–0.891] and 0.870 [95% CI: 0.849–0.890] respectively. A coefficient of intraclass correlation of 0.824 [95% CI: 0.314–0.936] (p ≤ 0.001) and a concordance coefficient of 0.694 [95% CI: 0.523–0.811] were obtained. Conclusions: The Spanish version of CEQ 2.0 (CEQ-E 2.0), has adequate psychometric properties and is a valid, useful, and reliable instrument for assessing the childbirth experience in Spanish women. [ABSTRACT FROM AUTHOR]

Wee Kyung Lee, Sung Rae Shin Department of Nursing, Sahmyook University, Seoul, South KoreaCorrespondence: Sung Rae Shin, Department of Nursing, Sahmyook University, 815 Hwarang-ro, Nowon-gu, Seoul, 01795, South Korea, Tel +82-2-3399-1588, Fax +82-2-3399-1594, Email shinsr@syu.ac.krIntroduction: Emerging Infectious Diseases are one of the world’s leading causes of death, and preventive measures must be implemented to minimize human casualties. Research on preventive behavior relies on the preventive behavior scale and it has an impact on the findings.Purpose: This study aimed to develop an Emerging Infectious Diseases Preventive Health Behavior (EID-PHB) Scale and verify the validity and reliability of the complex models.Methods: Initial items were generated through a literature review and interviews, based on the proposed conceptual framework of transmission-based precautions. 14 experts reviewed the preliminary items for content validity and 20 adults for face validity. Data were collected online by a research company from April 28 to May 3, 2023. A total of 533 participants completed the survey, and subjects were assigned through simple random sampling. The first sample (n = 330) was used for item analysis and Exploratory Factor Analysis (EFA), and the second sample (n = 203) was used for Confirmatory Factor Analysis (CFA), convergent validity, discriminant validity, criterion validity, and reliability. The test-retest reliability was assessed in 34 adults.Results: The final instrument derived six components (droplet, contact, airborne, bloodborne, environmental prevention, and psychological coping), nine indicators, and 34 items. The CFA indicated that all the complex models had a good fit and the integrated factors were confirmed through validity tests. The Cronbach’s alpha for the 34 items was 0.92, and the criterion validity was verified (r = 0.85, p < 0.001).Conclusion: The EID-PHB is a valid and reliable tool that can be used to determine preventive behaviors against emerging infectious diseases. This tool is expected to provide a conceptual framework for future research, contribute to the clinical practice and education, and establish strategies and policies for improving individual and public health.Keywords: emerging infectious disease, health behavior, primary prevention, validation studies as topic

Obstetric violence refers to dehumanized or derogative treatment of women in their pregnancy, childbirth or postpartum periods and may be manifested in different ways. Currently, there is no tool validated in Spain to measure women’s perception of obstetric violence. The objective of this study was to carry out the cultural adaptation and validation of an existing 14-item obstetric violence scale in the Spanish context and to evaluate its psychometric properties. The research was conducted in two phases: first, a methodological study designed to evaluate content validity, through assessments by eight experts (calculating the Aiken V coefficient) and face validity in a sample of 20 women; second, a cross-sectional study to evaluate construct validity (through confirmatory factor analysis and Rasch analysis), divergent validity against a scale of birth satisfaction, known-groups validity and, finally, reliability. In Phase 1, Aiken V values higher than 0.71 were obtained for all items. Phase 2 was conducted on a sample of 256 women and the fit values for the unidimensional model were RMSEA: 0.070 (95% CI: 0.059–0.105) and GFI: 0.982 (95% CI: 0.823–0.990). The Rasch analysis indicated poor performance of item 2, which was removed. The Omega and Cronbach’s Alpha coefficients were 0.863 and 0.860, respectively. A final 13-item version of the Obstetric Violence Scale was produced, with a total score ranging from 0 (no obstetric violence perception) to 52 (maximum obstetric violence perception). The Obstetric Violence Scale is a reliable and useful tool to measure women’s perception of obstetric violence. This study was not registered.

Obstetric violence refers to dehumanized or derogative treatment of women in their pregnancy, childbirth or postpartum periods and may be manifested in different ways. Currently, there is no tool validated in Spain to measure women's perception of obstetric violence. The objective of this study was to carry out the cultural adaptation and validation of an existing 14-item obstetric violence scale in the Spanish context and to evaluate its psychometric properties. The research was conducted in two phases: first, a methodological study designed to evaluate content validity, through assessments by eight experts (calculating the Aiken V coefficient) and face validity in a sample of 20 women; second, a cross-sectional study to evaluate construct validity (through confirmatory factor analysis and Rasch analysis), divergent validity against a scale of birth satisfaction, known-groups validity and, finally, reliability. In Phase 1, Aiken V values higher than 0.71 were obtained for all items. Phase 2 was conducted on a sample of 256 women and the fit values for the unidimensional model were RMSEA: 0.070 (95% CI: 0.059–0.105) and GFI: 0.982 (95% CI: 0.823–0.990). The Rasch analysis indicated poor performance of item 2, which was removed. The Omega and Cronbach's Alpha coefficients were 0.863 and 0.860, respectively. A final 13-item version of the Obstetric Violence Scale was produced, with a total score ranging from 0 (no obstetric violence perception) to 52 (maximum obstetric violence perception). The Obstetric Violence Scale is a reliable and useful tool to measure women's perception of obstetric violence. This study was not registered. [ABSTRACT FROM AUTHOR]

