Publications by authors named "Paul J Novotny"

132 Publications

Do Missing Values Influence Outcomes in a Cross-sectional Mail Survey?

Mayo Clin Proc Innov Qual Outcomes 2021 Feb 19;5(1):84-93. Epub 2021 Jan 19.

Department of Medicine, Mayo Clinic, Rochester, MN.

Objective: To determine the effects of missing and inconsistent data on a weight management mail survey results.

Patients And Methods: Weight management surveys were sent to 5000 overweight and obese individuals in the Learning Health System Network. Survey information was collected between October 27, 2017, and March 1, 2018. Some participants reported body mass index (BMI) values inconsistent with the intended overweight and obese sampling cohort. Analyses were performed after excluding these surveys and also performed again after setting these low BMI values to missing. Models were run after imputing missing values using expectation-maximization, Markov chain Monte Carlo, random forest imputation, multivariate imputation by chained equations, and multiple imputation and replacing missing BMI values with the minimum, maximum, mean, or median of the known BMI values.

Results: Of 2799 surveys, 222 (8%) had missing BMI values and 155 (6%) reported invalid BMI values. Overall, 725 of these 2799 surveys (26%) were missing at least 1 variable that was essential to the main analyses. Different imputation methods consistently found that BMI was related to age, sex, race, marital status, and education. Patients with a BMI of 35.0 kg/m or greater were more likely to feel judged because of their weight, and patients with a BMI of 40.0 kg/m or greater were more likely to feel they were not always treated with respect and treated as an equal.

Conclusion: Analyses using different imputation methods were consistent with the original published results. Missing data likely did not affect the study results.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.09.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930870PMC
February 2021

Choosing and Using Patient-Reported Outcome Measures in Clinical Practice.

Arch Phys Med Rehabil 2021 Mar 10. Epub 2021 Mar 10.

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.

The increasing use of patient-reported outcome (PRO) measures is forcing clinicians and health care systems to decide which to select and how to incorporate them into their records and clinical workflows. This overview addresses three topics related to these concerns. First, a literature review summarizes key psychometric and practical factors (such as reliability, responsiveness, computer adaptive testing, and interpretability) in choosing PROs for clinical practice. Second, three clinical decision support (CDS) issues are highlighted: gathering PROs, electronic health record impact on providers, and incorporating PROs into CDS design and implementation. Lastly, the salience of cross-cutting domains as well as nine key pragmatic decisions are reviewed. Cross-cutting domains are those that are relevant across most medical and mental health conditions, such as the SPADE symptom pentad (sleep problems, pain, anxiety, depression, and low energy/fatigue) and physical functioning. The nine pragmatic decisions include: 1) generic vs. disease-specific scales; 2) single- vs. multi-domain scales; 3) universal scales vs. user-choice selection; 4) number of domains to measure; 5) prioritization of domains when multiple domains are assessed; 6) action thresholds; 7) clinical purpose (screening vs. monitoring); as well as the 8) frequency and 9) logistical aspects of PRO administration.
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http://dx.doi.org/10.1016/j.apmr.2020.12.033DOI Listing
March 2021

Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

J Patient Rep Outcomes 2020 Dec 10;4(1):106. Epub 2020 Dec 10.

Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.

Background: Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another.

Methods: Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0-10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1-5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking.

Results: In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0.

Conclusion: We produced robust linking between single item symptom measures and PROMIS short forms.
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http://dx.doi.org/10.1186/s41687-020-00271-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7728866PMC
December 2020

Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non-Small Cell Lung Cancer in CALGB 9730 (Alliance A151729).

Oncologist 2021 03 1;26(3):e435-e444. Epub 2020 Oct 1.

Alliance Statistics and Data Center, Duke University, Durham, North Carolina, USA.

Background: Prior comparisons of chemotherapy adverse events (AEs) by age and performance status (PS) are limited by the traditional maximum grade approach, which ignores low-grade AEs and longitudinal changes.

Materials And Methods: To compare fatigue and neuropathy longitudinally by age (<65, ≥65 years) and PS (0-1, 2), we analyzed data from a large phase III trial of carboplatin and paclitaxel versus paclitaxel for advanced non-small cell lung cancer (CALGB 9730, n = 529). We performed multivariable (a) linear mixed models to estimate mean AE grade over time, (b) linear regression to estimate area under the curve (AUC), and (c) proportional hazards models to estimate the hazard ratio of developing grade ≥2 AE, as well as traditional maximum grade analyses.

Results: Older patients had on average a 0.17-point (95% confidence interval [CI], 0.00-0.34; p = .049) higher mean fatigue grade longitudinally compared with younger patients. PS 2 was associated with earlier development of grade ≥2 fatigue (hazard ratio [HR], 1.56; 95% CI, 1.07-2.27; p = .02). For neuropathy, older age was associated with earlier development of grade ≥2 neuropathy (HR, 1.41; 95% CI, 1.00-1.97; p = .049). Patients with PS 2 had a 1.30 point lower neuropathy AUC (95% CI, -2.36 to -0.25; p = .02) compared with PS 0-1. In contrast, maximum grade analyses only detected a higher percentage of older adults with grade ≥3 fatigue and neuropathy at some point during treatment.

