Development and Psychometric Evaluation of "Caregiver Burden Questionnaire for Family Caregivers of Patients Undergoing Hemodialysis": A Protocol for A Sequential Exploratory Mixed-Method Study

Protocol for Development of Caregiver Burden Questionnaire


Objective: Caregiver burden is defined as the physical, financial, mental, and social problems stemmed from providing care for one of the family members who is involved with a medical problem. The precise measurement of caregiver burden is crucial, and it is essential to have an appropriate and specific tool for measuring caregiver burden. This study will be carried out using sequential exploratory mixed-method design with the aim of development and psychometric evaluation of a questionnaire for caregiver burden in family caregivers of hemodialysis patients.

Method: The study will be done in 2 phases: 1. qualitative study and literature review, and 2. designing and psychometric evaluation of the questionnaire. In the qualitative phase, family caregivers of hemodialysis patients, patients, nurses, physicians, and social workers will be selected using the maximum variation purposive sampling method. Data will be gathered through semi-structured interviews using a combination of the questions derived from the model and open-ended questions and will be analyzed using directed content analysis. The literature review will be carried out based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses to improve the reporting of the systematic review. After developing the primary item pool, in the quantitative phase, the psychometric properties of the questionnaire will be evaluated. In this regard, face, content, and construct validity (exploratory factor analysis), internal consistency (Alpha’s Cronbach), reliability (test-retest), responsiveness, interpretability, and feasibility of the questionnaire will be assessed.

Results: The primary questionnaire will be developed based on the qualitative and systematic literature review; then, its psychometric properties will be assessed in the second phase. The result section will consist of the findings of these two phases.

Conclusion: It seems that a specific questionnaire could be a facilitator of identifying and measuring the actual caregiver burden.

