Abstract
Objectives: As part of the PIONEER Consortium objectives, we have explored which diagnostic and prognostic factors (DPFs) are available in relation to our previously defined clinician and patient-reported outcomes (PROs) for prostate cancer (PCa).
Design: We performed a systematic review to identify validated and non-validated studies. Data sources: MEDLINE, Embase and the Cochrane Library were searched on January 21, 2020.
Eligibility criteria: Only quantitative studies were included. Single studies with fewer than 50 participants, published before 2014 and looking at outcomes which are not prioritised in the PIONEER core outcome set will be excluded.
Data extraction and synthesis: After initial screening, we extracted data following the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of prognostic factor studies (CHARMS-PF) criteria and discussed the identified factors with a multidisciplinary expert group. The quality of the included papers was scored for applicability and risk of bias using validated tools such as PROBAST, QUIPS and QUADAS-2.
Results: The search identified 6,604 studies, from which 489 DPFs were included. Sixty-four of those were internally or externally validated. However, only three studies on diagnostic and seven studies on prognostic factors had a low risk of bias and a low risk concerning applicability.
Conclusion: Most of the DPFs identified require additional evaluation and validation in properly designed studies before they can be recommended for us e in clinical practice. The PIONEER online search tool for diagnostic and prognostic factors for prostate cancer will enable researchers to understand the quality of the current research and help them design future studies.
Ethics and Dissemination: There are no ethical implications.
Design: We performed a systematic review to identify validated and non-validated studies. Data sources: MEDLINE, Embase and the Cochrane Library were searched on January 21, 2020.
Eligibility criteria: Only quantitative studies were included. Single studies with fewer than 50 participants, published before 2014 and looking at outcomes which are not prioritised in the PIONEER core outcome set will be excluded.
Data extraction and synthesis: After initial screening, we extracted data following the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of prognostic factor studies (CHARMS-PF) criteria and discussed the identified factors with a multidisciplinary expert group. The quality of the included papers was scored for applicability and risk of bias using validated tools such as PROBAST, QUIPS and QUADAS-2.
Results: The search identified 6,604 studies, from which 489 DPFs were included. Sixty-four of those were internally or externally validated. However, only three studies on diagnostic and seven studies on prognostic factors had a low risk of bias and a low risk concerning applicability.
Conclusion: Most of the DPFs identified require additional evaluation and validation in properly designed studies before they can be recommended for us e in clinical practice. The PIONEER online search tool for diagnostic and prognostic factors for prostate cancer will enable researchers to understand the quality of the current research and help them design future studies.
Ethics and Dissemination: There are no ethical implications.
| Original language | English |
|---|---|
| Article number | e058267 |
| Number of pages | 10 |
| Journal | BMJ Open |
| Issue number | 12 |
| Early online date | 4 Apr 2022 |
| DOIs | |
| Publication status | Published - 4 Apr 2022 |
Bibliographical note
FundingPIONEER is funded through the IMI2 Joint Undertaking and is listed under Grant Agreement No. 777492 and is part of the Big Data for Better Outcomes Programme (BD4BO). IMI2 receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.
Data Availability Statement
Data availability statementNo data are available. not applicable.
Supplemental material
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Keywords
- Prostate cancer
- diagnostic factor
- prognostic factors
- big data
- RWE
Access to Document
- Beyer_etal_BMJ_Diagnostic_And_Prognostic_VoR
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