The influence of hospital volume on survival after resection for lung cancer.

BACKGROUND: Among patients who have undergone high-risk operations for cancer, postoperative mortality rates are often lower at hospitals where more of these procedures are performed. We undertook a population-based study to estimate the extent to which the number of procedures performed at a hospital (hospital volume) is associated with survival after resection for lung cancer. METHODS: We studied patients 65 years old or older who received a diagnosis of stage I, II, or IIIA non-small-cell lung cancer between 1985 and 1996, resided in 1 of the 10 study areas covered by the Surveillance, Epidemiology, and End Results Program, and underwent surgery at a hospital that participates in the Nationwide Inpatient Sample (2118 patients and 76 hospitals). RESULTS: The volume of procedures at the hospital was positively associated with the survival of patients (P<0.001). Five years after surgery, 44 percent of patients who underwent operations at the hospitals with the highest volume were alive, as compared with 33 percent of those who underwent operations at the hospitals with the lowest volume. Patients at the highest-volume hospitals also had lower rates of postoperative complications (20 percent vs. 44 percent) and lower 30-day mortality (3 percent vs. 6 percent) than those at the lowest-volume hospitals. CONCLUSIONS: Patients who undergo resection for lung cancer at hospitals that perform large numbers of such procedures are likely to survive longer than patients who have such surgery at hospitals with a low volume of lung-resection procedures.

Age and adjuvant chemotherapy use after surgery for stage III colon cancer.

BACKGROUND: Randomized trials have established that 5-fluorouracil-based adjuvant chemotherapy following resection of stage III colon cancer reduces subsequent mortality by as much as 30%. However, the extent to which adjuvant therapy is used outside the clinical trial setting, particularly among the elderly, is unknown. METHODS: A retrospective cohort study utilizing the Surveillance, Epidemiology, and End Results/Medicare-linked database identified 6262 patients aged 65 years and older with resected stage III colon cancer. The primary outcome was chemotherapy use within 3 months of surgery, as ascertained from Medicare claims. We examined the extent to which age at diagnosis was associated with adjuvant chemotherapy usage, and we adjusted for potential confounding based on differences in other patient characteristics with the use of multiple logistic regression. All P values were two-sided. RESULTS: Age at diagnosis was the strongest determinant of chemotherapy: 78% of patients aged 65-69 years, 74% of those aged 70-74 years, 58% of those aged 75-79 years, 34% of those aged 80-84 years, and 11% of those aged 85-89 years received postoperative chemotherapy. The age trend remained pronounced after adjustment for potential confounding based on variation in patients' demographic and clinical characteristics and after exclusion of patients with any evident comorbidity (all P values <.001). CONCLUSIONS: Adjuvant chemotherapy for stage III colon cancer is used extensively, especially for patients under the age of 75 years. However, treatment rates decline dramatically with chronologic age. Because patients in their 70s and even 80s have a reasonable life expectancy, further efforts are needed to ensure that elderly patients have the opportunity to make informed decisions regarding this potentially curative treatment.

Manifest refraction versus autorefraction for patients with subfoveal choroidal neovascularization.

PURPOSE: To compare the results from manifest refraction using trial lenses and a standard visual acuity protocol to results from autorefraction for obtaining refractive error and best corrected visual acuity in patients enrolled in a randomized clinical trial. METHODS: During a 4-month period, 29 patients with subfoveal choroidal neovascularization (CNV), who were enrolled in the Submacular Surgery Trials (SSTs) Pilot Study at the Wilmer Ophthalmological Institute, gave verbal consent to participate in this study. Best corrected visual acuity was obtained using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts and standardized room lighting after performance of manifest refraction, according to the SST protocol, and autorefraction. Refractive error (spherical equivalent) and visual acuity scores were obtained in both eyes of all patients. RESULTS: On average, manifest refraction gave a spherical equivalent that was 1.04 D more plus than autorefraction (95% limits of agreement = 0.74, 1.34). On average, the visual acuity score was 1.5 letters better after manifest refraction than after autorefraction (95% limits of agreement = 0, 3.0). The comparison of the two methods of refraction was subdivided according to visual acuity level and eye disease (age-related macular degeneration or ocular histoplasmosis syndrome). CONCLUSIONS: Despite large differences in spherical equivalent between manifest refraction and autorefraction, the visual acuity scores were close (mean difference, 1.5 letters). Other studies comparing subjective refraction and autorefraction have shown similar results. Autorefraction in patients with subfoveal CNV may be a satisfactory alternative to manifest refraction in clinical trials and field studies in which best corrected visual acuity is of interest.

