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1.
Medicine (Baltimore) ; 99(52): e23818, 2020 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-33350768

RESUMO

ABSTRACT: There have been increasing calls for clinicians to document social determinants of health (SDOH) in electronic health records (EHRs). One potential source of SDOH in the EHRs is in the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Z codes (Z55-Z65). In February 2018, ICD-10-CM Official Guidelines for Coding and Reporting approved that all clinicians, not just the physicians, involved in the care of a patient can document SDOH using these Z codes.To examine the utilization rate of the ICD-10-CM Z codes using data from a large network of EHRs.We conducted a retrospective analysis of EHR data between 2015 to 2018 in the OneFlorida Clinical Research Consortium, 1 of the 13 Clinical Data Research Networks funded by Patient-Centered Outcomes Research Institute. We calculated the Z code utilization rate at both the encounter and patient levels.We found a low rate of utilization for these Z codes (270.61 per 100,000 at the encounter level and 2.03% at the patient level). We also found that the rate of utilization for these Z codes increased (from 255.62 to 292.79 per 100,000) since the official approval of Z code reporting from all clinicians by the American Hospital Association Coding Clinic and ICD-10-CM Official Guidelines for Coding and Reporting became effective in February 2018.The SDOH Z codes are rarely used by clinicians. Providing clear guidelines and incentives for documenting the Z codes can promote their use in EHRs. Improvements in the EHR systems are probably needed to better document SDOH.


Assuntos
Registros Eletrônicos de Saúde , Classificação Internacional de Doenças , Determinantes Sociais da Saúde , Registros Eletrônicos de Saúde/normas , Registros Eletrônicos de Saúde/estatística & dados numéricos , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Melhoria de Qualidade , Estados Unidos , Revisão da Utilização de Recursos de Saúde
2.
Medicine (Baltimore) ; 99(44): e22915, 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33126350

RESUMO

BACKGROUND: The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines. METHODS: We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration's risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry. RESULTS: Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines. DISCUSSION: This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018110829.


Assuntos
Placebos/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Confiabilidade dos Dados , Humanos , Metanálise como Assunto , Avaliação de Resultados em Cuidados de Saúde/ética , Avaliação de Resultados em Cuidados de Saúde/normas , Pesquisa Farmacêutica/ética , Pesquisa Farmacêutica/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
3.
Value Health ; 23(9): 1120-1127, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32940228

RESUMO

The need for Health Economics and Outcomes Research (HEOR) has expanded globally, fueling demand for professionals trained in the discipline. By leveraging the expertise and perspectives of its members, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) established a set of competencies for HEOR professionals. The resulting 41 competencies were organized into 13 topic domains that collectively comprise the ISPOR Health Economics and Outcomes Research Competencies Framework. In this article, we explain the collaborative process used by the ISPOR Institutional Council and Faculty Advisor Council to identify and validate the framework. This process entailed expertise from the council members combined with natural language processing to examine competencies included in ISPOR Career Center HEOR job postings, qualitative input from a focused Institutional Council-Faculty Advisor Council workgroup, and quantitative input from 3 surveys of mutually exclusive member groups: a general member survey to assess importance and relevance of each competency, a faculty member survey to assess the extent to which HEOR graduate degree programs cover each of the competencies, and a student member survey to assess exposure to each of the competencies. Organization of the competencies into topic domains was achieved by engaging the Education Council, which applied a taxonomy consistent with ISPOR's educational programming. The resulting ISPOR Health Economics and Outcomes Research Competencies Framework has the important potential of serving as a tool to guide academic curricula, fellowships, and continuing education programs, and assessment of job candidates. As the HEOR field advances, so do the job types and the breadth of topics in which professionals must demonstrate competence. Future work will entail revisiting the competencies to ensure their currency and comprehensiveness, and tailoring the framework according to major specialty areas.


