A Single-Blind, Randomized, Placebo Controlled Study to Evaluate the Benefits and Safety of Endourage Targeted Wellness Formula C Sublingual +Drops in People with Post-Acute Coronavirus Disease 2019 Syndrome.

Introduction: Coronavirus Disease 2019 (COVID-19) causes a wide range of symptoms, including death. As persons recover, some continue to experience symptoms described as Post-Acute COVID-19 Syndrome (PACS). The objectives of this study were to measure the efficacy of Formula C™, a cannabidiol (CBD)-rich, whole-flower terpene-rich preparation in managing PACS symptoms. Materials and Methods: This randomized, placebo-controlled, single-blind, open-label crossover study was conducted in 2021. Informed consent was obtained from participants, and they were randomized to two treatment groups. Group 1 (n=15) received blinded active product for 28 days, and Group 2 (n=16) received blinded placebo for 28 days (Treatment Period 1). Both groups crossed over to open-label active product for 28 days (Treatment Period 2) with a safety assessment at day 70. Patient-Reported Outcomes Measurement Information System (PROMIS®) scores and the Patient Global Impression of Change (PGIC) score were used to assess primary and secondary objectives. Safety assessments were also done at each visit. Results: Twenty-four participants completed study, with 8 withdrawals, none related to study product. PGIC and PROMIS scores improved across both groups at day 28. This raised questions about the placebo. A reanalysis of the placebo confirmed absence of CBD and unexpected medical concentration of terpenes. The study continued despite no longer having a true placebo. The improved scores on outcome measures were maintained across the open label treatment period. There were no safety events reported throughout the study. Discussion: For persons with PACS who are nonresponsive to conventional therapies, this study demonstrated symptom improvement for participants utilizing Formula C. In addition, the benefits seen in Group 2 suggest the possibility that non-CBD formulations rich in antioxidants, omega-3, and omega-6 fatty acids, gamma-linoleic acid, and terpenes may also have contributed to the overall improvement of the partial active group through the study. Conclusion: Given that both groups demonstrated improvement, both formulations may be contributing to these findings. Limitations include the small number of participants, the lack of a true placebo, and limited time on study products. Additional studies are warranted to explore both CBD-rich hemp products and hempseed oil as treatment options for PACS. Trial Registration ClinicalTrials.gov Identifier: NCT04828668.

Barriers to completing colonoscopy after a positive fecal occult blood test.

BACKGROUND: Colorectal cancer leads to significant morbidity and mortality. Early detection and treatment are essential. Screening using fecal occult blood tests has increased significantly, but adherence to colonoscopy follow-up is suboptimal, increasing CRC mortality risk. The aim of this study was to identify barriers to colonoscopy following a positive FOBT at the level of the patient, physician, organization and policymakers. METHODS: This mixed methods study was conducted at two health care organizations in Israel. The study included retrospective analyses of 45,281 50-74 year-old members with positive fecal immunochemical tests from 2010 to 2014, and a survey of 772 patients with a positive test during 2015, with and without follow-up. The qualitative part of the study included focus groups with primary physicians and gastroenterologists and in-depth interviews with opinion leaders in healthcare. RESULTS: Patient lack of comprehension regarding the test was the strongest predictor of non-adherence to follow-up. Older age, Arab ethnicity, and lower socio economic status significantly reduced adherence. We found no correlation with gender, marital status, patient activation, waiting time for appointments or distance from gastroenterology clinics. Primary care physicians underestimate non-adherence rates. They feel responsible for patient follow-up, but express lack of time and skills that will allow them to ensure adherence among their patients. Gastroenterologists do not consider fecal occult blood an effective tool for CRC detection, and believe that all patients should undergo colonoscopy. Opinion leaders in the healthcare field do not prioritize the issue of follow-up after a positive screening test for colorectal cancer, although they understand the importance. CONCLUSIONS: We identified important barriers that need to be addressed to improve the effectiveness of the screening program. Targeted interventions for populations at risk for non-adherence, specifically for those with low literacy levels, and better explanation of the need for follow-up as a routine need to be set in place. Lack of agreement between screening recommendations and gastroenterologist opinion, and lack of awareness among healthcare authority figures negatively impact the screening program need to be addressed at the organizational and national level. TRIAL REGISTRATION: This study was approved by the IRB in both participating organizations (Meuhedet Health Care Institutional Review Board #02-2-5-15, Maccabi Healthcare Institutional Review Board BBI-0025-16). Participant consent was waived by both IRB's.

