Displaying publications 61 - 77 of 77 in total

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  1. Tan D, Mohamad NA, Wong YH, Yeong CH, Cheah PL, Sulaiman N, et al.
    Int J Hyperthermia, 2019;36(1):554-561.
    PMID: 31132888 DOI: 10.1080/02656736.2019.1610800
    Purpose: This study aimed to evaluate the effects of various computed tomography (CT) acquisition parameters and metal artifacts on CT number measurement for CT thermometry during CT-guided thermal ablation. Methods: The effects of tube voltage (100-140 kVp), tube current (20-250 mAs), pitch (0.6-1.5) and gantry rotation time (0.5, 1.0 s) as well as metal artifacts from a radiofrequency ablation (RFA) needle on CT number were evaluated using liver tissue equivalent polyacrylamide (PAA) phantom. The correlation between CT number and temperature from 37 to 80 °C was studied on PAA phantom using optimum CT acquisition parameters. Results: No statistical significant difference (p > 0.05) was found on CT numbers under the variation of different acquisition parameters for the same temperature setting. On the other hand, the RFA needle has induced metal artifacts on the CT images of up to 8 mm. The CT numbers decreased linearly when the phantom temperature increased from 37 to 80 °C. A linear regression analysis on the CT numbers and temperature suggested that the CT thermal sensitivity was -0.521 ± 0.061 HU/°C (R2 = 0.998). Conclusion: CT thermometry is feasible for temperature assessment during RFA with the current CT technology, which produced a high CT number reproducibility and stable measurement at different CT acquisition parameters. Despite being affected by metal artifacts, the CT-based thermometry could be further developed as a tissue temperature monitoring tool during CT-guided thermal ablation.
  2. Islam MN, Sulaiman N, Farid FA, Uddin J, Alyami SA, Rashid M, et al.
    PeerJ Comput Sci, 2021;7:e638.
    PMID: 34712786 DOI: 10.7717/peerj-cs.638
    Hearing deficiency is the world's most common sensation of impairment and impedes human communication and learning. Early and precise hearing diagnosis using electroencephalogram (EEG) is referred to as the optimum strategy to deal with this issue. Among a wide range of EEG control signals, the most relevant modality for hearing loss diagnosis is auditory evoked potential (AEP) which is produced in the brain's cortex area through an auditory stimulus. This study aims to develop a robust intelligent auditory sensation system utilizing a pre-train deep learning framework by analyzing and evaluating the functional reliability of the hearing based on the AEP response. First, the raw AEP data is transformed into time-frequency images through the wavelet transformation. Then, lower-level functionality is eliminated using a pre-trained network. Here, an improved-VGG16 architecture has been designed based on removing some convolutional layers and adding new layers in the fully connected block. Subsequently, the higher levels of the neural network architecture are fine-tuned using the labelled time-frequency images. Finally, the proposed method's performance has been validated by a reputed publicly available AEP dataset, recorded from sixteen subjects when they have heard specific auditory stimuli in the left or right ear. The proposed method outperforms the state-of-art studies by improving the classification accuracy to 96.87% (from 57.375%), which indicates that the proposed improved-VGG16 architecture can significantly deal with AEP response in early hearing loss diagnosis.
  3. Lim KH, Cheong YL, Sulaiman N, Yah XY, Mahadzir ME, Lim JH, et al.
    Tob Induc Dis, 2022;20:105.
    PMID: 36474605 DOI: 10.18332/tid/155376
    INTRODUCTION: Measuring the level of nicotine addiction among smokers is an integral part of enhancing smoking cessation as nicotine dependence is one of the barriers to smoking cessation. In this study, we compared the level of agreement between FTND and HSI in detecting high nicotine dependence among daily smokers.

    METHODS: We collected data from participants of a public smoking cessation clinic in Selangor. A trained pharmacist conducted face-to-face interviews with 152 daily smokers using a structured validated questionnaire. Respondents were classified as having high nicotine dependence using both the HSI (score ≥4) and the FTND (score ≥6), and concordance between the two measures, kappa statistics and sensitivity, specificity of the HSI were then determined with the FTND classification as the reference standard.

    RESULTS: The HSI had a substantial agreement with the FTND (Cohen's kappa=0.72) in measuring high levels of nicotine addiction, with good sensitivity (83.3%) and specificity (89.4%).

