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      Feasibility and acceptability of implementing the Global Scales for Early Development (GSED) package for children 0–3 years across three countries

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      1 , , 2 , 3 , 2 , 4 , 5 , 6 , 1 , 7 , 8 , 8 , 9 , 10 , 11 , 12 , 13 , 3 , 13 , 14 , 15 , 16 , 17 , 18 , 1 , 13 , 11 , 10 , 13 , 3 , 19 , 13 , 20 , 19 , 19 , 21 , 9 , 1 , 6 , 1 , 9 , 1 , 1 , 2
      Pilot and Feasibility Studies
      BioMed Central
      Early childhood development, Global, Scales, Measurement, Feasibility, Monitoring

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          Abstract

          Background

          To assess the neurodevelopment of children under three years, a multinational team of subject matter experts (SMEs) led by the World Health Organization (WHO) developed the Global Scales for Early Development (GSED). The measures include (1) a caregiver-reported short form (SF), (2) a directly administered long form (LF), and (3) a caregiver-reported psychosocial form (PF). The feasibility objectives of this study in Bangladesh, Pakistan, and the United Republic of Tanzania were to assess (1) the study implementation processes, including translation, training, reliability testing, and scheduling of visits and (2) the comprehensibility, cultural relevance, and acceptability of the GSED measures and the related GSED tablet-based application (app) for data collection for caregivers, children, and assessors.

          Methods

          In preparation for a large-scale validation study, we implemented several procedures to ensure that study processes were feasible during the main data collection and that the GSED was culturally appropriate, including translation and back translation of the GSED measures and country-specific training packages on study measures and procedures. Data were collected from at least 32 child-caregiver dyads, stratified by age and sex, in each country. Two methods of collecting inter-rater reliability data were tested: live in-person versus video-based assessment. Each country planned two participant visits: the first to gain consent, assess eligibility, and begin administration of the caregiver-reported GSED SF, PF, and other study measures and the second to administer the GSED LF directly to the child. Feedback on the implementation processes was evaluated by in-country assessors through focus group discussions (FGDs). Feedback on the comprehensibility, relevance, and acceptability of the GSED measures from caregivers was obtained through exit interviews in addition to the FGD of assessors. Additional cognitive interviews were conducted during administration to ensure comprehension and cultural relevance for several GSED PF items.

          Results

          The translation-back translation process identified items with words and phrases that were either mistranslated or did not have a literal matching translation in the local languages, requiring rewording or rephrasing. Implementation challenges reiterated the need to develop a more comprehensive training module covering GSED administration and other topics, including the consent process, rapport building, techniques for maintaining privacy and preventing distraction, and using didactic and interactive learning modes. Additionally, it suggested some modifications in the order of administration of measures. Assessor/supervisor concurrent scoring of assessments proved to be the most cost-effective and straightforward method for evaluating inter-rater reliability. Administration of measures using the app was considered culturally acceptable and easy to understand by most caregivers and assessors. Some mothers felt anxious about a few GSED LF items assessing motor skills. Additionally, some objects from the GSED LF kit (a set of props to test specific skills and behaviors) were unfamiliar to the children, and hence, it took extra time for them to familiarize themselves with the materials and understand the task.

          Conclusion

          This study generated invaluable information regarding the implementation of the GSED, including where improvements should be made and where the administered measures’ comprehensibility, relevance, and acceptability needed revisions. These results have implications both for the main GSED validation study and the broader assessment of children’s development in global settings, providing insights into the opportunities and challenges of assessing young children in diverse cultural settings.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s40814-024-01583-4.

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          Most cited references34

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          The brief resilience scale: assessing the ability to bounce back.

          While resilience has been defined as resistance to illness, adaptation, and thriving, the ability to bounce back or recover from stress is closest to its original meaning. Previous resilience measures assess resources that may promote resilience rather than recovery, resistance, adaptation, or thriving. To test a new brief resilience scale. The brief resilience scale (BRS) was created to assess the ability to bounce back or recover from stress. Its psychometric characteristics were examined in four samples, including two student samples and samples with cardiac and chronic pain patients. The BRS was reliable and measured as a unitary construct. It was predictably related to personal characteristics, social relations, coping, and health in all samples. It was negatively related to anxiety, depression, negative affect, and physical symptoms when other resilience measures and optimism, social support, and Type D personality (high negative affect and high social inhibition) were controlled. There were large differences in BRS scores between cardiac patients with and without Type D and women with and without fibromyalgia. The BRS is a reliable means of assessing resilience as the ability to bounce back or recover from stress and may provide unique and important information about people coping with health-related stressors.
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            Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.

