Publications by authors named "Anne P Ehlers"

28 Publications

  • Page 1 of 1

The human type 2 diabetes-specific visceral adipose tissue proteome and transcriptome in obesity.

Sci Rep 2021 Aug 30;11(1):17394. Epub 2021 Aug 30.

Department of Surgery, University of Michigan Medical School, 1301 Catherine St, Ann Arbor, MI, 48109, USA.

Dysfunctional visceral adipose tissue (VAT) in obesity is associated with type 2 diabetes (DM) but underlying mechanisms remain unclear. Our objective in this discovery analysis was to identify genes and proteins regulated by DM to elucidate aberrant cellular metabolic and signaling mediators. We performed label-free proteomics and RNA-sequencing analysis of VAT from female bariatric surgery subjects with DM and without DM (NDM). We quantified 1965 protein groups, 23 proteins, and 372 genes that were differently abundant in DM vs. NDM VAT. Proteins downregulated in DM were related to fatty acid synthesis and mitochondrial function (fatty acid synthase, FASN; dihydrolipoyl dehydrogenase, mitochondrial, E3 component, DLD; succinate dehydrogenase-α, SDHA) while proteins upregulated in DM were associated with innate immunity and transcriptional regulation (vitronectin, VTN; endothelial protein C receptor, EPCR; signal transducer and activator of transcription 5B, STAT5B). Transcriptome indicated defects in innate inflammation, lipid metabolism, and extracellular matrix (ECM) function, and components of complement classical and alternative cascades. The VAT proteome and transcriptome shared 13 biological processes impacted by DM, related to complement activation, cell proliferation and migration, ECM organization, lipid metabolism, and gluconeogenesis. Our data revealed a marked effect of DM in downregulating FASN. We also demonstrate enrichment of complement factor B (CFB), coagulation factor XIII A chain (F13A1), thrombospondin 1 (THBS1), and integrins at mRNA and protein levels, albeit with lower q-values and lack of Western blot or PCR confirmation. Our findings suggest putative mechanisms of VAT dysfunction in DM.
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http://dx.doi.org/10.1038/s41598-021-96995-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8405693PMC
August 2021

How do Patients Access Bariatric Surgery? An Analysis of Referrals to a Large Academic Medical Center.

Obes Surg 2021 Oct 22;31(10):4662-4665. Epub 2021 Jul 22.

Department of Surgery, Michigan Medicine, 1500 E Medical Center Drive, SPC 5343, 2210 Taubman Center, Ann Arbor, MI, 48109, USA.

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http://dx.doi.org/10.1007/s11695-021-05584-7DOI Listing
October 2021

SAGES guidelines for the surgical treatment of gastroesophageal reflux (GERD).

Surg Endosc 2021 Sep 19;35(9):4903-4917. Epub 2021 Jul 19.

Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Background: Gastroesophageal Reflux Disease (GERD) is an extremely common condition with several medical and surgical treatment options. A multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians, patients, and others in decisions regarding the treatment of GERD with an emphasis on evaluating different surgical techniques.

Methods: Literature reviews were conducted for 4 key questions regarding the surgical treatment of GERD in both adults and children: surgical vs. medical treatment, robotic vs. laparoscopic fundoplication, partial vs. complete fundoplication, and division vs. preservation of short gastric vessels in adults or maximal versus minimal dissection in pediatric patients. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Recommendations for future research were also proposed.

Results: The panel provided seven recommendations for adults and children with GERD. All recommendations were conditional due to very low, low, or moderate certainty of evidence. The panel conditionally recommended surgical treatment over medical management for adults with chronic or chronic refractory GERD. There was insufficient evidence for the panel to make a recommendation regarding surgical versus medical treatment in children. The panel suggested that once the decision to pursue surgical therapy is made, adults and children with GERD may be treated with either a robotic or a laparoscopic approach, and either partial or complete fundoplication based on surgeon-patient shared decision-making and patient values. In adults, the panel suggested either division or non-division of the short gastric vessels is appropriate, and that children should undergo minimal dissection during fundoplication.

Conclusions: These recommendations should provide guidance with regard to surgical decision-making in the treatment of GERD and highlight the importance of shared decision-making and patient values to optimize patient outcomes. Pursuing the identified research needs may improve future versions of guidelines for the treatment of GERD.
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http://dx.doi.org/10.1007/s00464-021-08625-5DOI Listing
September 2021

Implementation of a synoptic operative note for abdominal wall hernia repair: a statewide pilot evaluating completeness and communication of intraoperative details.

Surg Endosc 2021 Jul 14. Epub 2021 Jul 14.

Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, USA.