ObjectiveMercury sphygmomanometer (MS) has now been less and less used and no new devices have been manufactured (according to Minamata convention 2013). The application of the electronic sphygmomanometer (ES) in clinical practice has become increasingly common. However, reliable evidence for the use of the ES in high-altitude areas remains scarce. The purpose of this study was to validate the applicability of the ES in high altitude areas.MethodsIn Luhuo County, Sichuan Province, China, 3,400 m above the sea level, two trained physicians measured the blood pressure (BP) of participants using both the mercury sphygmomanometer and the ES. Pearson correlation analysis and paired T-test, respectively, were used to compare the correlation and the difference between the BP values measured by the two devices. The applicability of the ES in high-altitude areas was evaluated according to the validation standards of the 2018 Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.ResultsIn this study, 257 participants were included. There was a strong correlation between BP values measured by the two devices, with correlation coefficients for systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 0.97 and 0.93, respectively. Compared with the MS, the ES tended to measure the subjects' DBP (76.21 ± 13.29 mmHg vs. 76.53 ± 14.07 mmHg; P = 0.557) accurately, but overestimate the SBP of the subjects (123.32 ± 22.25 mmHg vs. 121.34 ± 22.88 mmHg; P

Abstract Introduction Patients undergoing major cardiothoracic or abdominal surgery are at increased risk of developing post‐operative pulmonary complications (PPC), but respiratory physiotherapy can prevent PPC. We have previously developed the PPC Risk Prediction Score to allocate physiotherapists' resources and stratify patients into three risk groups. In this study, we performed a temporal external validation of the PPC Risk Prediction Score. Such validation is rare and adds to the originality of this study. Methods A cohort of 360 patients, admitted to undergo elective cardiothoracic or abdominal surgery, were included. Performance and clinical usefulness of the PPC Risk Prediction Score were estimated through discrimination, calibration and clinical usefulness, and the score was updated. Results The score showed c‐statistics of 0.62. Related to clinical usefulness, a cut point at 8 gave a sensitivity of 0.49 and a specificity of 0.70, whereas a cut point at 12 gave a sensitivity of 0.13 and a specificity of 0.95. Two predictors included in the development sample score, thoraco‐abdominal incision odds ratio (OR) 2.74 (1.12;6.71) and sternotomy OR 2.09 (1.18;3.72), were statistically significantly associated to PPC in the validation sample. Conclusions The score was not able to discriminate between patients with and without PPC; neither was the updated score, but the study identified clinically relevant risk factors for developing PPC.

Background and Objectives: Validation of the tools used for assessing the quality of life (QoL) can help address the problems of patients with COVID-19 in Iran. Therefore, this study aims to validate the electronic form of the Persian version of health-related quality of life (HRQoL) questionnaire for Iranian patients with COVID-19. Methods: This is a psychometric study. The study population included all patients with COVID-19 in Tehran, Iran. Samples were selected by a cluster sampling method. In this regard, 100 patients were selected for determining the criterion validity and 330 were selected for assessing the convergence validity. The research data were collected electronically by using Hlubocky et al.’s HRQoL questionnaire and the World Health Organization quality of life-BREEF (WHOQoL-BREF) questionnaire. Content validity, convergence validity, and factor analysis methods were used to evaluate the psychometric properties of the Persian HRQoL. The reliability was assessed by internal consistency and split-half methods. Results: The results of exploratory factor analysis showed that the questionnaire had two factors. It had also good validity and reliability. The second-order confirmatory factor analysis confirmed its two-factor structure. Its score had good relationship with the score of WHOQoOL-BREF. Conclusion: The electronic form of the Persian HRQoL can be used to assess the QoL of patients with COVID-19 in Iran.

Background and Purpose: Adapting cross-culturally the Hospital Ethical Climate Survey to Brazilian nurses. Methods: A methodological study comprising translation, back translation, multidisciplinary committee, expert panel, pilot test and validation of the instrument. The validation was carried out with 269 nurses of a university hospital in the South of Brazil. Results: In the validation step, the quadratic weighted Kappa test–retest and the correlation coefficient ranged from 0.15 to 0.74. All factor loadings were higher than 0.4, ranging from 0.445 to 0.859. The Portuguese version of the instrument had a 0.93 Cronbach's alpha and the confirmatory analysis demonstrated the model's suitability with five factors and 26 items validated. Conclusions: The version of the instrument adapted to Brazilian Portuguese was considered valid and reliable in this sample. [ABSTRACT FROM AUTHOR]

Abstract Background Colorectal cancer is one of the most common cancers in the world. Several studies suggest using the Asia-Pacific colorectal screening (APCS) score and its modified versions to select high-risk populations for early colonoscopy, but external validation remains rare, and which score should be selected for CRC screening in China is unclear. Validation of multiple scores in the same population might help to choose the best performing score. Methods We conducted a cross-sectional study under the framework of Cancer Screening Program in Urban China, data from asymptomatic colorectal cancer screening in Xuzhou was used to validate the APCS score, the colorectal neoplasia predict (CNP) score, the Korean colorectal screening (KCS) score, the Modified APCS score and the 8-point risk score in predicting colorectal advanced neoplasia (CAN). Results 1804 subjects were included in the analysis and 112 CAN (6.21%) was detected. In each score, the detection rate of CAN was higher in the high-risk group than in the non-high-risk group (P

