Specification, validation, and adherence of quality indicators to optimize the safe use of nonsteroidal anti-inflammatory drugs for knee osteoarthritis pain in the primary care setting.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) used for osteoarthritis (OA) in primary care may cause gastrointestinal or renal injury. This study estimated adherence to two quality indicators (QIs) to optimize NSAID safety: add proton pump inhibitors (PPI) to NSAIDs for patients with gastrointestinal (GI) risk (QI #1 NSAID-PPI) and avoid oral NSAIDs in chronic kidney disease (CKD) stage G4 or G5 (QI #2 NSAID-CKD). METHODS: This retrospective study included index primary care clinic visits for knee OA at our health system in 2019. The validation cohort consisted of a random sample of 60 patients. The remainder were included in the expanded cohort. Analysis of structured data extracts was validated against chart review of clinic visit notes (validation cohort) and estimated QI adherence (expanded cohort). RESULTS: Among 60 patients in the validation cohort, analysis of data extracts was validated against chart review for QI #1 NSAID-PPI (100% sensitivity and 91% specificity) and QI #2 NSAID-CKD (100% accuracy). Among 335 patients in the expanded cohort, 44% used NSAIDs, 27% used PPIs, 73% had elevated GI risk, and only 2% had CKD stage 4 or 5. Twenty-one percent used NSAIDs and had elevated GI risk but were not using PPIs. Therefore, adherence to QI #1 NSAID-PPI was 79% (95% CI, 74-83%). No patients with CKD stage 4 or 5 used NSAIDs. Therefore, adherence to QI #2 NSAID-CKD was 100%. CONCLUSION: A substantial proportion of knee OA patients with GI risk factors did not receive PPI with NSAID therapy during primary care visits.

Quality indicators for osteoarthritis pain management in the primary care setting.

BACKGROUND: Development of valid and feasible quality indicators (QIs) is needed to track quality initiatives for osteoarthritis pain management in primary care settings. METHODS: Literature search identified published guidelines that were reviewed for QI extraction. A panel of 14 experts was assembled, including primary care physicians, rheumatologists, orthopedic surgeons, pain specialists, and outcomes research pharmacists. A screening survey excluded QIs that cannot be reliably extracted from the electronic health record or that are irrelevant for osteoarthritis in primary care settings. A validity screening survey used a 9-point Likert scale to rate the validity of each QI based on predefined criteria. During expert panel discussions, stakeholders revised QI wording, added new QIs, and voted to include or exclude each QI. A priority survey used a 9-point Likert scale to prioritize the included QIs. RESULTS: Literature search identified 520 references published from January 2015 to March 2021 and 4 additional guidelines from professional/governmental websites. The study included 41 guidelines. Extraction of 741 recommendations yielded 115 candidate QIs. Feasibility screening excluded 28 QIs. Validity screening and expert panel discussion excluded 73 QIs and added 1 QI. The final set of 15 prioritized QIs focused on pain management safety, education, weight-management, psychological wellbeing, optimizing first-line medications, referral, and imaging. CONCLUSION: This multi-disciplinary expert panel established consensus on QIs for osteoarthritis pain management in primary care settings by combining scientific evidence with expert opinion. The resulting list of 15 prioritized, valid, and feasible QIs can be used to track quality initiatives for osteoarthritis pain management.

Development of a combination antibiogram for Pseudomonas aeruginosa bacteremia in an oncology population.

PURPOSE: Development of a combination antibiogram to identify combinations of antibiotics that have the highest likelihood of attaining one active agent in the empiric management of presumed Pseudomonas aeruginosa bacteremia. METHODS: Patients with cancer and P. aeruginosa bacteremia from January 1 to December 31, 2012 were included in this analysis. The primary outcome was identification of effective combinations of beta-lactam and non-betalactam agents. An effective combination was defined as one which achieved in-vitro activity to greater than or equal to 85% of isolates collected. Furthermore, the addition of the non-beta-lactam agent was required to increase the in-vitro activity by at least 5% over beta-lactam monotherapy. Multiple secondary outcomes were evaluated. RESULTS: One hundred and twenty-three P. aeruginosa isolates were included from 99 patients. Single agent beta-lactam sensitivities ranged from 72.4 to 79.7%. Combination regimen sensitivities ranged from 73.5 to 96.7%. All combination regimens that included a beta-lactam plus an aminoglycoside were found to be effective per the study definition. Independent risk factors for MDR P. aeruginosa were receipt of intravenous (IV) antibiotics within 90 days and hospital length of stay (LOS) greater than or equal to five days. Increasing the number of antibiotics received was associated with a decrease in survival to hospital discharge. CONCLUSIONS: Effective combination regimens included all beta-lactam aminoglycoside regimens. Receipt of IV antibiotics within 90 days and hospital LOS greater than or equal to five days were independent risk factors for MDR isolates.

Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature.

