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A Self-Administered Quality of Life Questionnaire for Renal Transplant Recipients
Abstract
A selection of instruments has been developed to measure health-related quality of life (QOL). Generic instruments are designed for use across medical conditions, but may not detect small but clinically important QOL changes [1]. Disease-specific measures improve the sensitivity of QOL measurement, and may help detect differences between alternative interventions for kidney transplant recipients.
... The scale is easy to apply (0 = no complaint, 6 = the highest complaint), with scores ranging from 0 to 90 where higher scores denote a worse symptom burden [13]. The second questionnaire was the Kidney Transplant Questionnaire (KTQ), a disease-specific measure designed to evaluate health-related QoL in renal transplant patients [15,16]. The KTQ covers five domains (physical symptoms, fatigue, uncertainty-fear, appearance, and emotions) and considers symptoms or problems identified by the patient during the previous 4 weeks. ...
... One patient died following a pneumonia episode (infection by herpes zoster virus), and dialysis was started in two patients because of worsening of CAD. Twelve patients did not modify the prescribed dosage of EC-MPS (mean dosage: 1080 ± 394 mg/day; median follow-up: 13 months, range: [10][11][12][13][14][15][16][17][18]; in four patients the dose was reduced for leukopenia (one), to lower immunosuppression (one), for GI symptoms re-occurrence (two, median time from the shift: 6 months). In two patients, the dosage was even increased, on clinical basis, whereas the last patient preferred to return to MMF treatment which was better tolerated; this last patient belonged to the Group of 'nonresponders'. ...
Gastrointestinal (GI) adverse events in renal transplant patients are a common cause of mycophenolate mofetil (MMF) dose reductions, which result in an increased risk of graft rejection because of a low immunosuppression. This study investigated whether conversion from MMF to enteric-coated mycophenolate sodium (EC-MPS) in renal transplant patients with serious GI side-effects, alleviated these symptoms and allowed administration of higher doses of EC-MPS. Nineteen renal transplant patients with severe MMF-related GI side-effects underwent a progressive reduction in MMF dose until symptoms disappeared. At this point, 12-h AUC(MMF) was evaluated and patients were shifted to an equimolar dose of EC-MPS. The EC-MPS dose was then progressively increased until the highest recommended dose was reached or GI symptoms re-appeared. Four weeks post-conversion, AUC(EC-MPS) was determined. Conversion led to a mean increase in EC-MPS dose of 68% (P < 0.0001), with a corresponding rise in AUC(0-12) (60.5%, P < 0.0006) associated with significant benefits in terms of both quality of life (Kidney Transplant Questionnaire, P < 0.01) and GI symptoms (Gastrointestinal Symptom Rating Scale, P < 0.0001), using validated questionnaires. In five of 19 patients, the EC-MPS dose could not be increased because of the prompt insurgence of GI symptoms. Renal function and biochemical parameters remained stable post-conversion and no rejection episodes occurred. These findings suggest that, in selected patients, EC-MPS may be better tolerated than MMF when GI symptoms are particularly important and permits higher mycophenolic acid exposure, when required.
... Plusieurs études ont déjà utilisé ce questionnaire pour évaluer la qualité de vie chez des patients transplantés rénaux à différents délais post-greffe selon les études, notamment en Europe, en Australie, au Canada, aux Etats-Unis et en Iran (67,69,76,78,(100)(101)(102)(103)(104). ...
Among all existing studies/cohorts in kidney transplantation, only a few study the impact of the pharmacological parameters. In addition to the clinical file, the use of a self-administered questionnaire has been validated to collect these data. Comparison between clinical file and self-administered questionnaire concerning the reporting of adverse events highlighted some differences. Infections were the most reported adverse events by the physicians while the patients declared only a few. Adherence evaluated with the self-administered questionnaire decreased between the first and third post-transplantation year and so did the feeling of euphoria and revival. The « Mental health » dimension of the quality of life (QOL) ReTransQol score decreased over this period. However patients’ fear of losing the graft increased as shown by the decrease of the « Fear of losing the graft » dimension of the QOL score. QOL, evaluated by generic and kidney-transplanted-specific questionnaires is also an important parameter that must be considered in patient follow-up. Psychometric properties of the second version of the ReTransQol, as well as its reproducibility and its sensitivity to changes have been validated as early as the 3rd post-kidney-transplantation month. The pharmacoeconomic study Ephegren, development of Epigren cohort, will study the cost-effectiveness and cost-utility ratio of immunosuppressive and anti-cytomegalovirus strategies. Guidelines will then be proposed to standardise the treatments and decrease the management costs of kidney-transplant recipients.
