scholarly journals Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

Nutrients ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 81
Author(s):  
Hiroharu Kamioka ◽  
Hideki Origasa ◽  
Jun Kitayuguchi ◽  
Kiichiro Tsutani
Keyword(s):  
Clinical Trial ◽  
Cross Sectional Study ◽  
Scientific Basis ◽  
Health Claims ◽  
Selective Reporting ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Notification System ◽  
For Profit ◽  
Trial Protocols

Background: A new type of foods with a health claims notification system, the Foods with Function Claims (FFC), was introduced in Japan in April 2015. This cross-sectional study sought to clarify compliance of clinical trial protocols reported as the scientific basis of efficacy in the FFC system. Methods: All articles based on clinical trials published on the Consumer Affairs Agency website from 1 July 2018 to 30 June 2021 were reviewed. Items assessed included first author characteristics (for-profit or academia), journal name, year published, journal impact factor in 2020, article language, name of clinical trial registration (CTR), and seven compliance items (Title: T, Participant: P, Intervention: I, Comparison: C, Outcome: O, Study design: S, and Institutional Review Board, IRB). Among studies that conducted CTR, consistency with these seven compliance items was evaluated. Results: Out of 136 studies that met all inclusion criteria, 103 (76%) performed CTR, and CTR was either not performed or not specified for 33 (24%). Compliance between the protocol and the text was high (≥96%) for items P and S, but considerably lower for items T, I, C, O, and IRB (52%, 15%, 13%, 69%, and 27%, respectively). Furthermore, 43% of protocols did not include functional ingredients or food names in items T or I. The total score was 3.7 ± 1.1 pts (out of 7). Conclusions: Some CTs had no protocol registration, and even registered protocols were suboptimal in transparency. In addition to selective reporting, a new problem identified was that the content of the intervention (test food) was intentionally concealed.

scholarly journals Caffeine Health Claims on Sports Supplement Labeling. Analytical Assessment According to EFSA Scientific Opinion and International Evidence and Criteria

Molecules ◽  
2021 ◽  
Vol 26 (7) ◽  
pp. 2095
Author(s):  
Pedro Estevan Navarro ◽  
Isabel Sospedra ◽  
Alejandro Perales ◽  
Cristina González-Díaz ◽  
Rubén Jiménez-Alfageme ◽  
...  
Keyword(s):  
Food Safety ◽  
Endurance Performance ◽  
Food Supplement ◽  
Cross Sectional Study ◽  
European Food Safety Authority ◽  
Health Claims ◽  
Cross Sectional ◽  
Strength Performance ◽  
Scientific Opinion ◽  
Term Performance

Caffeine is a food supplement widely consumed by athletes, but it has not been established. So far, the veracity of their labeling in terms of the dosage and cause/effect relationship aimed at the consumer. The aim is to analyze the health claims and the dosage presented on the labeling of caffeine supplements and to evaluate if they follow the European Food Safety Authority (EFSA) and international criteria. A descriptive cross-sectional study of a sample of caffeine supplements was carried out. The search was done through the Amazon and Google Shopping web portals. In order to assess the adequacy of the health claims, the guidelines of reference established by European Food Safety Authority were compared to the Academy of Nutrition and Dietetics, International Olympic Committee, and Australian Institute of Sport guidelines; in addition, recent systematic reviews were addressed. A review of labels of 42 caffeine supplements showed that, in less than 3% of the products were the health claims supported by the recommendations and by the labeled quantity of caffeine. The claims that fully complied the recommendations were, “improves or increases endurance performance”, “improves strength performance”, or “improves short-term performance”. In most cases, the recommended dosage was 200 mg/day for these products, which is the minimum for the caffeine effects to be declared. The rest of the health claims were not adequate or need to be modified. Most of the health claims identified indicated an unproven cause and effect, which constitutes consumer fraud, and so must be modified or eliminated.

scholarly journals High prevalence of peripheral neuropathy in multiple myeloma patients and the impact of vitamin D levels, a cross-sectional study

2021 ◽  
Author(s):  
B. E. Oortgiesen ◽  
J. A. Kroes ◽  
P. Scholtens ◽  
J. Hoogland ◽  
P. Dannenberg - de Keijzer ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Vitamin D ◽  
Peripheral Neuropathy ◽  
Hypovitaminosis D ◽  
Cross Sectional Study ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Validated Questionnaire ◽  
Vitamin D Levels ◽  
The Impact

