Projected environmental and public health benefits of extended-interval dosing: an analysis of pembrolizumab use in a US national health system.

BACKGROUND: Health care is a major source of greenhouse gas emissions, leading to climate change and public health harms. Changes are needed to improve the environmental sustainability of health-care practices, but such changes should not sacrifice patient outcomes or financial sustainability. Alternative dosing strategies that reduce the frequency with which specialty drugs are administered, without sacrificing patient outcomes, are an attractive possibility for improving environmental sustainability. We sought to inform environmentally sustainable cancer care by estimating and comparing the environmental and financial effects of alternative, clinically equivalent strategies for pembrolizumab administration. METHODS: We conducted a retrospective analysis using a cohort of patients from the Veterans Health Administration (VHA) in the USA who received one or more pembrolizumab doses between May 1, 2020, and Sept 30, 2022. Using baseline, real-world administration of pembrolizumab, we generated simulated pembrolizumab use data under three near-equivalent counterfactual pembrolizumab administration strategies defined by combinations of weight-based dosing, pharmacy-level vial sharing and dose rounding, and extended-interval dosing (ie, every 6 weeks). For each counterfactual dosing strategy, we estimated greenhouse gas emissions related to pembrolizumab use across the VHA cohort using a deterministic environmental impact model that estimated greenhouse gas emissions due to patient travel, drug manufacture, and medical waste as the primary outcome measure. FINDINGS: We identified 7813 veterans who received at least one dose of pembrolizumab-containing therapy in the VHA during the study period. 59 140 pembrolizumab administrations occurred in the study period, of which 46 255 (78·2%) were dosed at 200 mg every 3 weeks, 12 885 (21·8%) at 400 mg every 6 weeks, and 14 955 (25·3%) were coadministered with infusional chemotherapies. Adoption of weight-based, extended-interval pembrolizumab dosing (4 mg/kg every 6 weeks) and pharmacy-level stewardship strategies (ie, dose rounding and vial sharing) for all pembrolizumab infusions would have resulted in 24·7% fewer administration events than baseline dosing (44 533 events vs 59 140 events) and an estimated 200 metric tons less CO2 emitted per year as a result of pembrolizumab use within the VHA (650 tons vs 850 tons of CO2, a relative reduction of 24%), largely due to reductions in distance travelled by patients to receive treatment. Similar results were observed when weight-based and extended-interval dosing were applied only to pembrolizumab monotherapy and pembrolizumab in combination with oral therapies. INTERPRETATION: Alternative pembrolizumab administration strategies might have environmental advantages over the current dosing and compounding paradigms. Specialty medication dosing can be optimised for health-care spending and environmental sustainability without sacrificing clinical outcomes. FUNDING: None.

Development of Patient Safety Measures to Identify Inappropriate Diagnosis of Common Infections.

BACKGROUND: Inappropriate diagnosis of infections results in antibiotic overuse and may delay diagnosis of underlying conditions. Here we describe the development and characteristics of 2 safety measures of inappropriate diagnosis of urinary tract infection (UTI) and community-acquired pneumonia (CAP), the most common inpatient infections on general medicine services. METHODS: Measures were developed from guidelines and literature and adapted based on data from patients hospitalized with UTI and CAP in 49 Michigan hospitals and feedback from end-users, a technical expert panel (TEP), and a patient focus group. Each measure was assessed for reliability, validity, feasibility, and usability. RESULTS: Two measures, now endorsed by the National Quality Forum (NQF), were developed. Measure reliability (derived from 24 483 patients) was excellent (0.90 for UTI; 0.91 for CAP). Both measures had strong validity demonstrated through (a) face validity by hospital users, the TEPs, and patient focus group, (b) implicit case review (ĸ 0.72 for UTI; ĸ 0.72 for CAP), and (c) rare case misclassification (4% for UTI; 0% for CAP) due to data errors (<2% for UTI; 6.3% for CAP). Measure implementation through hospital peer comparison in Michigan hospitals (2017 to 2020) demonstrated significant decreases in inappropriate diagnosis of UTI and CAP (37% and 32%, respectively, P < .001), supporting usability. CONCLUSIONS: We developed highly reliable, valid, and usable measures of inappropriate diagnosis of UTI and CAP for hospitalized patients. Hospitals seeking to improve diagnostic safety, antibiotic use, and patient care should consider using these measures to reduce inappropriate diagnosis of CAP and UTI.

Germline Genetic Testing After Cancer Diagnosis.

