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123 citation(s) found for "Novotny, Paul".

Low income as a determinant of exercise capacity in COPD
Porta, Ana Sofia , Lam, Nyanjok, Novotny, Paul J. , Benzo, Roberto , Bernard, Gordon R. , Hoffman, Jeanne M. , Kaplan, Robert C. , Novotny, Paul, Lam, Nyanjok M

Chronic Respiratory Disease | November 18, 2018 | Volume: 16 | Issue: No issue available | Pages: No page available

10.1177/1479972318809491 | PMID 30449156 Get It

Exercise capacity (EC) is a critical outcome in chronic obstructive lung disease (chronic obstructive pulmonary disease (COPD)). It measures the impact of the disease and the effect of specific interventions like pulmonary rehabilitation (PR). EC determines COPD prognosis and is associated with health-care utilization and quality of life. Field walking tests and cardiopulmonary exercise test (CPET) are two ways to measure EC. The 6-minute walking test (6MWT) is the commonest and easiest field test. CPET has the advantage of assessing maximal aerobic capacity. Determinants of EC include age, gender, breathlessness, and lung function. Previous research suggests that socioeconomic status (SES), a meaningful factor in COPD, may also be associated with EC. However, those findings have not been replicated. We aimed to determine whether SES is an independent factor associated with EC in COPD. For this analysis, we used the National Emphysema Treatment Trial (NETT) database. NETT was a multicenter clinical trial where severe COPD patients were randomized to lung volume reduction surgery or medical therapy. Measures used were taken at baseline, postrehabilitation. Patients self-reported their income and were divided in two groups whether it was less or above US$30,000. Patients with a lower income had worse results in 6MWT ( p < 0.0001). We found an independent association between income and the 6MWT in patients with severe COPD after adjusting for age, gender, lung function, dyspnea, and living conditions ( p < 0.0007). One previous publication stated the relationship between income and EC. Our research confirms and extends previous publications associating EC with income by studying a large and well characterized cohort of severe COPD patients, also addressing EC by two different methods (maximal watts and 6MWT). Our results highlight the importance of addressing social determinants of health such as income when assessing COPD patients.
Frailty and Clinical Outcomes in Chronic Obstructive Pulmonary Disease
Kennedy, Cassie C. , Novotny, Paul J. , Wise, Robert A. , Sciurba, Frank C. , Benzo, Roberto P. , Hoffman, Eric A. , Reardon, Michael J. , Mullan, Brian F. , Sieren, Jessica C. , Kennedy, Cassie C , Wise, Robert , Hoffman, Eric A , Reardon, Michael J , LeBrasseur, Nathan K.

Annals of the American Thoracic Society | November 15, 2018 | Volume: 16 | Issue: 2 | Pages: 217-224

10.1513/annalsats.201803-175oc | PMID 30433830 Get It

Abstract Rationale Frailty represents an increased vulnerability to adverse health outcomes. The frailty phenotype conceptual model (three or more patient attributes of wasting, exhaustion, low activity, slowness, and weakness) is associated with increased morbidity and mortality in geriatric populations. Objectives Our objective was to describe the risks associated with frailty in patients with chronic obstructive pulmonary disease. Methods Data from the National Emphysema Treatment Trial (NETT) were retrospectively analyzed. The frailty phenotype conceptual model was operationalized as three or more frailty parameters (a body mass index decrease of ≥5% over 12 months, self-reported exhaustion, low 6-minute walk distance, or physical activity or respiratory muscle strength in the lowest quartile). Frail participants were compared with participants with two or fewer frailty parameters. Participants were followed starting 12 months after NETT randomization (to minimize surgical effect) for 24 months. Univariate, multivariate, Kaplan-Meier, and Cox proportional hazard analyses were performed, adjusting for treatment arm, age, modified Medical Research Council dyspnea scale, sex, and baseline forced expiratory volume in 1 second (FEV1). Multiple imputation was used for missing values. Results The participants (N = 902) were predominantly white (94.5%) males (59.5%), with a median age of 67 years (interquartile range, 63–70 yr) and a median FEV1% predicted of 26 (interquartile range, 20–33). Six percent of the participants (95% confidence interval [CI], 4.5 to 7.6) were frail. The incidence rate of frailty was 6.4 per 100 person-years. Frail participants reported significantly worse disease-specific and overall quality of life by St. George’s Respiratory Questionnaire total score (mean difference of 11.6; 95% CI, 7.6 to 15.6; P &lt; 0.001), mental composite on Medical Outcomes Survey Short Form-36 (mean difference −6.8; 95% CI, −10.0 to −3.6; P &lt; 0.001), and physical composite scores on Medical Outcomes Survey Short Form-36 (mean difference −16.7; 95% CI, −21.3 to −12.1; P = 0.001). Frail participants had an increased rate of hospitalization (adjusted hazard ratio, 1.6; 95% CI, 1.1 to 2.5; P = 0.02) and an adjusted increase in hospital use of 8.0 days (95% CI, 4.4 to 11.6; P &lt; 0.001) compared with nonfrail participants. Frail participants had a higher mortality rate (adjusted hazard ratio, 1.4; 95% CI, 0.97 to 2.0; P = 0.07). Conclusions Among adults with chronic obstructive pulmonary disease, our measure of frailty (modified from the Fried frailty phenotype) was associated with incident and longer-duration hospitalization, and with poor quality of life.
Beyond maximum grade: A novel method to assess toxicity over time in clinical trials of targeted therapy in lymphoma.
Thanarajasingam, Gita , Atherton, Pamela J. , Pederson, Levi , Novotny, Paul J. , Sloan, Jeff A. , Grothey, Axel, Kumar, Shaji , Habermann, Thomas M. , Witzig, Thomas E.

