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BACKGROUND: Clinical guidelines recommend low-molecular-weight heparin for thromboprophylaxis in patients with fractures, but trials of its effectiveness as compared with aspirin are lacking. METHODS: In this pragmatic, multicenter, randomized, noninferiority trial, we enrolled patients 18 years of age or older who had a fracture of an extremity (anywhere from hip to midfoot or shoulder to wrist) that had been treated operatively or who had any pelvic or acetabular fracture. Patients were randomly assigned to receive low-molecular-weight heparin (enoxaparin) at a dose of 30 mg twice daily or aspirin at a dose of 81 mg twice daily while they were in the hospital. After hospital discharge, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome was death from any cause at 90 days. Secondary outcomes were nonfatal pulmonary embolism, deep-vein thrombosis, and bleeding complications. RESULTS: A total of 12,211 patients were randomly assigned to receive aspirin (6101 patients) or low-molecular-weight heparin (6110 patients). Patients had a mean (±SD) age of 44.6±17.8 years, 0.7% had a history of venous thromboembolism, and 2.5% had a history of cancer. Patients received a mean of 8.8±10.6 in-hospital thromboprophylaxis doses and were prescribed a median 21-day supply of thromboprophylaxis at discharge. Death occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight-heparin group (difference, 0.05 percentage points; 96.2% confidence interval, -0.27 to 0.38; P<0.001 for a noninferiority margin of 0.75 percentage points). Deep-vein thrombosis occurred in 2.51% of patients in the aspirin group and 1.71% in the low-molecular-weight-heparin group (difference, 0.80 percentage points; 95% CI, 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications, and other serious adverse events were similar in the two groups. CONCLUSIONS: In patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin in preventing death and was associated with low incidences of deep-vein thrombosis and pulmonary embolism and low 90-day mortality. (Funded by the Patient-Centered Outcomes Research Institute; PREVENT CLOT ClinicalTrials.gov number, NCT02984384.).
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Anticoagulantes , Aspirina , Quimioprevenção , Fraturas Ósseas , Heparina de Baixo Peso Molecular , Adulto , Humanos , Pessoa de Meia-Idade , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Quimioprevenção/métodos , Extremidades/lesões , Fraturas Ósseas/complicações , Fraturas Ósseas/mortalidade , Hemorragia/etiologia , Heparina de Baixo Peso Molecular/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Fraturas do Quadril/complicações , Fraturas do Quadril/mortalidade , Ossos Pélvicos/lesões , Ensaios Clínicos Pragmáticos como Assunto , Embolia Pulmonar/etiologia , Embolia Pulmonar/prevenção & controle , Fraturas da Coluna Vertebral/complicações , Fraturas da Coluna Vertebral/mortalidade , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/etiologia , Trombose Venosa/prevenção & controleRESUMO
OBJECTIVE: To describe current state-level policies in the United States, January 1, 2007-June 1, 2017, limiting high morphine equivalent daily dose (MEDD) prescribing. METHODS: State-level MEDD threshold policies were reviewed using LexisNexis and Westlaw Next for legislative acts and using Google for nonlegislative state-level policies. The websites of each state's Medicaid agency, health department, prescription drug monitoring program, workers' compensation board, medical board, and pharmacy board were reviewed to identify additional policies. The final policy list was checked against existing policy compilations and academic literature and through contact with state health agency representatives. Policies were independently double-coded on the categories: state, agency/organization, policy type, effective date, threshold level, and policy exceptions. RESULTS: Currently, 22 states have at least one type of MEDD policy, most commonly guidelines (14 states), followed by prior authorizations (four states), rules/regulations (four states), legislative acts (three states), claim denials (two states), and alert systems/automatic patient reports (two states). Thresholds range widely (30-300 mg MEDD), with higher thresholds generally corresponding to more restrictive policies (e.g., claim denial) and lower thresholds corresponding to less restrictive policies (e.g., guidelines). The majority of policies exclude some groups of opioid users, most commonly patients with terminal illnesses or acute pain. CONCLUSIONS: MEDD policies have gained popularity in recent years, but considerable variation in threshold levels and policy structure point to a lack of consensus. This work provides a foundation for future evaluation of MEDD policies and may inform states considering adopting such policies.
