National Medical Research Register Research Articles

First 100 Reported Cases of Supine Percutaneous Nephrolithotomy in Malaysia: An Alternative Effective and Safe Approach to Treat Renal Stones.

Supine percutaneous nephrolithotomy (s-PCNL) offers great benefits from urological and anaesthetic points of view. We present the first evaluation of the outcomes of s-PCNL in Malaysia. Our aim was to explore the safety and efficacy of s-PCNL. Institutional review board approval was obtained from the National Medical Research Register (NMRR ID-21002225-WLP). We retrospectively reviewed 115 patients with renal pelvis stones who underwent single renal access during s-PCNL between November 2020 and May 2023. Patients who underwent simultaneous ipsilateral or contralateral endourological procedures were included. The data were analysed to determine stone-free rates (SFR), major complication rates, blood transfusion rates, operative times and lengths of hospital stay (LOS). The SFR was higher for the single middle calyceal renal access (MCA) group than for the lower calyceal renal access (LCA) or upper calyceal renal access (UCA) groups (OR: 1.76; 95% confidence interval [CI]: 0.63, 4.92). In total, 0, 1 and 2 patients had major complications in the UCA, MCA and LCA groups, respectively (P = 0.453). One of the 115 patients (0.9%) needed blood transfusion. Subgroup analysis revealed mean operative times of 76.3 min and 78.6 min for patients who underwent sole s-PCNL (PCNL-only group) and those who had simultaneous ipsilateral and contralateral endourological procedures (PCNL-plus group), respectively (P = 0.786). The overall mean LOS was 2.9 days. s-PCNL is a safe and effective alternative treatment for renal stones. We would recommend s-PCNL for patients who require an ipsilateral/contralateral endourological procedure (URS/RIRS) because it is time-efficient. All renal accesses are safe. Single MCA is recommended for complete stone clearance.

Home-based circuit training improves blood lipid profile, liver function, musculoskeletal fitness, and health-related quality of life in overweight/obese older adult patients with knee osteoarthritis and type 2 diabetes: a randomized controlled trial during the COVID-19 pandemic

BackgroundThere is strong evidence showing the association between obesity, type 2 diabetes mellitus (T2DM), and knee pain resulting from osteoarthritis. Regular exercise has been reported as a foundational piece of the preventive therapy puzzle for knee osteoarthritis (KOA) patients. Nonetheless, evidence-based exercise protocols for people with comorbidities, such as obesity, T2DM, and KOA are limited. Therefore, the present trial aimed to assess the effectiveness of a 12-week home-based circuit training (HBCT) protocol on various indices related to cardiometabolic health, musculoskeletal fitness, and health-related quality of life (HRQoL) among overweight/obese older adult patients with KOA and T2DM during the COVID-19 lockdown.MethodsThis is a randomized controlled trial study registered at the National Medical Research Register (ID: RSCH ID-21-01180-KGTNMRR ID-21-02367-FUM) and obtained approval on December 9, 2021. Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a 12-week progressive protocol (seven exercises; 15–30 repetitions per exercise, 1 min passive rest between exercises; 2–4 rounds per session; 20–60 min total session duration). Blood samples were collected, and assays were performed to assess the lipid profile, liver function, and fasting blood glucose (FBG). In addition, the 30-s Chair Stand Test (30CST) was used to evaluate lower body muscular strength and endurance while the Timed Up and Go (TUG) test was used to evaluate lower limb function, mobility, and the risk of falls for all the participants. HRQoL was assessed using the Osteoarthritis Knee and Hip Quality of Life (OAKHQoL). All the assessments were conducted at pre-, mid-, and post-training stages during the application or practice of the exercise protocol, rather than during the training sessions themselves.ResultsHBCT significantly reduced total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), aminotransferase, alanine aminotransferase, FBG and knee pain (p < 0.05). Furthermore, HBCT induced meaningful increases in high-density lipoprotein (HDL-C), lower body muscular strength, endurance, function, mobility, and HRQoL in overweight/obese older adults with T2DM and KOA (p < 0.05).ConclusionThe present outcomes recommend that an injury-free HBCT program may improve various indicators related to cardiometabolic health, musculoskeletal fitness, and HRQoL in elderly with overweight/obesity, T2DM and KOA. These findings offer valuable insights for clinicians and practitioners seeking evidence-based exercise interventions tailored for patients managing substantial metabolic and musculoskeletal health challenges in clinical practice.

Overview of Retention Strategies for Medical Doctors in Low- and Middle-Income Countries and Their Effectiveness: Protocol for a Scoping Review.

