Breastfeeding Basic Competence in Primary Care: A Spanish Translation and Cross-Cultural Validation of the CAPA Questionnaire.

BACKGROUND: The number of validated questionnaires that assess the level of breastfeeding competence of primary care professionals who attend lactating mothers is limited. RESEARCH AIM: To validate the CAPA (Competència en l'Atenció Primària sobre Alletament [Breastfeeding Competence in Primary Care]) questionnaire into Spanish in collaboration with professionals from the primary care services of the Comunidad de Madrid (Spain). METHODS: In this multicentric study, four bilingual healthcare professionals translated the CAPA questionnaire into Spanish and back-translated it into Catalan. The cross-cultural adaptation included a discussion by an expert committee, a review by a philologist, and a pilot study that involved 13 healthcare residents. We randomly selected professionals from specialties involved in breastfeeding. The re-test was conducted 3 weeks later, aiming to avoid changes in the studied population. We performed a factor analysis to identify underlying constructs and hypothesis-testing to assess the validity of the questionnaire and estimated the Cronbach Alpha and intraclass correlation coefficient (ICC) to assess its reliability. RESULTS: A total of 198 professionals participated by responding to the questionnaire. Factorial analysis showed that the questionnaire was unidimensional. Hypothesis testing showed that, of all the considered professional groups, midwives achieved the highest mean score (M = 131.7, SD = 10.9, p < 0.001). Amongst the other professionals, only 26.5% achieved a basic level of breastfeeding competence. The Cronbach alpha and ICC were 0.852 (95% CI [0.821, 0.880]) and 0.890 (95% CI [0.800. 0.937]). CONCLUSIONS: The Spanish CAPA questionnaire is a valid and reliable tool for assessing breastfeeding basic competence among primary care professional groups who attend lactating mothers.

Content validation of the nursing diagnosis "Insufficient breast milk production (00216)".

PURPOSE: To review and validate the elements of the nursing diagnosis (ND) "Insufficient breast milk production" (00216) based on the literature and expert consensus, and to construct operational definitions (ODs) for its defining characteristics (DCs). METHODS: It is a methodological study carried out in two phases. In the first phase, a scoping review was conducted, and in the second, a committee of experts reviewed the elements' content. Items with a Content Validity Index ≥0.8 were validated for relevance, clarity, and precision. Discussions were conducted until a consensus was reached on all items and criteria evaluated. The Ethics Committee approved the study. FINDINGS: The final scoping review sample consisted of 61 articles, and 19 experts evaluated the content of the ND. All DCs were revised. Three at-risk populations, three associated conditions, and one related factor were added. Three elements had their category changed, and an element was deleted. Experts also validated ODs developed for all DCs. CONCLUSION: "Insufficient breast milk production (00216)" was validated by experts. This study improved the ND through literature and expert consensus. New elements were added, and existing ones were revised. IMPLICATIONS FOR NURSING PRACTICE: This study improves this ND based on scientific evidence and clinical expertise and potentially improves nurses' diagnostic accuracy through ODs.

OBJETIVO: Revisar e validar os elementos do Diagnóstico de Enfermagem "Produção insuficiente de leite materno (00216)", com base na literatura e no consenso de especialistas, e construir definições operacionais para suas características definidoras. MÉTODO: Estudo metodológico realizado em duas fases. Na primeira fase foi realizada uma revisão da literatura e na segunda um comitê de especialistas revisou o conteúdo dos elementos. Os itens com Índice de Validade de Conteúdo ≥ 0,8 foram validados quanto à relevância, clareza e precisão. As discussões foram conduzidas até que se chegasse a um consenso sobre todos os itens e critérios avaliados. O estudo foi aprovado por Comitê de Ética em Pesquisa. RESULTADOS: A amostra final da revisão foi composta por 61 artigos e 19 especialistas avaliaram o conteúdo do diagnóstico de enfermagem. Todas as características definidoras foram revisadas. Foram acrescentadas três populações de risco, três condições associadas e um fator relacionado. Três elementos tiveram sua categoria alterada e um elemento foi excluído. Os especialistas também validaram as definições operacionais desenvolvidas para todas as características definidoras. CONCLUSÃO: "Produção insuficiente de leite materno (00216)" foi validado por especialistas. Este estudo melhorou o diagnóstico de enfermagem por meio da literatura e do consenso de especialistas. Novos elementos foram adicionados e os existentes foram revisados. IMPLICAÇÕES PARA A PRÁTICA DE ENFERMAGEM: Este estudo melhora o diagnóstico de enfermagem estudado com base em evidências científicas e experiência clínica, assim como tem potencial para melhorar a precisão diagnóstica dos enfermeiros por meio do desenvolvimento de definições operacionais.

