Charlson Comorbidity Index: A Critical Review of Clinimetric Properties.

The present critical review was conducted to evaluate the clinimetric properties of the Charlson Comorbidity Index (CCI), an assessment tool designed specifically to predict long-term mortality, with regard to its reliability, concurrent validity, sensitivity, incremental and predictive validity. The original version of the CCI has been adapted for use with different sources of data, ICD-9 and ICD-10 codes. The inter-rater reliability of the CCI was found to be excellent, with extremely high agreement between self-report and medical charts. The CCI has also been shown either to have concurrent validity with a number of other prognostic scales or to result in concordant predictions. Importantly, the clinimetric sensitivity of the CCI has been demonstrated in a variety of medical conditions, with stepwise increases in the CCI associated with stepwise increases in mortality. The CCI is also characterized by the clinimetric property of incremental validity, whereby adding the CCI to other measures increases the overall predictive accuracy. It has been shown to predict long-term mortality in different clinical populations, including medical, surgical, intensive care unit (ICU), trauma, and cancer patients. It may also predict in-hospital mortality, although in some instances, such as ICU or trauma patients, the CCI did not perform as well as other instruments designed specifically for that purpose. The CCI thus appears to be clinically useful not only to provide a valid assessment of the patient's unique clinical situation, but also to demarcate major diagnostic and prognostic differences among subgroups of patients sharing the same medical diagnosis.

Examining the correlation between Altmetric Attention Score and citation count in the gynecologic oncology literature: Does it have an impact?

We sought to determine the correlation between Altmetric Attention Score and traditional bibliometrics in the gynecologic oncology literature. We identified the 10 most-cited gynecologic oncology articles from 5 major gynecology journals and 10 major "oncology" journals that publish on gynecologic oncology during 2014, 2016, and 2018. Article citation count and Altmetric Attention Score (AAS), as well as journal impact factor (IF) and date of Twitter account development were recorded. Pearson's correlation coefficient was used to describe the relationship between AAS, tweets, IF, and citation count. While the median citation counts significantly decreased for the top-cited gynecologic oncology articles from 2014 to 2018 (p < 0.001), the corresponding median AAS continuously increased during this period (p = 0.008). For articles published in 2014 and 2018, there was a strong positive relationship between the median citation count and the median AAS (2014: r = 0.92; 2018: r = 0.97), as well as between the IF (r = 0.78 and r = 0.89, respectively); these correlations were moderate to weak in 2016 (r = 0.5 and r = 0.41, respectively). There was a continuously increasing strong positive correlation from 2014 to 2018 between journal IF and median AAS (2014: r = 0.75; 2016: r = 0.82; 2018: r = 0.92). Gynecologic oncology articles published in higher impact journals are associated with increased social media visibility and attention. Our data support the idea that early online attention scores, like the AAS, might be useful for predicting future citation counts for oncology publications in general and gynecologic oncology specifically.

Clinimetric Criteria for Patient-Reported Outcome Measures.

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients' subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clini-metric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.

Overall and Cause-Specific Mortality in Randomized Clinical Trials Comparing Percutaneous Interventions With Coronary Bypass Surgery: A Meta-analysis.

Importance: Mortality is a common outcome in trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG). Controversy exists regarding whether all-cause mortality or cardiac mortality is preferred as a study end point, because noncardiac mortality should be unrelated to the treatment. Objective: To evaluate the difference in all-cause and cause-specific mortality in randomized clinical trials (RCTs) comparing PCI with CABG for the treatment of patients with coronary artery disease. Data Sources: MEDLINE (1946 to the present), Embase (1974 to the present), and the Cochrane Library (1992 to the present) databases were searched on November 24, 2019. Reference lists of included articles were also searched, and additional studies were included if appropriate. Study Selection: Articles were considered for inclusion if they were in English, were RCTs comparing PCI with drug-eluting or bare-metal stents and CABG for the treatment of coronary artery disease, and reported mortality and/or cause-specific mortality. Trials of PCI involving angioplasty without stenting were excluded. For each included trial, the publication with the longest follow-up duration for each outcome was selected. Data Extraction and Synthesis: For data extraction, all studies were reviewed by 2 independent investigators, and disagreements were resolved by a third investigator in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline. Data were pooled using fixed- and random-effects models. Main Outcomes and Measures: The primary outcomes were all-cause and cause-specific (cardiac vs noncardiac) mortality. Subgroup analyses were performed for PCI trials using drug-eluting vs bare-metal stents and for trials involving patients with left main disease. Results: Twenty-three unique trials were included involving 13 620 unique patients (6829 undergoing PCI and 6791 undergoing CABG; men, 39.9%-99.0% of study populations; mean age range, 60.0-71.0 years). The weighted mean (SD) follow-up was 5.3 (3.6) years. Compared with CABG, PCI was associated with a higher rate of all-cause (incidence rate ratio, 1.17; 95% CI, 1.05-1.29) and cardiac (incidence rate ratio, 1.24; 95% CI, 1.05-1.45) mortality but also noncardiac mortality (incidence rate ratio, 1.19; 95% CI, 1.00-1.41). Conclusions and Relevance: Percutaneous coronary intervention was associated with higher all-cause, cardiac, and noncardiac mortality compared with CABG at 5 years. The significantly higher noncardiac mortality associated with PCI suggests that even noncardiac deaths after PCI may be procedure related and supports the use of all-cause mortality as the end point for myocardial revascularization trials.

Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions.

Importance: Changes in evidence-based practice and guideline recommendations depend on high-quality randomized clinical trials (RCTs). Commercial device and pharmaceutical manufacturers are frequently involved in the funding, design, conduct, and reporting of trials, the implications of which have not been recently analyzed. Objective: To evaluate the design, outcomes, and reporting of contemporary randomized clinical trials of invasive cardiovascular interventions and their association with the funding source. Design, Setting, and Participants: This cross-sectional study analyzed published RCTs between January 1, 2008, to May 31, 2019. The trials included those involving coronary, vascular and structural interventional cardiology, and vascular and cardiac surgical procedures. Main Outcomes and Measures: We assessed (1) trial characteristics, (2) finding of a statistically significant difference in the primary end point favoring the experimental intervention, (3) reporting of implied treatment advantage in trials without significant differences in primary end point, (4) existence of major discrepancies between registered and published primary outcomes, (5) number of patients whose outcomes would need to switch from a nonevent to an event to convert a significant difference in primary end point to nonsignificant, and (6) association with funding source. Results: Of the 216 RCTs analyzed, 115 (53.2%) reported having commercial sponsorship. Most trials had 80% power to detect an estimated treatment effect of 30%, and 128 trials (59.3%) used composite primary end points. The median (interquartile range [IQR]) sample size was 502 (204-1702) patients, and the median (IQR) follow-up duration was 12 (1.0-14.4) months. Overall, 123 trials (57.0%) reported a statistically significant difference in the primary outcome favoring the experimental intervention; reporting strategies that implied an advantage were identified in 55 (65.5%) of 84 trials that reported nonsignificant differences. Commercial sponsorship was associated with a statistically significantly greater likelihood of favorable outcomes reporting (exponent of regression coefficient ß, 2.80; 95% CI, 1.09-7.18; P = .03) and with the reporting of findings that are inconsistent with the trial results. Discrepancies between the registered and published primary outcomes were found in 82 trials (38.0%), without differences in trial sponsorship. A median (IQR) number of 5 (2.8-12.5) patients experiencing a different outcome would have change statistically significant results to nonsignificant. Commercial sponsorship was associated with a greater number of patients (exponent of regression coefficient ß, 1.29; 95% CI, 1.00-1.66; P = .04). Conclusions and Relevance: These results suggest that contemporary RCTs of invasive cardiovascular interventions are relatively small and fragile, have short follow-up, and have limited power to detect large treatment effects. Commercial support appeared to be associated with differences in trial design, results, and reporting.

Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

Big Data Analytics and the Struggle for Equity in Health Care: The Promise and Perils.

Big data is both a product and a function of technology and the ever-growing analytic and computational power. The potential impact of big data in health care innovation cannot be ignored. The technology-mediated transformative potential of big data is taking place within the context of historical inequities in health and health care. Although big data analytics, properly applied, hold great potential to target inequities and reduce disparities, we believe that the realization of this potential requires us to explicitly address concerns of fairness, equity, and transparency in the development of big data tools. To mitigate potential sources of bias and inequity in algorithmic decision-making, a multipronged and interdisciplinary approach is required, combining insights from data scientists and domain experts to design algorithmic decision-making approaches that explicitly account and correct for these issues.

"It's Like They Forget That the Word 'Health' Is in 'Home Health Aide'": Understanding the Perspectives of Home Care Workers Who Care for Adults With Heart Failure.

