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1.
Trials ; 22(1): 631, 2021 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-34530868

RESUMO

BACKGROUND: Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients with localized disease, with minimal inclusion of patients with advanced prostate cancer and their decision partners. The use of a community patient navigator (CPN) has been shown to have a positive supportive role in health care, particularly with individuals from minority populations. Research is needed to evaluate decision support interventions tailored to the needs of advanced prostate cancer patients and their decision partners in diverse populations. METHODS: Guided by Janis and Mann's Conflict Model of Decision Making, the Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION) is a randomized controlled trial to assess the feasibility and acceptability of a mobile health (mHealth), CPN-administered decision support intervention designed to facilitate communication between patients, their decision partners, and the healthcare team. Adult prostate cancer patients and their decision partners at three mid-Atlantic hospitals in the USA were randomized to receive enhanced usual care or the decision intervention. The CHAMPION intervention includes a theory-based decision-making process tutorial, immediate and health-related quality of life graphical summaries over time (using mHealth), values clarification via a balance sheet procedure with the CPN support during difficult decisions, and facilitated discussions with providers to enhance informed, shared decision-making. DISCUSSION: The CHAMPION intervention is designed to leverage dynamic resources, such as CPN teams, mHealth technology, and theory-based information, to support decision-making for advanced prostate cancer patients and their decision partners. This intervention is intended to engage decision partners in addition to patients and represents a novel, sustainable, and scalable way to build on individual and community strengths. Patients from minority populations, in particular, may face unique challenges during clinical communication. CHAMPION emphasizes the inclusion of decision partners and CPNs as facilitators to help address these barriers to care. Thus, the CHAMPION intervention has the potential to positively impact patient and decision partner well-being by reducing decisional conflict and decision regret related to complex, treatment-based decisions, and to reduce cancer health disparities. Trial registration ClinicalTrials.gov NCT03327103 . Registered on 31 October 2017-retrospectively registered. World Health Organization Trial Registration Data Set included in Supplementary Materials.


Assuntos
Neoplasias da Próstata , Telemedicina , Adulto , Tomada de Decisões , Técnicas de Apoio para a Decisão , Humanos , Masculino , Participação do Paciente , Neoplasias da Próstata/terapia , Qualidade de Vida
2.
BMC Musculoskelet Disord ; 22(1): 783, 2021 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-34511058

RESUMO

BACKGROUND: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality. METHODS: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%. DISCUSSION: There is a high potential for transferring the intervention into routine practice if the evaluation is positive. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021.


Assuntos
Artroplastia do Joelho , Osteoartrite do Joelho , Médicos , Artroplastia do Joelho/efeitos adversos , Técnicas de Apoio para a Decisão , Humanos , Estudos Multicêntricos como Assunto , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/cirurgia , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
Spine (Phila Pa 1976) ; 46(17): 1165-1171, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-34334684

RESUMO

STUDY DESIGN: General population utility valuation study. OBJECTIVE: The aim of this study was to develop a technique for calculating utilities from the Spine Oncology Study Group Outcomes Questionnaire v2.0 (SOSGOQ2.0). SUMMARY OF BACKGROUND DATA: The ability to calculate quality-adjusted life-years (QALYs) for metastatic spine disease would enhance treatment decision-making and facilitate economic analysis. QALYs are calculated using utilities. METHODS: Using a hybrid concept-retention and factorial analysis shortening approach, we first shortened the SOSGOQ2.0 to eight items (SOSGOQ-8D). This was done to lessen the cognitive burden of the utility valuation exercise. A general population sample of 2730 adults was then asked to evaluate 12 choice sets based on SOSGOQ-8D health states in a Discrete Choice Experiment. A utility scoring rubric was then developed using a mixed multinomial-logit regression model. RESULTS: We were able to reduce the SOSGOQ2.0 to an SOSGOQ-8D with a mean error of 0.003 and mean absolute error of 3.078 compared to the full questionnaire. The regression model demonstrated good predictive performance and was used to develop a utility scoring rubric. Regression results revealed that participants did not regard all SOSGOQ-8D items as equally important. CONCLUSION: We provide a simple technique for converting the SOSGOQ2.0 to utilities. The ability to evaluate QALYs in metastatic spine disease will facilitate economic analysis and patient counseling. We also quantify the importance of individual SOSGOQ-8D items. Clinicians should heed these findings and offer treatments that maximize function in the most important items.Level of Evidence: 3.


