Sex and Gender in COVID-19 Vaccine Research: Substantial Evidence Gaps Remain

Since the start of the COVID-19 pandemic there has been a global call for sex/gender-disaggregated data to be made available, which has uncovered important findings about COVID-19 testing, incidence, severity, hospitalisations, and deaths. This mini review scopes the evidence base for efficacy, effectiveness, and safety of COVID-19 vaccines from both experimental and observational research, and asks whether (1) women and men were equally recruited and represented in vaccine research, (2) the outcomes of studies were presented or analysed by sex and/or gender, and (3) there is evidence of sex and/or gender differences in outcomes. Following a PubMed search, 41 articles were eligible for inclusion, including seven randomised controlled trials (RCTs), 11 cohort studies, eight cross-sectional surveys, eight routine surveillance studies, and seven case series. Overall, the RCTs contained equal representation of women and men; however, the observational studies contained a higher percentage of women. Of 10 studies with efficacy data, only three (30%) presented sex/gender-disaggregated results. Safety data was included in 35 studies and only 12 (34%) of these presented data by sex/gender. For those that did present disaggregated data, overall, the majority of participants reporting adverse events were women. There is a paucity of reporting and analysis of COVID-19 vaccine data by sex/gender. Research should be designed in a gender-sensitive way to present and, where possible analyse, data by sex/gender to ensure that there is a robust and specific evidence base of efficacy and safety data to assist in building public confidence and promote high vaccine coverage.

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The Role of Age in the Physiological Adaptations and Psychological Responses in Bikini-Physique Competitor Contest Preparation: A Case Series

10.21203/rs.3.rs-152618/v1 ◽

2021 ◽

Author(s):

Dan Newmire ◽

Heather E. Webb

Keyword(s):

Female Athletes ◽

Case Series ◽

Gluteus Maximus ◽

Muscle Thickness ◽

Reproductive Hormones ◽

Mean Difference ◽

Observational Research ◽

Hydration Status ◽

Mineral Density ◽

Cross Sectional

Abstract Even with the increased popularity of the bikini-physique division within bodybuilding, there is minimal observational research identifying the influence of age on typical adaptations during contest preparation. The purpose of this case series was to observe how age may influence the adaptations normally seen during preparation and the exploration of newer protocols to address adaptations more relative to the judging standards. Over a 16-week pre-contest preparation, a 32-y bikini competitor (BC) and 44-y master’s bikini competitor (MBC) visited the laboratory bi-weekly to observe changes in body fat mass (BF), lean body mass (LBM), bone mineral density (BMD), total body water (TBW); exploratory measures of deltoid cross-sectional area (DeltCSA), gluteus maximus muscle thickness (GMMT), and subcutaneous adipose tissue thickness (SAT); reproductive hormones estradiol (E2), luteinizing hormone (LH), and energy balance hormones triiodothyronine (T3), leptin and ghrelin; hydration status during contest preparation and during the week of competition; resting metabolic rate (RMR); psychometric data related to perceived anxiety, stress, and body image were assessed. No differences between BC and MBC were observed in BF, LBM, BMD, and TBW. Both competitors showed a small loss in LBM. Both BC and MBC showed a contrasting increase in DeltCSA and a loss in GMMT. MBC showed to be slightly more dehydrated (1.025 vs 1.021 g⋅mL− 1) than BC. Both competitors maintained a euhydration status the day of the competition. No time differences were found between BC and MBC during RMR. BC showed a higher mean difference RMR compared to MBC (2.66 ± 0.75 kcal⋅kgLBM− 1⋅d− 1). MBC showed a higher mean difference LH concentration (84.6 ± 6.01 IU⋅L− 1), which may be explained by perimenopausal status. MBC had a higher mean difference concentration of leptin (2.51 ± 0.24 ng⋅mL− 1⋅kgFM− 1), which was unperturbed by fat loss may be interrelated LH. BC self-reported a higher mean difference energy intake (15.07 ± 3.43 kcal⋅kgLBM− 1⋅d− 1) and higher aerobic training volume (93.26 ± 40.68 min⋅d). BC and MBC showed similar composition changes, slightly differing metabolic rates, and differing hormonal LH and leptin responses. This finding is in contrast to previous work showing both LH inhibition and leptin diurnal disturbance in younger, female athletes with low energy availability. The exploratory measures may have some benefit for bikini-physique competitors related to the judging criteria. Age did not seem to play a role in contest preparation adaptations.

