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2.
J Clin Oncol ; : JCO1901693, 2019 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-31577472

RESUMO

PURPOSE: We sought to generate informed and considered opinions regarding acceptable secondary uses of deidentified health information and consent models for oncology learning health care systems. METHODS: Day-long democratic deliberation sessions included 217 patients with cancer at four geographically and sociodemographically diverse sites. Patients completed three surveys (at baseline, immediately after deliberation, and 1-month follow-up). RESULTS: Participants were 67.3% female, 21.7% black, and 6.0% Hispanic. The most notable changes in perceptions after deliberation related to use of deidentified medical-record data by insurance companies. After discussion, 72.3% of participants felt comfortable if the purpose was to make sure patients receive recommended care (v 79.5% at baseline; P = .03); 24.9% felt comfortable if the purpose was to determine eligibility for coverage or reimbursement (v 50.9% at baseline; P < .001). The most notable change about secondary research use related to believing it was important that doctors ask patients at least once whether researchers can use deidentified medical-records data for future research. The proportion endorsing high importance decreased from baseline (82.2%) to 68.7% immediately after discussion (P < .001), and remained decreased at 73.1% (P = .01) at follow-up. At follow-up, non-Hispanic whites were more likely to consider it highly important to be able to conduct medical research with deidentified electronic health records (96.8% v 87.7%; P = .01) and less likely to consider it highly important for doctors to get a patient's permission each time deidentified medical record information is used for research (23.2% v 51.6%; P < .001). CONCLUSION: This research confirms that most patients wish to be asked before deidentified medical records are used for research. Policies designed to realize the potential benefits of learning health care systems can, and should be, grounded in informed and considered public opinion.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31513467

RESUMO

Background: A landmark National Academies report highlighted the need for rigorous evaluation of sexual harassment in medicine. We examined the prevalence and impact of sexual harassment using the Sexual Experiences Questionnaire, the standard for measurement of sexual harassment, but which has not been previously applied within academic medicine. Materials and Methods: A 20-minute online survey was administered to all faculty who had been working at University of Michigan Medical School for at least 1 year (n = 2723). We assessed sexual harassment within the past year from insiders (i.e., from staff, students, and faculty) and from patients and patients' families. We also evaluated mental health, job satisfaction, sense of safety at work, and turnover intentions. Results: In the final sample (n = 705; which included 25.9% of the originally targeted population), most respondents, 82.5% of women and 65.1% of men, reported at least one incident of sexual harassment from insiders in the past year; 64.4% of women and 44.1% of men reported harassment from patients and patients' families. The most frequently experienced dimension of sexual harassment for women and men was sexist gender harassment. Increased experiences of harassment were independently associated with lower mental health, job satisfaction, and sense of safety at work, as well as increased turnover intentions, with no significant interactions by gender. Conclusions: Sexual harassment against medical faculty is alarmingly common at an institution that is not expected to be atypical. Interventions must address sexual harassment, which affects mental health and career outcomes of male and female physicians.

8.
Mol Cancer Ther ; 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31413177

RESUMO

Sustained locoregional control of disease is a significant issue in patients with inflammatory breast cancer (IBC), with local control rates of 80% or less at 5 years. Given the unsatisfactory outcomes for these patients, there is a clear need for intensification of local therapy, including radiation. Inhibition of the DNA repair protein poly adenosine diphosphate-ribose polymerase 1 (PARP1) has had little efficacy as a single agent in breast cancer outside of studies restricted to patients with BRCA mutations; however, PARP1 inhibition (PARPi) may lead to the radiosensitization of aggressive tumor types. Thus, this study investigates inhibition of PARP1 as a novel and promising radiosensitization strategy in IBC. In all existing IBC models (SUM-149, SUM-190, MDA-IBC-3), PARPi (AZD2281-olaparib and ABT-888-veliparib) had limited single agent efficacy (IC50 > 10 µM) in proliferation assays. Despite limited single agent efficacy, sub-micromolar concentrations of AZD2281 in combination with RT led to significant radiosensitization (rER 1.12-1.76). This effect was partially dependent on BRCA1 mutational status. Radiosensitization was due, at least in part, to delayed resolution of double strand DNA breaks as measured by multiple assays. Using a SUM-190 xenograft model in vivo, the combination of PARPi and RT significantly delays tumor doubling and tripling times compared to PARPi or RT alone with limited toxicity. This study demonstrates that PARPi improves the effectiveness of radiotherapy in IBC models and provides the preclinical rationale for the opening phase II randomized trial of RT +/- PARPi in women with IBC (SWOG 1706, NCT03598257).

