Truth of Colorectal Enhanced Recovery Programs: Process Measure Compliance in 151 Hospitals.

BACKGROUND: Commonly cited studies have reported substantial improvements (defined as >20%) in process measure compliance after implementation of colorectal enhanced recovery programs (ERPs). However, hospitals have anecdotally reported difficulties in achieving similar improvement gains. This study evaluates improvement uniformity among 151 hospitals exposed to an 18-month implementation protocol for 6 colorectal ERP process measures (oral antibiotics, mechanical bowel preparation, multimodal pain control, early mobilization, early liquid intake, and early solid intake). STUDY DESIGN: One hundred fifty-one hospitals implemented a colorectal ERP with pathway, educational and supporting materials, and data capture protocols; 906 opportunities existed for process compliance improvement across the cohort (151 hospitals × 6 process measures). However, 240 opportunities were excluded due to high starting compliance rates (ie compliance >80%) and 3 opportunities were excluded because compliance rates were recorded for fewer than 2 cases. Thus, 663 opportunities for improvement across 151 hospitals were studied. RESULTS: Of 663 opportunities, minimal improvement (0% to 20% increase in compliance) occurred in 52% of opportunities, substantial improvement (>20% increase in compliance) in 20%, and worsening compliance occurred in 28%. Of the 6 processes, multimodal pain control and use of oral antibiotics improved the most. CONCLUSIONS: Contrary to published ERP literature, the majority of study hospitals had difficulty improving process compliance with 80% of the opportunities not achieving substantial improvement. This discordance between ERP implementation success rates reported in the literature and what is observed in a large sample could reflect differences in hospitals' culture or characteristics, or a publication bias. Attention needs to be directed toward improving ERP adoption across the spectrum of hospital types.

How Well Is Surgical Improvement Being Conducted? Evaluation of 50 Local Surgery-Related Improvement Efforts.

BACKGROUND: Delivering high-quality care is paramount; however, evaluations show mixed results. Studies assessing improvement efforts in nonsurgical disciplines show suboptimal conduct, yet little is known about how well improvement efforts in surgery are conducted. This study evaluates local surgical improvement efforts to determine whether opportunities exist to improve their conduct. STUDY DESIGN: Fifty consecutive improvement efforts were collected from hospitals participating in 1 of 5 American College of Surgeons Quality Accreditation/Verification Programs. Conduct of these efforts was evaluated using a quality framework (with 39 criteria grouped into 8 components). Descriptive, paired, and 1-way ANOVA analyses were undertaken. RESULTS: The mean percentage of 39 criteria fulfilled for the 50 improvement efforts was 36% (range 0% to 72%). Individual criterion scores ranged from 0% to 82%. The 2 highest scoring criteria were improvement planning and problem documentation; the 2 lowest scoring were value assessments and stakeholder value perspective. The highest scoring framework component addressed End-of-Project Decision-Making (47%); the lowest was Cost Evaluation (3%). Twenty-four percent of 50 improvement efforts reported full achievement of project goals, 32% reported partial achievement, and 44% reported no achievement. Higher scores were associated with projects having full/partial achievement of stated project goals vs projects not achieving project goals (p < 0.05). Higher scores were not associated with hospital characteristics (eg bed size, teaching status) or improvement characteristics (eg improvement strategy). CONCLUSIONS: Evaluation of local surgical improvement efforts shows opportunities for improvement. Better-conducted improvement efforts were associated with more effective improvement. To support better surgical quality of care, improvement efforts need to improve.

Activation of Inflammatory and Pro-Thrombotic Pathways in Acute Stress Cardiomyopathy.