Conclusion: Our comparison of complementary but distinct aspects of chemotherapy toxicity identified important longitudinal differences in fatigue and neuropathy by age and PS that are missed by the traditional maximum grade approach. Clinical trial identification number: NCT00003117 (CALGB 9730) IMPLICATIONS FOR PRACTICE: The traditional maximum grade approach ignores persistent low-grade adverse events (AEs) and changes over time. This toxicity over time analysis of fatigue and neuropathy during chemotherapy for advanced non-small cell lung cancer demonstrates how to use longitudinal methods to comprehensively characterize AEs over time by age and performance status (PS). We identified important longitudinal differences in fatigue and neuropathy that are missed by the maximum grade approach. This new information about how older adults and patients with PS 2 experience these toxicities longitudinally may be used clinically to improve discussions about treatment options and what to expect to inform shared decision making and symptom management.
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http://dx.doi.org/10.1002/onco.13527DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930405PMC
March 2021

Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.

Lancet Haematol 2020 Jun;7(6):e490-e497

Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.

Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease. Modern approaches to the evaluation and reporting of toxicity that capture the tolerability of treatment to the patient are imperative. In this Viewpoint, we present a focused, pilot, and longitudinal Toxicity over Time analysis of adverse events from lenalidomide and lenalidomide with rituximab in patients with follicular lymphoma treated in the CALGB 50401 (Alliance; NCT00238238) trial to define the trajectory of adverse events and quantify the burden of continuous, low-grade events. Toxicity over Time analyses provided clinically relevant descriptions of neutropenia and fatigue trajectories caused by lenalidomide that were not identified by standard analysis of the maximum grade events defined by the Common Terminology Criteria for Adverse Events. Systematic, rigorous incorporation of patient-reported outcomes in clinical trials will be crucial to our understanding of the tolerability of chronically administered therapies in patients with haematological malignancies.
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http://dx.doi.org/10.1016/S2352-3026(20)30067-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7457391PMC
June 2020

Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).

JNCI Cancer Spectr 2020 Feb 21;4(1):pkz088. Epub 2019 Oct 21.

Medical Oncology, Mayo Clinic, Rochester, MN.

Background: Hot flashes (HFs) negatively affect quality of life among perimenopausal and postmenopausal women. This study investigated the efficacy of oxybutynin vs placebo in decreasing HFs.

Methods: In this randomized, multicenter, double-blind study, women with and without breast cancer with 28 or more HFs per week, lasting longer than 30 days, who were not candidates for estrogen-based therapy, were assigned to oral oxybutynin (2.5 mg twice a day or 5 mg twice a day) or placebo for 6 weeks. The primary endpoint was the intrapatient change from baseline in weekly HF score between each oxybutynin dose and placebo using a repeated-measures mixed model. Secondary endpoints included changes in weekly HF frequency, HF-related daily interference scale questionnaires, and self-reported symptoms.

Results: We enrolled 150 women. Baseline characteristics were well balanced. Mean (SD) age was 57 (8.2) years. Two-thirds (65%) were taking tamoxifen or an aromatase inhibitor. Patients on both oxybutynin doses reported greater reductions in the weekly HF score (5 mg twice a day: -16.9 [SD 15.6], 2.5 mg twice a day: -10.6 [SD 7.7]), placebo -5.7 (SD 10.2);  < .005 for both oxybutynin doses vs placebo), HF frequency (5 mg twice a day: -7.5 [SD 6.6], 2.5 mg twice a day: -4.8 [SD 3.2], placebo: -2.6 [SD 4.3];  < .003 for both oxybutynin doses vs placebo), and improvement in most HF-related daily interference scale measures and in overall quality of life. Patients on both oxybutynin arms reported more side effects than patients on placebo, particularly dry mouth, difficulty urinating, and abdominal pain. Most side effects were grade 1 or 2. There were no differences in study discontinuation because of adverse effects.

Conclusion: Oxybutynin is an effective and relatively well-tolerated treatment option for women with HFs.
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http://dx.doi.org/10.1093/jncics/pkz088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050158PMC
February 2020

Club Fit: Development of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program.

J Prim Prev 2020 04;41(2):153-170

Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55901, USA.

Children and adolescents from minority and low income backgrounds face social and environmental challenges to engaging in physical activity and healthy eating to maintain a healthy weight. In this study, we present pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys & Girls Club (BGC) afterschool program. Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a Social Ecological Theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge and self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. We assessed pilot feasibility through a single group, pre-post study design with measures collected at baseline and 6 months. The sample included 61 children with a mean age of 10.4 years. Mean (SD) body mass index (BMI) percentile was 72.8 (28.9); 47.5% were in the healthy weight range for their age. We found statistically significant improvements of self-efficacy and motivation for physical activity. Self-efficacy and motivation for fruit and vegetable consumption, sugary beverage consumption, and screen time improved but were not statistically different from baseline. We found no improvements of perceived social support, objectively measured physical activity, or self-reported dietary quality. Though BMI did not improve overall, a dose effect was observed such that attendance in Club Fit specific programming was significantly correlated with decreased BMI z scores. Processes and products from this study may be helpful to other communities aiming to address childhood obesity prevention through afterschool programs.
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http://dx.doi.org/10.1007/s10935-020-00582-4DOI Listing
April 2020

Social networks and obesity among Somali immigrants and refugees.

BMC Public Health 2020 Feb 17;20(1):238. Epub 2020 Feb 17.

Department of Medicine, Mayo Clinic, Rochester, MN, USA.

Background: Somali immigrants and refugees to the United States are at high risk for obesity and related cardiovascular risk. Social network factors influence health behaviors and are important contributors to the obesity epidemic. The objective of this study was to describe social networks and obesity-related characteristics among adult Somali immigrants in a Minnesota city in order to inform a community-based, participatory, research-derived, social network intervention to decrease obesity rates.

