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2.
Int J Clin Pharm ; 44(4): 894-903, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35307788

ABSTRACT

BACKGROUND: Critical appraisal aids in assessing the quality of scientific literature, which is central to the practice of evidence-based medicine. Several tools and guidelines are available for critiquing and assessing the quality of specific study types. However, limited guidance exists for critical appraisal of clinical pharmacokinetic studies. AIM: We aimed to achieve experts' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool. METHOD: Quality markers related to clinical pharmacokinetic studies, were derived from the published literature and categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion, and conclusion). Questions that aid in appraising pharmacokinetic studies were formulated from these quality markers. Experts were involved in a modified Delphi process to achieve a consensus regarding the formulated questions. The proposed tool was pilot tested on 30 recently published clinical pharmacokinetic studies. Inter-observer agreement was measured to determine the reliability of the included items. RESULTS: Twenty-five experts consented to participate. Three rounds of a modified Delphi survey were required to generate a consensus for a 21-item tool aimed at appraising the quality of clinical pharmacokinetic studies. When applied to 30 recently published clinical pharmacokinetic studies, most items scored fair to moderate levels of agreement (61.90-95.24%). CONCLUSION: The clinical pharmacokinetic critical appraisal tool (CACPK) developed in this study consisted of 21 items aimed at helping an end-user to determine the quality of a pharmacokinetic study. Further studies are warranted to reaffirm the validity and reliability of the CACPK tool.


Subject(s)
Evidence-Based Medicine , Research Design , Consensus , Delphi Technique , Humans , Reproducibility of Results
3.
J Clin Pharm Ther ; 47(2): 178-183, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34668592

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Robust critical appraisal tools for clinical pharmacokinetic studies are limited. Before development of such a tool is possible, quality markers (items deemed important for credibility of study results) must be identified. We aim to create an inventory of quality markers intended for the appraisal of clinical pharmacokinetic studies and to categorize identified markers into associated domains of study quality. METHODS: Medline via ProQuest central (1946-Sep 2020, EMBASE (1974-Sep 2020), Cochrane database of systematic reviews, Google and Google Scholar were searched using the following search categories: pharmacokinetics, reporting guidelines and quality markers. Reference lists of the identified articles were searched manually. Any article (review, study or guideline) reporting quality markers related to the appraisal of pharmacokinetic literature was eligible for inclusion. Articles were further screened and limited to those reported in English on human subjects only. Cell-based and animal-based pharmacokinetic studies were excluded. Extracted data from included articles included identified or perceived markers of quality and baseline article data. Identified quality markers were then categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion and conclusion). RESULTS AND DISCUSSION: Of 789 studies identified, 17 articles were included for extraction of quality markers. A total of 35 quality markers were identified across eight categories. The most frequently reported quality markers were related to method (13/35) and result sections (6/35). Quality markers encompassed all aspects of study design and reporting and were both similar and different to established reporting checklists for clinical pharmacokinetic studies. WHAT IS NEW AND CONCLUSION: The inventory of quality markers is now suitable to undergo further testing for inclusion in a tool designed for the appraisal of clinical pharmacokinetic studies.


Subject(s)
Clinical Trials as Topic/standards , Guidelines as Topic/standards , Periodicals as Topic/standards , Pharmacokinetics , Quality Control , Checklist , Data Accuracy , Humans
4.
PLoS One ; 16(6): e0253588, 2021.
Article in English | MEDLINE | ID: mdl-34161388