BACKGROUND: Risk Evaluation and Mitigation Strategy (REMS) programs intend to improve medication safety but can add significant administrative burdens to providers and health systems. Various stakeholders have made efforts to use technology to improve REMS programs. OBJECTIVES: The objective of this scoping review is to describe studies evaluating workflows, automation, or electronic data exchange related to REMS programs. METHODS: A literature search of PubMed, Embase, and Web of Science was performed for articles published between January 2007 and July 2021. Studies were identified using the relevant Medical Subject Headings terms and related keywords. Articles must have described a workflow change and measured the impact of the workflow change. RESULTS: Of 299 citations initially identified, 7 were included in the final review after removing duplicates and articles not meeting predefined inclusion criteria. Included studies consisted of three manuscripts and four conference abstracts. Electronic health record interventions, such as customized order sets and clinical decision support alerts, were the most common strategy reported. Other strategies included developing a portal to verify REMS enrollment, requiring prescribers to contact the dispensing pharmacy, provider education, and restrictions based on the provider specialty. One study evaluated automated data exchange for REMS program processes in a mock environment. Although only three studies reported baseline metrics for comparison, all studies noted an improvement or benefit to the implemented workflow process changes. CONCLUSION: There is limited evidence describing REMS workflows, automation, and electronic data exchange. Various strategies to address REMS program requirements were reported, but no studies described the use of data exchange standards in a real-world setting despite efforts by the Food and Drug Administration and other stakeholders. Additional efforts are needed to automate REMS programs.

Prolonged propofol use in a critically ill pregnant patient.

OBJECTIVE: To describe the prolonged use of propofol for sedation of a critically ill pregnant patient in her second trimester. CASE SUMMARY: A 20-year-old pregnant woman at 14 weeks' gestation with non-Hodgkin's lymphoma required intubation and mechanical ventilation secondary to tumor-related airway obstruction. Immediately after intubation, propofol was initiated for sedation and maintained for 51 days with only one 5-day interruption in therapy. Over the course of the patient's stay in the intensive care unit, systemic chemotherapy was administered, resulting in a reduction in tumor burden and allowing for successful extubation. Ultimately, the fetus was deemed nonviable and the pregnancy was terminated. DISCUSSION: Propofol is an intravenous anesthetic agent commonly used for the sedation of mechanically ventilated patients and is the only sedative agent that carries a pregnancy category B rating. Fetal outcomes following long-term use of propofol during the first trimester have not been formally evaluated and few reports of propofol use outside of early pregnancy termination, outpatient procedures, or parturition exist in the medical literature. Our patient required early termination of pregnancy; however, we were unable to determine whether fetal loss was a result of propofol use, chemotherapy administration, the use of other pharmacologic agents, or perhaps a combined effect. CONCLUSIONS: Despite propofol's pregnancy category B rating, data are lacking in humans regarding its safe use during pregnancy and long-term developmental outcomes in children after exposure to propofol in utero. The safety of propofol as a sedative agent for critically ill pregnant patients remains unknown.

Parenteral Nutrition and Infection Risk in the Intensive Care Unit: A Practical Guide for the Bedside Clinician.

The safety of parenteral nutrition (PN) administration in critically ill patients has been the subject of much controversy. Historically, PN administration has been associated with an increased risk of bacterial and fungal infections, leading to significant morbidity and mortality. Much of the data showing increased infectious complications compared with either no nutrition or enteral nutrition was derived from early studies conducted in the 1980s-2000s. Poor glucose control and hyperalimentation are confounding factors in many early studies, making it difficult to determine the true PN infection risks. While PN studies conducted during the past 10 years have failed to show the same infection rates, these risks continue to be cited as dogma. Potential reasons for such discordant results include improved glycemic control, avoidance of overfeeding, and improved sterility and central venous catheter care. Understanding the true infectious risk of PN administration in the intensive care unit is necessary to optimize patient care, as inappropriately withholding such nutrition is potentially deleterious. This review is meant to serve as a practical guide to the bedside clinician who is evaluating the risks and benefits of initiating PN in a critically ill patient. Each component of PN will be evaluated based on risk of infection, and the potential ways to mitigate risks will be discussed.

Validation Study of Energy Requirements in Critically Ill, Obese Cancer Patients.

BACKGROUND: Current guidelines from the American Society for Parenteral and Enteral Nutrition and the Society of Critical Care Medicine (ASPEN/SCCM) regarding caloric requirements and the provision of nutrition support in critically ill, obese adults may not be suitable for similar patients with cancer. We sought to determine whether the current guidelines accurately estimate the energy requirements, as measured by indirect calorimetry (IC), of critically ill, obese cancer patients. MATERIALS AND METHODS: This was a retrospective validation study of critically ill, obese cancer patients from March 1, 2007, to July 31, 2010. All patients ≥18 years of age with a body mass index (BMI) ≥30 kg/m(2) who underwent IC were included. We compared the measured energy expenditure (MEE) against the upper limit of the recommended guideline (25 kcal/kg of ideal body weight [IBW]) and MEE between medical and surgical patients in the intensive care unit. RESULTS: Thirty-three patients were included in this study. Mean MEE (28.7 ± 5.2 kcal/kg IBW) was significantly higher than 25 kcal/kg IBW (P < .001), and 78% of patients had nutrition requirements greater than the current guideline recommendations. No significant differences in MEE between medical and surgical patients in the ICU were observed. CONCLUSIONS: Critically ill, obese cancer patients require more calories than the current guidelines recommend, likely due to malignancy-associated metabolic variations. Our results demonstrate the need for IC studies to determine the energy requirements in these patients and for reassessment of the current recommendations.