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Background Transcranial direct-current stimulation (tDCS) has shown promise to decrease fatigue. However, it has never been examined in primary Sjogren Syndrome (pSS). Objective To assess the effect of a tDCS protocol on fatigue in patients with pSS. Methods This is a parallel, double-blind pilot study (NCT04119128). Women aged 18–65 years, with pSS, on stable pharmacological therapy, with complaints of fatigue for at least three months, and with scores >5 on Fatigue Severity Scale (FSS) were included. We randomized 36 participants to receive five consecutive or sham tDCS sessions, with an intensity of 2 mA, for 20 min/day. Results After five tDCS sessions, fatigue severity assessed by the FSS (primary outcome) demonstrated a mean group difference of −0.85 [95% confidence interval (CI) −1.57, −0.13; effect size 0.80] favouring the active group. The active group presented significantly greater reductions in fatigue as measured by the EULAR Sjogren’s Syndrome Patient Reported Index after five tDCS sessions [mean group difference: 1.40; 95%CI -2.33, −0.48; effect size 1.04]. Although there were no between-group differences in the secondary outcomes of sleep, mood and anxiety, within-group comparisons evidenced a small but significant difference in the active group for pain and sleep. There were no significant cortisol changes. All reported adverse events were mild and transitory. Conclusion tDCS seems to be safe and reduce fatigue in pSS. A differential effect on pain and sleep may underlie its effects. Further studies are needed to optimise tDCS treatment strategies in pSS.

SUMMARY The aim of this rapid systematic review is to analyze the prevalence of clinical, socioeconomic, and demographic characteristics, laboratory and imaging findings, diagnostic tests, and treatment information of older adults with COVID-19. To conduct this systematic review, the Cochrane Handbook recommendations will be followed. Patients aged 60 years or older with a confirmed diagnosis of SARS-CoV-2 infection will be included. A comprehensive literature search will be performed in the following databases: MEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Latin American and Caribbean Health Sciences Literature (LILACS), Spanish Bibliographic Index on Health Sciences (IBECS) and Epistemonikos COVID-19 L·OVE platform. No language restrictions will be applied. To assess the methodological quality of the included studies and the certainty of the evidence, the Newcastle-Ottawa Scale, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used. The meta-analysis will be performed using R software. We believe this rapid systematic review will be able to summarize the currently available evidence on clinical, socioeconomic characteristics, and management of COVID-19 in older adults. Therefore, it will help implement adequate strategies to fight the pandemic and assist in understanding the clinical profile of older patients with COVID-19, providing data with due scientific support upon which to base future choices of procedures and interventions. RESUMO O objetivo desta rápida revisão sistemática é analisar a prevalência de características clínicas, socioeconômicas e demográficas, achados laboratoriais e de imagem, testes de diagnóstico e informações de tratamento de idosos com COVID-19. Para conduzir esta revisão sistemática, serão seguidas as recomendações do Manual Cochrane. Pacientes com 60 anos ou mais com diagnóstico confirmado de infecção por Sars-CoV-2 serão incluídos. Uma pesquisa bibliográfica abrangente será realizada nas seguintes bases de dados: Medline via PubMed, Embase, Cochrane Central Register of Controlled Trials (Central), Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs), Índice Bibliográfico Espanhol em Ciências da Saúde (Ibecs) e Epistemonikos Plataforma COVID-19 L · OVE. Nenhuma restrição de idioma será aplicada. Para avaliar a qualidade metodológica e a certeza das evidências dos estudos incluídos, serão utilizadas a Escala Newcastle-Ottawa e a abordagem Grading of Recommendations Assessment, Development and Evaluation (Grade). A meta-análise será realizada no software R. Acreditamos que esta revisão sistemática rápida será capaz de resumir as evidências atualmente disponíveis sobre as características clínicas, socioeconômicas e sobre o manejo de idosos com COVID-19. Portanto, ajudará a implementar estratégias adequadas para combater a pandemia e ajudará a entender o perfil clínico de pacientes idosos com COVID-19, fornecendo dados com o devido apoio científico sobre o qual basear futuras escolhas de procedimentos e intervenções.