The global shortage and maldistribution of health care workers, especially medical doctors, pose a significant threat to achieving the United Nations' sustainable development goal 3 of ensuring well-being and healthy lives for all. Low- and middle-income countries (LMICs) are disproportionately affected by this crisis, with a high rate of brain drain from rural to urban areas, as well as to high-income countries. Various retention strategies have been implemented in different settings and organizations. However, their effectiveness remains underexplored, particularly in LMICs. We aim to review the available retention strategies for medical doctors in LMICs and to determine the effectiveness of the various strategies. This review aims to compile relevant research findings on this issue to generate a thorough summary of all the retention strategies practiced in LMICs and, more importantly, to provide the current state of evidence of the effectiveness of these strategies in retaining medical doctors in countries with limited resources and high disease burden. The structured framework given by Arksey and O'Malley will serve as the basis for conducting this scoping review. A comprehensive search strategy will be conducted across 4 electronic databases (PubMed, EBSCOHost, Scopus, and ScienceDirect). A systematic approach following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines will be executed to search, screen, review, and extract data from studies that meet predefined inclusion criteria. Data encompassing bibliographical information, study location, retention strategies, influencing factors, and outcomes (effectiveness) will be obtained from the selected studies using standardized data extraction. Endnote and Microsoft Excel will be used for reference management and removal of duplicate studies. A narrative synthesis will be performed after categorizing and analyzing all the extracted data to identify recurrent themes. This ongoing review will generate a comprehensive compilation of retention strategies implemented in LMICs to prevent brain drain among medical doctors. Data extraction is currently in progress, and completion is expected by early 2024. Themes regarding the types of strategies, influencing factors, and outcomes will be synthesized. The findings will highlight effective retention strategies, gaps, and challenges in implementation for the benefits of future research. By identifying common barriers and facilitators, this review will provide insights into enhancing the policies and initiatives for doctor retention in LMICs. This scoping review explores the retention strategies practiced in LMICs and attempts to identify effective strategies from existing research. By evaluating the barriers and challenges that influence the effectiveness of these strategies, policymakers and health care leaders can strive to obtain balanced and optimal health human resources in their respective organizations and countries. Malaysian National Medical Research Register (NMRR) ID-23-01994-OGW; https://nmrr.gov.my/research-directory/ac4f5b88-8619-4b2b-b6c7-9abcef65fdcd. DERR1-10.2196/52938.

Freehand transperineal prostate biopsy with a coaxial needle under local anesthesia: Experience from a single institution in Malaysia

BackgroundFreehand transperineal prostate biopsy (TPPBx) using a coaxial needle technique offers an alternative to probe-mounted freehand or template-guided techniques in the diagnosis of prostate cancer (PCa). It only requires the same equipment used for transrectal ultrasound-guided (TRUS) biopsy. Our study is the first in Malaysia to report this experience and its outcomes. We aim to determine PCa detection rate and pain tolerability of freehand TPPBx utilizing a coaxial needle under local anesthesia (LA). MethodsInstitutional review board approval was obtained from National Medical Research Register (NMRR ID-21-02052-VIL). We retrospectively reviewed the medical records of patients who underwent TPPBx between August 2020 and April 2022. Records were reviewed for patients’ characteristics, prostate volume, prostate-specific antigen (PSA) results, biopsy results and pain tolerability. Data was analyzed to determine PCa and clinically significant prostate cancer (csPCa) detection rate. LA was achieved using perineal skin infiltration and a periprostatic nerve block. The commonly used standard side-firing transrectal ultrasound with its Prostate Biplane Transducer was used as an imaging guide. The principles of the Ginsburg protocol were followed. Pain tolerability was assessed using a visual analog scale. ResultsA total of 55 patients with elevated PSA levels underwent freehand TPPBx under LA. The mean age was 67.3 years, the median PSA was 14.2 ng/mL, and the median PSA density (PSAD) was 0.33 ng/mL/cc. The optimal PSAD cutoff for predicting csPCa was 0.35 ng/mL/cc (area under the curve [AUC], 0.792; sensitivity, 87.5%; specificity, 69.2%). PCa was detected in 24 patients (43.6%), of whom 16 (29.1%) had csPCa. The median pain scores during LA infiltration and biopsy were four and two, respectively, which were significant different (P < 0.05). TPPBx exhibited an infection rate of zero. ConclusionThe PCa detection rate and patient tolerability of freehand TPPBx using a coaxial needle are similar to those of a contemporary published series. The use of existing equipment that is used for TRUS biopsy allows for widespread use and transition from TRUS biopsy.

