5,117 results on '"Validation Studies as Topic"'
Search Results
2. Translation, cross-cultural adaptation and validation of the brazilian version of physical activity scale for individuals with physical disabilities (PASIPD) in people with lower limb amputation
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Luza, L.P., Ferreira, E.G., Pires, G.K.W., Gutierres Filho, P.J.B., and Silva, R.
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- 2024
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3. Assessment of management reasoning: Design considerations drawn from analysis of simulated outpatient encounters.
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Cook, David A., Durning, Steven J., Stephenson, Christopher R., Gruppen, Larry D., and Lineberry, Matt
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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]
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- 2025
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4. Making plaque assessment easier – a validation study of simplified versions of the Marginal Plaque Index
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Ulrike Weik, Zdenka Eidenhardt, and Renate Deinzer
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Dental Plaque Index ,Oral Hygiene Index ,Oral Hygiene ,Dental plaque ,Toothbrushing ,Validation Studies as Topic ,Dentistry ,RK1-715 - Abstract
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
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- 2024
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5. Psychometric analysis of ProQOL-BR in nursing: building hospital safety and protection
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Frederico Marques Andrade, Lanuza Borges Oliveira, Igor Monteiro Lima Martins, Maria Eduarda Borges Rodrigues, and Carla Silvana de Oliveira e Silva
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Nursing Staff ,Quality of Professional Life ,Burnout ,Validation Studies as Topic ,Health Status Indicators. ,Nursing ,RT1-120 - Abstract
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.
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- 2024
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6. Validation of the Uscom BP+ automated oscillometric blood pressure monitor for professional office use in children and adolescents according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
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Glenning, Jonathan P., Sheeran, Freya, Cuthbert, Jodie, Harris, William, Quinlan, Catherine, and Mynard, Jonathan P.
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- 2024
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7. Validity and Reliability Assessment of the Complete Persian Version of the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego Auto-Questionnaire in an Iranian Population.
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Sadr, Seyed Saeed, Haram, Roya Vaziri, Ardestani, Seyed Mehdi Samimi, and Dehghani, Shaghayegh
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PEARSON correlation (Statistics) , *TEMPERAMENT , *CRONBACH'S alpha , *RESEARCH methodology evaluation , *QUESTIONNAIRES , *CONTENT analysis , *QUANTITATIVE research , *DESCRIPTIVE statistics , *SURVEYS , *PSYCHOMETRICS , *ANALYSIS of variance , *RESEARCH methodology , *TEST validity , *DATA analysis software , *EVALUATION ,RESEARCH evaluation - Abstract
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]
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- 2024
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8. Cultural adaptation, validation and evaluation of the psychometric properties of Childbirth Experience Questionnaire version 2.0 in the Spanish context
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Elisabet Machín-Martín, Héctor González-de la Torre, Haridian Bordón-Reyes, Julia Jeppesen-Gutiérrez, and Alicia Martín-Martínez
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Obstetrics, labour ,Patient satisfaction ,Surveys and questionnaires ,Validation studies as topic ,Childbirth experience questionnaire ,Gynecology and obstetrics ,RG1-991 - Abstract
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.
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- 2024
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9. Validating an objective structured clinical examination to enhance assessment of clinical skills in physical therapy students.
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Gómez Miranda, Luis, Reyes Amigo, Tomás, and de la Barra Ortiz, Hernán Andrés
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PHYSICAL therapy students , *ELECTROPHYSIOLOGY , *CLINICAL competence , *FACTOR analysis , *TEST validity - Abstract
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]
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- 2024
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10. Cultural adaptation, validation and evaluation of the psychometric properties of Childbirth Experience Questionnaire version 2.0 in the Spanish context.
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Machín-Martín, Elisabet, González-de la Torre, Héctor, Bordón-Reyes, Haridian, Jeppesen-Gutiérrez, Julia, and Martín-Martínez, Alicia
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PSYCHOMETRICS ,CHILDBIRTH ,CONFIRMATORY factor analysis ,CRONBACH'S alpha ,SPANIARDS - 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. [ABSTRACT FROM AUTHOR]
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- 2024
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11. Development of Emerging Infectious Diseases Preventive Health Behavior (EID-PHB) Scale and Validation of the Complex Models
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Lee WK and Shin SR
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emerging infectious disease ,health behavior ,primary prevention ,validation studies as topic ,Medicine (General) ,R5-920 - Abstract
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
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- 2024
12. Cultural Adaptation, Validation and Evaluation of the Psychometric Properties of an Obstetric Violence Scale in the Spanish Context
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Héctor González-de la Torre, Paula Nikola González-Artero, Daniel Muñoz de León-Ortega, María Reyes Lancha-de la Cruz, and José Verdú-Soriano
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obstetric labor ,obstetric violence ,surveys and questionnaires ,validation studies as topic ,Nursing ,RT1-120 - Abstract
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.
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- 2023
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13. Cultural Adaptation, Validation and Evaluation of the Psychometric Properties of an Obstetric Violence Scale in the Spanish Context.
