Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.

BACKGROUND: Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety. METHODS: We conducted an observational study using data from a digital survey and EHR of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 mRNA vaccine across Kaiser Permanente Southern California during November 4, 2021-February 28, 2022. Parents/guardians who enrolled their children were sent a 14-day survey on reactions. Survey results were combined with EHR, and medical encounters were described for children whose parents or guardians indicated seeking medical care for vaccine-related symptoms. This study describes self-reported reactions (local and systemic) and additional symptoms (chest pain, tachycardia, and pre-syncope). RESULTS: The study recruited 7,077 participants aged 5-11 years who received the Pfizer-BioNTech COVID-19 mRNA vaccine. Of 6,247 participants with survey responses after dose 1, 2,176 (35 %) reported at least one systemic reaction, and 1,076 (32 %) of 3,401 respondents following dose 2 reported at least one systemic reaction. Local reactions were reported less frequently following dose 2 (1,113, 33 %) than dose 1 (3,140, 50 %). The most frequently reported reactions after dose 1 were pain at the injection site (48 %), fatigue (20 %), headache (12 %), myalgia (9 %) and fever (5 %). The most frequently reported symptoms after dose 2 were also pain at the injection site (30 %), fatigue (19 %), headache (13 %), myalgia (10 %) and fever (9 %). Post-vaccination reactions occurred most frequently-one day following vaccination. Chest pain or tachycardia were reported infrequently (1 %). EHR demonstrated that parents rarely sought care for post-vaccination symptoms, and among those seeking care, the most common symptoms documented in EHR were fever and nausea, comprising <0.5 % of children. No encounters were related to myocarditis. CONCLUSION: While post-vaccination reactions to the Pfizer-BioNTech COVID-19 mRNA vaccine were common in children aged 5-11 years, our data showed that in most cases they were transient and did not require medical care.

Identifying Cases of Shoulder Injury Related to Vaccine Administration (SIRVA) in the United States: Development and Validation of a Natural Language Processing Method.

BACKGROUND: Shoulder injury related to vaccine administration (SIRVA) accounts for more than half of all claims received by the National Vaccine Injury Compensation Program. However, due to the difficulty of finding SIRVA cases in large health care databases, population-based studies are scarce. OBJECTIVE: The goal of the research was to develop a natural language processing (NLP) method to identify SIRVA cases from clinical notes. METHODS: We conducted the study among members of a large integrated health care organization who were vaccinated between April 1, 2016, and December 31, 2017, and had subsequent diagnosis codes indicative of shoulder injury. Based on a training data set with a chart review reference standard of 164 cases, we developed an NLP algorithm to extract shoulder disorder information, including prior vaccination, anatomic location, temporality and causality. The algorithm identified 3 groups of positive SIRVA cases (definite, probable, and possible) based on the strength of evidence. We compared NLP results to a chart review reference standard of 100 vaccinated cases. We then applied the final automated NLP algorithm to a broader cohort of vaccinated persons with a shoulder injury diagnosis code and performed manual chart confirmation on a random sample of NLP-identified definite cases and all NLP-identified probable and possible cases. RESULTS: In the validation sample, the NLP algorithm had 100% accuracy for identifying 4 SIRVA cases and 96 cases without SIRVA. In the broader cohort of 53,585 vaccinations, the NLP algorithm identified 291 definite, 124 probable, and 52 possible SIRVA cases. The chart-confirmation rates for these groups were 95.5% (278/291), 67.7% (84/124), and 17.3% (9/52), respectively. CONCLUSIONS: The algorithm performed with high sensitivity and reasonable specificity in identifying positive SIRVA cases. The NLP algorithm can potentially be used in future population-based studies to identify this rare adverse event, avoiding labor-intensive chart review validation.

Risk for Shoulder Conditions After Vaccination: A Population-Based Study Using Real-World Data.

