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1.
J Gen Intern Med ; 35(1): 307-314, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31713031

RESUMO

With the increase in patient and consumer activism through the late twentieth century and into this century, patient roles in research evolved into a new model of research engagement, with patients serving as active advisors and co-leading or leading clinical research. By requiring active engagement of patients and other stakeholders, several government research funders have advanced this model, particularly in Canada, the United States (US), United Kingdom (UK), and Australia. A consortium of individuals from these countries formed a Multi-Stakeholder Engagement (MuSE) consortium to examine critical issues in engaged research, establish consensus on definitions, and provide guidance for the field, beginning with an overview of how to involve stakeholders in health research (Concannon et al. J Gen Intern Med. 2019;34(3):458-463) and continuing here with an examination of definitions of research engagement. The political and advocacy roots of engaged research are reflected in definitions. Engagement is conceptualized with reference to research project goals, from informing specific clinical decisions to informing health-system level decisions. Political and cultural differences across countries are evident. Some of these government funders focus on empirical rather than ethical rationales. In countries with centralized health technology assessment, the link between societal values and engaged research is explicit. Ethical rationales for engagement are explicit in most of the published literature on research engagement. Harmonization of definitions is recommended so that research engagement elements, methods, and outcomes and impacts can be clearly examined and understood, and so that the field of research engagement can proceed from a clear conceptual foundation. Specific recommendations for terminology definitions are provided. Placing engaged research on a continuum from specific clinical decisions to more global public and social justice concerns clarifies the type of engaged research, supports appropriate comparisons, and improves the rigor of engaged research methods. The results help identify knowledge gaps in this growing field.

2.
Ann Intern Med ; 2019 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-31711094

RESUMO

The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed to promote the conduct of, and provide guidance for, predictive analyses of heterogeneity of treatment effects (HTE) in clinical trials. The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risk with versus without the intervention, taking into account all relevant patient attributes simultaneously, to support more personalized clinical decision making than can be made on the basis of only an overall average treatment effect. The authors distinguished 2 categories of predictive HTE approaches (a "risk-modeling" and an "effect-modeling" approach) and developed 4 sets of guidance statements: criteria to determine when risk-modeling approaches are likely to identify clinically meaningful HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. They discuss limitations of these methods and enumerate research priorities for advancing methods designed to generate more personalized evidence. This explanation and elaboration document describes the intent and rationale of each recommendation and discusses related analytic considerations, caveats, and reservations.

3.
Ann Intern Med ; 2019 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-31711134

RESUMO

Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), HTE is typically examined through a subgroup analysis that contrasts effects in groups of patients defined "1 variable at a time" (for example, male vs. female or old vs. young). The authors of this statement present guidance on an alternative approach to HTE analysis, "predictive HTE analysis." The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed using a multidisciplinary technical expert panel, targeted literature reviews, simulations to characterize potential problems with predictive approaches, and a deliberative process engaging the expert panel. The authors distinguish 2 categories of predictive HTE approaches: a "risk-modeling" approach, wherein a multivariable model predicts the risk for an outcome and is applied to disaggregate patients within RCTs to define risk-based variation in benefit, and an "effect-modeling" approach, wherein a model is developed on RCT data by incorporating a term for treatment assignment and interactions between treatment and baseline covariates. Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision making. The authors developed 4 sets of guidance: criteria to determine when risk-modeling approaches are likely to identify clinically important HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. The PATH Statement, together with its explanation and elaboration document, may guide future analyses and reporting of RCTs.

