Keeping up with the evidence: Making healthcare safer IV

The first Making Health Care Safer report was published in 2001 on the heels of the landmark To Err is Human report released by the US National Academy of Medicine (NAM, then the Institute of Medicine) in 1999.^1,2 The NAM report set off an alarm about the pervasiveness of risks and patient harms occurring in the US healthcare system.

Dr John D. Eisenberg, Director of the Agency for Healthcare Research and Quality (AHRQ), had mapped out a campaign to ride the shock wave set off by the NAM report. He had drafted the speech given by President Bill Clinton in 1999 on reducing medical errors, and AHRQ had been designated the lead US Federal agency on patient safety. ³ Work on the Making Health Care Safer report had begun before the ink had dried on the NAM report.

AHRQ had created the Evidence-based Practice Centers (EPCs) in 1997 to provide research-grade evidence for its Effective Health Care program. ⁴ The EPCs are based at universities, medical centers, and research institutions across the US. Their role is to produce public reports on medications, devices, and healthcare services in response to requests and needs for evidence reviews from public and private organizations engaged in improving the quality of US healthcare. AHRQ assigned the EPC based at the University of California San Francisco (UCSF) and Stanford University to systematically review the scientific literature on patient safety.

The back story began with the establishment of the National Quality Forum (NQF) in 1999 to lead and coordinate healthcare quality measures. Under contract with AHRQ, the NQF was tasked with establishing a framework for evaluating candidate evidence-based safety practices, developing a set of measures related to these practices, and endorsing the selected set. To accelerate and inform this process, AHRQ contracted with the UCSF-Stanford EPC to develop a compendium of patient safety practices focusing on both those that were in use and those that could be adapted for use in patient care settings. The bar was set high. The EPC needed to define terminology (e.g. patient safety practice, and patient safety target); cast a wide net to capture relevant evidence within medicine and from fields such as human factors research, nursing, organizational theory, and aviation to learn from other industries; develop a novel grading system to accomplish multiple goals (e.g. prioritized practices for improving patient safety versus promising practices suggesting a need for further research); and produce the final report within six short months.

In the preface to Making Health Care Safer, the name coined by the EPC team, Dr Eisenberg wrote the report was intended to “… inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality.” ¹

The 672-page indexed report consolidated information for these stakeholders about practices that can improve patient safety (patient safety practices or PSPs) across the healthcare system, including hospitals, primary care practices, long-term care facilities, and other healthcare settings. The first report described 79 patient safety practices to address common adverse events associated with systemic and contextual factors. ¹ The most highly rated practices in terms of strength of evidence for widespread implementation included use of prophylaxis to prevent venous thromboembolism in patients at risk; use of antibiotic prophylaxis in surgical patients to prevent postoperative infections; asking patients to restate what they had been told during the informed consent process; use of pressure relieving bedding materials to prevent pressure injuries; use of real-time ultrasound guidance during central line placement; and patient self-management for warfarin in outpatient anticoagulation. As the first comprehensive attempt to apply the evidence-based lens to the emerging field of patient safety, the authors put forth the hope that the report would “provide a template for future clinicians, researchers, and policy makers as they extend, and inevitably improve upon, [their] work” (p. 18).

The second report, published by AHRQ in 2013, updated evidence-based safety practices, included 41 PSPs, and emphasized implementation potential. ⁵ The authors divided recommendations into “strongly encouraged” and “encouraged” practices. The 10 strongly encouraged practices included several advances in research and practice: preoperative checklists and anesthesia checklists to prevent operative and postoperative events; bundles that include checklists to prevent central line-associated bloodstream infections; interventions to reduce urinary catheter use, including catheter reminders, stop orders, and nurse-initiated removal protocols; bundles that include head-of-bed elevation, sedation vacations, oral care with chlorhexidine, and subglottic-suctioning of endotracheal tubes to prevent ventilator-associated pneumonia; hand hygiene; “Do Not Use” lists for hazardous abbreviations; multicomponent interventions to reduce pressure ulcers; barrier precautions to prevent healthcare-associated infections; use of real-time ultrasound for central line placement; and interventions to improve prophylaxis for venous thromboembolisms. The list of 12 “encouraged” patient safety practices was also deemed appropriate for adoption immediately. The authors encouraged further evaluations to advance knowledge on how to implement these practices and make them most effective.

The third report, published in 2020, reviewed publication between 2008 and 2018. ⁶ The five major threats to safety addressed included medication management issues, healthcare-associated infections, nursing sensitive events, procedural events, and diagnostic errors. The 47 PSPs described clinical decision support technologies, use of rapid-response teams, special hygiene and disinfection interventions to prevent healthcare acquired infections, and several practices designed to prevent medication errors and reduce opioid misuse and overdose. In addition to specific patient safety practices, the report identified a number of cross-cutting practices. These included improving safety culture; teamwork and team training; clinical decision support; person and family engagement; cultural and linguistic competency; staff education and training; and data monitoring, audit, and feedback.

A shortcoming of these reports has been that the reviews did not cover the entire patient safety field, which had grown exponentially since 1999. In addition, only English language publications were included in the reviews. Expert judgment was still applied alongside systematic review methods, especially for far-reaching safety strategies. ⁷ It is evident that additional research is still needed on the impact of the recommended practices on broadly measured patient outcomes, and population health in some circumstances. The tensions between snails and evangelists persist with the former wanting higher quality evidence while the latter push for scaling quickly. ⁸ The methodological approaches to focused interventions targeting specific safety events (e.g. falls and iatrogenic pneumothoraxes) versus more systemic approaches (e.g. safety culture and teamwork) complicate matters, though progress has been steady on highlighting the role of context-sensitivity. ⁹

Patient safey and harm from healthcare continue to be a significant problem worldwide.¹⁰ Accordingly, the fourth AHRQ report was commissioned in 2022 to address this continuing problem, as part of a continuous updating of patient safety harms and practices. ¹¹ AHRQ assigned the EPC team led by Johns Hopkins University, with partners at RAND Southern California and ECRI/University of Pennsylvania to conduct the latest round of systematic reviews. A total of 14 topics were selected for rapid review. ¹²

Beginning with this issue, Journal of Patient Safety and Risk Management will be publishing papers based on these rapid reviews. In this issue of the Journal, we present the papers based on two rapid reviews in the series.

Dukhanin and colleagues reviewed patient and family engagement safety practices that have been used to reduce patient harm, and the settings they have been used in. They also reviewed the evidence for the effectiveness of patient and family engagement as a component of interventions to make healthcare safer. ¹³

Waldfogel and colleagues reviewed the evidence for the effectiveness of opioid stewardship interventions for decreasing adverse events in healthcare. ¹⁴ They found that some multicomponent interventions including the electronic health record decreased opioid prescribing with no adverse clinical outcomes. They cautioned that interventions to reduce opioid prescribing should include access to alternative pain management resources.

Evidence is still emerging for the effectiveness of interventions that include patient and family engagement, and opioid stewardship to make patients safer. Further foundational research is needed to create tools for assessing the effectiveness of these safety practices and others. The Making Healthcare Safer series has helped policy makers and practitioners make sense of the rapidly expanding literature on patient safety, and pointed the way for future investigations. The sustained backing from the US Agency for Healthcare Research and Quality serves as a testament to the significance of national initiatives aimed at enhancing patient safety.