... Ce questionnaire a été utilisé dans deux études. [14][15][16][17][18][19]13,90 ...
... Few specific questionnaires of QOL have been developed171819 for Renal Transplant Recipients (RTR), but they were not validated or available in French. Among questionnaires adapted to the general population, SF36 remains the most widely used in studies of QOL [10,2021222324252627. We purposefully did not make a direct transcultural validation of one of the existent questionnaires for RTR because some dimensions were lacking in these questionnaires , such as those related to medical care. ...
In the absence of a French health-related quality of life (QOL) instrument for renal transplant recipients (RTR), we developed a self-administered questionnaire: the ReTransQol (RTQ).
This questionnaire was developed using classical methodology in the following three phases over a two-year period: Item Generation phase, identifying all possible items having adverse impact on the QOL of RTR, Item Reduction phase, selecting the most pertinent items related to QOL, and Validation phase, analyzing the psychometric properties. All RTR involved in these phases were over 18 and were randomly selected from a transplant registry.
Item generation was conducted through 24 interviews of RTR. The first version of RTQ (85 items) was sent to 225 randomized RTR, and 40 items were eliminated at the end of the item reduction phase. The second version of RTQ (45 items) was validated from 130 RTR, resulting in the RTQ final version. The factor analysis identified a structure of five factors: Physical Health (PH), Mental Health (MH), Medical Care (MC), Fear of losing the Graft (FG) and Treatment (TR). The psychometric properties of RTQ were satisfactory. Comparison between known groups from the literature confirmed the construct validity: patients without employment or living alone have lower QOL scores, and women have lower QOL scores than men. RTQ was more responsive than SF36 to detect changes in the QOL of RTR who were hospitalized secondary to their renal disease in the 4 weeks preceding their inclusion.
According to French public health priorities, RTQ appears to be a reliable and valid questionnaire.
... Health-related quality of life was specifically compared in SRL-treated kidney transplant patients after CsA elimination and in patients who were still treated with CsA at 2 years in the Tricontinental study (Oberbauer, Hutchison, et al 2003). Of the 361 patients studied, those in the CsA-withdrawal group improved significantly more than others, according to the replies in the "Kidney Transplant Questionnaire" (KTQ) (Laupacis et al 1993;Jacobs et al 1998) fatigue and appearance domains. SF-36 vitality score was also better in the CsA-withdrawal group. ...
Cyclosporine (CsA), a member of the family of calcineurin inhibitors, is a cornerstone of the immunosuppressive treatments used after organ transplantation. However, it exhibits significant toxicity, including nephrotoxicity and increased cardiovascular risk factors. CsA withdrawal has been used as a strategy to improve renal allograft function and other CsA-related toxicities. In order to maintain adequate immunosuppression levels, sirolimus may be used in association with CsA withdrawal. Sirolimus is a member of the mammalian target of rapamycin (mTOR) family. It presents a good immunosuppressive efficacy associated with antiproliferative actions. Early withdrawal of CsA with sirolimus is associated with a significant improvement of renal function. Despite numerically a higher incidence of acute rejection episodes, this maneuver seems also to be associated with a better allograft survival in the long-term, and improvement of renal histology and blood pressure. However, CsA withdrawal is only feasible in a selected population. Furthermore, the use of sirolimus is associated with other side-effects including lipid abnormalities, abnormal liver tests, and thrombocytopenia. Other studies are mandatory to define the population who can benefit from this maneuver. Finally, complete CsA avoidance has been already reported and is currently under clinical investigation.
Health related quality of life (HRQOL) indicators take into account the personal perception of health, and are proposed as an alternative for efficacy indicators in medical and therapeutic decision making. They provide, due to elaboration and validation of a questionnaire, a standardised assessment of the health status perception. This paper provides a review-of a variety of HRQOL instruments developed for patients suffering end-stage renal disease (ESRD). Generic instruments are designed to be applicable in general population and disease-targeted instrument are potentially mote sensitive to the characteristics of a specific population. Among HRQOL instruments, we found 4 generic questionnaires (the Sickness Impact Profile, the SF 36, the Nottingham Health Profile and the EQ-5D), 3 disease-targeted questionnaires developed for, ESRD patient undergoing dialysis (the Kidney Disease Quality of Life instrument, the Kidney Disease Questionnaire and the Choice Health Experience Questionnaire), 1 questionnaire specific for ESRD patients (the HRQOL questionnaire), and 2 specific disease-targeted instruments for renal, transplant (the Kidney Transplant Questionnaire and the ESRD Symptom Checklist-Transplantation Module). In France, very few studies on the quality of life of ESRD patients were published.