Abstract Purpose Peripheral neuropathy (PN) is common in patients with multiple myeloma (MM). We hypothesized that the relationship between hypovitaminosis D and PN described in diabetes mellitus patients may also be present in MM patients. Methods To study this potential association, we assessed the incidence of hypovitaminosis D (vitamin D < 75 nmol/L [= 30 ng/mL]) in smouldering and active MM patients in two Dutch hospitals. Furthermore, a validated questionnaire was used to distinguish different PN grades. Results Of the 120 patients included between January 2017 and August 2018, 84% had an inadequate vitamin D level (median vitamin D level 49.5 nmol/L [IQR 34–65 nmol/L]; mean age: 68 years [SD ± 7.7]; males: 58%). PN was reported by 69% of patients (n = 83); however, of these 83 patients, PN was not documented in the medical records of 52%. An association was found between lower vitamin D levels and higher incidence of PN in the total population (P = 0.035), and in the active MM patients (P = 0.016). Conclusion This multi-centre cohort study showed that PN and hypovitaminosis D are common in MM patients, and addressing low vitamin D levels in the treatment of MM patients might be beneficial in reducing the risk of PN. More attention for PN is warranted, as PN is underreported by clinicians. Further research is needed to fully understand the implications of vitamin D in the development of PN in patients with MM. Clinical trial registration Netherland Trial Register NL5835, date of registration July 28, 2016

What Is the Impact of Prior Authorization on the Incidence of Pediatric Tonsillectomy?

2020 ◽  
pp. 019459982096963
Author(s):  
Vanessa F. Torrecillas ◽  
Kaden Neuberger ◽  
Alexander Ramirez ◽  
Paul Krakovitz ◽  
Jeremy D. Meier
Keyword(s):  
Elective Surgery ◽  
Lag Time ◽  
Cross Sectional Study ◽  
Health Claims ◽  
Third Party ◽  
Prior Authorization ◽  
Cross Sectional ◽  
Before And After ◽  
The Mean ◽  
The Impact

Objective Third-party payers advocate for prior authorization (PA) to reduce overutilization of health care resources. The impact of PA in elective surgery is understudied, especially in cases where evidence-based clinical practice guidelines define operative candidacy. The objective of this study is to investigate the impact of PA on the incidence of pediatric tonsillectomy. Study Design Cross-sectional study. Setting Health claims database from a third-party payer. Methods Any pediatric patient who had evaluation for tonsillectomy from 2016 to 2019 was eligible for inclusion. A time series analysis was used to evaluate the change in incidence of tonsillectomy before and after PA. Lag time from consultation to surgery before and after PA was compared with segmented regression. Results A total of 10,047 tonsillectomy claims met inclusion and exclusion criteria. Female patients made up 51% of claims, and the mean age was 7.9 years. Just 1.5% of claims were denied after PA implementation. There was no change in the incidence of tonsillectomy for all plan types ( P = .1). Increased lag time from consultation to surgery was noted immediately after PA implementation by 2.38 days (95% CI, 0.23-4.54; P = .030); otherwise, there was no significant change over time ( P = .98). Conclusion A modest number of tonsillectomy claims were denied approval after implementation of PA. The value of PA for pediatric tonsillectomy is questionable, as it did not result in decreased incidence of tonsillectomy in this cohort.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

Intimate partner violence against pregnant women: sociodemographic profile and characteristics of the aggressions

2021 ◽  
Vol 42 ◽  
Author(s):  
Naiane Beatriz da Silva ◽  
Rosely Erlach Goldman ◽  
Hugo Fernandes
Keyword(s):  
Black Women ◽  
Pregnant Women ◽  
Partner Violence ◽  
Physical Violence ◽  
First Trimester ◽  
Cross Sectional Study ◽  
Disease Notification ◽  
Cross Sectional ◽  
Notification System ◽  
Sociodemographic Profile

ABSTRACT Objective: To identify the sociodemographic profile and the main characteristics of violence by intimate partners in pregnant women in São Paulo, Brazil. Method: Cross-sectional study based on notifications for suspected or confirmed cases of inter-police violence from the National Disease Notification System (SINAN) carried out in the 2016-2019 period. Collection was performed between March and June 2020. Chi-squared test or Fisher’s Exact test were used in statistical analysis. Results: A total of 4,269 notifications were obtained and the prevalent profile was women between 20 and 34 years old (62.5%), brown or black (51.3%), who have completed high school (22.5%) in the first trimester of pregnancy (44.2%). Physical violence was more frequent (48.3%), occurred at home (59.1%), motivated by sexism (22.29%). Sexual violence or rape was more frequent (85.4%) with abortion in cases provided for by law (39%). Conclusion: Adult brown or black women in the first gestational trimester experienced physical violence more frequently.