Methods: Survey data (demographics, general health measures, and sociobehavioral and network measures) and height and weight measures (for calculating body mass index) were collected from adult Somali immigrants by bilingual study team members at community locations. Descriptive statistics were used to report the survey and biometric data. Logistic regression models were used to describe the basic associations of participants and network factors. Network data were analyzed to identify nodes and ties, to visualize the network, and to identify potential interventionists for a future social network intervention.

Results: Of the 646 participants, 50% were overweight or affected by obesity. The network had 1703 nodes with 3583 ties between nodes, and modularity was high (0.75). Compared with respondents of normal weight, participants who were overweight or affected by obesity had more network members who were also overweight or obese (odds ratio [OR], 2.90; 95% CI, 1.11-7.56; P = .03); this was most notable for men (OR, 4.58; 95% CI, 1.22-17.22; P = .02) and suggestive for those 50 years or older (OR, 24.23; 95% CI, 1.55-377.83; P = .03). Weight loss intention among participants who were overweight or affected by obesity was associated with number of family members and friends trying to lose weight, enabling functional network factors (social norms for weight loss, social support for healthy eating, and social cohesion), and less favorable obesogenic social norms.

Conclusions: In this community sample of Somali immigrants, distinct social networks are clustered by weight status, and social contacts and functional network characteristics are related to individuals' weight loss intentions. These factors should be considered in weight loss interventions and programs. A social network intervention targeting weight loss, within a community-based participatory research framework, is feasible in this vulnerable population.
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http://dx.doi.org/10.1186/s12889-020-8315-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7026979PMC
February 2020

Association of social network factors with weight status and weight loss intentions among hispanic adults.

J Behav Med 2020 04 1;43(2):155-165. Epub 2020 Jan 1.

Department of Medicine, Mayo Clinic, Rochester, MN, USA.

Hispanic adults have the highest obesity prevalence in the United States, but little is known about weight-related social network influences. A community-based sample of 610 Hispanic participants completed height/weight and a survey. The proportion of overweight or obese (OW/OB) network members was higher for OW/OB respondents compared to normal weight respondents. Participants with high weight loss intentions reported more positive social norms for weight control, social support, and social cohesion. If most or all of OW/OB participant's social contacts were trying to lose weight, the odds that they were likely to try to lose weight was four times higher than other participants. The relationship between weight loss intentions and number of social contacts trying to lose weight was strongly mediated by social norms for weight control and social support. These results suggest that social contacts and functional network characteristics may impact weight status and weight control intentions among Hispanic adults.
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http://dx.doi.org/10.1007/s10865-019-00131-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7071972PMC
April 2020

Impact of Affect on Lung Transplant Candidate Outcomes.

Prog Transplant 2020 03 16;30(1):13-21. Epub 2019 Dec 16.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic Rochester, MN, USA.

Background: We examined the association of adult lung transplant candidates' self-reported affect with transplant-related outcomes, evaluating whether a positive (vs negative) frame of mind might be protective.

Method: Consenting waitlisted candidates from 6 centers completed the questionnaires including the Positive and Negative Affect Schedule annually and posttransplant. Univariate logistic regression analysis was performed to determine the association of baseline affect with outcomes of death or delisting. Models were subsequently adjusted for age, marital status, and education.

Results: Questionnaires were completed by 169 candidates (77.9% participation). Mean positive affect, negative affect, and positive-to-negative affect ratio (positivity ratio) were similar to expected norms. The scores of the questionnaire did not change significantly over time. Fifteen (8.9%) waitlisted participants died. Candidates who died while waiting had lower positivity ratios compared to those who survived (1.82 vs 2.45; = .02). A more negative affect was associated with increased death on the waiting list (adjusted odds ratio [OR] 1.10; = .021). Conversely, a higher positivity ratio was associated with decreased death while waiting (adjusted OR: 0.45; = .027).

Conclusion: Negative affect may represent a novel risk factor for death on the waitlist. Enhancing positive affect may represent a useful target for psychological optimization in lung transplant candidates.
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http://dx.doi.org/10.1177/1526924819892921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7271895PMC
March 2020

Prospective longitudinal cohort study of patient recovery after major gastrointestinal surgery: is there a difference between minimally invasive and open approaches?

Surg Endosc 2020 07 4;34(7):3126-3134. Epub 2019 Oct 4.

Department of Surgery, Mayo Clinic, Rochester, MN, USA.

Background: Surgeons use the absence of post-operative complications to define recovery while patients define recovery as return to normal function. We aimed to better define the recovery process after minimally invasive surgery (MIS) and open gastrointestinal surgery.

Methods: Patients scheduled for open or MIS pancreaticoduodenectomy, esophagectomy, colectomy, and proctectomy were prospectively enrolled. Patient-reported outcomes (PROs) were collected using validated PROMIS and LASA scales pre-operatively, on post-operative days 2, 7, 14, 30, and monthly until 6 months. Patients were also asked if they felt fully recovered. Descriptive statistics and area under the curve (AUC) were used to compare approaches. Multivariable mixed-effects repeated measures models and logistic regression were used to control for covariates.

