Calorie Restriction and Intermittent Fasting: Impact on Glycemic Control in People With Diabetes.

Intermittent fasting has been suggested as an option for managing overweight and obesity. The purpose of this article is to present a balanced review of the practice of intermittent fasting and its impact on glycemic control in people with diabetes.

Radiotherapy in the treatment of extracranial hemangiopericytoma/solitary fibrous tumor: Study from the Rare Cancer Network.

BACKGROUND AND PURPOSE: The role of radiotherapy (RT) in the treatment of hemangiopericytoma/solitary fibrous tumor (HPC/SFT) is still under debate. We aimed at investigating whether radiotherapy can improve the results in patients operated for extracranial HPC/SFT. MATERIALS AND METHODS: Data from patients with HPC/SFT, treated from 1982 to 2012, were retrospectively reviewed within the Rare Cancer Network framework. Actuarial local control (LC), disease-free survival (DFS), metastasis-free survival (MFS) and overall survival (OS) were calculated with Kaplan-Meyer method. Patient and tumor parameters were analyzed by univariate and multivariate analysis. RESULTS: Of 114 HPC/SFT, 58 (50.9%) occurred in the extremities/superficial trunk and 56 (49.1%) in intra-thoracic/retroperitoneum. Seventy-eight patients (68.4%) underwent surgery only (Sx), and 36 (31.6%) Sx and RT (Sx + RT). Median RT dose was 60 Gy (range 45-68.4 Gy) in 1.6-2.2 Gy fractions. In the extremities/superficial trunk group of patients, actuarial 5-year LC rates were 50.4% after Sx and 91.6% after Sx + RT (p < 0.0001) for LC, and 50.4% after Sx and 83.1% after Sx + RT (p = 0.008) for DFS. In the intra-thoracic/retroperitoneum group of patients, actuarial 5-year rates were 89.3% after Sx and 77.8% after Sx + RT (p = 0.99) for LC, and 73.8% after Sx and 77.8% after Sx + RT (p = 0.93) for DFS. At multivariate analysis, the addition of RT resulted in better LC and DFS in the whole series. The advantage was confirmed for LC in the group of patients affected by extremity/superficial trunk tumors. CONCLUSION: Addition of RT to Sx could improve the prognosis, in terms of LC and DFS, essentially in patients with extremities/superficial trunk tumor locations.

Implementing a clinical-educator curriculum to enrich internal medicine residents' teaching capacity.

INTRODUCTION: Physicians-in-training (residents) are typically the primary educators for medical students during clinical clerkships. However, residents are not formally trained to teach or to assess their teaching. The aim of this study was to assess the implementation of a clinical educator rotation aimed at developing residents' competencies related to clinical teaching. METHODS: A mixed-methods approach was used to develop and assess the clinical educator rotation at a teaching community hospital. Internal medicine residents who participated in the rotation and consented to the research were assigned to the clinical educator trainee (CET) group, the remaining residents were assigned to the control group. Osteopathic medical students rotating in the medicine service line were invited to participate. The study used descriptive and qualitative analyses to measure primary and secondary outcomes. RESULTS: The primary outcome measure showed a positive change in resident knowledge, skills and behaviors in communication, reflection, feedback, precepting, and facilitation. Medical student perceptions of resident teaching skills confirmed the observed changes in CETs. Some CETs continued to practice and build their capacity for teaching after completing the rotation. Qualitatively, we derived four common themes among the data; communication, professional engagement, practice-based learning, and systems-based learning. CONCLUSION: Resident teaching capacity was enriched after completing the clinical educator rotation. Other benefits included: enhanced patient communication and education, increased resident confidence, personal satisfaction with training, work life-balance and enhanced career satisfaction. Future research should focus on curricular content, faculty development, and delivery assessment. In addition, research efforts should identify appropriate emerging technologies to include in the curriculum for enhancing teaching capacity.

Electronic Health Records as an Educational Tool: Viewpoint.

