Abstract Objective The Kidney Disease Outcome Quality Initiative and Fistula First Breakthrough Initiative call for the indiscriminate creation of arteriovenous fistulas (AVFs) over arteriovenous ...grafts (AVGs) without providing patient-specific criteria for vascular access selection. Although the U.S. AVF rate has increased dramatically, several reports have found that this singular focus on increasing AVFs has resulted in increased AVF nonmaturation/early failure and a high prevalence of catheter dependence. The objective of this study was to determine the appropriateness of vascular access procedures in clinical scenarios constructed with combinations of relevant factors potentially influencing outcomes. Methods The RAND/UCLA Appropriateness Method was used. Accordingly, a comprehensive literature search was performed and a synthesis of results compiled. The RAND/UCLA Appropriateness Method was applied to 2088 AVF and 1728 AVG clinical scenarios with varying patient characteristics. Eleven international vascular access experts rated the appropriateness of each scenario in two rounds. On the basis of the distribution of the panelists' scores, each scenario was determined to be appropriate, inappropriate, or indeterminate. Results Panelists achieved agreement in 2964 (77.7%) scenarios; 860 (41%) AVF and 588 (34%) AVG scenarios were scored appropriate, 686 (33%) AVF and 480 (28%) AVG scenarios were scored inappropriate, and 542 (26%) AVF and 660 (38%) AVG scenarios were indeterminate. Younger age, larger outflow vein diameter, normal or obese body mass index (vs morbidly obese), larger inflow artery diameter, and higher patient functional status were associated with appropriateness of AVF creation. Older age, dialysis dependence, and smaller vein size were associated with appropriateness of AVG creation. Gender, diabetes, and coronary artery disease were not associated with AVF or AVG appropriateness. Dialysis status was not associated with AVF appropriateness. Body mass index and functional status were not associated with AVG appropriateness. To simulate the surgeon's decision-making, scenarios were combined to create situations with the same patient characteristics and both AVF and AVG options for access. Of these 864 clinical situations, 311 (36%) were rated appropriate for AVG but inappropriate or indeterminate for AVF. Conclusions The results of this study indicate that patient-specific situations exist wherein AVG is as appropriate as or more appropriate than AVF. These results provide patient-specific recommendations for clinicians to optimize vascular access selection criteria, to standardize care, and to inform payers and policy. Indeterminate scenarios will guide future research.
Background A gene expression profile (GEP) test able to accurately identify risk of metastasis for patients with cutaneous melanoma has been clinically validated. Objective We aimed for assessment of ...the prognostic accuracy of GEP and sentinel lymph node biopsy (SLNB) tests, independently and in combination, in a multicenter cohort of 217 patients. Methods Reverse transcription polymerase chain reaction (RT-PCR) was performed to assess the expression of 31 genes from primary melanoma tumors, and SLNB outcome was determined from clinical data. Prognostic accuracy of each test was determined using Kaplan-Meier and Cox regression analysis of disease-free, distant metastasis–free, and overall survivals. Results GEP outcome was a more significant and better predictor of each end point in univariate and multivariate regression analysis, compared with SLNB ( P < .0001 for all). In combination with SLNB, GEP improved prognostication. For patients with a GEP high-risk outcome and a negative SLNB result, Kaplan-Meier 5-year disease-free, distant metastasis–free, and overall survivals were 35%, 49%, and 54%, respectively. Limitations Within the SLNB-negative cohort of patients, overall risk of metastatic events was higher (∼30%) than commonly found in the general population of patients with melanoma. Conclusions In this study cohort, GEP was an objective tool that accurately predicted metastatic risk in SLNB-eligible patients.