Assuntos
Qualidade de Vida , Coluna Vertebral , Adulto , Técnicas de Apoio para a Decisão , Nível de Saúde , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Inquéritos e Questionários
4.
AMA J Ethics ; 23(8): E624-630, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-34459730

RESUMO

This article offers examples of how modeling can motivate health equity inquiry and research. This article also considers how equity fits into cost-effectiveness frameworks, how economic modeling can broaden the range of options for improving health equity, and how information other than results of cost-effectiveness analyses can inform health technology assessment.


Assuntos
Equidade em Saúde , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Humanos , Avaliação da Tecnologia Biomédica
5.
AMA J Ethics ; 23(8): E648-652, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-34459733

RESUMO

American health care is rife with inequity in access to services. Even among people with insurance, inequity can result from insurers' decisions about which services to cover. These decisions are often based on economic models that are seemingly objective but neglect factors affecting people who are economically disadvantaged. Laws and government programs designed to mitigate inequities in access have limited value in addressing bias in models that inform coverage decisions. As a reform, government agencies that fund research could require that studies on which decision models are based better account for factors affecting people who are economically disadvantaged, an approach this article explores.


Assuntos
Órgãos Governamentais , Equidade em Saúde , Técnicas de Apoio para a Decisão , Acesso aos Serviços de Saúde , Humanos , Seguro Saúde
6.
BMJ Open ; 11(8): e054032, 2021 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-34462283

RESUMO

OBJECTIVE: To develop and user test a patient decision aid for people with subacromial pain syndrome that presents evidence-based information on the benefits and harms of subacromial decompression surgery and rotator cuff repair surgery. DESIGN: Mixed-methods study outlining the development of a patient decision aid. SETTING: We assembled a multidisciplinary steering group, and used existing decision aids and decision science to draft the decision aid. Participants were recruited through social media (not restricted by country nor setting), local hospitals and the authors' collaboration network. PARTICIPANTS: People with shoulder pain and health professionals who manage people with shoulder pain. PRIMARY AND SECONDARY OUTCOMES: We interviewed participants to gather feedback on the decision aid, assessed useability and acceptability (using qualitative and quantitative methods) and performed iterative cycles of redrafting the decision aid and reinterviewing participants as necessary. Interview data were analysed using thematic analysis. Quantitative data were summarised descriptively. RESULTS: We interviewed 26 health professionals (11 physiotherapists, 7 orthopaedic surgeons, 4 general practitioners, 3 chiropractors and 1 osteopath) and 14 people with shoulder pain. Most health professionals and people with shoulder pain rated all aspects of decision aid acceptability as adequate-to-excellent (eg, length, presentation, comprehensibility). Interviews highlighted agreement among health professionals and people with shoulder pain on most aspects of the decision aid (eg, treatment options, summary of benefits, harms and practical issues, questions to ask a health professional, graphics, formatting). However, some aspects of the decision aid elicited divergent views among health professionals (eg, causes and symptoms of shoulder pain, evidence on benefits and harms). CONCLUSION: This decision aid could be an acceptable and valuable tool for helping people with subacromial pain syndrome make informed treatment choices. A randomised controlled trial evaluating whether this decision aid reduces people's intentions to undergo shoulder surgery and facilitates informed treatment choices is underway.Trial registration number ACTRN12621000992808.


Assuntos
Manguito Rotador , Dor de Ombro , Técnicas de Apoio para a Decisão , Descompressão Cirúrgica , Humanos , Dor de Ombro/cirurgia , Resultado do Tratamento
7.
Epilepsy Behav ; 122: 108222, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34371462

