Understanding data visualization techniques in qualitative studies used to develop and validate patient-reported outcome measures: a targeted literature review.
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| Názov: | Understanding data visualization techniques in qualitative studies used to develop and validate patient-reported outcome measures: a targeted literature review. |
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| Autori: | Seo C; BioPharmaceuticals Medical Evidence, AstraZeneca, Gaithersburg, MD, USA. caroline.seo@astrazeneca.com., Hu S; Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA., King-Kallimanis BL; Patient-Focused Research Center, LUNGevity Foundation, Chicago, IL, USA., Chang AE; Division of Plastic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA., Regnault A; Modus Outcomes, Lyon, France., Miller AS; Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA., Kaur MN; Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA. |
| Zdroj: | Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2025 Jul; Vol. 34 (7), pp. 2031-2048. Date of Electronic Publication: 2025 Apr 25. |
| Spôsob vydávania: | Journal Article; Review |
| Jazyk: | English |
| Informácie o časopise: | Publisher: Springer Netherlands Country of Publication: Netherlands NLM ID: 9210257 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2649 (Electronic) Linking ISSN: 09629343 NLM ISO Abbreviation: Qual Life Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2005- : Netherlands : Springer Netherlands Original Publication: Oxford, UK : Rapid Communications of Oxford, Ltd, c1992- |
| Výrazy zo slovníka MeSH: | Patient Reported Outcome Measures* , Qualitative Research* , Data Visualization*, Humans ; Reproducibility of Results ; Quality of Life |
| Abstrakt: | Competing Interests: Declarations. Conflicts of interest: Ms. Caroline Seo is a full time employee at AstraZeneca, Dr. King-Kallimanis reports receiving grant support directly paid to their institution and not related to the project from the following: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Jazz Pharma, Genentech, Eli Lilly, Janssen, Takeda, Daiichi Sankyo, Blueprint Medicines, Janssen, Amgen, Seagen, and Manta Cares. Dr. King-Kallimanis report receiving consulting fees from Eli Lilly, Bristol Myers Squibb, AbbVie, Adelphi Values and Shionogi. The remaining authors have no conflict of interest to disclose. Purpose: Qualitative data that reflects patients' experiences are the foundation of any patient-reported outcome measure (PROM) development and validation study; however, there is limited understanding of the type of data visualization techniques that facilitate communication of this data. The goal of this targeted literature review was to investigate data visualization methods that have been used in published PROM development and validation literature to report qualitative results. Methods: A literature search in OVID via MEDLINE was conducted among the top 10 non-disease-specific journals publishing PROM qualitative development and validation studies. Studies that reported qualitative methods to develop/validate a PROM and included data visualization in the form of tables or figures were included. Article characteristics and data visualization types were extracted. Results: A total of 185 articles were included in data extraction. Most articles (n = 109, 59.1%) included figures (n = 172, average 2 relevant figures per article) in the form of hierarchy/flowcharts (n = 124, 72.1%) and bar charts (n = 29, 16.9%). Information reported in figures included depiction of conceptual frameworks (n = 112, 65.1%) and concept frequency (n = 40, 24.4%). Most articles (n = 152, 81.7%) included tables (n = 307, average 2 relevant tables per article). Information reported in tables included concept frequency (n = 133, 43.3%) and cognitive debriefing and revisions (n = 91, 29.6%). Conclusion: Data visualization techniques used to report qualitative results in the identified PROM qualitative development and validation studies were heterogeneous, and many studies did not utilize any data visualization techniques. This study will inform the development of guidance for using data visualizations to report qualitative PROM research. (© 2025. The Author(s), under exclusive licence to Springer Nature Switzerland AG.) |
| References: | Black, N. (2013). Patient reported outcome measures could help transform healthcare. BMJ, 346, f167. https://doi.org/10.1136/bmj.f167. (PMID: 10.1136/bmj.f16723358487) Wolff, A. C., Dresselhuis, A., Hejazi, S., Dixon, D., Gibson, D., Howard, A. F., et al. (2021). Healthcare provider characteristics that influence the implementation of individual-level Patient-Centered Outcome Measure (PROM) and Patient-Reported Experience Measure (PREM) data across practice settings: a protocol for a mixed methods systematic review with a narrative synthesis. Systematic Reviews, 10(1), 169. https://doi.org/10.1186/s13643-021-01725-2. (PMID: 10.1186/s13643-021-01725-2341080248188663) Calvert, M. J., Cruz Rivera, S., Retzer, A., Hughes, S. E., Campbell, L., Molony-Oates, B., et al. (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. (PMID: 10.1038/s41591-022-01781-835513530) Litchfield, I., Greenfield, S., Turner, G. M., Finnikin, S., & Calvert, M. J. (2021). Implementing PROMs in routine clinical care: a qualitative exploration of GP perspectives. BJGP Open. https://doi.org/10.3399/bjgpopen20X101135. (PMID: 10.3399/bjgpopen20X101135331993067960526) United States Food and Drug Administration (2024) Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making. FDA. Retrieved September 20, 2024, from https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical. United States Food and Drug Administration (2021) Roadmap to Patient-Focused Outcome Measurement in Clinical Trials (text version). FDA. Retrieved September 20, 2024 from https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/roadmap-patient-focused-outcome-measurement-clinical-trials-text-version. Gagnier, J. J., Lai, J., Mokkink, L. B., & Terwee, C. B. (2021). COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Quality of Life Research, 30(8), 2197–2218. https://doi.org/10.1007/s11136-021-02822-4. (PMID: 10.1007/s11136-021-02822-433818733) Comins, J. D., Brodersen, J., Siersma, V., Jensen, J., Hansen, C. F., & Krogsgaard, M. R. (2021). How to develop a condition-specific PROM. Scandinavian Journal of Medicine and Science in Sports, 31(6), 1216–1224. https://doi.org/10.1111/sms.13868. (PMID: 10.1111/sms.1386833145839) Krogsgaard, M. R., Brodersen, J., Christensen, K. B., Siersma, V., Jensen, J., Hansen, C. F., et al. (2021). How to translate and locally adapt a PROM. Assessment of cross-cultural differential item functioning. Scandinavian Journal of Medicine and Science in Sports, 31(5), 999–1008. https://doi.org/10.1111/sms.13854. (PMID: 10.1111/sms.1385433089516) Shelton, C. L., Smith, A. F., & Mort, M. (2014). Opening up the black box: an introduction to qualitative research methods in anaesthesia. Anaesthesia, 69(3), 270–280. https://doi.org/10.1111/anae.12517. (PMID: 10.1111/anae.1251724548356) Sin, C. H. (2007). Using software to open up the ‘black box’ of qualitative data analysis in evaluations: the experience of a multi-site team using NUD*IST version 6. Evaluation, 13(1), 110–120. https://doi.org/10.1177/1356389007073684. (PMID: 10.1177/1356389007073684) Morse, J. M. (1994). Critical issues in qualitative research methods. Thousand Oaks: SAGE. Munoz, J. M. (2017). Global business intelligence. Routledge. (PMID: 10.4324/9781315471136) Slone, D. J. (2009). Visualizing qualitative information. Qual Rep, 14(3), 489–497. Rubinson, C. (2019). Presenting qualitative comparative analysis: notation, tabular layout, and visualization. Methodol Innov, 12(2), 2059799119862110. https://doi.org/10.1177/2059799119862110. (PMID: 10.1177/2059799119862110) Pokorny, J. J., Norman, A., Zanesco, A. P., Bauer-Wu, S., Sahdra, B. K., & Saron, C. D. (2018). Network analysis for the visualization and analysis of qualitative data. Psychological Methods, 23(1), 169–183. https://doi.org/10.1037/met0000129. (PMID: 10.1037/met000012928569530) Guetterman, T. C., Fàbregues, S., & Sakakibara, R. (2021). Visuals in joint displays to represent integration in mixed methods research: a methodological review. Methods Psychol, 5, 100080. https://doi.org/10.1016/j.metip.2021.100080. (PMID: 10.1016/j.metip.2021.100080) Hjollund, N. H. I. (2019). Fifteen years’ use of patient-reported outcome measures at the group and patient levels: trend analysis. Journal of Medical Internet Research, 21(9), e15856. https://doi.org/10.2196/15856. (PMID: 10.2196/15856315739436792031) Churruca, K., Pomare, C., Ellis, L. A., Long, J. C., Henderson, S. B., Murphy, L. E. D., et al. (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. (PMID: 