Summary Background Carbamazepine is widely accepted as a drug of first choice for patients with partial onset seizures. Several newer drugs possess efficacy against these seizure types but previous ...randomised controlled trials have failed to inform a choice between these drugs. We aimed to assess efficacy with regards to longer-term outcomes, quality of life, and health economic outcomes. Methods SANAD was an unblinded randomised controlled trial in hospital-based outpatient clinics in the UK. Arm A recruited 1721 patients for whom carbamazepine was deemed to be standard treatment, and they were randomly assigned to receive carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate. Primary outcomes were time to treatment failure, and time to 12-months remission, and assessment was by both intention to treat and per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748. Findings For time to treatment failure, lamotrigine was significantly better than carbamazepine (hazard ratio HR 0·78 95% CI 0·63–0·97), gabapentin (0·65 0·52–0·80), and topiramate (0·64 0·52–0·79), and had a non-significant advantage compared with oxcarbazepine (1·15 0·86–1·54). For time to 12-month remission carbamazepine was significantly better than gabapentin (0·75 0·63–0·90), and estimates suggest a non-significant advantage for carbamazepine against lamotrigine (0·91 0·77–1·09), topiramate (0·86 0·72–1·03), and oxcarbazepine (0·92 0·73–1·18). In a per-protocol analysis, at 2 and 4 years the difference (95% CI) in the proportion achieving a 12-month remission (lamotrigine-carbamazepine) is 0 (−8 to 7) and 5 (−3 to 12), suggesting non-inferiority of lamotrigine compared with carbamazepine. Interpretation Lamotrigine is clinically better than carbamazepine, the standard drug treatment, for time to treatment failure outcomes and is therefore a cost-effective alternative for patients diagnosed with partial onset seizures.
Background The use of post-acute care is common among the elderly and accounts for $62 billion in annual Medicare expenditures. However, little is known about post-acute care use after surgery. Study ...Design Data were merged between the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) and Medicare claims for 2005 to 2008. Post-acute care use, including skilled nursing facilities (SNF), inpatient rehabilitation facilities (IRF), and home health care (HHC) were analyzed for 3 operations: colectomy, pancreatectomy, and open abdominal aortic aneurysm repair. Controlling for both preoperative risk factors and the occurrence of postoperative complications, we used multinomial logistic regression to estimate the odds of use for each type of post-acute care after elective surgery compared with home discharge. Results Post-acute care was used frequently for patients undergoing colectomy (40.0%; total n = 10,932), pancreatectomy (46.0%; total n = 2,144), and open abdominal aortic aneurysm (AAA) repair (44.9%; total n = 1,736). Home health was the most frequently reported post-acute care service for each operation (range 23.2% to 31.5%) followed by SNF (range 12.0% to 15.0%), and then by IRF (range 2.5% to 5.4%). The majority of patients with at least 1 inpatient complication were discharged to post-acute care (range 58.6% for open AAA repair to 64.4% for colectomy). In multivariable analysis, specific preoperative risk factors, including advanced age, poor functional status, and inpatient complications were significantly associated with increased risk-adjusted odds of discharge to post-acute care for each operation studied. Conclusions Among elderly patients, post-acute care use is frequent after surgery and is significantly associated with several preoperative risk factors and postoperative inpatient complications. Further work is needed to ensure that post-acute care services are used appropriately and cost-effectively.
Summary Background Valproate is widely accepted as a drug of first choice for patients with generalised onset seizures, and its broad spectrum of efficacy means it is recommended for patients with ...seizures that are difficult to classify. Lamotrigine and topiramate are also thought to possess broad spectrum activity. The SANAD study aimed to compare the longer-term effects of these drugs in patients with generalised onset seizures or seizures that are difficult to classify. Methods SANAD was an unblinded randomised controlled trial in hospital-based outpatient clinics in the UK. Arm B of the study recruited 716 patients for whom valproate was considered to be standard treatment. Patients were randomly assigned to valproate, lamotrigine, or topiramate between Jan 12, 1999, and Aug 31, 2004, and follow-up data were obtained up to Jan 13, 2006. Primary outcomes were time to treatment failure, and time to 1-year remission, and analysis was by both intention to treat and per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748. Findings For time to treatment failure, valproate was significantly better than topiramate (hazard ratio 1·57 95% CI 1·19–2·08), but there was no significant difference between valproate and lamotrigine (1·25 0·94–1·68). For patients with an idiopathic generalised epilepsy, valproate was significantly better than both lamotrigine (1·55 1·07–2·24 and topiramate (1·89 1·32–2·70). For time to 12-month remission valproate was significantly better than lamotrigine overall (0·76 0·62–0·94), and for the subgroup with an idiopathic generalised epilepsy 0·68 (0·53–0·89). But there was no significant difference between valproate and topiramate in either the analysis overall or for the subgroup with an idiopathic generalised epilepsy. Interpretation Valproate is better tolerated than topiramate and more efficacious than lamotrigine, and should remain the drug of first choice for many patients with generalised and unclassified epilepsies. However, because of known potential adverse effects of valproate during pregnancy, the benefits for seizure control in women of childbearing years should be considered.