    CONCLUSIONS: The findings suggest that the HSI can be used instead of the FTND in clinical-based investigations to screen for high nicotine dependence among daily smokers in the clinical setting.

  4. Lim KH, Yun YX, Cheong YL, Sulaiman N, Mahadzir ME, Lim JH, et al.
    Tob Induc Dis, 2023;21:36.
    PMID: 36909814 DOI: 10.18332/tid/159624
    INTRODUCTION: The Fagerström test for nicotine dependence (FTND) was forward-backwards translated into the Malay language (FTND-M) and administered to 152 daily smokers who sought treatment for smoking cessation in government health clinics in Selangor state, Malaysia.

    METHODS: Using confirmatory factor analysis (CFA), four measurement models with the best relative fit were compared, one uni-dimensional model, and three different two-domain (morning and daytime smoking) models.

    RESULTS: The findings indicate that the best model of the FTND-M was a two-domain model, wherein domain one represented morning smoking (time to first cigarette of the day, smoking more in the morning, and which cigarette would you hate to give up) and domain two represented daytime smoking (cigarettes per day, difficulty refraining from smoking, and smoking when ill) which showed good model fit [χ2/df=1.932, goodness of fit (GFI) of 0.967, comparative fix index (CFI) of 0.945, incremental fit index (IFI) of 0.98, Tucker-Lewis index (TLI) of 0.95 and a real mean square end of approximation (RMSEA) of 0.079, and substantial reliability >0.70].

    CONCLUSIONS: This study indicates that the FTND-M can be used to assess these two dimensions of nicotine addiction among daily smokers in a clinical setting.

  5. Lih Yuan T, Sulaiman N, Nur Azurah AG, Maarof M, Razali RA, Koh B, et al.
    Int J Mol Sci, 2023 May 15;24(10).
    PMID: 37240142 DOI: 10.3390/ijms24108798
    Infertility is a condition affecting women who are born with an underdeveloped or absent vagina, a birth defect known as congenital absence of the vagina. It is a rare disorder where the development of the Mullerian duct is obstructed by unidentified causes. The case is seldom reported due to the low prevalence and sparse epidemiology studies worldwide. A potential solution for the disorder is neovaginal creation with in vitro cultured vaginal mucosa. Limited studies have reported its application, but none are reproducible or specific regarding the established processes for acquiring vaginal epithelial cells from vaginal biopsies. These research gaps were adequately answered with an epidemiology study of inpatient details in Hospital Canselor Tuanku Muhriz, Malaysia, established methods and outcomes of vaginal tissue processing and isolation, and characterization of vaginal epithelial cells using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-2H-tetrazolium bromide (MTT) and immunofluorescence assays. The reported evidence and speculation that the disorder arises because of a cellular transition event between epithelial and mesenchymal cells during the development of the Mullerian duct could be key in the creation of neovaginas using established culture procedures to improve surgical results and restore fertility.
  6. Isahak A, Reza MIH, Siwar C, Ismail SM, Sulaiman N, Hanafi Z, et al.
    Jamba, 2018;10(1):501.
    PMID: 29955268 DOI: 10.4102/jamba.v10i1.501
    Shelter centres are important locations to safeguard people from helpless situations and are an integral part of disaster risk reduction (DRR), particularly for flood DRR. The establishment of shelter centres, and their design based on scientific assessment, is crucial. Yet, they are very much related to the geographic location, socio-economic conditions and the livelihoods of the affected communities. However, many parts of the developing world are still lagging behind in ensuring such scientific design. Considering the flood disaster in 2014 that affected the residents living along the Pahang River Basin, in this study we delineate the communities at risk and evaluate the existing shelter centres to determine how they reduce people's vulnerability to the risks associated with rural and urban landscapes. We used spatial analysis tools to delineate risk zones and to evaluate existing evacuation systems. A flood disaster risk map was produced to determine which communities are living with risks. Subsequently, the distribution of shelter centres examined whether they are able to support people living at the flood risk zones. These centres were also evaluated using a set of international guidelines for effective disaster shelters. This reveals that the number of shelter centres is not adequate. The designation and designing of shelter centres are not being done scientifically. The maps produced here have a lot of potential to support disaster management decisions, in particular site selection and the prioritisation of centres. The study concludes with a set of guidelines and recommendations for structural and non-structural measures, such as alternative livelihoods and the potential of ecotourism, which may improve the resilience among flood-affected communities; and the decision-making process for the overall flood DRR initiatives.
  7. Rahman NIA, Lam CL, Sulaiman N, Abdullah NAH, Nordin F, Ariffin SHZ, et al.
    Int J Mol Sci, 2023 Aug 22;24(17).
    PMID: 37685856 DOI: 10.3390/ijms241713051
    Muscular dystrophy is a heterogenous group of hereditary muscle disorders caused by mutations in the genes responsible for muscle development, and is generally defined by a disastrous progression of muscle wasting and massive loss in muscle regeneration. Pax7 is closely associated with myogenesis, which is governed by various signaling pathways throughout a lifetime and is frequently used as an indicator in muscle research. In this review, an extensive literature search adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was performed to identify research that examined signaling pathways in living models, while quantifying Pax7 expression in myogenesis. A total of 247 articles were retrieved from the Web of Science (WoS), PubMed and Scopus databases and were thoroughly examined and evaluated, resulting in 19 articles which met the inclusion criteria. Admittedly, we were only able to discuss the quantification of Pax7 carried out in research affecting various type of genes and signaling pathways, rather than the expression of Pax7 itself, due to the massive differences in approach, factor molecules and signaling pathways analyzed across the research. However, we highlighted the thorough evidence for the alteration of the muscle stem cell precursor Pax7 in multiple signaling pathways described in different living models, with an emphasis on the novel approach that could be taken in manipulating Pax7 expression itself in dystrophic muscle, towards the discovery of an effective treatment for muscular dystrophy. Therefore, we believe that this could be applied to the potential gap in muscle research that could be filled by tuning the well-established marker expression to improve dystrophic muscle.
  8. Mahendra Kumar JL, Rashid M, Muazu Musa R, Mohd Razman MA, Sulaiman N, Jailani R, et al.
    PeerJ, 2021;9:e11182.
    PMID: 33850667 DOI: 10.7717/peerj.11182
    Brain Computer-Interface (BCI) technology plays a considerable role in the control of rehabilitation or peripheral devices for stroke patients. This is particularly due to their inability to control such devices from their inherent physical limitations after such an attack. More often than not, the control of such devices exploits electroencephalogram (EEG) signals. Nonetheless, it is worth noting that the extraction of the features and the classification of the signals is non-trivial for a successful BCI system. The use of Transfer Learning (TL) has been demonstrated to be a powerful tool in the extraction of essential features. However, the employment of such a method towards BCI applications, particularly in regard to EEG signals, are somewhat limited. The present study aims to evaluate the effectiveness of different TL models in extracting features for the classification of wink-based EEG signals. The extracted features are classified by means of fine-tuned Random Forest (RF) classifier. The raw EEG signals are transformed into a scalogram image via Continuous Wavelet Transform (CWT) before it was fed into the TL models, namely InceptionV3, Inception ResNetV2, Xception and MobileNet. The dataset was divided into training, validation, and test datasets, respectively, via a stratified ratio of 60:20:20. The hyperparameters of the RF models were optimised through the grid search approach, in which the five-fold cross-validation technique was adopted. The optimised RF classifier performance was compared with the conventional TL-based CNN classifier performance. It was demonstrated from the study that the best TL model identified is the Inception ResNetV2 along with an optimised RF pipeline, as it was able to yield a classification accuracy of 100% on both the training and validation dataset. Therefore, it could be established from the study that a comparable classification efficacy is attainable via the Inception ResNetV2 with an optimised RF pipeline. It is envisaged that the implementation of the proposed architecture to a BCI system would potentially facilitate post-stroke patients to lead a better life quality.
  9. Raziff HHA, Tan D, Tan SH, Wong YH, Lim KS, Yeong CH, et al.
    Phys Med, 2021 Feb;82:40-45.
    PMID: 33581616 DOI: 10.1016/j.ejmp.2021.01.067
    PURPOSE: To investigate the efficacy of a newly-developed laser-heated core biopsy needle in the thermal ablation of biopsy tract to reduce hemorrhage after biopsy using in vivo rabbit's liver model.