BACKGROUND: Although shoulder conditions have been reported as an adverse event after intramuscular vaccination in the deltoid muscle, epidemiologic data on shoulder conditions after vaccination are limited. OBJECTIVE: To estimate the risk for shoulder conditions after vaccination and assess possible risk factors. DESIGN: Retrospective cohort study. SETTING: Kaiser Permanente Southern California, a large integrated health care organization. PARTICIPANTS: Kaiser Permanente Southern California members aged 3 years or older who had an intramuscular vaccination administered in the deltoid muscle between 1 April 2016 and 31 December 2017. MEASUREMENTS: A natural language processing (NLP) algorithm was used to identify potential shoulder conditions among vaccinated persons with shoulder disorder diagnosis codes. All NLP-identified cases were manually chart confirmed on the basis of our case definition. The characteristics of vaccinated persons with and without shoulder conditions were compared. RESULTS: Among 3 758 764 administered vaccinations, 371 cases of shoulder condition were identified, with an estimated incidence of 0.99 (95% CI, 0.89 to 1.09) per 10 000 vaccinations. The incidence was 1.22 (CI, 1.10 to 1.35) for the adult (aged ≥18 years) and 0.05 (CI, 0.02 to 0.14) for the pediatric (aged 3 to 17 years) vaccinated populations. In the adult vaccinated population, advanced age, female sex, an increased number of outpatient visits in the 6 months before vaccination, lower Charlson Comorbidity Index, and pneumococcal conjugate vaccine were associated with a higher risk for shoulder conditions. Among influenza vaccines, quadrivalent vaccines were associated with an increased risk for shoulder conditions. Simultaneous administration of vaccines was associated with a higher risk for shoulder conditions among elderly persons. LIMITATION: Generalizability to other health care settings, use of administrative data, and residual confounding. CONCLUSION: These population-based data suggest a small absolute risk for shoulder conditions after vaccination. Given the high burden of shoulder conditions, clinicians should pay attention to any factors that may further increase risks. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.

Association Between 2-Dose vs 3-Dose Hepatitis B Vaccine and Acute Myocardial Infarction.

Importance: The 2-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine; Heplisav-B) generated higher seroprotection in prelicensure trials than did a 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine; Engerix-B). However, in 1 trial, a higher number of acute myocardial infarction (MI) events were observed among those who received the HepB-CpG vaccine than among those who received the HepB-alum vaccine, an outcome requiring further study. Objective: To compare the rate of acute MI between recipients of HepB-CpG vaccine and HepB-alum vaccine. Design, Setting, and Participants: This prospective cohort noninferiority study was conducted at Kaiser Permanente Southern California (KPSC), an integrated health care system with 15 medical centers and approximately 4.7 million members. The study included 69 625 adults not undergoing dialysis who received at least 1 dose of a hepatitis B vaccine in either family medicine or internal medicine departments at KPSC from August 7, 2018, to October 31, 2019 (November 30, 2020, final follow-up). Exposures: Receipt of HepB-CpG vaccine vs HepB-alum vaccine. The first dose during the study period was the index dose. Main Outcomes and Measures: Individuals were followed up for 13 months after the index dose for occurrence of type 1 acute MI. Potential events were identified using diagnosis codes and adjudicated by cardiologists. The adjusted hazard ratio (HR) of acute MI was estimated comparing recipients of HepB-CpG vaccine with recipients of HepB-alum vaccine, with inverse probability of treatment weighting (IPTW) to adjust for demographic and clinical characteristics. The upper limit of the 1-sided 97.5% CI was compared with a noninferiority margin of 2. Results: Of the 31 183 recipients of HepB-CpG vaccine (median age, 49 years; IQR, 38-56 years), 51.2% (n = 15 965) were men, and 52.7% (n = 16 423) were Hispanic. Of the 38 442 recipients of HepB-alum (median age, 49 years; IQR, 39-56 years), 50.8% (19 533) were men, and 47.1% (n = 18 125) were Hispanic. Characteristics were well-balanced between vaccine groups after IPTW. Fifty-two type 1 acute MI events were confirmed among recipients of HepB-CpG vaccine for a rate of 1.67 per 1000-person-years, and 71 type 1 acute MI events were confirmed among recipients of HepB-alum vaccine for a rate of 1.86 per 1000 person-years (absolute rate difference, -0.19 [95% CI, -0.82 to 0.44]; adjusted HR, 0.92 [1-sided 97.5% CI, ∞ to 1.32], which was below the noninferiority margin; P < .001 for noninferiority). Conclusions and Relevance: In this cohort study, receipt of HepB-CpG vaccine compared with HepB-alum vaccine did not meet the statistical criterion for increased risk of acute myocardial infarction.

Variation in SARS-CoV-2 molecular test sensitivity by specimen types in a large sample of emergency department patients.

BACKGROUND: Provider-collected nasopharyngeal specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular testing are the standard of care in many clinical settings, but patient-collected saliva and anterior nares specimens are less invasive and more flexible alternatives. Prior studies comparing specimen types for SARS-CoV-2 molecular testing have been limited by small sample sizes and low pretest probability. We conducted a large observational study among symptomatic adults at 7 emergency departments of Kaiser Permanente Southern California to examine sensitivity of SARS-CoV-2 molecular tests by specimen type and patient characteristics. METHODS: Provider-collected nasopharyngeal/oropharyngeal (NP/OP) specimens and patient-collected saliva and anterior nares specimens were collected at the same visit and analyzed with the Roche cobas® SARS-CoV-2 assay. Patients were considered truly positive for SARS-CoV-2 if any of the three specimens was positive and negative if all three specimens were negative. Factors associated with discordant and missed positive results were examined with multivariable logistic regression. RESULTS: Of 2112 patients, 350 (16.6%) were positive for SARS-CoV-2. Sensitivity of NP/OP was 93.7% (95% confidence interval [CI] 90.6%-96.0%), sensitivity of saliva was 87.7% (83.8%-91.0%), and sensitivity of anterior nares was 85.4% (81.3%-89.0%). Patients ages 18-39 years versus ≥40 years were more likely to have discordant results [adjusted odds ratio (aOR) 1.97 (1.12-3.45)], as were patients with <4 symptoms versus ≥4 [aOR 2.43 (1.39-4.25)]. Cycle threshold values were higher for saliva and anterior nares than NP/OP specimens, as well as for specimens in discordant versus concordant sets and patients with fewer symptoms. CONCLUSION: This study provides robust evidence that patient-collected saliva and anterior nares are sensitive for SARS-CoV-2 molecular testing in emergency department settings, particularly among adults ages ≥40 years and those with multiple symptoms. Higher sensitivity of provider-collected NP/OP specimens must be weighed against the benefits of patient-collected specimens in tailored strategies for SARS-CoV-2 testing.

Association of Number of Doses With Hepatitis B Vaccine Series Completion in US Adults.

Importance: Receipt of hepatitis B virus vaccine is important to prevent infection. However, adherence to the hepatitis B vaccine series among adults at risk of infection has been low. Objective: To assess whether recipients of a 2-dose hepatitis B vaccine with cytosine phosphoguanine adjuvant (HepB-CpG vaccine; Heplisav-B) are more likely to complete their series compared with recipients of a 3-dose vaccine with alum adjuvant (comparator vaccine; Engerix-B [HepB-alum]). Design, Setting, and Participants: This nested cohort study was conducted from August 7 to December 31, 2018, at Kaiser Permanente Southern California, an integrated health care system with a diverse population of approximately 4.6 million members. Adults not receiving dialysis who received a first dose of a hepatitis B vaccine series in family practice or internal medicine departments of 15 Kaiser Permanente Southern California medical centers were followed up through electronic health records for up to 1 year after receipt of the first dose. Data were analyzed from March 16 to September 23, 2020. Exposures: Receipt of a first dose of the HepB-CpG vaccine (2-dose vaccine) vs receipt of a first dose of the HepB-alum vaccine (3-dose vaccine). Main Outcomes and Measures: Series completion within the recommended vaccine schedule plus 3 months (primary outcome) and series completion within 1 year after receipt of the first dose (secondary outcome). Results: Of 4727 individuals who initiated the HepB-CpG vaccine series and 6161 individuals who initiated the HepB-alum vaccine series included in the study, 2876 (60.8%) and 3789 (61.5%), respectively, were ages 40 to 59 years, 2415 (51.1%) and 3113 (50.5%) were male, and 2364 (50.0%) and 2881 (46.8%) were Hispanic. The vaccine series was completed within the recommended schedule plus 3 months for 2111 (44.7%) individuals who initiated the HepB-CpG vaccine series and 1607 (26.1%) individuals who initiated the HepB-alum vaccine series, and within 1 year for 2858 (60.5%) and 1989 (32.3%) individuals, respectively. The individuals who initiated the HepB-CpG vaccine series were significantly more likely to complete the series (adjusted relative risk, 1.77; 95% CI, 1.68-1.87). Results were consistent across clinical and demographic strata. Conclusions and Relevance: In this study, use of the HepB-CpG vaccine was associated with hepatitis B vaccine series completion, but tailored strategies to increase completion of hepatitis B vaccine series are warranted.

The use of natural language processing to identify vaccine-related anaphylaxis at five health care systems in the Vaccine Safety Datalink.

PURPOSE: The objective was to develop a natural language processing (NLP) algorithm to identify vaccine-related anaphylaxis from plain-text clinical notes, and to implement the algorithm at five health care systems in the Vaccine Safety Datalink. METHODS: The NLP algorithm was developed using an internal NLP tool and training dataset of 311 potential anaphylaxis cases from Kaiser Permanente Southern California (KPSC). We applied the algorithm to the notes of another 731 potential cases (423 from KPSC; 308 from other sites) with relevant codes (ICD-9-CM diagnosis codes for anaphylaxis, vaccine adverse reactions, and allergic reactions; Healthcare Common Procedure Coding System codes for epinephrine administration). NLP results were compared against a reference standard of chart reviewed and adjudicated cases. The algorithm was then separately applied to the notes of 6 427 359 KPSC vaccination visits (9 402 194 vaccine doses) without relevant codes. RESULTS: At KPSC, NLP identified 12 of 16 true vaccine-related cases and achieved a sensitivity of 75.0%, specificity of 98.5%, positive predictive value (PPV) of 66.7%, and negative predictive value of 99.0% when applied to notes of patients with relevant diagnosis codes. NLP did not identify the five true cases at other sites. When NLP was applied to the notes of KPSC patients without relevant codes, it captured eight additional true cases confirmed by chart review and adjudication. CONCLUSIONS: The current study demonstrated the potential to apply rule-based NLP algorithms to clinical notes to identify anaphylaxis cases. Increasing the size of training data, including clinical notes from all participating study sites in the training data, and preprocessing the clinical notes to handle special characters could improve the performance of the NLP algorithms. We recommend adding an NLP process followed by manual chart review in future vaccine safety studies to improve sensitivity and efficiency.

Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project.

OBJECTIVES: We evaluate safety of routine vaccination among adults infected with human immunodeficiency virus (HIV) in five healthcare organizations in the United States. METHODS: We conducted a retrospective cohort study of HIV-infected adults who received inactivated influenza vaccines, hepatitis B vaccines, pneumococcal vaccines, or tetanus, diphtheria, and acellular pertussis vaccines between 2002 and 2013. We conducted self-controlled case series analysis to estimate the relative risk (RR) for 11 pre-specified adverse events (AEs) requiring medical attention. RESULTS: Among 20,417 HIV-infected adults (90.2% male), a total of 137,674 vaccine doses were administered. Based on ICD-9 codes, we detected an increased risk of cellulitis and infection (RR: 1.18, 95% CI: 1.03-1.35) among all patients, and an increased risk of stroke/cerebrovascular diseases among patients with an HIV viral load >10,000 copies/ml (adjusted RR: 3.94, 95% CI: 1.32-11.72). Further analyses on chart confirmed cases of stroke/cerebrovascular diseases indicated no statistically significant increased risk (adjusted RR: 1.72, 95% CI: 0.41-7.24). There was no evidence of increased risk for other AEs following routine vaccination in HIV-infected adults. CONCLUSIONS: Routinely administered vaccines are generally safe for HIV-infected adults.

The use of natural language processing to identify Tdap-related local reactions at five health care systems in the Vaccine Safety Datalink.

