The Use and Impact of a Decision Support Tool for Appendicitis Treatment.

OBJECTIVE: Since introducing new and alternative treatment options may increase decisional conflict, we aimed to describe the use of the decision support tool (DST) and its impact on treatment preference and decisional conflict. SUMMARY BACKGROUND DATA: For the treatment of appendicitis, antibiotics are an effective alternative to appendectomy, with both approaches associated with a different set of risks (e.g., recurrence vs surgical complications) and benefits (e.g., more rapid return to work vs decreased chance of readmission). Patients often have limited knowledge of these treatment options and decision support tools that include video-based educational materials and questions to elicit patient preferences about outcomes may be helpful. Concurrent to the Comparing Outcomes of Drugs and Appendectomy (CODA) trial, our group developed a DST for appendicitis treatment (www.appyornot.org). METHODS: A retrospective cohort including people who self-reported current appendicitis and used the AppyOrNot DST between 2021-2023. Treatment preferences before- and after- use of the DST, demographic information, and Ottawa Decisional Conflict Scale (DCS) were reported after completing the DST. RESULTS: 8,243 people from 66 countries and all 50 US states accessed the DST. Before the DST, 14% had a strong preference for antibiotics and 31% for appendectomy, with 55% undecided. After using the DST, the proportion in the undecided category decreased to 49% (P<0.0001). 52% of those who completed the Ottawa Decisional Conflict Score (DCS) (n=356) reported the lowest level of decisional conflict (<25) after using the DST; 43% had a DCS score of 25-50, 5.1% had a DCS score of >50 and 2.5% had and DCS score of >75. CONCLUSION: The publicly available DST appyornot.org reduced the proportion that was undecided about which treatment they favored and had a modest influence on those with strong treatment preferences. Decisional conflict was not common after use. The use of this DST is now a component of a nationwide implementation program aimed at improving the way surgeons share information about appendicitis treatment options. If its use can be successfully implemented, this may be a model for improving communication about treatment for patients experiencing emergency health conditions.

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).

Verbal Descriptions of the Probability of Treatment Complications Lead to High Variability in Risk Perceptions: A Survey Study.

OBJECTIVE: To assess whether different methods for communicating the probability of treatment complications for operative and nonoperative appendicitis treatments result in differences in risk perception. BACKGROUND: Surgeons must communicate the probability of treatment complications to patients, and how risks are communicated may impact the accuracy and variability in patient risk perceptions and ultimately their decision making. METHODS: A series of online surveys of American adults communicated the probability of complications associated with surgical or antibiotic treatment of acute appendicitis. Probability was communicated with verbal descriptors (eg, "uncommon"), point estimates (eg, "3% risk"), or risk ranges (eg, "1% to 5%"). Respondents then estimated the probability of a complication for a "typical patient with appendicitis." The Fligner-Killeen test of homogeneity of variance was used to compare the variability in respondent risk estimates based on the method of probability communication. RESULTS: Among 296 respondents, variance in probability estimates was significantly higher when verbal descriptions were used compared to point estimates ( P < 0.001) or risk ranges ( P < 0.001). Identical verbal descriptors produced meaningfully different risk estimates depending on the complication being described. For example, "common" was perceived as a 45.6% for surgical site infection but 61.7% for antibiotic-associated diarrhea. CONCLUSION: Verbal probability descriptors are associated with widely varying and inaccurate perceptions about treatment risks. Surgeons should consider alternative ways to communicate probability during informed consent and shared decision-making discussions.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

Factors associated with recurrent appendicitis after successful treatment with antibiotics.

