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Budget impact of increasing uptake of denosumab for the treatment of postmenopausal osteoporosis in Malaysia

Choo YW, Mohd Tahir NA, Mohamed Said MS, Makmor Bakry M, Li SC

Arch Osteoporos, 2023 Nov 30;18(1):145.
PMID: 38030861 DOI: 10.1007/s11657-023-01358-z

This study evaluated the financial impact of increasing denosumab usage for managing postmenopausal osteoporosis over a 5-year period from the Malaysian healthcare provider's perspective. A gradual moderate increase in denosumab uptake would have a minimal budget impact, with potential savings in fracture treatment expenses. Optimizing denosumab usage could be a cost-effective and potentially affordable strategy to alleviate the economic burden of osteoporosis in Malaysia.
PURPOSE: The study aimed to evaluate the budget impact of increasing the uptake of denosumab for the management of postmenopausal osteoporosis in Malaysia.
METHODS: A Markov budget impact model was developed to estimate the financial impact of osteoporosis treatment. We modelled a scenario in which the uptake of denosumab would increase each year compared with a static scenario. A 5-year time horizon from the perspective of a Malaysian MOH healthcare provider was used. Model inputs were based on Malaysian sources where available. Sensitivity analyses were performed to examine the robustness of the modelled results.
RESULTS: An increase in denosumab uptake of 8% per year over a 5-year time horizon would result in an additional budget impact, from MYR 0.26 million (USD 0.06 million) in the first year to MYR 3.25 million (USD 0.78 million) in the fifth year. When expressed as cost per-member-per-month (PMPM), these were less than MYR 0.01 across all five years of treatment. In sensitivity analyses, the acquisition cost of denosumab and medication persistence had the largest impact on the budget.
CONCLUSION: From the perspective of a Malaysian MOH healthcare provider, moderately increasing uptake of denosumab would have a minimal additional budget impact, partially offset by savings in fracture treatment costs. Increasing the use of denosumab appears affordable to reduce the economic burden of osteoporosis in Malaysia.
Polypharmacy and medication regimen complexity in transfusion-dependent thalassaemia patients: a cross- sectional study

Chun GY, Ng SSM, Islahudin F, Selvaratnam V, Mohd Tahir NA

Int J Clin Pharm, 2024 Mar 29.
PMID: 38551751 DOI: 10.1007/s11096-024-01716-y

BACKGROUND: Medication burden and complexity have been longstanding problems in chronically ill patients. However, more data are needed on the extent and impact of medication burden and complexity in the transfusion-dependent thalassaemia population.
AIM: The aim of this study was to determine the characteristics of medication complexity and polypharmacy and determine their relationship with drug-related problems (DRP) and control of iron overload in transfusion-dependent thalassaemia patients.
METHOD: Data were derived from a cross-sectional observational study on characteristics of DRPs conducted at a Malaysian tertiary hospital. The medication regimen complexity index (MRCI) was determined using a validated tool, and polypharmacy was defined as the chronic use of five or more medications. The receiver operating characteristic curve analysis was used to determine the optimal cut-off value for MRCI, and logistic regression analysis was conducted.
RESULTS: The study enrolled 200 adult patients. The MRCI cut-off point was proposed to be 17.5 (Area Under Curve = 0.722; sensitivity of 73.3% and specificity of 62.0%). Approximately 73% and 64.5% of the patients had polypharmacy and high MRCI, respectively. Findings indicated that DRP was a full mediator in the association between MRCI and iron overload.
CONCLUSION: Transfusion-dependent thalassaemia patients have high MRCI and suboptimal control of iron overload conditions in the presence of DRPs. Thus, future interventions should consider MRCI and DRP as factors in serum iron control.
Health-related quality of life in osteoporosis: a systematic review of measurement properties of the QUALEFFO-41

Choo YW, Mohd Tahir NA, Mohamed Said MS, Makmor Bakry M

Osteoporos Int, 2024 May;35(5):745-757.
PMID: 38194151 DOI: 10.1007/s00198-023-07005-0