4.
Br J Haematol ; 187(3): 377-385, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31290570

RESUMO

This study describes the use of a simple charcoal product (DOAC-RemoveTM ) to allow haemostasis assays on patients taking direct oral anticoagulants (DOAC). In the proposed algorithm, patients taking DOAC are screened using the dilute thrombin time (dTT) and anti-Xa assay. If either are positive then DOAC-Remove is utilised. In a validation, DOAC-Remove did not interfere with coagulation testing in normal plasma or in patients on DOAC with a known lupus anticoagulant (LA). Of 1566 routine patient samples tested, 125 (8%) had evidence of anti-Xa activity (>0·1 iu/ml) or prolonged dTT suggestive of either a direct/indirect Xa inhibitor or direct thrombin inhibitor. All of these 125 patients had a prolonged dilute Russell viper venom time (dRVVT) screening test and 106 had a LA detected by dRVVT after phospholipid correction. After DOAC-Remove, 91 patients (73%) had a negative dRVVT screen. After further investigation only 9 (7%) had a positive LA. DOAC-Remove prevented 5% of patients having a LA inappropriately detected. DOAC did not significantly affect the LA activated partial thromboplastin time (aPTT) ratio, protein S antigen or protein C activity. DOAC cause low intrinsic factor assays, high prothrombin time/aPTT and high activated protein C sensitivity ratio, which DOAC-Remove reversed (P < 0·05). Despite recommendations, haemostasis testing for patients on DOAC continues; this algorithm aids diagnostic accuracy. Further validation and research are warranted.

5.
JAMA Netw Open ; 2(1): e186828, 2019 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-30646197

RESUMO

Importance: Lumbar spinal stenosis (LSS) is the most common reason for spine surgery in older US adults. There is an evidence gap about nonsurgical LSS treatment options. Objective: To explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS. Design, Setting, and Participants: Three-arm randomized clinical trial of 3 years' duration (November 2013 to June 2016). Analysis began in August 2016. All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat. Interventions: Medical care, group exercise, and manual therapy/individualized exercise. Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors in senior community centers. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. Main Outcomes and Measures: Primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes). Results: A total of 259 participants (mean [SD] age, 72.4 [7.8] years; 137 women [52.9%]) were allocated to medical care (88 [34.0%]), group exercise (84 [32.4%]), or manual therapy/individualized exercise (87 [33.6%]). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care (-2.0; 95% CI, -3.6 to -0.4) or group exercise (-2.4; 95% CI, -4.1 to -0.8). Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates. Conclusions and Relevance: A combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity. Trial Registration: ClinicalTrials.gov Identifier: NCT01943435.


Assuntos
Tratamento Conservador/métodos , Terapia por Exercício/métodos , Injeções Epidurais/métodos , Vértebras Lombares/diagnóstico por imagem , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Manipulações Musculoesqueléticas/métodos , Estenose Espinal , Idoso , Instituições de Assistência Ambulatorial/estatística & dados numéricos , Feminino , Humanos , Imagem por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Estenose Espinal/diagnóstico , Estenose Espinal/terapia , Tomografia Computadorizada por Raios X/métodos
6.
Genet Med ; 21(7): 1639-1643, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30546084

RESUMO

PURPOSE: There is little long-term, population-based data on uptake of prenatal diagnosis for Huntington disease (HD), a late-onset autosomal dominant neurodegenerative disorder, and the effect of the availability of preimplantation genetic diagnosis (PGD) on families' decisions about conventional prenatal diagnosis is not known. We report trends in prenatal diagnosis and preimplantation diagnosis for HD in the United Kingdom since services commenced. METHODS: Long-term UK-wide prospective case record-based service evaluation in 23 UK Regional Genetic Centres 1988-2015, and four UK PGD centers 2002-2015. RESULTS: From 1988 to 2015, 479 prenatal diagnoses were performed in the UK for HD. An exclusion approach was used in 150 (31%). The annual rate of HD prenatal diagnosis has remained around 18 (3.5/million) over 27 years, despite a steady increase in the use of PGD for HD since 2002. CONCLUSION: Although increasing number of couples are choosing either direct or exclusion PGD to prevent HD in their offspring, both direct and exclusion prenatal diagnosis remain important options in a health system where both PGD and prenatal diagnosis are state funded. At-risk couples should be informed of all options available to them, preferably prepregnancy.


