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Sample size determination for conducting a pilot study to assess reliability of a questionnaire

Bujang MA, Omar ED, Foo DHP, Hon YK

Restor Dent Endod, 2024 Feb;49(1):e3.
PMID: 38449496 DOI: 10.5395/rde.2024.49.e3

This article is a narrative review that discusses the recommended sample size requirements to design a pilot study to assess the reliability of a questionnaire. A list of various sample size tables that are based on the kappa agreement test, intra-class correlation test and Cronbach's alpha test has been compiled together. For all calculations, type I error (alpha) was set at a maximum value of 0.05, and power was set at a minimum value of 80.0%. For the kappa agreement test, intra-class correlation test, and Cronbach's alpha test, the recommended minimum sample size requirement based on the ideal effect sizes shall be at least 15, 22, and 24 subjects respectively. By making allowances for a non-response rate of 20.0%, a minimum sample size of 30 respondents will be sufficient to assess the reliability of the questionnaire. The clear guideline of minimum sample size requirement for the pilot study to assess the reliability of a questionnaire is discussed and this will ease researchers in preparation for the pilot study. This study provides justification for a minimum requirement of a sample size of 30 respondents specifically to test the reliability of a questionnaire.
Fulltext Investigator-initiated clinical trials in Malaysia and the role of the Clinical Research Centre of the Ministry of Health

Sivanandam AF, Hon YK, Yuen S, Muninathan P, Goh PP, Lim TO

Med J Malaysia, 2010 Jun;65 Suppl A:138-42.
PMID: 21488475

The objective of this review is to better understand the concept of investigator-initiated trials and its benefits. While investigator-initiated trials can be an invaluable tool, there are several challenges in its initiation and management. However, it is for these reasons that Clinical Research Centre (CRC) had developed the Investigator Initiated Trial (IIT) Programme where financial support and technical assistance are provided to local investigators embarking on their own clinical trials. In the course of preparing the review, we found that the inclination of investigator-initiated trials has yet to be well established in Ministry of Health, Malaysia. Given the potential and impact of such trials, clinicians should be aware of their ability as well as the availability of a supportive network in mobilising their concerted research efforts. Greater research collaboration among investigators could foster more innovative, insightful and constructive research.
Fulltext Research landscape on 3D printing applications in healthcare within Southeast Asian countries: a systematic scoping review protocol

Mohd Noor MN, Leow ML, Lai WH, Hon YK, Tiong LL, Chern PM

BMJ Open, 2022 Dec 13;12(12):e065546.
PMID: 36523224 DOI: 10.1136/bmjopen-2022-065546

INTRODUCTION: Three-dimensional (3D) printing plays a significant role as a promising technological advancement in modern healthcare settings. 3D printing has been incorporated by many sectors worldwide including in Southeast Asian countries. However, there is a paucity of research, especially in the healthcare pertaining to 3D printing activity in the Southeast Asian region. Thus, a scoping review is conducted to gain insight into 3D printing healthcare research landscape in the Southeast Asian region.
METHODS AND ANALYSIS: The methodology draws on Arksey and O'Malley's seminal framework for the scoping review. The literature search will be conducted by using keywords to find suitable published literature. The existing literature will be searched using selected electronic databases such as PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science from the years 2011 and 2021. The selected publications will focus on 10 Southeast Asian countries: Malaysia, Indonesia, Singapore, Thailand, Brunei, Philippines, Laos, Vietnam, Cambodia and Myanmar. Two reviewers will be performing title and abstract screening for the criteria of each publication, in which they will be working independently of each other. The included publication will undergo a full-text review and references cited will be examined for relevance using the same inclusion criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram will guide throughout the process. Data will be extracted, analysed and charted within each category from the selected publications for each Southeast Asian country.
ETHICS AND DISSEMINATION: The results of this scoping review will illustrate an overview of the 3D printing healthcare research in the Southeast Asian context, which can be a guide for the advancement of 3D printing that can be accentuated in future research. The results will undergo dissemination which will be submitted for publication in a scientific journal.
Fulltext The National Medical Research Register--a vital link between current and future research

Lim TO, Asmaliza SI, Goh PP, Michael AJ, Hon YK, Thandapani R, et al.

Med J Malaysia, 2010 Jun;65 Suppl A:124-7.
PMID: 21488472

Registration of research proposal to a publicly accessible website with searchable function allows information sharing and ensures research transparency. The National Institutes of Health Malaysia, realising the importance of research registration, established the National Medical Research Register (NMRR) in 2007. The NMRR functions more than just a local register: it also links to ethics approval and MOH medical research grant application. It thus facilitates researchers in their application to the Ministry of Health Research and Ethics Committee (MREC) and for Ministry of Health research grant. In addition, MREC committee members can review research protocol on NMRR website, thus saving much time and resources. From May 2007 till December 2009, more than 3000 people have registered as NMRR public users and more than 1000 research proposals have been uploaded in NMRR. The number of registration of research proposals, clinical trials and industrial sponsored trials steadily increased from year 2007 to year 2009. The web-based NMRR is the first research register in the world that links research proposal registration to ethical review and research grant application. Its future plan is to be linked with publication. Therefore, it is indeed an innovation that Malaysians should be proud of.
Fulltext Measuring population health and quality of life: Developing and testing of the significant quality of life measure (SigQOLM)

Bujang MA, Lai WH, Hon YK, Yap EPP, Tiong XT, Ratnasingam S, et al.

