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Introduction: As people age, they often look back on their history to determine their accomplishments and shortcomings, which might cause them to feel regret. The present study was designed to assess the reliability and validity of the Persian version of the regret scale in the Iranian elderly.Methods: The research method was a descriptive evaluation type. The study was conducted in Tehran in 2023. The sample consisted of 293 elderly men and women, who were selected by available and online sampling methods. The elderly completed the demographic checklist, regret, psychological distress, and psychological well-being questionnaires. The psychometric properties of the regret scale were analyzed through confirmatory factor analysis and Cronbach’s alpha coefficient in SPSS software and R software.Results: The content validity of the questionnaire items was found to be satisfactory in terms of quality. The results of the factor analysis indicated that the regret scale had a single-factor structure. The model had an RMSEA of 0.07 and an SRMR of 0.04, which indicated the appropriateness of the model. The calculated values of other indices (GFI, CFI, NFI, NNFI, and IFI) were 0.99, 0.96, 0.94, 0.86, and 0.96, respectively, indicating that the obtained model was acceptable. Additionally, Cronbach’s alpha coefficient was 0.81.Conclusion: The findings indicated that the regret scale had construct validity and acceptable reliability among the Iranian elderly. Besides, the single-factor structure of this scale could help to identify regret in the Iranian elderly.

Scientific relevance. Viable cell counting is an important microbiological test for the quality assessment of medicinal products containing live microorganisms. To optimise labour and material costs and enhance testing precision and reproducibility, it is practical to use partially automated instrumental methods, such as the spiral plating method.Aim. The aim was to conduct a validation study of the spiral plating method for assessing the potency of biologicals containing live bacterial cells, using a lactobacillus-containing probiotic medicinal product as a case study.Materials and methods. This study used a culture of Lactiplantibacillus plantarum isolated from a probiotic medicinal product. Spiral plating on agar-based biological culture media was performed using an automatic Eddy Jet 2 plating system. The study used an IUL Flash & Go colony counter for automatic reporting of the results. The validation study was conducted according to the general chapter on the validation of microbiological testing methods (OFS.1.1.0021.18) of the State Pharmacopoeia of the Russian Federation.Results. According to the validation results for the main parameters, the spiral plating method had the range of 104–105 CFU/mL; the limit of quantification of 102 CFU/mL; and the coefficient of linear determination, R2, of 0.99. The accuracy of the spiral plating method in determining the potency of the test sample was 93%; the repeatability was 4.9%.Conclusions. The study results confirm the similarity of the spiral plating method with an automatic colony counter to Koch’s plating method, which is currently used in accordance with the State Pharmacopoeia of the Russian Federation, in terms of the validated parameters. Therefore, spiral plating can be used to evaluate the potency of lactobacillus-containing probiotics. Spiral plating can help improve the cost-effectiveness and accuracy of testing.

Objective To translate the 22-item Longer-term Unmet Needs after Stroke (LUNS) questionnaire, validate it in the Korean stroke population, and assess the reliability of face-to-face and telephone surveys. Methods Sixty-six adult patients with stroke from Seoul National University Bundang Hospital and Kangwon National University Hospital were involved in the validation. Participants were interviewed twice using the LUNS Korean version: first, a face-to-face survey for validation, and second, a telephone survey for test-retest reliability. Participants completed the Frenchay Activities Index (FAI) and Short Form 12 (SF-12) Mental and Physical Component Summary (MCS and PCS) scores at the first interview. For concurrent validity, the differences in health status (FAI, SF-12 MCS and PCS) between the groups that reported unmet needs and those that did not were analyzed for each item. Cohen’s kappa and percentage of agreement between the first and second administrations were calculated for each item to determine the test-retest reliability. Results The average age of the participants was 61.2±12.8 years and 74.2% were male. Fifty-seven patients were involved in the second interview. Depending on the unmet needs, SF-12 MCS, PCS, and FAI were significantly different in 12 of 22 items. In the test-retest reliability test, 12 items had a kappa of 0.6 or higher, and two had a kappa of

Study Design Validation of a novel retrospective comparative questionnaire to obtain post-intervention outcome data in patients with lumbar degenerative spinal disease. Purpose Acquiring prospective outcome data for spinal intervention is not frequently feasible in resource-depleted units in certain developing countries. Therefore, a novel retrospective instrument is being validated for clinical use, which can act as a standard method to describe outcomes when data are retrospectively collected. Overview of Literature The standard method of collecting outcome data after a spinal intervention has been prospective, including the Oswestry Disability Index, Roland-Morris Questionnaire, and Short Form-36. The process of content validation and reliability of the novel retrospective spinal questionnaires is highlighted. Methods Questionnaire items were created based on a literature review, followed by a process of content validation by experts and modification based on expert opinions to achieve an acceptable content validity index (CVI, 0.70–1.00). To calculate factor loadings for each question, a pilot test was subsequently conducted from a pool of patients who underwent lumbar spine surgeries for degenerative spine diseases. Results All items achieved a CVI of >0.85 for both relevancy and clarity and were successfully validated after appropriate corrections were made before the second validation phase. Except for Q9 and Q10, which showed low-loading factors in the pooled sample, the remainder of the items had acceptable loading factors across different subgroups, indicating that the passage of time did not affect the results of the exploratory factor analysis. Conclusions The retrospective questionnaire that encompasses the general well-being and lumbar-specific symptoms is a valid and reliable instrument to provide an impression of the outcome after intervention in a patient with a degenerative lumbar spinal disease. A summative score will indicate the overall outcome.

Background: The cutoff point of an instrument is a valuable clinical reference. Objective: To study the cutoff point of the Informal Caregiver Burden Assessment Questionnaire (QASCI). Methodology: A methodological cross-sectional study was conducted using secondary data analysis. The predictive validity of the instrument was assessed by measuring sensitivity and specificity, positive and negative predictive values, and the area under the ROC curve (AUC). The Portuguese versions of the Medical Outcomes Study 36-Item Short Form Survey Instrument (MOS SF36) and the Hospital Anxiety and Depression Scale (HADS) were used. Results: Caregivers exhibited elevated levels of anxiety and depression. The cutoff point 40 yielded the highest Youden Index score (0.59), indicating that the model has an 84% accuracy for predicting anxiety and depression disorders. In addition, the model demonstrated a sensitivity of 78% and a specificity of 81%. Conclusion: This study demonstrates that the QASCI effectively identifies caregivers at risk of anxiety and depression disorders and can inform interventions to enhance their mental health.

Background: Ensuring the validity of results from funded programs is a critical concern for agencies that sponsor biological research. In recent years, the open science movement has sought to promote reproducibility by encouraging sharing not only of finished manuscripts but also of data and code supporting their findings. While these innovations have lent support to third-party efforts to replicate calculations underlying key results in the scientific literature, fields of inquiry where privacy considerations or other sensitivities preclude the broad distribution of raw data or analysis may require a more targeted approach to promote the quality of research output. Methods: We describe efforts oriented toward this goal that were implemented in one human performance research program, Measuring Biological Aptitude, organized by the Defense Advanced Research Project Agency's Biological Technologies Office. Our team implemented a four-pronged independent verification and validation (IV&V) strategy including 1) a centralized data storage and exchange platform, 2) quality assurance and quality control (QA/QC) of data collection, 3) test and evaluation of performer models, and 4) an archival software and data repository. Results: Our IV&V plan was carried out with assistance from both the funding agency and participating teams of researchers. QA/QC of data acquisition aided in process improvement and the flagging of experimental errors. Holdout validation set tests provided an independent gauge of model performance. Conclusions: In circumstances that do not support a fully open approach to scientific criticism, standing up independent teams to cross-check and validate the results generated by primary investigators can be an important tool to promote reproducibility of results.

