METHODS AND ANALYSIS: The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional and cognitive state, compliance, concomitant medications, and side effects, if any, among patients on NeuroAiD. Patients who are taking or have been prescribed NeuroAiD may be included. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialisation of NeuroAiD) and during subsequent visits. The primary outcome assessed is safety (ie, non-serious and serious adverse event), while compliance and neurological status over time are secondary outcomes. The in-person follow-up assessments are timed with clinical appointments. Anonymised data will be extracted and collectively analysed. Initial target sample size for the registry is 2000. Analysis will be performed after every 500 participants entered with completed follow-up information.
ETHICS AND DISSEMINATION: Doctors who prescribe NeuroAiD will be introduced to the registry by local partners. The central coordinator of the registry will discuss the protocol and requirements for implementation with doctors who show interest. Currently, the registry has been approved by the Ethics Committees of Universiti Kebangsaan Malaysia (Malaysia) and National Brain Center (Indonesia). In addition, for other countries, Ethics Committee approval will be obtained in accordance with local requirements.
TRIAL REGISTRATION NUMBER: NCT02536079.
METHODS: This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization.
RESULTS: A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics.
CONCLUSIONS: The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.
BACKGROUND: The burden of noncommunicable diseases has increased globally, and it has negatively affected the QoL of diabetic patients.
METHODS: A quasi-experimental study was conducted by including 77 T2DM patients selected from 2 public health centers in Thailand. The respondents were randomly selected 38 in control group and 39 in intervention group. Pretested, piloted, and validated tool were used during this study. Knowledge on blood glucose level, stress, and QoL was measured at baseline and then compared to end line after 3 months of the intervention. The effects of intervention were estimated by regression coefficient of intervention on blood glucose level and QoL. The study was ethically approved by the Chulalongkorn University, Thailand.
FINDINGS: Baseline characteristics of both the groups were similar before the start of the intervention and there were no significant differences observed in age, education, blood sugar monitoring behavior, medical checkup, knowledge, self-care, stress, and hemoglobin HbA1c (>0.05). However, blood HbA1c, stress level, and QoL among the T2DM patients had significant changes (<0.05) after the intervention. The control group was remained same and there was no statistically significant difference reported (>0.05).
CONCLUSIONS: The study concluded that the designed intervention of DSME has proved effective in lowering the blood sugar level, HbA1c level, stress level, and improved QoL among T2DM patients during this limited period of time. Hence, policy-makers can replicate this intervention for diabetic patients in a similar context.
OBJECTIVE: The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.
METHODS: Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.
RESULTS: The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.
CONCLUSIONS: SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.
TRIAL REGISTRATION: Clinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG).
METHODS: 192 patients with MTBI and ICH were treated between November 2019 to December 2020 at a single level II trauma center. The Glasgow Coma Scale (GCS) was used to classify MTBI, and initial head CT was performed according to the Canadian CT head rule. Patients with a higher risk of ICH progression, including the elderly (≥65 years old), patients on antiplatelets or anticoagulants, or patients with an initial head CT that revealed EDH, contusional bleeding, or SDH > 5 mm, and multiple ICH underwent a repeat head CT within 12 to 24 h later. Data regarding types of intervention, length of stay in the hospital, and outcome were collected. The risk of further neurological deterioration and readmission rates were compared between these two groups. All patients were followed up in the clinic after one month or contacted via phone if they did not return.
RESULTS: 189 patients underwent scheduled repeated head CT, 18% had radiological intracranial bleed progression, and 82% had no changes. There were no statistically significant differences in terms of intervention rate, risk of neurological deterioration in the future, or readmission between them.
CONCLUSION: Repeat head CT in mild TBI patients with no neurological deterioration is not recommended, even in patients with a higher risk of ICH progression.