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      Translation and validation of the Arabic version of the Morisky, Green and Levine (MGL) adherence scale

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          Abstract

          The Morisky Green Levine (MGL) adherence scale is a 4-item tool used for the detection of medication nonadherence among patients with chronic health conditions. Despite being widely used in Arabic-speaking research contexts, it has never been validated in Arabic language. The aim of this study was to translate and validate the MGL tool into Arabic. A standard forward-backward process was used to translate the questionnaire. Cronbach’s alpha coefficient was measured to assess internal consistency of the scale. The test-retest reliability measured the consistency of participants’ responses over time. Construct validity was evaluated by Explanatory factor analysis (EFA); Kaiser-Meyer-Olkin value and Bartlett’s test of sphericity were determined. Convergent validity was assessed using a preexisting medications Arabic Adherence Assessment Tool (AAAT). The model fit was evaluated using confirmatory factor analysis (CFA). Associations between the MGL scale scores and the patient demographic/clinical characteristics were tested by linear regressions. A total of 201 participants were included into the study. The MGL scale categorization revealed that 20.9%, 59.2% and 19.9% of the participants had high, moderate and low levels of adherence respectively. Adequate internal consistency (alpha = 0.593) was observed. A significant strong ICC and Pearson’s correlations were generated between responses at time 1 and time 2. EFA results elucidated the suitability of the data for factor analysis. Pearson’s coefficient (r) revealed a significant strong correlation between MGL scale and AAAT. CFA results confirmed a good fit for the suggested model. Linear regression revealed higher number of medications, more frequent outpatient clinic visits and not experiencing medication adverse effect factors significantly associated with better adherence. The Arabic version of MLG scale is a reliable valid tool to assess adherence among Arabic-speaking communities. Implementing interventions targeting patients not compliant to regular clinic visits and those at higher risk of experiencing medication side effects can greatly enhance medication adherence.

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          Concurrent and predictive validity of a self-reported measure of medication adherence.

          Adherence to the medical regimen continues to rank as a major clinical problem in the management of patients with essential hypertension, as in other conditions treated with drugs and life-style modification. This article reviews the psychometric properties and tests the concurrent and predictive validity of a structured four-item self-reported adherence measure (alpha reliability = 0.61), which can be easily integrated into the medical visit. Items in the scale address barriers to medication-taking and permit the health care provider to reinforce positive adherence behaviors. Data on patient adherence to the medical regimen were collected at the end of a formalized 18-month educational program. Blood pressure measurements were recorded throughout a 3-year follow-up period. Results showed the scale to demonstrate both concurrent and predictive validity with regard to blood pressure control at 2 years and 5 years, respectively. Seventy-five percent of the patients who scored high on the four-item scale at year 2 had their blood pressure under adequate control at year 5, compared with 47% under control at year 5 for those patients scoring low (P less than 0.01).
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            Adherence to Medication

            New England Journal of Medicine, 353(5), 487-497
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              A tutorial on pilot studies: the what, why and how

              Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: SoftwareRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                7 October 2022
                2022
                : 17
                : 10
                : e0275778
                Affiliations
                [1 ] Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, University of Jordan, Amman, Jordan
                [2 ] Department of Pharmaceutics and Pharmaceutical Technology, School of Pharmacy, University of Jordan, Amman, Jordan
                [3 ] Department of Pharmacology and Therapeutics, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates
                PLOS: Public Library of Science, UNITED KINGDOM
                Author notes

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

                Author information
                https://orcid.org/0000-0003-1750-6684
                https://orcid.org/0000-0002-5177-1222
                Article
                PONE-D-21-25651
                10.1371/journal.pone.0275778
                9543961
                36206237
                5e5cda52-1255-4e7d-bb2b-c36ff176f1a1
                © 2022 Awwad et al

                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
                : 8 August 2021
                : 23 September 2022
                Page count
                Figures: 3, Tables: 7, Pages: 14
                Funding
                The author(s) received no specific funding for this work.
                Categories
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                Medicine and Health Sciences
                Health Care
                Health Care Facilities
                Outpatient Clinics
                Research and Analysis Methods
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                Statistical Methods
                Regression Analysis
                Linear Regression Analysis
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                Statistical Methods
                Regression Analysis
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                Research and Analysis Methods
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                Cognitive Psychology
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                Health Education and Awareness
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