Objective To describe the laboratory parameters and biomarkers of the cytokine storm syndrome associated with severe and fatal COVID-19 cases. Methods A search with standardized descriptors and synonyms was performed on November 28th, 2020 of the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, LILACS, and IBECS to identify studies of interest. Grey literature searches and snowballing techniques were additionally utilized to identify yet-unpublished works and related citations. Two review authors independently screened the retrieved titles and abstracts, selected eligible studies for inclusion, extracted data from the included studies, and then assessed the risk of bias using the Newcastle-Ottawa Scale. Eligible studies were those including laboratory parameters—including serum interleukin-6 levels—from mild, moderate, or severe COVID-19 cases. Laboratory parameters, such as interleukin-6, ferritin, hematology, C-Reactive Protein, procalcitonin, lactate dehydrogenase, aspartate aminotransferase, creatinine, and D-dimer, were extracted from the studies. Meta-analyses were conducted using the laboratory data to estimate mean differences with associated 95% confidence intervals. Data synthesis The database search yielded 9,620 records; 40 studies (containing a total of 9,542 patients) were included in the final analysis. Twenty-one studies (n = 4,313) assessed laboratory data related to severe COVID-19 cases, eighteen studies (n = 4,681) assessed predictors for fatal COVID-19 cases and one study (n = 548) assessed laboratory biomarkers related to severe and fatal COVID-19 cases. Lymphopenia, thrombocytopenia, and elevated levels of interleukin-6, ferritin, D-dimer, aspartate aminotransferase, C-Reactive-Protein, procalcitonin, creatinine, neutrophils and leucocytes were associated with severe and fatal COVID-19 cases. Conclusions This review points to interleukin-6, ferritin, leukocytes, neutrophils, lymphocytes, platelets, C-Reactive Protein, procalcitonin, lactate dehydrogenase, aspartate aminotransferase, creatinine, and D-dimer as important biomarkers of cytokine storm syndrome. Elevated levels of interleukin-6 and hyperferritinemia should be considered as red flags of systemic inflammation and poor prognosis in COVID-19.

BACKGROUND: Patients with immune-mediated inflammatory diseases (IMID) are at increased risk of infection. OBJECTIVE: To assess whether patients undergoing pharmacological treatment for IMID present higher risk of worse outcomes when diagnosed with COVID-19. DESIGN AND SETTING: Rapid systematic review conducted in the medical school of the Federal University of São Paulo (SP), Brazil. METHODS: We searched CENTRAL, MEDLINE, EMBASE, LILACS, SCOPUS, Web of Science, L·OVE, ClinicalTrials.gov and WHO-ICTRP for studies evaluating patients diagnosed with COVID-19 who were undergoing pharmacological treatment for IMID. Two authors selected studies, extracted data and assessed risk of bias and certainty of evidence, following the Cochrane recommendations. RESULTS: We identified 1,498 references, from which one cohort study was included. This compared patients with and without rheumatic diseases (RD) who all had been diagnosed with COVID-19. Those with RD seemed to have higher chances of hospitalization and mortality, but no statistical difference was detected between the groups: hospitalization: odds ratio (OR) 1.17; 95% confidence interval (CI) 0.6 to 2.29; mortality rate: OR 1.53; 95% CI 0.33 to 7.11 (very low certainty of evidence). Patients with RD were three times more likely to require admission to intensive care units (ICUs), with invasive mechanical ventilation (IMV), than those without RD: OR 3.72; 95% CI 1.35 to 10.26 (for both outcomes; very low certainty of evidence). CONCLUSION: Patients undergoing pharmacological treatment for IMID seem to present higher chances of requiring admission to ICUs, with IMV. Additional high-quality studies are needed to analyze the effects of different treatments for IMID.