Heliyon, 2023 Dec;9(12):e22668.
PMID: 38149205 DOI: 10.1016/j.heliyon.2023.e22668

Quality of life (QOL) should ideally be determined by a broader spectrum of measurable parameters. This study aims to develop and validate a study instrument that is designed to determine a holistic measure of health and non-health aspects of QOL, and it is called the 'Significant Quality of Life Measure' (SigQOLM). This study involves five phases which aim to (i) explore and understand the subject matter content, (ii) develop a questionnaire, (iii) assess its content validity and face validity, (iv) conduct a pilot study, and lastly (v) perform a field-test by using the questionnaire. For the field-testing phase, a cross-sectional study was conducted which elicited responses from healthcare workers via a self-administered survey for all the SigQOLM items. Based on the results, the overall framework of the SigQOLM consists of four elements, 18 domains with 69 items. The element of "Health" is measured by nine domains, while "Relationships", "Functional activities, and "Survival" are measured by three domains respectively. The SigQOLM has been developed successfully and then validated with a high level of reliability, validity, and overall model fit. Therefore, the SigQOLM will provide researchers and policymakers another viable option to elicit a more comprehensive outcome measure of QOL which shall then enable them to implement specific interventions for improving the QOL of all the people, both healthy or otherwise.
A cross-sectional study on the second victim experience and support at Sarawak General Hospital: A tertiary public hospital in Borneo Island, Malaysia

Kim ARJ, Hon YK, Guan CA, Lai WH, Bujang MA, Peter S, et al.

Med J Malaysia, 2025 Jan;80(1):81-87.
PMID: 39812433

INTRODUCTION: Second victim experience (SVE) refers to the emotional and psychological impact experienced by healthcare providers who are involved in patient safety incidents (PSIs). Despite growing awareness of patient safety in healthcare organizations, remedial actions often focus only on the first victim, the patient. Therefore, it is important to recognize and address the emotional and physical toll that PSIs to ensure the well-being of and to promote a culture of safety in healthcare settings. Hence, this study was initiated to determine the prevalence of SVE, assess symptoms related to SVE and evaluate the level of support needed by healthcare providers.
MATERIALS AND METHODS: The Second Victim Experience and Support Tool for Recovery (SVEST-R) questionnaire was utilized to conduct an anonymous survey on the healthcare providers in Sarawak General Hospital (SGH) from August to October 2018.
RESULTS: A total of 482 respondents participated in the survey and 46.1% of the respondents reported SVE following their involvement in PSIs. Notably, symptoms such as flashbacks, fear, and stress tend to persist for longer durations compared to other symptoms. It is worth noting that non-work-related support received the highest mean (medical doctors = 3.83; nurses = 3.70), indicating that respondents preferred to seek emotional support from their friends and families. Furthermore, nurses reported a significantly higher experience of absenteeism following PSIs than doctors (p=0.003). In addition, most respondents expressed a desire for discussion or counselling with a respected peer or supervisor following their involvement in PSIs.
CONCLUSION: Present study reported a relatively high prevalence of SVE among healthcare providers at SGH. Hence, proactive measures, including non-work related and supervisor support, are essential in facilitating their overall well-being and successful recovery.
Fulltext Quality of life and overall well-being between healthy individuals and patients with varied clinical diagnoses

Bujang MA, Lai WH, Tiong XT, Ratnasingam S, Kim ARJ, Husin M, et al.

BMC Public Health, 2025 Feb 04;25(1):443.
PMID: 39905413 DOI: 10.1186/s12889-025-21475-3

BACKGROUND: Chronic diseases are known to detrimentally impact an individual's quality of life (QOL) and well-being. Therefore, this study aims to evaluate the QOL and overall well-being among both healthy individuals and those with diverse primary diagnoses.
METHODS: This is a cross-sectional study and data collection took place from May 2022 to May 2023. Information regarding healthy participants was gathered from healthcare workers without any comorbidities. Data for non-healthy participants were collected from individuals diagnosed with various conditions across four specialist clinics: nephrology, oncology, psychiatry, and cardiology. All participants completed the Significant Quality of Life Measures (SigQOLM), a comprehensive assessment tool consisting of 69 items that evaluate 18 domains of QOL and well-being.
RESULTS: The study included a total of 452 participants, with 284 (62.8%) classified as healthy. Among the non-healthy participants, 41 (9.1%) had end-stage renal diseases (ESRD), 48 (10.6%) were diagnosed with cancer, 40 (8.8%) had depressive disorder, and the remaining had heart disease (8.6%). Statistical analysis revealed significant differences (p