| Methods |
Patients were randomly assigned to the intervention or control group using a sealed envelope technique |
| Participants |
76 dyspeptic patients, who at endoscopy were found to have gastritis, duodenitis, or ulceration, and a positive Helicobacter pylori (H. pylori) urease test, were recruited. Patients were excluded if they were unsuitable for eradication therapy or hypersensitive to its ingredients |
| Interventions |
After diagnosis and enrolment, all patients were to be prescribed a 1‐week regimen of lansoprazole 30 mg daily, amoxicillin 1 g twice a day (bid), and clarithromycin 500 mg bid. Patients in the intervention group received their medication from the hospital pharmacy and were counseled by the hospital pharmacist (average 9.5 minutes) on: their disease and the importance of eradication of the organism; the medicines to be taken and possible side effects, the importance of compliance with the prescribed dosage. Intervention patients received a patient information leaflet about their medication and the need for H. pylori eradication. They were also given a compliance diary chart and telephoned 3 days after the initiation of therapy to provide further counseling about the importance of complying to the medication regimen. Control patients were treated according to normal hospital procedures. They were given a letter to be given to their GP with the recommendation to start triple‐therapy and a letter explaining the nature of infection, the need for treatment, and the importance of compliance (ambiguous in the article, but it seems that the latter letter went to the patient rather than (just) their doctor) |
| Outcomes |
Compliance measurements 1) Patient interview by telephone (structured questionnaire) by the same pharmacist for both groups, after the intended end of the eradication course 2) Pill counts on returned medication when patients returned for a urea breath test. Patient clinical outcome measures included: H. pylori status: assessed with a urea breath test 4 to 6 weeks post‐eradication therapy. Eradication was defined as an absence of H. pylori. Adverse effects: contacted by hospital pharmacist 10 days post‐endoscopy and asked about any adverse effects experienced from the eradication therapy. Modified version of the Gastrointestinal Symptom Rating Scale: to assess the presence and severity of dyspeptic symptoms. The presence and severity symptoms was judged by the patient. They were assessed at the time of endoscopy, at 1 month and 6 months |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Minimal information given: (pg 164) Using a sealed envelope technique patients were randomly assigned to either the control group or the intervention group |
| Allocation concealment (selection bias) |
Low risk |
Minimal information given: (pg 164) Using a sealed envelope technique patients were randomly assigned to either the control group or the intervention group |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
No other biases noted in discussion section or otherwise obvious but difficult to determine if the study if free of other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) PATIENT INTERVIEW BY TELEPHONE ‐ No mention of blinding of study staff collecting the data |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) UREA BREATH TEST TO ASSESS H. PYLORI ERADICATION RATE ‐ objective measure |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PATIENT INTERVIEW BY TELEPHONE ‐ Patient would know if they saw the hospital pharmacist or not |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) UREA BREATH TEST TO ASSESS H. PYLORI ERADICATION RATE ‐ Objective measure |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) PATIENT INTERVIEW BY TELEPHONE ‐ No mention of blinding of staff |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) UREA BREATH TEST TO ASSESS H. PYLORI ERADICATION RATE ‐ objective measure |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) PATIENT INTERVIEW BY TELEPHONE ‐ Not enough information about how the data were collected or analyzed (used 2 methods to measure compliance, but no explanation of how they took and combined the data) |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) UREA BREATH TEST TO ASSESSH. PYLORI ERADICATION RATE ‐ Not enough information given to judge if the study is free of other types of bias |