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González-de la Torre, Héctor, González-Artero, Paula Nikola, Muñoz de León-Ortega, Daniel, Lancha-de la Cruz, María Reyes, and Verdú-Soriano, José
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CULTURE ,STATISTICS ,RESEARCH evaluation ,CONFIDENCE intervals ,RESEARCH methodology evaluation ,PSYCHOLOGY of mothers ,RESEARCH methodology ,CROSS-sectional method ,VIOLENCE ,PREGNANT women ,PSYCHOMETRICS ,TEST validity ,MULTITRAIT multimethod techniques ,CRONBACH'S alpha ,PSYCHOLOGY of women ,FACTOR analysis ,DATA analysis - Abstract
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]
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- 2023
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14. Applicability of electronic sphygmomanometer use in high-altitude areas according to the AAMI/ESH/ISO collaboration statement
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Xueting Liu, Runyu Ye, Xin Zhang, Wen Huang, Lirong Sun, Xingwei Huo, and Xiaoping Chen
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blood pressure determination ,sphygmomanometers ,oscillometry ,altitude ,validation studies as topic ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
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
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- 2024
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15. Validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) method to detect cannabinoids in whole blood and breath
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Hubbard, Jacqueline A, Smith, Breland E, Sobolesky, Philip M, Kim, Sollip, Hoffman, Melissa A, Stone, Judith, Huestis, Marilyn A, Grelotti, David J, Grant, Igor, Marcotte, Thomas D, and Fitzgerald, Robert L
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Cannabinoid Research ,Substance Misuse ,Drug Abuse (NIDA only) ,Aetiology ,2.2 Factors relating to the physical environment ,Good Health and Well Being ,Breath Tests ,Cannabidiol ,Cannabinoids ,Chromatography ,High Pressure Liquid ,Citric Acid ,Dronabinol ,Glucose ,Humans ,Limit of Detection ,Quality Control ,Reference Standards ,Reproducibility of Results ,Smoking ,Solid Phase Extraction ,Tandem Mass Spectrometry ,Validation Studies as Topic ,breath ,cannabis ,LC-MS/MS ,mass spectrometry ,THC ,whole blood ,Clinical Sciences ,Cognitive Sciences ,General Clinical Medicine - Abstract
Background The widespread availability of cannabis raises concerns regarding its effect on driving performance and operation of complex equipment. Currently, there are no established safe driving limits regarding ∆9-tetrahydrocannabinol (THC) concentrations in blood or breath. Daily cannabis users build up a large body burden of THC with residual excretion for days or weeks after the start of abstinence. Therefore, it is critical to have a sensitive and specific analytical assay that quantifies THC, the main psychoactive component of cannabis, and multiple metabolites to improve interpretation of cannabinoids in blood; some analytes may indicate recent use. Methods A liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed to quantify THC, cannabinol (CBN), cannabidiol (CBD), 11-hydroxy-THC (11-OH-THC), (±)-11-nor-9-carboxy-Δ9-THC (THCCOOH), (+)-11-nor-Δ9-THC-9-carboxylic acid glucuronide (THCCOOH-gluc), cannabigerol (CBG), and tetrahydrocannabivarin (THCV) in whole blood (WB). WB samples were prepared by solid-phase extraction (SPE) and quantified by LC-MS/MS. A rapid and simple method involving methanol elution of THC in breath collected in SensAbues® devices was optimized. Results Lower limits of quantification ranged from 0.5 to 2 μg/L in WB. An LLOQ of 80 pg/pad was achieved for THC concentrations in breath. Calibration curves were linear (R2>0.995) with calibrator concentrations within ±15% of their target and quality control (QC) bias and imprecision ≤15%. No major matrix effects or drug interferences were observed. Conclusions The methods were robust and adequately quantified cannabinoids in biological blood and breath samples. These methods will be used to identify cannabinoid concentrations in an upcoming study of the effects of cannabis on driving.
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- 2020
16. Population-Based Registry Linkages to Improve Validity of Electronic Health Record–Based Cancer Research
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Thompson, Caroline A, Jin, Anqi, Luft, Harold S, Lichtensztajn, Daphne Y, Allen, Laura, Liang, Su-Ying, Schumacher, Benjamin T, and Gomez, Scarlett Lin
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Health Services and Systems ,Health Sciences ,Cancer ,Networking and Information Technology R&D (NITRD) ,Patient Safety ,Clinical Research ,Good Health and Well Being ,Data Accuracy ,Electronic Health Records ,Humans ,Neoplasms ,Registries ,Reproducibility of Results ,Validation Studies as Topic ,Medical and Health Sciences ,Epidemiology ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundThere is tremendous potential to leverage the value gained from integrating electronic health records (EHR) and population-based cancer registry data for research. Registries provide diagnosis details, tumor characteristics, and treatment summaries, while EHRs contain rich clinical detail. A carefully conducted cancer registry linkage may also be used to improve the internal and external validity of inferences made from EHR-based studies.MethodsWe linked the EHRs of a large, multispecialty, mixed-payer health care system with the statewide cancer registry and assessed the validity of our linked population. For internal validity, we identify patients that might be "missed" in a linkage, threatening the internal validity of an EHR study population. For generalizability, we compared linked cases with all other cancer patients in the 22-county EHR catchment region.ResultsFrom an EHR population of 4.5 million, we identified 306,554 patients with cancer, 26% of the catchment region patients with cancer; 22.7% of linked patients were diagnosed with cancer after they migrated away from our health care system highlighting an advantage of system-wide linkage. We observed demographic differences between EHR patients and non-EHR patients in the surrounding region and demonstrated use of selection probabilities with model-based standardization to improve generalizability.ConclusionsOur experiences set the foundation to encourage and inform researchers interested in working with EHRs for cancer research as well as provide context for leveraging linkages to assess and improve validity and generalizability.ImpactResearchers conducting linkages may benefit from considering one or more of these approaches to establish and evaluate the validity of their EHR-based populations.See all articles in this CEBP Focus section, "Modernizing Population Science."
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- 2020
17. Risk stratification for post‐operative pulmonary complications following major cardiothoracic or abdominal surgery: Validation of the PPC Risk Prediction Score for physiotherapist's clinical decision‐making
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Sofie Langbo Salling, Janne Hastrup Jensen, Sebastian Breddam Mosegaard, Lotte Sørensen, and Inger Mechlenburg
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general surgery ,lung ,pneumonia ,post‐operative complication ,risk factors ,validation studies as topic ,Diseases of the respiratory system ,RC705-779 - Abstract
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.
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- 2023
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18. Validation of the Electronic Form of the Persian Version of Health-related Quality of Life Questionnaire for Iranian Patients With COVID-19
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Roghayeh Mirzazadeh, Azita Amirfakhraei, Kobra Haji Alizadeh, and Eqbal Zarei
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quality of life ,covid-19 ,factor analysis ,validation studies as topic ,Medicine (General) ,R5-920 - Abstract
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.
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- 2023
19. CROSS-CULTURAL ADAPTATION OF THE HOSPITAL ETHICAL CLIMATE SURVEY TO BRAZIL.
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Lanes, Taís Carpes, de Lima Dalmolin, Graziele, da Silva, Augusto Maciel, Ramos, Flávia Regina Souza, and Olson, Linda L.