Background Home care workers ( HCW s) increasingly provide long-term and posthospitalization care for community-dwelling adults with heart failure ( HF ). They observe, assist, and advise these patients, yet few studies have examined their role in HF . As the foundation for future interventions, we sought to understand the perspectives of HCW s caring for adults with HF . Methods and Results We conducted 8 focus groups in partnership with the Home Care Industry Education Fund, a benefit fund of the 1199 Service Employees International Union United Healthcare Workers East, the largest healthcare union in the United States. English- and Spanish-speaking HCW s with HF clients were eligible to participate. Data were analyzed thematically. Forty-six HCW s employed by 21 unique home care agencies participated. General and HF -specific themes emerged. Generally, HCW s (1) feel overworked and undervalued; (2) find communication and care to be fragmented; (3) are dedicated to clients and families but are caught in the middle; and, despite this, (4) love their job. With respect to HF , HCW s (1) find it frightening and unpredictable; (2) are involved in HF self-care without any HF training; and (3) find the care plan problematic. Conclusions Although frequently involved in HF self-care, most HCW s have not received HF training. In addition, many felt poorly supported by other healthcare providers and the care plan, especially when their clients' symptoms worsened. Interventions that provide HF -specific training and aim to improve communication between members of the home health care team may enhance HCW s' ability to care for adults with HF and potentially lead to better patient outcomes.

Medicine based evidence and personalized care of patients.

BACKGROUND: For the past 70- years patient care has been dominated by Evidence Based Medicine (EBM) with its emphasis on Randomized Controlled Trials (RCTs) and clinical guidelines to standardize medical decision-making. METHODS: Critical assessment of the literature and analyses of the arguments that favor patient care based primarily on individual variability in disease risk or treatment response versus emphasis on group standardization. RESULTS: Medicine Based Evidence (MBE) is used to guide decision making for an individual patient at hand by profiling the clinical features (biology) and life experience (biography) of the patient and then finding approximate matches to the patient in a clinical library of patients assembled from diverse sources (RCTs, cohorts, registries, electronic health records and more). CONCLUSION: Medicine is transitioning from population based model of clinical care that relies on average results from RCTs to an individual-based model of "personalized" medicine. For individualized care of the patient at hand, MBE is the preferred scientific strategy to generate evidence for patient care.

Impact of Depression and Demoralization on Blood Pressure Control in African Americans with Hypertension: Findings from the TRIUMPH Trial.

BACKGROUND: African Americans develop hypertension earlier and have worse cardiovascular outcomes than Caucasians. Accumulating evidence suggests that psychological distress may play a role in the observed racial differences in hypertension. Several studies have investigated the relationship between depression and hypertension while little is still known about the role of demoralization. METHODS: Using data from the Trial Using Motivational Interviewing, Positive Affect, and Self-affirmation in African Americans with Hypertension (TRIUMPH), logistic regression models were used to estimate differences in blood pressure control at 12 months among participants with demoralization, depression, and both conditions. RESULTS: Our logistic models showed that reported psychosocial symptoms significantly differed in predicting success in blood pressure control at 12 months. Contrast analyses showed that, after adjusting for sociodemographic, clinical, and psychosocial variables, demoralized patients were less likely to achieve blood pressure control than participants without affective conditions (p = 0.020). Similar results emerged for patients with depression (p = 0.042) and both conditions (p = 0.022). CONCLUSIONS: Depression can be extremely debilitating and has serious health consequence. Our findings confirm this result and show that, even though depression and demoralization share common features, they are two distinct clinical phenomena with similar negative impact on blood pressure control in African Americans.

Stress and Response to Treatment: Insights From a Pilot Study Using a 4-week Contemplative Self-Healing Meditation Intervention for Posttraumatic Stress in Breast Cancer.

Along with symptoms of anxiety and depression, many breast cancer survivors experience symptoms of posttraumatic stress disorder (PTSD) that may worsen in the setting of other stressful life events. The aim of this pilot study was to evaluate whether a 4-week version of our Contemplative Self-Healing program would have different effects in reducing PTSD symptoms between breast cancer survivors with or without chronic stress at baseline. PTSD symptoms were measured using the Impact of Events scale (IES). A linear mixed model analysis was used to evaluate within patients changes in IES score. Results showed that breast cancer patients who were experiencing chronic stress reported greater improvement in IES score than those without chronic stress. Our preliminary findings shed light on the need to evaluate life stressors in breast cancer patients. Evaluating chronic stress may be essential in predicting which cancer patients may benefit most from a psychological intervention.

Readmission After Ileostomy Creation: Retrospective Review of a Common and Significant Event.

