Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life Questionnaire

NCT06577480 | Active Not Recruiting

• 1 other identifier: SBA 24/665
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation is a crucial treatment for life-threatening liver diseases, including acute liver failure, end-stage chronic liver disease, primary liver cancers, and congenital metabolic disorders. Quality of life in liver transplant patients is vital. The World Health Organization defines quality of life as an individual's perception of their position in life within the context of culture, values, goals, and expectations. Liver transplantation improves quality of life. Recipients should be closely monitored and supported psychologically, with the effectiveness of the intervention in improving quality of life well-documented. Saab et al. developed the post-Liver Transplantation Quality of Life (pLTQ) questionnaire, which includes eight sub-dimensions across 32 items. To our knowledge, no Turkish-specific QoL tool for liver transplant patients currently exists. This study aims to validate and assess the reliability of the Turkish version of the pLTQ questionnaire.

Conditions

Liver Transplant Disorder; Quality of Life

Outcome Measures

Primary Outcomes (5)

• Assessment of quality of life - disease specific

  The post-Liver Transplant Quality of Life questionnaire consists of 32 items that assess specific factors that may affect the lives of liver transplant recipients, including symptoms, mood, limitation of activities of daily living, energy level, and transplant-related care. The items are scored on a seven-point Likert-type scale, where 1 means "always" and 7 means "never." Each subsection score and a total score are obtained with the post-Liver Transplant Quality of Life questionnaire. Higher values indicate higher quality of life.

  1st day

• Assessment of quality of life - general

  In order to evaluate the validity of the Turkish post-Liver Transplant Quality of Life questionnaire, the Short Form-36 will be used. The Short Form-36 consists of eight sub-sections: physical function, social function, role restriction due to physical problems, role restriction due to emotional problems, mental health, vitality, body pain, general health, and change in health. Each sub-score is scored between 0 and 100. Higher scores indicate better quality of life.

  1st day

• Assessment of health profile

  In order to evaluate the validity of the Turkish post-Liver Transplant Quality of Life questionnaire, Nottingham Health Profile will be used. Nottingham Health Profile consists of 38 items. It has six sub-sections: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical mobility (8 items). There is a possible score range for each sub-section ranging from 0 to 100 points. Higher scores indicate greater limitations in quality of life.

  1st day

• Psychosocial status assessment

  The Hospital Anxiety and Depression Scale will be used to assess the anxiety and depression levels of patients. This scale consists of 14 items that aim to determine the risk of anxiety and depression in the patient, and to measure its level and severity change. The scale, which is asked to be answered by taking into account the last few days, has two subscales consisting of seven separate items measuring anxiety and depression. Higher scores indicate a better psychosocial status.

  1st day

• Fatigue assessment

  The Fatigue Severity Scale will be used to assess fatigue. This scale questions the patient's fatigue status in the last month. The scale, which consists of a total of 9 items, is scored on a 7-point Likert type. The total score is calculated by taking the average of the items. As the score increases, the patient's perception of fatigue increases.

  1st day

Secondary Outcomes (2)

• Anthropometric and clinical characteristics

  1st day

• Model for End-Stage Liver Disease score index

  1st day

Study Arms (1)

Liver transplant recipients

Other: No intervention

Interventions

No intervention OTHER

No intervention

Liver transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver transplant recipients

You may qualify if:

• Being 18 years of age or older,
• Having received post-liver transplant treatment at Hacettepe University Adult Hospital General Surgery Units and being referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after routine clinical and laboratory examinations, if deemed appropriate for the study,
• Being willing to participate in the study.

You may not qualify if:

• Having undergone combined liver-kidney transplantation and multiple organ transplantation,
• Having uncontrolled cardiovascular and neurological problems,
• Having a cognitive problem that will prevent understanding the questionnaires,
• Not being willing to participate in the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (15)

• Mahmud N. Selection for Liver Transplantation: Indications and Evaluation. Curr Hepatol Rep. 2020;19(3):203-212. doi: 10.1007/s11901-020-00527-9. Epub 2020 Jun 19.

