Current practices in patient-reported outcome (PRO) data collection in clinical trials: a cross-sectional survey of UK trial staff and management
Open accessAbstract
Objectives: Patient-reported outcome measures (PROMs) collected in clinical trials should be administered in a standardised way across sites and routinely screened for avoidable missing data in order to maximise data quality/minimise risk of bias. Recent qualitative findings, however, have raised concerns about the consistency of PROM administration in UK trials. The purpose of this study was to determine the generalisability of these findings across the wider community of trial personnel. Design: Online cross-sectional survey. Setting: Participants were recruited from 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Participants: Research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials collecting PROMs. Analysis: We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. Factors associated with the management of missing PRO data were explored using logistic regression. Results: Survey data from 767 respondents supported the generalisability of qualitative study findings, suggesting inconsistencies in PROM administration with regard to: the level of assistance given to trial participants; the timing of PROM completion in relation to the clinical consultation; and the management of missing data. Having ≥10 years experience in a research role was significantly associated with the appropriate management of missing PROM data (OR 2.26 (95% CI 1.06 to 4.82), p=0.035). There was a consensus that more PROM guidance was needed in future trials and agreement between professional groups about the necessary components. Conclusions: There are inconsistencies in the way PROMs are administered by trial staff. Such inconsistencies may reduce the quality of data and have the potential to introduce bias. There is a need for improved guidance in future trials that support trial personnel in conducting optimal PROM data collection to inform patient care.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
There are many problems inherent in the use of patient-reported outcome measures (PROM) in clinical trials.
“There are many problems inherent in the use of patient-reported outcome measures (PROM) in clinical trials [60]”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Three Approaches to Qualitative Content Analysis
Hsieh, H.-F., & Shannon, S. E. (2005) · Qualitative Health Research · doi:10.1177/1049732305276687 · Cited by 44,601 · see citing works
A simulation study of the number of events per variable in logistic regression analysis
Peduzzi, P., Concato, J., Kemper, E., Holford, T. R., & Feinstein, A. R. (1996) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(96)00236-3 · Cited by 9,655 · see citing works
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015) · doi:10.1007/978-3-319-18539-2 · Cited by 2,237 · see citing works
Avoidable waste in the production and reporting of research evidence
Chalmers, I., & Glasziou, P. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60329-9 · Cited by 2,208 · see citing works
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010) · Springer eBooks · doi:10.1007/978-1-4419-1586-3 · Cited by 532 · see citing works
Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion
Leidy, N. K., Revicki, D. A., & Genesté, B. (1999) · Value in Health · doi:10.1046/j.1524-4733.1999.02210.x · Cited by 387 · see citing works
Response bias: Characteristics of detection theory, threshold theory, and "nonparametric" indexes.
Macmillan, N. A., & Creelman, C. D. (1990) · Psychological Bulletin · doi:10.1037/0033-2909.107.3.401 · Cited by 387 · see citing works
Getting the Most out of PROMs: Putting Health Outcomes at the Heart of NHS Decision-Making
Devlin, N. J., & Appleby, J. (2010) · Monographs · Cited by 343 · see citing works
Drug-grapefruit juice interactions
Pirmohamed, M. (2013) · BMJ · doi:10.1136/bmj.f1 · Cited by 140 · see citing works
Calvert, M., & Freemantle, N. (2003) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1046/j.0269-4727.2003.00521.x · Cited by 121 · see citing works
Self-citationFielding, S., MacLennan, G., Cook, J. A., & Ramsay, C. R. (2008) · Trials · doi:10.1186/1745-6215-9-51 · Cited by 93 · see citing works
Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols
Kyte, D., Duffy, H., Fletcher, B., Gheorghe, A., Mercieca-Bebber, R., King, M., Draper, H., Ives, J., Brundage, M., Blazeby, J., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0110229 · Cited by 82 · see citing works
Self-citationBhardwaj, A., Rehman, S., Mohammed, A. A., Gaggin, H. K., Barajas, L. J., Barajas, J. A., Moore, S. A., Sullivan, D. A., & Januzzi, J. L. (2012) · American Heart Journal · doi:10.1016/j.ahj.2012.08.015 · Cited by 60 · see citing works
Kyte, D. G., Ives, J., Draper, H., Keeley, T., & Calvert, M. (2013) · PLoS ONE · doi:10.1371/journal.pone.0076625 · Cited by 59 · see citing works
Self-citationPatient-Reported Outcome Alerts
Kyte, D. G., Draper, H., & Calvert, M. (2013) · JAMA · doi:10.1001/jama.2013.277222 · Cited by 45 · see citing works
Self-citationKyte, D. G., Draper, H., Ives, J., Liles, C. R., Gheorghe, A., & Calvert, M. (2013) · PLoS ONE · doi:10.1371/journal.pone.0060684 · Cited by 35 · see citing works
Self-citationBasch, E., Abernethy, A. P., & Reeve, B. B. (2011) · Value in Health · doi:10.1016/j.jval.2011.10.002 · Cited by 26 · see citing works
The Importance of Standard Operating Procedures in Clinical Trials
Sajdak, R., Trembath, L., & Thomas, K. S. (2013) · Journal of Nuclear Medicine Technology · doi:10.2967/jnmt.113.121467 · Cited by 24 · see citing works
Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.
