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1.
Anesthesiology ; 2024 May 16.
Article in English | MEDLINE | ID: mdl-38753986

ABSTRACT

BACKGROUND: Observational studies of anesthetic neurotoxicity may be biased because children requiring anesthesia commonly have medical conditions associated with neurobehavioral problems. This study takes advantage of a natural experiment associated with appendicitis, in order to determine if anesthesia and surgery in childhood were specifically associated with subsequent neurobehavioral outcomes. METHODS: We identified 134,388 healthy children with appendectomy and examined the incidence of subsequent externalizing or behavioral disorders (conduct, impulse control, oppositional defiant, or attention-deficit/hyperactivity disorder); or internalizing or mood/anxiety disorders (depression, anxiety, or bipolar disorder) when compared to 671,940 matched healthy controls as identified in Medicaid data between 2001-2018. For comparison, we also examined 154,887 otherwise healthy children admitted to the hospital for pneumonia, cellulitis, and gastroenteritis, of which only 8% received anesthesia, and compared them to 774,435 matched healthy controls. We also examined the difference-in-differences between matched appendectomy patients and their controls and matched medical admission patients and their controls. RESULTS: Compared to controls, children with appendectomy were more likely to have subsequent behavioral disorders (the hazard ratio (HR) was 1.04 (95% CI 1.01, 1.06), P = 0.0010), and mood/anxiety disorders (HR: 1.15 (95% CI 1.13, 1.17), P < 0.0001). Relative to controls, children with medical admissions were also more likely to have subsequent behavioral (HR: 1.20 (95% CI 1.18, 1.22), P < 0.0001), and mood/anxiety (HR: 1.25 (95% CI 1.23, 1.27), P < 0.0001) disorders. Comparing the difference between matched appendectomy patients and their matched controls to the difference between matched medical patients and their matched controls, medical patients had more subsequent neurobehavioral problems than appendectomy patients. CONCLUSIONS: Although there is an association between neurobehavioral diagnoses and appendectomy, this association is not specific to anesthesia exposure, and is stronger in medical admissions. Medical admissions, generally without anesthesia exposure, displayed significantly higher rates of these disorders than appendectomy-exposed patients.

2.
Ann Surg ; 279(4): 631-639, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38456279

ABSTRACT

OBJECTIVE: To compare general surgery outcomes at flagship systems, flagship hospitals, and flagship hospital affiliates versus matched controls. SUMMARY BACKGROUND DATA: It is unknown whether flagship hospitals perform better than flagship hospital affiliates for surgical patients. METHODS: Using Medicare claims for 2018 to 2019, we matched patients undergoing inpatient general surgery in flagship system hospitals to controls who underwent the same procedure at hospitals outside the system but within the same region. We defined a "flagship hospital" within each region as the major teaching hospital with the highest patient volume that is also part of a hospital system; its system was labeled a "flagship system." We performed 4 main comparisons: patients treated at any flagship system hospital versus hospitals outside the flagship system; flagship hospitals versus hospitals outside the flagship system; flagship hospital affiliates versus hospitals outside the flagship system; and flagship hospitals versus affiliate hospitals. Our primary outcome was 30-day mortality. RESULTS: We formed 32,228 closely matched pairs across 35 regions. Patients at flagship system hospitals (32,228 pairs) had lower 30-day mortality than matched control patients [3.79% vs. 4.36%, difference=-0.57% (-0.86%, -0.28%), P<0.001]. Similarly, patients at flagship hospitals (15,571/32,228 pairs) had lower mortality than control patients. However, patients at flagship hospital affiliates (16,657/32,228 pairs) had similar mortality to matched controls. Flagship hospitals had lower mortality than affiliate hospitals [difference-in-differences=-1.05% (-1.62%, -0.47%), P<0.001]. CONCLUSIONS: Patients treated at flagship hospitals had significantly lower mortality rates than those treated at flagship hospital affiliates. Hence, flagship system affiliation does not alone imply better surgical outcomes.


Subject(s)
Hospitals, Teaching , Medicare , Humans , Aged , United States , Treatment Outcome , Hospital Mortality
3.
Br J Anaesth ; 132(5): 899-910, 2024 May.
Article in English | MEDLINE | ID: mdl-38423824