Importance: Germline genetic testing is recommended by practice guidelines for patients diagnosed with cancer to enable genetically targeted treatment and identify relatives who may benefit from personalized cancer screening and prevention. Objective: To describe the prevalence of germline genetic testing among patients diagnosed with cancer in California and Georgia between 2013 and 2019. Design, Setting, and Participants: Observational study including patients aged 20 years or older who had been diagnosed with any type of cancer between January 1, 2013, and March 31, 2019, that was reported to statewide Surveillance, Epidemiology, and End Results registries in California and Georgia. These patients were linked to genetic testing results from 4 laboratories that performed most germline testing for California and Georgia. Main Outcomes and Measures: The primary outcome was germline genetic testing within 2 years of a cancer diagnosis. Testing trends were analyzed with logistic regression modeling. The results of sequencing each gene, including variants associated with increased cancer risk (pathogenic results) and variants whose cancer risk association was unknown (uncertain results), were evaluated. The genes were categorized according to their primary cancer association, including breast or ovarian, gastrointestinal, and other, and whether practice guidelines recommended germline testing. Results: Among 1 369 602 patients diagnosed with cancer between 2013 and 2019 in California and Georgia, 93 052 (6.8%) underwent germline testing through March 31, 2021. The proportion of patients tested varied by cancer type: male breast (50%), ovarian (38.6%), female breast (26%), multiple (7.5%), endometrial (6.4%), pancreatic (5.6%), colorectal (5.6%), prostate (1.1%), and lung (0.3%). In a logistic regression model, compared with the 31% (95% CI, 30%-31%) of non-Hispanic White patients with male breast cancer, female breast cancer, or ovarian cancer who underwent testing, patients of other races and ethnicities underwent testing less often: 22% (95% CI, 21%-22%) of Asian patients, 25% (95% CI, 24%-25%) of Black patients, and 23% (95% CI, 23%-23%) of Hispanic patients (P < .001 using the χ2 test). Of all pathogenic results, 67.5% to 94.9% of variants were identified in genes for which practice guidelines recommend testing and 68.3% to 83.8% of variants were identified in genes associated with the diagnosed cancer type. Conclusions and Relevance: Among patients diagnosed with cancer in California and Georgia between 2013 and 2019, only 6.8% underwent germline genetic testing. Compared with non-Hispanic White patients, rates of testing were lower among Asian, Black, and Hispanic patients.

A Statewide Collaborative Quality Initiative to Improve Antibiotic Duration and Outcomes in Patients Hospitalized With Uncomplicated Community-Acquired Pneumonia.

BACKGROUND: Community-acquired pneumonia (CAP) is a common cause for hospitalization and antibiotic overuse. We aimed to improve antibiotic duration for CAP across 41 hospitals participating in the Michigan Hospital Medicine Safety Consortium (HMS). METHODS: This prospective collaborative quality initiative included patients hospitalized with uncomplicated CAP who qualified for a 5-day antibiotic duration. Between 23 February 2017 and 5 February 2020, HMS targeted appropriate 5-day antibiotic treatment through benchmarking, sharing best practices, and pay-for-performance incentives. Changes in outcomes, including appropriate receipt of 5 ± 1-day antibiotic treatment and 30-day postdischarge composite adverse events (ie, deaths, readmissions, urgent visits, and antibiotic-associated adverse events), were assessed over time (per 3-month quarter), using logistic regression and controlling for hospital clustering. RESULTS: A total of 41 hospitals and 6553 patients were included. The percentage of patients treated with an appropriate 5 ±â€…1-day duration increased from 22.1% (predicted probability, 20.9% [95% confidence interval: 17.2%-25.0%]) to 45.9% (predicted probability, 43.9% [36.8%-51.2%]; adjusted odds ratio [aOR] per quarter, 1.10 [1.07-1.14]). Thirty-day composite adverse events occurred in 18.5% of patients (1166 of 6319) and decreased over time (aOR per quarter, 0.98 [95% confidence interval: .96-.99]) owing to a decrease in antibiotic-associated adverse events (aOR per quarter, 0.91 [.87-.95]). CONCLUSIONS: Across diverse hospitals, HMS participation was associated with more appropriate use of short-course therapy and fewer adverse events in hospitalized patients with uncomplicated CAP. Establishment of national or regional collaborative quality initiatives with data collection and benchmarking, sharing of best practices, and pay-for-performance incentives may improve antibiotic use and outcomes for patients hospitalized with uncomplicated CAP.

Type 2 Diabetes Management, Control and Outcomes During the COVID-19 Pandemic in Older US Veterans: an Observational Study.