Results: 340 patients met inclusion criteria (158 open and 182 MIS). Median age was 60 years with 44% women. The PRO showed improved post-operative QOL scores in MIS compared to open on all measures by AUC. None of these difference persisted at 6-months. After adjusting for covariates, MIS had higher overall QOL scores at day 14 (Estimate + 0.58, p = 0.02) and 30 (+ 0.56, p = 0.03). Differences did not persist at 3 and 6 months (both p > 0.05). At 1, 3, and 6 months, 20%, 47%, and 61% of patients reported feeling completely recovered. On adjusted analysis there was no difference in odds of complete recovery in MIS at 1 (OR 1.07 [95% CI 0.53-2.14] and 3 months (1.12 [0.63-2.01]) compared to open. MIS patients were more likely to report complete recovery at 6 months (1.87 [1.05-3.33]).

Conclusion: MIS patients reported improved PRO on selected QOL measures early in the recovery period compared to open. There was no difference in long-term QOL data between MIS and open patients. Two-thirds (61%) of patients reported being fully recovered at 6 months with MIS patients being more likely to report a complete recovery.
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http://dx.doi.org/10.1007/s00464-019-07073-6DOI Listing
July 2020

N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial.

Mayo Clin Proc 2019 09 9;94(9):1814-1824. Epub 2019 Aug 9.

Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ. Electronic address:

Objective: To determine whether N-acetylcysteine rinse was safe and could improve thickened secretions and dry mouth during and after radiotherapy.

Patients And Methods: We designed a prospective pilot double-blind, placebo-controlled randomized clinical trial (Alliance MC13C2). Adult patients (age ≥18 years) were enrolled if they underwent chemoradiotherapy (≥60 Gy). Patients initiated testing rinse within 3 days of starting radiotherapy. With swish-and-spit, they received 10% N-acetylcysteine (2500 mg daily) or placebo rinse solution 5 times daily during radiotherapy and 2 weeks postradiotherapy. The primary aim was to evaluate N-acetylcysteine in improvement of saliva viscosity with the Groningen Radiotherapy-Induced Xerostomia questionnaire. Secondary aims included evaluating xerostomia improvement by the same questionnaire and with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck-35 Questions survey and adverse-event profiles. The type I error rate was 20%.

Results: Thirty-two patients undergoing chemoradiotherapy were enrolled. Baseline characteristics were balanced for placebo (n=17) and N-acetylcysteine (n=15). N-acetylcysteine was better for improving sticky saliva (area under curve, P=.12). Scores of multiple secondary end points favored N-acetylcysteine, including sticky saliva daytime (P=.04), daytime and total xerostomia (both P=.02), pain (P=.18), and trouble with social eating (P=.15). Repeated measures models confirmed the findings. Taste was a major dissatisifer for N-acetylcysteine rinse; however, both testing rinses were safe and well tolerated overall.

Conclusion: Our pilot data showed that N-acetylcysteine rinse was safe and provided strong evidence of potential efficacy for improving thickened saliva and xerostomia by patient-reported outcome. A confirmatory phase 3 trial is required.

Trial Registration: clinicaltrials.gov Identifier: NCT02123511.
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http://dx.doi.org/10.1016/j.mayocp.2019.03.031DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742495PMC
September 2019

Spirituality and Emotional Distress Among Lung Cancer Survivors.

Clin Lung Cancer 2019 11 19;20(6):e661-e666. Epub 2019 Jun 19.

Department of Health Sciences Research, Mayo Clinic Arizona, Scottsdale, AZ.

Background: Emerging research is highlighting the importance of spirituality in cancer survivorship as well as the importance of early distress screening. The purpose of this study was to prospectively examine the relationships among spirituality, emotional distress, and sociodemographic variables during the early period of lung cancer survivorship.

Patients And Methods: Eight hundred sixty-four lung cancer survivors completed the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, and the Short-Form-8 for emotional distress within the first year after lung cancer diagnosis, and 474 of these survivors completed the survey again 1 year later.

Results: At baseline, spirituality was associated with lower prevalence of emotional distress, being married, fewer years of cigarette smoking, and better Eastern Cooperative Oncology Group performance status. Additionally, high baseline spirituality was associated with lower rates of high emotional distress at 1-year follow-up.

Conclusion: These findings suggest that spirituality might serve as a protective factor for emotional distress among lung cancer survivors. Further research is warranted to explore the role of spirituality in promoting distress management among lung cancer survivors.
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http://dx.doi.org/10.1016/j.cllc.2019.06.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6859202PMC
November 2019

Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial.

JAMA 2019 04;321(15):1481-1490

Department of Radiation Oncology, Mayo Clinic, Jacksonville, Florida.

Importance: Oral mucositis causes substantial morbidity during head and neck radiotherapy. In a randomized study, doxepin mouthwash was shown to reduce oral mucositis-related pain. A common mouthwash comprising diphenhydramine-lidocaine-antacid is also widely used.

Objective: To evaluate the effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash for the treatment of oral mucositis-related pain.

Design, Setting, And Participants: A phase 3 randomized trial was conducted from November 1, 2014, to May 16, 2016, at 30 US institutions and included 275 patients who underwent definitive head and neck radiotherapy, had an oral mucositis pain score of 4 points or greater (scale, 0-10), and were followed up for a maximum of 28 days.

Interventions: Ninety-two patients were randomized to doxepin mouthwash (25 mg/5 mL water); 91 patients to diphenhydramine-lidocaine-antacid; and 92 patients to placebo.

