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Abstract
Introduction: Adoptive cell therapy (ACT) is a rapidly evolving field. Patient-reported outcomes (PROs) allow patients to report the impact of treatment on their quality of life during and after treatment. The systematic review aims to characterise the breadth of PROs utilised in ACT cancer care and provide guidance for the use of PROs in this patient population in the future.
Methods: A systematic search was conducted (MEDLINE, PsycINFO, Embase and CINAHL) in August 2021 by two reviewers. Search terms covered the following: “adoptive cell therapy”, “patient-reported outcomes” and “cancer”. Studies were included if they used a PRO measure to report the impact of ACT. The methodological quality of PROs was assessed. Forward and backward reference searching was conducted of any relevant papers. A quality grading scale was applied based on Cochrane and Revenson criteria for classification of high-quality studies. Key data from the studies and the included PROs was extracted by two researchers and tabulated.
Results: One-hundred nine papers were identified; 11 papers were included. The majority of studies were single-arm trials or observational studies. Twenty-two different PROs were identified; none was ACT specific. The PROMIS-29 and EQ-5D were most commonly used. Few studies collected PRO data in the first 1–2 weeks. Four studies followed patients up for over a year, and a further four studies followed patients for approximately 3 months.
Discussion: None of the PROs identified have been designed specifically for ACT. Appropriateness of existing instruments should be considered. It should be considered whether it is appropriate to collect data more frequently in the acute stage and then less frequently during follow-up. It should be considered if one tool is suitable at all time points or if the tool should be adapted depending on time since treatment. More research is needed to identify the exact timings of PRO assessments, and qualitative work with patients is needed to determine the most important issues for them throughout the treatment and follow-up.
Methods: A systematic search was conducted (MEDLINE, PsycINFO, Embase and CINAHL) in August 2021 by two reviewers. Search terms covered the following: “adoptive cell therapy”, “patient-reported outcomes” and “cancer”. Studies were included if they used a PRO measure to report the impact of ACT. The methodological quality of PROs was assessed. Forward and backward reference searching was conducted of any relevant papers. A quality grading scale was applied based on Cochrane and Revenson criteria for classification of high-quality studies. Key data from the studies and the included PROs was extracted by two researchers and tabulated.
Results: One-hundred nine papers were identified; 11 papers were included. The majority of studies were single-arm trials or observational studies. Twenty-two different PROs were identified; none was ACT specific. The PROMIS-29 and EQ-5D were most commonly used. Few studies collected PRO data in the first 1–2 weeks. Four studies followed patients up for over a year, and a further four studies followed patients for approximately 3 months.
Discussion: None of the PROs identified have been designed specifically for ACT. Appropriateness of existing instruments should be considered. It should be considered whether it is appropriate to collect data more frequently in the acute stage and then less frequently during follow-up. It should be considered if one tool is suitable at all time points or if the tool should be adapted depending on time since treatment. More research is needed to identify the exact timings of PRO assessments, and qualitative work with patients is needed to determine the most important issues for them throughout the treatment and follow-up.
| Original language | English |
|---|---|
| Article number | 183 |
| Number of pages | 24 |
| Journal | Systematic Reviews |
| Volume | 12 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 30 Sept 2023 |
Bibliographical note
Funding:This work was supported by iMATCH (innovate Manchester Advanced Therapy Centre Hub) and funded by UKRI (InnovateUK) grant number: 107500 MC, OLA and FT disclosed receipt of the following financial support for the research, authorship and/or publication of this article. This work was supported by the Midlands-Wales Advanced Therapies Treatment Centre (MW-ATTC) programme grant from Innovate UK to a consortium of partners including Health Technology Wales, the Welsh Blood Service and the University of Birmingham (Grant number: IUK: 104232) and Innovate UK (part of UK Research and Innovation) grant patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies: PROmics (Grant No: IUK: 104777). The funder was not involved in any aspect of the research work.
Keywords
- Review
- Cancer
- Systematic
- Adoptive cell therapy (ACT)
- Quality of life
- Patient-reported outcomes (PROs)
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- 2 Finished
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Patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies:PROmics
Calvert, M., Newsome, P., Kyte, D., Harding, R. & Rowe, A.
1/12/18 → 31/03/22
Project: Other Government Departments
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Midland & Wales Advanced Therapy Treatment Centre (ATTC)
Newsome, P., Ghosh, S., Craddock, C., Calvert, M. & Filer, A.
1/03/18 → 31/03/22
Project: Other Government Departments