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  1. McDonald S, Turner T, Chamberlain C, Lumbiganon P, Thinkhamrop J, Festin MR, et al.
    PMID: 20594325 DOI: 10.1186/1471-2288-10-61
    Rates of maternal and perinatal mortality remain high in developing countries despite the existence of effective interventions. Efforts to strengthen evidence-based approaches to improve health in these settings are partly hindered by restricted access to the best available evidence, limited training in evidence-based practice and concerns about the relevance of existing evidence. South East Asia--Optimising Reproductive and Child Health in Developing Countries (SEA-ORCHID) was a five-year project that aimed to determine whether a multifaceted intervention designed to strengthen the capacity for research synthesis, evidence-based care and knowledge implementation improved clinical practice and led to better health outcomes for mothers and babies. This paper describes the development and design of the SEA-ORCHID intervention plan using a logical framework approach.
  2. Awaisu A, Samsudin S, Amir NA, Omar CG, Hashim MI, Mohamad MH, et al.
    PMID: 20492717 DOI: 10.1186/1471-2288-10-46
    The purpose of the linguistic validation of the Wisconsin Smoking Withdrawal Scale (WSWS) was to produce a translated version in Malay language which was "conceptually equivalent" to the original U.S. English version for use in clinical practice and research.
  3. Henderson-Smart DJ, Lumbiganon P, Festin MR, Ho JJ, Mohammad H, McDonald SJ, et al.
    PMID: 17892586
    Disorders related to pregnancy and childbirth are a major health issue in South East Asia. They represent one of the biggest health risk differentials between the developed and developing world. Our broad research question is: Can the health of mothers and babies in Thailand, Indonesia, the Philippines and Malaysia be improved by increasing the local capacity for the synthesis of research, implementation of effective interventions, and identification of gaps in knowledge needing further research?
  4. Mindell JS, Giampaoli S, Goesswald A, Kamtsiuris P, Mann C, Männistö S, et al.
    PMID: 26438235 DOI: 10.1186/s12874-015-0072-4
    Health examination surveys (HESs), carried out in Europe since the 1950's, provide valuable information about the general population's health for health monitoring, policy making, and research. Survey participation rates, important for representativeness, have been falling. International comparisons are hampered by differing exclusion criteria and definitions for non-response.
  5. Balami AD, Said SM, Zulkefli NAM, Bachok N, Balami EL
    BMC Med Res Methodol, 2019 07 18;19(1):157.
    PMID: 31319810 DOI: 10.1186/s12874-019-0803-z
    BACKGROUND: Sleeping under a long-lasting insecticidal net (LLIN) is recommended for all pregnant women in sub-Saharan Africa, due to the high prevalence of malaria infection and its associated complications in the region. Despite this, LLIN use has still remained sub-optimal among pregnant women in Maiduguri, Nigeria. Understanding the interplay of factors influencing this important health behaviour would guide the development of interventions to promote its adoption.

    METHODS: Data was collected from 380 randomly selected antenatal care attendees of a hospital in Maiduguri, using structured questionnaires. This data was then used to test the Information-Motivation-Behavioural Skills (IMB) model, for model fit, and interrelations among the constructs, using the structural equation modelling analysis with Smart-PLS.

    RESULTS: Information and motivation were significantly related to behavioural skills (r = 0.29, p 

  6. Webair HH, Ismail TAT, Ismail SB, Khaffaji AJ, Hussain NHN, Kadir AA, et al.
    BMC Med Res Methodol, 2021 09 20;21(1):188.
    PMID: 34544388 DOI: 10.1186/s12874-021-01376-w
    BACKGROUND: Patient-centered care is an essential component of health care quality. To achieve patient-centered care, health care authorities should have a clear definition and an applicable tool to measure the extent of its application. The real concept of patient centeredness should be developed by the patients themselves. We aimed to demonstrate a way to develop a draft Arabic patient-centered infertility care (PCIC) questionnaire for females clients following practical steps that address women with infertility.

    METHODS: An iterative process of questionnaire development was undertaken by combining two approaches: the steps proposed by Robert F. DeVellis for scale development and the recommended practices for questionnaire development and testing in the European statistical system. We attempted to develop the draft questionnaire that involved conceptualization and operationalization, generation of an item pool, development of the questionnaire format, review of the initial item pool by experts, and consideration of validation items for inclusion.