RESUMO

INTRODUCTION: Epilepsy is a serious neurological disease, ranking high in the top causes of disability. Approximately 40% of patients with epilepsy are pharmacoresistant after their seizures failed at least two antiseizure medications (ASMs). Adult patients experiencing focal-onset seizures (FOS) account for approximately 60% of all patients with epilepsy and they are more likely to become drug-resistant epilepsy (DRE) than those with generalized onset. Drug-resistant epilepsy is associated with mortality, morbidity, and reduced quality of life. The information available on the clinical management, health outcomes, and unmet needs of the disease within the Spanish healthcare environment is very limited. Multi-Criteria Decision Analysis (MCDA) allows determination of what represents value in a given indication considering all relevant criteria for healthcare decision-making in a transparent and systematic manner and from the perspective of relevant stakeholders. PURPOSE: The aim of this study was to identify the burden of DRE (clinical, quality of life, and economic) and the unmet needs in Spain and to determine what represents value in the treatment of FOS in DRE patients from the perspective of Spanish epileptologists. METHODS: The steps taken to carry out the MCDA were based on previously published good methodological practices. A systematic literature review (combining biomedical databases and gray literature sources) was performed between March and April 2020. Results were reviewed and validated with three epileptologists in June 2020 and used to develop a MCDA value framework, adapted for FOS in DRE, composed of 12 quantitative criteria and 3 contextual criteria. A group of six Spanish epileptologists from four Spanish regions were trained in MCDA methodology before individually validating value criteria (and their definitions based on literature review findings) and assigned relative weights using an ordinal 6-points scale. Results were analyzed and discussed in a group meeting through reflective MCDA discussion methodology. RESULTS: Drug-resistant epilepsy is considered a very severe health problem with important unmet needs affecting a considerably sized population. While safety and impact on quality of life of available ASMs are considered adequate, efficacy remains insufficient for patients to achieve seizure freedom and maintain it over time. Hence, the therapeutic benefit of pharmacological treatments currently used is regarded as suboptimal. Drug-resistant epilepsy management is associated with moderate pharmacological, relevant direct medical and high indirect costs. Quality of evidence available for current treatments is moderate. It is considered that DRE does not currently stand as a key priority for the Spanish healthcare system. CONCLUSIONS: Drug-resistant epilepsy is considered a very severe health problem associated with relevant unmet needs. These include the lack of availability of specific treatment protocols, the need to improve early diagnosis by increasing the number of referrals to specialized epilepsy units and the availability of specific ASMs with improved efficacy and safety profiles, allowing to reach treatment objectives. Reflective MCDA provided a standardized, transparent approach to evaluate multiple criteria ascertaining what represents value from a holistic point of view and from the perspective of clinical experts, facilitating decision-making.


Assuntos
Epilepsia , Preparações Farmacêuticas , Adulto , Técnicas de Apoio para a Decisão , Humanos , Qualidade de Vida , Convulsões/tratamento farmacológico , Espanha/epidemiologia
8.
BMC Health Serv Res ; 21(1): 884, 2021 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-34454494

RESUMO

BACKGROUND: To provide value-based care for patients with multi-morbidity, innovative integrated care programmes and comprehensive evaluations of such programmes are required. In Norway, a new programme called "Holistic Continuity of Patient Care" (HCPC) addresses the issue of multi-morbidity by providing integrated care within learning networks for frail elderly patients who receive municipal home care services or a short-term stay in a nursing home. This study conducts a multi-criteria decision analysis (MCDA) to evaluate whether the HCPC programme performs better on a large set of outcomes corresponding to the 'triple aim' compared to usual care. METHODS: Prospective longitudinal survey data were collected at baseline and follow-up after 6-months. The assessment of HCPC was implemented by a novel MCDA framework. The relative weights of importance of the outcomes used in the MCDA were obtained from a discrete choice experiment among five different groups of stakeholders. The performance score was estimated using a quasi-experimental design and linear mixed methods. Performance scores were standardized and multiplied by their weights of importance to obtain the overall MCDA value by stakeholder group. RESULTS: At baseline in the HCPC and usual care groups, respectively, 120 and 89 patients responded, of whom 87 and 41 responded at follow-up. The average age at baseline was 80.0 years for HCPC and 83.6 for usual care. Matching reduced the standardized differences between the groups for patient background characteristics and outcome variables. The MCDA results indicated that HCPC was preferred to usual care irrespective of stakeholders. The better performance of HCPC was mostly driven by improvements in enjoyment of life, psychological well-being, and social relationships and participation. Results were consistent with sensitivity analyses using Monte Carlo simulation. CONCLUSION: Frail elderly with multi-morbidity represent complex health problems at large costs for society in terms of health- and social care. This study is a novel contribution to assessing and understanding HCPC programme performance respecting the multi-dimensionality of desired outcomes. Integrated care programmes like HCPC may improve well-being of patients, be cost-saving, and contribute to the pursuit of evidence based gradual reforms in the care of frail elderly.


Assuntos
Prestação Integrada de Cuidados de Saúde , Idoso Fragilizado , Idoso , Técnicas de Apoio para a Decisão , Humanos , Noruega , Estudos Prospectivos
9.
Drug Des Devel Ther ; 15: 3349-3378, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34376971

RESUMO

Dalbavancin is a novel, long-acting lipoglycopeptide characterized by a long elimination half-life coupled with excellent in vitro activity against multidrug-resistant Gram-positives. Although it is currently approved only for the treatment of acute bacterial skin and skin structure infections, an ever-growing amount of evidence supports the efficacy of dalbavancin as a long-term therapy in osteomyelitis, prosthetic joint infections, endocarditis, and bloodstream infections. This article provides a critical reappraisal of real-world use of dalbavancin for off-label indications. A search strategy using specific keywords (dalbavancin, osteomyelitis, endocarditis, long-term suppressive therapy, bloodstream infection, pharmacokinetic/pharmacodynamic profile) until April 2021 was performed on the PubMed-MEDLINE database. As for other novel antibiotics, a conundrum between approved indications and potential innovative therapeutic uses has emerged for dalbavancin as well. The promising efficacy in challenging scenarios (i.e., osteomyelitis, endocarditis, prosthetic joint infections), coupled with the unique pharmacokinetic/pharmacodynamic properties, makes dalbavancin a valuable alternative to daily in-hospital intravenous or outpatient antimicrobial regimens in the treatment of long-term Gram-positive infections. This makes dalbavancin valuable in the current COVID-19 scenario, in which hospitalization and territorial medicine empowerment are unavoidable.


