Challenges to Navigating Pregnancy and Parenthood for Physician Parents: a Framework Analysis of Qualitative Data.

BACKGROUND: Some gender-based disparities in medicine may relate to pregnancy and parenthood. An understanding of the challenges faced by pregnant physicians and physician parents is needed to design policies and interventions to reduce these disparities. OBJECTIVE: Our objective was to characterize work-related barriers related to pregnancy and parenthood described by physicians. DESIGN: We performed framework analysis of qualitative data collected through individual, semi-structured interviews between May and October 2018. Data related to pregnancy or parenthood were organized chronologically to understand barriers throughout the process of pregnancy, planning a parental leave, taking a parental leave, returning from parental leave, and parenting as a physician. PARTICIPANTS: Physician faculty members of all genders, including parents and non-parents, from a single department at a large academic medical school in Canada were invited to participate in a department-wide study broadly exploring gender equity. APPROACH: Thematic analysis guided by constructivism. KEY RESULTS: Twenty-eight physicians were interviewed (7.2% of eligible physicians), including 22 women and 6 men, of which 18 were parents (15 mothers and 3 fathers). Common barriers included a lack of systems-level guidelines for pregnancy and parental leave, inconsistent workplace accommodations for pregnant physicians, a lack of guidance and support for planning parental leaves, and difficulties obtaining clinical coverage for parental leave. Without systems-level guidance, participants had to individually navigate challenges and resolve these difficulties, including negotiating with their leadership for benefits. This led to stress, wasted time and effort, and raised questions about fairness within the department. CONCLUSIONS: Physician parents face unique challenges navigating institutional policies as well as planning and taking parental leave. Systems-level interventions such as policies for pregnancy, parental leave, and return to work are needed to address barriers experienced by physician parents.

Communication in surgical decision-making while managing metastatic bone disease: matching patient expectations with surgical goals.

BACKGROUND: There is a paucity of research examining how surgical decision-making for metastatic bone disease (MBD) can be optimized to improve quality of life (QOL) and functional outcomes, while accurately aligning with patient goals and expectations. The objective of this study was to survey and interview patients with MBD and support persons (PS), physicians, and allied health care providers (HCP) with the goal of identifying (1) important surgical issues related to MBD management, (2) discordance in perioperative expectations, and (3) perceived measures of success in the surgical management of MBD. METHODS: Utilizing a custom survey developed by HCP and patients with MBD, participants were asked to (1) identify important issues related to MBD management, (2) rank perceived measures of success, and (3) answer open-ended questions pertaining to the management of MBD. RESULTS: From the survey, increased life expectancy, minimizing disease progression, removal of local tumour, timely surgery after diagnosis, increased length of hospitalization, and physiotherapy access were all identified as significant discordant goals between PS and physicians/HCP. Conversely, there was an agreement between physicians and HCP who considered improved QOL and functional outcomes as most important goals. Structured homogenous-group workshops identified the need for (1) improved discussions of prognosis, surgical options, expectations, timelines, and resources, (2) the use of a care team "quarterback", and (3) an increased use of multi-disciplinary treatment planning. CONCLUSIONS: We feel this data highlights the importance of improved communication and coordination in treating patients with MBD. Further research evaluating how surgical techniques influence survival and disease progression in MBD is highly relevant and important to patients.

Association of Physician Characteristics With Perceptions and Experiences of Gender Equity in an Academic Internal Medicine Department.

