How to cite this article: Mendoza-Sánchez F, Ramírez-González LR, Reyes-Cruz AA, González-Ojeda A, Hernández-Machuca JS,Fuentes-Orozco C. [Evaluation of quality of life in patients with liver transplant]. Rev Med Inst Mex Seguro Soc. 2016;54(2):170-5.
ORIGINAL CONTRIBUTIONS
Received: May 19th 2014
Accepted: November 4th 2015
Federico Mendoza-Sánchez,a Luis Ricardo Ramírez-González,b Alan Alejandro Reyes-Cruz,b Alejandro González-Ojeda,c Joel Sealtiel Hernández-Machuca,c Clotilde Fuentes-Orozcoc
aUnidad de Trasplantes
bDepartamento de Cirugía General
cUnidad de Investigación en Epidemiología Clínica
Hospital de Especialidades del Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, México
Communication with: Clotilde Fuentes-Orozco
Telephone: (33) 3123 0241
Email: clotilde.fuentes@gmail.com
Background: Complications in patients with liver transplant may occur in less than 10 % of cases. These appear in short and/or long term and are due to a vascular or biliary cause, rejection, recurrence of the disease or adverse effects of immunosuppression, among others, which may affect the quality of life. The aim of this article is to evaluate the quality of life in patients with deceased donor liver transplantation through the questionnaire SF-36.
Methods: A descriptive cross-sectional study. The quality of life of patients with deceased donor liver transplantation was assessed during the period from January 1, 2005 to December 31, 2012. The variables evaluated were: age, sex, time and main reason for transplantation and quality of life using the short form SF-36 version 1.1 for Mexican population.
Results: 37 patients were included. The mean age was 48.7 years. The most frequent cause was cirrhosis (n = 35). The highest average score corresponded to the mental health component, and the lowest score to the physical component. The average time of liver transplantation was 6.73 ± 3.53 years.
Conclusions: Liver transplantation is still the most effective treatment for end-stage liver disease. It can increase the patient’s life expectancy and their quality of life, assessed with the SF-36 questionnaire. The results were similar to those in other studies in both the physical and mental component.
Keywords: Liver transplantation; Quality of life; Health status indicators; Surgical procedures, operative
Despite advances in the medical management of complications of cirrhosis, a high percentage of patients have poor quality of life and liver failure;1,2 orthotopic liver transplantation is currently the only definitive treatment option. Survival at 6 months is 90%, at 1 year 85%, at 3 years 80.4%, at 5 years 75%, and 10 years 64%.2
The number of patients on the waiting list for transplantation is extremely high, it is estimated that 5 to 10% of patients die waiting for an organ that would allow the transplant.3
Although the results of liver transplantation have improved, attention has been focused on improving the quality of life of these patients.3 The concept of quality of life includes functional health status, perceived good health, satisfaction with life, and ability to compete.4
Various instruments have been developed to assess quality of life of patients by assessing physical and mental areas.
However, in the medical or social sphere there is no consensus on the concepts to be addressed by questionnaires;5 some include only specific aspects such as depression or vitality, and others integrate physical and mental aspects of quality of life.6
The SF-36 questionnaire is one of the most widely-used instruments to assess the impact on quality of life of patients with liver transplants, as it evaluates aspects in adult populations (over 16 years), and was designed by the Health Institute, New England Medical Center, Boston, Massachusetts.
In Mexico, a study was conducted with this assessment tool to analyze reliability and validity aspects.7
The aim of this study is to evaluate the quality of life of patients after liver transplant from a deceased donor, conducted at the Centro Médico Nacional de Occidente, in the city of Guadalajara, using the SF-36 questionnaire.
An analytical cross-sectional study assessing quality of life by applying the SF-36 questionnaire, version 1.1 in Spanish to patients from the outpatient service of Servicio de Trasplantes de la Unidad Médica de Alta Especialidad of the Centro Médico Nacional de Occidente of the Instituto Mexicano del Seguro Social, who underwent liver transplant from a deceased donor during the period January 1st, 2005 to December 31st, 2012.
The study variables were age, sex, time of transplant, reason for transplant, type of immunosuppression, and quality of life through the various components contained in the SF-36 questionnaire.