Background: Variable approaches to intraoperative communication impede our understanding of surgical decision-making and best practices. This is critical among hernia repairs, where improved outcomes are reliant on understanding the impact of different patient characteristics and surgical approaches. In this context, a hernia-specific synoptic operative note was piloted as part of an effort to create a statewide hernia registry. We aimed to understand the impact of the synoptic operative note on variable missingness and evaluate barriers and facilitators to improved intraoperative communication and note adoption.

Methods: In January 2020, the Michigan Surgical Quality Collaborative (MSQC) registry was expanded to capture hernia-specific intraoperative variables. A synoptic operative note for hernia repair was piloted at 8 hospitals. The primary outcome was change in hernia variable communication, measured by missingness. Using a sequential explanatory mixed-methods design, we performed semi-structured interviews with data abstractors (n = 4) and surgeons (n = 4) at 5 pilot sites to assess barriers and facilitators of implementation. Interviews were iteratively analyzed using content analysis with both deductive and inductive approaches.

Results: From January to June 2020, 870 hernia repairs were performed across 8 pilot and 53 control sites. Pilot sites had significantly less missingness for all hernia-specific variables. At pilot sites, 46% of notes were fully complete in regard to hernia variables, compared to 21% at control sites (p value < 0.001). While collection of intraoperative variables improved after synoptic note implementation, low note adoption was reported. Facilitators of improved variable collection were (1) communication with data abstractors and (2) stakeholder acknowledgment of widespread benefit, while barriers included (1) surgeon resistance to practice change, (2) EMR/technology, and (3) interruptions to communication and implementation.

Conclusion: This mixed-methods evaluation of a synoptic operative note implementation suggests that sustained communication, particularly with abstractors, was the most impactful intervention. Future implementation efforts may have improved effectiveness with interventions supplementary to surgeon-level direction.
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http://dx.doi.org/10.1007/s00464-021-08614-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8279380PMC
July 2021

Traditional Measures of Surgical Outcomes Only Tell a Portion of the Patient Story-Who Measures Success?

JAMA Surg 2021 Aug;156(8):765-766

Department of Surgery, University of Washington School of Medicine, Seattle.

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http://dx.doi.org/10.1001/jamasurg.2021.1558DOI Listing
August 2021

Post-Acute Care Utilization and Episode of Care Payments Following Common Elective Operations.

Ann Surg 2021 Feb 12. Epub 2021 Feb 12.

*Department of Surgery, University of Michigan, Ann Arbor, MI, USA †Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, USA ‡University of Michigan Medical School, Ann Arbor, MI, USA.

Objective: To describe post-acute care (PAC) utilization and associated payments for patients undergoing common elective procedures.

Summary Background Data: Utilization and costs of PAC are well described for benchmarked conditions and operations but remain understudied for common elective procedures.

Methods: Cross-sectional study of adult patients in a statewide administrative claims database undergoing elective cholecystectomy, ventral or incisional hernia repair (VIHR), and groin hernia repair from 2012-2019. We used multivariable logistic regression to estimate the odds of PAC utilization, and multivariable linear regression to determine the association of 90-day episode of care payments and PAC utilization.

Results: Among 34,717 patients undergoing elective cholecystectomy, 0.7% utilized PAC resulting in significantly higher payments ($19,047 vs $7,830, p < 0.001). Among 29,826 patients undergoing VIHR, 1.7% utilized PAC resulting in significantly higher payments ($19,766 vs $9,439, p < 0.001). Among 37,006 patients undergoing groin hernia repair, 0.3% utilized PAC services resulting in significantly higher payments ($14,886 vs $8,062, p < 0.001). We found both modifiable and non-modifiable risk factors associated with PAC utilization. Morbid obesity was associated with PAC utilization following VIHR (OR 1.61, 95% CI 1.29-2.02, p < 0.001). Male sex was associated with lower odds of PAC utilization for VIHR (OR 0.43, 95% CI 0.35-0.51, p < 0.001) and groin hernia repair (OR 0.62, 95% CI 0.39-0.98, p = 0.039).

Conclusions: We found both modifiable (e.g. obesity) and non-modifiable (e.g. female sex) patient factors that were associated with PAC. Optimizing patients to reduce PAC utilization requires an understanding of patient risk factors as well as systems and processes to address these factors.
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http://dx.doi.org/10.1097/SLA.0000000000004814DOI Listing
February 2021

Decision support tools: Best practice or failed experiment?

Am J Surg 2021 08 14;222(2):270-271. Epub 2021 Feb 14.

Department of Surgery, Michigan Medicine, Ann Arbor, MI, USA; Center for Healthcare Outcomes & Policy, Ann Arbor, MI, USA.

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http://dx.doi.org/10.1016/j.amjsurg.2021.02.011DOI Listing
August 2021

Evaluation of Patient Reported Gastroesophageal Reflux Severity at Baseline and at One-Year after Bariatric Surgery.