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Analgésicos Opioides/uso terapêutico , Legislação de Medicamentos , Padrões de Prática Médica , Prescrições de Medicamentos/normas , Humanos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Políticas , Estados UnidosRESUMO
BACKGROUND: In 2006, the American College of Surgeons Committee on Trauma mandated implementation of injury prevention programs as a requirement for Level I and II trauma center designation. Little is known about the factors that facilitate or create barriers to establishing evidence-based injury prevention program implementation. The purpose of this research is to generate hypotheses regarding processes used to implement injury prevention programs at trauma centers, identify the factors that facilitate and serve as a barrier to implementation, and develop a model reflecting these factors and relationships. METHODS: This is a qualitative study of injury prevention programs at trauma centers. Study participants were chosen from 24 sites representing trauma centers of different patient volumes, geographic regions, and settings in the United States. Subjects participated in phone interviews based on guides developed from pilot interviews with prevention coordinators. Transcribed interviews from eight subjects were analyzed using a system of member checking to code; analysis informed the identification of factors that influence the establishment of evidence-based injury prevention programs. RESULTS: Five themes emerged from the data analysis: external factors, internal organizational factors, program capacity, program selection, and program success. Analysis revealed that successful program implementation was related to supportive leaders and collaborative, interdepartmental relationships. Additional themes indicated that while organizations were motivated primarily by verification requirements (external factor), strong institutional leadership (internal factor) was lacking. Employee readiness (program capacity) was hindered by limited training opportunities, and programs were often chosen (selection) based on implementation ease rather than evidence base or local data. CONCLUSIONS: Data analysis reveals five emerging themes of program implementation; using these data, we suggest an initial model of barriers and facilitators for implementing evidence-based injury prevention programs that could serve as the springboard for additional research involving a larger representative sample.
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Serviços Preventivos de Saúde , Enfermagem em Ortopedia e Traumatologia , Humanos , Pesquisa Qualitativa , Estados UnidosRESUMO
BACKGROUND: This study aimed to address the current limitations of the use of composite endpoints in orthopaedic trauma research by quantifying the relative importance of clinical outcomes common to orthopaedic trauma patients and use those values to develop a patient-centered composite endpoint weighting technique. METHODS: A Best-Worst Scaling choice experiment was administered to 396 adult surgically-treated fracture patients. Respondents were presented with ten choice sets, each consisting of three out of ten plausible clinical outcomes. Hierarchical Bayesian modeling was used to determine the utilities associated with the outcomes. RESULTS: Death was the outcome of greatest importance (mean utility = - 8.91), followed by above knee amputation (- 7.66), below knee amputation (- 6.97), severe pain (- 5.90), deep surgical site infection (SSI) (- 5.69), bone healing complications (- 5.20), and moderate pain (- 4.59). Mild pain (- 3.30) and superficial SSI (- 3.29), on the other hand, were the outcomes of least importance to respondents. CONCLUSION: This study revealed that patients' relative importance towards clinical outcomes followed a logical gradient, with distinct and quantifiable preferences for each possible component outcome. These findings were incorporated into a novel composite endpoint weighting technique.
Assuntos
Fixação de Fratura , Fraturas Ósseas/cirurgia , Pesquisa sobre Serviços de Saúde , Assistência Centrada no Paciente , Projetos de Pesquisa , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de SaúdeRESUMO
BACKGROUND: Patient blood management (PBM) has become a topic of intense interest; however, implementing a robust PBM system in a large academic hospital can be a challenge. In a joint effort between transfusion medicine and information technology, we have developed three overlapping databases that allow for a comprehensive, semiautomated approach to monitoring up-to-date red blood cell (RBC) usage in our hospital. Data derived from this work have allowed us to target our PBM efforts. STUDY DESIGN AND METHODS: Information on transfusions is collected using three databases: daily report, discharge database, and denominator database. The daily report collects data on all transfusions in the past 24 hours. The discharge database integrates transfusion data and diagnostic billing codes. The denominator database allows for rate calculations by tracking all patients with a hemoglobin test ordered. A set of algorithms is applied to automatically audit RBC transfusions. The transfusions that do not fit the algorithms' rules are manually reviewed. Data from audits are compiled into reports and distributed to medical directors. Data are also used to target education efforts. RESULTS: Since our PBM program began, the percentage of appropriate RBC orders increased from an initial 70%-80% to 90%-95%, and the overall RBC transfusions/1000 patient-days has decreased by 67% in targeted areas of the hospital. Our PBM program has shaved approximately 3% from our hospital's blood budget. CONCLUSION: Our semiautomated auditing system allows us to quickly and comprehensively analyze and track blood usage throughout our hospital. Using this technology, we have seen improvements in our hospital's PBM.