ABSTRACT

BACKGROUND: The association between prenatal exposure to general anaesthesia for maternal surgery during pregnancy and subsequent risk of disruptive or internalising behavioural disorder diagnosis in the child has not been well-defined. METHODS: A nationwide sample of pregnant women linked to their liveborn infants was evaluated using the Medicaid Analytic eXtract (MAX, 1999-2013). Multivariate matching was used to match each child prenatally exposed to general anaesthesia owing to maternal appendectomy or cholecystectomy during pregnancy with five unexposed children. The primary outcome was diagnosis of a disruptive or internalising behavioural disorder in children. Secondary outcomes included diagnoses for a range of other neuropsychiatric disorders. RESULTS: We matched 34,271 prenatally exposed children with 171,355 unexposed children in the database. Prenatally exposed children were more likely than unexposed children to receive a diagnosis of a disruptive or internalising behavioural disorder (hazard ratio [HR], 1.31; 95% confidence interval [CI], 1.23-1.40). For secondary outcomes, increased hazards of disruptive (HR, 1.32; 95% CI, 1.24-1.41) and internalising (HR, 1.36; 95% CI, 1.20-1.53) behavioural disorders were identified, and also increased hazards of attention-deficit/hyperactivity disorder (HR, 1.32; 95% CI, 1.22-1.43), behavioural disorders (HR, 1.28; 95% CI, 1.14-1.42), developmental speech or language disorders (HR, 1.16; 95% CI, 1.05-1.28), and autism (HR, 1.31; 95% CI, 1.05-1.64). CONCLUSIONS: Prenatal exposure to general anaesthesia is associated with a 31% increased risk for a subsequent diagnosis of a disruptive or internalising behavioural disorder in children. Caution is advised when making any clinical decisions regarding care of pregnant women, as avoidance of necessary surgery during pregnancy can have detrimental effects on mothers and their children.


Subject(s)
Attention Deficit Disorder with Hyperactivity , Prenatal Exposure Delayed Effects , Child , Infant , Humans , Female , Pregnancy , Prenatal Exposure Delayed Effects/epidemiology , Attention Deficit Disorder with Hyperactivity/epidemiology , Attention Deficit Disorder with Hyperactivity/etiology , Mothers , Anesthesia, General/adverse effects , Proportional Hazards Models
4.
JAMA Surg ; 159(4): 397-403, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38265816

ABSTRACT

Importance: In surgical patients, it is well known that higher hospital procedure volume is associated with better outcomes. To our knowledge, this volume-outcome association has not been studied in ambulatory surgery centers (ASCs) in the US. Objective: To determine if low-volume ASCs have a higher rate of revisits after surgery, particularly among patients with multimorbidity. Design, Setting, and Participants: This matched case-control study used Medicare claims data and analyzed surgeries performed during 2018 and 2019 at ASCs. The study examined 2328 ASCs performing common ambulatory procedures and analyzed 4751 patients with a revisit within 7 days of surgery (defined to be either 1 of 4735 revisits or 1 of 16 deaths without a revisit). These cases were each closely matched to 5 control patients without revisits (23 755 controls). Data were analyzed from January 1, 2018, through December 31, 2019. Main Outcomes and Measures: Seven-day revisit in patients (cases) compared with the matched patients without the outcome (controls) in ASCs with low volume (less than 50 procedures over 2 years) vs higher volume (50 or more procedures). Results: Patients at a low-volume ASC had a higher odds of a 7-day revisit vs patients who had their surgery at a higher-volume ASC (odds ratio [OR], 1.21; 95% CI, 1.09-1.36; P = .001). The odds of revisit for patients with multimorbidity were higher at low-volume ASCs when compared with higher-volume ASCs (OR, 1.57; 95% CI, 1.27-1.94; P < .001). Among patients with multimorbidity in low-volume ASCs, for those who underwent orthopedic procedures, the odds of revisit were 84% higher (OR, 1.84; 95% CI, 1.36-2.50; P < .001) vs higher-volume centers, and for those who underwent general surgery or other procedures, the odds of revisit were 36% higher (OR, 1.36; 95% CI, 1.01-1.83; P = .05) vs a higher-volume center. The findings were not statistically significant for patients without multimorbidity. Conclusions and Relevance: In this observational study, the surgical volume of an ASC was an important indicator of patient outcomes. Older patients with multimorbidity should discuss with their surgeon the optimal location of their care.


Subject(s)
Ambulatory Surgical Procedures , Medicare , Humans , Aged , United States , Ambulatory Surgical Procedures/adverse effects , Case-Control Studies
5.
J Gen Intern Med ; 2023 Dec 12.
Article in English | MEDLINE | ID: mdl-38087179