10.1111/hex.13254339497558369118) Arnet, I., Messerli, M., Oezvegyi, J., Hersberger, K., & Sahm, L. (2020). Translation to English, cross-cultural adaptation, and pilot testing of the self-report questionnaire on swallowing difficulties with medication intake and coping strategies (SWAMECO) for adults with polypharmacy. British Medical Journal Open, 10(8), e036761. https://doi.org/10.1136/bmjopen-2020-036761. (PMID: 10.1136/bmjopen-2020-036761) Victorson, D. E., Cella, D., Grund, H., & Judson, M. A. (2014). A conceptual model of health-related quality of life in sarcoidosis. Quality of Life Research, 23(1), 89–101. https://doi.org/10.1007/s11136-013-0438-1. (PMID: 10.1007/s11136-013-0438-123709098) Parslow, R. M., Anderson, N., Byrne, D., Haywood, K. L., Shaw, A., & Crawley, E. (2020). Development of a conceptual framework to underpin a health-related quality of life outcome measure in paediatric Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): prioritisation through card ranking. Quality of Life Research, 29(5), 1169–1181. https://doi.org/10.1007/s11136-019-02399-z. (PMID: 10.1007/s11136-019-02399-z319078707190584) van Nooten, F. E., Cline, J., Elash, C. A., Paty, J., & Reaney, M. (2018). Development and content validation of a patient-reported endometriosis pain daily diary. Health and Quality of Life Outcomes, 16, 3. https://doi.org/10.1186/s12955-017-0819-1. (PMID: 10.1186/s12955-017-0819-1293015575753477) Brod, M., Alolga, S. L., Beck, J. F., Wilkinson, L., Højbjerre, L., & Rasmussen, M. H. (2017). Understanding burden of illness for child growth hormone deficiency. Quality of Life Research, 26(7), 1673–1686. https://doi.org/10.1007/s11136-017-1529-1. (PMID: 10.1007/s11136-017-1529-1282473155486907) Kelly, L., Potter, C. M., Hunter, C., Gibbons, E., Fitzpatrick, R., Jenkinson, C., & Peters, M. (2016). Refinement of the Long-Term Conditions Questionnaire (LTCQ): Patient and expert stakeholder opinion. Patient Relat Outcome Meas, 7, 183–193. https://doi.org/10.2147/PROM.S116987. (PMID: 10.2147/PROM.S116987278955235118027) Wiklund, I., Holmstrom, S., Stoker, M., Wyrwich, K. W., & Devine, M. (2013). Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire? Health and Quality of Life Outcomes, 11, 8. https://doi.org/10.1186/1477-7525-11-8. (PMID: 10.1186/1477-7525-11-8233320373598534) Hareendran, A., Mannix, S., Skalicky, A., Bayliss, M., Blumenfeld, A., Buse, D. C., et al. (2017). Development and exploration of the content validity of a patient-reported outcome measure to evaluate the impact of migraine- the Migraine Physical Function Impact Diary (MPFID). Health and Quality of Life Outcomes, 15, 224. https://doi.org/10.1186/s12955-017-0799-1. (PMID: 10.1186/s12955-017-0799-1291499015693572) Eskildsen, N. B., Ross, L., Bulsara, C., Dietz, S. M., Thomsen, T. G., Groenvold, M., et al. (2020). Development and content validation of a questionnaire measuring patient empowerment in cancer follow-up. Quality of Life Research, 29(8), 2253–2274. https://doi.org/10.1007/s11136-020-02483-9. (PMID: 10.1007/s11136-020-02483-932519187) Robson, J. C., Dawson, J., Cronholm, P. F., Milman, N., Kellom, K. S., Ashdown, S., et al. (2018). Health-related quality of life in ANCA-associated vasculitis and item generation for a disease-specific patient-reported outcome measure. Patient Relat Outcome Meas, 9, 17–34. https://doi.org/10.2147/PROM.S144992. (PMID: 10.2147/PROM.S144992293793225759851) Kleinman, L., Mannix, S., Arnold, L. M., Burbridge, C., Howard, K., McQuarrie, K., et al. (2014). Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary. Health and Quality of Life Outcomes, 12, 111. https://doi.org/10.1186/s12955-014-0111-6. (PMID: 10.1186/s12955-014-0111-6250174554110695) Hareendran, A., Palsgrove, A. C., Mocarski, M., Schaefer, M. L., Setyawan, J., Carson, R., & Make, B. (2013). The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease. Health and Quality of Life Outcomes, 11, 104. https://doi.org/10.1186/1477-7525-11-104. (PMID: 10.1186/1477-7525-11-104237998833701508) Crocker, H., Jenkinson, C., & Peters, M. (2018). Quality of life in coeliac disease: qualitative interviews to develop candidate items for the Coeliac disease assessment questionnaire. Patient Relat Outcome Meas, 9, 211–220. https://doi.org/10.2147/PROM.S149238. (PMID: 10.2147/PROM.S149238300134086038864) Jacobson, T. A., Edelman, S. V., Galipeau, N., Shields, A. L., Mallya, U. G., Koren, A., & Davidson, M. H. (2017). Development and content validity of the Statin Experience Assessment Questionnaire (SEAQ)©. Patient, 10(3), 321–334. https://doi.org/10.1007/s40271-016-0211-y. (PMID: 10.1007/s40271-016-0211-y27981439) Bell, J. A., Galaznik, A., Pompilus, F., Strzok, S., Bejar, R., Scipione, F., et al. (2019). A pragmatic patient-reported outcome strategy for rare disease clinical trials: application of the EORTC item library to myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia. J Patient Rep Outcomes, 3(1), 35. https://doi.org/10.1186/s41687-019-0123-4. (PMID: 10.1186/s41687-019-0123-4312184546584583) Fenwick, E. K., Pesudovs, K., Khadka, J., Dirani, M., Rees, G., Wong, T. Y., & Lamoureux, E. L. (2012). The impact of diabetic retinopathy on quality of life: qualitative findings from an item bank development project. Quality of Life Research, 21(10), 1771–1782. https://doi.org/10.1007/s11136-012-0110-1. (PMID: 10.1007/s11136-012-0110-122290480) Mannix, S., Skalicky, A., Buse, D. C., Desai, P., Sapra, S., Ortmeier, B., et al. (2016). Measuring the impact of migraine for evaluating outcomes of preventive treatments for migraine headaches. Health and Quality of Life Outcomes, 14(1), 143. https://doi.org/10.1186/s12955-016-0542-3. (PMID: 10.1186/s12955-016-0542-3277162285053168) Moher, D., Liberati, A., Tetzlaff, J., & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Annals of Internal Medicine, 151(4), 264. https://doi.org/10.7326/0003-4819-151-4-200908180-00135. (PMID: 10.7326/0003-4819-151-4-200908180-0013519622511) Moher, D., Schulz, K. F., & Altman, D. G. (2001). The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 357(9263), 1191–1194. https://doi.org/10.1016/S0140-6736(00)04337-3. (PMID: 10.1016/S0140-6736(00)04337-311323066) Remshard, M., & Queenborough, S. A. (2023). Design of tables for the presentation and communication of data in ecological and evolutionary biology. Ecology and Evolution, 13(7), e10062. https://doi.org/10.1002/ece3.10062. (PMID: 10.1002/ece3.100623745606710346464) Cleveland, W. S. (1985). The elements of graphing data. Belmont: Wadsworth Publ Co. https://doi.org/10.5555/4084. (PMID: 10.5555/4084) Wilke CO (2019) Fundamentals of data visualization: a primer on making informative and compelling figures. O’Reilly Media. https://books.google.com/books?hl=en&lr=&id=XmmNDwAAQBAJ&oi=fnd&pg=PP1&dq=Fundamentals+of+Data+Visualization:+A+primer+on+making+informative+and+compelling+figures.+O%27Rielly+Media,+Inc.+&ots=6MH-j0_zy6&sig=6P0yU3ms7T-jAYYiuz2zn8W4488. Ruzich, E., Ritchie, J., Ginchereau Sowell, F., Mansur, A., Griffiths, P., Birkett, H., et al. (2024). A powerful partnership: researchers and patients working together to develop a patient-facing summary of clinical trial outcome data. Journal of the American Medical Informatics Association, 31(2), 363–374. https://doi.org/10.1093/jamia/ocad099. (PMID: 10.1093/jamia/ocad09937341698) Slade, A. L., O’Hara, M. E., Quinn, D., Marley, L., Griffith, S., Calvert, M., et al. (2022). Living with a left ventricular assist device: capturing recipients experiences using group concept mapping software. PLoS ONE, 17(9), e0273108. https://doi.org/10.1371/journal.pone.0273108. (PMID: 10.1371/journal.pone.0273108361299289491568) Keeley, T. J. H., Satram, S., Ghafoori, P., Reyes, C., Birch, H. J., Raymond, K., et al. (2023). Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus©) instrument in patients with COVID-19. Quality of Life Research, 32(6), 1645–1657. https://doi.org/10.1007/s11136-022-03336-3. (PMID: 10.1007/s11136-022-03336-3367030199879742) Gater, A., Abetz-Webb, L., Battersby, C., Parasuraman, B., McIntosh, S., Nathan, F., & Piault, E. C. (2011). Pain in castration-resistant prostate cancer with bone metastases: a qualitative study. Health and Quality of Life Outcomes, 9, 88. https://doi.org/10.1186/1477-7525-9-88. (PMID: 10.1186/1477-7525-9-88219927203222603) Nguyen, A. M., Humphrey, L., Kitchen, H., Rehman, T., & Norquist, J. M. (2015). A qualitative study to develop a patient-reported outcome for dysmenorrhea. Quality of Life Research, 24, 181–191. (PMID: 2504873110.1007/s11136-014-0755-z) Tatlock, S., Grant, L., Spertus, J. A., Khan, I., Arbuckle, R., Manvelian, G., & Sanchez, R. J. (2015). Development and content validity testing of a patient-reported treatment acceptance measure for use in patients receiving treatment via subcutaneous injection. Value Health, 18(8), 1000–1007. (PMID: 2668678410.1016/j.jval.2015.09.2937) Borghs, S., Tomaszewski, E. L., Halling, K., & de la Loge, C. (2016). Understanding the patient perspective of seizure severity in epilepsy: development of a conceptual model. Patient, 9, 419–431. (PMID: 2700231810.1007/s40271-016-0165-0) Nelsen, L., Gater, A., Panter, C., Tolley, C., Lee, L., & Pascoe, S. (2018). Understanding and measuring symptoms and health status in asthma COPD overlap: content validity of the EXACT and SGRQ. J Patient Rep Outcomes, 2(1), 18. https://doi.org/10.1186/s41687-018-0038-5. (PMID: 10.1186/s41687-018-0038-55935047) Degboe, A., Knight, S. L., Halling, K., Trigg, A., Al-Zubeidi, T., Aldhouse, N., et al. (2018). Patients’ experience of recurrent/metastatic head and neck squamous cell carcinoma and their perspective on the EORTC QLQ-C30 and QLQ-H&N35 questionnaires: a qualitative study. J Patient Rep Outcomes, 2(1), 33. https://doi.org/10.1186/s41687-018-0060-7. (PMID: 10.1186/s41687-018-0060-7301482506092741) Gater, A., Nelsen, L., Fleming, S., Lundy, J. J., Bonner, N., Hall, R., et al. (2016). Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the asthma daily symptom diary. Value Health, 19(4), 440–450. (PMID: 2732533610.1016/j.jval.2016.01.007) Lorenz, E. C., Egginton, J. S., Stegall, M. D., Cheville, A. L., Heilman, R. L., Nair, S. S., et al. (2019). Patient experience after kidney transplant: a conceptual framework of treatment burden. J Patient Rep Outcomes, 3(1), 8. https://doi.org/10.1186/s41687-019-0095-4. (PMID: 10.1186/s41687-019-0095-4307013336353980) Paty, J., Elash, C. A., & Turner-Bowker, D. M. (2017). Content validity for the VVSymQ® instrument: a new patient-reported outcome measure for the assessment of varicose veins symptoms. Patient, 10(1), 51–63. https://doi.org/10.1007/s40271-016-0183-y. (PMID: 10.1007/s40271-016-0183-y27384669) Tatlock, S., Rüdell, K., Panter, C., Arbuckle, R., Harrold, L. R., Taylor, W. J., & Symonds, T. (2017). What outcomes are important for gout patients? In-depth qualitative research into the gout patient experience to determine optimal endpoints for evaluating therapeutic interventions. Patient, 10(1), 65–79. https://doi.org/10.1007/s40271-016-0184-x. (PMID: 10.1007/s40271-016-0184-x27384670) Tomaszewski, E. L., Moise, P., Krupnick, R. N., Downing, J., Meyer, M., Naidoo, S., & Holmstrom, S. (2017). Symptoms and impacts in non-metastatic castration-resistant prostate cancer: qualitative study findings. Patient, 10(5), 567–578. https://doi.org/10.1007/s40271-017-0227-y. (PMID: 10.1007/s40271-017-0227-y282854125605614) Martin, M. L., Halling, K., Eek, D., Krohe, M., & Paty, J. (2017). Understanding polycystic ovary syndrome from the patient perspective: a concept elicitation patient interview study. Health and Quality of Life Outcomes, 15(1), 162. https://doi.org/10.1186/s12955-017-0736-3. (PMID: 10.1186/s12955-017-0736-3288212945562990) Pfeiffer, K. M., Brod, M., Smith, A., Gianettoni, J., Viuff, D., Ota, S., & Charlton, R. W. (2021). Assessing the impacts of having a child with achondroplasia on parent well-being. Quality of Life Research, 30(1), 203–215. https://doi.org/10.1007/s11136-020-02594-3. (PMID: 10.1007/s11136-020-02594-332803627) Brod, M., Waldman, L. T., Smith, A., & Karpf, D. (2021). Living with hypoparathyroidism: development of the Hypoparathyroidism Patient Experience Scale-Impact (HPES-Impact). Quality of Life Research, 30(1), 277–291. https://doi.org/10.1007/s11136-020-02607-1. (PMID: 10.1007/s11136-020-02607-132833143) Gater, A., Taylor, F., Seitz, C., Gerlinger, C., Wichmann, K., & Haberland, C. (2020). Development and content validation of two new patient-reported outcome measures for endometriosis: the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS). J Patient Rep Outcomes, 4(1), 13. https://doi.org/10.1186/s41687-020-0177-3. (PMID: 10.1186/s41687-020-0177-3320723167028881) Mathias, S. D., Blum, S. I., Sikirica, V., Johansen, K. L., Colwell, H. H., & Okoro, T. (2020). Symptoms and impacts in anemia of chronic kidney disease. J Patient Rep Outcomes, 4(1), 64. https://doi.org/10.1186/s41687-020-00215-8. (PMID: 10.1186/s41687-020-00215-8327287797391458) Trudeau, J. J., He, J., Rose, E., Panter, C., Randhawa, S., & Gater, A. (2020). Content validity of patient-reported outcomes for use in lower-risk myelodysplastic syndromes. J Patient Rep Outcomes, 4(1), 69. https://doi.org/10.1186/s41687-020-00235-4. (PMID: 10.1186/s41687-020-00235-4328515697450032) Turner-Bowker, D. M., An Haack, K., Krohe, M., Yaworsky, A., Vivas, N., Kelly, M., et al. (2020). Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures. J Patient Rep Outcomes, 4(1), 80. https://doi.org/10.1186/s41687-020-00246-1. (PMID: 10.1186/s41687-020-00246-1330003277527387) Moshkovich, O., Benjamin, K., Hall, K., Murphy, R., Von Maltzahn, R., Gorsh, B., et al. (2020). Development of a conceptual model and patient-reported outcome measures for assessing symptoms and functioning in patients with heart failure. Quality of Life Research, 29(10), 2835–2848. https://doi.org/10.1007/s11136-020-02537-y. (PMID: 10.1007/s11136-020-02537-y324684057561560) Yucel, A., Skalicky, A., Eseyin, O. R., Yucel, E., Belani, R., & Bensink, M. (2021). Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF). J Patient Rep Outcomes, 5(1), 10. https://doi.org/10.1186/s41687-020-00277-8. (PMID: 10.1186/s41687-020-00277-8334598877813942) Chhina, H., Klassen, A. F., Kopec, J. A., Oliffe, J., Iobst, C., Dahan-Oliel, N., et al. (2021). What matters to children with lower limb deformities: an international qualitative study guiding the development of a new patient-reported outcome measure. J Patient Rep Outcomes, 5(1), 30. https://doi.org/10.1186/s41687-021-00299-w. (PMID: 10.1186/s41687-021-00299-w337927938017030) White, M. K., Saucier, C., Bailey, M., D’Alessio, D., Foster, A., St. Pierre, D., & Raymond, K. (2021). Content validation of a self-report daily diary in patients with sickle cell disease. J Patient Rep Outcomes, 5(1), 63. https://doi.org/10.1186/s41687-021-00337-7. (PMID: 10.1186/s41687-021-00337-7343183788316505) Patel, N., Maher, J., Lie, X., Gwaltney, C., Barzi, A., Karwal, M., et al. (2022). Understanding the patient experience in hepatocellular carcinoma: a qualitative patient interview study. Quality of Life Research, 31(2), 473–485. https://doi.org/10.1007/s11136-021-02903-4. (PMID: 10.1007/s11136-021-02903-434115280) Zaiser, E., Sehnert, A. J., Duenas, A., Saberi, S., Brookes, E., & Reaney, M. (2020). Patient experiences with hypertrophic cardiomyopathy: a conceptual model of symptoms and impacts on quality of life. J Patient Rep Outcomes, 4(1), 102. https://doi.org/10.1186/s41687-020-00269-8. (PMID: 10.1186/s41687-020-00269-8332590417708573) Fehnel, S. E., Ervin, C. M., Carson, R. T., Rigoni, G., Lackner, J. M., & Coons, S. J. (2017). Development of the diary for irritable bowel syndrome symptoms to assess treatment benefit in clinical trials: foundational qualitative research. Value Health, 20(4), 618–626. (PMID: 2840800410.1016/j.jval.2016.11.001) Leffler, D. A., Acaster, S., Gallop, K., Dennis, M., Kelly, C. P., & Adelman, D. C. (2017). A novel patient-derived conceptual model of the impact of celiac disease in adults: implications for patient-reported outcome and health-related quality-of-life instrument development. Value Health, 20(4), 637–643. (PMID: 2840800610.1016/j.jval.2016.12.016) Kleinman, L., Talbot, G. H., Hunsche, E., Schüler, R., & Nord, C. E. (2018). The CDI-DaySyms: content development of a new patient-reported outcome questionnaire for symptoms of Clostridium difficile infection. Value Health, 21(4), 441–448. (PMID: 2968010110.1016/j.jval.2017.08.3017) Hudgens, S., Schüler, R., Stokes, J., Eremenco, S., Hunsche, E., & Leist, T. P. (2019). Development and validation of the FSIQ-RMS: a new patient-reported questionnaire to assess symptoms and impacts of fatigue in relapsing multiple sclerosis. Value Health, 22(4), 453–466. (PMID: 3097539710.1016/j.jval.2018.11.007) Martins, A., Bennister, L., Fern, L. A., Gerrand, C., Onasanya, M., Storey, L., et al. (2020). Development of a patient-reported experience questionnaire for patients with sarcoma: the Sarcoma Assessment Measure (SAM). Quality of Life Research, 29(8), 2287–2297. https://doi.org/10.1007/s11136-020-02481-x. (PMID: 10.1007/s11136-020-02481-x32227293) Bonner, N., Abetz-Webb, L., Renault, L., Caballero, T., Longhurst, H., Maurer, M., et al. (2015). Development and content validity testing of a patient-reported outcomes questionnaire for the assessment of hereditary angioedema in observational studies. Health and Quality of Life Outcomes, 13(1), 92. https://doi.org/10.1186/s12955-015-0292-7. (PMID: 10.1186/s12955-015-0292-7261299304487558) Eton, D., Ridgeway, J., Egginton, J., Tiedje, K., Linzer, M., Boehm, D., et al. (2015). Finalizing a measurement framework for the burden