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.

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.