ORTH.Ord: An R package for analyzing correlated ordinal outcomes using alternating logistic regressions with orthogonalized residuals.

BACKGROUND AND OBJECTIVES: Marginal models with generalized estimating equations (GEE) are usually recommended for analyzing correlated ordinal outcomes which are commonly seen in a longitudinal study or clustered randomized trial (CRT). Within-cluster association is often of interest in longitudinal studies or CRTs, and can be estimated with paired estimating equations. However, the estimators for within-cluster association parameters and variances may be subject to finite-sample biases when the number of clusters is small. The objective of this article is to introduce a newly developed R package ORTH.Ord for analyzing correlated ordinal outcomes using GEE models with finite-sample bias corrections. METHODS: The R package ORTH.Ord implements a modified version of alternating logistic regressions with estimation based on orthogonalized residuals (ORTH), which use paired estimating equations to jointly estimate parameters in marginal mean and association models. The within-cluster association between ordinal responses is modeled by global pairwise odds ratios (POR). The R package also provides a finite-sample bias correction to POR parameter estimates based on matrix multiplicative adjusted orthogonalized residuals (MMORTH) for correcting estimating equations, and bias-corrected sandwich estimators with different options for covariance estimation. RESULTS: A simulation study shows that MMORTH provides less biased global POR estimates and coverage of their 95% confidence intervals closer to the nominal level than uncorrected ORTH. An analysis of patient-reported outcomes from an orthognathic surgery clinical trial illustrates features of ORTH.Ord. CONCLUSIONS: This article provides an overview of the ORTH method with bias-correction on both estimating equations and sandwich estimators for analyzing correlated ordinal data, describes the features of the ORTH.Ord R package, evaluates the performance of the package using a simulation study, and finally illustrates its application in an analysis of a clinical trial.

The utility of teledermatology in the evaluation of skin lesions.

INTRODUCTION: Past studies have shown mixed results about the accuracy of store-and-forward (SAF) teledermatology in the evaluation of skin lesions. The objective of this study is to determine the accuracy of SAF teledermatology in the diagnosis of skin lesions and biopsy decision compared to in-person clinical evaluation. METHODS: Histories and photographs of skin lesions gathered at clinic visits were sent as SAF consults to teledermatologists, whose diagnoses and biopsy decisions were recorded and compared statistically to the clinic data.Results and Discussion: We enrolled 206 patients with 308 lesions in the study. The study population was composed of 50% males (n = 104), and most patients were white (n = 179, 87%) and not Hispanic/Latino (n = 167, 81%). There was good concordance for biopsy decision between the clinic dermatologist (CD) and teledermatologist (TD) (Cohen's kappa (κ) = 0.51), which did not significantly differ when melanocytic lesions were excluded (κ = 0.54). The sensitivity and specificity of teledermatology based on biopsy decision was 0.71 and 0.85, respectively. Overall concordance in first diagnosis between the CD and TD was good (κ = 0.60). While there was no difference between CD and TD in proportion of correct diagnoses compared to histopathology, two skin cancers presentations were missed by TD. Study limitations included sample size, enrolment bias and differing amounts of teledermatologist case experience. Teledermatology has good concordance in diagnosis and biopsy decision when compared to clinic dermatology. Teledermatology may be utilized in the evaluation of skin lesions to expand access to dermatologic care.

Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial.

INTRODUCTION: Socioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may reduce health disparities by addressing barriers to patient engagement in decision-making that disproportionately impact socioeconomically disadvantaged patients. In this trial, we test the impact of a decision aid on increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making. METHODS AND ANALYSIS: This multisite randomised trial is conducted through 10 surgical clinics within the National Cancer Institute Community Oncology Research Program (NCORP). We plan a stepped-wedge design with clinics randomised to the time of transition from usual care to the decision aid arm. Study participants are female patients, aged ≥18 years, with newly diagnosed stage 0-III breast cancer who are planning breast surgery. Data collection includes a baseline surgeon survey, baseline patient survey, audio-recording of the surgeon-patient consultation, a follow-up patient survey and medical record data review. Interviews and focus groups are conducted with a subset of patients, surgeons and clinic stakeholders. The effectiveness of the decision aid at increasing patient engagement (primary outcome) is evaluated using generalised linear mixed-effects models. The extent to which the effect of the decision aid intervention on patient engagement is mediated through the mitigation of barriers is tested in joint linear structural equation models. Qualitative interviews explore how barriers impact engagement, especially for socioeconomically disadvantaged women. ETHICS AND DISSEMINATION: This protocol has been approved by the National Cancer Institute Central Institutional Review Board, and Certificate of Confidentiality has been obtained. We plan to disseminate the findings through journal publications and national meetings, including the NCORP network. Our findings will advance the science of medical decision-making with the potential to reduce socioeconomic health disparities. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03766009).