OBJECTIVE: Local reactions are the most common vaccine-related adverse event. There is no specific diagnosis code for local reaction due to vaccination. Previous vaccine safety studies used non-specific diagnosis codes to identify potential local reaction cases and confirmed the cases through manual chart review. In this study, a natural language processing (NLP) algorithm was developed to identify local reaction associated with tetanus-diphtheria-acellular pertussis (Tdap) vaccine in the Vaccine Safety Datalink. METHODS: Presumptive cases of local reactions were identified among members ≥ 11 years of age using ICD-9-CM codes in all care settings in the 1-6 days following a Tdap vaccination between 2012 and 2014. The clinical notes were searched for signs and symptoms consistent with local reaction. Information on the timing and the location of a sign or symptom was also extracted to help determine whether or not the sign or symptom was vaccine related. Reactions triggered by causes other than Tdap vaccination were excluded. The NLP algorithm was developed at the lead study site and validated on a stratified random sample of 500 patients from five institutions. RESULTS: The NLP algorithm achieved an overall weighted sensitivity of 87.9%, specificity of 92.8%, positive predictive value of 82.7%, and negative predictive value of 95.1%. In addition, using data at one site, the NLP algorithm identified 3326 potential Tdap-related local reactions that were not identified through diagnosis codes. CONCLUSION: The NLP algorithm achieved high accuracy, and demonstrated the potential of NLP to reduce the efforts of manual chart review in vaccine safety studies.

Using natural language processing for identification of herpes zoster ophthalmicus cases to support population-based study.

IMPORTANCE: Diagnosis codes are inadequate for accurately identifying herpes zoster (HZ) ophthalmicus (HZO). There is significant lack of population-based studies on HZO due to the high expense of manual review of medical records. BACKGROUND: To assess whether HZO can be identified from the clinical notes using natural language processing (NLP). To investigate the epidemiology of HZO among HZ population based on the developed approach. DESIGN: A retrospective cohort analysis. PARTICIPANTS: A total of 49 914 southern California residents aged over 18 years, who had a new diagnosis of HZ. METHODS: An NLP-based algorithm was developed and validated with the manually curated validation data set (n = 461). The algorithm was applied on over 1 million clinical notes associated with the study population. HZO versus non-HZO cases were compared by age, sex, race and co-morbidities. MAIN OUTCOME MEASURES: We measured the accuracy of NLP algorithm. RESULTS: NLP algorithm achieved 95.6% sensitivity and 99.3% specificity. Compared to the diagnosis codes, NLP identified significant more HZO cases among HZ population (13.9% vs. 1.7%). Compared to the non-HZO group, the HZO group was older, had more males, had more Whites and had more outpatient visits. CONCLUSIONS AND RELEVANCE: We developed and validated an automatic method to identify HZO cases with high accuracy. As one of the largest studies on HZO, our finding emphasizes the importance of preventing HZ in the elderly population. This method can be a valuable tool to support population-based studies and clinical care of HZO in the era of big data.

Pneumococcal Conjugate Vaccine Safety in Elderly Adults.

BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged ≥65 years. The study examines adults ≥65 years for risk of adverse events (AEs) requiring medical attention following vaccination with PCV13 as compared with vaccination with PPSV23, a long-standing vaccine with a satisfactory safety profile. METHODS: The cohort study included 6 Vaccine Safety Datalink sites. The exposed person-time included follow-up time of the first PCV13 received by subjects age ≥65 years from January 1 to August 15, 2015. The comparator person-time included follow-up time after the first PPSV23 received by subjects of the same age during Janaury 1 to August 15 of each year of 2011-2015. The prespecified AEs included cardiovascular events, Bell's palsy, Guillain-Barré syndrome, syncope, erythema multiforme, thrombocytopenia, cellulitis and infection, allergic reaction, and anaphylaxis. Inverse probability of treatment weighting-adjusted Poisson regression models was used to estimate the relative risk (RR) of each AE. RESULTS: A total of 313 136 doses of PCV13 and 232 591 doses of PPSV23 were included. The adjusted RRs comparing the incidence of AEs following PCV13 vs PPSV23 were all <1, except for anaphylaxis, which was insignificant with an RR of 1.32 (95% confidence interval, 0.30-5.79). Only 1 patient who received PCV13 and 4 other vaccines concomitantly was confirmed by medical chart review as having experienced anaphylaxis after vaccination. CONCLUSIONS: These data do not support an increased rate of adverse events following PCV13 administration in elders compared with PPSV23 and should provide reassurance regarding continued use of PCV13.