Assuntos
Assistência Ambulatorial , Antibacterianos/uso terapêutico , COVID-19 , Infecções por Bactérias Gram-Positivas/tratamento farmacológico , Uso Off-Label , Participação do Paciente , Teicoplanina/análogos & derivados , Algoritmos , Antibacterianos/efeitos adversos , Antibacterianos/farmacocinética , Tomada de Decisão Clínica , Técnicas de Apoio para a Decisão , Infecções por Bactérias Gram-Positivas/diagnóstico , Infecções por Bactérias Gram-Positivas/microbiologia , Humanos , Teicoplanina/efeitos adversos , Teicoplanina/farmacocinética , Teicoplanina/uso terapêutico , Resultado do Tratamento
10.
BMC Health Serv Res ; 21(1): 807, 2021 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-34384428

RESUMO

BACKGROUND: Medicine purchasing in Chinese public hospitals is decided by the hospital Pharmacy Management Committee (PMC), that is complex, subjective and requires efficient approaches to ensure transparency and consistency for the factors being considered. This study aimed to use the Evidence and Value: Impact on Decision Making (EVIDEM) framework to assess medicine in these hospitals. In this study anti-diabetic drugs DPP-4 inhibitors, which work by inhibiting the activation of the Dipeptidyl Peptidase 4 (DPP-4) inhibitors, were appraised. METHODS: Following EVIDEM methodology (EVIDEM-10th), we convened an appraisal group and asked each individual to express their perspectives by assigning weights to each criterion. A systematic literature search for information of each criterion of five DPP-4 inhibitors was completed. Then the appraisal group scored for each criterion of the five DPP-4 inhibitors. The estimated value of the five DPP-4 inhibitors was obtained by Multi-Criteria Decision Analysis (MCDA) which combined individual weighting of each criterion with individual scoring for each intervention in each criterion. RESULTS: By assigning weights, the most important criterion was the quality of evidence (4.01±0.52), and that the comparative cost consequences-non-medical cost was the least important criterion (2.87±1.03). Criteria included disease severity, size of the affected population, comparative effectiveness, type of therapeutic/preventive benefit and cost of intervention, all of which were assigned the same weight of 3.58. After MCDA, the overall value orders for each DPP-4 inhibitor included Sitagliptin (0.45), Linagliptin (0.44), Vildagliptin (0.43), Alogliptin (0.42) and Saxagliptin (0.40). CONCLUSIONS: Based on EVIDEM framework and MCDA, we found that overall value of five DPP-4 inhibitors was similar. It is feasible to use the EVIDEM framework and MCDA in purchasing medicine for Chinese public hospitals.


Assuntos
Diabetes Mellitus Tipo 2 , Inibidores da Dipeptidil Peptidase IV , China , Tomada de Decisões , Técnicas de Apoio para a Decisão , Diabetes Mellitus Tipo 2/tratamento farmacológico , Dipeptidil Peptidase 4 , Hospitais Públicos , Humanos
11.
Reprod Health ; 18(1): 170, 2021 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-34372864

