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Introduction: Indirect treatment comparisons (ITCs) evaluate novel treatments compared to appropriate comparators when direct evidence is unavailable or infeasible. The objective of this study was to highlight the prevalence of different ITC methods in oncology drug submissions and to provide insights into how ITCs have been used in recent regulatory approval, reimbursement recommendations, or pricing decisions across various regions and diverse assessment frameworks., Methods: A targeted literature review was conducted to identify assessment documents for oncology drug submissions that included ITCs. This included hand searches of the websites of four regulatory bodies and four health technology assessment (HTA) agencies with varying assessment frameworks across North America, Europe, and Asia-Pacific., Results: A total of 185 documents were included for synthesis. Documents were retrieved from all four HTA agencies and the European Medicines Agency (EMA), the only regulatory body with eligible records. Within these, 188 unique submissions included a total of 306 supporting ITCs of various methods. Authorities more frequently favored anchored or population-adjusted ITC techniques for their effectiveness in data adjustment and bias mitigation. Furthermore, ITCs in orphan drug submissions more frequently led to positive decisions compared to non-orphan submissions., Conclusions: This review highlights the crucial role and widespread use of ITCs in global healthcare decision-making, particularly when direct evidence is lacking, and in the discernment of market-specific clinical benefits. This work contributes to bolstering the credibility and recognition of ITCs across regulatory and HTA agencies of diverse regions and assessment frameworks., Competing Interests: Declarations. Conflict of Interest: Ataru Igarashi received consulting fees from PhRMA Japan, JPMA, EFPIA Japan, Janssen, Eli Lilly Japan K.K., Shionogi & Co. Ltd., Takeda Pharmaceuticals, Novo Nordisk Japan, Eisai Japan, Medtronic Japan, Chugai Pharmaceuticals, Edwards LifeScience, GSK Japan. Ataru Igarashi received collaborative research funds from Moderna Japan Inc, Taiho Yakuhin, Otsuka Pharmaceuticals, Intuitive Surgical Inc. Shiro Tanaka has received lecture fee from MSD K.K. and Datack. He has received consultation fee and outsourcing fee from Daiichi Sankyo Company, Limited, Janssen Pharmaceutical K.K., and Public Health Research Foundation. He has received a research grant from Novo Nordisk. De Moor Raf, Li Nan, and Hirozane Mariko are employees of Janssen Pharmaceutical K.K. Wu David Bin-Chia, Hong Li Wen, and Yu Dae Young are employees of Janssen Pharmaceutical Companies of Johnson and Johnson Asia Pacific Regional Office Singapore. Mahmoud Hashim is an employee of Janssen Vaccines & Prevention B.V. in the Netherlands. De Moor Raf, Li Nan, and Hirozane Mariko have stock or stock options of Johnson & Johnson. Brian Hutton has previously received honoraria from EVERSANA™ and Evidinno Outcomes Inc. for the provision of methodologic advice related to systematic reviews, meta-analyses, and indirect comparisons. Krista Tantakoun, Christopher Olsen, Fatemeh Mirzayeh Fashami, Imtiaz Samjoo, and Chris Cameron are employees of EVERSANA™, which was a paid consultant to Janssen Pharmaceutical K.K. in connection with the development of this manuscript; Chris Cameron is also a shareholder of EVERSANA™. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Ethical Approval: This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors., (© 2024. The Author(s).)

Background: Surgical site infections continue to be a significant challenge following colorectal surgery. These can result in extended hospital stays, hospital readmissions, increased treatment costs, and negative effects on patients' quality of life. Antibiotic prophylaxis plays a crucial role in preventing infection during surgery, specifically in preventing surgical site infections after colorectal surgery in adult patients. However, the optimal antibiotic regimen is still unclear based on current evidence. Considering the limitations of existing reviews, our goal is to conduct a comprehensive systematic review and network meta-analysis of randomized controlled trials to evaluate the comparative benefits and harms of available antibiotic prophylaxis regimens for preventing surgical site infections following colorectal surgery in adult patients., Methods: We will search the Medline, EMBASE, CINAHL, Scopus, and Cochrane Central Register of Controlled Trials databases to identify relevant randomized controlled trials. We will include trials that (1) enrolled adults who underwent colorectal surgeries and (2) randomized them to any systemic administration of antibiotic (single or combined) prophylaxis before surgery compared to an alternative systemic antibiotic (single or combined antibiotic), placebo, control, or no prophylactic treatment. Pairs of reviewers will independently assess the risk of bias among eligible trials using a modified Cochrane risk of bias instrument for randomized trials. Our outcomes of interest include the rate of surgical site infection within 30 days of surgery, hospital length of stay, 30-day mortality, and treatment-related adverse effects. We will perform a contrast-based network meta-analysis using a frequentist random-effects model assuming a common heterogeneity parameter. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach will be utilized to assess the certainty of evidence for treatment effects., Discussion: By synthesizing evidence from available RCTs, this study will provide valuable insight for clinicians, patients, and health policymakers on the most effective antibiotics for preventing surgical site infection., Systematic Review Registration: PROSPERO CRD42023434544., (© 2024. The Author(s).)

Objective. To assess validity of the Farsi-translated version of the Jefferson Scale of Empathy-Health Profession Student version (JSE-HPS) and measure empathy scores of Iranian pharmacy students. Methods. The JSE-HPS questionnaire was administered to 504 Iranian pharmacy students in 2019. Confirmatory factor analysis and exploratory factor analysis were used to explore the underlying components and construct validity. Group comparisons of the empathy scores and the underlying components were conducted using statistical tests. Results. Based on 496 useable survey questionnaires, three domains of empathy among Iranian pharmacy students were confirmed by confirmatory factor analysis: compassionate care, perspective taking, and standing in a patient's shoes. Two items in the JSE-HPS were removed, as their factor loadings were under the permissible limits in exploratory factor analysis. Empathy scores were significantly higher among female pharmacy students. Conclusion. These findings support the validity and reliability of the Farsi version of the JSE-HPS among Iranian pharmacy students., (© 2023 American Association of Colleges of Pharmacy.)

Objective. To identify factors and entrepreneurial characteristics associated with entrepreneurial and intrapreneurial intentions among Doctor of Pharmacy (PharmD) students in Iran. Methods. First, the Entrepreneurial-Intrapreneurial Pharmacist Questionnaire (EIPQ), which was developed in the United States, was translated from English to Persian. The paper-based Persian-EIPQ questionnaire was then tested in a convenience sample of student pharmacists enrolled in pharmacy schools in Iran. The entrepreneurial characteristics questionnaire was evaluated using exploratory factor analysis with varimax rotation. Internal consistency was examined using Cronbach alpha. The association of demographics and educational variables and entrepreneurial characteristics with entrepreneurial and intrapreneurial intentions was determined using a multiple linear regression model. Results. A total of 504 surveys, 98.6% of the completed questionnaires received, were analyzed. A majority of the participants were female (75.8%) and from 18 to 25 years old (92.2%). Entrepreneurial intention had a positive and significant association with risk-taking propensity, leadership self-efficacy, autonomy, achievement motivation, and having an entrepreneur in the family. Intrapreneurial intention had a positive and significant association with risk-taking propensity, leadership self-efficacy, achievement motivation, people liking, attending a private school, and having an entrepreneur in the family. Conclusion. Based on the findings, student pharmacists with higher levels of risk-taking propensity, achievement motivation, leadership self-efficacy, autonomy, and people liking may be more likely to have greater levels of entrepreneurial and/or intrapreneurial intention., (© 2021 American Association of Colleges of Pharmacy.)