of treatment in complex patients with chronic conditions. Patient Relat Outcome Meas. https://doi.org/10.2147/PROM.S78955. (PMID: 10.2147/PROM.S78955258483284383147) Herman, J. M., Kitchen, H., Degboe, A., Aldhouse, N. V. J., Trigg, A., Hodgin, M., et al. (2019). Exploring the patient experience of locally advanced or metastatic pancreatic cancer to inform patient-reported outcomes assessment. Quality of Life Research, 28(11), 2929–2939. https://doi.org/10.1007/s11136-019-02233-6. (PMID: 10.1007/s11136-019-02233-6312736246803577) Oladapo, A. O., Ito, D., Hibbard, C., Bean, S. E., Krupnick, R. N., & Ewenstein, B. M. (2019). Patient experience with congenital (hereditary) thrombotic thrombocytopenic purpura: a conceptual framework of symptoms and impacts. Patient, 12(5), 503–512. https://doi.org/10.1007/s40271-019-00365-y. (PMID: 10.1007/s40271-019-00365-y313593416697707) McCarrier, K. P., Hassan, M., Hodgkins, P., Suthoff, E., McGarry, L. J., & Martin, M. L. (2020). The cystic fibrosis impact questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis. J Patient Rep Outcomes, 4(1), 36. https://doi.org/10.1186/s41687-020-00199-5. (PMID: 10.1186/s41687-020-00199-5324058787221045) Howard, K., Berry, P., Petrillo, J., Wiklund, I., Roberts, L., Watkins, M., et al. (2012). Development of the Shortness of Breath with Daily Activities questionnaire (SOBDA). Value Health, 15(8), 1042–1050. (PMID: 2324480610.1016/j.jval.2012.06.018) Dowling, A., Slungaard, E., & Heneghan, N. R. (2021). Development of a patient-reported outcome measure for neck pain in military aircrew: qualitative interviews to inform design and content. British Medical Journal Open, 11(2), e039488. Lewis, S., Price, M., Dwyer, K. A., O’Brien, S., Heekin, R. D., Yates, P. J., et al. (2014). Development of a scale to assess performance following primary total knee arthroplasty. Value Health, 17(4), 350–359. (PMID: 2496899410.1016/j.jval.2014.01.006) Keininger, D., & Coteur, G. (2011). Assessment of self-injection experience in patients with rheumatoid arthritis: Psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ). Health and Quality of Life Outcomes, 9(1), 2. https://doi.org/10.1186/1477-7525-9-2. (PMID: 10.1186/1477-7525-9-2212321063027089) Whalley, D., Globe, G., Crawford, R., Doward, L., Tafesse, E., Brazier, J., & Price, D. (2018). Is the EQ-5D fit for purpose in asthma? Acceptability and content validity from the patient perspective. Health and Quality of Life Outcomes, 16(1), 160. https://doi.org/10.1186/s12955-018-0970-3. (PMID: 10.1186/s12955-018-0970-3300757296090889) Pompilus, F., Ciesluk, A., Strzok, S., Ciaravino, V., Harris, K., Szegvari, B., et al. (2020). Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire. Health and Quality of Life Outcomes, 18(1), 355. https://doi.org/10.1186/s12955-020-01606-7. (PMID: 10.1186/s12955-020-01606-7331482617640481) Luo, Y., Yang, J., & Zhang, Y. (2015). Development and validation of a patient-reported outcome measure for stroke patients. Health and Quality of Life Outcomes, 13(1), 53. https://doi.org/10.1186/s12955-015-0246-0. (PMID: 10.1186/s12955-015-0246-0259535084489208) Higgins, P. D. R., Harding, G., Revicki, D. A., Globe, G., Patrick, D. L., Fitzgerald, K., et al. (2018). Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro/SS) diary. J Patient Rep Outcomes, 2(1), 26. https://doi.org/10.1186/s41687-018-0049-2. (PMID: 10.1186/s41687-018-0049-25976680) Hamilton, C. B., Hoens, A. M., McQuitty, S., McKinnon, A. M., English, K., Backman, C. L., et al. (2018). Development and pre-testing of the Patient Engagement In Research Scale (PEIRS) to assess the quality of engagement from a patient perspective. PLoS ONE, 13(11), e0206588. (PMID: 30383823621172710.1371/journal.pone.0206588) Holm-Larsen, T., Andersson, F., van der Meulen, E., Yankov, V., Rosen, R. C., & Nørgaard, J. P. (2014). The nocturia impact diary: a self-reported impact measure to complement the voiding diary. Value Health, 17(6), 696–706. (PMID: 2523699310.1016/j.jval.2014.06.007) Toupin April, K., Stinson, J., Boon, H., Duffy, C. M., Huber, A. M., Gibbon, M., et al. (2016). Development and preliminary face and content validation of the “Which health approaches and treatments are you using?”(WHAT) Questionnaires assessing complementary and alternative medicine use in pediatric rheumatology. PLoS ONE, 11(3), e0149809. (PMID: 26964088478631810.1371/journal.pone.0149809) Alberts, J., Löwe, B., Glahn, M. A., Petrie, K., Laferton, J., Nestoriuc, Y., & Shedden-Mora, M. (2020). Development of the generic, multidimensional Treatment Expectation Questionnaire (TEX-Q) through systematic literature review, expert surveys and qualitative interviews. British Medical Journal Open, 10(8), e036169. Welch, L. C., Trudeau, J. J., Silverstein, S. M., Sand, M., Henderson, D. C., & Rosen, R. C. (2017). Initial development of a patient-reported outcome measure of experience with cognitive impairment associated with schizophrenia. Patient Relat Outcome Meas, 8, 71–81. https://doi.org/10.2147/PROM.S123266. (PMID: 10.2147/PROM.S123266286528365476762) Korlén, S., Richter, A., Amer-Wåhlin, I., Lindgren, P., & Von Thiele Schwarz, U. (2018). The development and validation of a scale to explore staff experience of Governance of economic Efficiency and Quality (GOV-EQ) of health care. BMC Health Services Research, 18(1), 963. https://doi.org/10.1186/s12913-018-3765-7. (PMID: 10.1186/s12913-018-3765-7305415376292102) Williams, L. A., Whisenant, M. S., Mendoza, T. R., Haq, S., Keating, K. N., Cuffel, B., & Cleeland, C. S. (2018). Modification of existing patient-reported outcome measures: qualitative development of the MD Anderson Symptom Inventory for Malignant Pleural Mesothelioma (MDASI-MPM). Quality of Life Research, 27(12), 3229–3241. https://doi.org/10.1007/s11136-018-1982-5. (PMID: 10.1007/s11136-018-1982-530187393) Bullinger, M., Quitmann, J., Power, M., Herdman, M., Mimoun, E., DeBusk, K., et al. (2013). Assessing the quality of life of health-referred children and adolescents with short stature: development and psychometric testing of the QoLISSY instrument. Health and Quality of Life Outcomes, 11(1), 76. https://doi.org/10.1186/1477-7525-11-76. (PMID: 10.1186/1477-7525-11-76236481123666886) Johnson, C. D., Arbuckle, R., Bonner, N., Connett, G., Dominguez-Munoz, E., Levy, P., et al. (2017). Qualitative assessment of the symptoms and impact of pancreatic Exocrine Insufficiency (PEI) to inform the development of a Patient-Reported Outcome (PRO) instrument. Patient, 10(5), 615–628. https://doi.org/10.1007/s40271-017-0233-0. (PMID: 10.1007/s40271-017-0233-0283320325605612) Carney, M. J., Golden, K. E., Weissler, J. M., Lanni, M. A., Bauder, A. R., Cakouros, B., et al. (2018). Patient-reported outcomes following ventral hernia repair: designing a qualitative assessment tool. Patient, 11, 225–234. (PMID: 2885660510.1007/s40271-017-0275-3) Horodniceanu, E. G., Bal, V., Dhatt, H., Carter, J. A., Huang, V., & Lasch, K. (2017). Qualitative modification and development of patient- and caregiver-reported outcome measures for iron chelation therapy. Health and Quality of Life Outcomes, 15(1), 129. https://doi.org/10.1186/s12955-017-0702-0. (PMID: 10.1186/s12955-017-0702-0286452705481883) McKenna, S. P., Meads, D. M., Doward, L. C., Twiss, J., Pokrzywinski, R., Revicki, D., et al. (2011). Development and validation of the living with chronic obstructive pulmonary disease questionnaire. Quality of Life Research, 20, 1043–1052. (PMID: 2131206510.1007/s11136-011-9850-6) Abetz, L., Rajagopalan, K., Mertzanis, P., Begley, C., Barnes, R., Chalmers, R., The impact of dry eye on everyday life (IDEEL) Study Group. (2011). Development and validation of the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire, a Patient-Reported Outcomes (PRO) measure for the assessment of the burden of dry eye on patients. Health and Quality of Life Outcomes, 9(1), 111. https://doi.org/10.1186/1477-7525-9-111. (PMID: 10.1186/1477-7525-9-111221521253269387) Eton, D., Ramalho De Oliveira, D., Egginton, J., Ridgeway, J., Odell, L., May, C., & Montori, V. (2012). Building a measurement framework of burden of treatment in complex patients with chronic conditions: a qualitative study. Patient Relat Outcome Meas. https://doi.org/10.2147/PROM.S34681. (PMID: 10.2147/PROM.S34681231851213506008) Brod, M., Blum, S. I., Bushnell, D. M., & Ramasamy, A. (2015). Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure. Quality of Life Research, 24, 3001–3014. (PMID: 2606873210.1007/s11136-015-1037-0) Hareendran, A., Setyawan, J., Pokrzywinski, R., Steenrod, A., Madhoo, M., & Erder, M. H. (2015). Evaluating functional outcomes in adolescents with attention-deficit/hyperactivity disorder: development and initial testing of a self-report instrument. Health and Quality of Life Outcomes, 13(1), 133. https://doi.org/10.1186/s12955-015-0302-9. (PMID: 10.1186/s12955-015-0302-9262972054546290) Howells, L. M., Chalmers, J. R., Cowdell, F., Ratib, S., Santer, M., & Thomas, K. S. (2017). ‘When it goes back to my normal I suppose’: a qualitative study using online focus groups to explore perceptions of ‘control’among people with eczema and parents of children with eczema in the UK. British Medical Journal Open, 7(11), e017731. Leidy, N. K., Wilcox, T. K., Jones, P. W., Murray, L., Winnette, R., Howard, K., et al. (2010). Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a Patient-Reported Outcome (PRO) measure. Value Health, 13(8), 965–975. (PMID: 2065927010.1111/j.1524-4733.2010.00772.x) Luquiens, A., Whalley, D., Crawford, S. R., Laramée, P., Doward, L., Price, M., et al. (2015). Development of the Alcohol Quality of Life Scale (AQoLS): a new patient-reported outcome measure to assess health-related quality of life in alcohol use disorder. Quality of Life Research, 24(6), 1471–1481. https://doi.org/10.1007/s11136-014-0865-7. (PMID: 10.1007/s11136-014-0865-725407634) Wilburn, J., McKenna, S. P., Twiss, J., Kemp, K., & Campbell, S. (2015). Assessing quality of life in Crohn’s disease: development and validation of the Crohn’s Life Impact Questionnaire (CLIQ). Quality of Life Research, 24(9), 2279–2288. https://doi.org/10.1007/s11136-015-0947-1. (PMID: 10.1007/s11136-015-0947-125702267) Greco, C. M., Yu, L., Johnston, K. L., Dodds, N. E., Morone, N. E., Glick, R. M., et al. (2016). Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient’s perspective. Quality of Life Research, 25(7), 1625–1634. https://doi.org/10.1007/s11136-015-1178-1. (PMID: 10.1007/s11136-015-1178-126563249) Sundaresan, P., Milross, C. G., Stockler, M. R., Costa, D. S. J., & King, M. T. (2016). Phase 1 in the development of a patient-reported measure to quantify perceived inconvenience of radiotherapy: generation of issues. Quality of Life Research, 25(9), 2361–2366. https://doi.org/10.1007/s11136-016-1265-y. (PMID: 10.1007/s11136-016-1265-y26980419) Carlozzi, N. E., Schilling, S. G., Lai, J. S., Paulsen, J. S., Hahn, E. A., Perlmutter, J. S., et al. (2016). HDQLIFE: development and assessment of health-related quality of life in Huntington Disease (HD). Quality of Life Research, 25(10), 2441–2455. https://doi.org/10.1007/s11136-016-1386-3. (PMID: 10.1007/s11136-016-1386-3275222136108175) Anthony, S. J., Selkirk, E., Sung, L., Klaassen, R. J., Dix, D., & Klassen, A. F. (2017). Quality of life of pediatric oncology patients: do patient-reported outcome instruments measure what matters to patients? Quality of Life Research, 26(2), 273–281. https://doi.org/10.1007/s11136-016-1393-4. (PMID: 10.1007/s11136-016-1393-427558784) Tian, J., Xue, J., Hu, X., Han, Q., & Zhang, Y. (2018). CHF-PROM: validation of a patient-reported outcome measure for patients with chronic heart failure. Health and Quality of Life Outcomes, 16(1), 51. https://doi.org/10.1186/s12955-018-0874-2. (PMID: 10.1186/s12955-018-0874-2295549635859646) Oikonomou, E., Chatburn, E., Higham, H., Murray, J., Lawton, R., & Vincent, C. (2019). Developing a measure to assess the quality of care transitions for older people. BMC Health Services Research, 19(1), 505. https://doi.org/10.1186/s12913-019-4306-8. (PMID: 10.1186/s12913-019-4306-8313241716642522) Greffin, K., Schmidt, S., Van Den Berg, N., Hoffmann, W., Ritter, O., Oeff, M., et al. (2021). Same same-but different: using qualitative studies to inform concept elicitation for quality of life assessment in telemedical care: a request for an extended working model. Health and Quality of Life Outcomes, 19(1), 175. https://doi.org/10.1186/s12955-021-01807-8. (PMID: 10.1186/s12955-021-01807-8342257378256487) Krenz, U., Timmermann, D., Gorbunova, A., Lendt, M., Schmidt, S., & von Steinbuechel, N. (2021). Health-related quality of life after pediatric traumatic brain injury: a qualitative comparison between children’s and parents’ perspectives. PLoS ONE, 16(2), e0246514. (PMID: 33566806787539410.1371/journal.pone.0246514) Lange, R., Kumagai, A., Weiss, S., Zaffke, K. B., Day, S., Wicker, D., et al. (2021). Vision-related quality of life in adults with severe peripheral vision loss: a qualitative interview study. J Patient Rep Outcomes, 5(1), 7. https://doi.org/10.1186/s41687-020-00281-y. (PMID: 10.1186/s41687-020-00281-y334393617806695) Skogestad, I. J., Kirkevold, M., Larsson, P., Borge, C. R., Indredavik, B., Gay, C. L., & Lerdal, A. (2021). Post-stroke fatigue: an exploratory study with patients and health professionals to develop a patient-reported outcome measure. J Patient Rep Outcomes, 5(1), 35. https://doi.org/10.1186/s41687-021-00307-z. (PMID: 10.1186/s41687-021-00307-z338816608060374) Curtis, J. R., Nebesky, J. M., De Bock, E., De La Loge, C., Arnould, B., Davey, R., et al. (2021). Development and validation of the methotrexate experience questionnaire, a new methotrexate oral treatment adherence tool in rheumatoid arthritis. J Patient Rep Outcomes, 5(1), 69. https://doi.org/10.1186/s41687-021-00339-5. (PMID: 10.1186/s41687-021-00339-5343739478353039) Robertson, A. O., Tadić, V., & Rahi, J. S. (2021). This is me: a qualitative investigation of young people’s experience of growing up with visual impairment. PLoS ONE, 16(7), e0254009. (PMID: 34234377826326410.1371/journal.pone.0254009) Gelhorn, H. L., Vernon, M. K., Stewart, K. D., Miller, M. G., Brod, M., Althof, S. E., et al. (2016). Content validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): a patient-reported outcome measure to evaluate symptoms of hypogonadism. Patient, 9(2), 181–190. https://doi.org/10.1007/s40271-015-0138-8. (PMID: 10.1007/s40271-015-0138-826334870) McCaffrey, N., Skuza, P., Breaden, K., Eckermann, S., Hardy, J., Oaten, S., et al. (2014). Preliminary development and validation of a new end-of-life patient-reported outcome measure assessing the ability of patients to finalise their affairs at the end of life. PLoS ONE, 9(4), e94316. (PMID: 24736285398806010.1371/journal.pone.0094316) Deal, L. S., Williams, V. S., & Fehnel, S. E. (2011). Development of an electronic daily uterine fibroid symptom diary. Patient, 4, 31–44. (PMID: 2176689210.2165/11537290-000000000-00000) Eberhart, N. K., Sherbourne, C. D., Edelen, M. O., Stucky, B. D., Sin, N. L., & Lara, M. (2014). Development of a measure of asthma-specific quality of life among adults. Quality of Life Research, 23, 837–848. (PMID: 2406223710.1007/s11136-013-0510-x) Thorvaldsdottir, K. B., Halldorsdottir, S., Johnson, R. M., Sigurdardottir, S., & Saint Arnault, D. (2021). Adaptation of the Barriers to Help-Seeking for Trauma (BHS-TR) scale: a cross-cultural cognitive interview study with female intimate partner violence survivors in Iceland. J Patient Rep Outcomes, 5(1), 22. https://doi.org/10.1186/s41687-021-00295-0. (PMID: 10.1186/s41687-021-00295-0336387507914310) Dür, M., Coenen, M., Stoffer, M. A., Fialka-Moser, V., Kautzky-Willer, A., Kjeken, I., et al. (2015). Do patient-reported outcome measures cover personal factors important to people with rheumatoid arthritis? A mixed methods design using the International Classification of Functioning, Disability and Health as frame of reference. Health and Quality of Life Outcomes, 13(1), 27. https://doi.org/10.1186/s12955-015-0214-8. (PMID: 10.1186/s12955-015-0214-8258794384379722) Shunmugasundaram, C., Dhillon, H. M., Butow, P. N., Sundaresan, P., & Rutherford, C. (2021). Enabling cross-cultural data pooling in trials: linguistic validation of head and neck cancer measures for Indian patients. Quality of Life Research, 30(9), 2649–2661. https://doi.org/10.1007/s11136-021-02837-x. (PMID: 10.1007/s11136-021-02837-x33797687) Sinclair, S., Jaggi, P., Hack, T. F., Russell, L., McClement, S. E., Cuthbertson, L., et al. (2020). Initial validation of a patient-reported measure of compassion: determining the content validity and clinical sensibility among patients living with a life-limiting and incurable illness. Patient, 13(3), 327–337. https://doi.org/10.1007/s40271-020-00409-8. (PMID: 10.1007/s40271-020-00409-831965536) Gorecki, C., Lamping, D. L., Nixon, J., Brown, J. M., & Cano, S. (2012). Applying mixed methods to pretest the Pressure Ulcer Quality of Life (PU-QOL) instrument. Quality of Life Research, 21(3), 441–451. https://doi.org/10.1007/s11136-011-9980-x. (PMID: 10.1007/s11136-011-9980-x21786186) Mathias, S. D., Berry, P., De Vries, J., Pascoe, K., Colwell, H. H., Chang, D. J., & Askanase, A. D. (2018). Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures. J Patient Rep Outcomes, 2(1), 11. https://doi.org/10.1186/s41687-018-0028-7. (PMID: 10.1186/s41687-018-0028-75934913) Sarda, S. P., De La Cruz, M., Flood, E. M., Vanya, M., Hwang, D. G., Ta, C. N., & Narvekar, A. (2019). Content validity of a novel patient-reported and observer-reported outcomes assessment to evaluate ocular symptoms associated with infectious conjunctivitis in both adult and pediatric populations. Health and Quality of Life Outcomes, 17(1), 163. https://doi.org/10.1186/s12955-019-1223-9. (PMID: 10.1186/s12955-019-1223-9316660746820993) Tractenberg, R. E., Garver, A., Ljungberg, I. H., Schladen, M. M., & Groah, S. L. (2017). Maintaining primacy of the patient perspective in the development of patient-centered patient reported outcomes. PLoS ONE, 12(3), e0171114. (PMID: 28257414533621610.1371/journal.pone.0171114) Prem Senthil, M., Khadka, J., Gilhotra, J. S., Simon, S., & Pesudovs, K. (2017). Exploring the quality of life issues in people with retinal diseases: a qualitative study. J Patient Rep Outcomes, 1(1), 15. https://doi.org/10.1186/s41687-017-0023-4. (PMID: 10.1186/s41687-017-0023-4297572975934910) Nelson, L. M., DiBenedetti, D., Pariser, D. M., Glaser, D. A., Hebert, A. A., Hofland, H., et al. (2019). Development and validation of the axillary sweating daily diary: a patient-reported outcome measure to assess axillary sweating severity. J Patient Rep Outcomes, 3(1), 59. https://doi.org/10.1186/s41687-019-0148-8. (PMID: 10.1186/s41687-019-0148-8314869516728105) Jean-Baptiste, M., Gries, K. S., Lenderking, W. R., & Fastenau, J. (2020). Symptom burden and health-related quality of life impacts of smoldering multiple myeloma: the patient perspective. J Patient Rep Outcomes, 4(1), 95. https://doi.org/10.1186/s41687-020-00253-2. (PMID: 10.1186/s41687-020-00253-2331656777652973) Doward, L. C., Balp, M.-M., Twiss, J., Slota, C., Cryer, D., Brass, C. A., et al. (2021). Development of a patient-reported outcome measure for Non-Alcoholic Steatohepatitis (NASH-CHECK): results of a qualitative study. Patient, 14(5), 533–543. https://doi.org/10.1007/s40271-020-00485-w. (PMID: 10.1007/s40271-020-00485-w33336323) van Leeuwen, M., Husson, O., Alberti, P., et al. (2018). Understanding the Quality of Life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire. Health and Quality of Life Outcomes, 16(1), 114. https://doi.org/10.1186/s12955-018-0920-0. (PMID: 10.1186/s12955-018-0920-0298661855987570) Pathak, A., Sharma, S., Heinemann, A. W., Stratford, P. W., Ribeiro, D. C., & Abbott, J. H. (2021). Development and assessment of a verbal response scale for the Patient-Specific Functional Scale (PSFS) in a low-literacy, non-western population. Quality of Life Research, 30(2), 613–628. https://doi.org/10.1007/s11136-020-02640-0. (PMID: 10.1007/s11136-020-02640-032965632) Pierzynski, J. A., Clegg, J. L., Sim, J., Forrest, C. B., Robison, L. L., Hudson, M. M., et al. (2020). Patient-reported outcomes in paediatric cancer survivorship: a qualitative study to elicit the content from cancer survivors and caregivers. British Medical Journal Open, 10(5), e032414. Kitchen, H., Seitz, C., Trigg, A., Aldhouse, N., Willgoss, T., Schmitz, H., et al. (2021). Patients’ and clinicians’ perspectives on item importance, scoring, and clinically meaningful differences for the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS). Health and Quality of Life Outcomes, 19(1), 7. https://doi.org/10.1186/s12955-020-01579-7. (PMID: 10.1186/s12955-020-01579-7334075607789138) Boban, S., Downs, J., Codde, J., Cohen, P. A., & Bulsara, C. (2021). Women diagnosed with ovarian cancer: patient and carer experiences and perspectives. Patient Relat Outcome Meas, 12, 33–43. https://doi.org/10.2147/PROM.S272688. (PMID: 10.2147/PROM.S272688336234647896761) Jones, J., Hughes, M., Pauling, J., Gooberman-Hill, R., & Moore, A. J. (2020). What narrative devices do people with systemic sclerosis use to describe the experience of pain from digital ulcers: a multicentre focus group study at UK scleroderma centres. British Medical Journal Open, 10(6), e037568. Osborne, R. H., Norquist, J. M., Elsworth, G. R., Busija, L., Mehta, V., Herring, T., & Gupta, S. B. (2011). Development and validation of the influenza intensity and impact questionnaire (FluiiQ™). Value Health, 14(5), 687–699. (PMID: 2183940710.1016/j.jval.2010.12.005) Tsakos, G., Blair, Y. I., Yusuf, H., Wright, W., Watt, R. G., & Macpherson, L. M. D. (2012). Developing a new self-reported scale of oral health outcomes for 5-year-old children (SOHO-5). Health and Quality of Life Outcomes, 10(1), 62. https://doi.org/10.1186/1477-7525-10-62. (PMID: 10.1186/1477-7525-10-62226767103413607) Rothrock, N. E., Jensen, S. E., Beaumont, J. L., Abernethy, A. P., Jacobsen, P. B., Syrjala, K., & Cella, D. (2013). Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer. Value Health, 16(5), 789–796. (PMID: 23947972588678810.1016/j.jval.2013.04.015) Stokes, J., Evans, C. J., Pompilus, F., Shields, A. L., & Summers, K. H. (2013). Development of a questionnaire to assess the impact of chronic low back pain for use in regulated clinical trials. Patient, 6, 291–305. (PMID: 2406223410.1007/s40271-013-0026-z) Matza, L. S., Boye, K. S., Stewart, K. D., Paczkowski, R., Jordan, J., & Murray, L. T. (2018). Development of the Diabetes Injection Device Experience Questionnaire (DID-EQ) and Diabetes Injection Device Preference Questionnaire (DID-PQ). J Patient Rep Outcomes, 2(1), 43. https://doi.org/10.1186/s41687-018-0068-z. (PMID: 10.1186/s41687-018-0068-z302947136153258) Martin, M. L., Stassek, L., Blum, S. I., Joshi, A. V., & Jones, D. (2019). Development and adaptation of patient-reported outcome measures for patients who experience itch associated with primary biliary cholangitis. J Patient Rep Outcomes, 3(1), 2. https://doi.org/10.1186/s41687-018-0090-1. (PMID: 10.1186/s41687-018-0090-1306457066333594) Newton, L., DeLozier, A. M., Griffiths, P. C., Hill, J. N., Hudgens, S., Symonds, T., et al. (2019). Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis. J Patient Rep Outcomes, 3(1), 42. https://doi.org/10.1186/s41687-019-0128-z. (PMID: 10.1186/s41687-019-0128-z313129406635522) Kamath, B. M., Abetz-Webb, L., Kennedy, C., Hepburn, B., Gauthier, M., Johnson, N., et al. (2018). Development of a novel tool to assess the impact of itching in pediatric cholestasis. Patient, 11(1), 69–82. https://doi.org/10.1007/s40271-017-0266-4. (PMID: 10.1007/s40271-017-0266-428710680) Mesa, R. A., Su, Y., Woolfson, A., Prchal, J. T., Turnbull, K., Jabbour, E., et al. (2019). Development of a symptom assessment in patients with myelofibrosis: qualitative study findings. Health and Quality of Life Outcomes, 17(1), 61. https://doi.org/10.1186/s12955-019-1121-1. (PMID: 10.1186/s12955-019-1121-1309751506460742) Flythe, J. E., Dorough, A., Narendra, J. H., Wingard, R. L., Dalrymple, L. S., & DeWalt, D. A. (2019). Development and content validity of a hemodialysis symptom patient-reported outcome measure. Quality of Life Research, 28, 253–265. (PMID: 3022953210.1007/s11136-018-2000-7) Brod, M., Waldman, L. T., Smith, A., & Karpf, D. (2020). Assessing the patient experience of hypoparathyroidism symptoms: development of the Hypoparathyroidism Patient Experience Scale-Symptom (HPES-Symptom). Patient, 13(2), 151–162. https://doi.org/10.1007/s40271-019-00388-5. (PMID: 10.1007/s40271-019-00388-531552607) Halstead, P., Arbuckle, R., Marshall, C., Zimmerman, B., Bolton, K., & Gelotte, C. (2020). Development and content validity testing of patient-reported outcome items for children to self-assess symptoms of the common cold. Patient, 13(2), 235–250. https://doi.org/10.1007/s40271-019-00404-8. (PMID: 10.1007/s40271-019-00404-831858430) AboAbat, A., Qannam, H., Bjorner, J. B., & Al-Tannir, M. (2020). Psychometric validation of a Saudi Arabian version of the sf-36v2 health survey and norm data for Saudi Arabia. J Patient Rep Outcomes, 4(1), 67. https://doi.org/10.1186/s41687-020-00233-6. (PMID: 10.1186/s41687-020-00233-6327897057426352) Globe, G., Currie, B., Leidy, N. K., Jones, P., Mannino, D., Martinez, F., et al. (2016). Development of the Chronic Obstructive Pulmonary Disease Morning Symptom Diary (COPD-MSD). Health and Quality of Life Outcomes, 14(1), 104. https://doi.org/10.1186/s12955-016-0506-7. (PMID: 10.1186/s12955-016-0506-7274241734947344) Witjes, S., Van Geenen, R. C. I., Koenraadt, K. L. M., Van Der Hart, C. P., Blankevoort, L., Kerkhoffs, G. M. M. J., & Kuijer, P. P. F. M. (2017). Expectations of younger patients concerning activities after knee arthroplasty: are we asking the right questions? Quality of Life Research, 26(2), 403–417. https://doi.org/10.1007/s11136-016-1380-9. (PMID: 10.1007/s11136-016-1380-927492606) Acquaye, A. A., Payén, S. S., Vera, E., Williams, L. A., Gilbert, M. R., Weathers, S.