Amado 2011.
| Methods | Randomized controlled trial | |
| Participants | The study location was Primary Health Care Centres (PHCC), Barcelona and its metropolitan area, Spain 515 participants were randomized to the intervention group and 481 participants were randomized to the control group The inclusion criteria were patients between 18 and 80 years old with hypertension who were visiting the clinic for at least 6 months for long‐term follow‐up and control of hypertension using anti‐hypertensive drug therapy The exclusion criteria were serious psychiatric, physical, or sensory alterations |
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| Interventions | Intervention: INTERVENTION (IG)
Patients in the Intervention Group (IG) had 4 visits with specially trained nurses who used standardized guidelines and who had attended a 10‐hour workshop that focused on the antihypertensive medications. Each visit lasted for an average of 15 minutes. Information was personalized to the needs of the patient. Schedule sheets with the treatment plan were provided, which contained information on the prescribed drugs and dosage schedule as well as basic advice on how to maximize the treatment schedule. The sheets were provided to reinforce the nurse's verbal instructions Control: CONTROL GROUP (CG) Control patients received usual clinic care without any standardized intervention |
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| Outcomes | The measures of adherence were self reported adherence and pill counts. The Haynes‐Sackett and Morisky‐Green tests were used to collect self reported adherence over the previous 3 months The patient outcomes were systolic and diastolic blood pressure, hypertension control, BMI, and number of hypertensive drugs at 12 months compared with baseline measures |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information about sequence generation. "The study was designed as multi‐centre, prospective, cluster randomised, controlled clinical trial, using the primary healthcare centre as a randomization unit." (pg 63) |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation not described. "The study was designed as multi‐centre, prospective, cluster randomised, controlled clinical trial, using the primary healthcare centre as a randomization unit." (pg 63) |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Other bias | Unclear risk | Most adherence measures were by self report (pg 66). Authors mention the possibility of contamination between intervention and control groups |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRES ‐ Not stated whether the nurses collecting the data were blinded |
| Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE ‐ Not stated whether nurse collecting data was blinded |
| Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) BMI ‐ Not stated whether nurse collecting data was blinded |
| Blinding of participants (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRES ‐ subjective outcome; no mention of blinding |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE ‐ Lack of blinding is not likely to affect the outcome |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) BMI ‐ No blinding of patients mentioned but lack of blinding not likely to affect this outcome |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRES ‐ Insufficient information about the blinding of key personnel |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) BMI ‐ No blinding of other study personnel mentioned |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) BLOOD PRESSURE ‐ No blinding of other study personnel mentioned |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRES ‐ Reasons for dropouts were similar in both groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) BLOOD PRESSURE ‐ Reasons for dropouts similar in both groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) BMI ‐ Reasons for dropouts similar in both groups |