Assuntos
Economia Médica/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Farmacoeconomia , Humanos , Inquéritos e Questionários
4.
Intern Emerg Med ; 15(8): 1457-1465, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32960429

RESUMO

The correlation between myocardial injury and clinical outcome in COVID-19 patients is gaining attention in the literature. The aim of the present study was to evaluate the role of cardiac involvement and of respiratory failure in a cohort of COVID-19 patients hospitalized in an academic hospital in Lombardy, one of the most affected Italian (and worldwide) regions by the epidemic. The study included 405 consecutive patients with confirmed COVID-19 admitted to a medical ward from February 25th to March 31st, 2020. Follow-up of surviving patients ended either at hospital discharge or by July 30th, 2020. Myocardial injury was defined on the basis of the presence of blood levels of hs-TnI above the 99th percentile upper reference limit. Respiratory function was assessed as PaO2/FiO2 (P/F) ratio. The primary end-point was death for any cause. During hospitalization, 124 patients died. Death rate increased from 7.9% in patients with normal hs-TnI plasma levels and no cardiac comorbidity to 61.5% in patients with elevated hs-TnI and cardiac involvement (p < 0.001). At multivariable analysis, older age, P/F ratio < 200 (both p < 0.001) and hs-TnI plasma levels were independent predictors of death. However, it must be emphasized that the median values of hs-TnI were within normal range in non-survivors. Cardiac involvement at presentation was associated with poor prognosis in COVID-19 patients, but, even in a population of COVID-19 patients who did not require invasive ventilation at hospital admission, mortality was mainly driven by older age and respiratory failure.


Assuntos
Doenças Cardiovasculares/etiologia , Infecções por Coronavirus/complicações , Avaliação de Resultados em Cuidados de Saúde/normas , Pneumonia Viral/complicações , Centros de Atenção Terciária/estatística & dados numéricos , Idoso , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Biomarcadores/análise , Biomarcadores/sangue , Doenças Cardiovasculares/epidemiologia , Infecções por Coronavirus/epidemiologia , Eletrocardiografia/métodos , Eletrocardiografia/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Pandemias , Pneumonia Viral/epidemiologia , Reação em Cadeia da Polimerase/métodos , Centros de Atenção Terciária/organização & administração , Centros de Atenção Terciária/normas , Troponina I/análise , Troponina I/sangue
5.
Med Care ; 58(10): 867-873, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32732781

RESUMO

BACKGROUND: Patient utilization of public reporting has been suboptimal despite attempts to encourage use. Lack of utilization may be due to discordance between reported metrics and what patients want to know when making health care choices. OBJECTIVE: The objective of this study was to identify measures of quality that individuals want to be presented in public reporting and explore factors associated with researching health care. RESEARCH DESIGN: Patient interviews and focus groups were conducted to develop a survey exploring the relative importance of various health care measures. SUBJECTS: Interviews and focus groups conducted at local outpatient clinics. A survey administered nationally on an anonymous digital platform. MEASURES: Likert scale responses were compared using tests of central tendency. Rank-order responses were compared using analysis of variance testing. Associations with binary outcomes were analyzed using multivariable logistic regression. RESULTS: Overall, 4672 responses were received (42.0% response rate). Census balancing yielded 2004 surveys for analysis. Measures identified as most important were hospital reputation (considered important by 61.9%), physician experience (51.5%), and primary care recommendations (43.2%). Unimportant factors included guideline adherence (17.6%) and hospital academic affiliation (13.3%, P<0.001 for all compared with most important factors). Morbidity and mortality outcome measures were not among the most important factors. Patients were unlikely to rank outcome measures as the most important factors in choosing health care providers, irrespective of age, sex, educational status, or income. CONCLUSIONS: Patients valued hospital reputation, physician experience, and primary care recommendations while publicly reported metrics like patient outcomes were less important. Public quality reports contain information that patients perceive to be of relatively low value, which may contribute to low utilization.


Assuntos
Pessoal de Saúde/normas , Hospitais/normas , Preferência do Paciente/estatística & dados numéricos , Qualidade da Assistência à Saúde/normas , Adulto , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/normas , Preferência do Paciente/psicologia , Registros Públicos de Dados de Cuidados de Saúde , Qualidade da Assistência à Saúde/estatística & dados numéricos , Inquéritos e Questionários
7.
Med Care ; 58(7): 658-662, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32520839

