Surveillance Colonoscopy in Older Stage I Colon Cancer Patients and the Association With Colon Cancer-Specific Mortality.

OBJECTIVES: Guideline-issuing groups differ regarding the recommendation that patients with stage I colon cancer receive surveillance colonoscopy after cancer-directed surgery. This observational comparative effectiveness study was conducted to evaluate the association between surveillance colonoscopy and colon cancer-specific mortality in early stage patients. METHODS: This was a retrospective cohort study of the Surveillance, Epidemiology, and End Results database combined with Medicare claims. Surveillance colonoscopy was assessed as a time-varying exposure up to 5 years after cancer-directed surgery with the following groups: no colonoscopy, one colonoscopy, and ≥ 2 colonoscopies. Inverse probability of treatment weighting was used to balance covariates. The time-dependent Cox regression model was used to obtain inverse probability of treatment weighting-adjusted hazard ratios (HRs), with 95% confidence intervals (CIs) for 5- and 10-year colon cancer, other cancer, and noncancer causes of death. RESULTS: There were 8,783 colon cancer cases available for analysis. Overall, compared with patients who received one colonoscopy, the no colonoscopy group experienced an increased rate of 10-year colon cancer-specific mortality (HR = 1.63; 95% CI 1.31-2.04) and noncancer death (HR = 1.36; 95% CI 1.25-1.49). Receipt of ≥ 2 colonoscopies was associated with a decreased rate of 10-year colon cancer-specific death (HR = 0.60; 95% CI 0.45-0.79), other cancer death (HR = 0.68; 95% CI 0.53-0.88), and noncancer death (HR = 0.69; 95% CI 0.62-0.76). Five-year cause-specific HRs were similar to 10-year estimates. DISCUSSION: These results support efforts to ensure that stage I patients undergo surveillance colonoscopy after cancer-directed surgery to facilitate early detection of new and recurrent neoplastic lesions.

The association between post-treatment surveillance testing and survival in stage II and III colon cancer patients: An observational comparative effectiveness study.

BACKGROUND: The best strategy for surveillance testing in stage II and III colon cancer patients following curative treatment is unknown. Previous randomized controlled trials have suffered from design limitations and yielded conflicting evidence. This observational comparative effectiveness research study was conducted to provide new evidence on the relationship between post-treatment surveillance testing and survival by overcoming the limitations of previous clinical trials. METHODS: This was a retrospective cohort study of the Surveillance, Epidemiology, and End Results database combined with Medicare claims (SEER-Medicare). Stage II and III colon cancer patients diagnosed from 2002 to 2009 and between 66 to 84 years of age were eligible. Adherence to surveillance testing guidelines-including carcinoembryonic antigen, computed tomography, and colonoscopy-was assessed for each year of follow-up and overall for up to three years post-treatment. Patients were categorized as More Adherent and Less Adherent according to testing guidelines. Patients who received no surveillance testing were excluded. The primary outcome was 5-year cancer-specific survival; 5-year overall survival was the secondary outcome. Inverse probability of treatment weighting (IPTW) using generalized boosted models was employed to balance covariates between the two surveillance groups. IPTW-adjusted survival curves comparing the two groups were performed by the Kaplan-Meier method. Weighted Cox regression was used to obtain hazard ratios (HRs) with 95% confidence intervals (CIs) for the relative risk of death for the Less Adherent group versus the More Adherent group. RESULTS: There were 17,860 stage II and III colon cancer cases available for analysis. Compared to More Adherent patients, Less Adherent patients experienced slightly better 5-year cancer-specific survival (HR = 0.83, 95% CI 0.76-0.90) and worse 5-year noncancer-specific survival (HR = 1.61, 95% CI 1.43-1.82) for years 2 to 5 of follow-up. There was no difference between the groups in overall survival (HR = 1.04, 95% CI 0.98-1.10). CONCLUSIONS: More surveillance testing did not improve 5-year cancer-specific survival compared to less testing and there was no difference between the groups in overall survival. The results of this study support a risk-stratified, shared decision-making surveillance strategy to optimize clinical and patient-centered outcomes for colon cancer patients in the survivorship phase of care.

Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database.