Introduction: Perceived Stress Scale (PSS), developed in 1983, is one among the widely used global scales to assess the perceived psychological stress status. Hence, our study aimed at developing a Tamil version of THE 10-item PSS (TPSS-10) and assess its construct validity and internal consistency among patients with diabetes in Puducherry, South India. Methods: We translated the TPSS-10 by language experts and pilot-tested the sample with a subsample of diabetes patients. The finalized version of TPSS-10 was administered to 117 Tamil-speaking diabetic patients availing services from the rural health center in Puducherry, South India. Construct validity was assessed using the exploratory factor analysis (EFA) and the principal component analysis (PCA). A confirmatory factor analysis (CFA) was also done to obtain the goodness-of-fit. Reliability of questionnaire was evaluated by Cronbach's alpha. Results: Two factors were obtained with Eigenvalues of 4.61 and 2.16. Both factors explained 67.8% of the total variance. The two-factor model assessed by CFA found a χ2 value of 714.99 (P < 0.001). Goodness-of-fit revealed acceptable comparative fit indices (0.93). The reliability coefficient (Cronbach's alpha) for complete TPSS-10 was 0.86, indicating good internal consistency. Discussion: Our study concludes that the TPSS-10 questionnaire is internally valid and consistent with good reliability coefficient after its administration to Tamil-speaking urban diabetic patients in order to measure perceived stress. However, further research is warranted to content-validate the tool with a standard diagnostic instrument.

The STOP-Bang has been promoted as a valuable tool for identifying obstructive sleep apnea-hypopnea syndrome (OSAHS) in medical and surgical patients. However, its performance in Colombian samples is unknown. The objective of this study was to determine the clinimetric performance of the STOP-Bang index versus the study of polysomnography in patients from Santa Marta, Colombia. An accuracy study of diagnostic tests with a test-based approach was designed. Seven hundred sixty-two adults referred for polysomnography to evaluate OSAHS were included in the research. They were aged between 18 and 94 years old (mean=47.2, SD=13.4), 63.3% were men, and 46.5% were classified as obese. The STOP-Bang performance was compared against the best reference criterion, the hypopnea/apnea index determined by polysomnography. The diagnosis of OSAHS was confirmed in 461 (60.5%) and corroborated in 301 (39.5%). The area under the curve was 0.70 (95%CI 0.66-0.74), and the best cut-off point was 4, with a sensitivity of 79.2%, a specificity of 53.5%, the positive predictive value of 72.2%, the negative predictive value of 62.6%, positive likelihood ratio was 1.70, negative likelihood ratio was 0.39; OR=4.08 (CI95% 2.99-5.56) and Cohen's kappa of 0.33. As conclusions, performance indicators show that STOP-Bang...

Abstract Objective To evaluate the interobserver agreement of two classifications for floating knee: Fraser and Blake & McBryde. Method Thirty-two observers, subdivided according to the degree of titration (26 resident physicians and 6 orthopedic physicians specialized in orthopedic trauma), classified 15 fractures of the ipsilateral femur and tibia. Interobserver agreement was evaluated by using the Kappa coefficient. Result When evaluating the agreement between the 9 R1, a Kappa index of 0.58 was obtained for the Fraser classification and of 0.46 for the Blake & McBryde classification. Among the 7 R2, a rate of 0.59 was obtained for the Fraser rating and 0.51 for the Blake & McBryderating. Among the 10 R3, theagreement index was higher for both classifications: 0.72 for the Fraser and 0.71 for the Blake & McBryde classification. Considering the 3 groups (R1, R2, R3) as one large group, the general Kappa index was calculated, which resulted in 0.63for the Fraser classification and 0.56 for the Blake & McBryde classification. In the group of traumaand orthopedic knee specialists, in turn, an agreement of 0.597 was obtained for the Blake and McBryde classification and of 0.843 for the Fraser classification. Conclusion Comparatively, the two classifications presented a weak to moderate degree of agreement. Fraser classification had better agreement in both groups. The agreement was higher when evaluating orthopedic trauma physicians.

Purpose This study presents a translation, cultural adaptation, and psychometric evaluation of two instruments of the Fertility Awareness and Attitudes Towards Parenthood (FAAP) questionnaire (Conditions and Life changes) for use in South Korea. Methods This methodological study included 166 university students for psychometric evaluation in the sixth step. The first five steps included forward translation, backward translation, committee review, assessment of content validity, and a pre-test. In the sixth step, psychometric properties, including internal consistency, construct validity, and criterion validity, were evaluated. Exploratory factor analysis and confirmatory factor analysis were conducted to identify the structure of the tool and to assess its validity. Results The Korean version showed acceptable internal consistency. Cronbach's ⍺ was .73 for FAAPC-conditions and .83 for FAAP-Life changes. FAAP-Conditions showed a four-factor structure (social conditions, relationship with partner, external environment, and child-rearing support) and FAAP-Life changes had a two-factor structure (reward and burden). In the confirmatory analysis, CMIN/DF, TLI, IFI, SRMR, CFI, and RMSEA were satisfactory. Conclusion This study provided preliminary evidence of the acceptability, reliability, and validity of the Korean version of the FAAP questionnaire in university students in South Korea. Nonetheless, further evaluation among Korean young adults is warranted to validate this instrument.

ABSTRACT Objective: To translate into Brazilian Portuguese and conduct the cross-cultural adaptation of the “Injury Report Form for Rugby Union” questionnaire. Methods: This is a cross-sectional study, level of evidence II, with following the steps: translation; synthesis; back-translation; review by a committee of experts and pre-final version; pre-test to verify comprehension; elaboration of the final version of the instrument and clinical application. Results: The two versions resulting from the translation and adaptation process did not show great differences. The pre-final version was filled by 23 male rugby players; three questions were not understood by 40%, 27% and 82.5% of the players, respectively, which required a new meeting with a multidisciplinary committee of experts. The modifications were made, requiring then a new application. The new version was filled by 25 male rugby players, aged 29.44 ± 5.90 years; of which 56% had complete higher education; finalizing the process of cross-cultural adaptation. Conclusion: The questionnaire “Formulário para Notificação/Avaliação de Lesão em Jogadores de Rugby” was translated and transculturally adapted into Brazilian Portuguese. Level of Evidence II, Diagnostic Studies - Investigating a Diagnostic Test.

Introduction Tinnitus affects a large portion of the world's population. There are several questionnaires being used for the evaluation of the severity of tinnitus and its impact in quality of life; however, they do not measure treatment-related changes. So, a new self-reported questionnaire was developed, the Tinnitus Functional Index (TFI), which has been translated into several languages. Objective To perform the translation, cultural adaptation and validation of the TFI questionnaire for Brazilian Portuguese. Method This is a multicenter project divided into two stages: translation and cultural adaptation; and validation and reliability. For the validation, the Brazilian Portuguese version of the TFI was correlated with the Tinnitus Handicap Inventory (THI) domains for tinnitus and quality of life and was evaluated by the Spearman ρ test. The reliability and internal consistency were evaluated by the Cronbach α test. Result The Brazilian version of the TFI was obtained through an initial translation process, synthesis of translations, backtranslation and evaluation by a committee of experts. This version was then applied in 88 patients complaining of tinnitus from speech therapy and otorhinolaryngology outpatient clinics of the three school clinics. The Brazilian version presented high reliability, as evidenced by the Cronbach α value (α = 0.870), and strong correlation (rho = 0.760 and p = 0.000). Conclusion The high reliability found in the results demonstrates that the Brazilian Portuguese version of the TFI is a valid and reliable instrument to evaluate the severity and impact of tinnitus on quality of life and changes related to its treatment.

