Background

Over recent decades, numerous medical procedures have migrated out of hospitals and into freestanding ambulatory surgery centers (ASCs) and physician offices, with possible implications for patient outcomes. In response, states have passed regulations for office-based surgeries, private organizations have established standards for facility accreditation, and professional associations have developed clinical guidelines. While abortions have been performed in office setting for decades, states have also enacted laws requiring that facilities that perform abortions meet specific requirements. The extent to which facility requirements have an impact on patient outcomes-for any procedure-is unclear.

Methods and findings

We conducted a systematic review to examine the effect of outpatient facility type (ASC vs. office) and specific facility characteristics (e.g., facility accreditation, emergency response protocols, clinician qualifications, physical plant characteristics, other policies) on patient safety, patient experience and service availability in non-hospital-affiliated outpatient settings. To identify relevant research, we searched databases of the published academic literature (PubMed, EMBASE, Web of Science) and websites of governmental and non-governmental organizations. Two investigators reviewed 3049 abstracts and full-text articles against inclusion/exclusion criteria and assessed the quality of 22 identified articles. Most studies were hampered by methodological challenges, with 12 of 22 not meeting minimum quality criteria. Of 10 studies included in the review, most (6) examined the effect of facility type on patient safety. Existing research appears to indicate no difference in patient safety for outpatient procedures performed in ASCs vs. physician offices. Research about specific facility characteristics is insufficient to draw conclusions.

Conclusions

More and higher quality research is needed to determine if there is a public health problem to be addressed through facility regulation and, if so, which facility characteristics may result in consistent improvements to patient safety while not adversely affecting patient experience or service availability.

Objective:To identify factors associated with pain severity and opioid consumption in the early perioperative period. Design:Prospective observational cohort study. Setting:Tertiary academic medical center. Subjects:Patients with osteoarthritis older than age 45 years undergoing primary total knee replacement at Brigham and Women's Hospital. A total of 126 patients enrolled. Methods:Preoperatively, pain questionnaires and quantitative sensory testing were performed on patients to develop a psychosocial and psychophysical profile. Postoperatively, pain scores and opioid consumption were measured as primary end points. Univariate and multiple linear regression analyses were performed to determine the predictive value of these characteristics on perioperative pain scores and opioid consumption. Results:Regression analysis revealed several predictors of acute postoperative pain scores including temporal summation of pain (TSP; P = 0.001), body mass index (BMI; P = 0.044), number of previous knee surgeries (P = 0.006), and female gender (P = 0.023). Similarly, predictors of opioid utilization included TSP (P = 0.011), BMI (P = 0.02), age (P = <0.001), and tourniquet time (P = 0.003). Conclusions:The only significant, unique predictors of both pain and opioid consumption were TSP, an index of central pain facilitatory processes, and BMI. Interestingly, psychosocial factors, such as catastrophizing and somatization, although correlated with postoperative pain scores and opioid consumption, generally did not independently explain substantial variance in these measures. This study suggests that BMI and quantitative sensory testing, specifically the temporal summation of pain, may provide value in the preoperative assessment of patients undergoing total knee arthroplasty and other surgeries via predicting their level of risk for adverse pain outcomes.

Background

Trauma prediction scores such as Revised Trauma Score (RTS) and Trauma and Injury Severity Score (TRISS)) are used to predict mortality, but do not include comorbidities. We analyzed the American Society of Anesthesiologists physical status (ASA PS) for predicting mortality in trauma patients undergoing surgery.

Methods

This multicenter, retrospective study compared the mortality predictive ability of ASA PS, RTS, Injury Severity Score (ISS), and TRISS using a complete case analysis with mixed effects logistic regression. Associations with mortality and AROC were calculated for each measure alone and tested for differences using chi-square.

Results

Of 3,042 patients, 230 (8%) died. The AROC for mortality for TRISS was 0.938 (95%CI 0.921, 0.954), RTS 0.845 (95%CI 0.815, 0.875), and ASA PS 0.886 (95%CI 0.864, 0.908). ASA PS + TRISS did not improve mortality predictive ability (p = 0.18).

Conclusions

ASA PS was a good predictor of mortality in trauma patients, although combined with TRISS it did not improve predictive ability.

Objectives

Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.

Design

A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.

Participants

Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.

Measurements and main results

The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.

Conclusions

These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.