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BACKGROUND: Peripheral intravenous catheters (PIVCs) contribute substantially to the global burden of infections. This systematic review assessed 24 infection prevention and control (IPC) interventions to prevent PIVC-associated infections and other complications. METHODS: We searched Ovid MEDLINE, Embase, Cochrane Library, WHO Global Index Medicus, CINAHL, and reference lists for controlled studies from 1 January 1980-16 March 2023. We dually selected studies, assessed risk of bias, extracted data, and rated the certainty of evidence (COE). For outcomes with 3 or more trials, we conducted Bayesian random-effects meta-analyses. RESULTS: 105 studies met our prespecified eligibility criteria, addressing 16 of the 24 research questions; no studies were identified for 8 research questions. Based on findings of low to high COE, wearing gloves reduced the risk of overall adverse events related to insertion compared with no gloves (1 non-randomized controlled trial [non-RCT]; adjusted risk ratio [RR], .52; 95% CI, .33-.85), and catheter removal based on defined schedules potentially resulted in a lower phlebitis/thrombophlebitis incidence (10 RCTs; RR, 0.74, 95% credible interval, .49-1.01) compared with clinically indicated removal in adults. In neonates, chlorhexidine reduced the phlebitis score compared with non-chlorhexidine-containing disinfection (1 RCT; 0.14 vs 0.68; P = .003). No statistically significant differences were found for other measures. CONCLUSIONS: Despite their frequent use and concern about PIVC-associated complications, this review underscores the urgent need for more high-quality studies on effective IPC methods regarding safe PIVC management. In the absence of valid evidence, adherence to standard precaution measures and documentation remain the most important principles to curb PIVC complications. CLINICAL TRIALS REGISTRATION: The protocol was registered in the Open Science Framework (https://osf.io/exdb4).
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Infecções Relacionadas a Cateter , Cateterismo Periférico , Humanos , Infecções Relacionadas a Cateter/prevenção & controle , Cateterismo Periférico/efeitos adversos , Controle de Infecções/métodos , Flebite/prevenção & controle , Flebite/etiologia , Flebite/epidemiologia , Teorema de BayesRESUMO
BACKGROUND: Major depressive disorder (MDD) is the most prevalent, disabling form of depression, with a high economic effect. PURPOSE: To assess evidence on cost-effectiveness of pharmacologic and nonpharmacologic interventions as first- and second-step treatments in patients with MDD. DATA SOURCES: Multiple electronic databases limited to English language were searched (1 January 2015 to 29 November 2022). STUDY SELECTION: Two investigators independently screened the literature. Seven economic modeling studies fulfilled the eligibility criteria. DATA EXTRACTION: Data abstraction by a single investigator was confirmed by a second; 2 investigators independently rated risk of bias. One investigator determined certainty of evidence, and another checked for plausibility. DATA SYNTHESIS: Seven modeling studies met the eligibility criteria. In a U.S. setting over a 5-year time horizon, cognitive behavioral therapy (CBT) was cost-effective compared with second-generation antidepressants (SGAs) as a first-step treatment from the societal and health care sector perspectives. However, the certainty of evidence is low, and the findings should be interpreted cautiously. For second-step treatment, only switch strategies between SGAs were assessed. The evidence is insufficient to draw any conclusions. LIMITATIONS: Methodologically heterogeneous studies, which compared only CBT and some SGAs, were included. No evidence on other psychotherapies or complementary and alternative treatments as first-step treatment or augmentation strategies as second-step treatment was available. CONCLUSION: Although CBT may be cost-effective compared with SGAs as a first-step treatment at a 5-year time horizon from the societal and health care sector perspectives, the certainty of evidence is low, and the findings need to be interpreted cautiously. For other comparisons, the evidence was entirely missing or insufficient to draw conclusions. PRIMARY FUNDING SOURCE: American College of Physicians.
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Antidepressivos de Segunda Geração , Terapia Cognitivo-Comportamental , Transtorno Depressivo Maior , Humanos , Transtorno Depressivo Maior/terapia , Análise Custo-Benefício , Psicoterapia , Antidepressivos de Segunda Geração/uso terapêuticoRESUMO
BACKGROUND: Developers of clinical practice guidelines need to take patient values and preferences into consideration when weighing benefits and harms of treatment options for depressive disorder. PURPOSE: To assess patient values and preferences regarding pharmacologic and nonpharmacologic treatments of depressive disorder. DATA SOURCES: MEDLINE (Ovid) and PsycINFO (EBSCO) were searched for eligible studies published from 1 January 2014 to 30 November 2022. STUDY SELECTION: Pairs of reviewers independently screened 30% of search results. The remaining 70% of the abstracts were screened by single reviewers; excluded abstracts were checked by a second reviewer. Pairs of reviewers independently screened full texts. DATA EXTRACTION: One reviewer extracted data and assessed the certainty of evidence, and a second reviewer checked for completeness and accuracy. Two reviewers independently assessed risk of bias. DATA SYNTHESIS: The review included 11 studies: 4 randomized controlled trials, 5 cross-sectional studies, and 2 qualitative studies. In 1 randomized controlled trial, participants reported at the start of therapy that they expected supportive-expressive psychotherapy and antidepressants to yield similar improvements. A cross-sectional study reported that non-Hispanic White participants and men generally preferred antidepressants over talk therapy, whereas Hispanic and non-Hispanic Black participants and women generally did not have a preference. Another cross-sectional study reported that the most important nonserious adverse events for patients treated with antidepressants were insomnia, anxiety, fatigue, weight gain, agitation, and sexual dysfunction. For other comparisons and outcomes, no conclusions could be drawn because of the insufficient certainty of evidence. LIMITATIONS: The main limitation of this review is the low or insufficient certainty of evidence for most outcomes. No evidence was available on second-step depression treatment or differences in values and preferences based on gender, race/ethnicity, age, and depression severity. CONCLUSION: Low-certainty evidence suggests that there may be some differences in preferences for talk therapy or pharmacologic treatment of depressive disorders based on gender or race/ethnicity. In addition, low-certainty evidence suggests that insomnia, anxiety, fatigue, weight gain, agitation, and sexual dysfunction may be the most important nonserious adverse events for patients treated with antidepressants. Evidence is lacking or insufficient to draw any further conclusions about patients' weighing or valuation of the benefits and harms of depression treatments. PRIMARY FUNDING SOURCE: American College of Physicians. (PROSPERO: CRD42020212442).