11.
Acad Med ; 2019 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-31348060

RESUMO

PURPOSE: To enhance understanding of challenges related to work-life integration in academic medicine and to inform the ongoing implementation of an existing program and the development of other interventions to promote success of physician-scientists. METHOD: This study is part of a prospective analysis of the effects of the Fund to Retain Clinical Scientists (FRCS), a national program launched by the Doris Duke Charitable Foundation at ten U.S. institutions, which provides financial support to physician-scientists facing caregiving challenges. In early 2018, 28 of 33 program awardees participated in semi-structured interviews. Questions were about challenges faced by physician-scientists as caregivers and their early perceptions of the FRCS. Multiple analysts reviewed de-identified transcripts, iteratively revised the coding scheme, and interpreted the data using qualitative thematic analysis. RESULTS: Participants' rich descriptions illuminated five interconnected themes: (1) Time is a critical and limited resource, (2) timing is key, (3) limited time resources and timing conflicts may have a particularly adverse effect on women's careers, (4) flexible funds enable reclamation and repurposing of time resources, and (5) FRCS leaders should be cognizant of time and timing conflicts when developing program-related offerings CONCLUSIONS:: Programs such as the FRCS are instrumental in supporting individuals to delegate time-consuming tasks and control how they spend their valuable time. Qualitative analysis suggests that access to and command of valuable time resources is crucial to career advancement, research productivity, and work-life flexibility, especially during critical time points along the physician-scientist trajectory.

12.
Plast Reconstr Surg ; 144(2): 303-313, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31348333

RESUMO

BACKGROUND: Disparities persist in the receipt of breast reconstruction after mastectomy, and little is known about the nature of communication received by patients and potential variations that may exist. METHODS: Women with early-stage breast cancer (stages 0 to II) diagnosed between July of 2013 and September of 2014 were identified through the Georgia and Los Angeles Surveillance, Epidemiology, and End Results registries and surveyed to collect additional data on demographics, treatment, and decision-making experiences. Treating general/oncologic surgeons were also surveyed. Primary outcomes measures included self-reported communication-related measures on receipt of information on breast reconstruction and on the receipt of breast reconstruction. RESULTS: The authors analyzed 936 women who underwent mastectomy for unilateral breast cancer. Four hundred eighty-four (51.7 percent) underwent mastectomy with reconstruction. Women who were older and for whom English was not their primary spoken language had lower odds of being informed by a doctor about breast reconstruction. Ultimately, women who were older, were Asian, had invasive disease, had bronchitis/emphysema, and had lower income were less likely to undergo breast reconstruction. Breast reconstruction was performed more often in patients undergoing bilateral mastectomies (OR, 3.27; 95 percent CI, 2.26 to 4.75). Women cared for by surgeons with higher volumes of breast cancer patients (≥51 patients per year) were more likely to undergo breast reconstruction (OR, 2.43; 95 percent CI, 1.40 to 4.20). CONCLUSION: To eliminate existing disparities, increased efforts should be made in consultations for surgical management of breast cancer to provide information to all patients regarding the option of breast reconstruction, the possibility of immediate reconstruction, and insurance coverage of all stages of reconstruction.

13.
Pract Radiat Oncol ; 2019 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-31326530

RESUMO

PURPOSE: Single-fraction (SF) radiation therapy is effective and convenient for patients with painful noncomplex bone metastases. Prior survey results reported a low recommendation of SF radiation therapy in the US. We sought to assess contemporary treatment recommendations for the management of bone metastases among diverse physicians participating in a statewide quality consortium. METHODS AND MATERIALS: Members of the Michigan Radiation Oncology Quality Consortium were surveyed between April and May 2017. Physicians rated the importance of 31 variables on their choice of dose fractionation. The survey also covered 7 patient scenarios. RESULTS: Fifty-six physicians responded who were practicing at 18 of 20 centers surveyed. Respondents recommended 23 dose-fractionation schedules across the 7 scenarios. Highest-rated factors considered when choosing a dose fractionation regimen were performance status, prognosis, spinal cord compression, and prior radiation therapy. Recommendations for SF overall were uncommon (16.1%). On multivariable analysis, factors associated with SF use included academic employment (odds ratio [OR] 2.04; 95% CI, 1.02-4.08; P = .044) and higher palliative case volume (OR 2.59; 95% CI, 1.45-4.63; P = .001). Stereotactic body radiation therapy (SBRT) was recommended in 16.4% of scenarios overall, and on multivariable analysis, significant predictors for SBRT use were academic employment (OR 2.99; 95% CI, 1.39-6.44; P = .005), more recent residency completion (OR 4.37; 95% CI, 1.26-15.17; P = .02), spine location (OR 12.54; 95% CI, 3.96-39.68; P < .001), and prior radiation therapy (OR 26.67; 95% CI, 7.86-90.57; P < .001). SF rates were higher than in a survey reported in 2009 (16.1% vs 9.4%, P = .0004). CONCLUSIONS: SF radiation therapy remains uncommonly recommended, although it may be recommended more now than it was 10 years ago despite the increased utilization of SBRT. We identify multiple key drivers in physician decision making affecting SF recommendations that have not been addressed by prior level one evidence. Further research with evidence-based recommendations to clarify the role of SF and SBRT in management of patients with bony metastases are needed.

