RESUMO
OBJECTIVES: The aim of this study was to synthesize best practices for addressing clinical heterogeneity in systematic reviews and health technology assessments (HTAs). METHODS: We abstracted information from guidance documents and methods manuals made available by international organizations that develop systematic reviews and HTAs. We searched PubMed® to identify studies on clinical heterogeneity and subgroup analysis. Two authors independently abstracted and assessed relevant information. RESULTS: Methods manuals offer various definitions of clinical heterogeneity. In essence, clinical heterogeneity is considered variability in study population characteristics, interventions, and outcomes across studies. It can lead to effect-measure modification or statistical heterogeneity, which is defined as variability in estimated treatment effects beyond what would be expected by random error alone. Clinical and statistical heterogeneity are closely intertwined but they do not have a one-to-one relationship. The presence of statistical heterogeneity does not necessarily indicate that clinical heterogeneity is the causal factor. Methodological heterogeneity, biases, and random error can also cause statistical heterogeneity, alone or in combination with clinical heterogeneity. CONCLUSIONS: Identifying potential modifiers of treatment effects (i.e., effect-measure modifiers) is important for researchers conducting systematic reviews and HTAs. Recognizing clinical heterogeneity and clarifying its implications helps decision makers to identify patients and patient populations who benefit the most, who benefit the least, and who are at greatest risk of experiencing adverse outcomes from a particular intervention.
Assuntos
Benchmarking/métodos , Tecnologia Biomédica , Guias de Prática Clínica como Assunto , Literatura de Revisão como Assunto , Avaliação da Tecnologia Biomédica/métodos , Viés , Pesquisa Comparativa da Efetividade , Tomada de Decisões , HumanosRESUMO
OBJECTIVE: To evaluate episode-based payments for upper respiratory tract infections (URI) and perinatal care in Arkansas's Medicaid population. STUDY SETTING: Upper respiratory infection and perinatal episodes among Medicaid-covered individuals in Arkansas and comparison states from fiscal year (FY) 2011 to 2014. STUDY DESIGN: Cross-sectional observational analysis using a difference-in-difference design to examine outcomes associated with URI and perinatal episodes of care (EOC) from 2011 to 2014. Key dependent variables include antibiotic use, emergency department visits, physician visits, hospitalizations, readmission, and preventive screenings. DATA COLLECTION: Claims data from the Medicaid Analytic Extract for Arkansas, Mississippi, and Missouri from 2010 to 2014 with supplemental county-level data from the Area Health Resource File (AHRF). PRINCIPAL FINDINGS: The URI EOC reduced the probability of antibiotic use (marginal effect [ME] = -1.8, 90% CI: -2.2, -1.4), physician visits (ME = 0.6, 90% CI: -0.8, -0.4), improved the probability of strep tests for children diagnosed with pharyngitis (ME = 9.4, 90% CI: 8.5, 10.3), but also increased the probability of an emergency department (ED) visit (ME = 0.1, 90% CI: 0.1, 0.2), relative to the comparison group. For perinatal EOCs, we found a reduced probability of an ED visit during pregnancy (ME = 0.1, 90% CI: -0.2, -0.0), an increased probability of screening for HIV (ME = 6.2, 90% CI: 4.0, 8.5), chlamydia (ME = 9.5, 90% CI: 7.2, 11.8), and group B strep-test (ME = 2.6, 90% CI: 0.5, 4.6), relative to the comparison group. Predelivery and postpartum hospitalizations also increased (ME = 1.2, 90% CI: 0.4, 2.0; ME = 0.4, 90% CI: 0.0, 0.8, respectively), relative to the comparison group. CONCLUSION: Upper respiratory infection and perinatal EOCs for Arkansas Medicaid beneficiaries produced mixed results. Aligning shared savings with quality metrics and cost-thresholds may help achieve quality targets and disincentivize over utilization within the EOC, but may also have unintended consequences.
