Hanlon JT, Weinberger M, Samsa GP, et al. A randomized controlled trial of a clinical pharmacist intervention with elderly outpatients with polypharmacy. American Journal of Medicine 1996;100:428-37
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/8610730
Graves T, Hanlon JT, Schmaler KE, et al. Adverse events after discontinuing medications in elderly outpatients. Archives of Internal Medicine 1997;157:2205-10
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/9342997
Full text article: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/623931
| Methods | Study design:
Hanlon Open-label parallel-group randomized controlled study Graves: Before-and-after study of the intervention group in the parent study Number of groups: Two groups |
| Participants | Number of participants: 208 randomized, 172 completed
· Active deprescribing group: 105 randomized, 88 completed · Control group: 103 randomized, 84 completed Age: Median 69 years,range 65 to 84 years Sex: 1 female, 123 males Participants with dementia: No Inclusion criteria: · Aged 65 years or older · Taking five or more regularly scheduled medications at baseline · Receiving primary care from 13 internal medicine faculty and 17 internal medicine residents paired with faculty physicians in the General Medicine Clinic Exclusion criteria: · Not described Concomitant medicines: Median 8, range 5 to 18 Country: United States of America Setting: Community – General Medicine Clinic of the Durham Veterans Affairs Medical Center in Durham, NC |
| Interventions | Medicine: Eligible medicines were regularly used long-term medicines (defined as used for three months or longer)
Withdrawal schedule: Not described Comparator: Usual and clinical pharmacist care compared to usual care Method to identify targets: Patient-specific intervention: investigator-led intervention: Intervention by research pharmacist who identified targets and implemented the deprescribing intervention Tool to identify deprescribing targets: Medicines Appropriateness Index |
| Outcomes | Hanlon 1996
Medicine Appropriateness Index Health-related quality of life using Short-form 36 health survey Adverse drug reactions Patient medication compliance and knowledge Graves 1997 Adverse drug withdrawal effects Medicines associated with adverse drug withdrawal effects Predictive factors of adverse drug withdrawal effects |
| Dates | Dates: Not described
Follow-up duration: 12 months |
| Funding sources | National Institute on Aging (AG00526-Dr. Schmader) and by the Claude D. Pepper Older Americans Independence Center (P60AGl i268-Drs. Schmader and Cohen, Weinberger and Feussner). |
| Notes | Additional information sought, and received. Further information from Professor Joseph Hanlon:
Thirty-six patients were not interviewed because they were institutionalized (5 per group), deceased (7 intervention and ten control), lost to follow-up (5 intervention and one control), refused (1 control), and no longer in General Medicine Clinic of the Durham Veterans Affairs Medical Center in Durham, NCcare (2 control). |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Randomization method not described. |
| Allocation concealment (selection bias) | High risk | Although Closeout telephone interviews were conducted by another pharmacist blinded to group assignment, the intervention was only performed on the study group i.e. there was no placebo intervention. This makes it an open trial. |
| Blinding of participants and personnel (performance bias) | High risk | Open trial but the outcome measures were largely assessed by blinded staff. – Prescribing appropriateness was assessed by a blinded, research clinical pharmacist. – Health-related quality of life was assessed by blinded interviewers. – Potential adverse drug events were assessed during closeout interviews i.e. by a blinded pharmacist. – Patient medication compliance and knowledge were assessed by patient self-report.ie not blinded. – Patient satisfaction at closeout was assessed by a blinded interviewer. – Physician receptivity for the clinical pharmacist intervention was assessed by an internist blinded. |
| Blinding of outcome assessment (detection bias) | Low risk | As above. |
| Incomplete outcome data (attrition bias) | Low risk | 83% of patients completed the closeout interview. Reasons for dropout were given, and no difference between groups in closeout status was seen. |
| Selective reporting (reporting bias) | Low risk | All outcome measures were reported however the stated intention to supplement bivariate analysis with multivariate analysis was not possible. |
| Other bias | High risk | This study does not eliminate the confounding effect of any extra attention being given to the patient having an effect on the outcomes. Ideally, the control group should have had a “placebo” visit from a clinical pharmacist who made no recommendations and did not do any of the other intervention work. The extra attention would have a positive effect on the intervention group. |
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