Kyte, D. G., Ives, J., Draper, H., & Calvert, M. (2016) · PLoS ONE · doi:10.1371/journal.pone.0144658 · Cited by 24 · see citing works
Self-citationPutting patients at the heart of health-care research
Calvert, M., Kyte, D. G., Hildebrand, M., King, M. T., & Moher, D. (2015) · The Lancet · doi:10.1016/s0140-6736(15)60599-2 · Cited by 18 · see citing works
Self-citationMosconi, P., Torri, V., Cifani, S., Ruggiata, R., Meyerowitz, B. E., Apolone, G., Liberati, A., & Interdisciplinary Group for Cancer Care Evaluation (GIVIO) (1998) · Statistics in Medicine · doi:10.1002/(sici)1097-0258(19980315/15)17:5/7 · Cited by 17 · see citing works
Basch, E., Abernethy, A. P., Mullins, C. D., Tiglao, M. R., & Tunis, S. (2011) · Value in Health · doi:10.1016/j.jval.2011.02.060 · Cited by 15 · see citing works
A Practical Guide on Incorporating and Evaluating Patient-Reported Outcomes in Clinical Trials
Luo, X., & Cappelleri, J. C. (2008) · Clinical Research and Regulatory Affairs · doi:10.1080/10601330802471162 · Cited by 13 · see citing works
Flagged first, then by citations
4 of the 28 references couldn’t be matched to a known paper.
Research works printed but not linked: 3
- [7]Bernhard J, Cella DF, Coates AS Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 1998; 17: 517– 32. 10.1002/(SICI)1097-0258(19980315/15)17:5/7<517::AID-SIM799>3.0.CO;2-S 9549801 · DOI
- [8]Bernhard J, Peterson HF, Coates AS Quality of life assessment in International Breast Cancer Study Group (IBCSG) trials: practical issues and factors associated with missing data. Stat Med 1998; 17: 587– 601. 10.1002/(SICI)1097-0258(19980315/15)17:5/7<587::AID-SIM806>3.0.CO;2-# 9549808 · DOI
- [10]Simes RJ, Greatorex V, Gebski VJ Practical approaches to minimize problems with missing quality of life data. Stat Med 1998; 17: 725– 37. 10.1002/(SICI)1097-0258(19980315/15)17:5/7<725::AID-SIM817>3.0.CO;2-1 9549819 · DOI
Cited by
Sorted by citations
Calvert, M., Kyte, D., Mercieca-Bebber, R., Slade, A., Chan, A.-W., King, M. T., and the SPIRIT-PRO Group, Hunn, A., Bottomley, A., Regnault, A., et al. (2018) · JAMA · doi:10.1001/jama.2017.21903 · Cited by 814 · see citing works
Self-citationCalvert, M., King, M. T., Mercieca‐Bebber, R., Aiyegbusi, O. L., Kyte, D. G., Slade, A. L., Chan, A., Basch, E., Bell, J. A., Bennett, A. V., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-045105 · Cited by 140 · see citing works
Self-citationRecommendations to address respondent burden associated with patient-reported outcome assessment
Aiyegbusi, O. L., Rivera, S. C., Roydhouse, J. K., Kamudoni, P., Alder, Y., Anderson, N. E., Baldwin, R. M., Bhatnagar, V., Black, J., Bottomley, A., et al. (2024) · Nature Medicine · doi:10.1038/s41591-024-02827-9 · Cited by 137 · see citing works
Self-citationSystematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials
Kyte, D. G., Retzer, A., Ahmed, K., Keeley, T., Armes, J., Brown, J. M., Calman, L. A., Gavin, A., Glaser, A., Greenfield, D., et al. (2019) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djz038 · Cited by 118 · see citing works
Self-citationFleischmann, M., & Vaughan, B. (2018) · International journal of osteopathic medicine · doi:10.1016/j.ijosm.2018.03.003 · Cited by 65 · see citing works
