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HOME >
Rwanda
Quality of Life Centre > Projects and Activities RWQOL PROJECTS AND ACTIVITIES
QUALITY OF LIFE OUTCOMES
IN ADULTS LIVING WITH HIV/AIDS AT LATE STAGE, A LONGITUDINAL STUDY.
A. Hakuzimana[1], L.E. Francis[2], Robert.W. Burgoyne[3]
1. ABSTRACT
Changes in quality of life and their relations to clinical findings for a number of 100 adults with HIV/AIDS at the stage IV of infection according to WHO classification will be assessed over 18 months. The locale of the study is the TRAC HIV Clinic. Clinical variables (CD4 count, symptoms, existence of antiretroviral therapy) and quality of life ratings (WHOQOLHIV BREF) will be measured in four waves (T1, September 2004; T2, March 2005; T3, September 2005 and T4, March 2006). The Inventory of Symptoms and Side Effects will be as well administered to subjects at the respective waves. Then results will be compared using the version 10.0 of SPSS for data analysis.
Key words : QOL, clinical findings, adults, advanced HIV infection
2. AIMS OF THE STUDY The general aim of the research is to study longitudinally the evolution of quality of life in advanced HIV-infected patients with regard to clinical variables. The specific aims are : - To evaluate the psychometric properties of the WHOQOL-HIV BREF in Rwandan adult HIV-infected patients at the late stage of the infection ; - To compare clinical variables with quality of life dimensions at the four waves ; - To identify contributing factors in the improvement and/or worsening of quality of life in the patients at late stage of the HIV infection. 3. BACKGROUND AND SIGNIFICANCE The advent and use of new and more effective antiretroviral drugs to control HIV infection progression, resulting in longer survival time for HIV-infected persons (UNAIDS, 2000; Pal et al, 1998; COA, 2000) have renewed the interest of scientists and clinicians on the quality of life in people living with HIV/AIDS (PLWHA). Quality of life assessment is currently considered essential for clinical trials development (Wu, 2000) as clinical and biological endpoints used during pharmacological trials (CD4 level, viral load, opportunistic infections) are considered inadequate to catch the complexity of care treatment outcomes (Weintfurtb et al, 2000). Quality of life is defined as “an individual’s perception of his/her position in life in the context of the culture and value systems in which he/she lives, and in relation to his/her goals, expectations, standards and concerns” (WHOQOL Group, 1995). The occurrence of symptoms namely dyspnea, oral and abdominal pain, discomfort, malaise, weight loss, severe headache, anorexia, vomiting, dizziness, paresthesia, fatigue, weakness, cognitive problems and others at late stage of the HIV infection besides financial and family problems such as stigma, isolation, loss of income have impact on the quality of life of HIV-infected persons. Then, although prophylaxis and treatment are useful, more attention should have to be taken for the better management of symptoms abovementioned and this will facilitate the adherence to antiretroviral therapy and to other drugs against opportunistic infections.
4. METHODS 4.1. DESIGN OF THE STUDY Quality of life dimensions and clinical variables including opportunistic infections, CD4 level, symptoms will be recorded at the 4 waves of the study period longitudinally. The duration of the study is 18 months from September 2004 to March 2006. At the end of every 6 months, subjects recruited at the baseline will be interviewed by the principal investigator, using the WHOQOL-HIV BREF and the Symptom Profile Inventory. Clinical variables will be also handled at the same time. Only HIV-infected adults at the 4th stage of the infection will be accepted. Outcomes expected are grossly quality of life changes with regard to immunologic changes compared to responsiveness to symptom changes. These will be presented to health workers dealing with PLWHA for behavioral changes where possible. 4.2. PARTICIPANTS At the start of the study, 100 adults will be recruited. Selection criteria are : stages 3 and 4 of HIV according to WHO classification of 1993, older than 14 years, willing and able to respond, resident of Kigali. Candidates will be selected with respect to WHOQOL-HIV BREF administration. 4.3. ANALYSIS AND STATISTICAL PLAN The data analyses will conducted using the Version 10.0 of Statistical Products and Service Solutions (SPSS). The internal consistency of WHOQOL-HIV BREF domains will be assessed by applying Cronbach’s alpha. The structure of the instrument will be examined by evaluating the correlation between each item and the corrected total score. Concurrent validity will be evaluated by using the Pearson’s product-moment correlation coefficients. The discriminant validity will be examined by using one-way ANOVA. Mean values of clinical factors (CD4 level, number of symptoms) as well as WHOQOL-HIV BREF ratings for the total T4 follow-up study sample will be evaluated for changes among the 4 study time-points using repeated-measures analysis of variance (ANOVA). 4.4. TIMETABLE AND ORGANISATIONAL STRUCTURE P.I: Alex HAKUZIMANA He will coordinate the project. Also responsible for data collection and statistical analysis will be conducted with the mentor. Co-investigators: Prof. L.E. FRANCIS and Robert W.BURGOYNE for statistical analysis and possible revisions. At each time-point, data collection by the author and a cross-sectional analysis by the project team. 4.5. HUMAN SUBJECTS For HIV serostatus is confidential, informed consent will be requested for all candidates recruited.
QUALITY OF LIFE ASSESSMENT IN PEOPLE LIVING WITH HIV/AIDS IN THE TRAC HIV CLINIC- A CROSS-SECTIONAL STUDY.
A. Hakuzimana1, L. E. Francis2, Robert W. Burgoyne and K. Rupert3.
1. BACKGROUND
In recent years, there has been more concern in the measurement of health ,beyond traditional health indicators such mortality and morbidity (1,2), to include measures of the impact of the disease and impairment of daily activities and behavior (3), perceived health measures (4) and disability/functional status measures ( 5). These measures, whilst beginning to provide a measure of the impact of the disease, do not assess Quality of Life per se, which has been aptly described as the missing measurement in health (6). The World Health Organization defined the Quality of Life as “the individual’s perception of their position in life in the context of culture and value systems, in which they live and in relation to their goals, expectations, standards and concerns”(7) and have been working towards devising an assessment tool that would be accepted and applicable cross-culturally. Focus task groups made over the world and run by the WHO resulted in the World Health Organization Quality of Life (WHOQOL) assessment instrument, a self-reporting multidimensional measure which is composed of the important aspects of life and covers not only physical health status but also the psychological, social and spiritual domains of life (8-10). The WHOQOL contains six domains namely physical, psychological, level of independence, social relationship, environment and spiritual domains. Recent analysis of available data using structural equation modeling has shown a four domain solution (physical, psychological, social relationship and environment). Each domain is composed of 6-18 questions, addressing 2-4 facets. The whole questionnaire compounds 24 facets added with 4 items relating to the overall quality of life and general health facet. In total, the WHOQOL is composed of 100 items, which is the WHOQOL-100. While this allows detailed assessment of each individual facet relating to QOL, sometimes in a practical sense it can be cumbersome, (e.g. in larger epidemiological studies). The WHOQOL-BREF version was then developed in order to enable a brief but accurate assessment of QOL in such cases (11, 12). The WHOQOL-BREF contains a total of 26 questions, one item from each of the 24 facets contained in the WHOQOL-100 and 2 items from the overall quality of life and general health facet. 2. PROBLEM DESCRIPTION HIV disease and the care of those living with HIV/AIDS have changed dramatically in the recent years. People living with HIV/AIDS (PLWHA) may present with multiple medical, social, and psychosocial problems concomitantly. Psychiatric diseases, disorders of temperament or personality and behavioral disorders have been reported in such patients .Up to 20% of PLWHA suffer from depression at the time of their initial presentation. A 9% incidence of mania was reported (13). Patients with HIV infection often have character traits that are impulsive and risk-taking and this may lead to both high-risk behaviors and non-compliance with treatment (13). Although the advent and use of antiretroviral drugs have changed the deadly evolution of HIV infection, the availability of such drugs, especially in developing world, is obviously crucial. Moreover, while prophylaxis and treatment strategies are useful, difficult problems surround items such as stigma, isolation, loss of income, pain, fatigue, weight loss, weakness, breathing problems, cognitive problems and others. Those have impact on the QOL of the HIV-infected persons. Undoubtedly, the Quality of Life of People living with HIV/AIDS (PLWHA) is increasingly worsened by the course of the disease. As the HIV infection, for many affected individuals, becomes a chronic illness, of relapsing and remitting nature, new challenges need to be met. The patient’s subjective perception of several aspects of QOL is rapidly emerging as the first goal to be pursued in HIV/AIDS clinical care (14). The WHOQOL-BREF has shown, from studies already done, the accuracy and relevancy of its psychometric properties i.e. internal consistency, test-retest reliability and discriminant validity (15-18). 3. HYPOTHESIS STATEMENT The hypothesis to test is “The Quality of Life is negatively affected in HIV patients”. 4. OBJECTIVES 4. I. General objective: To assess the Quality of Life in people living with HIV/AIDS in the TRAC HIV Clinic/ Kigali. 4.2. Specific objectives - To evaluate the WHOQOL- BREF properties in a Rwandan HIV-positive and HIV-negative population ; - To identify and compare contributing factors for poor QOL in the HIV-positive versus HIV-negative persons. 