Validation of the Spanish Version of the Breakthrough Pain Assessment Tool in Patients With Cancer.

INTRODUCTION AND BACKGROUND: Assessment of breakthrough pain is essential for adequate management of cancer pain. The Breakthrough Pain Assessment Tool (BAT) has been proven to be a brief, multidimensional, and reliable questionnaire for the assessment of breakthrough cancer pain (BTCP). Currently, there are no validated instruments in Spanish that allow assessing BTCP. OBJECTIVES: The objective of this study was to validate the Breakthrough Pain Assessment Tool - Spanish (BAT-S) version of the BAT in adult patients with cancer. METHODS: The BAT-S was tested in a prospective observational study conducted in adult patients with cancer-related pain and treated in a comprehensive cancer center in Mexico. We conducted a forward-backward translation and cross-cultural equivalence test in the Spanish language. The psychometric properties in patients with cancer were assessed using factor analysis, reliability, and validity. To assess reliability, the Kappa test and the intra-class correlation coefficient were used. For consistency, Cronbach's alpha test was used. RESULTS: Seventy patients participated in the study; 140 questionnaires were analyzed. The Spanish translation was well accepted by participants. Reliability was comprised between 0.746 for "use of analgesics" and 1.00 for "pain location." Thirteen of the 14 items had values above 0.8, and 12 above 0.9. Cronbach´s alpha coefficient was 0.7. CONCLUSION: This study confirms that BAT-S is a valid and reliable questionnaire to assess breakthrough pain in Mexican patients with cancer. This newly validated tool may be used to facilitate clinical management of primarily Spanish-speaking patients with breakthrough cancer pain. KEY MESSAGE: This study describes a prospective observational study to assess the validity and reliability of the Breakthrough Pain Assessment Tool in its Spanish version. The results support the use of this newly validated tool to facilitate clinical management of primarily Spanish-speaking patients with breakthrough cancer pain.

Validation of a Portable Respiratory Monitoring System for the Diagnosis of Obstructive Sleep Apnea in Patients with Chronic Obstructive Pulmonary Disease: A Crossectional Study.

Introduction Portable respiratory monitoring (PM) has been used to diagnose obstructive sleep apnea (OSA) in the general population. However, its validation in patients with both OSA and chronic obstructive pulmonary disease (COPD), remains unclear. Objective The aim of the study was to validate PM for the diagnosis of OSA in patients with COPD. Materials and Methods In this crossectional study, COPD patients were submitted simultaneously to polysomnography (PSG) and PM. Moreover, the risk for OSA was verified by the Berlin, NoSAS, and STOP-BANG questionnaires. Sensitivity, specificity, positive predictive value, and negative predictive value for PM were calculated for the cutoff points of the hypopnea apnea index (AHI) of 5, 15, and 30 events/hour, as well as for the questionnaires. The Bland-Altman test and correlation analyses between the AHI of the PSG and PM were performed. Results A total of 103 patients were evaluated (age 67.5 ± 9.9 years, 60% men). The STOP-BANG questionnaire had the highest sensitivity for OSA diagnosis, at 94.4% (72.7-99.9%). The sensitivity of PM decreased (87.0, 66.7, and 44.4%), and the specificity increased 40.0, 78.6, and 100.0%) as the AHI cutoff point increased from 5, 15, and 30. The Bland-Altman test indicated good limits of agreement (AHI = 5.5 ± 11.7 events/hour). Therefore, the AHI results of the PM showed a strong and positive correlation with those of the PSG (r = 0.70, p < 0.0001). Conclusion The PM test can be a useful tool for OSA diagnosis in patients with COPD.

Clinical Validation of the Nursing Diagnosis 'Inadequate Health Self-Efficacy' in People With Hypertension.

AIMS: To test the clinical validity of clinical indicators and causal relationships of aetiological factors of the new nursing diagnosis of inadequate health self-efficacy in people with hypertension. BACKGROUND: The diagnosis of inadequate health self-efficacy has both theoretical and content validity. However, a clinical validation study is needed to establish an appropriate framework for distinguishing individuals who manifest this unique human response. DESIGN: The study adopts a cross-sectional clinical validation approach, adhering strictly to the STROBE guidelines throughout its design and implementation. METHODS: Naturalistic sampling was used to identify 302 adults diagnosed with hypertension. Their data were subjected to latent class analysis, which facilitated the identification of a comprehensive set of clinical indicators that demonstrated better diagnostic accuracy and established posterior probabilities to guide the inference of inadequate health self-efficacy. In addition, logistic regression analysis was used to assess the magnitude of the impact of aetiological factors. RESULTS: The prevalence of inadequate health self-efficacy was 76.61%. Among the 13 indicators examined, seven demonstrated notable sensitivity: 'risk-prone health behaviour', 'failure to take action that prevents health problems', 'inadequate self-control', 'avoidance behaviours', 'negative health self-perception', 'inadequate health-related quality of life' and 'difficulty feeling good about adopting a healthy lifestyle'. Additionally, two indicators showed high specificity: 'difficulty feeling good about adopting a healthy lifestyle' and 'inadequate adherence to treatment regimen'. Notably, 15 aetiological factors were identified as significantly associated with an increased risk of inadequate health self-efficacy. CONCLUSIONS: A clinical framework consisting of eight clinical indicators and 15 aetiological factors was developed to characterise inadequate health self-efficacy in individuals with hypertension. RELEVANCE TO PRACTICE: Clinical validation provides insight into the precision of clinical indicators and the magnitude of the effect of putative causal elements, thereby facilitating identification and tailored intervention for individuals with hypertension and inadequate health self-efficacy.

Examining the Cycle of Physical Frailty in Falls Clinic Attendees Through Structural Equation Modeling.

In 1998, Fried and Walston introduced the Cycle of Frailty (CF) as a foundational concept for defining the physical frailty phenotype (FP). While the FP has been extensively validated, the CF hypothesis lacks equivalent support. This study aimed to internally validate the CF using structural equation modeling (SEM) in a clinical dataset of adults aged 50 or older attending an outpatient falls clinic. Measures included: age, morbidity, nutrition, sarcopenia by bioelectrical impedance, VO2max, handgrip strength, basal metabolic rate (BMR), 5-times chair stand test (5CST), physical activity, and total energy expenditure (TEE). The SEM, incorporating CF hypothesized causal pathways, was tested using IBM® SPSS® Amos 27.0.0 (maximum likelihood method) with a sample of 102 adults (mean age 69.8 years, 58.8% women). Overall, the SEM was supported by the data (χ2 = 44.4, df = 37, p = 0.189), with significant (p < 0.05) regression weights for morbidity→sarcopenia, age→sarcopenia, sarcopenia→VO2max, sarcopenia→handgrip strength, handgrip strength→5CST, physical activity→TEE, TEE→nutrition, and BMR→TEE. However, nutrition→sarcopenia, sarcopenia→BMR, VO2max→5CST, and 5CST→physical activity were not significant. Although the SEM was limited by inclusion of surrogate CF measures (e.g., 5CST instead of gait speed, VO2max based on age-predicted maximal/resting heart rate), it provided some internal support for the CF hypothesis.