To synthesize findings of economic evaluations investigating cost-effectiveness of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) and of strategies of organization of care related to CPAP therapy. Scoping review with searches conducted in MEDLINE, CRD, LILACS, and Embase in August 2020. Eligible studies were economic evaluations comparing CPAP to other alternative or assessing strategies of care for CPAP therapy. Results were presented narratively, and incremental cost-effectiveness ratios (ICER) were presented in evidence maps. Of 34 studies, 3 concluded that CPAP is less costly and more effective when compared to usual care. Most studies indicated that CPAP is associated with better health outcomes, but at higher prices. ICER ranged from USD 316 to 98,793 per quality-adjusted life years (QALY) gained (median 16,499; IQR 8267 to 33,119). One study concluded that CPAP is more costly and less effective, when treatment is applied to all patients, regardless of disease severity. Variability of ICER was mainly due to definition of population and applied time horizons. When CPAP was compared to mandibular advancement device, ICER ranged from USD 21,153 to 361,028 (median 89,671; IQR 26,829 to 295,983), which represents the investment in CPAP therapy required to obtain one extra QALY. Three studies assessed the effects of organizing CPAP therapy in primary care, which was cost-effective or cost-saving. Compared to usual care, CPAP is cost-effective after the second year of treatment, when indicated for moderate-to-severe OSA. CPAP therapy may be even more cost-effective by using different strategies of organization of care. These findings may inform decision making related to CPAP reimbursement in health systems. Not applicable

BACKGROUND: The numbers of cases of arboviral diseases have increased in tropical and subtropical regions while the coronavirus disease (COVID-19) pandemic overwhelms healthcare systems worldwide. The clinical manifestations of arboviral diseases, especially dengue fever, can be very similar to COVID-19, and misdiagnoses are still a reality. In the meantime, outcomes for patients and healthcare systems in situations of possible syndemic have not yet been clarified. OBJECTIVE: We set out to conduct a systematic review to understand and summarize the evidence relating to clinical manifestations, disease severity and prognoses among patients coinfected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and arboviruses. METHODS: We conducted a rapid systematic review with meta-analysis, on prospective and retrospective cohorts, case-control studies and case series of patients with confirmed diagnoses of SARS-CoV-2 and arboviral infection. We followed the Cochrane Handbook recommendations. We searched EMBASE, MEDLINE, Cochrane Library, LILACS, Scopus and Web of Science to identify published, ongoing and unpublished studies. We planned to extract data and assess the risk of bias and the certainty of evidence of the studies included, using the Quality in Prognosis Studies tool and the Grading of Recommendations Assessment. RESULTS: We were able to retrieve 2,407 citations using the search strategy, but none of the studies fulfilled the inclusion criteria. CONCLUSION: The clinical presentations, disease severity and prognoses of patients coinfected with SARS-CoV-2 and arboviruses remain unclear. Further prospective studies are necessary in order to provide useful information for clinical decision-making processes. Protocol registration number in the PROSPERO database: CRD42020183460

To assess the effects of bilingualism compared to monolingualism on the clinical manifestation of Alzheimer’s Disease. Data from meta-analyses suggest that bilingual individuals exhibit Alzheimer’s Disease symptoms are diagnosed later than monolingual participants. Bilingualism may delay the manifestation of symptoms and diagnosis of Alzheimer’s Disease. To assess the effects of bilingualism compared to monolingualism on the clinical manifestation of Alzheimer’s disease. We searched the databases: MEDLINE, The Cochrane Central Register of Controlled Trials, Embase and LILACS, and searched by hand and in gray literature for studies published before September 2019. The quality of included studies was assessed using the Newcastle–Ottawa Scale. Two reviewers independently searched for studies, extracted data, and performed the quality assessment. Eight studies were included in this review. Data from meta-analyses suggest that bilingual individuals with Alzheimer's disease exhibit symptoms (694 participants; mean difference (MD) (4.05 years; 95% CI: 1.87–6.22 and are diagnosed later (1012 participants; MD 2.0 years; 95% CI: 0.08–3.92) than monolingual participants. Bilingualism may delay the manifestation of symptoms and diagnosis of Alzheimer’s disease. Further studies with more rigorous methodology are needed to improve the precision of the results.