Efficacy of telemedicine for the management of cardiovascular disease: a systematic review and meta-analysis

BackgroundTelemedicine has been increasingly integrated into chronic disease management through remote patient monitoring and consultation, particularly during the COVID-19 pandemic. We did a systematic review and meta-analysis of studies reporting effectiveness of telemedicine interventions for the management of patients with cardiovascular conditions.MethodsIn this systematic review and meta-analysis, we searched PubMed, Scopus, and Cochrane Library from database inception to Jan 18, 2021. We included randomised controlled trials and observational or cohort studies that evaluated the effects of a telemedicine intervention on cardiovascular outcomes for people either at risk (primary prevention) of cardiovascular disease or with established (secondary prevention) cardiovascular disease, and, for the meta-analysis, we included studies that evaluated the effects of a telemedicine intervention on cardiovascular outcomes and risk factors. We excluded studies if there was no clear telemedicine intervention described or if cardiovascular or risk factor outcomes were not clearly reported in relation to the intervention. Two reviewers independently assessed and extracted data from trials and observational and cohort studies using a standardised template. Our primary outcome was cardiovascular-related mortality. We evaluated study quality using Cochrane risk-of-bias and Newcastle-Ottawa scales. The systematic review and the meta-analysis protocol was registered with PROSPERO (CRD42021221010) and the Malaysian National Medical Research Register (NMRR-20–2471–57236).Findings72 studies, including 127 869 participants, met eligibility criteria, with 34 studies included in meta-analysis (n=13 269 with 6620 [50%] receiving telemedicine). Combined remote monitoring and consultation for patients with heart failure was associated with a reduced risk of cardiovascular-related mortality (risk ratio [RR] 0·83 [95% CI 0·70 to 0·99]; p=0·036) and hospitalisation for a cardiovascular cause (0·71 [0·58 to 0·87]; p=0·0002), mostly in studies with short-term follow-up. There was no effect of telemedicine on all-cause hospitalisation (1·02 [0·94 to 1·10]; p=0·71) or mortality (0·90 [0·77 to 1·06]; p=0·23) in these groups, and no benefits were observed with remote consultation in isolation. Small reductions were observed for systolic blood pressure (mean difference –3·59 [95% CI –5·35 to –1·83] mm Hg; p<0·0001) by remote monitoring and consultation in secondary prevention populations. Small reductions were also observed in body-mass index (mean difference –0·38 [–0·66 to –0·11] kg/m2; p=0·0064) by remote consultation in primary prevention settings.InterpretationTelemedicine including both remote disease monitoring and consultation might reduce short-term cardiovascular-related hospitalisation and mortality risk among patients with heart failure. Future research should evaluate the sustained effects of telemedicine interventions.FundingThe British Heart Foundation.

Fall determinants in hospitalised older patients: a nested case control design - incidence, extrinsic and intrinsic risk in Malaysia

BackgroundThe older person is at greater risk of falls due to multiple intrinsic and extrinsic factors. This is compounded when the elderly is admitted to hospitals, as they are acutely ill and placed in an unfamiliar environment. Delirium and polypharmacy further complicate these problems. As falls reflect quality of care with potential for grave outcomes, this study aimed to identify the extent and risk of falls in public hospitals.MethodsWe conducted a nested case control study in 12 public hospitals in Malaysia. In the cohort section, we screened all inpatients 60 years of age and above daily until discharge, or the end of the study period. Daily, we identified those who fell, inclusive of near falls, in the preceding 24 h. Our enumerators interviewed patients on experience of fall, and supplemented data from the nurses and caregivers. For each case, ten controls were chosen.ResultsThe incidence of falls/near falls was 1.0 per 1000 patient days (95% CI: 0.9, 1.1). Intrinsic risk factors found to be significant included patients who were not from a nursing home or not cared for by a domestic helper prior to admission, had prior history of indoor fall either in home or hospital, had four or more clinical diagnoses or exited from the bed on the weak side. Significant extrinsic factors were the absence of transfer bar in toilet, call bells, light switches or walking aids that were not within reach, as well as not having a walking aid. Non-sturdy chair was associated with lesser falls than when sturdy chairs with armrests were present.ConclusionQuerying patients for falls produced better results than incident reporting. Several intrinsic factors such as history of indoor or in-hospital fall, having four or more clinical diagnoses or exiting from weaker side and residence history may help to identify those at higher risk. Addressing significant extrinsic factors such as transfer bars and the identification of switches may help in reducing falls risk in hospitals.Trial registrationThis study was registered in National Medical Research Register of Malaysia (NMRR-07-772-1044; date 26/05/2008) with Ethics Approval from Medical Research and Ethics Committee (MREC: MRG-07-LOI-HSR-1).