BACKGROUND: The COVID-19 pandemic required a change in outpatient care delivery models, including shifting from in-person to virtual visits, which may have impacted care of vulnerable patients. OBJECTIVE: To describe the changes in management, control, and outcomes in older people with type 2 diabetes (T2D) associated with the shift from in-person to virtual visits. DESIGN AND PARTICIPANTS: In veterans aged ≥ 65 years with T2D, we assessed the rates of visits (in person, virtual), A1c measurements, antidiabetic deintensification/intensification, ER visits and hospitalizations (for hypoglycemia, hyperglycemia, other causes), and A1c level, in March 2020 and April-November 2020 (pandemic period). We used negative binomial regression to assess change over time (reference: pre-pandemic period, July 2018 to February 2020), by baseline Charlson Comorbidity Index (CCI; > 2 vs. <= 2) and A1c level. KEY RESULTS: Among 740,602 veterans (mean age 74.2 [SD 6.6] years), there were 55% (95% CI 52-58%) fewer in-person visits, 821% (95% CI 793-856%) more virtual visits, 6% (95% CI 1-11%) fewer A1c measurements, and 14% (95% CI 10-17%) more treatment intensification during the pandemic, relative to baseline. Patients with CCI > 2 had a 14% (95% CI 12-16%) smaller relative increase in virtual visits than those with CCI <= 2. We observed a seasonality of A1c level and treatment modification, but no association of either with the pandemic. After a decrease at the beginning of the pandemic, there was a rebound in other-cause (but not hypo- and hyperglycemia-related) ER visits and hospitalizations from June to November 2020. CONCLUSION: Despite a shift to virtual visits and a decrease in A1c measurement during the pandemic, we observed no association with A1c level or short-term T2D-related outcomes, providing some reassurance about the adequacy of virtual visits. Further studies should assess the longer-term effects of shifting to virtual visits in different populations to help individualize care, improve efficiency, and maintain appropriate care while reducing overuse.

Applying User-Centered Design to Develop Practical Strategies that Address Overuse in Primary Care.

INTRODUCTION: Engaging patients and frontline clinicians in re-designing clinical care is essential for improving care delivery in a complex clinical environment. This study sought to assess an innovative user-centered design approach to improving clinical care quality, focusing on the use cases of de-intensifying non-beneficial care within the following areas: (1) de-intensifying diabetes treatment in high-risk patients; (2) stopping screening for carotid artery stenosis in asymptomatic patients; and (3) stopping colorectal cancer screening in average-risk, older adults. METHODS: The user-centered design approach, consisting of patient and patient-clinician charrettes (defined as intensive workshops where key stakeholders collaborate to develop creative solutions to a specific problem) and participant surveys, has been described previously. Following the charrettes, we used inductive coding to identify and categorize themes emerging from the de-intensification ideas prioritized by participants as well as facilitator notes and audio recordings from the charrettes. RESULTS: Thirty-five patients participated in the patient design charrettes, generating 134 unique de-intensification ideas and prioritizing 32, which were then distilled into six patient-generated principles of de-intensification by the study team. These principles provided a starting point for a subsequent patient-clinician charrette. In this follow-up charrette, 9 patients who had participated in an earlier patient design charrette collaborated with 7 clinicians to generate 63 potential de-intensification solutions. Six of these potential solutions were developed into multi-faceted, fully operationalized de-intensification strategies. DISCUSSION: The de-intensification strategies that patients and clinicians prioritized and operationalized during the co-design charrette process were detailed and multi-faceted. Each component of a strategy had a rationale based on feasibility, practical considerations, and ways of overcoming barriers. The charrette-based process may be a useful way to engage clinicians and patients in developing the complex and multi-faceted strategies needed to improve care delivery.

Interpretability, credibility, and usability of hospital-specific template matching versus regression-based hospital performance assessments; a multiple methods study.

BACKGROUND: Hospital-specific template matching (HS-TM) is a newer method of hospital performance assessment. OBJECTIVE: To assess the interpretability, credibility, and usability of HS-TM-based vs. regression-based performance assessments. RESEARCH DESIGN: We surveyed hospital leaders (January-May 2021) and completed follow-up semi-structured interviews. Surveys included four hypothetical performance assessment vignettes, with method (HS-TM, regression) and hospital mortality randomized. SUBJECTS: Nationwide Veterans Affairs Chiefs of Staff, Medicine, and Hospital Medicine. MEASURES: Correct interpretation; self-rated confidence in interpretation; and self-rated trust in assessment (via survey). Concerns about credibility and main uses (via thematic analysis of interview transcripts). RESULTS: In total, 84 participants completed 295 survey vignettes. Respondents correctly interpreted 81.8% HS-TM vs. 56.5% regression assessments, p < 0.001. Respondents "trusted the results" for 70.9% HS-TM vs. 58.2% regression assessments, p = 0.03. Nine concerns about credibility were identified: inadequate capture of case-mix and/or illness severity; inability to account for specialized programs (e.g., transplant center); comparison to geographically disparate hospitals; equating mortality with quality; lack of criterion standards; low power; comparison to dissimilar hospitals; generation of rankings; and lack of transparency. Five concerns were equally relevant to both methods, one more pertinent to HS-TM, and three more pertinent to regression. Assessments were mainly used to trigger further quality evaluation (a "check oil light") and motivate behavior change. CONCLUSIONS: HS-TM-based performance assessments were more interpretable and more credible to VA hospital leaders than regression-based assessments. However, leaders had a similar set of concerns related to credibility for both methods and felt both were best used as a screen for further evaluation.

Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults : A Retrospective Observational Study.

BACKGROUND: There are 2 approaches to intensifying antihypertensive treatment when target blood pressure is not reached, adding a new medication and maximizing dose. Which strategy is better is unknown. OBJECTIVE: To assess the frequency of intensification by adding a new medication versus maximizing dose, as well as the association of each method with intensification sustainability and follow-up systolic blood pressure (SBP). DESIGN: Large-scale, population-based, retrospective cohort study. Observational data were used to emulate a target trial with 2 groups, new medication and maximizing dose, who underwent intensification of their drug regimen. SETTING: Veterans Health Administration (2011 to 2013). PATIENTS: Veterans aged 65 years or older with hypertension, an SBP of 130 mm Hg or higher, and at least 1 antihypertensive medication at less than the maximum dose. MEASUREMENTS: The following 2 intensification approaches were emulated: adding a new medication, defined as a total dose increase with new medication, and maximizing dose, defined as a total dose increase without new medication. Inverse probability weighting was used to assess the observational effectiveness of the intensification approach on sustainability of intensified treatment and follow-up SBP at 3 and 12 months. RESULTS: Among 178 562 patients, 45 575 (25.5%) had intensification by adding a new medication and 132 987 (74.5%) by maximizing dose. Compared with maximizing dose, adding a new medication was associated with less intensification sustainability (average treatment effect, -15.2% [95% CI, -15.7% to -14.6%] at 3 months and -15.1% [CI, -15.6% to -14.5%] at 12 months) but a slightly larger reduction in mean SBP (-0.8 mm Hg [CI, -1.2 to -0.4 mm Hg] at 3 months and -1.1 mm Hg [CI, -1.6 to -0.6 mm Hg] at 12 months). LIMITATION: Observational data; largely male population. CONCLUSION: Adding a new antihypertensive medication was less frequent and was associated with less intensification sustainability but slightly larger reductions in SBP. Trials would provide the most definitive support for our findings. PRIMARY FUNDING SOURCE: National Institute on Aging and Veterans Health Administration.

Planning and Reporting Effective Web-Based RAND/UCLA Appropriateness Method Panels: Literature Review and Preliminary Recommendations.

BACKGROUND: The RAND/UCLA Appropriateness Method (RAM), a variant of the Delphi Method, was developed to synthesize existing evidence and elicit the clinical judgement of medical experts on the appropriate treatment of specific clinical presentations. Technological advances now allow researchers to conduct expert panels on the internet, offering a cost-effective and convenient alternative to the traditional RAM. For example, the Department of Veterans Affairs recently used a web-based RAM to validate clinical recommendations for de-intensifying routine primary care services. A substantial literature describes and tests various aspects of the traditional RAM in health research; yet we know comparatively less about how researchers implement web-based expert panels. OBJECTIVE: The objectives of this study are twofold: (1) to understand how the web-based RAM process is currently used and reported in health research and (2) to provide preliminary reporting guidance for researchers to improve the transparency and reproducibility of reporting practices. METHODS: The PubMed database was searched to identify studies published between 2009 and 2019 that used a web-based RAM to measure the appropriateness of medical care. Methodological data from each article were abstracted. The following categories were assessed: composition and characteristics of the web-based expert panels, characteristics of panel procedures, results, and panel satisfaction and engagement. RESULTS: Of the 12 studies meeting the eligibility criteria and reviewed, only 42% (5/12) implemented the full RAM process with the remaining studies opting for a partial approach. Among those studies reporting, the median number of participants at first rating was 42. While 92% (11/12) of studies involved clinicians, 50% (6/12) involved multiple stakeholder types. Our review revealed that the studies failed to report on critical aspects of the RAM process. For example, no studies reported response rates with the denominator of previous rounds, 42% (5/12) did not provide panelists with feedback between rating periods, 50% (6/12) either did not have or did not report on the panel discussion period, and 25% (3/12) did not report on quality measures to assess aspects of the panel process (eg, satisfaction with the process). CONCLUSIONS: Conducting web-based RAM panels will continue to be an appealing option for researchers seeking a safe, efficient, and democratic process of expert agreement. Our literature review uncovered inconsistent reporting frameworks and insufficient detail to evaluate study outcomes. We provide preliminary recommendations for reporting that are both timely and important for producing replicable, high-quality findings. The need for reporting standards is especially critical given that more people may prefer to participate in web-based rather than in-person panels due to the ongoing COVID-19 pandemic.