Content validation of the nursing diagnosis "ineffective protection" in the context of adolescents with cancer.

OBJECTIVE: To analyze the relevance of a set of clinical elements to represent the content domain of the nursing diagnosis Ineffective Protection. DESIGN AND METHODS: This study employed content validation, using expert judgment to assess the appropriateness of clinical indicators, etiological factors, and conceptual and operational definitions, integrating the collective wisdom framework, the theory of predictive diversity, and the determination of rater skill level. RESULTS: From the middle range theory, 28 clinical indicators and 17 etiological factors were identified, which were rated by 34 raters. The analysis showed that the clinical indicators restlessness and insomnia and the etiological factors ambient temperature and humidity were not considered relevant for the nursing diagnosis of Ineffective Protection, because the median content validity index was lower than 0.9. CONCLUSIONS: Content validation verified that most of the components of the nursing diagnosis of Ineffective Protection were considered relevant by judges. PRACTICAL IMPLICATIONS: It is believed that the data obtained can help nurses to more easily evaluate the related factors and clinical indicators of Ineffective Protection presented by adolescents with cancer, which favors the process of diagnostic inference.

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

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

Validation and cultural translation for the Brazilian Portuguese version of the Estro-Androgenic- Symptom Questionnaire in Women.

Objective: This study aimed to translate and validate the Estro-Androgenic-Symptom Questionnaire in Women (EASQ-W) into Brazilian Portuguese language, as we hypothesized that this tool would be consistent for addressing the specific context of hormonal symptoms in menopause. Methods: In a cross-sectional study, a total of 119 women with Genitourinary Syndrome of Menopause (GSM) and 119 climacteric women without GSM were included. The EASQ-W was translated, and its psychometric properties were rigorously examined. Participants completed questionnaires covering sociodemographic details, the EASQ-W, and the Menopause Rating Scale (MRS). A subgroup of 173 women was re-invited after 4 weeks for test-retest analysis of the EASQ-W. Additionally, the responsiveness of the questionnaire was evaluated in 30 women who underwent oral hormonal treatment. Results: The internal consistency of the EASQ-W was found to be satisfactory in both GSM and control groups (Cronbach's alpha ≥ 0.70). Notably, a floor effect was observed in both groups; however, a ceiling effect was only evident in the sexual domain of the GSM group. Construct validity was established by comparing the EASQ-W with the MRS, yielding statistically significant correlations (0.33831-0.64580, p < 0.001). The test-retest reliability over a 4-week period was demonstrated to be satisfactory in both the GSM and control groups (ICC 0.787-0.977). Furthermore, the EASQ-W exhibited appropriate responsiveness to oral hormonal treatment (p < 0.001). Conclusion: This study successfully translated and validated the Estro-Androgenic-Symptom Questionnaire in Women (EASQ-W) into Brazilian Portuguese, with satisfactory internal consistency, test-retest reliability, and construct validity.

Brazilian Version of the Vestibular Activities and Participation Measure: Cross-Cultural Adaptation, Validity, and Reliability.