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HOSPITALS ,WORK environment ,RESEARCH ,ORGANIZATIONAL ethics ,STATISTICAL reliability ,RESEARCH methodology evaluation ,PEARSON correlation (Statistics) ,CRONBACH'S alpha ,HOSPITAL nursing staff ,QUESTIONNAIRES ,INTRACLASS correlation ,DESCRIPTIVE statistics ,RESEARCH funding ,STATISTICAL sampling ,DATA analysis software ,CORPORATE culture ,ALGORITHMS - Abstract
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]
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- 2023
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20. General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy
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Li, Zhihua, Mirams, Gary R, Yoshinaga, Takashi, Ridder, Bradley J, Han, Xiaomei, Chen, Janell E, Stockbridge, Norman L, Wisialowski, Todd A, Damiano, Bruce, Severi, Stefano, Morissette, Pierre, Kowey, Peter R, Holbrook, Mark, Smith, Godfrey, Rasmusson, Randall L, Liu, Michael, Song, Zhen, Qu, Zhilin, Leishman, Derek J, Steidl‐Nichols, Jill, Rodriguez, Blanca, Bueno‐Orovio, Alfonso, Zhou, Xin, Passini, Elisa, Edwards, Andrew G, Morotti, Stefano, Ni, Haibo, Grandi, Eleonora, Clancy, Colleen E, Vandenberg, Jamie, Hill, Adam, Nakamura, Mikiko, Singer, Thomas, Polonchuk, Liudmila, Greiter‐Wilke, Andrea, Wang, Ken, Nave, Stephane, Fullerton, Aaron, Sobie, Eric A, Paci, Michelangelo, Tshinanu, Flora Musuamba, and Strauss, David G
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Pharmacology and Pharmaceutical Sciences ,Biomedical and Clinical Sciences ,Arrhythmias ,Cardiac ,Computer Simulation ,Drug-Related Side Effects and Adverse Reactions ,Humans ,Models ,Theoretical ,Risk Assessment ,Validation Studies as Topic ,Pharmacology & Pharmacy ,Pharmacology and pharmaceutical sciences - Abstract
This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration-sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model-based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia assessment. This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.
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- 2020
21. Validation of a consumer-grade activity monitor for continuous daily activity monitoring in individuals with multiple sclerosis
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Block, Valerie J, Zhao, Chao, Hollenbach, Jill A, Olgin, Jeffrey E, Marcus, Gregory M, Pletcher, Mark J, Henry, Roland, Gelfand, Jeffrey M, and Cree, Bruce AC
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Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Autoimmune Disease ,Bioengineering ,Brain Disorders ,Neurosciences ,Neurodegenerative ,Multiple Sclerosis ,Neurological ,Physical activity ,motor activity ,accelerometry ,multiple sclerosis ,validation studies as topic ,Epidemiology ,Health services and systems - Abstract
BackgroundTechnological advancements of remote-monitoring used in clinical-care and research require validation of model updates.ObjectivesTo compare the output of a newer consumer-grade accelerometer to a previous model in people with multiple sclerosis (MS) and to the ActiGraph, a waist-worn device widely used in MS research.MethodsThirty-one individuals with MS participated in a 7-day validation by the Fitbit Flex (Flex), Fitbit Flex-2 (Flex2) and ActiGraph GT3X. Primary outcome was step count. Valid epochs of 5-min block increments, where there was overlap of ≥1 step/min for both devices were compared and summed to give a daily total for analysis.ResultsBland-Altman plots showed no systematic difference between the Flex and Flex2; mean step-count difference of 25 more steps-per-day more recorded by Flex2 (95% confidence intervals (CI) = 2, 48; p = 0.04),interclass correlation coefficient (ICC) = 1.00. Compared to the ActiGraph, Flex2 (and Flex) tended to record more steps (808 steps-per-day more than the ActiGraph (95% CI= -2380, 765; p
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- 2019
22. Validation of the Asia-Pacific colorectal screening score and its modified versions in predicting colorectal advanced neoplasia in Chinese population
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Yunxin Kong, Lin Zhuo, Dong Dong, Lang Zhuo, Peian Lou, Ting Cai, Siting Chen, Jianqiang Pan, Yihuan Gao, Hang Lu, Yue Ma, Zongmei Dong, Xiaohu Luo, and Hongying Zhao
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Colorectal neoplasia ,Mass screening ,Early detection of cancer ,Risk assessment ,Validation studies as topic ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
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
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- 2022
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23. Translation and validation of the Hungarian Version of the infection control standardized questionnaire: a cross-sectional study
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Sahar Hammoud, Faten Amer, Haitham Khatatbeh, Huda Alfatafta, Miklós Zrínyi, and Béla Kocsis
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Factor analysis, statistical ,Health knowledge, attitudes, practice ,Infection control ,Nurses ,Reliability ,Validation studies as topic ,Nursing ,RT1-120 - Abstract
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.
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- 2022
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24. Psychometric Properties of the Persian Version of the COVID-19 Phobia Scale
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Nader Hajloo, saeed Pourabdol, Mahdi Beyki, and Amir Mohsen Rahnejat
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covid-19 ,phobic disorders ,validation studies as topic ,reliability ,Medicine (General) ,R5-920 - Abstract
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
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- 2022
25. Cross-Cultural Adaptation and Validation of the Perceptions of Empowerment in Midwifery Scale in the Spanish Context (PEMS-e).
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González-de la Torre, Héctor, Hernández-Rodríguez, María-Isabel, Moreno-Canino, Alba-María, Portela-Lomba, Ana-María, Berenguer-Pérez, Miriam, and Verdú-Soriano, José
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PILOT projects ,SCIENTIFIC observation ,CONFIDENCE intervals ,RESEARCH methodology evaluation ,RESEARCH methodology ,MIDWIFERY ,CROSS-sectional method ,SELF-efficacy ,CRONBACH'S alpha ,QUESTIONNAIRES ,DESCRIPTIVE statistics - Abstract
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]
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- 2023
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26. Exploration of the psychometric properties of the novel General Medication Adherence Scale (GMAS) for chronic illness patients.
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Meng, Xiaoxuan, Li, Siyuan, Shen, Wenting, Li, Dongyan, Lv, Qingyun, Wang, Xiaoxu, Wang, Yan, Zang, Xiaoying, Zhang, Qing, and Wang, Lan
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PATIENT compliance , *PSYCHOMETRICS , *CHRONIC diseases , *COMMUNITY health services , *RASCH models - Abstract
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]
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- 2023
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27. Validation of Blood Pressure Devices as per 2020 World Health Organization Technical Specifications: A Scoping Review of Global Literature.