Ann Surg 2020 Nov 17. Epub 2020 Nov 17.

Department of Surgery, Henry Ford Health System, Detroit, MI.

Objective: To assess patient-reported gastroesophageal reflux disease (GERD) severity before and after sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB).

Summary Background Data: Development of new-onset or worsening GERD symptoms following bariatric surgery varies by procedure, but there is a lack of patient-reported data to help guide decision-making.

Methods: Retrospective cohort study of patients undergoing bariatric surgery in a statewide quality collaborative between 2013-2017. We used a validated GERD survey with symptom scores ranging from 0 (no symptoms) to 5 (severe daily symptoms) and included patients who completed surveys both at baseline and one-year after surgery (n = 10,451). We compared the rates of improved and worsened GERD symptoms after SG and RYGB.

Results: Within our study cohort, 8,680 (83%) underwent SG and 1,771 (17%) underwent RYGB. Mean baseline score for all patients was 0.94. Patients undergoing SG experienced similar improvement in GERD symptoms when compared to RYGB (30.4% vs 30.8%, p = 0.7015). However, SG patients also reported higher rates of worsening symptoms (17.8% vs 7.5%, p < 0.0001) even though they were more likely to undergo concurrent hiatal hernia repair (35.1% vs 20.0%, p < 0.0001). More than half of patients (53.5%) did not report a change in their score.

Conclusions: Although SG patients reported higher rates of worsening GERD symptoms when compared to RYGB, the majority of patients (>80%) in this study experienced improvement or no change in GERD regardless of procedure. Using clinically relevant patient-reported outcomes can help guide decisions about procedure choice in bariatric surgery for patients with GERD.
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http://dx.doi.org/10.1097/SLA.0000000000004533DOI Listing
November 2020

Exploration of Factors Associated With Surgeon Deviation From Practice Guidelines for Management of Inguinal Hernias.

JAMA Netw Open 2020 11 2;3(11):e2023684. Epub 2020 Nov 2.

Department of Surgery, University of Michigan, Ann Arbor.

Importance: Despite availability of evidence-based guidelines for surgery, many patients receive guideline-discordant care. Reasons for this are largely unknown. For example, evidence-based guidelines recommend a minimally invasive approach for persons with bilateral or recurrent unilateral inguinal hernias. Benefits are also noted for primary unilateral inguinal hernia. However, findings from previous quantitative research indicate that only 26% of patients receive this treatment and only 42% of surgeons offer a minimally invasive approach, even for recurrent or bilateral hernias.

Objective: To explore factors associated with surgeon choice of approach (minimally invasive vs open) in inguinal hernia repair as a tool to gain an understanding of guideline-discordant care.

Design, Setting, And Participants: Qualitative study performed as part of a larger explanatory sequential mixed methods design. Purposive sampling was used to recruit 21 practicing surgeons from a large statewide quality collaborative who were diverse with regard to practice type, geographic location, and surgical specialty. Qualitative interviews consisted of a clinical vignette, followed by semi-structured interview questions. Through thematic analysis using qualitive data analysis software, patterns within the data were located, analyzed, and identified. All data were collected between April 24 and July 31, 2018.

Exposure: Clinical vignette as part of the qualitative interviews.

Main Outcomes And Measures: Capture of surgical approaches and factors motivating decision-making for inguinal hernia repair.

Results: Of the 21 participating surgeons, 17 (81%) were men, 18 (86%) were White, and all were 35 years of age or older. Data revealed 3 dominant themes: surgeon preference and autonomy (eg, favoring one approach over the other), access and resources (eg, availability of robot), and patient characteristics (eg, age, comorbidities).

Conclusions And Relevance: Decision-making for the approach to inguinal hernia repair is largely influenced by surgeon preference and access to resources rather than patient factors. Although a one-size-fits-all approach is not recommended, the operative approach should ideally be informed by patient factors, including hernia characteristics. Addressing surgeon preference and available resources with a clinician-facing decision aid may provide an opportunity to optimize care for patients undergoing inguinal hernia repair.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.23684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677759PMC
November 2020

Improving obesity treatment through telemedicine: increasing access to bariatric surgery.

Surg Obes Relat Dis 2021 Jan 15;17(1):9-11. Epub 2020 Sep 15.

Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, Michigan; Department of Surgery, University of Michigan, Ann Arbor, Michigan.

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http://dx.doi.org/10.1016/j.soard.2020.09.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490239PMC
January 2021

Convergent Mixed Methods Exploration of Telehealth in Bariatric Surgery: Maximizing Provider Resources and Access.