The 41-item Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) is a widely used and freely available patient-reported outcome measure (PROM). However, data on its reliability, validity, and responsiveness remain unclear. Therefore, this study aimed to systematically review the measurement properties of the QUALEFFO-41. A systematic search of MEDLINE, EBSCOhost, and Cochrane Library from their inception up to December 2022 was performed. Data were extracted, and the methodological quality of each measurement property was evaluated according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. The evidence of the measurement properties was rated against the updated criteria for good measurement properties, and the quality of evidence was graded using the modified GRADE approach. A total of 99 articles were identified, of which eight studies were included in the review. The QUALEFFO-41 is categorized as B as it demonstrated moderate quality evidence for sufficient content validity, moderate-to-high quality evidence for sufficient hypothesis testing for construct validity (except for the social function domain for convergent validity), and very low-quality evidence for sufficient responsiveness. For structural validity and internal consistency, only the domains of pain and general health perception were sufficient with low-quality evidence. For reliability, only the domain of physical function was sufficient with low-quality evidence. None of the studies reported measurement error, cross-cultural validity, and criterion validity. The QUALEFFO-41 may be a promising, valid, and reliable PROM to assess HRQoL in osteoporosis patients with vertebral fractures. However, future studies must focus on good methodological quality to strengthen the evidence of measurement properties, especially on structural validity, reliability, responsiveness, and cross-cultural validity. The systematic review evaluated the measurement properties of the QUALEFFO-41 questionnaire for assessing Health-Related Quality of Life (HRQoL) in osteoporosis patients. The review found moderate-to-high-quality evidence for construct validity but limited evidence for responsiveness and other properties. Future studies should focus on strengthening the evidence, particularly for structural validity, reliability, responsiveness, and cross-cultural validity. The QUALEFFO-41 shows promise as a valid and reliable PROM for HRQoL assessment in osteoporosis patients.
Fulltext Prevalence, Risk Factors, and Management of Metabolic Acidosis in Chronic Kidney Disease Patients: A Multicenter Retrospective Study in Malaysia

Chan JYM, Islahudin F, Mohd Tahir NA, Makmor-Bakry M, Tan CHH

Cureus, 2024 Mar;16(3):e56314.
PMID: 38628987 DOI: 10.7759/cureus.56314

Background Metabolic acidosis in chronic kidney disease (CKD) patients has lately gained attention due to the growing evidence of its treatment benefits. This study aims to provide baseline data on the prevalence, risk factors, and current management of metabolic acidosis among the pre-dialysis adult Malaysian CKD population. Methodology This multicenter cross-sectional retrospective study involved pre-dialysis CKD patients above 18 years old on regular nephrology clinic follow-up at three Malaysian government hospitals with nephrology subspecialty. Demographic data, clinical information, laboratory data, and a list of concomitant medications were collected. Factors associated with the occurrence of metabolic acidosis were identified via multiple logistic regression. Results Six hundred and fifty-seven CKD patients were screened for this study, in which only 39.4% (n=259) had available bicarbonate levels. From this, a total of 86.1% (n=223) had metabolic acidosis. Higher estimated glomerular filtration rate (odds ratio (OR) 0.96, 95% confidence interval (CI) 0.93-1.00, p=0.043) and those with cardiovascular disease (OR 0.33, 95% CI 0.15-0.73; p=0.007) were significantly associated with lower odds of metabolic acidosis. There were 43.0% (n=96) on alkali therapy with sodium bicarbonate solution being the most common (n=91, 94.8%). Among those receiving alkali therapy, only 19.8% (n=19) achieved bicarbonate levels of ≥ 22 mEq/L. Conclusion Our study showed that metabolic acidosis was highly prevalent, although few achieved target levels despite supplementation, supporting the need for focused management of metabolic acidosis in the CKD population.
Effects of CST3 Gene G73A Polymorphism on Cystatin C in a Prospective Multiethnic Cohort Study

Mohd Tahir NA, Mohd Saffian S, Islahudin FH, Abdul Gafor AH, Othman H, Abdul Manan H, et al.

Nephron, 2020;144(4):204-212.
PMID: 32050196 DOI: 10.1159/000505296

BACKGROUND/AIMS: G73A polymorphism in the CST3 gene of cystatin C has been associated with Alzheimer's disease, age-related macular degeneration, and cardiovascular disease. However, studies investigating the influence of this genetic variability on serum cystatin C and cystatin-based renal function estimate are limited. Therefore, the aim of this study is to investigate the possible association of single-nucleotide polymorphism (rs1064039) of the CST3 gene on the serum cystatin C level and cystatin C-based estimated glomerular filtration rate (eGFR).
METHODS: Study subjects include patients with various levels of renal function recruited from the nephrology clinic and wards of a tertiary hospital. The blood samples collected were analyzed for serum cystatin C and creatinine levels by particle-enhanced turbidimetric immunoassay and kinetic alkaline picrate method, respectively. DNA was extracted using a commercially available kit. -Polymerase chain reaction results were confirmed by direct DNA Sanger sequencing.
RESULTS: The genotype percentage (G/G = 73%, G/A = 24.1%, and A/A = 2.9%) adhere to the Hardy-Weinberg equilibrium. The dominant allele found in our population was CST3 73G allele (85%). The regression lines' slope of serum cystatin C against creatinine and cystatin C-based eGFR against creatinine-based eGFR, between G and A allele groups, showed a statistically significant difference (z-score = 3.457, p < 0.001 and z-score = 2.158, p = 0.015, respectively). Patients with A allele had a lower serum cystatin C level when the values were extrapolated at a fixed serum creatinine value, suggesting the influence of genetic factor.
CONCLUSION: Presence of CST3 gene G73A polymorphism affects serum cystatin C levels.
Fulltext Autonomy in refusing life saving interventions: religious and cultural misconceptions

van Rostenberghe H, Yong A, Mohd Zin F, Fuad MDF, Idris B, Tahir NA, et al.