-P., & Armstrong, T. S. (2019). Identifying symptom recurrences in primary brain tumor patients using the MDASI-BT and qualitative interviews. J Patient Rep Outcomes, 3(1), 58. https://doi.org/10.1186/s41687-019-0143-0. (PMID: 10.1186/s41687-019-0143-0314445796708028) Forrest, C. B., Forrest, K. D., Clegg, J. L., De La Motte, A., Amaral, S., Grossman, A. B., & Furth, S. L. (2020). Establishing the content validity of PROMIS Pediatric pain interference, fatigue, sleep disturbance, and sleep-related impairment measures in children with chronic kidney disease and Crohn’s disease. J Patient Rep Outcomes, 4(1), 11. https://doi.org/10.1186/s41687-020-0178-2. (PMID: 10.1186/s41687-020-0178-2320522057016154) Gwaltney, C., Reaney, M., Krohe, M., Martin, M. M., Falvey, H., & Mollon, P. (2017). Symptoms and functional limitations in the first year following a myocardial infarction: a qualitative study. Patient, 10(2), 225–235. https://doi.org/10.1007/s40271-016-0194-8. (PMID: 10.1007/s40271-016-0194-827637486) England, R. W., Bailey, C. R., Anatchkova, M. D., Skalicky, A. M., Meissner, M. H., Rosenblatt, M., et al. (2020). Qualitative study of patients with venous malformations: symptom experiences and content validity of patient-reported outcome measures. Quality of Life Research, 29(6), 1707–1719. https://doi.org/10.1007/s11136-020-02435-3. (PMID: 10.1007/s11136-020-02435-332020564) Aber, A., Phillips, P., Lumley, E., Radley, S., Thomas, S. M., Nawaz, S., et al. (2020). Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions. British Medical Journal Open, 10(8), e034154. Cruickshank, M., Newlands, R., Blazeby, J., Ahmed, I., Bekheit, M., Brazzelli, M., et al. (2021). Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set. British Medical Journal Open, 11(6), e045568. McCarrier, K. P., Deal, L. S., Abraham, L., Blum, S. I., Bush, E. N., Martin, M. L., et al. (2016). Patient-centered research to support the development of the Symptoms of Major Depressive Disorder Scale (SMDDS): initial qualitative research. Patient, 9(2), 117–134. https://doi.org/10.1007/s40271-015-0132-1. (PMID: 10.1007/s40271-015-0132-126113249) McMillan, C. V., Speight, J., Relan, A., Bellizzi, L., Haase, G., & Cicardi, M. (2012). Content validity of visual analog scales to assess symptom severity of acute angioedema attacks in adults with hereditary angioedema: an interview study. Patient, 5(2), 113–126. https://doi.org/10.2165/11597490-000000000-00000. (PMID: 10.2165/11597490-000000000-0000022462765) Askanase, A. D., Daly, R. P., Okado, M., Neville, K., Pong, A., Hanrahan, L. M., & Merrill, J. T. (2019). Development and content validity of the Lupus Foundation of America rapid evaluation of activity in lupus (LFA-REAL™): a patient-reported outcome measure for lupus disease activity. Health and Quality of Life Outcomes, 17(1), 99. https://doi.org/10.1186/s12955-019-1151-8. (PMID: 10.1186/s12955-019-1151-8311745416555910) Davidson, D., Slota, C., Vera-Llonch, M., Brown, T. M., Hsieh, A., & Fehnel, S. (2021). Development of a novel PRO instrument for use in familial chylomicronemia syndrome. J Patient-Rep Outcomes, 5(1), 72. https://doi.org/10.1186/s41687-021-00347-5. (PMID: 10.1186/s41687-021-00347-5343821148357905) Strickland, L. H., Murray, D. W., Pandit, H. G., & Jenkinson, C. (2020). Development of a Patient-Reported Outcome Measure (PROM) and change measure for use in early recovery following hip or knee replacement. J Patient-Rep Outcomes, 4(1), 91. https://doi.org/10.1186/s41687-020-00262-1. (PMID: 10.1186/s41687-020-00262-1331596107648815) Massie, S. E., Tolleson-Rinehart, S., DeWalt, D. A., Laughon, M. M., Powell, L. M., & Price, W. A. (2011). Development of a proxy-reported pulmonary outcome scale for preterm infants with bronchopulmonary dysplasia. Health and Quality of Life Outcomes, 9(1), 55. https://doi.org/10.1186/1477-7525-9-55. (PMID: 10.1186/1477-7525-9-55217910993161834) Kleinman, L., Benjamin, K., Viswanathan, H., Mattera, M. S., Bosserman, L., Blayney, D. W., & Revicki, D. A. (2012). The Anemia Impact Measure (AIM): development and content validation of a patient-reported outcome measure of anemia symptoms and symptom impacts in cancer patients receiving chemotherapy. Quality of Life Research, 21(7), 1255–1266. https://doi.org/10.1007/s11136-011-0034-1. (PMID: 10.1007/s11136-011-0034-121987032) Forinder, U., Claesson, L., Szybek, K., & Lindahl Norberg, A. (2015). Exploring the content of post-traumatic stress symptoms among parents after paediatric stem cell transplant. PLoS ONE, 10(5), e0126905. (PMID: 25965909442887810.1371/journal.pone.0126905) Lund, K. S., Siersma, V. D., Christensen, K. B., Waldorff, F. B., & Brodersen, J. (2018). Measuring bothersome menopausal symptoms: development and validation of the MenoScores questionnaire. Health and Quality of Life Outcomes, 16(1), 97. https://doi.org/10.1186/s12955-018-0927-6. (PMID: 10.1186/s12955-018-0927-6297690735956969) Irwin, D. E., Gross, H. E., Stucky, B. D., Thissen, D., DeWitt, E., Lai, J., et al. (2012). Development of six PROMIS pediatrics proxy-report item banks. Health and Quality of Life Outcomes, 10(1), 22. https://doi.org/10.1186/1477-7525-10-22. (PMID: 10.1186/1477-7525-10-22223571923312870) Withers, K. L., Wood, K. A., Carolan-Rees, G., Patrick, H., Lencioni, M., & Griffith, M. (2015). Establishing content validity in a novel patient reported outcome measure for cardiac arrhythmia ablation patients. Health and Quality of Life Outcomes, 13(1), 38. https://doi.org/10.1186/s12955-015-0233-5. (PMID: 10.1186/s12955-015-0233-5258845674520263) Rand, S., Caiels, J., Collins, G., & Forder, J. (2017). Developing a proxy version of the Adult social care outcome toolkit (ASCOT). Health and Quality of Life Outcomes, 15(1), 108. https://doi.org/10.1186/s12955-017-0682-0. (PMID: 10.1186/s12955-017-0682-0285260555438504) Boesen, V. B., Nissen, S. B., Groenvold, M., Bjorner, J. B., Hegedüs, L., Bonnema, S. J., et al. (2018). Conversion of standard retrospective patient-reported outcomes to momentary versions: cognitive interviewing reveals varying degrees of momentary compatibility. Quality of Life Research, 27, 1065–1076. (PMID: 2924304410.1007/s11136-017-1762-7) Murphy, M., Hollinghurst, S., & Salisbury, C. (2018). Qualitative assessment of the primary care outcomes questionnaire: a cognitive interview study. BMC Health Services Research, 18(1), 79. https://doi.org/10.1186/s12913-018-2867-6. (PMID: 10.1186/s12913-018-2867-6293910035796473) Bloemeke, J., Sommer, R., Witt, S., Bullinger, M., Nordon, C., Badia, F. J., et al. (2019). Cross-cultural selection and validation of instruments to assess patient-reported outcomes in children and adolescents with achondroplasia. Quality of Life Research, 28, 2553–2563. (PMID: 3109384810.1007/s11136-019-02210-z) Krohe, M., Tang, D. H., Klooster, B., Revicki, D., Galipeau, N., & Cella, D. (2019). Content validity of the National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy – Breast Cancer Symptom Index (NFBSI-16) and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form with advanced breast cancer patients. BMC Health Services Research, 17(1), 92. https://doi.org/10.1186/s12955-019-1162-5. (PMID: 10.1186/s12955-019-1162-5) Hepworth, L. R., Rowe, F. J., & Burnside, G. (2019). Development of a patient reported outcome measures for measuring the impact of visual impairment following stroke. BMC Health Services Research, 19(1), 348. https://doi.org/10.1186/s12913-019-4157-3. (PMID: 10.1186/s12913-019-4157-3311514496544926) Furtado, R., MacDermid, J. C., Bryant, D. M., Faber, K. J., & Athwal, G. S. (2020). Interpretation and content validity of the items of the numeric rating version short-WORC to evaluate outcomes in management of rotator cuff pathology: a cognitive interview approach. Health and Quality of Life Outcomes, 18(1), 88. https://doi.org/10.1186/s12955-020-01339-7. (PMID: 10.1186/s12955-020-01339-7322286227106799) Garfield, K., Husbands, S., Thorn, J. C., Noble, S., & Hollingworth, W. (2021). Development of a brief, generic, modular resource-use measure (ModRUM): cognitive interviews with patients. BMC Health Services Research, 21(1), 371. https://doi.org/10.1186/s12913-021-06364-w. (PMID: 10.1186/s12913-021-06364-w338829058058988) Dermott, J. A., Wright, F. V., Salbach, N. M., & Narayanan, U. G. (2021). Development of the gait outcomes assessment list for lower-limb differences (GOAL-LD) questionnaire: a child and parent reported outcome measure. Health and Quality of Life Outcomes, 19(1), 139. https://doi.org/10.1186/s12955-021-01775-z. (PMID: 10.1186/s12955-021-01775-z339522608097808) Mendoza, T. R., Williams, L. A., Shi, Q., Wang, X. S., Bamidele, O., Woodruff, J. F., & Cleeland, C. S. (2020). The Treatment-induced Neuropathy Assessment Scale (TNAS): a psychometric update following qualitative enrichment. J Patient Rep Outcomes, 4(1), 15. https://doi.org/10.1186/s41687-020-0180-8. (PMID: 10.1186/s41687-020-0180-8320768797031452) Parslow, R. M., Shaw, A., Haywood, K. L., & Crawley, E. (2019). Developing and pretesting a new patient reported outcome measure for paediatric Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME): cognitive interviews with children. J Patient Rep Outcomes, 3(1), 67. https://doi.org/10.1186/s41687-019-0156-8. (PMID: 10.1186/s41687-019-0156-8317076356842364) Laissaar, M., Hallik, R., Sillaste, P., Ragun, U., Pärn, M.