RESUMO

BACKGROUND: The use of a decision aid in clinical settings has been beneficial. It informs and educates patients about the available treatment options that can help them reduce decision-making conflicts related to feeling uninformed compared with routine care. There is a scarcity of published data about using a decision aid during family planning counseling with postpartum women focusing on long-acting reversible contraception in Tanzania. Therefore, we developed a "postpartum Green Star family planning decision aid" and assessed its feasibility. The study outcomes were practicality, usefulness, and acceptability perceived by pregnant adolescents and nurses/midwives. METHODS: We used an exploratory qualitative in-depth interview involving six nurses/midwives with three or more years of experience in family planning services and 12 pregnant adolescents aged 15-19 years. Purposive sampling was used to select the participants, and selection relied on the saturation principle of data collection. We used a semi-structured interview guide translated into the Kiswahili language. Data were transcribed and analyzed following inductive content analysis. RESULTS: The amount of information presented was just right, with the time of reading the data ranging from 20 min to 1 h. The study participants perceived the flow of information to be good, with small significant changes suggested. Kiswahili language was used and reported to be appropriate and well elaborated. However, a few words were told to be rephrased to reduce ambiguity. The nurses/midwives said that the decision aid included most of the vital information the participants wanted to know during their family planning counseling. Pregnant adolescents stated that the decision aid improved their knowledge and provided new details on the long-acting reversible contraception methods (intrauterine copper devices and implants) offered immediately after childbirth. The participants stated that the decision aid addressed long-acting reversible contraception methods' benefits and side effects and dispelled myths and misconceptions. The study participants considered the decision aid helpful in complementing the family planning counseling offered and improving pregnant adolescents' knowledge. CONCLUSION: The postpartum Green Star family planning decision aid was practical, useful, and acceptable in enhancing the objectivity of counseling about long-acting reversible contraception methods. It improved the knowledge of pregnant adolescents in Tanzania about the available contraception methods (i.e., the use of intrauterine copper devices and implants), which can be immediately used postpartum. Further research is needed to assess the effects of the decision aid on long-acting reversible contraception postpartum uptake among pregnant adolescents in Tanzania.


Assuntos
Serviços de Planejamento Familiar , Período Pós-Parto , Adolescente , Anticoncepção , Técnicas de Apoio para a Decisão , Estudos de Viabilidade , Feminino , Humanos , Gravidez , Tanzânia
12.
Artigo em Inglês | MEDLINE | ID: mdl-34360481

RESUMO

Colorectal cancer (CRC)-screening reduces mortality, yet remains underutilized. The use of electronic media (e-media) decision aids improves saliency and fosters informed decision-making. This systematic review aimed to determine the effectiveness of CRC-screening promotion, using e-media decision aids in primary healthcare (PHC) settings. Three databases (MEDLINE, Web of Science, and the Cochrane Library) were searched for eligible studies. Studies that evaluated e-media decision aids compared to usual care or other conditions were selected. Quality was assessed by using Cochrane tools. Their effectiveness was measured by CRC-screening completion rates, and meta-analysis was conducted to calculate the pooled estimates. Ten studies involving 9393 patients were included in this review. Follow-up durations spanned 3-24 months. The two types of decision-aid interventions used were videos and interactive multimedia programs, with durations of 6-15 min. Data from nine feasible studies with low or some risk of bias were synthesized for meta-analysis. A random-effects model revealed that CRC-screening promotion using e-media decision aids were almost twice as likely to have screening completion than their comparisons (OR 1.62, 95% CI: 1.03-2.62, p < 0.05). CRC-screening promotion through e-media has great potential for increasing screening participation in PHC settings. Thus, its development should be prioritized, and it should be integrated into existing programs.


Assuntos
Neoplasias Colorretais , Meios de Comunicação , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/prevenção & controle , Técnicas de Apoio para a Decisão , Detecção Precoce de Câncer , Humanos , Programas de Rastreamento
13.
Prog Cardiovasc Dis ; 66: 70-79, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34332662

RESUMO

Electrical storm is present when a cluster of ventricular arrhythmias (VAs) occurs within a short time frame. The most widely accepted definition is 3 or more episodes of VA within a 24-h period, although prognostic risk begins to rise when 2 or more events occur within 3months. Electrical storm often presents as a medical emergency in the form of recurrent implantable cardiac defibrillator (ICD) shocks, recurrent syncope in patients with no ICD or low cardiac output symptoms. Management often requires a multimodality approach including ICD management, pharmacologic therapy, catheter ablation and modulations of the autonomic nervous system. In this article, we review the definition, prognosis and management of electrical storm.


Assuntos
Antiarrítmicos/uso terapêutico , Denervação Autônoma , Estimulação Cardíaca Artificial , Ablação por Cateter , Oxigenação por Membrana Extracorpórea , Taquicardia Ventricular/terapia , Fibrilação Ventricular/terapia , Potenciais de Ação/efeitos dos fármacos , Antiarrítmicos/efeitos adversos , Denervação Autônoma/efeitos adversos , Denervação Autônoma/mortalidade , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/mortalidade , Ablação por Cateter/efeitos adversos , Ablação por Cateter/mortalidade , Tomada de Decisão Clínica , Técnicas de Apoio para a Decisão , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/mortalidade , Sistema de Condução Cardíaco/efeitos dos fármacos , Sistema de Condução Cardíaco/fisiopatologia , Sistema de Condução Cardíaco/cirurgia , Frequência Cardíaca/efeitos dos fármacos , Humanos , Marca-Passo Artificial , Recidiva , Medição de Risco , Fatores de Risco , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/mortalidade , Taquicardia Ventricular/fisiopatologia , Resultado do Tratamento , Fibrilação Ventricular/diagnóstico , Fibrilação Ventricular/mortalidade , Fibrilação Ventricular/fisiopatologia
14.
J Stroke Cerebrovasc Dis ; 30(9): 105963, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34247055

