While guidelines exist for returning genetic, biomarker, and radiologic research results, there is little guidance regarding the return of patient-reported outcome (PRO) research results. As a supplement to an ongoing trial of palliative care for Parkinson's disease, we conducted thirty qualitative, semi-structured interviews of persons with Parkinson's disease, their carepartners, community neurologists, primary care physicians, and researchers to elicit their perceptions of returning PRO research data to persons with Parkinson's disease and carepartners. Interviews were audio-taped, transcribed, double-coded, and analyzed for themes. Participants supported returning tailored PRO research results when feasible. Clinicians wanted clinically-actionable results. Researchers thought that returning aggregate results should be standard practice. However, our persons with Parkinson's disease and carepartners reported privacy concerns. Clinicians had mixed reactions about receiving non-actionable research results. Researchers worried whether returning individual results during a study could impact research integrity. Additional research is needed to develop optimal guidelines for future research studies.
BachmanS. L.Leonard-CorzoK. S.BlankenshipJ. M.BusaM. A.ServienteC.LimogesM. W.MarcotteR. T.ClayI.LydenK. (2025). Returning Individualized Wearable Sensor Results to Older Adult Research Participants: A Pilot Study. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 80(5). https://doi.org/10.1093/gerona/glaf027
2.
BockM. A.MacchiZ. A.HarrisonK. L.KatzM.DiniM.JonesJ.AyeleR.KutnerJ. S.PantilatS. Z.MartinC.SillauS.KlugerB. (2024). Does a novel community-based outpatient palliative care intervention for Parkinson's disease and related disorders improve care? Qualitative results from patients and care partners. Palliative Medicine, 38(2), 240–250. https://doi.org/10.1177/02692163231219923
3.
BonselJ. M.ItiolaA. J.HubertsA. S.BonselG. J.PentonH. (2024). The use of patient-reported outcome measures to improve patient-related outcomes – a systematic review. Health and Quality of Life Outcomes, 22(1), 101. https://doi.org/10.1186/s12955-024-02312-4
4.
BuJ.DeSanto-MadeyaS.LugassyM.BesbrisJ.BublitzS.KramerN. M.GursahaniR.LauW.KimE.RheeJ. Y.PaalP. (2024). So we brought these players together": A qualitative study of educators’ experiences to analyze the challenges of creating an e-learning program for neuropalliative care. BMC Medical Education, 24(1), 524. https://doi.org/10.1186/s12909-024-05437-8
5.
CalvertM. J.Cruz RiveraS.RetzerA.HughesS. E.CampbellL.Molony-OatesB.AiyegbusiO. L.StoverA. M.WilsonR.McMullanC.AndersonN. E.TurnerG. M.DaviesE. H.VerdiR.VelikovaG.KamudoniP.MuslimS.GheorgheA.O'ConnorD. …DennistonA. K. (2022). Patient reported outcome assessment must be inclusive and equitable. Nature Medicine, 28(6), 1120–1124. https://doi.org/10.1038/s41591-022-01781-8
6.
CarrR. L.ChanV.WestN. C.GörgesM. (2025). Developing requirements for a standardized system to return individual research results back to study participants: Narrative review. Interactive Journal of Medical Research, 14, e65606. https://doi.org/10.2196/65606
7.
ChurrucaK.PomareC.EllisL. A.LongJ. C.HendersonS. B.MurphyL. E. D.LeahyC. J.BraithwaiteJ. (2021). Patient-reported outcome measures (PROMs): A review of generic and condition-specific measures and a discussion of trends and issues. Health Expectations, 24(4), 1015–1024. https://doi.org/10.1111/hex.13254
8.
ConcannonT. W.FusterM.SaundersT.PatelK.WongJ. B.LeslieL. K.LauJ. (2014). A systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research. Journal of General Internal Medicine, 29(12), 1692–1701. https://doi.org/10.1007/s11606-014-2878-x
CritesJ. S.ChuangC.DimmockA.HwangW.JohannesB.ParanjapeA.WuA. W. (2016). PROs in the balance: Ethical implications of collecting patient reported outcome measures in the electronic health record. American Journal of Bioethics, 16(4), 67–68. https://doi.org/10.1080/15265161.2016.1146543
11.
FabsitzR. R.McGuireA.SharpR. R.PuggalM.BeskowL. M.BieseckerL. G.BookmanE.BurkeW.BurchardE. G.ChurchG.ClaytonE. W.EckfeldtJ. H.FernandezC. V.FisherR.FullertonS. M.GabrielS.GachupinF.JamesC.JarvikG. P.… BurkeG. L. (2010). Ethical and practical guidelines for reporting genetic research results to study participants: Updated guidelines from a national heart, lung, and blood institute working group. Circulation. Cardiovascular Genetics, 3(6), 574–580. https://doi.org/10.1161/circgenetics.110.958827
12.
ForsytheL.HeckertA.MargolisM. K.SchrandtS.FrankL. (2018). Methods and impact of engagement in research, from theory to practice and back again: Early findings from the Patient-Centered Outcomes Research Institute. Quality of Life Research, 27(1), 17–31. https://doi.org/10.1007/s11136-017-1581-x
13.
FrankL.ForsytheL.EllisL.SchrandtS.SheridanS.GersonJ.KonopkaK.DaughertyS. (2015). Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Quality of Life Research, 24(5), 1033–1041. https://doi.org/10.1007/s11136-014-0893-3
14.
GetzK.Farides-MitchellJ. (2019). Assessing the adoption of clinical trial results summary disclosure to patients and the public. Expert Review of Clinical Pharmacology, 12(7), 573–578. https://doi.org/10.1080/17512433.2019.1615441
15.
