Tertiary drug information sources for treatment and prevention of COVID-19.

Objective: To evaluate tertiary drug information databases in terms of scope, consistency of content, and completeness of COVID-19 drug information. Methods: Five electronic drug information databases: Clinical Pharmacology, Lexi-Drugs, AHFS DI (American Hospital Formulary Service Drug Information), eFacts and Comparisons, and Micromedex In-Depth Answers, were evaluated in this cross-sectional evaluation study, with data gathered from October 2021 through February 2022. Two study investigators independently extracted data (parallel extraction) from each resource. Descriptive statistics were primarily used to evaluate scope (i.e., whether the resource addresses use of the medication for treatment or prevention of COVID-19) and completeness of content (i.e., whether full information is provided related to the use of the medication for treatment or prevention of COVID-19) based on a 10-point scale. To analyze consistency among resources for scope, the Fleiss multi-rater kappa was used. To analyze consistency among resources for type of recommendation (i.e., in favor, insufficient evidence, against), a two-way mixed effects intraclass coefficient was calculated. Results: A total of 46 drug monographs, including 3 vaccination monographs, were evaluated. Use of the agents for treatment of COVID-19 was most frequently addressed in Lexi-Drugs (73.9%), followed by eFacts and Comparisons (71.7%), and Micromedex (54.3%). The highest overall median completeness score was held by AHFS DI followed by Micromedex, and Clinical Pharmacology. There was moderate consistency in terms of scope (kappa 0.490, 95% CI 0.399-0.581, p<0.001) and recommendations (intraclass correlation coefficient 0.518, 95% CI 0.385-0.651, p<0.001). Conclusion: Scope and completeness results varied by resource, with moderate consistency of content among resources.

Off-label use information in electronic drug information resources.

Objective: To compare electronic drug information resources for scope, completeness, and consistency of off-label uses information, and to group resources into tiers based on these endpoints. Methods: An evaluation study of six electronic drug information resources (Clinical Pharmacology, Lexi-Drugs, American Hospital Formulary Service Drug Information, Facts and Comparisons Off-Label, Micromedex Quick Answers, and Micromedex In-Depth Answers) was conducted. All off-label uses for the top 50 prescribed medications, by volume, were extracted from all resources and used to determine scope (i.e., whether the resource listed the use). Fifty randomly selected uses were then evaluated for completeness (i.e., whether the entry cited clinical practice guidelines, cited clinical studies, provided a dose, described statistical significance, and described clinical significance) and consistency (i.e., whether the resource provided the same dose as the majority). Results: A sample of 584 uses was generated. The largest number of listed uses was in Micromedex In-Depth Answers (67%), followed by Micromedex Quick Answers (43%), Clinical Pharmacology (34%), and Lexi-Drugs (32%). The highest scoring resources for completeness were Facts and Comparisons Off-Label (median score 4/5), Micromedex In-Depth Answers (median score 3.5/5), and Lexi-Drugs (median score 3/5). Consistency with the majority in terms of dosing was highest for Lexi-Drugs (82%), Clinical Pharmacology (62%), Micromedex In-Depth Answers (58%), and Facts and Comparisons Off-Label (50%). Conclusion: The top-tiered resources for scope were Micromedex In-Depth and Quick Answers. For completeness, the top-tiered resources were Facts and Comparisons Off-Label and Micromedex In-Depth Answers. Lexi-Drugs and Clinical Pharmacology were the most consistent in dosing.

Intranasal Ketamine for Treatment of Acute Pain in Pediatrics: A Systematic Review.

