Key-words:
Health-related quality of life - highly active antiretroviral therapy - HIV - Makurdi
Introduction
The HIV pandemic is one of the world's most serious public health problems in human
history, as it affects all areas of life including health, education, agriculture,
and social life. Nigeria ranks the third globally in the absolute numbers of people
infected with the virus despite a relative decline in prevalence rates from 5.8% in
2001 to 3.4% in 2012.[[1]] The advent of antiretroviral therapy (ART) using highly active antiretroviral regimen
was the most significant intervention ever put in place to fight the scourge of HIV
in its nearly four decades of existence, the target of placing 90% of people living
with HIV/AIDs (PLWHAs) on ART is achievable and being pursued as a global goal. Although
ART has turned HIV into a manageable chronic disease for millions of people worldwide
and dramatically reduced deaths from HIV, the physical, social, and economic challenges
associated with ARVs adherence is likely to lead to treatment failure, the emergence
of drug resistant and eventual poor health outcomes.
The assessment of medical interventions has conventionally focused on biological outcomes
such as symptoms, survival, disease progression, disability, morbidity, and mortality.[[2]] However, health-related quality of life (HRQL) is equally an important measure
of self-reported health status and well-being,[[3]] and it is increasingly being recognized as a supplement to the traditional biological
endpoints.[[2]],[[4]] HRQL provides information about the effects of disease progression and the effectiveness
of medical interventions that cannot be obtained using objective clinical measures.[[5]],[[6]] It could use physical health, mental and general health (GH) indices, and dimensions
to compute quality scores; in which case higher scores and ratings for the different
dimensions represent good or better HRQL for the dimension being measured; whereas
lower scores and ratings represent poor or worse HRQL.
Since the goals of ART are not limited only to achieving viral suppression, immunologic
recovery, clinical benefits, increased survival, and reduced HIV transmission, but
rather, to the overall improved quality of life of patients.[[4]],[[7]] HRQL is considered to be an important quality of care indicator for HIV/AIDS.[[8]] Studies conducted among PLWHA in several countries including Nigeria, have demonstrated
variations in scores and ratings of the different HRQL dimensions assessed; as well
as variations in associations between patient characteristics and HRQL dimensions.
The possibility of patient's socio-demographic and clinical characteristics influencing
HRQL scores cannot be underestimated.
Current study
For effective management of HIV, an assessment of a comprehensive set of disease outcomes
is desired. HRQL indices could provide information about the effects of disease progression
and the effectiveness of medical interventions that cannot be obtained using objective
clinical measures. The scoring and ratings of HRQL dimensions adopted in this study
would throw more lights on the effect of ART on HRQL among people living with HIV
in the study area. This study will form a baseline for future comparisons of HRQL
outcomes among PLWHAs. It will also provide information that will be used to guide
targeted clinical decision-making to optimize long-term HRQL of adult patients on
ART. The objective of this study was to assess HRQL of patients on highly active ART
(HAART) at the Federal Medical Center (FMC), Makurdi in North Central Nigeria.
Methods
Study area
The study site was the ART clinic of the FMC, Makurdi, Nigeria. At the time of the
study period, there were about 13,450 adult patients receiving ART at this clinic.
The FMC, Makurdi, is a tertiary health institution with a 400-bed capacity and occupancy
rate of approximately 95% at any given time. The study area, in which the health facility
resides, is Benue State, in the North Central geo-political zone of Nigeria, and it
is the state with the persistently highest prevalence of HIV infection in Nigeria
since the beginning of the epidemic.
Study design and scope
The study was a descriptive, cross-sectional survey which was conducted to assess
self-reported HRQL of patients receiving ART at the FMC, Makurdi, Nigeria. HRQL was
assessed in eight domains: Physical functioning (PF), role limitations due to physical
health problems, role limitations due to emotional problems, social functioning (SF),
pain, vitality (VT) (energy/fatigue), emotional well-being, and GH perceptions.
Study population
The study population comprised adult HIV patients aged ≥18 years and on first-line
ART regimens for at least 12 months. Patients on second line and salvage therapy were
excluded from the study.