RESUMO

BACKGROUND: Single-center comparative effectiveness studies evaluating outcomes that can occur posthospitalization may become biased if outcomes diagnosed at other facilities are not ascertained. Administrative datasets that link patients' records across facilities may improve outcome ascertainment. OBJECTIVE: To determine whether use of linked administrative data significantly augments thromboembolic outcome ascertainment. RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: Patients with an acute isolated calf deep vein thrombosis (DVT) diagnosed at 1 Californian center during 2010-2013. MEASURES: Proximal DVT or pulmonary embolism (PE) within 180 days. We ascertained outcomes from linked California hospitalization, emergency department, and ambulatory surgery data and compared this information to outcomes previously identified from review of the center's medical records. RESULTS: Among 384 patients with an isolated calf DVT, 333 could be linked to longitudinal administrative data records. Ten patients had a possible proximal DVT or PE (4 more clearly so) from administrative data; all were unknown from medical record review. Eleven patients with known outcomes from medical record review had no outcome from administrative data. The adjusted odds ratio of proximal DVT or PE with therapeutic anticoagulation attenuated from 0.33 [95% confidence interval (CI), 0.12-0.87] using only medical record review to 0.64 (95% CI, 0.29-1.40) using both medical record review and possible outcomes from administrative data. Restricting the outcome to diagnoses clearly involving proximal DVT or PE, the adjusted odds ratio was 0.46 (95% CI, 0.19-1.10). CONCLUSIONS: Use of linked hospital administrative data augmented detection of outcomes but imperfect linkage, nonspecific diagnoses, and documentation/coding errors introduced uncertainty regarding the accuracy of outcome ascertainment.


Assuntos
Anticoagulantes/uso terapêutico , Organização e Administração/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/normas , Tromboembolia Venosa/tratamento farmacológico , Adulto , Idoso , California , Estudos de Coortes , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Humanos , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/fisiopatologia , Masculino , Pessoa de Meia-Idade , Razão de Chances , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Qualidade da Assistência à Saúde/normas , Qualidade da Assistência à Saúde/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Tromboembolia Venosa/prevenção & controle
8.
Phys Ther ; 100(9): 1423-1433, 2020 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-32494809

RESUMO

OBJECTIVE: Therapists in the hospital are charged with making timely discharge recommendations to improve access to rehabilitation after stroke. The objective of this study was to identify the predictive ability of the Activity Measure for Post-Acute Care "6 Clicks" Basic Mobility Inpatient Short Form (6 Clicks mobility) score and the National Institutes of Health Stroke Scale (NIHSS) score for actual hospital discharge disposition after stroke. METHODS: In this retrospective cohort study, data were collected from an academic hospital in the United States for 1543 patients with acute stroke and a 6 Clicks mobility score. Discharge to home, a skilled nursing facility (SNF), or an inpatient rehabilitation facility (IRF) was the primary outcome. Associations among these outcomes and 6 Clicks mobility and NIHSS scores, alone or together, were tested using multinomial logistic regression, and the predictive ability of these scores was calculated using concordance statistics. RESULTS: A higher 6 Clicks mobility score alone was associated with a decreased odds of actual discharge to an IRF or an SNF. The 6 Clicks mobility score alone was a strong predictor of discharge to home versus an IRF or an SNF. However, predicting discharge to an IRF versus an SNF was stronger when the 6 Clicks mobility score was considered in combination with the NIHSS score, age, sex, and race. CONCLUSION: The 6 Clicks mobility score alone can guide discharge decision making after stroke, particularly for discharge to home versus an SNF or an IRF. Determining discharge to an SNF versus an IRF could be improved by also considering the NIHSS score, age, sex, and race. Future studies should seek to identify which additional characteristics improve predictability for these separate discharge destinations. IMPACT: The use of outcome measures can improve therapist confidence in making discharge recommendations for people with stroke, can enhance hospital throughput, and can expedite access to rehabilitation, ultimately affecting functional outcomes.


Assuntos
Avaliação de Resultados em Cuidados de Saúde/normas , Alta do Paciente/normas , Desempenho Físico Funcional , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral/fisiopatologia , Atividades Cotidianas , Doença Aguda , Idoso , Cognição , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , National Institute of Neurological Disorders and Stroke (USA) , Análise de Regressão , Centros de Reabilitação , Estudos Retrospectivos , Índice de Gravidade de Doença , Instituições de Cuidados Especializados de Enfermagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/terapia , Estados Unidos
9.
Medicine (Baltimore) ; 99(26): e20842, 2020 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-32590778

