BIBILOGRAPH

A pilot test of the instruments was done in October 2012, four weeks before the commencement of the study on fourteen GORD patients at the GOPD of JUTH and PSSH.

These fourteen patients were excluded from the main study since they had been pretested to avoid any undue advantage and influence on the study. The pretesting of the questionnaire was done to test duration, ease and feasibility of administration. The pre-test also assessed how well the participants understood the questions and helped in clarification of ambiguity. It revealed that self-administration of the questionnaires might be inappropriate considering varying levels of education and comprehension of the participants. Based on these findings

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during the pre-test of the questionnaires, the instruments were therefore administered by the recruited research assistant who was trained in administering the tools.

All patients completed a consent form (Appendix I). All questionnaires were administered by the trained nurse research assistant and/or reasearcher in English language and back translated in Hausa language (which is a common language spoken in the environment) for easy of comprehension to the subjects who understood and/or spoke Hausa language. The study – questionnaire (Appendix II) was administered. It indicated patients’ broad socio-demographic variables including age, sex, tribe, religion, education level, occupation and marital status, phone number, contact address; heartburn and regurgitation experiences’; past medical history and medication usage; assessment of reflux precipitating factors; postprandial recumbence attitude; usual sleep position and family and social history. Each patient also had a focused physical examination done.

The physical examination included the height, weight, body mass index (BMI), blood pressure and abdominal examination. The weight was to the nearest 0.01kg, height to the nearest 0.01m from which the BMI was calculated. Height was measured in centimetres (cm) using a wall-mounted stadiometre. The patients were without shoes and head gear and they stood erect with their hands at their sides. The head, buttocks and feet were against a vertical wall and the head level with the horizontal plane.¹⁸⁵ Weight was measured in kilograms (kg) to the nearest 100g without shoes and with minimal clothing using a digital bathroom scale that was calibrated with a known 10kg weight daily and the zero mark checked after each measurement for accuracy.¹⁸⁵ Body mass index (BMI) was calculated as weight (in kg) divided by height (in meters) squared (kg/m²). Using the WHO classification: Underweight:

BMI of <18.5kg/m², Normal weight: BMI of 18.5-24.9 kg/m², Overweight: BMI of 25.0-29.9 kg/m², Class 1 obesity: BMI of 30.0-34.9 kg/m,² Class II obesity: BMI of 35.0-39.9 kg/m²,

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Class III obesity (morbid obesity): BMI of ≥40 kg/m².¹⁸⁶ Patients’ blood pressure was measured on the left arm using a mercury sphygmomanometer: with the patient in sitting position. A cuff of appropriate size in width and encircling at least two thirds of the patient’s arm was attached to the level of the heart with the feet on the floor. Patient’s were relaxed and measurements taken after at least 5 minutes of rest. Auscultation over the brachial artery with the aid of a Littman’s stethoscope revealed five phases of Korotkoff sounds as the cuff was deflated with the phase 1 as the first appearance of the sound marking the systolic blood pressure and phase 5 as the disappearance of the sounds making the diastolic pressure.¹⁸⁷ All the measurements were done by the researcher at each visit to avoid inter-observer error.

The validated and reliable GerdQ questionnaire, designed in English language (Appendix III) was used to diagnose GORD. Eligible patients with a GerdQ score of 8 or more were then randomized into two groups, the control and the intervention groups as described previously.

The GerdQ questionnaire was subsequently used also for monitoring of treatment response and evaluation of the impact of disease on the patient's life. Ineligible patients (exclusion criteria and/or GerdQ score < 8) were evaluated and managed appropriately at their own cost.

GerdQ tool is a 6-item patient-centered validated questionnaire whose questions were derived from the combination of three validated patient-reported outcome (PRO) questionnaires, the Reflux Disease Questionnaire (RDQ), Gastrointestinal Symptom Rating Scale (GSRS) and Gastro-oesophageal reflux disease Impact Scale (GIS).²³ The 4 - graded scale (No symptoms, 1 day, 2–3 days and 4–7 days of symptoms) was derived from the original RDQ scale and also guided by the Montreal definition of GORD, where two or more days of reflux symptoms were considered troublesome by the patient and thus indicative of GORD.^1,23 GerdQ comprises four positive predictors of GORD: heartburn and regurgitation (the two characteristic symptoms of GORD, according to the Montreal definition), sleep disturbance because of these two reflux symptoms and use of over the counter (OTC) medication in

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addition to that prescribed and two negative predictors of GORD, epigastric pain and nausea.²³ Patients were asked to reflect on symptoms over the preceding week (the recall period). Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18 with increasing scores correlating with increasing severity of heartburn symptoms. The likelihood of GORD was 0%

when total score is 0 to 2 points; 50% when 3 to 7 points; 79% when 8 to 10 points; and 89%

when 11 to 18 points.^22,23 The tool has a sensitivity of 65% and a specificity of 71%.^22,23 The overall accuracy of clinical diagnosis by a gastroenterologist and GerdQ is high at approximately 70%.²³ It is a tool to improve and standardize symptom-based diagnosis and evaluation of treatment response in patients with GORD thereby contributing to better use of healthcare resources. Its administration was repeated at 2^nd, 4^th and 8^th week visits in all group participants.

