Outcome Measurement Instruments Used to Evaluate Dermatologic Adverse Events in Cancer Trials: A Systematic Review.

Importance: Assessment of type, severity, and impact of dermatologic adverse events (DAEs) necessitates well-developed and validated clinician-reported outcome measures (ClinROMs) and patient-reported outcome measures (PROMs) that evaluate concepts specific to mucocutaneous toxic effects and that allow appropriate interpretation and comparison of DAEs across trials. Objective: To evaluate heterogeneity and quality of ClinROMs and PROMs used to assess DAEs from systemic cancer therapy. Evidence Review: Two systematic reviews were conducted by searching PubMed and Embase databases from inception through March 7, 2023, and April 12, 2023. The first search included randomized clinical trials and observational studies reporting systemic cancer treatment-induced DAEs assessed by a ClinROM or PROM. The second included studies evaluating measurement properties of frequently used ClinROM and PROM instruments. The Consensus-Based Standards for the Selection of Health Measurement Instruments risk of bias tool was used to evaluate methodologic quality of validation assessments. Findings: A total of 395 studies were included. The Common Terminology Criteria for Adverse Events (CTCAE) was utilized in 331 studies meeting inclusion criteria (83.8%). At least 1 skin-related PROM was infrequently utilized in systemic chemotherapy clinical trials (79 studies [20.0%]). Most frequently utilized PROMs were the Dermatology Life Quality Index (DLQI; 34 studies [8.6%]) and Skindex-16 (20 studies [5.1%]). Among studies capturing DAEs, 115 (29.1%) reported a nondescript term (ie, rash) as the only DAE. Eight studies described 44 property assessments of the CTCAE, DLQI, and Skindex. There were no studies evaluating content validity, intrarater reliability, or measurement error for the CTCAE, DLQI, or Skindex. There were no studies evaluating structural validity, internal consistency, and responsiveness of DLQI or Skindex. Interrater reliability and responsiveness were each assessed for 1 DAE-related component of the CTCAE. Construct validity for CTCAE, DLQI, and Skindex was evaluated in 29 (65.9%), 3 (6.8%), and 9 (20.5%) assessments, respectively. Conclusions and Relevance: In this systematic review, there was a narrow spectrum of ClinROMs and PROMs with limited validity for the measurement of DAEs in the context of systemic chemotherapy interventions in clinical trials. Report of trial DAEs often had low morphologic specificity and meaning. Based on existing gaps in measurement and report of DAEs, a frequent and impactful adverse event to chemotherapy, the framework for evaluating cutaneous toxic effects in oncology trials may need collaborative reevaluation.

Extragenital lichen sclerosus: a comprehensive review of clinical features and treatment.

Lichen sclerosus (LS) is a chronic inflammatory skin disease commonly affecting the anogenital area with less frequent extragenital occurrence. Extragenital LS cutaneous manifestations vary and precipitating factors are not well described. Recent evidence for etiology and clinical associations of extragenital LS provide insight into disease recognition and pathogenesis. Novel diagnostic techniques as well as treatment standardization have the potential to improve management of this rare condition. This review details both past and new insights into the pathogenesis, clinical manifestations, and treatment options of extragenital LS.

Pathology Examination of Breast Reduction Specimens: Dispelling the Myth.

More than 100,000 reduction mammaplasties are performed in the United States each year. There is large variance in reported incidence of cancerous/high-risk lesions, ranging from 0.06% to 4.6%. There has been debate whether histological review of breast reduction specimen is necessary. This study aimed to determine the incidence of cancerous/high-risk lesions and to evaluate risk factors for their occurrence. METHODS: A retrospective review was conducted for all patients who underwent reduction mammaplasty in 2018 by the senior author. Variables collected included demographics, comorbidities, history of breast surgery, family/personal history of breast cancer, weight of specimen, and pathologic findings. All specimens underwent pathologic evaluation and categorized as benign, proliferative, or malignant. RESULTS: A total of 155 patients underwent 310 reduction mammaplasties. Pathologic evaluations found that 11 patients (7.1%) had positive findings, 9 (5.8%) had proliferative lesions, and 2 (1.29%) had cancerous lesions. Patients with pathology were older (P = 0.038), had a family history of breast cancer (P = 0.026), and had a greater weight of resected tissue (P = 0.005). Multivariable analysis showed family history of breast cancer (P = 0.001), prior breast surgery (P = 0.026), and greater weight of resected breast tissue (P = 0.008) had a higher likelihood of positive pathology. CONCLUSIONS: These findings demonstrate an incidence of positive pathology higher than that reported and illustrate the importance of histologic review of breast reduction specimens. Family history of breast cancer, prior breast surgery, and a greater weight of resected tissue increase risk for proliferative/cancerous lesions.

The Effect of Bladder Catheterization Technique on Postoperative Urinary Tract Infections After Primary Total Hip Arthroplasty.

BACKGROUND: Urinary bladder catheters are potential sources of infection after total hip arthroplasty (THA). Therefore, the goal of this study was to determine if intermittent catheterization provides a decreased risk of postoperative urinary tract infections (UTIs) compared with indwelling catheterization in THA patients. METHODS: Patients undergoing THA at 15 hospitals within a large health system were prospectively collected between 2017 and 2019 and then stratified based on catheterization technique: no-catheter; indwelling catheter-only; intermittent catheter-only; and both intermittent and indwelling catheter. Patient demographics, medical comorbidities, anesthesia types, and postoperative UTIs were assessed. Independent Student t-tests were used to perform univariate analyses for the catheterization groups. Multiple linear regression models were used to compare the different groups while controlling for confounding variables. RESULTS: There were a total of 7306 THA patients recorded with 5513 (75%) no-catheter, 1181 (16%) indwelling catheter-only, 285 (3.9%) intermittent catheter-only, and 327 (4.5%) indwelling and intermittent catheterization patients. A total of 580 patients experienced postoperative UTI. Urinary bladder catheterization increased the risk of postoperative UTIs (P < .001) in univariate analyses. Multiple linear regression models showed that indwelling catheter-only (OR: 2.178, P < .001), intermittent catheterization (OR: 1.975, P = .003), and both indwelling and intermittent (OR: 2.372, P = .002) were more likely to experience UTIs compared with no catheters. CONCLUSION: This study found that patients treated with indwelling catheterization, with or without preceding intermittent catheterization, were significantly more likely to experience UTIs. Therefore, in an effort to decrease the risk of UTIs, THA patients experiencing postoperative urinary retention should be treated with intermittent catheterization.

Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment.

PURPOSE OF REVIEW: Low back pain encompasses three distinct sources: axial lumbosacral, radicular, and referred pain. Annually, the prevalence of low back pain in the general US adult population is 10-30%, and the lifetime prevalence of US adults is as high as 65-80%. RECENT FINDINGS: Patient history, physical exam, and diagnostic testing are important components to accurate diagnosis and identification of patient pathophysiology. Etiologies of low back pain include myofascial pain, facet joint pain, sacroiliac joint pain, discogenic pain, spinal stenosis, and failed back surgery. In chronic back pain patients, a multidisciplinary, logical approach to treatment is most effective and can include multimodal medical, psychological, physical, and interventional approaches. Low back pain is a difficult condition to effectively treat and continues to affect millions of Americans every year. In the current investigation, we present a comprehensive review of low back pain and discuss associated pathophysiology, diagnosis, and treatment.

Aortic Angulation Does Not Impact Outcomes in Self-Expandable or Balloon-Expandable Transcatheter Aortic Valve Replacement.

OBJECTIVES: The role of aortic angulation in attenuating procedural success in balloon-expandable (BE) and self-expandable (SE) transcatheter aortic valve replacement (TAVR) has been controversial. METHODS: We retrospectively assessed patients undergoing SE and BE TAVR who had an aortic angle measured on multidetector computed tomography at a single tertiary referral center. The primary outcome was device success, measured per the Valve Academic Research Consortium-2 criteria. Clinical outcomes at 30 days (including mortality) were also assessed. RESULTS: A total of 251 patients were identified; 182 patients received a BE valve and 69 patients an SE valve. The median aortic angle was 46.8° (range 24.4-70°) in the BE group and 43.3° (range 20-71°) in the SE group. In multivariate logistic regression analysis, aortic angulation did not affect device success. Mortality at 30 days and 12 months and postprocedural clinical outcomes were similarly not associated with aortic angulation. CONCLUSION: In this cohort of patients undergoing BE and SE TAVR over a wide range of aortic angles, we found no associations between angle and device success or any other clinical metrics. Increased aortic angulation does not adversely affect outcomes in BE or SE TAVR.

Can Procalcitonin Be Used as a Reliable Marker for Infectious Fever in Patients with Intracranial Hemorrhage?

OBJECTIVE: To determine whether procalcitonin (PCT) levels are different in infected versus noninfected febrile patients with intracranial hemorrhage (ICH). METHODS: This prospective observational study included 104 patients with ICH and fever >38.3°C admitted to the intensive care unit of a tertiary care hospital. PCT was measured on day 1 (PCT 1) of fever and 48-72 hours later (PCT 2). Patients were determined to have an infection (pneumonia, urinary tract infection, or bacteremia) based on cultures, imaging, and clinical impression of treating clinicians. RESULTS: Analysis of variance indicated significant mean differences in patients with no, probable, and definite infection (F2,103 = 3.12, P = 0.048) between PCT 1 and PCT 2 (F2,72 = 4.64, P = 0.013). Patients with probable infection had the highest PCT 1 (mean = 0.47, SD = 0.93), and patients with definite infection had higher PCT 2 (mean = 0.62, SD = 0.85). Additional analyses of univariable mean differences showed mean PCT 1 that was significantly higher in the probable infection group compared with the no infection group. Mean PCT was significantly higher at both time points in the definite infection group compared with the no infection group. There were no significant differences between the probable and definite infection groups. CONCLUSIONS: PCT levels were higher in patients with ICH and infections and may be a useful marker to differentiate between infectious and noninfectious etiologies of fevers in these patients. Further studies, including randomized controlled trials, will help in establishing the utility of this marker in optimal management of febrile patients with ICH.

Are Episodic and Chronic Migraine One Disease or Two?

Migraine is a debilitating headache disorder that has a significant impact on the world population, in both economic and sociologic capacities. Migraine has two main categories: (1) chronic migraine (CM), defined as the patient having 15 or more headache days per month, with at least five attacks fulfilling measures for EM with aura or EM without aura, and (2) episodic migraine (EM), defined as less than 15 headache days per month. With this definition, CM can only exist in the presence of EM, and it questions whether the two are separate diseases. Migraine has a significant impact on the population, as each year, about 2.5 % of patients with EM develop new-onset CM (Manack et al., Curr Pain Headache Rep 15:70-78, 2011) (Loder et al. Headache 55:214-228, 2015), with certain risk factors being evident only with CM. In addition, there are comorbid diseases that are only associated with CM, suggesting two separate diseases rather than one. Differentiation in response to treatments, both preventive and abortive, demonstrates both a similarity and a difference in EM versus CM. Also, comparing the two processes based upon functional imaging has been a recent development, beginning to show a physiological difference in regional cortical thickness, cortical surface area, and regional volumes in patients with EM and CM. Evidence regarding whether EM and CM demonstrate one disease with a significant level of complication or if two independent processes is inconclusive, and additional research must be performed to further characterize their relationship.