Criterion Validity Research Articles

Validation and reliability of the Malay version of the painDETECT questionnaire (PDQ-M) among patients with neuropathic and nociceptive pain

Background: Neuropathic pain is chronic and debilitating. Early and accurate diagnosis is important for appropriate management. The painDETECT questionnaire (PDQ) is an effective screening tool for presence of neuropathic pain. We tested the validity and reliability of the translated Malay version of PDQ (PDQ-M). Methods: This was a multi-center cross-sectional study conducted over 24 months. The original English version of PDQ was translated into Malay version following international guidelines. Subsequently, patients with chronic pain were administered PDQ-M and Malay version of SF36 at baseline and 2-4 weeks later. The reliability, construct and criterion validity of PDQ-M were evaluated. Clinician diagnoses were used as gold standard for comparison of diagnostic accuracy. Multiple regression analysis was performed to determine correlation between PDQ-M and SF-36 scores. Results: A total of 97 patients were included in the study (53 with neuropathic pain, 44 with nociceptive pain). The EFA of PDQ-M produced three factors which explained 58.3% of the variance. It exhibited fair consistency with Cronbach’s alpha coefficient of 0.719 (for all 9 items) and 0.755 (for 7-item with Likert scale). PDQ-M is reliable with Cronbach’s alpha coefficient of 0.719 and 0.852 for test-retest reliability. A score of ≥17 was the best cut-off value for discriminating between neuropathic and non-neuropathic pain in PDQ-M (79.2% sensitivity, 50.0% specificity). Multiple regression analysis exhibited total PDQ-M score to have significant negative correlation with all components of SF-36 scores except role limitation due to physical health. Conclusions: PDQ-M is a reliable and valid self-administered screening tool for neuropathic pain.

Действительность усиленной квалифицированной электронной подписи, или Исчезающие чернила

This article analyses problematic aspects of the use of enhanced qualified electronic signature (EQES) in signing and using credit and collateral documentation on the example of “Bank “Saint-Petersburg” PJSC. The authors consider the prerequisites for the implementation by credit institutions of legally significant electronic document flow for signing and use of credit and collateral documentation, note the differences between handwritten and electronic signatures, characterise the advantages of the EQES in relation to other types of electronic signatures provided for by the legislation, identify problematic aspects associated with the limitation of the terms of usability of electronic documents signed by the EQES. The first is the legislative establishment of the EQES validity criterion, which requires to determine the authentic moment of signing an electronic document during the period of validity of a qualified certificate. The second is the absence in the law of provisions regulating the preservation of legal significance of an electronic document signed with an attached trusted time stamp beyond the validity period of a qualified certificate of the trusted time stamp service, which entails the risk of challenging the relevant electronic document. The authors believe it is necessary to fill this regulatory gap in order to ensure the suitability of electronic documents within an unlimited time period, and also propose to amend the Law on Electronic Signature with regard to the validity conditions imposed on the EQES.

Development of Game-Based Mathematics Learning Media to Improve Mathematical Understanding Abilities

This research aims to develop mathematics learning media in the form of games. Apart from that, this research aims to determine the feasibility and find out whether the learning media being developed is appropriate and can improve students' understanding abilities in mathematics subjects. This type of research is development research with the ADDIE model (Analysis, Design, Development, Implementation, and Evaluation). The research subjects were class VII students at YP Sunan Dalem Gumeno Middle School. The research instruments used in this research were (1) Interview Guide (2) Validation Sheet (3) Student Response Questionnaire (4) Mathematical Understanding Ability Test Questions. The mathematics learning media in the form of games developed is expected to improve students' mathematical understanding abilities. The validation results from media experts and material experts respectively obtained an average of 4.4 and 4.2 with valid criteria. The validation results of the mathematical understanding ability test obtained an average score of 4.2 with valid criteria. The results of the student response questionnaire obtained an average practicality of 4.2 with practical criteria. The results of the mathematical understanding ability test were carried out using a t-test using the SPSS program and the results showed that the significant value was 0.000 < 0.05, meaning that students' mathematical understanding ability after using game learning media was better before using the game learning media, so it can be concluded that the learning media Games can improve students' mathematical understanding abilities and can be said to be effective. The results of this research show that learning media is said to be valid, practical, and effective. In other words, game-based mathematics learning media can improve students' mathematical understanding abilities.