RESUMO

OBJECTIVE: To determine whether the intracerebral hemorrhage (ICH) score is accurate in predicting 30-day mortality in young adults, we calculated the ICH score for 156 young adults (aged 18-45) with primary spontaneous ICH and compared predicted to observed 30-day mortality rates. METHODS: We retrospectively reviewed all patients aged 18-45 consecutively presenting to the University of Iowa from 2009 to 2019 with ICH. We calculated the ICH score and recorded its individual subcomponents for each patient. Poisson regression was used to test the association of ICH score components with 30-day mortality. RESULTS: We identified 156 patients who met the inclusion criteria; mean± standard deviation (SD) age was 35±8 years. The 30-day mortality rate was 15% (n=24). The ICH score was predictive of 30-day mortality for each unit increase (p= 0.04 for trend), but the observed mortality rates for each ICH score varied considerably from the original ICH score predictions. Most notably, the 30-day mortality rates for ICH scores of 1, 2, and 3 are predicted to be 13%, 26%, and 72% respectively, but were observed in our population to be 0%, 3%, and 41%. An ICH volume of >30cc [relative risk (RR) 28, 95% confidence intervals (CI) 3-315, p=0.01] and a GCS score of <5 (RR 13, 95% CI 0.1-1176, p=0.01) were independently associated with 30-day mortality. CONCLUSIONS: The ICH score tends to overestimate mortality in young adults. ICH volume and GCS score are the most relevant items in predicting mortality at 30 days in young adults.


Assuntos
Hemorragia Cerebral/mortalidade , Técnicas de Apoio para a Decisão , Adolescente , Adulto , Fatores Etários , Hemorragia Cerebral/diagnóstico , Feminino , Escala de Coma de Glasgow , Humanos , Iowa , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Adulto Jovem
15.
BMC Med Inform Decis Mak ; 21(1): 225, 2021 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-34303358

RESUMO

BACKGROUND: Achilles tendon ruptures are common injuries in an otherwise healthy, active population. Several treatment options exist, with both surgical and non-surgical options. Each treatment option has a unique set of risks and harms, which may present patients with decisional conflict. The aim of the proposed study is to develop, alpha test and field test a patient decision aid for patients presenting with acute Achilles tendon ruptures. METHODS: This is a three-stage study protocol. First, we will assemble a multi-disciplinary steering group including patients, clinicians, educators, and researchers to develop the patient decision aid prototype using the Ottawa Decision Support Framework. Second, we will perform a mixed-methods alpha test of the decision aid prototype with patients and clinicians experienced in acute Achilles tendon ruptures. Outcomes measured will include acceptability and usability of the patient decision aid measured using validated outcome scales and semi-structured interviews. A minimum of three rounds of feedback will be obtained. Results will be analyzed using descriptive statistics, reviewed by the steering group, to guide revisions to decision aid prototype at each round. The third stage will be field testing the revised decision aid prototype in usual clinical care. A pre-/post-study will be performed with patients with acute Achilles tendon ruptures. Patients will be recruited from the emergency department and complete the pre-consultation decision aid prior to a one-week follow up with their surgeon. The primary outcome of field testing will be feasibility of implementing the decision aid in the clinical setting and will be measured with recruitment and completion metrics. Secondary outcomes include acceptability of the decision aid, knowledge, preparedness for decision making, and decisional conflict, measured using validated outcome measures. Statistical analysis will be performed using descriptive analysis for primary outcomes and a student t-test and Wilcoxon Rank-Sum test for secondary outcomes. DISCUSSION: This comprehensive study protocol outlines the development, alpha testing, and field testing of a patient decision aid for patients with acute Achilles tendon rupture. Systematic and transparent development and testing of patient decision aids is critical to improve decision aid quality. Trial registration Not Applicable.


