This was a cross sectional study that involved individuals attending the outpatient department (OPD) of Pakwach health centre IV and inpatients admitted with acute severe UGIB at the same health facility. Pakwach health centre is a rural primary health care facility located at the banks of the Albert Nile in a region that is a hot spot for S.mansoni infection. Pakwach health centre provides outpatient and inpatient health care services to a population who are mainly fisherpersons and/or farmers. Epidemiological data suggest close to 50% of the populations served by this facility are actively infected with S.mansoni despite over a decade of Praziquantel chemotherapy. Medical records from the facility indicated about 120 patients every year are admitted for acute UGIB attributable to chronic schistosomiasis. Eligibility for study participation included written informed consent and ascent, all patients ≥ 12 years of age with a medical history of UGIB (past or current). We excluded pregnant women, HIV positive individuals, and any participant unable to have endoscopy for UGIB. Upper gastrointestinal bleeding was defined by any lifetime history of hematemesis, melena, or hematochezia.
Participants at the OPD were systematically enrolled while inpatients were consecutively recruited over 6 weeks. A detailed medical history that included socio-demographic data, exposure to schistosoma species or alcohol, treatment of schistosomiasis and time from the last treatment, history of UGIB, and other relevant past medical history. Participants were examined for stigmata of chronic liver disease, and vital signs[15, 16].
Measures of health-related quality of life were obtained using the three-level European Quality of Life 5-Dimensions (EQ-5D-Y) questionnaire and the visual analogue scale (EQ-VAS) from the EuroQol Group (EQ-5D™).
The EQ-5D-Y is a multi-attribute utility instrument. The EQ-5D represents measures of personal well-being. It has 5 dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored as three levels: no problems (level 1), some problems (level 2), and extreme problems (level 3). The EQ-5D data was converted into an index of health (EQ5D index) using crosswalk values from Zimbabwe. The index represents a measure of health from 0 for death to 1 for perfect health. The EQ-VAS is a scale that varies from 0, the worst imaginable health state, to 100, the best imaginable health state. The EQ-VAS asks patients to indicate their overall health on a vertical visual analogue scale( 0 to 100).
The EQ-VAS and EQ5D index were then transformed to disability weights (DW) by the formulas [ EQVAS-DW = 1-(VAS/100)] and [EQ5D index -DW = 1-EQ5D index] respectively. A disability weight is a weight factor that reflects the severity of the disease on a scale from 0 (perfect health) to 1 (equivalent to death). Disability weights characterize the amount of health loss associated with specific health outcomes, and are used to calculate years lived with disability[12, 17–19].
Blood was analyzed generating 3-part hematology indices (using a compact Sysmex KX-21 hematology analyzer), hepatitis B and C viral blood serology results (obtained from commercially available rapid diagnostic test kits), and malaria antigen test results (from rapid diagnostic test kits). Stool microscopy was performed for ova and urine for schistosomiasis using the urine circulating cathodic antigen (CCA) test by Rapid diagnostics. Trans-abdominal ultrasonography performed by a trained sonographer according to the modified World Health Organization Niamey protocol using the SONOSTAR model SS8, a portable ultrasound with a 3.5 MHz convex probe. Upper digestive endoscopy was performed using a Pentax EPKi digital video processor and a Pentax 9.8 mm video gastroscope after a local anesthetic (Xylocaine spray) by a gastroenterologist.
Data was transcribed from questionnaires and later entered into a Microsoft Access database. This was edited to ensure quality and exported to Stata version 16 (STATA Corp, Lakeway, College Station, Texas, USA). Descriptive and inferential statistics were generated describing the study population and measures of HRQOL (EQVAS, EQ5D, EQ5D index, EQVAS-DW, and EQ5D index-DW), and factors associated with EQVAS-DW, and EQ5D index-DW. Other variables were designated covariates. Categorical data were summarized as proportions with standard errors (95% confidence intervals). Continuous data were summarized as means, medians, standard deviations (SD), and 95% confidence intervals. However, interquartile ranges were also generated for some medians. We generated a number of linear regression models describing the association between potential independent variables and the two separate dependent outcomes (EQVAS-DW and EQ5D index-DW). Selection of appropriate covariates and the best model was guided by background knowledge, significance criterion, information criteria, and penalized likelihood methods in Stata. We presented standardized beta coefficients for the best models with their standard errors and p-values. These were reported as percentage points ( percentage points = beta coefficient x 100). A significance level (p-value < 0.05) was considered, and confidence intervals or standard errors supported inference. These results were summarized as text, in tables, and as figures.
Ethics statement
This was a routine cross-sectional study that involved human participants. It was approved by School of Medicine, Makerere University, Institutional review board, Kampala, Uganda (#REC REF2011-244), and the Uganda National Council for Science and Technology, Kampala, Uganda (UNCST approval #, HS 1620). The study was conducted according to the principles expressed in the Declaration of Helsinki. Written informed consent was obtained from all participants.