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Poster 62: The Cleveland Clinic Knowledge Program: Use in the Rehabilitation Clinic
PM&R
Vol. 2, Iss. 9S, 2010
S33
Poster 58
Poster 61
Qutenza (Capsaicin) 8% Patch for the Treatment of Postherpetic Neuralgia: Efficacy Results Across a Range of Patient Populations. Miroslav Backonja, MD (University of Wisconsin, Madison, Madison, WI); Gordon Irving, MD; Jeffrey Tobias, MD; Geertrui Vanhove, MD, PhD; Lynn R. Webster, MD.
Sonography of Affected and Unaffected Shoulders in Hemiplegic Stroke Patients: Analysis of the Relationship Between Sonographic Imaging Data and Clinical Variables. HyoungSeop Kim (National Health Insurance Ilsan Hospital, Goyang, Republic of Korea); HyungKeun Cho; Zee-A Han; SeungHo Joo; WonYoung Lee; Jinyoung Park; JungBin Shin.
Disclosures: M. Backonja, Research grants, Allergan, Astellas, Johnson & Johnson, Lilly, Merck, Pfizer, NeurogesX. Objective: To investigate efficacy across a range of patient populations, subgroup analyses with Qutenza, an 8% capsaicin patch, FDA approved for the management of postherpetic neuralgia (PHN) were conducted. Design: Integrated data from 4 randomized, double-blind, 12-week controlled studies. Setting: Multicenter. Participants: Patients with PHN for ⱖ3-6 months. Interventions: A single 60-minute treatment with Qutenza (n⫽597) or a 0.04% capsaicin control patch (n⫽530). Main Outcome Measures: The mean percentage change from baseline to weeks 2-8 in Numeric Pain Rating Scale (NPRS) score, recorded daily, was the primary endpoint. Subgroup analyses were done by gender age, PHN duration, concomitant neuropathic pain medication use and baseline NPRS score. Treatments were compared using a gender-stratified ANCOVA model with baseline pain score as the covariate. Results: The Qutenza-treated group experienced a mean percentage NPRS score reduction of 31.2% vs 22.3% with control (P⬍.0001). Qutenza was efficacious regardless of gender (males: 26.7% vs 17.2%, P⫽.0002; females: 35.3% vs 27.0%, P⫽.0023), age (patients ⱖ73: 25.7% vs 17.2%, P⫽.0005; patients ⬍73: 37.0% vs 27.9%, P⫽.0012), duration of PHN (duration ⱖ2.1 years: 29.6% vs 20.5%, P⫽.0005; duration ⬍2.1 years: 33.1% vs 24.2%, P⬍.0011) or use of concomitant neuropathic pain medication (using medication: 26.1% vs 18.1%, P⫽.0011; not using medication: 36.5% vs 26.2%, P⫽.0002). The difference in absolute pain reduction between Qutenza and control was similar for the subgroups with higher or lower baseline pain scores (1.9 vs 1.5, P⫽.0241, for a baseline pain score ⱖ5.64; 1.5 vs 1.0, P⬍.0001, for a baseline pain score ⬍5.64). Results during weeks 2-12 reflected those of weeks 2-8. Conclusions: A single 60-minute application of Qutenza can produce significant pain reduction in PHN patients for up to 12 weeks, regardless of gender, age, PHN duration, baseline pain score or use of concomitant neuropathic pain medication.
Poster 59: Cancelled Poster 60: Cancelled
Disclosures: H. Kim, None. Objective: This study explored the relationship between a number of clinically relevant variables and sonographic imaging data on the level of impairment experienced in the affected and unaffected shoulders of hemiplegic stroke patients. Design: Analysis of data obtained from hemiplegic stroke patients using ultrasonography. Setting: Inpatient and outpatient rehabilitation center at a government owned hospital. Interventions: Not applicable. Main Outcome Measures: A musculoskeletal radiologist conducted a sonographic examination on both the affected and unaffected shoulders of all patients and classified the severity of the injury on a 6-point rating scale. Results: The sonographic rating scores of hemiplegic shoulders were positively correlated with age (P⬍.01) and negatively correlated with level of muscle spasticity (P⬍.05). The sonographic rating scores of unaffected shoulders were positively correlated with duration of injury (P⬍.01). Affected shoulders received sonographic rating scores that reflected significantly more impairment than those of unaffected shoulders (P⬍.001), and pre-morbid handedness did not affect the relationship between impairment rating and shoulder injury status. Conclusions: Hemiplegic stroke has an influence not only on affected shoulders but also on unaffected sides. Proper management of spasticity, enhancement of motor recovery, and avoidance of unaffected shoulder overuse should be considered as prevention methods for shoulder problems after strokes that result in hemiplegia.