BACKGROUND: As more patients with appendicitis are treated with antibiotics, factors associated with recurrence may help inform individualized prognostication and decision-making. METHODS: This cohort study, using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy trial, examined patients treated with antibiotics who did not undergo appendicectomy in the first 30 days. Patients who had appendicectomy between 30 days and 1 year were compared with those who did not. Marginalized logistic regression models were used to calculate adjusted risk differences (RDs) to estimate the association between baseline patient factors and the risk of undergoing an appendicectomy between 30 days and 1 year. RESULTS: Of 601 patients treated with antibiotics who did not undergo appendicectomy within 30 days (mean age 38.0 years; 217 women (36.1 per cent)), 144 had an appendicectomy and 56 were lost to follow-up between 30 days and 1 year. The estimated rate of appendicectomy between 30 days and 1 year was 28.6 (95 per cent c.i. 25.0 to 32.8) per cent. After adjustment for other factors, nausea, vomiting, or anorexia at baseline presentation was associated with an increased rate of appendicectomy between 30 days and 1 year (adjusted RD 17.52, 95 per cent c.i. 8.64 to 26.40). The presence of an appendicolith (adjusted RD 3.64, -6.08 to 13.36), or an abscess, perforation, or fat stranding on initial imaging (adjusted RD -7.23, -17.41 to 2.95) was not strongly associated with appendicectomy between 30 days and 1 year. CONCLUSION: Most factors commonly associated with appendicitis severity were not strongly associated with an increased risk of undergoing appendicectomy in the longer term after treatment with antibiotics.

Two decades of surgical randomized controlled trials: worldwide trends in volume and methodological quality.

BACKGROUND: RCTs are essential in guiding clinical decision-making but are difficult to perform, especially in surgery. This review assessed the trend in volume and methodological quality of published surgical RCTs over two decades. METHODS: PubMed was searched systematically for surgical RCTs published in 1999, 2009, and 2019. The primary outcomes were volume of trials and RCTs with a low risk of bias. Secondary outcomes were clinical, geographical, and funding characteristics. RESULTS: Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The most common subspecialty in 2019 was gastrointestinal surgery (50.7 per cent). The volume of surgical RCTs increased mostly in Asia (61, 159, and 199 trials), especially in China (7, 40, and 81). In 2019, countries with the highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect. CONCLUSION: The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs.

An RCT is a form of research in which patients are divided randomly into two or more treatment groups to allow a fair and unbiased comparison of both treatments. RCTs are essential in guiding clinical decision-making, but are difficult to perform, especially in surgery. This review assessed the trend in volume and quality of published surgical RCTs over two decades. Surgical RCTs published in 1999, 2009, and 2019 were identified. The main outcome measures were volume of RCTs and trials with a low risk of bias. Different forms of bias can occur when research results are influenced by external factors. Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The volume of surgical RCTs published in these years increased mostly in Asia (61, 159, and 199 RCTs), especially in China (7, 40, and 81). In 2019, the countries with highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect. The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs.

Development and Feasibility Testing of a Decision Aid for Acute Appendicitis.

INTRODUCTION: Patients with acute uncomplicated appendicitis will be increasingly asked to choose between surgery and antibiotic management. We developed a novel decision aid for patients in the emergency department (ED) with acute appendicitis who are facing this choice. We describe the development of the decision aid and an initial feasibility study of its implementation in a busy tertiary care ED. MATERIALS AND METHODS: We conducted a prepost survey analysis comparing patients before and after standardized implementation of the decision aid. Patients were surveyed about their experience making treatment decisions after discharge from the hospital. The primary outcome measure was the total score on the decisional conflict scale (; 0-100; lower scores better). RESULTS: The study included 24 participants (12 in the predecision aid period; 12 in the post period). Only 33% of participants in each group knew antibiotics were a treatment option prior to arriving at the ED. Prior to implementing the use of decision aid, only 75% of patients reported being told antibiotics were a treatment option, while this increased to 100% after implementation of the decision aid. The mean total decisional conflict scalescores were similar in the pre and post periods (mean difference = 0.13, 95% CI: -13 - 13, P > 0.9). CONCLUSIONS: This novel appendicitis decision aid was effectively integrated into clinical practice and helped toinform patients about multiple treatment options. These data support further large-scale testing of the decision aid as part of standardized pathways for the management of patients with acute appendicitis.

Association Between a Population Health Intervention and Hypertension Control.

