Displaying publications 21 - 26 of 26 in total

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  1. Croci DM, Dalolio M, Aghlmandi S, Taub E, Rychen J, Chiappini A, et al.
    Neurol Res, 2021 Jan;43(1):40-53.
    PMID: 33106124 DOI: 10.1080/01616412.2020.1819091
    Objective: Early permanent cerebrospinal fluid (CSF) diversion for hydrocephalus during the first 2 weeks after aneurysmal subarachnoid hemorrhage (aSAH) shortens the duration of external ventricular drainage (EVD) and reduces EVD-associated infections (EVDAI). The objective of this study was to detect any association with symptomatic delayed cerebral vasospasm (DCVS), or delayed cerebral ischemia (DCI) by the time of hospital discharge. Methods: We used a single-center dataset of aSAH patients who had received a permanent CSF diversion. We compared an 'early group' in which the procedure was performed up to 14 days after the ictus, to a 'late group' in which it was performed from the 15th day onward. Results: Among 274 consecutive aSAH patients, 39 (14%) had a permanent CSF diversion procedure with a silver-coated EVD. While the blood clot burden was similarly distributed, patients with early permanent CSF diversion (20 out of 39; 51%) had higher levels of consciousness on admission. Early permanent CSF diversion was associated with less colonized catheter, a shorter duration of extracorporeal CSF diversion (OR 0.73, 95%CI 0.58-0.92 per EVD day), and a lower rate of EVDAI (OR 0.08, 95%CI 0.01-0.80). The occurrence of CSF diversion device obstruction, the rate of symptomatic DCVS or detected DCI on computed tomography and the likelihood of a poor outcome at discharge did not differ between the two groups. Discussion: Early permanent CSF diversion lowers the occurrence of catheter colonization and infectious complication without affecting DCVS-related morbidity in good-grade aSAH patients. These findings need confirmation in larger prospective multicenter cohorts. Abbreviations: aSAH: aneurysmal subarachnoid hemorrhage; BNI: Barrow Neurological Institute Scale; CSF: Cerebrospinal fluid; DCVS: Delayed Cerebral Vasospasm; DCI: Delayed Cortical Ischemia; EKNZ: Ethik-Kommission Nordwest Schweiz; EVD: External ventricular drain; EVDAI: External ventricular drain-associated infections; GCS: Glasgow Coma Scale; IRB: Institutional Review Board; IVH: Inraventricular hemorrhage; mRS: Modified Rankin Scale; SOS: Swiss Study of Subarachnoid Hemorrhage Registry; WFNS: World Federation Neurological-Surgeon Scale.
    Matched MeSH terms: Ethics Committees, Research
  2. Bakrin FS, Makmor-Bakry M, Che Hon WH, Faizal SM, Manan MM, Ming LC
    Pharmacy (Basel), 2020 Dec 08;8(4).
    PMID: 33302438 DOI: 10.3390/pharmacy8040235
    INTRODUCTION: Drug utilization of analgesics in a private healthcare setting is useful to examine their prescribing patterns, especially the newer injectable cyclooxygenase (COX)-2 inhibitors (coxibs).

    OBJECTIVES: To evaluate the utilization of coxibs and traditional nonsteroidal anti-inflammatory drugs (tNSAIDs) indicated for postoperative orthopaedic pain control using defined daily dose (DDD) and ratio of use density to use rate (UD/UR).

    METHOD: A retrospective drug utilization review (DUR) of nonsteroidal anti-inflammatory drugs (NSAIDs) at an inpatient department of a private teaching hospital in Seremban, Malaysia was conducted. Patients' demographic characteristics, medications prescribed, clinical lab results, visual analogue scale (VAS) pain scores and length of hospital stay were documented. Orthopaedic surgeries, namely arthroscopy, reconstructive, and fracture fixation, were included. Stratified random sampling was used to select patients. Data were collected through patients' medical records. The DDD per 100 admissions and the indicator UD/UR were calculated with the World Health Organization's DDD as a benchmark. The inclusion criteria were patients undergoing orthopaedic surgery prescribed with coxibs (celecoxib capsules, etoricoxib tablets, parecoxib injections) and tNSAIDs (dexketoprofen injections, diclofenac sodium tablets). Data were analysed descriptively. This research was approved by the academic institution and the hospital research ethics committee.

    RESULT: A total of 195 records of patients who received NSAIDs were randomly selected among 1169 cases. In term of the types of orthopaedic surgery, the ratio of included records for arthroscopy:fracture fixation:reconstructive surgery was 55.4:35.9:8.7. Most of the inpatients had low rates of common comorbidities such as cardiovascular disease as supported by their baseline parameters. The majority were not prescribed with other concomitant prescriptions that could cause drug interaction (74.9%), or gastroprotective agents (77.4%). Overall, DDDs per 100 admissions for all NSAIDs were less than 100, except for parecoxib injections (389.23). The UD/UR for all NSAIDs were less than 100, except for etoricoxib tablets (105.75) and parecoxib injections (108.00).

    DISCUSSION: As per guidelines, the majority (96.9%) received other analgesics to ensure a multimodal approach was carried out to control pain. From the UD/UR results, the arthroscopy surgery was probably the most appropriate in terms of NSAID utilization.

