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      Clinical Outcomes, Patient-Reported Outcomes, and Economic Burden for Thai People Living with Chronic Urticaria (CORE-CU) in routine practice: A study protocol for a monocentric prospective longitudinal study

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          Abstract

          Background

          Few prospective longitudinal studies have been conducted in Thailand to account for the long-term response to chronic urticaria (CU) treatment, clinical outcomes, and patient-reported outcomes (PROs) among people living with CU based on routine practice. As such, a prospective longitudinal study will be conducted to better understand the long-term responses to treatment options and the burden of disease in Thai CU patients.

          Methods and design

          This study is a routine clinical practice registry-based, monocentric, prospective, observational longitudinal study in the northern region of Thailand. Adult patients in an outpatient clinic diagnosed with CU, including both chronic spontaneous urticaria and chronic inducible urticaria will be recruited for this study. The cohort will be collected and registered using the joint routine clinical practice data based on multiple datasets including claims outpatient and inpatient data, routine laboratory results, medication utilization, health care costs, clinical characteristics, long-term urticaria care and monitoring, and PRO measures. The point prevalence of adverse health outcomes will be estimated and reported corresponding to 95% confidence intervals (95% CIs). The overall trend analysis will be analyzed to explore the effect of over time across the cohort time frame.

          Conclusion

          This prospective longitudinal study will report the clinical outcomes, PROs, and economic burden among Thai people living with CU based on routine clinical practice. Findings will provide comprehensive evidence and could facilitate best practices for CU care management for health care professionals, researchers, policymakers, and public society.

          Trial registration

          Thai Clinical Trials Registry (TCTR, thaiclinicaltrials.org) registration TCTR20210706005. Registered on July 6, 2021.

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          Most cited references29

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement

            Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.
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              The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response.

              Although insomnia is a prevalent complaint with significant morbidity, it often remains unrecognized and untreated. Brief and valid instruments are needed both for screening and outcome assessment. This study examined psychometric indices of the Insomnia Severity Index (ISI) to detect cases of insomnia in a population-based sample and to evaluate treatment response in a clinical sample. Participants were 959 individuals selected from the community for an epidemiological study of insomnia (Community sample) and 183 individuals evaluated for insomnia treatment and 62 controls without insomnia (Clinical sample). They completed the ISI and several measures of sleep quality, fatigue, psychological symptoms, and quality of life; those in the Clinical sample also completed sleep diaries, polysomnography, and interviews to validate their insomnia/good sleep status and assess treatment response. In addition to standard psychometric indices of reliability and validity, item response theory analyses were computed to examine ISI item response patterns. Receiver operating curves were used to derive optimal cutoff scores for case identification and to quantify the minimally important changes in relation to global improvement ratings obtained by an independent assessor. ISI internal consistency was excellent for both samples (Cronbach α of 0.90 and 0.91). Item response analyses revealed adequate discriminatory capacity for 5 of the 7 items. Convergent validity was supported by significant correlations between total ISI score and measures of fatigue, quality of life, anxiety, and depression. A cutoff score of 10 was optimal (86.1% sensitivity and 87.7% specificity) for detecting insomnia cases in the community sample. In the clinical sample, a change score of -8.4 points (95% CI: -7.1, -9.4) was associated with moderate improvement as rated by an independent assessor after treatment. These findings provide further evidence that the ISI is a reliable and valid instrument to detect cases of insomnia in the population and is sensitive to treatment response in clinical patients.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: MethodologyRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLOS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                20 January 2023
                2023
                : 18
                : 1
                : e0279566
                Affiliations
                [1 ] Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
                [2 ] Pharmacoepidemiology and Statistics Research Center (PESRC), Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand
                [3 ] Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand
                Faculty of Health Sciences - Universidade da Beira Interior, PORTUGAL
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0000-0002-6654-3409
                https://orcid.org/0000-0003-1100-7171
                Article
                PONE-D-21-27924
                10.1371/journal.pone.0279566
                9858793
                36662843
                e900ad9f-4644-44ae-8c38-771bb51ad7c0
                © 2023 Chuamanochan, Nochaiwong

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 1 September 2021
                : 10 December 2022
                Page count
                Figures: 0, Tables: 3, Pages: 11
                Funding
                Funded by: Pharmacoepidemiology and Statistics Research Center (PESRC)
                Award Recipient :
                Pharmacoepidemiology and Statistics Research Center (PESRC) through the Chiang Mai University provides to SN The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Study Protocol
                Medicine and Health Sciences
                Medical Conditions
                Skin Diseases
                Rashes
                Urticaria
                Medicine and Health Sciences
                Dermatology
                Skin Diseases
                Rashes
                Urticaria
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Rashes
                Urticaria
                People and Places
                Population Groupings
                Ethnicities
                Asian People
                Thai People
                Medicine and Health Sciences
                Dermatology
                Medicine and Health Sciences
                Public and Occupational Health
                Social Sciences
                Economics
                Health Economics
                Medicine and Health Sciences
                Health Care
                Health Economics
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Research and Analysis Methods
                Research Design
                Longitudinal Studies
                Computer and Information Sciences
                Data Management
                Custom metadata
                No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

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                Uncategorized

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