Abstract Background To our knowledge, there is currently no psychometrically validated Hungarian scale to evaluate nurses’ knowledge about infection prevention and control (IPC) practices. Thus, we aim in this study to assess the validity and reliability of the infection control standardized questionnaire Hungarian version (ICSQ-H). Methods A cross-sectional, multisite study was conducted among 591 nurses in Hungary. The original ICSQ included 25 questions. First, the questionnaire was translated into Hungarian. Then, content validity was assessed by a committee of four specialists. This was done by calculating the item content validity index and scale content validity index. Afterward, structural validity was evaluated in a two-step process using principal component analysis and confirmatory factor analysis. The goodness of fit for the model was measured through fit indices. Convergent validity was assessed by calculating the average variance extracted. Additionally, discriminant validity was evaluated by computing the Spearman correlation coefficient between the factors. Finally, the interitem correlations, the corrected item-total correlations, and the internal consistency were calculated. Results The content validity of the questionnaire was established with 23 items. The final four-factor ICSQ-H including 10 items showed a good fit model. Convergent validity was met except for the alcohol-based hand rub (ABHR) factor, while discriminant validity was met for all factors. The interitem correlations and the corrected item-total correlations were met for all factors, but the internal consistency of ABHR was unsatisfactory due to the low number of items. Conclusions The results did not support the original three-factor structure of the ICSQ. However, the four-factor ICSQ-H demonstrated an adequate degree of good fit and was found to be reliable. Based on our findings, we believe that the ICSQ-H could pave the way for more research regarding nurses’ IPC knowledge to be conducted in Hungary. Nevertheless, its validation among other healthcare workers is important to tailor effective interventions to enhance knowledge and awareness.

Background and Objectives: It is predicted that the negative effects of the novel coronavirus disease 2019 (COVID-19) pandemic will continue. These negative effects are not limited to psychological problems. Serious physiological and economic problems have also been observed. It is important to develop and standardize appropriate tools to assess its different effects. This study aims to investigate the psychometric properties of the Persian version of the COVID-19 Phobia Scale (C19P-S) in Iranian samples. Methods: In this study, participants were people aged 18-60 years in Iran from March to May 2022, who were selected by a convenience sampling method. In order to evaluate the convergent and discriminant validity, the second version of the acceptance and action questionnaire, the brief version of the difficulty in emotion regulation scale, and the fear of COVID‐19 scale were used. The factor structure of the questionnaire was examined by confirmatory factor analysis. Reliability was examined using Cronbach’s alpha coefficient and the test-retest method. The data were analyzed in SPSS version 25 and LISREL version 8.8. Results: The results of confirmatory factor analysis confirmed the four-factor structure the Persian C19P-S. Cronbach’s alpha coefficient for the whole scale was 0.90; for the subscales of psychological, psychological, economic and social factors, it was 0.87, 0.88, 0.89, and 0.91, respectively. In addition, the test-retest reliability with a four-week interval for the whole scale was 0.86; for the subscales of psychological, psychological, economic and social factors, it was 0.83, 0.79, 0.82, and 0.88, respectively. The correlation coefficients indicated the favorable convergent and discriminant validity of the Persian C19P-S (P

Midwifery empowerment is an important topic. The most widely used instrument to measure the perceived empowerment of midwives is the Perceptions of Empowerment in Midwifery Scale (PEMS), which has not been validated in Spain. The aim of this study was to translate and adapt the PEMS to the Spanish context. This research was carried out in two phases; Phase 1: Methodological study; translation, backtranslation and cross-cultural adaptation of the PEMS and pilot study on the target population (10 midwives) for evaluation of face validity. Phase 2: Cross-sectional observational study to obtain a sample for construct validation by Exploratory Factor Analysis and measurement of PEMS-e reliability. Additionally, an inferential analysis was carried out to study the possible association between several collected variables and PEMS-e subscale-scores. A total of 410 midwives from 18 Spanish regions participated in the study through an online questionnaire. An initial Spanish version of the PEMS scale was produced, demonstrating adequate face validity. A final model was produced for the PEMS-e, which included 17 items classified into two subscales ("Organizational support" and "Own skills and teamwork") with fit indexes RMSEA = 0.062 (95%CI: 0.048–0.065) and AGFI = 0.985 (95%CI: 0.983–0.989) and Cronbach's alpha 0.922 for the total scale. Results showed that one in four midwives had considered abandoning the profession in the last 6 months (p ≤ 0.001). This research suggests that Spanish midwives perceive their empowerment level as low. The PEMS-e is a valid tool with solid psychometric properties that can be used in future research to identify factors that contribute to increased empowerment among Spanish midwives and inform strategies to improve job satisfaction and retention in the profession. [ABSTRACT FROM AUTHOR]

Many related scales have been developed and applied to measure patients' medication adherence, but the research on the psychometric characteristics of the scale still requires further studies. This study aims to provide further validation of the GMAS scale by using Rasch analysis and to make targeted recommendations for scale improvement. This is a cross-sectional study using secondary data. 312 Chinese adult patients were recruited from two tertiary hospitals and one community health service center in Tianjin to complete a questionnaire containing the GMAS, from January to June 2020. Participants included to have at least one chronic condition and also have been on medication for more than 3 months, but excluded patients with major life-threatening illnesses (e.g. heart failure, cancer), cognitive impairments preventing clear expression and significant communication difficulties. Rasch analysis was used to explore the psychometric properties of the GMAS scale. Key indicators including unidimensionality, validity and reliability, differential item functioning and degree of fit with Rasch model are validated. After fitting the Rasch model for the first time, 56 samples poorly fitting the model were deleted. The remaining 256 samples were used for Rasch analysis. The results show that GMAS can fit the Rasch model well, which proves that the scale has favourable psychometric characteristics. But some items had differential item functioning in whether patients have comorbidities. The GMAS was found to be useful as a screening tool for patients' medication adherence problems reported, except some issues to be addressed for further improvement of the scale. [ABSTRACT FROM AUTHOR]

Background: To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs. Methods: A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website. Results: We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings. Conclusions: Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation. [ABSTRACT FROM AUTHOR]