Main Outcome And Measures: The primary end point was total oral mucositis pain reduction (defined by the area under the curve and adjusted for baseline pain score) during the 4 hours after a single dose of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash compared with a single dose of placebo. The minimal clinically important difference was a 3.5-point change. The secondary end points included drowsiness, unpleasant taste, and stinging or burning. All scales ranged from 0 (best) to 10 (worst).

Results: Among the 275 patients randomized (median age, 61 years; 58 [21%] women), 227 (83%) completed treatment per protocol. Mucositis pain during the first 4 hours decreased by 11.6 points in the doxepin mouthwash group, by 11.7 points in the diphenhydramine-lidocaine-antacid mouthwash group, and by 8.7 points in the placebo group. The between-group difference was 2.9 points (95% CI, 0.2-6.0; P = .02) for doxepin mouthwash vs placebo and 3.0 points (95% CI, 0.1-5.9; P = .004) for diphenhydramine-lidocaine-antacid mouthwash vs placebo. More drowsiness was reported with doxepin mouthwash vs placebo (by 1.5 points [95% CI, 0-4.0]; P = .03), unpleasant taste (by 1.5 points [95% CI, 0-3.0]; P = .002), and stinging or burning (by 4.0 points [95% CI, 2.5-5.0]; P < .001). Maximum grade 3 adverse events for the doxepin mouthwash occurred in 3 patients (4%); diphenhydramine-lidocaine-antacid mouthwash, 3 (4%); and placebo, 2 (2%). Fatigue was reported by 5 patients (6%) in the doxepin mouthwash group and no patients in the diphenhydramine-lidocaine-antacid mouthwash group.

Conclusions And Relevance: Among patients undergoing head and neck radiotherapy, the use of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs placebo significantly reduced oral mucositis pain during the first 4 hours after administration; however, the effect size was less than the minimal clinically important difference. Further research is needed to assess longer-term efficacy and safety for both mouthwashes.

Trial Registration: ClinicalTrials.gov Identifier: NCT02229539.
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http://dx.doi.org/10.1001/jama.2019.3504DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6484809PMC
April 2019

Prevalence of Disagreement About Appropriateness of Treatment Between ICU Patients/Surrogates and Clinicians.

Chest 2019 06 26;155(6):1140-1147. Epub 2019 Mar 26.

Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.

Background: ICU patients/surrogates may experience adverse outcomes related to perceived inappropriate treatment. The objective was to determine the prevalence of patient/surrogate-reported perceived inappropriate treatment, its impact on adverse outcomes, and discordance with clinicians.

Methods: We conducted a multicenter, prospective, observational study of adult ICU patients.

Results: For 151 patients, 1,332 patient, surrogate, nurse, and physician surveys were collected. Disagreement between patients/surrogates and clinicians regarding "too much" treatment being administered occurred in 26% of patients. Disagreement regarding "too little" treatment occurred in 10% of patients. Disagreement about perceived inappropriate treatment was associated with prognostic discordance (P = .02) and lower patient/surrogate satisfaction (Likert scale 1-5 of 4 vs 5; P = .02). Patient/surrogate respondents reported "too much" treatment in 8% of patients and "too little" treatment in 6% of patients. Perceived inappropriate treatment was associated with moderate or high respondent distress for 55% of patient/surrogate respondents and 35% of physician/nurse respondents (P = .30). Patient/surrogate perception of inappropriate treatment was associated with lower satisfaction (Family Satisfaction in the ICU Questionnaire-24, 69.9 vs 86.6; P = .002) and lower trust in the clinical team (Likert scale 1-5 of 4 vs 5; P = .007), but no statistically significant differences in depression (Patient Health Questionnaire-2 of 2 vs 1; P = .06) or anxiety (Generalized Anxiety Disorder-7 Scale of 7 vs 4; P = .18).

Conclusions: For approximately one-third of ICU patients, there is disagreement between clinicians and patients/surrogates about the appropriateness of treatment. Disagreement about appropriateness of treatment was associated with prognostic discordance and lower patient/surrogate satisfaction. Patients/surrogates who reported inappropriate treatment also reported lower satisfaction and trust in the ICU team.
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http://dx.doi.org/10.1016/j.chest.2019.02.404DOI Listing
June 2019

Frailty and Clinical Outcomes in Chronic Obstructive Pulmonary Disease.

Ann Am Thorac Soc 2019 02;16(2):217-224

1 Division of Pulmonary and Critical Care Medicine.

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 (FEV). 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 FEV% 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 < 0.001), mental composite on Medical Outcomes Survey Short Form-36 (mean difference -6.8; 95% CI, -10.0 to -3.6; P < 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 < 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.
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http://dx.doi.org/10.1513/AnnalsATS.201803-175OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6376949PMC
February 2019

Multicenter derivation and validation of an early warning score for acute respiratory failure or death in the hospital.

Crit Care 2018 Oct 30;22(1):286. Epub 2018 Oct 30.

Division of Critical Care Medicine, Department of Medicine, Montefiore Health System, Albert Einstein College of Medicine, Main Floor, Gold Zone, 111 East 210th Street, Bronx, NY, 10467, USA.

Background: Acute respiratory failure occurs frequently in hospitalized patients and often starts before ICU admission. A risk stratification tool to predict mortality and risk for mechanical ventilation (MV) may allow for earlier evaluation and intervention. We developed and validated an automated electronic health record (EHR)-based model-Accurate Prediction of Prolonged Ventilation (APPROVE)-to identify patients at risk of death or respiratory failure requiring >= 48 h of MV.