Preoperative predictors of weight loss following bariatric surgery: systematic review.

BACKGROUND: Obesity affects 32% of adults in the USA. Surgery generates substantial weight loss, but 20-30% fails to achieve successful weight loss. Our objective was to identify preoperative psychosocial factors associated with weight loss following bariatric surgery. METHODS: We performed a literature search of PubMed® and the Cochrane Database of Reviews of Effectiveness between 1988 and April 2010. Articles were screened for bariatric surgery and weight loss if they included a preoperative predictor of weight loss: body mass index (BMI), preoperative weight loss, eating disorders, or psychiatric disorder/substance abuse. One thousand seven titles were reviewed, 534 articles screened, and 115 included in the review. RESULTS: Factors that may be positively associated with weight loss after surgery include mandatory preoperative weight loss (7 of 14 studies with positive association). Factors that may be negatively associated with weight loss include preoperative BMI (37 out of 62 studies with negative association), super-obesity (24 out of 33 studies), and personality disorders (7 out of 14 studies). Meta-analysis revealed a decrease of 10.1% excess weight loss (EWL) for super-obese patients (95% confidence interval (CI) [3.7-16.5%]), though there was significant heterogeneity in the meta-analysis, and an increase of 5.9% EWL for patients with binge eating at 12 months after surgery (95% CI [1.9-9.8%]). CONCLUSIONS: Further studies are necessary to investigate whether preoperative factors can predict a clinically meaningful difference in weight loss after bariatric surgery. The identification of predictive factors may improve patient selection and help develop interventions targeting specific needs of patients.

Quality improvement pilot program for vulnerable elderly surgical patients.

The elderly are a growing surgical population with more comorbidities and less physiological reserve compared with nonelderly patients. The objective of our study was to implement a quality improvement pilot program targeting the specific needs of the elderly. We prospectively enrolled consecutive patients aged 65 years or older undergoing inpatient general or vascular surgery operations. Patients completed a preoperative assessment including the Vulnerable Elder Survey (VES) to determine baseline functional status and incidence of polypharmacy (five or more medications). They were interviewed postdischarge Day 2 and Day 30 for changes in functional status. An intervention was implemented consisting of an elderly-specific postoperative order set and preoperative risk reports sent to the surgical team with instructions to order physical therapy consults and home health nursing on discharge for VES 3 or greater and geriatrics consults for patients with polypharmacy. The elderly-specific order set was used for 71 per cent of the postintervention group. There were no differences in the percentage of participants receiving physical therapy, geriatric, or home health nursing consults between the two groups. The postintervention group had significantly better functional status on postdischarge Day 30 (P < 0.01). Our preliminary data suggest that individualizing care for elderly patients is feasible and may improve postoperative outcomes.

Patient behaviors associated with weight regain after laparoscopic gastric bypass.

BACKGROUND: Patients undergoing gastric bypass lose substantial weight, but 20% regain weight starting at 2 years after surgery. Our objective was to identify behavioral predictors of weight regain after laparoscopic Roux-en-Y gastric bypass (LRYGB). METHODS: We retrospectively surveyed 197 patients for factors predictive of weight regain (≥15% from lowest weight to weight at survey completion). Consecutive patients who had bariatric surgery from 1/2003 through 12/2008 were identified from an existing database. Response rate was 76%, with 150 patients completing the survey. RESULTS: Follow-up after LRYGB was 45.0 ± 12.7 months, 22% of patients had weight regain. After controlling for age, gender, and follow-up time, factors associated with weight regain included low physical activity (odds ratio (OR) 6.92, P = 0.010), low self-esteem (OR 6.86, P = 0.008), and Eating Inventory Disinhibition (OR 1.30, P = 0.029). CONCLUSIONS: Physical activity, self-esteem, and maladaptive eating may be associated with weight regain after LRYGB. These factors should be addressed in prospective studies of weight loss following bariatric surgery, as they may identify patients at risk for weight regain who may benefit from tailored interventions.