Introduction: Patients undergoing major cardiothoracic or abdominal surgery are at increased risk of developing post‐operative pulmonary complications (PPC), but respiratory physiotherapy can prevent PPC. We have previously developed the PPC Risk Prediction Score to allocate physiotherapists' resources and stratify patients into three risk groups. In this study, we performed a temporal external validation of the PPC Risk Prediction Score. Such validation is rare and adds to the originality of this study. Methods: A cohort of 360 patients, admitted to undergo elective cardiothoracic or abdominal surgery, were included. Performance and clinical usefulness of the PPC Risk Prediction Score were estimated through discrimination, calibration and clinical usefulness, and the score was updated. Results: The score showed c‐statistics of 0.62. Related to clinical usefulness, a cut point at 8 gave a sensitivity of 0.49 and a specificity of 0.70, whereas a cut point at 12 gave a sensitivity of 0.13 and a specificity of 0.95. Two predictors included in the development sample score, thoraco‐abdominal incision odds ratio (OR) 2.74 (1.12;6.71) and sternotomy OR 2.09 (1.18;3.72), were statistically significantly associated to PPC in the validation sample. Conclusions: The score was not able to discriminate between patients with and without PPC; neither was the updated score, but the study identified clinically relevant risk factors for developing PPC. [ABSTRACT FROM AUTHOR]

Resumen: Introducción: La observación de una toma por parte de algún profesional es importante para afianzar la lactancia materna. Se tradujo al español y se validó la escala de observación de una toma, la Bristol Breastfeeding Assessment Tool (BBAT). Material y métodos: Se hizo traducción y retrotraducción de la escala original. Colaboraron seis pediatras y seis enfermeras de pediatría. En la primera visita del recién nacido se observó una toma y el pediatra y la enfermera puntuaron la escala BBAT de manera independiente. La enfermera también puntuó la escala de observación de una toma, LATCH Breastfeeding Assessment (LATCH), y cada madre rellenó la escala de autoeficacia para la lactancia, Breastfeeding Self-Efficacy Scale (BSES-SF). Las madres fueron citadas una semana después, volviendo a puntuar la BBAT la enfermera. Resultados: Participaron 62 madres. La BBAT presenta una buena consistencia interna (alfa de Cronbach = 0,83 en la valoración hecha por las enfermeras y alfa de Cronbach = 0,79 en la valoración hecha por las pediatras). La fiabilidad interjueces muestra un coeficiente de correlación intraclase de 0,91, mientras que para el test-retest fue de 0,67. La validez concomitante con la escala BSES-SF fue buena y con la escala LATCH muy buena. El análisis factorial mostró el carácter unidimensional de la escala y una buena homogeneidad de los cuatro ítems (posición = 0,771, agarre = 0,852, succión = 0,856 y deglución = 0,679). Conclusiones: La traducción obtenida presenta una buena fiabilidad y validez. La BBAT es una herramienta fácil de utilizar que permite valorar una toma y determinar los aspectos que se tienen que mejorar. Abstract: Introduction: The observation of a feeding by a professional is important to strengthen breastfeeding. The Bristol Breastfeeding Assessment Tool (BBAT) was translated into Spanish and validated. Material and methods: Translation and back-translation of the original scale was done. Six pediatricians and six pediatric nurses collaborated. At the newborn's first visit, a feeding was observed and the pediatrician and nurse scored the BBAT scale independently. The nurse also scored the LATCH Breastfeeding Assessment (LATCH) and each mother filled out the Breastfeeding Self-Efficacy Scale (BSES-SF). Mothers were appointed a week later and the nurse re-scored the BBAT. Results: A total of 62 mothers participated. There was good internal consistency for the BBAT (Cronbach's alpha = 0.83 in the assessment made by the nurses and Cronbach's alpha = 0.79 in the assessment made by the pediatricians). Inter-rater consistency showed an intra-class correlation coefficient of 0.91, while for the test–retest was 0.67. Concurrent validity with the BSES-SF scale was good and with the LATCH scale very good. The factor analysis showed the one-dimensional character of the scale and a good homogeneity of the 4 items (positioning = 0.771, attachment = 0.852, sucking = 0.856 and swallowing = 0.679). Conclusions: The scale obtained in Spanish shows good reliability and validity. The BBAT is an easy-to-use tool that allows breastfeeding assessment and determines the aspects that need to be improved.

N/a.

Good practices in artificial intelligence (AI) model validation are key for achieving trustworthy AI. Within the cancer imaging domain, attracting the attention of clinical and technical AI enthusiasts, this work discusses current gaps in AI validation strategies, examining existing practices that are common or variable across technical groups (TGs) and clinical groups (CGs). The work is based on a set of structured questions encompassing several AI validation topics, addressed to professionals working in AI for medical imaging. A total of 49 responses were obtained and analysed to identify trends and patterns. While TGs valued transparency and traceability the most, CGs pointed out the importance of explainability. Among the topics where TGs may benefit from further exposure are stability and robustness checks, and mitigation of fairness issues. On the other hand, CGs seemed more reluctant towards synthetic data for validation and would benefit from exposure to cross-validation techniques, or segmentation metrics. Topics emerging from the open questions were utility, capability, adoption and trustworthiness. These findings on current trends in AI validation strategies may guide the creation of guidelines necessary for training the next generation of professionals working with AI in healthcare and contribute to bridging any technical-clinical gap in AI validation. RELEVANCE STATEMENT: This study recognised current gaps in understanding and applying AI validation strategies in cancer imaging and helped promote trust and adoption for interdisciplinary teams of technical and clinical researchers. KEY POINTS: Clinical and technical researchers emphasise interpretability, external validation with diverse data, and bias awareness in AI validation for cancer imaging. In cancer imaging AI research, clinical researchers prioritise explainability, while technical researchers focus on transparency and traceability, and see potential in synthetic datasets. Researchers advocate for greater homogenisation of AI validation practices in cancer imaging., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: AJ-P is affiliated with Quibim SL. The remaining authors declare that they have no competing interests., (© 2025. The Author(s).)