ABSTRACT

INTRODUCTION: Medication errors are avoidable events that can occur at any stage of the medication use process. They are widespread in healthcare systems and are linked to an increased risk of morbidity and mortality. Several strategies have been studied to reduce their occurrence including different types of pharmacy-based interventions. One of the main pharmacist-led interventions is educational programs, which seem to have promising benefits. OBJECTIVE: To describe and compare various pharmacist-led educational interventions delivered to healthcare providers and to evaluate their impact qualitatively and quantitatively on medication error rates. METHODS: A systematic review and meta-analysis was conducted through searching Cochrane Library, EBSCO, EMBASE, Medline and Google Scholar from inception to June 2020. Only interventional studies that reported medication error rate change after the intervention were included. Two independent authors worked through the data extraction and quality assessment using Crowe Critical Appraisal Tool (CCAT). Summary odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a random-effects model for rates of medication errors. Research protocol is available in The International Prospective Register of Systematic Reviews (PROSPERO) under the registration number CRD42019116465. RESULTS: Twelve studies involving 115058 participants were included. The two main recipients of the educational interventions were nurses and resident physicians. Educational programs involved lectures, posters, practical teaching sessions, audit and feedback method and flash cards of high-risk abbreviations. All studies included educational sessions as part of their program, either alone or in combination with other approaches, and most studies used errors encountered before implementing the intervention to inform the content of these sessions. Educational programs led by a pharmacist were associated with significant reductions in the overall rate of medication errors occurrence (OR, 0.38; 95% CI, 0.22 to 0.65). CONCLUSION: Pharmacist-led educational interventions directed to healthcare providers are effective at reducing medication error rates. This review supports the implementation of pharmacist-led educational intervention aimed at reducing medication errors.


Subject(s)
Health Personnel/education , Medication Errors/prevention & control , Pharmaceutical Services , Pharmacists , Humans
5.
Int J Clin Pharm ; 42(4): 979-994, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32328958

ABSTRACT

Background Medication errors are avoidable events that may occur at any stage of the medication use process. Implementing a clinical pharmacist is one strategy that is believed to reduce the number of medication errors. Pediatric patients, who are more vulnerable to medication errors due to several contributing factors, may benefit from the interventions of a pharmacist. Aim of the review To qualitatively and quantitatively evaluate the impact of clinical pharmacist interventions on medication error rates for hospitalized pediatric patients. Methods PubMed, EMBASE, Cochrane Controlled Trials Register and Google Scholar search engines were searched from database inception to February 2020. Study selection, data extraction and quality assessment was conducted by two independent reviewers. Observational and interventional studies were included. Data extraction was done manually and the Crowe Critical Appraisal Tool was used to critically appraise eligible articles. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a random-effects model for rates of medication errors. Results 19 studies were systematically reviewed and 6 studies (29,291 patients) were included in the meta-analysis. Pharmacist interventions involved delivering educational sessions, reviewing prescriptions, attending rounds and implementing a unit-based clinical pharmacist. The systematic review indicated that the most common trigger for pharmacist interventions was inappropriate dosing. Pharmacist involvement was associated with significant reductions in the overall rate of medication errors occurrence (OR 0.27; 95% CI 0.15 to 0.49). Conclusion Pharmacist interventions are effective for reducing medication error rates in hospitalized pediatric patients.


Subject(s)
Medication Errors/prevention & control , Pharmacists/organization & administration , Pharmacy Service, Hospital/organization & administration , Child , Hospitalization , Humans , Professional Role
6.
Curr Pharm Teach Learn ; 10(8): 1026-1032, 2018 08.
Article in English | MEDLINE | ID: mdl-30314537