Improving breast cancer quality of care with the use of patient navigators.

The continuum of breast cancer care requires multidisciplinary efforts. Patient navigators, who perform outreach, coordination, and education, have been shown to improve some areas of care. However, little research has assessed the impact of navigators on breast cancer treatment in uninsured populations. Our objective is to report on the impact of a patient navigator program on breast cancer quality of care at a public hospital. One hundred consecutive newly diagnosed patients with breast cancer (Stages I to III) were identified (2005 to 2007). Forty-nine patients were treated before the use of navigators and 51 after program implementation. Nine breast cancer quality indicators were used to evaluate quality of care. Overall adherence to the quality indicators improved from 69 to 86 per cent with the use of patient navigators (P < 0.01). Only one individual indicator, use of surveillance mammography, improved significantly (52 to 76%, P < 0.05). All nine indicators reached 75 per cent or greater adherence rates after implementation of the navigator program compared with only four before implementation. Patient navigators appear to improve breast cancer quality of care in a public hospital. In populations in which cultural, linguistic, and financial barriers are prevalent, navigator programs can be effective in narrowing the observed gaps in the quality of cancer care.

Behavioral factors associated with successful weight loss after gastric bypass.

Patients undergoing bariatric surgery lose substantial weight (> or = 50% excess weight loss [EWL]), but an estimated 20 per cent fail to achieve this goal. Our objective was to identify behavioral predictors of weight loss after laparoscopic Roux-en-Y gastric bypass. We retrospectively surveyed 148 patients using validated instruments for factors predictive of weight loss. Success was defined as > or =50 per cent EWL and failure as <50 per cent EWL. Mean follow-up after laparoscopic Roux-en-Y gastric bypass was 40.1 +/- 15.3 months, with 52.7 per cent of patients achieving successful weight loss. After controlling for age, gender, and preoperative body mass index, predictors of successful weight loss included surgeon follow-up (odds ratio [OR] 8.2, P < 0.01), attendance of postoperative support groups (OR 3.7, P = 0.02), physical activity (OR 3.5, P < 0.01), single or divorced marital status (OR 3.2, P = 0.03), self-esteem (OR 0.3, P = 0.02), and binge eating (OR 0.9, P < 0.01). These factors should be addressed in prospective studies of weight loss after bariatric surgery, as they may identify patients at risk for weight loss failure who may benefit from early tailored interventions.

Exercise following bariatric surgery: systematic review.

The contribution of physical activity on the degree of weight loss following bariatric surgery is unclear. To determine impact of exercise on postoperative weight loss. Medline search (1988-2009) was completed using MeSH terms including bariatric procedures and a spectrum of patient factors with potential relationship to weight loss outcomes. Of the 934 screened articles, 14 reported on exercise and weight loss outcomes. The most commonly used instruments to measure activity level were the Baecke Physical Activity Questionnaire, the International Physical Activity Questionnaire, and a variety of self-made questionnaires. The definition of an active patient varied but generally required a minimum of 30 min of exercise at least 3 days per week. Thirteen articles reported on exercise and degree of postoperative weight loss (n = 4,108 patients). Eleven articles found a positive association of exercise on postoperative weight loss, and two did not. Meta-analysis of three studies revealed a significant increase in 1-year postoperative weight loss (mean difference = 4.2% total body mass index (BMI) loss, 95% confidence interval (CI; 0.26-8.11)) for patients who exercise postoperatively. Exercise following bariatric surgery appears to be associated with a greater weight loss of over 4% of BMI. While a causal relationship cannot be established with observational data, this finding supports the continued efforts to encourage and support patients' involvement in post-surgery exercise. Further research is necessary to determine the recommended activity guidelines for this patient population.

Quality of care in advanced ovarian cancer: the importance of provider specialty.