Introduction: Dementia is one of the most relevant widespread diseases, with a prevalence of currently 55 million people with dementia worldwide. However, about 60-75% of people with dementia have not yet received a formal diagnosis. Asymptomatic screening of cognitive impairments using neuropsychiatric tests has been proven to efficiently enhance diagnosis rates. Digital screening tools, in particular, provide the advantage of being accessible without spatial or time restrictions. The study aims to validate a digital cognitive screening test (digiDEM-SCREEN) as an app in the German language., Methods and Analysis: This is a multicentre study in Bavaria. Participants are people with mild cognitive impairment, people with dementia in an early stage and cognitively healthy people. Recruitment will take place in specialised diagnostic facilities (memory outpatient clinics). 135 participants are aimed based on a power analysis. Sociodemographic data, diagnosis and results of neuropsychiatric tests (Consortium to Establish a Registry for Alzheimer's Disease, Montreal Cognitive Assessment, digiDEM-SCREEN) will be collected at one point per person via electronic data capturing. The sensitivity, specificity and corresponding cut-off values will be determined based on receiver-operating-characteristic curves. The correlation of the digiDEM-SCREEN test with existing cognitive screening/testing procedures will be analysed., Ethics and Dissemination: The study obtained ethical approval from the Ethics Committee of the Julius-Maximilians-Universität of Würzburg (JMU) (application number: 177/23-sc). The test will give feedback about the current cognitive status and possible cognitive impairments that should lead to the users seeking further diagnostic measures by medical professionals. It will be accessible free of charge in established app stores. The results of the validation study will be published in peer-reviewed journals., Competing Interests: Competing interests: RP is a shareholder in Lenox uG, which has set itself the goal of translating scientific findings into digital health applications. Lenox uG holds shares in HealthStudyClub GmbH. For its part, HealthStudyClub GmbH is responsible for developing the technical app for this project. KK is also a shareholder in HealthStudyClub GmbH and has joined the company as chief technical developer. digiDEM Bayern that is funded by the Bavarian State Ministry of Health, Care and Prevention is owner of the data., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Heart failure (HF) is a complex clinical syndrome. Accurate risk stratification and early diagnosis of HF are challenging as its signs and symptoms are non-specific. We propose to address this global challenge by developing the STRATIFYHF artificial intelligence-driven decision support system (DSS), which uses novel analytical methods in determining the risk, diagnosis and prognosis of HF. The primary aim of the present study is to collect prospective clinical data to validate the STRATIFYHF DSS (in terms of diagnostic accuracy, sensitivity and specificity) as a tool to predict the risk, diagnosis and progression of HF. The secondary outcomes are the demographic and clinical predictors of risk, diagnosis and progression of HF., Methods and Analysis: STRATIFYHF is a prospective, multicentre, longitudinal study that will recruit up to 1600 individuals (n=800 suspected/at risk of HF and n=800 diagnosed with HF) aged ≥45 years old, with up to 24 months of follow-up observations. Individuals suspected of HF will be divided into two categories based on current definitions and predefined inclusion criteria. All participants will have their medical history recorded, along with data on physical examination (signs and symptoms), blood tests including serum natriuretic peptides levels, ECG and echocardiogram results, as well as demographic, socioeconomic and lifestyle data, and use of complete novel technologies (cardiac output response to stress test and voice recognition biomarkers). All measurements will be recorded at baseline and at 12-month follow-up, with medical history and hospitalisation also recorded at 24-month follow-up. Cardiovascular MRI assessment will be completed in a subset of participants (n=20-40) from eligible clinical centres only at baseline. Each clinical centre will recruit a subset of participants (n=30) who will complete a 6-month home-based monitoring of clinical characteristics and accelerometry (wrist-worn monitor) to determine the feasibility and acceptability of the STRATIFYHF mobile application. Focus groups and semistructured interviews will be conducted with up to 15 healthcare professionals and up to 20 study participants (10 at risk of HF and 10 diagnosed with HF) to explore the needs of patients and healthcare professionals prior to the development of the STRATIFYHF DSS and to evaluate the acceptability of this mobile application., Ethics and Dissemination: Ethical approval has been granted by the East Midlands - Leicester Central Research Ethics Committee (24/EM/0101). Dissemination activities will include journal publications and presentations at conferences, as well as development of training materials and delivery of focused training on the STRATIFYHF DSS and mobile application. We will develop and propose policy guidelines for integration of the STRATIFYHF DSS and mobile application into the standard of care in the HF care pathway., Trial Registration Number: NCT06377319., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Artificial Intelligence (AI) algorithms showcase the potential to steer a paradigm shift in clinical medicine, especially medical imaging. Concerns associated with model generalizability and biases necessitate rigorous external validation of AI algorithms prior to their adoption into clinical workflows. To address the barriers associated with patient privacy, intellectual property, and diverse model requirements, we introduce ClinValAI, a framework for establishing robust cloud-based infrastructures to clinically validate AI algorithms in medical imaging. By featuring dedicated workflows for data ingestion, algorithm scoring, and output processing, we propose an easily customizable method to assess AI models and investigate biases. Our novel orchestration mechanism facilitates utilizing the complete potential of the cloud computing environment. ClinValAI's input auditing and standardization mechanisms ensure that inputs consistent with model prerequisites are provided to the algorithm for a streamlined validation. The scoring workflow comprises multiple steps to facilitate consistent inferencing and systematic troubleshooting. The output processing workflow helps identify and analyze samples with missing results and aggregates final outputs for downstream analysis. We demonstrate the usability of our work by evaluating a state-of-the-art breast cancer risk prediction algorithm on a large and diverse dataset of 2D screening mammograms. We perform comprehensive statistical analysis to study model calibration and evaluate performance on important factors, including breast density, age, and race, to identify latent biases. ClinValAI provides a holistic framework to validate medical imaging models and has the potential to advance the development of generalizable AI models in clinical medicine and promote health equity.