INTRODUCTION: Although the colorectal cancer (CRC) mortality rate has significantly improved over the past several decades, many patients will have a recurrence following curative treatment. Despite this high risk of recurrence, adherence to CRC surveillance testing guidelines is poor which increases cancer-related morbidity and potentially, mortality. Several randomised controlled trials (RCTs) with varying surveillance strategies have yielded conflicting evidence regarding the survival benefit associated with surveillance testing. However, due to differences in study protocols and limitations of sample size and length of follow-up, the RCT may not be the best study design to evaluate this relationship. An observational comparative effectiveness research study can overcome the sample size/follow-up limitations of RCT designs while assessing real-world variability in receipt of surveillance testing to provide much needed evidence on this important clinical issue. The gap in knowledge that this study will address concerns whether adherence to National Comprehensive Cancer Network CRC surveillance guidelines improves survival. METHODS AND ANALYSIS: Patients with colon and rectal cancer aged 66-84 years, who have been diagnosed between 2002 and 2008 and have been included in the Surveillance, Epidemiology, and End Results-Medicare database, are eligible for this retrospective cohort study. To minimise bias, patients had to survive at least 12 months following the completion of treatment. Adherence to surveillance testing up to 5 years post-treatment will be assessed in each year of follow-up and overall. Binomial regression will be used to assess the association between patients' characteristics and adherence. Survival analysis will be conducted to assess the association between adherence and 5-year survival. ETHICS AND DISSEMINATION: This study was approved by the National Cancer Institute and the Institutional Review Board of the University of Central Florida. The results of this study will be disseminated by publishing in the peer-reviewed scientific literature, presentation at national/international scientific conferences and posting through social media.

Hospital treatment costs and length of stay associated with hypertension and multimorbidity after hemorrhagic stroke.

BACKGROUND: Previous studies have identified various treatment and patient characteristics that may be associated with higher hospital cost after spontaneous intracerebral hemorrhage (ICH); a devastating type of stroke. Patient morbidity is perhaps the least understood of these cost-driving factors. We describe how hypertension and other patient morbidities affect length of stay, and hospital treatment costs after ICH using primary and simulated data. We also describe the relationship between cost and length of stay within these patients. METHODS: We used a cohort design; evaluating 987 consecutive ICH patients across one decade in a Canadian center. Economic, treatment, and patient data were obtained from clinical and administrative sources. Multimorbidity was defined as the presence of one or more diagnoses at hospital admission in addition to a primary diagnosis of ICH. RESULTS: Hypertension was the most frequent (67%) morbidity within these patients, as well as the strongest predictor of longer stay (adjusted RR for >7 days: 1.31, 95% CI: 1.07-1.60), and was significantly associated with higher cost per visit when accounting for other morbidities (adjusted cost increase for hypertension $8123.51, 95% CI: $4088.47 to $12,856.72 USD). A Monte Carlo simulation drawing one million samples of patients estimated for a generation (100 years) assuming 0.94% population growth per year, and a hospitalization rate of 12 per 100,000 inhabitants, supported these findings (p = 0.516 for the difference in unadjusted cost: simulated vs primary). Using a restricted cubic spline, we observed that the rate of change in overall cost for all patients was greatest for the first 3 weeks (p < 0.001) compared to subsequent weeks. CONCLUSION: Patient multimorbidity, specifically hypertension, is a strong predictor of longer stay and cost after ICH. The non-linear relationship between cost and time should also be considered when forecasting healthcare spending in these patients.

Factors associated with early deterioration after spontaneous intracerebral hemorrhage: a systematic review and meta-analysis.

