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Improvements in Children With Cerebral Palsy Following Intrathecal Baclofen : Use of the
Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire (RIC CareQ)
Karin W. Baker, Beverley Tann, Akmer Mutlu and Deborah Gaebler-Spira The online version of this article can be found at: can be found at:
Journal of Child Neurology
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ª The Author(s) 2013Reprints and permission: Use of the Rehabilitation Institute ofChicago Care and Comfort CaregiverQuestionnaire (RIC CareQ) Karin W. Baker, MD1, Beverley Tann, RN2, Akmer Mutlu, PT, PhD3, andDeborah Gaebler-Spira, MD2 AbstractImplantation of an intrathecal baclofen pump is recommended for children with cerebral palsy as a means to improve care andcomfort when other options fail to control severe hypertonia. Making an assessment of a child’s spasticity-related limitations in bothroutine care and activity is a necessary component of selection of intrathecal baclofen candidates. The Rehabilitation Institute ofChicago Care and Comfort Caregiver Questionnaire (RIC CareQ) is a validated, easy-to-use questionnaire that elicits informationabout the ease of daily activity and caregiving in patients with severe spasticity. Questionnaires completed by caregivers and patientsat a pediatric physiatry spasticity clinic over an 11-year period were reviewed to evaluate whether the Rehabilitation Institute ofChicago Care and Comfort Caregiver Questionnaire captured improved caregiving and comfort of children with cerebral palsy andsevere spasticity following intrathecal baclofen pump implantation. The Questionnaire scores showed improvement after intrathecalbaclofen pump implantation, consistent with subjective reports of patient and caregiver satisfaction.
Keywordscerebral palsy, spasticity, intrathecal baclofen Received November 26, 2012. Accepted for publication December 17, 2012.
Spasticity, a velocity-dependent increased resistance to muscle decrease in spasticity of cerebral origin with intrathecal stretch, is present in patients who have experienced a central delivery of baclofen. In 1996, the intrathecal baclofen pump nervous system injury and occurs in patients with cerebral was approved by the Food and Drug Administration for the palsy, traumatic brain injury, and spinal cord injury. Spasticity management of spasticity caused by central nervous system may result in pain, orthopedic deformities, and difficulty with movement, activities of daily living, and mobility. Although The primary goal for tone management in intrathecal baclo- physical and occupational therapies are first implemented to fen pump candidates is improvement of activities of daily living, improve function, spasticity is often severe enough to warrant caregiving, and comfort. A secondary consideration is improve- ment in mobility. Without a means to objectively assess response Medical management of spasticity can include use of oral to treatment, the practitioner will generally use the subjective medications and focal injections; however, these options may response of the patient or caregiver to intrathecal baclofen pump be limited by total dosage or undesirable side effects such as treatment to guide management even when functional changes truncal weakness, somnolence, toxicity, or incomplete spasti- are not observable. One of the largest populations using city control. In patients in whom spastic tone or side effectsexceed successful treatment, medication administered directlyto the central nervous system can reduce negative systemic side effects by delivering the medication past the blood-brain bar- 2 Rehabilitation Institute of Chicago, Chicago, IL, USA3 rier. In 1985, Penn and Kroin1 were the first to demonstrate that baclofen, a commonly used spasticity medication, administered to the cerebrospinal fluid could reduce spinal cord injury– Karin W. Baker, MD, P.O. Box 5769, Columbus, GA 31906, USA.
mediated spasticity. In 1991, Albright et al2 found a similar intrathecal baclofen pump treatment is children with cerebral Table 1. Demographic Characteristics of 114 Patients Who Received palsy. In those cases, primary caregivers, rather than the patient, are often the main source of feedback.
The Caregiver Questionnaire (CQ) was developed at the Rehabilitation Institute of Chicago in 1990 for children with spastic quadriplegic cerebral palsy undergoing selective dorsal rhizotomy surgery for spasticity management.3 The Caregiver Questionnaire was developed as a health-related quality of life tool; however, conceptually it is a perceived burden of effort measurement because it captures the caregiver’s role. Schneider et al3 demonstrated that the overall Caregiver Questionnaire score correlated with the Child Health Questionnaire Parental Impact-Time subscale, which describes a caregiver’s personal time limitations based on the child’s health-related status. This finding was consistent with the overall goal of determining care- giver burden by use of the Caregiver Questionnaire.