Assuntos
Tendão do Calcâneo , Traumatismos dos Tendões , Doença Aguda , Técnicas de Apoio para a Decisão , Humanos , Ruptura , Resultado do Tratamento
16.
Aging (Albany NY) ; 13(14): 17961-17977, 2021 07 19.
Artigo em Inglês | MEDLINE | ID: mdl-34282057

RESUMO

We intend to evaluate the differences of the clinical characteristics, cytokine profiles and immunological features in patients with different severity of COVID-19, and to develop novel nomograms based on inflammatory cytokines or lymphocyte subsets for the differential diagnostics for severe or critical and non-severe COVID-19 patients. We retrospectively studied 254 COVID-19 patients, 90 of whom were severe or critical patients and 164 were non-severe patients. Severe or critical patients had significantly higher levels of inflammatory cytokines than non-severe patients as well as lower levels of lymphocyte subsets. Significantly positive correlations between cytokine profiles were observed, while they were all significantly negatively correlated with lymphocyte subsets. Two effective nomograms were developed according to two multivariable logistic regression cox models based on inflammatory cytokine profiles and lymphocyte subsets separately. The areas under the receiver operating characteristics of two nomograms were 0.834 (95% CI: 0.779-0.888) and 0.841 (95% CI: 0.756-0.925). The bootstrapped-concordance indexes of two nomograms were 0.834 and 0.841 in training set, and 0.860 and 0.852 in validation set. Calibration curves and decision curve analyses demonstrated that the nomograms were well calibrated and had significantly more clinical net benefits. Our novel nomograms can accurately predict disease severity of COVID-19, which may facilitate the identification of severe or critical patients and assist physicians in making optimized treatment suggestions.


Assuntos
COVID-19/diagnóstico , Citocinas/sangue , Técnicas de Apoio para a Decisão , Mediadores da Inflamação/sangue , Subpopulações de Linfócitos/imunologia , Nomogramas , Idoso , Biomarcadores/sangue , COVID-19/sangue , COVID-19/imunologia , COVID-19/terapia , Tomada de Decisão Clínica , Feminino , Humanos , Contagem de Linfócitos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Regulação para Cima
17.
Arthritis Care Res (Hoboken) ; 73(8): 1088-1105, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34235880

RESUMO

OBJECTIVE: To provide evidence-based recommendations and expert guidance for the management of antineutrophil cytoplasmic antibody-associated vasculitis (AAV), including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). METHODS: Clinical questions regarding the treatment and management of AAV were developed in the population, intervention, comparator, and outcome (PICO) format (47 for GPA/MPA, 34 for EGPA). Systematic literature reviews were conducted for each PICO question. The Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the quality of evidence and formulate recommendations. Each recommendation required ≥70% consensus among the Voting Panel. RESULTS: We present 26 recommendations and 5 ungraded position statements for GPA/MPA, and 15 recommendations and 5 ungraded position statements for EGPA. This guideline provides recommendations for remission induction and maintenance therapy as well as adjunctive treatment strategies in GPA, MPA, and EGPA. These recommendations include the use of rituximab for remission induction and maintenance in severe GPA and MPA and the use of mepolizumab in nonsevere EGPA. All recommendations are conditional due in part to the lack of multiple randomized controlled trials and/or low-quality evidence supporting the recommendations. CONCLUSION: This guideline presents the first recommendations endorsed by the American College of Rheumatology and the Vasculitis Foundation for the management of AAV and provides guidance to health care professionals on how to treat these diseases.


Assuntos
Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/tratamento farmacológico , Anticorpos Anticitoplasma de Neutrófilos/sangue , Imunossupressores/uso terapêutico , Reumatologia/normas , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/diagnóstico , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/imunologia , Biomarcadores/sangue , Tomada de Decisão Clínica , Consenso , Técnicas de Apoio para a Decisão , Medicina Baseada em Evidências/normas , Humanos , Imunossupressores/efeitos adversos , Índice de Gravidade de Doença , Resultado do Tratamento
18.
Arthritis Care Res (Hoboken) ; 73(8): 1071-1087, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34235871

RESUMO

OBJECTIVE: To provide evidence-based recommendations and expert guidance for the management of giant cell arteritis (GCA) and Takayasu arteritis (TAK) as exemplars of large vessel vasculitis. METHODS: Clinical questions regarding diagnostic testing, treatment, and management were developed in the population, intervention, comparator, and outcome (PICO) format for GCA and TAK (27 for GCA, 27 for TAK). Systematic literature reviews were conducted for each PICO question. The Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. Recommendations were developed by the Voting Panel, comprising adult and pediatric rheumatologists and patients. Each recommendation required ≥70% consensus among the Voting Panel. RESULTS: We present 22 recommendations and 2 ungraded position statements for GCA, and 20 recommendations and 1 ungraded position statement for TAK. These recommendations and statements address clinical questions relating to the use of diagnostic testing, including imaging, treatments, and surgical interventions in GCA and TAK. Recommendations for GCA include support for the use of glucocorticoid-sparing immunosuppressive agents and the use of imaging to identify large vessel involvement. Recommendations for TAK include the use of nonglucocorticoid immunosuppressive agents with glucocorticoids as initial therapy. There were only 2 strong recommendations; the remaining recommendations were conditional due to the low quality of evidence available for most PICO questions. CONCLUSION: These recommendations provide guidance regarding the evaluation and management of patients with GCA and TAK, including diagnostic strategies, use of pharmacologic agents, and surgical interventions.


