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Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit–risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.

Animal studies support RCT findings of improved liver function and short-term benefits using repurposed Granulocyte Colonic Stimulating Factor GCSF in adults with decompensated cirrhosis. We describe the protocol for phase 2 RCT of sequential Kasai-GCSF under an FDA-approved IND to test that GCSF improves early bile flow and post-Kasai biliary atresia BA clinical outcome. Immediate post-Kasai neonates, age 15-180 days, with biopsy-confirmed type 3 BA, without access to early liver transplantation, will be randomized 1:1 to standard of care SOC + GCSF at 10 ug/kg in 3 daily doses within 4 days of Kasai vs SOC + NO-GCSF (ClinicalTrials.gov NCT0437391). They will be recruited from children's hospitals in Vietnam, Pakistan and one US center. The primary objective is to demonstrate that GCSF decreases the proportion of subjects with a 3-month post-Kasai serum Total Bilirubin ≥ 34 umol/L by 20%, (for a = 0.05, b = 0.80, i.e., calculated sample size of 218 subjects). The secondary objectives are to demonstrate that the frequency of post-Kasai cholangitis at 6-month and 24-month transplant-free survival are improved. The benefits are that GCSF is an affordable BA adjunct therapy, especially in developing countries, to improve biliary complications, enhance quality of liver and survival while diminishing costly liver transplantation.Clinical trial registration: A phase 1 for GCSF dose and safety determination under ClinicalTrials.gov identifier NCT03395028 was completed in 2019. The current Phase 2 trial was registered under NCT04373941.

Purpose Ipratropium and salmeterol were found to stimulate oligodendrocyte differentiation in a high-throughput drug screening assay; thus, they may play a role in the risk reduction of multiple sclerosis (MS). So far, they have not been examined in any clinical data. This study aims at investigating the association between ipratropium and salmeterol and reduced diagnosis of MS with the use of real-world clinical data. Methods We conducted a 1:10 matched case–control study that compared the exposure of ipratropium and salmeterol between patients with MS and control patients over the past 2 years, using the MS Flowsheet Registry of OSF HealthCare Saint Francis Medical Center. Cases were matched to control patients, based on service year/quarter, age, sex, race, and payer type. The relationship was examined with a Poisson regression model and a generalized structural equation model. Findings The sample in our analysis included 217 patients with MS and 2164 matched control patients. The mean (SD) age for both patients with MS and control patients was 41 (11.8) years with a range of 18 to 75 years. The MS group had consistently less prescriptions of ipratropium and salmeterol than the control group in the past 1, 2, and 3 years before the index date. Our multivariable analysis found that the control group had 3.2 more prescriptions (95% CI, 1.4–7.1; P = 0.006) of either ipratropium or salmeterol in the past 2 years than the MS group, even if controlling for other confounders. In the generalized structural equation model, we found that use of ipratropium and salmeterol was significantly associated with reduced diagnosis of MS (P = 0.036), whereas smokers and people with family history of MS were more likely to have a diagnosis of MS (P Implications The observed association between ipratropium and salmeterol use and reduced diagnosis of MS indicates that they might potentially serve as agents in the treatment of MS.

Background: Achieving postsurgical pain control after total hip arthroplasty (THA) is a critical factor for successful recovery because inadequately treated pain may lead to a delay in ambulation and hospital discharge and have an adverse impact on a patient’s quality of life. Objective: This study compares the effectiveness of immediate-release local anesthetics for pain control in THA vs liposomal bupivacaine (LB) related to patient outcomes and costs of care. Methods: This is a retrospective cohort study of consecutive patients undergoing THA at 3 hospitals from January 2013 to July 2016. The control group received plain bupivacaine or ropivacaine while the study group received LB. Generalized linear models were used controlling for several patient factors. Primary measures included length of stay (LOS), hospitalization costs, pain relief, opioid use, and mobility. Secondary outcomes were discharge disposition and 30-, 60-, and 90-day readmissions. Results: One hundred and ninety-six patients were identified, with 103 as controls, 70 receiving LB, and 23 excluded. The LB group showed a decrease in LOS of 0.5 days (2.5 ± 2.6 vs 3.0 ± 2.1 days, P = .010), increased mobility on the day of surgery (27.6 ± 49.3 vs 12.5 ± 48.5 feet, P = .001) and the first day after surgery (186.8 ± 133.8 vs 155.2 ± 135.6, P = .039), and decreased hospital costs ($10 670 vs $11 351, P = .022). There were no significant differences in pain scores, opioid use, adverse events, discharge disposition, or readmissions. Study limitations include retrospective analysis, unblinded participants, and generalizability of results. Conclusions: LB provides an effective alternative to standard local anesthetics in patients undergoing THA based on improvements of inpatient parameters, LOS, and cost measures.

Aims: Post-surgical pain experienced by patients undergoing total knee arthroplasty (TKA) can be severe. Enhanced recovery after surgery programs incorporating multimodal analgesic regimens have ev...