HelfandM.BalshemH. (2010). AHRQ Series paper 2: Principles for developing guidance: AHRQ and the effective health-care program. Journal of Clinical Epidemiology, 63(5), 484–490. https://doi.org/10.1016/j.jclinepi.2009.05.005
16.
KlugerB. M.KatzM.GalifianakisN. B.PantilatS. Z.HauserJ. M.KhanR.FriedmanC.VaughanC. L.GotoY.LongS. J.MartinC. S.DiniM.McQueenR. B.PalmerL.FaircloughD.SeebergerL. C.SillauS. H.KutnerJ. S. (2024). Patient and family outcomes of community neurologist palliative education and telehealth support in Parkinson disease. JAMA Neurology, 81(1), 39–49. https://doi.org/10.1001/jamaneurol.2023.4260
17.
KyteD.DuffyH.FletcherB.GheorgheA.Mercieca-BebberR.KingM.DraperH.IvesJ.BrundageM.BlazebyJ.CalvertM. (2014). Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols. PLoS One, 9(10), e110229. https://doi.org/10.1371/journal.pone.0110229
18.
KyteD.IvesJ.DraperH.CalvertM. (2016). Management of patient-reported outcome (PRO) alerts in clinical trials: A cross sectional survey. PLoS One, 11(1), e0144658. https://doi.org/10.1371/journal.pone.0144658
19.
KyteD.RetzerA.AhmedK.KeeleyT.ArmesJ.BrownJ. M.CalmanL.GavinA.GlaserA. W.GreenfieldD. M.LanceleyA.TaylorR. M.VelikovaG.BrundageM.EfficaceF.Mercieca-BebberR.KingM. T.TurnerG.CalvertM. (2019). Systematic evaluation of patient-reported outcome protocol content and reporting in cancer trials. Journal of the National Cancer Institute, 111(11), 1170–1178. https://doi.org/10.1093/jnci/djz038
20.
Mercieca-BebberR.KingM. T.CalvertM. J.StocklerM. R.FriedlanderM. (2018). The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Related Outcome Measures, 9, 353–367. https://doi.org/10.2147/prom.S156279
21.
National Academies of Sciences, E., Medicine, Health, Medicine, D., Board on Health Sciences, P., & Committee on the Return of Individual-Specific Research Results Generated in Research, L. (2018). In A. S. Downey, E. R. Busta, M. Mancher, & J. R. Botkin (Eds.), Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. National Academies Press (US). Copyright 2018 by the National Academy of Sciences. All rights reserved. https://doi.org/10.17226/25094
22.
OerlemansS.ArtsL. P. J.KiefferJ. M.PrinsJ.HoogendoornM.van der PoelM.KosterA.LensenC.StevensW. B. C.IssaD.PruijtJ. F. M.OosterveldM.van der GriendR.NijzielM.TickL.PosthumaE. F. M.van de Poll-FranseL. V. (2021). Web-Based return of individual patient-reported outcome results among patients with lymphoma: Randomized controlled trial. Journal of Medical Internet Research, 23(12), e27886. https://doi.org/10.2196/27886
23.
PalA.ArnetI.ElgerB. S.WangmoT. (2024). Practices and barriers in developing and disseminating plain-language resources reporting medical research information: A scoping review. The Patient, 17(5), 493–518. https://doi.org/10.1007/s40271-024-00700-y
24.
PenlingtonM.SilvermanH.VasudevanA.PavithranP. (2020). Plain language summaries of clinical trial results: A preliminary study to assess availability of easy-to-understand summaries and approaches to improving public engagement. Pharmaceutical Medicine, 34(6), 401–406. https://doi.org/10.1007/s40290-020-00359-4
25.
Sciences, C. f. I. O. o. M. (2016). International Ethical Guidelines for Health-related Research Involving Humans: Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). . Retrieved 10-26-25 from https://www.ncbi.nlm.nih.gov/books/NBK614410/https://doi.org/10.56759/rgxl7405
26.
SgroG. M.MaurerM.NguyenB.SiegelJ. E. (2023). Return of aggregate results to study participants: Facilitators, barriers, and recommendations. Contemp Clin Trials Commun, 33, 101–136. https://doi.org/10.1016/j.conctc.2023.101136
27.
StollM.KerwerM.LiebK.ChasiotisA. (2022). Plain language summaries: A systematic review of theory, guidelines and empirical research. PLoS One, 17(6), e0268789. https://doi.org/10.1371/journal.pone.0268789
28.
ThomasD. R. (2006). A general inductive approach for analyzing qualitative evaluation data. American Journal of Evaluation, 27(2), 237–246. https://doi.org/10.1177/1098214005283748
29.
ThompsonJ.BissellP.CooperC. L.ArmitageC. J.BarberR. (2014). Exploring the impact of patient and public involvement in a cancer research setting. Qualitative Health Research: An International, Interdisciplinary Journal, 24(1), 46–54. https://doi.org/10.1177/1049732313514482
30.
VearsD. F.MinionJ. T.RobertsS. J.CummingsJ.MachiroriM.BlellM.Budin-LjøsneI.CowleyL.DykeS. O. M.GaffC.GreenR.HallA.JohnsA. L.KnoppersB. M.MulrineS.PatchC.WinklerE.MurtaghM. J. (2021). Return of individual research results from genomic research: A systematic review of stakeholder perspectives. PLoS One, 16(11), e0258646. https://doi.org/10.1371/journal.pone.0258646
31.
WaltzA.JohnsonB.SchwartzP. H. (2024). Returning clinically relevant research results to participants: Guidelines for investigators and the IRB. Ethics & Human Research, 46(2), 22–29. https://doi.org/10.1002/eahr.500204
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