Influence of hospital procedure volume on outcomes following surgery for colon cancer.

CONTEXT: Survival following high-risk cancer surgery, such as pancreatectomy and esophagectomy, is superior at hospitals where high volumes of these procedures are performed. Conflicting evidence exists as to whether the association between hospital experience and favorable health outcomes also applies to more frequently performed operations, such as those for colon cancer. OBJECTIVE: To determine whether hospital procedure volume predicts survival following colon cancer surgery. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of data from the Surveillance, Epidemiology and End Results-Medicare linked database on 27 986 colon cancer patients aged 65 years and older who had surgical resection for primary adenocarcinoma diagnosed between 1991 and 1996. MAIN OUTCOME MEASURES: Thirty-day postoperative mortality and overall and cancer-specific long-term survival, by hospital procedure volume. RESULTS: We found small differences in 30-day postoperative mortality for patients treated at low- vs high-volume hospitals (3. 5% at hospitals in the top-volume quartile vs 5.5% at hospitals in the bottom-volume quartile). However, the correlation was statistically significant and persisted after adjusting for age at diagnosis, sex, race, cancer stage, comorbid illness, socioeconomic status, and acuity of hospitalization (P<.001). The association was evident for subgroups with stage I, II, and III disease. Hospital volume directly correlated with survival beyond 30 days and also was not attributable to differences in case mix (P<.001). The association between hospital volume and long-term survival was concentrated among patients with stage II and III disease (P<.001 for both). Among stage III patients, variation in use of adjuvant chemotherapy did not explain this finding. CONCLUSION: Our data suggest that hospital procedure volume predicts clinical outcomes following surgery for colon cancer, although the absolute magnitudes of these differences are modest in comparison with the variation observed for higher-risk cancer surgeries.

High-dose carmustine, thiotepa and etoposide followed by autologous bone marrow rescue for the treatment of high risk central nervous system tumors.

Forty-two patients (29 newly diagnosed) with high grade gliomas (n = 37), medulloblastoma (n = 2) or non-biopsied tumors (n = 3) with supratentorial (n = 24), brain stem (n = 11), posterior fossa (n = 5) or spinal (n = 2) location were eligible for this study with adequate organ function and no bone marrow tumor infiltration. Median patient age was 12.2 years (range, 0.7-46.8). A total of 600 mg/m2 BCNU, 900 mg/m2 thiotepa and 1500 or 750 mg/m2 etoposide (VP-16) was administered followed by autologous bone marrow reinfusion (ABMR). Twenty-one newly diagnosed patients received local irradiation (RT) post ABMR. Nine early deaths were observed (21%), as well as one secondary graft failure. Half of the patients aged 18 years or older experienced toxic deaths, whereas only 15% of patients younger than 18 years experienced toxic death (P = 0.05). Of 25 evaluable newly diagnosed patients, 20% achieved complete remission (CR) and 4% partial remission (PR), while 28% remained in continuing complete remission (CCR) and 44% remained with stable disease prior to RT. Of eight evaluable patients with recurrent disease, one achieved CR and two PR, while one remained in CCR and four with stable disease for 1 to 110.2 months. Overall survival was 36%, 24% and 17% at 1, 2 and 3 years following ABMR, with three newly diagnosed patients and one patient treated for recurrent disease being alive, without disease progression 64.4, 67.0, 86.3 and 110.2 months after ABMR, respectively. The combination of high-dose BCNU/ thiotepa/VP-16 has substantial toxicity but definite activity for high risk CNS tumors. Similar protocols with lower toxicity merit further evaluation in both newly diagnosed and recurrent CNS tumors.

Comparing tumour staging and grading systems: a case study and a review of the issues, using thymoma as a model.