Obes Surg 2021 04 27;31(4):1877-1881. Epub 2020 Oct 27.

Department of Surgery, University of Michigan, Ann Arbor, MI, USA.

Background: Telehealth may be an important care delivery modality in reducing dropout from bariatric surgery programs which is reported globally at approximately 50%.

Methods: In this convergent mixed methods case study of a large, US healthcare system, we examine the impact of telehealth implementation in 2020 on pre-operative bariatric surgery visits and provider perspectives of telehealth use.

Results: We find that telehealth was significantly associated with a 38% reduction in no-show rate compared with the prior year. Additionally, providers had positive experiences with regard to the appropriateness and feasibility of using telehealth in the pre-operative bariatric surgery process.

Conclusions: Telehealth use in the pre-operative bariatric surgery process may lead to greater efficiency in healthcare resource utilization. Insurance providers and bariatric accreditation bodies globally should consider accepting telehealth visits and self-reported weights when determining coverage decisions to ensure access for patients.
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http://dx.doi.org/10.1007/s11695-020-05059-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591243PMC
April 2021

Exploration of Surgeon Motivations in Management of Abdominal Wall Hernias: A Qualitative Study.

JAMA Netw Open 2020 09 1;3(9):e2015916. Epub 2020 Sep 1.

Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor.

Importance: Although evidence-based guidelines designed to minimize health care variation and promote effective care are widely accepted, creating guidelines alone does not often lead to the desired practice change. Such knowledge-to-practice gaps are well-recognized in the management of patients with abdominal wall hernia, where wide variation in patient selection and operative approach likely contributes to suboptimal patient outcomes. To create sustainable, scalable, and widespread adherence to evidence-based guidelines, it is imperative to better understand individual surgeon motivations and behaviors associated with surgical decision-making.

Objective: To evaluate the systematic application of the Theoretical Domains Framework (TDF) to explore motivations and behaviors associated with surgical decision-making in abdominal wall hernia practice to help inform the future design of theory-based interventions for desired practice and behavior change.

Design, Setting, And Participants: This qualitative study used purposive sampling to recruit 21 practicing surgeons at community and academic hospitals from 5 health regions across Michigan. It used interviews consisting of clinical vignettes for highly controversial situations in abdominal wall hernia repair, followed by semistructured interview questions based on the domains of the TDF to gain nuance into motivating factors associated with surgical practice. Patterns within the data were located, analyzed, and identified through thematic analysis using software. All data were collected between May and July 2018, and data analysis was performed from August 2018 to July 2019.

Main Outcomes And Measures: Factors associated with decisions on the surgical approach to abdominal wall hernia repair were assessed using TDF.

Results: Seventeen (81%) of the 21 participants were men, with a median (interquartile range) age of 47 (45-54) years. Of the 14 TDF domains, 5 were found to be most associated with decisions on the surgical approach to abdominal wall hernia repair for surgeons in Michigan: knowledge, beliefs about consequences, social or professional role and identity, environmental context and resources, and social influences. Mapping of the findings to the sources of behavior identified the potential intervention functions and policy categories that could be targeted for intervention. The intervention functions found to be most relevant included education, persuasion, modeling, incentivization, and environmental restructuring.

Conclusions And Relevance: Using the TDF, this study found that the primary factors associated with individual practice were opinion leaders, practice conformity, and reputational concerns. These findings are important because they challenge traditional dogma, which relies mainly on dissemination of published evidence, education, and technical skills acquisition to achieve evidence-based practice. Such knowledge allows for the development of sustainable, theory-based interventions for adherence to evidence-based guidelines.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.15916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492915PMC
September 2020

In the eye of the beholder: surgeon variation in intra-operative perceptions of hiatal hernia and reflux outcomes after sleeve gastrectomy.

Surg Endosc 2021 06 1;35(6):2537-2542. Epub 2020 Jun 1.

Department of Surgery, University of Michigan, 1500 E Medical Center Drive, SPC 5343, 2210 Taubman Center, Ann Arbor, MI, 48109, USA.

Background: Hiatal hernia repair performed at the time of laparoscopic sleeve gastrectomy (LSG) may reduce post-operative reflux symptoms. It is unclear whether intra-operative diagnosis of hiatal hernia varies among surgeons or if it affects outcomes.

Study Design: Surgeons (n = 38) participating in a statewide bariatric surgery quality improvement collaborative reviewed 33 videos of LSG in which no hiatal hernia repair was performed. Reviewers were blinded to patient information and were asked whether they perceived a hiatal hernia. Surgeon characteristics and surgeon-specific patient outcomes for LSG were compared between surgeons who identified at least one hiatal hernia during video review and those who did not.