Instrument
The SF-36 questionnaire version 1.1 in Spanish consists of 36 questions grouped into 8 scales of health: 1) physical function (PF); 2) physical role (PR); 3) bodily pain, (BP); 4) general health, (GH); 5) vitality (VIT); 6) social function (SF); 7) emotional role (ER), and 8) mental health, (MH); corresponding to the physical health components (PHC) and mental health components (MHC) (Table I). In addition, general concepts include changes in the perception of health status currently and from the past year. The answer to this question describes the transition from the perceived improvement or worsening of the state of health.8
Table I Definition of scale of SF-36 questionnaire | ||
Concepts | Questions | Meaning |
Physical function | 10 | Extent to which lack of health limits physical activities of daily living such as personal care, walking, climbing stairs, lifting or carrying loads, and making efforts |
Physical role | 4 | Extent to which lack of health interferes with work and other daily activities, producing as a result less than the desired performance, or limiting the type of activities that can be done |
Bodily pain | 2 | Measurement of intensity of pain suffered and its effect on usual work and home activities |
General health | 5 | Personal assessment of health status, which includes current situation, future prospects, and resistance to getting sick |
Vitality | 4 | Sense of energy and vitality, versus tiredness |
Social function | 2 | Extent to which physical or emotional problems arising from lack of health interfere with usual social life |
Emotional Role | 3 | Extent to which emotional problems affect work and other daily activities, considering reduction of time spent, reduced performance, and dedication to work |
Mental health | 5 | Evaluation of mental health in general, considering depression, anxiety, self-control, and general well-being |
Each answer is coded and recoded, and the results are transferred to a scale of 0 to 100 (from worst to best health). The internal consistency of the questionnaire showed reliability (Cronbach's alpha) of 0.91. Based on the scale obtained, averages and quartiles were obtained for each component. Information was captured by reviewing clinical records and electronic files (IMSS, VISTA, and SICEH), and then the SF-36 survey applied personally.
Statistical analysis
Descriptive, using measures of central tendency and dispersion. The differences in the values of the SF-36 score between groups were analyzed by unpaired two-tailed t-test using SPSS, version 17.0.
Ethical considerations
The study was conducted according to the principles of the Declaration of Helsinki and the Normas de Salud in Mexico, 1989. The Research Committee of the Hospital de Especialidades approved the study. The consent of all patients was obtained before applying the questionnaire.
A total of 37 patients were included. The average age was 48.7 years, range 20-69 years. A total of 25 patients were female (67.6%) and 12 male (32.4%). The most common causes of liver transplant were: cryptogenic cirrhosis, n = 12 (32.4%); liver cirrhosis secondary to hepatitis C, n = 11 (29.7%); autoimmune hepatitis, n = 6 (16.2%); primary biliary cirrhosis, n = 4 (10.8%); hepatorenal polycystic disease, n = 2 (5.4%); hepatocellular carcinoma n = 1 (2.7%), and Caroli disease, n = 1 (2.7%).
The average time after liver transplantation of patients evaluated was 6.73 ± 3.53 years.
The results of the SF-36 in the eight different dimensions and physical and mental components are summarized in Table II. The lowest average was observed in vitality and the highest was in mental health. Distribution quartiles (Figure 1) were made for each dimension. The highest frequencies in the highest quartile were observed in mental health (56.7%), social function (54%), and emotional role (54%). The highest frequencies in the lowest quartile were observed in physical role (10.8%).
Table II Results of SF-36 (average score) for patients with liver transplantation | |||||||||||
Study population | n | PF | PR | BP | GH | Vit | SF | ER | MH | PHC | MHC |
37 | 72.7 ± 24.4 | 68.24 ± 23.44 | 74.18 ± 23.34 | 60.41 ± 22.37 | 60.14 ± 20.85 | 79.73 ± 23.26 | 76.35 ±
24.80 |
75.95 ± 16.90 | 47 ± 8.54 | 50.4 ± 8.69 | |
PF = physical function; PR = physical role; BP = bodily pain; GH = general health; Vit = vitality; SF = social function; ER = emotional role; MH = mental health; PHC = physical health components; MHC = mental health components |
Figure 1 Distribution by quartiles of each dimension of SF-36 quality of life questionnaire in 37 patients with liver transplantation
In relation to gender, it was found that the dimension of vitality presented the lowest scores (54.6 in male and 62.7 in female patients) and the highest in mental health, 76.6 in men, and social function, 83.5 in women (Table III). As for the age ranges, it was observed that the 26-35 age group obtained the highest scores, and the > 65 age group the lowest (Table IV).