Poster 62 The Cleveland Clinic Knowledge Program: Use in the Rehabilitation Clinic. Frederick S. Frost, MD (Cleveland Clinic Foundation, Cleveland, OH); Irene Katzan, MD; Trina Koudelka, RN; Vernon W. Lin, MD; Vinoth K. Ranganathan, MS, MBA. Disclosures: F. S. Frost, Pfizer Inc, Speakers bureau. Objective: To determine the utility of the Knowledge Program patient-reported outcome (PRO) data gathering process integrated with our electronic medical record.
S34
Design: We retrospectively analyzed the pre-appointment delivery of a PRO package, completed by the patient or a surrogate, either in the waiting room (via tablet computer) or at home via a secure Internet link. Setting: Academic medical center PM&R clinic. Participants: Convenience sample of rehabilitation outpatients. Interventions: None. Main Outcome Measures: The PRO process employed conventional test theory, with a validated quality of life (QOL) instrument (EQ-5D) and depression screen (PHQ-9). Patients were separated into 2 diagnostic groups, musculoskeletal (MSK) and neurorehabilitation (NR), on the basis of ICD-9 data. Demographic and descriptive data were tabulated, along with ratings of difficulty and usefulness of the PRO process. Groups were compared with Student t test. Results: A total of 1440 patients participated over 6 months. Of 1796 PRO completions, 97% used waiting room tablet computers and 3% were done online at home before the visit. NR patients (N⫽41) needed help to complete the assessment at twice the rate of MSK patients (N⫽235). At initial visit the NR patients reported higher levels of depression (P⫽.005) and lower QOL levels (P⬍.001) than the MSK group. Over 6 months, follow-up data were available for 270 patients (232 MSK; 38 NR). Over time, QOL scores increased and depression scores decreased in both groups, with statistically significant improvement in the MSK group (EQ-5D P⬍.0001; PHQ-9 P⬍.005). NR patients rated the PRO tool as more useful than the MSK patients, but also rated it more difficult to complete. Ratings of usefulness declined after repeated administration. By the third month of the project, successful pre-visit PRO completion rates stabilized at greater than 90%. Conclusions: This simple pre-visit PRO tool is well tolerated by outpatients, while it populates our electronic medical record with discreet functional data. We aim to promote higher utilization of online home completion. Future plans to employ computer adapted testing, rather than analog outcome measures, should further reduce respondent burden and vastly enhance the precision of PRO measurement.
