A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer.

BACKGROUND: Dysphagia palliation in inoperable esophageal cancer continues to be a challenge. Self-expandable metal stents have been the mainstay of endoscopic palliation but have a significant risk of adverse events (AEs). Liquid nitrogen spray cryotherapy is an established modality that can be used with systemic therapy. This study reports the outcomes of cryotherapy, including dysphagia and quality of life (QoL), in patients receiving systemic therapy. METHODS: This was a prospective multicenter cohort study of adults with inoperable esophageal cancer who underwent cryotherapy. QoL and dysphagia scores before and after cryotherapy were compared. RESULTS: 55 patients received 175 cryotherapy procedures. After a mean of 3.2 cryotherapy sessions, mean QoL improved from 34.9 at baseline to 29.0 at last follow-up (P < 0.001) and mean dysphagia improved from 1.9 to 1.3 (P = 0.004). Patients receiving more intensive cryotherapy (≥ 2 treatments within 3 weeks) showed a significantly greater improvement in dysphagia compared with those not receiving intensive therapy (1.2 vs. 0.2 points; P = 0.003). Overall, 13 patients (23.6 %) received another intervention (1 botulinum toxin injection, 2 stent, 3 radiation, 7 dilation) for dysphagia palliation. Within the 30-day post-procedure period, there were three non-cryotherapy-related grade ≥ 3 AEs (all deaths). The median overall survival was 16.4 months. CONCLUSION: In patients with inoperable esophageal cancer receiving concurrent systemic therapy, adding liquid nitrogen spray cryotherapy was safe and associated with improvement in dysphagia and QoL without causing reflux. More intensive treatment showed a greater improvement in dysphagia and should be considered as the preferred approach.

Disease burden of Crigler-Najjar syndrome: Systematic review and future perspectives.

BACKGROUND AND AIM: Crigler-Najjar syndrome (CNS) results from biallelic mutations of UGT1A1 causing partial or total loss of uridine 5'-diphosphate glucuronyltransferase activity leading to unconjugated hyperbilirubinemia and its attendant risk for irreversible neurological injury (kernicterus). CNS is exceedingly rare and has been only partially characterized through relatively small studies, each comprising between two and 57 patients. METHODS: A systematic literature review was conducted to consolidate data on the patient, caregiver, and societal burden of CNS. RESULTS: Twenty-eight articles on clinical aspects of CNS were identified, but no published data on its humanistic or economic burden were found. In patients with complete UGT1A1 deficiency (type 1 CNS [CNS-I]), unconjugated bilirubin levels increase 3-6 mg/dL/day during the newborn period and reach neurologically dangerous levels between 5 and 14 days of age. Phototherapy is the mainstay of treatment but poses significant challenges to patients and their families. Despite consistent phototherapy, patients with CNS-I have worsening hyperbilirubinemia with advancing age. Liver transplantation is the only definitive therapy for CNS-I and is increasingly associated with excellent long-term survival but also incurs high costs, medical and surgical morbidities, and risks of immunosuppression. CONCLUSIONS: Crigler-Najjar syndrome is associated with a substantial burden, even with existing standards of care. The development of novel disease-modifying therapies has the potential to reduce disease burden and improve the lives of CNS patients and their families.

Liquid nitrogen spray cryotherapy for dysphagia palliation in patients with inoperable esophageal cancer.

BACKGROUND AND AIMS: Dysphagia is a debilitating symptom in patients with inoperable esophageal cancer that contributes to poor quality of life and worsening nutritional status. The 2 most commonly used palliative modalities for dysphagia are radiation therapy and esophageal stent placement. However, radiation therapy is limited by adverse events (AEs) and total dose, and stent placement has a high rate of AEs, including reflux, migration, and chest pain. A relatively new modality of liquid nitrogen endoscopic spray cryotherapy has been described as salvage when other options have been exhausted and when patients are no longer receiving systemic therapy. We evaluated the safety and efficacy of cryotherapy as the primary modality for relieving dysphagia in inoperable esophageal cancer including patients receiving systemic cancer therapy. METHODS: This is a retrospective, multicenter, consecutive case series of 49 inoperable esophageal cancer patients undergoing palliative endoscopic cryotherapy at 4 specialized cancer centers from May 2014 to May 2016. The primary outcomes were change in dysphagia scores between pre- and postcryotherapy and AEs. Dysphagia was measured using a 5-point Likert scale: 0, no dysphagia; 1, dysphagia to solids; 2, dysphagia to semisolids; 3, dysphagia to liquids; 4, dysphagia to saliva. RESULTS: Thirty-nine men and 10 women with a mean age of 58 years underwent a total of 120 cryotherapy treatments. The mean dysphagia score improved significantly from 2.4 precryotherapy to 1.7 postcryotherapy (improvement of .7 points; P < .001). Minor AEs were seen in 6 of 120 (5.0%) cryotherapy treatments (1 intraprocedural and 5 postprocedural). In addition, 1 patient developed a severe intraprocedural AE of dilation-related perforation, whereas another patient developed a benign stricture requiring dilation. CONCLUSIONS: This preliminary retrospective study suggests that liquid nitrogen spray cryotherapy may be safe and effective for dysphagia palliation in inoperable esophageal cancer. Large prospective studies are needed to confirm these findings and identify patient and procedure characteristics associated with the greatest benefit.