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Transtorno Depressivo , Distúrbios do Início e da Manutenção do Sono , Masculino , Humanos , Feminino , Estudos Transversais , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Antidepressivos/efeitos adversos , FadigaRESUMO
BACKGROUND: Primary care patients and clinicians may prefer alternative options to second-generation antidepressants for major depressive disorder (MDD). PURPOSE: To compare the benefits and harms of nonpharmacologic treatments with second-generation antidepressants as first-step interventions for acute MDD, and to compare second-step treatment strategies for patients who did not achieve remission after an initial attempt with antidepressants. DATA SOURCES: English-language studies from several electronic databases from 1 January 1990 to 8 August 2022, trial registries, gray literature databases, and reference lists to identify unpublished research. STUDY SELECTION: 2 investigators independently selected randomized trials of at least 6 weeks' duration. DATA EXTRACTION: Reviewers abstracted data about study design and conduct, participants, interventions, and outcomes. They dually rated the risk of bias of studies and the certainty of evidence for outcomes of interest. DATA SYNTHESIS: 65 randomized trials met the inclusion criteria; eligible data from nonrandomized studies were not found. Meta-analyses and network meta-analyses indicated similar benefits of most nonpharmacologic treatments and antidepressants as first-step treatments. Antidepressants had higher risks for discontinuation because of adverse events than most other treatments. For second-step therapies, different switching and augmentation strategies provided similar symptomatic relief. The certainty of evidence for most comparisons is low; findings should be interpreted cautiously. LIMITATIONS: Many studies had methodological limitations or dosing inequalities; publication bias might have affected some comparisons. In some cases, conclusions could not be drawn because of insufficient evidence. CONCLUSION: Although benefits seem to be similar among first- and second-step MDD treatments, the certainty of evidence is low for most comparisons. Clinicians and patients should focus on options with the most reliable evidence and take adverse event profiles and patient preferences into consideration. PRIMARY FUNDING SOURCE: American College of Physicians. (PROSPERO: CRD42020204703).
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Antidepressivos de Segunda Geração , Transtorno Depressivo Maior , Médicos , Humanos , Adulto , Transtorno Depressivo Maior/tratamento farmacológico , Metanálise em Rede , Antidepressivos/uso terapêutico , Antidepressivos de Segunda Geração/efeitos adversosRESUMO
Emotions are at the core of all human experiences, but talking about emotions is challenging, particularly in the context of medical encounters focused on somatic symptoms. Transparent, normalizing, and validating communication about the mind-body connection opens the door for respectful, open dialogue between the family and members of the care team, acknowledging the lived experience that is brought to the table in understanding the problem and co-creating a solution.
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OBJECTIVE: After concussion, approximately 30% of adolescents experience symptoms that persist beyond 1 month postinjury. For some, these symptoms affect functioning, development, and quality of life. Somatization, where psychological distress contributes to physical symptoms, may contribute to persistent symptoms after concussion in some adolescents. Understanding how clinicians identify somatization in adolescents with persistent symptoms after concussion in practice is a critical next step in improving our understanding, identification, and subsequent treatment of somatization in this patient population. To address this, the investigators assessed and compared characteristics of adolescents with persistent symptoms after concussion with and without clinician-identified somatization. METHODS: Participants were adolescents (N=94) referred for persistent symptoms after concussion to a specialty youth concussion clinic between January 2016 and May 2018. A retrospective chart review extracted demographic and injury characteristics, symptoms after concussion, school attendance, premorbid experiences, mental health, and medical service use. Participants with physician-identified somatization were compared with those without physician-identified somatization on these measures. RESULTS: Adolescents with identified somatization had more severe and atypical neurological and psychiatric symptoms after concussion and more postinjury impairment in school attendance, were more likely to have a history of premorbid chronic pain or medically unexplained symptoms, and obtained more neuroimaging and health care after injury compared with those unaffected by somatization. They did not differ in mood or anxiety symptom self-reports. CONCLUSIONS: This study identified characteristic differences and similarities in adolescents with and without clinician-identified somatization after a prolonged concussion recovery. These findings have the potential to improve clinical identification of somatization in youths following a concussion and may aid in treatment among this demographic group.
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Concussão Encefálica , Sintomas Inexplicáveis , Síndrome Pós-Concussão , Adolescente , Ansiedade , Concussão Encefálica/complicações , Concussão Encefálica/epidemiologia , Humanos , Síndrome Pós-Concussão/epidemiologia , Síndrome Pós-Concussão/etiologia , Qualidade de Vida , Estudos RetrospectivosRESUMO
BACKGROUND: Dyspnea is a common and often debilitating symptom with a complex diagnostic work-up. PURPOSE: To evaluate the benefits, harms, and diagnostic test accuracy of point-of-care ultrasonography (POCUS) in patients with acute dyspnea. (PROSPERO: CRD42019126419). DATA SOURCES: Searches of multiple electronic databases without language limitations (January 2004 to August 2020) and reference lists of pertinent articles and reviews. STUDY SELECTION: Five randomized controlled trials (RCTs) and 44 prospective cohort-type studies in patients with acute dyspnea evaluated POCUS as a diagnostic tool to determine the underlying cause of dyspnea. Two investigators independently screened the literature for inclusion. DATA EXTRACTION: Data abstraction by a single investigator was confirmed by a second investigator; 2 investigators independently rated risk of bias and determined certainty of evidence. DATA SYNTHESIS: Point-of-care ultrasonography, when added to a standard diagnostic pathway, led to statistically significantly more correct diagnoses in patients with dyspnea than the standard diagnostic pathway alone. In-hospital mortality and length of hospital stay did not differ significantly between patients who did or did not receive POCUS in addition to standard diagnostic tests. Finally, POCUS consistently improved the sensitivities of standard diagnostic pathways to detect congestive heart failure, pneumonia, pulmonary embolism, pleural effusion, or pneumothorax; specificities increased in most but not all studies. LIMITATIONS: Most studies assessed diagnostic test accuracy, which has limited utility for clinical decision making. Studies rarely reported on the proportion of indeterminate sonography results, and no evidence is available on adverse health outcomes of false-positive or false-negative POCUS results. CONCLUSION: Point-of-care ultrasonography can improve the correctness of diagnosis in patients with acute dyspnea. PRIMARY FUNDING SOURCE: American College of Physicians.