INTRODUCTION: As part of the Centers for Medicare and Medicaid Innovation Practice Transformation Network, an integrated healthcare system implemented a multimodal, population health-based hypertension clinical pathway program (HCPP) focused on hypertension management. AIM: To determine whether the HCPP was associated with changes in hypertension control or process-of-care measures and whether associations varied for sites serving higher versus lower proportions of historically underserved patients. SETTING: An integrated academic health system encompassing 5 clinic networks and 85 primary and specialty care sites. PROGRAM DESCRIPTION: The HCPP was implemented at some sites (adopters) but not others (non-adopters) and had four components: (1) stakeholder engagement; (2) clinical staff retraining; (3) electronic health record-based prompts; and (4) performance monitoring and feedback. Program goals were to encourage clinical teams to increase the frequency of follow up visits and adopt standardized approaches to blood pressure (BP) measurements and antihypertensive medication regimen advancement defined as adding or titrating existing medication. PROGRAM EVALUATION: This quasi-experimental study used 2017-2019 data from 63,497 patients with hypertension and multivariable difference-in-differences analyses to evaluate changes in outcomes at 19 adopter versus 39 non-adopter sites before and after HCPP implementation. Adoption was associated with 3.5 times differentially greater odds of a BP reassessment (OR 3.5, 95% CI 3.3-3.8), 11% differentially greater odds of BP control (BP<140/90 mmHg) (OR 1.11, 95% CI 1.07-1.15), and 12% differentially greater odds of having non-severely elevated BP (systolic BP < 155 mmHg) (OR 1.12, 95% CI 1.05-1.19). HCPP adoption was not associated with differential changes in 90-day follow-up BP measurement. Adoption was associated with 23% differentially greater odds of appropriate medication advancement (OR 1.23, 95% CI 1.04-1.46). A similar pattern was observed when limiting comparisons to sites caring for a higher proportion of historically underserved populations. DISCUSSION: A multimodal population health approach to transforming hypertension care was associated with improved BP outcomes.

Applying Behavioral Nudges in a Dietary Comparator for Surgical Trials: Developing the MediDiet.

INTRODUCTION: Dietary interventions are increasingly being proposed as alternatives to surgery for common gastrointestinal conditions. Integrating aspects of cognitive psychology (e.g., behavioral nudges) into dietary interventions is becoming popular, but evidence is lacking on their effectiveness and unintended effects. We assessed the effects of including nudges in the development of a dietary intervention based on the Mediterranean diet. METHODS: We conducted two-arm randomized surveys of United States adults. After a validated dietary questionnaire, participants received feedback about dietary consistency with a Mediterranean diet with (A) no nudge versus (B) one of several nudges: peer comparison, positive affect induction + peer comparison, or defaults. Participants rated their negative and positive emotions, motivation for dietary change, and interest in recipes. Responses were analyzed using baseline covariate-adjusted regression. RESULTS: Among 1709 participants, 56% were men and the median age was 36 y. Nudges as a class did not significantly affect the extent of negative or positive emotions, motivation, or interest. However, specific nudges had different effects: compared to no nudge, peer comparison blunted negative emotions and increased motivation, although decreased interest in recipes, while defaults increased interest in recipes but reduced motivation. CONCLUSIONS: In this pilot, behavioral nudges as a class of strategies did not improve participants' reactions to dietary feedback nor did they promote negative reactions. However, specific nudges may be better considered separately in their effects. Future testing should explore whether specific nudges including peer comparison and defaults improve dietary intervention effectiveness, especially in people with the specific gastrointestinal conditions of interest.

Evaluating variation in enhanced recovery for colorectal surgery: a report from the Surgical Care Outcomes Assessment Program.

AIM: Robust data demonstrate that enhanced recovery protocols (ERPs) decrease length of stay, complications and cost. However, little is known about the reasons for variation in compliance with ERPs. The aim of this work was to confirm the efficacy of ERPs in a regional network, and to determine factors that are associated with ERP delivery in diverse hospital settings. METHOD: A prospective cohort of patients was created by recording all elective colorectal operations at hospitals in the Surgical Care Outcomes Assessment Program (SCOAP). The delivery of 12 ERP components was tracked at all sites, and factors associated with ERP component delivery and affecting outcomes were reported. RESULTS: From 2016 to 2019, 9274 elective colorectal operations were performed at 36 hospitals. Indications were 48% cancer, 23% diverticulitis and 8% inflammatory bowel disease. Minimally invasive surgery was used in 71%. The proportion of cases with six or more ERP components received increased from 23% in 2016 to 50% in 2019. An increase in components was associated with a shorter length of stay and fewer combined adverse events and reinterventions. Further, increasing numbers of ERP components provided an incremental benefit to patients even when delivered in a low-volume centre or by a low-volume surgeon, and regardless of patient presentation. CONCLUSION: At SCOAP hospitals, the delivery of increasing numbers of ERP components was associated with improved perioperative outcomes and decreased complications after elective colorectal surgery. The variation in delivery of these evidence-based components in subsets of our cohort indicates an important opportunity for quality improvement initiatives.