Background Fibromyalgia is a heterogeneous condition that appears to be associated with physiological and biochemical disturbances of pain modulation, and that consequently affects numerous other facets of life. Tramadol is currently being explored as an option to manage fibromyalgia pain and other symptoms because of its inhibitory activity of reuptake of neurotransmitters, but its safety and efficacy have not yet been established in these patients. Objective To evaluate the effectiveness and safety of tramadol on the management of symptoms of the syndrome. Methods We searched CENTRAL, MEDLINE, EMBASE, LILACS, Opengrey, ClinicalTrials.gov and WHO-ICTRP for randomised controlled trials analysing the association between tramadol used for fibromyalgia either single-agent or in combination with other drugs. Two reviewers independently extracted data and assessed risk of bias using the Cochrane risk-of-bias tool for all included studies. Quality of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results Four RCTs comprising 459 patients were included. Tramadol-either as a single-agent or in combination with an antidepressant or analgesic-had a positive effect on pain. Tramadol combined with analgesic showed improved quality of life over placebo as measured by the Fibromyalgia Impact Questionnaire at 91 days. However, this difference did not hold for tramadol as a single agent against placebo. The evidence in these articles was rated "low" using the GRADE approach. No serious adverse events were reported. No improvement in depression and quality of sleep were observed. Conclusions This systematic review found a dearth of clinical trials on tramadol in patients with fibromyalgia. Although the combination of monoamine and opioid mechanism of tramadol has shown positive effects for fibromyalgia, the available evidence is not sufficient to support or refute the use of tramadol in clinical practice for pain or symptom management. Protocol registration number in the PROSPERO database: CRD42017062139.

Objective Shoulder pain and dysfunction are highly prevalent after neck dissection in the treatment of head and neck cancer (HNC). They can lead to muscle weakness, limited range of motion, and shoulder tilt and pain, which can reduce patient functioning. The purpose of this study was to evaluate the effectiveness of rehabilitation interventions for shoulder dysfunction in patients with surgically treated HNC. Methods A search of principal databases (MEDLINE, Embase, CENTRAL, LILACS, IBECS, PEDro, and SciELO) was conducted, in addition to hand searches and a search of gray literature, for all randomized clinical trials (RCTs) published before February 2020. Two authors independently selected all relevant studies. The 7 RCTs fulfilling all inclusion and exclusion criteria were assessed for risk of bias and certainty of evidence using the Cochrane Collaboration risk-of-bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool, respectively. Results Moderate-certainty evidence suggests that progressive resistance training is better than conventional treatment for improving pain and dysfunction in patients with HNC (pooled data from 214 participants; mean difference = −5.92; 95% CI = −11.38 to −0.45). Low-certainty evidence (data from 2 RCTs with 106 participants that could not be combined) suggests that acupuncture seems to be more effective than conventional treatment. Conclusions Progressive resistance training is effective for improving shoulder pain and dysfunction in patients with HNC. Further high-quality RCTs are needed to examine the effectiveness of acupuncture for improving shoulder pain and dysfunction in these patients. Future studies with longer follow-up times are needed to clarify the effects of early postoperative intervention. Impact Clinicians can have confidence that progressive resistance training in patients with surgically treated HNC is effective. Lay Summary These study results show that people with head and neck cancer can benefit from gradually increased resistance training to reduce shoulder pain and improve function. This study will help researchers design clinical trials to determine whether treatments such as acupuncture and early physical therapy also could be effective in treating this population.