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Dispneia/diagnóstico por imagem , Dispneia/etiologia , Testes Imediatos , Ultrassonografia , Doença Aguda , Procedimentos Clínicos , Mortalidade Hospitalar , Humanos , Tempo de Internação , Readmissão do Paciente , Guias de Prática Clínica como Assunto , Sensibilidade e Especificidade , Ultrassonografia/efeitos adversosRESUMO
BACKGROUND: Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light therapy, or psychotherapy. OBJECTIVES: To assess the efficacy and safety of second-generation antidepressants (SGAs) for the treatment of seasonal affective disorder (SAD) in adults in comparison with placebo, light therapy, other SGAs, or psychotherapy. SEARCH METHODS: This is an update of an earlier review first published in 2011. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 1) in the Cochrane Library (all years), Ovid MEDLINE, Embase, and PsycINFO (2011 to January 2020), together with the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) (all available years), for reports of randomised controlled trials (RCTs). We hand searched the reference lists of all included studies and other systematic reviews. We searched ClinicalTrials.gov for unpublished/ongoing trials. We ran a separate update search for reports of adverse events in the Ovid databases. SELECTION CRITERIA: For efficacy we included RCTs of SGAs compared with other SGAs, placebo, light therapy, or psychotherapy in adult participants with SAD. For adverse events we also included non-randomised studies. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts and full-text publications against the inclusion criteria. Data extraction and 'Risk of bias' assessment were conducted individually. We pooled data for meta-analysis where the participant groups were similar, and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment. MAIN RESULTS: In this update we identified no new RCT on the effectiveness of SGAs in SAD patients. We included 2 additional single-arm observational studies that reported on adverse events of SGAs. For efficacy we included three RCTs of between five and eight weeks' duration with a total of 204 participants. For adverse events we included two RCTs and five observational (non-randomised) studies of five to eight weeks' duration with a total of 249 participants. All participants met the DSM (Diagnostic and Statistical Manual of Mental Disorders) criteria for SAD. The average age ranged from 34 to 42 years, and the majority of participants were female (66% to 100%). Results from one trial with 68 participants showed that fluoxetine (20/36) was numerically superior to placebo (11/32) in achieving clinical response; however, the confidence interval (CI) included both a potential benefit as well as no benefit of fluoxetine (risk ratio (RR) 1.62, 95% CI 0.92 to 2.83, very low-certainty evidence). The number of adverse events was similar in both groups (very low-certainty evidence). Two trials involving a total of 136 participants compared fluoxetine versus light therapy. Meta-analysis showed fluoxetine and light therapy to be approximately equal in treating seasonal depression: RR of response 0.98 (95% CI 0.77 to 1.24, low-certainty evidence), RR of remission 0.81 (95% CI 0.39 to 1.71, very low-certainty evidence). The number of adverse events was similar in both groups (low-certainty evidence). We did not identify any eligible study comparing SGA with another SGA or with psychotherapy. Two RCTs and five non-randomised studies reported adverse event data on a total of 249 participants who received bupropion, fluoxetine, escitalopram, duloxetine, nefazodone, reboxetine, light therapy, or placebo. We were only able to obtain crude rates of adverse events, therefore caution is advised regarding interpretation of this information. Between 0% and 100% of participants who received an SGA suffered an adverse event, and between 0% and 25% of participants withdrew from the study due to adverse events. AUTHORS' CONCLUSIONS: Evidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo showing a non-significant effect in favour of fluoxetine, and two small trials comparing fluoxetine against light therapy suggesting equivalence between the two interventions. The lack of available evidence precluded us from drawing any overall conclusions on the use of SGAs for SAD. Further, larger RCTs are required to expand and strengthen the evidence base on this topic, and should also include comparisons with psychotherapy and other SGAs. Data on adverse events were sparse, and a comparative analysis was not possible. The data we obtained on adverse events is therefore not robust, and our confidence in the data is limited. Overall, up to 25% of participants treated with SGAs for SAD withdrew from the study early due to adverse events.
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Antidepressivos de Segunda Geração/uso terapêutico , Transtorno Afetivo Sazonal/tratamento farmacológico , Adulto , Antidepressivos de Segunda Geração/efeitos adversos , Viés , Citalopram/efeitos adversos , Citalopram/uso terapêutico , Cloridrato de Duloxetina/efeitos adversos , Cloridrato de Duloxetina/uso terapêutico , Feminino , Fluoxetina/efeitos adversos , Fluoxetina/uso terapêutico , Humanos , Masculino , Morfolinas/efeitos adversos , Morfolinas/uso terapêutico , Estudos Observacionais como Assunto , Fototerapia , Placebos/uso terapêutico , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Reboxetina/uso terapêutico , Transtorno Afetivo Sazonal/terapia , Tiofenos/efeitos adversos , Tiofenos/uso terapêutico , Resultado do TratamentoRESUMO
OBJECTIVES: Pain and other physical symptoms commonly co-occur in childhood. There is debate about the relevance of somatization in understanding pain. The present review critically appraised and synthesized the extant literature on the relationship between pediatric pain and somatization. METHODS: A systematic review (PROSPERO registration #95956) was conducted in Medline, PsycINFO, EMBASE, and CINAHL using search terms related to pain and somatization in children and adolescents. A total of 156 articles were eligible for inclusion in the review. For studies that measured somatization using a symptom questionnaire, descriptions of "somatization" were extracted. Data regarding the relationship between pain and somatization were extracted for studies measuring somatization using a diagnostic category (e.g., Somatic Symptom and Related Disorders [SSRDs]). RESULTS: While many studies using somatic symptom questionnaires described somatization as having a psychological component, this was not always captured in measurement tools. Pain was reported as a common symptom in patients with an SSRD diagnosis, though rates varied depending on the specific diagnosis and pain location. Rates of SSRD diagnoses among pain patients were less frequent than rates of pain amongst SSRD patients. CONCLUSIONS: SSRDs and pain commonly co-occur, though rates differ depending on diagnosis and pain location. Understanding the relationship between pain and somatization is complicated by the discrepancy between how somatization is defined and measured in questionnaire studies. A comprehensive and measurable definition of somatization is needed so researchers can better identify the shared and unique contributions of pain and somatization in pediatric populations.