ABSTRACT

INTRODUCTION: Accreditation necessitates that assessment methods reflect the standards established by the accrediting body. The process of adapting assessments to a new context can present unique challenges with uncertainty around psychometric defensibility of the adapted exam. METHODS: A psychometric analysis of a summative multiple-choice-question (MCQ) assessment, adapted from Canada, for graduating pharmacy students from a Canadian accredited program in Qatar was conducted. Rates of difficult items, item discrimination measured by point biserial correlation (rpb), and non-functioning distractors (NFDs) were calculated to identify deficiencies and challenges with an adapted exam. Challenges encountered throughout the adaption process and recommendations were documented. RESULTS: Overall score of a 90-item, four option, MCQ exam ranged from 46.7% to 78.9% (mean of 61.9%). For difficulty, there were 17 items with less than 30% of students answering correctly, while 29 items had unacceptable or poor discrimination (rpb < 0.1). NFDs occurred in 78 items with 49 containing at least two NFDs. DISCUSSION AND CONCLUSIONS: Difficulty of the exam was deemed acceptable yet discriminator ability requires improvement. The high frequency of questions with NFDs suggests that faculty have difficulty developing plausible distractors for an adapted MCQ exam. This could be due to a lack of training or requirement for inclusion of too many distractor options. While it is feasible to implement an assessment adapted from a different learning environment, measures need to be taken to improve psychometric defensibility. The high number of questions with NFDs indicates that the current method of exam development does not encourage the incorporation of functional distractors.


Subject(s)
Educational Measurement/standards , Psychometrics/methods , Students, Pharmacy/statistics & numerical data , Adult , Canada , Educational Measurement/methods , Female , Humans , Pilot Projects , Psychometrics/instrumentation , Qatar/ethnology
7.
Curr Pharm Teach Learn ; 10(6): 779-784, 2018 06.
Article in English | MEDLINE | ID: mdl-30025780

ABSTRACT

BACKGROUND AND PURPOSE: Assess the reliability of first year pharmacy student assessments completed by faculty members in comparison with a standardized patient (SP), and student self-assessments during a structured educational module on communication. EDUCATIONAL ACTIVITY AND SETTING: Pharmacy students completed four stations focused on communication with an SP. During each encounter, students completed a self-assessment and were evaluated by a faculty member and a trained SP. A five point Likert scale was used to evaluate student performance. Faculty assessments were compared against all others. A Pearson correlation coefficient for total scores was used and a Cohen's kappa was used to compare inter-rater reliability. Agreement and correlation was performed with student results categorized into poor, adequate, and exceptional performance based on faculty evaluation. FINDINGS: Twenty-four students participated. In all stations, student self-assessments were graded higher than corresponding faculty and SP assessments. Agreement between faculty, SP, and self-assessment was fair to slight (k < 0.4) for all comparisons but only significant (p < 0.05) between the faculty and self-assessment. After categorization, there was a small, non-significant correlation between faculty and self-assessment (r = 0.13, p = 0.21) and moderate and significant correlation between faculty and SP (r = 0.32, p = 0.001). Categorized inter-rater agreement was fair for all comparisons (k < 0.2) and only significant (p < 0.05) between faculty and SP assessment. DISCUSSION: Pharmacy students in their first professional year assess their communication skills more positively than other evaluators. Further instruction for students and reflection may be required to build understanding of global assessment in communication. SUMMARY: There is high incongruity between student self-assessment and faculty appraisal.


Subject(s)
Communication , Educational Measurement/standards , Self-Assessment , Students, Pharmacy/statistics & numerical data , Adult , Curriculum/standards , Curriculum/trends , Faculty, Pharmacy , Female , Humans , Reference Standards
8.
Innov Pharm ; 9(3): 1-8, 2018.
Article in English | MEDLINE | ID: mdl-34007716

