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1.
Ann Surg Oncol ; 17(7): 1862-9, 2010 Jul.
Article in English | MEDLINE | ID: mdl-20162457

ABSTRACT

BACKGROUND: Invasive lobular breast cancer (ILC) is less common than invasive ductal breast cancer (IDC), more difficult to detect mammographically, and usually diagnosed at a later stage. Does delayed diagnosis of ILC affect survival? We used a national registry to compare outcomes of patients with stage-matched ILC and IDC. METHODS: Query of the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) tumor registry identified 263,408 women diagnosed with IDC or ILC between 1993 and 2003. Survival of patients matched by T and N stage was compared using Kaplan-Meier curves and log-rank analysis. RESULTS: When compared with IDC, ILC was more likely to be >2 cm (43.1 vs. 32.6%; P < 0.001), lymph node positive (36.8 vs. 34.4%; P < 0.001), and ER positive (93.1 vs. 75.6%; P < 0.001). The 5-year disease-specific survival (DSS) was significantly better for patients with ILC than for those with IDC, before (90 vs. 88%; P < 0.001) and after matching for stage T1N0 (98 vs. 96%; P < 0.001), T2N0 (94 vs. 88%; P < 0.001), and T3N0 (92 vs. 83%, P < 0.001). The 5-year DSS for patients with nodal metastasis of ILC vs. IDC was 89% vs. 88% (P = NS) for stage T1N1, 81 vs. 73% (P < 0.001) for T2N1, and 72 vs. 56% (P < 0.001) for T3N1. Multivariate analysis identified a 14% survival benefit for ILC (hazard ratio 0.86, 95% confidence interval 0.80-0.92). CONCLUSIONS: Stage-matched prognosis is better for patients with ILC than for those with IDC. Our findings support a different biology for ILC and are important for counseling and risk stratification.


Subject(s)
Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/pathology , Carcinoma, Lobular/pathology , Adult , Aged , Aged, 80 and over , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/radiotherapy , Carcinoma, Ductal, Breast/surgery , Female , Humans , Lymphatic Metastasis , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , SEER Program , Survival Rate
2.
Ann Surg Oncol ; 16(3): 554-61, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19002528

ABSTRACT

Procedure complexity and volume-outcome relationships have led to increased regionalization of pancreaticoduodenectomy (PD) for pancreas cancer. Knowledge regarding outcomes after PD comes from single-institutional series, which may be limited if a significant number of patients follow up at other hospitals. Thus, readmission data may be underreported. This study utilizes a population-based data set to examine readmission data following PD. California Cancer Registry (1994-2003) was linked to the California's Office of Statewide Health Planning and Development (OSHPD) database; patients with pancreatic adenocarcinoma who had undergone PD, excluding perioperative (30-day) mortality, were identified. All hospital readmissions within 1 year following PD were analyzed with respect to timing, location, and reason for readmission. Our cohort included 2,023 patients who underwent PD for pancreas cancer. Fifty-nine percent were readmitted within 1 year following PD and 47% were readmitted to a secondary hospital. Readmission was associated with worse median survival compared with those not readmitted (10.5 versus 22 months, p<0.0001). Multivariate analysis revealed that increasing T-stage, age, and comorbidities were associated with increased likelihood of readmission. Diagnoses associated with high rates of readmission included progression of disease (24%), surgery-related complications (14%), and infection (13%). Diabetes (1.4%) and pain (1.5%) were associated with low rates of readmission. We found a readmission rate of 59%, which is much higher than previously reported by single institutional series. Concordantly, nearly half of patients readmitted were readmitted to a secondary hospital. Common reasons for readmission included progression of disease, surgical complications, and infection. These findings should assist in both anticipating and facilitating postoperative care as well as managing patient expectations. This study utilizes a novel population-based database to evaluate incidence, timing, location, and reasons for readmission within 1 year following pancreaticoduodenectomy. Fifty-nine percent of patients were readmitted within 1 year after pancreaticoduodenectomy and 47% were readmitted to a secondary hospital.


Subject(s)
Adenocarcinoma/surgery , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/statistics & numerical data , Patient Readmission/statistics & numerical data , Adenocarcinoma/mortality , Aged , California/epidemiology , Cohort Studies , Female , Humans , Incidence , Length of Stay , Male , Middle Aged , Pancreatic Neoplasms/mortality , Patient Selection , Population Groups , Postoperative Complications/epidemiology , Postoperative Complications/surgery , Survival Rate
3.
Dig Dis Sci ; 54(3): 640-7, 2009 Mar.
Article in English | MEDLINE | ID: mdl-18612817

ABSTRACT

Evaluation of 12 lymph nodes has been mandated to prevent colon cancer understaging. Given that the probability of node metastases is largely associated with T-stage, are <12 nodes substandard for T1 and T2 lesions? We evaluated if survival for T1 and T2 tumors varies by nodes examined. In SEER, 61,237 patients undergoing colon cancer resection were identified. For each T-stage, 5-year survival rates were compared for node-negative cancers by using stepwise node cut-point comparisons (4 nodes, <4, etc.). Survival impact was determined by log-rank test and hazard regression. For T1 tumors, 4 nodes had 24% lower hazard of death compared to <4. For T2 tumors, 10 nodes had the biggest survival impact, 15% lower hazard of death. In conclusion, the number of nodes to stage T1 and T2 lesions may be <12.