We consider the problem of comparing alternative cancer staging and grading systems. Statistical comparisons are on the basis of the ability to predict survival, but more qualitative criteria, such as parsimony, and distinctive prognostic separability of the categories are relevant also. Furthermore, some staging systems are clearly ordinal, while others are not. Three candidate statistical measures are studied and compared: explained variation; area under the ROC curve; and the probability of concordance of stage and survival. Each of these has individual strengths and weaknesses. A data set involving the staging of thymoma is analysed in detail to motivate the problem and illustrate the results.

Validity and reliability of the dexter hand evaluation and therapy system in hand-injured patients.

This study compares measurements obtained using the Dexter Hand Evaluation and Therapy System with those obtained using manual goniometers and grip and pinch dynamometers. Intrarater and inter-rater reliabilities for each tool were also examined. Repeated digit range of motion and strength measurements were performed on 30 subjects who had prior upper extremity injuries. Three therapists performed all measurements on each subject three times, using both Dexter and manual instruments. Analyses of variance (ANOVAs) and intraclass correlation coefficients (ICCs) were used to assess concurrent validity and therapist reliability. The findings show that the computerized Dexter finger goniometer and grip and pinch dynamometers provide measurements that are statistically similar to those of their manual counterparts. The ANOVA results for concurrent validity showed no significant differences between mean measurement values across therapists for the Dexter tools compared with the manual tools (p> or =0.54). In addition, no significant differences were found among or between the therapists' measurements. The range of ICCs for intrarater and inter-rater reliability for all four tests was 0.86 to 0.99. However, a two-way ANOVA revealed a therapist effect during pinch strength measurements (p< or =0.05), suggesting the need for same-therapist and same-tool measurements until the Dexter pinch dynamometer has been further evaluated.

Racial differences in the treatment of early-stage lung cancer.

BACKGROUND: If discovered at an early stage, non-small-cell lung cancer is potentially curable by surgical resection. However, two disparities have been noted between black patients and white patients with this disease. Blacks are less likely to receive surgical treatment than whites, and they are likely to die sooner than whites. We undertook a population-based study to estimate the disparity in the rates of surgical treatment and to evaluate the extent to which this disparity is associated with differences in overall survival. METHODS: We studied all black patients and white patients 65 years of age or older who were given a diagnosis of resectable non-small-cell lung cancer (stage I or II) between 1985 and 1993 and who resided in 1 of the 10 study areas of the Surveillance, Epidemiology, and End Results (SEER) program (10,984 patients). Data on the diagnosis, stage of disease, treatment, and demographic characteristics of the patients were obtained from the SEER data base. Information on coexisting illnesses, type of Medicare coverage, and survival was obtained from linked Medicare inpatient-discharge records. RESULTS: The rate of surgery was 12.7 percentage points lower for black patients than for white patients (64.0 percent vs. 76.7 percent, P<0.001), and the five-year survival rate was also lower for blacks (26.4 percent vs. 34.1 percent, P<0.001). However, among the patients undergoing surgery, survival was similar for the two racial groups, as it was among those who did not undergo surgery. Furthermore, analyses in which adjustments were made for factors that are predictive of either candidacy for surgery or survival did not alter the influence of race on these outcomes. CONCLUSIONS: Our analyses suggest that the lower survival rate among black patients with early-stage, non-small-cell lung cancer, as compared with white patients, is largely explained by the lower rate of surgical treatment among blacks. Efforts to increase the rate of surgical treatment for black patients appear to be a promising way of improving survival in this group.

Hepatic sonography: comparison of tissue harmonic and standard sonography techniques.