Nemer McCoy et al4 later used the Caregiver Questionnaire to develop the Care and Comfort Hypertonicity Questionnaire to identify the severity of spasticity, where higher scores corre- late with patients who would be appropriate candidates for intrathecal baclofen pump implantation. The questionnaire has The Caregiver Questionnaire was also one of the question- naires used to develop the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), an instrument devel- oped to measure the ease of daily activity and caregiving of children with severe cerebral palsy. The Caregiver Priorities and Child Health Index of Life with Disabilities measures the effec- tiveness of interventions intended to improve or preserve outcomes for children with severe disabilities.5 As use of intrathecal baclofen evolved, the Caregiver Questionnaire was written and revised periodically for use in the spasticity clinic. Hwang et al6 evaluated the question- naire in 2011 and determined that it was a reliable measure of a caregiver’s perception of burden of care for the studied group of children. The questionnaire was called the CareQ at the time of publication; however, to avoid confusion with another similarly named questionnaire, it has been renamed the Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire (copyright 2011, Rehabilitation Institute of Chicago, Chicago, IL; all rights reserved).6 TheRehabilitation Institute of Chicago Care and Comfort Care- Abbreviations: GMFCS, Gross Motor Function Classification System; ITB,intrathecal baclofen.
giver Questionnaire focuses on daily care activities, use of aTotal complications greater than 114 as some patients had more than 1 equipment, positioning, and pain. Although the Questionnaire is not a health-related quality of life assessment, it doesaddress participation, especially as impacted or limited by Rehabilitation Institute of Chicago Care and Comfort Caregiver pain. It also provides an insight on caregiver burden by focus- Questionnaire can be completed before intrathecal baclofen ing on routine daily care, including the ease of using equip- pump implantation by or for patients who later may be candi- ment. Further, it is not specifically focused to the pediatric dates for intrathecal baclofen. The Questionnaire is used both population; both adults and caregivers have completed this before and after implantation because it is designed to educate questionnaire (Table 1). Finally, it allows respondents to indi- as well as evaluate performance of the intrathecal baclofen cate the amount that a patient is able to contribute to perfor- pump. It is first used as an educational tool to assist patients, their caregivers, and the medical team in establishing realistic Patients or caregivers of patients with significant hypertonia goals for spasticity treatment by concentrating on daily activities are asked to complete the Rehabilitation Institute of Chicago that could be improved with better spasticity control. This is an Care and Comfort Caregiver Questionnaire in the clinic. The important function of the Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire because patients Table 2. Age and GMFCS Classification of Cerebral Palsy Patients.
who had received intrathecal baclofen pumps indicated a need for greater education before pump implantation.7 The Question-naire is also administered intermittently in continuing follow-up appointments for patients after receiving an intrathecal baclofen pump to review how goals are being met. This information The Rehabilitation Institute of Chicago Care and Comfort Abbreviations: GMFCS, Gross Motor Function Classification System; ITB, Caregiver Questionnaire consists of 19 questions and takes only a few minutes to complete, making it ideal for a busyclinic setting. In our review of questionnaires completed in undergone intrathecal baclofen pump implantation. Three 11 years of use, all questionnaires were fully completed patients were excluded because of missing diagnosis or date without assistance from clinic staff. Answers are in the form of birth. More males (n ¼ 86) than females (n ¼ 28) received of a Likert scale, where 1 denotes an easy task and 5 indicates intrathecal baclofen pumps in the sample of 114 patients. The mean age was 14 years (range, 4-47 years). Sixty-eight percent We undertook this study to determine whether the Rehabili- of patients (n ¼ 78) had a diagnosis of moderate to severe tation Institute of Chicago Care and Comfort Caregiver (Gross Motor Function Classification System8 [GMFCS] IV Questionnaire captured patient and caregiver perceptions of or V) cerebral palsy (Table 1). Seventy-four percent of patients improved caregiving and comfort following management with (n ¼ 84) presented with spasticity as the primary tonal abnorm- intrathecal baclofen for the child with severe spasticity. Our ality, and an additional 23% (n ¼ 26) demonstrated a combina- hypothesis was that caregivers of children undergoing intrathe- tion of spasticity and dystonia. Nearly all patients had triplegic cal baclofen pump implantation would demonstrate changes in or quadriplegic distribution of their hypertonicity.