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Centros Médicos Acadêmicos/métodos , Armazenamento de Sangue/métodos , Bancos de Sangue/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Bases de Dados Factuais/normas , Alta do Paciente/estatística & dados numéricos , Algoritmos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Prática Clínica Baseada em Evidências/métodos , Prática Clínica Baseada em Evidências/estatística & dados numéricos , Humanos , Auditoria Médica/métodos , Auditoria Médica/estatística & dados numéricosRESUMO
The immune system plays an integral role in the regulation of cellular processes responsible for fracture healing. Local and systemic influences on fracture healing correlate in many ways with fracture-related outcomes, including soft tissue healing quality and fracture union rates. Impaired soft tissue healing, restricted perfusion of a fracture site, and infection also in turn affect the immune response to fracture injury. Modern techniques used to investigate the relationship between immune system function and fracture healing include precision medicine, using vast quantities of data to interpret broad patterns of inflammatory response. Early data from the PRECISE trial have demonstrated distinct patterns of inflammatory response in polytrauma patients, which thereby directly and indirectly regulate the fracture healing response. The clearly demonstrated linkage between immune function and fracture healing suggests that modulation of immune function has significant potential as a therapeutic target that can be used to enhance fracture healing.
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BACKGROUND: Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. METHODS: This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. RESULTS: No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. CONCLUSIONS: Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. TRIAL REGISTRATION: Please see Table 1 for individual trial registration numbers and dates of registration.
Assuntos
Orçamentos , Humanos , Análise Custo-Benefício , Estudos Prospectivos , Estudos RetrospectivosRESUMO
BACKGROUND: The PREVENT CLOT trial concluded that thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin (LMWH) in preventing death after orthopedic trauma. However, it was unclear if these results applied to patients at highest risk of thrombosis. Therefore, we assessed if the effect of aspirin versus LMWH differed based on patients' baseline risk of venous thromboembolism (VTE). METHODS: The PREVENT CLOT trial enrolled 12,211 adult patients with fractures. This secondary analysis stratified the study population into VTE risk quartiles: low (<1%) to high (>10%) using the Caprini score. We assessed stratum-specific treatment effects using the win ratio method, in which each patient assigned to aspirin was paired with each assigned to LMWH. In each pair, we compared outcomes hierarchically, starting with death, then pulmonary embolism, deep vein thrombosis, and bleeding. The secondary outcome added patients' medication satisfaction as a fifth composite component. RESULTS: In the high-risk quartile (n = 3052), 80% had femur fracture, pelvic, or acetabular fractures. Thoracic (47%) and head (37%) injuries were also common. In the low risk quartile (n = 3053), most patients had a tibia fracture (67%), 5% had a thoracic injury, and less than 1% had head or spinal injuries. Among high risk patients, thromboembolic events did not differ statistically between aspirin and LMWH (win ratio, 0.94; 95% confidence interval [CI], 0.82-1.08, p = 0.42). This result was consistent in the low (win ratio, 1.15; 95% CI, 0.90-1.47, p = 0.27), low-medium (win ratio, 1.05; 95% CI, 0.85-1.29, p = 0.68), and medium-high risk quartiles (win ratio, 0.94; 95% CI, 0.80-1.11, p = 0.48). When medication satisfaction was considered, favorable outcomes were 68% more likely with aspirin (win ratio, 1.68; 95% CI, 1.60-1.77; p < 0.001). CONCLUSION: Thromboembolic outcomes were similar with aspirin or LMWH, even among patients at highest risk of VTE. Aspirin was favored if medication satisfaction was also considered. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.
