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Quality of Life Research
Gepubliceerd in: Quality of Life Research 1/2019

18-09-2018

Development and content validity of a hemodialysis symptom patient-reported outcome measure

Auteurs: Jennifer E. Flythe, Adeline Dorough, Julia H. Narendra, Rebecca L. Wingard, Lorien S. Dalrymple, Darren A. DeWalt

Gepubliceerd in: Quality of Life Research | Uitgave 1/2019

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Abstract

Purpose

To describe the process and preliminary qualitative development of a new symptom-based patient-reported outcome measure (PROM) intended to assess hemodialysis treatment-related physical symptoms.

Methods

Experienced interviewers conducted concept elicitation and cognitive debriefing interviews with individuals receiving in-center hemodialysis in the United States. Concept elicitation interviews involved eliciting spontaneous reports of symptom experiences and probing to further explore and confirm concepts. We used patient-reported concepts to generate a preliminary symptom PROM. We conducted 3 rounds of cognitive debriefing interviews to evaluate symptom relevance, item interpretability, and draft item structure. We iteratively refined the measure based on cognitive interview findings.

Results

Forty-two adults receiving in-center hemodialysis participated in the concept elicitation interviews. A total of 12 symptoms were reported by > 10% of interviewees. We developed a 13-item initial draft instrument for testing in 3 rounds of cognitive interviews with an additional 52 hemodialysis patients. Participant responses and feedback during cognitive interviews led to changes in symptom descriptions, division of the single item “nausea/vomiting” into 2 distinct items, removal of daily activity interference items, addition of instructions, and clarification about the recall period, among other changes.

