Patients and study design
This was a descriptive, cross-sectional hospital-based study. It was conducted at Dr Salma dialysis center in Khartoum state among ESRD patients who received HD, the study was conducted over three- months during the period from September to December 2018. A total of One hundred thirty-eight patients on chronic HD were recruited in this study.
Sampling
This study covered all adult ESRD patients on HD at Dr Salma dialysis center. At the time of the study, there were 199 Hemodialysis patients served on 26 HD machines. However, those with co-morbidities with hepatitis infection were excluded.
Respondents
A total of 153 respondents meeting the inclusion criteria were recruited into the study. 138 patients were agreed to participate in the study, 11 patients were refused to participate, and 4 respondents withdrew from the study.
Inclusion criteria
It included all adult patients aged 18 years and above, suffering from ESRD of either sex and had received regular HD for at least three months at the dialysis center mentioned above, during the study period.
Exclusion criteria
Those with co-morbidities with hepatitis infection, rejection episodes, or any major surgical interventions in the previous three months were excluded.
Study area
The study was conducted at Dr Salma dialysis center in Khartoum state, Sudan. It is the first main HD center in Sudan.
Research methods and data collection procedure
Assessment
Many components of QoL cannot be observed directly, they are evaluated indirectly, according to the item-measurement theory [3]. This theory proposes that there is a true QoL value that can be measured indirectly by asking the patient a series of questions known as “items,” each of which measures the same true concept or construct [3]. The answers are converted into numerical scores that are combined to yield domains and summary scores [3]. Using this theory, the instrument most frequently used for QoL evaluation is the health profile measurement, presented as a questionnaire that requests a viewpoint, usually that of the patient.
QoL instruments
QoL instruments measure an individual’s own views of his wellbeing, and some of these instruments provide a standard assessment of health. These instruments include questionnaires designed to be applicable for the general population such as the Sickness Impact Profile (SIP), the SF-12, SF-36 [1]. The most used instrument for measuring QoL in ESRD patients is the Short Form health survey questionnaire (SF-36) [2,6,9,10].
The instruments used for data collection in this study included two sections, a general socio-demographic section, as well as a validated Arabic version of QoL section. The socio-demographic section, developed by the researcher. The patients were asked to complete the socio-demographic survey as well as the KDQoL-SF questionnaire. Socioeconomic and demographic information were age, gender, origin, educational level, current employment status (occupation), and current estimated household income (monthly), dialysis vintage (length of time on dialysis treatment), the average duration of the dialysis session, duration of the disease, family history of kidney disease, satisfaction, and the total number of chronic diseases or any co-morbidity.
KDQoL-SF
The QoL was measured using Kidney Disease Quality of Life- Short Form (KDQoL-SF TM) version 1.3. It is a standard self-report QoL measure developed for individuals with kidney disease on dialysis [10]. It is reliable and recommended by the National Kidney Foundation [9]. The KDQoL-SF 1.3 included 43 kidney disease targeted items (kidney disease-specific module), as well as 36 items that provide a generic core (SF-36), and overall health rating item [3].
The disease-specific part of the test focus on particular health-related concerns of individuals with kidney disease on dialysis, it includes 43 items: symptoms/ problems (12 items), effects of kidney disease on daily life (8 items), the burden of kidney disease (4 items), cognitive function (3 items), work status (2 items), sexual function (2 items), quality of social interaction (3 items) and sleep (4 items). Also included are three additional quality of life scales: social support (2 items), dialysis staff encouragement(2 items), and patient satisfaction (1 item) [3].
The Short-Form Health Survey 36-items (SF-36) instrument consists of 36 items describing the perception of health state during the last 4 weeks, these items representing eight different dimensions of functioning and well-being. These eight dimensions can be summarized in a Physical Component Scale (PCS) and a Mental Component Scale (MCS).
The PCS comprises physical functioning (10 items), role limitations caused by physical health problems (4 items), physical pain (2 items), general health perceptions (5 items), and the four scales of MCS were role limitations caused by emotional problems (3 items), Vitality/energy level (4 items), social functioning (2 items), and emotional well-being (5 items), The final item, the overall health rating item, asks respondents to rate their health on 0-10 response scale rating from worst possible to best possible health [6], this item asks respondents to rate their health on a response scale of 0 to 10 ranging from “worst possible” to “perfect health.” Each question is pre-coded numerically, and then transformed into a scale of 0 to 100; the higher numerical score reflects better QoL or less impairment.
The overall score could potentially total to 100, so I classified the results into two groups: Scores <50/100 as poor QoL and those with ≥ 50/100 as good QoL, that is, the higher the score, the better the QoL.
Statistical Analysis
All Statistical analyses were carried out using the Statistical Package for the Social Science (SPSS) software version 23 as well as Microsoft Excel 2016.
Continuous variables were reported using mean ± SD, median, and interquartile range (IQR). For categorical variables, absolute numbers and percentage were calculated. When comparing the categorical variables, Chi-square test/ Fisher's exact test was used. P-value <0.05 was considered statistically significant.
Ethical considerations
The research followed the tenets of the Declaration of Helsinki. All methods were carried in accordance with relevant guidelines and regulations. The study was approved by Local Ethics Committee and Institutional Review Board of Faculty of Medicine of University of Khartoum, and administrative permission from the national center for kidney disease and surgery, and Dr Salma dialysis center administration for data collection.
Participation in this study was voluntary; all patients were fully informed of their rights to decline or withdraw from participation in the study if desired. Informed consent has been obtained from the patients before data collection. Confidentiality was maintained on all data collection forms by using codes to identify each participant.