ORCID Profile
0000-0002-2538-9433
Current Organisation
University of Tasmania
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Publisher: Hindawi Limited
Date: 13-03-2013
DOI: 10.1111/JCPT.12048
Abstract: Prescribing sulfonamide-containing medications for patients with sulfonamide allergy continues to complicate medical decisions. We examined the cautionary recommendations in the approved drug monographs and primary literature, and formulated an evidence-based grading of cautionary recommendations for sulfonamide allergy and cross-reactivity among sulfonamide-containing medications. Drug monographs were collected from six countries and three drug compendia. Two reviewers independently extracted the data from the contraindication, warning and/or precaution sections of drug monographs. Evidence for cross-reactivity was examined in the primary literature and compared with drug monograph recommendations. Consequently, medications were categorized based on the strength of recommendation and level of evidence by consensus. We identified wide variability in cautionary recommendations ranging from no warning or precaution to contraindication among the sources reviewed. The recommendations were located mainly in the contraindication section of monographs for France (65·2%), United Kingdom (51·9%), Italy (50·0%), South Korea (43·5%), United States (38·2%) and Canada (37·0%), whereas in drug compendia, the recommendations were found in the precaution section for Martindale (51·4%) and Micromedex-Drugdex (33·3%), and contraindication and precaution section for the American Hospital Formulary Service Drug Information 2010 (30·8%). Evidence from the primary literature varied with recommendation included in drug monographs. Evidence-based categorization was carried out for 16 medications. Two sulfonamide-moiety-containing drugs were considered safe, six non-sulfonylarylamines required precaution, and eight medications from all three sulfonamide chemical classes were considered mostly unsafe. There are significant discrepancies in cautionary recommendations included in drug-labels and drug compendia. Statements concerning cross-reactive hypersensitivity with other sulfonamides generally suggest theoretical possibilities. The consensus evidence-based grading instrument developed may be useful for deriving cautionary recommendations for sulfonamide-allergic patients.
Publisher: S. Karger AG
Date: 2016
DOI: 10.1159/000446450
Abstract: b i Background: /i /b The impact of medication regimen complexity on adherence in hemodialysis patients is unknown. We investigated regimen complexity, perceived burden of medicines (PBM) and health-related quality of life (HR-QoL) as potential predictors of adherence. b i Methods: /i /b Adult (≥18 years) hemodialysis patients were included. Data on medication regimen complexity index (MRCI), self-reported and objective adherence, comorbidity index, PBM and HR-QoL were obtained using established measures. Sociodemographic and clinical characteristics were collected during interviews and by reviewing medical records. Predictors of adherence were determined using logistic regression. b i Results: /i /b Fifty-three out of 70 hemodialysis patients participated (response rate 75% male 58.5% age 67.9 ± 11.5 years). The mean MRCI, HR-QoL and PBM scores were 27.0 ± 10.9, 0.70 ± 0.13 and 1.7 ± 0.6, respectively. Based on self-reports, 43.4% (n = 23) were adherent, whereas for a subset of patients analyzed using objective measure (n = 33), much lower adherence rate was observed (27.3%, n = 9). The self-reported and objective measures were significantly correlated (r = 0.43, p = 0.01). Older age was the only significant predictor of self-reported adherence (OR 1.05 95% CI 1.00-1.11) whereas older age (OR 1.10 95% CI 1.00-1.21), higher comorbidity (OR 1.58 95% CI 1.03-2.42) and MRCI (OR 1.14 95% CI 1.02-1.27) were independent predictors of objective adherence. b i Conclusions: /i /b The findings of this exploratory study suggest that older patients with high comorbidities and highly complex regimen are more likely to be adherent based on an objective measure. Future research is needed using objective measures of adherence suitable for all patients and reflecting all medications.