5. METHODS AND MATERIALS 5.1. WHOQOL BREF The WHOQOL BREF was used in this study.. This questionnaire comprises 26 questions whose one item is from each of the 24 facets contained in the WHOQOL-100, and two items one for the overall quality of life and another for the general health facet. 5.2. DESIGN AND LOCALE OF THE STUDY Cross-sectional and analytical. The study will be carried out in the TRAC HIV Clinic/Kigali. 5.3. SUBJECTS With respect to the administration of the WHOQOL BREF, the sample size will be 300 (19). Sampling quota: - Age: 50 % will be between 15 and 36 years, 50 % older than 35 years. - Sex: 50 % will be male and 50 % will be female. - Health status: 250 HIV positive and 50 HIV negative. Within the ill persons a cross-section of people with varied levels of QOL will be defined with regard to WHO classification (20): a number of 62, 62, 63 and 63 for the first, second, third and fourth stages respectively. The category of seronegative persons will be assembled randomly from the people tested in the Treatment and Research AIDS Centre (TRAC) with group stratification. 5.4. METHODOLOGY OF INTERVIEW Before the interview starts, the author explained the reasons of the survey and the atmosphere of cooperation. 5.5. CONFIDENTIALITY AND ETHICS OF THE RESEARCH Since HIV serostatus is confidential, informed consent will be requested for all candidates completing the WHOQOL BREF. 5.6. SCORING AND STATISTICAL ANALYSIS (19) In order to make domain scores comparable with ones of WHOQOL-100 as stipulated by the rules regarding the WHOQOL use, mean scores will be multiplied by 4. Where more than 20 % will be missing, the assessment will be discarded. Where one item will be missing, the mean of other items in the domain will be substituted. Where more than 2 items are missing from the domain, the domain will not be calculated. In domain three, the domain will be calculated if ≤ 1 item is missing. Internal consistency will be assessed by using Cronbach alpha. Test-retest reliability with a two-week interval will be assesses by Pearson correlation coefficient. Discriminant validity will be determined via t-test for sex, age and health status. The SPSS syntax will be used to check recode data and compute domain scores. The SPSS software package will be used for data management and statistical analysis. 6. BENEFICIARIES The beneficiaries are divided into two groups: the first group is people living with HIV/AIDS (PLWHA) and the second are health professionals and health workers caring for. 7. REFERENCES
Visited on April 12, 2004.
19. World Health Organization.
Programme on Mental Health. WHOQOL-BREF:
Introduction, administration, scoring, and generic version of the assessment. Field trial version. Geneva. December 1996. 20. The Different Stages of HIV Infection. http://www.avert.org/hivstages.htm. Visited on May 16th, 2004. THE RWANDA QUALITY OF LIFE CENTRE PROJECT PLAN Project name: QOL assessment in Rwanda Name of the organisation: Rwanda Quality of Life Centre Address: Kigali City, Rwanda P O Box 6471 Phone : + 250 08570008 Email : alexqol@yahoo.co.uk. Location: Nationwide Duration: 12 months initially Objective: Promote quality of life of Rwandese in general and of chronically ill people in particular by disseminating information about quality of life throughout the country, the region, the continent and across the world and enhancing quality of life research. Activities: - Translating QOL instruments from foreign languages into Kinyarwanda ; - Carrying out studies on QOL assessment of domains relevant to chronic diseases especially HIV/AIDS, malaria, tuberculosis, diabetes, etc. - Training young investigators on QOL issues by holding workshops, seminars, lectures, TV and radio broadcasts. Beneficiaries: Rwandese society especially chronically ill people and most particularly people living with HIV/AIDS, tuberculosis and malaria. Implementing agent: Rwanda QOL Centre Submitting agency: Rwanda QOL Centre Funding agency: Amount requested: 57,800,000.00 RWF (101,403.49 US Dollars) State of project: The Rwanda QOL Centre is an innovative not for profit and independent organisation of volunteers willing to help society promote their QOL. Support is needed for the launching, contribution and then continuation of its valuable activities. Partners: WHOQOL Group, National University of Rwanda, MAPI Research Trust, University of Toronto, ISOQOL, ISPOR, Lux Development Project, Ministry of Health, Ministry of Education, Sciences and Technology, University Central Hospital of Kigali, Treatment and Research AIDS Center (TRAC).