The humanistic burden of Pompe disease: are there still unmet needs? A systematic review.

BACKGROUND: Humanistic burden considers the impact of an illness on a patient's health-related quality of life (HRQoL), activities of daily living (ADL), caregiver health, and caregiver QoL. Humanistic burden also considers treatment satisfaction and adherence to treatment regimens. Pompe disease is an autosomal recessive, progressive, multisystemic neuromuscular disease. Approval of enzyme-replacement therapy (ERT) markedly improved prognosis for patients, but considerable morbidity and a substantial humanistic burden remain. This article characterizes the humanistic burden of Pompe disease through a systematic literature review. METHODS: A systematic search of MEDLINE® and Embase® with back-referencing and supplementary literature searches was performed to retrieve data from interventional and non-interventional studies on the humanistic burden of Pompe disease. Publications were screened according to predefined criteria, extracted, and assessed for quality. Extracted data were narratively synthesized. RESULTS: No publications on the humanistic burden of infantile-onset Pompe disease (IOPD) were identified. As such, of 17 publications included here, all are in patients with late-onset Pompe disease (LOPD). Thirteen publications were initiated after approval of ERT, two were initiated before, and two overlapped the approval of ERT. The review shows that LOPD patients have a significantly lower HRQoL than the general population, even if treated with ERT. On transitioning to ERT, treatment was associated with improvement in the physical component score of the SF-36 and fatigue, although the SF-36 mental component score remained stable. Physical HRQoL remained below population norms after 4 years of ERT. Significantly more ERT-treated patients reported pain than controls, and bodily pain worsened in later years following ERT initiation. Treatment-naïve LOPD patients had significantly poorer ADL functioning compared with the general population, although ERT stabilized deteriorating functioning impairment. ERT studies showed caregivers provide 17.7 h/week informal care on average. Fifty percent, 40% and <20% of caregivers reported mental health, physical health, and financial/relational problems, respectively. In ERT-naïve patients, wheelchair use and home ventilatory support was associated with lower physical HRQoL and ADL functioning. In ERT-treated patients, key factors predicting worse HRQoL and ADL functioning were higher respiratory distress, poorer sleep quality, greater pain, and more fatigue. CONCLUSIONS: Pompe disease has a substantial humanistic burden, with strong inter-relationships among and between humanistic burden parameters and clinical progression.

Incidence of and factors associated with catheter-related bloodstream infection in patients with advanced solid tumors on home parenteral nutrition managed using a standardized catheter care protocol.

BACKGROUND: Catheter-related bloodstream infections (CRBSIs) are associated with high morbidity and mortality as well as increased medical costs. Cancer patients, who are often immunocompromised, are susceptible to CRBSI while receiving home parenteral nutrition (HPN). We evaluated the incidence of and factors associated with CRBSIs in cancer patients undergoing HPN managed using a standardized catheter care protocol. METHODS: This is a retrospective cohort study of 335 cancer patients receiving HPN between January 2012 and July 2015. The primary outcome of interest was the incidence of CRBSI expressed as events per 1000 HPN days. HPN days were calculated from the start date with the home infusion provider until the discontinuation of HPN, or the removal of the venous access device (VAD), or the death of the patient. The VADs used were either peripherally inserted central catheters (PICCs) or a subcutaneous implanted port or tunneled central catheters (TCCs). Univariate Poisson regression analyses were used to determine the variables associated with CRBSIs. RESULTS: Of 335 patients, 193 were females and 142 were males. The most common cancer types were colorectal, pancreatic, ovarian and stomach. A total of 408 VADs in 335 patients were studied, covering a total of 29,403 HPN days. Of 408 VADs, 206 (50.5%) were ports, 191 (46.8%) were PICCs, and 7 (2.7%) were TCCs. The median duration of HPN was 54 days. A total of 16 CRBSI episodes were recorded (8 in ports, 7 in PICCs and 1 in TCCs). The median duration from the start of HPN to the development of CRBSI episodes was 43.5 days. The overall incidence of CRBSI per 1000 HPN days was 0.54 (95% confidence interval: 0.32-0.86). Upon univariate analysis, no variables were found to be statistically significantly associated with CRBSI incidence. CONCLUSIONS: We found a low rate of CRBSI following a standardized catheter maintenance protocol in a high-risk oncology population undergoing HPN.