Methods: This was an observational study of adults admitted to four hospitals in 2013 or a fifth hospital in 2017. Clinical data were extracted from the EHRs. The 2013 patients were randomly split 50:50 into a derivation/validation cohort. The qualifying event was death or intubation leading to MV >= 48 h. Random forest method was used in model derivation. APPROVE was calculated retrospectively whenever data were available in 2013, and prospectively every 4 h after hospital admission in 2017. The Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS) were calculated at the same times as APPROVE. Clinicians were not alerted except for APPROVE in 2017cohort.

Results: There were 68,775 admissions in 2013 and 2258 in 2017. APPROVE had an area under the receiver operator curve of 0.87 (95% CI 0.85-0.88) in 2013 and 0.90 (95% CI 0.84-0.95) in 2017, which is significantly better than the MEWS and NEWS in 2013 but similar to the MEWS and NEWS in 2017. At a threshold of > 0.25, APPROVE had similar sensitivity and positive predictive value (PPV) (sensitivity 63% and PPV 21% in 2013 vs 64% and 16%, respectively, in 2017). Compared to APPROVE in 2013, at a threshold to achieve comparable PPV (19% at MEWS > 4 and 22% at NEWS > 6), the MEWS and NEWS had lower sensitivity (16% for MEWS and NEWS). Similarly in 2017, at a comparable sensitivity threshold (64% for APPROVE > 0.25 and 67% for MEWS and NEWS > 4), more patients who triggered an alert developed the event with APPROVE (PPV 16%) while achieving a lower false positive rate (FPR 5%) compared to the MEWS (PPV 7%, FPR 14%) and NEWS (PPV 4%, FPR 25%).

Conclusions: An automated EHR model to identify patients at high risk of MV or death was validated retrospectively and prospectively, and was determined to be feasible for real-time risk identification.

Trial Registration: ClinicalTrials.gov, NCT02488174 . Registered on 18 March 2015.
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http://dx.doi.org/10.1186/s13054-018-2194-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6206729PMC
October 2018

Age and sex differences in burnout, career satisfaction, and well-being in US neurologists.

Neurology 2018 11 10;91(20):e1928-e1941. Epub 2018 Oct 10.

From the Department of Neurology (K.L.), University of Louisville, KY; Department of Medicine (J.M.M.), University of Alberta, Canada; Member Insights Department (C.M.K., C.R., L.G.), American Academy of Neurology, Minneapolis, MN; Department of Neurology (K.H.L.), Cleveland Clinic, OH; Consulting Neurologist (E.C.J.), Specialists on Call, Bristol, RI; Department of Neurology (H.B.S.), University of Rochester School of Medicine and Dentistry, NY; Department of Neurology and Rehabilitation Medicine (J.R.M.), University of Cincinnati College of Medicine, OH; Department of Neurology (A.H.), University of Kentucky College of Medicine, Lexington; Department of Neurology (D.S.), University of Oklahoma College of Medicine, Oklahoma City; WellMD Center (T.D.S.), Stanford Medicine, CA; Division of Biomedical Statistics and Informatics (J.A.S., P.J.N.) and Department of Neurology (T.L.C.), Mayo Clinic, Rochester, MN; and Department of Neurology (N.A.B.), University of Pittsburgh School of Medicine, PA.

Objective: To examine age and sex differences in burnout, career satisfaction, and well-being in US neurologists.

Methods: Quantitative and qualitative analyses of men's (n = 1,091) and women's (n = 580) responses to a 2016 survey of US neurologists.

Results: Emotional exhaustion in neurologists initially increased with age, then started to decrease as neurologists got older. Depersonalization decreased as neurologists got older. Fatigue and overall quality of life in neurologists initially worsened with age, then started to improve as neurologists got older. More women (64.6%) than men (57.8%) met burnout criteria on univariate analysis. Women respondents were younger and more likely to work in academic and employed positions. Sex was not an independent predictive factor of burnout, fatigue, or overall quality of life after controlling for age. In both men and women, greater autonomy, meaning in work, reasonable amount of clerical tasks, and having effective support staff were associated with lower burnout risk. More hours worked, more nights on call, higher outpatient volume, and higher percent of time in clinical practice were associated with higher burnout risk. For women, greater number of weekends doing hospital rounds was associated with higher burnout risk. Women neurologists made proportionately more negative comments than men regarding workload, work-life balance, leadership and deterioration of professionalism, and demands of productivity eroding the academic mission.

Conclusions: We identified differences in burnout, career satisfaction, and well-being in neurologists by age and sex. This may aid in developing strategies to prevent and mitigate burnout and promote professional fulfillment for different demographic subgroups of neurologists.
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http://dx.doi.org/10.1212/WNL.0000000000006497DOI Listing
November 2018

Consequences of the 48-h rule: A lens into the psychiatric patient flow through an emergency department.

Am J Emerg Med 2018 11 18;36(11):2029-2034. Epub 2018 Mar 18.

Department of Health Sciences Research, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, United States. Electronic address:

Objective: Psychiatric patient boarding in emergency department (ED) is a severe and growing problem. In July 2013, Minnesota implemented a law requiring jailed persons committed to state psychiatric facilities be transferred within 48-h of commitment. This study aims to quantify the effect of this law on a large ED's psychiatric patient flow.