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Embolia Pulmonar , Tromboembolia Venosa , Adulto , Humanos , Heparina de Baixo Peso Molecular/uso terapêutico , Anticoagulantes/uso terapêutico , Aspirina/uso terapêutico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Hemorragia/tratamento farmacológico , Embolia Pulmonar/etiologia , Embolia Pulmonar/prevenção & controle , Embolia Pulmonar/tratamento farmacológico , Heparina/uso terapêuticoRESUMO
BACKGROUND: Current guidelines recommend low-molecular-weight heparin for thromboprophylaxis after orthopaedic trauma. However, recent evidence suggests that aspirin is similar in efficacy and safety. To understand patients' experiences with these medications, we compared patients' satisfaction and out-of-pocket costs after thromboprophylaxis with aspirin versus low-molecular-weight heparin. METHODS: This study was a secondary analysis of the PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT) trial, conducted at 21 trauma centers in the U.S. and Canada. We included adult patients with an operatively treated extremity fracture or a pelvic or acetabular fracture. Patients were randomly assigned to receive 30 mg of low-molecular-weight heparin (enoxaparin) twice daily or 81 mg of aspirin twice daily for thromboprophylaxis. The duration of the thromboprophylaxis, including post-discharge prescription, was based on hospital protocols. The study outcomes included patient satisfaction with and out-of-pocket costs for their thromboprophylactic medication measured on ordinal scales. RESULTS: The trial enrolled 12,211 patients (mean age and standard deviation [SD], 45 ± 18 years; 62% male), 9725 of whom completed the question regarding their satisfaction with the medication and 6723 of whom reported their out-of-pocket costs. The odds of greater satisfaction were 2.6 times higher for patients assigned to aspirin than those assigned to low-molecular-weight heparin (odds ratio [OR]: 2.59; 95% confidence interval [CI]: 2.39 to 2.80; p < 0.001). Overall, the odds of incurring any out-of-pocket costs for thromboprophylaxis medication were 51% higher for patients assigned to aspirin compared with low-molecular-weight heparin (OR: 1.51; 95% CI: 1.37 to 1.66; p < 0.001). However, patients assigned to aspirin had substantially lower odds of out-of-pocket costs of at least $25 (OR: 0.15; 95% CI: 0.12 to 0.18; p < 0.001). CONCLUSIONS: Use of aspirin substantially improved patients' satisfaction with their medication after orthopaedic trauma. While aspirin use increased the odds of incurring any out-of-pocket costs, it protected against costs of ≥$25, potentially improving health equity for thromboprophylaxis. LEVEL OF EVIDENCE: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.
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Heparina de Baixo Peso Molecular , Tromboembolia Venosa , Adulto , Feminino , Humanos , Masculino , Assistência ao Convalescente , Anticoagulantes , Aspirina/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Alta do Paciente , Satisfação Pessoal , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/induzido quimicamente , Pessoa de Meia-IdadeRESUMO
BACKGROUND: The Short Musculoskeletal Function Assessment (SMFA) is a well validated, widely used patient-reported outcome (PRO) measure for orthopaedic patients. Despite its widespread use and acceptance, this measure does not have an agreed upon minimal clinically important difference (MCID). The purpose of the present study was to create distributional MCIDs with use of a large cohort of research participants with severe lower extremity fractures. METHODS: Three distributional approaches were used to calculate MCIDs for the Dysfunction and Bother Indices of the SMFA as well as all its domains: (1) half of the standard deviation (one-half SD), (2) twice the standard error of measurement (2SEM), and (3) minimal detectable change (MDC). In addition to evaluating by patient characteristics and the timing of assessment, we reviewed these calculations across several injury groups likely to affect functional outcomes. RESULTS: A total of 4,298 SMFA assessments were collected from 3,185 patients who had undergone surgical treatment of traumatic injuries of the lower extremity at 60 Level-I trauma centers across 7 multicenter, prospective clinical studies. Depending on the statistical approach used, the MCID associated with the overall sample ranged from 7.7 to 10.7 for the SMFA Dysfunction Index and from 11.0 to 16.8 for the SMFA Bother Index. For the Dysfunction Index, the variability across the scores was small (<5%) within the sex and age subgroups but was modest (12% to 18%) across subgroups related to assessment timing. CONCLUSIONS: A defensible MCID can be found between 7 and 11 points for the Dysfunction Index and between 11 and 17 points for the Bother Index. The precise choice of MCID may depend on the preferred statistical approach and the population under study. While differences exist between MCID values based on the calculation method, values were consistent across the categories of the various subgroups presented. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
