Prevention of Morbidity in Sickle Cell Disease (POMS2a)-overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children

DESIGN: This randomised crossover trial compared nocturnal auto-adjusting continuous positive airway pressure (APAP) and nocturnal oxygen therapy (NOT) in adults and children with sickle cell anaemia, with patient acceptability as the primary outcome. Secondary outcomes included pulmonary physiology (adults), safety, and daily pain during interventions and washout documented using tablet technology. METHODS: Inclusion criteria were age > 8 years and the ability to use an iPad to collect daily pain data. Trial participation was 4 weeks; week 1 involved baseline data collection and week 3 was a washout between interventions, which were administered for 7 days each during weeks 2 and 4 in a randomised order. Qualitative interviews were transcribed verbatim and analysed for content using a funnelling technique, starting generally and then gaining more detailed information on the experience of both interventions. Safety data included routine haematology and median pain days between each period. Missing pain day values were replaced using multiple imputation. RESULTS: Ten adults (three female, median age 30.2 years, range 18-51.5 years) and eleven children (five female, median age 12 years, range 8.7-16.9 years) enrolled. Nine adults and seven children completed interviews. Qualitative data revealed that the APAP machine was smaller, easier to handle, and less noisy. Of 16 participants, 10 preferred APAP (62.5%, 95% confidence interval (CI) 38.6-81.5%). Haemoglobin decreased from baseline on APAP and NOT (mean difference -3.2 g/L (95% CI -6.0 to -0.2 g/L) and -2.5 g/L (95% CI -4.6 to 0.3 g/L), respectively), but there was no significant difference between interventions (NOT versus APAP, 1.1 (-1.2 to 3.6)). Pulmonary function changed little. Compared with baseline, there were significant decreases in the median number of pain days (1.58 for APAP and 1.71 for NOT) but no significant difference comparing washout with baseline. After adjustment for carry-over and period effects, there was a non-significant median difference of 0.143 (95% CI -0.116 to 0.401) days additional pain with APAP compared with NOT. CONCLUSION: In view of the point estimate of patient preference for APAP, and no difference in haematology or pulmonary function or evidence that pain was worse during or in washout after APAP, it was decided to proceed with a Phase II trial of 6 months APAP versus standard care with further safety monitoring for bone marrow suppression and pain. TRIAL REGISTRATION: ISRCTN46078697 . Registered on 18 July 2014

Prevention of Morbidity in Sickle Cell Disease (POMS2a)-overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children.

DESIGN: This randomised crossover trial compared nocturnal auto-adjusting continuous positive airway pressure (APAP) and nocturnal oxygen therapy (NOT) in adults and children with sickle cell anaemia, with patient acceptability as the primary outcome. Secondary outcomes included pulmonary physiology (adults), safety, and daily pain during interventions and washout documented using tablet technology. METHODS: Inclusion criteria were age > 8 years and the ability to use an iPad to collect daily pain data. Trial participation was 4 weeks; week 1 involved baseline data collection and week 3 was a washout between interventions, which were administered for 7 days each during weeks 2 and 4 in a randomised order. Qualitative interviews were transcribed verbatim and analysed for content using a funnelling technique, starting generally and then gaining more detailed information on the experience of both interventions. Safety data included routine haematology and median pain days between each period. Missing pain day values were replaced using multiple imputation. RESULTS: Ten adults (three female, median age 30.2 years, range 18-51.5 years) and eleven children (five female, median age 12 years, range 8.7-16.9 years) enrolled. Nine adults and seven children completed interviews. Qualitative data revealed that the APAP machine was smaller, easier to handle, and less noisy. Of 16 participants, 10 preferred APAP (62.5%, 95% confidence interval (CI) 38.6-81.5%). Haemoglobin decreased from baseline on APAP and NOT (mean difference -3.2 g/L (95% CI -6.0 to -0.2 g/L) and -2.5 g/L (95% CI -4.6 to 0.3 g/L), respectively), but there was no significant difference between interventions (NOT versus APAP, 1.1 (-1.2 to 3.6)). Pulmonary function changed little. Compared with baseline, there were significant decreases in the median number of pain days (1.58 for APAP and 1.71 for NOT) but no significant difference comparing washout with baseline. After adjustment for carry-over and period effects, there was a non-significant median difference of 0.143 (95% CI -0.116 to 0.401) days additional pain with APAP compared with NOT. CONCLUSION: In view of the point estimate of patient preference for APAP, and no difference in haematology or pulmonary function or evidence that pain was worse during or in washout after APAP, it was decided to proceed with a Phase II trial of 6 months APAP versus standard care with further safety monitoring for bone marrow suppression and pain. TRIAL REGISTRATION: ISRCTN46078697 . Registered on 18 July 2014