RESUMO

Sepsis is associated with impaired clinical outcomes. It requires timely diagnosis and urgent therapeutic management. Because staffing during after-hours is limited, we explored whether after-hour admissions are associated with worse clinical outcomes in patients with sepsis.In this retrospective cohort study, we analyzed nationwide acute care admissions for a main diagnosis of sepsis in Switzerland between 2006 and 2016 using prospective administrative data. The primary outcome was in-hospital mortality using multivariable logistic regression models. Secondary outcomes were intensive care unit (ICU) admission, intubation, and 30-day readmission.We included 86,597 hospitalizations for sepsis, 60.1% admitted during routine-hours, 16.8% on weekends and 23.1% during night shift. Compared to routine-hours, we found a higher odds ratio (OR) for in-hospital mortality in patients admitted on weekends (Adjusted OR 1.05, 95% confidence interval [95% CI] 1.01, 1.10, P = .041). Also, the OR for ICU admission (OR 1.14, 95% CI 1.10, 1.19, P < .001) and intubation (OR 1.18, 95% CI 1.12, 1.25 P < .001) was higher for weekends compared to routine-hours. Regarding 30-day readmission, evidence for an association could not be observed. Night shift admission, compared to routine-hours, was associated with a higher OR for ICU admission and intubation (ICU admission: OR 1.28 (1.23, 1.32), P < .001; intubation: OR 1.31, 95% CI 1.25, 1.37, P < .001) but with a lower OR for in-hospital mortality (OR 0.93, 19% CI 0.89, 0.97, P = .001).Among hospitalizations with a main diagnosis of sepsis, weekend admissions were associated with higher OR for in-hospital mortality, ICU admission, and intubation. Whether these findings can be explained by staffing-level differences needs to be addressed.


Assuntos
Plantão Médico/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Sepse/complicações , Fatores de Tempo , Plantão Médico/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Mortalidade Hospitalar/tendências , Hospitalização/estatística & dados numéricos , Humanos , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Razão de Chances , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Estudos Prospectivos , Estudos Retrospectivos , Sepse/epidemiologia , Sepse/mortalidade , Suíça
10.
Circ Heart Fail ; 13(7): e006720, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32580655

RESUMO

BACKGROUND: The usefulness of adjudication by central end point committees (CECs) is poorly assessed in heart failure (HF) trials. We aimed to assess its impact on the outcome of the SHIFT trial (Systolic HF Treatment With the If Inhibitor Ivabradine Trial). METHODS: SHIFT was a randomized placebo-controlled trial investigating the effect of ivabradine in 6505 HF patients with reduced ejection fraction. Prespecified end points, reported by investigators (all cardiologists) using specific case report form pages, included all-cause and specific causes of deaths and hospitalizations. The primary end point was a composite of cardiovascular deaths or hospitalizations for worsening HF. We compared the adjudication of prespecified end points made by investigators and by the CEC. RESULTS: Investigators identified 7529 prespecified end points, 6793 of which were confirmed by the CEC: 98.1% of cardiovascular deaths, 88.6% of all hospitalizations, and 84.4% of hospitalizations for worsening HF. These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83 (95% CI, 0.76-0.91) versus CEC, 0.82 (95% CI, 0.75-0.90), with similar results for each component of the primary end point (hazard ratio of 0.92 versus 0.91 for cardiovascular death and 0.78 versus 0.74 for hospitalization for worsening HF). CONCLUSIONS: Central adjudication by a CEC in the SHIFT study confirmed most of cardiovascular deaths and worsening HF hospitalizations assessed by cardiologists and did not result in a significant change of the final result as compared to investigator judgment. In this context, the benefits of CEC in blinded HF trials should be reconsidered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02441218. URL: http://www.isrctn.com/ISRCTN70429960; Unique identifier: ISRCTN70429960.


Assuntos
Insuficiência Cardíaca/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Determinação de Ponto Final/normas , Insuficiência Cardíaca/mortalidade , Hospitalização/estatística & dados numéricos , Humanos , Reprodutibilidade dos Testes , Resultado do Tratamento
11.
Pediatrics ; 146(1)2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32493710