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Serviço Hospitalar de Emergência/economia , Cuidado Periódico , Planos de Pagamento por Serviço Prestado/economia , Hospitalização/economia , Medicaid/economia , Assistência Perinatal/economia , Infecções Respiratórias/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Arkansas , Estudos Transversais , Serviço Hospitalar de Emergência/estatística & dados numéricos , Planos de Pagamento por Serviço Prestado/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Medicaid/estatística & dados numéricos , Pessoa de Meia-Idade , Assistência Perinatal/estatística & dados numéricos , Gravidez , Estudos Retrospectivos , Estados UnidosRESUMO
BACKGROUND: A key motivation for the large national investment in electronic health record systems is to promote electronic reporting of quality measures that can be used as the basis for moving to value-based payment. Given the fragmented delivery system, robust quality reporting requires aggregating data across sites of care. Health information exchanges (HIEs) have emerged to facilitate exchange of clinical data across provider organizations and, therefore, should be well-positioned to support clinical quality measure reporting. METHODS: By interviewing representatives from 36 HIEs across the United States, we aimed to determine whether HIEs are capable of computing National Quality Forum measures for 6 cardiovascular disease preventive services. RESULTS: Eleven HIEs (30%) reported computing at least one CQM; six computed one or more of the measures, and no HIE computed a measure in each of the 6 areas. Barriers to computing CQMs included data quality, completeness, sharing, and transmission issues; organizational structure, maturity, and sustainability issues; and vendor issues. CONCLUSIONS: The ability to compute CQMs at the HIE level is still yet to be developed; currently, very few HIEs are able to do so for a variety of reasons. As HIE services expand and HIEs mature organizationally, the viability and utility of CQM reporting at the HIE level will increase. IMPLICATIONS: As the healthcare system migrates towards a value-based payment system these broad challenges will need to be addressed. LEVEL OF EVIDENCE: Cross-sectional semi-structured qualitative interviews.
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Troca de Informação em Saúde/estatística & dados numéricos , Sistemas de Informação em Saúde/organização & administração , Disseminação de Informação , Qualidade da Assistência à Saúde/organização & administração , Estudos Transversais , Humanos , Pesquisa Qualitativa , Estados UnidosRESUMO
BACKGROUND: Prior to the implementation of the Hospital-Acquired Condition-Present on Admission (HAC-POA) payment policy, concerns regarding its potential impact were raised by a number of organizations and individuals. The purpose of this study was to explore direct and indirect effects of the HAC-POA payment policy on hospitals, patients, and other payers during the policy's first 3 years of implementation. METHODS: The study included semi-structured telephone interviews with representatives of national organizations, hospitals, patient advocacy organizations, and other payers. Interview notes were coded using QSR NVivo qualitative analysis software using inductive and deductive qualitative analysis techniques. We conducted interviews with 106 individuals representing 56 organizations. Hospital staff included physicians, nurses, patient safety officers, coders, and finance, senior management, and information management staff. Individuals from other organizations represented leadership positions. RESULTS: Key changes to hospitals included: cultural shifts involving attention, commitment, and support from hospital leadership for patient safety; hiring new staff to assure the accuracy of clinical documentation and POA oversight structures; increased time burden for physicians, nurses, and coders; need to upgrade or purchase new software; and need to collaborate with hospital departments or staff that did not interface directly in the past. The policy was adopted by a majority of other payers, although the list of conditions and payment penalties varies. The HAC-POA policy is invisible to patients; therefore, the presence or lack of unintended consequences to patients cannot be fully assessed at this time. Understanding of policy effects to all stakeholders is important for maximizing its successful implementation and desired impact.
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Custos de Cuidados de Saúde/estatística & dados numéricos , Política de Saúde/economia , Hospitalização/economia , Doença Iatrogênica/economia , Medicaid/economia , Medicare/economia , Feminino , Humanos , Masculino , Medicaid/estatística & dados numéricos , Medicare/estatística & dados numéricos , Estados UnidosRESUMO
AIMS: To evaluate the impact of systematic reviews on research funded by the Agency for Healthcare Research and Quality (AHRQ) through Evidence-based Practice Centers (EPCs), and to identify barriers to and facilitators for the effects of these documents on future research. METHODS & MATERIALS: Two AHRQ systematic reviews were selected as case studies to evaluate their impact on future research. Key citations generated by these reports were identified through ISI Web of Science and PubMed Central and traced forward to identify effects on subsequent studies through citation analysis from updated systematic reviews on the topics. Requests for applications and program announcements from the NIH Guide for Grants and Contracts website were reviewed and dissemination data were obtained from AHRQ. Finally, interviews were conducted with 13 key informants to help identify short-, medium- and long-term impacts of the EPC reviews. RESULTS: The measurable impact of the two EPC reviews is demonstrably greater on short-term outcomes (greater awareness of the issues) than on medium-term (e.g., the generation of new knowledge) or long-term outcomes (e.g., changes in patient practice or health outcomes). Factors such as the topic and the timing of the report relative to the development of the field may explain the impact of these two AHRQ reports. The degree to which the new research can be directly attributed to the AHRQ reviews remains unclear. Key informants discussed several benefits stemming from the EPC reports, including providing a foundation for the research community on which to build, heightening awareness of the gaps in knowledge, increasing the quality of research and sparking new directions of research. However, the degree to which these reports were influential hinged on several factors including marketing efforts, the very nature of the reports and other influences external to the EPC domain. CONCLUSIONS: The findings outlined in this article illustrate the importance of numerous factors influencing future research: the breadth, specificity and readiness of the topic for more research, ongoing developments in the field, availability of funding and active engagement of champions. AHRQ and the EPCs may be able to improve the likelihood of impact by creating more targeted products, planning for and expanding dissemination activities, improving the readability and other attributes of the reports themselves, and actively involving funders early on and throughout the process of creating and publishing the reviews.