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Dor/complicações , Transtornos Somatoformes/complicações , Adolescente , Criança , Feminino , Humanos , Masculino , Dor/fisiopatologia , Transtornos Somatoformes/fisiopatologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly emerging disease classified as a pandemic by the World Health Organization (WHO). To support the WHO with their recommendations on quarantine, we conducted a rapid review on the effectiveness of quarantine during severe coronavirus outbreaks. OBJECTIVES: To assess the effects of quarantine (alone or in combination with other measures) of individuals who had contact with confirmed or suspected cases of COVID-19, who travelled from countries with a declared outbreak, or who live in regions with high disease transmission. SEARCH METHODS: An information specialist searched the Cochrane COVID-19 Study Register, and updated the search in PubMed, Ovid MEDLINE, WHO Global Index Medicus, Embase, and CINAHL on 23 June 2020. SELECTION CRITERIA: Cohort studies, case-control studies, time series, interrupted time series, case series, and mathematical modelling studies that assessed the effect of any type of quarantine to control COVID-19. We also included studies on SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) as indirect evidence for the current coronavirus outbreak. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts and titles in duplicate. Two review authors then independently screened all potentially relevant full-text publications. One review author extracted data, assessed the risk of bias and assessed the certainty of evidence with GRADE and a second review author checked the assessment. We used three different tools to assess risk of bias, depending on the study design: ROBINS-I for non-randomised studies of interventions, a tool provided by Cochrane Childhood Cancer for non-randomised, non-controlled studies, and recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) for modelling studies. We rated the certainty of evidence for the four primary outcomes: incidence, onward transmission, mortality, and costs. MAIN RESULTS: We included 51 studies; 4 observational studies and 28 modelling studies on COVID-19, one observational and one modelling study on MERS, three observational and 11 modelling studies on SARS, and three modelling studies on SARS and other infectious diseases. Because of the diverse methods of measurement and analysis across the outcomes of interest, we could not conduct a meta-analysis and undertook a narrative synthesis. We judged risk of bias to be moderate for 2/3 non-randomized studies of interventions (NRSIs) and serious for 1/3 NRSI. We rated risk of bias moderate for 4/5 non-controlled cohort studies, and serious for 1/5. We rated modelling studies as having no concerns for 13 studies, moderate concerns for 17 studies and major concerns for 13 studies. Quarantine for individuals who were in contact with a confirmed/suspected COVID-19 case in comparison to no quarantine Modelling studies consistently reported a benefit of the simulated quarantine measures, for example, quarantine of people exposed to confirmed or suspected cases may have averted 44% to 96% of incident cases and 31% to 76% of deaths compared to no measures based on different scenarios (incident cases: 6 modelling studies on COVID-19, 1 on SARS; mortality: 2 modelling studies on COVID-19, 1 on SARS, low-certainty evidence). Studies also indicated that there may be a reduction in the basic reproduction number ranging from 37% to 88% due to the implementation of quarantine (5 modelling studies on COVID-19, low-certainty evidence). Very low-certainty evidence suggests that the earlier quarantine measures are implemented, the greater the cost savings may be (2 modelling studies on SARS). Quarantine in combination with other measures to contain COVID-19 in comparison to other measures without quarantine or no measures When the models combined quarantine with other prevention and control measures, such as school closures, travel restrictions and social distancing, the models demonstrated that there may be a larger effect on the reduction of new cases, transmissions and deaths than measures without quarantine or no interventions (incident cases: 9 modelling studies on COVID-19; onward transmission: 5 modelling studies on COVID-19; mortality: 5 modelling studies on COVID-19, low-certainty evidence). Studies on SARS and MERS were consistent with findings from the studies on COVID-19. Quarantine for individuals travelling from a country with a declared COVID-19 outbreak compared to no quarantine Very low-certainty evidence indicated that the effect of quarantine of travellers from a country with a declared outbreak on reducing incidence and deaths may be small for SARS, but might be larger for COVID-19 (2 observational studies on COVID-19 and 2 observational studies on SARS). AUTHORS' CONCLUSIONS: The current evidence is limited because most studies on COVID-19 are mathematical modelling studies that make different assumptions on important model parameters. Findings consistently indicate that quarantine is important in reducing incidence and mortality during the COVID-19 pandemic, although there is uncertainty over the magnitude of the effect. Early implementation of quarantine and combining quarantine with other public health measures is important to ensure effectiveness. In order to maintain the best possible balance of measures, decision makers must constantly monitor the outbreak and the impact of the measures implemented. This review was originally commissioned by the WHO and supported by Danube-University-Krems. The update was self-initiated by the review authors.
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COVID-19/prevenção & controle , Modelos Teóricos , Pandemias , Saúde Pública , Quarentena , Viés , COVID-19/epidemiologia , COVID-19/mortalidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/prevenção & controle , Humanos , Incidência , Estudos Observacionais como Assunto , Distanciamento Físico , SARS-CoV-2/patogenicidade , Instituições Acadêmicas , Síndrome Respiratória Aguda Grave/epidemiologia , Síndrome Respiratória Aguda Grave/mortalidade , Síndrome Respiratória Aguda Grave/prevenção & controle , Viagem , Organização Mundial da SaúdeRESUMO
BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly emerging disease that has been classified a pandemic by the World Health Organization (WHO). To support WHO with their recommendations on quarantine, we conducted a rapid review on the effectiveness of quarantine during severe coronavirus outbreaks. OBJECTIVES: We conducted a rapid review to assess the effects of quarantine (alone or in combination with other measures) of individuals who had contact with confirmed cases of COVID-19, who travelled from countries with a declared outbreak, or who live in regions with high transmission of the disease. SEARCH METHODS: An information specialist searched PubMed, Ovid MEDLINE, WHO Global Index Medicus, Embase, and CINAHL on 12 February 2020 and updated the search on 12 March 2020. WHO provided records from daily searches in Chinese databases up to 16 March 2020. SELECTION CRITERIA: Cohort studies, case-control-studies, case series, time series, interrupted time series, and mathematical modelling studies that assessed the effect of any type of quarantine to control COVID-19. We also included studies on SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) as indirect evidence for the current coronavirus outbreak. DATA COLLECTION AND ANALYSIS: Two review authors independently screened 30% of records; a single review author screened the remaining 70%. Two review authors screened all potentially relevant full-text publications independently. One review author extracted data and assessed evidence quality with GRADE and a second review author checked the assessment. We rated the certainty of evidence for the four primary outcomes: incidence, onward transmission, mortality, and resource use. MAIN RESULTS: We included 29 studies; 10 modelling studies on COVID-19, four observational studies and 15 modelling studies on SARS and MERS. Because of the diverse methods of measurement and analysis across the outcomes of interest, we could not conduct a meta-analysis and conducted a narrative synthesis. Due to the type of evidence found for this review, GRADE rates the certainty of the evidence as low to very low. Modeling studies consistently reported a benefit of the simulated quarantine measures, for example, quarantine of people exposed to confirmed or suspected cases averted 44% to 81% incident cases and 31% to 63% of deaths compared to no measures based on different scenarios (incident cases: 4 modelling studies on COVID-19, SARS; mortality: 2 modelling studies on COVID-19, SARS, low-certainty evidence). Very low-certainty evidence suggests that the earlier quarantine measures are implemented, the greater the cost savings (2 modelling studies on SARS). Very low-certainty evidence indicated that the effect of quarantine of travellers from a country with a declared outbreak on reducing incidence and deaths was small (2 modelling studies on SARS). When the models combined quarantine with other prevention and control measures, including school closures, travel restrictions and social distancing, the models demonstrated a larger effect on the reduction of new cases, transmissions and deaths than individual measures alone (incident cases: 4 modelling studies on COVID-19; onward transmission: 2 modelling studies on COVID-19; mortality: 2 modelling studies on COVID-19; low-certainty evidence). Studies on SARS and MERS were consistent with findings from the studies on COVID-19. AUTHORS' CONCLUSIONS: Current evidence for COVID-19 is limited to modelling studies that make parameter assumptions based on the current, fragmented knowledge. Findings consistently indicate that quarantine is important in reducing incidence and mortality during the COVID-19 pandemic. Early implementation of quarantine and combining quarantine with other public health measures is important to ensure effectiveness. In order to maintain the best possible balance of measures, decision makers must constantly monitor the outbreak situation and the impact of the measures implemented. Testing in representative samples in different settings could help assess the true prevalence of infection, and would reduce uncertainty of modelling assumptions. This review was commissioned by WHO and supported by Danube-University-Krems.