Education in Medicine Journal, 2014;6(1):70-73.
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Autonomy is widely accepted to be the third pillar of medical ethics. However, if it comes to refusal of life saving treatments, some extra considerations are necessary, especially if decisions are made by surrogate decision makers. Four cases of problematic decision making are presented here, followed by a discussion about the cultural and religious misconceptions about the rights of surrogate decision makers.
Challenges in Obtaining and Seeking Information Among Breast Cancer Survivors in an Asian Country: a Qualitative Study

Yussof I, Mohamed Shah N, Ab Muin NF, Abd Rahim S, Hatah E, Mohd Tahir NA, et al.

J Cancer Educ, 2024 Mar 26.
PMID: 38530598 DOI: 10.1007/s13187-024-02421-0

Breast cancer survivors on adjuvant endocrine therapy (AET) have distinct information-seeking experience compared to those in the diagnosis and intensive treatment phase. This study aimed to understand the challenges in obtaining and seeking information among Malaysian breast cancer survivors. We conducted semi-structured, one-to-one interviews among patients using AET from two hospitals and a local cancer organization. Interviews were conducted until theme saturation was achieved (N = 25). Interviews were de-identified, transcribed verbatim, and analysed using thematic analysis. To ensure rigor, coding was conducted through regular discussions between two researchers and the findings were shared with several participants after analysis was completed. Three main themes were identified: limitations in the healthcare system, pitfalls of seeking information online, and limited information from local sources. The participants perceived that their information needs were not met by their healthcare providers and sought information on the Internet to complement their information needs. However, they were faced with risks of misinformation, information overload, and unethical promotion of health products. Those with limited English proficiency had difficulties in accessing quality information, and suggested that there should be more content created by local health advocates in local languages, with information that is tailored for local cultures. As the Internet has become an important medium of health education, healthcare providers and patients should be equipped with the skills to share and search for information online. Digital health literacy needs to be incorporated in patient education modules to create a more informed and empowered patient community.
Fulltext Randomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol

Hamzah N, Narayanan V, Ramli N, Mustapha NA, Mohammad Tahir NA, Tan LK, et al.

BMJ Open, 2019 09 18;9(9):e028711.
PMID: 31537559 DOI: 10.1136/bmjopen-2018-028711

OBJECTIVES: To measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.
SETTING: A single centre study, Malaysia.
PARTICIPANTS: Adults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen's d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate).
INTERVENTIONS: Intervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks.
OUTCOME MEASURES: Primary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).
RESULTS: Results will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson's correlation coefficient.
CONCLUSION: This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.
ETHICS AND DISSEMINATION: The study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928-4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
TRIAL REGISTRATION NUMBER: NCT03237676.
Fulltext Decision making process and factors contributing to research participation among general practitioners: A grounded theory study

Tong SF, Ng CJ, Lee VKM, Lee PY, Ismail IZ, Khoo EM, et al.

PLoS One, 2018;13(4):e0196379.
PMID: 29694439 DOI: 10.1371/journal.pone.0196379

INTRODUCTION: The participation of general practitioners (GPs) in primary care research is variable and often poor. We aimed to develop a substantive and empirical theoretical framework to explain GPs' decision-making process to participate in research.
METHODS: We used the grounded theory approach to construct a substantive theory to explain the decision-making process of GPs to participate in research activities. Five in-depth interviews and four focus group discussions were conducted among 21 GPs. Purposeful sampling followed by theoretical sampling were used to attempt saturation of the core category. Data were collected using semi-structured open-ended questions. Interviews were recorded, transcribed verbatim and checked prior to analysis. Open line-by-line coding followed by focus coding were used to arrive at a substantive theory. Memoing was used to help bring concepts to higher abstract levels.
RESULTS: The GPs' decision to participate in research was attributed to their inner drive and appreciation for primary care research and their confidence in managing their social and research environments. The drive and appreciation for research motivated the GPs to undergo research training to enhance their research knowledge, skills and confidence. However, the critical step in the GPs' decision to participate in research was their ability to align their research agenda with priorities in their social environment, which included personal life goals, clinical practice and organisational culture. Perceived support for research, such as funding and technical expertise, facilitated the GPs' participation in research. In addition, prior experiences participating in research also influenced the GPs' confidence in taking part in future research.
CONCLUSIONS: The key to GPs deciding to participate in research is whether the research agenda aligns with the priorities in their social environment. Therefore, research training is important, but should be included in further measures and should comply with GPs' social environments and research support.