ABSTRACT Objective: To develop, adapt and validate an instrument named “CSII – Brazil” to assess users’ conceptual and procedural knowledge of continuous subcutaneous insulin infusion systems. Materials and methods: Methodological and exploratory study developed in three stages: a) instrument development; b) content validation and cultural adaptation (evaluation by a committee of experts and pre-test with CSII users); c) psychometric validation through instrument application in a sample of 60 patients by means of the web tool e-Surv. Internal consistency and reproducibility analyses were performed within IBM SPSS Statistics 20 programming environment. Results: The 16 multiple-choice question instrument successfully attained a content validity index of 0.97, showing satisfactory internal consistency, with 0.61 Cronbach's alpha [95% CI 0.462-0.746] and an intraclass correlation coefficient of 0.869 [95% CI: 0.789-0.919] between the test and retest scores. Conclusion: The CSII – Brazil instrument is considered adequate and validated to assess continuous subcutaneous infusion system users’ conceptual and procedural knowledge.

This study aimed to validate an array-based inertial measurement unit to measure cricket fast bowling kinematics as a first step in assessing feasibility for tele-sport-and-exercise medicine. We concurrently captured shoulder girdle relative to the pelvis, trunk lateral flexion, and knee flexion angles at front foot contact of eight cricket medium-fast bowlers using inertial measurement unit and optical motion capture. We used one sample t-tests and 95% limits of agreement (LOA) to determine the mean difference between the two systems and Smallest Worth-while Change statistic to determine whether any differences were meaningful. A statistically significant (p < 0.001) but small mean difference of −4.7° ± 8.6° (95% Confidence Interval (CI) [−3.1° to −6.4°], LOA [−22.2 to 12.7], SWC 3.9°) in shoulder girdle relative to the pelvis angle was found between the systems. There were no statistically significant differences between the two systems in trunk lateral flexion and knee flexion with the mean differences being 0.1° ± 10.8° (95% CI [−1.9° to 2.2°], LOA [−22.5 to 22.7], SWC 1.2°) and 1.6° ± 10.1° (95% CI [−0.2° to 3.3°], LOA [−19.2 to 22.3], SWC 1.9°) respectively. The inertial measurement unit-based system tested allows for accurate measurement of specific cricket fast bowling kinematics and could be used in determining injury risk in the context of tele-sport-and-exercise-medicine.

Objective: to presenting the linguistic validation of the Diabetic Foot Ulcer Scale Short-Form (DFS-SF) among patients with ulcer diabetic foot (DFU) to Brazilian Portuguese and evaluate its content, practicability and acceptability. Methods and casuistry: a cross-sectional, methodological research, was conducted among 30 outpatients in follow-up for DF, assessed regarding QoL, sociodemographic and clinical data. International recommendations provided by the Mapi Research Trust on adaptation procedures were followed: the stages of Forward translation, Backward translation and the Cognitive interview were carried out. The Content Validity Index was calculated and a pre-test were gathered to produce a pre-final version. Practicability and acceptability were also assessed. Results: the semantic, idiomatic, cultural and conceptual equivalences between the linguistic validated and the original version were obtained. The DFS-SF was practical, well accepted and easy to understand. Conclusion: the linguistic validation process of the Brazilian version of the DFS-SF has been completed in accordance with internationally recommended standards. The instrument was easy to apply, to understand and presented short time for administration.

Background: Substance abuse is a critical problem in most countries, especially in developing ones. Earlydetection is the pre-requisite of early control, for which reliable and valid tools are required. In the presentstudy, we aimed at measuring the psychometric properties of the 10-item Drug Abuse Screening Test (DAST-10)in Iranian individuals.Methods: After translation and back-translation of the questionnaire, 244 adults were recruited from TehranMegacity, Iran, and completed the questionnaires. Participants were recruited by a multistage randomizedcluster sampling method. Reliability was determined by Cronbach’s alpha. Also, construct validity wasevaluated using confirmatory factor analysis (CFA) and exploratory factor analysis (EFA).Findings: The internal consistency using Cronbach's alpha coefficients for the total score of the Persianversion of DAST-10 was 0.93. EFA evoked only one factor for DAST-10. The CFA for 1-factor models forDAST-10 indicated an acceptable fit for the proposed models.Conclusion: The results prove desirable reliability and validity of the Persian version of the DAST which canbe utilized as a screening instrument for drug abuse among Iranian adults.

Aim To develop and validate a screening questionnaire for migraine without aura with sufficient diagnostic accuracy to be used in primary care settings. Methods The study was designed as cross-sectional, multicentric, diagnostic accuracy trial of new questionnaire for screening patients who visit general practitioners, with an aim to reveal migraine without aura. The instrument was constructed for the purpose of this study, and validated on the sample of 429 primary care outpatients. The gold standard of diagnosing migraine without aura was clinical estimate by a neurologist based on the International Classification of Headache Disorders 3rd edition (ICHD-III) criteria. Diagnostic accuracy of the instrument was tested through construction of the Receiver Operator Curve. Results The Balkan Migraine Screening Questionnaire (BMSQ) instrument showed good diagnostic accuracy (sensitivity 83.4% and specificity 79.9%) for migraine without aura, with significant screening yield among previously undiagnosed patients of 75.9%. The study also confirmed a high percentage of patients with hidden migraine without aura (MWA) (52.9%) revealed by the BMSQ and the ICHD-III criteria that would otherwise remain undiagnosed. Conclusion The BMSQ is a valid and reliable clinical instrument for revealing migraine without aura, which could be easily self-administered by patients. It has high screening yield, discovering majority of patients with previously undiagnosed migraine without aura, whose definite diagnosis should later on be confirmed by the attending physicians using the ICHD-III criteria.

Abstract Objective The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a validated measure to assess interoceptive awareness. Although an earlier study evaluated the Japanese version of the MAIA, it did not examine the measure’s test–retest reliability and the data fit of the factor structure. This study aims to further validate the Japanese version of the MAIA. Results In this cross-sectional study, 268 Japanese individuals participated. They completed the Japanese version of the MAIA and concurrent validity measures. The test–retest reliability of the Japanese version’s subscales ranged from adequate to high (intra-class coefficients = 0.76–0.85). Confirmatory factor analysis demonstrated that the Japanese six-factor structure had a good fit in Japanese. The MAIA subscales were moderately associated with scores on the Body Awareness Scale (rho = 0.25–0.49). The results indicated high test–retest reliability and further confirmed the validity of the six-factor structure of the Japanese version of the MAIA. Hence, the Japanese version of the MAIA is a useful measure to assess interoceptive awareness in the Japanese population.