RESUMO

BACKGROUND: As rates of neonatal opioid withdrawal are increasing, the need for research to evaluate new treatments is growing. Large heterogeneity exists in health outcomes reported in current literature. Our objective is to develop an evidence-informed and consensus-based core outcome set in neonatal opioid withdrawal syndrome (NOWS-COS) for use in studies and clinical practice. METHODS: An international multidisciplinary steering committee was established. A systematic review and a 3-round Delphi was performed with open-ended and score-based assessments of the importance of each outcome to inform clinical management of neonatal opioid withdrawal. Interviews were conducted with parents and/or caregivers on outcome importance. Finally, a consensus meeting with diverse stakeholders was held to review all data from all sources and establish a core set of outcomes with definitions. RESULTS: The NOWS-COS was informed by 47 published studies, 41 Delphi participants, and 6 parent interviews. There were 63 outcomes evaluated. Final core outcomes include (1) pharmacologic treatment, (2) total dose of opioid treatment, (3) duration of treatment, (4) adjuvant therapy, (5) feeding difficulties, (6) consolability, (7) time to adequate symptom control, (8) parent-infant bonding, (9) duration of time the neonate spent in the hospital, (10) breastfeeding, (11) weight gain at hospital discharge, (12) readmission to hospital for withdrawal, and (13) neurodevelopment. CONCLUSIONS: We developed an evidence-informed and consensus-based core outcome set. Implementation of this core outcome set will reduce heterogeneity between studies and facilitate evidence-based decision-making. Future research will disseminate all the findings and pilot test the validity of the NOWS-COS in additional countries and populations to increase generalizability and impact.


Assuntos
Síndrome de Abstinência Neonatal/terapia , Avaliação de Resultados em Cuidados de Saúde/normas , Técnica Delfos , Humanos , Recém-Nascido , Resultado do Tratamento
12.
Lancet Infect Dis ; 20(8): e192-e197, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32539990

RESUMO

Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.


Assuntos
Betacoronavirus/isolamento & purificação , Ensaios Clínicos como Assunto/normas , Infecções por Coronavirus/terapia , Avaliação de Resultados em Cuidados de Saúde/normas , Avaliação de Resultados da Assistência ao Paciente , Pneumonia Viral/terapia , Resultado do Tratamento , Humanos , Pandemias , Análise de Sobrevida , Carga Viral
13.
Am J Kidney Dis ; 76(1): 109-120, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32414662

RESUMO

Cardiovascular disease (CVD) affects more than two-thirds of patients receiving hemodialysis and is the leading cause of death in this population, yet CVD outcomes are infrequently and inconsistently reported in trials in patients receiving hemodialysis. As part of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) initiative, we convened a consensus workshop to discuss the potential use of myocardial infarction and sudden cardiac death as core outcome measures for CVD for use in all trials in people receiving hemodialysis. Eight patients or caregivers and 46 health professionals from 15 countries discussed selection and implementation of the proposed core outcome measures. Five main themes were identified: capturing specific relevance to the hemodialysis population (acknowledging prevalence, risk, severity, unique symptomology, and pathophysiology), the dilemmas in using composite outcomes, addressing challenges in outcome definitions (establishing a common definition and addressing uncertainty in the utility of biomarkers in hemodialysis), selecting a meaningful metric for decision making (to facilitate comparison across trials), and enabling and incentivizing implementation (by ensuring that cardiologists are involved in the development and integration of the outcome measure into registries, trial design, and reporting guidelines). Based on these themes, participants supported the use of myocardial infarction and sudden cardiac death as core outcome measures of CVD to be reported in all hemodialysis trials.


Assuntos
Doenças Cardiovasculares , Ensaios Clínicos como Assunto/normas , Consenso , Educação/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Diálise Renal/normas , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Ensaios Clínicos como Assunto/métodos , Educação/métodos , Pessoal de Saúde/normas , Humanos , Internacionalidade , Avaliação de Resultados em Cuidados de Saúde/métodos , Participação do Paciente/métodos , Diálise Renal/métodos , Sociedades Médicas/normas
15.
BMJ Health Care Inform ; 27(1)2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32385040

RESUMO

BACKGROUND: Evidencing the impact of speech and language therapy interventions is challenging. The UK's professional body for speech and language therapists (SLTs) is supporting a consistent approach to outcome measurement and analysis using Therapy Outcome Measures (TOMs). OBJECTIVE: To develop a digital solution for collecting TOMs data, evaluate the impact of therapeutic interventions and explore contributing factors to outcome variation across clinical areas. METHOD: Agile methodology was applied to software development. Organisations were recruited to provide data. Criteria were identified to exemplify outcome variability. RESULTS: A digital tool was developed. 21 organisations provided data on 16 356 individuals. Improvement in at least one domain of TOMs occurred in 77.1% of instances. Data for two clinical areas exemplify the tool's effectiveness in highlighting the impact of speech and language therapy. CONCLUSION: This established outcomes data set can be used to evaluate the impact of speech and language therapy, and explore variation in outcomes.


