| Methods |
Patients who tested positive for H. pylori were randomly assigned to either usual care or special counseling using a computer‐generated random sequence. The participating pharmacies were provided with a supply of opaque randomization envelopes, and the pharmacists were trained to open the top envelope to determine the treatment assignment for each research participant |
| Participants |
325 adult dyspeptic patients positive for H. pylori participated in the study |
| Interventions |
All the patients were provided a standard antibiotic regimen and randomly assigned to receive either usual care counseling from a pharmacist (the control group participants met with the dispensing pharmacist for 5 minutes. The pharmacist described the proper protocol for taking the medication. This is consistent with standard care.) or a longer adherence counseling session and a follow‐up phone call from the pharmacist during drug treatment (patients received a 15‐minute counseling session with the pharmacist, including a detailed review of possible side effects, emphasis on the importance about possible barriers to adherence and coping strategies, and encouragement to call the pharmacist in the event of any problems. The pharmacist also scheduled a follow‐up telephone call with the patient 2 to 3 days after the start of therapy to check on adherence to the drug regimen.). All subjects were given the same 7‐day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT) |
| Outcomes |
All the patients were contacted by telephone and were asked to report their adherence to the regimen and their current symptoms |
| Notes |
The major problems with this study are that a) both groups received blister packs with daily doses clearly marked; b) both groups received counseling, although this was longer and more detailed for the intervention group than the control group; and c) self report was used for measuring adherence (insensitive). All these factors would bias towards no difference |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A computer‐generated random sequence used. "Participants who tested positive for H pylori were randomly assigned to either usual care or special counseling using a computer‐generated random sequence." (pg 94) |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelopes and computer‐generated random numbers were used. "Participants who tested positive for H pylori were randomly assigned to either usual care or special counseling using a computer‐generated random sequence. The participating pharmacies were provided with a supply of opaque randomization envelopes, and the pharmacists were trained to open the top envelope to determine the treatment assignment for each new research participant." (pg 94) |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
High risk |
Another limitation of our study is that the same pharmacists delivered both interventions and, therefore, may have mixed some elements of the counseling treatments. Occasional observation checks for quality control did not show evidence of this problem, but some contamination between treatments cannot be ruled out (pg 96) |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Staff were blinded. All data collectors were masked to treatment assignments(pg 93) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) UREA BREATH TEST (UBT) ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) UREA BREATH TEST (UBT) ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Pharmacists were not blind because it appears that both groups were seen by the same pharmacist |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) UREA BREATH TEST (UBT) ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Insufficient reporting of missing data for the outcome. No information provided regarding how many patients were contacted for adherence assessment ‐ 8th day phone call |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) UREA BREATH TEST (UBT) ‐ The article gives no information on who dropped out of which group or why |