            In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.
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              CONSORT 2010 statement: extension to randomised pilot and feasibility trials

              The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.
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                Author and article information

                Contributors
                ambreen.nizar@aku.edu
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                14 February 2025
                14 February 2025
                2025
                : 11
                : 18
                Affiliations
                [1 ]Department of Pediatrics and Child Health, The Aga Khan University, ( https://ror.org/03gd0dm95) Karachi, Pakistan
                [2 ]Department of Mental Health and Substance Use, World Health Organization, ( https://ror.org/01f80g185) Geneva, Switzerland
                [3 ]School of Medicine, Keele University, ( https://ror.org/00340yn33) Keele, UK
                [4 ]School of Public Health, University of Nevada Reno, ( https://ror.org/01keh0577) Reno, NV USA
                [5 ]Department of Women and Children’s Health, Institute of Life Course and Medical Sciences, University of Liverpool, ( https://ror.org/04xs57h96) Liverpool, UK
                [6 ]Offord Centre for Child Studies, Department of Psychiatry and Behavioural Neurosciences, McMaster University, ( https://ror.org/02fa3aq29) Hamilton, ON Canada
                [7 ]Center for Effective Global Action, University of California Berkeley School of Public Health, ( https://ror.org/01an7q238) Berkeley, CA USA
                [8 ]Center for Public Health Kinetics, CPHK Global, Pemba, Zanzibar Tanzania
                [9 ]Research, Projahnmo Research Foundation, Dhaka, Bangladesh
                [10 ]Child Health Advocacy Institute, National Children’s Medical Center, Shanghai Children’s Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine, ( https://ror.org/0220qvk04) Shanghai, People’s Republic of China
                [11 ]Department of Pediatrics, University of São Paulo Medical School, ( https://ror.org/036rp1748) São Paulo, Brazil
                [12 ]Innovations for Poverty Action, IPA Côte d’Ivoire, Abidjan, Côte d’Ivoire
                [13 ]Department of Child Health, Netherlands Organization for Applied Scientific Research, ( https://ror.org/01bnjb948) Leiden, Netherlands
                [14 ]Nutrition and Clinical Services Division (NCSD), International Centre for Diarrhoeal Disease Research Bangladesh, ( https://ror.org/04vsvr128) Dhaka, Bangladesh
                [15 ]International Education, RTI International, ( https://ror.org/052tfza37) Research Triangle Park, NC USA
                [16 ]Department of Pediatrics, University of Maryland School of Medicine, ( https://ror.org/04rq5mt64) Baltimore, MD USA
                [17 ]International Center for Maternal and Newborn Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, ( https://ror.org/00za53h95) Baltimore, MD USA
                [18 ]Education Policy and Program Evaluation, Harvard Graduate School of Education, ( https://ror.org/03vek6s52) Cambridge, MA USA
                [19 ]Health Promotion, University of Nebraska Medical Center College of Public Health, ( https://ror.org/00thqtb16) Omaha, NE USA
                [20 ]Department of Methodology and Statistics, Faculty of Social and Behavioural Sciences, University of Utrecht, ( https://ror.org/04pp8hn57) Utrecht, Netherlands
                [21 ]Social Protection and Health Division, Inter-American Development Bank, ( https://ror.org/02gjn4306) Washington, DC USA
                Author information
                http://orcid.org/0000-0002-0887-3725
                Article
                1583
                10.1186/s40814-024-01583-4
                11827458
                39953573
                a963bc82-83f2-4ed7-a55e-facc04dbb036
                © The Author(s) 2025

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.

                History
                : 12 December 2023
                : 24 December 2024
                Categories
                Research
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                © BioMed Central Ltd., part of Springer Nature 2025

                early childhood development,global,scales,measurement,feasibility,monitoring

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