Table III Average values of quality of life components assessed by SF-36 according to age group | ||||||
Dimension | 18-25 | 26-35 | 36-45 | 46-55 | 56-65 | > 65 |
Physical function | 98.3 | 91.2 | 76.6 | 75 | 63 | 60 |
Physical role | 85.4 | 95.3 | 56.2 | 68.7 | 64.2 | 50 |
Bodily pain | 82.5 | 88.7 | 55.8 | 76.5 | 73.5 | 51.2 |
General health | 73.3 | 81.2 | 56.6 | 60.5 | 53.5 | 55 |
Vitality | 75 | 87.5 | 37.5 | 63.7 | 57.1 | 50 |
Social function | 100 | 93.7 | 62.5 | 81.2 | 80.3 | 68.7 |
Emotional role | 75 | 100 | 63.8 | 73.3 | 77.9 | 87.5 |
Mental health | 80 | 95 | 61.6 | 75.5 | 78.2 | 60 |
Table IV Average values of quality of life components assessed by SF-36, according to sex | ||
Component | Male | Female |
Physical function | 71.2 | 73.5 |
Physical role | 60.9 | 71.7 |
Bodily pain | 71.2 | 75.6 |
General health | 55.8 | 62.6 |
Vitality | 54.6 | 62.7 |
Social function | 71.8 | 83.5 |
Emotional role | 68.7 | 80 |
Mental health | 76.6 | 75.6 |
As for marital status, it was found that 16 (43.2%) are married, 8 (21.6%) cohabiting, while 13 (35.2%) live alone, [divorced 10 (27%), widowed 3 (8.2%)], (Table V). The return to work at 12 months was found in 24 patients (65%), because 13 (35%) previously worked in the home. Of those who resumed their work activities, 14 (60%) work part-time and the rest full-time (Table VI).
Table V Results of SF-36 questionnaire (average ± SD in liver transplantation recipients in relation to marital status) | |||||||||
n | PF | PR | BP | GH | Vit | SF | ER | MH | |
Married / cohabitating | 24 | 74 ± 24 | 69.3 ± 20.2 | 70 ± 22 | 51 ± 18 | 57 ± 20 | 79 ± 23 | 73.26 ± 22.79 | 74 ± 16 |
Living alone | 13 | 72 ± 27 | 67.3 ± 29.4 | 75 ± 24 | 60 ± 30 | 61 ± 23 | 75 ± 25 | 66.67 ± 28.23 | 74 ± 18 |
P -value | 0.79 | 0.72 | 0.12 | 0.87 | 0.26 | 0.70 | 0.31 | 0.45 | |
SD = standard deviation; PF = physical function; PR = physical role; BP = bodily pain; GH = general health; Vit = vitality; SF = social function; ER = emotional role; MH = mental health; PHC = physical health components; MHC = mental health components |
Table VI Results of SF-36 questionnaire (average ± SD in liver transplantation recipients in relation to occupation ) | |||||||||
n | PF | PR | BP | GH | Vit | SF | ER | MH | |
Employed | 15 | 72 ± 26 | 65.8 ± 29.7 | 68 ± 20 | 61 ± 29 | 57 ± 21 | 76 ± 24 | 71.11 ± 31.16 | 74 ± 18 |
Unemployed | 22 | 74 ± 27 | 69.9 ± 23.2 | 78 ± 26 | 60 ± 23 | 61 ± 23 | 82 ± 22 | 79.92 ± 28.23 | 77 ± 17 |
P -value | 0.82 | 0.61 | 0.18 | 0.95 | 0.47 | 0.40 | 0.29 | 0.57 | |
SD = standard deviation; PF = physical function; PR = physical role; BP = bodily pain; GH = general health; Vit = vitality; SF = social function; ER = emotional role; MH = mental health; PHC = physical health components; MHC = mental health components |
As for immunosuppression, 32 patients (86.4%) received calcineurin inhibitors (CNI), mycophenolate mofetil (MMF), and steroids; while 4 patients (10.8%) received sirolimus and steroids, and 1 patient received MMF and sirolimus.