BACKGROUND: Electronic health records (EHRs) have been adopted by most hospitals and medical offices in the United States. Because of the rapidity of implementation, health care providers have not been able to leverage the full potential of the EHR for enhancing clinical care, learning, and teaching. Physicians are spending an average of 49% of their working hours on EHR documentation, chart review, and other indirect tasks related to patient care, which translates into less face time with patients. OBJECTIVE: The purpose of this article is to provide a preliminary framework to guide the use of EHRs in teaching and evaluation of residents. METHODS: First we discuss EHR educational capabilities that have not been reviewed in sufficient detail in the literature and expand our discussion for each educational activity with examples. We emphasize quality improvement of clinical notes as a basic foundational skill using a spreadsheet-based application as an assessment tool. Next, we integrate the six Accreditation Council for Graduate Medical Education (ACGME) Core Competencies and Milestones (CCMs) framework with the Reporter-Interpreter-Manager-Educator (RIME) model to expand our assessments of other areas of resident performance related to EHR use. Finally, we discuss how clinical utility, clinical outcome, and clinical reasoning skills can be assessed in the EHR. RESULTS: We describe a pilot conceptual framework-CCM framework-to guide and demonstrate the use of the EHR for education in a clinical setting. CONCLUSIONS: As EHRs and other supporting technologies evolve, medical educators should continue to look for new opportunities within the EHR for education. Our framework is flexible to allow adaptation and use in most training programs. Future research should assess the validity of such methods on trainees' education.

Use of Grading of Recommendations, Assessment, Development, and Evaluation to Combat Fake News: A Case Study of Influenza Vaccination in Pregnancy.

BACKGROUND: The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework is a validated evaluation tool used to assess the quality of scientific publications. It helps in enhancing clinicians' decision-making process and supports production of informed healthy policy. OBJECTIVE: The purpose of this report was two-fold. First, we reviewed the interpretation of observational studies. The second purpose was to share or provide an example using the GRADE criteria. METHODS: To illustrate the use of the GRADE framework to assess publications, we selected a study evaluating the risk of spontaneous abortion (SAB) after influenza vaccine administration. RESULTS: Since 2004, the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practice have recommended influenza vaccination of pregnant women. Previous studies have not found an association between influenza vaccination and SAB. However, in a recent case-control study by Donahue et al, a correlation with SAB in women who received the H1N1 influenza vaccine was identified. For women who received H1N1-containing vaccine in the previous and current influenza season, the adjusted odds ratio (aOR) for SAB was 7.7 (95% CI, 2.2-27.3), while the aOR for women not vaccinated in the previous season but vaccinated in the current season was 1.3 (95% CI, 0.7-2.7). CONCLUSIONS: Our goal is to enable the readers to critique published literature using appropriate evaluation tools such as GRADE.

Intermittent Fasting: The Choice for a Healthier Lifestyle.

Obesity is a worldwide epidemic due to the availability of many unhealthy food options and limited physical exercise. Restriction of the daily food intake results in weight loss, which is also associated with better health outcomes including triglycerides, total cholesterol, low-density lipoprotein cholesterol, blood pressure, glucose, insulin, and C-reactive protein. Our aim is to briefly discuss the effects of intermittent fasting on weight and other biochemical markers mentioned previously. The study is designed as a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. To assess the effectiveness of intermittent fasting, related studies were reviewed between 2000 and 2018 and 815 studies were identified. Only four articles met the preset inclusion and exclusion criteria. All four studies have shown a significant decrease in fat mass with P-values <0.01. It was also noted that some biochemical markers were significantly reduced such as the reduction in low-density lipoprotein and triglyceride with P-values < 0.05. Other biochemical markers had inconsistent results. Based on the qualitative analysis, intermittent fasting was found to be efficient in reducing weight, irrespective of the body mass index. Further studies are needed to assess the ability to maintain the lost weight without regaining it and the long-term effects of such dietary changes.

Transdermal Testosterone in Female Hypoactive Sexual Desire Disorder: A Rapid Qualitative Systematic Review Using Grading of Recommendations Assessment, Development and Evaluation.

