Citations

Objectives: Early results following arthroscopic superior capsular reconstruction(SCR) in patients with massive, irreparable rotator cuff tears are promising. However, no studies have compared patient reported outcomes between SCR or reverse total shoulder(rTSA) and rotator cuff debridement for these patients. Therefore, the purpose of this study was to compare 1-year outcomes between patients with massive irreparable rotator cuff tears who underwent a SCR, rTSA, or rotator cuff debridement with a concurrent biceps tenotomy or tenodesis. Methods: Patients(n=63) who underwent either SCR(n=21), rTSA(21), or cuff debridement(n=21) and biceps tenotomy or tenodesis for a massive, irreparable rotator cuff tear treated with a minimum 1-year follow up were retrospectively reviewed. Age, sex, BMI, smoking status, Charlson Index, Hamada classification, and ASES scores were recorded and compared using a multivariate ANOVA were used to compare between surgical approaches. A Chi Square analyses were used to compare sex distribution and the Charlson Deyo Index between groups (α=0.05). Results: Overall, patients across the 3 groups were not statistically different in age or follow up ASES score at minimum 14 month follow up ( P> 0.05). There was a significant interaction effect between surgery group and sex (P=0.02) on ASES score but not age ( P=0.08). Univariate F tests revealed that male patients who received an SCR displayed a 10-14% better outcome at follow up compared to other groups (Table 1) which exceeds the reported ASES score MCID. Conclusion: Our results show comparable results across surgical options for massive irreparable cuff tears with good patient reported outcomes. Male patients displayed clinically important greater ASES scores at 1 year follow up. Future studies should evaluate these preliminary results to assess if these preliminary results hold up at longer follow up times.

A microfluidic device was designed to efficiently fragment chromatin for downstream epigenetic assays.

Abstract Background Cystinuria is an autosomal recessive disorder resulting in poor proximal tubule reabsorption of cystine in the nephron, increasing the risk of cystine stone formation. A fast, inexpensive assay to screen for urinary cystine is needed because cystine stones are difficult to noninvasively differentiate from more common calcium-containing ones. Tandem mass spectrometry (MS/MS) is sensitive and specific but is labor-intensive and costly. Alternatively, a colorimetric assay is fast and cost-effective; however, creatinine interference is an issue. Methods A published cyanide-nitroprusside colorimetric assay was modified for a high-throughput microplate format. Creatinine interference was reduced using 0.1 mol/L PBS and a standard reaction time of 60 s and was further corrected using a formula derived from the slope of multiple creatinine standard curves. Results The limit of blank was determined to be 2.6 mg/L, the limit of detection 11.9 mg/L, and the limit of quantitation 15.3 mg/L. The analytic measurement range was established as 15.3–100 mg/L cystine. Intraassay and interassay CV was calculated to be 9.6% and 8.0%, respectively, for a high-level cystine concentration (83.6 mg/L). Low-level cystine (36.4 mg/L) intraassay and interassay CV was determined to be 18.1% and 17.6%, respectively. Passing–Bablok regression analysis of colorimetric vs LC-MS/MS results revealed a slope of 1.10 and y intercept of −7.14 mg/L, with an overall bias of 2% by Bland–Altman plot analysis. Conclusions We analytically validated a rapid colorimetric assay suitable to quantify urinary cystine. The effect of thiol drugs on this assay remains to be determined.

Background/aims The goal of this article is to illustrate the utility of multi-state models in cancer clinical trials. Our specific aims are to describe multi-state models and how they differ from standard survival methods, to illustrate how multi-state models can facilitate deeper understanding of the treatment effect on multiple paths along the disease process that patients could experience in cancer clinical trials, to explain the differences between multi-state models and time-dependent Cox models, and to briefly describe available software to conduct such analyses. Methods Data from 717 newly diagnosed acute myeloid leukemia patients who enrolled in the CALGB 10603 trial were used as an illustrative example. The current probability-in-state was estimated using the Aalen–Johansen estimator. The restricted mean time in state was calculated as the area under the probability-in-state curves. Cox-type regression was used to evaluate the effect of midostaurin on the various clinical paths. Simulation was conducted using a newly constructed shiny application. All analyses were performed using the R software. Results Multi-state model analyses of CALGB 10603 suggested that the overall improvement in survival with midostaurin seen in the primary analysis possibly resulted from a higher complete remission rate in combination with a lower risk of relapse and of death after complete remission in patients treated with midostaurin. Simulation results, in a three-state illness-death without recovery model, demonstrate that multi-state models and time-dependent Cox models evaluate treatment effects from different frameworks. Conclusion Multi-state models allow detailed evaluation of treatment effects in complex clinical trial settings where patients can experience multiple paths between study enrollment and the final outcome. Multi-state models can be used as a complementary tool to standard survival analyses to provide deeper insights to the effects of treatment in trial settings with complex disease process.