Increased risk for child maltreatment in those with developmental disability: A primary health care perspective from Israel.

BACKGROUND: Child Maltreatment (CM) is a worldwide phenomenon. Literature suggests that children with disabilities are at increased risk for CM. However, limited information exists regarding if such increased risk is noted in community primary care clinics. AIM: To report on the incidence of CM in children with and without disabilities attending community primary care clinics. METHOD: This was a cohort study of children belonging to a Health Maintenance Organization (HMO) in Israel. The study group consisted of children with disabilities and the control group consisted of children without disabilities. Formal reports to child protection services, medical and sociodemographic data were extracted from designated documentation and medical records. RESULTS: The odds to be identified as suspected CM, after adjusting for sociodemographic variables, was 6.2 times higher among children with disabilities compared to children without disabilities and 5.0 times higher among children with severe vs. mild disability. CONCLUSIONS: Developmental disability is a risk factor for CM, and is noted even more seriously in community primary care clinics. CM positively correlated with the severity of disability. The presented data marks higher figures than previously reported, enhancing understanding of the scope of the problem and its relation to the type of organization being examined.

CRC Screening Results: Patient Comprehension and Follow-up.

BACKGROUND:: Fecal occult blood tests are recommended for colorectal cancer screening, but are only effective if colonoscopy follows positive results. Patients with positive results often do not complete follow-up. This study examined the association between patient comprehension and adherence to colonoscopy after positive FIT (Fecal Immunochemical Test). METHODS:: Five hundred twenty-two patients completed a telephone questionnaire regarding the FIT and its implications 120 days after a positive result. Patients were asked whether they had the test, received the results, and required follow-up. These questions were used to identify the degree to which patients understood medical information. A participant who answered "no" to any question was defined as having "low comprehension" regarding the FIT, and participants who answered "yes" to all 3 questions, as having "high comprehension". RESULTS:: Comprehension and colonoscopy adherence were significantly associated. Adherence to colonoscopy was significantly higher among participants with high comprehension, after adjusting for gender, age, education, ethnicity, and socio-economic status. CONCLUSIONS:: This study demonstrates a link between health comprehension and patient follow-up after positive FIT and contributes to understanding the implications of health comprehension in terms of health promotion. We recommend patients undergoing screening tests receive clear explanations regarding need for follow-up of positive results thus reducing health disparities associated with health comprehension.

Repeated Automated Mobile Text Messaging Reminders for Follow-Up of Positive Fecal Occult Blood Tests: Randomized Controlled Trial.