OBJECTIVES: Intranasal ketamine has not been well studied in acute pain treatment and does not have a recognized place in therapy in current practice guidelines for pediatric patients. Ketamine has a unique mechanism of action with a favorable side effect profile that may provide benefit to the pediatric population for acute pain. The purpose of this review is to summarize the evidence evaluating intranasal ketamine versus any other comparator for children who require acute pain treatment. METHODS: A systematic review was performed to include clinical studies of intranasal ketamine for acute pain that reported any pain-related outcome and adverse events in children 0 to 17 years old. Trials were identified through PubMed, Google Scholar, clinical trial registries, research registries, and key journals through April 2018. The Jadad scoring system was used to assess the methodological quality of the included randomized controlled trials. RESULTS: Six studies consisting of 261 patients were reviewed. Intranasal ketamine demonstrated pain relief in all included clinical studies; however, there was inconsistency in dosing, comparators, scales, and indications. Two of the randomized controlled trials were rated as high quality, and 1 randomized controlled trial was rated as poor quality on the Jadad scale. CONCLUSIONS: Intranasal ketamine was safe and effective in the 6 clinical studies included in this systematic review.

Evaluation of drug information resources for interactions between therapeutic drugs and drugs of abuse.

OBJECTIVE: The study evaluated point-of-care resources for scope, completeness, and consistency of information describing interactions between therapeutic drugs and drugs of abuse (DoA). METHODS: A cross-sectional evaluation study was conducted focusing on seven resources: Clinical Pharmacology, Facts & Comparisons eAnswers, Lexicomp Online, Micromedex, Drug Interactions Analysis and Management, Drug Interaction Facts, and Stockley's Drug Interactions. A sample of clinically relevant interactions was developed through review of tertiary literature and resources, and input was solicited from subject matter experts. Entries from each resource for each interaction were evaluated for scope (i.e., whether there was an entry for the interaction); completeness (i.e., whether there was information addressing mechanism; clinical effects, severity, course of action, and level of certainty, described as a median rating on a 5-point scale); and consistency (i.e., whether the information in the resource was similar to the majority) among resources with an entry. RESULTS: Following review by subject matter experts, the final sample contained 159 interactions. Scope scores ranged from 0.6% (Drug Interactions Analysis and Management) to 43.4% (Lexicomp Online). Completeness scores ranged from 2 (interquartile range [IQR] 0 to 3, Stockley's Drug Interactions) to 5 (IQR 5 to 5, Drug Interaction Facts, Micromedex, Facts & Comparisons eAnswers). Consistency scores ranged from 30.8% (Stockley's Drug Interactions) to 87.1% (Clinical Pharmacology) for severity and from 15.4% (Facts & Comparisons eAnswers) to 71.4% (Drug Interaction Facts) for course of action. CONCLUSIONS: Although coverage of drug-DoA interactions was low and content was often inconsistent among resources, the provided information was generally complete.

Comparison of the effectiveness of venous thromboembolism prophylaxis with enoxaparin between obese and non-obese patients.

OBJECTIVE: The purpose of this study is to compare the incidence of venous thromboembolism between obese and non-obese hospitalized patients who received United States Food and Drug Administration-approved prophylactic enoxaparin doses and to describe enoxaparin dosing strategies used in obese patients. METHODS: This was a retrospective cohort study including patients who were admitted to Parkview Regional Medical Center, Parkview Hospital, or Parkview Orthopedic Hospital between September 2011 and August 2012 and received at least one dose of enoxaparin 30 mg twice daily or enoxaparin 40 mg once daily for venous thromboembolism prophylaxis. Patients classified based on their body mass index into three groups, Group 1 (non-obese: body mass index < 25 kg/m2), Group 2 (overweight: body mass index ≥ 25 kg/m2 but < 30 kg/m2), and Group 3 (obese: body mass index ≥ 30 kg/m2). The primary endpoint was venous thromboembolism occurrence within 90 days, considering day 1 of hospitalization as day 1. RESULTS: Of the 428 patients included, 8 cases of venous thromboembolism (1.9%) were identified; 3 in the non-obese group, 2 in the overweight group, and 3 in the obese group, no statistically significant differences were found between the three groups, p = 0.81. When venous thromboembolism incidence was adjusted for age and sex, no statistically significant differences were found between overweight (OR = 0.685; 95% CI 0.115-4.095), obese (OR = 0.797; 95% CI 0.353-1.796), and combined overweight and obese (OR = 0.656; 95% CI 0.154-2.799) groups compared to patients with normal body weight. CONCLUSION: This study did not find a statistically significant difference in venous thromboembolism incidence between obese, overweight, and non-obese hospitalized patients receiving approved enoxaparin prophylaxis doses.

Evaluation of drug information resources for drug-ethanol and drug-tobacco interactions.

OBJECTIVE: The research evaluated point-of-care drug interaction resources for scope, completeness, and consistency in drug-ethanol and drug-tobacco content. METHODS: In a cross-sectional analysis, 2 independent reviewers extracted data for 108 clinically relevant interactions using 7 drug information resources (Clinical Pharmacology Drug Interaction Report, Facts & Comparisons eAnswers, Lexicomp Interactions, Micromedex Drug Interactions, Drug Interactions Analysis and Management, Drug Interaction Facts, and Stockley's Drug Interactions). Scope (presence of an entry), completeness (content describing mechanism, clinical effects, severity, level of certainty, and course of action for each present interaction; up to 1 point per assessed item for a total possible score of 5 points), and consistency (similarity among resources) were evaluated. RESULTS: Fifty-three drug-ethanol and 55 drug-tobacco interactions were analyzed. Drug-ethanol interaction entries were most commonly present in Lexicomp (84.9%), Clinical Pharmacology (83.0%), and Stockley's Drug Interactions (73.6%), compared to other resources (p<0.05). Drug-tobacco interactions were more often covered in Micromedex (56.4%), Stockley's Drug Interactions (56.4%), Drug Interaction Facts (43.6%), and Clinical Pharmacology (41.8%) (p<0.001). Overall completeness scores were higher for Lexicomp, Micromedex, Drug Interaction Facts, and Facts & Comparisons (median 5/5 points, interquartile range [IQR] 5 to 5, p<0.001) for drug-ethanol and for Micromedex (median 5/5 points, IQR 5 to 5, p<0.05) for drug-tobacco, compared to other resources. Drug Interaction Facts and Micromedex were among the highest scoring resources for both drug-ethanol (73.7%, 68.6%) and drug-tobacco (75.0%, 32.3%) consistency. CONCLUSIONS: Scope and completeness were high for drug-ethanol interactions, but low for drug-tobacco interactions. Consistency was highly variable across both interaction types.

The Efficacy of Neutral Position Beractant Administration in Neonates.

OBJECTIVE: The objective was to compare the efficacy and adverse effects of beractant administration in neonates via a single aliquot in a neutral position versus positioning the neonates on their left then right side and two aliquots administration. STUDY DESIGN: This was a retrospective cohort chart review of neonates who were diagnosed with respiratory distress syndrome and received beractant during two 15-month periods between 2013 and 2015 and 2015 and 2016 to compare the change in the fraction of inspired oxygen (FiO2) 1 hour after beractant administration. RESULTS: There were no differences in FiO2 1 hour after beractant between groups (p = 0.617). Adverse events and other comorbidities did not differ between the groups. CONCLUSION: Changing administration of beractant from two aliquots and positions to a neutral position resulted in no significant change in FiO2 and may be considered as an option for administration in neonates.

Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives.

BACKGROUND: Intention-to-treat (ITT) analysis is commonly recommended for use, due to its benefits on external validity, in randomized, controlled trials (RCTs). No published reports describe how ITT analysis, as well as alternative approaches, are used in anti-infective RCTs. The purpose of this study is to describe the extent to which ITT analysis and alternative data approaches are used, the practices used to handle missing subject data, and whether non-inferiority trials present both ITT and per protocol (PP) analyses. Results of this analysis will help guide end users of infectious diseases primary drug literature. METHODS: A cross-sectional study of RCTs of anti-infectives published from January 1, 2013 through December 31, 2014 was conducted. A PubMed search identified relevant articles published in five specialty infectious diseases journals and four general medical journals. Each article was reviewed by two independent investigators with discrepancies resolved by consensus. Descriptive statistics were used to quantify results. RESULTS: One hundred four articles met study criteria. The most common medication classes represented in the RCTs were hepatitis C antivirals (26 %), antibacterials (25 %), and antiretrovirals (21 %). Thirty studies (29 %) were non-inferiority trials. Most studies (77 %) described use of ITT or modified ITT (mITT) in their methods. Of the ITT and mITT studies, most (73 %) did not describe practices used to handle missing data. Most (97 %) non-inferiority trials described use of ITT, mITT, or both; however, only 15 (50 %) also described use of PP. CONCLUSIONS: RCTs of anti-infectives commonly employ ITT and mITT. Most do not describe how missing data were addressed. Non-inferiority trials of anti-infectives do not consistently employ both ITT and PP populations.