Female hypoactive sexual desire disorder (HSDD) is a multifactorial sexual dysfunction disorder characterized by a decrease in sexual desire and personal distress. HSDD occurs in naturally occurring postmenopausal women or secondary to oophorectomy. Multiple studies have assessed the use of transdermal testosterone (TDT) as a management option for patients with HSDD. Our aim is to assess published studies using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework for the quality of evidence regarding testosterone use as a short- and long-term therapy for HSDD. We implemented this qualitative systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. We set a GRADE score of 4 (high evidence) as a cutoff point for the quality measure of published studies assessing the use of TDT in HSDD. The outcomes of interest were the efficacy of TDT on the total number of satisfying sexual activity, number of orgasms, sexual desire and distress level in patients with HSDD. These outcomes were evaluated through Sexual Activity Log (SAL), Profile of Female Sexual Function (PFSF), and Personal Distress Scale (PDS) evaluation tools. Five randomized controlled trials were identified to meet the inclusion criteria. The selected studies were of high evidence based on the GRADE score as two of the studies scored 4 points, the other two studies scored 5 points and one study scored 6 points. All of the high quality selected studies had similar outcomes suggesting high effectiveness for the use of 300 µg/d TDT with or without estrogen for the management of HSDD with minimal side effects. One study showed a trend for higher risk of breast cancer in long-term use (0.37%). The use of 300 µg/d of TDT in surgical and natural menopause is an effective plan to manage HSDD in the short- and long-term. Although side effects are minimal, further prospective research is needed to assess the more severe side effects such as breast cancer in the long-term use of TDT.

Response to Loco-Regional Therapy Predicts Outcomes After Liver Transplantation for Combined Hepatocellular-Cholangiocarcinoma.

INTRODUCTION AND AIM: Combined hepatocellular-cholangiocarcinoma (HCC-CCA) is a rare liver malignancy distinct from either hepatocellular carcinoma (HCC) or cholangiocarcinoma. Liver transplantation (LT) is not recommended for HCC-CCA because of suboptimal outcomes. Non-invasive diagnosis of HCC-CCA is extremely challenging; thus, some HCC-CCAs are presumed as HCC on imaging and listed for LT with the correct diagnosis ultimately made on explant pathology. We compared HCC-CCA with HCC to determine the utility of response to pre-transplant loco-regional therapy (LRT) in predicting outcomes for HCC-CCA after LT as a potential means of identifying appropriate HCC-CCA patients for LT. MATERIAL AND METHODS: Retrospective review of 19 patients with pathologically confirmed HCC-CCA were individually matched to 38 HCC patients (1:2) based on age, sex, and Milan criteria at listing was performed. The modified response evaluation criteria in solid tumors was used to categorize patients as responders or non-responders to pre-transplant LRT based on imaging performed before and after LRT. Overall survival (OS) and recurrence-free survival (RFS) were examined. RESULTS: OS at 3 years post-transplant was 74% for HCC-CCA and 87% for HCC. RFS at 3 years was 74% for HCC-CCA, and 87% for HCC. Among responders to LRT, the 3-year OS was 92% for HCC-CCA and 88% for HCC; among non-responders, 3-year OS was 43% for HCC-CCA and 83% for HCC. Higher 3-year OS was observed among HCC-CCA responders (77%) compared with HCC-CCA non-responders (23%). CONCLUSIONS: OS was similarly high among.

Comparison of miRNA quantitation by Nanostring in serum and plasma samples.

Circulating microRNAs that are associated with specific diseases have garnered much attention for use in diagnostic assays. However, detection of disease-associated miRNA can be affected by several factors such as release of contaminating cellular miRNA during sample collection, variations due to amplification of transcript for detection, or controls used for normalization for accurate quantitation. We analyzed circulating miRNA in serum and plasma samples obtained concurrently from 28 patients, using a Nanostring quantitative assay platform. Total RNA concentration ranged from 32-125 µg/ml from serum and 30-220 µg/ml from plasma. Of 798 miRNAs, 371 miRNAs were not detected in either serum or plasma samples. 427 were detected in either serum or plasma but not both, whereas 151 miRNA were detected in both serum and plasma samples. The diversity of miRNA detected was greater in plasma than in serum samples. In serum samples, the number of detected miRNA ranged from 3 to 82 with a median of 17, whereas in plasma samples, the number of miRNA detected ranged from 25 to 221 with a median of 91. Several miRNA such as miR451a, miR 16-5p, miR-223-3p, and mir25-3p were highly abundant and differentially expressed between serum and plasma. The detection of endogenous and exogenous control miRNAs varied in serum and plasma, with higher levels observed in plasma. Gene expression stability identified candidate invariant microRNA that were highly stable across all samples, and could be used for normalization. In conclusion, there are significant differences in both the number of miRNA detected and the amount of miRNA detected between serum and plasma. Normalization using miRNA with constant expression is essential to minimize the impact of technical variations. Given the challenges involved, ideal candidates for blood based biomarkers would be those that are indifferent to type of body fluid, are detectable and can be reliably quantitated.