A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-Alfa) vs. Eprex\xae in patients with anaemia of chronic renal failure

BackgroundErythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage. Biosimilar epoetin is a potential cost-effective alternative to originator for optimal renal anaemia management.ObjectiveTo determine efficacy and safety of PDA10 in treating renal anaemia in haemodialysis patients, in comparison to the originator epoetin-α, Eprex®.MethodsA phase 3, multicentre, multi-national, double-blind, randomised, active-controlled and parallel group study conducted over 40 weeks in Malaysia and Korea. End stage kidney disease patients undergoing regular haemodialysis who were on erythropoietin treatment were recruited. The study has 3 phases, which included a 12-week titration phase, followed by 28-week double-blind treatment phase and 24-week open-label extension phase.ResultsThe PDA10 and Eprex® were shown to be therapeutically equivalent (p < 0.0001) with mean absolute change in haemoglobin from baseline of − 0.176 (± 0.91) g/dl and − 0.118 (± 1.114) g/dl, respectively. Weekly dose change was 10.01 IU/kg/week in PDA10 group and 10.30 IU/kg/week in Eprex® group, which has no significant difference. There were no significant differences in the safety profile between PDA10 and Eprex® groups.ConclusionThis study has confirmed the therapeutic equivalence between PDA10 and Eprex® in terms of efficacy, dosage requirement and safety profile in haemodialysis patients with renal anaemia.Trial registrationThe study was registered with the National Medical Research Register (NMRR-13-400-16313). This study has been registered retrospectively with Clinical Research Information Service (CRiS), Republic of Korea on 25 March 2021.

Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial

In low-income and middle-income countries, affordable direct-acting antivirals are urgently needed to treat hepatitis C virus (HCV) infection. The combination of ravidasvir, a pangenotypic non-structural protein 5A (NS5A) inhibitor, and sofosbuvir has shown efficacy and safety in patients with chronic HCV genotype 4 infection. STORM-C-1 trial aimed to assess the efficacy and safety of ravidasvir plus sofosbuvir in a diverse population of adults chronically infected with HCV. STORM-C-1 is a two-stage, open-label, phase 2/3 single-arm clinical trial in six public academic and non-academic centres in Malaysia and four public academic and non-academic centres in Thailand. Patients with HCV with compensated cirrhosis (Metavir F4 and Child-Turcotte-Pugh class A) or without cirrhosis (Metavir F0-3) aged 18-69 years were eligible to participate, regardless of HCV genotype, HIV infection status, previous interferon-based HCV treatment, or source of HCV infection. Once daily ravidasvir (200 mg) and sofosbuvir (400 mg) were prescribed for 12 weeks for patients without cirrhosis and for 24 weeks for those with cirrhosis. The primary endpoint was sustained virological response at 12 weeks after treatment (SVR12; defined as HCV RNA <12 IU/mL in Thailand and HCV RNA <15 IU/mL in Malaysia at 12 weeks after the end of treatment). This trial is registered with ClinicalTrials.gov, number NCT02961426, and the National Medical Research Register of Malaysia, NMRR-16-747-29183. Between Sept 14, 2016, and June 5, 2017, 301 patients were enrolled in stage one of STORM-C-1. 98 (33%) patients had genotype 1a infection, 27 (9%) had genotype 1b infection, two (1%) had genotype 2 infection, 158 (52%) had genotype 3 infection, and 16 (5%) had genotype 6 infection. 81 (27%) patients had compensated cirrhosis, 90 (30%) had HIV co-infection, and 99 (33%) had received previous interferon-based treatment. The most common treatment-emergent adverse events were pyrexia (35 [12%]), cough (26 [9%]), upper respiratory tract infection (23 [8%]), and headache (20 [7%]). There were no deaths or treatment discontinuations due to serious adverse events related to study drugs. Of the 300 patients included in the full analysis set, 291 (97%; 95% CI 94-99) had SVR12. Of note, SVR12 was reported in 78 (96%) of 81 patients with cirrhosis and 153 (97%) of 158 patients with genotype 3 infection, including 51 (96%) of 53 patients with cirrhosis. There was no difference in SVR12 rates by HIV co-infection or previous interferon treatment. In this first stage, ravidasvir plus sofosbuvir was effective and well tolerated in this diverse adult population of patients with chronic HCV infection. Ravidasvir plus sofosbuvir has the potential to provide an additional affordable, simple, and efficacious public health tool for large-scale implementation to eliminate HCV as a cause of morbidity and mortality. National Science and Technology Development Agency, Thailand; Department of Disease Control, Ministry of Public Health, Thailand; Ministry of Health, Malaysia; UK Aid; Médecins Sans Frontières (MSF); MSF Transformational Investment Capacity; FIND; Pharmaniaga; Starr International Foundation; Foundation for Art, Research, Partnership and Education; and the Swiss Agency for Development and Cooperation.

Knowledge, attitude and practice of Malaysian healthcare professionals toward adverse drug reaction reporting: a systematic review.