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Classifying Disfluencies in Preschool- and School-Age Spanish–English Bilinguals Who Do Not Stutter: An Exploratory Study

Perspectives of the ASHA Special Interest Groups ◽

10.1044/2019_persp-19-00164 ◽

2020 ◽

Vol 5 (1) ◽

pp. 119-130

Author(s):

Raúl Rojas ◽

Farzan Irani

Keyword(s):

Exploratory Study ◽

Evidence Base ◽

Medium Effect ◽

Bilingual Children ◽

Linear Regression Models ◽

Cross Sectional ◽

Total Percentage ◽

Narrative Production ◽

Language Measures ◽

Mean Length Of Utterance

Purpose This exploratory study examined the language skills and the type and frequency of disfluencies in the spoken narrative production of Spanish–English bilingual children who do not stutter. Method A cross-sectional sample of 29 bilingual students (16 boys and 13 girls) enrolled in grades prekindergarten through Grade 4 produced a total of 58 narrative retell language samples in English and Spanish. Key outcome measures in each language included the percentage of normal (%ND) and stuttering-like (%SLD) disfluencies, percentage of words in mazes (%MzWds), number of total words, number of different words, and mean length of utterance in words. Results Cross-linguistic, pairwise comparisons revealed significant differences with medium effect sizes for %ND and %MzWds (both lower for English) as well as for number of different words (lower for Spanish). On average, the total percentage of mazed words was higher than 10% in both languages, a pattern driven primarily by %ND; %SLDs were below 1% in both languages. Multiple linear regression models for %ND and %SLD in each language indicated that %MzWds was the primary predictor across languages beyond other language measures and demographic variables. Conclusions The findings extend the evidence base with regard to the frequency and type of disfluencies that can be expected in bilingual children who do not stutter in grades prekindergarten to Grade 4. The data indicate that %MzWds and %ND can similarly index the normal disfluencies of bilingual children during narrative production. The potential clinical implications of the findings from this study are discussed.

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Hubungan antara Asupan Karbohidrat dan Lemak dengan Kadar Trigliserida pada Pesenam Aerobik Wanita

JURNAL NUTRISIA ◽

10.29238/jnutri.v19i2.15 ◽

2017 ◽

Vol 19 (2) ◽

pp. 84-89

Author(s):

Diah Nur Khasanah ◽

Idi Setiyobroto ◽

Weni Kurdanti

Keyword(s):

Coronary Heart Disease ◽

Triglyceride Level ◽

Observational Research ◽

Fat Intake ◽

Cross Sectional ◽

Exact Test ◽

High Carbohydrate ◽

High Consumption ◽

High Level ◽

High Triglyceride

Background: A long-standing association exists between elevated triglyceride levels and coronary heart disease (CHD). High consumption of fat and carbohydrate influences enhancement of triglycerides level. Sport can reduce cholesterol and triglycerides level. Objective: This research aims to analyze relationship between carbohydrates and fat intakes with triglycerides level on female aerobic gymnasts. Method: This is an observational research using cross sectional research design which was held in Miracle Gymnasium on February17- 18th 2017. 30 subjects were selected as subject because fulfill the requirement (older than 20 years and have willingness to be a subjects). Research variable areintakes of carbohydrate, fat, and triglyceride levels. Result: Result shows 53.3% subjects have high level of carbohydrate and fat intakes followed by 20% subjects with high level of triglycerides. Subjects with high level of carbohydrate, fat intakes and high triglyceride level are 28%. Subjects withsufficient carbohydrate, fat intakes and high triglyceride level are 12.5%.Fisher’s exact test was done to prove hypothesis with results there is no significant relationship between carbohydrate and fat intake with triglyceride level. Conclusions: Subjects with high carbohydrate and fat intake is 53.3% and 20% subjects have high triglyceride level. Relationship between carbohydrate and fat intake with triglyceride level on female aerobic gymnasts is not significant (p>0.05). Keywords: Intake, Carbohydrate, Fat, Aerobic Gymnasts, Triglyceride

