The limitations of this study included the small sample size and the variation in disease states and symptom severity. This variation made it impossible to analyze any predictors of successful withdrawal. The lack of appropriate, validated, and reliable spasticity evaluation scales applicable to all disease states makes it difficult to assess the effectiveness of therapy if one is monitoring efficacy with a single perspective. In this study, broadening the evaluation to include individualizedmeasures of function and pain helped to overcome the limitations of the available tools for measuring spasticity. The results of this study are descriptive only, and there was no control group. One physician declined to participate even though the Pharmacy and Therapeutics Committee and the Medical Advisory Committee supported the study. This limited the sample size further. Neither the patients nor the caregivers were blinded to the tapering process, which could have resulted in reporting bias. For example, some staff might have had preconceived notions that the monitoring parameters would worsen or improve with tapering. However, these potential biases were likely minimized by the multidisciplinary approach to monitoring and decision-making.
Some challenges were encountered in carrying out the project. Obtaining patient consent was often difficult because of the frequent need to arrange meetings with substitute decision makers. Some of the substitute decision makers did not visit routinely and were not available during the week or daytime. Enrolling patients was hampered by health care professionals’ concerns about an increase in workload. This limited the number of patients who could be enrolled at any one time and increased the overall duration of the project. Two patients who had originally been approved by their physicians for inclusion in the study had the approval withdrawn before enrollment because their condition deteriorated. It was initially difficult to arrange clinical team meetings to develop the individualized monitoring plans, but this problem abated as the team members became more familiar with how to design these plans and the research assistant exercised flexibility in her approach to how these meetings could occur. Completing and using the monitoring plan documentation was difficult. It was time consuming for staff, rotating nursing staff were reluctant to document, and non-nursing staff kept their documentation with their own clinical notes (making it hard to track down the information). In future, for any similar research project, funds would be allocated to pay for the time of health care professionals spent developing, using, and documenting the individualized monitoring plans.
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Overall, most physicians and health care staff supported the study wholeheartedly. The standardized tapering protocol and implied institutional support may have provided needed support to physicians deciding whether to attempt withdrawal. The use of individualized monitoring plans and involvement of the clinical team created a feeling of assurance that any changes would be noticed and that any necessary action could be taken quickly. Being able to depend on all of the involved health care professionals to do appropriate monitoring and report their findings enabled physicians to be comfortable with the withdrawal process, which may have encouraged buy-in from both physicians and patients. Use of individualized monitoring plans provided a patient-centred approach to medication withdrawal, close and frequent monitoring (which may not occur in regular practice), an opportunity for patients and family members to be actively involved in care, and an opportunity for the health care team to work closely together in the evaluation of medication changes.
Over $3000 annually was saved among the study patients through dose reduction or discontinuation of baclofen and dantrolene. Continued attempts to reduce medication to minimally effective doses is important in attempts to limit the growth of the institution’s drug budget.
The pragmatic approach used in this study allowed inclusion of a wide variety of patients with different diseases and different affected body parts. Individualized monitoring plans were used in the context of regular clinical care and included measures of spasticity as well as measures of functional impairment and pain that were relevant to the patient and the caregivers. This approach is consistent with literature recommendations that the evaluation of spasticity and its effects be comprehensive in scope and go beyond the use of only one scale to assess change in spasticity (e.g., the Ashworth scale) to assess how change in spasticity affects function. Although this approach did not support the type of quantitative evaluation done in the typical phase 2 or phase 3 drug trial, it did allow measurement of endpoints that were meaningful to individual patients.
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The success of baclofen and dantrolene withdrawal reported here lends support to continued use of Targeted Medication Withdrawal Programs in the authors’ institution. Institutional support, combined with a formal structure for medication withdrawal, detailed monitoring parameters, and assurance of follow-up, allows physicians, pharmacists, and other health care professionals to more easily make decisions to reassess medication efficacy in their patients.