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BACKGROUND: Although methamphetamine use associated heart failure (MU-HF) is increasing, data on its clinical course are limited due to a preponderance of single center studies and significant heterogeneity in the definition of MU-HF in the published literature. Our objective was to evaluate left ventricular ejection fraction (LVEF) distribution, methamphetamine use treatment engagement and postdischarge healthcare utilization among Veterans with heart failure hospitalization in the department of Veterans Affairs (VA) medical centers for MU-HF versus HF not associated with methamphetamine use (other-HF). METHODS: Observational study including a cohort of Veterans with a first heart failure hospitalization during 2007 - 2020 using data in the VA Corporate Data Warehouse. MU-HF was identified based on the presence of an ICD-code for methamphetmaine use or positive toxicology results within 1-year of heart failure hospitalization. LVEF values entered in the medical record were identified using a validated natural language processing algorithm. Healthcare utilization data was obtained using clinic stop-codes and hosptilaization records. RESULTS: Of 203,005 first-time heart failure hospitlaizations, 4080 were categorized as MU-HF. Median (interquartile range) of LVEF was 30 (20-45) % for MU-HF versus 40 (25-55)% for other-HF (P < .0001). Eighteen percent of MU-HF had LVEF ≥ 50% compared to 28% in other-HF. Discharge against medical advice was higher in MU-HF (8% vs 2%). Among Veterans with MU-HF, post hospital discharge methamphetamine use treatment engagement was low (18% at 30 days post discharge), with higher follow-up in primary care (76% at 30 days). Post discharge emergency department visits (33% versus 22% at 30 days) and rehospitalizations (24% versus 18% at 30 days) were higher in MU-HF compared to other-HF. CONCLUSIONS: While the majority of MU-HF hospitalizations are HFrEF, a sizeable minority have HFpEF. This finding has implications for accurate MU-HF classification, treatment, and prognosis. Patients with MU-HF have low addiction treatment receipt and high postdischarge unplanned healthcare utilization. Increasing substance use disorder treatment in this population must be a priority to improve health outcomes. Care-coordination and linkage interventions are urgently needed to increase post-hospitalization addiction treatment and follow-up in an effort to increase evidence-base care and mitigate unplanned healthcare utilization.
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Insuficiência Cardíaca , Função Ventricular Esquerda , Humanos , Volume Sistólico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/tratamento farmacológico , Assistência ao Convalescente , Alta do Paciente , Hospitalização , Prognóstico , Aceitação pelo Paciente de Cuidados de SaúdeRESUMO
Although incorporating cost-considerations during healthcare decision-making is increasingly important to American patients and physicians, content related to these constructs is not routinely included in medical education. As a result, physicians are ill-equipped to consider costs. This study sought input from practicing physicians on perceived deficiencies in current teaching and recommendations for necessary content to include in medical teaching. We conducted a qualitative descriptive study using semi-structured interviews utilizing a purposeful maximum variation sample of cardiologists and neonatologists practicing in diverse settings. We analyzed interviews using conventional content analysis. 18 cardiologists and 17 neonatologists participated in this study. Respondents perceived that current teaching does not impart sufficient knowledge of value and cost considerations to achieve patient-centered, high-value decision-making. They identified the following priority areas for education related to healthcare costs: the business of medicine and information about out-of-pocket patient costs, training in health research interpretation skills to critically appraise evidence, and communication skills to engage patients as partners in shared decision-making. Participants recommended a variety of teaching methods, including didactic sessions on core topics, role modeling and case studies. American physicians perceive learning needs related to the incorporation of costs into clinical decision-making that can inform curriculum development initiatives in this field. Physicians perceive knowledge of these topics and skills to be crucial to achieving patient-centered high-value care. Concomitant health system reforms supporting the needs of the patient at its center are essential to enable physicians to focus on a patient-centered approach to healthcare delivery.