The relationship between circulating 25-hydroxyvitamin D and survival in newly diagnosed advanced non-small-cell lung cancer.

BACKGROUND: Serum 25-hydroxyvitamin D [25(OH)D], the major circulating form of vitamin D used for evaluating the vitamin D status of patients, has been associated with survival in a variety of cancers with conflicting evidence. We aimed to investigate this association in newly diagnosed advanced non-small-cell lung cancer (NSCLC) patients. METHODS: This was a consecutive cohort of 359 newly diagnosed stages III-IV NSCLC patients who underwent a baseline serum 25(OH)D evaluation prior to receiving any treatment at our institution between January 2008 and December 2010. We used the vitamin D categories of "deficient (<20 ng/ml)" and "not deficient (> = 20 ng/ml)". Cox regression was used to evaluate the prognostic significance of serum 25(OH)D after adjusting for relevant confounders. RESULTS: Mean age at diagnosis was 57.4 years. Of the 359 patients, 151 (42.1 %) were deficient in vitamin D at the time of diagnosis. The median survival in deficient and not deficient cohorts was 11.7 and 12.8 months respectively (p = 0.06). Season of diagnosis, performance status, smoking status and hospital location significantly predicted vitamin D status. On univariate Cox analysis, gender, stage of disease, hospital location, histologic subtype, subjective global assessment (SGA), performance status, smoking status, body mass index and serum albumin were significantly associated with survival (p <0.05 for all). On multivariate Cox analysis, six variables demonstrated statistically significant associations with survival: stage of disease, hospital location, histologic subtype, SGA, smoking status and serum albumin (p <0.05 for all). Serum vitamin D, which was borderline significant in univariate analysis, lost its significance in multivariate analysis. CONCLUSIONS: We found season of diagnosis, performance status and smoking history to be predictive of vitamin D status. Consistent with previously published research in advanced NSCLC, we did not find any significant association between pre-treatment serum 25(OH)D and survival in our patients.

Self-rated health supersedes patient satisfaction with service quality as a predictor of survival in prostate cancer.

BACKGROUND: We have previously reported that higher patient satisfaction (PS) with service quality is associated with favorable survival outcomes in a variety of cancers. However, we argued that patients with greater satisfaction might be the ones with better self-rated health (SRH), a recognized predictor of cancer survival. We therefore investigated whether SRH can supersede patient satisfaction as a predictor of survival in prostate cancer. METHODS: Nine hundred seventeen prostate cancer treated at four Cancer Treatment Centers of America(®) hospitals between July 2011 and March 2013. PS was measured on a 7-point scale ranging from "completely dissatisfied" to "completely satisfied". SRH was measured on a 7-point scale ranging from "very poor" to "excellent". Both were dichotomized into two categories: top box response (7) versus all others (1-6). Patient survival was the primary end point. Cox regression was used to evaluate the association between PS and survival controlling for covariates. RESULTS: The response rate for this study was 72%. Majority of patients (n = 517) had stage II disease. Seven hundred eighty-seven (85.8%) patients were "completely satisfied". Three hundred nineteen (34.8%) patients had "excellent" SRH. There was a weak but significant correlation between satisfaction and SRH (Kendall's tau b = 0.18; p < 0.001). On univariate analysis, "completely satisfied" patients had a significantly lower risk of mortality (HR = 0.46; 95% CI: 0.25-0.85; p = 0.01). Similarly, patients with "excellent" SRH had a significantly lower risk of mortality (HR = 0.25; 95% CI: 0.11-0.58; p = 0.001). On multivariate analysis, SRH was found to be a significant predictor of survival (HR = 0.31; 95% CI: 0.12-0.79; p = 0.01) while patient satisfaction was not (HR = 0.76; 95% CI: 0.40-1.5; p = 0.40). CONCLUSIONS: SRH supersedes patient satisfaction with service quality as a predictor of survival in prostate cancer. SRH should be used as a control variable in analyses involving patient satisfaction as a predictor of clinical cancer outcomes.