ABSTRACT

Evaluation of pre-licensure students' competency in team-based decision-making is lacking. The purposes of this study were to evaluate pre-licensure pharmacy students' competency in team-based decision-making in the context of an objective structured clinical examination (OSCE), and to determine whether performance correlated with reflective assignment scores. Students' self-assessment and conceptualization of team-based decision-making in practice was also evaluated. Twenty-three pre-licensure pharmacy students' competency in team-based decision-making was evaluated in an OSCE station and with a reflective journal assignment; rubric scores for both evaluations were compared using Spearman's rank order analysis. Students completed an 18-item questionnaire regarding attitudes, confidence, and perceptions related to team-based decision-making. Descriptive statistics and construct analysis with open coding were used to analyse questionnaire results. Mean OSCE station and reflective journal scores were 45% and 66.3%, respectively, and were not correlated. Students' attitudes toward team-based decision-making were positive, and they reported performing associated behaviours during experiential education rotations. Students appropriately defined 'team-based decision-making' and were highly confident in performing related activities. However, students' conceptualization of team-based decision-making did not align with the pharmacy program's competency framework. Three key themes were identified through the study analyses: 1) student performance is dependent on assessment context when evaluating collaborator-related competencies; 2) there is a mismatch between students' perceived competency and objectively measured competence when collaborator outcomes were assessed within an OSCE; and 3) students' perceptions of team-based decision-making do not align with the program's competency framework. Future research is necessary to assess competency and perceptions of team-based decision-making in students from other healthcare professions, and to further evaluate whether pre-licensure students are "collaborative practice ready".

9.
J Evid Based Complementary Altern Med ; 21(4): NP110-26, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27432772

ABSTRACT

The clinical effectiveness and value of camel milk as a therapeutic agent is currently unclear. MEDLINE (1946 to March 2016), EMBASE (1974 to March 2016), and Google Scholar were searched using the following terms: milk, bodily secretions, camels, camelus, camelini, camelidae, dromedary, bactrian camel, body fluid, and bodily secretions. Articles identified were reviewed if the study was investigating the use of camel milk for the potential treatment of diseases affecting humans. Of 430 studies, 24 were included after assessment. Identified studies highlighted treatment with camel milk of diseases, including diabetes, autism, cancer, various infections, heavy metal toxicity, colitis, and alcohol-induced toxicity. Although most studies using both the human and animal model do show a clinical benefit with an intervention and camel milk, limitations of these studies must be taken into consideration before widespread use. Based on the evidence, camel milk should not replace standard therapies for any indication in humans.


Subject(s)
Biological Products/therapeutic use , Camelus , Milk , Animals , Autistic Disorder/drug therapy , Biomedical Research , Diabetes Mellitus/drug therapy , Humans , Rats
11.
Clin Pharmacokinet ; 54(4): 371-83, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25691367

ABSTRACT

Medications indicated for helminthes and other parasitic infections are frequently being used in mass populations in endemic areas. Currently, there is a lack of guidance for clinicians on how to appropriately manage drug interactions when faced with patients requiring short-term anthelmintic therapy with albendazole or mebendazole while concurrently taking other agents. The objective of this review was to systematically summarize and evaluate published literature on the pharmacokinetics of albendazole or mebendazole when taken with other interacting medications. A search of MEDLINE (1946 to October 2014), EMBASE (1974 to October 2014), International Pharmaceutical Abstracts (1970 to October 2014), Google, and Google Scholar was conducted for articles describing the pharmacokinetics of albendazole or mebendazole when given with other medications (and supplemented by a bibliographic review of all relevant articles). Altogether, 17 articles were included in the review. Studies reported data on pharmacokinetic parameters for albendazole or mebendazole when taken with cimetidine, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital, ivermectin, praziquantel, diethylcarbamazine, azithromycin, and levamisole. Cimetidine increased the elimination half-life of albendazole and maximum concentration (Cmax) of mebendazole; dexamethasone increased the area under the plasma concentration-time curve (AUC) of albendazole; levamisole decreased the Cmax of albendazole; anticonvulsants (phenytoin, phenobarbital, carbamazepine) decreased the AUC of albendazole; praziquantel increased the AUC of albendazole; and ritonavir decreased the AUC of both albendazole and mebendazole. No major interactions were found with ivermectin, azithromycin, or diethylcarbamazine. Future research is required to clarify the clinical relevance of the interactions observed.


Subject(s)
Albendazole/pharmacokinetics , Anthelmintics/pharmacokinetics , Mebendazole/pharmacokinetics , Adult , Child , Child, Preschool , Drug Interactions , Drug Therapy, Combination , Female , Humans , Male
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