Despite a proliferation of literature concerning quality of life (QOL) after transplantation, there remains a good deal of confusion in the transplant community over how to best interpret QOL data and measure QOL in patients. This article examines what exactly is meant by "QOL," examines the existing literature in transplantation focused on QOL, and makes several recommendations concerning future research directions. Also, the responsibilities of individual programs in measuring, reporting, and interpreting QOL data in patients are discussed.
Improvements in organ preservation methods, immunosuppressive regimens and general post-transplant care have resulted in an increased life expectancy and a continually decreasing morbidity after solid organ transplantation. As attention gradually moves towards improving subjective patient outcomes, the use of patient-reported outcome measures (PROs) thus becomes increasingly important in post-transplant patient management. This paper provides a brief systematic overview of the transplant-specific PRO measures, and their psychometric properties, developed and used in solid organ transplant recipients to date. PRO measures may focus on or encompass different aspects of life relevant to organ transplant patients: overall quality of life (QOL), physical, psychological and social functioning, and adherence. Overall QOL can be measured using transplant-specific or generic QOL instruments, or a combination of both. In general, very little information is available on the psychometric properties of PRO measures, and there is no gold standard for PRO measurement. Transplant-specific and generic PRO instruments are complementary. Generic instruments will continue to be important for economic evaluations, but transplant-specific instruments may be more useful for patient management purposes, as they are generally more sensitive to small but clinically relevant changes in outcomes in transplant populations.
Objectives: To develop a questionnaire to assess the responses of transplant recipients to the receipt of an organ, including their self‐care behaviour.
Design: Following a literature review, open‐ended interviews and a focus group, a transplant questionnaire was developed. Two studies (Study 1: N = 231, Study 2: N = 105) were conducted to evaluate its psychometric properties.
Methods: A pool of 51 items was derived from themes identified in published studies and from interviews and a focus group discussion with renal transplant recipients. These were constructed into a questionnaire and were then administered to two renal transplant out‐patients populations. Item responses of study sample 1 were subjected to principal components analysis (PCA) using varimax rotation to examine the structure of responses. In order to investigate the stability of the factor structure found in Study 1, item responses of the second sample were subjected to confirmatory factor analysis (CFA) using structural equation modelling.
Results: PCA indicated six factors that accounted for 64.2% of the variance. With extraneous items omitted, the final questionnaire derived from Study 1 has 24 items clustered around five conceptual coherent factors: worry about transplant (22.1%), guilt regarding donor (11.9%), disclosure (9.58%), medication adherence (8.73%), and responsibility (6.63%). CFA on the final 24‐item version of the TxEQ revealed that the resulting model was a good fit for the Study 2 data (RMSEA = 0.08, p close = .005).
Conclusions: The TxEQ has potential application as a measure in the area of transplantation research. CFA demonstrated that the factor structure of the TxEQ is consistent across different renal transplant out‐patients populations. Further research is currently in progress to assess other groups of transplant recipients and to examine its relationship to other measures.
This study compared 2-year health-related quality-of-life (HRQL) outcomes of sirolimus (SRL)-treated kidney transplant patients after elimination of cyclosporine A (CsA) to patients continuing on a combined CsA and SRL regimen.
A randomized, open-label, clinical trial was performed in Europe, Australia, and Canada. Four hundred thirty kidney transplant patients were randomly assigned to sirolimus plus steroids (ST) (n=215) or SRL and CsA+ST (n=215) therapy after 3 months of combined SRL+CsA+ST treatment. HRQL was measured using the Kidney Transplant Questionnaire (KTQ) and the SF-36 Health Survey at month 3 (time of randomization) and months 12 and 24 after transplantation. Repeated-measures analysis of covariance was used to evaluate treatment differences in HRQL scores over the 2-year period.
HRQL scores were available for 361 (86%) eligible study patients. Statistically significant treatment-by-assessment time interactions, favoring SRL+ST, were found on KTQ Fatigue (P=0.0158) and Appearance scores (P=0.0007). No treatment differences were observed in KTQ Physical Symptom, Uncertainty-Fear, and Emotion scores. Statistically significant treatment-by-assessment time interactions were observed for SF-36 Vitality scores (P=0.0203) but not other SF-36 scores (P>0.05). For Vitality scores, the SRL+ST group remained stable (mean, 0.4-point change) from month 3 to month 24 compared with decreases in the SRL+CsA+ST group (mean, -6.5-point change).
SRL-based therapy with early elimination of CsA results in fewer appearance-related problems, less fatigue, and better vitality compared with continuous treatment with SRL, CsA, and ST.
