Patient enrollment began in November 2002, and all eligible patients had completed the withdrawal protocol and monitoring period by July 2004.

At the time the project was started, 69 patients in the 348-bed complex continuing care unit were taking either baclofen or dantrolene or both. Twenty-nine of these patients were excluded from the study primarily because of physicians’ reasons; one physician declined to participate in the study, which affected 9 patients. Participating physicians judged the remaining 20 patients as ineligible for a variety of reasons, including the following:

• the medication seemed to be working (n = 9)
• the family was concerned about making changes to medication (n = 4)
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Common reasons for recommending inclusion in the study for the remaining 40 patients included the following:

• patient seemed stable, and physician was unsure whether medication was needed (n = 23)
• to decrease the number of medications (n = 13)
• to potentially minimize adverse effects (n = 6)

Of the 40 eligible patients, 26 (65%) agreed to participate in the withdrawal process. Common reasons for participating were the following:

• withdrawal may be of benefit to the patient (n = 14)
• to decrease number of medications (n = 9)
• research is important for the benefit of future patients (n = 8)
• to decrease side effects (n = 7)
• not sure if the medication is having any effect (n = 5) Among the patients or substitute decision makers

from whom it was not possible to obtain written consent, 2 patients died before they could be approached, 2 substitute decision makers could not be reached or did not return the written consent form despite verbal agreement, and 10 patients (or substitute decision makers) decided not to participate. The most common reason for not wanting to participate, cited by all 6 of the patients or substitute decision makers who agreed to answer the questionnaire but declined to participate in the withdrawal protocol, was that the medication seemed to be working. canada viagra online

An example of an individualized monitoring plan is shown in Appendix 1. Early in the project, it took up to an hour for the clinical team to develop such a plan for each patient. However, as the project progressed and staff became familiar with both the project and the effects of medication withdrawal, it took less time to develop a monitoring plan, and by the end of the project, a monitoring plan could be devised by 4 team members in 10 min. Examples of typical monitoring parameters used by the teams are outlined in Table 1.

Table 1. Examples of Monitoring Parameters Used for Different Patients and Who Did the Monitoring




Variable




Assessor




Spasticity


Ashworth score


Physiotherapist


Clonus score


Physiotherapist


Spasm frequency


Nursing staff


Spasm severity


Nursing staff


Stiffness of left hand (distance that hand can be opened, from
fingertips to palmar crease,


in centimetres)


Physiotherapist


Stiffness (e.g., when trying to help patient into car, leg sometimes too
stiff to bend)


Family member


Worsening of spasm


Mother




Pain


Rating from
0 to
10
using faces pain scale


Nursing staff, personal care workers


Use of analgesics as needed (prn)


Pharmacist


Foot pain leading to request for more pillows under feet in bed


Nursing staff




Functional status


Ease of perineal care (e.g., abduction of hips)


Nursing staff


Positioning in wheelchair


Occupational therapist, nursing staff


Seating (general)


Nursing staff


Seating (ability to flex at hips)


Occupational therapist


Ability to remove and put on eyeglasses


Physiotherapist


Ease of rolling patient in bed


Nursing staff


One-person assist from front to help patient stand from wheelchair


Physiotherapist


Standing transfer


Nursing staff


Range of motion (e.g., upper extremities, elbows, knees)


Occupational therapist


Fit of hand devices


Occupational therapist, nursing staff


Ability to stand on tilt table


Physiotherapist


Position of left foot on foot plate


Occupational therapist


Position of left arm on tray


Occupational therapist


Ease of dressing


Nursing staff


Increased stiffness of left hand causing inability to use handroll


Occupational therapist


Ability to finger feed


Nursing staff


Ability to walk with walker


Nursing staff


Stiffness in hands and legs when doing evening exercises


Husband

Of the 26 participating patients, 15 (58%) had baclofen or dantrolene discontinued. Six (23%) were maintained on a lower dose. Four (15%) were maintained on the same dose. Six (23%) of the patients had other changes made to their spasticity treatment, such as

• increase in gabapentin dose
• addition of tizanidine
• addition of botulinum toxin, clonazepam, and acetaminophen (for a patient who remained on baclofen but at a lower dose)
• addition of botulinum toxin and clonazepam (for a patient who remained on baclofen but at a lower dose)
• addition of botulinum toxin (for a patient who remained on the same dose of baclofen)
• addition of acetaminophen and tizanidine added (for a patient who remained on the same dose of baclofen)

None of these changes were attributed specifically to the dose reductions of either baclofen or dantrolene and may have been related to disease progression and active clinical management to improve symptom control. Decisions about adding other pharmacological agents were made by the physicians and pharmacists and reflected their knowledge of the patient, the disease state, the stage and severity of disease, affected limbs, other medications, and previous response to medications. There was no overall change in the pharmacy budget for either botulinum toxin or tizanidine over the course of the study.

Table 2. Characteristics of Participating Patients




Characteristic




No. of patients*




Sex


Male


10


Female


15




Age (years)


<60


13


>60


11


Mean (range)


60.2 (33-81)




Condition


Multiple sclerosis


12


Cerebrovascular accident


6


Head injury


3


Subarachnoid hemorrhage


2


Spinal cord injury


1


Cerebral palsy


1




Drug


Baclofen


19


Dantrolene


5


Both


1

Four (15%) of the 26 participants had improvements in other symptoms that could have been adverse effects of the antispasticity agents. These were identified by the pharmacist for each individual patient as part of usual monitoring responsibilities and were determined by the pharmacist to have been as a result of tapering the antispasticity agent (rather than stopping another sedating drug or some other reason). The respective improve­ments noted for each patient were
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• increased alertness
• improved level of communication, more interaction with others, less drowsiness
• more facial expressions, a more cheerful mood, more smiling
• improved muscle strength and a louder voice (for a patient who eventually started back on a small dose of baclofen)

One patient died during tapering because of disease progression.

Figure 1. Flow chart depicting

Figure 1. Flow chart depicting patient enrollment and outcomes. SDM = substitute decision maker.

The demographic characteristics of the participating patients (except for the patient who died) are listed in Table 2. The results of enrollment and medication with­drawal are outlined in Figure 1. No demographic variables were found to be predictive of successful withdrawal.