Zohair Ahmed,1 Jinma Ren,2 Adam Gonzalez,3 Umair Ahmed,4 Saqib Walayat,4 Daniel K Martin,5 Harsha Moole,4 Sherri Yong,6 Sean Koppe,7 Sonu Dhillon5 1Department of Gastroenterology and Hepatology, University of Illinois at Chicago, IL, USA; 2Department of Center for Outcomes Research, University of Illinois College of Medicine, Peoria, IL, USA; 3University of Illinois College of Medicine, Peoria, IL, USA; 4Department of Internal Medicine, University of Illinois College of Medicine, Peoria, IL, USA; 5Department of Gastroenterology and Hepatology, University of Illinois College of Medicine, Peoria, IL, USA; 6Department of Pathology, University of Illinois College of Medicine, Peoria, IL, USA; 7Department of Hepatology, University of Illinois at Chicago, IL, USA Aim: The purpose of this study was to create and validate a novel serological diagnostic index to predict cirrhosis of all etiologies.Methods: This was a retrospective observational study of 771 patients, age >18 years, who underwent a liver biopsy. The stage of fibrosis and routine laboratory values were recorded. The data were randomly separated into 2 datasets (training 50% and testing 50%). A stepwise logistic regression model was used to develop the novel index. The area under the curve of receiver operating characteristic (AUROC) was applied to compare the new index to existing ones (Fibro-Q, FIB4, APRI, AAR), which was also validated in the testing dataset.Results: Variables associated with the presence of cirrhosis were first assessed by univariate analysis then by multivariable analysis, which indicated serum glutamic-oxaloacetic acid transaminase, serum glutamic-pyruvic transaminase, international normalized ratio, albumin, blood urea nitrogen, glucose, platelet count, total protein, age, and race were the independent predictors of cirrhosis (P

Treatment for patients with systemic light chain (AL) amyloidosis remains challenging. Our study aims to describe treatment patterns for both newly diagnosed and relapsed/refractory AL (RRAL) amyloidosis, and to assess clinical outcomes, healthcare costs, and resource utilization during the first year following a diagnosis of RRAL amyloidsis.This was a retrospective observational study of adult patients with AL amyloidosis using the US Optum administrative claims data during 1/1/2008 to 6/30/2015. Diagnosis was based on both ICD-9 codes and treatments with a claim for AL-amyloidosis-specific anticancer systemic agents.Of 334 patients with AL amyloidosis, 43.1% were considered as RRAL amyloidosis. The majority (75%) of RRAL amyloidosis patients had organ involvement prior to the second line treatment. Proteasome-inhibitor-based regimens were most frequently used (41.0% for first-line AL, 30.6% for RRAL amyloidosis). Organ deterioration and mortality rates were 49.3% and 10.4%, respectively, during the two years following relapse. The average monthly cost was $14,369 per patient for RRAL amyloidosis including medical costs ($9441) and drug costs ($4928).RRAL amyloidosis is associated with high morbidity from target organ failure and mortality, which emphasizes the need for novel medications to improve care for patients with RRAL amyloidosis.

The associations between allergies, antibiotics use, and multiple sclerosis (MS) remain controversial and their mediating or moderating effects have not yet been examined. We aimed to assess the direct and indirect influences of allergies and antibiotics use on MS development, and their interactions.A 1:3 matched case-control study was performed using the National Ambulatory Medical Care Survey database from 2006 to 2013 in the USA. Multiple sclerosis was identified based on the ICD-9 code (340.0) in any position. Cases were matched to their controls based on survey year, age, gender, race, payer type, region, and tobacco use. Allergy diseases and antibiotics prescriptions were extracted by ICD-9 code and drug classification code, respectively. Both generalized structural equation model and MacArthur approach were used to examine their intrinsic relationships.The weighted prevalence of MS was 133.7 per 100,000 visits. A total of 829 MS patients and 2441 controls were matched. Both respiratory tract allergies (OR = 0.29, 95% CI: 0.18, 0.49) and other allergies (OR = 0.38, 95% CI: 0.19, 0.77) were associated with a reduction of the risk of MS. Patients with respiratory tract allergies were more likely to use penicillin (OR = 8.73, 95% CI: 4.12, 18.53) and other antibiotics (OR = 3.77, 95% CI: 2.72, 5.21), and those with other allergies had a higher likelihood of penicillin use (OR = 4.15, 95% CI: 1.27, 13.54); however, the link between antibiotics use and MS was not confirmed although penicillin use might mediate the relationship between allergies and MS.The findings supported allergy as a protective factor for MS development. We also suggest antibiotics use might not be a suitable indicator of bacterial infection to investigate the cause of MS.

Multiple surveys show that patients want medical privacy; however, there are costs to maintaining privacy. There are also risks if information is not shared. A review of previous surveys found that most surveys asked questions about patient's privacy concerns and willingness to share their medical information. We found only one study that asked about sharing medical information for better care and no survey that asked patients about the risk, cost or comparison between medical privacy and privacy in other areas. To fill this gap, we designed a survey to: (1) compare medical privacy preferences to privacy preferences in other areas; (2) measure willingness to pay the cost of additional privacy measures; and (3) measure willingness to accept the risks of not sharing information.A total of 834 patients attending physician offices at 14 sites completed all or part of an anonymous questionnaire.Over 95% of patients were willing to share all their medical information with their treating physicians. There was no difference in willingness to share between primary care and specialty sites including psychiatry and an HIV clinic. In our survey, there was no difference in sharing preference between standard medical information and information with additional legal protections including genetic testing, drug/alcohol treatment and HIV results. Medical privacy was ranked lower than sharing social security and credit card numbers, but was deemed more private than other information including tax returns and handgun purchases. There was no statistical difference for any questions by site except for HIV/AIDS clinic patients ranking privacy of the medical record more important than reducing high medical costs and risk of medical errors (p .05). Most patients were willing to spend a modest amount of additional time for privacy, but few were willing to pay more for additional medical privacy. Most patients were unwilling to take on additional risks to keep medical information hidden.Patients were very willing to share medical information with their providers. They were able to see the importance of sharing medical information to provide the best possible care. They were unwilling to hide information from providers if there was increased medical risk. Patients were willing to spend additional time for privacy, but most were unwilling to spend extra money. Sixty-eight percent of patients favored reducing medical costs over privacy.