Poster 63 The Effect of Contact Isolation on Inpatient Rehabilitation Outcomes. Nicholas R. Jasper, MD (Virginia Commonwealth University Health Systems, Richmond, VA); David X. Cifu, MD; Jason M. Edinger, DO; Michael Edmond, MD, MPH, MPA; Jessica M. Ketchum, PhD. Disclosures: N. R. Jasper, None. Objective: To better describe and understand the relationship that contact isolation plays in the rehabilitation process of a patient and the effects it has on a patient’s functional
PRESENTATIONS
outcome as measured by Functional Independence Measure (FIM) efficiency and length of stay (LOS). Design: This is a retrospective study utilizing a case-control design (isolation versus no isolation). ⌾2, t-tests, and non-parametric tests were used to compare the outcome measures between the groups (␣ ⫽ 0.05). Setting: Academic inpatient rehabilitation unit (41 beds). Participants: Consecutive admissions to the rehabilitation unit from January 2007 through June 2009 included a total of 1151 subjects, of which 111 were on contact isolation. Main Outcome Measures: Primary outcome measure was FIM efficiency. The secondary outcome measures included LOS, motor FIM, cognitive FIM, total FIM, and disposition. Results: The subjects were primarily men (55%), with a mean age of 55 years (SD 17.2). Isolated patients were significantly younger (51.7 vs 55.4 years; P⫽.029), had longer LOS (20 vs 14 days; P⬍.001), lower motor FIM at admission (29.5 vs 34; P⬍.001) and discharge (51.8 vs 57.4; P⬍.001), lower total FIM at admission (52 vs 57.8; P⬍.001) and discharge (78.0 vs. 84.6; P⬍.001), and lower motor FIM efficiency (1.28 vs 1.92; P⬍.001) and total FIM efficiency (1.47 vs 2.13; P⬍.001) compared with unisolated patients. There were no significant differences with respect to gender (56% vs 55%; P⫽.78), home disposition (75% vs 79%; P⫽.28), or any of the cognitive FIM measures (ps⬎.11). Conclusions: Patients in contact isolation have a lower total FIM efficiency, a lower motor FIM efficiency, and a longer LOS compared with their counterparts not in contact isolation.
Poster 64 The Influence of Obesity on Functional Independence and Mobility in Patients With Cardiac Disease Exacerbation During and After Inpatient Rehabilitation. Heather K. Vincent, PhD (University of Florida, Gainesville, FL); Margaret A. DiVita, MS; Carl V. Granger, MD; Samuel J. Markello, PhD; Kevin R. Vincent, MD, PhD. Disclosures: H. K. Vincent, None. Objective: To compare obesity effects on the functional and clinical outcomes in patients with cardiac disease exacerbations after inpatient rehabilitation and at 6 months of follow-up. Design: Prospective, comparative study using a subset of data from the Uniform Data System for Medical Rehabilitation’s UDSMR database. Setting: Multicenter independent inpatient rehabilitation facilities (IRF). Participants: Patients who were receiving care in an IRF for a cardiac disease exacerbation (N⫽3337); patients were stratified into non-obese (n⫽2898; 75.7 years) and obese groups (n⫽439; 70.2 years).
Vol. 2, Iss. 9S, 2010
S33
Poster 58
Poster 61
Qutenza (Capsaicin) 8% Patch for the Treatment of Postherpetic Neuralgia: Efficacy Results Across a Range of Patient Populations. Miroslav Backonja, MD (University of Wisconsin, Madison, Madison, WI); Gordon Irving, MD; Jeffrey Tobias, MD; Geertrui Vanhove, MD, PhD; Lynn R. Webster, MD.
Sonography of Affected and Unaffected Shoulders in Hemiplegic Stroke Patients: Analysis of the Relationship Between Sonographic Imaging Data and Clinical Variables. HyoungSeop Kim (National Health Insurance Ilsan Hospital, Goyang, Republic of Korea); HyungKeun Cho; Zee-A Han; SeungHo Joo; WonYoung Lee; Jinyoung Park; JungBin Shin.