Elective Surgery for Diverticulitis and the Risk of Recurrence and Ostomy.

OBJECTIVE: To assess the comparative risk of recurrence and ostomy after elective resection or medical therapy for uncomplicated diverticulitis, incorporating outpatient episodes of recurrence. BACKGROUND: While surgeons historically recommended colon resection for uncomplicated diverticulitis to reduce the risk of recurrence or colostomy, no prior studies have quantified this risk when considering outpatient episodes of disease. It remains to be determined whether surgery actually decreases those risks. METHODS: Retrospective cohort study employing an adjusted time-to-event analysis to assess the relationship of medical or surgical treatment with diverticulitis recurrence and/or receipt of an ostomy. Subjects were adults with ≥1 year continuous enrollment treated for ≥2 episodes of uncomplicated diverticulitis from a nationwide commercial claims dataset (2008-2014). RESULTS: Of 12,073 patients (mean age 56 ±â€Š14 yr, 59% women), 19% underwent elective surgery and 81% were treated by medical therapy on their second treatment encounter for uncomplicated diverticulitis. At 1 year, patients treated by elective surgery had lower rates of recurrence (6%) versus those treated by medical therapy (32%) [15% vs 61% at 5 years, adjusted hazard ratio 0.17 (95% confidence interval: 0.15-0.20)]. At 1 year, the rate of ostomy after both treatments was low [surgery (inclusive of stoma related to the elective colectomy), 4.0%; medical therapy, 1.6%]. CONCLUSIONS: Elective resection for uncomplicated diverticulitis decreases the risk of recurrence, still 6% to 15% will recur within 5 years of surgery. The risk of ostomy is not lower after elective resection, and considering colostomies related to resection, ostomy prevention should not be considered an appropriate indication for elective surgery.

Transforming Population-Based Depression Care: a Quality Improvement Initiative Using Remote, Centralized Care Management.

INTRODUCTION: With the growing prevalence of value-based contracts, health systems are incentivized to consider population approaches to service delivery, particularly for chronic conditions like depression. To this end, UW Medicine implemented the Depression-Population Approach to Health (PATH) program in primary care (PC) as part of a system-wide Center for Medicare and Medicaid Innovation (CMMI) quality improvement (QI) initiative. AIM: To examine the feasibility of a pilot PATH program and its impact on clinical and process-of-care outcomes. SETTING: A large, diverse, geographically disparate academic health system in Western Washington State including 28 PC clinics across five networks. PROGRAM DESCRIPTION: The PATH program was a population-level, centralized, measurement-based care intervention that utilized a clinician to provide remote monitoring of treatment progress via chart review and facilitate patient engagement when appropriate. The primary goals of the program were to improve care engagement and increase follow-up PHQ-9 assessments for patients with depression and elevated initial PHQ-9 scores. PROGRAM EVALUATION: We employed a prospective, observational study design, including commercially insured adult patients with new depression diagnoses and elevated initial PHQ-9 scores. The pilot intervention group, consisting of accountable care network (ACN) self-enrollees (N = 262), was compared with a similar commercially insured cohort (N = 2527) using difference-in-differences analyses adjusted for patient comorbidities, initial PHQ-9 score, and time trends. The PATH program was associated with three times the odds of PHQ-9 follow-up (OR 3.28, 95% CI 1.79-5.99), twice the odds of a follow-up PC clinic visit (OR 1.74, 95% CI 0.99-3.08), and twice the odds of treatment response, defined as reduction in PHQ-9 score by ≥ 50% (OR 2.02, 95% CI 0.97-4.21). DISCUSSION: Our results demonstrate that a centralized, remote care management initiative is both feasible and effective for large academic health systems aiming to improve depression outcome ascertainment, treatment engagement, and clinical care.

Development and Implementation of a Complex Health System Intervention Targeting Transitions of Care from Hospital to Post-acute Care.