Results: Ten surgeons (26%) identified at least one hiatal hernia after reviewing the videos. There were no significant differences in operative experience or practice type between surgeons who did and did not identify hiatal hernias. Surgeons who identified a hiatal hernia more often performed concurrent hiatal hernia repair in their practice when compared to those who did not (43.0% versus 36.5%, p < 0.001). Although complication rates were similar between surgeon groups, there were higher rates of de novo reflux symptoms (13.6% versus 11.1%, p = 0.032) and lower rates of antacid discontinuation at one-year (71.0% versus 77.2%, p = 0.043) among surgeons who identified hiatal hernias.

Conclusion: Surgeons who identified hiatal hernias during video review had a higher rate of concurrent hiatal hernia repairs in their practice. This was not associated with improved patient-reported reflux symptoms after LSG. Standardizing identification and management of hiatal hernias during bariatric surgery may help improve reflux outcomes post-operatively.
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http://dx.doi.org/10.1007/s00464-020-07668-4DOI Listing
June 2021

Bariatric Surgery Is Safe and It Works.

JAMA Surg 2020 03;155(3):205

Department of Surgery, University of Michigan, Ann Arbor.

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http://dx.doi.org/10.1001/jamasurg.2019.5471DOI Listing
March 2020

Opioid Use Following Bariatric Surgery: Results of a Prospective Survey.

Obes Surg 2020 Mar;30(3):1032-1037

Department of Surgery, University of Washington, Seattle, WA, USA.

Background: Opioid use after bariatric surgery is not clearly understood. Few guidelines exist to inform opioid-prescribing practices after bariatric surgery.

Objective: To understand opioid use following bariatric surgery.

Setting: University hospital.

Methods: Bariatric surgery patients at a single center were prospectively surveyed at the time of their post-operative visit (January-May 2018). Patients were asked about their opioid use following surgery, whether they received education about opioid use and what they did with leftover medications. Demographic and operative details were obtained from the medical record.

Results: Among 33 patients, the majority (n = 29, 88%) were female with a median age of 40 (20-68) and body mass index of 44.8 (33-78.5). Most patients had leftover narcotics (n = 25, 73%). The median number of pills used was 15 (0-48). Only 12 patients (36%) thought that they had been prescribed "too much" pain medication. Most patients reported receiving education about expectations for post-operative pain (n = 22, 69%); few recalled education about reducing or stopping opioids (n = 13, 40%). More than half of patients (n = 17, 53%) kept their leftover opioids rather than disposing of them or bringing them to an approved turn in location.

Conclusions: Despite most patients having leftover opioids following surgery, few patients recognized possible overprescription. Education regarding opioid use following surgery is inconsistent, potentially contributing to the amount of retained opioids currently available. Future guidelines should focus on determining the appropriate amount of opioids to be prescribed following surgery and standardizing and improving education given to patients.
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http://dx.doi.org/10.1007/s11695-019-04301-9DOI Listing
March 2020

Disclosure at #SAGES2018: An analysis of physician-industry relationships of invited speakers at the 2018 SAGES national meeting.

Surg Endosc 2020 06 6;34(6):2644-2650. Epub 2019 Aug 6.

Division of General Surgery, Department of Surgery, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.

Background: Financial conflicts of interest (COI) have been shown to affect the interpretation of scientific findings. Publications with unreported COI tend to be more favorable to industry. Since 2014 industry payments to United States (US) physicians are publicly reported in the Open Payments Database (OPD). Several studies show high levels of unreported COI in medical literature; however, there is no research examining COI reporting at surgical conferences. We hypothesized that compliance with the COI disclosure requirement would be high at the 2018 SAGES meeting. However, we expected to find significant discrepancy between speaker-reported and OPD-reported COI. A secondary aim was to characterize the amount, source, and variation in industry payments to invited speakers.

Methods: We reviewed all available presentations from SAGES 2018 as recorded and publicly available on YouTube™ for the presence of COI disclosure and the disclosed industry relationships. For US physicians we searched the OPD and recorded all industry payments > $500. We compared the self-disclosed COI for each speaker with OPD records. Presentation topics were divided into ten groups to determine which topics received the most funding.

Results: Of the 526 invited presentations, 479 (91%) videos were available. Disclosures were reported by 414 presenters (86.4%). There were 420 unique presenters of which 315 were listed in the OPD. Speaker-reported disclosures were fully concordant with the OPD in 38.3% (121/315) of cases with 39% (123/315) under-reporting disclosures. Of presenters listed in OPD, the median payment was $992 ($0-$374,502) with a total of $6,389,097 paid in 2017. SAGES speakers failed to disclose $2,049,535 worth of industry payments with an average undisclosed payment of $16,662.88 (± $40,733.19). The largest financial contributor was Intuitive Surgical with $1,981,169 paid. Among topics, robotics and hernia received the most funding with $2,593,925 (40.6%) and $2,591,671 (40.5%) paid, respectively.