OBJECTIVE: To evaluate causes and predictors of readmission after new ileostomy creation. BACKGROUND: New ileostomates have been reported to have higher readmission rates compared with other surgical patients, but data on predictors are limited. METHODS: A total of 1114 records at 2 associated hospitals were reviewed to identify adults undergoing their first ileostomy. Primary outcome was readmission within 60 days of surgery. Multiple logistic regression was used to identify independent predictors; area under the receiver-operator characteristic curves (AUC) were used to evaluate age-stratified models in secondary analysis. RESULTS: In all, 407 patients underwent new ileostomy; 58% had cancer, 31% IBD; 49% underwent LAR, 27% colectomy, and 14% proctocolectomy. Median length of stay was 8 days. Among the patients, 39% returned to hospital, and 28% were readmitted (n = 113) at a median of 12 days postdischarge. The most common causes of readmission were dehydration (42%), intraperitoneal infections (33%), and extraperitoneal infections (29%). Dehydration was associated with later, longer, and repeated readmission. Independent significant predictors of readmission were Clavien-Dindo complication grade 3 to 4 [odds ratio (OR) 6.7], Charlson comorbidity index (OR 1.4 per point), and loop stoma (OR 2.2); longer length of stay (OR 0.5) and age 65 years or older (OR 0.4) were protective. Cohort stratification above or below age 65 revealed that older patient readmissions were more predictable (AUC 0.84) with more preventable causes, whereas younger patient readmissions were difficult to predict or prevent (AUC 0.65). CONCLUSIONS: Readmissions are most commonly caused by dehydration, and are predicted by serious complications, comorbidity burden, loop stoma, shorter length of stay, and age. Readmissions in older patients are easier to predict, representing an important target for improvement.

Environmental influences on small eating behavior change to promote weight loss among Black and Hispanic populations.

Small eating behavior changes are proposed as more feasible to achieve and maintain than larger changes used in traditional behavioral weight loss studies. However, it is unclear whether overweight Black and Hispanic adults in a low-income urban setting experience small changes as feasible and what might influence feasibility. Participants' experiences in a 12-week pilot weight loss intervention were explored qualitatively to determine the feasibility of making small eating behavior changes in this population. After the intervention (69% retention), semi-structured interviews with 46 men and women (mean age 51, 50% Non-Hispanic Black, 43% Hispanic) revealed that making small eating changes was a process shaped by participants' intrapersonal and interpersonal eating environments. Participants responded to intrapersonal and interpersonal eating environmental challenges by adapting small change strategies, navigating eating environments, and negotiating household eating practices. Findings highlight how even small eating behavior changes called for adaptation, navigation, and negotiation of complex eating environments in daily life. These findings were used to improve the trial that followed and underline the importance of feasibility studies to inform community trials. Findings also add to understanding of contextual challenges and the skills needed to implement small changes in a low income, ethnic minority population.

Predictive value of the Age-Adjusted Charlson Comorbidity Index on perioperative complications and survival in patients undergoing primary debulking surgery for advanced epithelial ovarian cancer.

OBJECTIVE: To assess the ability of the Age-Adjusted Charlson Comorbidity Index (ACCI) to predict perioperative complications and survival in patients undergoing primary debulking for advanced epithelial ovarian cancer (EOC). METHODS: Data were analyzed for all patients with stage IIIB-IV EOC who underwent primary cytoreduction from 1/2001-1/2010 at our institution. Patients were divided into 3 groups based on an ACCI of 0-1, 2-3, and ≥4. Clinical and survival outcomes were assessed and compared. RESULTS: We identified 567 patients; 199 (35%) had an ACCI of 0-1, 271 (48%) had an ACCI of 2-3, and 97 (17%) had an ACCI of ≥4. The ACCI was significantly associated with the rate of complete gross resection (0-1=44%, 2-3=32%, and ≥4=32%; p=0.02), but was not associated with the rate of minor (47% vs 47% vs 43%, p=0.84) or major (18% vs 19% vs 16%, p=0.8) complications. The ACCI was also significantly associated with progression-free (PFS) and overall survival (OS). Median PFS for patients with an ACCI of 0-1, 2-3, and ≥4 was 20.3, 16, and 15.4 months, respectively (p=0.02). Median OS for patients with an ACCI of 0-1, 2-3, and ≥4 was 65.3, 49.9, and 42.3 months, respectively (p<0.001). On multivariate analysis, the ACCI remained a significant prognostic factor for both PFS (p=0.02) and OS (p<0.001). CONCLUSIONS: The ACCI was not associated with perioperative complications in patients undergoing primary cytoreduction for advanced EOC, but was a significant predictor of PFS and OS. Prospective clinical trials in ovarian cancer should consider stratifying for an age-comorbidity covariate.