Assuntos
Gestão da Informação em Saúde , Terapia da Linguagem , Avaliação de Resultados em Cuidados de Saúde/normas , Software , Fonoterapia , Coleta de Dados/normas , Humanos , Prática Profissional , Reino Unido
16.
JAMA Netw Open ; 3(4): e203767, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32347948

RESUMO

Importance: The utility-weighted modified Rankin Scale (UW-mRS) has been proposed as a patient-centered alternative primary outcome for stroke clinical trials. However, to date, there is no clear consensus on an approach to weighting the mRS. Objective: To characterize the between-study variability in utility weighting of the mRS in a population of patients who experienced stroke and its implications when applied to the results of a clinical trial. Data Sources: In this systematic review and meta-analysis, MEDLINE, Embase, and PsycINFO were searched from January 1987 through May 2019 using major search terms for stroke, health utility, and mRS. Study Selection: Original research articles published in English were reviewed. Included were studies with participants 18 years or older with ischemic or hemorrhagic stroke, transient ischemic attack, or subarachnoid hemorrhage, with mRS scores and utility weights evaluated concurrently. A total of 5725 unique articles were identified. Of these, 283 met criteria for full-text review, and 24 were included in the meta-analysis. Data Extraction and Synthesis: PRISMA guidelines for systematic review were followed. Data extraction was performed independently by multiple researchers. Data were pooled using mixed models. Main Outcomes and Measures: The mean utility weights and 95% CIs were calculated for each mRS score and health utility scale. Geographic differences in weighting for the EuroQoL 5-dimension (EQ-5D) and Stroke Impact Scale-based UW-mRS were explored using inverse variance-weighted linear models. The results of 18 major acute stroke trials cited in current guidelines were then reanalyzed using the UW-mRS weighting scales identified in the systematic review. Results: The meta-analysis included 22 389 individuals; the mean (SD) age of participants was 65.9 (4.0) years, and the mean (SD) proportion of male participants was 58.2% (7.5%). For all health utility scales evaluated, statistically significant differences were observed between the mean utility weights by mRS score. For studies using an EQ-5D-weighted mRS, between-study variance was higher for worse (mRS 2-5) compared with better (mRS 0-1) scores. Of the 18 major acute stroke trials with reanalyzed results, 3 had an unstable outcome when using different UW-mRSs. Conclusions and Relevance: Multiple factors, including cohort-specific characteristics and health utility scale selection, can influence mRS utility weighting. If the UW-mRS is selected as a primary outcome, the approach to weighting may alter the results of a clinical trial. Researchers using the UW-mRS should prospectively and concurrently obtain mRS scores and utility weights to characterize study-specific outcomes.


Assuntos
Avaliação de Resultados em Cuidados de Saúde/métodos , Qualidade de Vida , Acidente Vascular Cerebral/psicologia , Adulto , Humanos , Avaliação de Resultados em Cuidados de Saúde/normas
17.
Value Health ; 23(4): 409-415, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32327155

RESUMO

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR)'s "Good Practices Task Force" reports are highly cited, multistakeholder perspective expert guidance reports that reflect international standards for health economics and outcomes research (HEOR) and their use in healthcare decision making. In this report, we discuss the criteria, development, and evaluation/consensus review and approval process for initiating a task force. The rationale for a task force must include a justification, including why this good practice guidance is important and its potential impact on the scientific community. The criteria include: (1) necessity (why is this task force required?); (2) a methodology-oriented focus (focus on research methods, approaches, analysis, interpretation, and dissemination); (3) relevance (to ISPOR's mission and its members); (4) durability over time; (5) broad applicability; and 6) an evidence-based approach. In addition, the proposal must be a priority specifically for ISPOR. These reports are valuable to researchers, academics, students, health technology assessors, medical technology developers and service providers, those working in other commercial entities, regulators, and payers. These stakeholder perspectives are represented in task force membership to ensure the report's overall usefulness and relevance to the global ISPOR membership. We hope that this discussion will bring transparency to the process of initiating, approving, and producing these task force reports and encourage participation from a diverse range of experts within and outside ISPOR.


Assuntos
Comitês Consultivos , Farmacoeconomia , Avaliação de Resultados em Cuidados de Saúde/normas , Relatório de Pesquisa/normas , Prática Clínica Baseada em Evidências , Humanos , Internacionalidade , Projetos de Pesquisa
18.
Anesth Analg ; 130(5): 1133-1146, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32287121

RESUMO

Use of the electronic health record (EHR) has become a routine part of perioperative care in the United States. Secondary use of EHR data includes research, quality, and educational initiatives. Fundamental to secondary use is a framework to ensure fidelity, transparency, and completeness of the source data. In developing this framework, competing priorities must be considered as to which data sources are used and how data are organized and incorporated into a useable format. In assembling perioperative data from diverse institutions across the United States and Europe, the Multicenter Perioperative Outcomes Group (MPOG) has developed methods to support such a framework. This special article outlines how MPOG has approached considerations of data structure, validation, and accessibility to support multicenter integration of perioperative EHRs. In this multicenter practice registry, MPOG has developed processes to extract data from the perioperative EHR; transform data into a standardized format; and validate, deidentify, and transfer data to a secure central Coordinating Center database. Participating institutions may obtain access to this central database, governed by quality and research committees, to inform clinical practice and contribute to the scientific and clinical communities. Through a rigorous and standardized approach to ensure data integrity, MPOG enables data to be usable for quality improvement and advancing scientific knowledge. As of March 2019, our collaboration of 46 hospitals has accrued 10.7 million anesthesia records with associated perioperative EHR data across heterogeneous vendors. Facilitated by MPOG, each site retains access to a local repository containing all site-specific perioperative data, distinct from source EHRs and readily available for local research, quality, and educational initiatives. Through committee approval processes, investigators at participating sites may additionally access multicenter data for similar initiatives. Emerging from this work are 4 considerations that our group has prioritized to improve data quality: (1) data should be available at the local level before Coordinating Center transfer; (2) data should be rigorously validated against standardized metrics before use; (3) data should be curated into computable phenotypes that are easily accessible; and (4) data should be collected for both research and quality improvement purposes because these complementary goals bolster the strength of each endeavor.


Assuntos
Pesquisa Biomédica/normas , Registros Eletrônicos de Saúde/normas , Estudos Multicêntricos como Assunto/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Assistência Perioperatória/normas , Melhoria de Qualidade/normas , Pesquisa Biomédica/tendências , Registros Eletrônicos de Saúde/tendências , Humanos , Avaliação de Resultados em Cuidados de Saúde/tendências , Assistência Perioperatória/tendências , Melhoria de Qualidade/tendências
20.
Int J Pediatr Otorhinolaryngol ; 134: 110029, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32272377

RESUMO

INTRODUCTION: A Core Outcome Set (COS) is an agreed list of outcome domains to be reported by all studies investigating a condition. A COS for Otitis Media with Effusion (OME) in children with cleft palate exists (called MOMENT), but there isn't one for otherwise-healthy children. This study investigates whether the MOMENT COS could also be applicable to otherwise-healthy children. METHODS: A long list of potential outcomes was generated (independently of MOMENT) via three methods: literature review to establish which outcomes are reported by OME studies, a review of outcomes contained in OME questionnaires, and a focus group asking parents of children with OME what matters to them. The long list drawn up using these sources identified no outcomes additional to ones in the MOMENT long list. An online questionnaire was subsequently undertaken, asking parents/guardians and professionals/researchers whether they think that the MOMENT final list outcomes would also be applicable to otherwise healthy children. RESULTS: A total of 134 people took part: 53 parents/guardians (recruited through UK NHS hospitals) and 81 professionals/researchers (recruited internationally). Overall, 128 (95.5%) agreed that the MOMENT outcomes can also apply to otherwise healthy children (100% parents/guardians, 92.6% professionals/researchers). CONCLUSIONS: The outcome domains identified in the COS for OME management in children with cleft palate can also be used in otherwise-healthy children.


Assuntos
Pesquisa Biomédica/normas , Otite Média com Derrame/terapia , Avaliação de Resultados em Cuidados de Saúde/normas , Adulto , Criança , Pré-Escolar , Feminino , Grupos Focais , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/métodos , Pais , Pesquisa Qualitativa , Inquéritos e Questionários
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