14.
Elife ; 82019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31305239

RESUMO

A number of studies suggest that scientific papers with women in leading-author positions attract fewer citations than those with men in leading-author positions. We report the results of a matched case-control study of 1,269,542 papers in selected areas of medicine published between 2008 and 2014. We find that papers with female authors are, on average, cited between 6.5 and 12.6% less than papers with male authors. However, the standardized mean differences are very small, and the percentage overlaps between the distributions for male and female authors are extensive. Adjusting for self-citations, number of authors, international collaboration and journal prestige, we find near-identical per-paper citation impact for women and men in first and last author positions, with self-citations and journal prestige accounting for most of the small average differences. Our study demonstrates the importance of focusing greater attention on within-group variability and between-group overlap of distributions when interpreting and reporting results of gender-based comparisons of citation impact.

15.
J Natl Cancer Inst ; 2019 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-31350545

RESUMO

Landmark investigation two decades ago demonstrated sex-based disparities among participants in cancer cooperative group trials. While federal efforts have aimed to improve representation of female patients in government-sponsored research, less is known about sex disparities in the broader landscape of modern oncologic randomized controlled trials (RCTs). Using ClinicalTrials.gov, we identified RCTs related to colorectal or lung cancer (the 2 most common non-sex-specific disease sites). Among the 147 included trials, the proportion of female patients enrolled on trial was on average 6.8% (95%CI = -8.8% to -4.9%) less than the proportion of female patients in the population by disease site (p < 0.001). While no statistically significant underrepresentation of women was noted within the 26 cooperative group trials, sex disparities were markedly heightened for the 121 non-cooperative-group-sponsored trials. Furthermore, underrepresentation of women did not improve with time. Future efforts should therefore focus on addressing these pervasive sex-based enrollment disparities beyond cooperative group trials alone.

17.
Pract Radiat Oncol ; 2019 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-31228657

RESUMO

PURPOSE: Prior research suggests that patient education materials on radiation therapy from various professional groups are written at reading levels above national recommendations of sixth to eighth grade. Since publication of these initial findings, many materials from these sources have been updated or newly created. However, the extent to which readability was considered in the design of these new documents remains unknown. Therefore, the goal of this investigation was to evaluate readability of online education materials for radiation therapy, comparing readability of updated materials with those included in the previous study. METHODS AND MATERIALS: Patient education materials related to radiation oncology were identified from websites of the 3 professional societies used in the original investigation (the American College of Radiology, the American Cancer Society, and the American Society for Radiation Oncology). The documents included in the first analysis were used as a comparator. To allow for accurate evaluation across groups, materials were matched by content; when necessary, documents were combined from the original cohort to create topically equivalent materials to reflect those currently available on society websites. Identified materials were analyzed using 7 validated readability indices, and results are reported in grade-level equivalents. Original materials were also reanalyzed with the same method. RESULTS: American Cancer Society materials had the lowest average baseline levels (9.4-11.3 grade level) and showed improved readability in the more recent materials (8.0-10.5 grade level). By contrast, the American Society for Radiation Oncology materials had high average baseline readability levels (11.1-13.9 grade level) that actually worsened in the more recent materials (11.7-16.2 grade level). The number of documents meeting national recommendations did not improve in the updated cohort. CONCLUSION: Despite evidence that readability levels of patient education materials in radiation oncology are unacceptably high, the readability of newly created materials is not consistently improving across professional societies. Although certain groups may incorporate readability in the design of educational documents, more consistent consideration across all organizations is needed.