Variation in Provider Connectedness Associates With Outcomes of Inflammatory Bowel Diseases in an Analysis of Data From a National Health System.

BACKGROUND & AIMS: Inflammatory bowel diseases (IBD) often require multidisciplinary care with tight coordination among providers. Provider connectedness, a measure of the relationship among providers, is an important aspect of care coordination that has been linked to higher quality care. We aimed to assess variation in provider connectedness among medical centers, and to understand the association between this established measure of care coordination and outcomes of patients with IBD. METHODS: We conducted a national cohort study of 32,949 IBD patients with IBD from 2005 to 2014. We used network analysis to examine provider connectedness, defined using network properties that measure the strength of the collaborative relationship, team cohesiveness, and between-facility collaborations. We used multilevel modeling to examine variations in provider connectedness and association with patient outcomes. RESULTS: There was wide variation in provider connectedness among facilities in complexity, rural designation, and volume of patients with IBD. In a multivariable model, patients followed in a facility with team cohesiveness (odds ratio, 0.38; 95% CI, 0.16-0.88) and where providers often collaborated with providers outside their facility (odds ratio, 0.48; 95% CI, 0.31-0.75) were less likely to have clinically active disease, defined by a composite of outpatient flare, inpatient flare, and IBD-related surgery. CONCLUSIONS: A national study found evidence for heterogeneity in patient-sharing among IBD care teams. Patients with IBD seen at health centers with higher provider connectedness appear to have better outcomes. Understanding provider connectedness is a step toward designing network-based interventions to improve coordination and quality of care.

Hospital-specific Template Matching for Benchmarking Performance in a Diverse Multihospital System.

BACKGROUND: Hospital-specific template matching is a newer method of hospital performance measurement that may be fairer than regression-based benchmarking. However, it has been tested in only limited research settings. OBJECTIVE: The objective of this study was to test the feasibility of hospital-specific template matching assessments in the Veterans Affairs (VA) health care system and determine power to detect greater-than-expected 30-day mortality. RESEARCH DESIGN: Observational cohort study with hospital-specific template matching assessment. For each VA hospital, the 30-day mortality of a representative subset of hospitalizations was compared with the pooled mortality from matched hospitalizations at a set of comparison VA hospitals treating sufficiently similar patients. The simulation was used to determine power to detect greater-than-expected mortality. SUBJECTS: A total of 556,266 hospitalizations at 122 VA hospitals in 2017. MEASURES: A number of comparison hospitals identified per hospital; 30-day mortality. RESULTS: Each hospital had a median of 38 comparison hospitals (interquartile range: 33, 44) identified, and 116 (95.1%) had at least 20 comparison hospitals. In total, 8 hospitals (6.6%) had a significantly lower 30-day mortality than their benchmark, 5 hospitals (4.1%) had a significantly higher 30-day mortality, and the remaining 109 hospitals (89.3%) were similar to their benchmark. Power to detect a standardized mortality ratio of 2.0 ranged from 72.5% to 79.4% for a hospital with the fewest (6) versus most (64) comparison hospitals. CONCLUSIONS: Hospital-specific template matching may be feasible for assessing hospital performance in the diverse VA health care system, but further refinements are needed to optimize the approach before operational use. Our findings are likely applicable to other large and diverse multihospital systems.

Development of a video-observation method for examining doctors' clinical and interpersonal skills in a hospital outpatient clinic in Ibadan, Oyo State, Nigeria.

