Validation Studies

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

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: 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.

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: This study aims to establish the validity and reliability of the Malaytranslated version of the CES-D. Methods: This study employed a cross-sectional study design. The participants were female inmates (n=90) from local prisons which were selected based on purposive-selective sampling. The analyses include face validation, factor analysis, and reliability testing. A test-retest was conducted within a one-week interval. Results: The mean score for depression among the participants is 18.97 (SD=6.51). Further descriptive analysis showed that 58.9% of them scored above the mean score, which is considered high. Preliminary construct validation analysis confirmed that factor analysis was appropriate for the Malay-translated version of the CES-D. Furthermore, the factor analysis showed similar factor loadings to the original English version. The total internal consistency of the translated version, which was measured by Cronbach’s alpha coefficient, was equal to 0.75. The test-retest reliability of the total score, measured by Pearson’s correlation was equal to 0.69. Conclusions: Face validity, construct validity, and reliability analysis were found satisfactory for the Malay-translated version of the CES-D. The Malay-translated version of the CES-D was found valid and reliable to be used in future studies, with comparable properties to the original version and to previous studies.
Depression ; Female ; Prisons ; Validation Studies

This paper introduces the safety and effectiveness requirements of medical device software. And it discusses the methods on evaluating medical device software from two aspects, the design and development process of the software and software products.
Equipment Safety ; Equipment and Supplies ; Software ; Software Validation

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

PURPOSE: The purpose of this study was to develop dedicated software for quantitative analysis of the airways and to validate the software using airway phantoms and excised swine lung. MATERIALS AND METHODS: The dedicated software was validated in airway phantoms and excised swine lung through comparison of the actual values with the measurements acquired with dedicated software. The accuracy of the measurements according to the reconstruction methods (standard, lung, sharp) and spatial resolution were compared using airway phantoms. Repeatability of the measurement of airway phantoms was assessed with follow-up CT scans three months later. RESULTS: Airway dimension measurements obtained in airway phantoms and excised swine lung showed good agreements with actual values. Airway measurements were more accurate when the sharp reconstruction algorithm was used and when the spatial resolution was improved using pixels smaller than conventional size. There was good agreement between the initial airway measurements and those obtained three months later. CONCLUSION: We developed and validated dedicated software for quantitative airway measurement. Recon-struction with sharp algorithms and high spatial resolution images is recommended for obtaining airway measurements.
Bronchi ; Follow-Up Studies ; Lung ; Phantoms, Imaging ; Software Validation ; Swine ; Tomography, X-Ray Computed

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.
Accreditation ; Humans ; Laboratories/standards ; Lead/*blood/standards ; Reference Standards ; *Spectrophotometry, Atomic/standards ; *Validation Studies as Topic