Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection

doi:10.1038/s41467-022-33826-4

Review

. 2022 Oct 12;13(1):6026.

doi: 10.1038/s41467-022-33826-4.

Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection

Olalekan Lee Aiyegbusi^{1

2

3

4

5}, Jessica Roydhouse⁶, Samantha Cruz Rivera^{7

8

9}, Paul Kamudoni¹⁰, Peter Schache¹¹, Roger Wilson¹², Richard Stephens¹², Melanie Calvert^{7

13

14

15

8

16

17

18}

Affiliations

¹ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
² National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
³ NIHR Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
⁴ NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
⁵ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
⁶ Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
⁷ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁸ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK.
⁹ DEMAND Hub, University of Birmingham, Birmingham, UK.
¹⁰ EMD Serono Inc, Healthcare Business of Merck KGaA, Darmstadt, Germany.
¹¹ LAIFE Reply GmbH, Frankfurt, Germany.
¹² Patient partner, Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
¹³ National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK.
¹⁴ NIHR Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
¹⁵ NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK.
¹⁶ National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK.
¹⁷ Health Data Research UK, London, UK.
¹⁸ UK SPINE, University of Birmingham, Birmingham, UK.

PMID: 36224187
PMCID: PMC9556436
DOI: 10.1038/s41467-022-33826-4

Review

Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection

Olalekan Lee Aiyegbusi et al. Nat Commun. 2022.

. 2022 Oct 12;13(1):6026.

doi: 10.1038/s41467-022-33826-4.

Authors

Affiliations

¹ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
² National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
³ NIHR Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
⁴ NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
⁵ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK. O.L.Aiyegbusi@bham.ac.uk.
⁶ Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
⁷ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁸ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK.
⁹ DEMAND Hub, University of Birmingham, Birmingham, UK.
¹⁰ EMD Serono Inc, Healthcare Business of Merck KGaA, Darmstadt, Germany.
¹¹ LAIFE Reply GmbH, Frankfurt, Germany.
¹² Patient partner, Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
¹³ National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK.
¹⁴ NIHR Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
¹⁵ NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK.
¹⁶ National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK.
¹⁷ Health Data Research UK, London, UK.
¹⁸ UK SPINE, University of Birmingham, Birmingham, UK.

PMID: 36224187
PMCID: PMC9556436
DOI: 10.1038/s41467-022-33826-4

Abstract

Patient-reported outcomes (PROs) are used in clinical trials to provide evidence of the benefits and risks of interventions from a patient perspective and to inform regulatory decisions and health policy. The collection of PROs in routine practice can facilitate monitoring of patient symptoms; identification of unmet needs; prioritisation and/or tailoring of treatment to the needs of individual patients and inform value-based healthcare initiatives. However, respondent burden needs to be carefully considered and addressed to avoid high rates of missing data and poor reporting of PRO results, which may lead to poor quality data for regulatory decision making and/or clinical care.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

**Fig. 1. Issues pertaining to respondent burden in PRO collection for clinical trials and routine practice.**
PPIE patient and public Involvement and Engagement. ©[Chipolla, Studio, Connest byk] via Canva.com.