    MATERIALS AND METHODS: Five male New Zealand White rabbits weighed between 1.5 and 4.0 kg were anesthetized and their livers were exposed. 18 liver biopsies were performed under control group (without tract ablation, n = 9) and study group (with tract ablation, n = 9) settings. The needle insertion depth (~3 cm) and rate of retraction (~3 mm/s) were fixed in all the experiments. For tract ablation, three different needle temperatures (100, 120 and 150 °C) were compared. The blood loss at each biopsy site was measured by weighing the gauze pads before and after blood absorption. The rabbits were euthanized immediately and the liver specimens were stained with hematoxylin-eosin (H&E) for further histopathological examination (HPE).

    RESULTS: The average blood loss in the study group was reduced significantly (p 

  10. Koh B, Sulaiman N, Ismadi SNSW, Ramli R, Yunus SSM, Idrus RBH, et al.
    Biol Proced Online, 2021 Sep 15;23(1):18.
    PMID: 34521356 DOI: 10.1186/s12575-021-00155-7
    BACKGROUND: In the area of oral and maxillofacial surgery, regenerative endodontics aims to present alternative options to conventional treatment strategies. With continuous advances in regenerative medicine, the source of cells used for pulp tissue regeneration is not only limited to mesenchymal stem cells as the non-mesenchymal stem cells have shown capabilities too. In this review, we are systematically assessing the recent findings on odontoblastic differentiation induction with scaffold and non-scaffold approaches.

    METHODS: A comprehensive search was conducted in Pubmed, and Scopus, and relevant studies published between 2015 and 2020 were selected following the PRISMA guideline. The main inclusion criteria were that articles must be revolving on method for osteoblast differentiation in vitro study. Therefore, in vivo and human or animal clinical studies were excluded. The search outcomes identified all articles containing the word "odontoblast", "differentiation", and "mesenchymal stem cell".

    RESULTS: The literature search identified 99 related studies, but only 11 articles met the inclusion criteria. These include 5 odontoblastic differentiation induction with scaffold, 6 inductions without scaffolds. The data collected were characterised into two main categories: type of cells undergo odontoblastic differentiation, and odontoblastic differentiation techniques using scaffolds or non-scaffold.

    CONCLUSION: Based on the data analysis, the scaffold-based odontoblastic induction method seems to be a better option compared to the non-scaffold method. In addition of that, the combination of growth factors in scaffold-based methods could possibly enhance the differentiation. Thus, further detailed studies are still required to understand the mechanism and the way to enhance odontoblastic differentiation.

