Long-COVID-19 clinical and health outcomes: an umbrella review.

Background: A growing interest in long-term sequelae of COVID-19 has prompted several systematic literature reviews (SLRs) to evaluate long-COVID-19 effects. However, many of these reviews lack in-depth information on the timing, duration, and severity of these conditions. Objectives: Our aim was to synthesize both qualitative and quantitative evidence on prevalence and outcomes of long-term effect of COVID-19 through an umbrella review. Design: Umbrella review of relevant SLRs on long-COVID-19 in terms of prolonged symptoms and clinical conditions, and comprehensively synthesized the latest existing evidence. Data Sources and Methods: We systematically identified and appraised prior systematic reviews/meta-analyses using MEDLINE, Embase, and Cochrane database of systematic review from 2020 to 2021 following the preferred reporting items for systematic reviews and meta-analyses guidance. We summarized and categorized all relevant clinical symptoms and outcomes in adults with COVID-19 using the Medical Dictionary for Regulatory Activities System Organ Class (MedDRA SOC). Results: We identified 967 systematic reviews/meta-analyses; 36 were retained for final data extraction. The most prevalent SOC were social circumstances (40%), blood and lymphatic system disorders (39%), and metabolism and nutrition disorder (38%). The most frequently reported SOC outcomes within each MedDRA category were poor quality of life (59%), wheezing and dyspnea (19-49%), fatigue (30-64%), chest pain (16%), decreased or loss of appetite (14-17%), abdominal discomfort or digestive disorder (12-18%), arthralgia with or without myalgia (16-24%), paresthesia (27%) and hair loss (14-25%), and hearing loss or tinnitus (15%). Conclusion: This study confirmed a high prevalence of several long COVID-19 outcomes according to the MedDRA categories and indicated that the majority of evidence was rated as moderate to low. Registration: The review was registered at PROSPERO (https://www.crd.york.ac.uk/prospero/) (CRD42022303557).

Early Real-World Data to Assess Benefits and Risks of COVID-19 Vaccines: A Systematic Review of Methods.

Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 vaccines, four months after vaccine approval. MEDLINE and EMBASE were searched to identify published studies until 6 May 2021. Two independent researchers selected relevant publications and extracted data from included studies. The risk of bias was assessed using New-Castle Ottawa tools. After screening 1086 studies, 15 were included. Out of the 15 studies, 12 (80%) followed a cohort design, 8 (53%) were based on USA data, 7 (47%) assessed health care professionals, and 14 articles (93%) assessed the BNT162b2 vaccine. Data sources included institutional databases, electronic health records, and patient-generated data. The primary endpoint mainly described was SARS-CoV-2-infection. Hospitalization and mortality were assessed in 2 studies. For the comparability domain, six studies (40%) had a high risk of bias. A few months after the beginning of COVID-19 vaccination, Real-world Evidence (RWE) provided timely safety surveillance and comparative effectiveness with findings that showed similar findings to Randomized control trial (RCT). Most of the initiatives assessed BNT162b2 and were conducted in the USA and used healthcare workers' data.

Neurosurgical resection for locally recurrent brain metastasis.

BACKGROUND: In patients with locally recurrent brain metastases (LRBMs), the role of (repeat) craniotomy is controversial. This study aimed to analyze long-term oncological outcomes in this heterogeneous population. METHODS: Craniotomies for LRBM were identified from a tertiary neuro-oncological institution. First, we assessed overall survival (OS) and intracranial control (ICC) stratified by molecular profile, prognostic indices, and multimodality treatment. Second, we compared LRBMs to propensity score-matched patients who underwent craniotomy for newly diagnosed brain metastases (NDBM). RESULTS: Across 180 patients, median survival after LRBM resection was 13.8 months and varied by molecular profile, with >24 months survival in ALK/EGFR+ lung adenocarcinoma and HER2+ breast cancer. Furthermore, 102 patients (56.7%) experienced intracranial recurrence; median time to recurrence was 5.6 months. Compared to NDBMs (n = 898), LRBM patients were younger, more likely to harbor a targetable mutation and less likely to receive adjuvant radiation (P < 0.05). After 1:3 propensity matching stratified by molecular profile, LRBM patients generally experienced shorter OS (hazard ratio 1.67 and 1.36 for patients with or without a mutation, P < 0.05) but similar ICC (hazard ratio 1.11 in both groups, P > 0.20) compared to NDBM patients with similar baseline. Results across specific molecular subgroups suggested comparable effect directions of varying sizes. CONCLUSIONS: In our data, patients with LRBMs undergoing craniotomy comprised a subgroup of brain metastasis patients with relatively favorable clinical characteristics and good survival outcomes. Recurrent status predicted shorter OS but did not impact ICC. Craniotomy could be considered in selected, prognostically favorable patients.

Quantifying the impact of surgical decompression on quality of life and identification of factors associated with outcomes in patients with symptomatic metastatic spinal cord compression.

OBJECTIVE: Metastatic spinal cord compression (MSCC) imposes significant impairment on patient quality of life and often requires immediate surgical intervention. In this study the authors sought to estimate the impact of surgical intervention on patient quality of life in the form of mean quality-adjusted life years (QALY) gained and identify factors associated with positive outcomes. METHODS: The authors performed a retrospective chart review and collected data for patients who had neurological symptoms resulting from radiologically and histologically confirmed MSCC and were treated with surgical decompression during the last 12 years. RESULTS: A total of 151 patients were included in this study (mean age 60.4 years, 57.6% males). The 5 most common metastatic tumor types were lung, multiple myeloma, renal, breast, and prostate cancer. The majority of patients had radioresistant tumors (82.7%) and had an active primary site at presentation (67.5%). The median time from tumor diagnosis to cord compression was 12 months and the median time from identification of cord compression to death was 4 months. Preoperative presenting symptoms included motor weakness (70.8%), pain (70.1%), sensory disturbances (47.6%), and bowel or bladder disturbance (31.1%). The median estimated blood loss was 500 mL and the average length of hospital stay was 10.3 days. About 18% of patients had postoperative complications and the mean follow-up was 7 months. The mean pre- and postoperative ECOG (Eastern Cooperative Oncology Group) performance status grades were 3.2 and 2.4, respectively. At follow-up, 58.3% of patients had improved status, 31.5% had no improvement, and 10.0% had worsening of functional status. The mean QALY gained per year in the entire cohort was 0.55. The mean QALY gained in the first 6 months was 0.1 and in the first year was 0.4. For patients who lived 1-2, 2-3, 3-4, or 4-5 years, the mean QALY gained were 0.8, 1.4, 1.7, and 2.3, respectively. Preoperative motor weakness, bowel dysfunction, bladder dysfunction, and ASA (American Society of Anesthesiologists) class were identified as independent predictors inversely associated with good outcome. CONCLUSIONS: The mean QALY gained from surgical decompression in the first 6 months and first year equals 1.2 months and 5 months of life in perfect health, respectively. These findings suggest that surgery might also be beneficial to patients with life expectancy < 6 months.