Association of Tumor Characteristics With Insurance Type Among Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancer.

Importance: Little is known about the association between insurance type and tumor or treatment characteristics among patients undergoing Mohs micrographic surgery (MMS) for nonmelanoma skin cancer (NMSC). Objective: To investigate whether there are differences in tumor and treatment characteristics among patients undergoing MMS for NMSC by insurance type. Design, Setting, and Participants: This retrospective cohort study included patients with NMSC who presented for surgery at an academic MMS practice between May 2017 and May 2019. Main Outcomes and Measures: Preoperative and postoperative tumor diameters, number of MMS stages, type of closure, and number of high-risk tumors were compared based on insurance type among uninsured and underinsured patients and those with private insurance, Medicare, and Veterans Affairs (VA) insurance. Results: A total of 1397 patients with NMSC (978 [70%] male; mean [SD] age, 68.5 [12.4] years) underwent 1916 MMS procedures. Of these patients, 868 (45%) had Medicare, 570 (30%) had private insurance, 299 (16%) had VA insurance, and 179 (9%) were treated at a safety net clinic or were uninsured. Compared with patients with private insurance, uninsured and underinsured patients had significantly larger preoperative tumor bed diameters (difference, 28%; 95% CI, 14%-43%; P < .001) and postoperative defect sizes (difference, 28%, 95% CI, 16%-41%; P < .001). Patients with Medicare and VA insurance did not have significantly different preoperative tumor bed diameters compared with patients with private insurance. Patients with VA insurance had larger postoperative defect sizes than patients with private insurance (difference, 12%; 95% CI, 2%-23%; P = .02). The number of MMS stages and type of closure did not significantly differ based on insurance type. Conclusions and Relevance: In this cohort study of patients undergoing MMS for NMSC, larger preoperative tumor and postoperative defect sizes were associated with being uninsured or underinsured compared with privately insured. Future studies are required to determine why these differences exist to deliver optimal care to all patients.

A biobehavioral intervention to enhance recovery following hematopoietic cell transplantation: Protocol for a feasibility and acceptability randomized control trial.

Background: Insomnia, fatigue, and depression are among the most persistent and distressing concerns for hematologic cancer patients recovering from hematopoietic cell transplantation (HCT). This study will evaluate a novel behavioral intervention, Restoring Sleep and Energy after Transplant (ReSET), designed to alleviate insomnia, fatigue, and depression by improving rest-activity patterns. Evidence-based behavioral strategies to improve nighttime sleep and increase non-sedentary daytime activity will be combined to optimize 24-h rest-activity patterns. Methods: The protocol herein evaluates the feasibility and acceptability of ReSET by conducting a pilot randomized controlled trial to compare the intervention with usual care. Adults undergoing HCT will be randomly assigned to ReSET or usual care. The ReSET arm will receive 3 face-to-face sessions and telephone coaching delivered in an individual format tailored to each patient. Patient-reported insomnia, fatigue, and depression will be the primary outcome measures. Actigraphy will be used to objectively quantify rest-activity patterns. Semi-structured interviews will evaluate participant satisfaction with ReSET. The goals are to determine: (1) participant satisfaction with and acceptability of the behavioral techniques; (2) facilitator fidelity and participant uptake of key intervention components; (3) ability to recruit, retain, and collect complete data from participants; (4) participant willingness to be randomized and acceptability of the control condition; and (5) validity and acceptability of the assessment strategy. Conclusion: The overarching goal is to optimize recovery following HCT with a brief, non-invasive intervention that can be implemented as a part of routine clinical care.

Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol.

INTRODUCTION: Osteoarthritis (OA) is a major clinical and public health concern. The primary surgical treatment of knee OA is total knee replacement (TKR), a procedure that aims to alleviate pain and restore physical function. TKR is expensive, however, and based on professional guidelines, inappropriately performed in up to a third of patients. Patient-reported outcome measures (PROMs) help evaluate treatment options by quantifying health outcomes that matter to patients and can thus inform shared decision-making (SDM) between patients and health professionals. METHODS AND ANALYSIS: This is a US-based 2-year, two-site hybrid type 1 study to assess clinical effectiveness and implementation of a machine learning-based patient decision aid (PDA) integrating patient-reported outcomes and clinical variables to support SDM for patients with knee OA considering TKR. Substudy 1: At one study site, a randomised controlled trial is evaluating the clinical effectiveness of the PDA and SDM process on decision quality as measured after the baseline consultation and treatment choice measured 3 and 6 months after the baseline visit among 200 patients with knee OA. Substudy 2: At a second study site, a qualitative assessment using principles of behaviour design and intervention mapping is evaluating the feasibility and acceptability of the PROMs, PDA and SDM process by interviewing seven health professionals and 25 patients before and 25 patients after PDA implementation. ETHICS AND DISSEMINATION: Ethics approval has been obtained from The University of Texas at Austin Institutional Review Board (protocol number: 2018-11-0042). Informed consent will be obtained from all participants. Study results will be disseminated through conference presentations, publications and professional societies. TRIAL REGISTRATION NUMBER: NCT04805554.

Sleep Disruption, Fatigue, and Depression as Predictors of 6-Year Clinical Outcomes Following Allogeneic Hematopoietic Cell Transplantation.

BACKGROUND: Allogeneic hematopoietic cell transplantation (HCT) is a widely used treatment for hematologic cancers, with survival rates ranging from 25% to 78%. Known risk factors for chronic graft-versus-host disease (cGVHD), a serious and common long-term complication, disease relapse, and mortality following HCT have been identified, but much of the variability in HCT outcomes is unexplained. Biobehavioral symptoms including depression, sleep disruption, and fatigue are some of the most prevalent and distressing for patients; yet research on biobehavioral risk factors for HCT outcomes is limited. This study evaluated patient-reported depression, sleep disruption, and fatigue as risk factors for cGVHD, disease relapse, and mortality. METHODS: Adults receiving allogeneic HCT for a hematologic malignancy (N = 241) completed self-report measures of depression symptoms, sleep quality, and fatigue (severity, interference) pre-HCT and 100 days post-HCT. Clinical outcomes were monitored for up to 6 years. RESULTS: Cox proportional hazard models (2-tailed) adjusting for patient demographic and medical characteristics revealed that high pre-HCT sleep disruption (Pittsburgh Sleep Quality Index >9; hazard ratio [HR] = 2.74, 95% confidence interval [CI] = 1.27 to 5.92) and greater post-HCT fatigue interference (HR = 1.32, 95% CI = 1.05 to 1.66) uniquely predicted increased risk of mortality. Moderate pre-HCT sleep disruption (Pittsburgh Sleep Quality Index 6-9) predicted increased risk of relapse (HR = 1.99, 95% CI = 1.02 to 3.87). Biobehavioral symptoms did not predict cGVHD incidence. CONCLUSIONS: Biobehavioral symptoms, particularly sleep disruption and fatigue interference, predicted an increased risk for 6-year relapse and mortality after HCT. Because these symptoms are amenable to treatment, they offer specific targets for intervention to improve HCT outcomes.

National Trends in Centralization of Surgical Care and Multimodality Therapy for Pancreatic Adenocarcinoma.