Sample size estimation
The minimum sample size required was estimated using the formula for descriptive,
cross-sectional surveys of single proportion population n = z2 pq/d2.[[9]] At the time of the study, there was no readily available Nigerian literature that
provided proportion of patients on first-line HAART with good HRQL. Therefore, 50%
was used in the sample size calculation: Giving a calculated sample size of 384 that
was increased to 482 to compensate for nonresponse.
Sampling method
Patients were selected by a systematic sampling technique. Usually, about 150–200
patients are seen on each clinic day. With a calculated sample size of 482, this gave
a sampling interval of 3.21 (for 150 patients) and 2.41 (for 200 patients). This was
approximated to a sampling interval of 3. On the 1st day of data collection, the second out of the first three patients as they were listed
in the clinic register, was selected by simple balloting; and this became the starting
point. Then after, every third patient as listed in the clinic register was selected
and recruited on every interview day. Adult clinic days were Mondays, Wednesdays,
and Fridays, and the clinic registers on those days was used to select participants.
Instrument and measures
The instrument used for measuring HRQL was a modification of the 36-Item Short Form
Health Survey version 2 (English Version, SF-36v2 Health Survey Standard, United States).
The modified questionnaire was pretested among PLWHAs in the ART clinic of a nearby
hospital, and who were not included in the survey. Internal consistency reliability
tests were also performed on the pretested questionnaires. Cronbach's alpha (α) coefficient
was 0.85, 0.95, 0.82, 0.70, 0.75, 0.72, 0.53, and 0.73, for PF, role-physical (RP),
role-emotional (RE), VT, mental health (MH), SF, bodily pain (BP), and GH dimensions,
respectively.
Health-related quality of life measurements
The SF-36 was originally developed by Ware and Sherbourne,[[10]] and in Nigeria, it has been validated among the Yoruba population in Ile-Ife, Osun
State.[[11]] The SF-36 v2 measures HRQL in eight dimensions.[[12]],[[13]] (1) PF (limitations in physical activities because of one or more health problems);
(2) RP (limitations in usual role activities because of physical health problems);
(3) RE (limitations in usual role activities because of mental/emotional health problems);
(4) SF (limitations in social activities because of physical or emotional problems);
(5) BP; (6) VT (energy/fatigue); (7) MH (psychological distress and psychological
well-being); and (8) GH perceptions. Also included is a single item that provides
an indication of perceived change in health; i.e., self-evaluated transition (SET)
in health. Modifications made to the SF-36 v2 for use in this study included re-wording
some sections and replacing some of the activities with those which fit into the socio-cultural
context of Nigeria, which the respondents easily identified with.
Health related quality of life scoring
The modified SF-36 v2 was scored following instructions described by authors,[[14]],[[15]] with computed scores for each of the eight dimensions taking values between 0 and
100. For this study, the scores for each dimension were divided into four quartiles:
0–24 (quartile 1); 25–49 (quartile 2); 50–74 (quartile 3); and 75–100 (quartile 4).
Quartiles 1 and 2 were merged and interpreted as poor HRQL for each dimension. Similarly,
quartiles 3 and 4 were merged and interpreted as good HRQL for each dimension. Scores
for each dimension were also summarized using median and interquartile range (IQR).
Ethical considerations
The study was approved by the Health Research Ethical Committee of the FMC, Makurdi.
Written informed consent was obtained from every PLWHA who agreed to participate in
this study. The project site coordinator gave explicit permission to conduct the study
in the hospital.
Data collection
Data were collected between May and July 2017. The questionnaires were interviewer-administered
by the principal investigator and three-trained research assistants who were Medical
Officers. Only respondents who gave informed written consent were interviewed. Interviews
were conducted in private within the ART clinic as respondents waited to be called
for their drug pick-ups.