Validity of Project Model Science Learning Tools Assisted by Augmented Reality to Improve Students' Literacy and Creative Thinking Abilities

The development of project model science learning tools assisted by augmented reality has been carried out to improve students' literacy and creative thinking abilities. This development research aims to produce a valid product and describe the results of the validation of the learning device so that it is suitable for use in the learning process. This type of research is research and development with 4D model design which consists of the definition, design, development and dissemination stages. Validation of learning tools was carried out by three competent expert validators at Mataram University. The development of augmented reality-assisted project model science learning tools developed consists of a syllabus, lesson plans, teaching materials, LKPD, augmented reality media as well as scientific literacy test instruments and creative thinking ability test instruments. The results of the research show that the project model science learning tools assisted by augmented reality have very valid and reliable criteria so that they are suitable for use in the science learning process in schools to improve students' scientific literacy and creative thinking abilities.

Validity test of the Global Leadership Initiative on Malnutrition (GLIM) diagnostic criteria compared with the American Society for Parenteral and Enteral Nutrition (ASPEN) criteria in inpatients at Dr. Cipto Mangunkusumo hospital

Background: Malnutrition experienced by numerous inpatients is linked to various complications. The Global Leadership Initiative on Malnutrition (GLIM), which established the latest malnutrition criteria, recommends a two-step methodology for diagnosing malnutrition in adult inpatients. This study aims to evaluate the validity of the GLIM criteria for the diagnosis of malnutrition in hospitalized patients at Cipto Mangunkusomo Hospital Jakarta by comparing them with the ASPEN criteria. Methods: This cross-sectional study was conducted at Cipto Mangunkusomo Hospital, Jakarta. Secondary data was taken from 100 inpatients from October 2021 to February 2022 selected by consecutive sampling technique. The diagnosis of malnutrition in the patients applied the ASPEN and GLIM criteria. Furthermore, data were analyzed using Cohen's Kappa and chi-square tests. Results: Of 100 inpatients, 63% were diagnosed with malnutrition according to the GLIM diagnostic criteria. Meanwhile, 48% of them were found to be malnourished according to the ASPEN criteria. The GLIM criteria have a specificity of 69.2%, a sensitivity of 97.9%, a PPV of 74.6%, and an NPV of 97.3%. Conclusion: The GLIM diagnostic criteria are valid as an instrument for diagnosing malnutrition but require further research to assess the severity of malnutrition.

THE EFFECTS OF TRUST, STORE IMAGE AND CONSUMER JUDGMENT ON REPEAT PURCHASES MEDIATING CONSUMER SATISFACTION VARIABLES ALFAMIDI DEMAK AREA

The purpose of this study was to determine how much influence trust, store image and consumer judgment have on repeat purchases through customer satisfaction, because Alfamid customers are the mediator of research. The population of the people taken in the study is the number of Alfamidi customers in the Demak area, the exact number of which is unknown, the sampling technique of course uses purposive sampling, where the sample size is 110 consumer representatives. The validity and reliability criteria applied in this study also use Amos free calculations for data analysis and calculation. The main conclusions of this study are that trust has a positive and significant impact on customer satisfaction; customer satisfaction is positively affected by store image and also positively affects customer satisfaction; consumer judgment is positively affected by customer satisfaction but does not significantly affect customer satisfaction. trust has a positive and significant impact in relation to repeat purchases.Store image has a positive, but not significant impact in relation to repeat purchases; consumer judgment has a positive, but not significant impact in relation to repeat purchases. Consumer satisfaction has a positive and significant impact on repeat purchase behavior. trust has a positive and significant impact on the purchase of goods through consumer satisfaction feedback, while store image has a positive and significant impact on the purchase of goods through consumer consumer feedback, and consumer judgment evaluation has a positive and significant impact on the repurchase of goods through consumer satisfaction feedback

Validation of the Danish Version of the Overall Depression Severity and Impairment Scale (ODSIS): A Reliable Instrument for Assessing Depression Symptoms and Functional Impairment.