Limited accessibility to providers may delay appropriate control of asthma exacerbations. The objective of our study is to estimate the contributors to the hospital/emergency department (ED) visits among adults with asthma focusing on the availability of healthcare providers.We conducted a pooled cross-sectional analysis using the 2011-2013 Asthma Call-Back Survey linked with 2012-2016 Area Health Resource Files. We employed multivariable logistic regression with dichotomous outcomes of hospitalization and ED visits. Key covariates were the availability of county-level healthcare provider variables per 100,000 persons such as the number of lung disease specialists (including pulmonary care specialists, and allergy and immunology specialists), the number of hospitals, the number of safety-net facilities including rural health centers (RHCs) and federally qualified health centers (FQHCs), and the number of primary care physicians (PCPs).Among 25,621 adults, proportions of hospital visits and ED visits were 3.3% and 13.2%, respectively. An additional RHC reduced by 3% the odds of having an ED visit (odds ratio [OR] = 0.97, p = .004). Patients with cost barriers to seeing a PCP were 60% (OR = 1.60, p = .028) more likely to have a hospital visit than those without. In addition, patients with cost barriers to seeing a specialist were 90% (OR = 1.90, p = .007) and 111% (OR = 2.11, p = .001) more likely to have a hospital visit and ED visit, respectively, than those without.Hospital and ED visits among adults with asthma are partially related to the availability of providers, and more related to financial barriers. Therefore, financial support for the vulnerable asthma population might be a target for policy makers interested in reducing hospitalizations and ED visits.

Incident onset and survival outcomes involve multiple risk factors and complex interactions preferably investigated in a single study. A generalized structural equation model (GSEM) was used to build an integrative framework to analyse multiple risk factors for incident rheumatoid arthritis (RA) and factors affecting long-term survival outcome.Incident RA cases (n=54) had onsets between 1977 and 1994, after cohort entry in 1974. Four cohort control (CN) subjects (n=216) were matched on entry to each case in the community-based CLUE cohort and 270 subjects were followed from 1995 through 2017. Baseline variables included demographic, RA family history, behavioural factors and z-score levels of serum immunological, cytokine, isotype rheumatoid factors (RFs), adrenal steroids, luteinising hormone, prolactin and sex steroids. Four numerical integration methods of GSEM were performed in Stata 15.Cohort entry factors predicting RA onset included family history of RA, cigarette smoking and IgM RF. Total survival time from cohort entry was associated with incident RA and baseline variables of age, years of completed education, cigarette smoking, immunoreactive proteins and androgenic-anabolic steroids. Mortality of RA was significantly greater than CN subjects for cases having less than good therapy responses in 1995 and only for RA onset before age 60 years. Androgenic-anabolic steroid z-scores significantly correlated with improved survival only in CN subjects with assigned onset before the age of 60.Successful use of GSEM is feasible in analyses of prospective incident and subsequent survival data and promises to advance understanding of risk factors, survival, and casual pathways.

Aim: Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) are common types of non-Hodgkin's lymphoma, and real-world evidence continues to be lacking for healthcare costs and utilization among DLBCL and FL patients. Our study aims to describe medical and pharmacy costs and health resource utilization and to characterize longitudinal treatment patterns among these patients. Methods: A retrospective observational study was performed among adult patients with DLBCL or FL using the US MarketScan (Truven) administrative claims data from 1 January 2007 to 31 December 2015. Diagnoses of DLBCL and FL were based upon ICD-9 codes. Identifications of treatment lines involved 30 lymphoma-specific anticancer systemic agents. Direct healthcare costs and utilizations were computed in the 1-year postdiagnosis period. Generalized linear models with a gamma link were used to compare healthcare costs between therapies with and without rituximab. Results: A total of 2767 DLBCL and 5989 FL patients received frontline therapy. The majority received treatment within 3 months after initial diagnosis (DLBCL 79.9% and FL 62.4%) and were treated with rituximab or bendamustine either alone or in combination (DLBCL 67.4% and FL 84.7%). The total healthcare costs were US $15,555 and $10,192 per patient per month within 1 year following their initial diagnosis for DLBCL and FL, respectively. The medical costs were nearly twice as much as the drug costs for DLBCL patients. Both DLBCL and FL patients receiving rituximab had higher pharmacy costs but lower medical costs (p Conclusion: The healthcare costs and health resources utilized were considerable in non-Hodgkin's lymphoma, especially DLBCL patients.

OBJECTIVES Antimicrobial stewardship programs target antimicrobial use within the inpatient care setting. However, most antimicrobials are prescribed at ambulatory sites. We aim to determine the appropriateness of the diagnosis and treatment of uncomplicated urinary tract infection (UTI) in children within the outpatient setting at our institution, and to evaluate the cost of antibiotic treatment in our patient cohort.METHODS This retrospective study was conducted by reviewing electronic records of patients aged 2 to 18 years diagnosed with uncomplicated UTI and treated with antibiotics in the outpatient setting from January 1, 2016, to April 30, 2016. Appropriate diagnosis was defined as confirmed UTI that included: pyuria (>5 white blood cells per high-power field or positive for leukocyte esterase), a positive urine culture (≥50,000 colony units/mL of a single uropathogen for a catheterized sample or ≥100,000 colony units/mL for a clean catch urine sample), and lower urinary tract symptoms. Treatment was considered appropriate if the patient was prescribed first-line antibiotic for the susceptible isolate (trimethoprim sulfamethoxazole, amoxicillinclavulanate, nitrofurantoin, and cephalexin), and if the appropriate dose was used.RESULTS We included 178 patients receiving a diagnosis of uncomplicated UTI and treated with antibiotics. Of these, 70% received an inappropriate diagnosis (n = 125). 58% (n= 72) of improperly diagnosed patients had polymicrobial growth in their urine cultures. Antibiotics prescribed mostly in this group were trimethoprim-sulfamethoxazole (53%, n = 66) and cephalexin (22%, n = 27). Only 30% of all included patients received an appropriate diagnosis (n = 53). Of all appropriate diagnosis patients (n = 53), 26% were treated inappropriately (n = 14) with either wide-spectrum antibiotics (n = 8) or with low calculated dose (n = 6). The estimated cost of antibiotic treatment for the inappropriate diagnosis group (n = 125) was $10,755.87.CONCLUSION Antimicrobial stewardship programs should target the pediatric outpatient setting and antibiograms should be developed. Education of providers about the appropriate diagnosis and treatment of uncomplicated UTI in children is essential for reducing the cost of inappropriate therapy.

