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Background. Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages.Objectives. This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports.Article design and setting. Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers.Results and conclusion. This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.Source. This article is a translation of the original paper «CARE guidelines for case reports: explanation and elaboration document» in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia). Present translation was first published in Digital Diagnostics. doi: 10.17816/DD105291. It is published with minor changes related to the literary editing of the translation itself. Keywords: case report; case study; EQUATOR network; health research reporting guidelines; CARE guideline; timelines; N-of-1 For citation: Riley David S., Barber Melissa S., Kienle Gunver S., Aronson Jeffrey K., von Schoen-Angerer Tido, Tugwell Peter, Kiene Helmut, Helfand Mark, Altman Douglas G., Sox Harold, Werthmann Paul G., Moher David, Rison Richard A., Shamseer Larissa, Koch Christian A., Sun Gordon H., Hanaway Patrick, Sudak Nancy L., Kaszkin-Bettag Marietta, Carpenter James E., Gagnier Joel J. CARE Guidelines for Case Reports: Explanation and Elaboration Document. Translation into Russian. Voprosy sovremennoi pediatrii — Current Pediatrics. 2023;22(2):88–108. (In Russ). doi: https://doi.org/10.15690/vsp.v22i2.2540

BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 20112012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. ARTICLE DESIGN AND SETTING: Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. RESULTS AND CONCLUSION: This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports. SOURCE: This article is a translation of the original paper CARE guidelines for case reports: explanation and elaboration document in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia).

Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease that can rapidly escalate to respiratory failure and death. It has infected millions of people worldwide. The trajectory of this disease continues to progress in some areas of the United States and worldwide. The Institute for Health Metrics now predicts a resurgence of infections in the fall of 2020. The pathogenesis of COVID-19 includes an inflammatory phase with either resolution or the potential to accelerate to a cytokine storm, characterized by high interleukin (IL)-6 and other inflammatory markers. COVID-19 is a condition without a gold-standard treatment. The US Federal Drug Administration (FDA) issued an emergency use authorization for remdesivir in severe cases of COVID-19, which shortened the recovery time in hospitalized patients with lower respiratory tract infection in one study. Although several vaccine trials are underway, no vaccines are available for primary prevention of COVID-19 at this time. Dietary supplement sales have dramatically risen during the COVID-19 pandemic despite depressed economic conditions. Commonly used immune-modulating dietary supplements, including vitamin D, ascorbic acid, zinc, and melatonin, are reviewed in this manuscript highlighting biological plausibility for salutary benefit against COVID-19. Ongoing clinical trials recruiting subjects at the time of this writing are provided for each dietary supplement.

Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease that can rapidly escalate to respiratory failure and death. It has infected millions of people worldwide. The trajectory of this disease continues to progress in some areas of the United States and worldwide. The Institute for Health Metrics now predicts a resurgence of infections in the fall of 2020. The pathogenesis of COVID-19 includes an inflammatory phase with either resolution or the potential to accelerate to a cytokine storm, characterized by high interleukin (IL)-6 and other inflammatory markers. COVID-19 is a condition without a gold-standard treatment. The US Federal Drug Administration (FDA) issued an emergency use authorization for remdesivir in severe cases of COVID-19, which shortened the recovery time in hospitalized patients with lower respiratory tract infection in one study. Although several vaccine trials are underway, no vaccines are available for primary prevention of COVID-19 at this time. Dietary supplement sales have dramatically risen during the COVID-19 pandemic despite depressed economic conditions. Commonly used immune-modulating dietary supplements, including vitamin D, ascorbic acid, zinc, and melatonin, are reviewed in this manuscript highlighting biological plausibility for salutary benefit against COVID-19. Ongoing clinical trials recruiting subjects at the time of this writing are provided for each dietary supplement.

