Campbell AJ, Robertson MC, Gardner MM, et al. Psychotropic medication withdrawal and a home-based exercise program to prevent falls: a randomized, controlled trial. Journal of the American Geriatrics Society 1999;47:850-53.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/10404930
Campbell AJ, Robertson MC, Gardner MM, et al. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ 1997;315(7115):1065-69.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/9366737
Full text article: https://www.bmj.com/content/315/7115/1065.long
| Methods | Study design: Randomized double-blind placebo-controlled study with a two-by-two-factorial design
Number of groups: Four groups |
| Participants | Number of participants: 93 participants
· Group 1: Deprescribed and exercise program group: 24 participants · Group 2: Deprescribed and no exercise program: 24 participants · Group 3: Original medicine and exercise program: 21 participants · Group 4: Usual care (Original medicine and no exercise program): 24 participants Age: 74.6 ± 5.5 years Sex: 71 female, 22 male Inclusion criteria: · Over 65 years · Registered with New Zealand general practitioner · Currently taking psychotropic medication Exclusion criteria: · Cannot comply with at least seven out of ten requirements (requirements Not described) Concomitant medicines 6.5 ± 2.9 Country: New Zealand Setting: community, 17 general practice groups |
| Interventions | Medicine: Anti-anxiolytics, typical antipsychotic, atypical antipsychotic, antidepressants, benzodiazepines
Withdrawal Schedule: Not described Comparator: · Deprescribe in combination with lifestyle advice (i.e. exercise) · Deprescribe only · Continue medicine in combination with lifestyle advice (i.e. exercise) · No intervention Patient-specific intervention: investigator-led intervention: General practitioners recommended potential participants (i.e. identified their patients who may benefit from deprescribing target medications) Intervention by the investigator. Tool to identify deprescribing targets: Pre-specified list of target medications |
| Outcomes | Falls |
| Dates | Dates: Not described
Follow-up duration: 44 weeks |
| Funding sources | Accident Rehabilitation and Compensation Insurance Corporation of New Zealand (ACC)
DMB was sponsored by the Department of Veterans Affairs, USA |
| Notes | Group two and group four were used as the active deprescribing and control grouprespectively for the review to reduce the confounding effects of the exercise program on deprescribing. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | The method is not describedin this paper. However, in Campbell 1997 (first report on the study), it was described that: “the group allocation schedule using computer-generated random-numbers and the lit was held off-site by an independent person. Group allocation was made by telephone contact after all baseline questionnaires and assessments were completed.” |
| Allocation concealment (selection bias) | Low risk | Exercise group assignment was made by telephone contact to an independent person off site who held the exercise group allocation list. Only the pharmacist, based in a local pharmacy, held the medication group allocation list. |
| Blinding of participants and personnel (performance bias) | Low risk | “Drug group allocation was double-blinded and not broken until each participant withdrew from or completed the study.”
“The ingredients of individual participant’s psychotropic medication were reformulated into study capsules by grinding the tablets, mixing the powder with an inert substance, or packing into gelatin capsules If participants were taking more than one psychotropic medication;separate capsules were prepared for each of the medication. Capsules containing inert or active ingredients looked and tasted the same. At entry to the study, all participants were given study capsules containing their psychotropic medication at the current dose.” |
| Blinding of outcome assessment (detection bias) | Low risk | “The investigator confirming fall events was blind to group allocation.”
In Campbell 1997, it was stated: “The assessment physiotherapist and investigator classifying fall events remained blind to group allocation.” |
| Incomplete outcome data (attrition bias) | Unclear risk | Much of the data is given in relative terms rather than absolute, making it difficult to extrapolate.
“Any participant who stopped taking the study capsules was encouraged to stay in the study and complete the falls monitoring.” |
| Selective reporting (reporting bias) | Low risk | All pre-specified outcomes were reported. |
| Other bias | Low risk | There appears to be no conflict of interest or any other source of bias. The only concern is the participants would know if they were in the exercise group or no exercise group. This probably would not have influenced the outcome of the study. |
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