I. NEEDS STATEMENT
Quality of life is defined as individuals’ perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concern. It is a widely ranging concept incorporating in a complex way the persons’ physical health, psychological state, level of independence, social relationship, personal beliefs and their relationships to features of the environment. This definition reflects the view that quality of life is a subjective evaluation which is to be considered in the cultural, social and environmental context. Therefore, quality of life is not equal to « health status », « life style », « life satisfaction » or « well-being ». The recognition of this multi-dimensional nature of quality of life is reflected in the World Health Organisation Quality of Life structure. This is organised into six broad domains of quality of life i.e. physical, psychological, level of independence, social relationships, environment and spirituality/religion/personal beliefs. The initiative of the World Health Organisation to develop a quality of life assessment arose for three major reasons. First, measures in use such as Sickness Impact Profile, Nottingham Health Profile, Medical Outcomes Study SF-36, etc although providing a measure of the impact of disease do not assess QOL per se, which has been aptly described as the missing measurement in health. Second, most measures of health status have been developed in North America and United Kingdom, and their translation for use in other settings is time-consuming, and unsatisfactory for a set of reasons. Third, the increasingly mechanistic model of medicine, concerned only with the eradication of disease and symptoms, reinforces the need for the introduction of a humanistic element into health care. By calling for QOL assessments in health care, attention is focused on this aspect of health, and resulting interventions will pay increased attention to this aspect of patients’ well-being. WHO’s initiative to develop a QOL assessment arises from a need for genuinely international measure of QOL and a commitment to the continued promotion of an holistic approach to health and health care. With regard to the scope of the problem, a group of young Rwandese investigators in collaboration with other experts and organisations from abroad and with a close link to the WHOQOL Group has decided to create and launch the Rwanda Quality of Life Centre, in abbrevation RWQOL. The mission of the organisation is to promote quality of life of Rwandese in general and of ill chronically people in particular by disseminating information about quality of life (QOL) across the country, the region, the continent and over the world and to enhance research in quality of life.
II.GOALS AND OBJECTIVES
1) The first objective of the project is translation and back-translation of the instruments of the WHO for assessment of the QOL: WHOQOLBREF, WHOQOL-HIVBREF, WHOQOL-100 and WHOQOL-HIV module items into Rwandese version, and review of the back-translated items by the WHO/MNH. 2) The second objective is to carry out two substudies to test the WHOQOL instruments, short forms : - the first is to recruit and interview a sample of 300 individuals comprising 250 HIV-infected and 50 well persons. The instrument to test is the WHOQOLBREF. All instructions regarding its use will be respected. - the second sub-study is to recruit a cohort of 174 adult HI-infected subjects on antiretroviral therapy. Changes in QOL perceptions and their relations to clinical status will be assessed over a 18-month period. Clinical variables and QOL (WHOQOL-HIV BREF) ratings will be measured in four waves with the interval time of 6 months. Here the instrument to test is the WHOQOL-HIV BREF. The two substudies will be conducted in the City of Kigali, Capital of Rwanda. 3) The third objective is to train investigators of the region on QOL issues by holding workshops, seminars, lectures, TV and radio broadcasts and by participating in the international conferences and meetings. 4) The fourth objective is the development of website “Rwanda QOL Centre”. Web information would make the findings available for health care professionals. The website will assist in disseminating project results not only in Rwanda but also in the countries of the Eastern and Central Africa, the closest in mentality and common culture. It could be interesting for physicians, including infectious diseases specialists, medical doctors, psychologists, public health managers, representatives of public health care and researchers, and all those whose work is related to the social protection of these groups of the population. We should stress on the on-going of studies with specific diseases, besides HIV/AIDS, such as tuberculosis, malaria, diabetes, asthma, hypertension, psychological and physical trauma, etc. 5) The fifth objective is creation and publication of the manual on the QOL instruments: the Rwandese version which is extremely useful for Rwandese researchers who are interested in the area of the investigation on QOL. The project staff in Rwanda has to receive the permission from the authors of the instruments to publish them in national language. This manual will enable Rwandese scientists to continue their efforts in QOL research of different groups of patients.