BACKGROUND: Vestibular Activities and Participation Measure (VAP) subscales assess the effect of vestibular disorders on activity and participation. This study aimed to perform the cross-cultural adaptation and assess the validity, internal consistency, reliability, and measurement error of the Brazilian version of VAP subscales. METHODS: The cross-cultural adaptation followed the translation, synthesis, back-translation, review by a committee of experts, and pretesting phases. Structural validity was assessed using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), while Spearman's correlation between VAP subscales and the Dizziness Handicap Inventory (DHI) was used to assess construct validity. Cronbach's alpha measured internal consistency. Intraclass correlation coefficient (ICC) assessed intra- and inter-rater reliability, and measurement error was calculated by using the standard error of measurement (SEM) and minimal detectable change (MDC). RESULTS: Additional information was included in the Brazilian version of the Vestibular Activities and Participation measure (VAP-BR) after approval by one of the developers of the instrument to improve the understanding among individuals. One factor was found in the EFA for each subscale with 50% explained variance. Regarding CFA, the subscales 1 (S1) and 2 (S2) presented, respectively, adequate model fit indices (ie, comparative fit index of 0.99 and 0.97, and standardized root mean square residual of 0.04 for both subscales), but a very low factor load in item 6 of S1 (0.08). Chronbach's alpha was 0.80 (S1) and 0.82 (S2). For intra-rater assessment, the S1 and S2 presented an ICC of 0.87 and 0.90, SEM of 0.01 and 1.16, and MDC of 0.39 and 0.46, respectively. When assessed by 2 different raters, SEM values were 1.03 and 1.53, and MDC values were 2.85 and 4.23 for S1 and S2, respectively; both subscales showed an ICC of 0.92. Correlations between DHI and VAP subscales presented coefficients above 0.57. CONCLUSION: The Brazilian version of VAP subscales presents good measurement properties and may assist health professionals in identifying activity limitations and participation restrictions in individuals with vestibular disorders.

Validation of the delirium diagnostic tool-provisional (DDT-Pro) in geriatric medical inpatients with diagnostic permutations of the 3Ds with and without delirium.

OBJECTIVE: Validations of brief delirium tools have not included analysis of psychiatric disorders comorbidities or control groups. We validated the Delirium Diagnostic Tool-Provisional (DDT-Pro) in 422 geriatric inpatients with high incidence of depression and/or dementia. METHODS: Cross-sectional study using two delirium reference standards, DSM-5-TR and Delirium Rating Scale-Revised-98 (DRS-R98). We assessed concurrent and construct DDT-Pro validity too. RESULTS: There were 117 (27.7%) delirium cases using DDT-Pro, 104 (24.6%) per DSM-5-TR and 93 (22.0%) per DRS-R98; 133 patients (31.5%) had depression and 105 (24.9%) dementia, some comorbid with delirium. DDT-Pro accuracy (AUC under ROC curve) ranges were 88.3-95.9% vs DSM-5-TR and 92.7-95.0% vs DRS-R98 for whole sample and four diagnostic groups, without statistical differences. DDT-Pro ≤6 had the most balanced sensitivity-specificity for delirium diagnosis against both DSM-5-TR and DRS-R98 with similar specificity but higher sensitivity for DRS-R98 than DSM-5-TR delirium, with the highest values in patients with depression and dementia (≥92% sensitivity, ≥81% specificity). Positive and negative likelihood ratios support diagnostic strength. Concurrent validity was high reflected by significant correlations (p < 0.001) of DDT-Pro total and item scores with DRS-R98 and Delirium Frontal Index scores, highest in groups with comorbid depression and/or dementia. The DDT-Pro represented a single construct for delirium demonstrated by one factor with high item loadings and high internal consistency reliability of its items. CONCLUSIONS: The DDT-Pro demonstrated strong performance metrics in general hospital elderly inpatients with preexisting depression and/or dementia, which is unique among brief delirium tools. Its optimized cutoff score was the same as in other populations.

UnTWISTing the BALS: A study of predictive accuracy of clinical scoring tools for testicular torsion identification in adults.

OBJECTIVE: Testicular torsion is an uncommon but time-critical condition in EDs. If the diagnosis is missed or delayed, there are significant medicolegal and patient fertility implications. Scoring tools are advocated for use in children but have limited validation in adults. The aim of the present study was to explore the predictive accuracy of the testicular torsion scoring tools, Testicular Workup for Ischemia and Suspected Torsion (TWIST) and Boettcher Alert Score (BALS), in adult patients with a final ED diagnosis of torsion. METHODS: All patients with an ED working diagnosis of testicular torsion were identified retrospectively. Data collected from digital medical records included demographics, processes of care and clinical information. The outcome of interest was the predictive performance of the scores for a confirmed diagnosis of testicular torsion as adjudicated by an urologist or a surgeon. RESULTS: Fifty-four patients had complete clinical data, of whom 13 had confirmed torsion. The TWIST score had a high area under the receiver operating characteristics curve (AUROC) of 0.89 (95% confidence interval [CI] = 0.78-0.999) with a score of 6-7 corresponding to a positive predictive value (PPV) of 80% (95% CI = 38-96%). The BAL score had an AUROC of 0.79 (95% CI = 0.69-0.92). PPV for a score ≥2 was 38% (95% CI = 22-56%). CONCLUSION: A high TWIST score correlates to a high likelihood of torsion and can inform surgical decision-making in the absence of US.

