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BACKGROUND: Improving quality of life (QOL) is a key goal in the care of patients with COPD. Pulmonary rehabilitation (PR) has clearly been shown to improve QOL, but is not accessible to many eligible patients. There is a need for alternative programs designed to improve patient well-being that are accessible to all patients with COPD. Our goal was to pilot test a simple, telephone-based health-coaching intervention that was recently shown to decrease readmission among hospitalized COPD patients and stable COPD patients eligible for PR. METHODS: Subjects received a 3-month intervention consisting of 10 health-coaching telephone calls based on motivational interviewing principles. Outcome measures included dyspnea level, measured by the modified Medical Research Council scale, and QOL, measured by the Chronic Respiratory Questionnaire and a single-item general self-rated health status. RESULTS: Fifty subjects with moderate to severe COPD were enrolled in the study. Forty-four subjects (86%) completed the study intervention. Dyspnea measured by the modified Medical Research Council score improved significantly after the intervention ( P = .002). The domains of fatigue, emotional function, and mastery on the Chronic Respiratory Disease Questionnaire and the single-item QOL question also improved significantly after the 3 months of health coaching ( P = .001, P = .001, P = .007, and P = .03, respectively). Thirty-six (71%) subjects had a clinically meaningful improvement in at least 1 study end point (either in the severity of dyspnea or a domain of QOL). Thirty subjects (58%) had an improvement of ≥0.5 points, the minimum clinically important difference in at least 1 component of the Chronic Respiratory Disease Questionnaire. CONCLUSIONS: A telephone-delivered motivational interviewing-based coaching program for COPD patients is a feasible, well-accepted (by both participants and providers), simple, and novel intervention to improve the well-being of patients with COPD. This pilot study provides insight into a possible alternative to a conventional PR program for patients with limited access to that program.

Females demonstrate less robust Frank‐Starling mechanism with respect to cardiac preload than males at rest. We asked whether this phenomenon would also affect cardiac performance during exercise. We hypothesized that stroke volume (SV) response to exercise would be more limited in deconditioned females such that cardiac output would be mainly rate dependent, compared with males. We conducted a chart audit of clinical exercise tests performed by adolescents with chronic fatigue. Oxygen uptake () was measured breath‐by‐breath at rest and during cycle ergometry, while cardiac output was measured by acetylene rebreathing at rest plus 2‐3 subthreshold workloads. SV response was analyzed in two ways: after normalization for body surface area (SV index, SVI) and as percentage change from resting values. Among 304 adolescents (78% females) with chronic fatigue, 189 (80%) of 236 females and 52 (76%) of 68 males were deconditioned (peakO2 <90% predicted). Heart rate trajectory during exercise was steeper for unfit than fit females, 70 vs 61 beat·min−1 per L·min−1 , (P=.003); but not for males, 47 vs 42 beat·min−1 per L·min−1 (P=.23). The highest measured SVI did not differ between unfit vs fit females (42.8 vs 41.5 mL·m−2, P=.39) while fit males showed larger SV during exercise than their unfit peers (highest SVI 55.9 vs 48.0 mL·m−2, P=.014). Both qualitative and quantitative sex differences exist in SV responses to exercise among chronically fatigued adolescents, suggesting volume loading may be more efficacious in girls.