scholarly journals The Predictive Factors for Severe Leptospirosis Cases in Kedah

2020 ◽  
Vol 5 (2) ◽  
pp. 79
Author(s):  
Rakesh Singh Sandhu ◽  
Halim Bin Ismail ◽  
Mohd Hasni Bin Ja’afar ◽  
Sanjay Rampal
Keyword(s):  
Predictive Factors ◽  
Health Department ◽  
Cross Sectional Study ◽  
Severe Form ◽  
Industrialized Countries ◽  
Cross Sectional ◽  
Notification System ◽  
Number Of Patients ◽  
Severe Leptospirosis ◽  
The Cost

Over the past decade, increased awareness about leptospirosis disease in developing and industrialized countries has resulted in increased numbers of leptospirosis cases being reported worldwide. About 5% to 15% of leptospirosis patients end up with severe forms of the disease. Complication due to leptospirosis requires monitoring, specific treatments, and intensive care admission, thus increasing the cost of treating severe leptospirosis cases. Currently, we have data on incident and mortality rates, but we do not have data on the number of patients with severe form of leptospirosis or how many patients have complications, and whether or not these complications were resolved. Therefore, we carried out this study to determine the predictive factors for severe leptospirosis cases in Kedah. We conducted a cross-sectional study. The data of patients diagnosed with leptospirosis were obtained from the surveillance unit, Kedah Health Department, through the e-notification system. These data were then sorted according to the hospitals where the patients were admitted. The patients’ medical records were collected, and their information was obtained using a checklist. A total of 456 confirmed leptospirosis cases were included in the study, with 199 patients classified as severe cases and 257 patients as mild cases, based on the Malaysian leptospirosis guidelines. Most patients were male (71.5%) with a mean SD age of 36.62 ± 20.75 years. The predictive factors for severe leptospirosis include abnormal lung sounds (OR: 3.07 [CI 1.58–6.00]), hepatomegaly (OR: 7.14 [1.10–45.98]), hypotension (OR: 2.16 [1.08–4.34]), leukocytosis (OR: 2.12 [1.37–3.29]), low hematocrit (OR: 2.33 [1.43–3.81]), and increased alanine aminotransferase (SGPT ALT) (OR: 2.12 [1.36–3.30]). In conclusion, knowing these predictive factors will help clinicians identify severe leptospirosis cases earlier and develop their treatment plans accordingly, to reduce the complications and death from severe leptospirosis.

Practice of Postpartum Warming Among Mothers in Brunei

2020 ◽  
Vol 31 (6) ◽  
pp. 576-581
Author(s):  
Illyana Rashidah Muhammad Wafiuddin Wa’ie ◽  
David Koh Soo Quee ◽  
Shahrimawati H. Sharbini ◽  
Salmah H. Mohd Noor ◽  
Ramlah Kisut ◽  
...  
Keyword(s):  
Fire Hazard ◽  
Carbon Monoxide Poisoning ◽  
Health And Safety ◽  
Cross Sectional Study ◽  
Health Claims ◽  
Cross Sectional ◽  
Nuclear Families ◽  
Family Expectations ◽  
Sources Of Knowledge ◽  
Burning Coal

Introduction: Postpartum warming is widely practiced among women in Asian countries despite unsubstantiated health claims. This study aimed to identify sources of knowledge and explore the practices of postpartum warming among mothers in Brunei. Methods: A cross-sectional study using a self-administered questionnaire was conducted on 124 mothers who had experience in postpartum warming. Results: Coal was commonly used for heat. Main source of knowledge came from family members. Older women had significantly lower intention to perform the practice in future pregnancies. Women who lived in nuclear families practiced it to a significantly higher frequency compared with those living in extended families. Discussion: Women still practice warming to adhere with family expectations and traditions although noticeable changes have been observed as society modernizes. It still poses a risk of carbon monoxide poisoning and fire hazard from burning coal. Future studies should focus on health and safety aspects to provide evidence on the actual health benefits and ameliorate risk factors.