Subject(s)
Adenocarcinoma/pathology , Colon/pathology , Colonic Neoplasms/pathology , Lymphatic Metastasis/diagnosis , Neoplasm Staging/standards , Adenocarcinoma/mortality , Aged , Colonic Neoplasms/mortality , Female , Humans , Incidence , Kaplan-Meier Estimate , Male , Proportional Hazards Models , SEER Program , United States/epidemiology
4.
Ann Surg Oncol ; 15(7): 1820-7, 2008 Jul.
Article in English | MEDLINE | ID: mdl-18369675

ABSTRACT

BACKGROUND: Ampullary cancer is the second most common periampullary cancer, with a resection and survival rate more favorable than that for pancreatic cancer. However, most reports have been conducted at single institutions with small sample sizes, and results may not reflect the practices and outcomes in the community. Our objective was to complete a population-based analysis of patients undergoing resection for ampullary carcinoma and compare it with outcomes in the published literature. METHODS: Patients diagnosed with ampullary cancer reported in the Surveillance, Epidemiology, and End Results program (1988-2003) were collected. Primary outcome was survival (5-year), and secondary outcome was stage at presentation. Comparisons were made with outcomes reported in the literature (resection rate, perioperative mortality, and 5-year survival). RESULTS: Of the 3292 ampullary cancer patients, 1301 (40%) underwent resection. Thirty-seven percent presented with stage I tumors. Perioperative mortality (30 day) was 7.6% after resection, and 5-year survival was 36.8%. Few patients died if they survived at least 5 years. The cancer registry data showed less early stage disease, higher perioperative mortality, and lower 5-year survival compared with published reports. CONCLUSIONS: This is the largest population-based analysis of ampullary carcinoma. Resection rates and survival at the national level are lower, in general, compared with cancer center reports, which may have implications for regionalizing these procedures. Many patients surviving at least 5 years seem to be cured by surgical resection.


Subject(s)
Adenocarcinoma/mortality , Adenocarcinoma/surgery , Ampulla of Vater/surgery , Common Bile Duct Neoplasms/mortality , Common Bile Duct Neoplasms/surgery , Adenocarcinoma/pathology , Aged , Ampulla of Vater/pathology , Common Bile Duct Neoplasms/pathology , Female , Humans , Male , Middle Aged , Neoplasm Staging , Pancreaticoduodenectomy , Survival Analysis , Survival Rate , Treatment Outcome
5.
Am Surg ; 74(10): 1001-5, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18942632

ABSTRACT

The rate of small bowel obstruction (SBO) after colectomy is unknown. Given the large number of colectomies performed in the United States, elucidating SBO rates, outcomes, and identifying predictors of readmission is important. Using the California Inpatient File, we identified all patients readmitted with a principle diagnosis of SBO at least once in the 3 years after colectomy (n = 4555). Patients admitted with a diagnosis of SBO in the 3 years before surgery were excluded. Overall, 10 per cent of patients were readmitted for SBO at least once after colectomy. Approximately 58 per cent were readmitted in the first year and 22 per cent of these patients required surgery. The most common operation performed was lysis of adhesions. Median length of stay was twice as long in the surgery group versus the no surgery group (12 vs 6 days). Overall mortality was higher in the nonsurgery group compared with the surgery group (33% vs 21%, P < 0.001) and highest in the elderly (44% vs 30%, P < 0.001). One in 10 patients without a history of SBO who undergoes a colectomy will be readmitted at least once in the subsequent 3 years for SBO, and there is a high mortality rate in this group, especially in the elderly.