Assuntos
Doença de Huntington/diagnóstico , Diagnóstico Pré-Natal , Feminino , Humanos , Masculino , Gravidez , Diagnóstico Pré-Implantação , Estudos Prospectivos , Reino Unido
7.
Diabetes Care ; 41(5): 985-993, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29678865

RESUMO

OBJECTIVE: Quality improvement (QI) interventions can improve glycemic control, but little is known about their value. We systematically reviewed economic evaluations of QI interventions for glycemic control among adults with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: We used English-language studies from high-income countries that evaluated organizational changes and reported program and utilization-related costs, chosen from PubMed, EconLit, Centre for Reviews and Dissemination, New York Academy of Medicine's Grey Literature Report, and WorldCat (January 2004 to August 2016). We extracted data regarding intervention, study design, change in HbA1c, time horizon, perspective, incremental net cost (studies lasting ≤3 years), incremental cost-effectiveness ratio (ICER) (studies lasting ≥20 years), and study quality. Weighted least-squares regression analysis was used to estimate mean changes in HbA1c and incremental net cost. RESULTS: Of 3,646 records, 46 unique studies were eligible. Across 19 randomized controlled trials (RCTs), HbA1c declined by 0.26% (95% CI 0.17-0.35) or 3 mmol/mol (2 to 4) relative to usual care. In 8 RCTs lasting ≤3 years, incremental net costs were $116 (95% CI -$612 to $843) per patient annually. Long-term ICERs were $100,000-$115,000/quality-adjusted life year (QALY) in 3 RCTs, $50,000-$99,999/QALY in 1 RCT, $0-$49,999/QALY in 4 RCTs, and dominant in 1 RCT. Results were more favorable in non-RCTs. Our limitations include the fact that the studies had diverse designs and involved moderate risk of bias. CONCLUSIONS: Diverse multifaceted QI interventions that lower HbA1c appear to be a fair-to-good value relative to usual care, depending on society's willingness to pay for improvements in health.


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 1/economia , Diabetes Mellitus Tipo 1/terapia , Diabetes Mellitus Tipo 2/terapia , Melhoria de Qualidade/economia , Adulto , Análise Custo-Benefício , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Humanos , Masculino , Melhoria de Qualidade/organização & administração , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Análise de Regressão
8.
Health Aff (Millwood) ; 37(2): 248-256, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29401022

RESUMO

People with serious mental illness experience decreased life expectancy related to co-occurring medical conditions. A nonprofit behavioral health managed care organization implemented an innovative behavioral health home, in partnership with community mental health providers, to build a culture of wellness among all staff members, with a focus on prevention and holistic (that is, behavioral, social, and physical) health. The behavioral health home added one of two distinct care approaches, one patient driven and the other provider driven. The innovative approaches were implemented at eleven community mental health providers: Six delivered patient-driven care, and five delivered provider-driven care. We studied outcomes in the period October 2013-January 2016. Multiple diffusion strategies were utilized to encourage uptake. Our results revealed that both approaches significantly increased patient activation in care (more quickly in provider-supported care), engagement in primary and specialty care, and perceived mental health status. The success of this behavioral health home in improving important outcomes and the use of novel diffusion strategies led to its dissemination to forty-three additional providers across Pennsylvania.


Assuntos
Serviços Comunitários de Saúde Mental/organização & administração , Programas de Assistência Gerenciada , Transtornos Mentais/terapia , Assistência Centrada no Paciente/organização & administração , Atenção Primária à Saúde/organização & administração , Adulto , Feminino , Grupos Focais , Nível de Saúde , Humanos , Masculino , Transtornos Mentais/psicologia , Participação do Paciente , Pennsylvania , Inquéritos e Questionários
9.
Am J Prev Med ; 54(2): 299-315, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29362167