Cantekin I, Kavurmacı M, Tan M. An analysis of caregiver burden of patients with hemodialysis and peritoneal dialysis. Hemodial Int. 2016;20(1):94-7.
2. Fekete C. Caregiver Burden. International Encyclopedia of the Social & Behavioral Sciences. 2nd ed. Oxford: Elsevier; 2015.
3. Hoang VL, Green T, Bonner A. Informal caregivers' experiences of caring for people receiving dialysis: A mixed-methods systematic review. 2018;44(2):82-95.
4. Low J, Smith G, Burns A, Jones L. The impact of end-stage kidney disease (ESKD) on close persons: a literature review. NDT Plus. 2008;1(2):67-79.
5. Oyegbile YO, Brysiewicz P. Exploring caregiver burden experienced by family caregivers of patients with End-Stage Renal Disease in Nigeria. Int J Afr Nurs Sci. 2017;7:136-43.
6. Salehitali S, Ahmadi F, Hasanpour Dehkordi A, Noorian K, Fereidooni-Moghadam M, Zarea K. Progressive exhaustion: A qualitative study on the experiences of Iranian family caregivers regarding patients undergoing hemodialysis. Int J Nurs Sci. 2018;5(2):193-200.
7. Alnazly E. Coping strategies and socio-demographic characteristics among Jordanian caregivers of patients receiving hemodialysis. Saudi J Kidney Dis Transpl. 2016;27(1):101-6.
8. Gilbertson EL, Krishnasamy R, Foote C, Kennard AL, Jardine MJ, Gray NA. Burden of Care and Quality of Life Among Caregivers for Adults Receiving Maintenance Dialysis: A Systematic Review. Am J Kidney Dis. 2019;73(3):332-43.
9. Sajadi SAM, Ebadi AP, Moradian STP. Quality of Life among Family Caregivers of Patients on Hemodialysis and its Relevant Factors: A Systematic Review. Int J Community Based Nurs Midwifery. 2017;5(3):206-18.
10. Glajchen M, Kornblith A, Homel P, Fraidin L, Mauskop A, Portenoy RK. Development of a brief assessment scale for caregivers of the medically ill. J Pain Symptom Manage. 2005;29(3):245-54.
11. Creswell J, Creswell D. Research Design: Qualitative, Quantitative, and Mixed Methods Approaches. 5th ed: SAGE Publications; 2018.
12. Chou KR, LaMontagne LL, Hepworth JT. Burden experienced by caregivers of relatives with dementia in Taiwan. Nurs Res. 1999;48(4):206-14.
13. Chou KR. Caregiver burden: a concept analysis. J Pediatr Nurs. 2000;15(6):398-407.
14. Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs. 2008;62(1):107-15.
15. Assarroudi A, Heshmati Nabavi F, Armat MR, Ebadi A, Vaismoradi M. Directed qualitative content analysis: the description and elaboration of its underpinning methods and data analysis process. J Res Nurs. 2018;23(1):42-55.
16. Polit DF, Beck CT. Essentials of Nursing Research: Appraising Evidence for Nursing Practice. 9th ed. Wolter Kluwer; 2017.
17. Whiting LS. Semi-structured interviews: guidance for novice researchers. Nurs Stand. 2008;22(23):35-40.
18. Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995;18(2):179-83.
19. Speziale HS, Streubert HJ, Carpenter DR. Qualitative research in nursing: Advancing the humanistic imperative: Lippincott Williams & Wilkins; 2011.
20. Thomas E, Magilvy JK. Qualitative rigor or research validity in qualitative research. J Spec Pediatr Nurs. 2011;16(2):151-5.
21. Lincoln YS, Guba EG. But is it rigorous? Trustworthiness and authenticity in naturalistic evaluation. New directions for program evaluation. 1986;1986(30):73-84.
22. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
23. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010;63(7):737-45.
24. Waltz C, Strickland OL, Lenz E. Measurement in Nursing and Health Research. Fifth ed. New York: Springer Publishing Company; 2016.
25. Zamanzadeh V, Ghahramanian A, Rassouli M, Abbaszadeh A, Alavi-Majd H, Nikanfar AR. Design and Implementation Content Validity Study: Development of an instrument for measuring Patient-Centered Communication. J Caring Sci. 2015;4(2):165-78.
26. Nikpour M, Tirgar A, Ebadi A, Ghaffari F, Firouzbakht M, Hajiahmadi M. Development and psychometric evaluation of a women shift workers' reproductive health questionnaire: study protocol for a sequential exploratory mixed-method study. Reprod Health. 2018;15(1):22.
27. Taghizadeh Z, Ebadi A, Montazeri A, Shahvari Z, Tavousi M, Bagherzadeh R. Psychometric properties of health related measures. Part 1: Translation, development, and content and face validity. Payesh (Health Monitor). 2017;16(3):343-57.
28. Lawshe CH. A quantitative approach to content validity. Personnel psychology. 1975;28(4):563-75.
29. Polit. D F, Yang. F. Measurement and the Measurement of Change. 1st ed: LWW; 2015.
30. Piedmont RL, Hyland ME. Inter-item correlation frequency distribution analysis: A method for evaluating scale dimensionality. Educ Psychol Meas. 1993;53(2):369-78.
31. Gaskin CJ, Happell B. On exploratory factor analysis: a review of recent evidence, an assessment of current practice, and recommendations for future use. Int J Nurs Stud. 2014;51(3):511-21.
32. Plichta Kellar S, Kelvin E. Munro's Statistical Methods for Health Care Research 6th ed: Lippincott Williams & Wilkins; 2012.
33. Hair Jr J, Black W, Babin B, Anderson R. Multivariate Data Analysis. Seventh ed: Pearson; 2014.
34. Polit DF. Assessing measurement in health: Beyond reliability and validity. Int J Nurs Stud. 2015;52(11):1746-53.
35. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34-42.
36. Ebadi A, Taghizadeh Z, Montazeri A, Shahvari Z, Tavousi M, Bagherzadeh R. Translation, development and psychometric properties of health related measures-Part 2: construct validity, reliability and responsiveness. Payesh (Health Monitor). 2017;16(4):445-55.
37. Mokkink LB, Terwee CB, Gibbons E, Stratford PW, Alonso J, Patrick DL, et al. Inter-rater agreement and reliability of the COSMIN (COnsensus-based Standards for the selection of health status Measurement Instruments) checklist. BMC Med Res Methodol. 2010;10:82.
38. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649-55.
39. Elmståhl S, Malmberg B, Annerstedt L. Caregiver's burden of patients 3 years after stroke assessed by a novel caregiver burden scale. Arch Phys Med Rehabil. 1996;77(2):177-82.
40. Bakas T, Austin JK, Jessup SL, Williams LS, Oberst MT. Time and difficulty of tasks provided by family caregivers of stroke survivors. J Neurosci Nurs. 2004;36(2):95-106.
41. Ravaghi H, Behzadifar M, Behzadifar M, Taheri Mirghaed M, Aryankhesal A, Salemi M, et al. Prevalence of Depression in Hemodialysis Patients in Iran: a Systematic Review and Meta-analysis. Iran J Kidney Dis. 2017;11(2):90-8.
42. Mellon L, Regan D, Curtis R. Factors influencing adherence among Irish haemodialysis patients. Patient Educ Couns. 2013;92(1):88-93.
43. Katzir Z, Boaz M, Backshi I, Cernes R, Barnea Z, Biro A. Medication apprehension and compliance among dialysis patients--a comprehensive guidance attitude. Nephron Clin Pract. 2010;114(2):c151-7.
44. Alosaimi FD, Asiri M, Alsuwayt S, Alotaibi T, Bin Mugren M, Almufarrih A, et al. Psychosocial predictors of nonadherence to medical management among patients on maintenance dialysis. Int J Nephrol Renovasc Dis. 2016;9:263-72.
45. Aghakhani N, Sharif F, Molazem Z, Habibzadeh H. Content analysis and qualitative study of hemodialysis patients, family experience and perceived social support. Iran Red Crescent Med J. 2014;16(3): e13748.
46. Song YY, Hu RJ, Diao YS, Chen L, Jiang XL. Effects of Exercise Training on Restless Legs Syndrome, Depression, Sleep Quality, and Fatigue Among Hemodialysis Patients: A Systematic Review and Meta-analysis. J Pain Symptom Manage. 2018;55(4):1184-95.
IssueVol 16 No 4 (2021) QRcode
Caregiver Burden End-Stage Renal Disease Hemodialysis Psychometrics Questionnaire

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
Hejazi SS, Hosseini M, Ebadi A, Alavi Majd H. Development and Psychometric Evaluation of "Caregiver Burden Questionnaire for Family Caregivers of Patients Undergoing Hemodialysis": A Protocol for A Sequential Exploratory Mixed-Method Study. Iran J Psychiatry. 2021;16(4):471-479.