Initial experience with genomic profiling of heavily pretreated breast cancers.

BACKGROUND: Rapidly evolving advances in the understanding of theorized unique driver mutations within individual patient's cancers, as well as dramatic reduction in the cost of genomic profiling, have stimulated major interest in the role of such testing in routine clinical practice. The aim of this study was to report our initial experience with genomic testing in heavily pretreated breast cancer patients. METHODS: Patients with primary or recurrent breast cancer managed at any of our five hospitals and whose malignancy had failed to respond to therapy or had progressed on all recognized standard-of-care options were offered the opportunity to have their cancer undergo next-generation sequencing genomic profiling. RESULTS: Of a total of 101 patients, 98 (97 %) had at least one specific genomic alteration identified. A total of 465 different somatic genetic abnormalities were revealed in this group of patients. Although 52 % of patients were found to have an abnormality for which an U.S. Food and Drug Administration (FDA)-approved drug was available, 69 % of patients had an FDA-approved agent for an indication other than breast cancer. The most common genomic alterations of potential clinical consequence were PIK3 (25 %), FGFR1 (16 %), AKT (11 %), PTEN (10 %), ERBB2 (8 %), JAK2 (6 %), and RAF1 (5 %). CONCLUSIONS: Almost all advanced breast cancers possess at least one well-characterized genomic alteration that might be actionable at the clinical level. Further, in most cases, a plausible argument can be advanced for the potential biological and clinical relevance of an FDA-approved antineoplastic agent not currently indicated in the treatment of breast cancer.

A longitudinal study investigating quality of life and nutritional outcomes in advanced cancer patients receiving home parenteral nutrition.

BACKGROUND: In cancer patients where gastrointestinal function is marginal and malnutrition significant enough to result in the requirement for intensive nutrition support, parenteral nutrition (PN) is indicated. This longitudinal study examined the quality of life (QoL) and nutritional outcomes in advanced cancer patients receiving home PN (HPN). METHODS: Fifty-two adult cancer patients (21 males, 31 females, average age 53 years) treated at a specialized cancer facility between April 2009 and November 2011 met criteria. QoL and nutritional status were measured at baseline and every month while on HPN using EORTC-QLQ-C30, Karnofsky Performance Status (KPS), and Subjective Global Assessment (SGA). Repeated measures ANOVA and Generalized Estimating Equations (GEE) were used to evaluate longitudinal changes in QoL and SGA. RESULTS: Cancer diagnoses included pancreatic (n = 14), colorectal (n = 11), ovarian (n = 6), appendix (n = 5), stomach (n = 4) and others (n = 12). Average weight loss 6-months prior to HPN was 13.2 kg (16.9%). Average weight at initiation of HPN was 62.2 kg. In patients with available follow-up data after 1 month (n = 39), there was a significant improvement in SGA, weight (61.5 to 63.1 kg; p = 0.03) and KPS (61.6 to 67.3; p = 0.01) from baseline. Similarly, after 2 months (n = 22), there was an improvement in global QoL (37.1 to 49.2; p = 0.02), SGA, weight (57.6 to 60 kg; p = 0.04) and KPS (63.2 to 73.2; p = 0.01) from baseline. Finally, after 3 months (n = 15), there was an improvement in global QoL (30.6 to 54.4; p = 0.02), SGA, weight (61.1 to 65.9 kg; p = 0.04) and KPS (64.0 to 78.7; p = 0.002) from baseline. Upon GEE analysis, every 1 month of HPN was associated with an increase of 6.3 points in global QoL (p<0.001), 1.3 kg in weight (p = 0.009) and 5.8 points in KPS (p<0.001). CONCLUSIONS: HPN is associated with an improvement in QoL, KPS and nutritional status in advanced cancer patients, irrespective of their tumor type, who have compromised enteral intake and malnutrition. The greatest benefit was seen in patients with 3 months of HPN, although patients receiving HPN for 1 or 2 months also demonstrated significant improvements.

Patient satisfaction with service quality as a predictor of survival outcomes in breast cancer.