III.METHODOLOGY AND TIMETABLE
The Principal Investigator of the project is Alex HAKUZIMANA, the President and the Co-founder of the Rwanda QOL Centre. A. The facet definitions and questions of the WHOQOL instruments will be translated into colloquial Rwandese (Kinyarwanda) by two psychiatrists and one clinical psychologist. Then four high school graduates will review the translated WHOQOL instruments and highlight sections difficult to understand. These words and sentence structures will be modified and the Rwandese version back-translated into English by a bilingual psychologist. This version will be sent to the WHO, and final correction will be made according to the WHOQOL group instructions. The final Rwandese versions are expected to be available after a period of 4 months but the short forms will be handled in one month. The study of the validation of the WHOQOLBREF is cross-sectional and analytical. With respect to the administration of the WHOQOLBREF, sampling quota will be taken into account. Scoring and statistical analysis will respect the rules regarding the WHOQOL use. Results are expected after 2 months ie 3 months since the start of the project.
The second sub-study with use of the WHOQOL-HIV BREF is longitudinal and analytical. The duration is 18 months. The questionnaire will be administered to HIV-infected subjects at every time interval of 6 months, the first being done before antiretroviral commences. Simultaneously, clinical variables (CD4, opportunistic infections and malignancies, viral load, staging and so forth) will be recorded. At every wave, data will be analysed and at the end of the study period study, a global analysis with regard to results of the four time-points will be done. Professor Francis Edmond LAMBERT of the University Central Hospital of Kigali has accepted to act as the consultant, Robert BURGOYNE as statistician and Kaul RUPERT as consultant of the University of Toronto. Further experts in QOL research are being contacted for the best on-going of the studies especially members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the MAPI Research Trust and the Cochrane Health-Related Quality of Life Methods Group. The Principal Investigator, Alex HAKUZIMANA, will coordinate the project and is responsible of other tasks (selection of the study participants, study procedures, enrollment, interview, ethics, data collection, reporting, etc) under auspices of the WHOQOL Group and in close collaboration of the RWQOL. B. Training on QOL issues will start by the first year of the project. At least 3 workshops or seminars or conferences are scheduled. The PI has a prior invitation to the ISOQOL Annual Meeting to be held in Hong Kong on 16-19 October 2004. Two others would be held in Rwanda. C. The development of website RWQOL is in the hand of the webmaster, a member of the Executive Committee of the Centre. His duties are well explained in the Constitution and Bylaws. D. The manual « QOL instruments » in Rwandese version will be set up by an editing committee under the direction of the Executive Committee of the Centre. The first publication is expected to appear by the end of six months with reference to the start of the project.
IV. EVALUATION
A set of experts in QOL and an advisory committee will be called upon for the evaluation of the project. The advisory committee should be set up from the project’s beginning to monitor and guide its development. Reports will be handled over to our partners at every three months.
V. ORGANISATIONAL CAPACITY
The Rwanda QOL Centre needs manpower for the better management of its activities. These manpower needs include its willing membership and psychologists.
VI. FUTURE FUNDING RESOURCES
At the end of one year of work, Rwanda Quality of Life Centre will have its seat, office materials, and transport facilities if funds are available. For we assure that initial activities will attain their success, new partners and funders with regard to pathology to evaluate are expected to support the Centre. Several intensive contacts will be made during this first year so that we find almost permanent funders and the government officials through the Ministries of Education and of Health have accepted to adhere to our activities. Emphasis should be done to international organisations such as MAPI RESEARCH TRUST and the International Quality of Life Assessment (IQOLA). We hope to work with high educational institutions particularly University of Toronto (Canada), National University of Rwanda and the University of Bath (United Kingdom), Liverpool School of Tropical Medicine (UK).
[1] Rwanda Quality of Life Centre, Kigali City, Rwanda, email: alexhak75@yahoo.co.uk [2] Teaching Hospital of Kigali, Rwanda. [3] University of Toronto, Canada 1.Rwanda Quality of Life Centre, alexqol@yahoo.co.uk 2 University Central Hospital of Kigali 3 Co investigators: Bob Burgoyne (University of Toronto) and Rupert Kaul, University of Toronto.
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