Methods: A pre- and post- comparison of 2011-2015 ED length of stay (LOS) for adult psychiatric patients was performed using electronic medical record data. Comparisons of the median LOS were assessed using a segmented regression model with time series error, and risk differences (RD) were used to determine changes in the proportion of patients with LOS ≥3 and ≥5days. Changes in patient disposition proportions were assessed using risk ratios.

Results: The median ED LOS for patients admitted for psychiatric care increased by 5.22h from 2011 to 2015 (95% CI: (4.33, 7.15)), while the frequency of patient encounters remained constant. Although no significant difference in the rate of ED LOS increase was found pre- and post- implementation, the proportion of adults with LOS ≥3days and ≥15days increased (RD 0.017 (95% CI: (0.013, 0.021)); 0.002 (95% CI: (0.001,0.004)), respectively).

Conclusions: The proportion of ED adult psychiatric patients experiencing prolonged LOS increased following the implementation of a statewide law requiring patients committed through the criminal justice system be transferred to a state psychiatric hospital within 48h. Identifying characteristics of subsets of psychiatric patients disproportionally affected could suggest focused healthcare system improvements to improve ED psychiatric care.
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http://dx.doi.org/10.1016/j.ajem.2018.03.016DOI Listing
November 2018

Combining Survival and Toxicity Effect Sizes from Clinical Trials: NCCTG 89-20-52 (Alliance).

Int J Stat Med Res 2018 16;7(4):137-146. Epub 2018 Nov 16.

Division of Biomedical Statistics and Bioinformatics, Mayo Clinic, Rochester, MN 55905, USA.

Background: How can a clinician and patient incorporate survival and toxicity information into a single expression of comparative treatment benefit? Sloan . recently extended the ½ standard deviation concept for judging the clinical importance of findings from clinical trials to survival and tumor response endpoints. A new method using this approach to combine survival and toxicity effect sizes from clinical trials into a quality-adjusted effect size is presented.

Methods: The quality-adjusted survival effect size (QASES) is calculated as survival effect size (ESS) minus the calibrated toxicity effect sizes (EST) (QASES=ESS-EST). This combined effect size can be weighted to adjust for the relative emphasis placed by the patient on survival and toxicity effects.

Results: As an example, consider clinical trial NCCTG 89-20-52 which randomized patients to once-daily thoracic radiotherapy (ODTRT) versus twice-daily treatment of thoracic radiotherapy (TDRT) for the treatment of lung cancer. The ODTRT vs. TDRT arms had median survival time of 22 vs. 20 months (p=0.49) and toxicity rate of 39% vs. 54%, (p<0.05). The QASES of 0.18 standard deviations translates to a quality-adjusted survival difference of 5.7 months advantage for the ODRT arm over the TDRT treatment arm (22(16.3) months), p<0.05). Similar results are presented for the four possible case combinations of significant/non-significant survival and toxicity benefits using completed clinical trials.

Conclusions: We used a novel approach to re-analyze clinical trial data to produce a single estimate for each treatment that combines survival and toxicity data. The QASES approach is an intuitive and mathematically simple yet robust approach.
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http://dx.doi.org/10.6000/1929-6029.2018.07.04.4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686677PMC
November 2018

Long-Term Return to Functional Baseline After Mechanical Ventilation in the ICU.

Crit Care Med 2018 04;46(4):562-569

METRIC (Multidisciplinary Epidemiology and Translational Research in Intensive Care), Mayo Clinic, Rochester, MN.

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.
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http://dx.doi.org/10.1097/CCM.0000000000002927DOI Listing
April 2018

Healthy Immigrant Families: Randomized Controlled Trial of a Family-Based Nutrition and Physical Activity Intervention.

Am J Health Promot 2018 02 29;32(2):473-484. Epub 2017 Nov 29.

13 Division of Infectious Diseases, Mayo Clinic, Rochester, MN, USA.

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.
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http://dx.doi.org/10.1177/0890117117733342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797671PMC
February 2018

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).

J Clin Oncol 2017 Dec 12;35(35):3949-3955. Epub 2017 Oct 12.

Charles L. Shapiro, Icahn School of Medicine, Mt Sinai, NY; James P. Moriarty, Paul J. Novotny, and Bijan J. Borah, Mayo Clinic Cancer Center; Paul J. Novotny, Mayo Clinic, Rochester, MN; Stacie Dusetzina, University of North Carolina at Chapel Hill, Chapel Hill, NC; Andrew L. Himelstein, Helen F. Graham Cancer Center and Research Institute; Stephen S. Grubbs, Christiana Care NCI Community Oncology Research Program, Newark, DE; and Jared C. Foster, University of Michigan, Grand Rapids, MI.

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.
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http://dx.doi.org/10.1200/JCO.2017.73.7437DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5721226PMC
December 2017

Pilot Feasibility Study of a Digital Storytelling Intervention for Immigrant and Refugee Adults With Diabetes.

Diabetes Educ 2017 08 7;43(4):349-359. Epub 2017 Jun 7.

Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota (Dr Sia).