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Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Atividades Humanas , Mortalidade , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Quarentena , Betacoronavirus/patogenicidade , COVID-19 , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/transmissão , Monitoramento Epidemiológico , Medicina Baseada em Evidências , Saúde Global , Humanos , Incidência , Mortalidade/tendências , Pneumonia Viral/epidemiologia , Pneumonia Viral/transmissão , Saúde Pública , SARS-CoV-2 , ViagemRESUMO
BACKGROUND: Lead exposure is a serious health hazard, especially for children. It is associated with physical, cognitive and neurobehavioural impairment in children. There are many potential sources of lead in the environment, therefore trials have tested many household interventions to prevent or reduce lead exposure. This is an update of a previously published review. OBJECTIVES: To assess the effects of household interventions intended to prevent or reduce further lead exposure in children on improvements in cognitive and neurobehavioural development, reductions in blood lead levels and reductions in household dust lead levels. SEARCH METHODS: In March 2020, we updated our searches of CENTRAL, MEDLINE, Embase, 10 other databases and ClinicalTrials.gov. We also searched Google Scholar, checked the reference lists of relevant studies and contacted experts to identify unpublished studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs of household educational or environmental interventions, or combinations of interventions to prevent lead exposure in children (from birth to 18 years of age), where investigators reported at least one standardised outcome measure. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed all eligible studies for inclusion, assessed risk of bias and extracted data. We contacted trialists to obtain missing information. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 17 studies (three new to this update), involving 3282 children: 16 RCTs (involving 3204 children) and one quasi-RCT (involving 78 children). Children in all studies were under six years of age. Fifteen studies took place in urban areas of North America, one in Australia and one in China. Most studies were in areas with low socioeconomic status. Girls and boys were equally represented in those studies reporting this information. The duration of the intervention ranged from three months to 24 months in 15 studies, while two studies performed interventions on a single occasion. Follow-up periods ranged from three months to eight years. Three RCTs were at low risk of bias in all assessed domains. The other 14 studies were at unclear or high risk of bias; for example, we considered two RCTs and one quasi-RCT at high risk of selection bias and six RCTs at high risk of attrition bias. National or international research grants or governments funded 15 studies, while the other two did not report their funding sources. Education interventions versus no intervention None of the included studies in this comparison assessed effects on cognitive or neurobehavioural outcomes, or adverse events. All studies reported data on blood lead level outcomes. Educational interventions showed there was probably no evidence of a difference in reducing blood lead levels (continuous: mean difference (MD) -0.03, 95% confidence interval (CI) -0.13 to 0.07; I² = 0%; 5 studies, 815 participants; moderate-certainty evidence; log-transformed data), or in reducing floor dust levels (MD -0.07, 95% CI -0.37 to 0.24; I² = 0%; 2 studies, 318 participants; moderate-certainty evidence). Environmental interventions versus no intervention Dust control: one study in this comparison reported data on cognitive and neurobehavioural outcomes, and on adverse events in children. The study showed numerically there may be better neurobehavioural outcomes in children of the intervention group. However, differences were small and the CI included both a beneficial and non-beneficial effect of the environmental intervention (e.g. mental development (Bayley Scales of Infant Development-II): MD 0.1, 95% CI -2.1 to 2.4; 1 study, 302 participants; low-certainty evidence). The same study did not observe any adverse events related to the intervention during the eight-year follow-up, but observed two children with adverse events in the control group (1 study, 355 participants; very low-certainty evidence). Meta-analysis also found no evidence of effectiveness on blood lead levels (continuous: MD -0.02, 95% CI -0.09 to 0.06; I² = 0%; 4 studies, 565 participants; moderate-certainty evidence; log-transformed data). We could not pool the data regarding floor dust levels, but studies reported that there may be no evidence of a difference between the groups (very low-certainty evidence). Soil abatement: the two studies assessing this environmental intervention only reported on the outcome of 'blood lead level'. One study showed a small effect on blood lead level reduction, while the other study showed no effect. Therefore, we deem the current evidence insufficient to draw conclusions about the effectiveness of soil abatement (very low-certainty evidence). Combination of educational and environmental interventions versus standard education Studies in this comparison only reported on blood lead levels and dust lead levels. We could not pool the studies in a meta-analysis due to substantial differences between the studies. Since the studies reported inconsistent results, the evidence is currently insufficient to clarify whether a combination of interventions reduces blood lead levels and floor dust levels (very low-certainty evidence). AUTHORS' CONCLUSIONS: Based on available evidence, household educational interventions and environmental interventions (namely dust control measures) show no evidence of a difference in reducing blood lead levels in children as a population health measure. The evidence of the effects of environmental interventions on cognitive and neurobehavioural outcomes and adverse events is uncertain too. Further trials are required to establish the most effective intervention for reducing or even preventing further lead exposure. Key elements of these trials should include strategies to reduce multiple sources of lead exposure simultaneously using empirical dust clearance levels. It is also necessary for trials to be carried out in low- and middle-income countries and in differing socioeconomic groups in high-income countries.