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Penggunaan Standar Bumbu Masakan Lauk Hewani dan Nabati di RSUD Panembahan Senopati Bantul Yogyakarta

JURNAL NUTRISIA ◽

10.29238/jnutri.v19i2.28 ◽

2017 ◽

Vol 19 (2) ◽

pp. 131-139

Author(s):

Kukuh Probo Sukmawati ◽

Setyowati Setyowati ◽

Th Ninuk Sri Hartini

Keyword(s):

Animal Protein ◽

Plant Protein ◽

Observational Research ◽

Plant Proteins ◽

Tabular Form ◽

Cross Sectional ◽

Herbs And Spices

Background: Using of herbs and spices greatly affect the taste of foods, although the ingredients used are the same, different formulations of herbs will produce different flavors. Standardized seasonings are needed to produce a relatively similar food taste. Objective: The research aims to determine the use of herbs in animal and plant proteins. Method: This research was an observational research with cross sectional approach at PanembahanSenopati Hospital Bantul. The objects of this research were standardized seasonings inanimal and plant proteinsin the menu cycle of 10 days in Juny 2015. The data were analyzed descriptively and presented in tabular form and textural. Result: Standardized Seasonings in animal protein were B for satay and C for semur. Standardized seasonings in plant protein were B for bali, terik, rujak and D for bacem. The percentage of the use of seasoning than standardized seasoning for satay (148,7%), bali (130,3%), rujak(372%),for semur, terik and bacem the conformity are not not known because the standardized seasonings unwritten. The conformity of ingredient herbskind for satay (66,7%), semur (100%), bali (54,5%), rujak (50%), bacem (100%) and terik (100%). Conclusion:The conformity of herbs weight foranimal protein (124,3%) and plant protein (175,5%). The conformity of ingredient herbskind for animal protein (83,3%) and plant protein (76,1%). Standardized seasonings used were B, C and D. Keywords: standardized seasonings, animal protein, plant protein

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Hubungan Status Gizi Dengan Proses Penyembuhan Luka Di Rsud H. Andi Sulthan Daeng Radja Kabupaten Bulukumba

Jurnal Kesehatan Panrita Husada ◽

10.37362/jkph.v2i1.147 ◽

2017 ◽

Vol 2 (1) ◽

pp. 20-28

Author(s):

Fitriani ◽

Tenriwati

Keyword(s):

Wound Healing ◽

Nutritional Status ◽

Healing Process ◽

Data Retrieval ◽

Observational Research ◽

Wound Healing Process ◽

P Value ◽

Chi Square ◽

Cross Sectional ◽

Chi Square Test

At present, the incidence of injuries in Indonesia is quite high, as seen from data on traffic accidents in the general public. There are several factors that affect wound healing, one of which is nutritional status. Based on the preliminary data retrieval conducted by researchers in the seruni surgery room in the last 1 month namely in March, it was found that the number of wounded patients was 109 patients, where the number of men was 78 (71.56%) while the number of women was 31 ( 28.44%) The purpose of this study was to determine the relationship between nutritional status and the wound healing process in RSUD. H. Andi. Sulthan Daeng Radja Kab. Bulukumba. This research uses the type of design of this research is quantitative research. This type of research uses analytic observational research with cross sectional approach. The sample of this study were 41 respondents taken by purposive sampling method. Data analysis in this study used the chi-square test (chi square test). The results of the analysis used the chi-square statistical test with a confidence level (α = 0.05). Based on the results of this test, the p value is 0.001, thus p <α (0.001 <0.05), then Ho is rejected and Ha is accepted. The conclusion of this study is that there is a relationship between nutritional status and the process of wound healing in RSUD. H. Andi. Sulthan Daeng Radja Kab. Bulukumba. Researchers suggest that this study be used as a material consideration in the fulfillment of nutrition in wound care patients in RSUD.H.A. Sulthan Daeng Radja Kab. Bulukumba and this research can be continued by conducting research related to the wound healing process and linking it with other variables.