BackgroundDespite treatment advances for inflammatory arthritis, a significant amount of patients fail to achieve remission. Other modifiable factors such as diet, physical activity and environmental exposures may be an important area of focus to help patients achieve disease remission and greater overall health. Functional medicine focuses on these lifestyle factors and may be an important adjunctive therapy. In this study, we examined the impact of functional medicine on patient-reported outcomes in patients with inflammatory arthritis.Materials and methodsIn this 12-week, retrospective study, patients with confirmed diagnoses of rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were treated according to guidelines from the American College of Rheumatology for RA or PSA respectively. Those in the functional medicine group underwent a functional medicine program adjunctive to the standard of care. Patient reported outcomes, such as PROMIS (Patient Reported Outcomes Measurement Information System) global physical health, mental health and pain scores were collected at baseline and 12 weeks. Multivariable statistical modeling was used to identify the impact of functional medicine on patient-reported outcomes.Results318 patients were screened and 54 patients (mean age 52.9±11.3 years, females 74(67.9%)), were included. Baseline characteristics were similar in both patient groups with the exception of PROMIS global physical health and pain (PROMIS global physical health score 43·2 ± 6·6 and 39·7 ± 8·7 and pain scores of 3·5 ± 1·9 and 5·2 ± 2·7 in the functional medicine group vs. standard of care group respectively). Using multivariable model to account for these differences, patients in the functional medicine group had a statistically significant reduction in pain (0.92, p-value = 0.007) and change in PROMIS physical health score (2·84, p-value = 0.001) as compared to the standard of care. Changes in PROMIS global mental health scores were also significant and were dependent on age and were greatest in those older than 55.LimitationsRetrospective design, baseline difference in patient reported outcomes.ConclusionsFunctional medicine may have an important role as adjunctive therapy to improve patients' pain, physical and mental health in those who do not see improvement with conventional therapy alone.

Key Points Question Is the functional medicine model of care associated with patient-reported health-related quality of life? Findings In this cohort study of 7252 eligible patients (functional medicine center: 1595; family health center: 5657), functional medicine patients exhibited significantly larger improvements in Patient-Reported Outcome Measurement Information System Global Physical Health at 6 months than propensity-matched patients at a family health center (398 matched pairs). Improvements in Patient-Reported Outcome Measurement Information System Global Physical Health appeared to be sustained at 12 months but not significantly different from those at the family health center. Meaning The findings of this study suggest that functional medicine may have the ability to improve global health in patients., Importance The incidence of chronic disease is increasing along with health care–related costs. The functional medicine model of care provides a unique operating system to reverse illness, promote health, and optimize function. The association between this model of care and patient’s health-related quality of life (HRQoL) is unknown. Objective To assess the association between functional medicine and patient-reported HRQoL using Patient-Reported Outcome Measurement Information System (PROMIS) global health measures. Design, Setting, and Participants A retrospective cohort study was performed to compare 7252 patients aged 18 years or older treated in a functional medicine setting with propensity score (PS)–matched patients in a primary care setting. Sensitivity analyses assessed improvement limited to patients seen at both 6 and 12 months. The study included patients who visited the Cleveland Clinic Center for Functional Medicine or a Cleveland Clinic family health center between April 1, 2015, and March 1, 2017. Main Outcomes and Measures The primary outcome was change in PROMIS Global Physical Health (GPH) at 6 months. Secondary outcomes included PROMIS Global Mental Health (GMH) at 6 months and PROMIS GPH and GMH at 12 months. The PROMIS GPH and GMH scores were transformed to a T-score from 0 to 100 with a mean of 50. Higher scores indicate a better health-related quality of life. Results Of the 7252 patients (functional medicine center: 1595; family health center: 5657), 4780 (65.9%) were women; mean (SD) age was 54.1 (16.0) years. At 6 months, functional medicine patients exhibited significantly larger improvements in PROMIS GPH T-score points than were seen in patients treated at a family health center (mean [SD] change, functional medicine center: 1.59 [6.29] vs family health center: 0.33 [6.09], P = .004 in 398 PS-matched pairs). At 12 months, functional medicine patients showed improvement similar to that observed at 6 months; however, comparisons with patients seen at the family health center were not significant. Patients in the functional medicine center with data at both 6 and 12 months demonstrated improvements in PROMIS GPH (mean [SD], 2.61 [6.53]) that were significantly larger compared with patients seen at a family health center (mean [SD], 0.25 [6.54]) (P = .02 in 91 PS-matched pairs). Conclusions and Relevance In this study, the functional medicine model of care demonstrated beneficial and sustainable associations with patient-reported HRQoL. Prospective studies are warranted to confirm these findings., This cohort study uses the Patient-Reported Outcome Measurement Information System to assess the association between the functional medicine model of care and patient-reported health-related quality of life among adults.

© 2017 Elsevier Inc. Background Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. Objectives This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. Article Design and Setting Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. Results and Conclusion This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.