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Murthy, Shruti, Rajwar, Eti, Johnson, Rosemol, Shrivastava, Krati, Kamath, Prashanthi, Rahman, Rinsy, Devaria, Abhinav, Ismavel, Vijay Anand, Vetter, Beatrice N., Jacob, Anil G., and John, Oommen
- Abstract
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]
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- 2023
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28. Risk stratification for post‐operative pulmonary complications following major cardiothoracic or abdominal surgery: Validation of the PPC Risk Prediction Score for physiotherapist's clinical decision‐making.
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Salling, Sofie Langbo, Jensen, Janne Hastrup, Mosegaard, Sebastian Breddam, Sørensen, Lotte, and Mechlenburg, Inger
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DISEASE risk factors ,ABDOMINAL surgery ,PHYSICAL therapists ,DECISION making ,SENSITIVITY & specificity (Statistics) ,CLINICAL prediction rules - 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. [ABSTRACT FROM AUTHOR]
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- 2023
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29. Traducción al español y validación de una escala para la observación de una toma de lactancia materna: la «Bristol Breastfeeding Assessment Tool»
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Josep Vicent Balaguer-Martínez, Jessica Noelia Esquivel-Ojeda, Inmaculada Valcarce-Pérez, Edurne Ciriza-Barea, Carmen García-Sotro, Amalia López-Santiveri, and Alícia Hernández-Gil
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Breast feeding ,Validation studies as topic ,Process assessment (health care) ,Surveys and questionnaires ,Reproducibility of result ,Pediatrics ,RJ1-570 - Abstract
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.
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- 2022
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30. A Short Guide on How to Carry Out Validation of Scales Measuring Health Outcomes
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Edgar Martins Mesquita
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Reproducibility of Results ,Sample Size ,Surveys and Questionnaires ,Validation Studies as Topic ,Medicine ,Medicine (General) ,R5-920 - Abstract
N/a.
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- 2023
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31. Bad Behavior: Improving Reproducibility in Behavior Testing.
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Andrews, Anne, Cheng, Xinyi, Altieri, Stefanie, and Yang, Hongyan
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Reproducibility ,behavior testing ,model system ,Animals ,Behavior Rating Scale ,Behavior ,Animal ,Feeding Behavior ,Female ,Male ,Maze Learning ,Mice ,Transgenic ,Reproducibility of Results ,Research Design ,Serotonin Plasma Membrane Transport Proteins ,Validation Studies as Topic - Abstract
Systems neuroscience research is increasingly possible through the use of integrated molecular and circuit-level analyses. These studies depend on the use of animal models and, in many cases, molecular and circuit-level analyses. Associated with genetic, pharmacologic, epigenetic, and other types of environmental manipulations. We illustrate typical pitfalls resulting from poor validation of behavior tests. We describe experimental designs and enumerate controls needed to improve reproducibility in investigating and reporting of behavioral phenotypes.
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- 2018
32. Real‐space refinement in PHENIX for cryo‐EM and crystallography
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Afonine, Pavel V, Poon, Billy K, Read, Randy J, Sobolev, Oleg V, Terwilliger, Thomas C, Urzhumtsev, Alexandre, and Adams, Paul D
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Animals ,Computer Simulation ,Cryoelectron Microscopy ,Crystallography ,Databases ,Protein ,Humans ,Macromolecular Substances ,Models ,Molecular ,Software ,TRPV Cation Channels ,Validation Studies as Topic ,real-space refinement ,cryo-EM ,crystallography ,map interpolation ,atomic-centered targets ,PHENIX - Abstract
This article describes the implementation of real-space refinement in the phenix.real_space_refine program from the PHENIX suite. The use of a simplified refinement target function enables very fast calculation, which in turn makes it possible to identify optimal data-restraint weights as part of routine refinements with little runtime cost. Refinement of atomic models against low-resolution data benefits from the inclusion of as much additional information as is available. In addition to standard restraints on covalent geometry, phenix.real_space_refine makes use of extra information such as secondary-structure and rotamer-specific restraints, as well as restraints or constraints on internal molecular symmetry. The re-refinement of 385 cryo-EM-derived models available in the Protein Data Bank at resolutions of 6 Å or better shows significant improvement of the models and of the fit of these models to the target maps.
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- 2018
33. Differences in technical and clinical perspectives on AI validation in cancer imaging: mind the gap!
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Chouvarda I, Colantonio S, Verde ASC, Jimenez-Pastor A, Cerdá-Alberich L, Metz Y, Zacharias L, Nabhani-Gebara S, Bobowicz M, Tsakou G, Lekadir K, Tsiknakis M, Martí-Bonmati L, and Papanikolaou N
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- Humans, Diagnostic Imaging methods, Reproducibility of Results, Validation Studies as Topic, Neoplasms diagnostic imaging, Artificial Intelligence
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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).)
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- 2025
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34. Digital screening tool for the assessment of cognitive impairment in unsupervised setting-digiDEM-SCREEN: study protocol for a validation study.
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Zeiler M, Dietzel N, Kammerer K, Frick U, Pryss R, Heuschmann P, Prokosch HU, Graessel E, and Kolominsky-Rabas PL
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- Humans, Germany, Mass Screening methods, Mobile Applications, Neuropsychological Tests, Mental Status and Dementia Tests standards, Dementia diagnosis, Aged, Female, Validation Studies as Topic, Sensitivity and Specificity, Reproducibility of Results, Male, ROC Curve, Cognitive Dysfunction diagnosis
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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.)
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- 2025
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35. Clinical validation of an artificial intelligence-based decision support system for diagnosis and risk stratification of heart failure (STRATIFYHF): a protocol for a prospective, multicentre longitudinal study.
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Charman SJ, Okwose NC, Groenewegen A, Del Franco A, Tafelmeier M, Preveden A, Garcia Sebastian C, Fuller AS, Sinclair D, Edwards D, Nelissen AP, Malitas P, Zisaki A, Darba J, Bosnic Z, Vracar P, Barlocco F, Fotiadis D, Banerjee P, MacGowan GA, Fernandez O, Zamorano J, Jiménez-Blanco Bravo M, Maier LS, Olivotto I, Rutten FH, Mant J, Velicki L, Seferović PM, Filipovic N, and Jakovljevic DG
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- Aged, Female, Humans, Male, Middle Aged, Longitudinal Studies, Multicenter Studies as Topic, Prognosis, Prospective Studies, Risk Assessment methods, Observational Studies as Topic, Validation Studies as Topic, Artificial Intelligence, Decision Support Systems, Clinical, Heart Failure diagnosis
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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.)