Conclusions: Overall compliance with SAGES disclosure rules is high. There remains a discrepancy between speaker- and industry-reported disclosures, including a number of undisclosed payments, some of which are substantial. Adjustments to disclosure rules to include the relative amount of compensation may be warranted.
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http://dx.doi.org/10.1007/s00464-019-07037-wDOI Listing
June 2020

American College of Surgeons' Guidelines for the Perioperative Management of Antithrombotic Medication.

J Am Coll Surg 2018 11 24;227(5):521-536.e1. Epub 2018 Aug 24.

Department of Surgery, Moffitt Cancer Center, University of South Florida, Tampa, FL.

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http://dx.doi.org/10.1016/j.jamcollsurg.2018.08.183DOI Listing
November 2018

Methods for Incorporating Stakeholder Engagement into Clinical Trial Design.

EGEMS (Wash DC) 2017 May 10;5(1). Epub 2017 May 10.

Department of Surgery, University of Washington.

Context: Lack of engagement with healthcare stakeholders results in missed opportunities to understand translation of evidence into practice.

Case: Stakeholder engagement is a key component of the Comparing Outcomes of Drugs and Appendectomy (CODA) Study, a pragmatic clinical trial funded by PCORI to evaluate the effectiveness of antibiotics versus urgent appendectomy for acute uncomplicated appendicitis. We provide a framework for developing a stakeholder coordinating center (SCC) and describe two examples of how stakeholder engagement can inform study development.

Findings: Coordinating engagement activities through the SCC established a commitment to the important partnership with stakeholders. It also facilitated communication and provided a central mechanism for obtaining input on key decisions such as development of patient-centered consent documents and appropriate stopping rules for a specific sub-population of patients with appendicitis.

Major Themes: Translatable lessons include thoughtful planning for engagement, identifying stakeholders with a direct interest in the study conduct and findings, and integration of input received into the decisions that drive the conduct of the study.

Conclusions: Standards for conducting patient-centered research should address the ability to successfully engage patients by demonstrating the capacity to recruit study participants, engage them over the duration of the study, and disseminate findings that are congruent with stakeholder needs. The process of sharing important clinical research findings has improved patient care, and we believe that dissemination of novel engagement strategies can lead to increased success in study design and execution.
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http://dx.doi.org/10.13063/2327-9214.1274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5994960PMC
May 2017

Use of patient-reported outcomes and satisfaction for quality assessments.

Am J Manag Care 2017 Oct;23(10):618-622

University of Washington, 1107 NE 45th St, Ste 502, Box 354808, Seattle, WA 98195. E-mail:

Objectives: Recent focus on patient-reported outcomes (PROs) has created a new challenge as we learn how to integrate these outcomes into practice along with other quality metrics. We investigated the relationship between PROs and satisfaction among spine surgery patients. We hypothesized that there would be significant disparities between patient satisfaction and PROs at the 1-year postoperative time point.

Study Design: Retrospective cohort study of adults undergoing elective lumbar spine surgery at 12 hospitals participating in the Spine Surgical Care and Outcomes Assessment Program.

Methods: Satisfaction, pain, and function scores were collected at 1 year post operation, along with clinical information, to determine the relationship between PROs and satisfaction at the patient level.

Results: Among 520 patients (mean age = 63 ± 13 years; 47% male), the majority of patients (82%) reported being satisfied with surgery. Satisfaction was associated with both improvement in pain (odds ratio [OR], 1.33; 95% CI, 1.17-1.51) and function (OR, 1.06; 95% CI, 1.04-1.08). However, even among patients who did not improve in pain or function, more than half (59%) reported being satisfied.

Conclusions: Overall, patients undergoing elective lumbar spine surgery reported being satisfied with outcomes, but the reported responses in PROs were much more variable. As the expectations increase to include PRO measures as valid quality indicators, it is necessary to dedicate time and consideration to understanding the relationships among these measures to support meaningful translations into healthcare policy.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5846490PMC
October 2017

Achalasia Treatment, Outcomes, Utilization, and Costs: A Population-Based Study from the United States.

J Am Coll Surg 2017 Sep 7;225(3):380-386. Epub 2017 Jun 7.

Division of Cardiothoracic Surgery, University of Washington, Seattle, WA.

Background: Randomized trials show that pneumatic dilation (PD) ≥30 mm and laparoscopic myotomy (LM) provide equivalent symptom relief and disease-related quality of life for patients with achalasia. However, questions remain about the safety, burden, and costs of treatment options.