ABSTRACT

BACKGROUND: We define a "flagship hospital" as the largest academic hospital within a hospital referral region and a "flagship system" as a system that contains a flagship hospital and its affiliates. It is not known if patients admitted to an affiliate hospital, and not to its main flagship hospital, have better outcomes than those admitted to a hospital outside the flagship system but within the same hospital referral region. OBJECTIVE: To compare mortality at flagship hospitals and their affiliates to matched control patients not in the flagship system but within the same hospital referral region. DESIGN: A matched cohort study PARTICIPANTS: The study used hospitalizations for common medical conditions between 2018-2019 among older patients age ≥ 66 years. We analyzed 118,321 matched pairs of Medicare patients admitted with pneumonia (N=57,775), heart failure (N=42,531), or acute myocardial infarction (N=18,015) in 35 flagship hospitals, 124 affiliates, and 793 control hospitals. MAIN MEASURES: 30-day (primary) and 90-day (secondary) all-cause mortality. KEY RESULTS: 30-day mortality was lower among patients in flagship systems versus control hospitals that are not part of the flagship system but within the same hospital referral region (difference= -0.62%, 95% CI [-0.88%, -0.37%], P<0.001). This difference was smaller in affiliates versus controls (-0.43%, [-0.75%, -0.11%], P=0.008) than in flagship hospitals versus controls (-1.02%, [-1.46%, -0.58%], P<0.001; difference-in-difference -0.59%, [-1.13%, -0.05%], P=0.033). Similar results were found for 90-day mortality. LIMITATIONS: The study used claims-based data. CONCLUSIONS: In aggregate, within a hospital referral region, patients treated at the flagship hospital, at affiliates of the flagship hospital, and in the flagship system as a whole, all had lower mortality rates than matched controls outside the flagship system. However, the mortality advantage was larger for flagship hospitals than for their affiliates.

6.
BMJ Open ; 13(5): e066813, 2023 05 11.
Article in English | MEDLINE | ID: mdl-37169502

ABSTRACT

OBJECTIVES: Evaluate whether hospital factors, including nurse resources, explain racial differences in Medicare black and white patient surgical outcomes and whether disparities changed over time. DESIGN: Retrospective tapered-match. SETTING: 571 hospitals at two time points (Early Era 2003-2005; Recent Era 2013-2015). PARTICIPANTS: 6752 black patients and three sets of 6752 white controls selected from 107 001 potential controls (Early Era). 4964 black patients and three sets of 4964 white controls selected from 74 108 potential controls (Recent Era). INTERVENTIONS: Black patients were matched to white controls on demographics (age, sex, state and year of procedure), procedure (demographics variables plus 136 International Classification of Diseases (ICD)-9 principal procedure codes) and presentation (demographics and procedure variables plus 34 comorbidities, a mortality risk score, a propensity score for being black, emergency admission, transfer status, predicted procedure time). OUTCOMES: 30-day and 1-year mortality. RESULTS: Before matching, black patients had more comorbidities, higher risk of mortality despite being younger and underwent procedures at different percentages than white patients. Whites in the demographics match had lower mortality at 30 days (5.6% vs 6.7% Early Era; 5.4% vs 5.7% Recent Era) and 1-year (15.5% vs 21.5% Early Era; 12.3% vs 15.9% Recent Era). Black-white 1-year mortality differences were equivalent after matching patients with respect to presentation, procedure and demographic factors. Black-white 30-day mortality differences were equivalent after matching on procedure and demographic factors. Racial disparities in outcomes remained unchanged between the two time periods spanning 10 years. All patients in hospitals with better nurse resources had lower odds of 30-day (OR 0.60, 95% CI 0.46 to 0.78, p<0.010) and 1-year mortality (OR 0.77, 95% CI 0.65 to 0.92, p<0.010) even after accounting for other hospital factors. CONCLUSIONS: Survival disparities among black and white patients are largely explained by differences in demographic, procedure and presentation factors. Better nurse resources (eg, staffing, work environment) were associated with lower mortality for all patients.


Subject(s)
Black or African American , Medicare , Humans , Aged , United States/epidemiology , Retrospective Studies , Hospitals , Healthcare Disparities , White
7.
JAMA ; 329(16): 1356-1366, 2023 04 25.
Article in English | MEDLINE | ID: mdl-37060545

