Objectives:To test the effects of pregabalin on the induction of neurogenic claudication.Methods:This study was a randomized, double-blind, active placebo-controlled, 2-period, crossover trial. Twenty-nine subjects were randomized to receive pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, including a 2-step titration. Periods were separated by a 10-day washout period, including a 3-day taper phase after the first period. The primary outcome variable was the time to first moderate pain symptom (Numeric Rating Scale score ≥4) during a 15-minute treadmill test (Tfirst). Secondary outcome measures included pain intensity at rest, pain intensity at the end of the treadmill test, distance walked, and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire, modified Brief Pain Inventory–Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.Results:No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (difference in median Tfirst = −1.08 [95% confidence interval −2.25 to 0.08], p = 0.61). In addition, none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo.Conclusions:Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis.Classification of evidence:This study provides Class I evidence that for patients with neurogenic claudication, compared with diphenhydramine, pregabalin does not increase the time to moderate pain during a treadmill test.
These data support the use of CTA as an accurate method of calculating carotid artery stenosis based on agreement with Strandness criteria applied to CDUS velocities. When additional imaging beyond CDUS is necessary, we report no significant difference between diameter and CSA measurements obtained from CTA for preoperative evaluation of carotid disease.
We consider a study-level meta-analysis with a normally distributed outcome variable and possibly unequal study-level variances, where the object of inference is the difference in means between a treatment and control group. A common complication in such an analysis is missing sample variances for some studies. A frequently-used approach is to impute the weighted (by sample size) mean of the observed variances (mean imputation). Another approach is to include only those studies with variances reported (complete case analysis). Both mean imputation and complete case analysis are only valid under the missing-completely-at-random assumption (MCAR), and even then the inverse variance weights produced are not necessarily optimal. We propose a multiple imputation method employing gamma meta-regression to impute the missing sample variances. Our method takes advantage of study-level covariates that may be used to provide information about the missing data. Through simulation studies, we show that multiple imputation, when the imputation model is correctly specified, is superior to competing methods in terms of confidence interval coverage probability and type I error probability when testing a specified group difference. Finally, we describe a similar approach to handling missing variances in cross-over studies.
BACKGROUND: Survivors of Hodgkin lymphoma (HL) are at an increased risk of developing second malignancies. To the authors' knowledge, the risks of head and neck cancer (HNC) after HL and subsequent survival have not been thoroughly investigated. METH-ODS: From the US population-based Surveillance, Epidemiology, and End Results (SEER) database for 1973 through 2011, survivors of HL who developed HNC as a second cancer were analyzed. Patients with a first primary HNC were used as a comparison group. Observed-to-expected ratios and summary statistics were performed on patients with HL with squamous cell carcinoma (HL-SCC) and salivary gland cancer (HL-SGC). The impact of HL history on overall survival was assessed using a multivariate Cox proportional hazards model. RESULTS: The observed-to-expected ratio for SCC among patients with HL was 1.73 (95% confidence interval [95% CI], 1.36-2.16; P<.05), whereas it was 8.56 for SGC (95% CI, 5.82-12.15; P<.05). Using Cox proportional hazards modeling, a history of HL was found to be an adverse prognostic factor for overall survival for SCC (hazard ratio, 1.37; 95% CI, 1.08-1.73 [P 5.009]) but not SGC (hazard ratio, 1.21; 95% CI, 0.82-1.79 [P 5.34]). The inferior survival of the patients in the HL-SCC cohort appears to be attributable to more deaths from HL and other malignancies diagnosed after SCC. CONCLUSIONS: There is a significantly increased risk of salivary and nonsalivary HNC after HL, and worse survival for patients with HL-SCC versus those with a first primary SCC. Clinicians should be aware of the risks of HNC after HL. In the absence of evidence-based criteria, the authors recommend that survivors of HL undergo periodic head and neck examination. Cancer 2015;121:1436-45. V C 2015 American Cancer Society.KEYWORDS: second malignancy, Hodgkin lymphoma, head and neck cancer, salivary gland cancer, squamous cell carcinoma. INTRODUCTIONThe increased incidence of second malignant neoplasms (SMNs) after Hodgkin lymphoma (HL) has been well described. 1-4 The excess incidence of subsequent cancers in survivors of HL compared with that of the general population is due in part to the well-known late carcinogenic effects of chemotherapy and radiotherapy. However, survivors of HL may be even more susceptible to the development of SMNs compared with survivors of other malignancies because of genomic susceptibilities associated with HL. 5,6 In fact, 15 to 30 years after therapy for HL, the cumulative mortality from SMNs exceeds deaths due to HL. 1,[7][8][9] Examining patients derived from the population-based Surveillance, Epidemiology, and End Results (SEER) program, our group previously demonstrated that a history of HL adversely impacts survival among patients with breast, 6 lung, 5 and gastrointestinal 10 primary cancers. For patients who developed breast cancer after HL, the worse survival was largely attributable to deaths from other cancers.To our knowledge, there have been no studies specifically examining survival after a diagnosis of head and neck cancer (HNC) in pati...
Reasonable survival and local control can be achieved with SBRT. We identified several prognostic factors testable in future prospective trials that may help improve patient selection.
Hodgkin lymphoma (HL) survivors are at increased risk of thyroid cancer (TC). We sought to determine whether increased risks of high-risk pathology or mortality are seen with thyroid cancer after HL (HL-TC) compared with first primary thyroid cancer (TC-1). From the Surveillance, Epidemiology and End Results (SEER) registry, we compared patient and tumor characteristics as well as survival outcomes between HL-TC and TC-1 and fit a multivariable Cox model to assess for a possible association between HL history and overall survival after TC. Among 139,297 TC-1 and 174 HL-TC patients, history of HL was not associated with anaplastic or sarcoma TC. Multivariable analyzes showed that history of HL was not associated with a difference in risk of death after TC (hazard ratio: 0.96, 95% confidence interval: (0.81, 1.13), p = .61). Despite a significantly increased risk of TC among HL survivors, prior HL is not associated with more aggressive pathologic subtypes or worse prognosis.
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