  11. Koh B, Sulaiman N, Fauzi MB, Law JX, Ng MH, Yuan TL, et al.
    Int J Mol Sci, 2023 Feb 13;24(4).
    PMID: 36835154 DOI: 10.3390/ijms24043745
    Xeno-free three-dimensional cultures are gaining attention for mesenchymal stem cell (MSCs) expansion in clinical applications. We investigated the potential of xeno-free serum alternatives, human serum and human platelet lysate, to replace the current conventional use of foetal bovine serum for subsequent MSCs microcarrier cultures. In this study, Wharton's Jelly MSCs were cultured in nine different media combinations to identify the best xeno-free culture media for MSCs culture. Cell proliferation and viability were identified, and the cultured MSCs were characterised in accordance with the minimal criteria for defining multipotent mesenchymal stromal cells by the International Society for Cellular Therapy (ISCT). The selected culture media was then used in the microcarrier culture of MSCs to determine the potential of a three-dimensional culture system in the expansion of MSCs for future clinical applications, and to identify the immunomodulatory potential of cultured MSCs. Low Glucose DMEM (LG) + Human Platelet (HPL) lysate media appeared to be good candidates for replacing conventional MSCs culture media in our monolayer culture system. MSCs cultured in LG-HPL achieved high cell yield, with characteristics that remained as described by ISCT, although the overall mitochondrial activity of the cells was lower than the control and the subsequent effects remained unknown. MSC microcarrier culture, on the other hand, showed comparable cell characteristics with monolayer culture, yet had stagnated cell proliferation, which is potentially due to the inactivation of FAK. Nonetheless, both the MSCs monolayer culture and the microcarrier culture showed high suppressive activity on TNF-α, and only the MSC microcarrier culture has a better suppression of IL-1 secretion. In conclusion, LG-HPL was identified as a good xeno-free media for WJMSCs culture, and although further mechanistic research is needed, the results show that the xeno-free three-dimensional culture maintained MSC characteristics and improved immunomodulatory activities, suggesting the potential of translating the monolayer culture into this culture system in MSC expansion for future clinical application.
  12. Bakeri NA, Amirullah NA, Sulaiman N, Gan WY, Loh SP, Ahmad Fuzi SF, et al.
    Cureus, 2024 Jun;16(6):e61984.
    PMID: 38984009 DOI: 10.7759/cureus.61984
    Sugar-sweetened beverages (SSBs) are a major source of dietary sugar, and their consumption is on the rise among children and adolescents. Excessive sugar intake is a significant contributor to overweight, obesity, and non-communicable diseases (NCDs). The consumption of SSBs, particularly that of children and adolescents, has been of interest as of late, as they are implicated in affecting body weight status. Thus, the goal of this study was to determine the predictive criterion-related validity of the SSB questionnaire that was administered to children and adolescents to assess their SSB and non-SSB intake. A nationwide cross-sectional study involving 5211 respondents aged 7-17 years old and their parents was conducted. The self-administered Malay questionnaire was distributed to collect information on socioeconomic background, the frequency of eating out at restaurants or other food premises, the availability of SSBs at home, and SSB consumption patterns of children and adolescents within a week. The predictive criterion-related validity was determined by using six hypotheses that can differentiate between two independent sample means of SSB consumption based on age, gender, locality, monthly household income, frequency of eating out at restaurants or other food premises, and availability of SSBs at home. The independent samples t-test and one-way ANOVA were used to conduct the validation process. Five out of six hypotheses were accepted. Significant mean differences were observed between sociodemographic factors, such as age (t=-10.56, p<0.001), localities (t=-5.37, p<0.001), monthly household income (F=26.83, p<0.001), and SSB consumption. Behavioural factors, including eating out at restaurants or other food premises (t=9.93, p<0.001) and environmental factors such as the availability of SSBs at home (F=136.24, p<0.001) also showed a significant difference with SSB consumption. The SSB questionnaire demonstrated the ability to differentiate between groups. Thus, this SSB questionnaire appears to be valid to measure the SSB consumption of children and adolescents.
  13. Haron NA, Ishak MF, Yazid MD, Vijakumaran U, Ibrahim R, Raja Sabudin RZA, et al.
    J Clin Med, 2024 Aug 14;13(16).
    PMID: 39200916 DOI: 10.3390/jcm13164774
    Coronary artery bypass grafting (CABG) utilizing saphenous vein grafts (SVGs) stands as a fundamental approach to surgically treating coronary artery disease. However, the long-term success of CABG is often compromised by the development of intimal hyperplasia (IH) and subsequent graft failure. Understanding the mechanisms underlying this pathophysiology is crucial for improving graft patency and patient outcomes. Objectives: This study aims to explore the potential of an ex vivo model utilizing SVG to investigate IH and re-endothelialization. Methods: A thorough histological examination of 15 surplus SVG procured from CABG procedures at Hospital Canselor Tuanku Muhriz, Malaysia, was conducted to establish their baseline characteristics. Results: SVGs exhibited a mean diameter of 2.65 ± 0.93 mm with pre-existing IH averaging 0.42 ± 0.13 mm in thickness, alongside an observable lack of luminal endothelial cell lining. Analysis of extracellular matrix components, including collagen, elastin, and glycosaminoglycans, at baseline and after 7 days of ex vivo culture revealed no significant changes in collagen but demonstrated increased percentages of elastin and glycosaminoglycans. Despite unsuccessful attempts at re-endothelialization with blood outgrowth endothelial cells, the established ex vivo SVG IH model underscores the multifaceted nature of graft functionality and patency, characterized by IH presence, endothelial impairment, and extracellular matrix alterations post-CABG. Conclusions: The optimized ex vivo IH model provides a valuable platform for delving into the underlying mechanisms of IH formation and re-endothelialization of SVG. Further refinements are warranted, yet this model holds promise for future research aimed at enhancing graft durability and outcomes for CAD patients undergoing CABG.
  14. Salleh R, Man CS, Ahmad MH, Palaniveloo L, Zulkafly N, Ab Halim SA, et al.
    Geriatr Gerontol Int, 2020 Dec;20 Suppl 2:73-78.
    PMID: 33370860 DOI: 10.1111/ggi.14006
    AIM: Older persons are vulnerable to food insecurity. Therefore, this study aimed to determine the prevalence of food insecurity and associated factors among older persons in Malaysia.