Data analysis
Data were analyzed with Statistical Package for Social Sciences (SPSS) software version
17 (SPSS Inc., Chicago, IL, USA). Descriptive statistics were generated for each study
variable including frequencies and percentages for categorical variables, mean and
standard deviation for symmetrical continuous variables, and median and IQR for skewed
continuous variables. Chi-square was used to test associations between each HRQL dimension,
and sociodemographic and clinical characteristics. Multivariate logistic regression
analyses were performed to identify independent risk factors that predicted good HRQL
for the various dimensions. Each HRQL dimensions was used as the dependent variable
in a separate logistic regression model including the patients' sociodemographic and
clinical characteristics as independent variables. Level of statistical significance
was set at 5%.
Results
Sociodemographic and clinical characteristics
The socio-demographic and clinical predictors of good HRQL among respondents are shown
in [[Table 1]]. A total of 546 respondents took part in this study of which 213 (39%) were males
and 333 (61%) were females. The mean ± SD age was 38.1 ± 10.6 years, with 332 (60.8%)
aged <40 years and 214 (39.2%) aged ≥40 years; 308 (56.4%) were co-habiting with spouse/partner;
498 (91.2%) lived with nuclear/extended family; 439 (80.4%) had child (ren); 334 (61.2%)
had a less than postsecondary education; while 462 (84.6%) were employed.
Table 1: Sociodemographic and clinical predictors of health-related quality of life (n=546)
Seventy-two (13.2%) experienced stigma; 349 (63.9%) had a caregiver; 84 (15.4%) consumed
alcohol; 311 (57%) enjoyed social support; and 506 (92.7%) had disclosed their HIV-positive
status to others. Two hundred and ninety-two (53.5%) had been attending the clinic
<4 years; 217 (39.7%) had been on ART <3 years; 71 (1.3%) experienced side effects
of ARVs; 481 (88%) were satisfied with general medical care; and 447 (82%) experienced
an improved change in health.
Health-related quality of life scores and ratings for good health-related quality
of life
[[Table 2]] shows the scores for each of the HRQL dimensions. High scores were obtained on
all the eight dimensions. Nevertheless, maximum scores were obtained for RP and SF;
whereas the least score was obtained for GH. Furthermore, median (IQR) scores for
each of the dimensions were: 100 (100–100) (role physical); 100 (100–100) (SF); 100
(95–100) (PF); 100 (91.7–100) (role emotional); 90 (80–100) (BP); 87.5 (75–87.5) (VT);
85 (70–90) (MH); and 75 (75–87.5) (GH).
Table 2: Respondentsʼ scoring and ratings of health-related quality of life dimensions
[[Figure 1]] shows ratings for good HRQL for each of the dimensions. Majority of respondents
reported good HRQL on all the eight dimensions. Nevertheless, the three highest ratings
of good HRQL were reported for PF (98.9%), RE (98.7%), and SF (98.2%), respectively;
whereas the least good HRQL was reported for GH (93.4%).
Figure 1: Percentages of respondents reporting good health-related quality of life for eight
dimensions
Associations between selected socio-demographic variables and some health-related
quality of life measures
[[Table 3]] shows association between RP (with the highest median IQR score), GH (with lowest
median IQR score) and respondents' sociodemographic characteristics. Good HRQL with
RP was expressed by over 90% of the respondents on all socio-demographic characteristics
measured. Furthermore, a significantly higher proportion of 326 (98.2%) persons aged
<40 years compared with 201 (93.9%) aged ≥40 years (χ2 = 7.06, P = 0.008); and 233 (99.1%) respondents who did not enjoy social support compared with
294 (94.5%) who did (χ2 = 8.49, P = 0.004), demonstrated a good HRQL with RP, respectively.
Table 3: Association between selected sociodemographic characteristics and role-physical,
general health, and physical functioning (n=546)
[[Table 3]] also shows association between sociodemographic characteristics and GH. Co-habiting
with partner/spouse, 293 (95.1%) compared with being single/separated/divorced/widowed,
214 (89.9%) (χ2 = 5.50, P = 0.019); having a caregiver, 330 (94.6%) compared with not having a caregiver, 177
(89.8%) (χ2 = 4.21, P = 0.040); were significantly associated with good general HRQL, respectively. Age
<40 years (odds ratio [OR] = 4.26, confidence interval [CI] = 1.49–12.11, P = 0.007) and being employed (OR = 3.20, CI = 1.08–9.49, P = 0.036) were significantly associated with good HRQL for RP. Conversely, enjoying
social support (OR = 0.12, CI = 0.03–0.55, P = 0.006) was significantly associated with the less likelihood of good HRQL for RP
[[Table 3]]. Only general satisfaction with care received (OR = 6.05, CI = 2.78–13.17, P < 0.001) predicted good general HRQL. Conversely, being single/separated/divorced/widowed
(OR = 0.43, CI = 0.21–0.91, P = 0.027) predicted the less likelihood of good general HRQL [[Table 3]].