Haywood, K. L., Pearson, N. A., Morrison, L. J., Castrén, M. K., Lilja, G., & Perkins, G. D. (2017) · Resuscitation · doi:10.1016/j.resuscitation.2017.11.065 · Cited by 58 · see citing works
A patient-centred approach to measuring quality in kidney care
Aiyegbusi, O. L., Kyte, D. G., Cockwell, P., Anderson, N. E., & Calvert, M. (2017) · Current Opinion in Nephrology & Hypertension · doi:10.1097/mnh.0000000000000357 · Cited by 56 · see citing works
Self-citationHow to Include Patient-Reported Outcome Measures in Clinical Trials
McGee, R. (2020) · Current Osteoporosis Reports · doi:10.1007/s11914-020-00611-5 · Cited by 49 · see citing works
Cheung, Y. B., Yeo, K. K., Chong, K. J., Khoo, E. Y. H., & Wee, H. L. (2019) · Health and Quality of Life Outcomes · doi:10.1186/s12955-019-1130-0 · Cited by 48 · see citing works
Roydhouse, J. K., King‐Kallimanis, B. L., Howie, L. J., Singh, H., & Kluetz, P. G. (2018) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djy181 · Cited by 42 · see citing works
Yu, H., Yu, Q., Nie, Y., Xu, W., Pu, Y., Dai, W., Wei, X., & Shi, Q. (2021) · Journal of Medical Internet Research · doi:10.2196/28915 · Cited by 35 · see citing works
Daliya, P., Gemmill, E. H., Lobo, D. N., & Parsons, S. L. (2019) · HepatoBiliary Surgery and Nutrition · doi:10.21037/hbsn.2019.03.16 · Cited by 28 · see citing works
Lai-Kwon, J. E., Cohen, J. E., Lisy, K., Rutherford, C., Girgis, A., Basch, E., & Jefford, M. (2023) · JCO Clinical Cancer Informatics · doi:10.1200/cci.22.00185 · Cited by 28 · see citing works
Krüger, K., Burmester, G. R., Wassenberg, S., Bohl-Bühler, M. H. J., & Thomas, M. H. (2018) · Rheumatology International · doi:10.1007/s00296-018-4180-4 · Cited by 25 · see citing works
Lai-Kwon, J. E., Vanderbeek, A. M., Minchom, A. R., Aiyegbusi, O. L., Ogunleye, D., Stephens, R. J., Calvert, M., & Yap, C. (2022) · The Oncologist · doi:10.1093/oncolo/oyac117 · Cited by 17 · see citing works
Self-citationMeaningful improvement thresholds in measures of pain and quality of life in oral lichen planus
Wiriyakijja, P., Porter, S. R., Fedele, S., Hodgson, T. A., McMillan, R., Shephard, M. K., & Ríordáin, R. N. (2020) · Oral Diseases · doi:10.1111/odi.13379 · Cited by 16 · see citing works
Bachmann, J. M., Shiflet, M., Palacios, J. R., Turer, R. W., Wallace, G. H., Rosenbloom, S. T., & Rice, T. W. (2024) · Ethics & Human Research · doi:10.1002/eahr.500216 · Cited by 10 · see citing works
Psaltis, E., Varghese, C., Pandanaboyana, S., & Nayar, M. K. (2022) · World Journal of Gastrointestinal Endoscopy · doi:10.4253/wjge.v14.i7.443 · Cited by 11 · see citing works
Hughes, S., McMullan, C., Rowe, A. L., Retzer, A., Malpass, R., Bathurst, C. L., Davies, E. H., Frost, C., McNamara, G., Harding, R., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-063199 · Cited by 9 · see citing works
Self-citationToxicity and quality of life in published clinical trials for advanced lung cancer
Zwitter, M. (2018) · Supportive Care in Cancer · doi:10.1007/s00520-018-4214-1 · Cited by 9 · see citing works
Lloyd, M., Tang, C. Y., Callander, E. J., Janus, E. D., Karahalios, A., Skinner, E. H., Lowe, S., & Karunajeewa, H. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0481-y · Cited by 8 · see citing works