Background This study aims to describe the magnitude of hospital costs among patients undergoing elective colectomy, cholecystectomy, and pancreatectomy, determine whether these costs relate as ...expected to duration of care, patient case-mix severity and comorbidities, and whether risk-adjusted costs vary significantly by hospital. Correctly estimating the cost of production of surgical care may help decision makers design mechanisms to improve the efficiency of surgical care. Study Design Patient data from 202 hospitals in the ACS-NSQIP were linked to Medicare inpatient claims. Patient charges were mapped to cost center cost-to-charge ratios in the Medicare cost reports to estimate costs. The association of patient case-mix severity and comorbidities with cost was analyzed using mixed effects multivariate regression. Cost variation among hospitals was quantified by estimating risk-adjusted hospital cost ratios and 95% confidence intervals from the mixed effects multivariate regression. Results There were 21,923 patients from 202 hospitals who underwent an elective colectomy (n = 13,945), cholecystectomy (n = 5,569), or pancreatectomy (n = 2,409). Median cost was lowest for cholecystectomy ($15,651) and highest for pancreatectomy ($37,745). Room and board costs accounted for the largest proportion (49%) of costs and were correlated with length of stay, R = 0.89, p < 0.001. The patient case-mix severity and comorbidity variables most associated with cost were American Society of Anesthesiologists (ASA) class IV (estimate 1.72, 95% CI 1.57 to 1.87) and fully dependent functional status (estimate 1.63, 95% CI 1.53 to 1.74). After risk-adjustment, 66 hospitals had significantly lower costs than the average hospital and 57 hospitals had significantly higher costs. Conclusions The hospital costs estimates appear to be consistent with clinical expectations of hospital resource use and differ significantly among 202 hospitals after risk-adjustment for preoperative patient characteristics and procedure type.
Study objective Emergency departments (EDs) frequently refer patients for needed outpatient specialty care, but little is known about the dynamics of these referrals when patients are publicly ...insured. Hence, we explored factors, including the role of ED referrals, associated with specialists' willingness to accept patients covered by Medicaid and the Children's Health Insurance Program (CHIP). Methods We conducted semistructured qualitative interviews with a purposive sample of 26 specialists and 14 primary care physicians in Cook County, Illinois, from April to September 2009, until theme saturation was reached. Transcripts and notes were entered into ATLAS.ti and analyzed using an iterative coding process to identify patterns of responses, ensure reliability, examine discrepancies, and achieve consensus through content analysis. Results Themes that emerged indicate that primary care physicians face considerable barriers getting publicly insured patients into outpatient specialty care and use the ED to facilitate this process. Specialty physicians reported that decisions to refuse or limit the number of patients with Medicaid/CHIP are due to economic strain or direct pressure from their institutions. Factors associated with specialist acceptance of patients with Medicaid/CHIP included high acuity or complexity, personal request from or an informal economic relationship with the primary care physician, geography, and patient hardship. Referral through the ED was a common and expected mechanism for publicly insured patients to access specialty care. Conclusion These exploratory findings suggest that specialists are willing to see children with Medicaid/CHIP if they are referred from an ED. As health systems restructure, EDs have the potential to play a role in improving care coordination and access to outpatient specialty care.
