Multicenter precision of cortical and trabecular bone quality measures assessed by high‐resolution peripheral quantitative computed tomography

High‐resolution peripheral quantitative computed tomography (HR‐pQCT) has recently been introduced as a clinical research tool for in vivo assessment of bone quality. The utility of this technology to address important skeletal health questions requires translation to standardized multicenter data pools. Our goal was to evaluate the feasibility of pooling data in multicenter HR‐pQCT imaging trials. Reproducibility imaging experiments were performed using structure and composition‐realistic phantoms constructed from cadaveric radii. Single‐center precision was determined by repeat scanning over short‐term (<72 hours), intermediate‐term (3–5 months), and long‐term intervals (28 months). Multicenter precision was determined by imaging the phantoms at nine different HR‐pQCT centers. Least significant change (LSC) and root mean squared coefficient of variation (RMSCV) for each interval and across centers was calculated for bone density, geometry, microstructure, and biomechanical parameters. Single‐center short‐term RMSCVs were <1% for all parameters except cortical thickness (Ct.Th) (1.1%), spatial variability in cortical thickness (Ct.Th.SD) (2.6%), standard deviation of trabecular separation (Tb.Sp.SD) (1.8%), and porosity measures (6% to 8%). Intermediate‐term RMSCVs were generally not statistically different from short‐term values. Long‐term variability was significantly greater for all density measures (0.7% to 2.0%; p < 0.05 versus short‐term) and several structure measures: cortical thickness (Ct.Th) (3.4%; p < 0.01 versus short‐term), cortical porosity (Ct.Po) (15.4%; p < 0.01 versus short‐term), and trabecular thickness (Tb.Th) (2.2%; p < 0.01 versus short‐term). Multicenter RMSCVs were also significantly higher than short‐term values: 2% to 4% for density and micro–finite element analysis (µFE) measures (p < 0.0001), 2.6% to 5.3% for morphometric measures (p < 0.001), whereas Ct.Po was 16.2% (p < 0.001). In the absence of subject motion, multicenter precision errors for HR‐pQCT parameters were generally less than 5%. Phantom‐based multicenter precision was comparable to previously reported in in vivo single‐center precision errors, although this was approximately two to five times worse than ex vivo short‐term precision. The data generated from this study will contribute to the future design and validation of standardized procedures that are broadly translatable to multicenter study designs. © 2013 American Society for Bone and Mineral Research.     

Endoscopic access to fascia lata for use in static facial reanimation—a cadaveric and clinical study

Background

Current methods of autogenous fascia lata harvest for the static surgical treatment of longstanding facial paralysis often result in a high level of donor site morbidity and unsightly visual scarring on the patient’s lateral thigh due to the open technique traditionally used. With endoscopic access already being widely used in other areas of plastic and reconstructive surgery, it was hypothesised that it would be feasible to retrieve sufficient amounts of fascia lata endoscopically to achieve satisfactory static facial reanimation.

Methods

In the first instance, we used an 85-year-old female cadaver selected from the regular stock at the University of Glasgow to establish if retrieval of fascia lata endoscopically was feasible. Through two small incisions on the lateral aspect of the thigh (proximally and distally), we successfully retrieved a strip of fascia lata measuring 9?×?2.5 cm. Due to the ease of access, one of the authors then performed endoscopic retrieval of the fascia lata for five patients requiring static facial reanimation.

Results

It was shown that in all cases it was feasible to retrieve sufficient amounts of fascia lata to perform static facial reanimation with a similar operating time compared to the open technique which is currently used. In addition, there were no complications related to donor site morbidity.

Conclusions

We have shown that endoscopic access to the fascia lata for use in static facial reanimation is perfectly feasible, with no complications, minimal scarring and no significant increase in operating time compared to the traditional open technique currently used. Level of Evidence: Level V, therapeutic study.     

C.E.R.A. maintains stable hemoglobin in Latin American patients on dialysis

Background

C.E.R.A. is a continuous erythropoietin receptor activator with characteristics that permit a once-monthly schedule of administration for the maintenance treatment for chronic kidney disease (CKD) patients. The main objective of this study was to assess the maintenance of Hb concentration with once-monthly intravenous and/or subcutaneous C.E.R.A. therapy in Latin American dialysis patients with chronic renal anemia previously treated with epoetin alfa s.c or i.v 1–3 times per week.