    RESULTS: We generated an item pool from in-depth interviews with 14 women who sought infertility care within 6 months before the interview time. We then added more items from a literature review. The item pool contained 123 items distributed through 10 domains. Ten women with infertility were included for face validation. Then, experts with backgrounds in Obstetrics and Gynecology, Family Medicine, and Public Health reviewed the item pool using content validation (n = 10 professors and/or specialists). The item pool was finally reduced to 57 items. We developed the draft Arabic patient-centered infertility care questionnaire for female clients (PCIQ-F) with three sections, including 66 items: background variables, PCIC experience variables, and a general question about the quality of infertility care in the health facility. The draft questionnaire was further reviewed and edited last by experts in preparation for part 2, which will test the questionnaire and prepare the final version.

    CONCLUSION: The PCIQ-F questionnaire development is a multi-step iterative process started and ended by the target users as experts. Experts' participation in infertility care and in questionnaire format development had a great impact on questionnaire development and conflict resolution. We recommend this transparent and replicable approach for new instrument developers; it is likely to generate a questionnaire that is valid and acceptable to target users. The draft PCIQ-F questionnaire is ready for testing of its psychometric properties before the final version to measure the PCIC level in health facilities.

  7. Hosseinpoor AR, Nambiar D, Schlotheuber A, Reidpath D, Ross Z
    BMC Med Res Methodol, 2016 10 19;16(1):141.
    PMID: 27760520
    BACKGROUND: It is widely recognised that the pursuit of sustainable development cannot be accomplished without addressing inequality, or observed differences between subgroups of a population. Monitoring health inequalities allows for the identification of health topics where major group differences exist, dimensions of inequality that must be prioritised to effect improvements in multiple health domains, and also population subgroups that are multiply disadvantaged. While availability of data to monitor health inequalities is gradually improving, there is a commensurate need to increase, within countries, the technical capacity for analysis of these data and interpretation of results for decision-making. Prior efforts to build capacity have yielded demand for a toolkit with the computational ability to display disaggregated data and summary measures of inequality in an interactive and customisable fashion that would facilitate interpretation and reporting of health inequality in a given country.

    METHODS: To answer this demand, the Health Equity Assessment Toolkit (HEAT), was developed between 2014 and 2016. The software, which contains the World Health Organization's Health Equity Monitor database, allows the assessment of inequalities within a country using over 30 reproductive, maternal, newborn and child health indicators and five dimensions of inequality (economic status, education, place of residence, subnational region and child's sex, where applicable).

    RESULTS/CONCLUSION: HEAT was beta-tested in 2015 as part of ongoing capacity building workshops on health inequality monitoring. This is the first and only application of its kind; further developments are proposed to introduce an upload data feature, translate it into different languages and increase interactivity of the software. This article will present the main features and functionalities of HEAT and discuss its relevance and use for health inequality monitoring.

  8. Kee CC, Lim KH, Sumarni MG, Teh CH, Chan YY, Nuur Hafizah MI, et al.
    BMC Med Res Methodol, 2017 Jun 02;17(1):85.
    PMID: 28577547 DOI: 10.1186/s12874-017-0362-0
    BACKGROUND: Self-reported weight and height are commonly used in lieu of direct measurements of weight and height in large epidemiological surveys due to inevitable constraints such as budget and human resource. However, the validity of self-reported weight and height, particularly among adolescents, needs to be verified as misreporting could lead to misclassification of body mass index and therefore overestimation or underestimation of the burden of BMI-related diseases. The objective of this study was to determine the validity of self-reported weight and height among Malaysian secondary school children.

    METHODS: Both self-reported and directly measured weight and height of a subgroup of 663 apparently healthy schoolchildren from the Malaysian Adolescent Health Risk Behaviour (MyAHRB) survey 2013/2014 were analysed. Respondents were required to report their current body weight and height via a self-administrative questionnaire before they were measured by investigators. The validity of self-reported against directly measured weight and height was examined using intraclass correlation coefficient (ICC), the Bland-Altman plot and weighted Kappa statistics.

    RESULTS: There was very good intraclass correlation between self-reported and directly measured weight [r = 0.96, 95% confidence interval (CI): 0.93, 0.97] and height (r = 0.94, 95% CI: 0.90, 0.96). In addition the Bland-Altman plots indicated that the mean difference between self-reported and direct measurement was relatively small. The mean difference (self-reported minus direct measurements) was, for boys: weight, -2.1 kg; height, -1.6 cm; BMI, -0.44 kg/m2 and girls: weight, -1.2 kg; height, -0.9 cm; BMI, -0.3 kg/m2. However, 95% limits of agreement were wide which indicated substantial discrepancies between self-reported and direct measurements method at the individual level. Nonetheless, the weighted Kappa statistics demonstrated a substantial agreement between BMI status categorised based on self-reported weight and height and the direct measurements (kappa = 0.76, 95% CI: 0.67, 0.84).