Publisher: Public Library of Science (PLoS)
Date: 04-12-2015
Publisher: Springer Science and Business Media LLC
Date: 07-06-2012
Abstract: The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7% 159/271), reported the specific objective/hypothesis (72.7% 197/271), described participant eligibility criteria with settings for data collection (60.9% 165/271), detailed the interventions for both groups (90.8% 246/271), and clearly defined the primary outcome (94.8% 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8% 32/271) and details of blinding (21.0% 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3% 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively. These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.
Publisher: Wiley
Date: 28-08-2019
DOI: 10.1111/JOCN.14642
Abstract: To measure renal nurses' perceptions on assessing medication adherence in patients undergoing dialysis. Renal nurses play a vital role in caring for patients undergoing dialysis. Despite the high prevalence of medication nonadherence in chronic dialysis patients, little is known about renal nurses' perceptions and current adherence assessment practices. A cross-sectional survey. Participants completed an online survey between March-May 2016. Five psychometric scales were used to measure perception on prevalence and contributors of nonadherence, effective methods of assessment, barriers to assessment and confidence to assess adherence. The survey also captured current adherence assessment practices using a 4-point graded response (1 = do not practice at all to 4 = practice for every patient). A total of 113 dialysis nurses completed the survey. The majority agreed that patients in their unit are nonadherent to their medicines (74.5%, n = 82 median = 8). Most nurses agreed that having dedicated professionals conducting medication history interviews can be effective in identifying nonadherence (88.9%, n = 96 median = 8). Objective assessment through blood results was the most frequently used method to determine nonadherence (83.2%, n = 89), with little attention being paid to patients' self-reports of adherence (55.1%, n = 59). Time constraints, administrative support and patients' disinterest in discussing medication-related issues with the nurses were perceived as barriers to assessing adherence. Patient self-reported measures to assess adherence were underutilised by the renal nurses, whereas objective blood monitoring was routinely used. Overcoming dialysis nurses' work-related barriers may facilitate the effective monitoring and promotion of medication adherence in chronic dialysis patients. Results from this study emphasise the need for proper assessment of dialysis patient's medication-taking behaviour during routine dialysis to ensure the benefits of prescribed therapies.
Publisher: Elsevier BV
Date: 06-2014
DOI: 10.1016/J.JCLINEPI.2013.10.012
Abstract: The aims of this study were to evaluate the quality of randomized controlled trial (RCT) abstracts published in the field of oncology and identify characteristics associated with better reporting quality. All phase III trials published during 2005-2007 [before Consolidated Standards of Reporting Trials (CONSORT)] and 2010-2012 (after CONSORT) were searched electronically in MEDLINE/PubMed and retrieved for review using an 18-point overall quality score (OQS) for reporting based on the CONSORT for Abstract guidelines. Descriptive statistics followed by multivariate linear regression were used to identify features associated with improved reporting quality. The mean OQS was 8.2 (range: 5-13 95% confidence interval (CI): 8.0, 8.3) and 9.9 (range: 5-18 95% CI: 9.7, 10.2) in the pre- and post-CONSORT periods, respectively. The method for random sequence generation, allocation concealment, blinding details, and funding sources were missing in pre-CONSORT abstracts and insufficiently reported (<20%) in post-CONSORT abstracts. A high impact factor (P < 0.001) and the journal of publication (P < 0.001) were independent factors that were significantly associated with higher reporting quality on multivariate analysis. The reporting quality of RCT abstracts in oncology showed suboptimal improvement over time. Thus, stricter adherence to the CONSORT for Abstract guidelines is needed to improve the reporting quality of RCT abstracts published in oncology.