BACKGROUND: Studies have demonstrated that multimodality therapy and surgery at high volume centers are associated with a longer survival. However, it is unknown if these data have translated into national changes in care delivery. METHODS: Patients with stages I-III pancreatic adenocarcinomas who underwent resections between 2004 and 2010 were identified from the National Cancer Data Base. The primary outcome was a 3-year overall survival. Temporal trends in survival outcomes and treatment variables were measured. A mediation analysis using the Lin method was used to discern the relative contribution of changes in treatment variables towards improvements in survival over time. RESULTS: A total of 22,196 patients were identified. Between 2004 and 2010, a 90-day peri-operative mortality remained unchanged (8.5 % to 8.4 %, p = 0.488), 3-year overall survival improved from 26 to 30% (p < 0.001), use of adjuvant/neoadjuvant chemotherapy increased (51 % to 61 %, p < 0.001), and more cases shifted to high volume centers (46 % at institutions performing > 10 cases/year in 2004 vs. 65 % in 2010, p < 0.001). On multivariable analysis, 32 % of the improvement in survival over time was attributable to receipt of chemotherapy, while 12 % was due to the shift of patients towards high volume centers (p < 0.001). CONCLUSIONS: Over the period from 2004 to 2010, a 3-year survival increased for patients undergoing resection for pancreatic cancer. This survival improvement can be partially attributed to the increasing utilization of chemotherapy and centralization of surgical care at high volume centers. A continued emphasis on these factors will likely result in further prolongation of a survival following resection.

Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial.

Importance: Poor preoperative communication can have serious consequences, including unwanted treatment and postoperative conflict. Objective: To compare the effectiveness of a question prompt list (QPL) intervention vs usual care on patient engagement and well-being among older patients considering major surgery. Design, Setting, and Participants: This randomized clinical trial used a stepped-wedge design to randomly assign patients to a QPL intervention (n = 223) or usual care (n = 223) based on the timing of their visit with 1 of 40 surgeons at 5 US study sites. Patients were 60 years or older with at least 1 comorbidity and an oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) problem that could be treated with major surgery. Family members were also enrolled (n = 263). The study dates were June 2016 to November 2018. Data analysis was by intent-to-treat. Interventions: A brochure of 11 questions to ask a surgeon developed by patient and family stakeholders plus an endorsement letter from the surgeon were sent to patients before their outpatient visit. Main Outcomes and Measures: Primary patient engagement outcomes included the number and type of questions asked during the surgical visit and patient-reported Perceived Efficacy in Patient-Physician Interactions scale assessed after the surgical visit. Primary well-being outcomes included (1) the difference between patient's Measure Yourself Concerns and Well-being (MYCaW) scores reported after surgery and scores reported after the surgical visit and (2) treatment-associated regret at 6 to 8 weeks after surgery. Results: Of 1319 patients eligible for participation, 223 were randomized to the QPL intervention and 223 to usual care. Among 446 patients, the mean (SD) age was 71.8 (7.1) years, and 249 (55.8%) were male. On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes. The difference in MYCaW scores for family members was greater in usual care (effect estimate, 1.51; 95% CI, 0.28-2.74; P = .008). When the QPL intervention group was restricted to patients with clear evidence they reviewed the QPL, a nonsignificant increase in the effect size was observed for questions about options (odds ratio, 1.88; 95% CI, 0.81-4.35; P = .16), expectations (odds ratio, 1.59; 95% CI, 0.67-3.80; P = .29), and risks (odds ratio, 2.41; 95% CI, 1.04-5.59; P = .04) (nominal α = .01). Conclusions and Relevance: The results of this study were null related to primary patient engagement and well-being outcomes. Changing patient-physician communication may be difficult without addressing clinician communication directly. Trial Registration: ClinicalTrials.gov identifier: NCT02623335.

Extending the Case-Control Design to Longitudinal Data: Stratified Sampling Based on Repeated Binary Outcomes.