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The Worrying Trend of Diabetes Mellitus in Saudi Arabia: An Urgent Call to Action

Current Diabetes Reviews ◽

10.2174/1573399815666190531093735 ◽

2020 ◽

Vol 16 (3) ◽

pp. 204-210 ◽

Cited By ~ 6

Author(s):

Asirvatham A. Robert ◽

Mohamed A. Al Dawish

Keyword(s):

Diabetes Mellitus ◽

Saudi Arabia ◽

Present Report ◽

Adult Population ◽

Current Trend ◽

Fold Increase ◽

Developed Countries ◽

Evidence Base ◽

Small Sample ◽

Cross Sectional

From last few years, the pervasiveness of diabetes mellitus (DM), in Saudi Arabia, is growing at a frightening rate. Overall, one-fourth of the adult population is affected by DM, which is further predicted to rise to more than double by the year 2030. The most alarming is possibly the escalation propensity of diabetes, in recent years, where a nearly ten-fold increase has been witnessed over the past thirty years in Saudi Arabia. However, the number of research arbitrations on the prevalence and incidence of DM is woefully inadequate, as compared to developed countries. Apart from this, most of the existing research data carried out in Saudi Arabia is cross-sectional, with small sample sizes, which most often involve only certain parts of the country. Consequently, the present scenario demands more multidimensional and multisectoral research to strengthen the evidence base and to accumulate greater knowledge as a basis for measures and programmes to confront diabetes and its complications. Thus, the present report makes an attempt to depict the current trend of diabetes as well as intends to put forward essential measures for controlling diabetes in Saudi Arabia.

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COVID-19 Vaccine Intention among Healthcare Workers in Saudi Arabia: A Cross-Sectional Survey

Vaccines ◽

10.3390/vaccines9080835 ◽

2021 ◽

Vol 9 (8) ◽

pp. 835

Author(s):

Mohammed Noushad ◽

Mohammad Zakaria Nassani ◽

Anas B. Alsalhani ◽

Pradeep Koppolu ◽

Fayez Hussain Niazi ◽

...

Keyword(s):

Saudi Arabia ◽

Healthcare System ◽

Healthcare Workers ◽

Vaccine Coverage ◽

Vaccination Campaign ◽

Herd Immunity ◽

Positive Sign ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Public Health Strategies

The COVID-19 pandemic has caused largescale morbidity and mortality and a tremendous burden on the healthcare system. Healthcare workers (HCWs) require adequate protection to avoid onward transmission and minimize burden on the healthcare system. Moreover, HCWs can also influence the general public into accepting the COVID-19 vaccine. Therefore, determining COVID-19 vaccine intention among HCWs is of paramount importance to plan tailor-made public health strategies to maximize vaccine coverage. A structured questionnaire was administered in February and March 2021 among HCWs in Saudi Arabia using convenience sampling, proceeding the launch of the vaccination campaign. HCWs from all administrative regions of Saudi Arabia were included in the study. In total, 674 out of 1124 HCWs responded and completed the survey (response rate 59.9%). About 65 percent of the HCWs intended to get vaccinated. The intention to vaccinate was significantly higher among HCWs 50 years of age or older, Saudi nationals and those who followed the updates about COVID-19 vaccines (p < 0.05). The high percentage (26 percent) of those who were undecided in getting vaccinated is a positive sign. As the vaccination campaign gathers pace, the attitude is expected to change over time. Emphasis should be on planning healthcare strategies to convince the undecided HCWs into accepting the vaccine in order to achieve the coverage required to achieve herd immunity.

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Cardio-Pulmonary Sequelae in Recovered COVID-19 Patients: Considerations for Primary Care

Journal of Primary Care & Community Health ◽

10.1177/21501327211023726 ◽

2021 ◽

Vol 12 ◽

pp. 215013272110237

Author(s):

Zouina Sarfraz ◽

Azza Sarfraz ◽

Alanna Barrios ◽

Radhika Garimella ◽

Asimina Dominari ◽

...