Large Language Models (LLMs) have shown significant promise across a wide array of fields, including biomedical research, but face notable limitations in their current applications. While they offer a new paradigm for data analysis and hypothesis generation, their efficacy in computational biology trails other applications such as natural language processing. This workshop addresses the state of the art in LLMs, discussing their challenges and the potential for future development tailored to computational biology. Key issues include difficulties in validating LLM outputs, proprietary model limitations, and the need for expertise in critical evaluation of model failure modes.

Immunoassays play an important role in drug development of products targeting the immune system. Consistent quality of the results from an immunoassay is essential to make unbiased and accurate claims about the drug product during preclinical and clinical development stages. Assay qualification and validation shed light on the performance of the assay. It is the first evaluation and the verification, respectively, of the assay's performance. This tutorial explains and illustrates the calculation methodology for important assay qualification parameters including precision, relative accuracy, linearity, the lower limit of quantification (LLOQ), the upper limit of quantification (ULOQ), the assay range and dilutability. This tutorial focuses on assays used for (pre-) clinical purposes, characterized by a lognormal distribution of the measurements on its original untransformed scale and by the lack of well characterized reference material. Statistical calculations are illustrated with qualification data from an enzyme-linked immunosorbent assay (ELISA) vaccine immunoassay., (© 2024 John Wiley & Sons Ltd.)

Introduction and hypothesis: The Overactive Bladder Questionnaire (OAB-q) measures overactive bladder patients' severity of symptoms and their impact on health-related quality of life (HRQoL). The aim of this study was to validate the OAB-q in Greek patients with overactive bladder and report clinical implications of the disease. Methods: In total, 107 patients were recruited consecutively in our clinic. They completed the OAB-q and Short Form-36 Health Survey (SF-36) twice, 3 months apart. Simultaneously, they initiated lifestyle changes and drug therapy. The reliability of OAB-q was estimated by its internal consistency (Cronbach's α). Validity was estimated by criterion validity and concurrent validity by comparison with SF-36. Results: The sample's mean age was 62.1 years, and 74.8% were women. Cronbach's α exceeded the 0.7 threshold in all OAB-q subscales, implying good reliability of internal consistency for the OAB-q. In addition, moderate (Pearson's r > 0.3) or strong (r > 0.5) correlations were observed between OAB-q subscales and the relevant SF-36 subscales, implying concurrent validity. Clinically, urgency incontinence affected symptom bother (p = 0.001), concern/worry (p = 0.031) and social interaction (p = 0.027). Nocturia had the largest impact on HRQoL in patients with overactive bladder, as it affected all the OAB-q subscales (p < 0.001). Conclusions: The Greek version of the OAB-q has shown strong psychometric properties of reliability and validity in our study. Urgency incontinence and especially nocturia seem to affect the HRQoL of patients with overactive bladder. OAB-q is valid for Greek patients with overactive bladder and can be used for clinical and academic purposes. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer is one of the most common cancers in the world. Several studies suggest using the Asia-Pacific colorectal screening (APCS) score and its modified versions to select high-risk populations for early colonoscopy, but external validation remains rare, and which score should be selected for CRC screening in China is unclear. Validation of multiple scores in the same population might help to choose the best performing score.Methods: We conducted a cross-sectional study under the framework of Cancer Screening Program in Urban China, data from asymptomatic colorectal cancer screening in Xuzhou was used to validate the APCS score, the colorectal neoplasia predict (CNP) score, the Korean colorectal screening (KCS) score, the Modified APCS score and the 8-point risk score in predicting colorectal advanced neoplasia (CAN).Results: 1804 subjects were included in the analysis and 112 CAN (6.21%) was detected. In each score, the detection rate of CAN was higher in the high-risk group than in the non-high-risk group (P < 0.05), and the RR (95%C.I.) ranged 2.20 (1.50-3.22) [8-point risk] to 4.00 (2.41-6.65) [Modified APCS]. The c-statistics (95%C.I.) of the scoring systems ranged from 0.58 (0.53-0.62) [8-point risk] to 0.65 (0.61-0.69) [KCS]. The sensitivity (95%C.I.) of these systems ranged from 31.25 (22.83-40.70) [8-point risk] to 84.82 (76.81-90.90) [Modified APCS], while the specificity (95%C.I.) ranged from 43.50 (41.12-45.90) [Modified APCS] to 83.81 (81.96-85.53) [8-point risk]. Using the APCS scoring system as a comparator, the net reclassification improvement (NRI) of each modified version ranged from - 10.34% (95%C.I.: - 22.63 to 1.95%) [8-point risk] to 4.79% (95%C.I.: - 1.50% to 11.08) [KCS]. The colonoscopy resource load (95%C.I.) ranged from 9 [1-3] [8-point risk] to 11 [3-5] [APCS and Modified APCS].Conclusions: The APCS score and its modified versions have certain ability to predict the risk of advanced neoplasia and reduce the resource load. The modified APCS score and the KCS score seemed the preferable systems to classify high risk subjects based on its high RR, sensitivity and predictive ability in the selected population. Future research could focus on adding risk factors or combining with laboratory test results to improve the predictive power of the scoring system. [ABSTRACT FROM AUTHOR]