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Tomada de Decisão Clínica , Educação Médica , Gastos em Saúde , Competência Clínica , Feminino , Financiamento Pessoal , Humanos , Entrevistas como Assunto , Masculino , Pesquisa Qualitativa , Qualidade da Assistência à Saúde/economia , EnsinoRESUMO
BACKGROUND: There are diverse opinions and confusion about defining and including patient values and preferences (i.e. the importance people place on the health outcomes) in the guideline development processes. This article aims to provide an overview of a process for systematically incorporating values and preferences in guideline development. METHODS: In 2013 and 2014, we followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to adopt, adapt and develop 226 recommendations in 22 guidelines for the Ministry of Health of the Kingdom of Saudi Arabia. To collect context-specific values and preferences for each recommendation, we performed systematic reviews, asked clinical experts to provide feedback according to their clinical experience, and consulted patient representatives. RESULTS: We found several types of studies addressing the importance of outcomes, including those reporting utilities, non-utility measures of health states based on structured questionnaires or scales, and qualitative studies. Guideline panels used the relative importance of outcomes based on values and preferences to weigh the balance of desirable and undesirable consequences of alternative intervention options. However, we found few studies addressing local values and preferences. CONCLUSIONS: Currently there are different but no firmly established processes for integrating patient values and preferences in healthcare decision-making of practice guideline development. With GRADE Evidence-to-Decision (EtD) frameworks, we provide an empirical strategy to find and incorporate values and preferences in guidelines by performing systematic reviews and eliciting information from guideline panel members and patient representatives. However, more research and practical guidance are needed on how to search for relevant studies and grey literature, assess the certainty of this evidence, and best summarize and present the findings.
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Medicina Baseada em Evidências/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Preferência do Paciente/psicologia , Guias de Prática Clínica como Assunto/normas , Qualidade de Vida , Humanos , Arábia Saudita , Valores SociaisRESUMO
Background Inhaled nitric oxide (iNO) is being increasingly used in preterm infants < 34 weeks with hypoxemic respiratory failure (HRF) and/or pulmonary hypertension (PH). Objective To evaluate the risk factors, survival characteristics, and lung histopathology in preterm infants with PH/HRF. Methods Retrospective chart review was conducted to determine characteristics of 93 preterm infants treated with iNO in the first 28 days and compared with 930 matched controls. Factors associated with survival with preterm HRF and smooth muscle actin from nine autopsies were evaluated. Results Preterm neonates treated with iNO had a higher incidence of preterm prolonged rupture of membrane (pPROM ≥ 18 hours), oligohydramnios and delivered by C-section. In infants treated with iNO, antenatal steroids (odds ratio [OR],3.7; confidence interval [CI], 1.2-11.3; p = 0.02), pPROM (OR, 1.001; CI, 1.0-1.004; p = 0.3), and oxygenation response to iNO (OR, 3.7; CI, 1.08-13.1; p = 0.037) were associated with survival. Thirteen infants with all three characteristics had 100% (13/13) survival without severe intraventricular hemorrhage (IVH)/periventricular leukomalacia (PVL) compared with 48% survival (12/25, p = 0.004) and 16% severe IVH/PVL without any of these factors. Severity of HRF correlated with increased smooth muscle in pulmonary vasculature. Conclusion Preterm infants with HRF exposed to antenatal steroids and pPROM had improved oxygenation with iNO and survival without severe IVH/PVL. Precisely targeting this subset may be beneficial in future trials of iNO.