Methods

This was a single-arm, open-label, multicenter, 32-week study of anemic patients with CKD previously treated with epoetin alfa sc or iv 1–3 times per week. After a 4-week screening period, during which mean Hb levels were maintained between 10.5 and 12.5 g/dL on their previous erythropoiesis stimulating agent, eligible patients entered a 16-week C.E.R.A. dose titration period followed by a 4-week efficacy evaluation period (EEP) and a 28-week safety follow-up. The starting dose of C.E.R.A. was based on the previous dose of epoetin alfa. Doses of C.E.R.A. were then adjusted to maintain Hb levels within ±1.0 g/dL of the reference concentration and between 10.5 and 12.5 g/dL. The Hb reference concentration was defined as the mean of all Hb levels during screening. The primary end point was the proportion of patients maintaining a mean Hb concentration (g/dL) within ±1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the EEP.

Results

A total of 163 patients from 27 centers in Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, and Venezuela entered the treatment period and 102 completed the prescribed course of C.E.R.A. Forty-five patients (43.7 %) maintained a mean Hb concentration within ±1 g/dL of their reference Hb value and between 10.5 and 12.5 g/dL during the EEP. The median monthly dose remained constant at 120 μg during the titration period and during the EEP. On the average, there were only 2.3 dose changes per patient in 28 weeks of treatment, covering 7 C.E.R.A. scheduled administrations. 53 % of all dose changes were dose decreases, 47 % increases. A total of 10 AEs and 4 SAEs were considered to be related to the study treatment.

Conclusions

Once-monthly C.E.R.A. treatment effectively maintains stable Hb concentrations in patients with chronic renal anemia undergoing dialysis with a good safety and tolerability profile.     

Effect of Diabetes on Outcomes in Patients Undergoing Emergent Cholecystectomy for Acute Cholecystitis

Background

The purpose of the present study was to determine the prevalence of diabetes and its effect on surgical outcomes in patients undergoing emergent, in-patient cholecystectomy for acute cholecystitis. Some 8.3 % of the U.S. population has diabetes and this number is projected to rise to 21–33 % by 2050. Diabetes is considered to be associated with a higher incidence of acute cholecystitis; however, its impact on outcomes is unknown.

Methods

The American College of Surgeons National Surgical Quality Improvement Program database was queried to identify all patients with acute cholecystitis who underwent emergent in-patient cholecystectomy from 2004 to 2010. The study population was divided into two groups: diabetics and non-diabetics. Diabetics were further subdivided into those taking oral medication and those on insulin. Demographics, co-morbidities, and wound classification were compared with univariate analysis, and 30-day outcomes were compared with univariate and multivariate analyses.

Results

A total of 5,460 patients met the inclusion criteria. Of these 770 (14.10 %) had a diagnosis of diabetes. Mortality was higher for diabetics than for non-diabetics [4.4 vs 1.4 %, adjusted odds ratio (AOR) (95 % CI): 1.79 (1.09, 2.94), adj-p = 0.022]. Preoperative perforation rates were 25.1 and 13.0 %, respectively [AOR (95 % CI): 1.34 (1.09, 1.65), adj-p = 0.005]. The adjusted risk of cardiovascular events and renal failure was significantly higher for diabetics. Insulin treatment, but not oral medication, was associated with a significant increase in mortality, preoperative perforation, superficial surgical site infection, septic shock, cardiovascular incidents, and renal insufficiency.

Conclusions

In patients undergoing cholecystectomy for acute cholecystitis, diabetes increases the risk of mortality, cardiovascular events, and renal failure. Insulin-treated diabetics have more co-morbidities and poorer outcomes.     

Applications of complementary therapies during rehabilitation for individuals with traumatic Spinal Cord Injury: Findings from the SCIRehab Project

Objective: Evaluate the use of complementary therapies during rehabilitation for patients with traumatic spinal cord injury (SCI).

Design: Secondary analyses were conducted to identify the use and associated outcomes of complementary therapies provided by occupational therapists (OTs) and physical therapists (PTs) during rehabilitation from a public dataset.

Setting: Inpatient rehabilitation.

Participants: A public dataset composed of 1376 patients with SCI that were enrolled in a five-year, multi-center investigation, the SCIRehab Project. Secondary analyses focused on a subset of 93 patients (47 who received complementary therapy during treatment and 46 case-matched controls who received no complementary therapy).

Interventions: OTs and PTs recorded use of complementary therapies during sessions, including yoga, Pilates, tai chi, aromatherapy, relaxation techniques, imagery and other.

Outcome Measures: Pain interference, pain severity, mobility, and social integration.

Results: Three percent of participants received any complementary therapies. Patients who received complementary therapies showed greater reductions in pain severity from 6 months to 12 months relative to matched controls. Furthermore, the amount of time that patients received complementary therapies during physical therapy sessions was associated with reduced pain interference at 6 months and with reduced pain severity at the 6-month and 12-month follow-ups. Complementary therapy use was not associated with mobility or social integration.

Conclusion: The current study provides preliminary evidence documenting the limited use of complementary therapies in rehabilitation settings and highlights the opportunity for further research, particularly regarding pain-related outcomes.