    CONCLUSION: The prescribing pattern of NSAIDs except parecoxib was appropriate based on adverse effect and concurrent medication profile. The findings of this DUR provide insight for a low-risk patient population at a private specialized teaching hospital on the recommended use of NSAIDs for postoperative orthopaedic pain control.

    Matched MeSH terms: Ethics Committees, Research
  3. Naqvi AA, Mahmoud MA, AlShayban DM, Alharbi FA, Alolayan SO, Althagfan S, et al.
    Saudi Pharm J, 2020 Sep;28(9):1055-1061.
    PMID: 32922135 DOI: 10.1016/j.jsps.2020.07.005
    Purpose: The study aimed to translate and validate the Arabic version of General Medication Adherence Scale (GMAS) in Saudi patients with chronic diseases.

    Methods: A multi-center cross sectional study was conducted for a month in out-patient wards of hospitals in Khobar, Dammam, Makkah, and Madinah, Saudi Arabia. Patients were randomly selected from a registered patient pools at hospitals and the item-subject ratio was kept at 1:20. The tool was assessed for factorial, construct, convergent, known group and predictive validities as well as, reliability and internal consistency of scale were also evaluated. Sensitivity, specificity, and accuracy were also evaluated. Data were analyzed using SPSS v24 and MedCalc v19.2. The study was approved by concerned ethics committees (IRB-129-25/6/1439) and (IRB-2019-05-002).

    Results: A total of 282 responses were received. The values for normed fit index (NFI), comparative fit index (CFI), Tucker Lewis index (TLI) and incremental fit index (IFI) were 0.960, 0.979, 0.954 and 0.980. All values were >0.95. The value for root mean square error of approximation (RMSEA) was 0.059, i.e., <0.06. Hence, factorial validity was established. The average factor loading of the scale was 0.725, i.e., >0.7, that established convergent validity. Known group validity was established by obtaining significant p-value <0.05, for the associations based on hypotheses. Cronbach's α was 0.865, i.e., >0.7. Predictive validity was established by evaluating odds ratios (OR) of demographic factors with adherence score using logistic regression. Sensitivity was 78.16%, specificity was 76.85% and, accuracy of the tool was 77.66%, i.e., >70%.

    Conclusion: The Arabic version of GMAS achieved all required statistical parameters and was validated in Saudi patients with chronic diseases.

    Matched MeSH terms: Ethics Committees, Research
  4. Ng SC, Kaplan GG, Tang W, Banerjee R, Adigopula B, Underwood FE, et al.
    Am J Gastroenterol, 2019 01;114(1):107-115.
    PMID: 30177785 DOI: 10.1038/s41395-018-0233-2
    INTRODUCTION: Living in an urban environment may increase the risk of developing inflammatory bowel disease (IBD). It is unclear if this observation is seen globally. We conducted a population-based study to assess the relationship between urbanization and incidence of IBD in the Asia-Pacific region.

    METHODS: Newly diagnosed IBD cases between 2011 and 2013 from 13 countries or regions in Asia-Pacific were included. Incidence was calculated with 95% confidence interval (CI) and pooled using random-effects model. Meta-regression analysis was used to assess incidence rates and their association with population density, latitude, and longitude.

    RESULTS: We identified 1175 ulcerative colitis (UC), 656 Crohn's disease (CD), and 37 IBD undetermined (IBD-U). Mean annual IBD incidence per 100 000 was 1.50 (95% CI: 1.43-1.57). India (9.31; 95% CI: 8.38-10.31) and China (3.64; 95% CI, 2.97-4.42) had the highest IBD incidence in Asia. Incidence of overall IBD (incidence rate ratio [IRR]: 2.19; 95% CI: 1.01-4.76]) and CD (IRR: 3.28; 95% CI: 1.83-9.12) was higher across 19 areas of Asia with a higher population density. In China, incidence of IBD (IRR: 2.37; 95% CI: 1.10-5.16) and UC (IRR: 2.63; 95% CI: 1.2-5.8) was positively associated with gross domestic product. A south-to-north disease gradient (IRR: 0.94; 95% CI: 0.91-0.98) was observed for IBD incidence and a west-to-east gradient (IRR: 1.14; 95% CI: 1.05-1.24) was observed for CD incidence in China. This study received IRB approval.

    CONCLUSIONS: Regions in Asia with a high population density had a higher CD and UC incidence. Coastal areas within China had higher IBD incidence. With increasing urbanization and a shift from rural areas to cities, disease incidence may continue to climb in Asia.

    Matched MeSH terms: Ethics Committees, Research
  5. Kaur S, Balan S
    Theor Med Bioeth, 2015 Oct;36(5):341-61.
    PMID: 26438122 DOI: 10.1007/s11017-015-9339-3
    The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.
    Matched MeSH terms: Ethics Committees, Research/standards; Ethics Committees, Research/trends; Ethics Committees, Research/ethics*
  6. Ting CY, Adruce SAZ, Hassali MA, Ting H, Lim CJ, Ting RS, et al.
    Trials, 2019 05 10;20(1):267.
    PMID: 31077233 DOI: 10.1186/s13063-019-3348-x
    After publication of the original article [1], the authors have notified us that there are changes to the primary outcome of the study, instrument, subject's inclusion criteria, the funding and acknowledgements. These changes were made during the recruitment of participants and after approved by the Medical Research and Ethics Committee (MREC), National Institutes of Health Malaysia, on 16th November 2018.
    Matched MeSH terms: Ethics Committees, Research
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