  PMID: 32837824 BACKGROUND

• Akarsu M. Liver transplantation in Turkey: The importance of experience. Turk J Gastroenterol. 2018 Nov;29(6):629-630. doi: 10.5152/tjg.2018.81018. No abstract available.

  PMID: 30381270 BACKGROUND

• Muller PC, Kabacam G, Vibert E, Germani G, Petrowsky H. Current status of liver transplantation in Europe. Int J Surg. 2020 Oct;82S:22-29. doi: 10.1016/j.ijsu.2020.05.062. Epub 2020 May 23.

  PMID: 32454252 BACKGROUND

• Girgenti R, Tropea A, Buttafarro MA, Ragusa R, Ammirata M. Quality of Life in Liver Transplant Recipients: A Retrospective Study. Int J Environ Res Public Health. 2020 May 27;17(11):3809. doi: 10.3390/ijerph17113809.

  PMID: 32471157 BACKGROUND

• Onghena L, Develtere W, Poppe C, Geerts A, Troisi R, Vanlander A, Berrevoet F, Rogiers X, Van Vlierberghe H, Verhelst X. Quality of life after liver transplantation: State of the art. World J Hepatol. 2016 Jun 28;8(18):749-56. doi: 10.4254/wjh.v8.i18.749.

  PMID: 27366301 BACKGROUND

• Jay CL, Butt Z, Ladner DP, Skaro AI, Abecassis MM. A review of quality of life instruments used in liver transplantation. J Hepatol. 2009 Nov;51(5):949-59. doi: 10.1016/j.jhep.2009.07.010. Epub 2009 Jul 28.

  PMID: 19775771 BACKGROUND

• Vedadi A, Khairalla R, Che A, Nagee A, Saqib M, Ayub A, Wasim A, Macanovic S, Orchanian-Cheff A, Selzner-Malekkiani N, Bartlett S, Mucsi I. Patient-reported outcomes and patient-reported outcome measures in liver transplantation: a scoping review. Qual Life Res. 2023 Sep;32(9):2435-2445. doi: 10.1007/s11136-023-03405-1. Epub 2023 Apr 6.

  PMID: 37022585 BACKGROUND

• Rimmer B, Jenkins R, Russell S, Craig D, Sharp L, Exley C. Assessing quality of life in solid organ transplant recipients: A systematic review of the development, content, and quality of available condition- and transplant-specific patient-reported outcome measures. Transplant Rev (Orlando). 2024 Apr;38(2):100836. doi: 10.1016/j.trre.2024.100836. Epub 2024 Feb 13.

  PMID: 38359538 BACKGROUND

• Saab S, Ng V, Landaverde C, Lee SJ, Comulada WS, Arevalo J, Durazo F, Han SH, Younossi Z, Busuttil RW. Development of a disease-specific questionnaire to measure health-related quality of life in liver transplant recipients. Liver Transpl. 2011 May;17(5):567-79. doi: 10.1002/lt.22267.

  PMID: 21506245 BACKGROUND

• Kim WR, Mannalithara A, Heimbach JK, Kamath PS, Asrani SK, Biggins SW, Wood NL, Gentry SE, Kwong AJ. MELD 3.0: The Model for End-Stage Liver Disease Updated for the Modern Era. Gastroenterology. 2021 Dec;161(6):1887-1895.e4. doi: 10.1053/j.gastro.2021.08.050. Epub 2021 Sep 3.

  PMID: 34481845 BACKGROUND

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 BACKGROUND

• Soyyigit S, Erk M, Guler N, Kilinc G. [The value of SF-36 questionnaire for the measurement of life quality in chronic obstructive pulmonary disease]. Tuberk Toraks. 2006;54(3):259-66. Turkish.

  PMID: 17001544 BACKGROUND

• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

  PMID: 10826123 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.

  PMID: 17293726 BACKGROUND

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Study Officials

• Aslihan Cakmak-Onal, PhD, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Naciye Vardar-Yagli, PhD, PT

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aslihan Cakmak-Onal

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)