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Decision Support Tools for Regenerative Medicine: Systematic Review.

ABSTRACT: BACKGROUND:Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE:The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine. METHODS:We systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively. RESULTS:We identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling. CONCLUSIONS:Our review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated.

SUBMITTER: Lam C

PROVIDER: S-EPMC6315273 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Decision Support Tools for Regenerative Medicine: Systematic Review.

Lam Ching C Meinert Edward E Alturkistani Abrar A Carter Alison R AR Karp Jeffrey J Yang Aidong A Brindley David D Cui Zhanfeng Z

Journal of medical Internet research 20181219 12

<h4>Background</h4>Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients.<h4>Objective</h4>The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine.<h4>Methods</h4>We systematically searched MEDLINE to identif ...[more]

PMID: 30567696

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Project description:BackgroundTherapeutic decision-making in oncology is a complex process because physicians must consider many forms of medical data and protocols. Another challenge for physicians is to clearly communicate their decision-making process to patients to ensure informed consent. Computer-based decision tools have the potential to play a valuable role in supporting this process.ObjectiveThis systematic review aims to investigate the extent to which computer-based decision tools have been successfully adopted in oncology consultations to improve patient-physician joint therapeutic decision-making.MethodsThis review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 checklist and guidelines. A literature search was conducted on February 4, 2021, across the Cochrane Database of Systematic Reviews (from 2005 to January 28, 2021), the Cochrane Central Register of Controlled Trials (December 2020), MEDLINE (from 1946 to February 4, 2021), Embase (from 1947 to February 4, 2021), Web of Science (from 1900 to 2021), Scopus (from 1969 to 2021), and PubMed (from 1991 to 2021). We used a snowball approach to identify additional studies by searching the reference lists of the studies included for full-text review. Additional supplementary searches of relevant journals and gray literature websites were conducted. The reviewers screened the articles eligible for review for quality and inclusion before data extraction.ResultsThere are relatively few studies looking at the use of computer-based decision tools in oncology consultations. Of the 4431 unique articles obtained from the searches, only 10 (0.22%) satisfied the selection criteria. From the 10 selected studies, 8 computer-based decision tools were identified. Of the 10 studies, 6 (60%) were conducted in the United States. Communication and information-sharing were improved between physicians and patients. However, physicians did not change their habits to take advantage of computer-assisted decision-making tools or the information they provide. On average, the use of these computer-based decision tools added approximately 5 minutes to the total length of consultations. In addition, some physicians felt that the technology increased patients' anxiety.ConclusionsOf the 10 selected studies, 6 (60%) demonstrated positive outcomes, 1 (10%) showed negative results, and 3 (30%) were neutral. Adoption of computer-based decision tools during oncology consultations continues to be low. This review shows that information-sharing and communication between physicians and patients can be improved with the assistance of technology. However, the lack of integration with electronic health records is a barrier. This review provides key requirements for enhancing the chance of success of future computer-based decision tools. However, it does not show the effects of health care policies, regulations, or business administration on physicians' propensity to adopt the technology. Nevertheless, it is important that future research address the influence of these higher-level factors as well.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42021226087; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021226087.

Dataset Information

Decision Support Tools for Regenerative Medicine: Systematic Review.

Publications

Decision Support Tools for Regenerative Medicine: Systematic Review.

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