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Objective: To describe differences in clinical and demographic characteristics between patients with episodic migraine (EM) or chronic migraine (CM) and determine the effect of migraine subtype on patient‐reported outcome measures (PROM). Background: Prior studies have characterized migraine in the general population. While this provides a basis for our understanding of migraine, we have less insight into the characteristics, comorbidities, and outcomes of migraine patients who present to subspecialty headache clinics. These patients represent a subset of the population that bears the greatest burden of migraine disability and are more representative of migraine patients who seek medical care. Valuable insights can be gained from a better understanding of CM and EM in this population. Methods: We conducted a retrospective observational cohort study of patients with CM or EM seen in the Cleveland Clinic Headache Center between January 2012 and June 2017. Demographics, clinical characteristics, and patient‐reported outcome measures (3‐Level European Quality of Life 5‐Dimension [EQ‐5D‐3L], Headache Impact Test‐6 [HIT‐6], Patient Health Questionnaire‐9 [PHQ‐9]) were compared between groups. Results: Eleven thousand thirty‐seven patients who had 29,032 visits were included. More CM patients reported being on disability 517/3652 (14.2%) than EM patients 249/4881 (5.1%) and had significantly worse mean HIT‐6 (67.3 ± 7.4 vs. 63.1 ± 7.4, p < 0.001) and median [interquartile range] EQ‐5D‐3L (0.77 [0.44–0.82] vs. 0.83 [0.77–1.00], p < 0.001), and PHQ‐9 (10 [6–16] vs. 5 [2–10], p < 0.001). Conclusions: There are multiple differences in demographic characteristics and comorbid conditions between patients with CM and EM. After adjustment for these factors, CM patients had higher PHQ‐9 scores, lower quality of life scores, greater disability, and greater work restrictions/unemployment. [ABSTRACT FROM AUTHOR]

Aims: Many large-scale population-based surveys, research studies, and clinical care allow for inclusion of proxy reporting as a strategy to collect outcomes when patients are unavailable or unable to provide reliable self-report. Prior work identified an absence of methodological guidelines regarding proxy reporting in adult populations, including who can serve as a proxy, and considerations for data collection, analysis, and reporting. The primary objective of this work by the ISOQOL Proxy Task Force was to review documents and clinical outcome assessment measures with respect to proxy reporting and to develop, through consensus, considerations for proxy reporting. Methods: We assembled an international group with clinically relevant and/or methodological expertise on proxy use in adult populations. We conducted a targeted review of documentation based on regulatory, non-regulatory, professional society, and individual measure sources. Using a standardized collection form, proxy-related information was extracted from each source including definitions of a proxy, characteristics of a proxy, domains addressable or addressed by a proxy, and observer-reporting. Results: The definition of proxy was inconsistent across 39 sources, except regulatory documents which defined a proxy as a person other than the patient who reports on an outcome as if she/he were the patient. While proxy report was discouraged in regulatory documentation, it was acknowledged there were instances where self-report was impossible. Many documentation sources indicated proxies would be well-justified in certain contexts, but did not indicate who could act as a proxy, when proxies could be used, what domains of patient health they could report on, or how data should be reported. Observer-reported outcomes were typically defined as those based on observed behaviors, however there was not a consistent differentiation between proxy and observer reporting. Based on information extracted from these resources, we developed a checklist of considerations when including proxy-reported measures or using proxies in study design, data collection, analysis, interpretation and reporting of proxy reported data. Conclusion: Our targeted review highlights a lack of clarity in capturing, interpreting and reporting data from proxies in adult populations. We provide a checklist of considerations to assist researchers and clinicians with including proxies in research studies and clinical care. Lastly, our review identified areas where further guidance and future research are necessary. [ABSTRACT FROM AUTHOR]