A score to determine the likelihood of response to omeprazole® (Appendix IV) was performed at baseline and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire (Appendix V) administered. The QOLRAD questionnaire is one of the best-characterized disease-specific validated instruments that capture health-related problems and symptom-patterns in patients with gastro-oesophageal reflux disease. ^24,100,106 It was originally developed in US (English), and has subsequently been translated and culturally adapted for use in international studies.^100,106 It can be self-administered or physician-aided.

The heartburn version of the QOLRAD questionnaire is a disease-specific quality of life instrument that includes 25- items combined into five domains: Emotional distress, Sleep disturbance, Food and drink problems, Physical and social functioning and Vitality. The composition of the domains is as follows: emotional distress with six questions (12,14,15,17,19, 22); sleep disturbance with five questions (8,10,11,18,21), vitality with three

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questions (1,4,7); food and drink problems with six questions (3,5,9,13,16,20); and physical and social functioning with five questions (2,6,23,24,25).^106,188 It measures the impact of reflux symptoms on patients’ emotional health, sleep, vitality, eating and drinking, and physical and social functioning in the preceeding week prior to review. Questions are rated on a 7- point Likert scale; the lower the value the more severe the impact on daily functioning.^106,188

Control Group

In the control group, a pill [Omeprazole 20 mg (Omez^® manufactured by Glaxosmithkline, GSK, PLC)] in plastic pack was given at each visit (baseline, 2^nd and 4^th week) for the duration prior to next review i.e two weeks, two weeks and four weeks duration. Clear verbal and written instruction on the pill pack was given to the participants; they were to take their pill daily and appropriately at 30 to 60 minutes before first meal of the day (breakfast) during the study period. They were instructed to bring their pill packs at each visit for pill refill and during which period, adherence was also assessed through any available pill count and pill adherence counselling re-emphasized. The pill, verbal and written advice on pill dosing and timing, the need to return the pill pack for a refill, and visit adherence counselling were given to the intervention group as well. Also at 2^nd, 4^th and 8^th week follow-up visit, the Proton Pump Inhibitor Acid Suppression (PASS) Test questionnaires (Appendices VII), structured therapeutic adherence assessment questionnaire (Appendix VIII) were administered to participants.

The PASS test questionnaire is a simple and clinically applicable tool that helps primary care physicians (PCPs) to identify undertreated patients and assess their response to a change in therapy. It is composed of five, clear, easy-to-understand (yes/no) questions relevant to patient experience.¹⁰⁵ These questions are similar to those in GerdQ tool.

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The control group did not receive the structured-lifestyle modification adherence counselling.

Intervention group

The participants in this group were evaluated, administered the pill (omeprazole^®) and followed up as in the control group participants. In addition, they received the structured-lifestyle modification adherence counseling at baseline, 2^nd week, 4^th week and 8^th week.

They were counselled on: (1) avoidance of spicy in their meals at all times; (2) avoidance of recumbence for at least 3 hours after meals and not to snack after dinner, preferably to eat dinner before or at 7:00 pm; and (3) to sleep on their left lateral position always as they go to bed, possibly place a pillow behind their back to enhance the likelihood that they will stay in this position for a longer time (if no spousal effect), and ensure a left lateral position each time in the night they noticed they have changed position. The goal of attaining full adherence to these measures in the intervention group participants was negotiated between the patient and the investigator, they were asked to rephrase the information given and comprehension was ascertained. This was assessed at each visit using the structured-lifestyle modification adherence questionnaire (Appendix IX) and counselling repeated to enhance full adherence and sustain adopted measures. The intervention group participants’ appointments after baseline assessment were scheduled for 8 to 11:30am on their dates and where promptly reviewed on their arrival while that of the control group was from 12 noon to avoid contamination.

All participants were assessed at baseline, 2^nd week, 4^th week and 8^th week. The follow-up schedule was negotiated with each participant after the initial recruitment. They were reminded of their appointment a day prior to clinic review view text messages or calls for those who could not read messages. The research assistant (a nurse) had the list of phone numbers and identification numbers booked in a diary to which contact was effected. The

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average cost of text message on all networks was four naira. Home visit was embarked upon for defaulters to reduce attrition using their contact addresses. At the end of the study, follow – up and on – demand patient management was continued in the GOPCs and funded by the patient.