BACKGROUND: One of the cornerstones of ovarian cancer therapy is cytoreductive surgery, which can be performed by surgeons with different specialty training. We examined whether surgeon specialty impacts quality of life (as proxied by presence of ostomy) and overall survival for women with advanced ovarian cancer. METHODS: Stage IIIC/IV ovarian cancer patients were identified using 4 state cancer registries: California, Washington, New York, and Florida and linked records to the corresponding inpatient-hospital discharge file, AMA Masterfile, and 2000 U.S. Census SF4 File. Predictors of receipt of care by a general surgeon and creation of fecal ostomy were analyzed. Multivariate modeling was performed to assess the association of hospital volume (low volume (LV) [0-4 cases], middle volume (MV) [5-9], high volume (HV) [10-19], and very high volume (VHV) [20+]) and surgeon specialty training (gynecologic oncologists/gynecologists, general surgeons, and other specialty) on survival. RESULTS: We identified 31,897 Stage IIIC/IV patients; mean age was 64 years. Treatment of patients by a general surgeon was predicted by LV, rural patient residence, poverty, and high level of comorbidity. Patients had lower hazard of death when treated in higher volume hospitals as compared to LV [VHV hazard ratio (HR)=0.79, P<.0001; HV HR=0.89, P<0.001]. Patients treated by a general surgeon had higher likelihood of an ostomy (OR=4.46, P<.0001) and hazard of death (HR=1.63, P<.0001) compared to gynecologic oncologist/gynecologist. CONCLUSIONS: Advanced stage ovarian cancer patients have better survival when treated by gynecologic oncology/gynecology trained surgeons. Data suggest that referral to these specialists may optimize surgical debulking and minimize the creation of a fecal ostomy.

Does weight loss immediately before bariatric surgery improve outcomes: a systematic review.

BACKGROUND: Preoperative weight loss before bariatric surgery has been proposed as a predictive factor for improved patient compliance and the degree of excess weight loss achieved after surgery. In the present study, we sought to determine the effect of preoperative weight loss on postoperative outcomes. METHODS: A search of MEDLINE was completed to identify the patient factors associated with weight loss after bariatric surgery. Of the 909 screened reports, 15 had reported on preoperative weight loss and the degree of postoperative weight loss achieved. A meta-analysis was performed that compared the postoperative weight loss and perioperative outcomes in patients who had lost weight preoperatively compared to those who had not. RESULTS: Of the 15 articles (n = 3404 patients) identified, 5 found a positive effect of preoperative weight loss on postoperative weight loss, 2 found a positive short-term effect that was not sustained long term, 5 did not find an effect difference, and 1 found a negative effect. A meta-analysis revealed a significant increase in the 1-year postoperative weight loss (mean difference of 5% EWL, 95% confidence interval 2.68-7.32) for patients who had lost weight preoperatively. A meta-analysis of other outcomes revealed a decreased operative time for patients who had lost weight preoperatively (mean difference 23.3 minutes, 95% confidence interval 13.8-32.8). CONCLUSION: Preoperative weight loss before bariatric surgery appears to be associated with greater weight loss postoperatively and might help to identify patients who would have better compliance after surgery.

Quality of care in surgical oncology.

BACKGROUND: High-quality health care is safe, effective, efficient, timely, patient-centered, and equitable. A current focus on quality assessment and improvement in oncology care, specifically in surgical oncology, is aimed toward providing optimal health services that consistently fulfill these elements for cancer patients. METHODS: In surgical oncology, outcomes have historically focused on perioperative morbidity and mortality. To assess care metrics in the United States, we review structural and process measures of quality care in surgical oncology. RESULTS: Most quality metrics in surgical oncology pertain to structural measures of care such as accreditation, procedure volumes, provider specialization, and multidisciplinary teams. Process measures, such as surgical technique, are also important but are not easily quantified. CONCLUSIONS: Policy implications of quality metrics in surgical oncology include formal regionalization of care, changes in payment structures, and public reporting. More comprehensive assessments of outcomes are gaining traction in the field of surgical oncology; this shift in focus to the patient's perspective will enhance the quality of care delivered by surgical oncologists.