Conclusions

Symptom Monitoring on Renal Replacement Therapy-Hemodialysis (SMaRRT-HD™) is a 14-item PROM intended for use in hemodialysis patents. SMaRRT-HD™ uses a single treatment recall period and a 5-point Likert scale to assess symptom severity. Qualitative interview data provide evidence of its content validity. SMaRRT-HD™ is undergoing additional testing to assess measurement properties and inform measure scoring.
vorige artikel Psychometric properties of a modified version of the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) in a clinical sample of children with aggressive behavior
volgende artikel Confirmatory factor analysis of the Minnesota living with heart failure questionnaire among patients following open heart surgery for valve dysfunction
Literatuur
1.
Saran, R., Robinson, B., Abbott, K. C., Agodoa, L. Y., Albertus, P., Ayanian, J., et al. (2017) U.S. renal data system 2016 annual data report: Epidemiology of kidney disease in the United States. American Journal of Kidney Diseases, 69(Suppl 1), A7–A8.CrossRefPubMedPubMedCentral
2.
Abdel-Kader, K., Unruh, M. L., & Weisbord, S. D. (2009). Symptom burden, depression, and quality of life in chronic and end-stage kidney disease. Clinical Journal of the American Society of Nephrology, 4(6), 1057–1064.CrossRefPubMedPubMedCentral
3.
Merkus, M. P., Jager, K. J., Dekker, F. W., de Haan, R. J., Boeschoten, E. W., & Krediet, R. T. (1999). Physical symptoms and quality of life in patients on chronic dialysis: Results of The Netherlands Cooperative Study on Adequacy of Dialysis (NECOSAD). Nephrology Dialysis Transplantation, 14(5), 1163–1170.CrossRef
4.
Weisbord, S. D., Fried, L. F., Arnold, R. M., Fine, M. J., Levenson, D. J., Peterson, R. A., et al. (2005). Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. Journal of the American Society of Nephrology, 16(8), 2487–2494.CrossRefPubMed
5.
Cox, K. J., Parshall, M. B., Hernandez, S. H., Parvez, S. Z., & Unruh, M. L. (2017). Symptoms among patients receiving in-center hemodialysis: A qualitative study. Hemodialysis International, 21(4), 524–533.CrossRefPubMed
6.
Flythe, J. E., Dorough, A., Narendra, J. H., Forfang, D., Hartwell, L., & Abdel-Rahman, E. (2018) Perspectives on symptom experiences and symptom reporting among individuals on hemodialysis. Nephrology Dialysis Transplantation. https://​doi.​org/​10.​1093/​ndt/​gfy069 (Epub ahead of print).CrossRef
7.
Evangelidis, N., Tong, A., Manns, B., Hemmelgarn, B., Wheeler, D. C., Tugwell, P., et al. (2017). Developing a set of core outcomes for trials in hemodialysis: An International Delphi survey. American Journal of Kidney Diseases, 70(4), 464–475.CrossRefPubMed
8.
Manns, B., Hemmelgarn, B., Lillie, E., Dip, S. C., Cyr, A., Gladish, M., et al. (2014). Setting research priorities for patients on or nearing dialysis. Clinical Journal of the American Society of Nephrology, 9(10), 1813–1821.CrossRefPubMedPubMedCentral
9.
Weisbord, S. D., Fried, L. F., Mor, M. K., Resnick, A. L., Unruh, M. L., Palevsky, P. M., et al. (2007). Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clinical Journal of the American Society of Nephrology, 2(5), 960–967.CrossRefPubMed
10.
Basch, E., Deal, A. M., Kris, M. G., Scher, H. I., Hudis, C. A., Sabbatini, P., et al. (2016). Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. Journal of Clinical Oncology, 34(6), 557–565.CrossRefPubMed
11.
Peipert, J. D., Bentler, P. M., Klicko, K., & Hays, R. D. (2018). Psychometric properties of the kidney disease quality of life 36-item short-form survey (KDQOL-36) in the United States. American Journal of Kidney Diseases, 71(4), 461–468.CrossRefPubMed
12.
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—eliciting concepts for a new PRO instrument. Value Health, 14(8), 967–977.CrossRefPubMed
13.
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: Part 2—assessing respondent understanding. Value Health, 14(8), 978–988.CrossRefPubMed
14.
U.S. Department of Health and Human Services FaDA. (2009). Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring: U.S. Food and Drug Administration.
15.
Flythe, J. E., Powell, J. D., Poulton, C. J., Westreich, K. D., Handler, L., Reeve, B. B., et al. (2015). Patient-reported outcome instruments for physical symptoms among patients receiving maintenance dialysis: A systematic review. American Journal of Kidney Diseases, 66(6), 1033–1046.CrossRefPubMedPubMedCentral
16.
Sandelowski, M. (2000). Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Research in Nursing & Health, 23(3), 246–255.CrossRef
17.
Patton, M. (2014). Qualitative research and evaluation methods (4th ed.). Thousand Oaks: Sage.
18.
Paige, S. R., Krieger, J. L., Stellefson, M., & Alber, J. M. (2016). eHealth literacy in chronic disease patients: An item response theory analysis of the eHealth literacy scale (eHEALS). Patient Education and Counseling, 100(2), 320–326.CrossRefPubMedPubMedCentral
19.
20.
Norman, C. D., & Skinner, H. A. (2006). eHealth literacy: Essential skills for consumer health in a Networked world. Journal of Medical Internet Research, 8(2), e9.CrossRefPubMedPubMedCentral
21.
Ericsson, K. A., & Simon, H. A. (1980). Verbal reports as data. Psychological Review, 87, 215–251.CrossRef
22.
Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks: Sage.CrossRef
23.