We detail study design options that generalize case-control sampling when longitudinal outcome data are already collected as part of a primary cohort study, but new exposure data must be retrospectively processed for a secondary analysis. Furthermore, we assume that cost will limit the size of the subsample that can be evaluated. We describe a novel class of stratified outcome-dependent sampling designs for longitudinal binary response data where distinct strata are created for subjects who never, sometimes, and always experienced the event of interest during longitudinal follow-up. Individual designs within this class are differentiated by the stratum-specific sampling probabilities. We show for parameters associated with time-varying exposures, subjects who experience the event/outcome at some but not at all of the follow-up times (i.e., those who exhibit response variation) are highly informative. If the time-varying exposure varies exclusively within individuals (i.e., intraclass correlation coefficient is 0), then sampling all subjects with response variability can yield highly precise parameter estimates even when compared with an analysis of the original cohort. The flexibility of the designs and analysis procedures also permits estimation of parameters that correspond to time-fixed covariates, and we show that with an imputation-based estimation procedure, baseline covariate associations can be estimated with very high precision irrespective of the design. We demonstrate features of the designs and analysis procedures via a plasmode simulation using data from the Lung Health Study.

Outcome-related, Auxiliary Variable Sampling Designs for Longitudinal Binary Data.

BACKGROUND: Epidemiologists have long used case-control and related study designs to enhance variability of response and information available to estimate exposure-disease associations. Less has been done for longitudinal data. METHODS: We discuss an epidemiological study design and analysis approach for longitudinal binary response data. We seek to gain statistical efficiency by oversampling relatively informative subjects for inclusion into the sample. In this methodological demonstration, we develop this concept by sampling repeatedly from an existing cohort study to estimate the relationship of chronic obstructive pulmonary disease to past-year smoking in a panel of baseline smokers. To account for oversampling, we describe a sequential offsetted regressions approach for valid inferences in this setting. RESULTS: Targeted sampling can lead to increased statistical efficiency when combined with sequential offsetted regressions. Efficiency gains are degraded with increased prevalence of the disease response variable, with decreased association between the sampling variable and the response, and with other design and analysis parameters, providing guidance to those wishing to use these types of designs in the future. CONCLUSIONS: These designs hold promise for efficient use of resources in longitudinal cohort studies.

Thirty-day readmission and mortality among Medicare beneficiaries discharged to skilled nursing facilities after vascular surgery.

BACKGROUND: Readmission within 30 d of an acute hospital stay is frequent, costly, and increasingly subject to penalties. Early readmission is most common after vascular surgery; these patients are often discharged to skilled nursing facilities (SNFs), making postacute care an essential partner in reducing readmissions. We characterize 30-day readmissions among vascular surgery patients discharged to SNF to provide evidence for this understudied segment of readmission after specialty surgery. METHODS: We utilize the Centers for Medicare & Medicaid Services Chronic Conditions Warehouse, a longitudinal 5% national random sample of Medicare beneficiaries to study 30-day readmission or death after discharge to SNF following abdominal aortic aneurysm repair or lower extremity revascularization from 2005-2009. Descriptive statistics and logistic regression with Least Adaptive Shrinkage and Selection Operator were used for analysis. RESULTS: Two thousand one hundred ninety-seven patients underwent an abdominal aortic aneurysm procedure or lower extremity revascularization at 686 hospitals and discharged to 1714 SNFs. Eight hundred (36%) were readmitted or had died at 30 d. In adjusted analysis, predictors of readmission or death at 30 d included SNF for-profit status (OR [odds ratio] = 1.2; P = 0.032), number of hospitalizations in the previous year (OR = 1.06; P = 0.011), number of comorbidities (OR = 1.06; P = 0.004), emergent procedure (OR = 1.69; P < 0.001), renal complication (OR = 1.38; P = 0.003), respiratory complication (OR = 1.45; P < 0.001), thromboembolic complication (OR = 1.57; P = 0.019), and wound complication (OR = 0.70; P = 0.017). CONCLUSIONS: Patients discharged to SNF following vascular surgery have exceptionally high rates of readmission or death at 30 d. Many factors predicting readmission or death potentially modify decision-making around discharge, making early detection, discharge planning, and matching patient needs to SNF capabilities essential to improving outcomes.

Are Parents Who Feel the Need to Watch Over Their Children's Care Better Patient Safety Partners?