BACKGROUND: Improving the quality of primary healthcare provision is a key goal in low-and middle-income countries (LMICs). However, to develop effective quality improvement interventions, we first need to be able to accurately measure the quality of care. The methods most commonly used to measure the technical quality of care all have some key limitations in LMICs settings. Video-observation is appealing but has not yet been used in this context. We examine preliminary feasibility and acceptability of video-observation for assessing physician quality in a hospital outpatients' department in Nigeria. We also develop measurement procedures and examine measurement characteristics. METHODS: Cross-sectional study at a large tertiary care hospital in Ibadan, Nigeria. Consecutive physician-patient consultations with adults and children under five seeking outpatient care were video-recorded. We also conducted brief interviews with participating physicians to gain feedback on our approach. Video-recordings were double-coded by two medically trained researchers, independent of the study team and each other, using an explicit checklist of key processes of care that we developed, from which we derived a process quality score. We also elicited a global quality rating from reviewers. RESULTS: We analysed 142 physician-patient consultations. The median process score given by both coders was 100 %. The modal overall rating category was 'above standard' (or 4 on a scale of 1-5). Coders agreed on which rating to assign only 44 % of the time (weighted Cohen's kappa = 0.26). We found in three-level hierarchical modelling that the majority of variance in process scores was explained by coder disagreement. A very high correlation of 0.90 was found between the global quality rating and process quality score across all encounters. Participating physicians liked our approach, despite initial reservations about being observed. CONCLUSIONS: Video-observation is feasible and acceptable in this setting, and the quality of consultations was high. However, we found that rater agreement is low but comparable to other modalities that involve expert clinician judgements about quality of care including in-person direct observation and case note review. We suggest ways to improve scoring consistency including careful rater selection and improved design of the measurement procedure for the process score.

Head to head randomized trial of two decision aids for prostate cancer.

BACKGROUND: While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient-provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer. METHODS: 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients' use and satisfaction with the DA. RESULTS: Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p's < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received. CONCLUSIONS: The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients' treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.

Using Qualitative Methods to Explore Communication Practices in the Context of Patient Care Rounds on General Care Units.

BACKGROUND: Poor communication between physicians and nurses is a significant contributor to adverse events for hospitalized patients. Overcoming communication difficulties requires examining communication practices to better understand some of the factors that affect the nurse-physician communication process. OBJECTIVE: To develop a more detailed understanding of communication practices between nurses and physicians on general care units. We focused on patient care rounds as an important activity in the care delivery process for communication. DESIGN: Qualitative study design PARTICIPANTS: A total of 163 physicians, registered nurses, and nurse practitioners who worked on pre-specified general care units in each of four hospitals in the Midwest. APPROACH: On each unit, data collection consisted of 2 weeks of observing and shadowing clinicians during rounds and at other times, as well as asking clinicians questions about rounds and communication during interviews and focus groups. A directed content analysis approach was used to code and analyze the data. KEY RESULTS: Workflow differences contributed to organizational complexity, affecting rounds and subsequently communication practices, both across and within provider types. Nurse and patient participation during rounds appeared to reduce interruptions and hence cognitive load for physicians and nurses. Physicians adopted certain behaviors within the social context to improve communication, such as socializing and building relationships with the nurses, which contributed to nurse participation in rounds. When rapport was lacking, some nurses felt uncomfortable joining physicians during rounds unless they were explicitly invited. CONCLUSIONS: Improving communication requires bringing attention to three contextual dimensions of communication: organizational complexity, cognitive load, and the social context. Initiatives that seek to improve communication may be more successful if they acknowledge the complexity of communication and the context in which it occurs.

Ranking Hospitals Based on Preventable Hospital Death Rates: A Systematic Review With Implications for Both Direct Measurement and Indirect Measurement Through Standardized Mortality Rates.