Background. We test the hypotheses that use of the Chest Pain Choice (CPC) decision aid (DA) would be similarly effective in potentially vulnerable subgroups but increase knowledge more in patients with higher education and trust in physicians more in patients from racial minority groups. Methods. This was a secondary analysis of a multicenter randomized trial in adults with chest pain potentially due to acute coronary syndrome. The trial compared an intervention group engaged in shared decision making (SDM) using CPC to a control group receiving usual care (UC). We assessed for subgroup effects based on age, sex, race, income, insurance, education, literacy, and numeracy. We dichotomized each characteristic and tested for interactions using regression models with indicators for arm assignment and study site. Results. Of 898 patients (451 DA, 447 UC), over 50% were female, over one-third were black, nearly one-third had a high school education or less, and over 60% had “low” health literacy. The DA did not increase knowledge more in patients with higher education ( P for interaction = 0.06) but did increase knowledge more in the “typical” than in the “low” numeracy subgroup (10.6% v. 4.7%, absolute difference [AD] = 5.9%, P for interaction = 0.025). The DA did not significantly increase patient trust in physicians in racial minorities ( P for interaction = 0.06) but did increase trust more in patients with “low” literacy compared with those with “typical” literacy (3.7% v. –1.4%, AD = 5.1, P for interaction = 0.011). Conclusions. CPC benefited all sociodemographic groups to a similar extent, with greater knowledge transfer in patients with higher numeracy and greater physician trust in patients with “low” health literacy. Tailoring SDM interventions to patient characteristics may be necessary for optimal effectiveness.

OBJECTIVECurrent costs associated with spine care are unsustainable. Productivity loss and time away from work for patients who were once gainfully employed contributes greatly to the financial burden experienced by individuals and, more broadly, society. Therefore, it is vital to identify the factors associated with return to work (RTW) after lumbar spine surgery. In this analysis, the authors used data from a national prospective outcomes registry to create a predictive model of patients’ ability to RTW after undergoing lumbar spine surgery for degenerative spine disease.METHODSData from 4694 patients who underwent elective spine surgery for degenerative lumbar disease, who had been employed preoperatively, and who had completed a 3-month follow-up evaluation, were entered into a prospective, multicenter registry. Patient-reported outcomes—Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain (BP) and leg pain (LP), and EQ-5D scores—were recorded at baseline and at 3 months postoperatively. The time to RTW was defined as the period between operation and date of returning to work. A multivariable Cox proportional hazards regression model, including an array of preoperative factors, was fitted for RTW. The model performance was measured using the concordance index (c-index).RESULTSEighty-two percent of patients (n = 3855) returned to work within 3 months postoperatively. The risk-adjusted predictors of a lower likelihood of RTW were being preoperatively employed but not working at the time of presentation, manual labor as an occupation, worker’s compensation, liability insurance for disability, higher preoperative ODI score, higher preoperative NRS-BP score, and demographic factors such as female sex, African American race, history of diabetes, and higher American Society of Anesthesiologists score. The likelihood of a RTW within 3 months was higher in patients with higher education level than in those with less than high school–level education. The c-index of the model’s performance was 0.71.CONCLUSIONSThis study presents a novel predictive model for the probability of returning to work after lumbar spine surgery. Spine care providers can use this model to educate patients and encourage them in shared decision-making regarding the RTW outcome. This evidence-based decision support will result in better communication between patients and clinicians and improve postoperative recovery expectations, which will ultimately increase the likelihood of a positive RTW trajectory.

OBJECTIVEQuality and outcomes registry platforms lie at the center of many emerging evidence-driven reform models. Specifically, clinical registry data are progressively informing health care decision-making. In this analysis, the authors used data from a national prospective outcomes registry (the Quality Outcomes Database) to develop a predictive model for 12-month postoperative pain, disability, and quality of life (QOL) in patients undergoing elective lumbar spine surgery.METHODSIncluded in this analysis were 7618 patients who had completed 12 months of follow-up. The authors prospectively assessed baseline and 12-month patient-reported outcomes (PROs) via telephone interviews. The PROs assessed were those ascertained using the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for back pain (BP) and leg pain (LP). Variables analyzed for the predictive model included age, gender, body mass index, race, education level, history of prior surgery, smoking status, comorbid conditions, American Society of Anesthesiologists (ASA) score, symptom duration, indication for surgery, number of levels surgically treated, history of fusion surgery, surgical approach, receipt of workers’ compensation, liability insurance, insurance status, and ambulatory ability. To create a predictive model, each 12-month PRO was treated as an ordinal dependent variable and a separate proportional-odds ordinal logistic regression model was fitted for each PRO.RESULTSThere was a significant improvement in all PROs (p < 0.0001) at 12 months following lumbar spine surgery. The most important predictors of overall disability, QOL, and pain outcomes following lumbar spine surgery were employment status, baseline NRS-BP scores, psychological distress, baseline ODI scores, level of education, workers’ compensation status, symptom duration, race, baseline NRS-LP scores, ASA score, age, predominant symptom, smoking status, and insurance status. The prediction discrimination of the 4 separate novel predictive models was good, with a c-index of 0.69 for ODI, 0.69 for EQ-5D, 0.67 for NRS-BP, and 0.64 for NRS-LP (i.e., good concordance between predicted outcomes and observed outcomes).CONCLUSIONSThis study found that preoperative patient-specific factors derived from a prospective national outcomes registry significantly influence PRO measures of treatment effectiveness at 12 months after lumbar surgery. Novel predictive models constructed with these data hold the potential to improve surgical effectiveness and the overall value of spine surgery by optimizing patient selection and identifying important modifiable factors before a surgery even takes place. Furthermore, these models can advance patient-focused care when used as shared decision-making tools during preoperative patient counseling.