Publisher: Springer Science and Business Media LLC
Date: 30-05-2013
DOI: 10.1007/S00408-013-9479-Z
Abstract: The methodology of conducting clinical trials in lung cancer has been challenged by the particular characteristics of new targeted agents. Thus, the choice of correct outcome measures and selection of best study designs are essential. We assessed the trends in reporting of outcome measures in phase II and phase III trials conducted in advanced non-small-cell lung cancer (NSCLC) patients. Data from September 2000 to September 2012 were extracted from the ClinicalTrials.gov database, and a descriptive-comparative analysis was performed to evaluate outcome-measures reporting for the two phases. We identified 459 phase II and 128 phase III trials that met our inclusion criteria. The frequently reported primary outcomes in phase II trials were progression-free survival (PFS 32%), response rate (RR 21.4%), and safety and toxicity (adverse events [AEs] 14.6%). In contrast, overall survival (OS 60.9%) and PFS (26.6%) were frequently reported primary outcomes in phase III trials. AEs were reported as a secondary outcome measure in 50.1 and 64.8% of phase II and phase III trials, respectively. Improvement in quality of life was identified as a secondary outcome measure significantly more frequently in phase III than in phase II trials. Our study identified recent trends in reports of outcome measures in advanced-stage NSCLC phase II and phase III trials. The outcomes of this study can be valuable for investigators with minimal or some experience in the field of oncology who are conducting clinical research.
Publisher: Wiley
Date: 12-03-2019
DOI: 10.1111/JOCN.14821
Abstract: To explore clinician assessment of patient adherence and identify strategies to improve adherence assessment practices in haemodialysis settings. Patients with chronic kidney disease undergoing haemodialysis are typically prescribed complex regimens as such, they are at high risk of medication nonadherence. Current clinical practices focus on prescribing medications however, little attention is paid to measuring and ensuring patient adherence to their prescribed treatments. A qualitative study. Semi-structured in idual interviews were conducted in November and December 2016, with 12 nurses and 6 pharmacists, working in Australian haemodialysis settings. The study was conducted and reported in accordance with COREQ guidelines. Participants were 25-60 years old and had 1-27 years of experience in dialysis. Seven themes related to assessing adherence were identified: prioritisation of resources, interplay between workload and available time, awareness of formalised adherence measures and training deficits, concerns about practicality/suitability of adherence measures, communication of assessment services, patient participation and trust. Three themes related to strategies for improving adherence assessment practices were identified: formalisation of adherence assessment process, integration of assessment processes and tools into routine, and use of multidisciplinary support to assess and promote adherence. Current adherence assessment practices could be improved through formalisation and integration of the assessment process into dialysis unit policy rocedures. Additionally, as barriers to assessing adherence were identified at organisational, professional and patient levels, there is a need to address barriers from each level in order to improve adherence assessment practices in haemodialysis settings. This qualitative study highlights the challenges and practical ways by which adherence assessment practices could be improved in haemodialysis settings. This would encourage renal clinicians to actively participate in adherence assessment and promotion activities to ensure patients benefit from their therapies.
Publisher: Springer Science and Business Media LLC
Date: 27-02-2013
DOI: 10.1007/S00246-013-0658-8
Abstract: Postoperative arrhythmia (POA) is the most common complication encountered after cardiopulmonary bypass (CPB). The preventive effect of magnesium in POA has been confirmed by metaanalyses in adults, but less is known in pediatric patients. A metaanalysis of published trials was conducted to examine the efficacy of magnesium supplementation in POA prevention among pediatric patients undergoing CPB. Relevant trials were identified from electronic databases (Medline, Embase, Web of Science, and Cochrane library). Pooled relative risk (RR) and 95 % confidence intervals (CI) were calculated using Mantel-Haenszel random-effects models, and heterogeneity was determined qualitatively according to I (2) and chi-squared statistical analyses. Among 121 potentially relevant studies, five randomized controlled trials met the inclusion criteria, resulting in a pooled total of 348 participants. Compared with placebo, magnesium supplementation decreased the incidence of arrhythmia after CPB in pediatric patients by 66 % (RR, 0.34 95 % CI, 0.18-0.65 P = 0.001), with no heterogeneity between trials (heterogeneity P = 0.68 I (2) = 0 %). Magnesium supplementation significantly reduces the incidence of postoperative arrhythmias in pediatric patients undergoing CPB. Although the findings encourage the use of magnesium as an alternative to postoperative arrhythmias after CPB in pediatric patients, higher-quality randomized clinical trials are necessary before the findings can be generalized.
No related grants have been discovered for Saurav Ghimire.