Objectives: To compare clinical characteristics among outpatient headache clinic patients who do and do not self‐report visiting the emergency department for headache. Background: Headache is the fourth most common reason for emergency department visits, compromising 1%–3% of visits. Limited data exist about patients who are seen in an outpatient headache clinic but still opt to frequent the emergency department. Clinical characteristics may differ between patients who self‐report emergency department use and those who do not. Understanding these differences may help identify which patients are at greatest risk for emergency department overutilization. Methods: This observational cohort study included adults treated at the Cleveland Clinic Headache Center between October 12, 2015 and September 11, 2019, who completed self‐reported questionnaires. Associations between self‐reported emergency department utilization and demographics, clinical characteristics, and patient‐reported outcome measures (PROMs: Headache Impact Test [HIT‐6], headache days per month, current headache/face pain, Patient Health Questionnaire‐9 [PHQ‐9], Patient‐Reported Outcomes Measurement Information System [PROMIS] Global Health [GH]) were evaluated. Results: Of the 10,073 patients (mean age 44.7 ± 14.9, 78.1% [7872/10,073] female, 80.3% [8087/10,073] White patients) included in the study, 34.5% (3478/10,073) reported visiting the emergency department at least once during the study period. Characteristics significantly associated with self‐reported emergency department utilization included younger age (odds ratio = 0.81 [95% CI = 0.78–0.85] per decade), Black patients (vs. White patients) (1.47 [1.26–1.71]), Medicaid (vs. private insurance) (1.50 [1.29–1.74]), and worse area deprivation index (1.04 [1.02–1.07]). Additionally, worse PROMs were associated with greater odds of emergency department utilization: higher (worse) HIT‐6 (1.35 [1.30–1.41] per 5‐point increase), higher (worse) PHQ‐9 (1.14 [1.09–1.20] per 5‐point increase), and lower (worse) PROMIS‐GH Physical Health T‐scores (0.93 [0.88–0.97]) per 5‐point increase. Conclusion: Our study identified several characteristics associated with self‐reported emergency department utilization for headache. Worse PROM scores may be helpful in identifying which patients are at greater risk for utilizing the emergency department. [ABSTRACT FROM AUTHOR]

Objectives: Research has indicated proxies overestimate symptoms on patients' behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time. The objective of this study is to assess patient-proxy agreement over time, as well as agreement on identification of meaningful change, across 10 health domains in patients who underwent acute rehabilitation following stroke. Methods: Stroke patients were recruited from an ambulatory clinic or inpatient rehabilitation unit, and were included in the study if they were undergoing rehabilitation. At baseline and again after 30 days, patients and their proxies completed PROMIS Global Health and eight domain-specific PROMIS short forms. Reliability of patient-proxy assessments at baseline, follow-up, and the change in T-score was evaluated for each domain using intra-class correlation coefficients (ICC(2,1)). Agreement on meaningful improvement or worsening, defined as 5+ T-score points, was compared using percent exact agreement. Results: Forty-one patient-proxy dyads were included in the study. Proxies generally reported worse symptoms and functioning compared to patients at both baseline and follow-up, and reported less change than patients. ICCs for baseline and change were primarily poor to moderate (range: 0.06 (for depression change) to 0.67 (for physical function baseline)), and were better at follow-up (range: 0.42 (for anxiety) to 0.84 (for physical function)). Percent exact agreement between indicating meaningful improvement versus no improvement ranged from 58.5–75.6%. Only a small proportion indicated meaningful worsening. Conclusions: Patient-proxy agreement across 10 domains of health was better following completion of rehabilitation compared to baseline or change. Overall change was minimal but the majority of patient-proxy dyads agreed on meaningful change. Our study provides important insight for clinicians and researchers when interpreting change scores over time for questionnaires completed by both patients and proxies. [ABSTRACT FROM AUTHOR]

The efficacy of mandatory medically supervised preoperative weight loss (MPWL) prior to bariatric surgery continues to be a controversial topic. The purpose of this observational study was to assess the efficacy of a MPWL program in a single institution, which mandated at least 10% excess body weight loss before surgery, by comparing outcomes of patients undergoing primary bariatric surgery with and without a compulsory preoperative weight loss regimen. We analyzed our database of 757 patients who underwent primary bariatric surgery between March 2008 and January 2015. Patients were placed into two cohorts based on their participation in a MPWL program requiring at least 10% excess weight loss (EWL) prior to surgery. Patients were evaluated at 3, 6, 12, and 24 months after surgery for weight loss, comorbidity resolution, and the occurrences of hospital readmissions. A total of 717 patients met the inclusion criteria of whom 465 underwent surgery without a preoperative weight loss requirement and 252 participated in the MPWL program. One year after surgery, 67.1% of non-participants and 62.5% of MPWL participants showed a resolution of at least one of five associated comorbidities (p = 0.45). Non-participants showed an average of 58.6% EWL, while MPWL participants showed 59.1% EWL at 1 year postoperatively (p = 0.84). Readmission rates, excluding those which were ulcer-related, at 30 days (3.4 vs. 6.40%, p = 0.11) and 90 days (9.9 vs. 7.5%, p = 0.29) postoperatively were not significantly different between the non-participants and MPWL patients, respectively. A mandatory preoperative weight loss program prior to bariatric surgery did not result in significantly greater %EWL or comorbidity resolution 1 year after surgery compared to patients not required to lose weight preoperatively. Additionally, the program did not result in significantly lower 30- or 90-day readmission rates for these patients. The value of a MPWL program must be weighed against the potential loss of bariatric surgery candidates. Patients who fail to lose 10% excess weight preoperatively are thus ineligible for a procedure from which they would otherwise benefit. Our data suggest these patients will have similar positive outcomes. [ABSTRACT FROM AUTHOR]