RESUMO

CONTEXT: Influenza vaccination rates remain below Healthy People 2020 goals. This project sought to systematically review economic evaluations of healthcare-based quality improvement interventions for improving influenza vaccination uptake among general populations and healthcare workers. EVIDENCE ACQUISITION: The databases MEDLINE, Econlit, Centre for Reviews & Dissemination, Greylit, and Worldcat were searched in July 2016 for papers published from January 2004 to July 2016. Eligible studies evaluated efforts by bodies within the healthcare system to encourage influenza vaccination by means of an organizational or structural change. For each study, program costs per enrollee and per additional enrollee vaccinated were derived (excluding vaccine costs, standardized to 2017 U.S. dollars). Complete economic evaluations were examined when available. EVIDENCE SYNTHESIS: Of 2,350 records, 18 articles were eligible and described 29 unique interventions. Most interventions improved vaccine uptake. Among 23 interventions in general populations, the median program cost was $3.27 (interquartile range, $0.82-$11.53) per enrollee and $50.78 (interquartile range, $27.85-$124.84) per additional enrollee vaccinated. Among ten complete economic evaluations in general populations, three studies reported net cost savings, four reported costs <$50,000 per quality-adjusted life year, and three reported costs <$60,000 per life saved. Among six interventions in healthcare workers, the median program cost was $8.09 (interquartile range, $5.03-$10.31) per worker enrolled and $125.24 (interquartile range, $96.06-$171.38) per additional worker vaccinated (there were no complete economic analyses). CONCLUSIONS: Quality improvement interventions for influenza vaccination involve per-enrollee costs that are similar to the cost of the vaccine itself ($11.78-$36.08/dose). Based on limited available evidence in general populations, quality improvement interventions may be cost saving to cost effective for the health system.


Assuntos
Análise Custo-Benefício , Programas de Imunização/economia , Influenza Humana/prevenção & controle , Vacinação em Massa/métodos , Melhoria de Qualidade/economia , Redução de Custos/métodos , Redução de Custos/estatística & dados numéricos , Efeitos Psicossociais da Doença , Humanos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/economia , Influenza Humana/economia , Vacinação em Massa/economia , Anos de Vida Ajustados por Qualidade de Vida
10.
11.
J Clin Epidemiol ; 90: 37-42, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28720512

RESUMO

BACKGROUND AND OBJECTIVE: Advanced analytic methods for synthesizing evidence about complex interventions continue to be developed. In this paper, we emphasize that the specific research question posed in the review should be used as a guide for choosing the appropriate analytic method. METHODS: We present advanced analytic approaches that address four common questions that guide reviews of complex interventions: (1) How effective is the intervention? (2) For whom does the intervention work and in what contexts? (3) What happens when the intervention is implemented? and (4) What decisions are possible given the results of the synthesis? CONCLUSION: The analytic approaches presented in this paper are particularly useful when each primary study differs in components, mechanisms of action, context, implementation, timing, and many other domains.


Assuntos
Projetos de Pesquisa , Literatura de Revisão como Assunto , Teorema de Bayes , Tomada de Decisões , Medicina Baseada em Evidências , Análise de Elementos Finitos , Guias como Assunto , Humanos , Metanálise como Assunto , Pesquisa Qualitativa
12.
J Clin Epidemiol ; 90: 28-36, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28720515

RESUMO

BACKGROUND: Systematic reviews of complex interventions can vary widely in purpose, data availability and heterogeneity, and stakeholder expectations. RATIONALE: This article addresses the uncertainty that systematic reviewers face in selecting methods for reviews of complex interventions. Specifically, it lays out parameters for systematic reviewers to consider when selecting analytic approaches that best answer the questions at hand and suggests analytic techniques that may be appropriate in different circumstances. DISCUSSION: Systematic reviews of complex interventions comprising multiple questions may use multiple analytic approaches. Parameters to consider when choosing analytic methods for complex interventions include nature and timing of the decision (clinical practice guideline, policy, or other); purpose of the review; extent of existing evidence; logistic factors such as the timeline, process, and resources for deciding the scope of the review; and value of information to be obtained from choosing specific systematic review methods. Reviewers may elect to revise their analytic approach based on new or changing considerations during the course of the review but should guard against bias through transparency of reporting.