the perceived burden of care and that the Rehabilitation Insti- Of the original 114 patients in this study, 67 continued to tute of Chicago Care and Comfort Caregiver Questionnaire receive care at our medical center. Thirty-seven patients moved would be a sensitive measure to detect such changes.
or received care closer to their homes, which is thought to beconsistent with transition of care from a major medical centerto the local community, especially as intrathecal baclofen pump availability has grown. Ten patients had died from med- A chart review was done to evaluate responses on the Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire in 11 Seventy-four patients did not have any known complication years of clinical practice from 1996 to 2007. Basic demographic events. Of the recorded known complications, catheter discon- characteristics including date of birth, gender, ethnicity, diagnosis, nection from the pump was the most frequent complication (25 tone type and distribution, and outcome were collected for all patients occurrences), followed by infection (16 occurrences). Six who have undergone intrathecal baclofen pump implantation at our patients were believed to have some type of malfunction of medical center. Information including date of implantation, known their pumps (Table 1). Seventy-five patients were classified complications, and other surgeries was also abstracted from the with moderate to severe cerebral palsy (Gross Motor Function In order to characterize the intrathecal baclofen experience at our Classification System IV or V). Comparisons by severity of facility, data were abstracted on all patients receiving this medication cerebral palsy were not conducted as only 5 patients were clas- within the interval of study and were analyzed descriptively. Differ- sified with less severe involvement (Gross Motor Function ences between Rehabilitation Institute of Chicago Care and Comfort Classification System II or III). Notably, patients with greater Caregiver Questionnaire scores before and after implantation of the severity were younger at the time of intrathecal baclofen pump intrathecal baclofen pump were evaluated by paired t test for each implantation. There was a mean age of 14 years and 12 years at domain. Moreover, linear regression models that included covariates implantation in patients with Gross Motor Function Classifica- such as time since pump implantation and length of intrathecal tion System IV and V, respectively, as compared with a mean baclofen treatment were constructed to examine the influence of these age of 21 and 18 years in patients with Gross Motor Function variables on post–intrathecal baclofen care and comfort questionnaire Classification System II and III, respectively (Table 2).
scores. Values of P <.05 were considered statistically significant when By conclusion of the chart review period, 33 patients had testing differences (paired t test) and when examining partialcorrelation coefficients (linear regression). Continuous variables are undergone implantation of a second pump, with most under- presented as mean + standard deviation and discrete variables as n going replacement 4 to 5 years after receiving the first pump.
(%). Data were evaluated using the Statistical Package for Social Three of the 33 patients who received a second pump required Sciences version 15.0 for Windows (SPSS Inc, Chicago, IL).
replacement because of infection and again had difficulty withinfection, necessitating a second explantation.
Twenty-five patients (22%) underwent orthopedic surgery prior to pump placement and 33 patients (29%) underwent At the end date for chart review and abstraction in June 2007, orthopedic surgery after the implantation. Of the patients who 117 patients who received care in the spasticity clinic had had orthopedic surgery prior to pump implantation, 2 had bony Table 3. Care and Comfort Scores Before and After ITB and P Value Table 4. P Values for Post-ITB Care and Comfort Domain Scores in Linear Regression Models Controlling for Interval Since ITBImplantation, Age at ITB, and Presence of Complications.a Abbreviations: ITB, intrathecal baclofen; NS, not significant.
Abbreviation: ITB, intrathecal baclofen.
aValues in bold indicate significance.
procedures, 9 had soft tissue surgery, 6 had combined bony andsoft tissue surgery, and 8 had multiple orthopedic surgeries. Ofthe patients who had orthopedic surgery after pump implanta- tion, 14 had bony surgery, 9 had soft tissue surgery, 6 had acombination of bony and soft tissue surgery, and 4 had multiple Patients and caregivers generally report overall satisfaction with the intrathecal baclofen pump in spasticity management.