Policy Points The use of standardized mortality rates (SMRs) to profile hospitals presumes differences in preventable deaths, and at least one health system has suggested measuring preventable death rates of hospitals for comparison across time or in league tables. The influence of reliability on the optimal review number per case note or hospital for such a program has not been explored. Estimates for preventable death rates using implicit case note reviews by clinicians are quite low, suggesting that SMRs will not work well to rank hospitals, and any misspecification of the risk-adjustment models will produce a high risk of mislabelling outliers. Most studies achieve only fair to moderate reliability of the direct assessment of whether a death is preventable, and thus it is likely that substantial numbers of reviews of deaths would be required to distinguish preventable from nonpreventable deaths as part of learning from individual cases, or for profiling hospitals. Furthermore, population- and hospital system-specific data on the variation in preventable deaths or adverse events across the hospitals and providers to be compared are required in order to design a measurement procedure and the number of reviews needed to distinguish between the patients or hospitals. CONTEXT: There is interest in monitoring avoidable or preventable deaths measured directly or indirectly through standardized mortality rates (SMRs). While there have been numerous studies in recent years on adverse events, including preventable deaths, using implicit case note reviews by clinicians, no systematic reviews have aimed to summarize the estimates or the variations in methodologies used to derive these estimates. We reviewed studies that use implicit case note reviews to estimate the range of preventable death rates observed, the measurement characteristics of those estimates, and the measurement procedures used to generate them. We comment on the implications for monitoring SMRs and illustrate a way to calculate the number of reviews needed to establish a reliable estimate of the preventability of one death or the hospital preventable death rate. METHODS: We conducted a systematic review of the literature supplemented by a reanalysis of authors' previously published and unpublished data and measurement design calculations. We conducted initial searches in PubMed, MEDLINE (OvidSP), and ISI Web of Knowledge in June 2010 and updated them in June 2012 and December 2017. Eligibility criteria included studies of hospital-wide admissions from general and acute medical wards where preventable death rates are provided or can be estimated and that can provide interobserver variations. FINDINGS: Twenty-three studies were included from 1985 to 2017. Recent larger studies suggest consistently low rates of preventable deaths (interquartile range of 3.0%-6.0% since 2008). Reliability of a single review for distinguishing between individual cases with regard to the preventability of death had a Kappa statistic of 0.10-0.50 for deaths and 0.21-0.76 for adverse events. A Kappa of 0.35 would require an average of 8 to 17 reviews of a single case to be precise enough to have confidence in high-stakes decisions to change care procedures or impose sanctions within a hospital as a result. No study estimated the variation in preventable deaths across hospitals, although we were able to reanalyze one study to obtain an estimate. Based on this estimate, 200 to 300 total case note reviews per hospital could be required to reliably distinguish between hospitals. The studies displayed considerable heterogeneity: 13/23 studies defined preventable death with a threshold of greater than or equal to four in a six-category Likert scale and 11/24 involved a two-stage screening process with nurses at the first stage and physicians at the second. Fifteen studies provided expert clinical review support for reviewer disagreements, advice, and quality control. A "generalist/internist" was the modal physician specialty for reviewers and they received one to three days of generic tools orientation and case note review practice. Methods did not consider the influence of human or environmental factors. CONCLUSIONS: The literature provides limited information about the measurement characteristics of preventable deaths, suggesting that substantial numbers of reviews may be needed to create reliable estimates of preventable deaths at the individual or hospital level. Any operational program would require population-specific estimates of reliability. Preventable death rates are low, which is likely to make it difficult to use SMRs based on all deaths to validly profile hospitals. The literature provides little information to guide improvements in the measurement procedures.

Chemotherapy decisions and patient experience with the recurrence score assay for early-stage breast cancer.

BACKGROUND: The 21-gene recurrence score (RS) assay stratifies early-stage, estrogen receptor-positive breast cancer by recurrence risk. Few studies have examined the ways in which physicians use the RS to recommend adjuvant systemic chemotherapy or patients' experiences with testing and decision making. METHODS: This study surveyed 3880 women treated for breast cancer in 2013-2014; they were identified from the Los Angeles County and Georgia Surveillance, Epidemiology, and End Results registries (response rate, 71%). Women reported chemotherapy recommendations, the receipt of chemotherapy, testing experiences, and decision satisfaction. Registries linked the tumor data, RS, and surveys. Regression models examined factors associated with chemotherapy recommendations and receipt by the RS and subgroups. RESULTS: There were 1527 patients with stage I/II, estrogen receptor/progesterone receptor-positive, human epidermal growth factor 2-negative disease: 778 received an RS (62.6% of patients with node-negative, favorable disease, 24.3% of patients with node-negative, unfavorable disease, and 13.0% of patients with node-positive disease; P < .001). Overall, 47.2% of the patients received a recommendation against chemotherapy, and 40.5% received a recommendation for it. RS results correlated with recommendations: nearly all patients with high scores (31-100) received a chemotherapy recommendation (86.9%-96.5% across clinical subgroups), whereas the majority of the patients with low-risk results (0-18) received a recommendation against it (65.9%-78.2% across subgroups). Most patients with high RSs received chemotherapy (87.0%, 91.1%, and 100% across subgroups), whereas few patients with low scores received it (2.9%, 9.5%, and 26.6% across subgroups). There were no substantial racial/ethnic differences in testing or treatment. Women were largely satisfied with the RS and chemotherapy decisions. CONCLUSIONS: Oncologists use the RS to personalize treatment, even for those with node-positive disease. High satisfaction and an absence of disparities in testing and treatment suggest that precision-medicine advances have improved systemic breast cancer treatment. Cancer 2017;43-51. © 2016 American Cancer Society.

Treatment-associated toxicities reported by patients with early-stage invasive breast cancer.