PURPOSE: Despite the recognized relevance of symptom burden in breast cancer, there has been limited exploration of whether an individual patient's assessment of the overall quality of care received might influence outcome. We therefore evaluated the relationship between patient-reported satisfaction with service quality and survival in breast cancer. METHODS: A random sample of 1,521 breast cancer patients treated at Cancer Treatment Centers of America. A questionnaire which covered several dimensions of patient satisfaction was administered. Items were measured on a seven-point Likert scale ranging from "completely dissatisfied" to "completely satisfied". Univariate and multivariate Cox regression was used to evaluate the association between patient satisfaction and survival. RESULTS: Of 1,521 patients, 836 were newly diagnosed, and 685 had previously been treated. A number of 409, 611, 323, and 178 patients had stage I, II, III, and IV disease, respectively. A total of 1,106 (72.7 %) patients were completely satisfied with the overall service quality, while 415 (27.3 %) were not. On univariate analysis, completely satisfied patients had a significantly lower risk of mortality compared to those not completely satisfied (HR = 0.62; 95 % CI 0.50-0.76; p < 0.001). On multivariate analysis, completely satisfied patients demonstrated significantly lower mortality (HR = 0.71; 95 % CI 0.57-0.87; p = 0.001) compared to those not completely satisfied. CONCLUSIONS: Patient satisfaction with service quality was an independent predictor of survival in breast cancer. Further exploration of a possible meaningful relationship between patient satisfaction with the care they receive and outcomes in breast cancer is indicated.

The relationship between baseline nutritional status with subsequent parenteral nutrition and clinical outcomes in cancer patients undergoing hyperthermic intraperitoneal chemotherapy.

BACKGROUND: The combination of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a promising treatment option for selected patients with peritoneal carcinomatosis. This retrospective study investigated the relationship between baseline nutritional assessment with subsequent parenteral nutritional (PN) and clinical outcomes in cancer patients undergoing CRS and HIPEC. METHODS: A consecutive series of 60 patients undergoing CRS and HIPEC at our institution between January 2009 and May 2011. Subjective Global Assessment (SGA) was used to assess nutritional status. Patients were classified preoperatively as: well nourished (SGA-A), mildly-moderately malnourished (SGA-B), and severely malnourished (SGA-C). For PN, patients were divided into 2 groups: those who received PN (PN+) and those who did not receive PN (PN-). The primary outcomes of interest were length of stay (LOS), postoperative complications, ECOG performance status (PS) and survival. LOS was calculated as the number of days in the hospital post surgery. Performance status was measured on a scale of 0-4. Survival was calculated from the date of first visit to the date of death/last contact. RESULTS: Of 60 patients, 19 were males and 41 females. The mean age at presentation was 50.3 years. The most common cancer types were colorectal (n = 24) and gynecologic (n = 19) with the majority of patients (n = 47) treated previously before coming to our institution. 33 patients were SGA-A, 22 SGA-B and 5 SGA-C prior to surgery. Of a total of 60 patients, 31 received PN. Mean LOS for the entire cohort was 16.2 days (SD = 9.8). Mean LOS for preoperative SGA-A, SGA-B and SGA-C were 15.0, 15.2 and 27.8 days respectively (ANOVA p = 0.02). Overall incidence of complications was 26.7% (16/60). Complications were recorded in 9 of 33 (27.3%) preoperative SGA-A patients and 7 of 27 (25.9%) SGA-B + C patients (p = 0.91). The median overall survival was 17.5 months (95% CI = 13.0 to 22.1 months). Median survival for preoperative SGA-A and SGA-B + C cohorts was 22.4 and 10.4 months respectively (p = 0.006). CONCLUSIONS: The preoperative SGA predicts LOS and survival in cancer patients undergoing HIPEC. Future randomized clinical trials in this patient population should investigate the systematic provision of PN to all malnourished patients in the preoperative period for a minimum of 7-10 days with the continuation of PN in the postoperative period.

Prognostic value of changes in quality of life scores in prostate cancer.

BACKGROUND: Several studies in the oncology literature have demonstrated the prognostic value of baseline quality of life (QoL). We investigated whether changes in QoL could predict survival in prostate cancer patients. METHODS: We evaluated 250 prostate cancer patients treated at our institution between Jan 2001 and Dec 2009 who were available for a minimum follow-up of 3 months. QoL was evaluated at baseline and after 3 months of treatment initiation using EORTC-QLQ-C30. Cox regression evaluated the prognostic significance of baseline and changes in QoL scores after adjusting for relevant clinical and demographic variables. RESULTS: Median overall survival was 89.1 months (95% CI: 56.5-121.7). Baseline QoL scale predictive of survival upon multivariate analysis was fatigue (p = 0.001). Associations between changes in QoL and survival, upon multivariate analysis, were observed for dyspnea and cognitive functioning. Every 10-point increase (worsening) in dyspnea was associated with a 16% increased risk of death (HR = 1.16; 95% CI = 1.02 to 1.30, p = 0.02), and every 10-point increase (improvement) in cognitive functioning was associated with a 24% decreased risk of death (HR = 0.76; 95% CI = 0.54 to 0.98, p = 0.04). CONCLUSIONS: This study provides preliminary evidence to indicate that prostate cancer patients with better baseline fatigue and patients whose dyspnea and cognitive functioning improves within 3 months of treatment are at a significantly decreased risk of mortality.