Healthcare professionals have an important role in ensuring that adverse drug reactions are well documented and reported. The key determinants of adverse drug reactions reporting are the knowledge, attitude and practice of healthcare professionals. A systematic review of the literature was undertaken to identify, critically evaluate and summarise the findings on the knowledge, attitude and practice of Malaysian healthcare professionals towards adverse drug reaction reporting. Literature search using electronic databases including PubMed, Google Scholar and National Medical Research Register was conducted. Additional articles were identified by reviewing the bibliography of the retrieved articles. The articles were searched with any of the Medical Subject Headings (MeSH) terms in the title: adverse drug reaction, attitude, awareness, behaviour, experience, knowledge, Malaysia, perspectives, pharmacovigilance, practice and view. Studies were selected based on fulfilment of inclusion and exclusion criteria. The articles were scrutinised using thematic analysis. Nine studies conducted among doctors, pharmacists and nurses met the inclusion criteria. Five themes emerged which included knowledge, attitude, practice, barriers and facilitators of adverse drug reaction reporting among healthcare professionals. In general, healthcare professionals in Malaysia have good knowledge on and positive attitudes towards adverse drug reaction reporting. However, the practice of adverse drug reaction reporting was found to be unsatisfactory among healthcare professional in Malaysia. The approaches taken to enhance ADR reporting among Malaysian healthcare professionals should focus on alleviating lethargy and ignorance associated with ADR reporting.

Efficacy and Safety of Ravidasvir Plus Sofosbuvir in Chronic Hepatitis C Infected Subjects Without Cirrhosis or with Compensated Cirrhosis: Interim Analysis Results of a Two-Stage, Open-Label, Multicentre, Phase 2/3 Trial

Background: In low- and middle-income countries, affordable direct-acting antivirals are urgently needed to treat hepatitis C virus (HCV) infection. The combination of ravidasvir, a pangenotypic NS5A inhibitor, and sofosbuvir has shown efficacy and safety in chronically HCV infected patients with genotype (GT) 4. The STORM-C-1 trial aims to assess the efficacy and safety of sofosbuvir plus ravidasvir in a more diverse population of adults chronically infected with HCV. Methods: STORM-C-1 is a two-stage, open-label, multicentre clinical trial in Malaysia and Thailand. HCV infected subjects with compensated cirrhosis (Metavir F4 and Child-Turcotte-Pugh class A) or without cirrhosis (Metavir F0-F3) were eligible to participate, regardless of HCV genotype, HIV infection status, prior interferon-based HCV treatment or source of HCV infection. Stage 1 results are reported here. Once-daily ravidasvir (200mg) and sofosbuvir (400mg) were prescribed for 12 (without cirrhosis) or 24 (with cirrhosis) weeks. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12). This trial is registered with ClinicalTrials.gov: NCT02961426 and the National Medical Research Register of Malaysia NMRR-16-747-29183. Findings: Between October 2016 and June 2017, 301 subjects were enrolled and 300 included in the full analysis set: 97 with GT1a, 27 GT1b, 2 GT2, 158 GT3, and 16 GT6; 81 (27%) had compensated cirrhosis; 90 (30%) had HIV co-infection; and 99 (33%) had prior interferon-based treatment. 291/300 subjects (97%, 95% CI 94%-99%) achieved SVR12. Three subjects prematurely discontinued study treatment due to adverse events. There were no deaths or treatment discontinuations due to the study drugs. Interpretation: In this first stage, ravidasvir plus sofosbuvir was found to be highly effective and well tolerated in all subgroups of this diverse adult population chronically infected with HCV. Trial Registration Number: This trial is registered with ClinicalTrials.gov: NCT02961426 and the National Medical Research Register of Malaysia NMRR-16-747-29183. Funding: Drugs for Neglected Diseases initiative; National Science and Technology Development Agency, Thailand; Department of Disease Control, Ministry of Public Health, Thailand; Ministry of Health, Malaysia. Conflict of Interest: Dr. Avihingsanon reports grants from National Science and Technology Development Agency (NSTDA) during the conduct of the study, and also from ViiV Healthcare outside of thesubmitted work. Tim Cressey and Nicolas Salvadori report a service agreement with DNDi.Isabelle Andrieux-Meyer, Caroline Menetrey, Francois Simon, Jean-Michel Piedagnel,Sasikala Siva, Alistair Swanson, Francois Bompart, Vishal Goyal, and Bernard Pecoul are employed by the Drugs for Neglected Diseases initiative. All other authors do not report any potential conflicts of interest. Ethical Approval: The initial protocol and all protocol amendments were reviewed and approved before implementation by the applicable individual institutional or national ethics committees. All subjects provided written informed consent.