ABSTRACT

Importance: The effect of rationally defined nonpathogenic, nontoxigenic, commensal strains of Clostridia on prevention of Clostridioides difficile infection (CDI) is unknown. Objective: To determine the efficacy of VE303, a defined bacterial consortium of 8 strains of commensal Clostridia, in adults at high risk for CDI recurrence. The primary objective was to determine the recommended VE303 dosing for a phase 3 trial. Design, Setting, and Participants: Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted from February 2019 to September 2021 at 27 sites in the US and Canada. The study included 79 participants aged 18 years or older who were diagnosed with laboratory-confirmed CDI with 1 or more prior CDI episodes in the last 6 months and those with primary CDI at high risk for recurrence (defined as aged ≥75 years or ≥65 years with ≥1 risk factors: creatinine clearance <60 mL/min/1.73 m2, proton pump inhibitor use, remote [>6 months earlier] CDI history). Interventions: Participants were randomly assigned to high-dose VE303 (8.0 × 109 colony-forming units [CFUs]) (n = 30), low-dose VE303 (1.6 × 109 CFUs) (n = 27), or placebo capsules (n = 22) orally once daily for 14 days. Main Outcomes and Measures: The primary efficacy end point was the proportion of participants with CDI recurrence at 8 weeks using a combined clinical and laboratory definition. The primary efficacy end point was analyzed in 3 prespecified analyses, using successively broader definitions for an on-study CDI recurrence: (1) diarrhea consistent with CDI plus a toxin-positive stool sample; (2) diarrhea consistent with CDI plus a toxin-positive, polymerase chain reaction-positive, or toxigenic culture-positive stool sample; and (3) diarrhea consistent with CDI plus laboratory confirmation or (in the absence of a stool sample) treatment with a CDI-targeted antibiotic. Results: Baseline characteristics were similar across the high-dose VE303 (n = 29; 1 additional participant excluded from efficacy analysis), low-dose VE303 (n = 27), and placebo (n = 22) groups. The participants' median age was 63.5 years (range, 24-96); 70.5% were female; and 1.3% were Asian, 1.3% Black, 2.6% Hispanic, and 96.2% White. CDI recurrence rates through week 8 (using the efficacy analysis 3 definition) were 13.8% (4/29) for high-dose VE303, 37.0% (10/27) for low-dose VE303, and 45.5% (10/22) for placebo (P = .006, high-dose VE303 vs placebo). Conclusions and Relevance: Among adults with laboratory-confirmed CDI with 1 or more prior CDI episodes in the last 6 months and those with primary CDI at high risk for recurrence, high-dose VE303 prevented recurrent CDI compared with placebo. A larger, phase 3 study is needed to confirm these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03788434.


Subject(s)
Clostridioides difficile , Clostridium Infections , Probiotics , Adult , Female , Humans , Male , Middle Aged , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Clostridium Infections/complications , Clostridium Infections/microbiology , Clostridium Infections/prevention & control , Clostridium Infections/therapy , Diarrhea/etiology , Diarrhea/microbiology , Diarrhea/prevention & control , Diarrhea/therapy , Feces/chemistry , Feces/microbiology , Gastrointestinal Microbiome , Probiotics/administration & dosage , Probiotics/therapeutic use , Recurrence , Reinfection/prevention & control , Symbiosis , Treatment Outcome , Double-Blind Method , Bacterial Toxins/analysis , Young Adult , Aged , Aged, 80 and over
8.
J Am Coll Surg ; 236(5): 1011-1022, 2023 05 01.
Article in English | MEDLINE | ID: mdl-36919934

ABSTRACT

BACKGROUND: Multimorbidity in surgery is common and associated with worse postoperative outcomes. However, conventional multimorbidity definitions (≥2 comorbidities) label the vast majority of older patients as multimorbid, limiting clinical usefulness. We sought to develop and validate better surgical specialty-specific multimorbidity definitions based on distinct comorbidity combinations. STUDY DESIGN: We used Medicare claims for patients aged 66 to 90 years undergoing inpatient general, orthopaedic, or vascular surgery. Using 2016 to 2017 data, we identified all comorbidity combinations associated with at least 2-fold (general/orthopaedic) or 1.5-fold (vascular) greater risk of 30-day mortality compared with the overall population undergoing the same procedure; we called these combinations qualifying comorbidity sets. We applied them to 2018 to 2019 data (general = 230,410 patients, orthopaedic = 778,131 patients, vascular = 146,570 patients) to obtain 30-day mortality estimates. For further validation, we tested whether multimorbidity status was associated with differential outcomes for patients at better-resourced (based on nursing skill-mix, surgical volume, teaching status) hospitals vs all other hospitals using multivariate matching. RESULTS: Compared with conventional multimorbidity definitions, the new definitions labeled far fewer patients as multimorbid: general = 85.0% (conventional) vs 55.9% (new) (p < 0.0001); orthopaedic = 66.6% vs 40.2% (p < 0.0001); and vascular = 96.2% vs 52.7% (p < 0.0001). Thirty-day mortality was higher by the new definitions: general = 3.96% (conventional) vs 5.64% (new) (p < 0.0001); orthopaedic = 0.13% vs 1.68% (p < 0.0001); and vascular = 4.43% vs 7.00% (p < 0.0001). Better-resourced hospitals offered significantly larger mortality benefits than all other hospitals for multimorbid vs nonmultimorbid general and orthopaedic, but not vascular, patients (general surgery difference-in-difference = -0.94% [-1.36%, -0.52%], p < 0.0001; orthopaedic = -0.20% [-0.34%, -0.05%], p = 0.0087; and vascular = -0.12% [-0.69%, 0.45%], p = 0.6795). CONCLUSIONS: Our new multimorbidity definitions identified far more specific, higher-risk pools of patients than conventional definitions, potentially aiding clinical decision-making.