Youth gambling is an increasing concern. As a response, the “Don’t Gamble Away our Future (DGAOF)” program has been implemented among children in central Illinois. We aim to assess the long-term effectiveness of this school-based youth gambling prevention program in Illinois using the data from 2005 to 2009. The intervention included interactive PowerPoint presentations and prevention materials in parent packets. Students aged 8 to 18 years were eligible to participate in the intervention and the questionnaire pre-post knowledge tests (total score 0–9). Students in 5th grade and above also received a gambling behavior screen test using the Modified South Oaks Gambling Screening for Teens (MSOGST) for identifying probable gamblers. Multivariable generalized mixed models were conducted to detect the effects of a 5-year youth gambling prevention program as controlling potential confounders. A total of 16,262 and 16,421 students completed pre-post tests and MSOGST tests, respectively. Of 16,262, half were female, the majority (76.1%) were from senior high school, and 21.3% received the intervention at least twice. The median gap between interventions was 368 days. Students receiving multiple interventions had higher scores on the pre-test as compared to those receiving a single intervention (P

Aims: Effective postsurgical analgesia hastens recovery, reduces hospital length of stay (LOS), and decreases hospitalization costs for total hip arthroplasty (THA). Improving these outcomes is critical for value-based surgical bundled payment programs such as the Medicare Comprehensive Care for Joint Replacement and similar programs for commercial insurance providers. This study compared clinical outcomes and hospitalization costs for patients undergoing THA with and without liposomal bupivacaine (LB). Materials and methods: This retrospective, comparative cohort study used data from the Premier Healthcare Database from the 10 hospitals with highest use of LB for THA from January 2011 through April 2017. A cohort undergoing THA with LB at those hospitals was compared with a propensity-score matched cohort at those hospitals who had THA without LB. Descriptive, univariate, and multivariable analyses compared post-surgical inpatient opioid consumption, hospital LOS, discharge status, same-hospital readmissions, and total hospitalization costs. Analyses were performed using the Pearson Chi-square test (categorical variables) and Wilcoxon or Student t-test (continuous variables). Results: For patients with Medicare (with LB, n = 3622; without LB, n = 3610) and commercial insurance (with LB, n = 2648; without LB, n = 2709), use of LB was associated with lower post-surgical inpatient opioid consumption (105 and 81 mg, respectively; p p p p ≥ 0.103). Total hospitalization costs were $561 lower with LB in the Medicare population (p p = 0.7697). Limitations: Hospitalization costs were estimated from the hospital chargemaster. Findings from these 10 hospitals may not represent other US hospitals. Conclusions: At select hospitals, THA with LB was associated with reduced post-surgical inpatient opioid consumption, shorter hospital LOS, increased likelihood of home discharge, and lower hospitalization costs. Post-surgical pain management with LB may help hospitals in value-based bundled payment programs.

Perioperative pain management is an important aspect of recovery from total knee arthroplasty (TKA) because severe pain can delay ambulation and hospital discharge. The objective of this retrospective sequential cohort study was to determine the impact of local infiltration analgesia using liposome bupivacaine (ExparelThis retrospective cohort study included consecutive patients who underwent TKA between April 2011 and April 2014, and received one of three interventions. Study Group A received adductor canal infiltration with bupivacaine HCl and knee infiltration with liposome bupivacaine. Study Group B received adductor canal infiltration with liposome bupivacaine and knee infiltration with liposome bupivacaine. The control group received a continuous FNB with ropivacaine HCl delivered via an elastomeric pump. Numeric pain rating scores (NPRS), distance walked, length of stay (LOS), and dose of narcotic medication were the key efficacy variables of interest.A total of 237 patients were included in this study: 98 in Group A, 34 in Group B, and 105 controls. On postoperative day (POD) 0, mean (standard deviation [SD]) NPRSs were similar between Group A (1.8 [1.7]), Group B (2.7 [1.8]), and the control group (2.3 [2.4]). Significantly (p 0.05) more patients in Group A (58%) and Group B (44%) walked on POD0 than in the control group (0%); almost all patients walked on POD1. The mean (SD) distance walked was also significantly greater (p 0.05) on POD1 in Group A (193 [203] feet) and Group B (211 [144] feet) than in the control group (46 [73] feet). Mean (SD) LOS was significantly (p 0.05) shorter in Group B (2.2 [1.2] days), than in the control group (3.2 [0.7] days) and Group A (3.0 [1.7] days).Local infiltration analgesia using liposome bupivacaine was associated with improved ambulation and shorter LOS following TKA when compared with continuous FNB in this retrospective cohort study.