Performance of risk scores in predicting major bleeding in left ventricular assist device recipients: a comparative external validation.

Background: Implantation of a left ventricular assist device (LVAD) is a crucial therapeutic option for selected end-stage heart failure patients. However, major bleeding (MB) complications postimplantation are a significant concern. Objectives: We evaluated current risk scores' predictive accuracy for MB in LVAD recipients. Methods: We conducted an observational, single-center study of LVAD recipients (HeartWare or HeartMate-3, November 2010-December 2022) in the Netherlands. The primary outcome was the first post-LVAD MB (according to the International Society on Thrombosis and Haemostasis [ISTH] and Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and INTERMACS combined with intracranial bleeding [INTERMACS+] criteria). Mortality prior to MB was considered a competing event. Discrimination (C-statistic) and calibration were evaluated for the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly score, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke score, Anticoagulation and Risk Factors in Atrial Fibrillation score, Outpatient Bleeding Risk Index, venous thromboembolism score, atrial fibrillation score, and Utah Bleeding Risk Score (UBRS). Results: One hundred four patients were included (median age, 64 years; female, 20.2%; HeartWare, 90.4%; HeartMate-3, 9.6%). The cumulative MB incidence was 75.7% (95% CI 65.5%-85.9%) by ISTH and INTERMACS+ criteria and 67.0% (95% CI 56.0%-78.0%) per INTERMACS criteria over a median event-free follow-up time of 1916 days (range, 59-4521). All scores had poor discriminative ability on their intended prediction timeframe. Cumulative area under the receiving operator characteristic curve ranged from 0.49 (95% CI 0.35-0.63, venous thromboembolism-BLEED) to 0.56 (95% CI 0.47-0.65, UBRS) according to ISTH and INTERMACS+ criteria and from 0.48 (95% CI 0.40-0.56, Anticoagulation and Risk Factors in Atrial Fibrillation) to 0.56 (95% CI 0.47-0.65, UBRS) per INTERMACS criteria. All models showed poor calibration, largely underestimating MB risk. Conclusion: Current bleeding risk scores exhibit inadequate predictive accuracy for LVAD recipients. There is a need for an accurate risk score to identify LVAD patients at high risk of MB who may benefit from patient-tailored antithrombotic therapy.

Validation of Database Autopsy for Review of Pregnancy-Associated Deaths in Canada.

The database autopsy method was developed to determine probable causes of maternal deaths in the Canadian Institute for Health Information's hospital discharge abstract database; however, the method has yet to be validated. Using immediate cause of death information from Québec's hospitalization database as the gold standard, this study assessed the validity and reliability of the database autopsy method for pregnancy-associated deaths. The method had high sensitivity and specificity for identifying the most common causes of these deaths, as well as high interobserver agreement. We conclude that the database autopsy method is valid and reliable overall.

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.

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 forward-backward 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.

Design and validation of a GMP stem cell manufacturing protocol for MPSII hematopoietic stem cell gene therapy.