Clinical Characteristics and Risk Factors for Severe COVID-19 infections in Malaysia

Background: COVID-19 emerged as a major public health outbreak in China in late 2019. Malaysia reported its first imported case on 25 January 2020, and adopted a policy of extensive contact tracing and hospitalizing of all patients, regardless of severity. We describe clinical characteristics of COVID-19 patients nationwide and determine the risk factors associated with disease severity. Method: Clinical records of all RT-PCR confirmed COVID-19 patients admitted to 18 designated hospitals in Malaysia between 1 February and 30 April 2020 with complete outcomes were retrieved. Epidemiological history, co-morbidities, clinical features, investigations, management and complications were captured using REDCap database. Variables were compared among patients with mild and severe diseases. Univariate and multivariate regression analyses were used to identify determinants for disease severity. Findings:The sample comprised of 5889 cases (median age 34 years, male 71·7%). Majority were mild (92%) and 3·3% required intensive care with 80% admitted within the first 5 days. Older age (> 51 years), fever, cough, diarrhoea, breathlessness, tachypnoea, abnormal chest radiographs and high serum CRP (≥5mg/dL) on admission were significant determinants for disease severity (p < 0·05). The case fatality rate was 1·2% and the three commonest complications were liver injuries (6·7%), kidney injuries (4%), and acute respiratory distress syndrome (2·3%). Interpretations: Lower case fatality rate was contributed by young patients with mild presenting COVID-19 and early hospitalisation. Abnormal chest radiographic findings in symptomatic elderly with tachypnoea require close monitoring in first 5 days to detect early deterioration. Funding Statement: Supported by NIH, Malaysia Declaration of Interests: None to declare. Ethics Approval Statement: The study was registered with the National Medical Research Register (NMRR-20-580- 54339) and approved by the Medical Research and Ethics Committee, Ministry of Health, Malaysia (KKM/NIHSEC/P20-706).

A qualitative study on the implementation of family health team: the perspectives of providers and patients

BackgroundMalaysia has committed to the global call to achieve universal health coverage, and with the adoption of Sustainable Development Goals, is further strengthening the health system through the primary health care services, particularly the family doctor concept. The Enhanced Primary Health Care (EnPHC) initiative was implemented to address the worrying upward trend of non-communicable disease prevalence, and incorporates the Family Health Team (FHT) concept. The aim of this paper is to describe the implementation of the FHT as part of the EnPHC intervention.MethodsIn-depth interviews and focus group discussions were conducted with the intervention design team, healthcare providers and patients in two rounds during the implementation period. A total of 121 individuals in the two rounds, split into different groups, where some of the participants of the FGD were also interviewed individually. Data were analysed using a thematic analysis, with codes being organised into larger themes.ResultsThemes that emerged from the data were around the process of FHT implementation and the advantages of the FHT, which included continuity of health care and improved quality of care. Patients and health care providers were receptive to the FHT concept, and took the effort to adapt the concept in the local settings.ConclusionsThe FHT concept implemented at 20 public primary health clinics has benefits appreciated by health care providers and patients. Addressing the viable shortcomings would better prepare the current primary healthcare system to scale up the FHT concept nationwide and enhance its feasibility and sustainability.Trial registrationThe study is registered with the National Medical Research Register, Ministry of Health Malaysia (NMRR-17-295-34711).

How young children learn independent asthma self-management: a qualitative study in Malaysia

ObjectiveWe aimed to explore the views of Malaysian children with asthma and their parents to enhance understanding of early influences on development of self-management skills.DesignThis is a qualitative study conducted...

Creation of consensus recommendations for collaborative practice in the Malaysian psychiatric system: a modified Delphi study

BackgroundThere is strong evidence that collaborative practice in mental healthcare improves outcomes for patients. The concept of collaborative practice can include collaboration between healthcare workers of different professional backgrounds and collaboration with patients, families and communities. Most models of collaborative practice were developed in Western and high-income countries and are not easily translatable to settings which are culturally diverse and lower in resources. This project aimed to develop a set of recommendations to improve collaborative practice in Malaysia.MethodsIn the first phase, qualitative research was conducted to better understand collaboration in a psychiatric hospital (previously published). In the second phase a local hospital level committee from the same hospital was created to act on the qualitative research and create a set of recommendations to improve collaborative practice at the hospital for the hospital. Some of these recommendations were implemented, where feasible and the outcomes discussed. These recommendations were then sent to a nationwide Delphi panel. These committees consisted of healthcare staff of various professions, patients and carers.ResultsThe Delphi panel reached consensus after three rounds. The recommendations include ways to improve collaborative problem solving and decision making in the hospital, ways to improve the autonomy and relatedness of patients, carers and staff and ways to improve the levels of resources (e.g. skills training in staff, allowing people with lived experience of mental disorder to contribute).ConclusionsThis study showed that the Delphi method is a feasible method of developing recommendations and guidelines in Malaysia and allowed a wider range of stakeholders to contribute than traditional methods of developing guidelines and recommendations.Trial registration Registered in the National Medical Research Register, Malaysia, NMRR-13-308-14792

Prevalence and risk factors of postpartum depression, general depressive symptoms, anxiety and stress (PODSAS) among mothers during their 4-week postnatal follow-up in five public health clinics in Perak: A study protocol for a cross-sectional study.