Purpose Results of a cost–benefit analysis of intraoperative use of liposomal bupivacaine for postsurgical pain management in patients undergoing total knee arthroplasty (TKA) are presented. Methods In a retrospective single-site study, clinical and cost outcomes were compared in a group of 134 consecutive patients who received liposomal bupivacaine (by local infiltration) during TKA and a propensity score–matched historical cohort of 134 patients undergoing TKA who received usual care (continuous femoral nerve blockade with conventional bupivacaine delivered via elastomeric pump). Results Postsurgical pain scores and opioid use were similar in the two study groups; the mean total amount of nonsteroidal antiinflammatory drugs administered was lower in the liposomal bupivacaine group. Patients who received liposomal bupivacaine typically ambulated earlier than those who received usual care (22% and 3%, respectively, walked on the day of surgery; p < 0.05) and were more likely to be discharged within two days (50% versus 19%, p < 0.001); on average, liposomal bupivacaine– treated patients walked farther on the day of surgery (6.0 m versus 3.1 m, p < 0.001) and the day after surgery (63.7 m versus 25.5 m, p < 0.001) and had a shorter length of stay (LOS) (3.1 days versus 3.6 days, p < 0.03). The mean adjusted total direct hospital cost per patient was significantly lower with liposomal bupivacaine use versus usual care ($8758 versus $9213, p = 0.033). Conclusion In patients undergoing TKA, intraoperative administration of liposomal bupivacaine for management of postsurgical pain was found to offer advantages over usual care, including decreased time to ambulation and reduced hospital LOS.

Zohair Ahmed,1 Umair Ahmed,2 Saqib Walayat,2 Jinma Ren,3 Daniel K Martin,4 Harsha Moole,2 Sean Koppe,5 Sherri Yong,6 Sonu Dhillon4 1Department of Gastroenterology and Hepatology, University of Illinois, Chicago, IL, USA; 2Department of Internal Medicine, University of Illinois College of Medicine, Peoria, IL, USA; 3Department of Center for Outcomes Research, University of Illinois College of Medicine, Peoria, IL, USA; 4Department of Gastroenterology and Hepatology, University of Illinois College of Medicine, Peoria, IL, USA; 5Department of Hepatology, University of Illinois at Chicago, Chicago, IL, USA; 6Department of Pathology, University of Illinois College of Medicine, Peoria, IL, USA Background and aims: Many patients with liver disease come to medical attention once they have advanced cirrhosis or acute decompensation. Most often, patients are screened for liver disease via liver function tests (LFTs). There is very limited published data evaluating laboratory values with biopsy-proven stages of hepatic fibrosis. We set out to evaluate whether any correlation exists between routine LFTs and stages of hepatic fibrosis.Methods: A large retrospective observational study on 771 liver biopsies was conducted for evaluating the stage of fibrosis with AST, ALT, INR, BUN, creatinine, platelets, alkaline phosphatase, bilirubin, and albumin. Mean and 95% confidence intervals were used to describe the distributions of serum markers in different fibrosis stages. Multivariable generalized linear models were used and a two-tailed P-value was calculated.Results: ALT was not statistically significant for any stage, and AST was statistically significant for stage 3 and 4 fibrosis. INR was statistically significant only in stage 4 disease but remained near the upper limit of normal range. Albumin failed to show a clinically relevant association. Platelets remained within normal laboratory range for all stages. The remaining laboratory values failed to show statistical and clinical significance.Conclusion: The health care burden from chronic liver disease (CLD) will likely continue to rise, unless clinicians are made aware that normal or near normal laboratory findings may be seen in asymptomatic patients. Earlier identification of asymptomatic patients will allow for treatment with new promising modalities and decrease morbidity and mortality from CLD. Our study shows that laboratory values correlate poorly with liver disease. Keywords: chronic liver disease, hepatic fibrosis, serum markers, cirrhosis, NAFLD, HCV

Thoracic Epidural has long been the most recommended treatment for postoperative pain management in general thoracic surgery. This study compares liposomal bupivacaine (LB) as an alternative method for pain control and compares it to the standard.LB was compared to thoracic epidural bupivacaine hydrochloride (TE BH) in 387 patients who underwent video-assisted thoracoscopic pulmonary resection (VATS-R) at our institution. Patients received either continuous TE BH or intraoperative LB at a predetermined dose. A total of 237 patients received TE BH from April 2010 to March 2014 and 143 patients received LB from April 2014 to March 2016. After propensity matching, 95 patients in each group had similar demographics and clinical characteristics including gender, age, race, American Society of Anesthesia (ASA) classification, Zubrod scores, and FEV1 and DLCO percent predicted measurements. Outcome measures included hospital costs, length of stay (LOS), adverse events, postoperative opioid medication use, and pain scores.Compared to the TE BH group, the LB group had significantly lower pain scores (average visual analogue scale the day of surgery: 3.9 versus 4.5, p 0.05), decreased postoperative opioid medication (morphine equivalent dose during the first 3 days: 344.5 versus 269.5, p 0.05), and lower total and direct hospital costs ($2906 and $1865 respectively, p 0.05). Although a shorter LOS in the LB group was not statistically significant (4.3 versus 5.1 days, p = 0.156), more patients in the LB group were discharged directly home than the control group (44.2% versus 28.4%, p 0.05). There was no difference noted in overall adverse events including 30-day readmissions between the two groups.LB is a viable alternative for pain management in patients undergoing VATS-R. With recent scrutiny on healthcare costs and the opioid epidemic, these results are encouraging and should be further investigated.

Aims: Postsurgical pain experienced by patients undergoing total knee arthroplasty (TKA) can be severe. Enhanced recovery after surgery programs incorporating multimodal analgesic regimens have evolved in an attempt to improve patient care while lowering overall costs. We examined clinical and economic outcomes in hospitals using liposomal bupivacaine (LB) for pain control following TKA. Methods: This retrospective observational study utilized hospital chargemaster data from the Premier Healthcare Database from January 2011 through April 2017 for the 10 hospitals with the highest number of primary TKA procedures using LB. Within these hospitals, patients undergoing TKA who received LB were propensity-score matched in a 1:1 ratio to a control group not receiving LB. Outcomes included hospital length of stay (LOS), discharge status, 30-day same-hospital readmissions, total hospitalization costs, and opioid consumption; only patients with Medicare or commercial insurance as the primary payer for TKA were considered. Results: The study population included 20,907 Medicare-insured patients (LB =10,411; control =10,496) and 12,505 patients with commercial insurance (LB =6242; control =6263). Overall, LOS was 0.6 days shorter with LB (P P P P P Limitations: Costs were estimated using Premier charge-to-cost ratios and limited to goods and services recorded in the chargemaster. Findings from these 10 hospitals may not be representative of other US hospitals. Conclusions: In a subset of 10 US hospitals with the highest use of LB for TKA, LB use was associated with shorter hospital LOS, increased home discharge, lower total hospitalization costs, and decreased opioid use after TKA.