Abstract Objective Telemedicine arises as an attractive intervention for reducing the waiting time for appointments with medical specialists in Chile. Successful implementation of this technology requires safeguarding the patient/clinician trust relationship; however, no studies have been conducted to evaluate quality perception of a telemedicine program in Chile. To assess patient satisfaction with the Teleneurology program at the Hospital Higueras Talcahuano (HHT), addressing patient/clinician trust relationship. Results A perception survey was constructed with 23 questions, distributed into 5 key areas (items) of user satisfaction. Its face validity was performed by five neurology specialists from the Teleneurology unit of HHT. The survey was applied to 167 patients of the HHT, recruited between 2018 and 2019, for conducting a pilot cross-sectional descriptive study to assess internal consistency (Cronbach alpha) and reliability (factorial analysis of main components). The survey showed an internal consistency of 0.88. Removing any of the items maintained its reliability in values over 0.8. All items showed point biserial correlations greater than 0.30. Overall, the survey constructed and evaluated in this study showed high internal consistency and reliability values, which will allow its application in further studies of quality assessment of the Teleneurology unit of HHT.

ABSTRACT BACKGROUND: Self-efficacy refers to one’s belief in one’s ability to organize, perform actions and face challenges in order to achieve goals and motivation. High self-efficacy improves disease coping and adherence to treatment among patients with rheumatoid arthritis. The objective of this study was to translate, culturally adapt and test the reproducibility of the 8-item Arthritis Self-Efficacy Scale (ASES-8) questionnaire for use in Brazil. DESIGN AND SETTING: Validation study conducted in university outpatient clinics. METHODS: The questionnaire was translated into Brazilian Portuguese and then back-translated into English. The final version in Portuguese was tested on 30 patients with rheumatoid arthritis and was shown to be understandable and culturally adapted. A further 32 patients with rheumatoid arthritis were evaluated three times using the questionnaire. On the first occasion, two evaluators applied the questionnaire to check inter-evaluator reproducibility. After 15 days, one of the evaluators reassessed the patients to verify intra-evaluator reproducibility. At the first assessment, to test the construct validity of ASES-8, the Numerical Pain Scale, Health Assessment Questionnaire, Beck Depression Inventory and Short Form-36 questionnaire were also applied to all the patients. RESULTS: The inter and intra-evaluator correlation coefficients for ASES-8 were high. Cronbach’s alpha was higher than 0.90 for the questionnaire, indicating excellent internal consistency. There were moderate correlations between ASES-8 and most of the instruments tested, indicating good construct validity. CONCLUSION: ASES-8 was translated and adapted to the Portuguese language for Brazil. This instrument is valid, reproducible and reliable for evaluating self-efficacy among patients with rheumatoid arthritis.

Study Design Descriptive cross-sectional study. Purpose To validate the Persian version of the Million Visual Analogue Scale Questionnaire (MVAS), a self-administered low back pain (LBP) questionnaire. Overview of Literature The majority of LBP questionnaires translated into Persian evaluate the impact of LBP on daily living. The MVAS is one of the most commonly used self-administered LBP questionnaires, and was developed to assess a different direction and effect of activities of daily living on LBP intensity. Methods The questionnaire was translated into Persian with the forward-backward method and was administered to 150 patients randomly sampled from an occupational medicine clinic in Tehran in 2017. Results Cronbach’s alpha for all subscales ranged between 0.670 and 0.799. Confirmatory factor analysis showed adequate construct validity of the Persian version of the MVAS, with root mean square error of approximation 0.046, goodness of fit index 0.902, and comparative fit index 0.969. Other indexes were satisfactory. Conclusions The Persian MVAS is a valid and reliable instrument that can assess the effect of various daily activities on the intensity of LBP.

Introduction: Workplace violence is becoming increasingly frequent in the health sector. Therefore, valid and reliable instruments are required to measure this phenomenon. Objective: To validate the factor structure of the Spanish version of the “Workplace Violence in the Health Sector” questionnaire in Chilean prehospital care workers. Material and methods: Quantitative, multivariate study in which the main components of the Spanish version of the questionnaire were analyzed. After being reviewed by experts and conducting a pilot test, 6 questions were eliminated. The adapted version was administered to 74 health professionals (nurses-kinesiologists) and 148 paramedics working in prehospital care. Data were analyzed using descriptive statistics and inferential statistics (chi-square test). The SPSS v15 software was used to perform data analysis and the principal component analysis (PCA). Results: The questionnaire had a high overall reliability (α=0.912). According to the PCA, three factors were identified, namely, physical violence (eigenvalue: 8.3), verbal abuse (eigenvalue: 3.7) and mobbing or workplace harassment (eigenvalue: 3.6), which explain 86% of the variance. Conclusions: The proposed instrument is valid for measuring workplace violence among health professionals working in prehospital care. Having a validated tool to quantify this phenomenon in the country is a significant contribution since it allows carrying out similar studies in other health areas and, based on the results, work on its prevention and the promotion of healthier work environments.

Abstract Background Many tinnitus scales are available, but all of them have certain limitations. The aim of the current study was to present a psychometric data of a new brief and reliable questionnaire that could be conveniently used for evaluating tinnitus complaint in adults (either with normal or impaired hearing)—Skarzynski Tinnitus Scale (STS). Methods The study included 125 participants with at least 1 month of tinnitus duration. All participants were asked to complete the STS, Tinnitus and Hearing Survey (THS), Tinnitus Functional Index (TFI), Tinnitus Handicap Inventory (THI), and Beck Depression Inventory. Psychometric properties of the new tool were tested using exploratory factor analysis (EFA), Pearson bivariate correlation with other tinnitus questionnaires, Pearson bivariate correlation with pure-tone audiometry, Cronbach’s alpha coefficient, limits of agreement, smallest detectable change, and floor and ceiling effects. Norms for tinnitus severity as measured by the STS are proposed. Results As a whole, the STS has excellent reliability (ICC = 0.94) and good internal consistency (α = 0.91). The results of EFA and content analysis of wording of the items justified the three-factorial structure. The convergent validity was proven by a significant positive correlation with THI, TFI and THS Subscale A scores. Additionally, the authors proposed norms dividing the results into four tinnitus severity grades. Conclusions Statistical analysis shows that STS is a brief but robust tool well-suited to clinical practice. A feature of STS is that it takes into account the impact of tinnitus on the patient’s psychological (emotional, cognitive) and functional domains as well as their ability to cope with tinnitus-related distress.

The aim of the work. To validate a method for the related impurities determination in the enisamium iodide active pharmaceutical ingredient (API) by means of high-performance liquid chromatography (HPLC). To characterize the sensitivity of the method by establishing the limit of detection and limit of quantification for the following impurities: benzylamine, isonicotinic acid (raw materials for API synthesis), isonicotinic acid benzylamide (intermediate product of API synthesis) and unidentified impurities. To confirm the method compatibility with validation characteristics as recommended by the International Conference on Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH). Materials and methods. The liquid chromatograph Agilent 1200 equipped with degasser, four-channel pump, auto sampler, chromatographic column thermostat and diode array detector was used. The Zorbax Eclipse XDB-C18 chromatographic column with dimensions 150.0 ×4.6 mm filled by octadecylsilane sorbent with a particles size of 5 μm, was used. The mobile phase was a mixture of a buffer solution pH 2.5 containing sodium octane-1-sulfonate in an amount of 0.1 %: water : acetonitrile (30 : 44 : 26 v/v/v). The primary standards of Farmak JSC were used: enisamium iodide (b. 07-16) and isonicotinic acid benzylamide (b. 10413). Other materials and reagents were used with sufficient purity (Sigma-Aldrich). Results. Detection limits and limits of quantification for identified and unidentified impurities have been determined. Validation characteristics such as specificity, accuracy, precision, range of use, robustness, intermediate precision have been confirmed. The linearity has been confirmed within the range of 0.01–0.06 % for each of the impurities (with a maximum permitted content of each impurity of 0.05 %). The correlation coefficients of linear regression (r) between the entered and found values for each of the determined impurities are greater than 0.990 and the relative confidence intervals (Dz) are at the level not more than 5.0 %. Stability of the test solution, reference solution and solution for system suitability test upon storage at room temperature for 48 hours have been confirmed. Conclusions. It has been experimentally proved that the described method can be used for quality control of enisamium iodide substance.