OBJECTIVES: Many parents report needing to watch over their child's hospital care to prevent mistakes. In this study, we assessed whether needing to watch over care predicts parent performance of recommended safety behaviors to reduce medication errors and health care-associated infections. METHODS: At admission, we surveyed 170 parents about their need to watch over care, demographics, and hospitalization factors. At discharge, parents were surveyed about medication awareness and hand hygiene behaviors. Logistic regression was used to examine how parents' need to watch over care predicted each behavior, adjusting for demographics and hospitalization factors. RESULTS: Thirty-eight percent of parents reported needing to watch over care. Most parents (77%) reported frequently or very frequently asking providers for drug names or doses. Fewer parents asked to check drug or infusion accuracy (29%) or to show or read aloud medication labels (21%). Few parents reminded providers to clean hands (4%), but most stated they would be comfortable asking (82%) and likely to speak up if a provider did not (78%). After adjustment, parents needing to watch over care were significantly more likely to ask providers to check drug or infusion accuracy (adjusted odds ratio = 4.59, 95% confidence interval 2.14-9.94) and for drug name or dose (adjusted odds ratio = 3.04, 95% confidence interval 1.25-7.39). CONCLUSIONS: Parents who report the need to watch over care are more likely to perform behaviors specific to safe medication use (but not hand hygiene) compared with those not reporting this need. Opportunities exist to engage parents as safety partners by leveraging their need to watch over care toward system-level safety initiatives.

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

INTRODUCTION: Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. METHODS AND ANALYSIS: This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings. TRIAL REGISTRATION NUMBER: NCT02623335.

A Framework to Improve Surgeon Communication in High-Stakes Surgical Decisions: Best Case/Worst Case.

Importance: Although many older adults prefer to avoid burdensome interventions with limited ability to preserve their functional status, aggressive treatments, including surgery, are common near the end of life. Shared decision making is critical to achieve value-concordant treatment decisions and minimize unwanted care. However, communication in the acute inpatient setting is challenging. Objective: To evaluate the proof of concept of an intervention to teach surgeons to use the Best Case/Worst Case framework as a strategy to change surgeon communication and promote shared decision making during high-stakes surgical decisions. Design, Setting, and Participants: Our prospective pre-post study was conducted from June 2014 to August 2015, and data were analyzed using a mixed methods approach. The data were drawn from decision-making conversations between 32 older inpatients with an acute nonemergent surgical problem, 30 family members, and 25 surgeons at 1 tertiary care hospital in Madison, Wisconsin. Interventions: A 2-hour training session to teach each study-enrolled surgeon to use the Best Case/Worst Case communication framework. Main Outcomes and Measures: We scored conversation transcripts using OPTION 5, an observer measure of shared decision making, and used qualitative content analysis to characterize patterns in conversation structure, description of outcomes, and deliberation over treatment alternatives. Results: The study participants were patients aged 68 to 95 years (n = 32), 44% of whom had 5 or more comorbid conditions; family members of patients (n = 30); and surgeons (n = 17). The median OPTION 5 score improved from 41 preintervention (interquartile range, 26-66) to 74 after Best Case/Worst Case training (interquartile range, 60-81). Before training, surgeons described the patient's problem in conjunction with an operative solution, directed deliberation over options, listed discrete procedural risks, and did not integrate preferences into a treatment recommendation. After training, surgeons using Best Case/Worst Case clearly presented a choice between treatments, described a range of postoperative trajectories including functional decline, and involved patients and families in deliberation. Conclusions and Relevance: Using the Best Case/Worst Case framework changed surgeon communication by shifting the focus of decision-making conversations from an isolated surgical problem to a discussion about treatment alternatives and outcomes. This intervention can help surgeons structure challenging conversations to promote shared decision making in the acute setting.

Endovascular Versus Open Revascularization for Peripheral Arterial Disease.