Evaluation of resources for analyzing drug interactions.

OBJECTIVE: The research sought to evaluate seven drug information resources, specifically designed for analyzing drug interactions for scope, completeness, and ease of use, and determine the consistency of content among the seven resources. METHODS: A cross-sectional study was conducted where 100 drug-drug and drug-dietary supplement interactions were analyzed using 7 drug information resources: Lexicomp Interactions module, Micromedex Drug Interactions, Clinical Pharmacology Drug Interaction Report, Facts & Comparisons eAnswers, Stockley's Drug Interactions (10th edition), Drug Interactions Analysis and Management (2014), and Drug Interaction Facts (2015). The interaction sample was developed based on published resources and peer input. Two independent reviewers gathered data for each interaction from each of the 7 resources using a common form. RESULTS: Eighty-two drug-drug and 18 drug-dietary supplement interactions were analyzed. Scope scores were higher for Lexicomp Interactions (97.0%), Clinical Pharmacology Drug Interaction Report (97.0%), and Micromedex Drug Interactions (93.0%) compared to all other resources (p<0.05 for each comparison). Overall completeness scores were higher for Micromedex Drug Interactions (median 5, interquartile range [IQR] 4 to 5) compared to all other resources (p<0.01 for each comparison) and were higher for Lexicomp Interactions (median 4, IQR 4 to 5), Facts & Comparisons eAnswers (median 4, IQR 4 to 5), and Drug Interaction Facts (4, IQR 4 to 5) compared to all other resources, except Micromedex (p<0.05 for each comparison). Ease of use, in terms of time to locate information and time to gather information, was similar among resources. Consistency score was higher for Micromedex (69.9%) compared to all other resources (p<0.05 for each comparison). CONCLUSIONS: Clinical Pharmacology Drug Interaction Report, Lexicomp Interactions, and Micromedex Drug Interactions scored highest in scope. Micromedex Drug Interactions and Lexicomp Interactions scored highest in completeness. Consistency scores were overall low, but Micromedex Drug Interactions was the highest.

Pharmacist perception and use of UpToDate®.

A cross-sectional survey of a convenience sample of 1,199 pharmacists was conducted to describe pharmacists' use and perception of UpToDate®. Of 472 (39%) respondents, 217 (46%) reported using UpToDate. Most respondents who used or had heard of UpToDate indicated willingness to change a treatment plan based on UpToDate recommendations (77%). Many believed that UpToDate is updated weekly (31%) or monthly (49%) and that all articles undergo external peer review (51%). In conclusion, the majority of respondents reported that they would adjust drug therapy based on UpToDate recommendations; however, many pharmacists may hold misconceptions regarding the updating and peer-review processes.

Rethinking the core list of journals for libraries that serve schools and colleges of pharmacy.

The Core List of Journals for Libraries that Serve Schools and Colleges of Pharmacy is a guide for developing and maintaining pharmacy-affiliated library collections. A work group was created to update the list and design a process for updating that will streamline future revisions. Work group members searched the National Library of Medicine catalog for an initial list of journals and then applied inclusion criteria to narrow the list. The work group finalized the fifth edition of the list with 225 diverse publications and produced a sustainable set of criteria for journal inclusion, providing a structured, objective process for future updates.

Assessment of vaccination-related information for consumers available on Facebook.