BACKGROUND: Fecal occult blood tests (FOBTs) are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer (CRC), but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation. OBJECTIVE: The objective of this study was to examine the effectiveness of text messaging (short message service, SMS) in increasing adherence to colonoscopy follow-up after a positive FOBT result. METHODS: This randomized controlled trial was conducted with patients who had positive CRC screening results. Randomization was stratified by residential district and socioeconomic status (SES). Subjects in the control group (n=238) received routine care that included an alert to the physician regarding the positive FOBT result. The intervention group (n=232) received routine care and 3 text messaging SMS reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their electronic medical records. Physicians of study patients completed an attitude survey regarding FOBT as a screening test for CRC. Intervention and control group variables (dependent and independent) were compared using chi-square test. Logistic regression was used to calculate odds ratios (ORs) and 95% CIs for performing colonoscopy within 120 days for the intervention group compared with the control group while adjusting for potential confounders including age, gender, SES, district, ethnicity, and physicians' attitude. RESULTS: Overall, 163 of the 232 patients in the intervention group and 112 of the 238 patients in the control group underwent colonoscopy within 120 days of the positive FOBT results (70.3% vs 47.1%; OR 2.17, 95% CI 1.49-3.17; P<.001); this association remained significant after adjusting for potential confounders (P=.001). CONCLUSIONS: A text message (SMS) reminder is an effective, simple, and inexpensive method for improving adherence among patients with positive colorectal screening results. This type of intervention could also be evaluated for other types of screening tests. TRIAL REGISTRATION: ClinicalTrials.gov NCT03642652; https://clinicaltrials.gov/ct2/show/NCT03642652 (Archived by WebCite at http://www.webcitation.org/74TlICijl).

Is the patient activation measure associated with adherence to colonoscopy after a positive fecal occult blood test result?

BACKGROUND: Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide, but these can be reduced significantly with population screening using annual fecal occult blood tests (FOBT)A positive FOBT requires timely follow-up with colonoscopy to maximize screening benefits.. Several barriers to follow-up have been identified, with patient health behaviors and choices comprising a significant part of these. The Patient Activation Measure (PAM) assesses knowledge, skills, beliefs, and confidence in managing health. Increased patient activation is related to positive health outcomes. The aim of this study is to examine the association between patient empowerment, as reflected in the PAM, and follow-up colonoscopy within 90 days of a positive FOBT result. METHODS: This case-control study included 429 patients with a positive FOBT, 174 who had a colonoscopy within 90 days, and 255 who did not.. Participants completed a PAM telephone questionnaire (Cronbach's α = 0.785). We used both univariate and multivariate analyses to examine the effect of the PAM score as on the likelihood of undergoing colonoscopy, after adjusting for the independent variables. RESULTS: In this study we did not find a significant association between PAM and adherence to colonoscopy, using both univariate and multivariate analyses (p = .334 and p = .697, whether PAM was defined as a continuous or as categorical, respectively). CONCLUSIONS: This study was the first to examine the association between patient empowerment, as reflected in the patient activation measure, and adherence to colonoscopy after a positive FOBT. The findings did not support such an association. Further examination is required to clarify the relation between patient empowerment and activation and personal healthcare in general, and in the Israeli population in particular. Future policy should include specific, technical interventions to improve FOBT follow-up among all groups, until the patient-related barriers are better understood. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02534142 https://clinicaltrials.gov/ct2/show/NCT02534142.

Child maltreatment identification rates in a child development center: suggestions for improved detection.

Under-identification of child maltreatment (CM) remains a significant problem. The study aim was to examine rates of CM identification in a child development center (CDC) vs. a community clinic (CC). This was a cross-sectional study, involving study (CDC) and comparison groups (CC) and using administrative data for the period 2011-2015. The study group consisted of children 0-18 years belonging to the Meuhedet Health Maintenance Organization (HMO)-Northern Region, who attended the CDC, including satellite clinics, for assessment/treatment. The CDC employed a multi-disciplinary approach to improve CM identification. The comparison group consisted of children with a disability belonging to the HMO, who attended a CC, but were not known to the CDC. Rates of CM identification, socio-demographic characteristics, and disability severity were compared. CM identification during the study period was 2.1% for the CDC vs. 0.8% for the CC. Children visiting the CDC had five times higher odds to be identified with suspected CM than children in the CC, after adjusting for age, gender, socioeconomic status, ethnicity, and disability severity. CONCLUSION: CM identification rates in children with disability were higher in a CDC vs. CC. The approach used in the CDC may significantly improve CM identification in children with disability. What is Known: • There is significant under-identification of CM. What is New: • By examining child maltreatment identification rates in a child development center vs. the community, the study found that a multi-disciplinary staff approach can significantly improve CM Identification.