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Hipertensão Pulmonar/tratamento farmacológico , Doenças do Prematuro/tratamento farmacológico , Óxido Nítrico/uso terapêutico , Insuficiência Respiratória/tratamento farmacológico , Vasodilatadores/uso terapêutico , Actinas/metabolismo , Administração por Inalação , Estudos de Casos e Controles , Hemorragia Cerebral Intraventricular/etiologia , Feminino , Ruptura Prematura de Membranas Fetais/etiologia , Idade Gestacional , Humanos , Hipertensão Pulmonar/patologia , Hipóxia/etiologia , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/patologia , Leucomalácia Periventricular/etiologia , Masculino , Músculo Liso Vascular/metabolismo , Óxido Nítrico/administração & dosagem , Oxigênio/sangue , Seleção de Pacientes , Cuidado Pré-Natal , Fatores de Proteção , Artéria Pulmonar/metabolismo , Veias Pulmonares/metabolismo , Insuficiência Respiratória/complicações , Insuficiência Respiratória/patologia , Estudos Retrospectivos , Esteroides/uso terapêutico , Taxa de Sobrevida , Vasodilatadores/administração & dosagemAssuntos
Óxido Nítrico/administração & dosagem , Síndrome da Persistência do Padrão de Circulação Fetal/prevenção & controle , Insuficiência Respiratória/prevenção & controle , Administração por Inalação , Tomada de Decisões , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/tratamento farmacológico , Masculino , Neoplasias/complicações , Estudos Observacionais como Assunto , Pediatria/organização & administração , Síndrome da Persistência do Padrão de Circulação Fetal/tratamento farmacológico , Guias de Prática Clínica como Assunto , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial , Insuficiência Respiratória/tratamento farmacológicoRESUMO
OBJECTIVE: Guidelines are meant to facilitate evidence-based clinical decision-making but vary in methodological rigor and quality of reporting. We assessed the quality of guidelines published in major pediatric surgery journals. METHODS: A MEDLINE search of 4 key pediatric surgery journals was performed. Included studies had guidelines, clinical practice guidelines, and consensus statements as a subject heading or keyword. Evaluations of guidelines were excluded. Eligible guidelines were assessed by three reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE II) Instrument. RESULTS: Our search identified ten guidelines for review. Agreement for study selection was excellent [K = 0.81 (95 % CI 0.63-0.99)]. The mean AGREE II score for individual guidelines was 18 % (SD 5.7 %). The best-scored quality domains were "scope and purpose" [mean score 49 % (SD 8.7 %)] and "clarity of presentation" [mean score 40 % (SD 18.7 %)]. The poorest score was for "editorial independence" [mean score 2 % (SD 3.7 %)]. CONCLUSIONS: The overall quality of guidelines in pediatric surgery, using AGREE II, is poor and may lead to inappropriate clinical decisions. Increased awareness of proper reporting and the methodological requirements for guideline development are needed to optimize the potential of guideline recommendations to improve practice. LEVEL OF EVIDENCE: n/a (Quality Appraisal).
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Medicina Baseada em Evidências , Pediatria/normas , Guias de Prática Clínica como Assunto , Procedimentos Cirúrgicos Operatórios/normas , HumanosRESUMO
Deprescribing is the intentional dose reduction or discontinuation of a medication. The development of deprescribing interventions should take into consideration important organizational, interprofessional, and patient-specific barriers that can be further complicated by the presence of multiple prescribers involved in a patient's care. Patients who receive care from an increasing number of prescribers may experience disruptions in the timely transfer of relevant healthcare information, increasing the risk of exposure to drug-drug interactions and other medication-related problems. Furthermore, the fragmentation of healthcare information across health systems can contribute to the refilling of discontinued medications, reducing the effectiveness of deprescribing interventions. Thus, deprescribing interventions must carefully consider the unique characteristics of patients and their prescribers to ensure interventions are successfully implemented. In this special article, an international working group of physicians, pharmacists, nurses, epidemiologists, and researchers from the United States Deprescribing Research Network (USDeN) developed a socioecological model to understand how multiple prescribers may influence the implementation of a deprescribing intervention at the individual, interpersonal, organizational, and societal level. This manuscript also includes a description of the concept of multiple prescribers and outlines a research agenda for future investigations to consider. The information contained in this manuscript should be used as a framework for future deprescribing interventions to carefully consider how multiple prescribers can influence the successful implementation of the service and ensure the intervention is as effective as possible.