Background: To our knowledge, there is currently no psychometrically validated Hungarian scale to evaluate nurses' knowledge about infection prevention and control (IPC) practices. Thus, we aim in this study to assess the validity and reliability of the infection control standardized questionnaire Hungarian version (ICSQ-H). Methods: A cross-sectional, multisite study was conducted among 591 nurses in Hungary. The original ICSQ included 25 questions. First, the questionnaire was translated into Hungarian. Then, content validity was assessed by a committee of four specialists. This was done by calculating the item content validity index and scale content validity index. Afterward, structural validity was evaluated in a two-step process using principal component analysis and confirmatory factor analysis. The goodness of fit for the model was measured through fit indices. Convergent validity was assessed by calculating the average variance extracted. Additionally, discriminant validity was evaluated by computing the Spearman correlation coefficient between the factors. Finally, the interitem correlations, the corrected item-total correlations, and the internal consistency were calculated. Results: The content validity of the questionnaire was established with 23 items. The final four-factor ICSQ-H including 10 items showed a good fit model. Convergent validity was met except for the alcohol-based hand rub (ABHR) factor, while discriminant validity was met for all factors. The interitem correlations and the corrected item-total correlations were met for all factors, but the internal consistency of ABHR was unsatisfactory due to the low number of items. Conclusions: The results did not support the original three-factor structure of the ICSQ. However, the four-factor ICSQ-H demonstrated an adequate degree of good fit and was found to be reliable. Based on our findings, we believe that the ICSQ-H could pave the way for more research regarding nurses' IPC knowledge to be conducted in Hungary. Nevertheless, its validation among other healthcare workers is important to tailor effective interventions to enhance knowledge and awareness. [ABSTRACT FROM AUTHOR]