Background Rates of hospital readmission are currently used for public reporting and pay for performance. Colectomy procedures account for a large number of readmissions among operative procedures. ...Our objective was to compare the importance of 3 groups of clinical variables (demographics, preoperative risk factors, and postoperative complications) in predicting readmission after colectomy procedures. Methods Patient records (2005–2008) from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) were linked to Medicare inpatient claims. Patient demographics ( n = 2), preoperative risk factors ( n = 23), and 30-day postoperative complications ( n = 17) were identified from ACS-NSQIP, whereas 30-day postoperative readmissions and costs were determined from Medicare. Multivariable logistic regression models were used to examine risk-adjusted predictors of colectomy readmission. Results Among 12,981 colectomy patients, the 30-day postoperative readmission rate was 13.5%. Readmitted patients had slightly greater rates of comorbidities and indicators of clinical severity and substantially greater rates of complications than non-readmitted patients. After risk adjustment, patients with a complication were 3.3 times as likely to be readmitted as patients without a complication. Among individual complications, progressive renal failure and organ-space surgical site infection had the highest risk-adjusted relative risks of readmission (4.6 and 4.0, respectively). Demographic, preoperative risk factor, and postoperative complication variables increased the ability to discriminate readmissions (reflected by the c-statistic) by 5.3%, 23.3%, and 35.4%, respectively. Conclusion Postoperative complications after colectomy are more predictive of readmission than traditional risk factors. Focusing quality improvement efforts on preventing and managing postoperative complications may be the most important step toward reducing readmission rates.
Background Existing large clinical registries capture short-term follow-up. Yet, there are many important long-term outcomes in surgery, such as recurrence of a ventral hernia after ventral hernia ...repair. The goal of the current study was to conduct an exploratory analysis to determine whether the rates, timing, and risk factors for ventral hernia re-repair in claims data linked to registry data were consistent with the known clinical literature. Study Design The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) and Medicare inpatient claims linked data set from 2005 to 2008 was queried to identify ventral hernia re-repairs after index ventral hernia repairs. Survival analysis was used to examine the ventral hernia re-repair rate over time and to quantify the relationship with clinical variables. Results Of 3,730 index ventral hernia repairs identified in ACS-NSQIP, 247 patients (6.6%) underwent re-repair of a ventral hernia during the study period (2005–2008) in the Medicare claims data. ACS-NSQIP clinical variables that were associated with the ventral hernia re-repair rate in Medicare claims data 1 year after index ventral hernia repair were being a smoker (hazard ratio HR = 1.70, P = .02), body mass index (HR = 1.16, P = .04), and postoperative superficial surgical-site infection (HR = 2.88, P < .001). Conclusion Long-term rate and timing of ventral hernia re-repair obtained from claims data were an underestimate compared with clinical studies. Yet, several known clinical risk factors for recurrence in the clinical registry were associated with the re-repair rate in claims data at one year. It may be possible to study certain long-term outcomes using selected reoperation rates using the technique of linked clinical registry-claims data, with an understanding that event rates are conservative estimates.
Background A variety of data sources are available for measuring the quality of health care. Linking records from different sources can create unique and powerful databases that can be used to ...evaluate clinically relevant questions and direct health care policy. The objective of this study was to develop and validate a deterministic linkage algorithm that uses indirect patient identifiers to reliably match records from a surgical clinical registry with Medicare inpatient claims data. Methods Patient records from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), years 2005–2008, were linked to claims data in the Medicare Provider Analysis and Review file (MedPAR) by the use of a deterministic linkage algorithm and the following indirect patient identifiers: hospital, age, sex, diagnosis, procedure and dates of admission, discharge, and procedure. We validated the linkage procedure by systematically reviewing subsets of matched and unmatched records and by determining agreement on patient-level coding of inpatient mortality. Results Of the 150,454 records in ACS-NSQIP eligible for matching, 80.5% were linked to a MedPAR record. This percentage is within the expected match range given the estimated percentage of ACS-NSQIP patients likely to be Medicare beneficiaries. Systematic checks revealed no evidence of bias in the linkage procedure and there was excellent agreement on patient-level coding of mortality (kappa 0.969). The final linked database contained 121,070 patient records from 217 hospitals. Conclusion This study demonstrates the feasibility and validity of a method for linking 2 data sources without direct personal identifiers. As clinical registries and other data sources continue to proliferate, linkage algorithms such as described here will be critical for quality measurement purposes.
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