Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making.

INTRODUCTION: High-quality randomised controlled trials (RCTs) provide the most reliable evidence on the comparative efficacy of new medicines. However, non-randomised studies (NRS) are increasingly recognised as a source of insights into the real-world performance of novel therapeutic products, particularly when traditional RCTs are impractical or lack generalisability. This means there is a growing need for synthesising evidence from RCTs and NRS in healthcare decision making, particularly given recent developments such as innovative study designs, digital technologies and linked databases across countries. Crucially, however, no formal framework exists to guide the integration of these data types. OBJECTIVES AND METHODS: To address this gap, we used a mixed methods approach (review of existing guidance, methodological papers, Delphi survey) to develop guidance for researchers and healthcare decision-makers on when and how to best combine evidence from NRS and RCTs to improve transparency and build confidence in the resulting summary effect estimates. RESULTS: Our framework comprises seven steps on guiding the integration and interpretation of evidence from NRS and RCTs and we offer recommendations on the most appropriate statistical approaches based on three main analytical scenarios in healthcare decision making (specifically, 'high-bar evidence' when RCTs are the preferred source of evidence, 'medium,' and 'low' when NRS is the main source of inference). CONCLUSION: Our framework augments existing guidance on assessing the quality of NRS and their compatibility with RCTs for evidence synthesis, while also highlighting potential challenges in implementing it. This manuscript received endorsement from the International Society for Pharmacoepidemiology.

An Experimental Education Project for Consultations of Older Adults during the Pandemic and Healthcare Lockdown.

OBJECTIVE: To develop a mentor-supervised, interprofessional, geriatric telemedicine experiential education project in response to the COVID-19 pandemic. METHOD: Medical and pharmacy students collaborated via remote consultations to address the coexistence of multimorbidity and polypharmacy in geriatric patients. In-depth interviews of students and patients as well as Likert scale-based telephonic survey were performed for a comprehensive evaluation of the project's significance. RESULTS: To date, 49 consultations have been conducted. Remote consultations performed by medical and pharmacy students working collaboratively were beneficial for both students, participants. CONCLUSIONS AND PRACTICE IMPLICATIONS: This experimental education project provided students with authentic challenges while simultaneously delivering care to the older adults who are susceptible to disruption of care associated with the pandemic. Further development and expanded implementation of such approaches may be a post-pandemic practice to provide more accessible care for senior patients while incorporating interprofessional education.

Dementia for the Primary Care Provider.

Dementia represents one of the most important and growing public health issues facing society today. Primary care clinics serve a crucial role as the first line of defense in the recognition and treatment of dementia. Increased awareness and treatment of risk factors for dementia are important for lessening disease burden in the population. Diagnostic workup should include screening for medical and nondegenerative causes of cognitive impairment that may be remedial. Treatment approaches should include multimodal approaches to address cognitive decline and behavioral/psychiatric symptoms of dementia in an effort to maximize quality of life for both patients and caregivers.

Atypical antipsychotic initiation and the risk of type II diabetes in children and adolescents.

PURPOSE: To estimate the risk of type II diabetes (T2DM) in children and adolescents initiating atypical antipsychotic (AAP) therapy. METHODS: We conducted a retrospective cohort study using a new user design approach. Medical and pharmacy claims data between 1 January 2007 and 31 December 2009 for dependents ages 4 to 18 from an employed, commercially insured population from across the USA were included. AAP exposure was defined in the presence of a pharmacy claim preceded by at least six months of AAP-free history. We used propensity score (PS) methodology to identify and match incident AAP users and non-users. New-onset T2DM, was defined based on medical and pharmacy claims. Follow-up was extended until the date of new-onset T2DM or the end of the study period. The risk of T2DM was evaluated in an intent to treat fashion using the Kaplan-Meier estimator and Cox proportional hazard regression that provided hazard ratio (HR) and associated 95% confidence interval (CI). RESULTS: Our study population included 6236 new AAP users and 22 080 non-users. In this PS-matched sample, the estimated risk of T2DM was twice as high in AAP users as non-users (HR 2.18, 95% CI 1.45-3.29). Noticeable risk differences between AAP-treated and control groups materialized within four months of AAP initiation and became constant after six months until the end of the follow-up. CONCLUSIONS: Children and adolescents who were prescribed an AAP medication had a two times higher risk of developing T2DM; our study raises questions about continued AAP use in children and adolescents.