Subject(s)
Colectomy/adverse effects , Colonic Diseases/surgery , Intestinal Obstruction/epidemiology , Intestine, Small , Age Factors , Aged , California/epidemiology , Female , Humans , Incidence , Intestinal Obstruction/etiology , Male , Postoperative Complications , Risk Factors
6.
JAMA ; 300(19): 2286-96, 2008 Nov 19.
Article in English | MEDLINE | ID: mdl-19017915

ABSTRACT

CONTEXT: Use of bariatric surgery has increased dramatically during the past 10 years, particularly among women of reproductive age. OBJECTIVES: To estimate bariatric surgery rates among women aged 18 to 45 years and to assess the published literature on pregnancy outcomes and fertility after surgery. EVIDENCE ACQUISITION: Search of the Nationwide Inpatient Sample (1998-2005) and multiple electronic databases (Medline, EMBASE, Controlled Clinical Trials Register Database, and the Cochrane Database of Reviews of Effectiveness) to identify articles published between 1985 and February 2008 on bariatric surgery among women of reproductive age. Search terms included bariatric procedures, fertility, contraception, pregnancy, and nutritional deficiencies. Information was abstracted about study design, fertility, and nutritional, neonatal, and pregnancy outcomes after surgery. EVIDENCE SYNTHESIS: Of 260 screened articles, 75 were included. Women aged 18 to 45 years accounted for 49% of all patients undergoing bariatric surgery (>50,000 cases annually for the 3 most recent years). Three matched cohort studies showed lower maternal complication rates after bariatric surgery than in obese women without bariatric surgery, or rates approaching those of nonobese controls. In 1 matched cohort study that compared maternal complication rates in women after laparoscopic adjustable gastric band surgery with obese women without surgery, rates of gestational diabetes (0% vs 22.1%, P < .05) and preeclampsia (0% vs 3.1%, P < .05) were lower in the bariatric surgery group. Findings were supported by 13 other bariatric cohort studies. Neonatal outcomes were similar or better after surgery compared with obese women without laparoscopic adjustable gastric band surgery (7.7% vs 7.1% for premature delivery; 7.7% vs 10.6% for low birth weight, P < .05; 7.7% vs 14.6% for macrosomia, P < .05). No differences in neonatal outcomes were found after gastric bypass compared with nonobese controls (26.3%-26.9% vs 22.4%-20.2% for premature delivery, P = not reported [1 study] and P = .43 [1 study]; 7.7% vs 9.0% for low birth weight, P = not reported [1 study]; and 0% vs 2.6%-4.3% for macrosomia, P = not reported [1 study] and P = .28 [1 study]). Findings were supported by 10 other studies. Studies regarding nutrition, fertility, cesarean delivery, and contraception were limited. CONCLUSION: Rates of many adverse maternal and neonatal outcomes may be lower in women who become pregnant after having had bariatric surgery compared with rates in pregnant women who are obese; however, further data are needed from rigorously designed studies.


Subject(s)
Bariatric Surgery , Fertility , Pregnancy Outcome , Adolescent , Adult , Bariatric Surgery/statistics & numerical data , Cesarean Section , Female , Humans , Middle Aged , Obstetric Labor Complications , Pregnancy , Pregnancy Complications , Risk , Young Adult
7.
Arch Surg ; 142(8): 767-723; discussion 773-4, 2007 Aug.
Article in English | MEDLINE | ID: mdl-17709731

ABSTRACT

OBJECTIVE: To determine the optimal number of lymph nodes to examine for accurate staging of node-negative pancreatic adenocarcinoma after pancreaticoduodenectomy. DESIGN, SETTING, AND PATIENTS: Data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program (1988-2002) were used to identify 3505 patients who underwent pancreaticoduodenectomy for adenocarcinoma of the pancreas, including 1150 patients who were pathologically node negative (pN0) and 584 patients with a single positive node (pN1a). Perioperative deaths were excluded. Univariate and multivariate survival analyses were performed. MAIN OUTCOME MEASURE: Examination of 15 lymph nodes appears to be optimal for accurate staging of node-negative adenocarcinoma of the pancreas after pancreaticoduodenectomy. RESULTS: The number of nodes examined ranged from 1 to 54 (median, 7 examined nodes). Univariate survival analysis demonstrated that dichotomizing the pN0 cohort on 15 or more examined lymph nodes resulted in the most statistically significant survival difference (log-rank chi(2) = 14.49). Kaplan-Meier survival curves demonstrated a median survival difference of 8 months (P < .001) in favor of the patients who had 15 or more examined nodes compared with patients with fewer than 15 examined nodes. Multivariate analysis validated that having 15 or more examined nodes was a statistically significant predictor of survival (hazard ratio, 0.63; 95% confidence interval, 0.49-0.80; P < .0001). Furthermore, a multivariate model based on the survival benefit of each additional node evaluated in the pN0 cohort demonstrated only a marginal survival benefit for analysis of more than 15 nodes. Approximately 90% of the pN1a cohort was identified with examination of 15 nodes. CONCLUSIONS: Examination of 15 lymph nodes appears to be optimal to accurately stage node-negative adenocarcinoma of the pancreas after pancreaticoduodenectomy. Furthermore, evaluation of at least 15 lymph nodes of a pancreaticoduodenectomy specimen may serve as a quality measure in the treatment of pancreatic adenocarcinoma.