Disclosures: M. Backonja, Research grants, Allergan, Astellas, Johnson & Johnson, Lilly, Merck, Pfizer, NeurogesX. Objective: To investigate efficacy across a range of patient populations, subgroup analyses with Qutenza, an 8% capsaicin patch, FDA approved for the management of postherpetic neuralgia (PHN) were conducted. Design: Integrated data from 4 randomized, double-blind, 12-week controlled studies. Setting: Multicenter. Participants: Patients with PHN for ⱖ3-6 months. Interventions: A single 60-minute treatment with Qutenza (n⫽597) or a 0.04% capsaicin control patch (n⫽530). Main Outcome Measures: The mean percentage change from baseline to weeks 2-8 in Numeric Pain Rating Scale (NPRS) score, recorded daily, was the primary endpoint. Subgroup analyses were done by gender age, PHN duration, concomitant neuropathic pain medication use and baseline NPRS score. Treatments were compared using a gender-stratified ANCOVA model with baseline pain score as the covariate. Results: The Qutenza-treated group experienced a mean percentage NPRS score reduction of 31.2% vs 22.3% with control (P⬍.0001). Qutenza was efficacious regardless of gender (males: 26.7% vs 17.2%, P⫽.0002; females: 35.3% vs 27.0%, P⫽.0023), age (patients ⱖ73: 25.7% vs 17.2%, P⫽.0005; patients ⬍73: 37.0% vs 27.9%, P⫽.0012), duration of PHN (duration ⱖ2.1 years: 29.6% vs 20.5%, P⫽.0005; duration ⬍2.1 years: 33.1% vs 24.2%, P⬍.0011) or use of concomitant neuropathic pain medication (using medication: 26.1% vs 18.1%, P⫽.0011; not using medication: 36.5% vs 26.2%, P⫽.0002). The difference in absolute pain reduction between Qutenza and control was similar for the subgroups with higher or lower baseline pain scores (1.9 vs 1.5, P⫽.0241, for a baseline pain score ⱖ5.64; 1.5 vs 1.0, P⬍.0001, for a baseline pain score ⬍5.64). Results during weeks 2-12 reflected those of weeks 2-8. Conclusions: A single 60-minute application of Qutenza can produce significant pain reduction in PHN patients for up to 12 weeks, regardless of gender, age, PHN duration, baseline pain score or use of concomitant neuropathic pain medication.
Poster 59: Cancelled Poster 60: Cancelled
Disclosures: H. Kim, None. Objective: This study explored the relationship between a number of clinically relevant variables and sonographic imaging data on the level of impairment experienced in the affected and unaffected shoulders of hemiplegic stroke patients. Design: Analysis of data obtained from hemiplegic stroke patients using ultrasonography. Setting: Inpatient and outpatient rehabilitation center at a government owned hospital. Interventions: Not applicable. Main Outcome Measures: A musculoskeletal radiologist conducted a sonographic examination on both the affected and unaffected shoulders of all patients and classified the severity of the injury on a 6-point rating scale. Results: The sonographic rating scores of hemiplegic shoulders were positively correlated with age (P⬍.01) and negatively correlated with level of muscle spasticity (P⬍.05). The sonographic rating scores of unaffected shoulders were positively correlated with duration of injury (P⬍.01). Affected shoulders received sonographic rating scores that reflected significantly more impairment than those of unaffected shoulders (P⬍.001), and pre-morbid handedness did not affect the relationship between impairment rating and shoulder injury status. Conclusions: Hemiplegic stroke has an influence not only on affected shoulders but also on unaffected sides. Proper management of spasticity, enhancement of motor recovery, and avoidance of unaffected shoulder overuse should be considered as prevention methods for shoulder problems after strokes that result in hemiplegia.
Poster 62 The Cleveland Clinic Knowledge Program: Use in the Rehabilitation Clinic. Frederick S. Frost, MD (Cleveland Clinic Foundation, Cleveland, OH); Irene Katzan, MD; Trina Koudelka, RN; Vernon W. Lin, MD; Vinoth K. Ranganathan, MS, MBA. Disclosures: F. S. Frost, Pfizer Inc, Speakers bureau. Objective: To determine the utility of the Knowledge Program patient-reported outcome (PRO) data gathering process integrated with our electronic medical record.
S34
Design: We retrospectively analyzed the pre-appointment delivery of a PRO package, completed by the patient or a surrogate, either in the waiting room (via tablet computer) or at home via a secure Internet link. Setting: Academic medical center PM&R clinic. Participants: Convenience sample of rehabilitation outpatients. Interventions: None. Main Outcome Measures: The PRO process employed conventional test theory, with a validated quality of life (QOL) instrument (EQ-5D) and depression screen (PHQ-9). Patients were separated into 2 diagnostic groups, musculoskeletal (MSK) and neurorehabilitation (NR), on the basis of ICD-9 data. Demographic and descriptive data were tabulated, along with ratings of difficulty and usefulness of the PRO process. Groups were compared with Student t test. Results: A total of 1440 patients participated over 6 months. Of 1796 PRO completions, 97% used waiting room tablet computers and 3% were done online at home before the visit. NR patients (N⫽41) needed help to complete the assessment at twice the rate of MSK patients (N⫽235). At initial visit the NR patients reported higher levels of depression (P⫽.005) and lower QOL levels (P⬍.001) than the MSK group. Over 6 months, follow-up data were available for 270 patients (232 MSK; 38 NR). Over time, QOL scores increased and depression scores decreased in both groups, with statistically significant improvement in the MSK group (EQ-5D P⬍.0001; PHQ-9 P⬍.005). NR patients rated the PRO tool as more useful than the MSK patients, but also rated it more difficult to complete. Ratings of usefulness declined after repeated administration. By the third month of the project, successful pre-visit PRO completion rates stabilized at greater than 90%. Conclusions: This simple pre-visit PRO tool is well tolerated by outpatients, while it populates our electronic medical record with discreet functional data. We aim to promote higher utilization of online home completion. Future plans to employ computer adapted testing, rather than analog outcome measures, should further reduce respondent burden and vastly enhance the precision of PRO measurement.