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Desprescrições , Médicos , Humanos , Farmacêuticos , Interações Medicamentosas , PolimedicaçãoRESUMO
OBJECTIVES: Antihypertensive treatment changes are common in long-term care residents, yet data on the frequency and predictors of changes are lacking. We described the patterns of antihypertensive changes and examined the triggering factors. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: A total of 24,870 Department of Veterans Affairs (VA) nursing home residents aged ≥65 years with long-term stays (≥180 days) from 2006 to 2019. METHODS: We obtained data from the VA Corporate Data Warehouse. Based on Bar Code Medication Administration medication data, we defined 2 types of change events in 180 days of admission: deprescribing (reduced number of antihypertensives or dose reduction of ≥30% compared with the previous week and maintained for at least 2 weeks) and intensification (opposite of deprescribing). Mortality was identified within 2 years after admission. RESULTS: More than 85% of residents were prescribed antihypertensives and 68% of them experienced ≥1 change event during the first 6 months of the nursing home stay. We categorized residents into 10 distinct patterns: no change (27%), 1 deprescribing (11%), multiple deprescribing (5%), 1 intensification (10%), multiple intensification (7%), 1 deprescribing followed by 1 intensification (3%), 1 intensification followed by 1 deprescribing (4%), 3 changes with mixed events (7%), >3 changes with mixed events (10%), and no antihypertensive use (15%). Treatment changes were more frequent in residents with better physical function and/or cognitive function. Potentially triggering factors differed by the type of antihypertensive change: incident high blood pressure and cardiovascular events were associated with intensification, and low blood pressure, weight loss, and falls were associated with deprescribing. Death occurred in 7881 (32%) residents over 2 years. The highest mortality was for those without antihypertensive medication (incidence = 344/1000 person-years). CONCLUSIONS AND IMPLICATIONS: Patterns of medication changes existing in long-term care residents are complex. Future studies should explore the benefits and harms of these antihypertensive treatment changes.
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OBJECTIVE: To conduct a systematic review of observational studies on methamphetamine-associated heart failure (MethHF) . METHODS: Six databases were searched for original publications on the topic. Title/abstract and included full-text publications were reviewed in duplicate. Data extraction and critical appraisal for risk of bias were performed in duplicate. RESULTS: Twenty-one studies are included in the final analysis. Results could not be combined because of heterogeneity in study design, population, comparator, and outcome assessment. Overall risk of bias is moderate due to the presence of confounders, selection bias and poor matching; overall certainty in the evidence is very low. MethHF is increasing in prevalence, affects diverse racial/ethnic/sociodemographic groups with a male predominance; up to 44% have preserved left-ventricular ejection fraction. MethHF is associated with significant morbidity including worse heart failure symptoms compared with non-methamphetamine related heart failure. Female sex, methamphetamine abstinence and guideline-directed heart failure therapy are associated with improved outcomes. Chamber dimensions on echocardiography and fibrosis on biopsy predict the extent of recovery after abstinence. CONCLUSIONS: The increasing prevalence of MethHF with associated morbidity underscores the urgent need for well designed prospective studies of people who use methamphetamine to accurately assess the epidemiology, clinical features, disease trajectory and outcomes of MethHF. Methamphetamine abstinence is an integral part of MethHF treatment; increased availability of effective non-pharmacological interventions for treatment of methamphetamine addiction is an essential first step. Availability of effective pharmacological treatment for methamphetamine addiction will further support MethHF treatment. Using harm reduction principles in an integrated addiction/HF treatment programme will bolster efforts to stem the increasing tide of MethHF.
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Insuficiência Cardíaca , Metanfetamina , Humanos , Masculino , Feminino , Metanfetamina/efeitos adversos , Volume Sistólico , Função Ventricular Esquerda , Estudos Prospectivos , Insuficiência Cardíaca/induzido quimicamente , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologiaRESUMO
While the opioid epidemic has garnered worldwide attention, increasing methamphetamine use has drawn less scrutiny. Methamphetamine is a highly addictive psychostimulant affecting people from all backgrounds and regions. It is a potent vasoconstrictor, is associated with arrhythmias and dilated cardiomyopathy. Cardiovascular disease-related mortality is a leading cause of death in methamphetamine users. Women of childbearing age increasingly use methamphetamine and continue during pregnancy. In the short term, prenatal methamphetamine use is associated with fetal growth restriction and low birth weight in the newborn. Animal studies show reduction in uterine and umbilical blood flow following maternal methamphetamine administration. Based on currently available evidence, prenatal methamphetamine exposure has transient effects on gross motor development, no effect on language and cognition, and modest effects on behavior and executive functioning with poor inhibitory control, which may be attributable to early adversity. Further research is needed to evaluate long-term effects of prenatal methamphetamine exposure.
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Estimulantes do Sistema Nervoso Central , Metanfetamina , Efeitos Tardios da Exposição Pré-Natal , Animais , Estimulantes do Sistema Nervoso Central/efeitos adversos , Cognição , Feminino , Retardo do Crescimento Fetal/induzido quimicamente , Feto , Humanos , Metanfetamina/efeitos adversos , GravidezRESUMO
BACKGROUND: Health guideline development requires sequential prioritization of the guideline topic, questions, and health outcomes. In this paper we report on new approaches for prioritizing questions and outcomes in guidelines. METHODS: Ten guideline panels on venous thromboembolism rated potential guideline questions on a 9-point scale according to their overall importance and 6 criteria: common in practice, uncertainty in practice, variation in practice, new evidence available, cost consequences, not previously addressed. We randomized panelists to rate one potential question with and without the 6 criteria. Panelists rated importance of outcomes, defined with health outcome descriptors (HODs), using a 9-point scale, and health utility of outcomes on a visual analogue scale. RESULTS: Of 469 potential questions identified, 72.5% were rated as important but not of high priority, and 25.4% as high priority. Each criterion was significantly associated with the overall importance rating. The overall importance rating means were 5.96 (SD 2.38) and 6.53 (SD 2.45) (P = 0.25) for those randomized to rate questions with and without the criteria, respectively. The mean importance rating for 121 outcomes was 6.01 (SD 1.25), with 35.5% rated as critical for decision-making. Panelists provided health utility ratings for 127 outcomes, with a minimum mean rating of 0.12 (SD 0.10) and maximum of 0.91 (SD 0.15). CONCLUSION: Our structured process provided information to help explain perspectives of question importance, to facilitate panels' outcome prioritization, and to facilitate decision-making in guideline development.
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Tromboembolia Venosa , Humanos , Avaliação de Resultados em Cuidados de SaúdeRESUMO
Both medical and surgical therapy represent potential management options for patients with asymptomatic primary hyperparathyroidism (PHPT). Because uncertainty remains regarding both medical and surgical therapy, this systematic review addresses the efficacy and safety of medical therapy in asymptomatic patients or symptomatic patients who decline surgery and surgery in asymptomatic patients. We searched Medline, Embase, Cochrane Central Register of Controlled Trials, and PubMed from inception to December 2020, and included randomized controlled trials in patients with PHPT that compared nonsurgical management with medical therapy versus without medical therapy and surgery versus no surgery in patients with asymptomatic PHPT. For surgical complications we included observational studies. Paired reviewers addressed eligibility, assessed risk of bias, and abstracted data for patient-important outcomes. We conducted random-effects meta-analyses to pool relative risks and mean differences with 95% confidence intervals and used Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) to assess quality of evidence for each outcome. For medical therapy, 11 trials reported in 12 publications including 438 patients proved eligible: three addressed alendronate, one denosumab, three cinacalcet, two vitamin D, and two estrogen therapy. Alendronate, denosumab, vitamin D, and estrogen therapy all increased bone density. Cinacalcet probably reduced serum calcium and parathyroid hormone (PTH) levels. Cinacalcet and vitamin D may have a small or no increase in overall adverse events. Very-low-quality evidence raised the possibility of an increase in serious adverse events with alendronate and denosumab. The trials also provided low-quality evidence for increased bleeding and mastalgia with estrogen therapy. For surgery, six trials presented in 12 reports including 441 patients proved eligible. Surgery achieved biochemical cure in 96.1% (high quality). We found no convincing evidence supporting an impact of surgery on fracture, quality of life, occurrence of kidney stones, and renal function, but the evidence proved low or very low quality. Surgery was associated with an increase in bone mineral density. For patients with symptomatic and asymptomatic PHPT, who are not candidates for parathyroid surgery, cinacalcet probably reduced serum calcium and PTH levels; anti-resorptives increased bone density. For patients with asymptomatic PHPT, surgery usually achieves biochemical cure. These results can help to inform patients and clinicians regarding use of medical therapy and surgery in PHPT. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
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Hiperparatireoidismo Primário , Humanos , Cinacalcete , Hiperparatireoidismo Primário/tratamento farmacológico , Hiperparatireoidismo Primário/cirurgia , Alendronato , Cálcio , Qualidade de Vida , Denosumab , Ensaios Clínicos Controlados Aleatórios como Assunto , Hormônio Paratireóideo , Vitamina D , EstrogêniosRESUMO
AIMS: The American College of Cardiology appropriate use criteria (AUC) provide clinicians with evidence-informed recommendations for cardiac care. Adopting AUC into clinical workflows may present challenges, and there may be specific implementation strategies that are effective in promoting effective use of AUC. We sought to assess the effect of implementing AUC in clinical practice. METHODS AND RESULTS: We conducted a meta-analysis of studies found through a systematic search of the MEDLINE, Web of Science, Cochrane, or CINAHL databases. Peer-reviewed manuscripts published after 2005 that reported on the implementation of AUC for a cardiovascular test or procedure were included. The main outcome was to determine if AUC implementation was associated with a reduction in inappropriate/rarely appropriate care. Of the 18 included studies, the majority used pre/post-cohort designs; few (n = 3) were randomized trials. Most studies used multiple strategies (n = 12, 66.7%). Education was the most common individual intervention strategy (n = 13, 72.2%), followed by audit and feedback (n = 8, 44.4%) and computerized physician order entry (n = 6, 33.3%). No studies reported on formal use of stakeholder engagement or 'nudges'. In meta-analysis, AUC implementation was associated with a reduction in inappropriate/rarely appropriate care (odds ratio 0.62, 95% confidence interval 0.49-0.78). Funnel plot suggests the possibility of publication bias. CONCLUSION: We found most published efforts to implement AUC observed reductions in inappropriate/rarely appropriate care. Studies rarely explored how or why the implementation strategy was effective. Because interventions were infrequently tested in isolation, it is difficult to make observations about their effectiveness as stand-alone strategies. STUDY REGISTRATION: PROSPERO 2018 CRD42018091602. Available from https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018091602.
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Cardiologia , Técnicas de Diagnóstico Cardiovascular , HumanosRESUMO
OBJECTIVE: Stakeholders involved in developing recommendations need to have a common understanding of health outcomes and the perspective of affected individuals. In this paper we report on the development and application of health outcome descriptors (HODs) to inform decision-making by panels developing guideline recommendations. STUDY DESIGN AND SETTING: Ten American Society of Hematology guideline panels addressing the management of venous thromboembolism developed HODs, rated their importance and health utility, applied them to prioritize outcomes, and to balance potential benefits and harms to formulate recommendations. RESULTS: It was feasible to involve 18 panelists in developing 127 HODs. There was high agreement (82%) across the ten panels about outcomes perceived as critical or important for decision-making. Panelists' utility ratings of the outcomes were strongly correlated with panelists' outcome importance ratings (Pearson's r=-0.88). HODs were incorporated into Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence-to-decision (EtD) frameworks to support a shared understanding of health outcomes in panel deliberations. CONCLUSION: HODs serve as a valuable tool to promote an explicit, common understanding of health outcomes during clinical guideline development and across different stakeholders. They are helpful across multiple steps of guideline development to facilitate panels' judgements, aiming to avoid variable implicit interpretations of health outcomes.
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Tomada de Decisão Clínica/métodos , Medicina Baseada em Evidências/normas , Fibrinolíticos/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Guias de Prática Clínica como Assunto/normas , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/terapia , Humanos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Estados UnidosRESUMO
The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients' decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients' values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients' perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Preferência do Paciente , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/psicologia , Estenose da Valva Aórtica/cirurgia , Tomada de Decisões , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/psicologia , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Risco Ajustado , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/psicologia , Resultado do TratamentoRESUMO
CLINICAL QUESTION: What are the benefits and harms of sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists when added to usual care (lifestyle interventions and/or other diabetes drugs) in adults with type 2 diabetes at different risk for cardiovascular and kidney outcomes? CURRENT PRACTICE: Clinical decisions about treatment of type 2 diabetes have been led by glycaemic control for decades. SGLT-2 inhibitors and GLP-1 receptor agonists are traditionally used in people with elevated glucose level after metformin treatment. This has changed through trials demonstrating atherosclerotic cardiovascular disease (CVD) and chronic kidney disease (CKD) benefits independent of medications' glucose-lowering potential. RECOMMENDATIONS: The guideline panel issued risk-stratified recommendations concerning the use of SGLT-2 inhibitors or GLP-1 receptor agonists in adults with type 2 diabetes⢠Three or fewer cardiovascular risk factors without established CVD or CKD: Weak recommendation against starting SGLT-2 inhibitors or GLP-1 receptor agonists.⢠More than three cardiovascular risk factors without established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and weak against starting GLP-1 receptor agonists.⢠Established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and GLP-1 receptor agonists.⢠Established CVD and CKD: Strong recommendation for starting SGLT-2 inhibitors and weak recommendation for starting GLP-1 receptor agonists.⢠For those committed to further reducing their risk for CVD and CKD outcomes: Weak recommendation for starting SGLT-2 inhibitors rather than GLP-1 receptor agonists. HOW THIS GUIDELINE WAS CREATED: An international panel including patients, clinicians, and methodologists created these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel applied an individual patient perspective. THE EVIDENCE: A linked systematic review and network meta-analysis (764 randomised trials included 421 346 participants) of benefits and harms found that SGLT-2 inhibitors and GLP-1 receptor agonists generally reduce overall death, and incidence of myocardial infarctions, and end-stage kidney disease or kidney failure (moderate to high certainty evidence). These medications exert different effects on stroke, hospitalisations for heart failure, and key adverse events in different subgroups. Absolute effects of benefit varied widely based on patients' individual risk (for example, from five fewer deaths in the lowest risk to 48 fewer deaths in the highest risk, for 1000 patients treated over five years). A prognosis review identified 14 eligible risk prediction models, one of which (RECODe) informed most baseline risk estimates in evidence summaries to underpin the risk-stratified recommendations. Concerning patients' values and preferences, the recommendations were supported by evidence from a systematic review of published literature, a patient focus group study, a practical issues summary, and a guideline panel survey. UNDERSTANDING THE RECOMMENDATION: We stratified the recommendations by the levels of risk for CVD and CKD and systematically considered the balance of benefits, harms, other considerations, and practical issues for each risk group. The strong recommendation for SGLT-2 inhibitors in patients with CVD and CKD reflects what the panel considered to be a clear benefit. For all other adults with type 2 diabetes, the weak recommendations reflect what the panel considered to be a finer balance between benefits, harms, and burdens of treatment options. Clinicians using the guideline can identify their patient's individual risk for cardiovascular and kidney outcomes using credible risk calculators such as RECODe. Interactive evidence summaries and decision aids may support well informed treatment choices, including shared decision making.
