Impact of age, sex and medical history on adverse reactions to the first and second dose of BNT162b2 mRNA COVID-19 vaccine in Japan: a cross-sectional study.

BACKGROUND: Vaccines for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being promoted worldwide. In this study, we analyzed the relationship between adverse reactions and the profile of vaccinated recipients. METHODS: Vaccinated subjects who received two doses of BNT162b2 between May 17 and June 11, 2021, at Osaka University Dental Hospital were included in this study. Adverse reactions and profiles were collected by questionnaires, and the relationship between the presence of adverse reactions and the profiles of the vaccinated persons was analyzed by logistic regression analysis. The correlation between the severity of adverse reactions and age was analyzed by Spearman's rank correlation. RESULTS: Logistic regression analysis showed that, for many kinds of adverse reactions, the incidence was significantly higher in females than in males and in younger than in older people. There was a very weak but significant negative correlation between age and the severity of many kinds of adverse reactions. The relationship between sex and the incidence of each adverse reaction was significant for injection site reactions and fatigue in the first vaccination, whereas significant relationships were found for fatigue, chills, fever, arthralgia, myalgia and headache in the second vaccination, all of which were clearly more likely to occur in females. CONCLUSION: Adverse reactions to BNT162b2 were found to be more frequent and more intense in females and younger people in Japan, especially after the second vaccination.

Differences in specific concerns perceived by parents of children with cleft lip and/or palate based on the types of cleft.

BACKGROUND: Parents of children with cleft lip and/or palate (CL/P) have concerns including guilt and worry. Differences in concerns by cleft type is, however, under-researched. AIM: To compare differences in perceived concerns among parents of children with CL/P by cleft type, adjusting for children's gender and age. DESIGN: Cross-sectional study conducted in an outpatient centre, assessing psychological status of 171 parents of children aged <12 with CL/P using 12 items. RESULTS: Across cleft types, 'I am worried about whether the child's teeth will be straight' was the most strongly perceived concern (70.8%). After adjusting for gender and age, logistic regression showed significant differences in type of CL/P for (eg) 'I am worried that the child's appearance will not be beautiful', associated with CL over CP (OR = 0.07, 95% CI: 0.02-0.26) and CLP over CP (8.52, 3.23-22.50);' 'I am concerned about my child being able to speak well', associated with CP (3.12, 1.07-9.11) and CLP (5.69, 2.43-13.33) over CL, and 'I am worried that the child could suffer due to his/her appearance', associated with CL over CP (0.08, 0.02-0.29) and CLP over CP (10.07, 13.78-27.36). CONCLUSIONS: Parents' concerns were influenced by cleft type.

Decision-making process to undergo surgery among adolescent patients with cleft lip and/or palate.

AIM: As patients with cleft lip and/or palate grow older, the main decision-making process for treatment is likely to shift from a parent-centered to a patient-centered process. However, many adolescent patients have difficulty in treatment decision-making. This study aimed to clarify the decision-making process regarding undergoing surgery among adolescent patients with cleft lip and/or palate. METHODS: Participants were adolescent patients with cleft lip and/or palate aged 14-18 years who were admitted to a hospital in Japan for surgery. Fourteen patients (six boys, eight girls) and their parents agreed to participate in this study. Data were collected in face-to-face semi-structured interviews. Data were analyzed qualitatively with inductive content analysis. RESULTS: Fifteen categories were classified into three themes for adolescent patients' decision-making processes regarding undergoing surgery. The three themes were: (a) a doctor's recommendation for surgery, (b) psychological conflict about surgery, and (c) a final decision about surgery. CONCLUSION: This study's findings suggest that adolescent patients with cleft lip and/or palate were not adequately involved in the decision-making process before undergoing surgery. Medical staff need to explain other treatment options, the risks and benefits of surgery with materials and methods that adolescent patients can understand as part of "a doctor's recommendation for surgery." Medical staff and parents need to encourage adolescent patients to communicate their preferences and values to reduce patients' "psychological conflict about surgery" and adolescent patients' intentions should be considered in "a final decision about surgery."

Resilience and difficulties of parents of children with a cleft lip and palate.

AIM: The present study explored the differences in emotional difficulties and resilience between fathers and mothers of a child with a cleft lip and palate. METHODS: Married couples were recruited who were accompanying their child with a cleft lip and palate (<12 years old) on regular visits to an outpatient clinic in a Japanese hospital. The participants were distributed an anonymous questionnaire that included items regarding emotional difficulties with the cleft lip and palate and a scale to measure resilience when caring for the children. In the data analysis, the paired t-test was used to compare the individuals within the couples. RESULTS: By analyzing the data of 64 couples who provided valid responses, two items with the highest mean score for the difficulties that were faced by both the father and mother of a child with a cleft lip and palate were: "I am worried about whether the child's teeth will be straightened" and "I am worried that the children could suffer due to their appearance." The mothers felt significantly more worry about their child's future and more guilt than did the fathers. In contrast, the fathers had greater resilience, in terms of problem-solving skills and recognition and acceptance than did the mothers. CONCLUSION: It is important that healthcare providers understand the difference between the fathers' and mothers' worries about their child with a cleft lip and palate. Specific support services should be offered to fathers with a high level of resilience, in terms of the acceptance of reality and problem-solving, which could increase their parenting ability.