BackgroundDural arteriovenous fistulas (DAVFs) at the craniocervical junction are uncommon but clinically important abnormalities.ObjectiveTo investigate the clinical characteristics of patients with DAVFs at the craniocervical junction and assess angiographic features associated with bleeding at presentation.MethodsWe systematically reviewed the literature and searched PubMed and EMBASE for all relevant English language articles published between 1980 and 2014. The clinical presentation, angiographic characteristics, and treatment were assessed. The clinical differences between a subarachnoid hemorrhage (SAH) group and a non-SAH group were statistically examined.ResultsFifty-six patients were identified after a review of the literature (mean age 55.6 years; male to female ratio=3:1). Twenty-one patients (37.5%) presented with hemorrhage including SAH and posterior fossa hemorrhage. There was no significant difference in patient age, sex, or location of the DAVF between the SAH group and the non-SAH group. Intracranial venous drainage was significantly associated with SAH (pConclusionsDAVFs at the craniocervical junction are rare lesions, which often present with hemorrhage. Intracranial venous drainage and a venous varix are associated with increased risk of SAH. Surgical interruption of the feeding arteries or draining veins is an effective and reliable method for treating DAVFs at the craniocervical junction. Embolization is a feasible alternative to surgery in the treatment of selective DAVFs.

OBJECTIVE:Describe the etiology of bacteremia among a geographically diverse sample of previously well infants with fever admitted for general pediatric care and to characterize demographic and clinical characteristics of infants with bacteremia according to bacterial etiology. We hypothesized that the epidemiology of bacteremia in febrile infants from a geographically diverse cohort would show similar results to smaller or single-center cohorts previously reported.METHODS:This was a retrospective review of positive, pathogenic blood cultures in previously healthy, febrile infants ≤90 days old admitted to a general unit. In total, there were 17 participating sites from diverse geographic regions of the United States. Cultures were included if the results were positive for bacteria, obtained from an infant 90 days old or younger with a temperature ≥38.0°C, analyzed using an automated detection system, and treated as pathogenic.RESULTS:Escherichia coli was the most prevalent species, followed by group B Streptococcus, Streptococcus viridans, and Staphylococcus aureus. Among the most prevalent bacteria, there was no association between gender and species (Ps > .05). Age at presentation was associated only with Streptococcus pneumoniae. There were no cases of Listeria monocytogenes.CONCLUSIONS:Our study confirms the data from smaller or single-center studies and suggests that the management of febrile well-appearing infants should change to reflect the current epidemiology of bacteremia. Further research is needed into the role of lumbar puncture, as well as the role of Listeria and Enterococcus species in infantile bacteremia.

To assess postsurgical clinical and economic outcomes of patients who received local infiltration containing liposomal bupivacaine versus traditional bupivacaine for pain management following total hip arthroplasty (THA).This retrospective study included two groups of consecutive patients undergoing THA. The experimental group received local infiltration with a combination of liposomal bupivacaine, bupivacaine HCl 0.25% with epinephrine 1:200,000, and ketorolac for postsurgical analgesia. The historical control group received the previous standard of care: local infiltration with a combination of bupivacaine HCl 0.25% with epinephrine 1:200,000 and ketorolac. Key outcomes included distance walked, length of stay (LOS), opioid medication use, numeric pain scores, hospital charges, hospital costs, all-cause 30 day readmission rate, and adverse events (AEs). Both unadjusted and adjusted (i.e. age, sex, insurance type, living situation, body mass index, procedure side, and comorbidity) outcomes were compared between the two groups.The experimental group (n = 64) demonstrated statistically significant improvement versus the historical control group (n = 66) in mean distance walked on discharge day (249.2 vs. 180.0 feet; unadjusted p = .025, adjusted p = .070), mean LOS (2.0 vs. 2.7 days; p .001, p = .002), proportion of patients who used opioid rescue medication on postoperative day (POD) 1 (29.7% vs. 56.1%; p = .002, p = .003) and POD 2 (7.8% vs. 30.3%; p = .001, p = .003), mean cumulative area under the curve for pain score on POD 0 (127.6 vs. 292.5; p .001, both), POD 1 (92.9 vs. 185.0; p .001, both), and POD 2 (93.8 vs. 213.8; p = .006, both). Among a subgroup of patients with available financial information, mean hospital charges were lower in the experimental group ($43,794 [n = 24] vs. $48,010 [n = 66]; p .001, both). Rates of all-cause 30 day readmission and AEs were not significantly different between groups. No falls occurred.Infiltration at the surgical site with liposomal bupivacaine was associated with improved postsurgical outcomes when compared with traditional bupivacaine in patients undergoing THA.