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Pesquisa Comparativa da Efetividade/métodos , Medicina Baseada em Evidências , Literatura de Revisão como Assunto , Humanos , Projetos de Pesquisa , Estados Unidos , United States Agency for Healthcare Research and QualityRESUMO
BACKGROUND: Diagnostic errors (missed, delayed or wrong diagnosis) have recently gained attention and are associated with significant preventable morbidity and mortality. The authors reviewed the recent literature and identified interventions that address system-related factors that contribute directly to diagnostic errors. METHODS: The authors conducted a comprehensive search using multiple search strategies. First, they performed a PubMed search to identify articles exclusively related to diagnostic error or delay published in English between 2000 and 2009. They then sought papers from references in the initial dataset, searches of additional databases, and subject matter experts. Articles were included if they formally evaluated an intervention to prevent or reduce diagnostic error; however, papers were also included if interventions were suggested and not tested to inform the state of the science on the subject. Interventions were characterised according to the step in the diagnostic process they targeted: patient-provider encounter; performance and interpretation of diagnostic tests; follow-up and tracking of diagnostic information; subspecialty and referral-related issues; and patient-specific care-seeking and adherence processes. RESULTS: 43 articles were identified for full review, of which six reported tested interventions and 37 contained suggestions for possible interventions. Empirical studies, although somewhat positive, were non-experimental or quasi-experimental and included a small number of clinicians or healthcare sites. Outcome measures in general were underdeveloped and varied markedly among studies, depending on the setting or step in the diagnostic process. CONCLUSIONS: Despite a number of suggested interventions in the literature, few empirical studies in the past decade have tested interventions to reduce diagnostic errors. Advancing the science of diagnostic error prevention will require more robust study designs and rigorous definitions of diagnostic processes and outcomes to measure intervention effects.
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Erros de Diagnóstico/prevenção & controle , Garantia da Qualidade dos Cuidados de Saúde/métodos , HumanosRESUMO
BACKGROUND: Errors in clinical reasoning occur in most cases in which the diagnosis is missed, delayed or wrong. The goal of this review was to identify interventions that might reduce the likelihood of these cognitive errors. DESIGN: We searched PubMed and other medical and non-medical databases and identified additional literature through references from the initial data set and suggestions from subject matter experts. Articles were included if they either suggested a possible intervention or formally evaluated an intervention and excluded if they focused solely on improving diagnostic tests or provider satisfaction. RESULTS: We identified 141 articles for full review, 42 reporting tested interventions to reduce the likelihood of cognitive errors, 100 containing suggestions, and one article with both suggested and tested interventions. Articles were classified into three categories: (1) Interventions to improve knowledge and experience, such as simulation-based training, improved feedback and education focused on a single disease; (2) Interventions to improve clinical reasoning and decision-making skills, such as reflective practice and active metacognitive review; and (3) Interventions that provide cognitive 'help' that included use of electronic records and integrated decision support, informaticians and facilitating access to information, second opinions and specialists. CONCLUSIONS: We identified a wide range of possible approaches to reduce cognitive errors in diagnosis. Not all the suggestions have been tested, and of those that have, the evaluations typically involved trainees in artificial settings, making it difficult to extrapolate the results to actual practice. Future progress in this area will require methodological refinements in outcome evaluation and rigorously evaluating interventions already suggested, many of which are well conceptualised and widely endorsed.