OBJECTIVE: The aim of this study was to determine whether endovascular or open revascularization provides an advantageous approach to symptomatic peripheral arterial disease (PAD) over the longer term. SUMMARY OF BACKGROUND DATA: The optimal revascularization strategy for symptomatic lower extremity PAD is not established. METHODS: We evaluated amputation-free survival, overall survival, and relative rate of subsequent vascular intervention after endovascular or open lower extremity revascularization for propensity-score matched cohorts of Medicare beneficiaries with PAD from 2006 through 2009. RESULTS: Among 14,685 eligible patients, 5928 endovascular and 5928 open revascularization patients were included in matched analysis. Patients undergoing endovascular repair had improved amputation-free survival compared with open repair at 30 days (7.4 vs 8.9%, P = 0.002). This benefit persisted over the long term: At 4 years, 49% of endovascular patients had died or received major amputation compared with 54% of open patients (P < 0.001). An endovascular procedure was associated with a risk-adjusted 16% decreased risk of amputation or death compared with open over the study period (hazard ratio: 0.84; 95% confidence interval, 0.79-0.89; P < 0.001). The amputation-free survival benefit associated with an endovascular revascularization was more pronounced in patients with congestive heart failure or ischemic heart disease than in those without (P = 0.021 for interaction term). The rate of subsequent intervention at 30 days was 7.4% greater for the endovascular vs the open revascularization cohort. At 4 years, this difference remained stable at 8.6%. CONCLUSIONS: Using population-based data, we demonstrate that an endovascular approach is associated with improved amputation-free survival over the long term with only a modest relative increased risk of subsequent intervention.

External validity of a hierarchical dimensional model of child and adolescent psychopathology: Tests using confirmatory factor analyses and multivariate behavior genetic analyses.

Several recent studies of the hierarchical phenotypic structure of psychopathology have identified a General psychopathology factor in addition to the more expected specific Externalizing and Internalizing dimensions in both youth and adult samples and some have found relevant unique external correlates of this General factor. We used data from 1,568 twin pairs (599 MZ & 969 DZ) age 9 to 17 to test hypotheses for the underlying structure of youth psychopathology and the external validity of the higher-order factors. Psychopathology symptoms were assessed via structured interviews of caretakers and youth. We conducted phenotypic analyses of competing structural models using Confirmatory Factor Analysis and used Structural Equation Modeling and multivariate behavior genetic analyses to understand the etiology of the higher-order factors and their external validity. We found that both a General factor and specific Externalizing and Internalizing dimensions are necessary for characterizing youth psychopathology at both the phenotypic and etiologic levels, and that the 3 higher-order factors differed substantially in the magnitudes of their underlying genetic and environmental influences. Phenotypically, the specific Externalizing and Internalizing dimensions were slightly negatively correlated when a General factor was included, which reflected a significant inverse correlation between the nonshared environmental (but not genetic) influences on Internalizing and Externalizing. We estimated heritability of the general factor of psychopathology for the first time. Its moderate heritability suggests that it is not merely an artifact of measurement error but a valid construct. The General, Externalizing, and Internalizing factors differed in their relations with 3 external validity criteria: mother's smoking during pregnancy, parent's harsh discipline, and the youth's association with delinquent peers. Multivariate behavior genetic analyses supported the external validity of the 3 higher-order factors by suggesting that the General, Externalizing, and Internalizing factors were correlated with peer delinquency and parent's harsh discipline for different etiologic reasons. (PsycINFO Database Record

Inter-rater agreement and checklist validation for postoperative wound assessment using smartphone images in vascular surgery.

OBJECTIVE: Surgical site infection (SSI) is the most common nosocomial infection, in vascular surgery patients, who experience a high rate of readmission. Facilitating transition from hospital to outpatient care with digital image-based wound monitoring has the potential to detect and to enable treatment of SSI at an early stage. In this study, we evaluated whether smartphone digital images can supplant in-person evaluation of postoperative vascular surgery wounds. METHODS: We developed a wound assessment checklist using previously validated criteria. We recruited adults who underwent a vascular surgical procedure between 2014 and 2015, involving an incision of at least 3 cm, from a high-volume academic vascular surgery service. Vascular surgery care providers evaluated wounds in person using the assessment checklist; a different group of providers evaluated wounds by a smartphone digital image. Inter-rater agreement coefficients for wound characteristics and treatment plan were calculated within and between the in-person group and the digital image group; the sensitivity and specificity of digital images relative to in-person evaluation were determined. RESULTS: We assessed a total of 80 wounds. Regardless of modality, inter-rater agreement was poor when wounds were evaluated for the presence of ecchymosis and redness; moderate for cellulitis; and high for the presence of a drain, necrosis, or dehiscence. As expected, the presence of drainage was more readily observed in person. Inter-rater agreement was high for both in-person and image-based assessment with respect to course of treatment, with near-perfect agreement for treatments ranging from antibiotics to surgical débridement to hospital readmission. No difference in agreement emerged when raters evaluated poor-quality compared with high-quality images. For most parameters, specificity was higher than sensitivity for image-based compared with "gold standard" in-person assessment. CONCLUSIONS: Using smartphone digital images is a valid method for evaluating postoperative vascular surgery wounds and is comparable to in-person evaluation with regard to most wound characteristics. The inter-rater reliability for determining treatment recommendations was universally high. Remote wound monitoring and assessment may play an integral role in future transitional care models to decrease readmission for SSI in vascular or other surgical patients. These findings will inform smartphone implementation in the clinical care setting as wound images transition from informal clinical communication to becoming part of the care standard.