Poster 63 The Effect of Contact Isolation on Inpatient Rehabilitation Outcomes. Nicholas R. Jasper, MD (Virginia Commonwealth University Health Systems, Richmond, VA); David X. Cifu, MD; Jason M. Edinger, DO; Michael Edmond, MD, MPH, MPA; Jessica M. Ketchum, PhD. Disclosures: N. R. Jasper, None. Objective: To better describe and understand the relationship that contact isolation plays in the rehabilitation process of a patient and the effects it has on a patient’s functional
PRESENTATIONS
outcome as measured by Functional Independence Measure (FIM) efficiency and length of stay (LOS). Design: This is a retrospective study utilizing a case-control design (isolation versus no isolation). ⌾2, t-tests, and non-parametric tests were used to compare the outcome measures between the groups (␣ ⫽ 0.05). Setting: Academic inpatient rehabilitation unit (41 beds). Participants: Consecutive admissions to the rehabilitation unit from January 2007 through June 2009 included a total of 1151 subjects, of which 111 were on contact isolation. Main Outcome Measures: Primary outcome measure was FIM efficiency. The secondary outcome measures included LOS, motor FIM, cognitive FIM, total FIM, and disposition. Results: The subjects were primarily men (55%), with a mean age of 55 years (SD 17.2). Isolated patients were significantly younger (51.7 vs 55.4 years; P⫽.029), had longer LOS (20 vs 14 days; P⬍.001), lower motor FIM at admission (29.5 vs 34; P⬍.001) and discharge (51.8 vs 57.4; P⬍.001), lower total FIM at admission (52 vs 57.8; P⬍.001) and discharge (78.0 vs. 84.6; P⬍.001), and lower motor FIM efficiency (1.28 vs 1.92; P⬍.001) and total FIM efficiency (1.47 vs 2.13; P⬍.001) compared with unisolated patients. There were no significant differences with respect to gender (56% vs 55%; P⫽.78), home disposition (75% vs 79%; P⫽.28), or any of the cognitive FIM measures (ps⬎.11). Conclusions: Patients in contact isolation have a lower total FIM efficiency, a lower motor FIM efficiency, and a longer LOS compared with their counterparts not in contact isolation.
Poster 64 The Influence of Obesity on Functional Independence and Mobility in Patients With Cardiac Disease Exacerbation During and After Inpatient Rehabilitation. Heather K. Vincent, PhD (University of Florida, Gainesville, FL); Margaret A. DiVita, MS; Carl V. Granger, MD; Samuel J. Markello, PhD; Kevin R. Vincent, MD, PhD. Disclosures: H. K. Vincent, None. Objective: To compare obesity effects on the functional and clinical outcomes in patients with cardiac disease exacerbations after inpatient rehabilitation and at 6 months of follow-up. Design: Prospective, comparative study using a subset of data from the Uniform Data System for Medical Rehabilitation’s UDSMR database. Setting: Multicenter independent inpatient rehabilitation facilities (IRF). Participants: Patients who were receiving care in an IRF for a cardiac disease exacerbation (N⫽3337); patients were stratified into non-obese (n⫽2898; 75.7 years) and obese groups (n⫽439; 70.2 years).