Subject(s)
Adenocarcinoma/pathology , Neoplasm Staging/standards , Pancreatic Neoplasms/pathology , Adenocarcinoma/mortality , Adenocarcinoma/surgery , Female , Follow-Up Studies , Humans , Lymph Nodes/pathology , Male , Middle Aged , Pancreatic Neoplasms/mortality , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy , Postoperative Period , Prognosis , Reproducibility of Results , Retrospective Studies , SEER Program/statistics & numerical data , Survival Rate , United States/epidemiology
8.
Arch Surg ; 141(11): 1125-30; discussion 1131, 2006 Nov.
Article in English | MEDLINE | ID: mdl-17116806

ABSTRACT

The growth of new knowledge continues to advance the surgical disciplines, and several types of literature reviews attempt to consolidate this expansion of information. Meta-analysis is one such method that integrates findings on the same subject from different studies. Within surgery, there is a wealth of literature on a given topic, which needs to be considered collectively. As such, meta-analyses have been performed to address issues like the use of bowel preparation for colorectal surgery and comparisons of outcomes for laparoscopic vs open surgical approaches. A basic understanding of the groundwork required for meta-analysis is fundamental toward interpreting and critiquing its results. This review provides an overview of the principles, application, and limitations of meta-analysis in the context of surgery.


Subject(s)
General Surgery , Meta-Analysis as Topic , Humans , Publishing/standards , Research Design , Review Literature as Topic
9.
Am Surg ; 72(10): 870-4, 2006 Oct.
Article in English | MEDLINE | ID: mdl-17058724

ABSTRACT

Quality indicators will likely be used in comprehensive surgical quality assessment and improvement programs. Quality indicators are the actions equated with good quality of care. As a case example, bariatric surgery quality indicators were developed using evidence in the literature combined with formal expert opinion validation. Qualitative analysis was performed to identify the critical thematic issues surrounding development of these surgical quality indicators. Researchers identified five major thematic categories during the development process. These included feasibility in medical records (availability, ease of abstraction, and cost), the number of indicators developed (optimal number), the lack of evidence in the literature (weight on expert opinion), structural versus process indicators, and linkage to outcomes (need to demonstrate that adherence to indicators is associated with better outcomes). This project, using bariatric surgery as an example, uncovered important issues that need to be addressed when developing quality assessment and quality improvement programs for evaluating surgical quality. As quality indicators will likely be developed and used increasingly, future projects in this regard will benefit from these lessons.


Subject(s)
Bariatric Surgery/standards , Quality Indicators, Health Care/standards , Evidence-Based Medicine/standards , Expert Testimony/standards , Humans , Medical Records/standards , Outcome Assessment, Health Care/standards , Process Assessment, Health Care/standards , Quality Indicators, Health Care/classification , Quality of Health Care/classification , Quality of Health Care/standards
10.
Ann Intern Med ; 142(7): 547-59, 2005 Apr 05.
Article in English | MEDLINE | ID: mdl-15809466

ABSTRACT

BACKGROUND: Controversy exists regarding the effectiveness of surgery for weight loss and the resulting improvement in health-related outcomes. PURPOSE: To perform a meta-analysis of effectiveness and adverse events associated with surgical treatment of obesity. DATA SOURCES: MEDLINE, EMBASE, Cochrane Controlled Trials Register, and systematic reviews. STUDY SELECTION: Randomized, controlled trials; observational studies; and case series reporting on surgical treatment of obesity. DATA EXTRACTION: Information about study design, procedure, population, comorbid conditions, and adverse events. DATA SYNTHESIS: The authors assessed 147 studies. Of these, 89 contributed to the weight loss analysis, 134 contributed to the mortality analysis, and 128 contributed to the complications analysis. The authors identified 1 large, matched cohort analysis that reported greater weight loss with surgery than with medical treatment in individuals with an average body mass index (BMI) of 40 kg/m2 or greater. Surgery resulted in a weight loss of 20 to 30 kg, which was maintained for up to 10 years and was accompanied by improvements in some comorbid conditions. For BMIs of 35 to 39 kg/m2, data from case series strongly support superiority of surgery but cannot be considered conclusive. Gastric bypass procedures result in more weight loss than gastroplasty. Bariatric procedures in current use (gastric bypass, laparoscopic adjustable gastric band, vertical banded gastroplasty, and biliopancreatic diversion and switch) have been performed with an overall mortality rate of less than 1%. Adverse events occur in about 20% of cases. A laparoscopic approach results in fewer wound complications than an open approach. LIMITATIONS: Only a few controlled trials were available for analysis. Heterogeneity was seen among studies, and publication bias is possible. CONCLUSIONS: Surgery is more effective than nonsurgical treatment for weight loss and control of some comorbid conditions in patients with a BMI of 40 kg/m2 or greater. More data are needed to determine the efficacy of surgery relative to nonsurgical therapy for less severely obese people. Procedures differ in efficacy and incidence of complications.