Introduction: Management of diabetes mellitus is largely dependent on patients’ active participation in care. The ‘Patient Activation Measure 13’ assesses patients’ knowledge, skills, and confidence in self-care. We aimed to translate, culturally adapt, and validate the ‘Patient Activation Measure 13’ to Portuguese, in people with type 2 diabetes. Material and Methods: The translation and cultural adaptation occurred in six phases. A convenience sample of people with type 2 diabetes was recruited from the waiting rooms of a diabetes outpatient centre in Lisbon, between March and April 2014. The questionnaire was self-administered; medical records were reviewed to obtain glycated haemoglobin levels. Main statistical analyses were based on the Rasch rating scale model. Results: The response rate for the final questionnaire was 76%. Rasch analysis was conducted on 193 respondents. Respondents had a mean age of 67.1 (SD 10.1) years, 42.7% were women, and the mean patient activation measure score (0 - 100) in the sample was 58.5 (SD 10.1). The sample was low to moderate in terms of activation: 40.4% were low in activation (levels 1 and 2), 49.7% were in level 3, and 9.8% were in level 4, the highest level of activation. All items had good fit and the response categories functioned well. Item reliability was 0.97 and person reliability was between 0.77 (real) and 0.83 (model). Discussion: The ‘Patient Activation Measure 13’ was translated and culturally adapted to European Portuguese and validated in people with diabetes, showing good psychometric properties. Future research should aim at evaluating test-retest reliability of the Portuguese ‘Patient Activation Measure 13’, and exploring its ability to measure changes in activation over time. Conclusion: The ‘Patient Activation Measure 13’ is now available in European Portuguese and has good psychometric properties.

Objectives Organizational justice is an important predictor of employees’ well-being and job performance. Colquitt’s Organizational Justice Measure (OJM) was designed to assess four aspects of justice – distributive, procedural, interpersonal and informational. The lack of a Polish version of the tool, however, has precluded its application in Poland. The objective of this study was to test the psychometric properties of the OJM in a Polish sample. Material and methods The validating study was conducted on 2 participant samples (N = 209 and N = 659), employed in public and private companies. Both the exploratory and confirmatory factor analyses (EFA, CFA) as well as the estimation of internal consistency with Cronbach’s α method were conducted. Predictive validity was assessed by correlating organizational justice with job-related factors and outcomes, including job resources and counterproductive work behavior. Results The EFA and CFA supported a 4-dimension model of the OJM Polish version. This model indicated a better fit to data than the alternatively tested 1-factor, 2-factor and 3-factor models. The internal consistency of the scales was satisfactory, ranging 0.81–0.93 for various subscales. As expected, the overall organizational justice and the four subscales correlated positively with job resources and negatively with counterproductive work behavior. Conclusions The Polish version of OJM has satisfactory psychometric properties and may be useful in assessing organizational justice in a Polish setting. Int J Occup Med Environ Health 2018;31(4):415–427

, Objectives. Spectrophotometric method is one of the most convenient methods in pharmaceutical analysis, as it is sensitive, precise and cost effective. Therefore, the aim of the present work was the development of simple and available method for the quantitative determination of betahistine dihydrochloride in dosage forms. Materials and methods. Sodium 1,2-napthoquinone-4-sulphonate was assessed as chemical reagent for the quantitative determination of betahistine dihydrochloride by visible spectrophotometric method. Results. Different variables affecting the reactions between sodium 1,2-napthoquinone-4-sulphonate and the drug were carefully studied and optimized. It was established that betahistine dihydrochloride reacts with sodium 1,2-napthoquinone-4-sulphonate in alkaline medium with the colored reaction product formation with absorption maximum at 485 nm. The proposed method was subjected to validation tests. The method was validated for the parameters like linearity, precision, accuracy, robustness and scope of application. Beer’s law was obeyed over the concentration range of 2.40–4.00 mg/100 ml. Parameters of linear dependence were calculated with the help of regression analysis by means of least squares. Coefficients of stoichiometric relationship were also determined by means of molar ratios and continuous changes. The proposed procedure meets the requirements of State Pharmacopoeia of Ukraine that are made for dosage forms. Conclusion. On the basis of the carried out investigations of betahistine dihydrochloride quantitative determination, spectrophotometric procedure has been developed and validated. This procedure is successfully applied for dosage forms analysis. Investigation results show that the procedure is highly sensitive, precise, simple in performance and relevant to be applied at the quality control laboratories for dosage forms.

ABSTRACT BACKGROUND: Evaluation of sodium and potassium intake can be carried out using different methods. Biological markers are able to capture intra and inter-individual variability and are used as separate measurements of consumption. The aim of this study was to test the validity of a single measurement of urinary sodium and potassium excretion as representative of habitual intake. DESIGN AND SETTING: Longitudinal study, federal university. METHODS: Food consumption data from a sample of adult university students and public servants (25 to 74 years old) were collected through 24-hour records and 12-hour urinary sodium and potassium excretion at five different times over a one-year period. The dietary data were entered into a nutritional research data software system and the sodium and potassium intakes were estimated. The variables were tested for normal distribution using the Kolmogorov-Smirnov test. One-way analysis of variance or the Kruskal-Wallis test was used to evaluate means. Correlations between measurements using Pearson or Spearman coefficients were calculated. The degree of agreement between the five measurements was given by the intraclass correlation coefficient. RESULTS: Satisfactory agreement was found between the five measurements of urinary sodium and potassium excretion over a year, with little variability in consumption. CONCLUSION: A single measurement of urinary sodium and potassium accurately estimated the usual average consumption of these electrolytes. This can be used in population-based studies.

ObjectiveTo investigate the relationship between the buttoning test and Jebsen-Taylor Hand Function Test (JTHFT), and to determine the validity of using the buttoning test as a tool to evaluate hand disability in patients with stroke.MethodsThis was a retrospective study of the medical records of 151 ischemic stroke patients affecting the dominant hand. Patients underwent the buttoning test and JTHFT for their affected hand. All patients were divided into three groups depending on how quickly they fastened a button (group A, not completed; group B, slowly completed over 18 seconds; and group C, completed within 18 seconds).ResultsThe button fastening time was negatively correlated with the total score and subtest scores of the JTHFT. Patients who experienced difficulty during the buttoning test had lower mean scores in the JTHFT (group A, 28.0±23.9; group B, 62.9±21.7; group C, 75.4±13.3; p

Objectives: To validate hand hygiene (HH) observers following training and determine the concordance between the observers and the Kappa index. Methods: This study was conducted during June 2017. HH observers from 15 hospital units received eight-hours training including a two-hour workshop conducted by the infection control practitioner and hospital epidemiologist. After its completion, parallel observations were conducted by trained nurses from each respective unit for a maximum of 20 minutes per session at any time or day. Results: A total of 789 parallel observations were performed. In observed HH actions, the percentage of agreement between trained and experienced observers was 75.4%, with a Kappa index of agreement of 0.61 (95% confidence interval (CI): 0.57−0.66). For the observed HH moments, the agreement among observers was 83.8% with a Kappa index of 0.71 (95% CI: 0.66−0.75). Conclusions: HH observers were validated after a dedicated training in correspondence with the recommendation to improve HH monitoring. Additional studies should focus on evaluating the sustainability of the agreement, the requirement of retraining, and other alternatives for observers’ validation.

