Recommendations to address respondent burden associated with patient-reported outcome assessment

被引：42

作者：

Aiyegbusi, Olalekan Lee ^{[1
,2
,3
,4
,5
,6
]}

Rivera, Samantha Cruz ^{[1
,5
]}

Roydhouse, Jessica ^{[7
,8
]}

Kamudoni, Paul ^{[9
]}

Alder, Yvonne ^{[1
]}

Anderson, Nicola ^{[1
,2
,3
,4
,10
]}

Baldwin, Robert Mitchell ^{[11
]}

Bhatnagar, Vishal ^{[12
]}

Black, Jennifer ^{[11
]}

Bottomley, Andrew ^{[13
]}

Brundage, Michael ^{[14
]}

Cella, David ^{[15
]}

Collis, Philip ^{[1
]}

Davies, Elin-Haf ^{[16
]}

Denniston, Alastair K. ^{[2
,3
,10
]}

Efficace, Fabio ^{[17
,18
]}

Gardner, Adrian ^{[19
,20
]}

Gnanasakthy, Ari ^{[21
]}

Golub, Robert M. ^{[22
]}

Hughes, Sarah E. ^{[1
,2
,3
,4
,5
]}

Jeyes, Flic ^{[1
]}

Kern, Scottie ^{[23
]}

King-Kallimanis, Bellinda L. ^{[24
]}

Martin, Antony ^{[25
]}

McMullan, Christel ^{[1
,5
]}

Mercieca-Bebber, Rebecca ^{[26
]}

Monteiro, Joao ^{[27
]}

Peipert, John Devin ^{[15
]}

Quijano-Campos, Juan Carlos ^{[28
,29
,30
]}

Quinten, Chantal ^{[31
]}

Rantell, Khadija Rerhou ^{[32
]}

Regnault, Antoine ^{[33
]}

Sasseville, Maxime ^{[11
]}

Schougaard, Liv Marit Valen ^{[34
]}

Sherafat-Kazemzadeh, Roya ^{[35
]}

Snyder, Claire ^{[36
,37
]}

Stover, Angela M. ^{[38
,39
]}

Verdi, Rav ^{[1
]}

Wilson, Roger ^{[1
,40
]}

Calvert, Melanie J. ^{[1
,2
,3
,4
,5
,6
]}

机构：

[1] Univ Birmingham, Inst Appl Hlth Res, Ctr Patient Reported Outcomes Res CPROR, Birmingham, England

[2] Univ Hosp Birmingham, Natl Inst Hlth & Care Res NIHR, Birmingham Biomed Res Ctr BRC, Birmingham, England

[3] Univ Birmingham, Birmingham, England

[4] Univ Birmingham, Natl Inst Hlth & Care Res NIHR, Appl Res Collaborat ARC West Midlands, Birmingham, England

[5] Univ Birmingham, NIHR Blood & Transplant Res Unit BTRU Precis Trans, Birmingham, England

[6] Univ Birmingham, Birmingham Hlth Partners Ctr Regulatory Sci & Inno, Birmingham, England

[7] Univ Tasmania, Menzies Inst Med Res, Hobart, Tas, Australia

[8] Brown Univ, Sch Publ Hlth, Providence, RI USA

[9] Merck KGaA, Darmstadt, Germany

[10] Univ Hosp Birmingham NHS Fdn Trust, Birmingham, England

[11] Hlth Canada, Ottawa, ON, Canada

[12] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA

[13] Bottomley Consulting Grp, Overijse, Belgium

[14] Queens Univ, Kingston, ON, Canada

[15] Northwestern Univ, Feinberg Sch Med, Dept Med Social Sci, Chicago, IL USA

[16] Aparito, Wrexham, Wales

[17] Data Ctr, Italian Grp Adult Hematol Dis GIMEMA, Rome, Italy

[18] Italian Grp Adult Hematol Dis GIMEMA, Hlth Outcomes Res Unit, Rome, Italy

[19] Royal Orthopaed Hosp NHS Fdn Trust, Birmingham, England

[20] Aston Univ, Birmingham, England

[21] RTI Hlth Solut, Durham, NC USA

[22] Northwestern Univ, Feinberg Sch Med, Dept Med, Chicago, IL USA

[23] Crit Path Inst, Tucson, AZ USA

[24] LUNGev Fdn, Bethesda, MD USA

[25] QC Med, Liverpool, England

[26] Univ Sydney, Fac Med & Hlth, NHMRC Clin Trials Ctr, Sydney, NSW, Australia

[27] Nat Med, New York, NY USA

[28] Queen Mary Univ London, William Harvey Res Inst, London, England

[29] St Bartholomews Hosp, Barts Hlth NHS Trust, London, England

[30] Royal Papworth Hosp NHS Fdn Trust, Cambridge, England

[31] European Med Agcy, Amsterdam, Netherlands

[32] Med & Healthcare Prod Regulatory Agcy, London, England

[33] Modus Outcomes, Lyon, France

[34] Godstrup Hosp, Ctr Patient Reported Outcomes, AmbuFlex, Herning, Denmark

[35] Mapi Res Trust, Lyon, France

[36] Johns Hopkins Sch Med, Baltimore, MD USA

[37] Johns Hopkins Sch Publ Hlth, Baltimore, MD USA

[38] Univ North Carolina, Chapel Hill, NC USA

[39] Univ North Carolina, Lineberger Comprehens Canc Ctr, Chapel Hill, NC USA

[40] Canc Res Advocacy Forum, London, England

来源：

NATURE MEDICINE | 2024年 / 30卷 / 03期

关键词：

PRO MEASURES; QUESTIONNAIRE;

D O I：

10.1038/s41591-024-02827-9

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden. Patient-reported outcomes are invaluable tools, but may impose a burden on patients; this consensus statement provides a set of 19 recommendations to reduce respondent burden.

引用

页码：650 / 659

页数：10

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