A withdrawal protocol template, involving weekly 50% dose reductions at the discretion of the clinical teams, was developed for both baclofen and dantrolene. The proposed monitoring parameters included but were not limited to the following:
• a measure of spasticity (e.g., Ashworth score, clonus score)
• assessment of pain (e.g., rating of pain, on a scale of 0 to 10, using faces pain scale; use of “as needed” pain medications)
• measures of physical function (e.g., ease of seating in wheelchair, ease of perineal care, ability to feed self, positioning in bed)
• documentation of any symptoms that could have been related to these medications and that improved upon tapering or discontinuation of the drugs
Because spasticity was caused by a variety of conditions in these patients and because the patients were at different stages of their diseases, it was felt that the patients’ clinical teams would be in the best position to design the individualized monitoring plan for each patient. Thus, although the monitoring plans needed to address the four main categories listed above, the specific measures for each category could differ from one patient to another.
The study was descriptive, with data being collected before, during, and after the intervention. Results are presented in terms of proportions.
Two questionnaires, one for physicians and the other for patients or their substitute decision makers, were developed to determine the reasons for having patients participate or not participate in the withdrawal program. These questionnaires were administered orally, with the research assistant asking the following questions:
• To each physician for each of his or her patients: “What reasons or factors did you consider when deciding if this patient should be included in or excluded from the withdrawal protocol?”
• To each patient and/or substitute decision maker: “What are your reasons for participating in this medication withdrawal?” or “What are your reasons for not participating in this medication withdrawal?” A physician consent process (both to have their eligible patients participate in the withdrawal protocol and to themselves participate in the questionnaire) and a patient or substitute decision maker consent process (both to participate in the withdrawal protocol and to participate in the questionnaire) were developed. canadian pharmacy cialis
Approval to carry out the project was received from the SCO Health Service Research Ethics Board. The responsibilities of the research assistant (V.P.) for this study were to conduct education sessions for health care professionals, carry out the physician and patient consent process, guide development of the patients’ individualized monitoring plans, assist with documentation, and maintain the study binders.
Education sessions for the pharmacists, physiotherapists, occupational therapists, and nurses covered the study rationale and methods. These provided an opportunity for staff to ask questions and clarify concerns. A study information sheet stating the rationale and methods was distributed to each physician. Physicians were also informed about the study (including the results of the Cochrane collaboration reports) through the normal committee structure of the institution (i.e., meetings of the Pharmacy and Therapeutics Committee, the Medical Advisory Committee, and medical staff). revatio online