BACKGROUND AND PURPOSE: Spontaneous intracerebral hemorrhage (ICH) is a devastating form of stroke with a poor prognosis overall. We conducted a systematic review and meta-analysis to identify and describe factors associated with early neurologic deterioration (END) after ICH. METHODS: We sought to identify any factor which could be prognostic in the absence of an intervention. The Cochrane Library, EMBASE, the Global Health Library, and PubMed were searched for primary studies from the years 1966 to 2012 with no restrictions on language or study design. Studies of patients who received a surgical intervention or specific experimental therapies were excluded. END was defined as death, or worsening on a reliable outcome scale within seven days after onset. RESULTS: 7,172 abstracts were reviewed, 1,579 full-text papers were obtained and screened. 14 studies were identified; including 2088 patients. Indices of ICH severity such as ICH volume (univariate combined OR per ml:1.37, 95%CI: 1.12-1.68), presence of intraventricular hemorrhage (2.95, 95%CI: 1.57-5.55), glucose concentration (per mmol/l: 2.14, 95%CI: 1.03-4.47), fibrinogen concentration (per g/l: 1.83, 95%CI: 1.03-3.25), and d-dimer concentration at hospital admission (per mg/l: 4.19, 95%CI: 1.88-9.34) were significantly associated with END after random-effects analyses. Whereas commonly described risk factors for ICH progression such as blood pressure, history of hypertension, and ICH growth were not. CONCLUSIONS: This study summarizes the evidence to date on early ICH prognosis and highlights that the amount and distribution of the initial bleed at hospital admission may be the most important factors to consider when predicting early clinical outcomes.

Cost of spontaneous intracerebral hemorrhage in Canada during 1 decade.

BACKGROUND AND PURPOSE: Spontaneous intracerebral hemorrhage (ICH) is widely considered to be the most devastating form of stroke in North America. Currently there is no clear understanding of the cost of treatment in Canada and thus no way of understanding how to manage ICH spending in this country. METHODS: We used a cohort study design to report and to examine the cost of ICH hospital care in a Canadian health center during 1 decade. Economic, treatment, and patients data were obtained from clinical and administrative sources. RESULTS: Analyses were performed using 987 consecutive patients with ICH from 1999 to 2008. The total inflation-adjusted cost of care was highly variable (median cost per discharge, $10,544.45 and $363.54 [min] to $265 470.43 [max] United States Dollars). Total cost did not change significantly during the decade. Patients age (cost change per year older, -$114.06 and -$189.01 to -$38.78) and in-hospital mortality (cost change for death, -$5092.84 and -$6270.65 to -$3697.09) were significantly associated with lower cost, whereas Charlson Comorbidity Index (cost change for ≥1, $5726.27 and $3965.36 to $7755.45), having surgery (cost change for surgery, $25,499.78 and $20,813.95 to $30,933.06), and admission National Institutes of Health Stroke Scale (cost change for ≥15 points, $7800.20 and $1637.78 to $17,026.38) were significantly associated with higher cost. CONCLUSIONS: To our knowledge, this is the most thorough published study to date to report and to examine predictors of ICH treatment costs in Canada. This study provides evidence that it may be reasonable to consider patients age, probability of death, level of comorbidity, need for surgery, and baseline ICH severity when forecasting health spending.

The reliability and sensitivity of the National Institutes of Health Stroke Scale for spontaneous intracerebral hemorrhage in an uncontrolled setting.

BACKGROUND AND PURPOSE: The National Institutes of Health Stroke Scale (NIHSS) is commonly used to measure neurologic function and guide treatment after spontaneous intracerebral hemorrhage (ICH) in routine stroke clinics. We evaluated its reliability and sensitivity to detect change with consecutive and unique rater combinations in a real-world setting. METHODS: Conservative measures of interrater reliability (unweighted Kappa (κ), Intraclass Correlation Coefficient (ICC1,1) and sensitivity to detect change (Minimal Detectable Difference (MDD)) were estimated. Sixty-one repeated ratings were completed within 1 week after ICH by physicians and nurses with no investigator intervention. RESULTS: Reliability (consistency) of the NIHSS total score was good for both physicians vs. nurses and nurses vs. nurses (ICC=0.78, 95%CI: 0.58-0.89 and ICC=0.75, 95%CI: 0.55-0.87 respectively) in this scenario. Reliability (agreement) of items 1C and 9 were excellent (κ>=0.61) for both rater comparisons, however, reliability was poor to fair on most remaining items (κ:0.01-0.60), with item 11 being completely unreliable in this scenario (κ<0.01). The MDD95 of the total NIHSS score was ±10 and ±11 points for physician vs. nurse and nurse vs. nurse comparisons. CONCLUSIONS: The reliability of the NIHSS is good overall for ICH even in an uncontrolled setting. However, on repeated measurements changes in total NIHSS score of at least >=10 points need to be observed for clinicians to be confident that real changes had occurred within 1 week after ICH.