Study Design: We performed a retrospective cohort study of achalasia patients initially treated with PD or LM (2009 to 2014) using the Truven Health MarketScan Research Databases. All patients had 1 year of follow-up after initial treatment. We compared safety, health care use, and total and out-of-pocket costs using generalized linear models.

Results: Among 1,061 patients, 82% were treated with LM. The LM patients were younger (median age 49 vs 52 years; p < 0.01), but were similar in terms of sex (p = 0.80) and prevalence of comorbid conditions (p = 0.11). There were no significant differences in the 1-year cumulative risk of esophageal perforation (LM 0.8% vs PD 1.6%; p = 0.32) or 30-day mortality (LM 0.3% vs PD 0.5%; p = 0.71). Laparoscopic myotomy was associated with an 82% lower rate of reintervention (p < 0.01), a 29% lower rate of subsequent diagnostic testing (p < 0.01), and a 53% lower rate of readmission (p < 0.01). Total and out-of-pocket costs were not significantly different (p > 0.05).

Conclusions: In the US, LM appears to be the preferred treatment for achalasia. Both LM and PD appear to be safe interventions. Along a short time horizon, the costs of LM and PD were not different. Mirroring findings from randomized trials, LM is associated with fewer reinterventions, less diagnostic testing, and fewer hospitalizations.
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http://dx.doi.org/10.1016/j.jamcollsurg.2017.05.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5599146PMC
September 2017

Improved Risk Prediction Following Surgery Using Machine Learning Algorithms.

EGEMS (Wash DC) 2017 Apr 20;5(2). Epub 2017 Apr 20.

University of Washington School of Medicine.

Background: Machine learning is used to analyze big data, often for the purposes of prediction. Analyzing a patient's healthcare utilization pattern may provide more precise estimates of risk for adverse events (AE) or death. We sought to characterize healthcare utilization prior to surgery using machine learning for the purposes of risk prediction.

Methods: Patients from MarketScan Commercial Claims and Encounters Database undergoing elective surgery from 2007-2012 with ≥1 comorbidity were included. All available healthcare claims occurring within six months prior to surgery were assessed. More than 300 predictors were defined by considering all combinations of conditions, encounter types, and timing along with sociodemographic factors. We used a supervised Naive Bayes algorithm to predict risk of AE or death within 90 days of surgery. We compared the model's performance to the Charlson's comorbidity index, a commonly used risk prediction tool.

Results: Among 410,521 patients (mean age 52, 52 ± 9.4, 56% female), 4.7% had an AE and 0.01% died. The Charlson's comorbidity index predicted 57% of AE's and 59% of deaths. The Naive Bayes algorithm predicted 79% of AE's and 78% of deaths. Claims for cancer, kidney disease, and peripheral vascular disease were the primary drivers of AE or death following surgery.

Conclusions: The use of machine learning algorithms improves upon one commonly used risk estimator. Precisely quantifying the risk of an AE following surgery may better inform patient-centered decision-making and direct targeted quality improvement interventions while supporting activities of accountable care organizations that rely on accurate estimates of population risk.
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http://dx.doi.org/10.13063/2327-9214.1278DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5983054PMC
April 2017

Understanding clinical and non-clinical decisions under uncertainty: a scenario-based survey.

BMC Med Inform Decis Mak 2016 12 1;16(1):153. Epub 2016 Dec 1.

Department of Surgery, University of Washington, Seattle, WA, USA.

Background: Prospect theory suggests that when faced with an uncertain outcome, people display loss aversion by preferring to risk a greater loss rather than incurring certain, lesser cost. Providing probability information improves decision making towards the economically optimal choice in these situations. Clinicians frequently make decisions when the outcome is uncertain, and loss aversion may influence choices. This study explores the extent to which prospect theory, loss aversion, and probability information in a non-clinical domain explains clinical decision making under uncertainty.

Methods: Four hundred sixty two participants (n = 117 non-medical undergraduates, n = 113 medical students, n = 117 resident trainees, and n = 115 medical/surgical faculty) completed a three-part online task. First, participants completed an iced-road salting task using temperature forecasts with or without explicit probability information. Second, participants chose between less or more risk-averse ("defensive medicine") decisions in standardized scenarios. Last, participants chose between recommending therapy with certain outcomes or risking additional years gained or lost.

Results: In the road salting task, the mean expected value for decisions made by clinicians was better than for non-clinicians(-$1,022 vs -$1,061; <0.001). Probability information improved decision making for all participants, but non-clinicians improved more (mean improvement of $64 versus $33; p = 0.027). Mean defensive decisions decreased across training level (medical students 2.1 ± 0.9, residents 1.6 ± 0.8, faculty1.6 ± 1.1; p-trend < 0.001) and prospect-theory-concordant decisions increased (25.4%, 33.9%, and 40.7%;p-trend = 0.016). There was no relationship identified between road salting choices with defensive medicine and prospect-theory-concordant decisions.

Conclusions: All participants made more economically-rational decisions when provided explicit probability information in a non-clinical domain. However, choices in the non-clinical domain were not related to prospect-theory concordant decision making and risk aversion tendencies in the clinical domain. Recognizing this discordance may be important when applying prospect theory to interventions aimed at improving clinical care.
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http://dx.doi.org/10.1186/s12911-016-0391-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5131551PMC
December 2016

Alvimopan Use, Outcomes, and Costs: A Report from the Surgical Care and Outcomes Assessment Program Comparative Effectiveness Research Translation Network Collaborative.

J Am Coll Surg 2016 05 5;222(5):870-7. Epub 2016 Feb 5.

Department of Surgery, University of Washington, Seattle, WA.

Background: Randomized trials have found that alvimopan hastens return of bowel function and reduces length of stay (LOS) by 1 day among patients undergoing colorectal surgery. However, its effectiveness in routine clinical practice and its impact on hospital costs remain uncertain.

Study Design: We performed a retrospective cohort study of patients undergoing elective colorectal surgery in Washington state (2009 to 2013) using data from a clinical registry (Surgical Care and Outcomes Assessment Program) linked to a statewide hospital discharge database (Comprehensive Hospital Abstract Reporting System). We used generalized estimating equations to evaluate the relationship between alvimopan and outcomes, and adjusted for patient, operative, and management characteristics. Hospital charges were converted to costs using hospital-specific charge to cost ratios, and were adjusted for inflation to 2013 US dollars.

Results: Among 14,781 patients undergoing elective colorectal surgery at 51 hospitals, 1,615 (11%) received alvimopan. Patients who received alvimopan had a LOS that was 1.8 days shorter (p < 0.01) and costs that were $2,017 lower (p < 0.01) compared with those who did not receive alvimopan. After adjustment, LOS was 0.9 days shorter (p < 0.01), and hospital costs were $636 lower (p = 0.02) among those receiving alvimopan compared with those who did not.

Conclusions: When used in routine clinical practice, alvimopan was associated with a shorter LOS and limited but significant hospital cost savings. Both efficacy and effectiveness data support the use of alvimopan in routine clinical practice, and its use could be measured as a marker of higher quality care.
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http://dx.doi.org/10.1016/j.jamcollsurg.2016.01.051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4848460PMC
May 2016

Intra-Wound Antibiotics and Infection in Spine Fusion Surgery: A Report from Washington State's SCOAP-CERTAIN Collaborative.

Surg Infect (Larchmt) 2016 Apr 2;17(2):179-86. Epub 2016 Feb 2.

1 Department of Surgery, University of Washington , Seattle, Washington.

Background: Surgical site infection (SSI) after spine surgery is classified as a "never event" by the Centers for Medicare and Medicaid. Intra-wound antibiotics (IWA) have been proposed to reduce the incidence of SSI, but robust evidence to support its use is lacking.

Methods: Prospective cohort undergoing spine fusion at 20 Washington State hospitals (July 2011 to March 2014) participating in the Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP) linked to a discharge tracking system. Patient, hospital, and operative factors associated with SSI and IWA use during index hospitalizations through 600 days were analyzed using a random effects logistic model (index), and a time-to-event analysis (follow-up) using Cox proportional hazards.

Results: A total of 9,823 patients underwent cervical (47%) or lumbar (53%) procedures (mean age, 58; 54% female) with an SSI rate of 1.1% during index hospitalization. Those with SSI were older, more often had diabetes mellitus, and more frequently underwent lumbar (versus cervical) fusion compared with those without SSI (all p < 0.01). Unadjusted rates of SSI during index hospitalization were lower in patients who received IWA (0.8% versus 1.5%). After adjustment for patient, hospital, and operative factors, no benefit was observed in those receiving IWA (odds ratio [OR] 0.65, 95% confidence interval [CI]: 0.42-1.03). At 12 mo, unadjusted rates of SSI were 2.4% and 3.0% for those who did and did not receive antibiotics; after adjustment there was no significant difference (hazard ratio [HR] 0.94, 95% CI: 0.62-1.42).

Conclusions: Whereas unadjusted analyses indicate a nearly 50% reduction in index SSI using IWA, we did not observe a statistically significant difference after adjustment. Despite its size, this study is underpowered to detect small but potentially relevant improvements in rates of SSI. It remains to be determined if IWA should be promoted as a quality improvement intervention. Concerns related to bias in the use of IWA suggest the benefit of a randomized trial.
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http://dx.doi.org/10.1089/sur.2015.146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4790200PMC
April 2016
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