ABSTRACT
BACKGROUND: Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. METHODS: A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. RESULTS: Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. CONCLUSIONS: Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population's particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.
Subject(s)
Communication , Cultural Competency , Attitude , HumansABSTRACT
The COVID-19 pandemic has struck health service providers around the world with dire shortages, inflated prices, and volatile demand of personal protective equipment (PPE). This paper discusses supply chain resilience in the context of a Canadian provincial healthcare provider during the COVID-19 pandemic. A multi-period multi-objective mixed-integer programming model is presented for PPE supply planning under disruption risk. The deterministic formulation is extended to consider both two-stage and multi-stage uncertainty in the supply, price, and demand of PPE using stochastic programming (SP) and chance-constrained programming (CCP). The first objective is to minimize a risk measure of the stochastic total cost, either its Expected Value (EV) or its Value-at-Risk (VaR), and the second objective is to minimize the maximum shortage of any product in any time period. The ϵ-constraint method is used to generate sets of Pareto-optimal solutions and analyze the trade-off between these two competing objectives. Numerical experiments are conducted to analyze the efficacy of emergency inventory and increased inventory levels as risk mitigation strategies. We consider uncertainty scenarios based on plausible and actual pandemic trajectories seen around the world during the COVID-19 pandemic including single-wave, two-wave, and exponential growth. © 2023, The Author(s), under exclusive licence to Springer Nature Switzerland AG.