In psychotherapy, having a reliable tracking tool is vital for effective treatment. We have validated the Danish version of the 'Overall Depression Severity and Impairment Scale' (ODSIS), which is used in the Unified Protocol for Emotional Disorders (UP) and other cognitive behavioural therapies. This five-item self-rating scale is expected to correspond closely to the gold-standard Beck Depression Inventory-II (BDI-II), but also to self-rating scales addressing daily functioning and well-being. Internal consistency is assessed using Cronbach's alpha and McDonald's omega. Criterion validity is explored through Pearson's correlation coefficient with BDI-II, the Work and Social Adjustment Scale (WSAS), the Five-Item World Health Organization Well-Being Index (WHO-5) and scatter plots, and an optimal cut-off score is determined using a receiver operating characteristic curve. The study included 340 respondents: 234 from a recent clinical trial, 56 psychiatric patients from inpatient/outpatient units and 50 healthy volunteers. ODSIS demonstrates strong internal consistency (Cronbach's alpha: 0.887-0.956, McDonald's omega: 0.888-0.957). Correlations with BDI-II, WSAS and WHO-5 highlight its strong criterion validity (BDI-II: 0.847, WSAS: 0.751, WHO-5: 0.771). The optimal cut-off score (> 7.5) for detecting depression shows great sensitivity (0.862) and specificity (0.731). The Danish version of ODSIS proves to be a reliable instrument for quantification of a combination of depression level and functional impairment from the symptoms. Its high correlation with established BDI-II makes it a brief and handy tool for repeated measurement in clinical and research settings.

Sino-Nasal Outcome Test-22: translation, cross-cultural adaptation, and validation in Polish-speaking patients.

There are many specific instruments for assessing the quality of life (QoL) in patients with chronic rhinosinusitis. Of all these tests, the Sino-Nasal Outcome Test-22 (SNOT-22) is the most widely used internationally. The purpose of the study was linguistic adaptation and validation of the SNOT-22 scale in the Polish language. The SNOT-22 was adapted into Polish and was administered to 148 subjects (108 patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and 40 asymptomatic controls. Seventy-one patients completed the SNOT-22 a second time to evaluate test-retest reliability. The Polish SNOT-22 was assessed for internal consistency, test-retest reliability, discriminant validity, criterion validity, and sensitivity and specificity. The Polish SNOT-22 exhibited satisfactory psychometric properties. A high Cronbach's alpha coefficient (α = 0.89) was obtained. Significantly higher scores (p < 0.01) were revealed in the Study Group with a median score of 32 (range 15-53) points in comparison with controls: 5 (range 0-20). A moderate correlation was found between SNOT-22 and the Lund-Kennedy test score (r = 0.334; p < 0.001) and a strong correlation between SNOT-22 and the Lund-Macay test score (r = 0.469; p < 0.001). The best cut-off point was set at a 16 score with a sensitivity of 0.981 and a specificity of 0.995. The determined Area Under Curve (AUC = 0.997; p < 0.001) confirms the diagnostic accuracy of the Polish SNOT-22. The Polish version of the SNOT-22 is a valid and reliable tool for measuring health-related quality of life in patients with CRSwNP in the Polish-speaking population.