Journal of Clinical Oncology | September 6, 2018 | Volume: 34 | Issue: 15_suppl | Pages: 7546-7546

10.1200/jco.2016.34.15_suppl.7546 Get It

Toward understanding toxicity over time (ToxT) in myeloma cooperative group trials: Feasibility of a novel longitudinal adverse event analysis in ECOG-ACRIN E1A06.
Jacobus, Susanna , Novotny, Paul J. , Stewart, A. Keith, Warsame, Rahma , Midathada, Madhu, Singh, Avina A., O’Brien, Timothy E., MacFarlene, Donald, Grinblatt, David L. , Chanan‐Khan, Asher , Thanarajasingam, Gita , Callander, Natalie S. , Fonseca, Rafaël , Rajkumar, S. Vincent , Dueck, Amylou C.

Journal of Clinical Oncology | September 5, 2018 | Volume: 36 | Issue: 15_suppl | Pages: 6580-6580

10.1200/jco.2018.36.15_suppl.6580 Get It

Patient-reported outcomes, emoji, and activity measured on the Apple Watch in cancer patients.
Thompson, Carrie A. , Yost, Kathleen J. , Bartz, Alicia, Ruddy, Kathryn J. , Uhm, Joon H. , Warsame, Rahma , Novotny, Paul J. , Sloan, Jeffrey A., Kumar, Amanika , Stan, Daniela , Witzig, Thomas E.

Journal of Clinical Oncology | September 5, 2018 | Volume: 36 | Issue: 15_suppl | Pages: 6501-6501

10.1200/jco.2018.36.15_suppl.6501 Get It

Development of novel emoji scale to measure patient-reported outcomes in cancer patients.
Thompson, Carrie A. , Novotny, Paul J. , Bartz, Alicia, Yost, Kathleen J. , Sloan, Jeff A.

Journal of Clinical Oncology | May 29, 2018 | Volume: 36 | Issue: 7_suppl | Pages: 174-174

10.1200/jco.2018.36.7_suppl.174 Get It

174 Background: Patient-reported outcomes (PROs), including physical function and quality of life (QOL), are important outcomes in cancer patients. Emoji are a near-universal, popular form of communication, understandable by diverse populations, including those with low health literacy. We aimed to explore whether emoji could be a valid, reliable scale for assessing PROs in cancer patients. Methods: To develop the emoji scale, 5 emoji faces were selected from the Apple emoji dictionary by study authors. 20 cancer patients participated in a card-sorting exercise to rank the emoji from negative to positive; 19 out of 20 selected the same order, which exceeded Coomb’s criteria for being a valid ordinal scale. Patients were recruited from Mayo Clinic practices. Eligibility included: adult patients with a diagnosis of lymphoma, multiple myeloma, brain, pancreatic, breast, and ovarian cancer within the past 5 years; life expectancy of > 6 months; and own an iPhone version ≥ 5.0. All patients were provided with an Apple Watch and downloaded the study app. Baseline PRO data was collected on the iPhone, including single-item linear analog self-assessments (LASA) and emoji scales for fatigue, physical function, emotional well-being, and overall QOL. Results: From 2/2017-8/2017, 294 eligible patients were recruited. 25% were male, and median age was 53 years (range 20-79). The median time since diagnosis was 8.4 months (range 0-60); 63% were on active therapy, 27% were in observation post-treatment, and 10% had not been treated. All patients were “extremely” confident filling out forms, 99% had used a computer in the past 12 months, and 27% had ever used a smart watch. Emoji responses were significantly associated with validated measures of PROs; the Spearman correlations between the ordinal emoji scales and LASAs were -0.83 for fatigue, 0.72 for physical well-being, 0.72 for emotional well-being, and 0.77 for overall QOL (all p < 0.0001). Of the 75 patients who have completed the study thus far, 92% reported they would use emoji scales again and 89% would recommend that others use emoji scales. Conclusions: A novel ordinal emoji scale is strongly associated with accepted measures of PROs in cancer patients and should be studied further.
Long-Term Return to Functional Baseline After Mechanical Ventilation in the ICU*
Wilson, Michael E. , Barwise, Amelia , Heise, Katherine J., Loftsgard, Theodore O. , Dziadzko, Mikhail , Majzoub, Abdul M., Novotny, Paul J. , Gajić, Ognjen, Biehl, Michelle, Majzoub, Abdul, Barwise, Amelia K , Cheville, Andrea , Gajic, Ognjen