See this image and copyright information in PMC

Cited by

Pilot Study on the Efficacy and Safety of Long-Term Oral Imepitoin Treatment for Control of (Thunder)Storm-Associated Noise Phobia/Noise Aversion in Dogs Using an Individualized-Dose Titration Approach.
Muñoz Amezcua AC, Jones JM, Griffith EH, Gruen ME. Muñoz Amezcua AC, et al. Animals (Basel). 2024 Feb 6;14(4):545. doi: 10.3390/ani14040545. Animals (Basel). 2024. PMID: 38396513 Free PMC article.
Patterns of drinking behavior around a treatment episode for alcohol use disorder: Predictions from pre-treatment measures.
Witkiewitz K, Kirouac M, Baurley JW, McMahan CS. Witkiewitz K, et al. Alcohol Clin Exp Res (Hoboken). 2023 Nov;47(11):2138-2148. doi: 10.1111/acer.15183. Epub 2023 Sep 15. Alcohol Clin Exp Res (Hoboken). 2023. PMID: 38226755 Free PMC article.
Translation, cultural adaptation, and content validation of the Hong Kong Chinese version of Self-completion Adult Social Care Outcomes Toolkit (ASCOT-SCT4) for care service users.
Yu S, Sze JCD, Cheung AWL, Wang K, Welch E, Smith N, Xu RH, Wong ELY. Yu S, et al. Health Qual Life Outcomes. 2025 Jun 4;23(1):57. doi: 10.1186/s12955-025-02389-5. Health Qual Life Outcomes. 2025. PMID: 40468338 Free PMC article.
International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.
Brady KJS, Peipert JD, Atkinson TM, Pompili C, Pinto M, Shaw JW, Roydhouse J; International Society for Quality of Life Research Clinical Practice Special Interest Group, the International Society for Quality of Life Research Clinical Practice Special Interest Group, the International Society for Quality of Life Research Regulatory Health, Technology Assessment Engagement Special Interest Group, and the International Society for Quality of Life Research Psychometrics Special Interest Group. Brady KJS, et al. Qual Life Res. 2023 Aug;32(8):2155-2163. doi: 10.1007/s11136-023-03396-z. Epub 2023 May 23. Qual Life Res. 2023. PMID: 37217665 Free PMC article.
Toward a more patient-centered drug development process in clinical trials for patients with myelodysplastic syndromes/neoplasms (MDS): Practical considerations from the International Consortium for MDS (icMDS).
Efficace F, Buckstein R, Abel GA, Giesinger JM, Fenaux P, Bewersdorf JP, Brunner AM, Bejar R, Borate U, DeZern AE, Greenberg P, Roboz GJ, Savona MR, Sparano F, Boultwood J, Komrokji R, Sallman DA, Xie Z, Sanz G, Carraway HE, Taylor J, Nimer SD, Della Porta MG, Santini V, Stahl M, Platzbecker U, Sekeres MA, Zeidan AM. Efficace F, et al. Hemasphere. 2024 May 21;8(5):e69. doi: 10.1002/hem3.69. eCollection 2024 May. Hemasphere. 2024. PMID: 38774655 Free PMC article. Review.

See all "Cited by" articles

References

1. FDA. Guidance for Industry. Patient-reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims (US Department of Health and Human Services Food and Drug Administration, Silver Spring, MD, 2009).
1. Wilson R. Patient led PROMs must take centre stage in cancer research. Res. Involv. Engagem. 2018;4:7. doi: 10.1186/s40900-018-0092-4. - DOI - PMC - PubMed
1. Stevenson DA, Carey JC. Health-related quality of life measures in genetic disorders: an outcome variable for consideration in clinical trials. Am. J. Med. Genet. Part C Semin. Med. Genet. 2009;151c:255–260. doi: 10.1002/ajmg.c.30217. - DOI - PMC - PubMed
1. Encyclopedia of Survey Research Methods. (2008).
1. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–2194. doi: 10.1001/jama.2013.281053. - DOI - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions

Grants and funding

DH_/Department of Health/United Kingdom

LinkOut - more resources

Full Text Sources
Miscellaneous
- NCI CPTAC Assay Portal

[1] FDA. Guidance for Industry. Patient-reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims (US Department of Health and Human Services Food and Drug Administration, Silver Spring, MD, 2009).

[2] FDA. Guidance for Industry. Patient-reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims (US Department of Health and Human Services Food and Drug Administration, Silver Spring, MD, 2009).

[3] Wilson R. Patient led PROMs must take centre stage in cancer research. Res. Involv. Engagem. 2018;4:7. doi: 10.1186/s40900-018-0092-4. - DOI - PMC - PubMed

[4] Wilson R. Patient led PROMs must take centre stage in cancer research. Res. Involv. Engagem. 2018;4:7. doi: 10.1186/s40900-018-0092-4. - DOI - PMC - PubMed

[5] Stevenson DA, Carey JC. Health-related quality of life measures in genetic disorders: an outcome variable for consideration in clinical trials. Am. J. Med. Genet. Part C Semin. Med. Genet. 2009;151c:255–260. doi: 10.1002/ajmg.c.30217. - DOI - PMC - PubMed

[6] Stevenson DA, Carey JC. Health-related quality of life measures in genetic disorders: an outcome variable for consideration in clinical trials. Am. J. Med. Genet. Part C Semin. Med. Genet. 2009;151c:255–260. doi: 10.1002/ajmg.c.30217. - DOI - PMC - PubMed

[7] Encyclopedia of Survey Research Methods. (2008).

[8] Encyclopedia of Survey Research Methods. (2008).

[9] World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–2194. doi: 10.1001/jama.2013.281053. - DOI - PubMed

[10] World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–2194. doi: 10.1001/jama.2013.281053. - DOI - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection

Affiliations

Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous