RESUMO
BACKGROUND: Psoriasis is an immune-mediated disease for which some people have a genetic predisposition. The condition manifests in inflammatory effects on either the skin or joints, or both, and it has a major impact on quality of life. Although there is currently no cure for psoriasis, various treatment strategies allow sustained control of disease signs and symptoms. Several randomised controlled trials (RCTs) have compared the efficacy of the different systemic treatments in psoriasis against placebo. However, the relative benefit of these treatments remains unclear due to the limited number of trials comparing them directly head-to-head, which is why we chose to conduct a network meta-analysis. This is the baseline update of a Cochrane Review first published in 2017, in preparation for this Cochrane Review becoming a living systematic review. OBJECTIVES: To compare the efficacy and safety of conventional systemic agents, small molecules, and biologics for people with moderate-to-severe psoriasis, and to provide a ranking of these treatments according to their efficacy and safety. SEARCH METHODS: We updated our research using the following databases to January 2019: the Cochrane Skin Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and the conference proceedings of a number of dermatology meetings. We also searched five trials registers and the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) reports (until June 2019). We checked the reference lists of included and excluded studies for further references to relevant RCTs. SELECTION CRITERIA: Randomised controlled trials (RCTs) of systemic treatments in adults (over 18 years of age) with moderate-to-severe plaque psoriasis or psoriatic arthritis whose skin had been clinically diagnosed with moderate-to-severe psoriasis, at any stage of treatment, in comparison to placebo or another active agent. The primary outcomes of this review were: the proportion of participants who achieved clear or almost clear skin, that is, at least Psoriasis Area and Severity Index (PASI) 90 at induction phase (from 8 to 24 weeks after the randomisation), and the proportion of participants with serious adverse effects (SAEs) at induction phase. We did not evaluate differences in specific adverse effects. DATA COLLECTION AND ANALYSIS: Several groups of two review authors independently undertook study selection, data extraction, 'Risk of bias' assessment, and analyses. We synthesised the data using pair-wise and network meta-analysis (NMA) to compare the treatments of interest and rank them according to their effectiveness (as measured by the PASI 90 score) and acceptability (the inverse of serious adverse effects). We assessed the certainty of the body of evidence from the NMA for the two primary outcomes, according to GRADE, as either very low, low, moderate, or high. We contacted study authors when data were unclear or missing. MAIN RESULTS: We included 140 studies (31 new studies for the update) in our review (51,749 randomised participants, 68% men, mainly recruited from hospitals). The overall average age was 45 years; the overall mean PASI score at baseline was 20 (range: 9.5 to 39). Most of these studies were placebo-controlled (59%), 30% were head-to-head studies, and 11% were multi-armed studies with both an active comparator and a placebo. We have assessed a total of 19 treatments. In all, 117 trials were multicentric (two to 231 centres). All but two of the outcomes included in this review were limited to the induction phase (assessment from 8 to 24 weeks after randomisation). We assessed many studies (57/140) as being at high risk of bias; 42 were at an unclear risk, and 41 at low risk. Most studies (107/140) declared funding by a pharmaceutical company, and 22 studies did not report the source of funding. Network meta-analysis at class level showed that all of the interventions (conventional systemic agents, small molecules, and biological treatments) were significantly more effective than placebo in terms of reaching PASI 90. At class level, in terms of reaching PASI 90, the biologic treatments anti-IL17, anti-IL12/23, anti-IL23, and anti-TNF alpha were significantly more effective than the small molecules and the conventional systemic agents. At drug level, in terms of reaching PASI 90, infliximab, all of the anti-IL17 drugs (ixekizumab, secukinumab, bimekizumab and brodalumab) and the anti-IL23 drugs (risankizumab and guselkumab, but not tildrakizumab) were significantly more effective in reaching PASI 90 than ustekinumab and 3 anti-TNF alpha agents: adalimumab, certolizumab and etanercept. Adalimumab and ustekinumab were significantly more effective in reaching PASI 90 than certolizumab and etanercept. There was no significant difference between tofacitinib or apremilast and between two conventional drugs: ciclosporin and methotrexate. Network meta-analysis also showed that infliximab, ixekizumab, risankizumab, bimekizumab, guselkumab, secukinumab and brodalumab outperformed other drugs when compared to placebo in reaching PASI 90. The clinical effectiveness for these seven drugs was similar: infliximab (versus placebo): risk ratio (RR) 29.52, 95% confidence interval (CI) 19.94 to 43.70, Surface Under the Cumulative Ranking (SUCRA) = 88.5; moderate-certainty evidence; ixekizumab (versus placebo): RR 28.12, 95% CI 23.17 to 34.12, SUCRA = 88.3, moderate-certainty evidence; risankizumab (versus placebo): RR 27.67, 95% CI 22.86 to 33.49, SUCRA = 87.5, high-certainty evidence; bimekizumab (versus placebo): RR 58.64, 95% CI 3.72 to 923.86, SUCRA = 83.5, low-certainty evidence; guselkumab (versus placebo): RR 25.84, 95% CI 20.90 to 31.95; SUCRA = 81; moderate-certainty evidence; secukinumab (versus placebo): RR 23.97, 95% CI 20.03 to 28.70, SUCRA = 75.4; high-certainty evidence; and brodalumab (versus placebo): RR 21.96, 95% CI 18.17 to 26.53, SUCRA = 68.7; moderate-certainty evidence. Conservative interpretation is warranted for the results for bimekizumab (as well as tyrosine kinase 2 inhibitor, acitretin, ciclosporin, fumaric acid esters, and methotrexate), as these drugs, in the NMA, have been evaluated in few trials. We found no significant difference between any of the interventions and the placebo for the risk of SAEs. Nevertheless, the SAE analyses were based on a very low number of events with low to very low certainty for just under half of the treatment estimates in total, and moderate for the others. Thus, the results have to be viewed with caution and we cannot be sure of the ranking. For other efficacy outcomes (PASI 75 and Physician Global Assessment (PGA) 0/1) the results were very similar to the results for PASI 90. Information on quality of life was often poorly reported and was absent for several of the interventions. AUTHORS' CONCLUSIONS: Our review shows that compared to placebo, the biologics infliximab, ixekizumab, risankizumab, bimekizumab, guselkumab, secukinumab and brodalumab were the best choices for achieving PASI 90 in people with moderate-to-severe psoriasis on the basis of moderate- to high-certainty evidence (low-certainty evidence for bimekizumab). This NMA evidence is limited to induction therapy (outcomes were measured from 8 to 24 weeks after randomisation) and is not sufficient for evaluation of longer-term outcomes in this chronic disease. Moreover, we found low numbers of studies for some of the interventions, and the young age (mean age of 45 years) and high level of disease severity (PASI 20 at baseline) may not be typical of patients seen in daily clinical practice. Another major concern is that short-term trials provide scanty and sometimes poorly-reported safety data and thus do not provide useful evidence to create a reliable risk profile of treatments. Indeed, we found no significant difference in the assessed interventions and placebo in terms of SAEs, but the evidence for all the interventions was of very low to moderate quality. In order to provide long-term information on the safety of the treatments included in this review, it will also be necessary to evaluate non-randomised studies and postmarketing reports released from regulatory agencies. In terms of future research, randomised trials comparing directly active agents are necessary once high-quality evidence of benefit against placebo is established, including head-to-head trials amongst and between conventional systemic and small molecules, and between biological agents (anti-IL17 versus anti-IL23, anti-IL23 versus anti-IL12/23, anti-TNF alpha versus anti-IL12/23). Future trials should also undertake systematic subgroup analyses (e.g. assessing biological-naïve participants, baseline psoriasis severity, presence of psoriatic arthritis, etc.). Finally, outcome measure harmonisation is needed in psoriasis trials, and researchers should look at the medium- and long-term benefit and safety of the interventions and the comparative safety of different agents. Editorial note: This is a living systematic review. Living systematic reviews offer a new approach to review updating, in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.
Assuntos
Anticorpos Monoclonais/uso terapêutico , Imunossupressores/uso terapêutico , Psoríase/tratamento farmacológico , Anticorpos Monoclonais Humanizados , Doença Crônica , Citocinas/antagonistas & inibidores , Citocinas/metabolismo , Humanos , Terapia de Alvo Molecular , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Índice de Gravidade de Doença , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
Competency in healthcare practice has become a priority for sustaining the goals of quality and safety in patient care delivery. Evaluating maintenance of competency for practitioners beyond their initial licensure and credentialing has become a topic of focus in recent years. A systematic review was conducted to evaluate testing as a method of assessing continued competency in nurse anesthesia practice. Using the Joanna Briggs Institute method for a comprehensive systematic review, a literature search followed by critical appraisal of included manuscripts was performed. Sixty-three published and unpublished manuscripts were included in this systematic review. Testing should be used solely for the purpose of assessing knowledge necessary for current practice unique to the individual test taker. Testing should reflect real life and should allow the test taker access to materials and resources normally available in the provision of patient care.
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Anestesiologistas/normas , Competência Clínica , Atenção à Saúde , Enfermagem/normas , HumanosRESUMO
A systematic review represents the highest level of evidence to inform clinical practice and research. The results of this systematic review report on the impact of intraoperative brain activity monitoring on postanesthesia care unit length of stay. If used to guide anesthesia practice, the intraoperative brain activity monitor will have a statistically insignificant impact on reducing postanesthesia care unit length of stay. Clinicians should be aware, however, that there is a clinically useful reduction in postanesthesia care unit length of stay resulting in potential cost savings.
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Encéfalo/fisiopatologia , Tempo de Internação , Enfermagem em Pós-Anestésico , Humanos , Período IntraoperatórioRESUMO
BACKGROUND: In the USA, access to quality healthcare varies greatly across racial and ethnic groups, resulting in significant health disparities. A new term, "racial health equity" (RHE), is increasingly reported in the medical literature, but there is currently no consensus definition of the term. Additionally, related terms such as "health disparities," "health inequities," and "equality" have been inconsistently used when defining RHE. METHODS: The primary purpose of this scoping review is to investigate the current use and underlying concepts used to define racial health equity. The study will address two key questions: (1) "What terminology and definitions have been used to characterize RHE?" and (2) "What knowledge gaps and challenges are present in the current state of RHE research and theory?" The review will collect and analyze data from three sources: (1) websites from key national and international health organizations, (2) theoretical and narrative published articles, and (3) evidence synthesis studies addressing interventions targeting racial health equity and minority stakeholder engagement. DISCUSSION: Defining "racial health equity" and related terminology is the first step to advancing racial health equity within the USA. This review aims to offer an improved understanding of RHE constructs and definitions, bringing greater unity to national racial health equity research efforts across disciplines. SYSTEMATIC REVIEW REGISTRATION: This protocol is registered with the Open Science Framework at https://osf.io/7pvzq .
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Equidade em Saúde , Humanos , Etnicidade , Disparidades nos Níveis de Saúde , Grupos Minoritários , Grupos Raciais , Literatura de Revisão como Assunto , Revisões Sistemáticas como AssuntoRESUMO
Joanna Briggs Institute (JBI) is an international research organization and collaborative network hosted in the Faculty of Health and Medical Sciences at the University Of Adelaide, South Australia. Now in its 25th year of activity, JBI is concerned with improving health outcomes in communities globally by promoting and supporting the use of the best available evidence to inform decision making in health policy and practice. The JBI Model of Evidence Based Healthcare, developed in the early 2000s, represents an articulation of the evidence ecosystem and the pragmatic approach required to navigate the complexity of health systems globally to improve health outcomes. The programs of JBI are aligned with the JBI Model and are representative of the supportive structures that facilitate the pragmatic realization of each of the elements of evidence based healthcare.
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Ecossistema , Prática Clínica Baseada em Evidências , Humanos , Política de SaúdeRESUMO
BACKGROUND: Exertional rhabdomyolysis (ER) is the breakdown of skeletal muscle tissue following intense physical activity that results in impairment of the cell membrane, which allows intracellular contents to be released into the bloodstream. Signs and symptoms include myalgia, myoglobinuria and increased creatine kinase (CK) levels. Athletes are vulnerable to this condition due to their increased level of physical activity. The severity and effects of this condition vary between individuals; however, all athletes are at risk of significant muscle damage, renal failure and perhaps death if not recognized and treated quickly. Effective methods for treatment and return to activity following this condition should be established. OBJECTIVES: The objective of this review was to identify effective treatment methods associated with ER in athletes. INCLUSION CRITERIA TYPES OF PARTICIPANTS: Adult and adolescent patients (15 years of age and older) in the athletic population who have been diagnosed with ER. TYPES OF INTERVENTIONS: Fluid resuscitation/replacement or other treatment methods that aim to improve CK levels and decrease myoglobinuria and treat ER. TYPES OF STUDIES: Due to the absence of randomized control trials, the quantitative component of the review considered descriptive studies, case series and individual case reports for inclusion. PRIMARY OUTCOMES: CK and myoglobinuria levels. SECONDARY OUTCOMES: length of hospital stay; length of time from diagnosis to premorbid levels of physical activity. SEARCH STRATEGY: A comprehensive search of the following databases with no date limitation was conducted: CINAHL, PubMed, ProQuest, Embase, SPORTDiscus and Physical Education Index. Results were limited to those available in English. METHODOLOGICAL QUALITY: Two independent reviewers evaluated the retrieved articles for methodological quality using the standardized critical appraisal instrument from the Joanna Briggs Institute Meta-Analysis of Statistics and Review Instruments. DATA EXTRACTION: Data were extracted from the articles by two independent reviewers using the standardized Joanna Briggs Institute extraction tool. DATA SYNTHESIS: Narrative and tabular synthesis. RESULTS: Fourteen studies with a combined total of 53 participants were included. Aggressive intravenous (IV) fluid resuscitation was found to be the most commonly utilized treatment method for decreasing CK levels and resolving myoglobinuria. The addition of compounds within the IV fluid varied between studies. CONCLUSION: Due to the types of included studies and variation in reported treatment methods and outcomes for ER among athletes, effectiveness of treatment could not be determined. The limited evidence available indicates that IV fluid replacement, specifically normal saline, is the most commonly reported treatment for decreasing CK levels and myoglobinuria following ER. It appears that normal saline may be combined with other compounds including sodium bicarbonate, sodium chloride or potassium chloride to achieve reduction of CK levels and myoglobinuria. Clinically, early IV fluid replacement appears to be delivered at a rate of approximately 400 ml/hour, with adjustments ranging between 200 and 1000âml/hour, depending on severity and volume states. Hospitalization time varies, depending on severity of condition, and return to activity is widely inconsistent among the athletic population.
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Rabdomiólise/terapia , Esportes , Adolescente , Adulto , Atletas , Hospitalização , Humanos , Tempo de Internação , Músculo Esquelético/fisiopatologiaRESUMO
AIM: Pharmacogenomic testing is useful in helping to predict and explain patient responsiveness to medication. In clinical practice, the use of pharmacogenomic testing has been shown to help reduce adverse drugs events and increase patient satisfaction with their healthcare. Prior to a test being useful, it must have clinical utility. There is a gap in the literature about the perceived clinical utility of pharmacogenomic testing among anesthesia providers. METHODS: This qualitative-quantitative sequential mixed-method study used focused interviews to formulate probes for a quantitative survey aimed at quantifying the perceptions of anesthesia providers about pharmacogenomic testing. RESULTS: The results indicate anesthesia providers do not have enough knowledge about pharmacogenomic testing for it to be considered clinically useful in anesthesia practice. CONCLUSION: Although outcomes data indicate pharmacogenomic testing can help predict outcomes, anesthesia providers do not have enough knowledge and have concerns about the ethical implications of pharmacogenomic testing.
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Enfermeiros Anestesistas/psicologia , Testes Farmacogenômicos/métodos , Anestesiologia/métodos , Atitude do Pessoal de Saúde , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
BACKGROUND: In 2012, a working group was established to review and enhance the Joanna Briggs Institute (JBI) guidance for conducting systematic review of evidence from economic evaluations addressing a question(s) about health intervention cost-effectiveness. OBJECTIVES: The objective is to present the outcomes of the working group. METHODS: The group conducted three activities to inform the new guidance: review of literature on the utility/futility of systematic reviews of economic evaluations and consideration of its implications for updating the existing methodology; assessment of the critical appraisal tool in the existing guidance against criteria that promotes validity in economic evaluation research and two other commonly used tools; and a workshop. RESULTS: The debate in the literature on the limitations/value of systematic review of economic evidence cautions that systematic reviews of economic evaluation evidence are unlikely to generate one size fits all answers to questions about the cost-effectiveness of interventions and their comparators. Informed by this finding, the working group adjusted the framing of the objectives definition in the existing JBI methodology. The shift is away from defining the objective as to determine one cost-effectiveness measure toward summarizing study estimates of cost-effectiveness and informed by consideration of the included study characteristics (patient, setting, intervention component, etc.), identifying conditions conducive to lowering costs and maximizing health benefits. The existing critical appraisal tool was included in the new guidance. The new guidance includes the recommendation that a tool designed specifically for the purpose of appraising model-based studies be used together with the generic appraisal tool for economic evaluations assessment to evaluate model-based evaluations. The guidance produced by the group offers reviewers guidance for each step of the systematic review process, which are the same steps followed in JBI reviews of other types of evidence. DISCUSSION: The updated JBI guidance will be useful for researchers wanting to synthesize evidence about economic questions, either as stand-alone reviews or part of comprehensive or mixed method evidence reviews. Although the updated methodology produced by the work of the working group has improved the JBI guidance for systematic reviews of economic evaluations, there are areas where further work is required. These include adjusting the critical appraisal tool to separate out questions addressing intervention cost and effectiveness measurement; providing more explicit guidance for assessing generalizability of findings; and offering a more robust method for evidence synthesis that facilitates achieving the more ambitious review objectives.
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Economia , Medicina Baseada em Evidências/organização & administração , Projetos de Pesquisa/normas , Literatura de Revisão como Assunto , Viés , Controle de Custos , Análise Custo-Benefício , Pesquisa Empírica , Medicina Baseada em Evidências/normas , Guias como Assunto/normas , HumanosRESUMO
Perioperative care is comprised of preoperative, intraoperative, and postoperative care. Given the vulnerable status of the perioperative patient, coupled with the complex nature of these areas, evidence-based practice and clinical decision-making must be rooted in high-quality evidence for safe and effective patient and family care. Evidence-based practice is comprised of patient and family preferences, clinical expertise, and best available evidence. This article showcases systematic reviews that have focused on clinical issues within the preoperative, intraoperative, and postoperative care areas. A case study presents the importance of applying best available evidence to solve a thorny clinical problem and improve patient outcomes.
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Enfermagem Baseada em Evidências , Assistência Perioperatória , HumanosRESUMO
BACKGROUND: The use of intraoperative brain activity monitoring helps to guide the administration of general anesthesia. Additional benefits of brain activity monitoring in the face of general anesthesia include increased patient satisfaction, decreased nausea and vomiting, decreased pain, and decreased risk of intraoperative recall. Conflicting reports in the literature exist concerning the efficacy of brain activity monitoring at reducing the post-anesthesia care unit length of stay. OBJECTIVES: The objective of this systematic review was to determine the effect of intraoperative brain activity monitoring on post-anesthesia care unit length of stay. INCLUSION CRITERIA: The review considered studies that included all patients over eight years of age receiving general anesthesia for any medical procedure.The review included studies that compared the use of intraoperative brain activity monitoring to standard clinical practice and reported post-anesthesia care unit length of stay data.This review included randomized controlled trials which met all inclusion criteria.The review considered studies that included as outcome the length of stay in the post-anesthesia care unit following general anesthesia. SEARCH STRATEGY: A three-step search strategy was utilized to find both published and unpublished studies in English language only. The search time frame was January 1990 through December 2010. An initial limited MEDLINE search was completed followed by analysis of the text words contained in the title and abstract, and the index terms used to describe the article. A second search using all identified terms was then undertaken across all included databases. Finally, the reference list for all identified studies was searched for additional studies. METHODOLOGICAL QUALITY: The reviewers utilized the Joanna Briggs Institute Critical Appraisal Checklist for Randomized Controlled Trials to assess methodological quality. DATA COLLECTION: Data was extracted using the Joanna Briggs Institute Data Extraction Form for Observational/Experimental Studies. DATA SYNTHESIS: Results were analyzed using SUMARI software from the Joanna Briggs Institute. Nine randomized control trials were included in the final analysis. Results indicated a statistically insignificant 3.47 minute (p=0.14) reduction in post-anesthesia care unit length of stay when intraoperative brain activity monitoring was utilized. RESULTS: Pooling of data indicated a statistically nonsignificant 3.47 minute (p=0.14) reduction in post-anesthesia care unit length of stay when general anesthesia administration was guided by intraoperative brain activity monitoring. CONCLUSIONS: Based on the results of this review, the use of intraoperative brain activity monitoring can be recommended to help decrease the post-anesthesia care unit length of stay in patients receiving general anesthesia. Although statistically insignificant, any reduction in post-anesthesia care unit length of stay will decrease cost to the patient, decrease burden to the post-anesthesia care unit, and expedite patient throughput thereby reducing cost and impact on the healthcare system as a whole. IMPLICATIONS FOR PRACTICE: Anesthesia providers utilizing intraoperative brain activity monitoring will realize a clinically relevant reduction in post-anesthesia care unit length of stay for their patients receiving general anesthesia. Impact on practice includes increased efficiency and decreased patient and health care system cost. Although not necessarily realized in small surgical settings, the cumulative reduction in post-anesthesia care unit length of stay in larger facilities will be significant. IMPLICATIONS FOR RESEARCH: Additional work to quantify the range of depth of general anesthesia to produce the best reduction in post-anesthesia care unit length of stay is needed. This review simply looked at the use of the technology and did not stratify the range or level of general anesthesia, as determined by intraoperative brain activity monitoring, that would result in the greatest reduction in post-anesthesia care unit length of stay.