PENGEMBANGAN LEMBAR KERJA PESERTA DIDIK (LKPD) BERBASIS ETNOMATEMATIKA PADA MATERI TRANSFORMASI

This study aims to produce teaching materials in the form of ethnomathematics-based worksheets on Lampung batik motifs in understanding valid and practical geometric transformation concepts. The type of research used is Research and Development (R&amp;D). This research produced a product in the form of ethnomathematics-based worksheets on transformation material at SMP PGRI Kesumadadi. The research procedure used is the Borg and Gall development model which goes through several stages including: potentials and problems, data collection, product design, design validation, design revision, product testing, and product revision. In the product trial stage, a limited trial was carried out involving 15 class IX students at SMP PGRI Kesumadadi. The research instruments used were material expert validation sheets, media expert validation sheets, and student response questionnaires. The results of this development research show that the assessment of the material expert validation obtained an average validation result of 88.12% with the validation criterion of "Very Valid". Furthermore, the results of the validation of media experts obtained an average validation result of 91.66% with the validation criterion of "Very Valid". The results of the analysis of the student response questionnaire at the limited trial stage obtained a percentage of 92.6% with the practicality criterion "Very Practical".

Development of Numeracy Problems Based on Education for Sustainable Development (ESD) to Measure Critical Thinking Ability

One of the 21st-century skills that students must possess is critical thinking. An instrument is needed to assess the level of success in developing students' critical thinking abilities. The contribution of this research is the development of numeracy problems based on Education for Sustainable Development (ESD) that can measure students' critical thinking abilities. This research is quantitative, with analysis using Ministep software and involving 75 students as research subjects. Numeracy problems were developed using the 3-D model with the stages of define, design, and develop. The results of this study indicate that the 15 developed numeracy problems are valid as they meet at least one criterion of validity and reliability, with an item reliability value of 0.96. This suggests that the instrument can effectively measure critical thinking skills, cover a diverse range of difficulty levels, and ensure that the formulated questions are suitable for measuring and assessing various student abilities. These results indicate that the ESD-based numeracy problems developed can be used as reference material in similar research or studies related to the analysis of students' critical thinking abilities in solving ESD-based numeracy problems.

The validity and reliability study of the theory of mind inventory-2 (TOMI-2) Turkish version

This study aims to conduct the Turkish adaptation, validity, and reliability study of the Theory of Mind Inventory-2 (TOMI-2) developed by Hutchins and Prelock (2016) for 3-5-year-old children. The study group consists of 310 mothers with children in the 3-5 age group in Konya city center. Personal Information Form and Theory of Mind Inventory-2 (TOMI-2) were used as data collection tools in the study. After the TOMI-2 was translated into Turkish, the normality assumption was checked with the "Shapiro-Wilk" test. The relationship between two continuous variables was evaluated with the Pearson Correlation Coefficient. Exploratory Factor Analysis, Confirmatory Factor Analysis, Content Validity, Criterion Validity, and Reliability analyses were also used in the study. The findings of the analyses show that the Turkish version of the TOMI-2 is a valid and reliable measurement tool for children aged 3-5, with 60 items in the original form.

Validation of activity trackers to estimate energy expenditure in older adults with cardiovascular risk factors.

To compare different types of activity trackers recording physical activity energy expenditure (PAEE) and examine their criterion validity against indirect calorimetry (IC) as the gold standard in adults over 60 years of age with a special focus on women with cardiovascular risk. Synchronous registrations of PAEE were performed with up to four different devices to determine criterion validity against IC while participants performed a protocol of simulated activities in a laboratory setting. Thirty-four participants (25 women, 9 men) with at least a light cardiac risk performed a protocol of simulated activities in a laboratory setting (daily living activities, cycle ergometer test). PAEE was simultaneously assessed by IC, two research-grade activity trackers (ActiGraph-wGT3X-BT and Actiheart-4) and two consumer-level activity trackers (OMRON pedometer and Fitbit Charge-3). Tracker-derived PAEE was compared with PAEE calculated from IC descriptively and by Bland-Altman plots. The ActiGraph (0.7 ± 0.4 kcal/min), the Actiheart (1.1 ± 0.6 kcal/min) and the OMRON (0.8 ± 0.6 kcal/min) underestimated, while the Fitbit (3.4 ± 1.2 kcal/min) overestimated PAEE compared to IC-PAEE (2.0 ± 0.5 kcal/min). The Bland-Altman limits of agreement (LoA) against IC were +0.5/+2.2 kcal/min for the ActiGraph, -0.3/+2.1 kcal/min for the Actiheart, -3.7/+1.0 kcal/min for the Fitbit, and -0.5/+2.9 kcal/min for the OMRON. The magnitude of the deviation varied considerably depending on the activity (e.g. walking, cleaning, cycle ergometer test). The research-grade activity trackers estimated PAEE with higher validity than the commercially available activity trackers. The partly very wide LoA have to be critically considered when assessing PAEE in the context of health service research, as individual Physical Activity behaviour may be under- or overestimated.