Use of a novel statistical technique to examine the delivery of breast cancer follow-up care by different types of oncology providers.

RATIONALE, AIMS AND OBJECTIVES: Frequent follow-up is recommended for the more than 3 million breast cancer survivors living in the USA. Given the multidisciplinary nature of breast cancer treatment, follow-up may be provided by medical oncologists, radiation oncologists, surgeons and primary care providers. This creates the potential for significant redundancy as well as gaps in care. The objective was to examine patterns of breast cancer follow-up provided by different types of oncologists and develop a statistical means of quantifying visit distribution over time. METHODS: We identified stage I-III breast cancer patients who underwent breast conservation from 2000 to 2006 (n = 12 139) within the SEER-Medicare linked database. Provider type was defined using Medicare specialty provider codes and AMA Masterfile. The coefficient of variation (CV) for time between oncologist follow-up visits was calculated. Ordinal logistic regression assessed factors associated with CV. RESULTS: Substantial variation in CV was observed. Sixty-seven per cent of patients with low CV (high visit regularity) received follow-up from a single oncologist type, versus 8% with high CV (low visit regularity). The number of oncologist types participating in follow-up had the greatest association with high CV (odds ratio 7.4 [6.7-8.3] and 15.4 [13.6-17.6] for two and three oncologist types). CONCLUSIONS: Using a novel means of quantifying follow-up visit regularity, we determined that breast cancer patients with dispersed follow-up with more than one oncologist have more disordered care. The CV could be used in electronic medical records to identify cancer survivors with more disordered.

Practice variations in voice treatment selection following vocal fold mucosal resection.

OBJECTIVES/HYPOTHESIS: To characterize initial voice treatment selection following vocal fold mucosal resection in a Medicare population. STUDY DESIGN: Retrospective analysis of a large, nationally representative Medicare claims database. METHODS: Patients with > 12 months of continuous Medicare coverage who underwent a leukoplakia- or cancer-related vocal fold mucosal resection (index) procedure during calendar years 2004 to 2009 were studied. The primary outcome of interest was receipt of initial voice treatment (thyroplasty, vocal fold injection, or speech therapy) following the index procedure. We evaluated the cumulative incidence of each postindex treatment type, treating the other treatment types as competing risks, and further evaluated postindex treatment utilization using the proportional hazards model for the subdistribution of a competing risk. Patient age, sex, and Medicaid eligibility were used as predictors. RESULTS: A total of 2,041 patients underwent 2,427 index procedures during the study period. In 14% of cases, an initial voice treatment event was identified. Women were significantly less likely to receive surgical or behavioral treatment compared to men. From age 65 to 75 years, the likelihood of undergoing surgical treatment increased significantly with each 5-year age increase; after age 75 years, the likelihood of undergoing either surgical or behavioral treatment decreased significantly every 5 years. Patients with low socioeconomic status were significantly less likely to undergo speech therapy. CONCLUSION: The majority of Medicare patients do not undergo voice treatment following vocal fold mucosal resection. Further, the treatments analyzed here appear disproportionally utilized based on patient sex, age, and socioeconomic status. Additional research is needed to determine whether these observations reflect clinically explainable differences or disparities in care. LEVEL OF EVIDENCE: 2c. Laryngoscope, 126:2505-2512, 2016.