McMullan, C., Retzer, A., Hughes, S., Aiyegbusi, O. L., Bathurst, C. L., Boyd, A., Coleman, J. J., Davies, E. H., Denniston, A. K., Dunster, H., et al. (2023) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-023-00634-3 · Cited by 8 · see citing works
Self-citationMorris, M. E., Brusco, N. K., Woods, J., Myles, P. S., Hodge, A., Jones, C. H., Lloyd, D., Rovtar, V., Clifford, A. M., & Atkinson, V. (2021) · BMJ Open · doi:10.1136/bmjopen-2021-049937 · Cited by 7 · see citing works
What are the experiences of nurses delivering research studies in primary care?
Ballintine, A., & Potter, R. C. (2023) · Primary Health Care Research & Development · doi:10.1017/s146342362300035x · Cited by 7 · see citing works
Do Patient-Reported Outcome Measures Tell Us the Full Story?
Meadows, K. (2022) · Clinical Nursing Research · doi:10.1177/10547738221078335 · Cited by 7 · see citing works
Sacrococcygeal teratomas: midline reconstruction improves cosmesis without compromising outcomes
O’shea, K. M., Sanders, E., Farrelly, P. J., Wilkinson, D. J., Minshull, K., & Craigie, R. (2022) · Pediatric Surgery International · doi:10.1007/s00383-021-05055-1 · Cited by 6 · see citing works
Patient-reported outcome measures (PROMs) after laparoscopic cholecystectomy: systematic review
Melly, C., McGeehan, G., O’Connor, N., Johnston, A., Bass, G. A., Mohseni, S., Donohoe, C. L., Bucholc, M., & Sugrue, M. (2022) · BJS Open · doi:10.1093/bjsopen/zrac062 · Cited by 6 · see citing works
Webster, J., Northfield, S., Larsen, E. N., Marsh, N. M., Rickard, C. M., & Chan, R. J. (2018) · The Journal of Vascular Access · doi:10.1177/1129729818757965 · Cited by 6 · see citing works
Mediavilla, R., Muñoz-Sanjose, A., Rodriguez-Vega, B., Bayon, C., Palao, A., Lahera, G., Sanchez-Castro, P., Roman, E., Cebolla, S., de Diego, A., et al. (2019) · BMC Psychiatry · doi:10.1186/s12888-019-2206-4 · Cited by 5 · see citing works
Rogers, A., Morrison, I., Rorie, D. A., Mackenzie, I. S., & MacDonald, T. M. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-021890 · Cited by 5 · see citing works
Woo, J. M. P., Simmonds, F. C., Dennos, A. C., Son, M. B. F., Lewandowski, L. B., Rubinstein, T. B., & for the CARRA Registry investigators (2023) · Arthritis Care & Research · doi:10.1002/acr.25136 · Cited by 4 · see citing works
Hoffmann, C., AVERY, K. N. L., Macefield, R. C., Dvořák, T., Snelgrove, V., Blazeby, J. M., Hopkins, D., Hickey, S., Gibbison, B., Rooshenas, L., et al. (2024) · JMIR Human Factors · doi:10.2196/46698 · Cited by 4 · see citing works
Phenomenology: A Method for the Interpretation of Patient-Reported Outcomes
Meadows, K. (2024) · Clinical Nursing Research · doi:10.1177/10547738241240032 · Cited by 4 · see citing works
Wearable Accelerometers in Cancer Patients
Dadhania, S., & Williams, M. (2021) · Intelligent systems reference library · doi:10.1007/978-3-030-83620-7_5 · Cited by 2 · see citing works
Skovfoged, M. M., Mavromati, K., Tvrdá, L., Quinn, T. J., Körner, F., Chiesurin, S., Némcová, V., Mikulík, R., & Knoche, H. O. (2026) · ACM Transactions on Computing for Healthcare · doi:10.1145/3799983 · Cited by 2 · see citing works
The Test–Retest Reliability of Pain Outcome Measures in People With Phantom Limb Pain