Introduction: In Portugal, health literacy has started to be addressed through national policies, but research on the topic is still scarce. We aimed to estimate the prevalence and sociodemographic correlates of limited health literacy in Portugal using an existing health literacy instrument, the Newest Vital Sign. Materials and Methods: Following cross-cultural adaptation of the instrument, a sample of 249 participants was evaluated to assess reliability and construct validity of the Newest Vital Sign; the latter was tested assuming physicians would score highest, followed by health researchers, then by engineering researchers and finally by laypersons from the general population. We applied this validated version in a representative sample of 1544 Portuguese-speaking residents in Portugal aged between 16 and 79 years and quantified the associations between limited health literacy and sociodemographic characteristics. Results: The instrument showed high reliability (Cronbach’s α = 0.85). Health-related occupation showed association with higher scores in the Newest Vital Sign (p trend < 0.001). The prevalence of limited health literacy in the Portuguese population was 72.9% (95% CI: 69.4 - 76.4). We found no differences between men and women, but persons with limited health literacy were significantly older (p < 0.001) and less educated (p < 0.001). Discussion: The burden of limited health literacy in Portugal is higher than that in other European countries. It should drive a universal precautions approach to health communication at all levels of the health system. Conclusion: We validated a brief and simple instrument and estimated the prevalence of limited health literacy in the literate Portuguese population at roughly three out of four people.

Introduction: The Exercise Self-Efficacy scale (ESES) is a reliable measure, in the English language, of exercise self-efficacy in individuals with spinal cord injury. The aim of this study was to culturally adjust and validate the Exercise Self-Efficacy scale in the Portuguese language. Material and Methods: The Exercise Self-Efficacy scale was applied to 76 subjects, with three-month intervals (three applications in total). The reliability was appraised using the intra-class correlation coefficient and Bland-Altman methods, and the internal consistency was evaluated using Cronbach´s alpha. The Exercise Self-Efficacy scale was correlated with the domains of the Quality of life Questionnaire SF-36 and Functional Independence Measure and tested using the Spearman rho coefficient. Results: The Exercise Self-Efficacy scale-Brazil presented good internal consistency (alpha 1 = 0.856; alpha 2 = 0.855; alpha 3 = 0.822) and high reliability in the test-retest (intra-class correlation coefficient = 0.97). There was a strong correlation between the Exercise Self-Efficacy scale-Brazil and the SF-36 only in the functional capacity domain (rho = 0.708). There were no changes in Exercise Self-Efficacy scale-Brazil scores between the three applications (p = 0.796). Discussion: The validation of the Exercise Self-Efficacy scale questionnaire permits the assessor to use it reliably in Portuguese speaking countries, since it is the first instrument measuring self-efficacy specifically during exercises in individuals with spinal cord injury. Furthermore, the questionnaire can be used as an instrument to verify the effectiveness of interventions that use exercise as an outcome. Conclusion: The results of the Brazilian version of the Exercise Self-Efficacy scale support its use as a reliable and valid measurement of exercise self-efficacy for this population.

Abstract Objective To evaluate the misclassification resulting from the use of body mass index (BMI) cut-points defined by rounded percentiles instead of Z-scores in early childhood. Using data from the TARGet Kids primary care network we conducted a cross-sectional study among 5836 children 1.0, > 2.0, > 3.0 are recommended to define wasted, at risk of overweight, overweight and obese. However, rounded percentiles of the 3rd, 85th, 97th, and 99.9th are commonly used. Misclassification was calculated comparing the frequency distributions for BMI categories defined by rounded percentiles and Z-score cut-points. Results Using rounded percentiles, the proportion of children who were wasted, at risk of overweight, overweight, and obese was 4.2, 12.5, 4.3 and 0.8%, whereas the distribution using Z-scores was: 3.6, 13.8, 3.4 and 1.0%, respectively. Overall, 117 (2%) children were misclassified when using percentiles instead of Z-scores; however, 13% (33/245) of children who were wasted and 14% (8/57) of children who were obese were misclassified. Misclassification of child growth results from the use of cut-points defined by rounded percentiles instead of Z-scores and limits comparability between studies. Trial registration Clinicaltrials.gov NCT01869530 June 5, 2013

Objectives: The main aim has been to examine psychometric properties of STOP-Bang (snoring, tiredness, observed apnea, high blood pressure, body mass index (BMI), age, neck circumference, male gender) scoring model (Serbian translation), an obstructive sleep apnea (OSA) screening tool, in a sample of commercial drivers. Material and Methods: After formal translation, validation was performed on a sample of bus and truck drivers evaluating test-retest reliability, construct and criterion validity. Overnight polysomnography or cardiorespiratory polygraphy were used for OSA diagnosis purposes. Results: One hundred male participants, 24–62 years old, were included. STOP-Bang classified 69% as potential OSA patients. Polysomnography identified OSA in 57% of the sample. Test-retest reliability (Cohen’s κ = 0.89) was adequate. STOP-Bang score was significantly correlated to apnea-hypopnea index (AHI) and OSA severity. Sensitivity was 100% for AHI ≥ 15, highest specificity was 53.5% (AHI ≥ 5). Conclusions: STOP-Bang showed good measurement properties, supporting its further use in OSA screening of commercial drivers. Int J Occup Med Environ Health 2016;30(5):751–761

Introduction: The objective of this study was to adapt the Brazilian version, and verify the validity, reliability and internal consistency of the Oliveira questionnaire on low back pain in young people. Material and Methods: The questionnaire was translated from European Portuguese into Brazilian Portuguese by means of translation and re-translation. The validity of the contents was determined by experts who analyzed the clarity and pertinence of the questions. Fifteen young people aged 15 to 18 took part in the pre-test step (qualitative analysis), 40 in the test-retest (reliability) and 679 in the evaluation of internal consistency. The intra-class correlation coefficient and Spearman’s correlation coefficient were used in the reliability analysis (test-retest), and Cronbach’s alpha to determine the internal consistency (stability). Results: In the translation phase the questionnaire was modified and considered suitable, observing similarity and equivalence of the two versions. After being corrected by the experts in the validation of the contents, the instrument was considered suitable and valid, and in the pre-test, the young people suggested some modifications to make the questionnaire more succinct. With respect to reliability, the values for the intra-class correlation coefficient were between 0.512 – acceptable and 1 – excellent and Spearman’s correlation coefficient varied between 0.525 and 1, classifying the instrument as reproducible. The internal consistency was considered acceptable with a 0.757 Cronbach’s alpha. Discussion: The Oliveira questionnaire was choosen since it has been used in several Portuguese studies; moreover, it addresses the need to raise data regarding low back pain and associated risk factors. Conclusions: The Brazilian version of the Oliveira questionnaire on low back pain in young people showed valid and reliable cultural adaptation, with good reliability and stability.