Subject(s)
Multimorbidity , Aged , Humans , Comorbidity , Inpatients , Medicare , Multimorbidity/trends , United States/epidemiology
9.
Med Care ; 61(5): 328-337, 2023 05 01.
Article in English | MEDLINE | ID: mdl-36929758

ABSTRACT

BACKGROUND: Surgery for older Americans is increasingly being performed at ambulatory surgery centers (ASCs) rather than hospital outpatient departments (HOPDs), while rates of multimorbidity have increased. OBJECTIVE: To determine whether there are differential outcomes in older patients undergoing surgical procedures at ASCs versus HOPDs. RESEARCH DESIGN: Matched cohort study. SUBJECTS: Of Medicare patients, 30,958 were treated in 2018 and 2019 at an ASC undergoing herniorrhaphy, cholecystectomy, or open breast procedures, matched to similar HOPD patients, and another 32,702 matched pairs undergoing higher-risk procedures. MEASURES: Seven and 30-day revisit and complication rates. RESULTS: For the same procedures, HOPD patients displayed a higher baseline predicted risk of 30-day revisits than ASC patients (13.09% vs 8.47%, P < 0.0001), suggesting the presence of considerable selection on the part of surgeons. In matched Medicare patients with or without multimorbidity, we observed worse outcomes in HOPD patients: 30-day revisit rates were 8.1% in HOPD patients versus 6.2% in ASC patients ( P < 0.0001), and complication rates were 41.3% versus 28.8%, P < 0.0001. Similar patterns were also found for 7-day outcomes and in higher-risk procedures examined in a secondary analysis. Similar patterns were also observed when analyzing patients with and without multimorbidity separately. CONCLUSIONS: The rates of revisits and complications for ASC patients were far lower than for closely matched HOPD patients. The observed initial baseline risk in HOPD patients was much higher than the baseline risk for the same procedures performed at the ASC, suggesting that surgeons are appropriately selecting their riskier patients to be treated at the HOPD rather than the ASC.


Subject(s)
Ambulatory Surgical Procedures , Outpatients , Humans , Aged , United States , Cohort Studies , Ambulatory Surgical Procedures/adverse effects , Multimorbidity , Medicare , Hospitals
10.
J Gen Intern Med ; 38(6): 1449-1458, 2023 05.
Article in English | MEDLINE | ID: mdl-36385407

ABSTRACT

BACKGROUND: The term "multimorbidity" identifies high-risk, complex patients and is conventionally defined as ≥2 comorbidities. However, this labels almost all older patients as multimorbid, making this definition less useful for physicians, hospitals, and policymakers. OBJECTIVE: Develop new medical condition-specific multimorbidity definitions for patients admitted with acute myocardial infarction (AMI), heart failure (HF), and pneumonia patients. We developed three medical condition-specific multimorbidity definitions as the presence of single, double, or triple combinations of comorbidities - called Qualifying Comorbidity Sets (QCSs) - associated with at least doubling the risk of 30-day mortality for AMI and pneumonia, or one-and-a-half times for HF patients, compared to typical patients with these conditions. DESIGN: Cohort-based matching study PARTICIPANTS: One hundred percent Medicare Fee-for-Service beneficiaries with inpatient admissions between 2016 and 2019 for AMI, HF, and pneumonia. MAIN MEASURES: Thirty-day all-location mortality KEY RESULTS: We defined multimorbidity as the presence of ≥1 QCS. The new definitions labeled fewer patients as multimorbid with a much higher risk of death compared to the conventional definition (≥2 comorbidities). The proportions of patients labeled as multimorbid using the new definition versus the conventional definition were: for AMI 47% versus 87% (p value<0.0001), HF 53% versus 98% (p value<0.0001), and pneumonia 57% versus 91% (p value<0.0001). Thirty-day mortality was higher among patients with ≥1 QCS compared to ≥2 comorbidities: for AMI 15.0% versus 9.5% (p<0.0001), HF 9.9% versus 7.0% (p <0.0001), and pneumonia 18.4% versus 13.2% (p <0.0001). CONCLUSION: The presence of ≥2 comorbidities identified almost all patients as multimorbid. In contrast, our new QCS-based definitions selected more specific combinations of comorbidities associated with substantial excess risk in older patients admitted for AMI, HF, and pneumonia. Thus, our new definitions offer a better approach to identifying multimorbid patients, allowing physicians, hospitals, and policymakers to more effectively use such information to consider focused interventions for these vulnerable patients.


Subject(s)
Heart Failure , Myocardial Infarction , Pneumonia , Humans , Aged , United States/epidemiology , Patient Readmission , Medicare , Hospitalization , Myocardial Infarction/epidemiology , Myocardial Infarction/therapy , Heart Failure/epidemiology , Heart Failure/therapy , Pneumonia/epidemiology , Pneumonia/therapy , Inpatients
11.
J Am Geriatr Soc ; 70(9): 2498-2507, 2022 09.
Article in English | MEDLINE | ID: mdl-35699153

ABSTRACT

Older adults experience a higher prevalence of multiple chronic conditions (MCCs). Establishing the presence and pattern of MCCs in individuals or populations is important for healthcare delivery, research, and policy. This report describes four emerging approaches and discusses their potential applications for enhancing assessment, treatment, and policy for the aging population. The National Institutes of Health convened a 2-day panel workshop of experts in 2018. Four emerging models were identified by the panel, including classification and regression tree (CART), qualifying comorbidity sets (QCS), the multimorbidity index (MMI), and the application of omics to network medicine. Future research into models of multiple chronic condition assessment may improve understanding of the epidemiology, diagnosis, and treatment of older persons.