Morris, N. S., MacLean, C. D., Chew, L. D., & Littenberg, B. (2006). The single item literacy screener: Evaluation of a brief instrument to identify limited reading ability. BMC Family Practice, 7, 21.CrossRefPubMedPubMedCentral
24.
Borson, S., Scanlan, J. M., Chen, P., & Ganguli, M. (2003). The Mini-Cog as a screen for dementia: Validation in a population-based sample. Journal of the American Geriatrics Society, 51(10), 1451–1454.CrossRefPubMed
25.
Lindsay, R. M., Heidenheim, P. A., Nesrallah, G., Garg, A. X., Suri, R., & Daily Hemodialysis Study Group London Health Sciences Centre (2006). Minutes to recovery after a hemodialysis session: A simple health-related quality of life question that is reliable, valid, and sensitive to change. Clinical Journal of the American Society of Nephrology, 1(5), 952–959.CrossRefPubMed
26.
Davison, S. N., Jhangri, G. S., & Johnson, J. A. (2006). Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrology Dialysis Transplantation, 21(11), 3189–3195.CrossRef
27.
Virga, G., Mastrosimone, S., Amici, G., Munaretto, G., Gastaldon, F., et al. (1998). Symptoms in hemodialysis patients and their relationship with biochemical and demographic parameters. The International Journal of Artificial Organs, 21(12), 788–793.CrossRefPubMed
28.
Scherer, J. S., Combs, S. A., & Brennan, F. (2017). Sleep disorders, restless legs syndrome, and uremic pruritus: Diagnosis and treatment of common symptoms in dialysis patients. American Journal of Kidney Diseases, 69(1), 117–128.CrossRefPubMed
29.
Hays, R. D., Kallich, J. D., Mapes, D. L., Coons, S. J., & Carter, W. B. (1994). Development of the kidney disease quality of life (KDQOL) instrument. Quality of Life Research, 3(5), 329–338.CrossRefPubMed
30.
Rao, S., Carter, W. B., Mapes, D. L., Kallich, J. D., Kamberg, C. J., Spritzer, K. L., et al. (2000). Development of subscales from the symptoms/problems and effects of kidney disease scales of the kidney disease quality of life instrument. Clinical Therapeutics, 22(9), 1099–1111.CrossRefPubMed
31.
Weisbord, S. D., Fried, L. F., Arnold, R. M., Rotondi, A. J., Fine, M. J., Levenson, D. J., et al. (2004). Development of a symptom assessment instrument for chronic hemodialysis patients: The Dialysis Symptom Index. Journal of Pain and Symptom Management, 27(3), 226–240.CrossRefPubMed
32.
Davison, S. N., Jhangri, G. S., & Johnson, J. A. (2006). Cross-sectional validity of a modified Edmonton symptom assessment system in dialysis patients: A simple assessment of symptom burden. Kidney International, 69(9), 1621–1625.CrossRefPubMed
33.
Flythe, J. E., Hilliard, T., Castillo, G., Ikeler, K., Orazi, J., Abdel-Rahman, E., et al. (2018). Symptom prioritization among adults receiving in-center hemodialysis: A mixed methods study. Clinical Journal of the American Society of Nephrology, 13(5), 735–745.CrossRefPubMedPubMedCentral
34.
Tong, A., Manns, B., Hemmelgarn, B., Wheeler, D. C., Evangelidis, N., Tugwell, P., et al. (2017). Establishing core outcome domains in hemodialysis: Report of the standardized outcomes in nephrology-hemodialysis (SONG-HD) consensus workshop. American Journal of Kidney Diseases, 69(1), 97–107.CrossRefPubMed
35.
Jhamb, M., Liang, K., Yabes, J., Steel, J. L., Dew, M. A., Shah, N., et al. (2013). Prevalence and correlates of fatigue in chronic kidney disease and end-stage renal disease: Are sleep disorders a key to understanding fatigue? The American Journal of Nephrology, 38(6), 489–495.CrossRefPubMed
36.
Ju, A., Unruh, M. L., Davison, S. N., Dapueto, J., Dew, M. A., Fluck, R., et al. (2018). Patient-reported outcome measures for fatigue in patients on hemodialysis: A systematic review. American Journal of Kidney Diseases, 71(3), 327–343.CrossRefPubMed
37.
Gedney, J. J., Logan, H., & Baron, R. S. (2003). Predictors of short-term and long-term memory of sensory and affective dimensions of pain. The Journal of Pain, 4(2), 47–55.CrossRefPubMed
38.
Brodie, E. E., & Niven, C. A. (2000). Remembering an everyday pain: The role of knowledge and experience in the recall of the quality of dysmenorrhoea. Pain, 84(1), 89–94.CrossRefPubMed
39.
Lavin, R., & Park, J. (2014). A characterization of pain in racially and ethnically diverse older adults: A review of the literature. Journal of Applied Gerontology, 33(3), 258–290.CrossRefPubMed
40.
Bagayogo, I. P., Interian, A., & Escobar, J. I. (2013). Transcultural aspects of somatic symptoms in the context of depressive disorders. Advances in Psychosomatic Medicine, 33, 64–74.CrossRefPubMed
41.
Koffman, J., Morgan, M., Edmonds, P., Speck, P., & Higginson, I. (2008). Cultural meanings of pain: A qualitative study of Black Caribbean and White British patients with advanced cancer. Palliative Medicine, 22(4), 350–359.CrossRefPubMed
42.
Hoeppner, B. B., Kelly, J. F., Urbanoski, K. A., & Slaymaker, V. (2011). Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. The Journal of Substance Abuse Treatment, 41(3), 305–312.CrossRefPubMed
Metagegevens
Titel
Development and content validity of a hemodialysis symptom patient-reported outcome measure
Auteurs
Jennifer E. Flythe
Adeline Dorough
Julia H. Narendra
Rebecca L. Wingard
Lorien S. Dalrymple
Darren A. DeWalt
Publicatiedatum
18-09-2018
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 1/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-2000-7

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