Predictive Criterion Validity of the Parsley Symptom Index Against the Patient-Reported Outcomes Measurement Information System-10 in a Chronic Disease Cohort: Retrospective Cohort Study.

BACKGROUND: Approximately 60% of US adults live with chronic disease, imposing a significant burden on patients and the health care system. With the rise of telehealth, patient-reported outcomes measures (PROMs) have emerged as pivotal tools for managing chronic disease. While numerous PROMs exist, few have been designed explicitly for telehealth settings. The Parsley Symptom Index (PSI) is an electronic patient-reported outcome measure (ePROM) developed specifically for telehealth environments. OBJECTIVE: Our aim is to determine whether the PSI predicts changes in the established Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Health, a 10-question short form. METHODS: We conducted a retrospective cohort study using data from 367 unique patients, amassing 1170 observations between August 30, 2017, and January 30, 2023. Patients completed the PSI and the PROMIS-10 multiple times throughout the study period. Using univariate regression models, we assess the predictive criterion validity of the PSI against PROMIS-10 scores. RESULTS: This study revealed significant relationships between the PSI and PROMIS-10 physical and mental health scores through comprehensive univariate analyses, thus establishing support for the criterion validity of the PSI. These analyses highlighted the PSI's potential as an insightful tool for understanding and predicting both mental and physical health dimensions. CONCLUSIONS: Our findings emphasize the importance of the PSI in capturing the nuanced interactions between symptomatology and health outcomes. These insights reinforce the value of the PSI in clinical contexts and support its potential as a versatile tool in both research and practice.

A Randomized, Placebo-Controlled Clinical Trial of a Novel Dietary Supplement on Standardized CNS Vital Signs Cognitive Performance Parameters in Adults.

Objective: To test the effectiveness of a novel dietary supplement as a support for cognitive function in healthy younger and older adults Design: A double-blind, randomized, placebo-controlled trial of the dietary supplement, Braini® in two age cohorts with 60 participants: 31 healthy younger adults (18-30 years) and 29 healthy older adults (55-80 years). Intervention: A 28-day intervention of a dietary supplement (active or placebo) taken daily with cognitive assessment using CNS Vital Signs computer-based testing at day 0 and 28. Participants were asked to fill out a daily survey regarding compliance with supplement protocol, changes in health, adherence to the protocol, and reported side effects. CNS Vital Signs provides aged normed aggregated outcome measures for Processing Speed, Psychomotor Speed, Reaction Time, Cognitive Flexibility, Executive Function, and Motor Speed. Results: Significant improvements in performance were found for two CNS Vital Signs domains, Cognitive Flexibility (p = 0.048), and Executive Function (p = 0.025) in the treated younger adults (n = 12) compared with the placebo group (n = 19) at day 28 compared with baseline. The Shifting Attention Test Reaction Time (SAT-RT), a measure of shifting attention correct response reaction time, showed significant improvement at 28 days in those taking Braini in both younger (p = 0.004) and older adult cohorts (p = 0.05) with an average improvement over the control subjects of 44%. No serious side effects were reported. Conclusions: The dietary formulation, Braini, safely and significantly improved cognitive flexibility and executive function in younger adults and trended positively in older adults in this study that was stopped prematurely due to pandemic restrictions. Scores on SAT-RT significantly improved in both younger and older adults. Further studies are needed to confirm that Braini reliably improves cognitive function in additional CNS domains in healthy adults. Clinical Trial Registration: Clinicaltrials.gov under registration number: NCT04025255.

Dietary Supplements for COVID-19.

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.

The impact of functional medicine on patient-reported outcomes in inflammatory arthritis: A retrospective study.

BACKGROUND: Despite 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 METHODS: In 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. RESULTS: 318 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. LIMITATIONS: Retrospective design, baseline difference in patient reported outcomes. CONCLUSIONS: Functional 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.

Association of the Functional Medicine Model of Care With Patient-Reported Health-Related Quality-of-Life Outcomes.

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.

CARE guidelines for case reports: explanation and elaboration document.

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.

Novel Testing Enhances Irritable Bowel Syndrome Medical Management: The IMMINENT Study.

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.

Systems approaches: a global and historical perspective on integrative medicine.

The globalization of healing systems is a dance of cultural awareness and cultural dominance that has arisen throughout history. With the development of greater communication and interest in whole-systems approaches to healing, the opportunity for the development of a global perspective on healing has emerged with new life force. The birth of integrative holistic healing systems in the West, such as naturopathic, homeopathic, anthroposophic, integral and functional medicine, and others, echoes the ocean of wisdom present in traditional healing systems, such as traditional Chinese medicine (TCM) and Ayurveda. In working to integrate the lessons from these systems, we see the inextricable link between man and the natural world, we work to understand the root cause of disease, we focus on the whole person to return balance, and we use empiric observation in large populations over time to grasp the interrelationships inherent in the whole-systems view of illness and wellness.

Fecal calprotectin is useful in predicting disease relapse in pediatric inflammatory bowel disease.

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 mug/g in CD. Eighty-nine percent of CD encounters with FC levels less than 400 mug/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.

Probiotics in children.

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.

Balance of flora, galt, and mucosal integrity.

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.

Analysis of pancreatic elastase-1 concentrations in duodenal aspirates from healthy subjects and patients with chronic pancreatitis.

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.