Subject(s)
Multiple Chronic Conditions , Aged , Aged, 80 and over , Aging , Chronic Disease , Comorbidity , Humans , Multiple Chronic Conditions/epidemiology , Multiple Chronic Conditions/therapy , Prevalence
12.
Cell Host Microbe ; 30(4): 583-598.e8, 2022 04 13.
Article in English | MEDLINE | ID: mdl-35421353

ABSTRACT

Manipulation of the gut microbiota via fecal microbiota transplantation (FMT) has shown clinical promise in diseases such as recurrent Clostridioides difficile infection (rCDI). However, the variable nature of this approach makes it challenging to describe the relationship between fecal strain colonization, corresponding microbiota changes, and clinical efficacy. Live biotherapeutic products (LBPs) consisting of defined consortia of clonal bacterial isolates have been proposed as an alternative therapeutic class because of their promising preclinical results and safety profile. We describe VE303, an LBP comprising 8 commensal Clostridia strains under development for rCDI, and its early clinical development in healthy volunteers (HVs). In a phase 1a/b study in HVs, VE303 is determined to be safe and well-tolerated at all doses tested. VE303 strains optimally colonize HVs if dosed over multiple days after vancomycin pretreatment. VE303 promotes the establishment of a microbiota community known to provide colonization resistance.


Subject(s)
Clostridioides difficile , Clostridium Infections , Microbiota , Clostridium Infections/microbiology , Clostridium Infections/therapy , Fecal Microbiota Transplantation/methods , Healthy Volunteers , Humans
14.
Ann Surg ; 276(5): e377-e385, 2022 11 01.
Article in English | MEDLINE | ID: mdl-33214467

ABSTRACT

OBJECTIVE: The aim of this study was to determine whether surgery and anesthesia in the elderly may promote Alzheimer disease and related dementias (ADRD). BACKGROUND: There is a substantial conflicting literature concerning the hypothesis that surgery and anesthesia promotes ADRD. Much of the literature is confounded by indications for surgery or has small sample size. This study examines elderly patients with appendicitis, a common condition that strikes mostly at random after controlling for some known associations. METHODS: A matched natural experiment of patients undergoing appendectomy for appendicitis versus control patients without appendicitis using Medicare data from 2002 to 2017, examining 54,996 patients without previous diagnoses of ADRD, cognitive impairment, or neurological degeneration, who developed appendicitis between ages 68 through 77 years and underwent an appendectomy (the ''Appendectomy'' treated group), matching them 5:1 to 274,980 controls, examining the subsequent hazard for developing ADRD. RESULTS: The hazard ratio (HR) for developing ADRD or death was lower in the Appendectomy group than controls: HR = 0.96 [95% confidence interval (CI) 0.94-0.98], P < 0.0001, (28.2% in Appendectomy vs 29.1% in controls, at 7.5 years). The HR for death was 0.97 (95% CI 0.95-0.99), P = 0.002, (22.7% vs 23.1% at 7.5 years). The HR for developing ADRD alone was 0.89 (95% CI 0.86-0.92), P < 0.0001, (7.6% in Appendectomy vs 8.6% in controls, at 7.5 years). No subgroup analyses found significantly elevated rates of ADRD in the Appendectomy group. CONCLUSION: In this natural experiment involving 329,976 elderly patients, exposure to appendectomy surgery and anesthesia did not increase the subsequent rate of ADRD.


Subject(s)
Alzheimer Disease , Anesthesia , Appendicitis , Cognitive Dysfunction , Aged , Alzheimer Disease/diagnosis , Alzheimer Disease/epidemiology , Appendicitis/surgery , Humans , Medicare , United States
15.
Med Care ; 59(8): 743-756, 2021 08 01.
Article in English | MEDLINE | ID: mdl-33974576