    METHODS: This is a cross-sectional study with two-stage stratified random sampling. In total, 3977 older persons participated in this study. Face-to-face interviews were conducted using a mobile device to obtain information about socio-demographic background, food insecurity, non-communicable diseases, social support and living arrangements. Descriptive and multiple complex sample logistic regression analyses were performed for data analysis.

    RESULTS: The overall prevalence of food insecurity among older persons was 10.4%. Older persons from rural areas with no or only primary and secondary education, income less than RM 2000 (USD 477.57), at risk of malnutrition and not receiving very high social support were more likely to be food-insecure.

    CONCLUSION: Approximately, one-tenth of Malaysian older adults were classified as food-insecure; particularly those living in rural areas from lower socio-economic status, not receiving very high social support and malnourished were more likely to be at risk. A specific nutrition program, such as meals on wheels and food vouchers, should be targeted toward older persons who are at risk to improve their malnutrition status. Geriatr Gerontol Int 2020; 20: 73-78.

  15. De Lira Mota MA, Dunkley Jones T, Sulaiman N, Edgar KM, Yamaguchi T, Leng MJ, et al.
    Nat Commun, 2023 Aug 08;14(1):4748.
    PMID: 37553323 DOI: 10.1038/s41467-023-39806-6
    Continental-scale expansion of the East Antarctic Ice Sheet during the Eocene-Oligocene Transition (EOT) is one of the largest non-linear events in Earth's climate history. Declining atmospheric carbon dioxide concentrations and orbital variability triggered glacial expansion and strong feedbacks in the climate system. Prominent among these feedbacks was the repartitioning of biogeochemical cycles between the continental shelves and the deep ocean with falling sea level. Here we present multiple proxies from a shallow shelf location that identify a marked regression and an elevated flux of continental-derived organic matter at the earliest stage of the EOT, a time of deep ocean carbonate dissolution and the extinction of oligotrophic phytoplankton groups. We link these observations using an Earth System model, whereby this first regression delivers a pulse of organic carbon to the oceans that could drive the observed patterns of deep ocean dissolution and acts as a transient negative feedback to climate cooling.
  16. Dzaraly ND, Mohd Desa MN, Muthanna A, Masri SN, Taib NM, Suhaili Z, et al.
    Sci Rep, 2021 Apr 15;11(1):8220.
    PMID: 33859249 DOI: 10.1038/s41598-021-87428-z
    Pilus has been recently associated with pneumococcal pathogenesis in humans. The information regarding piliated isolates in Malaysia is scarce, especially in the less developed states on the east coast of Peninsular Malaysia. Therefore, we studied the characteristics of pneumococci, including the piliated isolates, in relation to antimicrobial susceptibility, serotypes, and genotypes at a major tertiary hospital on the east coast of Peninsular Malaysia. A total of 100 clinical isolates collected between September 2017 and December 2019 were subjected to serotyping, antimicrobial susceptibility test, and detection of pneumococcal virulence and pilus genes. Multilocus sequence typing (MLST) and phylogenetic analysis were performed only for piliated strains. The most frequent serotypes were 14 (17%), 6A/B (16%), 23F (12%), 19A (11%), and 19F (11%). The majority of isolates were resistant to erythromycin (42%), tetracycline (37%), and trimethoprim-sulfamethoxazole (24%). Piliated isolates occurred in a proportion of 19%; 47.3% of them were multidrug-resistant (MDR) and a majority had serotype 19F. This study showed ST236 was the most predominant sequence type (ST) among piliated isolates, which was related to PMEN clone Taiwan19F-14 (CC271). In the phylogenetic analysis, the piliated isolates were grouped into three major clades supported with 100% bootstrap values. Most piliated isolates belonged to internationally disseminated clones of S. pneumoniae, but pneumococcal conjugate vaccines (PCVs) have the potential to control them.
  17. Karbwang J, Koonrungsesomboon N, Torres CE, Jimenez EB, Kaur G, Mathur R, et al.
    BMC Med Ethics, 2018 09 15;19(1):79.
    PMID: 30219106 DOI: 10.1186/s12910-018-0318-x
    BACKGROUND: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.

    METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).

    RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).

    CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

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