Patient satisfaction with service quality in an oncology setting: implications for prognosis in non-small cell lung cancer.

OBJECTIVE: To evaluate the relationship between self-reported satisfaction with service quality and overall survival in non-small cell lung cancer (NSCLC). DESIGN: A prospective cohort study. SETTING: Cancer Treatment Centers of America(®) from July 2007 and December 2010. PARTICIPANTS: Nine hundred and eighty-six returning NSCLC patients. INTERVENTION: Overall patient experience 'considering everything, how satisfied are you with your overall experience' was measured on a 7-point Likert scale ranging from 'completely dissatisfied' to 'completely satisfied.'. MAIN OUTCOME MEASURE: Patient survival was the primary end point. RESULTS: The response rate for this study was 69%. Six hundred patients were newly diagnosed, while 386 were previously treated. Four hundred sixty-nine were males, while 517 were females. 101, 59, 288 and 538 patients had stage I, II, III and IV disease, respectively. Mean age was 58.9 years. Six hundred and thirty (63.9%) patients had expired at the time of this analysis. Seven hundred and sixty-two (77.3%) patients were 'completely satisfied'. Median overall survival was 12.1 months (95% confidence interval (CI): 10.9-13.2 months). On univariate analysis, 'completely satisfied' patients had a significantly lower risk of mortality compared with those not 'completely satisfied' [hazard ratio (HR) = 0.70; 95% CI: 0.59-0.84; P < 0.001]. On multivariate analysis controlling for stage at diagnosis, prior treatment history, age and gender, 'completely satisfied' patients demonstrated significantly lower mortality (HR = 0.71; 95% CI: 0.60-0.85; P < 0.001) compared with those not 'completely satisfied'. CONCLUSIONS: Self-reported experience with service quality was an independent predictor of survival in NSCLC patients undergoing oncologic treatment, a novel finding in the literature. Based on these provocative findings, further exploration of this relationship is warranted in well-designed prospective studies.

The association between brain volume loss and disability in multiple sclerosis: A systematic review.

BACKGROUND: Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, degenerative disease of the central nervous system that affects approximately 2.8 million people worldwide. Compelling evidence from observational studies and clinical trials indicates a strong association between brain volume loss (BVL) and the accumulation of disability in MS. However, the considerable heterogeneity in study designs and methods of assessment of BVL invites questions concerning the generalizability of the reported findings. Therefore, we conducted this systematic review to characterize the relationship between BVL and physical disability in patients with MS. METHODS: A systematic literature search of MEDLINE and EMBASE databases was performed supplemented by gray literature searches. The following study designs were included: prospective/retrospective cohort, cross-sectional and case-control. Only English language articles published from 2010 onwards were eligible for final inclusion. There were no restrictions on MS subtype, age, or ethnicity. Of the 1620 citations retrieved by the structured searches, 50 publications met our screening criteria and were included in the final data set. RESULTS: Across all BVL measures, there was considerable heterogeneity in studies regarding the underlying study population, the definitions of BVL and image analysis methodologies, the physical disability measure used, the measures of association reported and whether the analysis conducted was univariable or multivariable. A total of 36 primary studies providing data on the association between whole BVL and physical disability in MS collectively suggest that whole brain atrophy is associated with greater physical disability progression in MS patients. Similarly, a total of 15 primary studies providing data on the association between ventricular atrophy and physical disability in MS suggest that ventricular atrophy is associated with greater physical disability progression in MS patients. Along similar lines, the existing evidence based on a total of 13 primary studies suggests that gray matter atrophy is associated with greater physical disability progression in MS patients. Four primary studies suggest that corpus callosum atrophy is associated with greater physical disability progression in MS patients. The majority of the existing evidence (6 primary studies) suggests no association between white matter atrophy and physical disability in MS. It is difficult to assign a relationship between basal ganglia volume loss and physical disability as well as medulla oblongata width and physical disability in MS due to very limited data. CONCLUSION: The evidence gathered from this systematic review, although very heterogeneous, suggests that whole brain atrophy is associated with greater physical disability progression in MS patients. Our review can help define future imaging biomarkers for physical disability progression and treatment monitoring in MS.