Pancreatic cancer is one of the most fatal common cancers affecting both men and women, representing about 3% of all new cancer cases in the United States. In this study, we aimed to investigate the association of pancreatic cancer risk with alcohol consumption as well as folate intake. We performed a case-control study of 384 patients diagnosed with pancreatic cancer from May 2004 to December 2009 and 983 primary care healthy controls in a largely white population (>96%). Our findings showed no significant association between risk of pancreatic cancer and either overall alcohol consumption or type of alcohol consumed (drinks/day). Our study showed dietary folate intake had a modest effect size, but was significantly inversely associated with pancreatic cancer (odds ratio (OR) = 0.99, p < 0.0001). The current study supports the hypothesis that pancreatic cancer risk is reduced with higher food-based folate intake.

TPS511 Background: Despite decades of basic and clinical research, effective therapy for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) remains one of the greatest unmet clinical needs in oncology today. Albumin-bound paclitaxel (AP) and gemcitabine (G) reported on an improvement in overall survival in metastatic (m) PDAC [NEJM 2013; 369:1691-1703]. The addition of cisplatin (C) has shown promising clinical data in previously reported studies [Cancer Res 2015; 75(15 Suppl):Abstract nr LB-003]. Through further preclinical work, vitamin D analog therapy decreases myeloid derived suppressor cell (MDSC) and regulating T cells (Tregs) thus turning PDAC into a more immune friendly microenvironment. This trial combines AP/C/G with the vitamin D analog paricalcitol (P) and the antibody-PD-1 drug Nivolumab (N) as a combination therapy for individuals with previously untreated metastatic PDAC. This trial evaluates the efficacy and safety of NAPPCG in patients in that population (NCT02754726). Methods: Key eligibility criteria include Stage IV PDAC, no prior chemotherapy for systemic disease, KPS ≥ 70; life expectancy ≥ 12 weeks and measurable disease. Key exclusion criteria include prior PD-1 or PD-L1 therapy. Doses are AP 125 mg/m2 undiluted, G 1000 mg/m2 in 500 ml of normal saline (NS), each infused over 30 minutes with C 25mg/ m2 in 500 ml of NS infused over 60 minutes on days 1, 8, 22, and 29 of a 42 day cycle. N is given at a fixed dose of 240 mg as a 60 minute infusion on days 1, 15, and 29. P is given at a fixed dose of 25 µg IV on days 1,4,8,12,15,22,26,29,32,36,and 39. Primary objective is to determine the efficacy of the combination NAPPCG for patients with previously untreated metastatic PDAC through determining CR, ORR, PFS, and OS. The secondary objective is to evaluate the safety of NAPPCG in patients with previously untreated metastatic PDAC. The study initiated accrual in April of 2016. If 4 of the first 10 patients are determined to have a PR the trial will expand to a total of 25 patients. Clinical trial information: NCT02754726.