Discussion
Scores and ratings of health-related quality of life dimensions
This study has demonstrated that ART leads to a significant improvement in HRQL for
HIV-positive adults. High ratings of good HRQL were obtained across all the eight
dimensions measured. Nevertheless, respondents' ratings of good HRQL were highest
with PF, RE, and SF dimensions, in that order. The highest rating of PF indicated
that the vast majority of respondents had experienced little or no limitations with
performing moderate-to-vigorous physical activities including lifting or carrying
shopping items, climbing stairs, bending/kneeling/stooping, walking moderate distances,
and caring for one's self (bathing and dressing).[[12]] This further suggests that the majority of the patients had experienced a significant
improvement in their health because of ART and they were particularly more able to
perform physical functions that they were hitherto unable to perform.
In Ile-Ife, Nigeria, however, the highest mean scores were obtained with MH, GH, VT,
and PF dimensions, in that order.[[11]] The disparity between this Ife study and the present study may be due to sociocultural
differences. While the Ife study was conducted in South West Nigeria, the present
study was conducted in North Central Nigeria. Nonetheless, findings similar to the
present study were obtained in Ilorin, Nigeria,[[16]] and other countries,[[17]],[[18]],[[19]] where the highest mean score was observed with PF compared to the other HRQL dimensions
measured.
In the present study, the second and third highest reported HRQL were regarding RE
and SF dimensions. This indicated that majority of the respondents were able to accomplish
their work and other usual/social activities with the same care and within the normal
time; and within the normal levels in terms of quantity and quality with which they
usually perform them, without experiencing limitations due to emotional problems.[[12]] In contrast, respondents had rated SF at the second position,[[20]],[[21]] whereas RE scores were the fourth highest at baseline, but later increased to attain
the third position after 12-month of HAART,[[19]] and this further demonstrates the importance of focusing treatment goals on optimizing
HRQL rather than on improving survival only.[[22]]
In the present study, majority of the respondents also reported high rates regarding
VT, RP, MH and BP dimensions. This indicated that in most respondents: Energy levels
were high; and feelings of peace, happiness, and calm were experienced all or most
of the time; while there was minimal/no pain.[[12]] In another study, high scores were also obtained on the energy, MH, and pain dimensions.[[20]] In contrast, of the dimensions assessed in another study, HRQL had increased significantly
after 12 months of HAART on all the dimensions except for VT and MH.[[23]] In that study, the least scores were obtained on the VT dimension and after 12
months of HAART, VT scores appreciated marginally but still remained the least. Whereas
in another study,[[19]] role functioning scores were the second highest at baseline, but later dropped
to the fourth position at 12-months of HAART. Patients' depressive symptoms at baseline
were reported to be significantly predictive of this negative change in role functioning.
The least rating in the present study was obtained with GH dimension (93.4%). This
implied that the remaining (6.6%) respondents were expecting that their GH might probably
get worse.[[12]] Nonetheless, about three-quarters of respondents had perceived an appreciable improvement
with regard to SET in health and this was believed to be due to the efficacy of HAART.
Conclusions
This study adds to the body of knowledge that HAART improves the health outcomes of
HIV patients in terms of HRQL. Given the changing epidemiology of HIV, and the associated
stigma, discrimination, poor social support and challenges facing disclosure, clinicians
should endeavor to assess these quality of life indices as they manage their clients,
most especially in a chronic debilitating illnesses like HIV when patients have to
cope with long period of ARVs which are not without side effects. Clinicians also
need to be responsive to factors related to disclosure, having a care giver and social
support as a means of improving HRQL.