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- 2025
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36. ClinValAI: A framework for developing Cloud-based infrastructures for the External Clinical Validation of AI in Medical Imaging.
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Ramwala OA, Lowry KP, Hippe DS, Unrath MPN, Nyflot MJ, Mooney SD, and Lee CI
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- Humans, Female, Workflow, Mammography statistics & numerical data, Mammography standards, Mammography methods, Breast Neoplasms diagnostic imaging, Validation Studies as Topic, Cloud Computing, Algorithms, Computational Biology, Artificial Intelligence, Diagnostic Imaging standards, Diagnostic Imaging statistics & numerical data
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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.
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- 2025
37. Leveraging Foundational Models in Computational Biology: Validation, Understanding, and Innovation.
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Beaulieu-Jones B and Brenner S
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- Humans, Validation Studies as Topic, Computational Biology, Natural Language Processing
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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.
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- 2025
38. Introduction to qualification and validation of an immunoassay.
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Janssen S
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- Humans, Immunoassay methods, Immunoassay standards, Reproducibility of Results, Drug Development methods, Validation Studies as Topic, Vaccines, Enzyme-Linked Immunosorbent Assay methods, Enzyme-Linked Immunosorbent Assay statistics & numerical data
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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.)
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- 2025
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39. Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion.
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Fjording MS, Goodman J, and Briscoe C
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- Humans, Biological Assay methods, Biological Assay standards, Guidelines as Topic, Reproducibility of Results, Validation Studies as Topic, Pharmacokinetics
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The ICH M10 guideline establishes global standards for bioanalytical method validation for pharmacokinetic assays, focusing on data reliability and accuracy across studies. A significant component is cross-validation, which should be performed to ensure data comparability when multiple methods or laboratories are involved in a single study or across studies where comparison will be performed. However, ICH M10 does not specify acceptance criteria for cross-validation, creating challenges for the industry because traditionally many laboratories have always utilized acceptance criteria to "pass" or "fail" the study. This editorial discusses how bioanalytical labs should conduct cross-validation for PK assays post-ICH M10, highlighting the role of statistical methods and the need for close collaboration with clinical pharmacology and biostatistics departments. Proper implementation and strategic focus on relevant studies are essential for effective cross-validation.
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- 2025
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40. Psychometric evaluation of the Overactive Bladder Questionnaire (OAB-q) for measuring quality of life and clinical implications in Greek patients with overactive bladder.
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Kontogiannis, Stavros, Athanasopoulos, Anastasios, Tsagkarakis, Michail, and Kontodimopoulos, Nikolaos
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OVERACTIVE bladder , *PSYCHOMETRICS , *TEST validity , *QUALITY of life - Abstract
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]
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- 2022
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41. Validation of the Asia-Pacific colorectal screening score and its modified versions in predicting colorectal advanced neoplasia in Chinese population.
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Kong, Yunxin, Zhuo, Lin, Dong, Dong, Zhuo, Lang, Lou, Peian, Cai, Ting, Chen, Siting, Pan, Jianqiang, Gao, Yihuan, Lu, Hang, Ma, Yue, Dong, Zongmei, Luo, Xiaohu, and Zhao, Hongying
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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]- Published
- 2022
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42. Translation and validation of the Hungarian Version of the infection control standardized questionnaire: a cross-sectional study.
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Hammoud, Sahar, Amer, Faten, Khatatbeh, Haitham, Alfatafta, Huda, Zrínyi, Miklós, and Kocsis, Béla
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STATISTICS ,RESEARCH evaluation ,RESEARCH methodology evaluation ,RESEARCH methodology ,CROSS-sectional method ,DISCRIMINANT analysis ,QUESTIONNAIRES ,FACTOR analysis ,DESCRIPTIVE statistics ,CHI-squared test ,DATA analysis ,STATISTICAL sampling ,TRANSLATIONS ,EVALUATION - 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. [ABSTRACT FROM AUTHOR]
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- 2022
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43. Developing the Korean Educational Needs Assessment Tool (Korean ENAT) in rheumatoid arthritis: cross-cultural validation using Rasch analysis
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Yoon-Kyoung Sung, Hyoungyoung Kim, Sung Joo Cha, Sae-Hyung Kim, Mwidimi Ndosi, and Soo-Kyung Cho
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patient education as topic ,needs assessment ,validation studies as topic ,rasch analysis ,arthritis, rheumatoid ,Medicine - Abstract
Background/Aims This study was performed to undertake cross-cultural adaptation and validation of the Educational Needs Assessment Tool (ENAT) in rheumatoid arthritis (RA) for use in Korea. Methods The study involved two main phases: cross-cultural adaptation of the ENAT from English into Korean, and validation of the Korean ENAT. The first phase followed the established process of cross-cultural adaptation of self-report measures, and in the second phase, the Korean ENAT data were analyzed using the Rasch measurement model. Fit to the model was determined using the observed data infit and outfit statistics. Additional tests of validity included unidimensionality and internal consistency. Results Adequate conceptual equivalence was achieved following the adaptation process. A total of 123 patients completed the Korean ENAT. The mean age was 46.7 ± 12.3 years and the majority of patients (81.3%) were female. Thirty-five of the 39 items gave good fit to the model. The four items deviating from the model had infit and outfit > 1.50. The item separation index (5.26) and item reliability index (0.97) provided evidence for good reliability of items. All seven domains of the Korean ENAT fit the Rasch model. The internal consistency of the Korean ENAT was high, and unidimensionality was confirmed (person separation index, 3.41; reliability index, 0.92; item separation index, 16.82; reliability index, 1.00). Conclusions Using the standard procedure for cross-cultural adaptation, the ENAT has been adapted into Korean, and Rasch analysis has confirmed the construct validity, reliability, and unidimensionality of the Korean ENAT.