Assuntos
Projetos de Pesquisa , Literatura de Revisão como Assunto , Interpretação Estatística de Dados , Tomada de Decisões , Medicina Baseada em Evidências , Guias como Assunto , Humanos , Pesquisa Qualitativa
13.
JAMA Intern Med ; 177(7): 975-985, 2017 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-28558095

RESUMO

Importance: Quality improvement (QI) interventions can reduce hospital readmission, but little is known about their economic value. Objective: To systematically review economic evaluations of QI interventions designed to reduce readmissions. Data Sources: Databases searched included PubMed, Econlit, the Centre for Reviews & Dissemination Economic Evaluations, New York Academy of Medicine's Grey Literature Report, and Worldcat (January 2004 to July 2016). Study Selection: Dual reviewers selected English-language studies from high-income countries that evaluated organizational or structural changes to reduce hospital readmission, and that reported program and readmission-related costs. Data Extraction and Synthesis: Dual reviewers extracted intervention characteristics, study design, clinical effectiveness, study quality, economic perspective, and costs. We calculated the risk difference and net costs to the health system in 2015 US dollars. Weighted least-squares regression analyses tested predictors of the risk difference and net costs. Main Outcomes and Measures: Main outcomes measures included the risk difference in readmission rates and incremental net cost. This systematic review and data analysis is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Results: Of 5205 articles, 50 unique studies were eligible, including 25 studies in populations limited to heart failure (HF) that included 5768 patients, 21 in general populations that included 10 445 patients, and 4 in unique populations. Fifteen studies lasted up to 30 days while most others lasted 6 to 24 months. Based on regression analyses, readmissions declined by an average of 12.1% among patients with HF (95% CI, 8.3%-15.9%; P < .001; based on 22 studies with complete data) and by 6.3% among general populations (95% CI, 4.0%-8.7%; P < .001; 18 studies). The mean net savings to the health system per patient was $972 among patients with HF (95% CI, -$642 to $2586; P = .23; 24 studies), and the mean net loss was $169 among general populations (95% CI, -$2610 to $2949; P = .90; 21 studies), reflecting nonsignificant differences. Among general populations, interventions that engaged patients and caregivers were associated with greater net savings ($1714 vs -$6568; P = .006). Conclusions and Relevance: Multicomponent QI interventions can be effective at reducing readmissions relative to the status quo, but net costs vary. Interventions that engage general populations of patients and their caregivers may offer greater value to the health system, but the implications for patients and caregivers are unknown.


Assuntos
Sobremedicalização , Readmissão do Paciente/normas , Melhoria de Qualidade/organização & administração , Análise Custo-Benefício , Humanos , Sobremedicalização/economia , Sobremedicalização/prevenção & controle , Inovação Organizacional
14.
JAMA ; 317(14): 1451-1460, 2017 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-28399251

RESUMO

Importance: Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT. Objective: To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. Data Sources: Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms. Data Extraction and Synthesis: Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Main Outcomes and Measures: Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks. Findings: Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, -9.95 [95% CI, -15.6 to -4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, -0.39 [95% CI, -0.71 to -0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT. Conclusions and Relevance: Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.


Assuntos
Dor Aguda/terapia , Dor Lombar/terapia , Manipulação da Coluna/métodos , Adulto , Humanos , Manipulação da Coluna/efeitos adversos , Estudos Observacionais como Assunto , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica
15.
J Am Geriatr Soc ; 65(8): 1748-1755, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28369687