IntroductionPostpartum depression, general depressive symptoms, anxiety and stress (PODSAS) are often overlooked, and may cause morbidity to new mothers, their babies and families. This study aims to determine the point prevalence of depression (post partum and general), anxiety and stress among mothers in five public health clinics in Perak at 4 weeks postdelivery and identify their associated risk factors. Findings from this study will be used to identify the needs for early screening and detection, encourage development of interventions to reduce its occurrence and support mothers with PODSAS.Methods and analysisThis cross-sectional study will recruit 459 postpartum mothers during their 4-week postnatal follow-up in five selected public health clinics in Perak from September 2019 to May 2020. Participants will be mothers aged 18 years and above at 4 weeks postdelivery who are able to understand the English and Malay languages. Non-Malaysians and mothers with known diagnosis of psychotic disorders will be excluded from the study. Sociodemographic information and possible risk factors of the participants will be captured via a set of validated questionnaires, postpartum depression (PPD) will be measured using the Edinburgh Postpartum Depression Scale questionnaire and general depressive symptoms, anxiety and stress will be measured using the 21-item Depression, Anxiety and Stress Scale. Data analysis will be conducted using SPSS V.25.0 (IBM). Besides descriptive statistics, multivariable regression analyses will be done to identify possible risk factors and their independent associations with depression (PPD and general depressive symptoms, combined and separately), anxiety and stress.Ethics and disseminationThe study protocol was reviewed and approved by the Medical Research Ethics Committee, Ministry of Health Malaysia on 7 August 2019. Results of this study will be reported and shared with the local health stakeholders and disseminated through conference proceedings and journal publications.Registration numberThis study is registered in the Malaysian National Medical Research Register with the ID: NMRR-19-868-47647

Clinical Characteristics and Risk Factors for Severity of COVID-19 Infections in Malaysia

Background: COVID-19 emerged as a major public health outbreak in China in late 2019. Malaysia reported its first imported case on 25 January 2020, and adopted a policy of extensive contact tracing and hospitalizing of all patients, regardless of severity. We describe clinical characteristics of COVID-19 patients nationwide and determine the risk factors associated with disease severity.Method: Clinical records of all RT-PCR confirmed COVID-19 patients admitted to 18 designated hospitals in Malaysia between 1 February and 30 April 2020 with complete outcomes were retrieved. Epidemiological history, co-morbidities, clinical features, investigations, management and complications were captured using REDCap database. Variables were compared among patients with mild and severe diseases. Univariate and multivariate regression analyses were used to identify determinants for disease severity.Findings:The sample comprised of 5889 cases (median age 34 years, male 71·7%). Majority were mild (92%) and 3·3% required intensive care with 80% admitted within the first 5 days. Older age (> 51 years), fever, cough, diarrhoea, breathlessness, tachypnoea, abnormal chest radiographs and high serum CRP (≥5mg/dL) on admission were significant determinants for disease severity (p Interpretations: Lower case fatality rate was contributed by young patients with mild presenting COVID-19 and early hospitalisation. Abnormal chest radiographic findings in symptomatic elderly with tachypnoea require close monitoring in first 5 days to detect early deterioration.Funding Statement: Supported by NIH, MalaysiaDeclaration of Interests: None to declare.Ethics Approval Statement: The study was registered with the National Medical Research Register (NMRR-20-580- 54339) and approved by the Medical Research and Ethics Committee, Ministry of Health, Malaysia (KKM/NIHSEC/P20-706).

Induction of labor compared to expectant management in term nulliparas with a latent phase of labor of more than 8\u2009hours: a randomized trial