scholarly journals Open access policies of leading medical journals: a cross-sectional study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028655
Author(s):  
Tim S Ellison ◽  
Tim Koder ◽  
Laura Schmidt ◽  
Amy Williams ◽  
Christopher C Winchester
Keyword(s):  
Open Access ◽  
Cross Sectional Study ◽  
Original Research ◽  
Cross Sectional ◽  
Medical Journals ◽  
Funded Research ◽  
For Profit ◽  
Creative Commons ◽  
Commercial Research ◽  
Access Policies

ObjectivesAcademical and not-for-profit research funders are increasingly requiring that the research they fund must be published open access, with some insisting on publishing with a Creative Commons Attribution (CC BY) licence to allow the broadest possible use. We aimed to clarify the open access variants provided by leading medical journals and record the availability of the CC BY licence for commercially funded research.MethodsWe identified medical journals with a 2015 impact factor of ≥15.0 on 24 May 2017, then excluded from the analysis journals that only publish review articles. Between 29 June 2017 and 26 July 2017, we collected information about each journal’s open access policies from their websites and/or by email contact. We contacted the journals by email again between 6 December 2017 and 2 January 2018 to confirm our findings.ResultsThirty-five medical journals publishing original research from 13 publishers were included in the analysis. All 35 journals offered some form of open access allowing articles to be free-to-read, either immediately on publication or after a delay of up to 12 months. Of these journals, 21 (60%) provided immediate open access with a CC BY licence under certain circumstances (eg, to specific research funders). Of these 21, 20 only offered a CC BY licence to authors funded by non-commercial organisations and one offered this option to any funder who required it.ConclusionsMost leading medical journals do not offer to authors reporting commercially funded research an open access licence that allows unrestricted sharing and adaptation of the published material. The journals’ policies are therefore not aligned with open access declarations and guidelines. Commercial research funders lag behind academical funders in the development of mandatory open access policies, and it is time for them to work with publishers to advance the dissemination of the research they fund.

scholarly journals Recusa da vacinação em área urbana do norte de Portugal

2018 ◽  
Vol 28 (4) ◽  
pp. 32152
Author(s):  
Margarida Silva Fonseca ◽  
Maria da Assunção L. N. Varela ◽  
Assunção Frutuoso ◽  
Maria de Fátima F. R. Pinto Monteiro
Keyword(s):  
Cross Sectional Study ◽  
Scientific Basis ◽  
Health Centers ◽  
Vaccination Program ◽  
Cross Sectional ◽  
Vaccine Refusal ◽  
Academic Level ◽  
Refusal Rate ◽  
The One ◽  
Attending Physician

AIMS: To know the number of vaccine refusals and to investigate the reasons for non-compliance with vaccination by the parents of children and adolescents living in an urban area of northern Portugal.METHODS: A cross-sectional study was carried out with a sample of children/adolescents up to the age of 14 enrolled in health units in a metropolitan area of Porto, Portugal, belonging to the health centers groupings of Porto Ocidental, Porto Oriental, Gaia, Gondomar and Matosinhos, whose parents refused any vaccination of the National Vaccination Program in the period from January 2009 to December 2015. We studied the characterization of the sample and the reasons for vaccine rejection through the application of a questionnaire to parents.RESULTS: We identified 150 cases of children/adolescents to whom the parents refused any vaccine, in a global population of 103,406 children, resulting in a vaccine refusal rate of 0.14%. The highest rate occurred in the Porto Ocidental health centers grouping: 0.31%. Among the 150 cases, 86 parents accepted to respond to the questionnaire, corresponding to an adhesion rate of 64%. The median age of children/adolescents whose parents refused vaccination was seven years; most of them were healthy and had no perinatal problems. All parents were adults, mostly married and female. Most parents had a college degree and were professionally active. The Porto Oriental health centers grouping was the one where the parents who refused vaccines were mostly males, had a higher academic level and were more professionally active. The vaccine with the highest refusal rate was BCG, followed by anti-human papillomavirus and measles, mumps and rubella vaccine. The four main reasons for vaccination refusal by the parents were "vaccines are not a priority", "vaccines are not safe", "indication of the attending physician" and "fear of side effects." The reason for the "indication of the attending physician" was in all cases referred to the BCG vaccine.CONCLUSIONS: In this population the vaccination refusal rate was low; however, based on the results obtained, intervention efforts can be directed towards the families, aiming at combating the arguments without scientific basis and obtaining an unequivocal adhesion to the National Vaccination Program in Portugal.

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