The Rehabilitation Institute of Chicago Care and Comfort This correlates with the statistically significant improvements Caregiver Questionnaire was completed by 84 patients or seen in the Rehabilitation Institute of Chicago Care and Com- caregivers in the clinic. Sixty-three (75%) had completed fort Caregiver Questionnaire scores for upper extremity, lower questionnaires both before and after intrathecal baclofen pump extremity, orthotic devices, and positioning. All questionnaires implantation. A paired t test was used to evaluate the care and were fully completed without supervision from clinic staff, comfort questionnaire scores for each domain before and after indicating that patients and caregivers found the survey easy implantation. The event of orthopedic surgeries could not be to finish in a busy clinic setting. The overall educational goal examined for influence on questionnaire domains because of of the questionnaire appears to be satisfied from patient and the small sample size. Statistically significant improvements caregiver communication of achieved expectations.
were seen in each domain of the care and comfort questionnaire Literature suggests variable pain response to intrathecal baclofen pump management. Earlier publications have Patients or their caregivers completed the post–intrathecal reported subjective improvements in pain.7,9,10 Small numbers baclofen questionnaire an average of 37 months after pump of patients reported worsening pain in one prior study,7 and implantation. A linear regression model was used to examine Parke et al11 noted that patients with neuropathic pain com- the influence of time since pump implantation on Rehabilita- plaints did not have any reported improvement in pain. In our tion Institute of Chicago Care and Comfort Caregiver patients, the small change in pain scores was insignificant.
Questionnaire scores. The findings indicated that the length The impact of time from pump implantation on Rehabilita- of time with intrathecal baclofen spasticity management did tion Institute of Chicago Care and Comfort Caregiver Ques- not affect Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire scores for upper extremity, lower completed shortly after intrathecal baclofen pump placement extremity, and pain. There was an unclear relationship with the might not reflect optimal treatment dosage. In a multicenter positioning and orthotic devices domains (Table 4).
study, Albright et al12 reported that most intrathecal baclofen The influence of increased age in the intrathecal baclofen dosage changes were made in the first 2 years. On average, our recipient was examined using a linear regression model. The population completed a follow-up questionnaire at 37 months data indicated that age did not affect upper extremity, lower after pump implantation, which suggests that patients were extremity, and pain scores. Pain scores were significantly lower typically at a stable dose. Krach et al7 also found little correla- as patient’s age increased. Age at time of intrathecal baclofen tion between time from implantation to any outcome measures.
pump implantation did not have a clear effect on either the This is consistent with our analysis, which suggested that time positioning or orthotic devices domains (Table 4).
did not affect most Rehabilitation Institute of Chicago Care and There were 49 documented complication events reported in Comfort Caregiver Questionnaire scores.
40 patients who received intrathecal baclofen pumps. Using a A linear regression model that controlled for age at time linear regression model, the presence of complications was of intrathecal baclofen pump implantation was used to eval- used to examine influence on Rehabilitation Institute of uate whether proxy reports from caregivers affected Rehabi- Chicago Care and Comfort Caregiver Questionnaire scores.
litation Institute of Chicago Care and Comfort Caregiver There was not a clear impact on the orthotic devices or posi- Questionnaire answers. Our data did show that scores in the tioning domains. Complications did not appear to affect Rehabilitation Institute of Chicago Care and Comfort Care- improvement seen in the remaining questionnaire domains giver Questionnaire pain domain decreased as patients aged, and presumably were able to self-report pain. This finding would seem to suggest that caregivers do have some diffi- culty with approximating their child’s pain levels. Most The authors thank Maxine M. Kuroda, PhD, MPH, for her assistance questions on the Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire allow caregivers togive a direct report of their difficulty or ease with activities of daily living. This is consistent with our finding that age Rehabilitation Institute of Chicago, RIC, and RIC CareQ are at time of intrathecal baclofen pump implantation did not trademarks of the Rehabilitation Institute of Chicago.