Subject(s)
Obesity, Morbid/surgery , Adolescent , Adult , Child , Gastric Bypass/adverse effects , Gastroplasty/adverse effects , Gastroplasty/methods , Humans , Randomized Controlled Trials as Topic , Weight Loss
11.
Surg Obes Relat Dis ; 2(4): 423-9; discussion 429-30, 2006.
Article in English | MEDLINE | ID: mdl-16925372

ABSTRACT

OBJECTIVES: Bariatric surgery is one of the most common complex intraabdominal operations, and there are reports of variations in outcome among providers. There is a need to standardize the processes of care in this specialty, and, as an attempt to do so, quality indicators were developed. METHODS: Candidate indicators, covering preoperative to follow-up care (5 domains), were developed based on evidence in the literature. Indicators were formally rated as valid by use of the RAND/UCLA Validity and Appropriateness method, which quantitatively assesses the expert judgment of a group using a 9-point scale (1 = not valid; 9 = definitely valid). Fourteen individuals participated in the expert panel, including bariatric surgeons and obesity experts. The method is iterative with 2 rounds of ratings and a group discussion. Indicators with a median rating > or =7 were valid. This method has been shown to have content, construct, and predictive validity. RESULTS: Of 63 candidate indicators, 51 were rated as valid measures of good quality of care covering the spectrum of perioperative care for bariatric surgery. Of the 51 indicators rated as valid (> or =7), all had sufficient "agreement" scores among panelists. Indicators included structural measures (e.g., procedural volume requirements) as well as processes of care (e.g., receipt of preoperative antibiotics, use of clinical pathway). CONCLUSIONS: This is the first formal attempt at development of quality indicators for bariatric surgery. Adherence to the indicators should equate with better quality of care, and their implementation will allow for quantitative assessment of quality of care.


Subject(s)
Bariatric Surgery/standards , Obesity/surgery , Quality Assurance, Health Care , Quality Indicators, Health Care/trends , Adult , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Period , Time Factors , Treatment Outcome
12.
Surgery ; 138(2): 171-9, 2005 Aug.
Article in English | MEDLINE | ID: mdl-16153424

ABSTRACT

BACKGROUND: The use of beta blockers in surgical patients has been suggested to decrease perioperative cardiac events. However, the overall risk reduction, on the basis of solely aggregate data from randomized studies, is unknown. The objective is to evaluate the effect of perioperative beta blockade in noncardiac surgery for protection against mortality or cardiac events. METHODS: We performed a formal meta-analysis. The Medline database was searched for articles published from 1966-2004 by using the terms perioperative, beta blocker, surgery, and noncardiac. Inclusion criteria were randomized controlled trials evaluating perioperative beta blockade in noncardiac surgery. Studies were evaluated independently by 2 researchers. Cochrane Collaboration Software (Review Manager 4.2) was used to calculate relative risk (RR), risk difference (RD), and 95% confidence interval (CI). Six distinct postoperative adverse events were analyzed. RESULTS: Eligible studies included 6 randomized controlled trials evaluating perioperative beta blockade in patients undergoing noncardiac surgery. These studies evaluated a total of 632 patients: 354 received perioperative beta blockade and 278 did not. Results for the 6 postoperative outcomes are shown. [table: see text] The 2 largest effects were a decrease in long-term cardiac mortality from 12% to 2% and a decrease in myocardial ischemia from 33% to 15%. All outcomes except perioperative overall mortality had improvements (P < .02), which favor the use of perioperative beta blockade. CONCLUSIONS: This report highlights for the first time the aggregated risk reduction from all published randomized controlled trials, and shows the protection of perioperative beta blockade against both short-term complications and mortality.


Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Myocardial Infarction/mortality , Myocardial Ischemia/mortality , Surgical Procedures, Operative/mortality , Humans , Myocardial Infarction/drug therapy , Myocardial Ischemia/drug therapy , Randomized Controlled Trials as Topic , Risk Reduction Behavior
13.
Am Surg ; 71(10): 803-8, 2005 Oct.
Article in English | MEDLINE | ID: mdl-16468523

ABSTRACT

Negative appendectomy rate varies significantly depending on patient age and sex. However, the impact of computed tomography (CT) scans on the diagnosis of appendicitis is unknown. The goal of this study was to examine the negative appendectomy rate using a statewide database and analyze the association of receipt of CT scan. Using the California Inpatient File, all patients undergoing appendectomy in 1999-2000 were identified (n = 75,452). Demographic and clinical data were analyzed, including procedure approach (open vs laparoscopic) and appendicitis type (negative, simple, abscess, peritonitis). Patients with CT scans performed were identified to compare the negative appendectomy rate. For the entire cohort, appendicitis type was 59 per cent simple, 10 per cent with abscess, 18.7 per cent with peritonitis, and 9.3 per cent negative. Males had a lower rate of negative appendicitis than females (6.0% vs 13.4%, P < 0.0001). The use of CT scans was associated with an overall lower negative appendectomy rate for females, especially in the < 5 years and > 45 years age categories. Use of CT scans in males does not appear to be efficacious, as the negative appendectomy rates were similar across all age categories. In conclusion, use of CT was associated with lower rate of negative appendectomy, depending on patient age and sex.


Subject(s)
Appendectomy/statistics & numerical data , Appendicitis/diagnostic imaging , Appendicitis/surgery , Diagnostic Errors , Tomography, X-Ray Computed , Adolescent , Adult , California/epidemiology , Child , Child, Preschool , Female , Humans , Male , Middle Aged
14.
Surgery ; 134(2): 275-9, 2003 Aug.
Article in English | MEDLINE | ID: mdl-12947329

ABSTRACT

BACKGROUND: Randomized controlled trials (RCTs) are considered the gold standard for evidence-based clinical research, but prior work has suggested that there may be poor reporting of sample sizes in the surgical literature. Sample size calculations are essential for planning a study to minimize both type I and type II errors. We hypothesized that sample size calculations may not be performed consistently in surgery studies and, therefore, many studies may be "underpowered." To address this issue, we reviewed RCTs published in the surgical literature to determine how often sample size calculations were reported and to analyze each study's ability to detect varying degrees of differences in outcomes. METHODS: A comprehensive MEDLINE search identified RCTs published in Annals of Surgery, Archives of Surgery, and Surgery between 1999 and 2002. Each study was evaluated by two independent reviewers. Sample size calculations were performed to determine whether they had 80% power to detect differences between treatment groups of 50% (large) and 20% (small), with one-sided test, alpha = 0.05. For the underpowered studies, the degree to which sample size would need to be increased was determined. RESULTS: One hundred twenty-seven RCT articles were identified; of these, 48 (38%) reported sample size calculations. Eighty-six (68%) studies reported positive treatment effect, whereas 41 (32%) found negative results. Sixty-three (50%) of the studies were appropriately powered to detect a 50% effect change, whereas 24 (19%) had the power to detect a 20% difference. Of the studies that were underpowered, more than half needed to increase sample size by more than 10-fold. CONCLUSIONS: The reporting of sample size calculations was not provided in more than 60% of recently published surgical RCTs. Moreover, only half of studies had sample sizes appropriate to detect large differences between treatment groups.


Subject(s)
Data Interpretation, Statistical , Sample Size , Surgical Procedures, Operative , Humans , MEDLINE , Observer Variation , Randomized Controlled Trials as Topic , Research Design
15.
Arch Surg ; 139(4): 423-8, 2004 Apr.
Article in English | MEDLINE | ID: mdl-15078711

ABSTRACT

BACKGROUND: With the aging of the baby boomers, individuals aged 65 years and older make up the fastest-growing segment of the US population. This aging of the population will lead to new challenges for the US health care system because older individuals are the largest consumers of health care. HYPOTHESIS: The general surgery workload will increase dramatically by 2020 as a result of the aging population. DATA SOURCES: The National Hospital Discharge Survey, National Survey of Ambulatory Surgery, US Census Bureau, and Centers for Medicare and Medicaid Services. SETTING: A nationally representative random sample of inpatient and outpatient general surgical operations performed in 1996 in the United States. METHODS: Age- and procedure-specific rates of general surgery were obtained from the National Hospital Discharge Survey and National Survey of Ambulatory Surgery. Population projections were derived from the census bureau. We used relative-value units as a proxy for surgical work. By linking these 3 data sources, we predicted the future general surgery workload by analyzing the rates of surgery and modeling both the aging and expansion of the population. RESULTS: General surgery operations (n = 63) were classified into 5 procedure categories. Whereas the population will grow by 18% between 2000 and 2020, the workload of general surgeons will increase by 31.5%. The amount of growth (19.9%-40.3%) varies among different categories of operations. CONCLUSIONS: To our knowledge, this is one of the only studies to analyze the future workload of general surgery. We project a dramatic increase in workload in the next 20 years, largely as a result of the aging US population. Our baseline assumptions are relatively conservative, so this forecast may be an underestimation. Hence, the challenge for general surgeons is to develop strategies to address this problem while maintaining quality of care for our patients.