    CONCLUSION: Our results show that the self-reported weight and height were consistent with direct measurements and therefore can be used in assessing the nutritional status of Malaysian school children from the age of 13 to 17 years old in epidemiological studies and for surveillance purposes when direct measurements are not feasible, but not for assessing nutritional status at the individual level.
  9. Amin L, Hashim H, Mahadi Z, Ismail K
    BMC Med Res Methodol, 2018 12 05;18(1):163.
    PMID: 30518344 DOI: 10.1186/s12874-018-0619-2
    BACKGROUND: The demand in biobanking for the collection and maintenance of biological specimens and personal data from civilians to improve the prevention, diagnosis and treatment of diseases has increased notably. Despite the advancement, certain issues, specifically those related to privacy and data protection, have been critically discussed. The purposes of this study are to assess the willingness of stakeholders to participate in biobanking and to determine its predictors.

    METHODS: A survey of 469 respondents from various stakeholder groups in the Klang Valley region of Malaysia was carried out. Based on previous research, a multi-dimensional instrument measuring willingness to participate in biobanking, and its predictors, was constructed and validated. A single step Structural Equation Modelling was performed to analyse the measurements and structural model using the International Business Machines Corporation Software Package for Social Sciences, Analysis of Moment Structures (IBM SPSS Amos) version 20 with a maximum likelihood function.

    RESULTS: Malaysian stakeholders in the Klang Valley were found to be cautious of biobanks. Although they perceived the biobanks as moderately beneficial (mean score of 4.65) and were moderately willing to participate in biobanking (mean score of 4.10), they professed moderate concern about data and specimen protection issues (mean score of 4.33). Willingness to participate in biobanking was predominantly determined by four direct predictors: specific application-linked perceptions of their benefits (β = 0.35, p 
  10. Vaingankar JA, Subramaniam M, Tan LWL, Abdin E, Lim WY, Wee HL, et al.
    BMC Med Res Methodol, 2018 03 15;18(1):29.
    PMID: 29544448 DOI: 10.1186/s12874-018-0487-9
    BACKGROUND: Measures of mental well-being and positive mental health (PMH) have been largely developed and used in Western populations, however, data on representative Asian communities are lacking. Using data from a population sample, this study sought to establish psychometric properties and norms of the PMH Instrument (PMH-I), a measure of positive mental health developed in Singapore.

    METHODS: We conducted a nationally representative survey among 1925 adults aged 18-79 years of Chinese, Malay, Indian or other ethnicity. Participants reported socio-demographic characteristics and completed the PMH-I along with measures of health-related quality of life (HRQoL) and psychological distress. Construct validity of the PMH-I was assessed using confirmatory factor analysis and concurrent validity was tested through correlation with other psychological measures. Normative PMH values and differences in population subgroups were estimated.

    RESULTS: The six-factor-higher-order structure of the PMH-I comprising six subscales of general coping, emotional support, spirituality, interpersonal skills, personal growth and autonomy and global affect was confirmed. Concurrent validity was shown through significant positive correlation of the total PMH score and its subscales with HRQoL and an inverse correlation with psychological distress. Weighted age, gender and ethnicity-specific norms were derived for the Singapore population. Total PMH was significantly higher in participants aged over 40 years as compared with 18-29 year olds and in non-Chinese ethnic groups as compared with Chinese. These differences were observed for all PMH-I subscales, with the exception of emotional support and interpersonal skills score differences by age. In contrast, gender, marital status, and education level were significantly associated with some of the subscales, but not with total PMH.

    CONCLUSIONS: These results support the psychometric properties of the PMH-I in a multi-ethnic Asian population sample. The generalizable population-based norms support the application of the PMH-I for measuring mental health and assessing its determinants within the Singapore general population.

  11. Chew BH, Vos RC, Heijmans M, Shariff-Ghazali S, Fernandez A, Rutten GEHM
    BMC Med Res Methodol, 2017 Aug 03;17(1):118.
    PMID: 28774271 DOI: 10.1186/s12874-017-0394-5
    BACKGROUND: Illness perceptions involve the personal beliefs that patients have about their illness and may influence health behaviours considerably. Since an instrument to measure these perceptions for Malay population in Malaysia is lacking, we translated and examined the psychometric properties of the Malay version of the Brief Illness Perception Questionnaire (MBIPQ) in adult patients with type 2 diabetes mellitus.