Assuntos
Poeira/prevenção & controle , Exposição Ambiental/prevenção & controle , Recuperação e Remediação Ambiental/métodos , Intoxicação por Chumbo/prevenção & controle , Prevenção Secundária/métodos , Viés , Pré-Escolar , Poeira/análise , Feminino , Pisos e Cobertura de Pisos , Humanos , Lactente , Chumbo/sangue , Masculino , Pintura/toxicidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Poluentes do SoloRESUMO
Objective: Acute agitation in pediatrics is commonly encountered in hospital settings, can contribute to significant physical and psychological distress, and management is highly varied in practice. As such, the development of a standardized pharmacologic guideline is paramount. We aimed to develop a novel clinical pathway (CP) for management of acute agitation for all hospitalized pediatric patients in Canada. Methods: Healthcare professionals in Canada with expertise in treating and managing pediatric agitation formed a working group and developed a CP through conducting a literature review, engaging key partners, and obtaining interdisciplinary consensus (iterative real-time discussions with content experts). Once developed, the preliminary CP was presented to additional internal and external partners via multiple grand rounds and a webinar; feedback from participants guided final CP revisions. Results: The working group created a pediatric inpatient CP to guide pharmacologic management of agitation and serve as an easy-to-use clinical and educational resource with three complementary sections including: 1) a treatment algorithm, 2) a quick reference medication chart, and 3) two supporting documents, which provide a general overview of non-pharmacologic strategies prior to CP implementation and an illustrative scenario to accompany the medication chart to ensure effective utilization. Conclusions: This is the first CP to standardize pharmacological treatment and management of acute agitation in children in inpatient settings in Canada. Although further research is warranted to assess implementation and support process improvement, the CP can be adapted by individual institutions to assist in prompt pharmacological management of pediatric agitation to potentially improve outcomes for patients, families, and healthcare professionals.
Objectif: L'agitation aiguë en pédiatrie survient couramment en milieu hospitalier, elle peut contribuer à une détresse physique et psychologique significative, et la prise en charge en est très variée dans la pratique. Ainsi, l'élaboration de lignes directrices pharmacologiques standardisées est essentielle. Nous cherchions à développer un nouveau parcours clinique (PC) de la prise en charge de l'agitation aiguë pour tous les patients pédiatriques hospitalisés au Canada. Méthodes: Les professionnels de la santé au Canada qui ont l'expertise du traitement et de la prise en charge de l'agitation pédiatrique ont formé un groupe de travail et développé un PC en menant une revue littéraire, en embauchant des partenaires cibles, et en obtenant un consensus interdisciplinaire (discussions itératives en temps réel avec des experts en contenu). Une fois développé, le PC préliminaire a été présenté à des partenaires internes et externes additionnels lors de multiples grandes rondes et à un webinaire; les commentaires des participants ont guidé les révisions finales du PC. Résultats: Le groupe de travail a créé un PC pour patient psychiatrique hospitalisé afin de guider la prise en charge pharmacologique de l'agitation et de servir de ressource clinique et éducative facile à utiliser munie de trois sections complémentaires notamment : 1) un algorithme de traitement, 2) un tableau des médicaments de référence, et 3) deux documents de soutien, qui offrent un aperçu général de stratégies non-pharmacologiques avant la mise en Åuvre du PC et un scénario illustré pour accompagner le tableau des médicaments afin d'assurer une utilisation efficace. Conclusions: C'est le premier PC qui normalise le traitement pharmacologique et la prise en charge de l'agitation aiguë chez les enfants en milieu hospitalier au Canada. Bien que plus de recherche soit justifiée afin d'évaluer la mise en Åuvre et de soutenir l'amélioration du processus, le PC peut être adapté par les institutions individuelles afin d'aider à une gestion pharmacologique rapide de l'agitation pédiatrique et de potentiellement aider à la gestion pharmacologique de l'agitation pédiatrique pour les patients, les familles et les professionnels de la santé.
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BACKGROUND: Breast cancer is the most common malignant disease diagnosed in women worldwide. Screening with mammography has the ability to detect breast cancer at an early stage. The diagnostic accuracy of mammography screening largely depends on the radiographic density of the imaged breasts. In radiographically dense breasts, non-calcified breast cancers are more likely to be missed than in fatty breasts. As a consequence, some cancers are not detected by mammography screening. Supporters of adjunct ultrasonography to the screening regimen for breast cancer argue that it might be a safe and inexpensive approach to reduce the false negative rates of the screening process. Critics, however, are concerned that performing supplemental ultrasonography on women at average risk will also increase the rate of false positive findings and can lead to unnecessary biopsies and treatments. OBJECTIVES: To assess the comparative effectiveness and safety of mammography in combination with breast ultrasonography versus mammography for breast cancer screening for women at average risk of breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register, MEDLINE (via OvidSP) and EMBASE up until February 2012.To detect ongoing or unpublished studies, we searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and the National Cancer Institute's clinical trial database until June 2012. In addition, we conducted grey literature searches using the following sources: OpenGrey; National Institute of Health RePORTER; Health Services Research Projects in Progress (HSRPROJ); Hayes, Inc. Health Technology Assessment; The New York Academy of Medicine's Grey Literature Index and Conference Papers Index. SELECTION CRITERIA: For efficacy, we considered randomised controlled trials (RCTs), with either individual or cluster randomisation, and prospective, controlled non-randomised studies with a low risk of bias and a sample size of at least 500 participants.In addition to studies eligible for efficacy, we considered any controlled, non-randomised study with a low risk of bias and a study size of at least 500 participants for the assessment of harms.Our population of interest were women between the ages of 40 and 75 years who were at average risk for breast cancer. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full-text publications against the inclusion criteria. None of the studies met our inclusion criteria. MAIN RESULTS: Our review did not detect any controlled studies on the use of adjunct ultrasonography for screening in women at average risk for breast cancer. One ongoing randomised controlled trial was identified (J-START, Japan). AUTHORS' CONCLUSIONS: Presently, there is no methodologically sound evidence available justifying the routine use of ultrasonography as an adjunct screening tool in women at average risk for breast cancer.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Detecção Precoce de Câncer/métodos , Mamografia/métodos , Ultrassonografia Mamária/métodos , Feminino , HumanosRESUMO
OBJECTIVES: To assess the language used by systematic review authors to emphasize that statistically nonsignificant results show meaningful differences. To determine whether the magnitude of these treatment effects was distinct from nonsignificant results that authors interpreted as not different. STUDY DESIGN AND SETTING: We screened Cochrane reviews published between 2017 and 2022 for statistically nonsignificant effect estimates that authors presented as meaningful differences. We classified interpretations qualitatively and assessed them quantitatively by calculating the areas under the curve of the portions of confidence intervals exceeding the null or a minimal important difference, indicating one intervention's greater effect. RESULTS: In 2,337 reviews, we detected 139 cases where authors emphasized meaningful differences in nonsignificant results. Authors commonly used qualifying words to express uncertainty (66.9%). Sometimes (26.6%), they made absolute claims about one intervention's greater benefit or harm without acknowledging statistical uncertainty. The areas under the curve analyses indicated that some authors may overstate the importance of nonsignificant differences, whereas others may overlook meaningful differences in nonsignificant effect estimates. CONCLUSION: Nuanced interpretations of statistically nonsignificant results were rare in Cochrane reviews. Our study highlights the need for a more nuanced approach by systematic review authors when interpreting statistically nonsignificant effect estimates.