Critical Care Medicine | December 20, 2017 | Volume: 46 | Issue: 4 | Pages: 562-569

10.1097/ccm.0000000000002927 | PMID 29261564 Get It

Objective: Predictors of long-term functional impairment in acute respiratory failure of all causes are poorly understood. Our objective was to assess the frequency and predictors of long-term functional impairment or death after invasive mechanical ventilation for acute respiratory failure of all causes. Design: Population-based, observational cohort study. Setting: Eight adult ICUs of a single center. Patients: All adult patients from Olmsted County, Minnesota, without baseline functional impairment who received mechanical ventilation in ICUs for acute respiratory failure of all causes from 2005 through 2009. Interventions: None. Measurements and Main Results: In total, 743 patients without baseline functional impairment received mechanical ventilation in the ICU. At 1- and 5-year follow-up, the rates of survival with return to baseline functional ability were 61% (366/597) and 53% (356/669). Among 71 patients with new functional impairment at 1 year, 55% (39/71) had recovered and were alive without functional impairment at 5 years. Factors predictive of new functional impairment or death at 1 year were age, comorbidities, discharge to other than home, mechanical ventilation of 7 days or longer, and stroke. Of factors known at the time of intubation, the following are predictive of new functional impairment or death: age, comorbidities, nonsurgical condition, Acute Physiology and Chronic Health Evaluation III score, stroke, and sepsis. Post hoc sensitivity analyses revealed no significant change in predictor variables in patient populations when stroke was excluded or who received more than 48 hours of mechanical ventilation. Conclusions: At 1- and 5-year follow-up, many patients who received mechanical ventilation for acute respiratory failure from all causes are no longer alive or have new moderate-to-severe functional impairment. Functional recovery between year 1 and year 5 is possible and common. Sepsis, stroke, illness severity, age, and comorbidities predict long-term functional outcome at intubation.
Healthy Immigrant Families: Randomized Controlled Trial of a Family-Based Nutrition and Physical Activity Intervention
Wieland, Mark L. , Hanza, Marcelo M., Weis, Jennifer A., Clark, Matthew M. , Sloan, Jeff A. , Novotny, Paul J. , Njeru, Jane W. , Abbenyi, Adeline, Levine, James A. , Goodson, Miriam, Capetillo, Graciela D. Porraz, Hared, Abdullah, Nigon, Julie A., Sia, Irene G. , Hanza, Marcelo M M, Patten, Christi A. , Wieland, Mark L , Meiers, Sonja J. , Capetillo, Graciela Porraz, Osman, Ahmed , Sia, Irene G

American Journal of Health Promotion | November 29, 2017 | Volume: 32 | Issue: 2 | Pages: 473-484