18.
JAMA Oncol ; 2019 06 03.
Artigo em Inglês | MEDLINE | ID: mdl-31158272

RESUMO

Importance: Seminal investigation 2 decades ago alerted the oncology community to age disparities in participation in cooperative group trials; less is known about whether these disparities persist in industry-funded research. Objective: To characterize the age disparities among trial enrollees on randomized clinical trials (RCTs) of common cancers in clinical oncology and identify factors associated with wider age imbalances. Data Sources: Phase 3 clinical oncology RCTs were identified through ClinicalTrials.gov. Study Selection: Multiarm RCTs assessing a therapeutic intervention for patients with breast, prostate, colorectal, or lung cancer (the 4 most common cancer disease sites) were included. Data Extraction and Synthesis: Trial data were extracted from ClinicalTrials.gov. Trial screening and parameter identification were independently performed by 2 individuals. Data were analyzed in 2018. Main Outcomes and Measures: The difference in median age (DMA) between the trial participant median age and the population-based disease-site-specific median age was determined for each trial. Results: Three hundred two trials met inclusion criteria. The trials collectively enrolled 262 354 participants; 249 trials (82.5%) were industry-funded. For all trials, the trial median age of trial participants was a mean of 6.49 years younger than the population median age (95% CI, -7.17 to -5.81 years; P < .001). Age disparities were heightened among industry-funded trials compared with non-industry-funded trials (mean DMA, -6.84 vs -4.72 years; P = .002). Enrollment criteria restrictions based on performance status or age cutoffs were associated with age disparities; however, industry-funded trials were not more likely to use these enrollment restrictions than non-industry-funded trials. Age disparities were also larger among trials that evaluated a targeted systemic therapy and among lung cancer trials. Linear regression modeling revealed a widening gap between trial and population median ages over time at a rate of -0.19 years annually (95% CI, -0.37 to -0.01 years; P = .04). Conclusions and Relevance: Age disparities between trial participants and the incident disease population are pervasive across trials and appear to be increasing over time. Industry sponsorship of trials is associated with heightened age imbalances among trial participants. With an increasing role of industry funding among cancer trials, efforts to understand and address age disparities are necessary to ensure generalizability of trial results as well as equity in trial access.

19.
J Natl Cancer Inst ; 2019 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-31165160

RESUMO

Two decades following the creation of the Office of Cancer Complementary and Alternative Medicine at the National Cancer Institute, the status of complementary and alternative medicine (CAM) research within oncology remains opaque. To better understand the landscape of CAM studies in oncology, we identified CAM-related phase III randomized controlled trials (RCTs) through ClinicalTrials.gov, and compared these CAM trials to all non-CAM oncologic RCTs. Pearson's chi-square testing was used to compare proportions across groups and all tests were two-sided. Comparing the 25 identified CAM RCTs to 739 non-CAM RCTs, CAM studies were more likely to be sponsored by a cooperative group (64.0% vs 28.6%, p < 0.001), and less likely to be industry-funded (8.0% vs 76.5%, p < 0.001). CAM trials disproportionately excluded disease-related outcomes as endpoints (8.0% vs 84.6%, p < 0.001), were unsupported by prior early-phase data (55.0% vs 96.1%, p < 0.001), and failed to meet the primary endpoint (8.7% vs 53.0%, p < 0.001). Given the observed relationship between encouraging pilot data and subsequent phase III trial success, we contend that future CAM RCTs may yield more promising findings if better supported by appropriately designed and well-characterized early-phase signals.

20.
J Clin Oncol ; 37(20): 1721-1731, 2019 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-31141431

RESUMO

PURPOSE: End-of-life (EOL) chemotherapy has been described as the most widespread, wasteful, and unnecessary practice in oncology, with benchmarking aimed to reduce physician use of chemotherapy within 14 days of EOL. We evaluated the recent transformation of EOL chemotherapy and targeted therapy practices nationally. METHODS: In patients older than 65 years of age who died as a result of breast (n = 19,887), lung (n = 79,613), colorectal (n = 29,844), or prostate (n = 17,910) cancer between 2007 and 2013, we evaluated the guideline-benchmarked measure of chemotherapy use within 14 days of EOL in SEER-Medicare. Comparison outcomes were nonbenchmarked measures of chemotherapy and targeted therapy across time points within 6 months of EOL. Cochran-Armitage test was used to evaluate temporal trends. Multilevel logistic models and intraclass correlation coefficient was used to evaluate variation in EOL chemotherapy use at the physician level. RESULTS: From 2007 to 2013, chemotherapy within 14 days of EOL declined from 6.7% to 4.9% of patients (Ptrend < .001; ∆ = -1.8%). Similar declines occurred for chemotherapy within 1 month (Ptrend < .001; ∆ = -1.8%) and 2 months (Ptrend < .001; ∆ = -1.3%) of EOL. In contrast, chemotherapy within 4 to 6 months of EOL rose (Ptrend ≤ .04; ∆ = 0.7% to 1.7%), and 43.0% of all patients received chemotherapy within 6 months of EOL. Frequency of targeted therapy use across all time points within 6 months of EOL was stable to marginally rising from 2007 to 2013 (Ptrend = .09 to .82; ∆ = -0.2% to 1.8%); overall, 1.2% received targeted therapy within 14 days and 3.6% within 1 month of EOL. By 2013, 13.2% of patients received any targeted therapy within 6 months of EOL. In a multilevel model, 5.19% (intraclass correlation coefficient) of variation in 14-day EOL chemotherapy was attributed to the physician level. CONCLUSION: With national benchmarking, chemotherapy within 14 days of EOL successfully declined to less than 5%, with comprehensive benchmark uptake by physicians. Results may inform current strategies to help to achieve high-value EOL oncology practice.

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