ABSTRACT

BACKGROUND: Adults have a higher prevalence of multimorbidity-or having multiple chronic health conditions-than having a single condition in isolation. Researchers, health care providers, and health policymakers find it challenging to decide upon the most appropriate assessment tool from the many available multimorbidity measures. OBJECTIVE: The objective of this study was to describe a broad range of instruments and data sources available to assess multimorbidity and offer guidance about selecting appropriate measures. DESIGN: Instruments were reviewed and guidance developed during a special expert workshop sponsored by the National Institutes of Health on September 25-26, 2018. RESULTS: Workshop participants identified 4 common purposes for multimorbidity measurement as well as the advantages and disadvantages of 5 major data sources: medical records/clinical assessments, administrative claims, public health surveys, patient reports, and electronic health records. Participants surveyed 15 instruments and 2 public health data systems and described characteristics of the measures, validity, and other features that inform tool selection. Guidance on instrument selection includes recommendations to match the purpose of multimorbidity measurement to the measurement approach and instrument, review available data sources, and consider contextual and other related constructs to enhance the overall measurement of multimorbidity. CONCLUSIONS: The accuracy of multimorbidity measurement can be enhanced with appropriate measurement selection, combining data sources and special considerations for fully capturing multimorbidity burden in underrepresented racial/ethnic populations, children, individuals with multiple Adverse Childhood Events and older adults experiencing functional limitations, and other geriatric syndromes. The increased availability of comprehensive electronic health record systems offers new opportunities not available through other data sources.


Subject(s)
Information Storage and Retrieval , Multimorbidity , Adult , Electronic Health Records , Humans , Insurance Claim Review , Medical Records , Surveys and Questionnaires
17.
BMJ Qual Saf ; 30(1): 46-55, 2021 01.
Article in English | MEDLINE | ID: mdl-32220938

ABSTRACT

BACKGROUND: There are known clinical benefits associated with investments in nursing. Less is known about their value. AIMS: To compare surgical patient outcomes and costs in hospitals with better versus worse nursing resources and to determine if value differs across these hospitals for patients with different mortality risks. METHODS: Retrospective matched-cohort design of patient outcomes at hospitals with better versus worse nursing resources, defined by patient-to-nurse ratios, skill mix, proportions of bachelors-degree nurses and nurse work environments. The sample included 62 715 pairs of surgical patients in 76 better nursing resourced hospitals and 230 worse nursing resourced hospitals from 2013 to 2015. Patients were exactly matched on principal procedures and their hospital's size category, teaching and technology status, and were closely matched on comorbidities and other risk factors. RESULTS: Patients in hospitals with better nursing resources had lower 30-day mortality: 2.7% vs 3.1% (p<0.001), lower failure-to-rescue: 5.4% vs 6.2% (p<0.001), lower readmissions: 12.6% vs 13.5% (p<0.001), shorter lengths of stay: 4.70 days vs 4.76 days (p<0.001), more intensive care unit admissions: 17.2% vs 15.4% (p<0.001) and marginally higher nurse-adjusted costs (which account for the costs of better nursing resources): $20 096 vs $19 358 (p<0.001), as compared with patients in worse nursing resourced hospitals. The nurse-adjusted cost associated with a 1% improvement in mortality at better nursing hospitals was $2035. Patients with the highest mortality risk realised the greatest value from nursing resources. CONCLUSION: Hospitals with better nursing resources provided better clinical outcomes for surgical patients at a small additional cost. Generally, the sicker the patient, the greater the value at better nursing resourced hospitals.


Subject(s)
Nursing Staff, Hospital , Aged , Female , Hospitals , Humans , Male , Retrospective Studies , Workplace
18.
Ann Surg ; 273(2): 280-288, 2021 02 01.
Article in English | MEDLINE | ID: mdl-31188212

ABSTRACT

OBJECTIVE: To determine whether outcomes achieved by new surgeons are attributable to inexperience or to differences in the context in which care is delivered and patient complexity. BACKGROUND: Although prior studies suggest that new surgeon outcomes are worse than those of experienced surgeons, factors that underlie these phenomena are poorly understood. METHODS: A nationwide observational tapered matching study of outcomes of Medicare patients treated by new and experienced surgeons in 1221 US hospitals (2009-2013). The primary outcome studied is 30-day mortality. Secondary outcomes were examined. RESULTS: In total, 694,165 patients treated by 8503 experienced surgeons were matched to 68,036 patients treated by 2119 new surgeons working in the same hospitals. New surgeons' patients were older (25.8% aged ≥85 vs 16.3%,P<0.0001) with more emergency admissions (53.9% vs 25.8%,P<0.0001) than experienced surgeons' patients. Patients of new surgeons had a significantly higher baseline 30-day mortality rate compared with patients of experienced surgeons (6.2% vs 4.5%,P<0.0001;OR 1.42 (1.33, 1.52)). The difference remained significant after matching the types of operations performed (6.2% vs 5.1%, P<0.0001; OR 1.24 (1.16, 1.32)) and after further matching on a combination of operation type and emergency admission status (6.2% vs 5.6%, P=0.0007; OR 1.12 (1.05, 1.19)). After matching on operation type, emergency admission status, and patient complexity, the difference between new and experienced surgeons' patients' 30-day mortality became indistinguishable (6.2% vs 5.9%,P=0.2391;OR 1.06 (0.97, 1.16)). CONCLUSIONS: Among Medicare beneficiaries, the majority of the differences in outcomes between new and experienced surgeons are related to the context in which care is delivered and patient complexity rather than new surgeon inexperience.