10.1177/0890117117733342 | PMID 29186984 Get It

Purpose: To evaluate a healthy eating and physical activity intervention for immigrant families, derived through community-based participatory research. Design: The Healthy Immigrant Families study was a randomized controlled trial with delayed intervention control group, with families as the randomization unit. Setting: US Midwest city. Participants: Participants were recruited by community partners from Hispanic, Somali, and Sudanese immigrant communities. Intervention: Family health promoters from participating communities delivered 6 healthy eating modules, 4 physical activity modules, and 2 modules synthesizing information in 12 home visits (60-90 minutes) within the first 6 months. Up to 12 follow-up phone calls to each participant occurred within the second 6 months. Measures: Primary measures were dietary quality measured with weekday 24-hour recall and reported as Healthy Eating Index score (0-100) and physical activity measured with accelerometers (14 wear days) at baseline, 6, 12, and 24 months. Results: In total, 151 persons (81 adolescents and 70 adults; 44 families) were randomly assigned. At 12 months, significant improvement occurred in Healthy Eating Index scores for adults in the intervention group compared with controls (change, +8.6 vs −4.4; P < .01) and persisted at 24 months (+7.4 from baseline; P < .01). No differences were observed for adolescents and no significant differences occurred between groups for physical activity. Conclusion: This intervention produced sustained dietary quality improvement among adults but not among adolescents. Program outcomes are relevant to communities working to decrease cardiovascular risk among immigrant populations.
Cost-Effectiveness Analysis of Monthly Zoledronic Acid, Zoledronic Acid Every 3 Months, and Monthly Denosumab in Women With Breast Cancer and Skeletal Metastases: CALGB 70604 (Alliance)
Moriarty, James P. , Dusetzina, Stacie B. , Himelstein, Andrew L., Foster, Jared C. , Grubbs, Stephen S., Novotny, Paul J. , Shapiro, Charles L. , Dusetzina, Stacie, Borah, Bijan J. , Dusetzina, Stacie

Journal of Clinical Oncology | October 12, 2017 | Volume: 35 | Issue: 35 | Pages: 3949-3955

10.1200/jco.2017.73.7437 | PMID 29023215 Get It

Purpose Skeletal-related events (SREs) such as pathologic fracture, spinal cord compression, or the necessity for radiation or surgery to bone metastasis cause considerable morbidity, decrements in quality of life, and costs to the health care system. The results of a recent large randomized trial (Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology [CALGB/Alliance 70604]) showed that zoledronic acid (ZA) every 3 months was noninferior to monthly ZA in reducing the risks of SREs. We sought to determine the cost-effectiveness (CE) of monthly ZA, ZA every 3 months, and monthly denosumab in women with breast cancer and skeletal metastases. Methods Using a Markov model, costs per SRE avoided were calculated for the three treatments. Sensitivity analyses were performed where denosumab SRE probabilities were assumed to be 50%, 75%, and 90% lower than the ZA SRE probabilities. Quality-adjusted life-years were also calculated. The analysis was from the US payer perspective. Results The mean costs of the denosumab treatment strategy are nine-fold higher than generic ZA every 3 months. Quality-adjusted life-years were virtually identical in all the three treatment arms; hence, the optimal treatment would be ZA every 3 months because it was the least costly treatment. The sensitivity analyses showed that relative to ZA every 3 months, the incremental costs per mean SRE avoided for denosumab ranged from $162,918 to $347,655. Conclusion ZA every 3 months was more CE in reducing the risks of SRE than monthly denosumab. This analysis was one of the first to incorporate the costs of generic ZA and one of the first independent CE analyses not sponsored by either Novartis or Amgen, the makers of ZA and denosumab, respectively. ZA every 3 months is the more CE option and more reasonable alternative to monthly denosumab.
Caregiver Role Stress: When Families Become Providers
Teschendorf, Bonnie, Schwartz, Carolyn E. , Ferrans, Carol Estwing , O’Mara, Ann M., Novotny, Paul J. , Sloan, Jeff A.

Cancer Control | August 30, 2017 | Volume: 14 | Issue: 2 | Pages: 183-189

10.1177/107327480701400212 | PMID 17387304 Get It

Background In view of the large number of families engaged in caregiving, this study was initiated to describe informal cancer care provision from the perspective of the caregiver. Methods A professional data collection site was used to convene focus groups in four cities. Participants included 63 caregivers, 87% of whom were female, mean age of 56 years. Caregivers responded to an open-ended question regarding the challenges of providing care. The study utilized qualitative analysis of verbatim transcripts. Transcript coding with four independent raters, using an iterative process, achieved a high inter-rater reliability. Results The project elucidates self-reported concerns confronted in cancer caregiving. Five primary themes emerged: supportive care demands, emotional toll, impact on health status, coping strategies, and rewards and affirmation. Providing supportive care introduced a balancing act in caregivers’ lives as they attempted to address complex and overlapping roles. They felt alone in their decisions, were under-prepared for tasks they assumed, and tried to shield the care recipient. Conclusions This qualitative approach confirmed past research while identifying novel concepts related to maintaining well-being and a sense of purpose despite caregiving hardships. Some aspects of caregiver suffering were identified. Caregiver self-regulation strategies revealed by this work suggest ideas for psychosocial interventions caregivers could use to protect themselves and the care recipient from impending distress.