-L., & Suija, K. (2021). Translation and cultural adaptation of IPOS (integrated palliative care outcome scale) in Estonia. J Patient-Rep Outcomes, 5(1), 15. https://doi.org/10.1186/s41687-021-00288-z. (PMID: 10.1186/s41687-021-00288-z335074197841376) Carlton, J. (2013). Developing the draft descriptive system for the child amblyopia treatment questionnaire (CAT-Qol): a mixed methods study. Health and Quality of Life Outcomes, 11(1), 174. https://doi.org/10.1186/1477-7525-11-174. (PMID: 10.1186/1477-7525-11-174241488003854484) Verstraete, J., Ramma, L., & Jelsma, J. (2020). Item generation for a proxy health related quality of life measure in very young children. Health and Quality of Life Outcomes, 18(1), 11. https://doi.org/10.1186/s12955-020-1271-1. (PMID: 10.1186/s12955-020-1271-1319373116961344) Fenwick, E. K., Pesudovs, K., Khadka, J., Rees, G., Wong, T. Y., & Lamoureux, E. L. (2013). Evaluation of item candidates for a diabetic retinopathy quality of life item bank. Quality of Life Research, 22(7), 1851–1858. https://doi.org/10.1007/s11136-012-0307-3. (PMID: 10.1007/s11136-012-0307-323135924) Ploughman, M., Austin, M., Stefanelli, M., & Godwin, M. (2010). Applying cognitive debriefing to pre-test patient-reported outcomes in older people with multiple sclerosis. Quality of Life Research, 19(4), 483–487. https://doi.org/10.1007/s11136-010-9602-z. (PMID: 10.1007/s11136-010-9602-z20151208) Leary, J. M., Ice, C., & Cottrell, L. (2012). Adaptation and cognitive testing of physical activity measures for use with young, school-aged children and their parents. Quality of Life Research, 21(10), 1815–1828. https://doi.org/10.1007/s11136-011-0095-1. (PMID: 10.1007/s11136-011-0095-122200939) Bobrovitz, N., Santana, M. J., Kline, T., Kortbeek, J., & Stelfox, H. T. (2015). The use of cognitive interviews to revise the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM). Quality of Life Research, 24(8), 1911–1919. https://doi.org/10.1007/s11136-015-0919-5. (PMID: 10.1007/s11136-015-0919-525589232) Fischer, J., Jansen, B., Rivera, A., Gómez, L. J., Barbosa, M. C., Bilbao, J. L., et al. (2019). Validation of a cross-NTD toolkit for assessment of NTD-related morbidity and disability. A cross-cultural qualitative validation of study instruments in Colombia. PLoS ONE, 14(12), e0223042. (PMID: 31794554689016810.1371/journal.pone.0223042) Mitchell, P. M., Caskey, F. J., Scott, J., Sanghera, S., & Coast, J. (2020). Response process validity of three patient reported outcome measures for people requiring kidney care: a think-aloud study using the EQ-5D-5L ICECAP-A and ICECAP-O. British Medical Journal Open, 10(5), e034569. Høeg, B. L., Saltbæk, L., Christensen, K. B., Karlsen, R. V., Johansen, C., Dalton, S. O., et al. (2021). The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)—a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer. Quality of Life Research, 30, 2671–2682. (PMID: 3386416410.1007/s11136-021-02841-1) Peters, M., Potter, C., Kelly, L., Hunter, C., Gibbons, E., Jenkinson, C., et al. (2016). The long-term conditions questionnaire: conceptual framework and item development. Patient Relat Outcome Meas, 7, 109–125. https://doi.org/10.2147/PROM.S104552. (PMID: 10.2147/PROM.S104552276216785012841) Hill, J. C., Thomas, E., Hill, S., Foster, N. E., & Van Der Windt, D. A. (2015). Development and validation of the keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM). PLoS ONE, 10(4), e0124557. (PMID: 25928807441591010.1371/journal.pone.0124557) Koster, E. B., Baars, E. W., & Delnoij, D. M. J. (2016). Patient-centered outcomes on quality of life and anthroposophic healthcare: a qualitative triangulation study. Quality of Life Research, 25(9), 2257–2267. https://doi.org/10.1007/s11136-016-1276-8. (PMID: 10.1007/s11136-016-1276-827020057) Zhang, Y., Yang, Y., Lv, J., & Zhang, Y. (2016). LC-PROM: validation of a patient reported outcomes measure for liver cirrhosis patients. Health and Quality of Life Outcomes, 14(1), 75. https://doi.org/10.1186/s12955-016-0482-y. (PMID: 10.1186/s12955-016-0482-y271650364862042) White, M. K., Bayliss, M. S., Guthrie, S. D., Raymond, K. P., Rizio, A. A., & McCausland, K. L. (2017). Content validation of the SF-36v2® health survey with AL amyloidosis patients. J Patient-Rep Outcomes, 1(1), 13. https://doi.org/10.1186/s41687-017-0020-7. (PMID: 10.1186/s41687-017-0020-7297573085934916) Flynn, K. E., Kliems, H., Saoji, N., Svenson, J., & Cox, E. D. (2018). Content validity of the PROMIS® pediatric family relationships measure for children with chronic illness. Health and Quality of Life Outcomes, 16(1), 203. https://doi.org/10.1186/s12955-018-1030-8. (PMID: 10.1186/s12955-018-1030-8303405006194608) Sasseville, M., Chouinard, M.-C., & Fortin, M. (2021). Understanding patient outcomes to develop a multimorbidity adapted patient-reported outcomes measure: a qualitative description of patient and provider perspectives. Health and Quality of Life Outcomes, 19(1), 43. https://doi.org/10.1186/s12955-021-01689-w. (PMID: 10.1186/s12955-021-01689-w335413837863435) Gibbons, C. J., Mills, R. J., Thornton, E. W., Ealing, J., Mitchell, J. D., Shaw, P. J., et al. (2011). Development of a patient reported outcome measure for fatigue in motor neurone disease: the Neurological Fatigue Index (NFI-MND). Health and Quality of Life Outcomes, 9(1), 101. https://doi.org/10.1186/1477-7525-9-101. (PMID: 10.1186/1477-7525-9-101221077563282643) Hornsey, S., Stuart, B., Muller, I., Layton, A. M., Morrison, L., King, J., et al. (2021). Patient-Reported outcome measures for acne: a mixed-methods validation study (acne PROMs). British Medical Journal Open, 11(3), e034047. |
| Contributed Indexing: | Keywords: Data visualization; Development; Patient-reported outcome; Qualitative; Validation |
| Entry Date(s): | Date Created: 20250425 Date Completed: 20250624 Latest Revision: 20250718 |
| Update Code: | 20250718 |
| DOI: | 10.1007/s11136-025-03964-5 |
| PMID: | 40279025 |
| Databáza: | MEDLINE |
| Abstrakt: | Competing Interests: Declarations. Conflicts of interest: Ms. Caroline Seo is a full time employee at AstraZeneca, Dr. King-Kallimanis reports receiving grant support directly paid to their institution and not related to the project from the following: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Jazz Pharma, Genentech, Eli Lilly, Janssen, Takeda, Daiichi Sankyo, Blueprint Medicines, Janssen, Amgen, Seagen, and Manta Cares. Dr. King-Kallimanis report receiving consulting fees from Eli Lilly, Bristol Myers Squibb, AbbVie, Adelphi Values and Shionogi. The remaining authors have no conflict of interest to disclose.<br />Purpose: Qualitative data that reflects patients' experiences are the foundation of any patient-reported outcome measure (PROM) development and validation study; however, there is limited understanding of the type of data visualization techniques that facilitate communication of this data. The goal of this targeted literature review was to investigate data visualization methods that have been used in published PROM development and validation literature to report qualitative results.<br />Methods: A literature search in OVID via MEDLINE was conducted among the top 10 non-disease-specific journals publishing PROM qualitative development and validation studies. Studies that reported qualitative methods to develop/validate a PROM and included data visualization in the form of tables or figures were included. Article characteristics and data visualization types were extracted.<br />Results: A total of 185 articles were included in data extraction. Most articles (n = 109, 59.1%) included figures (n = 172, average 2 relevant figures per article) in the form of hierarchy/flowcharts (n = 124, 72.1%) and bar charts (n = 29, 16.9%). Information reported in figures included depiction of conceptual frameworks (n = 112, 65.1%) and concept frequency (n = 40, 24.4%). Most articles (n = 152, 81.7%) included tables (n = 307, average 2 relevant tables per article). Information reported in tables included concept frequency (n = 133, 43.3%) and cognitive debriefing and revisions (n = 91, 29.6%).<br />Conclusion: Data visualization techniques used to report qualitative results in the identified PROM qualitative development and validation studies were heterogeneous, and many studies did not utilize any data visualization techniques. This study will inform the development of guidance for using data visualizations to report qualitative PROM research.<br /> (© 2025. The Author(s), under exclusive licence to Springer Nature Switzerland AG.) |
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| ISSN: | 1573-2649 |
| DOI: | 10.1007/s11136-025-03964-5 |
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