Subject(s)
Clinical Competence , Postoperative Complications/epidemiology , Surgical Procedures, Operative/statistics & numerical data , Aged , Female , Humans , Length of Stay , Male , Medicare , Outcome Assessment, Health Care , Surgical Procedures, Operative/adverse effects , Surgical Procedures, Operative/mortality , United States
19.
J Gen Intern Med ; 36(1): 84-91, 2021 01.
Article in English | MEDLINE | ID: mdl-32869196

ABSTRACT

BACKGROUND: Nursing resources, such as staffing ratios and skill mix, vary across hospitals. Better nursing resources have been linked to better patient outcomes but are assumed to increase costs. The value of investments in nursing resources, in terms of clinical benefits relative to costs, is unclear. OBJECTIVE: To determine whether there are differential clinical outcomes, costs, and value among medical patients at hospitals characterized by better or worse nursing resources. DESIGN: Matched cohort study of patients in 306 acute care hospitals. PATIENTS: A total of 74,045 matched pairs of fee-for-service Medicare beneficiaries admitted for common medical conditions (25,446 sepsis pairs; 16,332 congestive heart failure pairs; 12,811 pneumonia pairs; 10,598 stroke pairs; 8858 acute myocardial infarction pairs). Patients were also matched on hospital size, technology, and teaching status. MAIN MEASURES: Better (n = 76) and worse (n = 230) nursing resourced hospitals were defined by patient-to-nurse ratios, skill mix, proportions of bachelors-degree nurses, and nurse work environments. Outcomes included 30-day mortality, readmission, and resource utilization-based costs. KEY RESULTS: Patients in hospitals with better nursing resources had significantly lower 30-day mortality (16.1% vs 17.1%, p < 0.0001) and fewer readmissions (32.3% vs 33.6%, p < 0.0001) yet costs were not significantly different ($18,848 vs 18,671, p = 0.133). The greatest outcomes and cost advantage of better nursing resourced hospitals were in patients with sepsis who had lower mortality (25.3% vs 27.6%, p < 0.0001). Overall, patients with the highest risk of mortality on admission experienced the greatest reductions in mortality and readmission from better nursing at no difference in cost. CONCLUSIONS: Medicare beneficiaries with common medical conditions admitted to hospitals with better nursing resources experienced more favorable outcomes at almost no difference in cost.


Subject(s)
Heart Failure , Myocardial Infarction , Aged , Cohort Studies , Hospital Costs , Hospitals , Humans , Medicare , Patient Readmission , United States/epidemiology
20.
JCO Oncol Pract ; 17(6): e882-e890, 2021 06.
Article in English | MEDLINE | ID: mdl-33090897

ABSTRACT

PURPOSE: The 2010 Dependent Coverage Provision (DCP) of the Affordable Care Act (ACA) allowed enrollees to remain on their parents' health insurance until 26 years of age. We compared rates of insurance disenrollment among patients with cancer who were DCP-eligible at age 19 to those who were not eligible at age 19. METHODS: Using OptumLabs Data Warehouse, which contains longitudinal, real-world, de-identified administrative claims for commercial enrollees, we examined patients born between 1982 and 1993 and diagnosed with cancer between 2000 and 2015. In the recent cohort, patients who turned 19 in 2010-2012 (DCP-eligible to stay on parents' insurance) were matched to patients who turned 19 in 2007-2009 (not DCP-eligible when turning 19). In an earlier control cohort, patients who turned 19 between 2004 and 2006 (not DCP-eligible) were matched to patients who turned 19 between 2001 and 2003 (not DCP-eligible). Patients were matched on cancer type, diagnosis date, demographics, and treatment characteristics. The time to loss of coverage was estimated using Cox models. Difference-in-difference between the recent and earlier cohorts was also evaluated. RESULTS: A total of 2,829 patients who turned 19 years of age in 2010-2012 were matched to patients who turned 19 in 2007-2009. Median time to disenrollment was 26 months for younger patients versus 22 months for older patients (hazard ratio [HR], 0.85; 95% CI, 0.80 to 0.90; P = .001). In 8,978 patients who turned 19 between 2001 and 2006, median time to disenrollment was 20 months among both younger and older patients (HR, 0.99; 95% CI, 0.94 to 1.03; P = .59). The difference between the recent cohort and the earlier control cohort was a 15% greater reduction in coverage loss (P < .0001), favoring those turning 19 after the DCP went into effect. CONCLUSION: In the vulnerable population of adolescent and young adult cancer survivors, the ACA may have lowered the insurance dropout rate.


Subject(s)
Neoplasms , Patient Protection and Affordable Care Act , Adolescent , Adult , Humans , Insurance Coverage , Insurance, Health , Neoplasms/therapy , United States , Young Adult
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