BackgroundProlonged latent phase of labor is associated with adverse maternal and neonatal outcomes. Preliminary data indicate that labor induction for prolonged latent phase may reduce cesarean delivery. We performed a study powered to Cesarean delivery to evaluate labor induction compared to expectant management in full term nulliparas hospitalized for persistent contractions but non-progressive to established labor after an overnight stay.MethodsFrom 2015 and 2017, nulliparas, ≥ 39 weeks’ gestation with prolonged latent phase of labor (persistent contractions after overnight hospitalization > 8 h), cervical dilation ≤3 cm, intact membranes and reassuring cardiotocogram were recruited. Participants were randomized to immediate induction of labor (with vaginal dinoprostone or amniotomy or oxytocin as appropriate) or expectant management (await labor for at least 24 h unless indicated intervention as directed by care provider). Primary outcome measure was Cesarean delivery.ResultsThree hundred eighteen women were randomized (159 to each arm). Data from 308 participants were analyzed. Cesarean delivery rate was 24.2% (36/149) vs. 23.3%, (37/159) RR 1.0 95% CI 0.7–1.6; P = 0.96 in induction of labor vs. expectant arms. Interval from intervention to delivery was 17.1 ± 9.9 vs. 40.1 ± 19.8 h; P < 0.001, intervention to active labor 9.6 ± 10.2 vs. 29.6 ± 18.5 h; P < 0.001, active labor to delivery 7.6 ± 3.6 vs. 10.5 ± 7.2 h; P < 0.001, intervention to hospital discharge 2.4 ± 1.2 vs. 2.9 ± 1.4 days; P < 0.001 and dinoprostone use was 19.5% (29/149) vs. 8.2% (13/159) RR 2.4 95% CI 1.3–4.4; P = 0.01 in IOL compared with expectant arms respectively. Intrapartum oxytocin use, epidural analgesia and uterine hyperstimulation syndrome, postpartum hemorrhage, patient satisfaction on allocated intervention, during labor and delivery and baby outcome were not significantly different across trial arms.ConclusionsInduction of labor did not reduce Cesarean delivery rates but intervention to delivery and to hospital discharge durations are shorter. Patient satisfaction scores were similar. Induction of labor for prolonged latent phase of labor can be performed without apparent detriment to expedite delivery.Trial registrationRegistered in Malaysia National Medical Research Register (NMRR-15-16-23,886) on 6 January 2015 and the International Standard Randomised Controlled Trials Number registry, registration number ISRCTN14099170 on 5 Nov 2015.

An Analysis of the Quality Of Life among Diabetic Foot Ulcer Patients in Kuantan, Pahang

Introduction: Foot ulcer is one of the most serious complications associated with diabetes mellitus that mat resulted in a disability and impairment of health related quality of life. Materials and Methods: The main objective of this cross-sectional study was to determine the factors adversely associated with quality of life among diabetic foot ulcer patients. Diabetic patients with evidence of diabetic foot ulcer attending outpatient orthopaedics and general surgical clinic of Hospital Tengku Ampuan Afzan were recruited into this study. A set of validated SF-36 questionnaire was employed to evaluate the health-related quality of life for each patient. This study was registered with the National Medical Research Register (NMRR registration no. 17-1520-36332). Results: There is a slightly higher proportion of female among the 104 respondents. Its prevalence is most pronounces in the lower income group. Majority presented with Wagner stage 2 and 3. Amputation has been performed in 54% of these patients. Physical health score fair worse than mental health. Age, low socioeconomic status, presence of comorbidities, major amputation, ulcer at the forefoot and wheelchair usage associated with an adverse effect on the physical health aspect in these patients. Interestingly, smoker seems to score better on the mental health aspect of the quality of life. Conclusion: Diabetic foot ulcer affected physical health aspect much more than mental health aspect within the context of the quality of life.

Prevalence of Lower Extremity Peripheral Arterial Disease among Diabetic Patients and Its Relationship with Quality Of Life (QOL) In Primary Care: A Single Centre Experience

Introduction: Peripheral Occlusive Arterial Disease (POAD) is an important cardiovascular morbidity especially among diabetics. The goal of the treatment is to improve patients’ quality of life (QoL) starting by quantifying the disease burden in our population especially among high risk group such as diabetics. Materials and Methods: This cross-sectional study aims to provide a data on the prevalence of POAD among diabetic population in a primary health care in Kuantan and its’ effects on the patient’s QoL. Additionally, we examined for any other stipulated associated factors that may have contributed towards the development of POAD. We applied a universal sampling for the purpose of patient selection. POAD is universally defined as ankle-brachial index (ABI) of lower than 0.9. Individuals were assessed on validated Malay version of WHOQOL BREF to assess their QoL parameters. P value of &lt;0.05 considered as statistically significant. This study was registered with the National Medical Research Register (NMRR registration no. 17-1375-35710). Results: The prevalence of PAD among diabetic patients in Klinik Kesihatan (Local General Practitioner) Jaya Gading, Kuantan was found to be 20%. We found a significant relationship between lower levels of education (p = 0.016), older age group (p = 0.02) and lower economic class (p = 0.03) with the presence of POAD among diabetics. The presence of POAD has a significant adverse effect on QoL evidenced by lower Physical Domain (p=0.001), Psychological Domain (p=0.066), Social Domain (p=0.005), and Environmental Domain (p=0.027) scores using validated WHOQOL BREF questionnaires. Conclusion: The significant prevalence of POAD among diabetics prompts a greater urgency for early detection to prevent the development of its’ associated morbidity and deterioration of their QoL.

Environmental management for dengue control: a systematic review protocol

IntroductionDengue is among the most important mosquito-borne diseases, with more than half of the world’s population at risk of infection in dengue endemic countries. Environmental management, which includes any activities...