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Background: Pediatric intensive care unit (PICU)-associated delirium contributes to a decline in postdischarge quality of life, with worse outcomes for individuals with delayed identification. As delirium screening rates remain low within PICUs, caregivers may be able to assist with early detection, for which they need more education, as awareness of pediatric delirium among caregivers remains limited. Objective: This study aimed to develop an educational tool for caregivers to identify potential delirium symptoms during their child's PICU stay, educate them on how to best support their child if they experience delirium, and guide them to relevant family resources. Methods: Web-based focus groups were conducted at a tertiary pediatric hospital with expected end users of the tool (ie, PICU health care professionals and caregivers of children with an expected PICU length of stay of over 48 h) to identify potential educational information for inclusion in a family resource guide and to identify strategies for effective implementation. Data were analyzed thematically to generate requirements to inform prototype development. Participants then provided critical feedback on the initial prototype, which guided the final design. Results: In all, 24 participants (18 health care professionals and 6 caregivers) attended 7 focus groups. Participants identified five informational sections for inclusion: (1) delirium definition, (2) key features of delirium (signs and symptoms), (3) postdischarge outcomes associated with delirium, (4) tips to inform family-centered care, and (5) education or supportive resources. Participants identified seven design requirements: information should (1) be presented in an order that resembles the structure of the clinical discussion around delirium; (2) increase accessibility, recall, and preparedness by providing multiple formats; (3) aim to reduce stress by implementing positive framing; (4) minimize cognitive load to ensure adequate information processing; (5) provide supplemental electronic resources via QR codes; (6) emphasize collaboration between caregivers and the health care team; and (7) use prompting questions to act as a call to action for caregivers. Conclusions: Key design requirements derived from end-user feedback were established and guided the development of a novel pediatric delirium education tool. Implementing this tool into regular practice has the potential to reduce distress and assist in the early recognition and treatment of delirium in the PICU domain. Future evaluation of its clinical utility is necessary.
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OBJECTIVE: To summarize the evidence on the effectiveness of soil remediation to prevent or reduce lead exposure. METHODS: We systematically searched MEDLINE, the Agricultural & Environmental Science Database, Web of Science, and Scopus from 1980 to February 15, 2021. We also performed reference list checking, hand-searched websites, and contacted experts. Eligible studies evaluated the effect of soil remediation to prevent or reduce lead exposure in humans of any age. We screened all records dually; one investigator performed the data extraction; a second checked for completeness and accuracy. Two investigators independently rated the risk of bias of included studies and graded the certainty of evidence. We synthesized findings narratively. RESULTS: We identified 6614 potentially relevant publications, all focused on children, of which five studies (six records) fulfilled our prespecified inclusion criteria. The number of evaluated participants ranged from 31 to 1425, with follow-up periods of 11 months to one year. The primary soil remediation method was the replacement of the upper layer with clean soil. Outcomes were limited to blood lead levels (BLL), dust lead levels, and soil lead levels. The largest study, a controlled before- after study (n = 1425) reported favorable effects of soil remediation compared to no intervention. This finding was consistent with results from two cross-sectional studies and one uncontrolled before-after study. One year post-remediation, the mean reduction in BLL was 2.1 µg/dL (p < 0.0001) greater in the intervention group than in the control group. Two randomized controlled trials with a total of 511 participants showed no statistically significant incremental effect of soil remediation when combined with paint and/or dust abatement. The certainty of evidence for all outcomes was low. CONCLUSION: Soil remediation appears to reduce BLL in children when used as a single intervention. The incremental benefit of soil remediation when part of other interventions is limited.
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Intoxicação por Chumbo , Chumbo , Criança , Estudos Transversais , Exposição Ambiental , Humanos , SoloRESUMO
BACKGROUND: Abdominal pain-related functional gastrointestinal disorders (FGIDs) are among the most common medical problems in paediatric medicine. Frequently, physicians prescribe antidepressants as a second-line treatment for children and adolescents with FGIDs. To date, the evidence on the benefits and harms of antidepressants for the treatment of abdominal pain-related FGIDs has not been assessed systematically. OBJECTIVES: The primary objectives were to conduct a systematic review to evaluate the efficacy and safety of antidepressants for the treatment of abdominal pain-related FGIDs in children and adolescents. SEARCH STRATEGY: We searched The Cochrane Library, PubMed, EMBASE, IPA, CINAHL, PsycINFO, ISI Web of Science, Biosis Previews and the International Clinical Trials Registry Platform of the World Health Organization with appropriate filters (from inception to January 31, 2011). SELECTION CRITERIA: For efficacy we included double-blind, randomised controlled trials (RCTs) of antidepressants for treatment of abdominal pain-related FGIDs in children and adolescents 18 years or younger. Open-label and uncontrolled experimental studies, as well as observational studies were eligible for the assessment of harms. The minimum study duration was 4 weeks. The minimum study size was 30 participants. DATA COLLECTION AND ANALYSIS: Two authors independently assessed all abstracts and full text articles, and rated the risk of bias for included studies. Data were extracted independently by one author and checked for accuracy by another author. Data were analysed using RevMan 5. MAIN RESULTS: Two RCTs (123 participants), both using amitriptyline, met the pre-specified inclusion criteria. These studies provided mixed findings on the efficacy of amitriptyline for the treatment of abdominal pain-related FGIDs. The larger, publicly-funded study reported no statistically significant difference in efficacy between amitriptyline and placebo in 90 children and adolescents with FGIDs after 4 weeks of treatment. On intention-to-treat (ITT)- analysis, 59% of the children reported feeling better in the amitriptyline group compared with 53% in the placebo group (RR 1.12; 95% CI: 0.77 to 1.63; P = 0.54). The risk of bias for this study was rated as low.The second RCT enrolled 33 adolescents with irritable bowel syndrome. Patients receiving amitriptyline experienced greater improvements in the primary outcome, overall quality of life, at weeks 6, 10, and 13 compared with those on placebo (P= 0.019, 0.004, and 0.013, respectively). No effect estimates were calculated for the quality of life outcome because mean quality of life scores and standard deviations were not reported. For most secondary outcomes no statistically significant differences between amitriptyline and placebo could be detected. The risk of bias for this study was rated as unclear for most items. However, it was rated as high for other bias due to multiple testing. The results of this study should be interpreted with caution due to the small number of patients and multiple testing.The larger study reported mild adverse events including fatigue, rash and headache and dizziness. On ITT analysis, 4% of the amitriptyline group experienced at least one adverse event compared to 2% of the placebo group. There was no statistically significant difference in the proportion of patients who experienced at least one adverse event (RR 1.91; 95% CI 0.18 to 20.35; P = 0.59). The smaller study reported no adverse events. The methods of adverse effects assessment was poorly reported in both studies and no clear conclusions on the risks of harms of amitriptyline can be drawn. AUTHORS' CONCLUSIONS: Clinicians must be aware that for the majority of antidepressant medications no evidence exists that supports their use for the treatment of abdominal pain-related FGIDs in children and adolescents. The existing randomised controlled evidence is limited to studies on amitriptyline and revealed no statistically significant differences between amitriptyline and placebo for most efficacy outcomes. Amitriptyline does not appear to provide any benefit for the treatment of FGIDs in children and adolescents. Studies in children with depressive disorders have shown that antidepressants can lead to substantial, sometimes life-threatening adverse effects. Until better evidence evolves, clinicians should weigh the potential benefits of antidepressant treatment against known risks of antidepressants in paediatric patients.
