BACKGROUND

Hand grip strength (HGS) is a tool to measure muscle strength, which is an important component in sarcopenia and frailty. Grip strength (GS) in midlife can predict physical disability in senior years and help evaluate a patient's overall health.

The general purpose of this study is to validate the HGS using an aneroid sphygmomanometer and Jamar dynamometer as a diagnostic tool for sarcpenia. The specific aims of this study are (a) to determine the concurrent criterion validity, (b) to determine the reliability, and (c) to measure the inter-rater agreement of the aneroid sphygmomanometer against the Jamar dynamometer in measuring HGS.

This prospective validation study measures HGS using an aneroid sphygmomanometer and Jamar dynamometer obtained from seventy participants 50 years old and above. Statistical methods used in data analysis include Spearman Rho, univariate linear regression analyses, intra-class correlation, inter-rater reliability, intra-rater reliability, Bland-Altman plots, and Lin’s concordance.

There was a significant correlation of HGS with the Jamar dynamometer and aneroid sphygmomanometer regardless of the rater [Spearman Rho (rs=0.762 to 0.778, p=0.001)]. Jamar GS is comparable to GS using a sphygmomanometer with the formula of [Jamar = 0.54 x sphygmomanometer (mmHg) - 45.12].

Aneroid sphygmomanometer can be used as an option to measure GS and has a valid value to predict the Jamar GS value. Hence, it can be an alternate tool for diagnosing sarcopenia.

Objectives: This study aims to translate the WHO VF-20 questionnaire into Filipino (Tagalog) and validate the translated questionnaire. Methods: Patient information such as age, sex, educational background, and employment was recorded. Preoperative uncorrected and best-corrected visual acuities were also obtained. The VF-20 questionnaire was first translated into Filipino by an independent translator. The Filipino version was then back-translated to English by another translator. The original VF-20 questionnaire and back-translated English version were compared and checked for discrepancies. The Filipino questionnaire was then pretested on 60 participants who met the inclusion and exclusion criteria. Cronbach's alpha coefficient was determined. Results: No major discrepancies in content were noted between the original VF-20 and the back-translated version. Cronbach's alpha coefficient was more than 0.9 for all the 20 items when each item was removed. The translated questionnaire shows high internal consistency (Cronbach's alpha coefficient, 0.9144). Conclusion The Filipino version of the WHO VF-20 is a valid tool to assess vision-related quality of life in patients with visual impairment due to cataract. The questionnaire can be used as a tool for clinical evaluation, monitoring response to treatment, and future research studies.
questionnaire ; quality of life ; validation

Objective: Musculoskeletal ultrasound has gained recognition in early identification of crystal deposits in the joints and soft tissues. This study aims to validate the sonographic features of 1st metatarsophalangeal joints (MTPJs) in gout and asymptomatic hyperuricemia (AH). Methods Patients with gout (n=20) and AH (n=16) underwent a gray-scale ultrasound assessment of both 1st MTPJs on 3 positions (dorsal, medial, plantar) in longitudinal view. The static images were read by 2 blinded trained sonologists for the presence of double contour sign (DCS), erosions, and tophi.
Gout ; Validation Study

Background: In 2009, the World Health Organization revised the Dengue Fever guidelines to more accurately identify patients at risk of developing severe dengue. Despite these guidelines, early diagnosis of severe dengue remains challenging for clinicians. Several scoring systems have been developed to identify patients at highest risk for severe dengue however; these studies have a study population limited to children and did not include adult patients. Objective: The purpose of this study is to validate the Simple Clinical Risk Score in predicting who will develop severe Dengue among adult patients with Dengue fever. Methods: This is a prospective cohort, single-center, observational study conducted at Silliman University Medical Center from August 2019 to August 2020. A total of 481 laboratory confirmed dengue patients were included and categorized into two models based on the day of illness. Each model used a clinical risk score of 1 point as a cut-off for predicting severe Dengue. Validation was done using the risk-odds ratio and substantiated by the odds ratio, signifying that there is more likely greater association between dengue patients to develop severe dengue. Results: In model 1, a total of 339 patients were analyzed with 6 patients who achieved a score of 1 developed severe Dengue. In model 2, a total of 142 patients were analyzed and 3 patients who achieved a score of 1 developed severe dengue. Conclusion The simple clinical risk score can assist clinicians in deciding and stratifying dengue patients who need hospitalization not only in resource-limited areas but also during this height of the pandemic. While the findings had a lesser number of participants, it still remained context-specific and is able to demonstrate a predictive ability for severe disease, thereby optimizing informed decisions for hospital admissions in settings with limited laboratory resources.
Validation Study

Background: A well-informed patient with Type 2 diabetes may be more compliant with treatment. This study aims to evaluate the diabetes-related knowledge and socio demographic determinants of patients seen at University of Santo Tomas Hospital through a translated and validated Filipino-DKT questionnaire.

Methods: Standard translation procedure was used to produce the Filipino version of the DKT2. A convenience sample of 112 outpatients with Type 2 diabetes was identified for six months at the University of Santo Tomas Hospital, Philippines. All data were collected using the Filipino-DKT and a demographic questionnaire.

Results: The Filipino-DKT demonstrated an acceptable Cronbach's alpha of 0.70 and an acceptable average inter-item correlation of 0.40 (p<0.001). The test-retest reliability was excellent, with a Pearson coefficient r of 1.00 (p<0.001). Our study demonstrated that of the 112 patients with diabetes who answered the general knowledge test, the majority had average knowledge of 78.64%, while 16.07% had poor knowledge. A total of 55 participants on insulin answered the second part of Filipino-DKT that measures insulin knowledge. Surprisingly, 56% of the subjects on insulin had poor knowledge, and only 7% had good knowledge. Results showed that the majority (56%) had poor knowledge. Participants who reported poor control of their diabetes (HbA1c >7%) also reported lower levels of knowledge about diabetes and insulin use. There was no association between duration of diabetes, family history of diabetes, and type of diabetes with knowledge of diabetes.

Conclusion: The Filipino diabetic knowledge of diabetes is poor and not related to age, sex, and duration of diabetes. Filipino-DKT is an acceptable, reliable, and valid measure of diabetes knowledge used in our clinical practice and research.

The paper describes the validation of the Malay Preschool Language Assessment Tool (MPLAT), a standardized normed referenced language assessment tool for Malay preschoolers within the ages of 4;0-6;11 and whose native language is Malay. The MPLAT (A Razak et al. 2010) is an assessment tool which is designed to assess the areas of receptive language, expressive language and early literacy skills. The MPLAT contains six subtests i.e. picture vocabulary, grammatical understanding, sentence repetition, referential meaning, relational meaning and early literacy skills. This paper is divided into 2 studies. Study 1 tested the psychometric properties and normative data of the diagnostic version of MPLAT on 300 participants recruited from preschools in the rural area of Gua Musang and the urban area of Kota Bahru located in the East Coast state of Kelantan. The construct validity is high with a strong correlation (r = 0.942) between test scores and age, validating the developmental nature of the test. There was also moderate to strong positive correlation between each subtest and the test total, as well as between subtests. It also has high test-retest reliability (r = 0.998 (p < 0.01) and inter-rater reliability (rho = 1.000). The second study looked at the psychometrics properties of the MPLAT short version (screening) compared to the full version diagnostic. The short version of MPLAT is about a quarter of the full (diagnostic) version. About 108 subjects in the urban area of the the Klang Valley, consisting of Kuala Lumpur and Selangor, were administered both versions of the MPLAT. The Pearson correlation revealed a strong positive correlation between the total scores and age (r = 0.718, p<.01), and strong positive correlation for the test-retest reliability (r = 0.881, n=12) for the short MPLAT version. For the full version, the Spearman correlation revealed a strong positive correlation between total scores and age (r = 0.791, p<.01) and a very strong positive Pearson correlation for test-retest reliability (r = 0.943). Cronbach's Alpha values demonstrated the internal consistency of the full version (0.972) and short version (0.929). In summary, both versions of the MPLAT were found to be valid tools to screen and diagnose language problems among Malay preschool children in Malaysia. MPLAT also has the potential to be a useful research tool to delineate language development of the preschool Malay children.
Malay Preschool Language Assessment Tool (MPLAT) ; screening tool ; diagnostic tool ; language assessment ; Malay preschool children ; test development ; test validation

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.
Artificial Intelligence ; Delivery of Health Care ; Device Approval ; Diagnosis ; Diagnostic Imaging ; Humans ; Insurance Coverage ; Korea ; Patient Care ; Societies ; Software Validation ; United States ; United States Food and Drug Administration

Objective: This study aims to determine the convergent and discriminant validity and internal consistent reliability of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Tagalog among adult Filipinos with differentiated thyroid cancer (DTC). Methodology: 104 adult Filipinos with DTC at various disease stages self-administered the EORTC QLQ-C30 version 3 Tagalog and Short Form-36 (SF-36) version 2 Tagalog. Concurrent validity between conceptually-related scales from both tools was determined. Convergent and discriminant validity of multi-item scales of the EORTC QLQ-C30 Tagalog were assessed by Spearman’s correlation. Cronbach's α was computed. Results: The EORTC QLQ-C30 Tagalog showed moderate correlation with similar scales in the SF-36 Tagalog particulary for physical, role and social functioning, pain, and global health (r=0.42-0.48, p<0.001). It showed satisfactory item-domain convergent and discriminant validity for all scales except pain, fatigue, physical and cognitive functioning. Internal consistent reliability was good with cronbachs α ranging from 0.77 to 0.88 for global health, emotional and role functioning and symptom scale of nausea/vomiting. Conclusion The EORTC QLQ-C30 Tagalog had acceptable convergent and discriminant validity and internal consistent reliability for the scales of global health, role, social and emotional functioning and nausea/vomiting when applied among adult Filipinos with DTC.
Thyroid Neoplasms ; Quality of Life ; Validation Study

OBJECTIVES: The study aims to develop and validate a health-related quality of life (HRQoL) questionnaire for adult Filipinos with differentiated thyroid cancer (DTC) that can be used in combination with the European Organization for Research and Treatment of Cancer QLQ-C30 Questionnaire.
METHODOLOGY: The study had 4 phases. Phase I involved generation of HRQoL issues from literature review, focus group discussions with 6 DTC patients and 5 health care professionals (HCP). Subsequent assessment for relevance and importance of the HRQoL issues by 20 patients and HCP panel was done. Phase II was formulation of the HRQoL issues into questionnaire and subsequent translation into Filipino. Phase III was pilot testing of the questionnaire in 15 patients. Phase IV was validation of the pre-final questionnaire in 231 patients.
RESULTS: In Phase I, 28 HRQoL issues were generated. In Phase II, a 28-item Filipino questionnaire was created. In Phase III, 22 items that were not upsetting or confusing to patients and with good range of responses were retained. After Phase IV, a 22-item questionnaire with 5 conceptual scales (perceived fears, psychological distress/anxiety, functionality, voice complaints, neck complaints) was created.
CONCLUSIONS: The developed and validated 22-item questionnaire can be used to assess HRQoL issues in adult Filipinos with DTC.

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards ; Software Validation