Limited data have suggested that an “obesity paradox” exists for mortality and cardiovascular outcomes in patients undergoing coronary artery bypass grafting. Much less is known about the role of the preoperative body mass index (BMI) in patients undergoing valve surgery. We evaluated 2,640 consecutive patients who underwent valve surgery between April 2004 and March 2011. The patients were classified by the World Health Organization standards as “underweight” (BMI 11.5 to 18.4 kg/m2, n = 61), “normal weight” (BMI 18.5 to 24.9 kg/m2, n = 865), “overweight” (BMI 25 to 29.9 kg/m2, n = 1,020), and “obese” (BMI 30 to 60.5 kg/m2, n = 694). Mortality was ascertained using the Social Security Death Index. Hazard ratios (HRs), adjusted for known preoperative risk factors, were obtained using Cox regression models. The mean follow-up was 31.9 ± 20.5 months. The long-term mortality rate was 1.21, 0.52, 0.32, and 0.44 per 10 years of person-time for underweight, normal, overweight, and obese patients, respectively. Compared to the normal BMI category, overweight patients (adjusted HR 0.60, 95% confidence interval 0.46 to 0.79, p <0.001) and obese patients (adjusted HR 0.67, 95% confidence interval 0.50 to 0.91, p = 0.009) were at a lower hazard of long-term all-cause mortality. Underweight patients remained at a greater adjusted risk of long-term mortality than normal weight patients (adjusted HR 1.69, 95% confidence interval 1.01 to 2.85, p = 0.048). Similar patterns of mortality outcomes were noted in the subset of patients undergoing isolated valve surgery. In conclusion, overweight and obese patients had greater survival after valve surgery than patients with a normal BMI. Very lean patients undergoing valve surgery are at a greater hazard for mortality and might require more rigorous preoperative candidate screening and closer postoperative monitoring. [Copyright &y& Elsevier]

Background: Tricuspid regurgitation is common in patients with advanced heart failure. The ideal operative strategy for managing tricuspid valve regurgitation (TR) in patients undergoing left ventricular assist device (LVAD) implantation is unclear. This study was designed to evaluate the effect on outcomes of concomitant tricuspid valve repair (TVR) for moderate to severe (3+/4+) TR at the time of LVAD implantation. Methods: Patients with >3+ TR who underwent LVAD implantation from 2005 to 2009 were retrospectively evaluated. Pre-, intra- and post-operative data, including hemodynamics, inotrope requirements and end-organ function parameters, were considered. Outcomes of patients receiving TVR were compared with those who did not receive TVR (NTVR). Results: Seventy-two LVADs were implanted during the study period. Forty-two (58%) patients had ≥3+ TR prior to LVAD implantation. Eight patients underwent TVR and 34 patients did not undergo TVR (NTVR). There were no significant differences in baseline characteristics or severity of TR between the two groups. The TVR group had a longer cardiopulmonary bypass time (p < 0.01) and required more blood products (p < 0.05). Higher post-operative creatinine and blood urea nitrogen (BUN) values were noted in the TVR group. One patient in the TVR group and 3 patients in the NTVR group required right-sided mechanical assistance (p = 0.6). There was no significant difference in short- or long-term mortality between the two groups. Conclusions: TVR for ≥3+ TR prolonged operative time and showed similar outcomes compared with LVAD implantation alone. A benefit of performing TVR was not demonstrated. As such, TVR may not be necessary at the time of LVAD implantation. [ABSTRACT FROM AUTHOR]