The mental imagery scale for art students: Building and validating a short form

Mental imagery is a vital cognitive skill that significantly influences how reality is perceived while creating art. Its multifaceted nature reveals various dimensions of creative expression, amplifying the inherent complexities of measuring it. This study aimed to shorten the Mental Imagery Scale in Artistic Creativity (MISAC) via the Ant Colony Optimization algorithm (ACO), a metaheuristic methodology for developing psychometrically robust brief scales. Answering 63 items in the original version of MISAC demands a higher cognitive load and, consequently, more time. Therefore, our goal was to shorten it while preserving its psychometric properties. In this study, responses to the MISAC were obtained from 500 undergraduate students enrolled in an art education program. The items on the short form of the MISAC were selected based on pre-specified validity criteria and content representability. The 28-item short form of MISAC demonstrated comparable performance to the original version regarding construct validity, criteria-related validity, and reliability coefficients. Moreover, strict invariance was attained across both gender groups in the validation process of the short form. These results highlight the utility of the shortened version of the MISAC as a valid measure with minimal loss of information of scores compared to the full version.

Development and Initial Validation of the Novel Scleroderma Clinical Trials Consortium Activity Index.

Accurate measurement of disease activity in systemic sclerosis (SSc) remains a significant clinical challenge. The Scleroderma Clinical Trials Consortium (SCTC) convened an Activity Index (AI) Working Group (WG) to develop a novel measure of disease activity (SCTC-AI). Using consensus methodology, we developed a conceptual definition of disease activity. Literature review and expert consensus generated provisional SCTC-AI items, which were reduced by Delphi survey. Provisional items were weighted against a combined endpoint of morbidity and mortality, using time-dependent Cox proportional hazards regression analysis of the Australian Scleroderma Cohort Study (ASCS) (n = 1,254). External validation of the SCTC-AI was performed using data collected from 1,103 Canadian Scleroderma Research Group Study participants. Disease activity in SSc was defined using consensus methodology as "aspects of disease that are reversible, or can be arrested, with time and, or effective therapy." One-hundred and forty-one provisional SCTC-AI items were generated and reduced using three rounds of Delphi survey and statistical reduction and weighting, against mortality and quality of life measures, yielding a final 24-item index with a maximum possible score of 140. Survival analysis in an external cohort showed a graded relationship between disease activity scores and survival (P < 0.01). We present a novel instrument to quantify the burden of disease activity in SSc. We have employed a rigorous consensus-based process in combination with data-driven methods to develop an instrument that has face, content, and criterion validity. Further work is required to fully validate and confirm the construct and discriminative validity of the SCTC-AI.