Primary Study Objective: To evaluate the economic utility of a fecal biomarker panel structured to suggest alternative, treatable diagnoses in patients with symptoms of irritable bowel syndrome (IBS) by quantifying, comparing, and contrasting health service costs between tested and non-tested patients. Study Design: Retrospective, matched cohort study comparing direct medical costs for IBS patients undergoing fecal biomarker testing with those of matched control subjects. Methods: We examined de-identified medical and pharmacy claims of a large American pharmacy benefit manager to identify plan members who underwent panel testing, were eligible for covered benefits for at least 180 days prior to the test date, and had data available for 30, 90, and 365 days after that date. We used propensity score matching to develop population-based control cohorts for each tested cohort, comprised of records with IBS-related diagnoses but for which panel testing was not performed. Primary outcome measures were diagnostic and medical services costs as determined from claims data. Results: Two hundred nine records from tested subjects met inclusion criteria. The only significant baseline differences between groups were laboratory costs, which were significantly higher in each tested cohort. At each follow-up time point, total medical and gastrointestinal procedural costs were significantly higher in non-tested cohorts. Within tested cohorts, costs declined significantly from baseline, while costs rose significantly in non-tested control cohorts; these differences were also significant between groups at each time point. Conclusions: Structured fecal biomarker panel testing was associated with significantly lower medical and gastrointestinal procedural costs in this study of patients with IBS symptoms.

Editor’s note: This Commentary is a companion to Refractory Depression, Fatigue, Irritable Bowel Syndrome, and Chronic Pain: A Functional Medicine Case Report on page 104 (available at: www.thepermanentejournal.org/issues/2016/fall/6239-ibs.html). Also note that material describing the foundation and practice of Functional Medicine has been excerpted, with permission, from Introduction to Functional Medicine by David S Jones and Sheila Quinn, ©The Institute for Functional Medicine, 2016. Discosure Statement The author(s) have no conflicts of interest to disclose.

Discussions of diversity bring about a wide variety of social, political, emotional, and intellectual responses. Biodiversity, or biological diversity, describes the variety and population of all life forms in a given place—plants, animals, bacteria, viruses, fungi, etc. Biodiversity also describes the structures and functions that sustain this variety and allow it to adapt to changing environmental circumstances. The human gastrointestinal microbiota is one of the most complex and diverse ecosystems on the planet, with each of us offering a home to more than 100 trillion organisms, 150 to 300 species, 100 times more DNA than each human cell, and an array of essential functions without which we could not live.

Globalization-the increasing transnational circulation of money, goods, people, ideas, and information worldwide-is generally recognized as one of the most powerful forces shaping our current and future history. How is it affecting healthcare, and in that context, what is the purpose and significance of Global Advances in Health and Medicine (GAHM), publisher of this journal? Our goal is not homogenization but rather to provide an opportunity for integration, convergence, and collaboration across cultures. By respecting and conserving the richness and diversity of each new medicine, we embrace globalization. Globalization is of course not new; it began in the Renaissance and particularly with the 15th- and 16th-century voyages of exploration by Columbus, Magellan, and others. Since the beginning of time, there have been interactions and exchanges among different peoples and cultures. However, the current magnitude of globalization is unprecedented and yet still expanding rapidly.

Background: Fecal calprotectin (FC) has been proposed as a noninvasive surrogate marker to determine the degree of intestinal inflammation and predicting relapse in patients with inflammatory bowel disease (IBD). The aim was to compare FC levels in IBD and healthy controls, to correlate FC levels with clinical disease activity, and to assess whether FC levels can be used to predict clinical relapse in children with IBD. Methods: Enzyme-linked immunosorbent assay (ELISA) determined levels of FC were measured in more than 1 stool samples (n) from 32 IBD patients (n = 97) and from 34 healthy controls (n = 37). Disease activity was assessed by the Harvey–Bradshaw index in Crohn's disease (CD) and by Physician's Global Assessment (PGA) in both CD and ulcerative colitis (UC). Clinical events were recorded up to 9 months following stool collection in CD patients. Wilcoxon rank sum test and Fisher's exact tests were used to compare FC levels in IBD patients and in control. Kaplan–Meyer analysis was used to determine a risk of clinical relapse in relation to FC levels. Results: The IBD group had higher FC levels (range 17–7500 g/g) compared with control (16–750 g/g, P < 0.0001). FC levels were higher during relapse (CD, 3214 ± 2186; UC, 2819 ± 1610) compared to remission (CD, 1373 ± 1630; UC, 764 ± 869; P < 0.0001). Among those with clinical relapse, 90% had FC levels more than 400 μg/g in CD. Eighty-nine percent of CD encounters with FC levels less than 400 μg/g remained in clinical remission. Conclusions: FC levels differentiate active IBD from controls. Among children with CD and in remission, FC levels may be useful in predicting impending clinical relapse. (Inflamm Bowel Dis 2008)

The gastrointestinal flora plays a complex and important role in the development of healthy immunologic and digestive function in children. Probiotics are safe in healthy children and effective in reducing the risk of antibiotic-associated diarrhea and the duration of acute infectious diarrhea. Probiotics may also be effective in preventing community-acquired diarrheal infections, in reducing the risk of necrotizing enterocolitis in premature infants, and in the prevention and treatment of atopic dermatitis. The exact strain or combination of strains most effective for common clinical indications has yet to be determined, but the exact strain used seems less important than whether an adequate dose is used (typically 5 to 10 billion CFUs per day or higher). Clinicians should familiarize themselves with the products available because there is a wide range in their quality.