RESUMO

OBJECTIVES: To determine the effect of integrating informal caregivers into discharge planning on postdischarge cost and resource use in older adults. DESIGN: A systematic review and metaanalysis of randomized controlled trials that examine the effect of discharge planning with caregiver integration begun before discharge on healthcare cost and resource use outcomes. MEDLINE, EMBASE, and the Cochrane Library databases were searched for all English-language articles published between 1990 and April 2016. SETTING: Hospital or skilled nursing facility. PARTICIPANTS: Older adults with informal caregivers discharged to a community setting. MEASUREMENTS: Readmission rates, length of and time to post-discharge rehospitalizations, costs of postdischarge care. RESULTS: Of 10,715 abstracts identified, 15 studies met the inclusion criteria. Eleven studies provided sufficient detail to calculate readmission rates for treatment and control participants. Discharge planning interventions with caregiver integration were associated with a 25% fewer readmissions at 90 days (relative risk (RR) = 0.75, 95% confidence interval (CI) = 0.62-0.91) and 24% fewer readmissions at 180 days (RR = 0.76, 95% CI = 0.64-0.90). The majority of studies reported statistically significant shorter time to readmission, shorter rehospitalization, and lower costs of postdischarge care among discharge planning interventions with caregiver integration. CONCLUSION: For older adults discharged to a community setting, the integration of caregivers into the discharge planning process reduces the risk of hospital readmission.


Assuntos
Cuidadores/estatística & dados numéricos , Recursos em Saúde/economia , Alta do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Custos de Cuidados de Saúde , Humanos , Readmissão do Paciente
16.
Clin Trials ; 14(1): 5-16, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27681658

RESUMO

BACKGROUND: The aim of patient-centered comparative effectiveness research is to conduct stakeholder-driven investigations that identify which interventions are most effective for which patients under specific circumstances. Conducting this research in real-world settings comes with unique experiences and challenges. We provide the study design, challenges confronted, and the solutions we devised for Optimal Health, a stakeholder-informed patient-centered comparative effectiveness study focused on the needs of seriously mentally ill individuals receiving case management services in community mental health centers across Pennsylvania. METHODS: Optimal Health, supported by the Patient-Centered Outcomes Research Institute, is a cluster-randomized trial of two evidence-based interventions for improving health and wellness across 11 provider sites. Participants were followed for 18-24 months, with repeated measurements of self-reported health status and activation in care and administrative measurements of primary and specialty health service utilization. Health-related quality of life, engagement in care, and service utilization are to be compared via random effects mixed models. Stakeholders were, and continue to be, engaged via focus groups, interviews, and stakeholder advisory board meetings. A learning collaborative model was used to support shared learning and implementation fidelity across provider sites. RESULTS: From 1 November 2013 through 15 July 2014, we recruited 1229 adults with serious mental illness, representing 85.1% of those eligible for study participation. Of these, 713 are in the Provider-Supported arm of the study and 516 in Patient Self-Directed Care. Across five data collection time points, we retained 86% and 83% of the participants in the Provider-Supported and Self-Directed arms, respectively. LESSONS LEARNED: Lessons learned relate to estimation of the size of our study population, the value of multiple data sources, and intervention training and implementation. The use of historical claims data can lead to an overestimation of eligible participants and, subsequently, a reduced study sample and an imbalance between intervention arms. Disruptions in continuity of care in real-world settings can pose challenges to on-site self-report data collection, although the inclusion of multiple data sources in study design can improve data completeness. Geographic dispersion of rural provider sites and staff turnover can lead to training and intervention fidelity challenges that can be overcome with the use of a "train-the-trainer" model, "wellness champions," and the use of a Learning Collaborative approach. Stakeholder engagement in mitigating these challenges proved to be critical to study progress. CONCLUSION: Conducting real-world patient-centered comparative effectiveness research in healthcare systems that care for seriously mentally ill persons is an important yet challenging undertaking, one which requires flexibility in identifying potential adaptations within all major study phases. Advice from a wide range of stakeholders is critical in development of successful strategies.