The prevalence and risk factors of depression in engineering college students: A cross-sectional study.

Background: Engineering students like any other students face several stressors in their lives, which make them vulnerable to depression. Depression may affect students' academic performance. Aim: The present study aims to estimate the prevalence and associated risk factors of depression among engineering students. Material and Methods: A cross-sectional study was conducted in December 2016 among 110 randomly selected students from an engineering college in a rural area of Pune district, India. PHQ-9 questionnaire was used. Univariate and multivariable ordinal logistic regression was used to quantify association. Results: Of a total of 110 students, 71.8% were males, while 28.2% were females. The mean age was 20.7 years. 29.1% had no depression, 48.2% had mild depression, and 22.7% had moderate depression. Univariate analysis found four variables significantly associated with a greater risk of depression: parental stress, sibling stress, economic stress, and interpersonal conflict. In the adjusted (multivariable) ordinal logistic regression analysis controlling for all independent variables, only lack of economic support and interpersonal conflicts retained their statistical significance. Conclusion: The prevalence of depression in engineering students is high and strongly associated with the presence of economic and personal stress. Screening for depression and giving them care and support is of paramount importance.

Predicting survival in prostate cancer: the role of quality of life assessment.

PURPOSE: While the use of quality of life (QoL) assessment has been increasing in clinical oncology, few studies have examined its prognostic significance in prostate cancer. We investigated the association between QoL at presentation and survival in prostate cancer. METHODS: We retrospectively reviewed 673 patients treated at two single-system cancer centers between January 2001 and December 2008. QoL was evaluated using EORTC-QLQ-C30. Patient survival was defined as the time interval between the date of first patient visit and the date of death/date of last contact. Univariate and multivariate Cox regression was performed to evaluate the prognostic significance of QoL. RESULTS: Mean age at presentation was 63.2 years. Patient stage of disease at diagnosis was I, 4; II, 464; III, 76; IV, 107; and 22 indeterminate. Median overall survival was 89.1 months (95% CI: 46.1-132.0). QoL scales predictive of survival upon univariate analysis were physical, role, emotional, social, fatigue, nausea/vomiting, pain, dyspnea, insomnia, loss of appetite, and constipation (p < 0.01 for all). Multivariate analyses found fatigue (p = 0.02) and constipation (p = 0.01) to be significantly associated with survival. CONCLUSIONS: Baseline QoL provides useful prognostic information in prostate cancer. These findings have important implications for patient stratification in clinical trials and may aid decision making in clinical practice.

Role of nutritional status in predicting quality of life outcomes in cancer--a systematic review of the epidemiological literature.

Malnutrition is a significant factor in predicting cancer patients' quality of life (QoL). We systematically reviewed the literature on the role of nutritional status in predicting QoL in cancer. We searched MEDLINE database using the terms "nutritional status" in combination with "quality of life" together with "cancer". Human studies published in English, having nutritional status as one of the predictor variables, and QoL as one of the outcome measures were included. Of the 26 included studies, 6 investigated head and neck cancer, 8 gastrointestinal, 1 lung, 1 gynecologic and 10 heterogeneous cancers. 24 studies concluded that better nutritional status was associated with better QoL, 1 study showed that better nutritional status was associated with better QoL only in high-risk patients, while 1 study concluded that there was no association between nutritional status and QoL. Nutritional status is a strong predictor of QoL in cancer patients. We recommend that more providers implement the American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines for oncology patients, which includes nutritional screening, nutritional assessment and intervention as appropriate. Correcting malnutrition may improve QoL in cancer patients, an important outcome of interest to cancer patients, their caregivers, and families.

Quality of life assessment as a predictor of survival in non-small cell lung cancer.

