Lai 2011.
| Methods | Randomized controlled trial | |
| Participants | The study location was University Malaya Medical Centre, Malaya Medical Centre, Kuala Lumpur, Malaysia 100 participants were randomized to the intervention group and 98 participants were randomized to the control group The inclusion criteria were postmenopausal women who had just been diagnosed with osteoporosis, never on any active osteoporosis therapy within the past 6 months, and just been prescribed once‐weekly alendronate. Patients who were either on alendronate or risedronate were included The exclusion criteria were metabolic bone disease or any other medical conditions or treatment likely to affect bone metabolism, history of chronic renal, hepatic, or gastrointestinal disease or traumatic lumbar compression fracture |
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| Interventions | Intervention: PHARMACIST COUNSELING
The intervention was enhanced pharmacist care. Patients were followed over a 12‐month period that included 4 visits. All participants were given a 3‐month supply of their drugs at each visit, and instructed on how to take their medications. Intervention participants received an explanation on osteoporosis, risk factors, lifestyle modifications, goals of osteoporosis therapy, side effects and the importance of medication adherence. Verbal counseling was reinforced with an osteoporosis booklet. The pharmacist also reviewed participant's medications and conducted monthly follow‐up via telephone calls for the first 6 months, then every 3 months until month 12 Control: USUAL CARE Participants were dispensed 3 months' supply of bisphosphonate and instructed on how to take their medications. Received no counseling |
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| Outcomes | The measures of adherence were direct reporting, pill counts, and self recording. For direct reporting, patients were asked by a research assistant how many doses had been missed since the last meeting. This was assessed at month 3, 6, and 12. Pill counts were taken at months 3, 6, and 12 by counting the number of pills left at each visit. Patients were asked to self record the date they took their medication The patient outcomes were bone turnover markers (BTM). BTMs were measured 2 ways, serum C‐terminal cross‐linking telopeptide of type I collagen (CTX‐I), a bone resorption marker and serum osteocalcin (OC), a bone formation marker. 6 tests were performed for each BTM over a 10‐day period. Serum for BTM was collected at baseline, month 3, and month 6 of the study |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table used, so low risk of bias. (pg 559 sheet) "This study used a stratified block randomization design to ensure that the number of participants on alendronate and risedronate in the control and intervention group were the same. Therefore, participants were first divided into whether they were on alendronate or risedronate, then randomly allocated to the intervention group using the random digits table while the rest were allocated to the control group." |
| Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment. "This study used a stratified block randomization design to ensure that the number of participants on alendronate and risedronate in the control and intervention group were the same. Therefore, participants were first divided into whether they were on alendronate or risedronate, then randomly allocated to the intervention group using the random digits table while the rest were allocated to the control group." (pg 557) |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Unclear risk | The author notes the following: "...one of the limitations in this study is that data were collected from only one site and hence cannot be considered as population‐based." (pg 565) "There was no significant difference between the BTMs of the control and intervention participants in this study at 3 and 6 months. The lack of significant correlation may be due to the already high medication adherence observed in both the control and intervention group and hence did not affect the BTMs. In addition, the half‐life of bisphosphonates is very long and its serum levels are only transiently elevated after each dose. As a result, if adherence is interrupted at weekly intervals, most of the active sites will be only a few days old on an average and relatively little resorption will occur and hence, this small change will not be detected by the BTMs. Changes in the BTMs will only be detected if the patient stops bisphosphonate therapy for more than a month." (pg 565) |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) DIRECT REPORTING ‐ "An independent research assistant collected the data on medication adherence to minimize pharmacist interaction with control participants and to reduce intervention bias" (pg 559) |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) BONE TURNOVER MARKER ‐ This outcome is unlikely to be subject to bias (objective outcome) |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) DIRECT REPORTING ‐ No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding. Also there is potential for recall bias in this type of measure (pg 560) |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) BONE TURNOVER MARKER ‐ This outcome is unlikely to be subject to bias (objective outcome) |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) DIRECT REPORTING ‐ Self recorded by patients; unlikely other personnel could bias this outcome |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) BONE TURNOVER MARKER ‐ This outcome is unlikely to be subject to bias (objective outcome) |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) DIRECT REPORTING ‐ Refer to Figure 2 for details. Adverse events: 10; withdrew consent: 2; did not start biophosphate treatment 1; lost to follow‐up: 6; deceased: 1; diagnosed with thalassemia: 1. Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) BONE TURNOVER MARKER ‐ Refer to Figure 2 for details. Adverse events: 10; withdrew consent: 2; did not start biophosphate treatment 1; lost to follow‐up: 6; deceased: 1; diagnosed with thalassemia: 1. Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |