Prenatal detection rates for congenital heart disease using abnormal obstetrical screening ultrasound alone as indication for fetal echocardiography.

OBJECTIVE: To determine the live born prenatal detection rate of significant congenital heart disease (CHD) in a large, integrated, multi-center community-based health system using a strategy of referral only of patients with significant cardiac abnormalities on obstetrical screening ultrasound for fetal echocardiography. Detection rates were assessed for screening in both radiology and maternal fetal medicine (MFM). The impact on fetal echocardiography utilization was also assessed. METHODS: This was a retrospective cohort study using an electronic health record, outside claims databases and chart review to determine all live births between 2016 and 2020 with postnatally confirmed sCHD that were prenatally detectable and resulted in cardiac surgery, intervention, or death within 1 year. RESULTS: There were 214,486 pregnancies resulting in live births. Prenatally detectable significant CHD was confirmed in 294 infants. Of those 183 were detected for an overall live-born detection rate of 62%. Detection rates in MFM were 75% and in radiology were 52%. The number of fetal echocardiograms needed to detect (NND) sCHD was 7. CONCLUSIONS: A focus on quality and standardization of obstetrical screening ultrasound with referral to fetal echocardiography for cardiac abnormalities alone achieves benchmark targets for live-born detection of significant CHD requiring fewer fetal echocardiograms.

Neurotrophic keratopathy: Clinical presentation and outcomes in 354 eyes in a community-based population.

PURPOSE: To describe the frequency, clinical presentation, and outcomes of neurotrophic keratopathy (NK). METHODS: Retrospective cohort study of Kaiser Permanente Northern California patients diagnosed with NK using ICD-10 code H16.23X from October 1, 2016 through May 31, 2021 was conducted. The electronic medical record was used to obtain demographic information, systemic and ocular comorbidities, corrected distance visual acuity (CDVA), Mackie stage, laterality, etiology, complications, interventions, and medications. The data were analyzed using cross-tabulations. RESULTS: 354 eyes in 322 patients presented with an initial or recurrent episode of NK. 9.9% had bilateral NK, 40% were 75 years and older, and 55% were women. Baseline vision was worse than 20/100 in 47.5%. Mackie staging was stage 1 in 37.3%, stage 2 in 32.5%, and stage 3 in 30.2%. Herpetic causes comprised 34.9%, followed by diabetes (12.4%), ocular surgery (10.4%), and central nervous system etiologies (9.0%). Topical antibiotics (74.5%), steroids (54.0%), autologous serum tears (46.0%), and oral antivirals (43.8%) were the most used treatments. There were 8 eyes with perforation, 4 endophthalmitis, and 3 evisceration/enucleations. An increased difference of approximately 0.1 logMAR in CDVA in the affected eye compared with the unaffected eye over one year was not statistically significant. Clinic utilization for stage 2 (average visits per month, 3.2) and stage 3 (5.0) NK gradually decreased over 6 months. CONCLUSIONS: Summary of the current management, outcomes, and healthcare utilization of NK provides valuable benchmarks in assessing the disease burden in the community and for further development of novel therapies.

Effectiveness of Bundled Hyperpolypharmacy Deprescribing Compared With Usual Care Among Older Adults: A Randomized Clinical Trial.

Importance: Older patients using many prescription drugs (hyperpolypharmacy) may be at increased risk of adverse drug effects. Objective: To test the effectiveness and safety of a quality intervention intended to reduce hyperpolypharmacy. Design, Setting, and Participants: This randomized clinical trial allocated patients 76 years or older who used 10 or more prescription medications to a deprescribing intervention or to usual care (1:1 ratio) at an integrated health system with multiple preexisting deprescribing workflows. Data were collected from October 15, 2020, to July 29, 2022. Intervention: Physician-pharmacist collaborative drug therapy management, standard-of-care practice recommendations, shared decision-making, and deprescribing protocols administered by telephone over multiple cycles for a maximum of 180 days after allocation. Main Outcomes and Measures: Primary end points were change in the number of medications and in the prevalence of geriatric syndrome (falls, cognition, urinary incontinence, and pain) from 181 to 365 days after allocation compared with before randomization. Secondary outcomes were use of medical services and adverse drug withdrawal effects. Results: Of a random sample of 2860 patients selected for potential enrollment, 2470 (86.4%) remained eligible after physician authorization, with 1237 randomized to the intervention and 1233 to usual care. A total of 1062 intervention patients (85.9%) were reached and agreed to enroll. Demographic variables were balanced. The median age of the 2470 patients was 80 (range, 76-104) years, and 1273 (51.5%) were women. In terms of race and ethnicity, 185 patients (7.5%) were African American, 234 (9.5%) were Asian or Pacific Islander, 220 (8.9%) were Hispanic, 1574 (63.7%) were White (63.7%), and 257 (10.4%) were of other (including American Indian or Alaska Native, Native Hawaiian, or >1 race or ethnicity) or unknown race or ethnicity. During follow-up, both the intervention and usual care groups had slight reductions in the number of medications dispensed (mean changes, -0.4 [95% CI, -0.6 to -0.2] and -0.4 [95% CI, -0.6 to -0.3], respectively), with no difference between the groups (P = .71). There were no significant changes in the prevalence of a geriatric condition in the usual care and intervention groups at the end of follow-up and no difference between the groups (baseline prevalence: 47.7% [95% CI, 44.9%-50.5%] vs 42.9% [95% CI, 40.1%-45.7%], respectively; difference-in-differences, 1.0 [95% CI, -3.5 to 5.6]; P = .65). No differences in use of medical services or adverse drug withdrawal effects were observed. Conclusions and Relevance: In this randomized clinical trial from an integrated care setting with various preexisting deprescribing workflows, a bundled hyperpolypharmacy deprescribing intervention was not associated with reduction in medication dispensing, prevalence of geriatric syndrome, utilization of medical services, or adverse drug withdrawal effects. Additional research is needed in less integrated settings and in more targeted populations. Trial Registration: ClinicalTrials.gov Identifier: NCT05616689.

The implementation checklist: A pragmatic instrument for accelerating research-to-implementation cycles.

Introduction: Learning health systems require rapid-cycle research and nimble implementation processes to maximize innovation across disparate specialties and operations. Existing detailed research-to-implementation frameworks require extensive time commitments and can be overwhelming for physician-researchers with clinical and operational responsibilities, inhibiting their widespread adoption. The creation of a short, pragmatic checklist to inform implementation processes may substantially improve uptake and implementation efficiency across a variety of health systems. Methods: We conducted a systematic review of existing implementation frameworks to identify core concepts. Utilizing comprehensive stakeholder engagement with 25 operational leaders, embedded physician-researchers, and delivery scientists, concepts were iteratively integrated to create and implement a final concise instrument. Results: A systematic review identified 894 publications describing implementation frameworks, which included 15 systematic reviews. Among these, domains were extracted from three commonly utilized instruments: the Quality Implementation Framework (QIF), the Consolidated Framework for Implementation Research (CFIR), and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Iterative testing and stakeholder engagement revision of a four-page draft implementation document with five domains resulted in a concise, one-page implementation planning instrument to be used at project outset and periodically throughout project implementation planning. The instrument addresses end-user feasibility concerns while retaining the main goals of more complex tools. This instrument was then systematically integrated into projects within the Kaiser Permanente Northern California Delivery Science and Applied Research program to address stakeholder engagement, efficiency, project planning, and operational implementation of study results. Conclusion: A streamlined one-page implementation planning instrument, incorporating core concepts of existing frameworks, provides a pragmatic, robust framework for evidence-based healthcare innovation cycles that is being broadly implemented within a learning health system. These streamlined processes could inform other settings needing a best practice rapid-cycle research-to-implementation tool for large numbers of diverse projects.

Reduction in Long-term Mortality After Sleeve Gastrectomy and Gastric Bypass Compared to Nonsurgical Patients With Severe Obesity.

OBJECTIVE: To separately compare the long-term risk of mortality among bariatric surgical patients undergoing either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) to large, matched, population-based cohorts of patients with severe obesity who did not undergo surgery. BACKGROUND: Bariatric surgery has been associated with reduced long-term mortality compared to usual care for severe obesity which is particularly relevant in the COVID-19 era. Most prior studies involved the RYGB operation and there is less long-term data on the SG. METHODS: In this retrospective, matched cohort study, patients with a body mass index ≥35 kg/m 2 who underwent bariatric surgery from January 2005 to September 2015 in three integrated health systems in the United States were matched to nonsurgical patients on site, age, sex, body mass index, diabetes status, insulin use, race/ethnicity, combined Charlson/Elixhauser comorbidity score, and prior health care utilization, with follow-up through September 2015. Each procedure (RYGB, SG) was compared to its own control group and the two surgical procedures were not directly compared to each other. Multivariable-adjusted Cox regression analysis investigated time to all-cause mortality (primary outcome) comparing each of the bariatric procedures to usual care. Secondary outcomes separately examined the incidence of cardiovascular-related death, cancer related-death, and diabetes related-death. RESULTS: Among 13,900 SG, 17,258 RYGB, and 87,965 nonsurgical patients, the 5-year follow-up rate was 70.9%, 72.0%, and 64.5%, respectively. RYGB and SG were each associated with a significantly lower risk of all-cause mortality compared to nonsurgical patients at 5-years of follow-up (RYGB: HR = 0.43; 95% CI: 0.35,0.54; SG: HR = 0.28; 95% CI: 0.13,0.57) Similarly, RYGB was associated with a significantly lower 5-year risk of cardiovascular-(HR = 0.27; 95% CI: 0.20, 0.37), cancer- (HR = 0.54; 95% CI: 0.39, 0.76), and diabetes-related mortality (HR = 0.23; 95% CI:0.15, 0.36). There was not enough follow-up time to assess 5-year cause-specific mortality in SG patients, but at 3-years follow-up, there was significantly lower risk of cardiovascular- (HR = 0.33; 95% CI:0.19, 0.58), cancer- (HR = 0.26; 95% CI:0.11, 0.59), and diabetes-related (HR = 0.15; 95% CI:0.04, 0.53) mortality for SG patients. CONCLUSION: This study confirms and extends prior findings of an association with better survival following bariatric surgery in RYGB patients compared to controls and separately demonstrates that the SG operation also appears to be associated with lower mortality compared to matched control patients with severe obesity that received usual care. These results help to inform the tradeoffs between long-term benefits and risks of bariatric surgery.

Association of Standardized Radiology Reporting and Management of Abdominal CT and MRI With Diagnosis of Pancreatic Cancer.

BACKGROUND & AIMS: Follow-up of abdominal computed tomography (CT) and magnetic resonance imaging (MRI) findings suspicious for pancreatic cancer may be delayed if documentation is unclear. We evaluated whether standardized reporting and follow-up of imaging results reduced time to diagnosis of pancreatic cancer. METHODS: We used a quasi-experimental stepped-wedge cluster design to evaluate the effectiveness of newly implemented radiology reporting system. The system standardizes the reporting of CT and MRI reports using hashtags that classify pancreatic findings. The system also automates referral of patients with findings suspicious for pancreatic cancer to a multidisciplinary care team for rapid review and follow-up. The study examined 318,331 patients who underwent CT or MRI that included the abdomen from 2016 through 2019 who had not had an eligible CT or MRI in the preceding 24 months. We evaluated the association of the intervention with incidence of pancreatic cancer within 60 days and 120 days after imaging. RESULTS: Thirty-eight percent of patients received the intervention, and 1523 patients (0.48%) were diagnosed with pancreatic cancer. In multivariable analysis accounting for age, race/ethnicity, sex, Charlson comorbidity, history of cancer, diabetes, and 4-month calendar period, the intervention was associated with nearly 50% greater odds of diagnosing pancreatic cancer within 60 days (adjusted odds ratio, 1.47; 95% confidence interval, 1.05-2.06) and 120 days (adjusted odds ratio, 1.46; 95% confidence interval, 1.04-2.06). CONCLUSIONS: In this large quasi-experimental, community-based observational study, implementing standardized reporting of abdominal CT and MRI reports with clinical navigation was effective for increasing the detection and diagnosis of pancreatic cancer.

Risk of cardiac events after elective versus urgent or emergent noncardiac surgery: Implications for quality measurement and improvement.

INTRODUCTION: Patient populations differ for elective vs urgent and emergent surgery. The effect of this difference on surgical outcome is not well understood and may be important for improving surgical safety. Our primary hypothesis was that there is an association of surgical acuity with risk of postoperative cardiac events. Secondarily, we examined elective vs urgent and emergent patients separately to understand patient characteristics that are associated with postoperative cardiac events. METHODS: We performed a retrospective cohort study of patients ≥65 years undergoing noncardiac elective or urgent/emergent surgery. Logistic regression estimated the association of surgical acuity with a postoperative cardiac event, which was defined as myocardial infarction or cardiac arrest within 30 days of surgery. For the secondary analysis, we modeled the outcome after stratifying by acuity. RESULTS: The study included 161,177 patients with 1014 cardiac events. The unadjusted risk of a postoperative cardiac event was 3.2 per 1000 among elective patients and 28.7 per 1000 among urgent and emergent patients (adjusted odds ratio 4.10, 95% confidence interval 3.56-4.72). After adjustment, increased age, higher baseline cardiac risk, peripheral vascular disease, hypertension, worse American Society of Anesthesiologist (ASA) physical classification, and longer operative time were associated with a postoperative cardiac event. Higher baseline cardiac risk was more strongly associated with postoperative cardiac events in elective patients. In contrast, worse ASA physical classification was more strongly associated with postoperative cardiac events in urgent and emergent patients. Black patients had higher odds of a postoperative cardiac event only in urgent and emergent patients compared to White patients. CONCLUSIONS: Quality measurement and improvement to address postoperative cardiac risk should consider patients based on surgical acuity.

Limitations to Health Care Quality Measurement: Assessing Hospital Variation in Risk of Cardiac Events After Noncardiac Surgery.

Limited sample size, incomplete measures, and inadequate risk adjustment adversely influence accurate health care quality measurements, surgical quality measurements, and accurate comparisons among hospitals. Since these measures are linked to resources for quality improvement and reimbursement, improving the accuracy of measurement has substantial implications for patients, clinicians, hospital administrators, insurers, and purchasers. The team examined risk-adjusted differences of postoperative cardiac events among 20 geographically dispersed, community-based medical centers within an integrated health care system and compared it with the National Surgical Quality Improvement Program (NSQIP) hospital-specific differences. The exposure included the hospital at which patients received noncardiac surgical care, with stratification of patients by the acuity of surgery (elective vs. urgent/emergent). Among 157,075 surgery patients, the unadjusted risk of cardiac event per 1000 ranged among hospitals from 2.1 to 6.9 for elective surgery and from 10.3 to 44.5 for urgent/emergent surgery. Across the 20 hospitals, hospital rankings estimated in the present analysis differed significantly from ranking reported by NSQIP (P for difference: elective, P = 0.0001; urgent/emergent, P < 0.0001) with significantly and substantially lower variation after risk adjustment. Current surgical quality measures may not adequately account for limitations of sample size, data capture, adequate risk adjustment, and surgical acuity in a given hospital, particularly for rare outcomes. These differences have implications for quality reporting and may introduce bias into hospital comparisons, particularly for hospitals with incomplete capture of their patients' baseline risk and acuity.

Remission and Relapse of Hypertension After Bariatric Surgery: A Retrospective Study on Long-Term Outcomes.

To compare hypertension remission and relapse after bariatric surgery compared with usual care. Background: The effect of Roux-en-Y gastric bypass and sleeve gastrectomy on hypertension remission and relapse has not been studied in large, multicenter studies over long periods and using clinical blood pressure (BP) measurements. Methods: This retrospective cohort study was set in Kaiser Permanente Washington, Northern California, and Southern California. Participants included 9432 patients with hypertension 21-65 years old who underwent bariatric surgery during 2005-2015 and 66,651 nonsurgical controls matched on an index date on study site, age, sex, race/ethnicity, body mass index, comorbidity burden, diabetes status, diastolic and systolic BP, and number of antihypertensive medications. Results: At 5 years, the unadjusted cumulative incidence of hypertension remission was 60% (95% confidence interval [CI], 58-61%) among surgery patients and 14% (95% CI, 13-14%) among controls. At 1 year, the adjusted hazard ratio for the association of bariatric surgery with hypertension remission was 10.24 (95% CI, 9.61-10.90). At 5 years, the adjusted hazard ratio was 2.10 (95% CI, 1.57-2.80). Among those who remitted, the unadjusted cumulative incidence of relapse at 5 years after remission was 54% (95% CI, 51-56%) among surgery patients and 78% (95% CI 76-79%) among controls, although the adjusted hazard ratio was not significant (hazard ratio, 0.71; 95% CI, 0.46-1.08). Conclusions: Bariatric surgery was associated with greater hypertension remission than usual care suggesting that bariatric surgery should be discussed with patients with severe obesity and hypertension. Surgical patients who experience remission should be monitored carefully for hypertension relapse.

Association of teledermatology workflows with standardising co-management of rashes by primary care physicians and dermatologists.

INTRODUCTION: For patients with a rash, the effect of teledermatology workflow on utilization has not been defined. We compared utilization across four teledermatology workflows in patients with a rash. METHODS: The observational longitudinal cohort study included 28,857 Kaiser Permanente Northern California members with a new rash diagnosis seen in primary care and with dermatology advice obtained using teledermatology. The workflows differed in camera and image quality; who took the picture; how the image was forwarded; and synchronicity and convenience. RESULTS: On average, 23% of patients had a follow-up office visit in dermatology within 90 days of their primary care visit. In multivariable analysis, the four technologies differed substantially in the likelihood of a follow-up dermatology office visit. In contrast, the likelihood was only negligibly related to medical centre or primary care provider. DISCUSSION: Technologies and workflows that offer the mobility of a smartphone with a high level of synchronicity in communication were associated with standardised co-management of rashes.

Bariatric Surgery and Risk of Death in Persons With Chronic Kidney Disease.

OBJECTIVE: A retrospective cohort study investigated the association between having surgery and risk of mortality for up to 5 years and if this association was modified by incident ESRD during the follow-up period. Summary of Background Data: Mortality risk in individuals with pre-dialysis CKD is high and few effective treatment options are available. Whether bariatric surgery can improve survival in people with CKD is unclear. METHODS: Patients with class II and III obesity and pre-dialysis CKD stages 3-5 who underwent bariatric surgery between January 1, 2006 and September 30, 2015 (n = 802) were matched to patients who did not have surgery (n = 4933). Mortality was obtained from state death records and ESRD was identified through state-based or healthcare system-based registries. Cox regression models were used to investigate the association between bariatric surgery and risk of mortality and if this was moderated by incident ESRD during the follow-up period. RESULTS: Patients were primarily women (79%), non-Hispanic White (72%), under 65 years old (64%), who had a body mass index > 40kg/m 2 (59%), diabetes (67%), and hypertension (89%). After adjusting for incident ESRD, bariatric surgery was associated with a 79% lower 5-year risk of mortality compared to matched controls (hazard ratio = 0.21; 95% confidence interval: 0.14-0.32; P < 0.001). Incident ESRD did not moderate the observed association between surgery and mortality (hazard ratio = 1.59; 95% confidence interval: 0.31-8.23; P =0.58). CONCLUSIONS: Bariatric surgery is associated with a reduction in mortality in pre-dialysis patients regardless of developing ESRD. These findings are significant because patients with CKD are at relatively high risk for death with few efficacious interventions available to improve survival.

Cohort and nested case-control study of cutaneous squamous cell carcinoma in solid organ transplant recipients, by medication.

BACKGROUND: Knowledge is needed about the risk of cutaneous squamous cell carcinoma (cSCC) in solid organ transplant recipients (SOTRs) using contemporary immunosuppressive regimens. OBJECTIVE: Evaluate the risk of cSCC in relation to medications used by SOTRs. METHODS: The cohort and nest case-control study included 3308 SOTRs and 65,883 persons without transplantation during 2009-2019. Incident cSCC was identified from pathology data, and medications were identified from pharmacy data. Adjusted hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards analysis, with voriconazole examined as a time-dependent variable. RESULTS: The annual incidence of cSCC was 1.69% in SOTRs and 0.30% in persons without transplantation. The adjusted hazard ratio of cSCC associated with lung transplant was 14.83 (95% CI, 9.85-22.33) for lung and 6.53-10.69 for other organs. Risk in Latinx persons was higher than in other non-White groups. Among lung recipients, the hazard ratio was 1.14 for each month of voriconazole use (95% CI, 1.04-1.26). Azathioprine use for ≥7 months, relating to mycophenolate mofetil intolerance, was associated with a 4.22-fold increased risk of cSCC (95% CI, 1.90-9.40). Belatacept and other immunsuppressive medications were not associated with risk. LIMITATION: The number of events was somewhat small. CONCLUSIONS: The knowledge of risks and benefits in diverse patients can translate to improvements in care.

Patient Experience and Satisfaction With Immediate Sequential and Delayed Sequential Bilateral Cataract Surgery.

PURPOSE: In bilaterally pseudophakic patients who received immediate or delayed sequential bilateral cataract surgery (ISBCS or DSBCS), we sought to determine patient experience, particularly related to the loss of opportunity to modify the surgical plan for the second eye. DESIGN: Cross-sectional. METHODS: Patients who received ISBCS (n = 1818) and DSBCS (n = 1818) in the Kaiser Permanente Northern California system between 2017 and 2019 who actively used the electronic patient portal were randomly selected and sent a survey link. The survey inquired about reasons for choosing ISBCS or DSBCS, concerns about surgery, and whether the loss of opportunity to modify the surgical plan for the second eye affected the patient's decision to undergo ISBCS. RESULTS: Participation was 18% among patients who received ISBCS and 17% among patients who received DSBCS. Of the patients who received ISBCS, 96% would choose ISBCS again while 80% of patients who received DSBCS would choose DSBCS again (P < .0001). Convenience was the leading reason patients chose ISBCS (65%), whereas surgeon recommendation was the primary reason patients chose DSBCS (68%). Sixteen percent of patients who received ISBCS and 38% of patients who received DSCBS reported that the possibility of modifying the surgical plan to reduce the need for corrective lenses in the second eye was an important consideration (P < .0001). CONCLUSIONS: Compared with patient who chose DSBCS, patients who chose ISBCS were more likely to choose ISBCS again and to recommend ISBCS to a family member or friend. The option to modify the surgical plan for the second eye to reduce need for glasses or contact lenses was not an important consideration for most of either group.

Outcomes following interventions to sustain body weight in esophageal cancer patients starting preoperative therapy: a retrospective cohort study.

BACKGROUND: To improve nutritional status and dysphagia, esophageal cancer patients starting neoadjuvant therapy in advance of curative-intent surgery may receive a jejunostomy tube (J-tube) or esophageal stent, or they may be managed without a feeding modality. We examined percent total weight loss (%TWL), reinterventions, and progression to surgery in relation to these options. METHODS: The retrospective cohort study included stage II-III esophageal cancer patients diagnosed during 2010-2017 who received J-tube, stent, or nutritional counseling only, without a procedure, when starting chemotherapy or combined modality chemoradiation. Data were obtained from the electronic medical record and chart review. We compared median %TWL between intervention groups and reinterventions using Chi-square and Kruskal-Wallis tests. RESULTS: Among the 366 patients, median %TWL reached a nadir at 120 days, when it was 7% for patients with no procedure (N=307), 4% for J-tube (N=39), and 16% for stent (N=20) (P=0.01). Individual case analysis revealed 72-80% of the patients in the three groups started chemotherapy or chemoradiation as neoadjuvant curative-intent therapy (P difference =0.79). In J-tube patients, the reasons for intervention was anticipation of weight loss in 49% and mitigation of actual weight loss in 15%, whereas 95% of stent patients received the stent for dysphagia (P<0.001). A complication of the procedure was recorded in 85% of stent patients and 74% of J-tube patients (P<0.001). Among those who received no procedure initially, 25% received one later, compared with 15% of J-tube patients and 70% of stent patients who received a second procedure (P<0.001). Progression to surgery was observed in 65% of patients with no procedure, 51% of patients with J-tube, and 40% of stent patients, P=0.28). CONCLUSIONS: For stage II-III esophageal cancer patients starting chemotherapy, this study gives evidence that stents were associated with significant %TWL and risk of reintervention. Although J-tube patients returned to baseline weight sooner than those with no procedure, they experienced complications from their J-tubes. For esophageal cancer patients undergoing curative-intent treatment and with acceptable levels of weight loss, no procedure at all may be superior to placing a J-tube in terms of complications, weight loss, and progression to curative-intent surgery.

Adjusting for selection bias due to missing data in electronic health records-based research.