Burden of Cardio- and Cerebro-vascular Diseases and the Conventional Risk Factors in South Asian Population.

Similar to most populations, South Asian countries are also witnessing the dramatic transitions in health during the last few decades with the major causes of adverse health shifting from a predominance of nutritional deficiencies and infectious diseases to chronic diseases such as cardio and cerebrovascular disease (CVD). We summarized the available information of the burden of CVD and risk factors in the South Asian populations. The prevalence of conventional cardiovascular has been increasing among all South Asian populations. Extensive urbanization, shift in dietary pattern and sedentary daily life style is contributing towards the worsening of the CVD risk factor scenario. The burdens of the chronic cardiovascular risk factors are much prevalent in the South Asian populations. These are also rising alarmingly which ought to influence the already existed heavy CVD burden. Similar to the rest of the world, management for the conventional cardiovascular risk factors is very important for the prevention of CVD in South Asia.

Radiographic measures of knee alignment in patients with varus gonarthrosis: effect of weightbearing status and associations with dynamic joint load.

BACKGROUND: Radiographic measures of lower limb malalignment are used to indicate abnormal loading of the knee and to plan corrective procedures. HYPOTHESES: Weightbearing status during hip-to-ankle radiographs will significantly affect malalignment measures; malalignment in single-limb standing will be most highly correlated to the external knee adduction moment during gait, a proposed dynamic measure of functional knee joint load. STUDY DESIGN: Controlled laboratory study. METHODS: Mechanical axis angle was measured in 40 patients with varus gonarthrosis from hip-to-ankle radiographs taken with patients in single-limb standing, double-limb standing, and supine positions. Kinematic and kinetic data were collected during walking and used to calculate the peak adduction moment about the knee. RESULTS: Repeated-measures analysis of variance and Scheffé post hoc tests indicated that mechanical axis angle measured on single-limb standing radiographs (-8.7 degrees +/- 4.0 degrees) was significantly greater than on double-limb standing radiographs (-7.1 degrees +/- 3.8 degrees), which was significantly greater than on supine radiographs (-5.5 degrees +/- 2.8 degrees). The peak knee adduction moment (2.8 +/- 0.8 percentage body weight x height) was only moderately correlated with mechanical axis angle on single-limb standing (r = -0.46), double-limb standing (r = -0.45), and supine (r = -0.43) radiographs. CONCLUSION: Patient position significantly affects frontal plane knee alignment. However, the peak knee adduction moment is only moderately correlated to mechanical axis angle, regardless of weightbearing status. CLINICAL RELEVANCE: These findings are inconsistent with the hypothesis that mechanical axis angle measured in single-limb standing is more representative of dynamic joint load and further highlight the differences between static and dynamic measures. Results also underscore the importance of reporting patient position during radiographs and keeping positions consistent when evaluating patients over time.

Reliability of lower limb frontal plane alignment measurements using plain radiographs and digitized images.

This study evaluated the reliability of lower limb frontal plane alignment measures obtained from plain radiographs measured manually and digitized images measured using a custom computer software package (TheHTO Pro; Fowler Kennedy Sport Medicine Clinic, London, Ontario, Canada). Radiographic measurements used in the planning of high tibial osteotomy, including the mechanical axis angle and mechanical axis deviation, were measured on 42 hip-to-ankle radiographs on two separate occasions by two different raters (A.V.S., J.J.D.). Intraclass correlation coefficients (0.96-0.99) indicated excellent agreement between the manual and computer measurements, suggesting both methods can be used interchangeably. Although test-retest and inter-rater reliability tended to be slightly better when using TheHTO Pro, intraclass correlation coefficients were excellent for both methods (0.97-0.99). The standard errors of measurement were <1 degree for mechanical axis angle and <2 mm for mechanical axis deviation, regardless of method or rater. Based on the observed standard errors of measurement, conservative estimates for the error associated with an individual's mechanical axis angle at one point is approximately 1.5 degrees, and the minimal detectable change on reassessment is approximately 2 degrees. The error associated with an individual's mechanical axis deviation at one point is approximately 4 mm, and the minimal detectable change on reassessment is approximately 6 mm. These results suggest that manual and computer measurements of lower limb frontal plane alignment can be calculated with minimal measurement error. However, the small errors associated with both methods should be considered when making clinical decisions.