Keyword(s):

Primary Care ◽

Primary Infection ◽

Clinical Laboratory ◽

Point Of Care ◽

Case Reports ◽

Case Series ◽

Infectious Complications ◽

Care Physician ◽

Cross Sectional ◽

Infection Period

Background: Current literature lacks characterization of the post-recovery sequelae among COVID-19 patients. This review characterizes the course of clinical, laboratory, radiological findings during the primary infection period, and the complications post-recovery. Primary care findings are presented for long-COVID care. Methods: Adhering to PRISMA guidelines, 4 databases were searched (PubMed, Embase, CINAHL Plus, Scopus) through December 5, 2020, using the keywords “COVID-19 and/or recovered and/or cardiovascular and/or long-term and/or sequelae and/or sub-acute and/or complication.” We included published peer-reviewed case reports, case series, and cross-sectional studies providing the clinical course of COVID-19 infection, and cardiopulmonary complications of patients who recovered from COVID-19, while making healthcare considerations for primary care workers. Results: We identified 29 studies across 9 countries including 37.9% Chinese and 24.1% U.S. studies, comprising 655 patients (Mean Age = 45) with various ethnical backgrounds including Asian and European. Based on the WHO COVID-19 severity classification scale, initial disease severity was mild for 377 patients and severe for 52 patients. Treatments during primary infection included corticosteroids, oxygen support, and antivirals. The mean value (in days) for complication onset after acute recovery was 28 days. Complete blood counts and RT-PCR tests were the most common laboratory results described. In 22 of the studies, patients showed signs of clinical improvement and were prescribed medications such as anticoagulants or corticosteroids. Conclusion: Post-recovery infectious complications are common in long-COVID-19 patients ranging from mild infections to life-threatening conditions. International thoracic and cardiovascular societies need to develop guidelines for patients recovering from COVID-19 pneumonia, while focused patient care by the primary care physician is crucial to curb preventable adverse events. Recommendations for real-time and lab-quality diagnostic tests are warranted to establish point-of-care testing, detect early complications, and provide timely treatment.

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Patellar fractures in cats: Repair techniques and treatment decision-making

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x211021539 ◽

2021 ◽

Vol 23 (7) ◽

pp. 649-661

Author(s):

Sorrel J Langley-Hobbs

Keyword(s):

Decision Making ◽

Case Reports ◽

Case Series ◽

Treatment Decision ◽

Evidence Base ◽

Treatment Technique ◽

Treatment Decision Making ◽

Fracture Types ◽

Patellar Fractures ◽

Repair Techniques

Practical relevance: While feline patellar fractures are not commonly encountered in practice, they tend to be found more often in younger cats; no breed or sex predispositions are recognised. If there is no evidence of a traumatic aetiology, the cat may be suspected of having patellar fracture and dental anomaly syndrome (PADS). Patellar fractures are easy to diagnose on lateral radiographs and there are several different fracture types. The type of fracture, the age of the cat at fracture occurrence and whether there is suspicion of a pathological aetiology are all relevant when considering treatment technique. Clinical challenges: While some cats with patellar fractures will do well with conservative management, surgical treatment is often indicated and decision-making can be challenging. Evidence base: Information and recommendations provided in this review are based on the literature and the author’s own clinical experience. There are several publications on PADS, but there is limited evidence as to what the underlying cause of this condition is, and the best method for managing patellar fractures is still an area where more research is needed. Aim: This review aims to gather the papers, case series and case reports published over the past few decades in order to discuss how best to manage different types of patellar fractures.

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Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study

BMC Medical Imaging ◽

10.1186/s12880-021-00600-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jarl Åsbjørn Jakobsen ◽

Carlo Cosimo Quattrocchi ◽

Frank H. H. Müller ◽

Olivier Outteryck ◽

Andrés Alcázar ◽

...

Keyword(s):

Image Quality ◽

Observational Study ◽

Contrast Agents ◽

Marketing Authorisation ◽

Safety Data ◽

Radiological Diagnosis ◽

Routine Practice ◽

Diagnostic Confidence ◽

Cross Sectional ◽

Wide Range

Abstract Background The EU gadolinium-based contrast agents (GBCA) market has changed in recent years due to the European Medicines Agency decision to suspend the marketing authorisation of linear GBCA and the marketing authorisation of new generic macrocyclic GBCA. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. Methods Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. Reported usage patterns included indication, referral and examination details. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Safety data were collected by spontaneous patient adverse event (AE) reporting. Results 2118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol) and ProHance (gadoteridol) were utilised in 1513 (71.4%), 356 (16.8%), 237 (11.2%) and 12 (0.6%) patients, respectively. Most were performed in CNS-related indications (46.2%). Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Image quality was considered excellent or good in 96.1% of patients and across all GBCA. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. Conclusions This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used.

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