OBJECTIVE: This study was performed to compare tissue harmonic sonography of the liver with conventional sonography of the liver. SUBJECTS AND METHODS: Forty-eight patients underwent tissue harmonic and conventional sonography of the liver, using a randomized imaging sequence. Imaging parameters were standardized, but gain varied. Techniques were compared using predetermined impact analysis categories. If a finding was revealed by only one sonographic technique, additional confirmation was obtained by another imaging technique or by surgery. In a separate image quality analysis, masked images were reviewed by two experienced radiologists to evaluate fluid-solid differentiation, near-field, far-field, and overall image quality. Rankings were correlated with field of view of images and body habitus of patients as determined by body mass index. RESULTS: Tissue harmonic sonography provided the same information as conventional sonography in 34 patients (71%) and added information in 14 patients (29%). The findings from tissue harmonic sonography resulted in altered treatment in five patients (10%). Eight patients (17%) had lesions revealed by tissue harmonic sonography only. Four patients (8%) had inadequate far-field visualization by both techniques. Both observers ranked tissue harmonic sonography the same as or better than standard sonography in 46 patients (96%) for fluid-solid differentiation, in 46 patients (96%) for near-field image quality, and in 45 patients (94%) for overall image quality. For far-field image quality, one observer ranked tissue harmonic sonography the same as or better than conventional sonography in 40 patients (83%), and the second observer, in 41 patients (85%). Image quality ratings showed no correlation with body habitus of the patients or field of view of images. CONCLUSION: Tissue harmonic sonography of the liver provides more information and better image quality than does conventional sonography of the liver.

Varicella vaccine in non-immune household contacts of children with cancer or leukaemia.

OBJECTIVE: To assess the immunogenicity and reactogenicity of a new formulation of live attenuated varicella vaccine (Oka strain) in non-immune household contacts of children with cancer or leukaemia. METHODOLOGY: This was an open study with one group. Healthy varicella-susceptible adults and children living in the same household as children with cancer or leukaemia were vaccinated with a new live attenuated varicella vaccine (Oka strain) which is stable when stored at 2-8°C (refrigerator temperature) for at least 24 months (Varilrix). Children less than 13 years of age received one dose (0.5 mL containing at least 103.3 plaque forming units) by subcutaneous injection and those aged over 13 years received two doses 8 weeks apart. Adverse reactions following vaccination were recorded daily by the vaccinees. Post-vaccination antibody estimation was determined using indirect immunofluorescence 6 weeks after vaccination. RESULTS: Thirty-five seronegative subjects (28 children and 7 adults and adolescents) were vaccinated. All subjects tested (34) had seroconverted after vaccination. Local injection site reactions were experienced by 15/35. Other adverse reactions were uncommon (rash 2/35, fever (≥ 37.5°C) 3/35). No cases of clinical varicella occurred amongst the high-risk household contacts of the vaccine. CONCLUSION: This is the first study of this formulation of varicella vaccine in household contacts of children with cancer or leukaemia. The vaccine was found to be safe and immunogenic, but further follow-up is needed to document duration of immunity.

Impact of hospital volume on operative mortality for major cancer surgery.

CONTEXT: Hospitals that treat a relatively high volume of patients for selected surgical oncology procedures report lower surgical in-hospital mortality rates than hospitals with a low volume of the procedures, but the reports do not take into account length of stay or adjust for case mix. OBJECTIVE: To determine whether hospital volume was inversely associated with 30-day operative mortality, after adjusting for case mix. DESIGN AND SETTING: Retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database in which the hypothesis was prospectively specified. Surgeons determined in advance the surgical oncology procedures for which the experience of treating a larger volume of patients was most likely to lead to the knowledge or technical expertise that might offset surgical fatalities. PATIENTS: All 5013 patients in the SEER registry aged 65 years or older at cancer diagnosis who underwent pancreatectomy, esophagectomy, pneumonectomy, liver resection, or pelvic exenteration, using incident cancers of the pancreas, esophagus, lung, colon, and rectum, and various genitourinary cancers diagnosed between 1984 and 1993. MAIN OUTCOME MEASURE: Thirty-day mortality in relation to procedure volume, adjusted for comorbidity, patient age, and cancer stage. RESULTS: Higher volume was linked with lower mortality for pancreatectomy (P=.004), esophagectomy (P<.001), liver resection (P=.04), and pelvic exenteration (P=.04), but not for pneumonectomy (P=.32). The most striking results were for esophagectomy, for which the operative mortality rose to 17.3% in low-volume hospitals, compared with 3.4% in high-volume hospitals, and for pancreatectomy, for which the corresponding rates were 12.9% vs 5.8%. Adjustments for case mix and other patient factors did not change the finding that low volume was strongly associated with excess mortality. CONCLUSIONS: These data support the hypothesis that when complex surgical oncologic procedures are provided by surgical teams in hospitals with specialty expertise, mortality rates are lower.