The fear of childbirth is a topical concern, yet the issue has barely been studied in Spain, and only one fear of childbirth measurement instrument has been validated in the country. The aim of this study was to translate, adapt and validate the Fear of Childbirth Questionnaire (CFQ) for use in Spain, as well as to describe and evaluate the psychometric properties of the Spanish version of this instrument. In a first phase, a methodological study was carried out (translation–backtranslation and cross-cultural adaptation), and pilot study was carried out in the target population. In addition, content validation of the instrument was obtained (CFQ-e) from 10 experts. In the second phase, a cross-sectional study was carried out at several centres in Gran Canaria Island to obtain a validation sample. The evaluation of the psychometric properties of the CFQ-e, including construct validity through exploratory factor analysis and confirmatory factor analysis, the calculation of reliability via factor consistency using the ORION coefficients as well as alpha and omega coefficients were carried out. The CFQ-e showed evidence of content validity, adequate construct validity and reliability. The CFQ-e is composed of 37 items distributed in four subscales or dimensions: "fear of medical interventions"; "fear of harm and dying"; "fear of pain" and "fears relating to sexual aspects and embarrassment". The CFQ-e constitutes a valid and reliable tool to measure the fear of childbirth in the Spanish pregnant population. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to develop the nursing diagnosis concept "compromised end‐of‐life syndrome" in palliative care. Methods: The authors used the integrative strategy by Meleis to develop the concept in this study and identifying clinical indicators from a literature review. For data organization, we applied the Preferred Reporting Items for Systematic Reviews and Metanalysis (PRISMA). Findings: Some clusters of unpleasant signs and symptoms in palliative care patients at the end of life, such as pain, dyspnea, depression, constipation, and anxiety, were identified. Through conceptualization, the authors propose a new nursing diagnosis, "compromised end‐of‐life syndrome." The manuscript includes a model case of a patient with nursing diagnosis syndrome as a clinical example. Conclusions: Simultaneous patterns of signs and symptoms present in the literature reinforce the utility of the proposition of end‐of‐life syndrome as a nursing diagnostic construct. Implications for nursing practice: The concept development related to patients' unpleasant signs and symptoms critically ill at palliative care supports the proposition of a new nursing diagnosis relevant to selecting adequate nursing interventions and nursing outcomes. Some clusters of unpleasant signs and symptoms in palliative care patients at the end of life, such as pain, dyspnea, depression, constipation, and anxiety were identified. Conceptualization was used to propose a new nursing diagnosis, "compromised end‐of‐life syndrome." A model case of a patient with nursing diagnosis syndrome is described as a clinical example. Conclusion: Simultaneous patterns of signs and symptoms present in the literature reinforce the utility of the proposition of end‐of‐life syndrome as nursing diagnostic construct. Implications for Nursing practice: The concept development related to patients' unpleasant signs and symptoms critically ill at palliative care supports the proposition of a new nursing diagnosis relevant to selecting adequate nursing interventions and nursing outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Asthma exacerbations or 'attacks' can vary in severity from mild worsening of symptoms to life-threatening changes that require urgent hospital care. Understanding these exacerbations is crucial to improving treatment and support for patients. Electronic health records (EHR) using anonymised data from people with asthma in primary and secondary care can be used to understand exacerbations and outcomes. However, previous studies found significant heterogeneity in the algorithms used to define asthma exacerbations. Validating definitions of asthma exacerbations in EHR will lead to more robust and comparable evidence in future research., Methods and Analysis: Medline and Embase will be searched for the key concepts relating to asthma exacerbations, EHR and validation. All studies that validate exacerbations of asthma in EHR and administrative claims databases published before 30 May 2024 and written in English will be considered. Validated algorithms for asthma exacerbations or attacks must be compared against a reference or gold standard definition, and a measure of validity must be included. Articles will be screened for inclusion by two independent reviewers with any disagreements resolved by consensus or arbitration by a third reviewer. Study details will be extracted, and the risk of bias will be assessed using a QUADAS-2 tailored to this review., Ethics & Dissemination: No ethical approval is required as this is a review of previously published literature. Results will be disseminated in a peer-reviewed journal with the aim of being used in future research to help identify asthma exacerbation in EHR., Prospero Registration Number: CRD42024545081., Competing Interests: Competing interests: The author JKQ has been supported by institutional research grants from the Medical Research Council, NIHR, Health Data Research, GSK, BI, AZ, Insmed and Sanofi and received personal fees for advisory board participation, consultancy or speaking fees from GlaxoSmithKline, Chiesi and AstraZeneca., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees' duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Clinicians, researchers, regulators, and other decision-makers increasingly rely on evidence from real-world data (RWD), including data routinely accumulating in health and administrative databases. RWD studies often rely on algorithms to operationalize variable definitions. An algorithm is a combination of codes or concepts used to identify persons with a specific health condition or characteristic. Establishing the validity of algorithms is a prerequisite for generating valid study findings that can ultimately inform evidence-based health care. In this paper, we aim to systematize terminology, methods, and practical considerations relevant to the conduct of validation studies of RWD-based algorithms. We discuss measures of algorithm accuracy, gold/reference standards, study size, prioritization of accuracy measures, algorithm portability, and implications for interpretation. Information bias is common in epidemiologic studies, underscoring the importance of transparency in decisions regarding choice and prioritizing measures of algorithm validity. The validity of an algorithm should be judged in the context of a data source, and one size does not fit all. Prioritizing validity measures within a given data source depends on the role of a given variable in the analysis (eligibility criterion, exposure, outcome, or covariate). Validation work should be part of routine maintenance of RWD sources. This article is part of a Special Collection on Pharmacoepidemiology., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard., Methods and Analysis: In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn's disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test., Ethics and Dissemination: This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20-085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals., Trial Registration Number: NCT05886322., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Federal legislation still prohibits the cultivation, sale, and consumption of cultivars of delta 9-tetrahydrocannabinol cannabis (>0.3%); however, as of November 2022, 39 states have legalized cannabis and cannabis derived products for medicinal consumption and 21 states have legalized for adult-use consumption. This state-by-state approach has produced a patch work of regulations that multi-state operators (MSOs) must learn to navigate. Furthermore, cannabis laboratories often lack the space and skill needed to perform method validations, adding another layer of complexity. While these barriers exist, it is paramount for MSOs to demonstrate the fitness of purpose of their methods., Objective: This review presents the complexity that an MSO navigated in developing microbiology method validation study designs for two proprietary real-time PCR (RT-PCR) assays to meet four state (California, Florida, Michigan, and Oklahoma) testing requirements. The testing in each state was conducted in addition to certification of the assays through the AOAC Performance Tested MethodSM (PTM) program., Methods: Matrix studies were conducted targeting three analytes (Aspergillus spp., Salmonella spp., and Shiga toxin-producing Escherichia coli) as directed by the state regulatory authorities. For California, inclusivity and exclusivity studies were performed. The number of contamination levels, test portion replicates, and total target organisms evaluated varied by state. Culture confirmation was not performed outside of the AOAC PTM studies., Results: Data from each study was collected, summarized, and provided to the state regulatory agencies. Review of the data consisted of identifying discrepant results and verification of controls. After review, each assay was certified for use in the respective state., Conclusion: Requirements from each of the states demonstrate the complexities MSOs face and emphasize the need for a more standardized approach to streamline acceptance of alternative methods., Highlights: While varying state regulations can be complex, validation studies performed for the candidate methods have led to adoption across 31 states., (© The Author(s) 2024. Published by Oxford University Press on behalf of AOAC INTERNATIONAL. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission's In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures., Objectives: This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory., Sources: It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory., Content: The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given., Implications: With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Validation of a quantitative model is a critical step in establishing confidence in the model's suitability for whatever analysis it was designed. While processes for validation are well-established in the statistical sciences, the field of quantitative systems pharmacology (QSP) has taken a more piecemeal approach to defining and demonstrating validation. Although classical statistical methods can be used in a QSP context, proper validation of a mechanistic systems model requires a more nuanced approach to what precisely is being validated, and what role said validation plays in the larger context of the analysis. In this review, we summarize current thoughts of QSP validation in the scientific community, contrast the aims of statistical validation from several contexts (including inference, pharmacometrics analysis, and machine learning) with the challenges faced in QSP analysis, and use examples from published QSP models to define different stages or levels of validation, any of which may be sufficient depending on the context at hand., Competing Interests: Declarations Competing interests The authors declare no competing interests., (© 2023. The Author(s).)

Benchmarking in healthcare, particularly in the context of complex surgical procedures like pancreatic surgery, plays a pivotal role in comparing and evaluating the quality of care provided to patients. There is a growing body of evidence validating existent metrics and introducing new ones in the pursuit of safety and excellence in pancreatic surgery. A systematic review adhering to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines was conducted on metric development and validation across multiple databases, including PUBMED Medline, Scopus, and Web of Science, until February 2024. The extracted data were categorized into three domains according to the Donabedian model: structure, process, and outcomes. Thirty-four studies were deemed eligible for inclusion in this review. Among these articles, 20 contributed to metric development, while 14 studies validated them. A total of 234 metrics were identified across the 34 studies, of which 185 were included in the analysis. Thirty-three of these metrics were relative to structure, 79 to processes, and 73 to outcomes. The distribution of metric domains across the included studies revealed that structure, process, and outcome domains were reported in 12, 26, and 26 studies, respectively. In conclusion, this systematic review underscores the heterogeneity in metric development methodologies and the varying degrees of consensus among different quality indicators, despite the growing interest in benchmarking in pancreatic surgery. This review aims to inform future research efforts and contribute to the ongoing pursuit of excellence in pancreatic surgical care., (© 2024. Italian Society of Surgery (SIC).)