It is clear that there is a dynamic relationship involving the gastrointestinal flora, environmental inputs (food and other nutrients), and the health of the immune system. Recent research has taught us a great deal about the role of diet and commensal bacteria in promoting health. It appears that Nobel Laureate Eli Metchnikov may have been correct in his assertion that live bacterial cultures are "the elixir of life". We are unlocking a number of secrets about immune system functioning, but we keep coming back to a simple intervention that has an ever-expanding opus of research to support it, and an extremely low toxicity ratio. Future studies will help us to clarify the best strains and the best dosages for individual patients and specific conditions. Assessment of commensal flora and a genomic scan for markers of immunologic dysregulation will be more accurate and more widely available. It appears, however, that the diagnostic and therapeutic tools we have to work with today can make a tremendous difference in reducing the burden of suffering for our patients. If "form follows function," as Buckminster Fuller was fond of saying, then the form of our immune system may be following the precise functions that our commensal flora is dictating. We have the opportunity to encourage breastfeeding, decrease unnecessary antibiotic and antimicrobial usage (especially in the first two years of life), improve oral tolerance with a healthy n-6/n-3 fatty acid ratio, and support the development of a healthy commensal flora. These actions on behalf of our immune systems will pay dividends for years to come.

Fecal pancreatic elastase 1 (PE-1) has been advocated as a noninvasive marker of pancreatic function and allows detection of moderate and severe exocrine insufficiency. Few studies have evaluated the utility of measuring PE-1 in duodenal fluid for the diagnosis of pancreatic insufficiency. Our purpose was (1) to determine the feasibility of measuring PE-1 concentrations in duodenal aspirates obtained through our endoscopic pancreatic function test (ePFT) in healthy subjects and patients with chronic pancreatitis (CP) and (2) to determine correlations between duodenal PE-1 concentrations and bicarbonate and lipase concentrations in duodenal fluid. Healthy subjects (HS) and CP patients underwent an ePFT with CCK or secretin. CP was defined as endoscopic retrograde pancreatography (ERP) Cambridge class III-IV, endoscopic ultrasound (EUS) score >5, or presence of pancreatic calcifications on CT scan. Duodenal fluid PE-1, lipase, and bicarbonate concentrations were measured in each study group. Duodenal lipase and bicarbonate concentrations were measured using an autoanalyzer (Roche Diagnostics, Indianapolis, IN). PE-1 was measured using an ELISA (Genova Diagnostics, Asheville, NC). Ten HS and 10 CP patients were studied. In the CCK test the median peak lipase for HS and CP was 1605 and 113 IU/L, respectively (P < 0.008). In the secretin test the median peak bicarbonate for HS and CP was 102 and 40 mEq/L, respectively (p < 0.008). Median PE-1 concentrations for HS and CP were 317 and 63 microg/ml, respectively, after CCK stimulation (p = 0.046) and 87 and 17 microg/ml, respectively, after secretin stimulation (p = 0.033). Statistically significant correlations were found between [PE-1] and peak [lipase] (r = 0.83, P < 0.001), as well as [PE-1] and peak [HCO3(3)-] (r = 0.65, P = 0.037). Conclusions are as follows: (1) PE-1 concentrations can be measured from duodenal fluid obtained by endoscopic aspiration. (2) Duodenal fluid PE-1 concentrations are decreased in CP compared to HS. (3) Duodenal fluid [PE-1] has an excellent correlation with [lipase] and therefore is a marker of acinar cell function. (4) Secretin-stimulated endoscopic function testing with measurement of bicarbonate and PE-1 may provide a simultaneous assessment of both ductal cell and acinar cell function.

Focus Areas: Integrative Approaches to Care, Supporting Behavioral Change This brief presentation will offer a view of obesity and diabetes from a functional medicine approach. It will include the use of the Functional Medicine Matrix Model, the GO.TO.IT operating system, and the clinical timeline. Assessing pre-diabetes, diabetes, and obesity must include an evaluation of digestive function and nutritional status, the role of inflammation and insulin resistance, and the consideration of persistent organic pollutants (POPs) as a driver, as well as the relationship to mitochondrial energy production. This presentation will use a case-based format to highlight the unique Functional Medicine approach to assessing the root cause(s) of obesity and diabetes, as well as demonstrating appropriate treatment modalities.