    METHODS: The MBIPQ has nine items, all use a 0-10 response scale, except the ninth item about causal factors, which is an open-ended item. A standard procedure was used to translate and adapt the English BIPQ into Malay language. Construct validity was examined comparing item scores and scores on the Diabetes Management Self-Efficacy Scale, the Morisky Medication Adherence Scale, the World Health Organization Quality of Life-brief, the 9-item Patient Health Questionnaire, the 17-item Diabetes Distress Scale, HbA1c and the presence of complications. In addition, 2-week and 4-week test-retest reliability were studied.

    RESULTS: A total of 312 patients completed the MBIPQ. Out of this, 97 and 215 patients completed the 2- or 4-weeks test-retest reliability questionnaire, respectively. Moderate inter-items correlations were observed between illness perception dimensions (r = -0.31 to 0.53). MBIPQ items showed the expected correlations with self-efficacy (r = 0.35), medication adherence (r = 0.29), quality of life (r = -0.17 to 0.31) and depressive symptoms (r = -0.18 to 0.21). People with severe diabetes-related distress also were more concern (t-test = 4.01, p 

  12. Mak JWY, Sun Y, Limsrivilai J, Abdullah M, Kaibullayeva J, Balderramo D, et al.
    BMC Med Res Methodol, 2023 May 25;23(1):129.
    PMID: 37231405 DOI: 10.1186/s12874-023-01944-2
    BACKGROUND: There is a rapid increase in the incidence of inflammatory bowel diseases (IBD) in newly industrialized countries, yet epidemiological data is incomplete. We herein report the methodology adopted to study the incidence of IBD in newly industrialized countries and to evaluate the effect of environmental factors including diet on IBD development.

    METHODS: Global IBD Visualization of Epidemiology Studies in the 21st Century (GIVES-21) is a population-based cohort of newly diagnosed persons with Crohn's disease and ulcerative colitis in Asia, Africa, and Latin America to be followed prospectively for 12 months. New cases were ascertained from multiple sources and were entered into a secured online system. Cases were confirmed using standard diagnostic criteria. In addition, endoscopy, pathology and pharmacy records from each local site were searched to ensure completeness of case capture. Validated environmental and dietary questionnaires were used to determine exposure in incident cases prior to diagnosis.

    RESULTS: Through November 2022, 106 hospitals from 24 regions (16 Asia; 6 Latin America; 2 Africa) have joined the GIVES-21 Consortium. To date, over 290 incident cases have been reported. All patients have demographic data, clinical disease characteristics, and disease course data including healthcare utilization, medication history and environmental and dietary exposures data collected. We have established a comprehensive platform and infrastructure required to examine disease incidence, risk factors and disease course of IBD in the real-world setting.

    CONCLUSIONS: The GIVES-21 consortium offers a unique opportunity to investigate the epidemiology of IBD and explores new clinical research questions on the association between environmental and dietary factors and IBD development in newly industrialized countries.

  13. Lai PS, Chua SS, Tan CH, Chan SP
    BMC Med Res Methodol, 2012 Feb 24;12:18.
    PMID: 22361093 DOI: 10.1186/1471-2288-12-18
    BACKGROUND: Patient's knowledge on diabetes, hypertension and hyperlipidaemia and its medications can be used as one of the outcome measures to assess the effectiveness of educational intervention. To date, no such instrument has been validated in Malaysia. Therefore, the aim of this study was to evaluate the validity and reliability of the Diabetes, Hypertension and Hyperlipidemia (DHL) knowledge instrument for assessing the knowledge of patients with type 2 diabetes in Malaysia.

    METHODS: A 28-item instrument which comprised of 5 domains: diabetes, hypertension, hyperlipidemia, medications and general issues was designed and tested. One point was given for every correct answer, whilst zero was given for incorrect answers. Scores ranged from 0 to 28, which were then converted into percentage. This was administered to 77 patients with type 2 diabetes in a tertiary hospital, who were on medication(s) for diabetes and who could understand English (patient group), and to 40 pharmacists (professional group). The DHL knowledge instrument was administered again to the patient group after one month. Excluded were patients less than 18 years old.

    RESULTS: Flesch reading ease was 60, which is satisfactory, while the mean difficulty factor(SD) was 0.74(0.21), indicating that DHL knowledge instrument was moderately easy. Internal consistency of the instrument was good, with Cronbach's α = 0.791. The test-retest scores showed no significant difference for 26 out of the 28 items, indicating that the questionnaire has achieved stable reliability. The overall mean(SD) knowledge scores was significantly different between the patient and professional groups [74.35(14.88) versus 93.84(6.47), p < 0.001]. This means that the DHL knowledge instrument could differentiate the knowledge levels of participants. The DHL knowledge instrument shows similar psychometric properties as other validated questionnaires.