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/uso terapêutico , Transportador 2 de Glucose-Sódio/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Humanos , Nefropatias/prevenção & controle , Guias de Prática Clínica como Assunto , Medição de RiscoRESUMO
OBJECTIVES: The objective of the study is to present the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) conceptual approach to the assessment of certainty of evidence from modeling studies (i.e., certainty associated with model outputs). STUDY DESIGN AND SETTING: Expert consultations and an international multidisciplinary workshop informed development of a conceptual approach to assessing the certainty of evidence from models within the context of systematic reviews, health technology assessments, and health care decisions. The discussions also clarified selected concepts and terminology used in the GRADE approach and by the modeling community. Feedback from experts in a broad range of modeling and health care disciplines addressed the content validity of the approach. RESULTS: Workshop participants agreed that the domains determining the certainty of evidence previously identified in the GRADE approach (risk of bias, indirectness, inconsistency, imprecision, reporting bias, magnitude of an effect, dose-response relation, and the direction of residual confounding) also apply when assessing the certainty of evidence from models. The assessment depends on the nature of model inputs and the model itself and on whether one is evaluating evidence from a single model or multiple models. We propose a framework for selecting the best available evidence from models: 1) developing de novo, a model specific to the situation of interest, 2) identifying an existing model, the outputs of which provide the highest certainty evidence for the situation of interest, either "off-the-shelf" or after adaptation, and 3) using outputs from multiple models. We also present a summary of preferred terminology to facilitate communication among modeling and health care disciplines. CONCLUSION: This conceptual GRADE approach provides a framework for using evidence from models in health decision-making and the assessment of certainty of evidence from a model or models. The GRADE Working Group and the modeling community are currently developing the detailed methods and related guidance for assessing specific domains determining the certainty of evidence from models across health care-related disciplines (e.g., therapeutic decision-making, toxicology, environmental health, and health economics).
Assuntos
Abordagem GRADE , Revisões Sistemáticas como Assunto/normas , Tomada de Decisão Clínica/métodos , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Humanos , Comunicação Interdisciplinar , Competência Profissional/normas , Viés de Publicação , Avaliação da Tecnologia Biomédica/métodos , Avaliação da Tecnologia Biomédica/organização & administraçãoRESUMO
Thrombolytic therapy might reduce venous thromboembolism-related mortality and morbidity, but it could also increase the risk of major bleeding. We systematically reviewed the literature to evaluate the effectiveness and safety of thrombolytics in patients with pulmonary embolism (PE) and/or deep venous thrombosis (DVT). We searched Medline, Embase, and Cochrane databases for relevant randomized controlled trials up to February 2019. Multiple investigators independently screened and collected data. We included 45 studies (4740 participants). Pooled estimates of PE studies indicate probable reduction in mortality with thrombolysis (risk ratio [RR], 0.61; 95% confidence interval [CI], 0.40-0.94) (moderate certainty) and possible reduction in nonfatal PE recurrence (RR, 0.56; 95% CI, 0.35-0.89) (low certainty). Pooled estimates of DVT studies indicate the possible absence of effects on mortality (RR, 0.77; 95% CI, 0.26-2.28) (low certainty) and recurrent DVT (RR, 0.99; 95% CI, 0.56-1.76) (low certainty), but possible reduction in postthrombotic syndrome (PTS) with thrombolytics (RR, 0.70; 95% CI, 0.59-0.83) (low certainty). Pooled estimates of the complete body of evidence indicate increases in major bleeding (RR, 1.89; 95% CI, 1.46-2.46) (high certainty) and a probable increase in intracranial bleeding (RR, 3.17; 95% CI 1.19-8.41) (moderate certainty) with thrombolytics. Our findings indicate that thrombolytics probably reduce mortality in patients with submassive- or intermediate-risk PE and may reduce PTS in patients with proximal DVT at the expense of a significant increase in major bleeding. Because the balance between benefits and harms is profoundly influenced by the baseline risks of critical outcomes, stakeholders involved in decision making would need to weigh these effects to define which clinical scenarios merit the use of thrombolytics.