Purpose The purpose of this pilot feasibility project was to examine the potential effectiveness of a digital storytelling intervention designed through a community-based participatory research (CBPR) approach for immigrants and refugees with type 2 diabetes mellitus (T2DM). Methods The intervention was a 12-minute culturally and linguistically tailored video consisting of an introduction, 4 stories, and a concluding educational message. A structured interview was used to assess the intervention for acceptability, interest level, and usefulness among 25 participants with T2DM (15 Latino, 10 Somali) across 5 primary care clinical sites. After watching the video, participants rated their confidence and motivation about managing T2DM as a result of the intervention. Baseline A1C and follow-up values (up to 6 months) were abstracted from medical records. Results All participants reported that the intervention got their attention, was interesting, and was useful; 96% reported that they were more confident about managing their T2DM than before they watched the video, and 92% reported that the video motivated them to change a specific behavior related to T2DM self-management. The mean baseline A1C level for the intervention participants was 9.3% (78 mmol/mol). The change from baseline to first follow-up A1C level was -0.8% (-10 mmol/mol) ( P < .05). Conclusions Implementation of a digital storytelling intervention for T2DM among immigrant populations in primary care settings is feasible and resulted in self-rated improvement in psychosocial constructs that are associated with healthy T2DM self-management behaviors, and there was some evidence of improvement in glycemic control. A large-scale efficacy trial of the intervention is warranted.
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http://dx.doi.org/10.1177/0145721717713317DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5834233PMC
August 2017

Emotional Problems, Quality of Life, and Symptom Burden in Patients With Lung Cancer.

Clin Lung Cancer 2017 09 2;18(5):497-503. Epub 2017 Mar 2.

Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.

Objectives: Lung cancer is associated with a greater symptom burden than other cancers, yet little is known about the prevalence of emotional problems and how emotional problems may be related to the physical symptom burden and quality of life in newly diagnosed patients with lung cancer. This study aimed to identify the patient and disease characteristics of patients with lung cancer experiencing emotional problems and to examine how emotional problems relate to quality of life and symptom burden.

Patients And Methods: A total of 2205 newly diagnosed patients with lung cancer completed questionnaires on emotional problems, quality of life, and symptom burden.

Results: Emotional problems at diagnosis were associated with younger age, female gender, current cigarette smoking, current employment, advanced lung cancer disease, surgical or chemotherapy treatment, and a lower Eastern Cooperative Oncology Group performance score. Additionally, strong associations were found between greater severity of emotional problems, lower quality of life, and greater symptom burden.

Conclusion: Certain characteristics place patients with lung cancer at greater risk for emotional problems, which are associated with a reduced quality of life and greater symptom burden. Assessment of the presence of emotional problems at the time of lung cancer diagnosis provides the opportunity to offer tailored strategies for managing negative mood, and for improving the quality of life and symptom burden management of patients with lung cancer.
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http://dx.doi.org/10.1016/j.cllc.2017.02.008DOI Listing
September 2017

Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial.

JAMA 2017 01;317(1):48-58

Icahn School of Medicine at Mount Sinai, New York, New York.

Importance: Zoledronic acid, a third-generation aminobisphosphonate, reduces the incidence of skeletal-related events and pain in patients with bone metastases. The optimal dosing interval for zoledronic acid is uncertain.

Objective: To determine whether zoledronic acid administered every 12 weeks is noninferior to zoledronic acid administered every 4 weeks.

Design, Setting, Participants: Randomized, open-label clinical trial conducted at 269 academic and community sites in the United States. Patients (n = 1822) with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma who had at least 1 site of bone involvement were enrolled between May 2009 and April 2012; follow-up concluded in April 2014.

Interventions: Patients were randomized to receive zoledronic acid administered intravenously every 4 weeks (n = 911) vs every 12 weeks (n = 911) for 2 years.

Main Outcomes And Measures: The primary end point was the proportion of patients having at least 1 skeletal-related event (defined as clinical fracture, spinal cord compression, radiation to bone, or surgery involving bone) within 2 years after randomization and a between-group absolute difference of 7% as the noninferiority margin. Secondary end points included the proportion of patients with at least 1 skeletal-related event by disease type, pain as assessed by the Brief Pain Inventory (range, 0-10; higher scores indicate worse pain), Eastern Cooperative Oncology Group performance status (range, 0-4; higher scores indicate worse disability), incidence of osteonecrosis of the jaw, kidney dysfunction, skeletal morbidity rate (mean number of skeletal-related events per year), and, in a subset of 553 patients, suppression of bone turnover (assessed by C-terminal telopeptide levels).

Results: Among 1822 patients who were randomized (median age, 65 years; 980 [53.8%] women; 855 with breast cancer, 689 with prostate cancer, and 278 with multiple myeloma), 795 completed the study at 2 years. A total of 260 patients (29.5%) in the zoledronic acid every 4-week dosing group and 253 patients (28.6%) in the every 12-week dosing group experienced at least 1 skeletal-related event within 2 years of randomization (risk difference of -0.3% [1-sided 95% CI, -4% to ∞]; P < .001 for noninferiority). The proportions of skeletal-related events did not differ significantly between the every 4-week dosing group vs the every 12-week dosing group for patients with breast cancer, prostate cancer, or multiple myeloma. Pain scores, performance status scores, incidence of jaw osteonecrosis, and kidney dysfunction did not differ significantly between the treatment groups. Skeletal morbidity rates were numerically identical in both groups, but bone turnover was greater (C-terminal telopeptide levels were higher) among patients who received zoledronic acid every 12 weeks.

Conclusions And Relevance: Among patients with bone metastases due to breast cancer, prostate cancer, or multiple myeloma, the use of zoledronic acid every 12 weeks compared with the standard dosing interval of every 4 weeks did not result in an increased risk of skeletal events over 2 years. This longer interval may be an acceptable treatment option.

Trial Registration: clinicaltrials.gov Identifier: NCT00869206.
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http://dx.doi.org/10.1001/jama.2016.19425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321662PMC
January 2017