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Competência Clínica/normas , Cognição , Técnicas de Apoio para a Decisão , Erros de Diagnóstico/prevenção & controle , Aprendizagem Baseada em Problemas/métodos , Bases de Dados Bibliográficas , Erros de Diagnóstico/psicologia , HumanosRESUMO
OBJECTIVE: The purpose of this project was to engage a diverse group of stakeholders (N=38) to help establish priorities to guide patient-centered outcomes research (PCOR) in serious mental illness. METHODS: Three meetings, two Web-based and one on site, were held to generate and prioritize an initial list of topics. Topics were then sorted and organized into common themes. RESULTS: About 140 topics were identified and sorted into 21 main themes, ranked by priority. Three of the top four themes focused on how research was conducted, particularly the need to develop consensus measurement and outcomes definitions; improving infrastructure for research, longitudinal studies, and new data sets and investigators; and developing PCOR methodology. Stakeholders also identified a need to focus on service delivery, treatment settings, and structure of the delivery of care. CONCLUSIONS: Engagement by a broad group of stakeholders in a transparent process resulted in the identification of priority areas for PCOR. Stakeholders clearly indicated a need to fundamentally change how research on serious mental illness is conducted and a critical need for the development of methodology and infrastructure. Most current PCOR has been focused on relatively short-term outcomes, but real world, long-term studies providing guidance for treatment over the lifetime of a serious mental illness are needed.
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Consenso , Transtornos Mentais , Avaliação de Resultados em Cuidados de Saúde , Assistência Centrada no Paciente , Pesquisa , Prática Clínica Baseada em Evidências , Processos Grupais , Humanos , Índice de Gravidade de Doença , Estados Unidos , Comunicação por VideoconferênciaRESUMO
OBJECTIVES: To update a 2004 systematic review of health care service use and health outcomes related to differences in health literacy level and interventions designed to improve these outcomes for individuals with low health literacy. Disparities in health outcomes and effectiveness of interventions among different sociodemographic groups were also examined. DATA SOURCES: We searched MEDLINE®, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, PsychINFO, and the Educational Resources Information Center. For health literacy, we searched using a variety of terms, limited to English and studies published from 2003 to May 25, 2010. For numeracy, we searched from 1966 to May 25, 2010. REVIEW METHODS: We used standard Evidence-based Practice Center methods of dual review of abstracts, full-text articles, abstractions, quality ratings, and strength of evidence grading. We resolved disagreements by consensus. We evaluated whether newer literature was available for answering key questions, so we broadened our definition of health literacy to include numeracy and oral (spoken) health literacy. We excluded intervention studies that did not measure health literacy directly and updated our approach to evaluate individual study risk of bias and to grade strength of evidence. RESULTS: We included good- and fair-quality studies: 81 studies addressing health outcomes (reported in 95 articles including 86 measuring health literacy and 16 measuring numeracy, of which 7 measure both) and 42 studies (reported in 45 articles) addressing interventions. Differences in health literacy level were consistently associated with increased hospitalizations, greater emergency care use, lower use of mammography, lower receipt of influenza vaccine, poorer ability to demonstrate taking medications appropriately, poorer ability to interpret labels and health messages, and, among seniors, poorer overall health status and higher mortality. Health literacy level potentially mediates disparities between blacks and whites. The strength of evidence of numeracy studies was insufficient to low, limiting conclusions about the influence of numeracy on health care service use or health outcomes. Two studies suggested numeracy may mediate the effect of disparities on health outcomes. We found no evidence concerning oral health literacy and outcomes. Among intervention studies (27 randomized controlled trials [RCTs], 2 cluster RCTs, and 13 quasi-experimental designs), the strength of evidence for specific design features was low or insufficient. However, several specific features seemed to improve comprehension in one or a few studies. The strength of evidence was moderate for the effect of mixed interventions on health care service use; the effect of intensive self-management inventions on behavior; and the effect of disease-management interventions on disease prevalence/severity. The effects of other mixed interventions on other health outcomes, including knowledge, self-efficacy, adherence, and quality of life, and costs were mixed; thus, the strength of evidence was insufficient. CONCLUSIONS: The field of health literacy has advanced since the 2004 report. Future research priorities include justifying appropriate cutoffs for health literacy levels prior to conducting studies; developing tools that measure additional related skills, particularly oral (spoken) health literacy; and examining mediators and moderators of the effect of health literacy. Priorities in advancing the design features of interventions include testing novel approaches to increase motivation, techniques for delivering information orally or numerically, "work around" interventions such as patient advocates; determining the effective components of already-tested interventions; determining the cost-effectiveness of programs; and determining the effect of policy and practice interventions.