Treatment of Closed Femoral Shaft Fractures in Children Aged 6 to 10

BACKGROUND: Management of pediatric femoral shaft fractures remains controversial, particularly in children between the ages of 6 and 10. In the current push toward cost containment, hospital type, and surgeon subspecialization have emerged as important factors influencing this treatment decision. Thus, in the present study, we use a nationwide pediatric inpatient database to compare the: (a) incidence; (b) demographic characteristics; (c) hospital costs; (d) length of stay; and (e) treatment method of pediatric closed femoral shaft fractures admitted to general versus children\u27s hospitals. METHODS: The Kids\u27 Inpatient Database (KID) was queried for all patients aged 6 to 10 who sustained a closed femoral shaft fracture in 2009 or 2012, and patient records were stratified into children\u27s hospitals and general hospitals. Primary outcome measures included method of treatment, total hospital costs, and length of stay. Student/Welch t testing and χ analysis were utilized to compare continuous and categorical outcomes, respectively, between hospital types. RESULTS: The total incidence of closed femoral shaft fractures decreased between 2009 and 2012 (1919 to 1581 patients; P=0.020), as did the proportion of patients treated in children\u27s hospitals (58.6% to 32.3%; P CONCLUSIONS: The present study demonstrates a decrease in the incidence of closed femoral shaft fractures in 6- to 10-year old patients from 2009 to 2012, as well as decreased definitive management in children\u27s hospitals and increased selection of operative treatment. In addition, treatment in a nonchildren\u27s hospital was associated with decreased total inpatient costs and decreased treatment with closed reduction with internal fixation in favor of open reduction with internal fixation. Future studies should seek to identify the specific surgical procedures performed and match patients more closely based specific fracture pattern. LEVEL OF EVIDENCE: Prognostic level II

An Analysis of Centers for Medicare & Medicaid Service Payment in Maryland: Can a Global Budget Revenue Model Save Money in Lower Extremity Arthroplasty?

BACKGROUND: Maryland is the only state utilizing the Global Budget Revenue (GBR) model to reduce costs. The purpose of this study is to evaluate whether the GBR payment model effectively reduced the following: (1) costs of inpatient hospital stays; (2) post-acute care costs; (3) lengths of stay (LOS); (4) readmission rates; and (5) discharge disposition in patients who underwent primary total hip and knee arthroplasty (THA and TKA). METHODS: We evaluated the Maryland Centers for Medicare & Medicaid Service database for THAs and TKAs performed at 6 hospitals 1 year prior to (2012) and after the initiation of GBR (2015). We compared differences in costs for each inpatient care episode, post-acute care periods (total costs, acute rehabilitation, short-term nursing facility, home health, durable medical equipment), readmissions, LOS, and discharge disposition. RESULTS: Hospitals had a significant reduction in mean inpatient care costs for THA and TKA (P \u3c .0001). There was a significant reduction in total post-acute care costs following THA (P \u3c .001). Home healthcare had a significant increase in cost following THA and TKA (P \u3c .0001). There was a significant reduction in durable medical equipment costs for THA (P \u3c .0001). There was a significant decrease in LOS for THA and TKA (P \u3c .0001). There was a significant increase in patients discharged home (THA, P = .0262; TKA, P = .0058). CONCLUSION: The Maryland healthcare model may be associated with a reduction in inpatient and post-acute care costs. Furthermore, implementation of GBR may result in reductions in LOS and readmission rates