Clinical cut-off scores for the Borderline Personality Features Scale for Children to differentiate among adolescents with Borderline Personality Disorder, other psychopathology, and no psychopathology: a replication study

BackgroundDespite being one of the most popular measures of borderline pathology in adolescents, only one study has evaluated clinical cut-off scores for the Borderline Personality Features Scale for Children (BPFS-C) using a small sample without a healthy comparison group (Chang B, Sharp C, Ha C. The Criterion Validity of the Borderline Personality Features Scale for Children in an Adolescent Inpatient Setting. J Personal Disord. 2011;25(4):492–503. https://doi.org/10.1521/pedi.2011.25.4.492.). The purpose of the current study was to replicate and improve on the limitations of the prior study conducted by Chang et al. to more definitively establish clinical cut-off scores for the self- and parent-report versions of the BPFS-C to detect clinical and sub-clinical borderline personality disorder (BPD) in a large sample of adolescents with BPD, other psychopathology, and no psychopathology.MethodsA total of 900 adolescents ranging from ages 12–17 participated in this study. The clinical sample consisted of 622 adolescents recruited from an inpatient psychiatric facility, and the healthy control sample consisted of 278 adolescents recruited from the community. All participants completed the BPFS-C and were administered the Child Interview for DSM-IV Borderline Personality Disorder (CI-BPD).ResultsUsing three-way ROC analyses, cut-off scores on the self- and parent-report versions of the BPFS-C distinguishing adolescents with BPD from those with subclinical BPD, and those with subclinical BPD from healthy adolescents were established.ConclusionsThese findings support the use of both versions of the BPFS-C to detect adolescents with BPD and sub-clinical BPD.

DEVELOPMENT OF POWTOON APPLICATION-BASED LEARNING MEDIA FOR XI IPS CLASS STUDENTS IN TUGUMULYO STATE HIGH SCHOOL

This study aims to develop and produce powtoon application-based history learning media that are valid, practical, and effective in learning History class XI IPS at SMA Negeri Tugumulyo. This research uses a Research and Development approach with the application of the ADDIE model. The research subjects consisted of 3 validation experts, 1 history subject teacher, and 34 students of XI IPS 2 class at SMA Negeri Tugumulyo. Data collection techniques included observation, interviews, questionnaires, tests, and documentation. The results of the expert assessment analysis showed that the powtoon application-based history learning media met the validity criteria, with a percentage of 86% linguist assessment, 92% material expert, and 77% media expert. In addition, the results of the practicality sheet assessment from teachers and students showed that the media also met the practical criteria, with an average practicality score of 88%. While the large group test shows that the learning media has high effectiveness, with an N-gain (g) value of 0.72, which is classified as high. Thus, it can be concluded that the powtoon application-based history learning media proved to be valid, practical, and effective in the context of History learning class XI IPS 2 at SMA Negeri Tugumulyo.

Validity and Practicality of the Physics E-Module Based on the Orientation, Identify, Discussion, Decision, and Engage in Behavior Model to Improve Students' 21st Century Skills

The development of science and technology in the 21st century requires skills for an individual to be able to compete, which are called 4C skills. Initial studies show that students' 4C skills still need to be improved. The physics e-module based on the orientation, identify, discussion, and engage in behavior model is an important aspect that supports improving students' 21st century skills. This research aims to determine the validity and practicality of e-modules. The instrument used to collect data was a validity and practicality test questionnaire. The physics e-module based on the orientation identify, discussion, decision, and engage in behavior can be used in the learning process. Judging from the results of validity and practicality, the physics E-module based on the orientation, identify, discussion, decision, and engage in behavior model to improve students' 21st century skills has valid and practical criteria with an average validity value (Aiken's value) of 0, 93 with valid criteria. The teacher's practicality score is 89.6% with very practical criteria and the students' practicality is 87.4% with very practical criteria. This means that e-modules can be applied to physics learning and in theory can improve students' 21st century competency abilities.