Background: The treatment of irritable bowel syndrome (IBS) is a challenge because its cause remains unknown. Previous clinical trials to examine the efficacy of probiotic Bifidobacterium infantis 35624 (B. infantis) in patients with IBS have shown inconsistent findings. This study aimed to assess the combined effect of B. infantis on reducing the symptom severity of IBS based on the published data. Methods: A meta-analysis was conducted using fixed-effect models to estimate the combined effect of B. infantis on primary outcomes, which included abdominal pain, bloating/distention, and bowel habit satisfaction. A systematic review was performed based on PubMed, Cochrane Library, and EMBASE databases to identify the randomized controlled trials comparing probiotic B. infantis with placebo in treating IBS symptoms, published up until 31 December 2016. The standardized mean difference (SMD) method was used to combine data since scales to measure the efficacy of probiotics were different among studies. Results: A total of five studies were identified as suitable for inclusion, including three studies with single probiotic B. infantis and two studies with composite probiotics containing B. infantis. Treatment with single probiotic B. infantis didn’t impact on abdominal pain, bloating/distention, or bowel habit satisfaction among IBS patients. However, patients who received composite probiotics containing B. infantis had significantly reduced abdominal pain (SMD, 0.22; 95% CI, 0.03–0.41) and bloating/distention (SMD, 0.30; 95% CI, 0.04–0.56). After combining the data from six studies, the improvement of bloating/distention among IBS patients remained significant (SMD, 0.21; 95% CI, 0.07–0.35). Conclusion: Composite probiotics containing B. infantis might be an effective therapeutic option for IBS patients, which could significantly alleviate the symptoms of IBS without significant adverse effects. However, the efficacy of single probiotic B. infantis on IBS has not been confirmed yet, which needs to be further validated by more large-sized randomized clinical trials.

Treatment strategies for colorectal cancer (CRC) are highly variable. The aim of this study is to examine the patterns of chemotherapy and biologic therapy use for CRC patients in a national medical claims database.A retrospective and observational analysis was performed using the i3 Innovus claims database to identify healthcare services consumed by patients aged 18 years and older, diagnosed with CRC between 1 January 2005 and 30 June 2009 in commercial health plans.Of 9,876 subjects diagnosed with CRC, fluorouracil (23.5 %) and capecitabine (10.0 %) were the dominant first-line monotherapies, followed by bevacizumab (3.2 %) and oxaliplatin (2.9 %). The most common combination regimen at first line and first and second line was FOLFOX (fluorouracil, leucovorin, and oxaliplatin; more than 25 %). The combinations FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab (14.2 %) and FOLFOX plus bevacizumab (13.9 %) were significantly more frequent in third and successive lines of CRC therapy than other regimens (χ(2) = 191.2; P 0.01). Additionally, the average annualized cost of CRC treatment for all patients was $US66,452, and the adjusted analysis demonstrated that patients receiving FOLFOX-A (FOLFOX + avastin) or FOLFIRI-A (FOLFIRI + avastin) had higher costs for CRC treatment.With the exception of a sizeable portion of patients on monotherapy, the treatment patterns for CRC were largely consistent with National Comprehensive Cancer Network (NCCN) guidelines.

The relationship between dense packing and incidence of angiographic recurrence after endovascular treatment of intracranial aneurysms has been shown but remains controversial. We retrospectively analyzed intracranial aneurysms treated with detachable coils to determine the relation between aneurysm volume, packing, and recurrence.We reviewed 221 aneurysms in 199 patients who underwent endovascular coiling using detachable coils from November 2009 to December 2011. Aneurysm volumes were determined using three-dimensional images obtained from rotational angiography. Aneurysm packing was defined as the ratio between the volume of coils inserted and the volume of aneurysm. At follow-up, angiographic results were dichotomized into presence or absence of recurrence. The relationship between aneurysm volume to fill, packing, and angiographic recurrence was determined by multivariable logistic regression.Follow-up angiography (mean follow-up 8.8 months) revealed recurrence in 14.5% of the aneurysms studied in our series. Recurrent aneurysms had a mean packing of 15.1% while stable aneurysms (non-recurrent) had a mean packing of 23.7%. Multivariable logistic regression analysis showed that aneurysm volume and packing were significantly associated with angiographic recurrence. Large volume aneurysms (600 mm(3)) were found to have a higher incidence of recurrence than those with small volumes (OR=30.49, p0.001). Compared with those with high packing (≥20%), the less packed aneurysms (20%) had a higher incidence of recurrence (OR=29.01, p=0.002). There was no significant difference between aneurysm location, clinical presentation, stent assistance, duration of follow-up, and recurrence.Coiling large volume (600 mm(3)) intracranial aneurysms are more likely to have a recurrence than small ones. High packing (≥20%) provides better protection against recurrence of the aneurysm.

The methadone maintenance treatment (MMT) program has been implemented in Shanghai since 2005. This study aims to portray the trend of MMT dropout and identify predictive factors that may influence dropout in Shanghai MMT clinics, which could assist in the intervention strategy development.A retrospective evaluation was used in the Shanghai component of the National MMT data management system between January 1, 2005 and December 31, 2011. The Cox model for recurrence events was employed to estimate hazard ratio (HR) predicting dropout during the follow-up period.Of all 6169 participants, 63% dropped out of the program at least once (ranging from 0 to 10 times), and 74% of them did not return by the end of this study. The average monthly incidence rate of dropout was 4.4% with a range from 0 to 9.3%. Adjusted analyses demonstrated that the individuals with methadone tapering didn't have a greater probability of dropping out compared to those with stable dosage (HR = 1.07, 95% CI: 0.90-1.27). However, there was a higher dropout rate among younger individuals (30 years vs. ≥50 years old; HR = 1.41, 95% CI: 1.16-1.71), among those who were less educated (HR = 1.48, 95% CI: 1.17-1.87), among those who shared needles with others (HR = 1.29, 95% CI: 1.06-1.58), among those whose urine tested positive for opiates (HR = 1.69, 95% CI: 1.51-1.89), and among those who had a low average methadone dose at the initial stable stage of treatment (≤35 mg/day vs.65 mg/day; HR = 1.39, 95% CI: 1.19-1.63).Shanghai has been facing the challenge of keeping a high MMT retention rate. Increasing the use of methadone tapering after a stable treatment stage with sufficient dosage could be attempted in the MMT program, as well as considering comprehensive interventions among specific populations, such as young, poorly educated, opiate-positive and needle sharing individuals.