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- 2021
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44. Convergent and discriminative validity of the Frail-VIG index with the EQ-5D-3L in people cared for in primary health care
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Juan-José Zamora-Sánchez, Edurne Zabaleta-del-Olmo, Vicente Gea-Caballero, Iván Julián-Rochina, Gemma Pérez-Tortajada, and Jordi Amblàs-Novellas
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Frailty ,Health status ,Primary health care ,Psychometrics ,Validation studies as topic ,Geriatrics ,RC952-954.6 - Abstract
Abstract Background The Frail-VIG frailty index has been developed recently. It is an instrument with a multidimensional approach and a pragmatic purpose that allows rapid and efficient assessment of the degree of frailty in the context of clinical practice. Our aim was to investigate the convergent and discriminative validity of the Frail-VIG frailty index with regard to EQ-5D-3L value. Methods We carried out a cross-sectional study in two Primary Health Care (PHC) centres of the Catalan Institute of Health (Institut Català de la Salut), Barcelona (Spain) from February 2017 to January 2019. Participants in the study were all people included under a home care programme during the study period. No exclusion criteria were applied. We used the EQ-5D-3L to measure Health-Related Quality of Life (HRQoL) and the Frail-VIG index to measure frailty. Trained PHC nurses administered both instruments during face-to-face assessments in a participant’s home during usual care. The relationships between both instruments were examined using Pearson’s correlation coefficient and multiple linear regression analyses. Results Four hundred and twelve participants were included in this study. Frail-VIG score and EQ-5D-3L value were negatively correlated (r = − 0.510; P
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- 2021
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45. Desafios na elaboração e validação de instrumentos de pesquisa na área de educação em Moçambique
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Napapacha, Vital de Melo Lopes, Mussi, Ricardo Franklin de Freitas, Chalenga, Damasco Rocha Mateus, Napapacha, Vital de Melo Lopes, Mussi, Ricardo Franklin de Freitas, and Chalenga, Damasco Rocha Mateus
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La calidad de una investigación está determinada por el rigor de sus métodos. El éxito de la recolección de datos depende de la robustez de los instrumentos utilizados para obtenerlos, de acuerdo con su validez, objetividad y confiabilidad. Así, este trabajo cualitativo, del tipo revisión de la literatura, tiene como objectivo analizar los modelos de elaboración y validación de instrumentos de recolección de datos en la investigación educativa de las instituciones de Educación Superior de Mozambique. Para ello, se revisaron 30 trabajos de pregrado y 30 de maestría, con análisis enfocados en la parte metodológica, particularmente en lo que respecta a los procedimientos de elaboración de los instrumentos y su validación. Los resultados revelaron que los instrumentos son creados por los estudiantes y revisados por sus supervisores y co-supervisores. Metodológicamente, los trabajos analizados hacen mención limitada (tres disertaciones) de la adopción de algún proceso que pueda reconocerse como un esfuerzo de validación de instrumentos de investigación; sin embargo, no adoptan estrictamente los criterios técnicos para tal fin. Por lo tanto, para que los hallazgos de la investigación sean aún más calificados, se sugiere que los proyectos finales en Mozambique, tanto de pregrado como de posgrado, comiencen a adoptar un mayor rigor metodológico en cuanto a los procedimientos de desarrollo y validación de los instrumentos de obtención de datos., A qualidade de uma pesquisa é determinada pelo rigor nos seus métodos. Uma colecta de dados exitosa depende da robustez dos instrumentos para a sua obtenção, conforme a sua validade, objectividade e fiabilidade. Assim, este trabalho de natureza qualitativa, do tipo revisão de literatura, objectiva analisar os modelos de elaboração e validação dos instrumentos de recolha de dados em pesquisas educacionais das instituições de ensino superior moçambicanas. Para o efeito, foram revistos 30 trabalhos de culminação de licenciatura e 30 de mestrado, com análise focada na parte metodológica, nomeadamente quanto aos procedimentos de elaboração dos instrumentos e sua validação. Os resultados revelaram que os instrumentos são elaborados pelos estudantes e revistos pelos seus supervisores e co-supervisores. Metodologicamente os trabalhos analisados fazem restrita menção (três dissertações) da adopção de algum processo que possa ser reconhecido como um esforço para a validação dos instrumentos de pesquisa, no entanto, não adoptam rigorosamente os critérios técnicos para esse propósito. Então, para que os achados das pesquisas sejam ainda mais qualificados, sugere-se que os trabalhos de culminação de curso em Moçambique, tanto da graduação como da pós-graduação, comecem a adoptar maior rigor metodológico sobre os procedimentos de elaboração e validação dos instrumentos para a obtenção dos dados., The quality of a research is determined by the rigor of its methods. Successful data collection depends on the robustness of the instruments used to obtain them, according to their validity, objectivity and reliability. Thus, this qualitative literature review aims to analyze the models of elaboration and validation of data collection instruments in educational research of Mozambican Higher Education institutions. To this end, 30 undergraduate and 30 master's degree final projects were reviewed, with analysis focusing on the methodological part, namely regarding the procedures for developing the instruments and their validation. The results revealed that the instruments are created by the students and reviewed by their supervisors and co-supervisors. Methodologically, the works analyzed make limited mention (three dissertations) of the adoption of some process that can be recognized as an effort to validate research instruments; however, they do not strictly adopt the technical criteria for this purpose. Therefore, for the research findings to be even more qualified, it is suggested that the final projects in Mozambique, both undergraduate and postgraduate, begin to adopt greater methodological rigor regarding the procedures for developing and validating the instruments for obtaining data.