BACKGROUND: There are conflicting and inconsistent results in the literature on the prognostic role of quality of life (QoL) in cancer. We investigated whether QoL at admission could predict survival in lung cancer patients. METHODS: The study population consisted of 1194 non-small cell lung cancer patients treated at our institution between Jan 2001 and Dec 2008. QoL was evaluated using EORTC-QLQ-C30 prior to initiation of treatment. Patient survival was defined as the time interval between the date of first patient visit and the date of death from any cause/date of last contact. Univariate and multivariate Cox regression evaluated the prognostic significance of QoL. RESULTS: Mean age at presentation was 58.3 years. There were 605 newly diagnosed and 589 previously treated patients; 601 males and 593 females. Stage of disease at diagnosis was I, 100; II, 63; III, 348; IV, 656; and 27 indeterminate. Upon multivariate analyses, global QoL as well as physical function predicted patient survival in the entire study population. Every 10-point increase in physical function was associated with a 10% increase in survival (95% CI = 6% to 14%, p < 0.001). Similarly, every 10-point increase in global QoL was associated with a 9% increase in survival (95% CI = 6% to 11%, p < 0.001). Furthermore, physical function, nausea/vomiting, insomnia, and diarrhea (p < 0.05 for all) in newly diagnosed patients, but only physical function (p < 0.001) in previously treated patients were predictive of survival. CONCLUSIONS: Baseline global QoL and physical function provide useful prognostic information in non-small cell lung cancer patients.

The association of quality of life with potentially remediable disruptions of circadian sleep/activity rhythms in patients with advanced lung cancer.

BACKGROUND: Cancer patients routinely develop symptoms consistent with profound circadian disruption, which causes circadian disruption diminished quality of life. This study was initiated to determine the relationship between the severity of potentially remediable cancer-associated circadian disruption and quality of life among patients with advanced lung cancer. METHODS: We concurrently investigated the relationship between the circadian rhythms of 84 advanced lung cancer patients and their quality of life outcomes as measured by the EORTC QLQ C30 and Ferrans and Powers QLI. The robustness and stability of activity/sleep circadian daily rhythms were measured by actigraphy. Fifty three of the patients in the study were starting their definitive therapy following diagnosis and thirty one patients were beginning second-line therapy. Among the patients who failed prior therapy, the median time between completing definitive therapy and baseline actigraphy was 4.3 months, (interquartile range 2.1 to 9.8 months). RESULTS: We found that circadian disruption is universal and severe among these patients compared to non-cancer-bearing individuals. We found that each of these patient's EORTC QLQ C30 domain scores revealed a compromised capacity to perform the routine activities of daily life. The severity of several, but not all, EORTC QLQ C30 symptom items correlate strongly with the degree of individual circadian disruption. In addition, the scores of all four Ferrans/Powers QLI domains correlate strongly with the degree of circadian disruption. Although Ferrans/Powers QLI domain scores show that cancer and its treatment spared these patients' emotional and psychological health, the QLI Health/Function domain score revealed high levels of patients' dissatisfaction with their health which is much worse when circadian disruption is severe. Circadian disruption selectively affects specific Quality of Life domains, such as the Ferrans/Powers Health/Function domain, and not others, such as EORTC QLQ C30 Physical Domain. CONCLUSIONS: These data suggest the testable possibility that behavioral, hormonal and/or light-based strategies to improve circadian organization may help patients suffering from advanced lung cancer to feel and function better.

Can changes in health related quality of life scores predict survival in stages III and IV colorectal cancer?

BACKGROUND: Several studies have demonstrated the predictive significance on survival of baseline quality of life (QoL) in colorectal cancer (CRC) with little information on the impact of changes in QoL scores on prognosis in CRC. We investigated whether changes in QoL during treatment could predict survival in CRC. METHODS: We evaluated 396 stages III-IV CRC patients available for a minimum follow-up of 3 months. QoL was evaluated at baseline and after 3 months of treatment using EORTC QLQ-C30. Cox regression evaluated the prognostic significance of baseline, 3-month and changes in QoL scores after adjusting for age, gender and stage at diagnosis. RESULTS: After adjusting for covariates, every 10-point increase in both baseline appetite loss and global QoL score was associated with a 7% increased risk of death with HR = 1.07 (95% CI, 1.01-1.14; P = 0.02) and (HR = 0.93 (95% CI, 0.87-0.98; P = 0.01) respectively. A lower risk of death was associated with a 10-point improvement in physical function at 3 months (HR, 0.86; 95% CI, 0.78-0.94; P = 0.001). Surprisingly, a higher risk of death was associated with a 10-point improvement in social function at 3 months (HR, 1.08; 95% CI, 1.02-1.13; P = 0.008). CONCLUSIONS: This study provides preliminary evidence to indicate that CRC patients whose physical function improves within 3 months of treatment have a significantly increased probability of survival. These findings should be used in clinical practice to systematically address QoL-related problems of CRC patients throughout their treatment course.