While electronic health records data provide unique opportunities for research, numerous methodological issues must be considered. Among these, selection bias due to incomplete/missing data has received far less attention than other issues. Unfortunately, standard missing data approaches (e.g. inverse-probability weighting and multiple imputation) generally fail to acknowledge the complex interplay of heterogeneous decisions made by patients, providers, and health systems that govern whether specific data elements in the electronic health records are observed. This, in turn, renders the missing-at-random assumption difficult to believe in standard approaches. In the clinical literature, the collection of decisions that gives rise to the observed data is referred to as the data provenance. Building on a recently-proposed framework for modularizing the data provenance, we develop a general and scalable framework for estimation and inference with respect to regression models based on inverse-probability weighting that allows for a hierarchy of missingness mechanisms to better align with the complex nature of electronic health records data. We show that the proposed estimator is consistent and asymptotically Normal, derive the form of the asymptotic variance, and propose two consistent estimators. Simulations show that naïve application of standard methods may yield biased point estimates, that the proposed estimators have good small-sample properties, and that researchers may have to contend with a bias-variance trade-off as they consider how to handle missing data. The proposed methods are motivated by an on-going, electronic health records-based study of bariatric surgery.

Clinical Outcomes Following Regionalization of Gastric Cancer Care in a US Integrated Health Care System.

PURPOSE: In 2016, Kaiser Permanente Northern California regionalized gastric cancer care, introducing a regional comprehensive multidisciplinary care team, standardizing staging and chemotherapy, and implementing laparoscopic gastrectomy and D2 lymphadenectomy for patients eligible for curative-intent surgery. This study evaluated the effect of regionalization on outcomes. METHODS: The retrospective cohort study included gastric cancer cases diagnosed from January 2010 to May 2018. Information was obtained from the electronic medical record, cancer registry, state vital statistics, and chart review. Overall survival was compared in patients with all stages of disease, stage I-III disease, and curative-intent gastrectomy patients using annual inception cohorts. For the latter, the surgical approach and surgical outcomes were also compared. RESULTS: Among 1,429 eligible patients with gastric cancer with all stages of disease, one third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery. Among surgical patients, neoadjuvant chemotherapy utilization increased from 35% to 66% (P < .0001), laparoscopic gastrectomy increased from 18% to 92% (P < .0001), and D2 lymphadenectomy increased from 2% to 80% (P < .0001). Dissection of ≥ 15 lymph nodes increased from 61% to 95% (P < .0001). Surgical complication rates did not appear to increase after regionalization. Length of hospitalization decreased from 7 to 3 days (P < .001). Overall survival at 2 years was as follows: all stages, 32.8% pre and 37.3% post (P = .20); stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among surgery patients, 72.7% and 85.5%, respectively (P < .03). CONCLUSION: Regionalization of gastric cancer care within an integrated system allowed comprehensive multidisciplinary care, conversion to laparoscopic gastrectomy and D2 lymphadenectomy, increased overall survival among surgery patients, and no increase in surgical complications.

Risk stratification for colorectal cancer in individuals with subtypes of serrated polyps.

OBJECTIVE: The longitudinal risk of colorectal cancer (CRC) associated with subtypes of serrated polyps (SPs) remains incompletely understood. DESIGN: This community-based, case-control study included 317 178 Kaiser Permanente Northern California members who underwent their first colonoscopy during 2006-2016. Nested within this population, we identified 695 cases of CRC and 3475 CRC-free controls (matched 5:1 to cases for age, sex and year of colonoscopy). Two expert pathologists reviewed the tissue slides of all SPs identified on the first colonoscopy and reclassified them to sessile serrated lesions (SSLs), hyperplastic polyps (HPs) and traditional serrated adenomas. SPs with borderline characteristics of SSLs but insufficient to make a definitive diagnosis were categorised as unspecified SPs. The association with development of CRC was assessed using multivariable logistic regression. RESULTS: Compared with individuals with no polyp, the adjusted ORs (aORs) for SSL alone or with synchronous adenoma were 2.9 (95% CI: 1.8 to 4.8) and 4.4 (95% CI: 2.7 to 7.2), respectively. The aORs for SSL with dysplasia, large proximal SSL,and small proximal SSL were 10.3 (95% CI: 2.1 to 50.3), 12.8 (95% CI: 3.5 to 46.9) and 1.9 (95% CI: 0.8 to 4.7), respectively. Proximal unspecified SP also conferred an increased risk (aOR: 5.8, 95% CI: 2.2 to 15.2). Women with SSL were associated with higher risk (aOR: 4.4; 95% CI: 2.3 to 8.2) than men (aOR: 1.7; 95% CI: 0.8 to 3.8). CONCLUSION: Increased risk of CRC was observed in individuals with SSLs, particularly large proximal ones or with dysplasia, supporting close endoscopic surveillance. Proximal unspecified SPs were also associated with increased risk of CRC and should be managed as SSLs.