Stress cardiomyopathy (SCM) is a unique cardiac disorder that more often occurs in women. SCM presents in a similar fashion as acute myocardial infarction (AMI), with chest pain, ECG changes, and congestive heart failure. The primary distinguishing feature is the absence of thrombotic coronary occlusion in SCM. How this reduction in cardiac function occurs in the absence of coronary occlusion remains unknown. Therefore, we tested the hypothesis that a targeted proteomic comparison of patients with acute SCM and AMI might identify relevant mechanistic differences. Blood was drawn in normal controls (n = 6), women with AMI (n = 12), or women with acute SCM (n = 15). Two-week follow-up samples were available in AMI (n = 4) and SCM patients (n = 11). Relative concentrations of 1,310 serum proteins were measured in each of the 48 samples using the SOMAscan assay. Women with AMI had greater myocyte necrosis, as reflected by a higher peak troponin I concentration (AMI 32.03 ± 29.46 vs. SCM 2.68 ± 2.6 ng/ml, p < 0.05). AMI and SCM patients had equivalent reductions in left ventricular ejection fraction [LVEF (%) 39 ± 12 vs. 37 ± 12, p = 0.479]. In follow-up, women with SCM had a greater improvement in cardiac function [LVEF (%) 60 ± 7 vs. 45 ± 13, p < 0.001]. No differentially expressed proteins were detected (absolute log2-fold change >1; q < 0.05) between AMI and SCM in the acute or recovery phase. However, when we compared normal controls to patients with AMI, there was differential expression of 35 proteins. When we compared normal controls to patients with SCM, 45 proteins were differentially expressed. In comparison to normal controls, biological processes such as complement, coagulation, and inflammation were activated in both AMI and SCM. There were four proteins that showed a non-significant trend to be increased in acute SCM vs. AMI (netrin-1, follistatin-like 3, kallikrein 7, kynureninase). Despite a lesser degree of myocardial necrosis than AMI, SCM is characterized by a similar activation of inflammatory, complement, and coagulation pathways. These findings may explain reported thromboembolic complications in the short term and elevated risk of mortality in the long term of SCM.

An Integrated Systems Approach is Needed to Ensure the Sustainability of Antibiotic Effectiveness for Both Humans and Animals.

The growing demand for animal products and the widespread use of antibiotics in bringing food animals to market have heightened concerns over cross-species transmission of drug resistance. Both the biology and emerging epidemiology strongly support the need for global coordination in stemming the generation and propagation of resistance, and the patchwork of global and country-level regulations still leaves significant gaps. More importantly, discussing such a framework opens the door to taking modular steps towards solving these challenges - for example, beginning among targeted parties rather than all countries, tying accountability to financial and technical support, or taxing antibiotic use in animals to deter low-value usage of these drugs. An international agreement would allow integrating surveillance data collection, monitoring and enforcement, research into antibiotic alternatives and more sustainable approaches to agriculture, technical assistance and capacity building, and financing under the umbrella of a One Health approach.

New business models for antibiotic innovation.

The increase in antibiotic resistance and the dearth of novel antibiotics have become a growing concern among policy-makers. A combination of financial, scientific, and regulatory challenges poses barriers to antibiotic innovation. However, each of these three challenges provides an opportunity to develop pathways for new business models to bring novel antibiotics to market. Pull-incentives that pay for the outputs of research and development (R&D) and push-incentives that pay for the inputs of R&D can be used to increase innovation for antibiotics. Financial incentives might be structured to promote delinkage of a company's return on investment from revenues of antibiotics. This delinkage strategy might not only increase innovation, but also reinforce rational use of antibiotics. Regulatory approval, however, should not and need not compromise safety and efficacy standards to bring antibiotics with novel mechanisms of action to market. Instead regulatory agencies could encourage development of companion diagnostics, test antibiotic combinations in parallel, and pool and make transparent clinical trial data to lower R&D costs. A tax on non-human use of antibiotics might also create a disincentive for non-therapeutic use of these drugs. Finally, the new business model for antibiotic innovation should apply the 3Rs strategy for encouraging collaborative approaches to R&D in innovating novel antibiotics: sharing resources, risks, and rewards.

Measuring dilution of microbicide gels with optical imaging.

We present a novel approach for measuring topical microbicide gel dilution using optical imaging. The approach compares gel thickness measurements from fluorimetry and multiplexed low coherence interferometry in order to calculate dilution of a gel. As a microbicide gel becomes diluted at fixed thickness, its mLCI thickness measurement remains constant, while the fluorimetry signal decreases in intensity. The difference between the two measurements is related to the extent of gel dilution. These two optical modalities are implemented in a single endoscopic instrument that enables simultaneous data collection. A preliminary validation study was performed with in vitro placebo gel measurements taken in a controlled test socket. It was found that change in slope of the regression line between fluorimetry and mLCI based measurements indicates dilution. A dilution calibration curve was then generated by repeating the test socket measurements with serial dilutions of placebo gel with vaginal fluid simulant. This methodology can provide valuable dilution information on candidate microbicide products, which could substantially enhance our understanding of their in vivo functioning.