Assuntos
Administração de Caso , Pesquisa Comparativa da Efetividade , Transtornos Mentais/terapia , Assistência Centrada no Paciente , Atenção Primária à Saúde/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Centros Comunitários de Saúde Mental , Serviços de Saúde/estatística & dados numéricos , Humanos , Pennsylvania , Qualidade de Vida
17.
JAMA ; 316(20): 2104-2114, 2016 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-27893131

RESUMO

Importance: The use of palliative care programs and the number of trials assessing their effectiveness have increased. Objective: To determine the association of palliative care with quality of life (QOL), symptom burden, survival, and other outcomes for people with life-limiting illness and for their caregivers. Data Sources: MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL to July 2016. Study Selection: Randomized clinical trials of palliative care interventions in adults with life-limiting illness. Data Extraction and Synthesis: Two reviewers independently extracted data. Narrative synthesis was conducted for all trials. Quality of life, symptom burden, and survival were analyzed using random-effects meta-analysis, with estimates of QOL translated to units of the Functional Assessment of Chronic Illness Therapy-palliative care scale (FACIT-Pal) instrument (range, 0-184 [worst-best]; minimal clinically important difference [MCID], 9 points); and symptom burden translated to the Edmonton Symptom Assessment Scale (ESAS) (range, 0-90 [best-worst]; MCID, 5.7 points). Main Outcomes and Measures: Quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Results: Forty-three RCTs provided data on 12 731 patients (mean age, 67 years) and 2479 caregivers. Thirty-five trials used usual care as the control, and 14 took place in the ambulatory setting. In the meta-analysis, palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08 to 0.83; FACIT-Pal mean difference, 11.36] and symptom burden at the 1- to 3-month follow-up (standardized mean difference, -0.66; 95% CI, -1.25 to -0.07; ESAS mean difference, -10.30). When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06 to 0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was not statistically significant (standardized mean difference, -0.21; 95% CI, -0.42 to 0.00; ESAS mean difference, -3.28). There was no association between palliative care and survival (hazard ratio, 0.90; 95% CI, 0.69 to 1.17). Palliative care was associated consistently with improvements in advance care planning, patient and caregiver satisfaction, and lower health care utilization. Evidence of associations with other outcomes was mixed. Conclusions and Relevance: In this meta-analysis, palliative care interventions were associated with improvements in patient QOL and symptom burden. Findings for caregiver outcomes were inconsistent. However, many associations were no longer significant when limited to trials at low risk of bias, and there was no significant association between palliative care and survival.


Assuntos
Cuidadores/psicologia , Cuidados Paliativos , Qualidade de Vida , Planejamento Antecipado de Cuidados , Idoso , Humanos , Satisfação do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida
18.
JAMA Intern Med ; 176(12): 1843-1854, 2016 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-27775764

RESUMO

Importance: Although quality improvement (QI) interventions can reduce central-line-associated bloodstream infections (CLABSI) and catheter-related bloodstream infections (CRBSI), their economic value is uncertain. Objective: To systematically review economic evaluations of QI interventions designed to prevent CLABSI and/or CRBSI in acute care hospitals. Evidence Review: A search of Ovid MEDLINE, Econlit, Centre for Reviews & Dissemination, New York Academy of Medicine's Grey Literature Report, Worldcat, prior systematic reviews (January 2004 to July 2016), and IDWeek conference abstracts (2013-2016), was conducted from 2013 to 2016. We included English-language studies of any design that evaluated organizational or structural changes to prevent CLABSI or CRBSI, and reported program and infection-related costs. Dual reviewers assessed study design, effectiveness, costs, and study quality. For each eligible study, we performed a cost-consequences analysis from the hospital perspective, estimating the incidence rate ratio (IRR) and incremental net savings. Unadjusted weighted regression analyses tested predictors of these measures, weighted by catheter-days per study per year. Findings: Of 505 articles, 15 unique studies were eligible, together representing data from 113 hospitals. Thirteen studies compared Agency for Healthcare Research and Quality-recommended practices with usual care, including 7 testing insertion checklists. Eleven studies were based on uncontrolled before-after designs, 1 on a randomized controlled trial, 1 on a time-series analysis, and 2 on modeled estimates. Overall, the weighted mean IRR was 0.43 (95% CI, 0.35-0.51) and incremental net savings were $1.85 million (95% CI, $1.30 million to $2.40 million) per hospital over 3 years (2015 US dollars). Each $100 000-increase in program cost was associated with $315 000 greater savings (95% CI, $166 000-$464 000; P < .001). Infections and net costs declined when hospitals already used checklists or had baseline infection rates of 1.7 to 3.7 per 1000 catheter-days. Study quality was not associated with effectiveness or costs. Conclusions and Relevance: Interventions related to central venous catheters were, on average, associated with 57% fewer bloodstream infections and substantial savings to hospitals. Larger initial investments may be associated with greater savings. Although checklists are now widely used and infections have started to decline, additional improvements and savings can occur at hospitals that have not yet attained very low infection rates.