OBJECTIVES: To assess the magnitude, interest, purpose and validity of vaccination-related information on Facebook and to determine whether information varies by site viewpoint. METHODS: The 10 largest vaccination-focused Facebook pages, groups and places in each category were identified and classified by viewpoint (i.e. anti-, pro-, neutral) and purpose. Number of members, posts per week, likes, comments and shares per post were recorded. Posts were assessed for concordance with CDC and FDA recommendations. RESULTS: Of 30 sites, 43% (n = 13) were anti-vaccination, 7% (n = 2) neutral and 50% (n = 15) pro-vaccination. Most sites were most popular with American users. Median members were similar between anti-vaccination (2703 members, range 337-33 631 members) and pro-vaccination sites (2142 members, range 456-61,565 members, P = 0.262); however, anti-vaccination sites accumulated more posts per week by authors (median 15 vs. 3, P = 0.031) and members (median 33 vs. 1, P < 0.001). Pro-vaccination sites more commonly had commercial purpose (53% [n = 8] vs. 8% [n = 1], P = 0.02). Anti-vaccination sites more commonly gave medical advice (54% [n = 7] vs. 0%, P = 0.004). Overall, 48% (n = 22) of author posts were concordant with regulatory recommendations; concordance was more common on pro-vaccination sites (78% [n = 21] vs. 5% [n = 1], P = 0.0002). CONCLUSION: Vaccination-related information is prevalent on Facebook regardless of viewpoint; however, anti-vaccination information generates more interest. Anti-vaccination sites were likely to provide medical advice and disagree with regulatory bodies.

Best practices for PGY1 letters of intent: Recommendations from a modified Delphi process.

PURPOSE: The aim of this study was to provide consensus recommendations from residency program leaders on letters of intent (LOIs) written by postgraduate year 1 (PGY1) pharmacy residency candidates. METHODS: A 3-round modified Delphi process was used to determine consensus among PGY1 residency program leaders across the country. A screening and demographic survey was utilized to ensure representation of panelists. The initial items for round 1 of the study were developed using existing published literature, with pilot testing by 2 residency program directors. For each round, respondents rated items on a 7-point Likert scale, with opportunities to provide qualitative feedback and modifications for lower-rated items. For future rounds, items were adjusted based on respondent feedback. Only items meeting predefined consensus were included in the final recommendations. RESULTS: A total of 254 pharmacists were invited to participate in the panel, with 41 completing the demographic and study consent survey. There were 35 participants in round 1, 34 of whom remained for rounds 2 and 3. The panel created 18 LOI recommendations for PGY1 residency candidates. Most recommendations were focused on the content of the LOI, while others were related to formatting. CONCLUSION: The recommendations from this study can be employed by PGY1 pharmacy residency candidates to enhance their likelihood of success in the residency application process.

Development and Assessment of a Rubric for Evaluating Teaching Portfolios Developed by Teaching and Learning Curriculum (TLC) Program Participants.

OBJECTIVE: To describe the validation and reliability assessment of a rubric designed to assess the participants' teaching portfolios and identify teaching excellence among teaching and learning curriculum (TLC) program participants. METHODS: Following focus groups with program leadership at a single TLC program, an initial rubric was developed, consisting of criteria mapped to 5 domains, to be rated on a 4-point scale. The rubric was then redistributed to the TLC program leadership and external stakeholders for evaluation of face and content validity. The rubric was piloted using teaching portfolios from 3 cycles of the program. Cronbach αwas used to measure internal consistency and a 2-way random-effects model was used to assess the inter-rater reliability. RESULTS: A total of 18 portfolios were independently evaluated by 4 raters. The overall mean Cronbach α for internal consistency was 0.90 and ranged from 0.65 to 0.84 by domain. The overall mean intraclass correlation coefficient for inter-rater reliability was 0.95 and ranged from 0.57 to 0.91 by domain. CONCLUSION: The rubric evaluates characteristics of teaching portfolios important to internal and external stakeholders and had good to excellent internal consistency and inter-rater reliability. It can be adapted and applied by TLC programs to identify teaching excellence.