AbstractBackgroundDiabetes mellitus (DM) is estimated to affect 9% of Americans and is associated with significant morbidity, mortality, and increased healthcare costs.MethodsA retrospective review of a home enteral nutrition (HEN) database of patients seen between March 1, 2004, and April 31, 2014, at our institution was conducted to identify HEN patients who had a diagnosis of DM or were diagnosed within the acute period (4 months) of starting HEN therapy.Results174 (3.7%) of 4682 patients in the HEN program had DM. HEN was provided through a gastrostomy tube in 82 patients and through a jejunostomy tube in 92 patients. At 3 months, data were available for 42 gastrostomy patients; 44% had a change in DM management, with 60% undergoing a change to insulin. Similarly, 34 patients with jejunostomy had data available, with 41% undergoing change in medication and 93% being changed to insulin therapy. For patients with available glycated hemogloblin values, at 3 months the gastrostomy patients noted a decrease of 0.5% (7.3% ± 1.1% to 6.8% ± 0.7%, not significant) and the jejunostomy patients noted a decrease of 0.4% (6.9% ± 0.9% to 6.5% ± 1.1%, P = .06). Conclusions: Overall, our results suggest that closer follow‐up and laboratory assessment are necessary for management of HEN patients with DM. In those with data available, glycemic control can be maintained in patients receiving HEN with appropriate adjustment of DM management and focus on ensuring that patients are not overfed.

AbstractBackgroundEnteral nutrition (EN) is a safe and cost‐effective intervention with significant morbidity and mortality benefit that can also be associated with complications. Peristomal infections can occur in 5%–30% of cases after percutaneous endoscopic gastrostomy placement. Despite this common occurrence, widespread use of objective diagnostic criteria is not prevalent, possibly leading to overuse of antibiotics.MethodsAll patients who were reporting symptoms consistent with peristomal infection were evaluated. Criteria based on erythema, induration, and exudates were applied with cumulative score ≥8 indicating peristomal infection. All patients were followed, with additional factors being collected if available.ResultsForty‐three patients noted complaints consistent with peristomal infection. In patients with a score <8 (n = 16), only 2 required antibiotics (12.5%) and 1 patient was hospitalized (6.3%). In patients with a score ≥8 (n = 27), 16 had a score of 8 or 9; all patients responded to antibiotics (100%), and 1 was hospitalized (6.3%). In patients with a score ≥10, all (100%) were treated with antibiotics. Five of 11 (45%) patients were hospitalized, with the most common diagnosis being sepsis. Of the baseline variables analyzed, higher body mass index correlated with score ≥10 (26.36 ± 2.94 vs 22.91 ± 4.35 in score <9, P = .0128).ConclusionsObjective criteria were effective in risk stratifying patients who presented with reports of peristomal infection. Patients with a score <8 tended to be at low risk, scores of 8–9 were of moderate risk, and patients with a score ≥10 were at high risk and required very close monitoring or hospitalization.

Background: Paclitaxel-treated patients can suffer from years of peripheral neuropathy with pain, numbness, and tingling. Promising preclinical data with poly (ADP-ribose) polymerase (PARP) inhibitors led us to explore this class of agents to palliate this neuropathy. Methods: We relied on a completed trial that tested the antineoplastic effects of veliparib (NCT01012817). Data from patients who had been enrolled on NCT01012817, who previously received paclitaxel, and who had completed a validated pain assessment instrument were evaluated for improvement in their pain scores. Results: All 34 eligible patients were women, and all had a metastatic gynecological malignancy. On a 10-point scale (higher numbers indicative of worse pain), the average baseline score was 3.6 (range: 0-7). Seven patients (21%; 95% confidence interval: 9%-38%) manifested a drop in pain score (1 score lower than baseline followed by at least one consecutive value also below baseline). Of note, no patients initiated other therapy for neuropathy while on NCT01012817. Conclusion: The PARP inhibitors merit further study for chemotherapy-induced peripheral neuropathy. For patients suffering from peripheral neuropathy, these putative palliative effects might prompt earlier consideration of a PARP inhibitor as part of cancer treatment.