Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial.

AIM: To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids. METHODS: In this double blind, randomized, active comparator trial, adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone (Amitza(®)), orally twice a day or Senna (generic) two capsules administered daily for six days. Subjects were assessed using the patient assessment of constipation (PAC)-symptoms (PAC-SYM) and the PAC-quality of life (PAC-QOL) scales measured at baseline and Day 7; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency, specific bowel symptom score (Nausea, cramping, straining, completeness, abdominal pain, time per lavatory attempt, assistance needed), adverse events and rescue medications required. Function was measured using the functional independence measure (FIM) at admission and discharge; length of stay (LOS) and missed treatments due to gastrointestinal symptoms were also assessed. RESULTS: 64 adults were enrolled; 56 participants (28 in each group) had baseline and follow up measures and were included in the intention to treat (ITT) analyses. 43 participants completed the study, 21 in the active lubiprostone and 22 in the active Senna group. The mean age of the participants was 71.5 years (SD = 11.4 years, range: 28-96 years). In the ITT analyses, participants showed significant improvement in bowel symptoms as measured by the PAC-SYM (mean ± SD, -0.28 ± 0.60, range: -1-2.33) and PAC-QOL (mean ± SD, 0.33 ± 0.81, range: -1.5-2.0) over time, but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM (-0.20 ± 0.60 vs -0.36 ± 0.61, P = 0.61 respectively) or the PAC-QOL (0.29 ± 0.76 vs 0.37 ± 0.87, P = 0.61 respectively). The mean change in each bowel symptom also did not significantly differ between treatment groups on ITT analyses, except for completeness of bowel movement, with the Senna group showing greater negative mean change in bowel movement completeness (-0.56 ± 1.01 vs -2.00 ± 1.41, P = 0.03) and for reduction of abdominal pain, favoring Senna (-0.14 ± 0.73 vs -0.73 ± 1.08, P = 0.04). Fifteen (75%) participants in the lubiprostone and in the Senna group requested rescue treatments. Participants made significant functional improvement from admission to discharge over a median LOS of 12 d, with a mean FIM change of 29.13 ± 13.58 and no significant between group differences (27.0 ± 9.2 vs 31.5 ± 16.6, P = 0.27). CONCLUSION: Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation, with no significant between-group differences.

Comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after hip fracture repair.

OBJECTIVE: To examine differences in rehabilitation outcomes across 3 post-acute care (PAC) rehabilitation settings for patients after hip fracture repair. DESIGN: Prospective, observational cohort study. SETTING: Six skilled nursing facilities (SNFs), 4 inpatient rehabilitation facilities (IRFs), and 8 home health agencies (HHAs) in 10 states. PARTICIPANTS: Patients (N=181) receiving PAC rehabilitation following hip fracture with internal fixation (n=116) or total hip replacement (n=64), or no surgical intervention (n=1). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Self-care and mobility status at PAC discharge measured by the Inpatient Rehabilitation Facility Patient Assessment Instrument. RESULTS: IRF and HHA patients had lower self-care function at discharge relative to SNF patients controlling for patient characteristics, severity, comorbidities, and services. Adding length of stay (LOS) resulted in nonsignificant differences between IRFs and SNFs. In contrast, there was no setting-specific advantage in discharge mobility for patients with or without the addition of LOS. The average LOS of HHA patients was 2 weeks longer than that of SNF patients, whose average LOS was 9 days longer than that of IRF patients (average, 15d). IRF and SNF patients received about the same total minutes of therapy over their PAC stays (∼2100min on average), whereas HHA patients received only approximately 25% as many minutes. CONCLUSIONS: Setting-specific effects varied depending on whether self-care or mobility was the outcome of focus. It remains unclear to what extent rehabilitation intensity or natural recovery effects changes in functional status for patients with hip fracture. This study points to important directions for PAC setting comparative effectiveness studies in the future, including uniform measurement, limited consensus on factors affecting recovery, accounting for selection bias, and using end-point data collection that is at the same follow-up time periods for all settings.

A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery.

OBJECTIVE: To examine differences in outcomes of patients after lower-extremity joint replacement across 3 post-acute care (PAC) rehabilitation settings. DESIGN: Prospective observational cohort study. SETTING: Skilled nursing facilities (SNFs; n=5), inpatient rehabilitation facilities (IRFs; n=4), and home health agencies (HHAs; n=6) from 11 states. PARTICIPANTS: Patients with total knee (n=146) or total hip replacement (n=84) not related to traumatic injury. INTERVENTIONS: None. MAIN OUTCOME MEASURE: Self-care and mobility status at PAC discharge measured by using the Inpatient Rehabilitation Facility Patient Assessment Instrument. RESULTS: Based on our study sample, HHA patients were significantly less dependent than SNF and IRF patients at admission and discharge in self-care and mobility. IRF and SNF patients had similar mobility levels at admission and discharge and similar self-care at admission, but SNF patients were more independent in self-care at discharge. After controlling for differences in patient severity and length of stay in multivariate analyses, HHA setting was not a significant predictor of self-care discharge status, suggesting that HHA patients were less medically complex than SNF and IRF patients. IRF patients were more dependent in discharge self-care even after controlling for severity. For the full discharge mobility regression model, urinary incontinence was the only significant covariate. CONCLUSIONS: For the patients in our U.S.-based study, direct discharge to home with home care was the optimal strategy for patients after total joint replacement surgery who were healthy and had social support. For sicker patients, availability of 24-hour medical and nursing care may be needed, but intensive therapy services did not seem to provide additional improvement in functional recovery in these patients.

Increasing physical activity in patients with arthritis: a tailored health promotion program.

OBJECTIVE: Despite recent studies showing the benefit of physical activity for people with arthritis, the vast majority of persons with arthritis are not sufficiently physically active. The purpose of this report is to describe a tailored health promotion intervention aimed at increasing physical activity among persons with arthritis. The intervention is designed to be useful for health systems and insurers interested in a chronic disease management program that could be disseminated to large populations of arthritis patients. METHODS: The intervention is carried out by a clinician who is designated as the client's physical activity advocate. The approach emphasizes motivational interviewing, individualized goal setting, tailored strategies for increasing physical activity and for monitoring progress, and a plan of 2 years of follow-up. The intervention includes a standardized assessment of barriers to and strengths supporting increased lifestyle physical activity. A randomized, controlled trial is underway to evaluate the efficacy and cost-effectiveness of this intervention. CONCLUSION: This intervention is unique in that it implements a program tailored to the individual that focuses on lifestyle physical activity and long-term monitoring. The approach recognizes that persons with arthritis present with varying levels of motivation for change in physical activity and that behavior change can take a long time to become habitual.