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Dor Abdominal/tratamento farmacológico , Amitriptilina/uso terapêutico , Gastroenteropatias/tratamento farmacológico , Dor Abdominal/psicologia , Adolescente , Amitriptilina/efeitos adversos , Antidepressivos Tricíclicos/efeitos adversos , Antidepressivos Tricíclicos/uso terapêutico , Criança , Gastroenteropatias/psicologia , Humanos , Síndrome do Intestino Irritável/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light therapy or psychotherapy. OBJECTIVES: To assess the efficacy and safety of SGAs for the treatment of SAD in adults in comparison with placebo, light therapy, other SGAs or psychotherapy. SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neuorosis Review Group's specialised register (CCDANCTR) on the 26 August 2011. The CCDANCTR contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). In addition, we searched pharmaceutical industry trials registers via the Internet to identify unpublished trial data. Furthermore, we searched OVID MEDLINE, MEDLINE In-process, EMBASE and PsycINFO to 27July 2011 for publications on adverse effects (including non-randomised studies). SELECTION CRITERIA: For efficacy we included randomised trials of SGAs compared with other SGAs, placebo, light therapy or psychotherapy in adult participants with SAD. For adverse effects we also included non-randomised studies. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full-text publications against the inclusion criteria. Data abstraction and risk of bias assessment were conducted by one reviewer and checked for accuracy and completeness by a second. We pooled data for meta-analysis where the participant groups were similar and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment. MAIN RESULTS: For efficacy we included three randomised trials of between five and eight weeks duration with a total of 204 participants. For adverse effects we included two randomised trials and three observational (non-randomised) studies of five to eight weeks duration with a total of 225 participants. Overall, the randomised trials had low-to-moderate risk of bias, and the observational studies had a high risk of bias (due to small size and high attrition). The participants in the studies all met DSM (Diagnostic and Statistics Manual of Mental Disorders) criteria for SAD. The average age was approximately 40 years and 70% of the participants were female.Results from one trial with 68 participants showed that fluoxetine was not significantly more effective than placebo in achieving clinical response (risk ratio (RR) 1.62, 95% confidence interval (CI) 0.92 to 2.83). The number of adverse effects were similar between the two groups.We located two trials that contained a total of 136 participants for the comparison fluoxetine versus light therapy. Our meta-analysis of the results of the two trials showed fluoxetine and light therapy to be approximately equal in treating seasonal depression: RR of response 0.98 (95% CI 0.77 to 1.24), RR of remission 0.81 (95% CI 0.39 to 1.71). The number of adverse effects was similar in both groups.Two of the three randomised trials and three non-randomised studies contained adverse effect data on 225 participants who received fluoxetine, escitalopram, duloxetine, reboxetine, light therapy or placebo. We were only able to obtain crude rates of adverse effects, so any interpretation of this needs to be undertaken with caution. Between 22% and 100% of participants who received a SGA suffered an adverse effect and between 15% and 27% of participants withdrew from the studies because of adverse effects. AUTHORS' CONCLUSIONS: Evidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo, which shows a non-significant effect in favour of fluoxetine, and two small trials comparing fluoxetine against light therapy, which suggest equivalence between the two interventions. The lack of available evidence precludes the ability to draw any overall conclusions on the use of SGAs for SAD. Further larger RCTs are required to expand and strengthen the evidence base on this topic, and should also include comparisons with psychotherapy and other SGAs.Data on adverse events were sparse, and a comparative analysis was not possible. Therefore the data we obtained on adverse effects is not robust and our confidence in the data is limited. Overall, up to 27% of participants treated with SGAs for SAD withdrew from the studies early due to adverse effects. The overall quality of evidence in this review is very low.
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Antidepressivos de Segunda Geração/uso terapêutico , Transtorno Afetivo Sazonal/tratamento farmacológico , Adulto , Citalopram/efeitos adversos , Citalopram/uso terapêutico , Cloridrato de Duloxetina , Feminino , Fluoxetina/efeitos adversos , Fluoxetina/uso terapêutico , Humanos , Masculino , Morfolinas/efeitos adversos , Morfolinas/uso terapêutico , Fototerapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reboxetina , Tiofenos/efeitos adversos , Tiofenos/uso terapêuticoRESUMO
Leiomyosarcomas are soft tissue tumours that rarely occur in the larynx. This case report describes the presentation and management of a 77-year-old man referred to the otolaryngology clinic with hoarseness who was found to have a large supraglottic leiomyosarcoma after panendoscopy and biopsies. He subsequently underwent laryngectomy for treatment of this tumour but, unexpectedly, the histological analysis of the laryngectomy specimen revealed a second primary tumour in the larynx-a squamous cell carcinoma (SCC). The patient had further treatment with neck radiotherapy. Three years after treatment, there are no signs of recurrence of either tumour. This case report discusses the very few similar cases of leiomyosarcoma coexisting with SCC in the larynx, collating the evidence surrounding the treatment of this rare presentation.