    CONCLUSIONS: The DHL knowledge instrument shows good promise to be adopted as an instrument for assessing diabetic patients' knowledge concerning their disease conditions and medications in Malaysia.

  14. Aoki N, Chen PY, Chen W, Chng WJ, Gan GG, Goh YT, et al.
    BMC Med Res Methodol, 2024 May 02;24(1):102.
    PMID: 38698331 DOI: 10.1186/s12874-024-02227-0
    BACKGROUND: Multiple myeloma (MM) is the second most common haematological cancer worldwide. Along with related diseases including monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukaemia (PCL) and plasmacytoma, MM incidence is rising, yet it remains incurable and represents a significant disease burden. Clinical registries can provide important information on management and outcomes, and are vital platforms for clinical trials and other research. The Asia-Pacific Myeloma and Related Diseases Registry (APAC MRDR) was developed to monitor and explore variation in epidemiology, treatment regimens and their impact on clinical outcomes across this region. Here we describe the registry's design and development, initial data, progress and future plans.

    METHODS: The APAC MRDR was established in 2018 as a multicentre collaboration across the Asia-Pacific, collecting prospective data on patients newly diagnosed with MM, MGUS, PCL and plasmacytoma in Korea, Singapore, Malaysia and Taiwan, with China recently joining. Development of the registry required a multidisciplinary team of clinicians, researchers, legal and information technology support, and financial resources, as well as local clinical context from key opinion leaders in the APAC region. Written informed consent is obtained and data are routinely collected throughout treatment by hospital staff. Data are stored securely, meeting all local privacy and ethics requirements. Data were collected from October 2018 to March 2024.

    RESULTS: Over 1700 patients from 24 hospitals have been enrolled onto the APAC MRDR to date, with the majority (86%) being newly diagnosed with MM. Bortezomib with an immunomodulatory drug was most frequently used in first-line MM therapy, and lenalidomide-based therapy was most common in second-line. Establishment and implementation challenges include regulatory and a range of operational issues.

    CONCLUSION: The APAC MRDR is providing 'real-world' data to participating sites, clinicians and policy-makers to explore factors influencing outcomes and survival, and to support high quality studies. It is already a valuable resource that will continue to grow and support research and clinical collaboration in MM and related diseases across the APAC region.

  15. Riberholt CG, Olsen MH, Milan JB, Hafliðadóttir SH, Svanholm JH, Pedersen EB, et al.
    BMC Med Res Methodol, 2024 Sep 09;24(1):196.
    PMID: 39251912 DOI: 10.1186/s12874-024-02318-y
    BACKGROUND: Systematic reviews and data synthesis of randomised clinical trials play a crucial role in clinical practice, research, and health policy. Trial sequential analysis can be used in systematic reviews to control type I and type II errors, but methodological errors including lack of protocols and transparency are cause for concern. We assessed the reporting of trial sequential analysis.

    METHODS: We searched Medline and the Cochrane Database of Systematic Reviews from 1 January 2018 to 31 December 2021 for systematic reviews and meta-analysis reports that include a trial sequential analysis. Only studies with at least two randomised clinical trials analysed in a forest plot and a trial sequential analysis were included. Two independent investigators assessed the studies. We evaluated protocolisation, reporting, and interpretation of the analyses, including their effect on any GRADE evaluation of imprecision.

    RESULTS: We included 270 systematic reviews and 274 meta-analysis reports and extracted data from 624 trial sequential analyses. Only 134/270 (50%) systematic reviews planned the trial sequential analysis in the protocol. For analyses on dichotomous outcomes, the proportion of events in the control group was missing in 181/439 (41%), relative risk reduction in 105/439 (24%), alpha in 30/439 (7%), beta in 128/439 (29%), and heterogeneity in 232/439 (53%). For analyses on continuous outcomes, the minimally relevant difference was missing in 125/185 (68%), variance (or standard deviation) in 144/185 (78%), alpha in 23/185 (12%), beta in 63/185 (34%), and heterogeneity in 105/185 (57%). Graphical illustration of the trial sequential analysis was present in 93% of the analyses, however, the Z-curve was wrongly displayed in 135/624 (22%) and 227/624 (36%) did not include futility boundaries. The overall transparency of all 624 analyses was very poor in 236 (38%) and poor in 173 (28%).

    CONCLUSIONS: The majority of trial sequential analyses are not transparent when preparing or presenting the required parameters, partly due to missing or poorly conducted protocols. This hampers interpretation, reproducibility, and validity.

    STUDY REGISTRATION: PROSPERO CRD42021273811.

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