Development, Validation, and Reliability of a P1 Objective Structured Clinical Examination Assessing the National EPAs.

OBJECTIVE: To document the performance of first-year pharmacy students on a revised objective structured clinical examination (OSCE) based on national entrustable professional activities, identify risk factors for poor performance, and assess its validity and reliability. METHODS: A working group developed the OSCE to verify students' progress toward readiness for advanced pharmacy practice experiences at the L1 level of entrustment (ready for thoughtful observation) on the national entrustable professional activities, with stations cross-mapped to the Accreditation Council for Pharmacy Education educational outcomes. Baseline characteristics and academic performance were used to investigate risk factors for poor performance and validity, respectively, by comparing students who were successful on the first attempt with those who were not. Reliability was evaluated using re-grading by a blinded, independent grader, and analyzed using Cohen's kappa. RESULTS: A total of 65 students completed the OSCE. Of these, 33 (50.8%) successfully completed all stations on first attempt, and 32 (49.2%) had to re-attempt at least 1 station. Successful students had higher Health Sciences Reasoning Test scores (mean difference 5, 95% CI 2-9). First professional year grade point average was higher for students who passed all stations on first attempt (mean difference 0.4 on a 4-point scale, 95% CI 0.1-0.7). When evaluated in a multiple logistic regression, no differences were statistically significant between groups. Most kappa values were above 0.4 (range 0.404-0.708), suggesting moderate to substantial reliability. CONCLUSION: Though predictors of poor performance were not identified when accounting for covariates, the OSCE was found to have good validity and reliability.

Abiraterone for the treatment of metastatic castrate-resistant prostate cancer.

OBJECTIVE: To review the clinical pharmacology, efficacy, and safety of abiraterone acetate for metastatic castrate-resistant prostate cancer (mCRPC) and evaluate the drug for health-system formulary inclusion. DATA SOURCES: Literature was identified through a search of MEDLINE (1977-February 2012) and International Pharmaceutical Abstracts (1977-February 2012) using the search term abiraterone. References of identified articles were reviewed. STUDY SELECTION AND DATA EXTRACTION: All clinical trials published in English were evaluated. Studies conducted in the setting of mCRPC were included in the literature review. DATA SYNTHESIS: Despite benefits from androgen deprivation for the treatment of prostate cancer, most patients experience disease progression within 12-48 months, a phase described as castrate resistant. Abiraterone is the only Food and Drug Administration-approved hormonal treatment option for mCRPC in men who have received docetaxel and is recommended as a second-line agent for this indication in the National Comprehensive Cancer Network prostate cancer guidelines. One Phase 3 study, 2 Phase 2 studies, and 2 Phase 1 studies conducted in the setting of second-line treatment of mCRPC were identified. Treatment with abiraterone was associated with at least a 50% reduction in prostate-specific antigen (PSA) in 38-51% of patients; PSA progression ranged from 5.6-10.2 months. The only study assessing mortality outcomes found a 13% absolute reduction in mortality (ie, 42% vs 55%; HR 0.65; 95% CI 0.54 to 0.77), relative to placebo, over a median 12.8 months of follow-up. Abiraterone has been compared only to placebo, not to existing treatment options. CONCLUSIONS: Abiraterone provides a moderate improvement in disease progression and mortality in a patient population with limited treatment options. It is recommended to add this medication to outpatient formularies restricted to second-line treatment of mCRPC.

Factors associated with reported preventable adverse drug events: a retrospective, case-control study.