Hematopoietic stem cell gene therapy (HSCGT) is a promising therapeutic strategy for the treatment of neurodegenerative, metabolic disorders. The approach involves the ex vivo introduction of a missing gene into patients' own stem cells via lentiviral-mediated transduction (TD). Once transplanted back into a fully conditioned patient, these genetically modified HSCs can repopulate the blood system and produce the functional protein, previously absent or non-functional in the patient, which can then cross-correct other affected cells in somatic organs and the central nervous system. We previously developed an HSCGT approach for the treatment of Mucopolysaccharidosis type II (MPSII) (Hunter syndrome), a debilitating pediatric lysosomal disorder caused by mutations in the iduronate-2-sulphatase (IDS) gene, leading to the accumulation of heparan and dermatan sulfate, which causes severe neurodegeneration, skeletal abnormalities, and cardiorespiratory disease. In HSCGT proof-of-concept studies using lentiviral IDS fused to a brain-targeting peptide ApoEII (IDS.ApoEII), we were able to normalize brain pathology and behavior of MPSII mice. Here we present an optimized and validated good manufacturing practice hematopoietic stem cell TD protocol for MPSII in preparation for first-in-man studies. Inclusion of TEs LentiBOOST and protamine sulfate significantly improved TD efficiency by at least 3-fold without causing adverse toxicity, thereby reducing vector quantity required.

Instrument to evaluate the perception of abuse and/or disrespectful treatment during childbirth: A validation study.

AIM: To design and validate a tool to assess a woman's perception of whether she has experienced a situation of abuse or disrespect during childbirth attendance: "Childbirth Abuse and Respect Evaluation-Maternal Questionnaire" (CARE-MQ). METHODS: Multidisciplinary panel of experts (gynecologists, midwives, mothers) participated in creating CARE-MQ. A cross-sectional study was carried out on 901 Spanish women who had given birth between 1 and 3 months before to determine psychometric characteristics. Finally, an exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and a convergent validity study were carried out with the Quality Questionnaire from the Patient's Perspective-Intrapartum (QPP-I), and a reliability study using internal consistency (Cronbach's α) and coefficient of intraclass correlation (CCI). FINDINGS: The KMO test gave a value of 0.935, and Bartlett's sphericity test was <0.001. The EFA identified four components ("Emotional Abuse", "Inadequate Professionalism", "Physical Abuse" y "Lost contact") that explained 55.16 % of variance. In the CFA, a good fit was observed for most of the evaluated indicators. CARE-MQ correlated negatively with QPP-I (Spearman's rho = -0.641, 95 % CI: -0.679, -0.600; p < 0.001) and was statistically associated with variables related to childbirth experience (p < 0.005) such as the use of a birth plan, use of regional analgesia, type of birth, episiotomy, presence of severe tears, skin-to-skin contact, length of hospital stay and postpartum surgical intervention. Cronbach's α value was 0.903. The ICC of absolute agreement after administering the questionnaire one week after was 0.927 (95 % CI: 0.85-0.97). CONCLUSIONS: CARE-MQ is a valid and reliable instrument to evaluate the perception of a woman regarding the situation of abuse and/or disrespect that she may have experienced during birth in a population of Spanish postpartum women.

Construct validity and reliability of the BARRIERS scale in the Spanish context.

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.

Development and validation of meta-measurement instruments: A methodological approach.

A valid and reliable nursing assessment is essential for identifying required care and ensuring patient safety. The convenience of conducting a comprehensive assessment of the patient has led to a significant increase in assessment tools that may slow down the process. Nevertheless, the possibility of consolidating various instruments that measure common or similar constructs into a meta-instrument is considered an alternative that could enhance assessment efficiency. A meta-instrument can be defined as a measurement tool that consolidates other instruments based on measuring related constructs and sharing dimensions or items, aiming to achieve a more parsimonious measurement. Literature on such assessment tools is scarce, and there are numerous options for their construction and initial validation. Additionally, it is advisable to confirm their psychometric properties and ensure that they maintain, at the very least, the same diagnostic capacity as the original instruments. This article presents a proposal for the phases to follow in constructing meta-instruments, along with various methodological alternatives that can be employed based on the characteristics of the original instruments and the purpose of creating the meta-instrument. Furthermore, special attention is given to the checklists that should be used to study the psychometric properties and diagnostic capacity of the meta-instruments. Finally, future lines of research and challenges in the development of nursing assessment meta-instruments are discussed.