Assuntos
Bacteriemia/prevenção & controle , Infecções Relacionadas a Cateter/prevenção & controle , Cateteres Venosos Centrais/efeitos adversos , Controle de Infecções/economia , Controle de Infecções/métodos , Melhoria de Qualidade/economia , Bacteriemia/economia , Infecções Relacionadas a Cateter/economia , Lista de Checagem/economia , Análise Custo-Benefício , Humanos , Avaliação de Programas e Projetos de Saúde
19.
J Clin Epidemiol ; 71: 3-10, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26548541

RESUMO

OBJECTIVES: Patient care decisions demand high-quality research. To assist those decisions, numerous observational studies are being performed. Are the standards and guidelines to assess observational studies consistent and actionable? What policy considerations should be considered to ensure decision makers can determine if an observational study is of high-quality and valid to inform treatment decisions? STUDY DESIGN AND SETTING: Based on a literature review and input from six experts, we compared and contrasted nine standards/guidelines using 23 methodological elements involved in observational studies (e.g., study protocol, data analysis, and so forth). RESULTS: Fourteen elements (61%) were addressed by at least seven standards/guidelines; 12 of these elements disagreed in the approach. Nine elements (39%) were addressed by six or fewer standards/guidelines. Ten elements (43%) were not actionable in at least one standard/guideline that addressed the element. CONCLUSION: The lack of observational study standard/guideline agreement may contribute to variation in study conduct; disparities in what is considered credible research; and ultimately, what evidence is adopted. A common set of agreed on standards/guidelines for conducting observational studies will benefit funders, researchers, journal editors, and decision makers.


Assuntos
Medicina Baseada em Evidências/métodos , Estudos Observacionais como Assunto/métodos , Estudos Observacionais como Assunto/normas , Projetos de Pesquisa , Humanos
20.
Acad Med ; 90(10): 1302-8, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25993282

RESUMO

Criteria for evaluating faculty are traditionally based on a triad of scholarship, teaching, and service. Research scholarship is often measured by first or senior authorship on peer-reviewed scientific publications and being principal investigator on extramural grants. Yet scientific innovation increasingly requires collective rather than individual creativity, which traditional measures of achievement were not designed to capture and, thus, devalue. The authors propose a simple, flexible framework for evaluating team scientists that includes both quantitative and qualitative assessments. An approach for documenting contributions of team scientists in team-based scholarship, nontraditional education, and specialized service activities is also outlined. Although biostatisticians are used for illustration, the approach is generalizable to team scientists in other disciplines.The authors offer three key recommendations to members of institutional promotion committees, department chairs, and others evaluating team scientists. First, contributions to team-based scholarship and specialized contributions to education and service need to be assessed and given appropriate and substantial weight. Second, evaluations must be founded on well-articulated criteria for assessing the stature and accomplishments of team scientists. Finally, mechanisms for collecting evaluative data must be developed and implemented at the institutional level. Without these three essentials, contributions of team scientists will continue to be undervalued in the academic environment.


Assuntos
Centros Médicos Acadêmicos , Comportamento Cooperativo , Avaliação de Desempenho Profissional , Docentes de Medicina/normas , Pesquisa , Autoria , Docentes/normas , Humanos , Ensino
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