Mullan 2009.
| Methods | Randomized controlled trial | |
| Participants | The study location was 11 primary care and family medicine sites within the Mayo Clinic Health System and Olmsted Medical Center, all in southeast Minnesota, USA 48 participants were randomized to the intervention group and 37 participants were randomized to the control group The inclusion criteria were adults with a diagnosis of type 2 diabetes mellitus for at least 1 year who had a scheduled appointment with an enrolled clinician and were able and willing to give informed consent to participate in the trial. Patients with incomplete glycemic control who had remaining antihyperglycemic medication options were included based on HbA1c tests conducted less than 6 months prior to enrollment and results between 7.0% and 9.5% while taking 3 or fewer antihyperglycemic medications and not using insulin |
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| Interventions | Intervention: DIABETES MEDICATION CHOICE DECISION AID TOOL
The intervention was the use of a decision aid tool in one appointment with the patient. The tool was designed to enable clinicians to discuss with patients the potential advantages and disadvantages of adding an agent from 1 of the following antihyperglycemic classes to their regimen: metformin, insulin, thiazolidinediones, exenatide, and sulfonylureas. The tool consists of 6 cards that describe the possible effects of the medications on 6 outcomes: "weight change," "low blood sugar," "blood sugar," "daily routine," "daily sugar testing," and "side effects". After reviewing and discussing the cards that the patient and the clinician chose to discuss, they arrived at the medication that best matched the patient's circumstances and preferences. The patient received a copy of the cards in the form of a take‐home pamphlet Control: USUAL CARE Participants in the usual care arm discussed antihyperglycemic medication in the usual manner. In addition, patients received a professionally produced (by the Mayo Clinic Patient Education Center) 12‐page general pamphlet on oral antihyperglycemic medications to take home |
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| Outcomes | The measures of adherence were self reported interviews wherein research staff telephoned patients at 1, 3, and 6 months after the visit to assess adherence to diabetes medications. Patients were asked a single question: "People often have difficulty taking their pills for one reason or another. How many times do you think you may have missed taking your pills in the last week?" Any patient reporting a missed dose was considered to be non‐adherent. We collected the patients' pharmacy records for all diabetes medications 6 months after their clinical visit as another measure of adherence to prescribed antihyperglycemic regimens. Patients continuing to take the medications that they were using before the visit were presumed to have enough medication to cover the time until their first prescription fill after the visit, up to a 100‐day supply. A gap of longer than 90 days was considered discontinuation, rather than a temporary suspension, of the medication regimen The patient outcomes were HbA1c and self reported health. HbA1c was obtained from patient health records for the appointment closest to the end of the study (after 6 months). Self reported health was measured via a telephone call at the end of the study that asked patients to rate their health as excellent, very good, good, fair, or poor |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated sequence was used. "We randomized clinicians to either use the decision aid with all of their eligible patients (intervention) or discuss antihyperglycemic medications in their usual manner (control) during a regularly scheduled clinical visit. A computer‐generated allocation sequence, unavailable to personnel enrolling patients or clinicians, randomized clinicians to intervention (decision aid) or usual care and was accessed by the study coordinators via telephone. The sequence was stratified by practice type (eg, family medicine or primary care) and practice location, with a block size of 4. Consequently, patient eligibility was assessed prior to randomization for the first patient a clinician saw while enrolled in the trial, but any subsequent patients the clinician saw were assessed for eligibility without being blind to the study arm". (pg 1562) |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed. "We randomized clinicians to either use the decision aid with all of their eligible patients (intervention) or discuss antihyperglycemic medications in their usual manner (control) during a regularly scheduled clinical visit. A computer‐generated allocation sequence, unavailable to personnel enrolling patients or clinicians, randomized clinicians to intervention (decision aid) or usual care and was accessed by the study coordinators via telephone. The sequence was stratified by practice type (eg, family medicine or primary care) and practice location, with a block size of 4. Consequently, patient eligibility was assessed prior to randomization for the first patient a clinician saw while enrolled in the trial, but any subsequent patients the clinician saw were assessed for eligibility without being blind to the study arm". (pg 1562) |
| Selective reporting (reporting bias) | Unclear risk | No protocol is available. On pg 1563, it states that the phone calls to participants were made at 1, 3, and 6 months to assess adherence and self reported health. Only 6‐month results are reported on |
| Other bias | Low risk | The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY RECORD ‐ No mention of blinding of outcome assessors. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) HBA1C ‐ No mention of outcome assessor blinding. Review of medical records provided information about the baseline glycemic control (HBA1C levels) |
| Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) PHARMACY RECORD ‐ Patients were not told the goal of the study. Pharmacy records unlikely to be influenced |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ it is unlikely patient could influence their HBA1C measure |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY RECORD ‐ No mention of blinding. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ No mention of research staff blinding. This is unlikely to influence outcome measure |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) PHARMACY RECORD ‐ There is a small amount of missing data but it is balanced across the conditions |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ Complete data for this measure |