Subject(s)
General Surgery/statistics & numerical data , Surgical Procedures, Operative/statistics & numerical data , Workload/statistics & numerical data , Adolescent , Adult , Age Factors , Aged , Health Care Surveys/statistics & numerical data , Humans , Middle Aged , Surgical Procedures, Operative/trends , United States/epidemiology
16.
Arch Surg ; 138(10): 1106-11; discussion 1111-2, 2003 Oct.
Article in English | MEDLINE | ID: mdl-14557128

ABSTRACT

BACKGROUND: The practice environment for surgery is changing. However, little is known regarding the trends or current status of inpatient surgery at a population level. HYPOTHESIS: Inpatient surgical care has changed significantly over the last 10 years. DESIGN: Longitudinal analysis of California inpatient discharge data (January 1, 1990, through December 31, 2000). SETTING: All 503 nonfederal acute care hospitals in California. PATIENTS: All inpatients undergoing general, vascular, and cardiothoracic surgery in California from January 1, 1990, through December 31, 2000, were obtained. MAIN OUTCOME MEASURES: Volume, mean age, comorbidity profile, length of hospital stay, and in-hospital mortality were obtained for inpatient general, vascular, and cardiothoracic surgical procedures performed during the period 1990 to 2000. Rates of change and trends were evaluated for the 10-year period. RESULTS: Between January 1, 1990, and December 31, 2000, 1.64 million surgical procedures were performed. The number of surgical procedures increased 20.4%, from 135,795 in 1990 to 163,468 in 2000. Overall, patients were older and had more comorbid disease in 2000 compared with 1990. Both crude and adjusted (by type of operation) in-hospital mortality decreased from 3.9% in 1990 to 2.75% (P<.001) and 2.58% (P<.001), respectively, in 2000. Length of hospital stay decreased over the period for all operations analyzed. CONCLUSIONS: The total number of inpatient general, vascular, and cardiothoracic surgical procedures has increased over the past decade. Furthermore, our findings indicate that the outcomes of care (eg, in-hospital mortality and length of hospital stay) for patients who undergo general, vascular, and cardiothoracic surgical procedures have improved. However, continued evaluations at the population level are needed.


Subject(s)
Inpatients/statistics & numerical data , Surgical Procedures, Operative/statistics & numerical data , California , Hospital Mortality , Humans , Linear Models , Longitudinal Studies , Outcome Assessment, Health Care , Practice Patterns, Physicians'/statistics & numerical data , Statistics, Nonparametric , Surgical Procedures, Operative/mortality
17.
Am J Surg ; 187(3): 343-8, 2004 Mar.
Article in English | MEDLINE | ID: mdl-15006562

ABSTRACT

BACKGROUND: Colorectal cancer (CRC) is generally thought of as a disease of older persons; however a significant proportion of patients <40 years present with this disease. Many investigators have published single-institution series on CRC in the young, yet the data vary markedly. We performed a structured review of the current literature aiming to (1) characterize CRC in the young population and (2) determine how CRC in this population should be further addressed regarding detection and treatment. DATA SOURCES: A Medline literature search was completed. Articles were chosen to include those studies that examined patients <40 years old. A total of 55 articles were chosen from the search and review of the bibliographies. CONCLUSIONS: We found that CRC in the young population appears to be more aggressive, to present with later stage, and to have poorer pathologic findings. However, if detected early, young patients with Dukes' stage A or B lesions have better overall 5-year survival rates. These findings emphasize the need for health care providers to have a heightened awareness when caring for this young population, particularly because excellent modalities exist to diagnose and treat colorectal cancer.


Subject(s)
Colorectal Neoplasms/epidemiology , Colorectal Neoplasms/pathology , Adult , Age Distribution , Biopsy, Needle , Colorectal Neoplasms/therapy , Combined Modality Therapy , Disease-Free Survival , Female , Humans , Immunohistochemistry , Male , Neoplasm Staging , Prognosis , Retrospective Studies , Risk Assessment , Sex Distribution , Survival Analysis , United States/epidemiology
18.
Am Surg ; 69(1): 59-62, 2003 Jan.
Article in English | MEDLINE | ID: mdl-12575783

ABSTRACT

In 2001 approximately 40,000 deaths from breast cancer will occur in the United States. Although some estimates suggest possible state-to-state variations in breast cancer mortality rates the reasons for such differences remain unknown. Our objective was to confirm whether breast cancer mortality rates are significantly different by state and to identify predictors for such variation. Administrative data from the National Center for Health Statistics (NCHS) report were used to determine statewide death rates. Analyses were similarly performed with the Surveillance, Epidemiology, and End Results (SEER) cancer database to determine predictors of high versus low mortality rates. State-level variation in breast cancer mortality rates was demonstrated in the NCHS database. A subsequent analysis of high versus low mortality states in the SEER cancer registry demonstrates that stage at presentation was a significant predictor of mortality, as "high" mortality states had more patients presenting with later-stage disease. We conclude that variations in the breast cancer mortality rates exist between states. A nearly 50 per cent increase is observed between the states with the highest and lowest mortality rates. Adjusted analyses demonstrate that stage at presentation is a more important predictor of mortality variation than treatment differences. As such breast cancer mortality rates may be best improved by targeting screening and access-to-care issues rather than treatment.