The SF-36 questionnaire was first used to assess the quality of life of liver transplant patients in 1993, and it remains the most popular instrument, appearing in 11 of the 13 studies in 2008.10
In liver transplant recipients, SF-36 scores were significantly associated with rates of unemployment and disability after transplantation. The predictive validity of the SF-36 has been demonstrated in patients with liver transplantation, showing a significant correlation between pre-transplant SF-36 scores and post-transplant morbidity, mortality, and resource use.10 The number of longitudinal studies using the SF -36 is limited; however, several studies have demonstrated the responsiveness of this instrument to changes in health over time, and has demonstrated better scores after transplantation.11
The capacity of the SF-36 to detect significant differences in health among patients with end-stage liver disease and transplant recipients still leaves doubts about the sensitivity of the SF-36 to detect minimal changes over time. Saab et al. demonstrated a lack of correlation between measured quality of life in patients awaiting transplantation and severity of the disease according to the results of the model for end-stage liver disease (MELD). These results highlight possible weaknesses in the SF-36 to capture relevant and specific health aspects for liver transplantation. However, due to the deficiencies of other instruments to measure quality of life, SF-36 remains one of the most used for this end.12,13
The quality of life in a patient with liver transplantation is affected in physical and social aspects by various factors such as age, reason for transplant, transplant type, severity of the patient's physical condition at the time of transplant, trans- and post-operative complications, immunosuppressive therapy, concomitant diseases, etc. In our study, only one patient had morbid obesity and their scores were not below the average of the study population.
Kousoulas et al. consider other factors that have an impact on quality of life, including marital status, occupational status during the first year after transplantation, and immunosuppressive regime.4 In our study, marital and occupational status reflected better scores of the SF-36, however they were not significant for a better quality of life. Conversion schemes including CNI for MMF and sirolimus or MMF as monotherapy reduced renal toxicity.
The quality of life reflected in the integrity of the person represents an important measure of success of a medical intervention, beyond a high survival rate, because quality of life involves every detail of the activities of daily life of a person and their social functioning.14
Although inherent to post-transplant recovery are effects such as: limitation of physical activity, fatigue, tiredness, and weakness, participants did not feel affected in their quality of life, they proved to have better self-control. The results of our research showed that the category of social function obtained the highest score (79.73 ± 23.26). The quality of life of patients with liver transplantation is related to the possibility of good health regardless of time post-transplant, integrating into their social, work, and family areas with physical independence, carrying out activities that allow them to have fun and work.
Patients and their families consider transplantation a chance to improve their quality of life by changing their health status.14,15
The study reported by Chen et al. found that patients who received an organ from a live donor scored lower on the SF-36 scale than patients who obtained the graft from a deceased donor, additionally reporting a higher total cost, higher incidence of complications, and recurrence of hepatocellular carcinoma. Elevated serum levels of tacrolimus in the group of patients receiving from a living donor also resulted in lower scores on the SF-36 scale. It was also found that a high level of anxiety and depressive symptoms after transplantation are deleterious in the long term in patients receiving the liver graft, increasing long-term mortality risk.15
With liver transplantation quality of life and survival is improved; according to Duffy et al., more than 50% of recipients survive 20 years and significantly improve their socioeconomic status by joining work activities, doing better in relation to patients with liver disease or other chronic illnesses.16 In our study all patients returned to their working life and / or daily activities between 6 and 12 months after transplantation.
Saab et al. found better quality of life in liver transplant patients upon return to their social and working lives, 22% of patients returned to their work activities completely, 5% partially, and the rest (73%) remained unemployed.
The main factors associated with these statistically significant results were age, gender, number of working hours pre-transplant, indication for transplant, absence of comorbidities (mostly diabetes mellitus), and level of schooling at the time of transplant.12 In our study, 65% of patients returned to their work activities full-time and part-time; the rest did their daily activities, including housework.
For end-stage liver disease, liver transplantation is the only effective treatment that achieves increased life expectancy and improved quality of life. Work activity after transplantation did not have a positive effect on the quality of life in the categories of physical function and physical role, while marital status had a positive effect on the quality of life of liver transplant recipients in the medium term.
To Dr. Enrique Cervantes Pérez and Dr. Bertha Estefanía García Ramírez for their support in verifying and implementing surveys, and reviewing medical records for information.
Declaración de conflicto de interés: los autores han completado y enviado la forma traducida al español de la declaración de conflictos potenciales de interés del Comité Internacional de Editores de Revistas Médicas, y no fue reportado alguno que tuviera relación con este artículo.