BACKGROUND: Patient-reported toxicities help to appraise the breast cancer treatment experience. Yet extant data come from clinical trials and health care claims, which may be biased. Using patient surveys, the authors sought to quantify the frequency, severity, and burden of treatment-associated toxicities. METHODS: Between 2013 and 2014, the iCanCare study surveyed a population-based sample of women residing in Los Angeles County and Georgia with early-stage, invasive breast cancer. The authors assessed the frequency and severity of toxicities; correlated toxicity severity with unscheduled health care use (clinic visits, emergency department visits/hospitalizations) and physical health; and examined patient, tumor, and treatment factors associated with reporting increased toxicity severity. RESULTS: The overall survey response rate was 71%. From the analyzed cohort of 1945 women, 866 (45%) reported at least 1 toxicity that was severe/very severe, 9% reported unscheduled clinic visits for toxicity management, and 5% visited an emergency department or hospital. Factors associated with reporting higher toxicity severity included receipt of chemotherapy (odds ratio [OR], 2.2; 95% confidence interval [95% CI], 2.0-2.5), receipt of both chemotherapy and radiotherapy (OR, 1.3; 95% CI, 1.0-1.7), and Latina ethnicity (OR vs whites: 1.3; 95% CI, 1.1-1.5). A nonsignificant increase in at least 1 severe/very severe toxicity report was observed for bilateral mastectomy recipients (OR, 1.2; 95% CI, 1.0-1.4). CONCLUSIONS: Women with early-stage invasive breast cancer report substantial treatment-associated toxicities and related burden. Clinicians should collect toxicity data routinely and offer early intervention. Toxicity differences observed by treatment modality may inform decision making. Cancer 2017;123:1925-1934. © 2017 American Cancer Society.

Oncologists' influence on receipt of adjuvant chemotherapy: does it matter whom you see for treatment of curable breast cancer?

PURPOSE: We know little about whether it matters which oncologist a breast cancer patient sees with regard to receipt of chemotherapy. We examined oncologists' influence on use of recurrence score (RS) testing and chemotherapy in the community. METHODS: We identified 7810 women with stages 0-II breast cancer treated in 2013-15 through the SEER registries of Georgia and Los Angeles County. Surveys were sent 2 months post-surgery, (70% response rate, n = 5080). Patients identified their oncologists (n = 504) of whom 304 responded to surveys (60%). We conducted multi-level analyses on patients with ER-positive HER2-negative invasive disease (N = 2973) to examine oncologists' influence on variation in RS testing and chemotherapy receipt, using patient and oncologist survey responses merged to SEER data. RESULTS: Half of patients (52.8%) received RS testing and 27.7% chemotherapy. One-third (35.9%) of oncologists treated >50 new breast cancer patients annually; mean years in practice was 15.8. Oncologists explained 17% of the variation in RS testing but little of the variation in chemotherapy receipt (3%) controlling for clinical factors. Patients seeing an oncologist who was one standard deviation above the mean use of RS testing had over two-times higher odds of receiving RS (2.47, 95% CI 1.47-4.15), but a parallel estimate of the association of oncologist with the odds of receiving chemotherapy was much smaller (1.39, CI 1.03-1.88). CONCLUSIONS: Clinical algorithms have markedly reduced variation in chemotherapy use across oncologists. Oncologists' large influence on variation in RS use suggests that they variably seek tumor profiling to inform treatment decisions.

The influence of 21-gene recurrence score assay on chemotherapy use in a population-based sample of breast cancer patients.

PURPOSE: To quantify the influence of RS assay on changing chemotherapy plans in a general practice setting using causal inference methods. METHODS: We surveyed 3880 newly diagnosed breast cancer patients in Los Angeles and Georgia in 2013-14. We used inverse propensity weighting and multiple imputations to derive complete information for each patient about treatment status with and without testing. RESULTS: A half of the 1545 women eligible for testing (ER+ or PR+, HER2-, and stage I-II) received RS. We estimate that 30% (95% confidence interval (CI) 10-49%) of patients would have changed their treatment selections after RS assay, with 10% (CI 0-20%) being encouraged to undergo chemotherapy and 20% (CI 10-30%) being discouraged from chemotherapy. The subgroups whose treatment selections would be changed the most by RS were patients with positive nodes (44%; CI 24-64%), larger tumor (43% for tumor size >2 cm; CI 23-62%), or younger age (41% for <50 years, CI 23-58%). The assay was associated with a net reduction in chemotherapy use by 10% (CI 4-16%). The reduction was much greater for women with positive nodes (31%; CI 21-41%), larger tumor (30% for tumor size >2 cm; CI 22-38%), or younger age (22% for <50 years; CI 9-35%). CONCLUSION: RS substantially changed chemotherapy treatment selections with the largest influence among patients with less favorable pre-test prognosis. Whether this is optimal awaits the results of clinical trials addressing the utility of RS testing in selected subgroups.