Subject(s)
Breast Neoplasms/mortality , Age Factors , Breast Neoplasms/therapy , Databases as Topic , Female , Humans , Logistic Models , Marital Status , Middle Aged , Multivariate Analysis , National Center for Health Statistics, U.S. , SEER Program , United States/epidemiology
19.
Am Surg ; 70(10): 928-31, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15529854

ABSTRACT

A common operation for patients with complicated sigmoid diverticulitis is resection and placement of an ostomy (Hartmann procedure). This population-based study examines that proportion of ostomates who undergo reversal. In the California inpatient file, patients admitted for acute diverticulitis in 1995 were identified, including a subset that had surgical resection. Data regarding receipt of ostomy were obtained (4-year follow-up). Demographics and clinical data (procedure, ostomy reversal, time to reversal, comorbidity score, and complications) were collected. In 1995, 11,582 admissions for diverticulitis occurred in California. Of these, 24.2 per cent (n = 2808) underwent surgery at admission; 88.9 per cent were sigmoid/left colectomies; and 41.7 per cent had a Hartmann procedure. Patients with ostomies were older (P = 0.0004) and male (P = 0.03). Median comobidity score was the same for patients with or without an ostomy. Of the 1176 patients who had the Hartmann procedure, 65 per cent underwent reversal (mean 143 days). A larger proportion of men than women had their ostomies reversed (74.5% vs 55.9%, respectively, P < 0.0001). Median comorbidity scores for both groups were low, 0 for those reversed and 1 for nonreversed. Our study shows that although the majority of patients had their ostomies reversed, over 35 per cent did not at 4-year follow-up. Further studies are required to evaluate how this rate may be improved.


Subject(s)
Colostomy/statistics & numerical data , Digestive System Surgical Procedures/statistics & numerical data , Diverticulitis, Colonic/surgery , Adolescent , Adult , Aged , Aged, 80 and over , Anastomosis, Surgical/statistics & numerical data , California/epidemiology , Colectomy/statistics & numerical data , Digestive System Surgical Procedures/methods , Diverticulitis, Colonic/epidemiology , Female , Humans , Male , Middle Aged , Reoperation
20.
Am Surg ; 69(11): 961-5, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14627256

ABSTRACT

Elderly (80+ year old) individuals are the fastest-growing segment of the U.S. population. The objective of this study was to use population-based data to examine trends in the number of elderly undergoing major general, vascular, and cardiothoracic surgical procedures. California inpatient data from 1990-2000 was used to identify patients undergoing six procedures: abdominal aortic aneurysm repair (AAA), coronary artery bypass graft (CABG), carotid endarterectomy (CEA), colon resections, lung resections, and pancreatic resections. Despite comprising only 2.7 per cent of the California population, elderly patients were a significant percentage (6-22%) of the caseloads for the six procedures examined. For all six procedures, the percentage of patients that were elderly increased during the study period. The age-specific incidence rates for elderly individuals increased significantly for three of these procedures (CABG, CEA, lung resection), remained unchanged for two (AAA, pancreas resection), and decreased for one (colon resection). Elderly patients are a large and growing part of surgical caseloads. In the near future, the number of elderly individuals in the California state and the U.S. populations will increase dramatically (41% and 35% between 2000 and 2020). To provide the best quality of care, surgeons should embrace research, training, and educational opportunities regarding the treatment of elderly patients.


Subject(s)
Aged, 80 and over/statistics & numerical data , Surgical Procedures, Operative/statistics & numerical data , Aged , Aortic Aneurysm, Abdominal/surgery , California , Colectomy/statistics & numerical data , Colectomy/trends , Coronary Artery Bypass/statistics & numerical data , Coronary Artery Bypass/trends , Endarterectomy, Carotid/statistics & numerical data , Endarterectomy, Carotid/trends , Humans , Middle Aged , Pancreatectomy/statistics & numerical data , Pancreatectomy/trends , Pneumonectomy/statistics & numerical data , Pneumonectomy/trends , Surgical Procedures, Operative/trends
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