| Methods |
119 patients were randomly allocated to intervention (n = 60) and control (n = 59) groups. The trial was single‐blinded in that, although patients were aware of the names of the study medication and the fact the study was an H. Pylori treatment trial, they were unaware of either the differences between the treatment groups or the compliance enhancing purpose of the trial |
| Participants |
All adult patients over the age of 18 years with H. Pylori infection were screened for eligibility. Patient exclusion criteria included inability or refusal to give informed consent, contraindication to the study medication, consultant's recommendation not to treat patient, consultant wish to use an H. pylori therapy other than the study medication, and inpatient status as patient compliance is imposed in this situation |
| Interventions |
All patients received 10 days of omeprazole 20 mg twice a day, amoxycillin 500 mg 3 times a day, and metronidazole 400 mg 3 times a day, as well as verbal advice on medication use and possible side effects, in an initial 20‐minute consultation. In addition, patients in the intervention group received medication in dose‐dispensing units, an information sheet on H. Pylori treatment, and a medication chart. Compliance in intervention group patients was also encouraged by a phone call 2 days after the start of therapy |
| Outcomes |
Measurement of compliance: compliance was assessed by phone interview on day 10 of therapy, and by returned tablet count at the follow‐up C‐urea breath test (C‐UBT) visit. Patients were defined as compliant if they were assessed by both pill count and interview as taking = 80% of study medications. Total percentage of tablets taken in both groups was assessed by taking the lower of the 2 estimates of tablet consumption (pill count or interview data) for each patient. Measurement for healthcare outcomes: Patients were considered H. Pylori‐positive if the CLO‐test, histopathology, or 13C‐UBT was positive. 13C‐UBT test using kits sent to a single central laboratory for analysis was performed for more than one month after cessation ofH. pylori treatment and any other antimicrobial therapy (including bismuth), 2 weeks after cessation of proton‐pump inhibitor therapy and 1 week after cessation of histamine‐receptor antagonists. An increase of 5 per million in the CO2 30 minutes after ingestion of C‐urea compared with baseline measurements was considered positive for H. Pylori. Treatment was considered successful if 13C‐UBT was negative. Side effects were assessed by phone interview on day 10 of therapy and by returned side effects form. Patients were asked to rate specific side effects and give an overall rating where none = 0, mild = 1 (does not limit daily activities), moderate = 2 (interferes with daily activities), and severe = 3 (incapacitating, stops normal daily activities) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information in the article. (pg 811) "...were prospectively recruited from the endoscopy unit and outpatient gastroenterological clinic of our teaching hospital and randomized to one of two treatment groups. All adult patients (age .18 yr) were screened for eligibility." |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information provided in the article. (pg 811) "...were prospectively recruited from the endoscopy unit and outpatient gastroenterological clinic of our teaching hospital and randomized to one of two treatment groups. All adult patients (age .18 yr) were screened for eligibility." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
No biases other than measurement bias noted in discussion; no other clear risks of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) TELEPHONE INTERVIEW ‐ (pg 812) "The trial was single‐blinded" with respect to patients, so no other blinding was done |
| Blinding of outcome assessment (detection bias)
Patient outcome |
High risk |
(PRIMARY) CURE RATE ‐ (pg 812) "The trial was single‐blinded" with respect to patients, so no other blinding was done |
| Blinding of participants (performance bias)
Adherence measure |
Low risk |
(PRIMARY) TELEPHONE INTERVIEW ‐ (pg 812) "The trial was single‐blinded in that, although patients were aware of the names of the study medication and the fact that the study was an H. pylori treatment trial, they were unaware of either the differences between the treatment groups or the compliance enhancing purpose of the trial". |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) CURE RATE ‐ Patients were blinded. (pg 812) "The trial was single‐blinded in that, although patients were aware of the names of the study medication and the fact that the study was antipylori treatment trial, they were unaware of either the differences between the treatment groups or the compliance enhancing purpose of the trial." |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) TELEPHONE INTERVIEW ‐ (pg 812) "The trial was single‐blinded" with respect to patients, so no other blinding was done |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) CURE RATE ‐ (pg 812) "The trial was single‐blinded" with respect to patients, so no other blinding was done |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) TELEPHONE INTERVIEW ‐ Few incomplete data and handled conservatively |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) CURE RATE ‐ Few missing; handled conservatively |