Assuntos
Arterite de Células Gigantes/tratamento farmacológico , Glucocorticoides/uso terapêutico , Imunossupressores/uso terapêutico , Reumatologia/normas , Arterite de Takayasu/tratamento farmacológico , Tomada de Decisão Clínica , Consenso , Técnicas de Apoio para a Decisão , Quimioterapia Combinada , Medicina Baseada em Evidências/normas , Arterite de Células Gigantes/diagnóstico , Arterite de Células Gigantes/imunologia , Glucocorticoides/efeitos adversos , Humanos , Imunossupressores/efeitos adversos , Arterite de Takayasu/diagnóstico , Arterite de Takayasu/imunologia , Resultado do Tratamento
19.
Arthritis Care Res (Hoboken) ; 73(8): 1061-1070, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34235889

RESUMO

OBJECTIVE: To provide evidence-based recommendations and expert guidance for the management of systemic polyarteritis nodosa (PAN). METHODS: Twenty-one clinical questions regarding diagnostic testing, treatment, and management were developed in the population, intervention, comparator, and outcome (PICO) format for systemic, non-hepatitis B-related PAN. Systematic literature reviews were conducted for each PICO question. The Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the quality of evidence and formulate recommendations. Each recommendation required ≥70% consensus among the Voting Panel. RESULTS: We present 16 recommendations and 1 ungraded position statement for PAN. Most recommendations were graded as conditional due to the paucity of evidence. These recommendations support early treatment of severe PAN with cyclophosphamide and glucocorticoids, limiting toxicity through minimizing long-term exposure to both treatments, and the use of imaging and tissue biopsy for disease diagnosis. These recommendations endorse minimizing risk to the patient by using established therapy at disease onset and identify new areas where adjunctive therapy may be warranted. CONCLUSION: These recommendations provide guidance regarding diagnostic strategies, use of pharmacologic agents, and imaging for patients with PAN.


Assuntos
Ciclofosfamida/uso terapêutico , Glucocorticoides/uso terapêutico , Imunossupressores/uso terapêutico , Poliarterite Nodosa/tratamento farmacológico , Reumatologia/normas , Tomada de Decisão Clínica , Consenso , Ciclofosfamida/efeitos adversos , Técnicas de Apoio para a Decisão , Quimioterapia Combinada , Medicina Baseada em Evidências/normas , Glucocorticoides/efeitos adversos , Humanos , Imunossupressores/efeitos adversos , Poliarterite Nodosa/diagnóstico , Poliarterite Nodosa/imunologia , Índice de Gravidade de Doença , Resultado do Tratamento
20.
J Surg Oncol ; 124(5): 801-809, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34231222

RESUMO

INTRODUCTION: Neoadjuvant therapy (NAT) is an emerging strategy for operable pancreatic ductal adenocarcinoma (PDAC). While NAT increases multimodal therapy completion, it risks functional decline and treatment dropout. We used decision analysis to determine optimal management of localized PDAC and consider risks faced by elderly patients. METHODS: A Markov cohort decision analysis model evaluated treatment options for a 60-year-old patient with resectable PDAC: (1) upfront pancreaticoduodenectomy or (2) NAT. One-way and probabilistic sensitivity analyses were performed. A subanalysis considered the scenario of a 75-year-old patient. RESULTS: For the base case, NAT offered an incremental survival gain of 4.6 months compared with SF (overall survival: 26.3 vs. 21.7 months). In one-way sensitivity analyses, findings were sensitive to recurrence-free survival for NAT patients undergoing adjuvant, probability of completing NAT, and probability of being resectable at exploration after NAT. On probabilistic analysis, NAT was favored in a majority of trials (97%) with a median survival benefit of 5.1 months. In altering the base case for the 75-year-old scenario, NAT had a survival benefit of 3.8 months. CONCLUSIONS: This analysis demonstrates a significant benefit to NAT in patients with localized PDAC. This benefit persists even in the elderly cohort.


Assuntos
Adenocarcinoma/terapia , Carcinoma Ductal Pancreático/terapia , Técnicas de Apoio para a Decisão , Cadeias de Markov , Terapia Neoadjuvante/mortalidade , Pancreatectomia/mortalidade , Neoplasias Pancreáticas/terapia , Adenocarcinoma/patologia , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Ductal Pancreático/patologia , Terapia Combinada , Seguimentos , Humanos , Pessoa de Meia-Idade , Neoplasias Pancreáticas/patologia , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida
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