Translation and validation of the Thai Version of the Japanese Sleep Questionnaire for Preschoolers (JSQ-P)

PurposeThis study aimed to translate and validate the Japanese Sleep Questionnaire for Preschoolers (JSQ-P) into a Thai version and to evaluate factors associated with sleep problems in preschoolers. MethodsThe cross-cultural adaptation of JSQ-P into Thai version of JSQ-P (TH-JSQ-P) was performed including forward translation, reconciliation, backward translation, and final approval by the original creator. Children aged 2–6 years from community and clinical settings were enrolled. The TH-JSQ-P was completed by parents of preschool children twice within 10–14 days to assess its reliability and validity. Six validity tests including face validity, content validity, structural validity, construct validity, criterion validity and predictive validity were assessed. Demographic data, Epworth sleepiness scale (ESS), medical and behavior problems, and socioeconomic status were collected for analysis. ResultsA total of 2613 participants completed the TH-JSQ-P, with 1207 completing it twice to assess test-retest reliability. The TH-JSQ-P had good internal consistency reliability and test-retest ability with Cronbach's alpha value of 0.898 and intraclass correlation coefficient of 0.814. The content validity was acceptable. The ESS had correlation with sleep problems in almost all subscales except for sleep habit. ConclusionsThe TH-JSQ-P is a valid and reliable instrument for evaluating sleep problems in preschool children in Thailand. It has the potential to be extensively utilized to screen for sleep problems, thereby enabling healthcare professionals to identify them early and implement prompt management.

Assessment of Journalism Principles in Media: An Evaluative Instrument

ABSTRACT The integration of emerging technologies in journalism raises concerns about their impact on journalistic principles. During these technologies’ early adoption stages, there is significant experimentation with platform affordances to apply these principles in new media contexts. Current evaluations struggle to be universally applicable due to their focus on specific media platforms and contexts. To address this gap, this article introduces the Assessment of Journalism Principles in Media (AJPM) rubric, a tool that operationalizes and empirically evaluates normative journalistic principles across media technologies. The tool offers a framework for examining and comparing how different media platforms’ affordances are aligning and impacting the implementation and perception of journalistic principles. Developed using the Questionnaire Appraisal System (QAS-99), the AJPM was refined through feedback from 17 news editors and journalists from the United States, who evaluated a tool that operationalizes 21 terms from the Oxford Dictionary of Journalism. This process established content validity of the AJPM. These evaluations are crucial in validating the AJPM's effectiveness for evolving journalistic forms such as immersive journalism and AI in journalism. Future research will establish the AJPM's face, criterion, and construct validity, thereby confirming its utility in assessing journalistic principles in diverse media forms, from traditional to emerging.

Validation of combiomed hipermax-BF model A7101 automatic oscillometric upper-arm sphygmomanometer in general population: AAMI/ESH/ISO universal standard (ISO 81060-2:2018/Amd 1:2020).

This study evaluates the accuracy of the Hipermax-BF model A7101 (Combiomed, Havana, Cuba) automatic oscillometric upper-arm sphygmomanometer for office and home use in general population as part of the HEARTS in the Americas initiative. The research was developed according to the Universal Standard AAMI/ESH/ISO ISO 81060-2:2018/Amd 1:2020. The subjects were recruited according to the requirements of age, gender, blood pressure values and upper-arm circumference. The same upper-arm sequential blood pressure measurement method was used. For measurements with the device under test, the 2-piece cuff from 22-44 cm limb circumference range was used. 92 subjects were recruited and 85 were analyzed. Mean age was 44.8 ± 14.7 years, mean upper-arm circumference was 32.3 ± 6.2, and 56.5% were female. For Validation Criterion 1, the mean value ± standard deviation of the differences in readings between the device under test and the reference device was 1.2 ± 4.9/0.8 ± 4.9 mmHg (systolic/diastolic). For both pressures, in criterion 1 the standard requires a mean value of the differences ≤ ± 5 mmHg and a standard deviation ≤ ± 8 mmHg. For Validation Criterion 2, the standard deviation of the mean blood pressure differences per subject was 4.2/4.2 mmHg (systolic/diastolic). According to Table 1 of criterion 2, for the mean values of 1.2/0.8 mmHg (systolic/diastolic), the maximum allowable standard deviation had to be < 6.84 for systolic and < 6.89 for diastolic pressure. The Combiomed Hipermax-BF A7101 automatic sphygmomanometer meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018/Amd 1:2020) in the general population.