Patient-reported distress and survival among patients receiving definitive radiation therapy.

OBJECTIVE: Patient-reported distress (PRD) has not been well assessed in association with survival after radiation therapy (RT). The aims of this study were to evaluate the association between PRD level and survival after definitive RT and to identify the main causes of distress in definitive RT patients. METHODS AND MATERIALS: A total of 678 consecutive patients receiving definitive RT at our institution from April 2012 through May 2015 were included. All patients answered a PRD questionnaire that contained 30 items related to possible causes of distress, which could be rated from 1 (no distress) to 5 (high distress). Additionally, patients were asked to rate their overall distress level from 0 (no distress) to 10 (extreme distress). This overall distress level was our primary patient-reported distress measure and was examined as a continuous variable and as a categorical variable with 3 PRD levels (low, 0-3 [n = 295]; moderate, 4-6 [n = 222]; and high, 7-10 [n = 161]). RESULTS: As a continuous variable in multivariable Cox regression analysis, a higher overall PRD level was associated with poorer survival after RT (hazard ratio [HR], 1.39; P = .004). As a categorical variable, compared with patients with low distress, survival was poorer for patients with moderate distress (HR, 1.62; P = .038) or high distress (HR, 1.49; P = .12), but the latter difference was not significant. When the moderate and high distress levels were combined, survival was significantly poorer compared with the low distress level (HR, 1.57; P = .034). The top 5 specific causes of distress that patients mentioned were "How I feel during treatment," "Fatigue," "Out-of-pocket medical costs," "Pain that affects my daily functioning," and "Sleep difficulties." CONCLUSIONS: PRD before or during RT is a prognostic factor associated with decreased survival. Distress screening guidelines and interventions should be implemented for patients receiving definitive RT.

Adult prostatic sarcoma: A contemporary multicenter Rare Cancer Network study.

INTRODUCTION: Adult prostatic sarcoma (PS) is a rare disease. While surgery is considered the standard approach, the role of other therapies is not completely established. We report results of the largest multicentric contemporary cohort of PS patients. MATERIALS AND METHODS: This study included 61 adult PS patients treated in 16 American and European Institutions. Median age was 64.4 years (range: 22-87). Curative surgery was delivered in 48 patients (prostatectomy = 26, cystoprostatectomy = 22), usually with lymphadenectomy (n = 40). Curative radiotherapy (RT) was delivered in 32 patients, as radical (n = 5), neoadjuvant (n = 10), or postoperative treatment (n = 17). Eighteen patients received chemotherapy. None of the patients received hormonal therapy. RESULTS: Median follow-up was 72 months (95%CI: 55-not reached). Five-year local control (LC), overall survival (OS), cancer-specific survival, disease-free survival, and metastases-free rates were 47%, 53%, 56%, 35%, and 35%, respectively. Notably, curative RT (neoadjuvant, adjuvant, or definitive) was associated with improved 5-year LC (55% vs. 31%, P = 0.02) and OS (59% vs. 46%, P = 0.1). Surgically treated patients presenting with a cT3-4 tumor (n = 31), who received RT (n = 24), had a significantly improved 5-year LC (68% vs, 33%, P = 0.004) and OS (65% vs. 21%, P < 0.001) rates compared to patients not receiving RT. cT4 patients demonstrated a significantly lower 5-year OS (43% vs. 61%, P = 0.006) and LC (29% vs. 69%, P < 0.001) rates. Histologic subtype was not associated with LC and OS, but patients with prostatic stromal sarcoma, rhabdomyosarcoma, or sarcomatoid carcinoma had worse 5-year LC compared to other types (47% vs. 55%) and OS (49% vs. 58%). CONCLUSION: Adult PS has a poor prognosis. Locally advanced tumors have poor LC and OS rates. Curative RT should be considered part of the multidisciplinary approach to PS.