Introducción. El análisis de las propiedades psicométricas de un instrumento reviste importancia para el control de sesgos en la medición. Objetivo. Comparar la validez de constructo y la consistencia interna de tres estructuras factoriales del cuestionario de salud general de 12 ítems. Materiales y métodos. Se hizo un estudio de validación en una muestra anidada de 483 estudiantes de odontología de Cartagena, Colombia. Además de las preguntas del instrumento, se hicieron otras sobre aspectos personales. Se evaluó la validez de constructo de la estructura unidimensional, de la unidimensional con corrección del sesgo de respuesta, y de la de dos y tres factores y sistemas de puntuación del tipo de la escala de Likert (0-1-2-3) y dicotómico (0-0-1-1). La validez se determinó con un análisis factorial confirmatorio y, la consistencia interna, con el coeficiente alfa de Cronbach para la escala de Likert y la fórmula 20 de Kuder-Richardson para el método dicotómico empleando los programas Stata™, versión 13.2 (Stata Corp, USA) y Mplus™, versión 7.11 (Muthen and Muthen, USA). Resultados. Los índices de ajuste revelaron que el mejor modelo era el unidimensional con corrección del sesgo de respuesta y puntación dicotómica (grados de libertad=36; ji al cuadrado=52,432; raíz cuadrada del error medio de aproximación=0,03; IC90% 0,008-0,048; índice comparativo de ajuste=0,982; índice de Tucker-Lewis=0,966). La consistencia interna fue de 0,70. Conclusiones. El ajuste del modelo obtenido en este estudio permitió controlar el sesgo de medición y, así, garantizar la validez externa de los resultados del uestionario de salud general de 12 ítems para la evaluación de las condiciones mentales en esta población. Las propiedades psicométricas de las escalas deben evaluarse críticamente antes del análisis de los resultados.

Objectives: This study aimed to develop and validate a health education programme to encourage breast cancer awareness and early detection behaviours among Arab women. Methods: This study took place between December 2015 and March 2016. The Enabling Systems Raising Awareness model was used to develop a breast cancer health education programme which was subsequently implemented by trained health educators at three female-only fitness clubs in Muscat, Oman. Breast cancer knowledge among 53 women was assessed using the breast module of the Cancer Awareness Measure before and after each health education session. Overall pre- and post-session knowledge scores were then compared. Additionally, three focus group discussions were conducted with 10 participants from each location. Thematic analysis was used to analyse the transcribed discussions and collect feedback on the programme. Results: The health education sessions resulted in a statistically significant increase in overall mean knowledge scores (P

Introduction: Eustachian tube dysfunction is a common cause of morbidity in both adults and children, associated with nasal and otologic symptoms. Symptomatic evaluation is very important for the correct diagnosis and evaluation of the treatment efficacy of this entity. The “7-item Eustachian Tube Dysfunction Questionnaire” was described and validated by McCoul et al and proved to be a useful tool, easy to apply, with good validity in the evaluation of eustachian tube dysfunction symptoms. This study presents the validation process of the European Portuguese version of the “7-item Eustachian Tube Dysfunction Questionnaire”. The aim of this study was to translate and validate the European Portuguese version of “Eustachian Tube Dysfunction Questionnaire-7”. Material and Methods: The “7-item Eustachian Tube Dysfunction Questionnaire” was adapted and translated to European Portuguese using standard validation methodology. The European Portuguese version of “7-item Eustachian Tube Dysfunction Questionnaire” was completed by a group of 50 consecutive adult patients diagnosed with eustachian tube dysfunction and 25 healthy patients who served as a control group. All respondents in the Eustachian tube dysfunction group repeated the “7-item Eustachian Tube Dysfunction Questionnaire” in a two week-period. Statistical analysis was performed to determine its psychometric properties (reliability -internal consistency and test–retest reproducibility, and discriminant validity). Results: Face and content validity were confirmed, and reliability testing revealed similar internal consistency for the entire instrument as the original questionnaire, and strong correlation between individual items and total score. The questionnaire was easy and quick to administer. Test-retest reliability of the European Portuguese version was adequate, with excellent intraclass correlation coefficients and without significant differences between the total score from the first and second evaluations. Discriminative validity was confirmed by statistically significant differences between scores of the test and control groups. Discussion: This study presents the European Portuguese version of the “7-item Eustachian Tube Dysfunction Questionnaire” questionnaire, an adapted, validated and well-accepted instrument to evaluate the symptoms of eustachian tube dysfunction in the European Portuguese speaking population. Conclusion: The European Portuguese version of the “7-item Eustachian Tube Dysfunction Questionnaire” is recommended as a routine procedure in the assessment of patients with eustachian tube dysfunction in the European Portuguese speaking population and for the evaluation of treatment outcome.

Background The Orofacial Esthetic Scale (OES) is an instrument to assess an individual’s perception of their Orofacial Appearance (OA). However, its translation and evaluation of psychometric properties is necessary for its use in Brazilian individuals. Objectives To develop the Portuguese version of OES (OES-Pt), estimate its psychometric properties (validity, measurement invariance and reliability) when applied to Brazilian individuals aged 18–40 years, and estimate the relationship between sociodemographic characteristics and OA. Methods This was a cross‐sectional study using a convenience sample. The sample consisted of 1,072 Brazilian individuals (70.1% female, 25.1% dental patients; mean ± SD age: 25.7 ± 5.7 years). After cross-cultural adaptation of OES-Pt, factorial validity was evaluated by confirmatory factor analysis. Convergent validity (average variance extracted (AVE)) and reliability (Cronbach’s alpha coefficient (α) and Composite Reliability (CR)) were also estimated. Concurrent validity was assessed (Pearson’s correlational analysis (r) between OES-Pt total score and item eight of the OES which refers to global assessment of OA). Measurement invariance of the factorial model (multigroup analysis using ΔCFI) was evaluated for independent samples (sample randomly split into two: “Test Sample” and “Validation Sample” and according to sex: male and female, age range: 18–30 and 31–40 years, and whether the individual is undergoing dental treatment or not). A Structural Equation Model estimated the relationship between sociodemographic characteristics and OA. Results OES-Pt presented adequate fit to the sample. Convergent validity (AVE ≥ 0.56) and reliability (α and CR ≥ 0.89) were adequate. Concurrent validity was adequate (r = 0.88; p-value < 0.001). OES-Pt presented strict invariance for independent samples. Age, sex, and socioeconomic status (SES) were related to OA, indicated by standardized beta coefficients (standardized β) of 0.036 (standard error: 0.007), 0.001 (0.094) and 0.196 (0.061), respectively on OA. These three relationships were either weak or not statistically significant. Conclusions When measuring OA in Brazilian individuals, the OES-Pt was valid, reliable and invariant for independent samples. Age, sex and SES were weak or not statistically significantly related to OA.

Introduction: In Colombia, due to the difficult access to health services and to geographic conditions, the implementation and innovation of telemedicine technological tools is a priority. Having a validated vital signs monitor (VSM) improves proper medical treatment and diagnosis. Objective: To design and perform clinical trials for the SignCare VSM. Materials and methods: A device for continuous monitoring of electrocardiography, respiration, oxygen saturation, temperature and noninvasive blood pressure (NIBP) was designed. This device was validated in a laboratory in order to ensure a robust prototype, close to the level of commercial medical devices. Clinical trials were performed through a cross-section study with 98 patients, whose vital signs were measured using the SignCare monitor and a commercial monitor. These two measurements were compared using Pearson’s correlation coefficients. Results: There were no statistically significant differences between the results obtained with the SignCare VSM and the commercial monitor. The highest correlations were found for the following items: heart rate by electrocardiogram (r=0.844), heart rate by oxymetry (r=0.821), body temperature (r=0.895), systolic blood pressure (r=0.780), and diastolic blood pressure (r=0.811). Conclusions: The SignCare device is as reliable as the commercial monitor in the qualitative detection of morphologic alterations of electrocardiogram records, as well as in breathing, temperature, oxygen saturation and blood pressure parameters, which makes it recommendable for clinical use in adult population.