With continuously rising survival rates following renal transplantation, health-related quality of life (HQOL) of long-term transplant survivors becomes increasingly important.
Recipients more than 15 years after successful renal transplantation were studied retrospectively. HQOL in 139 long-term transplant recipients was assessed using the SF-36 and the disease-specific kidney transplant questionnaire (KTQ-25).
Long-term transplant recipients revealed satisfactory HQOL that was comparable to the healthy population in four of eight SF-36 categories (role physical, social functioning, role emotional and mental health). Other SF-36 categories such as physical functioning, physical pain, general health, and vitality were reduced. Among the study population, disease-specific HQOL was comparable or even improved to that of patients awaiting transplantation. In contrast to retired or unemployed patients, employed recipients revealed a highly significant improved HQOL in numerous SF-36 categories such as physical functioning (P<0.001), physical pain (P<0.001), general health (P<0.001), vitality (P<0.001), social functioning (P<0.005), and mental health (P<0.001), as well as for the KTQ-dimensions physical symptoms (P<0.001), fatigue (P>0.001), uncertainty/fear (P<0.01), and emotions (P<0.05). Other factors positively correlating with improved HQOL in certain dimensions were living situation, systolic blood pressure, and recipient age.
More than 15 years after renal transplantation, recipients present satisfactory HQOL comparable to the general healthy population or at least to pretransplant patients. Vocational rehabilitation following renal transplantation is of highest importance among long-term survivors and is associated with improved HQOL.
Tests or measures in clinical medicine or the social sciences can be used for three purposes: discriminating between subjects, predicting either prognosis or the results of some other test, and evaluating change over time. The choices made at each stage of constructing a quality of life index will differ depending on the purpose of the instrument. We explore the implications of index purpose for each stage of instrument development: selection of the item pool, item scaling, item reduction, determination of reliability, of validity, and of responsiveness. At many of these stages, not only are the requirements for discriminative, predictive, and evaluative instruments not complementary, they are actually competing. Attention to instrument purpose will clarify the choices both for those developing quality of life measures and for those selecting an appropriate instrument for clinical studies.
The final development of the Sickness Impact Profile (SIP), a behaviorally based measure of health status, is presented. A large field trial on a random sample of prepaid group practice enrollees and smaller trials on samples of patients with hyperthyroidism, rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses. Test-retest reliability (r = 0.92) and internal consistency (r - 0.94) were high. Convergent and discriminant validity was evaluated using the multitrait--multimethod technique. Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores. The relationship between the SIP and criterion measures were moderate to high and in the direction hypothesized. A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis. The final SIP contains 136 items in 12 categories. Overall, category, and dimension scores may be calculated.
Many health status surveys have been designed for mail, telephone, or in-person administration. However, with rare exception, investigators have not studied the effect the survey mode of administration has on the way respondents assess their health and other important parameters (such as response rates, nonresponse bias, and data quality), which can affect the generalizability of results. Using a national sampling frame of noninstitutionalized adults from the General Social Survey, we randomly assigned adults to a mail survey (80%) or a computer-assisted telephone survey (20%). The surveys were designed to provide national norms for the SF-36 Health Survey. Total data collection costs per case for the telephone survey (27.07). A significantly higher response rate was achieved among respondents randomly assigned to the mail (79.2%) than telephone survey (68.9%). Nonresponse bias was evident in both modes but, with the exception of age, was not differential between modes. The rate of missing responses was higher for mail than telephone respondents (1.59 vs. 0.49 missing items). Health ratings based on the SF-36 scales were less favorable, and reports of chronic conditions were more frequent, for mail than telephone respondents. Results are discussed in light of the trade-offs involved in choosing a survey methodology for health status assessment applications. Norms for mail and telephone versions of the SF-36 survey are provided for use in interpreting individual and group scores.
A disease-specific questionnaire to assess the quality of life of renal transplant recipients was developed. A list of items of potential relevance to these patients was created and 50 transplant recipients rated the importance of each item. A combination of factor analysis and clinical judgment was then used to create the final questionnaire which consists of 25 questions in 5 dimensions (physical symptoms, fatigue, uncertainty/fear, appearance and emotions). The physical symptoms dimension is patient specific. All questions are scored on a 7-point Likert scale. The reproducibility of the questionnaire when it was administered to stable transplant recipients was high (intraclass correlation coefficients between 0.82 and 0.91 for the 5 dimensions). The scores of all dimensions except appearance improved 6 months after transplantation, when compared to pretransplantation scores. Patients who had a well-functioning graft (creatinine < 250 mmol/l) had higher scores than those with poorly functioning grafts. This questionnaire is easy to administer and is valid, reproducible in stable patients and responsive to change.