Evidence for surveillance intervals of colonoscopy are primarily based on adenoma recurrence rate rather than on colorectal cancer (C.R.C.) incidence. Little is known about long-term risk of C.R.C. after positive colonoscopy. In view of men have significantly higher C.R.C. risk than women, we aimed to estimate the gender-specific C.R.C. incidence after positive colonoscopy (adenoma or malignant lesion) at follow-up colonoscopy.A retrospective cohort study was conducted using data from a database of colonoscopy screening and surveillance. Patients having had a colonoscopy (January 2010-March 2014) were selected as study subjects and the history of prior colonoscopies was reviewed. Multivariable Weibull regression models were used to estimate the incidence of C.R.C. at follow-up colonoscopy for subjects who were assigned a stratified risk level. The benchmark risk was defined according to a national survey.The interval incidence of C.R.C. at a 10 year follow-up was 164 (95% C.I. 63-343) and 79 (95% C.I. 26-188) per 100,000 person-years for low-risk men and women respectively, which tallied with our benchmark risk. Men exceeded the benchmark risk in 3-5 years if they had an incomplete polyp removal, ≥3 adenomas during their last colonoscopy or a personal C.R.C. history, and in 7-8 years if they only had familial C.R.C.Women had a lower risk of C.R.C., and reached a same risk level 3-5 years later than men. Coexisting above risk factors resulted in a sharp increase in the incidence of C.R.C. at follow-up exceeding the benchmark much earlier.Surveillance intervals for men based on incidence of C.R.C. are in line with that recommended by the current guidelines for colonoscopy. However, an extension of 3-5 years may be appropriate for women. To target personalized medicine, a risk predictive model could be used to identify an appropriate surveillance interval for each individual in the future.

Minchul Kim,1 Jinma Ren,1 William Tillis,2,3 Carl V Asche,1,4 Inkyu K Kim,5 Carmen S Kirkness1 1Department of Internal Medicine, Center for Outcomes Research, University of Illinois College of Medicine at Peoria, 2OSF St Francis Medical Center, 3Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Peoria, 4Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago College of Pharmacy, Chicago, IL, 5Battelle Memorial Institute, Atlanta, GA, USA Background: Limited accessibility to health care may be a barrier to obtaining good care. Few studies have investigated the association between access-to-care factors and COPD hospitalizations. The objective of this study is to estimate the association between access-to-care factors and health care utilization including hospital/emergency department (ED) visits and primary care physician (PCP) office visits among adults with COPD utilizing a nationally representative survey data. Methods: We conducted a pooled cross-sectional analysis based upon a bivariate probit model, utilizing datasets from the 2011–2012 Behavioral Risk Factor Surveillance System linked with the 2014 Area Health Resource Files among adults with COPD. Dichotomous outcomes were hospital/ED visits and PCP office visits. Key covariates were county-level access-to-care factors, including the population-weighted numbers of pulmonary care specialists, PCPs, hospitals, rural health centers, and federally qualified health centers. Results: Among a total of 9,332 observations, proportions of hospital/ED visits and PCP office visits were 16.2% and 44.2%, respectively. Results demonstrated that access-to-care factors were closely associated with hospital/ED visits. An additional pulmonary care specialist per 100,000 persons serves to reduce the likelihood of a hospital/ED visit by 0.4 percentage points (pp) (P=0.028). In contrast, an additional hospital per 100,000 persons increases the likelihood of hospital/ED visit by 0.8 pp (P=0.008). However, safety net facilities were not related to hospital utilizations. PCP office visits were not related to access-to-care factors. Conclusion: Pulmonary care specialist availability was a key factor in reducing hospital utilization among adults with COPD. The findings of our study implied that an increase in the availability of pulmonary care specialists may reduce hospital utilizations in counties with little or no access to pulmonary care specialists and that since availability of hospitals increases hospital utilization, directing patients with COPD to pulmonary care specialists may decrease hospital utilizations. Keywords: pulmonary specialist, COPD, hospital utilization

Background : High-quality bowel preparation is crucial for achieving the goals of colonoscopy. However, choosing a bowel preparation in clinical practice can be challenging because of the many formulations. This study aims to assess the impact the type of bowel preparation on the quality of colonoscopy in a community hospital setting. Methods : A retrospective, observational study was conducted utilizing a colonoscopy screening/surveillance database in central Illinois during the period of January 1, 2010, to March 31, 2014. Patients without bowel preparation assessment were excluded from this study. Controlling for the confounders, generalized linear models were used to estimate the adjusted impact [odds ratio (OR)] of bowel preparation type on the quality of preparation (excellent, good, fair, and poor), and on the detection of advanced adenoma. The association between the time of withdrawal after insertion and the quality of preparation was also examined using a linear model. Results : A total of 28,368 colonoscopies; half the patients were male, and the average age was 61±9 years. Polyethylene glycol (PEG) was used in the majority (70.2%) of bowel preparations, followed by sodium sulfate (21.4%), sodium phosphate (2.5%), magnesium sulfate (0.4%), and others. Compared with PEG, magnesium sulfate had a poorer quality of bowel preparations (OR=0.6, 95% CI 0.4–0.9; p

Decision makers often struggle with how to make a decision to test everyone or not for a disease. As we all know, health-care decision making must be based on plenty of scientific evidences instead of gambling. On the other hand, any decision might have to take a certain risk because uncertainty always exists in the real world. The key question is how to understand and measure the risk of decision making.

It is challenging to translate the huge valuable information into practice in order to solve humanity problems of the world. From evidence to recommendation is a critical step to reach this goal. This chapter uses plenty of examples to introduce how to identify and assess evidence, how to evaluate recommendation’s direction and strength, and how to develop a good recommendation in practice.