BACKGROUND: It has been reported that error occurs at some point during the medication use process in approximately 6% of medication doses administered in the inpatient setting. An estimated 1-10% of medication errors lead to patient harm; however, factors affecting the risk of harm from a medication error are undefined in the literature. OBJECTIVE: To identify independent factors affecting the risk of reported preventable adverse drug events (ADEs) (ie, medication errors contributing to patient harm) compared to medication errors that did not contribute to patient harm in a diverse patient population. METHODS: This was a retrospective, case-control study conducted at 3 hospitals within a large health system. Medication error reports from July 1, 2009, through June 30, 2010, were assessed. All reported medication errors determined to have contributed to patient harm were matched 1:1 with a medication error that did not contribute to harm. Data collected through review of the incident report and medical record included patient, provider, medication, and other related factors. Multivariable logistic regression was used to determine the relationship of potential factors to patient harm. RESULTS: Of 4321 medication errors reported at study sites, 182 (4%) contributed to patient harm. Factors associated with increased independent risk of harm were 30-day readmission, time of day 0300-0659, and Institute for Safe Medication Practices (ISMP) high-alert medications. Factors associated with decreased independent risk of harm were multiple medication errors, occurrence during February or April, dispensing errors, and pharmacist review of medication order. CONCLUSIONS: Health systems should develop programs to promote safe, conscientious use of ISMP high-alert medications, promote pharmacist review, control the use of cabinet overrides, and direct provider attention toward recently admitted patients. Efforts should be made to determine factors associated with risk of harm at local levels.

Clinical studies of dapagliflozin in pediatric patients: a rapid review.

The oral sodium-glucose cotransporter 2 inhibitor, dapagliflozin, is used to treat kidney disease, heart failure, and diabetes in adults, but has not been well studied in pediatrics, and does not have a recognized place in therapy in current practice guidelines. The purpose of this review is to summarize studies that have investigated the efficacy of dapagliflozin in pediatric patients. A systematic review was performed to identify clinical studies of oral dapagliflozin in children 0 to 17 years. Studies were identified through searches of Scopus, Web of Science, PubMed, Google Scholar, Embase, clinical trial registries, research registries, and key journals through August 2022. The Cochrane scoring system was used to assess the methodological quality of the included randomized trials. Five studies were reviewed and included in this analysis. Dapagliflozin at a dose of 5 to 10 mg was utilized in adolescents and young adults with heart failure, chronic kidney disease with proteinuria, type 1 diabetes, or type 2 diabetes. Studies evaluating dapagliflozin in type 1 diabetes evaluated single doses while the other studies monitored long-term use. Dapagliflozin was overall considered to be safe and effective in the studies included in this review, but further studies in larger populations and over extended periods of time are necessary.

Use of the AGREE II instrument to evaluate critical care practice guidelines addressing pharmacotherapy.

RATIONALE, AIMS AND OBJECTIVES: Clinical practice guidelines (CPGs) have been evaluated for reporting transparency and methodological quality in a number of studies in various disciplines, but few studies have focused on critical care and none on pharmacotherapy-related guidelines specifically. The objective of this study was to evaluate the quality of critical care CPGs with a focus on pharmacotherapy using the Appraisal of Guidelines, Research and Evaluation (AGREE) II instrument. METHOD: A cross-sectional study of CPGs published from 2013 through August 2021 was conducted. Following establishment of interrater reliability, guidelines were independently evaluated by three reviewers to rate guidelines on criteria set forth by the AGREE II instrument. Domain scores and item scores were calculated using the AGREE II user manual, and results described with descriptive statistics. RESULTS: Out of 192 guidelines identified, 73 met inclusion criteria and were screened using the AGREE II instrument. Most guidelines were authored by a professional organization or government agency. Domain quality scores were calculated for each domain as recommended by the AGREE II instrument. Domain 4 (clarity of presentation) had the highest AGREE II domain score with a median score of 87.0% (interquartile range: 79.6%-92.6%). Domain 5 (applicability) received the lowest domain score with a mean score of 41.8 ± 21.1%. The majority of guidelines were recommended for use as published or with modifications, while only six guidelines (8.2%) were not recommended for use. CONCLUSIONS: The majority of critical care guidelines that include pharmacotherapy recommendations were recommended for use by study authors when the AGREE II instrument was applied. While guidelines generally scored highly in clarity of presentation, additional time and effort should focus on providing solutions to guideline implementation and inclusion of patient preferences.