Cada vez somos más las enfermeras que mostramos interés en validar herramientas de medición. Creo que podría interpretarse esto como otro paso adelante de nuestra disciplina (entre los muchos que ya hemos dado) hacia una Enfermería verdaderamente científica que, además de basarse en la mejor evidencia disponible, también se ocupa de que las bases de la información que manejamos sean válidas y fiables. De hecho, validez y fiabilidad son los dos requisitos que se exigen a una herramienta de medida. La validación servirá para, por un lado, identificar el grado en el que el constructo y sus indicadores se han vinculado correctamente (cuanto más estrecha sea relación entre ambos mayor será la validez), y por otro, servirá para diferenciar unos constructos de otros. La fiabilidad se refiere a que la medición sea precisa y estable. Puede ser que este creciente interés por validar escalas que puedan sernos útiles a las enfermeras sea una consecuencia más de nuestro crecimiento como disciplina ya que, como ya apuntaba en otro editorial, creo que crecemos como investigadores de forma análoga a como lo hacemos como personas y quizás, después de ocuparnos de investigar sobre aspectos más estrechamente relacionados con la práctica estamos ahora evolucionando hacia la investigación que permita establecer marcos de referencia sólidos en los que basar nuestra práctica clínica y nuestras investigaciones. Abstract Every time, more and more nurses show interest on validating tools of measurement. I think this could be understood as another step forward on our discipline (among all the ones we have already given) towards a really scientific Nursing that, besides being based on the best evidence, it also worries about managing validated and reliable information. Actually, validity and reliability are the two requirements for a measurement tool. Validity will be useful to, on the one hand, identify the grade in which the construct and its indicators have been linked correctly (the narrower the relation between them is, the more validity the tool will have), and, on the other hand, it will be useful to discriminate one construct from others. Reliability refers to the precision of the measurement and its stability. It may be that this increasing interest on validating scales that could be useful for nurses is just a consequence more of our development as a discipline because, as I argued in other editorial, I think we grow up as researchers the same way as we grow up as a person and, perhaps, after having done studies related to our practice, we are now evolving towards a research that allows the establishment of solid reference backgrounds were our clinical practice and our research studies could be based.

Model of study: Validation study. Objective: To evaluate the psychometric performance of the Brazilian version of the Insulin Management Diabetes Self-Efficacy Scale - IMDSES. Methodology: Reliability (internal consistency - Cronbach’s α), convergent and criterion validity were assessed. Data were gathered from 127 patients with type 2 diabetes mellitus (T2DM) in use of insulin through the application of sociodemographic and clinical instruments and the Brazilian versions of the Summary of Diabetes Self-Care Activities Measures - SDSCA and the IMDSES. Results: It was observed “ceiling effect” in Insulin domain. Reliability was confirmed in all IMDSES domains and Total Score (α=0.87). The convergent construct validity was supported by significant negative moderate to weak magnitude correlations between the scores of IMDSES domains and the scores of SDSCA domains. Criterion validity was partially supported by the weak magnitude correlation between the General Managements domain and the Total Score of IMDSES and serum levels of glycated hemoglobin (r=0.22; p=0.02). Conclusion: The Brazilian version of IMDSES presented satisfactory psychometric measures and may be useful to evaluate the effectiveness of nursing interventions aimed at optimizing the selfefficacy of the T2DM patient in the management of his treatment.

O objetivo do presente estudo foi validar a autorreferência de colesterol elevado em residentes de São Paulo, Brasil, e verificar os fatores associados à sensibilidade dessa informação. Foram utilizados dados do Inquérito de Saúde de São Paulo de 2015, estudo transversal de base populacional com amostra probabilística de residentes do município. Foram incluídos 886 indivíduos com informações do questionário estruturado, dosagem de colesterol total e frações ou que referiram tratamento farmacológico do colesterol elevado. A validade da informação autorreferida de colesterol elevado foi determinada por meio da sensibilidade, especificidade, valores preditivos positivo (VPP) e negativo (VPN) e kappa, considerando as dosagens de colesterol total e LDL-c e o tratamento farmacológico como padrão-ouro. Modelos de regressão logística foram realizados a fim de investigar os fatores associados à sensibilidade dessa informação. A sensibilidade da informação de colesterol elevado tendo em conta o colesterol total como referência foi de 50,6%, a especificidade de 90,19%, VPP de 51,64%, VPN de 89,82% e kappa de 0,41. Considerando o LDL-c como padrão-ouro, a sensibilidade foi 53,52%, a especificidade 89,93%, o VPP 49,22%, o VPN 91,39% e kappa 0,43. Utilizando a dosagem de colesterol total como referência, a idade (OR = 1,69; IC95%: 1,24-2,29) e o plano de saúde (OR = 2,91; IC95%: 1,06-7,99) se associaram à sensibilidade dessa informação. Considerando a dosagem de LDL-c como padrão-ouro, a idade (OR = 1,71; IC95%: 1,13-2,57), o tabagismo (OR = 3,33; IC95%: 1,08-10,27) e o plano de saúde (OR = 3,64; IC95%: 1,10-12,08) foram associados à sensibilidade dessa informação. Os resultados indicam baixa sensibilidade e VPP da autorreferência do colesterol elevado em residentes de São Paulo.

Resumo: Este estudo teve por objetivo avaliar a estrutura dimensional e a consistência interna da versão brasileira do Functional Activities Questionnaire (FAQ-BR) para aferição da capacidade funcional do idoso, com base no relato de informante. Trata-se de um estudo seccional desenvolvido com 525 informantes de idosos não institucionalizados, em que análises fatoriais confirmatórias (AFC) e análises fatoriais exploratórias (AFC/E), modeladas segundo os princípios da AFC, foram usadas para identificar o modelo mais parcimonioso e mais bem ajustado. A consistência interna do FAQ-BR foi avaliada pela confiabilidade composta, e correlações entre suas dimensões foram examinadas a fim de investigar validade fatorial discriminante. A AFC não corroborou a estrutura unidimensional originalmente proposta. Em seguida, a AFC/E ajustou uma estrutura bidimensional que foi reavaliada por AFC, evidenciando um modelo sem cargas cruzadas como o mais parcimonioso e com adequados índices de ajuste. A consistência interna do FAQ-BR foi considerada satisfatória, e a correlação entre suas dimensões, aceitável. Esses achados são importantes, pois revelam a capacidade de a escala capturar o construto capacidade funcional do idoso em um contexto sociocultural distinto daquele em que foi desenvolvido. Portanto, o FAQ-BR pode ser considerado um instrumento bidimensional apropriado para aferir a capacidade funcional do idoso com base no relato do informante, e seu uso em pesquisas com populações semelhantes é recomendado.

Aim. In order to quantify diphenhydramine tablets the methods based on reverse phase high-performance liquid chromatography with UV-spectrometry detection at 254 nm (HPLC-UV) have been used. Methods and results. The mobile phase used a mixture of a phosphate buffer: acetonitrile (80:20). The proposed method is applied to the two dosage forms of diphenhydramine – tablets to 0.1 and 0.05, produced by various Ukrainian pharmaceutical companies. The main characteristics are validated by Pharmacopoeia of Ukraine. Conclusion. According to the experimental data, the technique can be correctly reproduced, and is suitable for use in pharmaceutical and forensic analytic laboratories.