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- 2024
46. Construct validity and reliability of the BARRIERS scale in the Spanish context
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Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia, González de la Torre, Héctor, Díaz-Pérez, David, Rodríguez-Suárez, Claudio-Alberto, Pinto-Plasencia, Ricardo José, Verdú, José, Cidoncha-Moreno, M. Ángeles, Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia, González de la Torre, Héctor, Díaz-Pérez, David, Rodríguez-Suárez, Claudio-Alberto, Pinto-Plasencia, Ricardo José, Verdú, José, and Cidoncha-Moreno, M. Ángeles
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Objective: To establish the construct validity of the Spanish version of the BARRIERS scale. Method: Methodological study of validation of a measurement instrument based on data from previously published studies. The study population consisted of nurses from the Basque Health Service and the Canary Health Service. The following variables were extracted and unified: Years of professional experience, possession of a specialist nursing degree, possession of a doctorate, type of activity performed by the professional and field of work. For construct validation, a confirmatory factor analysis (CFA) was performed based on the initial model proposed for the scale and RASCH analysis. A polychoric correlation matrix, factor extraction by unweighted least squares and PROMIN oblique rotation were used. For the RASCH analysis, the Joint Maximun Likelihood estimation (JMLE) method was used; the fit of the items and persons were estimated by means of outfit - Unweighted Mean Square fit statistic (UMS) and infit -Weighted Mean Square Fit Statistic (WMS), as well as the reliability and separation of items and persons. Results: A total of 1200 nurses and midwives made up the final validation sample (n = 1200), with a mean professional experience of 21.22 ± 9.26 years. The CFA presented a good fit to the data (KMO = 0.935 [95%CI:0.921-0.945]), changing the factorial assignment in 6 items, while 5 items received factorial scores in more than one factor. The fit values for the 4-factor solution were RMSEA = 0.026 [95% CI:0.026-0.027] and GFI = 0.991 [95% CI = 0.986-0.991]. In the RASCH analysis most items presented infit-WMS and outfit-UMS values with a good fit. Conclusions: The Spanish version of the BARRIERS scale has adequate construct validity although there are changes in the assignment of items to the dimensions compared to the original model. The RASCH analysis indicates adequate fit for both persons and items., Objetivo: Establecer la validez de constructo de la versión española de la escala BARRIERS. Método: Estudio metodológico de validación de un instrumento de medida a partir de los datos de estudios previamente publicados. La población a estudio estuvo conformada por enfermeras del Servicio Vasco de Salud y del Servicio Canario de la Salud. Se extrajeron y unificaron las variables: Años de experiencia profesional, tenencia de la titulación de enfermera especialista, posesión del doctorado, tipo de actividad que desempeñaba el profesional y ámbito de trabajo. Para la validación de constructo se realizó un análisis factorial confirmatorio (AFC) en base al modelo inicial propuesto para la escala y análisis RASCH. Se usó una matriz de correlaciones de tipo policórico, extracción de factores por mínimos cuadrados no ponderados y rotación oblicua PROMIN. Para el análisis RASCH se usó el método de Joint Maximun Likelihood estimation (JMLE); el ajuste de los Ítems y las personas se estimaron mediante outfit - Unweighted Mean Square fit statistic (UMS) e infit -Weighted Mean Square Fit Statistic (WMS), así como la fiabilidad y separación de ítems y personas. Resultados: Un total de 1.200 enfermeras y matronas conformaron la muestra final de validación (n = 1200), con una media de experiencia profesional de 21,22 ± 9,26 años. El AFC presentó buena adecuación de los datos (KMO = 0,935 [IC95%:0,921-0,945]), modificando la asignación factorial en 6 ítems, mientras que 5 ítems recibieron cargas factoriales en más de un factor. Los valores de ajuste para la solución de 4 factores fueron RMSEA = 0,026 [IC95%:0,026-0,027] y GFI = 0,991 [IC95% = 0,986-0,991]. En el análisis RASCH la mayoría de ítems presentaron valores infit-WMS y outfit-UMS con un buen ajuste. Conclusiones: La versión española de la escala BARRIERS posee una adecuada validez de constructo, aunque existen cambios en la asignación de ítems a las dimensiones en comparación al modelo original. El análisis RASCH indica ade
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- 2024
47. Validez de constructo y fiabilidad de la escala BARRIERS en el contexto español
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Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia, González de la Torre, Héctor, Díaz-Pérez, David, Rodríguez-Suárez, Claudio-Alberto, Pinto-Plasencia, Ricardo José, Verdú, José, Cidoncha-Moreno, M. Ángeles, Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia, González de la Torre, Héctor, Díaz-Pérez, David, Rodríguez-Suárez, Claudio-Alberto, Pinto-Plasencia, Ricardo José, Verdú, José, and Cidoncha-Moreno, M. Ángeles
- Abstract
Objetivo: Establecer la validez de constructo de la versión española de la escala The BARRIERS to Research Utilization Scale (BARRIERS). Método: Estudio metodológico de validación de un instrumento de medida a partir de los datos de estudios previamente publicados. La población a analizar estuvo conformada por enfermeras del Servicio Vasco de Salud y del Servicio Canario de la Salud. Se extrajeron y unificaron las variables: años de experiencia profesional, tenencia de la titulación de enfermera especialista, posesión del doctorado, tipo de actividad que desempeñaba el profesional y ámbito de trabajo. Para la validación de constructo se realizó un análisis factorial confirmatorio (AFC) con base en el modelo inicial propuesto para la escala y el análisis Rasch. Se usó una matriz de correlaciones de tipo policórico, la extracción de factores por mínimos cuadrados no ponderados y rotación oblicua PROMIN. Para el análisis Rasch se empleó el método de Joint Maximun Likelihood estimation (JMLE); el ajuste de los ítems y las personas se estimaron mediante outfit - Unweighted Mean Square fit statistic (UMS) e infit -Weighted Mean Square Fit Statistic (WMS), así como la fiabilidad y la separación de ítems y personas. Resultados: Un total de 1.200 enfermeras y matronas conformaron la muestra final de validación (n = 1.200), con una media de experiencia profesional de 21,22 ± 9,26 años. El AFC presentó una buena adecuación de los datos (índice de Kaiser Meyer Olkin [KMO] = 0,935 [intervalo de confianza {IC} 95%: 0,921-0,945]), modificando la asignación factorial en seis ítems, mientras que cinco recibieron cargas factoriales en más de un factor. Los valores de ajuste para la solución de cuatro factores fueron Root Mean Square Error of Approximation (RMSEA) = 0,026 (IC 95%: 0,026-0,027) y Goodness of Fit Index (GFI) = 0,991 (IC 95%: 0,986-0,991). En el análisis Rasch la mayoría de los ítems presentaron valores infit-WMS y outfit-UMS con un buen ajuste. Conclusiones: La versión, Objective: To establish the construct validity of the Spanish version of the BARRIERS scale. Method: Methodological study of validation of a measurement instrument based on data from previously published studies. The study population consisted of nurses from the Basque Health Service and the Canary Health Service. The following variables were extracted and unified: Years of professional experience, possession of a specialist nursing degree, possession of a doctorate, type of activity performed by the professional and field of work. For construct validation, a confirmatory factor analysis (CFA) was performed based on the initial model proposed for the scale and Rasch analysis. A polychoric correlation matrix, factor extraction by unweighted least squares and PROMIN oblique rotation were used. For the Rasch analysis, the Joint Maximun Likelihood estimation (JMLE) method was used; the fit of the items and persons were estimated by means of outfit - Unweighted Mean Square fit statistic (UMS) and infit -Weighted Mean Square Fit Statistic (WMS), as well as the reliability and separation of items and persons. Results: A total of 1200 nurses and midwives made up the final validation sample (n = 1200), with a mean professional experience of 21.22 ± 9.26 years. The CFA presented a good fit to the data (KMO = 0.935 [95% CI:0.921-0.945]), changing the factorial assignment in 6 items, while 5 items received factorial scores in more than one factor. The fit values for the 4-factor solution were RMSEA = 0.026 [95% CI:0.026-0.027] and GFI = 0.991 [95% CI = 0.986-0.991]. In the Rasch analysis most items presented infit-WMS and outfit-UMS values with a good fit. Conclusions: The Spanish version of the BARRIERS scale has adequate construct validity although there are changes in the assignment of items to the dimensions compared to the original model. The Rasch analysis indicates adequate fit for both persons and items.