appear to influence reported outcomes in most of the Reha-bilitation Institute of Chicago Care and Comfort Caregiver KB and DGS (author of the Rehabilitation Institute of Chicago Care The most common complication, catheter disconnection and Comfort Caregiver Questionnaire) wrote the manuscript and from the intrathecal baclofen pump, has decreased in frequency analyzed the data. BT reviewed the manuscript. All authors contribu- over time with revised surgical techniques and modifications made to the pump and catheter hardware. The 11-year period encompasses the period during which these evolutionsoccurred and accounts for the relatively large number of cathe- The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:Gaebler-Spira has served as an advisor or consultant for Merz Pharma- The presence of complications did not affect scores on the ceuticals and has received grants for clinical research from Cerebral Rehabilitation Institute of Chicago Care and Comfort Care- Palsy Research Registry, National Institute on Disability and Rehabi- giver Questionnaire. Part of this effect could be attributed to litation Research, National Institutes of Health and National Science overall satisfaction with the intrathecal baclofen pump. In the Foundation, Ultraflex, Accorda, and CNS Therapeutics.
absence of a controlled study, we were not able to examine thetiming with complications.
The frequency of orthopedic surgery both before and after The authors disclosed receipt of the following financial support for the intrathecal baclofen pump implantation is consistent with the research, authorship, and/or publication of this article: Deborah severity of hypertonicity and the resultant deforming musculos- Gaebler-Spira received research funding from CNS Therapeutics, keletal effects in this population. A contributing factor in the manufacturers of intrathecal gablofen.
larger numbers of surgeries after implantation of the pump isthe frequency of planned surgeries when overall spastic tone The research conducted in this study was under the approval of the Analysis performed was based on available data. In the Northwestern University Institutional Review Board.
absence of a controlled setting, conclusions about the short-termimpact of complications or other interventions, such as surgery, could not be evaluated and would be of interest for future study.
1. Penn RD, Kroin JS. Continuous intrathecal baclofen for severe 2. Albright AL, Cervi A, Singletary J. Intrathecal baclofen for spas- ticity in cerebral palsy. JAMA. 1991;265:1418-1422.
Spasticity treatment is initiated on the premise that attempted 3. Schneider JW, Gurucharri LM, Gutierrez AL, Gaebler-Spira DJ.
control of spasticity may make a small but powerful difference Health-related quality of life and functional outcome measures for in the life of the patient and the caregiver. Our findings indicate children with cerebral palsy. Dev Med Child Neurol. 2001;43: that the Rehabilitation Institute of Chicago Care and Comfort Caregiver Questionnaire is a measurement scale that ade- 4. Nemer McCoy RN, Blasco PA, Russman BS, O’Malley JP.
quately captures the impact of severe spasticity on care and Validation of a care and comfort hypertonicity questionnaire. Dev comfort while helping to set realistic goals for medical man- 5. Narayanan UG, Fehlings D, Weir S, Knights S, Kiran S, Campbell The Rehabilitation Institute of Chicago Care and Comfort K. Initial development and validation of the Caregiver Priorities Caregiver Questionnaire allows a non-labor–intensive means and Child Health Index of Life with Disabilities (CPCHILD). Dev for ongoing evaluation of spasticity treatment goals. It can be administered to both pediatric and adult populations with or 6. Hwang M, Kuroda MM, Tann B, Gaebler-Spira DJ. Measuring without intrathecal baclofen pump management for hypertonia.
care and comfort in children with cerebral palsy: the care and The Questionnaire allows the reporting of caregiver and patient comfort caregiver questionnaire. PM&R. 2011;3:912-919.
contribution to performance of activities of daily living.
7. Krach LE, Nettleton A, Klempka B. Satisfaction of individuals treated Although it is not a health-related quality-of-life measure, long-term with continuous infusion of intrathecal baclofen by findings on the Rehabilitation Institute of Chicago Care and implanted programmable pump. Pediatr Rehabil. 2006;9:210-218.
Comfort Caregiver Questionnaire give an approximation of 8. Palisano RJ, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi activity limitations and caregiver burden.
B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol.
11. Parke B, Penn RD, Savoy SM, Corcos D. Functional outcome after delivery of intrathecal baclofen. Arch Phys Med Rehabil.
9. Gooch JL, Oberg WA, Grams B, Ward LA, Walker ML. Care pro- vider assessment of intrathecal baclofen in children. Dev Med 12. Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for 10. Krach LE, Kriel RL, Gilmartin RC, et al. GMFM 1 year after contin- severe spasticity of cerebral origin. J Neurosurg. 2003;98: uous intrathecal baclofen infusion. Pediatr Rehabil. 2005;8:207-213.

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