Importance: The persistence of inequities that disadvantage women physicians remains empirically underexplained. Understanding the cultural factors that are associated with disparities in harassment, discrimination, remuneration, and career trajectory are critical to addressing inequities. Objectives: To explore how physicians perceive the climate for women physicians and compare perceptions and experiences of gender inequity among physicians based on characteristics including gender, faculty status, parental status, and years in practice. Design, Setting, and Participants: This sequential, explanatory, mixed-methods qualitative study used the Culture Conducive to Women's Academic Success (CCWAS; range 45-225, with higher scores indicating better perceived culture toward women), followed by individual semistructured interviews with physicians at the Department of Medicine of the University of Calgary. All 389 physician members of the Department of Medicine, including academic and clinical physicians and those of any gender, were invited to participate in the survey and interview phases. Main Outcomes and Measures: The culture within the department for women physicians was assessed using the CCWAS score. Scores were compared between respondents' gender and years in practice. Interviews with physicians were used to further explore findings from the CCWAS and to understand experiences and perceptions of gender disparities. Results: A total of 169 of 389 physicians completed the survey (response rate, 43.4%; 102 [59.9%] women; 65 [38.9%] men; and 2 [1.2%] who did not disclose gender); 28 participants (7.2%) elected to participate in an interview (22 [78.6%] women; 6 [21.4%] men). Women physicians perceived the culture of the department toward women as significantly worse than men physicians (median [interquartile range] CCWAS score, 137.0 [118.0-155.0] vs 164.5 [154.0-183.4]; P < .001). Physicians with more than 15 years in practice perceived the culture toward women as significantly more favorable than physicians with 15 years or less in practice (median [interquartile range] CCWAS score, 157.0 [138.8-181.3] vs 147.0 [127.5-164.3]; P = .02). Qualitative data demonstrated that experiences of junior women (ie, physicians who graduated medical school after 1996, when an equal number of men and women in medical school was achieved in Canada) and perceptions of senior men (ie, those who graduated before 1996) were most different; junior women reported high rates of discrimination and harassment, while senior men perceived that the Department of Medicine had achieved gender equity. Conclusions and Relevance: In this study, senior men physicians' perceptions of gender equity were different from lived experiences of gender inequity reported by junior women physicians. This demographic mismatch between perceptions and experiences of gender equity in medicine may explain the lack of action by leaders and decision-makers in medicine to mitigate disparities.

Clinical Relevance of Home Monitoring of Vital Signs and Blood Glucose Levels: A Narrative Review.

OBJECTIVES: We sought to assess the presence and reporting quality of peer-reviewed literature concerning the accuracy, precision, and reliability of home monitoring technologies for vital signs and glucose determinations in older adult populations. METHODS: A narrative literature review was undertaken searching the databases Medline, Embase, and Compendex. Peer-reviewed publications with keywords related to vital signs, monitoring devices and technologies, independent living, and older adults were searched. Publications between the years 2012 and 2018 were included. Two reviewers independently conducted title and abstract screening, and four reviewers independently undertook full-text screening and data extraction with all disagreements resolved through discussion and consensus. RESULTS: Two hundred nine articles were included. Our review showed limited assessment and low-quality reporting of evidence concerning the accuracy, precision, and reliability of home monitoring technologies. Of 209 articles describing a relevant device, only 45 percent (n = 95) provided a citation or some evidence to support their validation claim. Of forty-eight articles that described the use of a comparator device, 65 percent (n = 31) used low-quality statistical methods, 23 percent (n = 11) used moderate-quality statistical methods, and only 12 percent (n = 6) used high-quality statistical methods. CONCLUSIONS: Our review found that current validity claims were based on low-quality assessments that do not provide the necessary confidence needed by clinicians for medical decision-making purposes. This narrative review highlights the need for standardized health technology reporting to increase health practitioner confidence in these devices, support the appropriate adoption of such devices within the healthcare system, and improve health outcomes.

Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib.

BACKGROUND: Little is known about the total patient burden associated with clinical development and where burdens fall most heavily during a drug development program. Our goal was to quantify the total patient burden/benefit in developing a new drug. METHODS: We measured risk using drug-related adverse events that were grade 3 or higher, benefit by objective response rate, and trial outcomes by whether studies met their primary endpoint with acceptable safety. The differences in risk (death rate) and benefit (overall response rate) between industry and nonindustry trials were analyzed with an inverse-variance weighted fixed effects meta-analysis implemented as a weighted regression analysis. All statistical tests were two-sided. RESULTS: We identified 103 primary publications of sunitinib monotherapy, representing 9092 patients and 3991 patient-years of involvement over 10 years and 32 different malignancies. In total, 1052 patients receiving sunitinib monotherapy experienced objective tumor response (15.7% of intent-to-treat population, 95% confidence interval [CI] = 15.3% to 16.0%), 98 died from drug-related toxicities (1.08%, 95% CI = 1.02% to 1.14%), and at least 1245 experienced grade 3-4 drug-related toxicities (13.7%, 95% CI = 13.3% to 14.1%). Risk/benefit worsened as the development program matured, with several instances of replicated negative studies and almost no positive trials after the first responding malignancies were discovered. CONCLUSIONS: Even for a successful drug, the risk/benefit balance of trials was similar to phase I cancer trials in general. Sunitinib monotherapy development showed worsening risk/benefit, and the testing of new indications responded slowly to evidence that sunitinib monotherapy would not extend to new malignancies. Research decision-making should draw on evidence from whole research programs rather than a narrow band of studies in the same indication.

Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials.

OBJECTIVE: To quantify the proportion of trials for unsuccessfully licensed drugs that are not published. DESIGN: A systematic assessment of the availability of published research reports for publicly registered trials testing drugs stalling in clinical development ("stalled drugs") and drugs receiving regulatory licensure in the same time period ("licensed drugs"). DATA SOURCES: Searches of clinicaltrials.gov, Google Scholar, PubMed, Embase, and electronic query of contacts in registries to identify trials and assess publication status. ELIGIBILITY CRITERIA: The cohort of licensed drugs consisted of all disease modifying drugs in cancer, cardiovascular disease, or neurological disorders that received Food and Drug Administration licensure during 2005 to 2009 inclusive. The cohort of stalled drugs included unlicensed drugs in the same disease areas that had at least one completed phase III trial before 2009 and no evidence of any clinical trial activity after 31 December 2009. Inclusion criteria for registered trials advanced into publication searching were an intervention tested in a disease modifying, phase II, III, or IV trial registered on clinicaltrials.gov, with enrolment of at least one patient, that reported primary outcome collection end date between 1 January 2006 and 31 December 2008. RESULTS: The unadjusted publication proportion for registered trials of licensed drugs was 75% (72/96) versus 37% (30/81) for stalled drugs. The adjusted hazard ratio for publication was 2.7 (95% confidence interval 1.7 to 4.3) in favour of licensed drug trials. Higher publication rates for licensed drug trials were observed regardless of disease type, sponsorship, trial phase, and geography. The rate of non-publication of stalled drug trials was significantly higher for studies that did not complete enrolment compared with licensed drug trials. A total of 20,135 patients participated in trials of stalled drugs that were never published. CONCLUSIONS: Much of the information collected in unsuccessful drug trials is inaccessible to the broader research and practice communities. These findings provide an evidence base and rationale for policy reforms aimed at promoting transparency, ethics, and accountability in clinical research.

Publication and reporting conduct for pharmacodynamic analyses of tumor tissue in early-phase oncology trials.

PURPOSE: In principle, nondiagnostic biopsies for pharmacodynamic (PD) studies are carried out to inform decision-making in drug development. Because such procedures have no therapeutic value, their ethical justification requires that results be published. We aimed to assess the frequency of nonpublication of PD data in early phase cancer trials and to identify factors that prevent full publication of data. METHODS: We identified a sample of early-phase cancer trials containing invasive nondiagnostic tissue procurement for PD analysis from American Society of Clinical Oncology and American Association for Cancer Research meeting abstracts published between 1995 and 2005. These trials were followed to publication to determine frequency of nonpublication of PD data. Corresponding authors on early-phase cancer trials using invasive nondiagnostic research procedures were also surveyed to identify factors preventing full publication of PD data. RESULTS: In a sample of 90 trials, 22.2% (20 trials) resulted in no trial publication. Of published trials expected to contain PD reports, 16 (17.8%) did not include any PD data, and 21 (23.3%) reported incomplete PD data. We surveyed 92 authors; nonpublication was regarded as a frequent occurrence, and the most commonly cited barrier to full publication of PD data was strategic considerations in publication (58.8% of responding authors). CONCLUSIONS: Our results suggest ways that investigators, study planners, and reviewers can improve the burden/knowledge value balance in PD studies.