Graham, A. N., Ryan, C. G., MacSween, A., Atkinson, G., Smith, S., & Martin, D. (2024) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000001219 · Cited by 1 · see citing works
Nuttall, J., & Rolls, C. (2024) · Hand Therapy · doi:10.1177/17589983241301451 · Cited by 1 · see citing works
Retzer, A., Al-Jilaihawi, S., Bailey, S., Buenger, V., Damery, S. L., Darlington, A., Diezi, M., Peipert, J. D., Roydhouse, J. K., & Reeve, B. B. (2025) · EJC Paediatric Oncology · doi:10.1016/j.ejcped.2025.100232 · Cited by 1 · see citing works
Sanjida, S. (2020) · Queensland University of Technology · doi:10.5204/thesis.eprints.192103 · Cited by 1 · see citing works
Senarath, G. H., Haghighi, P. D., O’Connor, D. A., Snowdon, D. A., Andrew, N. E., & Srikanth, V. K. (2022) · doi:10.31219/osf.io/3w8xz · Cited by 1 · see citing works
Nesterchuk, N. E., & Блайда, І. М. (2025) · Scientific Journal of National Pedagogical Dragomanov University Series 15 Scientific and pedagogical problems of physical culture (physical culture and sports) · doi:10.31392/udu-nc.series15.2025.02(187).25
McMullan, C., Retzer, A., Hughes, S., Aiyegbusi, O. L., Bathurst, C. L., Boyd, A., Coleman, J., Davies, E. H., Denniston, A. K., Dunster, H., et al. (2023) · Figshare · doi:10.6084/m9.figshare.24277167
Self-citationKnight, L., Withers, K. L., Beddard, M., Lloydwin, C., White, J., Puntoni, S., & Lewis, S. (2026) · IJQHC Communications · doi:10.1093/ijcoms/lyag012
McMullan, C., Hughes, S., Rowe, A. L., Retzer, A., Bathurst, C. L., Harding, R., Kyte, D. G., Davies, E. H., Wilson, R., Newsome, P. N., et al. (2026) · doi:10.2196/preprints.96973
Self-citationHealthcare Data Is So Dirty: Practical Data Cleaning Methods
Lyu, S., Craig, S., O’Reilly, G., & Taniar, D. (2026) · Springer handbooks · doi:10.1007/978-3-031-92372-2_29
- Authors
- Kyte, D., Ives, J., Draper, H., & Calvert, M.
- Affiliations
- University of Birmingham (GB)
- University of Bristol (GB)
- Corresponding author
- Kyte, Derek
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2016-10
- Volume
- 6
- Issue
- 10
- Pages
- e012281
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC5073494
- OpenAlex
- W2529787110
- Cited by
- 46
- References
- 28
- Citations by year
- 2026: 4 · 2025: 2 · 2024: 6 · 2023: 5 · 2022: 7 · 2021: 4 · 2020: 3 · 2019: 6 · 2018: 7 · 2017: 2
- FWCI
- 14.26
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMJ Open (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion, cc-by)
- HighWire Press Open Archive (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
- Explore Bristol Research (submittedVersion, cc-by)
- Funders
- National Institute for Health Research (School for Primary Care Research Studentship)
- Topics
- Social Sciences › Sociology and Political Science › Survey Methodology and Nonresponse
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- patient-reported outcome measures, clinical trials, research nurses, data quality, risk of bias, professional guidance
- MeSH terms
- Data Accuracy, Patient Reported Outcome Measures, Adult, Cross-Sectional Studies, United Kingdom, Humans, Middle Aged, Surveys and Questionnaires, Research Design, Research Personnel, Bias, Biomedical Research, Qualitative Research, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