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- 2024
48. Content Validity and Psychometric Properties of the German Version of the Holm and Cordoba Urinary Tract Infection Score for Uncomplicated Urinary Tract Infections in Women:Protocol for a Validation Study
- Author
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Piontek, Katharina, Nestler, Sophie, Holm, Anne, Brodersen, John Brandt, Apfelbacher, Christian, Piontek, Katharina, Nestler, Sophie, Holm, Anne, Brodersen, John Brandt, and Apfelbacher, Christian
- Abstract
BACKGROUND: Uncomplicated urinary tract infections (UTIs) in women are among the most common bacterial infections in primary care. Given the health threats related to the overuse of antibiotics, alternative options are of increasing importance. Patient-reported outcome measures are valuable tools for including the patients' perspective when evaluating the efficacy of these strategies. Aiming to identify a suitable instrument to measure the severity and bothersomeness of UTI symptoms in women, we performed a systematic review of the literature and identified the Holm and Cordoba Urinary Tract Infection Score (HCUTI), which measures the severity, bothersomeness, and impact of uncomplicated UTIs on daily activities. This instrument showed sufficient content validity but needs translation and further validation before it can be used in German research.OBJECTIVE: For use in the German setting, we aim (1) to perform translation and linguistic validation of the HCUTI and (2) to evaluate content validity and psychometric properties of the German version of the HCUTI in a population of women with uncomplicated UTIs.METHODS: The HCUTI will be translated and linguistically validated using the dual-panel method. This process involves a bilingual translation panel and a lay panel to check the comprehensibility of the translation. Content validity of the translated questionnaire will be assessed using cognitive interviews according to the criteria for good content validity as recommended by the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group involving women with uncomplicated UTIs and health care professionals. Subsequent psychometric validation of the German version of the HCUTI in a population of women with uncomplicated UTIs will include the assessment of structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, and interpretability.RESULTS: Results of the transla
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- 2024
49. Patient-specific Meta-analysis of 2 Clinical Validation Studies to Predict Pathologic Outcomes in Prostate Cancer Using the 17-Gene Genomic Prostate Score.
- Author
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Brand, Timothy C, Zhang, Nan, Crager, Michael R, Maddala, Tara, Dee, Anne, Sesterhenn, Isabell A, Simko, Jeffry P, Cooperberg, Matthew R, Srivastava, Shiv, Rosner, Inger L, Chan, June M, Febbo, Phillip G, Carroll, Peter R, Cullen, Jennifer, and Lawrence, H Jeffrey
- Subjects
Humans ,Prostatic Neoplasms ,Prognosis ,Genomics ,Adult ,Aged ,Middle Aged ,Male ,Validation Studies as Topic ,Clinical Sciences ,Urology & Nephrology - Abstract
ObjectiveTo perform patient-specific meta-analysis (MA) of two independent clinical validation studies of a 17-gene biopsy-based genomic assay as a predictor of favorable pathology at radical prostatectomy.Materials and methodsPatient-specific MA was performed on data from 2 studies (732 patients) using the Genomic Prostate Score (GPS; scale 0-100) together with Cancer of the Prostate Risk Assessment (CAPRA) score or National Comprehensive Cancer Network (NCCN) risk group as predictors of the likelihood of favorable pathology (LFP). Risk profile curves associating GPS with LFP by CAPRA score and NCCN risk group were generated. Decision curves and receiver operating characteristic curves were calculated using patient-specific MA risk estimates.ResultsPatient-specific MA-generated risk profiles ensure more precise estimates of LFP with narrower confidence intervals than either study alone. GPS added significant predictive value to each clinical classifier. A model utilizing GPS and CAPRA provided the most risk discrimination. In decision-curve analysis, greater net benefit was shown when combining GPS with each clinical classifier compared with the classifier alone. The area under the receiver operating characteristic curve improved from 0.68 to 0.73 by adding GPS to CAPRA, and 0.64 to 0.70 by adding GPS to NCCN risk group. The proportion of patients with LFP >80% increased from 11% using NCCN risk group alone to 23% using GPS with NCCN. Using GPS with CAPRA identified the highest proportion-31%-of patients with LFP >80%.ConclusionPatient-specific MA provides more precise risk estimates that reflect the complete body of evidence. GPS adds predictive value to 3 widely used clinical classifiers, and identifies a larger proportion of low-risk patients than identified by clinical risk group alone.
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- 2016
50. Validation and Psychometric Properties of the Spanish Version of the Fear of Childbirth Questionnaire (CFQ-e).
- Author
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González-de la Torre, Héctor, Domínguez-Gil, Adela, Padrón-Brito, Cintia, Rosillo-Otero, Carla, Berenguer-Pérez, Miriam, and Verdú-Soriano, José
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PSYCHOMETRICS , *CHILDBIRTH , *CONFIRMATORY factor analysis , *EXPLORATORY factor analysis , *CRONBACH'S alpha - Abstract
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]
- Published
- 2022
- Full Text
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