BACKGROUND: Telemedicine has emerged as a tool for overcoming the challenges of healthcare systems and is likely to become increasingly viable, since information and communication technologies have become more sophisticated and user-friendly. OBJECTIVE: We aimed to identify all Cochrane systematic reviews (CSRs) on telemedicine within healthcare and to summarize the current evidence regarding its use. DESIGN AND SETTING: Review of CSRs, developed at the Discipline of Emergency and Evidence-Based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo. METHODS: We searched for studies that compared use of telemedicine with conventional treatment or management of diseases within healthcare. Diagnostic telemedicine studies or studies using automatic text, voice-text or even self-managed care were excluded. The main characteristics and the certainty of evidence were synthetized and critically discussed by all authors. RESULTS: We included 10 CSRs that investigated a broad range of diseases. There is still insufficient evidence to determine what types of telemedicine interventions are effective, for which patients and in which settings, and whether such interventions can be used as a replacement for the standard treatment. Harm relating to telemedicine technologies needs to be better investigated and addressed. CONCLUSION: Telemedicine might be an excellent way to facilitate access to treatment, monitoring and dissemination of important clinical knowledge. However, given the recognition of systematic reviews as the best evidence resource available for decision-making, further randomized controlled trials with stricter methods are necessary to reduce the uncertainties in evidence-based use of telemedicine.

Background: Knee osteoarthritis (OA) has been the main cause behind chronic pain and disabilities in the elderly population. The traditional treatment for knee OA pain currently concerns a number of combinations of pharmacological and nonpharmacological therapies. However, such combinations have displayed little effects on a significant group of subjects. In addition to this, pharmacological treatments often cause adverse effects, which limits their use on this population. Previous studies showed that chronic knee OA pain may be associated with maladaptive compensatory plasticity in pain-related neural central circuits indexed by a defective descending pain-inhibitory system. Transcranial direct current stimulation (tDCS) can revert some of these maladaptive changes, thus decreasing chronic pain sensation. Numerous studies have demonstrated that the use of anodal tDCS stimulation over the primary motor cortex (M1) has positive effects on chronic neuropathic pain. Yet, data on OA pain in elderly patients, including its effects on the endogenous pain-inhibitory system, remain limited. Objective: The objective of this study is to evaluate the efficacy of tDCS in reducing pain intensity caused by knee OA in elderly subjects with defective endogenous pain-inhibitory systems. Methods: We designed a randomized, sham-controlled, single-center, double-blinded clinical trial. Patients with knee OA who have maintained a chronic pain level during the previous 6 months and report a pain score of 4 or more on a 0-10 numeric rating scale (NRS) for pain in that period will undergo a conditioned pain modulation (CPM) task. Participants who present a reduced CPM response, defined as a decrease in NRS during the CPM task of less than 10%, and meet all of the inclusion criteria will be randomly assigned to receive 15 sessions of 2 mA active or sham tDCS for 20 minutes. A sample size of 94 subjects was calculated. The Brief Pain Inventory pain items will be used to assess pain intensity as our primary outcome. Secondary outcomes will include pain impact on functioning, mobility performance, quality of life, CPM, pressure pain threshold, touch-test sensory evaluation, and safety. Follow-up visits will be performed 2, 4, and 8 weeks following intervention. The data will be analyzed using the principle of intention-to-treat. Results: This study was approved by the institutional review board with the protocol number 1685/2016. The enrollment started in April 2018; at the time of publication of this protocol, 25 subjects have been enrolled. We estimate we will complete the enrollment process within 2 years. Conclusions: This clinical trial will provide relevant data to evaluate if anodal tDCS stimulation over M1 can decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will advance the investigation of the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it. Trial Registration: ClinicalTrials.gov NCT03117231; https://clinicaltrials.gov/ct2/show/NCT03117231 (Archived by WebCite at http://webcitation.org/73WM1LCdJ) International Registered Report Identifier (IRRID): RR1-10.2196/11660