Side effects of COVID-19 vaccines in paediatric patients: a review systematic and meta-analysis protocol.

INTRODUCTION: The paediatric population represents a quarter of the world's population, and like adult patients, they have also suffered immeasurably from the SARS-CoV-2 pandemic. Immunisation is an effective strategy for reducing the number of COVID-19 cases. With the advancements in vaccination for younger age groups, parents or guardians have raised doubts and questions about adverse effects and the number of doses required. Therefore, systematic reviews focusing on this population are needed to consolidate evidence that can help in decision-making and clinical practice. This protocol aims to assess the safety of COVID-19 vaccines in paediatric patients and evaluate the correlation between the number of vaccine doses and side effects. METHODS AND ANALYSIS: We will search the PubMed, ClinicalTrials.gov, Web of Science, Embase, CINAHL, Latin American and Caribbean Health Sciences Literature, Scopus and Cochrane databases for randomised and quasi-randomised clinical trials that list the adverse effects of the COVID-19 vaccine and assess its correlation with the number of doses, without any language restrictions. Two reviewers will select the studies according to the inclusion and exclusion criteria, extract data and asses for risk of bias using the Cochrane risk-of-bias tool. The Review Software Manager (RevMan V.5.4.1) will be used to synthesise the data. We will use the Working Group's Grading of Recommendations Assessment, Development and Evaluations to grade the strength of the evidence of the results. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42023390077.

Drug therapies for obstructive sleep apnoea: a systematic review and meta-analysis protocol.

INTRODUCTION: Obstructive sleep apnoea (OSA) is a common disorder that can affect the quality of life and increase the risk for psychiatric, neurological and cardiometabolic diseases. Despite the significant burden, it poses on health and well-being, there is a lack of evidence regarding the use of drug therapies in these patients. This work aims to evaluate the efficacy and safety of pharmacological treatment alternatives for patients with OSA. METHODS AND ANALYSIS: Databases, including PubMed, Embase, Web of Science, SciELO, LILACS, Scopus, Cochrane Register of Controlled Trials and ClinicalTrials.gov, will be used for the search. A search strategy was developed to retrieve clinical trials that have evaluated polysomnographic primary outcome (Apnoea-Hypopnoea index) and secondary outcomes (eg, daytime sleepiness, adverse events) of any drug therapy used for OSA. No date or language restrictions will be applied. Two authors will independently select the studies meeting the inclusion criteria by screening the title, abstract and full text. Data will be extracted, and the risk of bias will be evaluated using the Cochrane Risk of Bias Tool. Review Manager V.5.4.1 will be used for data synthesis. The Grading of Recommendation Assessment, Development and Evaluation will be used to assess the strength of the evidence. ETHICS AND DISSEMINATION: As a review of published data, it is not necessary to obtain ethical approval. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022362639.

Laser and radiofrequency for treating genitourinary syndrome of menopause in breast cancer survivors: a systematic review and meta-analysis protocol.

INTRODUCTION: Breast cancer survivors (BCSs) experience more severe symptoms of genitourinary syndrome of menopause (GSM) than healthy postmenopausal women. As hormonal therapy with oestrogen should be avoided in BCSs, finding an effective and safe therapy to address vaginal symptoms and sexual dysfunction is urgently needed. Physical methods may be promising alternatives for the specificities of this group of women. This review aims to evaluate the efficacy and safety of physical methods (laser and radiofrequency) for treating GSM in BCSs. METHODS AND ANALYSIS: The PubMed, Embase, Web of Science, SciELO, LILACS, Scopus, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov databases will be searched. A search strategy was developed to retrieve clinical trials that evaluate the efficacy and safety of any physical method (laser or radiofrequency) used for GSM in BCSs. No date or language restrictions will be imposed. Two authors will independently select studies by title, abstract and full text to meet the inclusion criteria. Data will be extracted, and the risk of bias will be evaluated using the Cochrane risk-of-bias tool (RoB 2). Review Manager 5.4.1 will be used for data synthesis. The Grading of Recommendations, Assessment, Development and Evaluation will be used to assess the strength of the evidence. ETHICS AND DISSEMINATION: This study reviews the published data; thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023387680.

Perinodal fibrosis developed after ultrasonography-guided core-needle biopsy of a contrast-enhanced ultrasound-detected sentinel axillary node interferes with subsequent surgical sentinel node dissection.

OBJECTIVE: To evaluate perinodal fibrosis after 14-gauge staging core-needle biopsy (CNB) of the axillary sentinel lymph node (SLN) identified using contrast-enhanced ultrasonography (CEUS) and its interference with subsequent surgical SLN dissection in breast cancer patients. METHODS: Frequencies or means of main clinical, sonographic, pathological, and surgical characteristics were calculated. We also compared patient groups with and without perinodal pathological fibrosis. RESULTS: Forty-eight patients who underwent CEUS + CNB and axillary surgery were eligible for this cross-sectional study. Axillary surgical specimens showed perinodal fibrosis in 9/48 (18.7%) patients. Interference with SLN dissection was reported in 4/48 (8.3%) patients (two hematomas, three abnormal palpation findings, and four difficult dissections). The overall surgical detection rate of SLN was 43/48 (89.6%). In the majority of cases, perinodal fibrosis was described as moderate (4/9 [44.4%]) or severe (4/9 [44.4%]). The mean time elapsed between CEUS + CNB and axillary dissection was shorter in patients with perinodal fibrosis (P = .04). Interference with SLN dissection was only reported in patients with perinodal fibrosis (P < .001). Surgical SLN detection was successful in all nine cases in which perinodal pathological fibrosis or interference with SLN dissection was reported. CONCLUSION: Perinodal fibrosis may impair the surgical SLN dissection in early stage breast cancer patients who were staged using CEUS + CNB using a14-gauge needle.