Table 1 Overview of the articles and books
Title | Year | Author | Purpose | Ref# | Sec # |
|---|---|---|---|---|---|
Articles | 13 | ||||
Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency | 2009 | Bottomley A, et al. | Differences in the PRO/HRQL Guidance by FDA and EMEA | [42] | NA |
Multinational trials - Recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report | 2009 | Wild D, et al. | Translation of PRO questionnaire and linguistic validation | [34] | 1.2 |
Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 | 2012 | Cocks K, et al. | Interpretation of PRO evaluation results (MCID) | [27] | 4.2 |
Patient-reported outcome measures in safety event reporting: PROSPER consortium guidance | 2013 | Banerjee Ak, et al. | Use of PRO measures for safety data collection | [51] | 5.3.1 |
Reporting of patient-reported outcomes in randomized trials: The CONSORT-PRO extension | 2013 | Calvert M, et al. | Description of PRO measurement report | [29] | 2 |
ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. | 2013 | Reeve BB, et al. | Requirements for selecting a PRO measures | [35] | 1.3 |
Methods for interpreting change over time in patient-reported outcome measures | 2013 | Wyrwich KW, et al. | Interpretation of PRO evaluation results (MCID) | [28] | 4.2 |
Validation of electronic systems to collect patient-reported outcome (PRO) data - recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force | 2013 | Zbrozek A, et al. | Requirements for ePRO systems validation | [52] | 3.1 |
Clinician’s checklist for reading and using an article about patient-reported outcomes. | 2014 | Wu AW, et al. | Use of PRO assessment articles in clinical practice | [54] | 5.3.3 |
Appendix 2 to the Guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (PRO) measures in oncology studies. | 2016 | European Medicines Agency | Use of PRO measures for regulatory submissions in Europe (in cancer clinical trials) | [15] | 1, 2, 4.2 |
How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” - a practical guideline | 2016 | Prinsen CA, et al. | Core clinical outcome selection | [30] | 1.3 |
Users’ guide to integrating patient-reported outcomes in electronic health records | 2017 | Snyder C, Wu AW, Ed. | Integrating PRO measures into electronic health records | [46] | 3.2 |
Mapping to estimate health-state utility from non-preference-based outcome measures: An ISPOR good practices for outcomes research task force report | 2017 | Wailoo AJ, et al. | Mapping from non-preference based measure to utility | [53] | 5.2 |
Articles | 13 | ||||
The COMET Handbook: version 1.0. | 2017 | Williamson PR, et al. | COS development, implementation, review and feedback | [5] | 1.1, |
Reflection paper on copyright, patient reported outcome instruments and their translations | 2018 | Anfray et al. | Copy right for PRO and its interpretation | [55] | 1.2 |
Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO extension | 2018 | Calvert M, et al. | Description of PRO measurement protocol | [31] | 2 |
Standards for instrument migration when implementing paper patient-reported outcome instruments electronically: Recommendations from a qualitative synthesis of cognitive interview and usability studies | 2018 | Muehlhausen, W, et al. | Requirements for ePRO equivalence assessment | [36] | 3.1 |
COSMIN guideline for systematic reviews of patient-reported outcome measures | 2018 | Prinsen CAC, et al. | Review methods for PRO evaluation reports | [18] | 5.1 |
Scoping review of response shift methods: current reporting practices and recommendations | 2018 | Sajobi TT, et al. | Reliability of the PRO questionnaire (response shift) | [43] | 4.3 |
Implementing patient-reported outcome measures in clinical practice: a companion guide to the ISOQOL user’s guide | 2019 | Chan EKH, et al. | PRO assessment in clinical practice (for diverse uses) | [47] | 1.3, 3.2, 5.3 |
Training on the use of technology to collect patient-reported outcome data electronically in clinical trials: Best practice recommendations from the ePRO Consortium | 2019 | Ly JJ, et al. | Training ePRO use in clinical trials | [37] | 3.1 |
International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomized controlled trials: recommendations of the SISAQOL Consortium | 2020 | Coens C, et al. | Statistical considerations in PRO measurement | [39] | 4.1 |
Translation of patient-reported outcomes in oncology clinical trials to everyday practice | 2020 | Ivatury SJ, et al. | PRO assessment in clinical practice (from cancer clinical research) | [44] | 3.2 |
Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures | 2020 | McKown S, et al. | Considerations for translating the non-PRO questionnaires | [38] | 1.2 |
The OMERACT Handbook. Ver 2.1. 2021. | 2021 | Beaton D, et al. | Patient engagement in the development of PRO | [49] | 1.1 |
International guidance on the selection of patient-reported outcome measures in clinical trials: a review | 2021 | Crossnohere NL, et al. | Requirements for selecting a PRO measures | [45] | 1.3 |
COSMIN reporting guideline for studies on measurement properties of patient‑reported outcome measures | 2021 | Gagnier JJ, et al. | Reporting guideline for the property of PRO measures | [32] | 1.3 |
Articles | 7 | ||||
Using structural equation modeling to investigate change and response shift in patient‑reported outcomes: practical considerations and recommendations | 2021 | Verdam MGE, et al. | Response shift in PRO evaluation | [40] | 4.3 |
The PROTEUS guide to implementing patient-reported outcomes in clinical practice: A synthesis of resources. | 2023 | Crossnohere N, et al. | PRO assessment in clinical practice (for systematic use) | [48] | 1.3, 3.2, 5.3 |
EUnetHTA 21 – Individual practical guideline document, D4.4 – OUTCOMES (ENDPOINTS) | 2023 | EUnetHTA 21 | Outcomes in HTA including PRO | [33] | 5.2 |
Best practice recommendations for electronic patient-reported outcome dataset structure and standardization to support drug development | 2023 | Hudgens S, et al. | Structuring of ePRO datasets incorporating CDISC standards | [41] | 3.1 |
Chapter 18: Patient-reported outcomes, In Higgins J, Thomas J, (Ed.) Cochrane Handbook for Systematic Reviews of Interventions, Version 6.4, 2023 | 2023 | Johnston BC, et al. | PRO in systematic reviews | [50] | 5.1 |
FDA Patient-Focused Drug Development guidance series for enhancing the incorporation of the patient’s voice in medical product development and regulatory decision making | 2018–2023 | US Food and Drug Administration | Methods for collecting and submitting patient information required for drug approval applications | [14] | 1, 2, 4.2 |
Books | |||||
Electronic patient-reported outcome measures: An implementation handbook for clinical research | 2018 | Byrom B, Muehlhausen W | Entire landscape of ePROs | [56] | 3.1 |