BACKGROUND: Failure of effective transitions of care following hospitalization can lead to excess days in the hospital, readmissions, and adverse events. Evidence identifies both patient and system factors that influence poor care transitions, yet health systems struggle to translate evidence into complex interventions that have a meaningful impact on care transitions. OBJECTIVE: We report on our experience developing, pilot testing, and evaluating a complex intervention (Addressing Complex Transitions program, or ACT program) that aims to improve care transitions for complex patients. DESIGN: Following the Medical Research Council (MRC) framework, we engaged in iterative, stakeholder-driven work to develop a complex care intervention, assess feasibility and pilot methods, evaluate the intervention in practice, and facilitate ongoing implementation monitoring and dissemination. PARTICIPANTS: Patients receiving care from UW Medicine's health system including 4 hospitals and 20-site Post-Acute Care network. INTERVENTION: Literature review and prospective data collection activities informed ACT program design. ACT program components include a tailored risk calculator that provides real-time scoring of transitions of care risk factors, a multidisciplinary team with the capacity to address complex barriers to safe transitions, and enhanced discharge workflows to improve care transitions for complex patients. KEY MEASURES: Program evaluation metrics included estimated hospital days saved and program acceptance by care team members. KEY RESULTS: During the 6-month pilot, 565 patients were screened and 97 enrolled in the ACT program. An estimated 664 hospital days were saved for the index admission of ACT program participants. Analysis of pre/post-hospital utilization for ACT program participants showed an estimated 3227 fewer hospital days after ACT program enrollment. CONCLUSIONS: Health systems need to address increasingly difficult challenges in care delivery. The use of evidence-based frameworks, such as the MRC framework, can guide systems to design complex interventions that respond to their local context and stakeholder needs.

Establishing Clinically Significant Patient-reported Outcomes for Diverticular Disease.

BACKGROUND: Diverticular disease can undermine health-related quality of life. The diverticulitis quality of life (DV-QOL) instrument was designed and validated to measure patient-reported burden of diverticular disease. However, values reflecting meaningful improvement (i.e., minimal clinically important difference [MCID]) and the patient acceptable symptom state (PASS) have yet to be established. We sought to establish the MCID and PASS of the DV-QOL and describe the characteristics of those with DV-QOL above the PASS threshold. MATERIALS AND METHODS: We performed a prospective cohort study of adults with diverticular disease from seven centers in Washington and California (2016-2018). Patients were surveyed at baseline, then quarterly up to 30 mo. To determine the MCID and PASS for DV-QOL, we applied various previously established distribution- and anchor-based approaches and compared the resulting values. RESULTS: The study included 177 patients (mean age 57 y, 43% women). A PASS threshold of 3.2/10 distinguished between those with and without health-related quality of life-impacting diverticulitis with acceptable accuracy (area under the curve 0.76). A change of 2.2 points in the DV-QOL was the most appropriate MCID: above the distribution-based MCIDs and corresponding to patient perception of importance of change (AUC 0.70). Patients with DV-QOL ≥ PASS were more often men, younger, had Medicaid, had more serious episodes of diverticulitis, and had an occupational degree or high-school education or less. CONCLUSIONS: Our study is the first to define MCID and PASS for DV-QOL. These thresholds are critical for measuring the impact of diverticular disease and the evaluation of treatment effectiveness.

Integrating Formal Technology Assessment into an Integrated Healthcare Delivery System: Smart Innovation.

OBJECTIVES: We designed, developed, and implemented a new hospital-based health technology assessment (HB-HTA) program called Smart Innovation. Smart Innovation is a decision framework that reviews and makes technology adoption decisions. Smart Innovation was meant to replace the fragmented and complex process of procurement and adoption decisions at our institution. Because use of new medical technologies accounts for approximately 50 percent of the growth in healthcare spending, hospitals and integrated delivery systems are working to develop better processes and methods to sharpen their approach to adoption and management of high cost medical innovations. METHODS: The program has streamlined the decision-making process and added a robust evidence review for new medical technologies, aiming to balance efficiency with rigorous evidence standards. To promote system-wide adoption, the program engaged a broad representation of leaders, physicians, and administrators to gain support. RESULTS: To date, Smart Innovation has conducted eleven HB-HTAs and made clinician-led adoption decisions that have resulted in over $5 million dollars in cost avoidance. These are comprised of five laboratory tests, three software-assisted systems, two surgical devices, and one capital purchase. CONCLUSIONS: Smart Innovation has achieved cost savings, avoided uncertain or low-value technologies, and assisted in the implementation of new technologies that have strong evidence. The keys to its success have been the program's collaborative and efficient decision-making systems, partnerships with clinicians, executive support, and proactive role with vendors.

Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes.

BACKGROUND: The utility of serum biomarkers related to inflammation and adiposity as predictors of metabolic disease prevalence and outcomes after bariatric surgery are not well-defined. METHODS: Associations between pre- and post-operative serum levels of four biomarkers (C-reactive protein (CRP), cystatin C (CC), leptin, and ghrelin) with baseline measures of adiposity and metabolic disease prevalence (asthma, diabetes, sleep apnea), and weight loss and metabolic disease remission after bariatric surgery were studied in the Longitudinal Assessment of Bariatric Surgery (LABS) cohort. RESULTS: Baseline CRP levels were positively associated with the odds of asthma but not diabetes or sleep apnea; baseline CC levels were positively associated with asthma, diabetes, and sleep apnea; baseline leptin levels were positively associated with asthma and negatively associated with diabetes and sleep apnea; baseline ghrelin levels were negatively associated with diabetes and sleep apnea. Increased weight loss was associated with increased baseline levels of leptin and CRP and decreased baseline levels of CC. Remission of diabetes and asthma was not associated with baseline levels of any biomarker. A higher likelihood of asthma remission was associated with a greater decrease in leptin levels, and a higher likelihood of diabetes remission was predicted by a lesser decrease in CC. Bariatric surgery was associated with decreased post-operative CC, CRP, and leptin levels, and increased post-operative ghrelin levels. CONCLUSION: This is the largest study to date of serum biomarkers of inflammation and adiposity in a bariatric surgery cohort. Biomarker levels correlate with metabolic disease prevalence prior to bariatric surgery, and with weight loss but not metabolic disease remission after surgery. Bariatric surgery regulates serum biomarker levels in a manner consistent with anti-inflammatory and compensatory orexigenic effects. These data contribute to our understanding of the mechanisms underlying the biologic effects of bariatric surgery.

Comparison of outcomes in women and men following carotid interventions in the Washington state's Vascular Interventional Surgical Care and Outcomes Assessment Program.

BACKGROUND: The benefit for carotid endarterectomy (CEA) to prevent a potential stroke has been shown to be less beneficial for women compared with men and the risk of carotid stenting (CAS) is higher in women than men. We hypothesized that a community-based Washington state registry data would also reveal increased morbidity and mortality for women undergoing carotid interventions. METHODS: Deidentified data for CEA and CAS between 2010 and 2015 were obtained from 19 hospitals participating in the Washington State Vascular-Interventional Surgical Care and Outcomes Assessment Program. Data analysis compared in-hospital composite outcome of stroke and mortality from CEA and CAS between women and men. RESULTS: Over the study period, 3704 individuals underwent CEA (n = 2759; 49.5% symptomatic) and CAS (n = 945; 60.9% symptomatic). Women accounted for 39.5% of the cohort. Women were slightly younger than men (70.0 ± 10.2 vs 71.0 ± 9.6 years respectively; P < .01), less likely to be smokers (70.1% vs 75.6%; P < .01), and less likely to have a diagnosis of coronary artery disease (32.9% vs 46.5%; P < .01). Fewer women underwent CEA for symptomatic carotid disease (46.1% vs 51.8%; P < .01). There were no statistically significant differences in the postoperative in-hospital stroke and mortality among women and men undergoing CEA (asymptomatic, 0.8% vs 1.4% [P = .36]; symptomatic, 1.8% vs 2.2% [P = .58]) and CAS (asymptomatic, 1.4% vs 2.2% [P = .56]; symptomatic, 4.6% vs 2.5% [P = .18]). Hospital duration of stay and discharge disposition were similar for women and men. A subanalysis of the octogenarian cohort undergoing CAS demonstrated a substantial increase in-hospital stroke and mortality among women and men (11.6% [CAS] vs 2.2% [CEA]; P = .024). CONCLUSIONS: In the Washington state Vascular-Interventional Surgical Care and Outcomes Assessment Program registry, hospital composite outcome of stroke and mortality following carotid interventions from 2010 to 2015 were noted to be similar for women and men. The notable exception to this finding was observed in subcohort of women undergoing CAS for symptomatic carotid disease at age 80 years or older. These findings should be taken into account when risk stratifying patients for carotid interventions.