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BACKGROUND: Patients at risk for generating high health care expenditures often receive fragmented, low-quality, inefficient health care. Guided Care is designed to provide proactive, coordinated, comprehensive care for such patients. OBJECTIVE: We hypothesized that Guided Care, compared to usual care, produces better functional health and quality of care, while reducing the use of expensive health services. DESIGN: 32-month, single-blind, matched-pair, cluster-randomized controlled trial of Guided Care, conducted in eight community-based primary care practices. PATIENTS: The "Hierarchical Condition Category" (HCC) predictive model was used to identify high-risk older patients who were insured by fee-for-service Medicare, a Medicare Advantage plan or Tricare. Patients with HCC scores in the highest quartile (at risk for generating high health care expenditures during the coming year) were eligible to participate. INTERVENTION: A registered nurse collaborated with two to five primary care physicians in providing eight services to participants: comprehensive assessment, evidence-based care planning, proactive monitoring, care coordination, transitional care, coaching for self-management, caregiver support, and access to community-based services. MAIN MEASURES: Functional health was measured using the Short Form-36. Quality of care and health services utilization were measured using the Patient Assessment of Chronic Illness Care and health insurance claims, respectively. KEY RESULTS: Of the eligible patients, 904 (37.8 %) gave written consent to participate; of these, 477 (52.8 %) completed the final interview, and 848 (93.8 %) provided complete claims data. In intention-to-treat analyses, Guided Care did not significantly improve participants' functional health, but it was associated with significantly higher participant ratings of the quality of care (difference = 0.27, 95 % CI = 0.08-0.45) and 29 % lower use of home care (95 % CI = 3-48 %). CONCLUSIONS: Guided Care improves high-risk older patients' ratings of the quality of their care, and it reduces their use of home care, but it does not appear to improve their functional health.
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Serviços de Saúde Comunitária/organização & administração , Prestação Integrada de Cuidados de Saúde/organização & administração , Serviços de Saúde para Idosos/organização & administração , Atenção Primária à Saúde/organização & administração , Idoso , Serviços de Saúde Comunitária/normas , Prestação Integrada de Cuidados de Saúde/normas , Feminino , Gastos em Saúde/estatística & dados numéricos , Serviços de Saúde/estatística & dados numéricos , Serviços de Saúde para Idosos/normas , Humanos , Masculino , Satisfação do Paciente , Atenção Primária à Saúde/normas , Qualidade da Assistência à Saúde , Método Simples-Cego , Estados UnidosRESUMO
BACKGROUND: Self-care management is recognized as a key component of care for multimorbid older adults; however, the characteristics of those most likely to participate in Chronic Disease Self-Management (CDSM) programs and strategies to maximize participation in such programs are unknown. OBJECTIVES: To identify individual factors associated with attending CDSM programs in a sample of multimorbid older adults. RESEARCH DESIGN: Participants in the intervention arm of a matched-pair cluster-randomized controlled trial of the Guided Care model were invited to attend a 6-session CDSM course. Logistic regression was used to identify factors independently associated with attendance. SUBJECTS: All subjects (N = 241) were aged 65 years or older, were at high risk for health care utilization, and were not homebound. MEASURES: Baseline information on demographics, health status, health activities, and quality of care was available for CDSM participants and nonparticipants. Participation was defined as attendance at 5 or more CDSM sessions. RESULTS: A total of 22.8% of multimorbid older adults who were invited to CDSM courses participated in 5 or more sessions. Having better physical health (odds ratio [95% confidence interval] = 2.3 [1.1-4.8]) and rating one's physician poorly on support for patient activation (odds ratio [95% confidence interval] = 2.8 [1.3-6.0]) were independently associated with attendance. CONCLUSIONS: Multimorbid older adults who are in better physical health and who are dissatisfied with their physicians' support for patient activation are more likely to participate in CDSM courses.
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Doença Crônica/terapia , Autocuidado/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Feminino , Nível de Saúde , Humanos , Masculino , Qualidade da Assistência à Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Características de Residência/estatística & dados numéricos , Fatores SocioeconômicosRESUMO
OBJECTIVES: To compare outcomes in patients with open tibia shaft fractures based on defect size. DESIGN: Retrospective review. SETTING: Eighteen trauma centers. POPULATION: The study included 132 patients with diaphyseal tibia bone defects >1 cm and ≥50% cortical loss treated with intramedullary nail. OUTCOMES: The primary outcome was number of secondary surgeries to promote healing (bone graft, revision fixation, or bone transport). Additional outcomes included occurrence of secondary surgeries (bone graft, infection, amputation, and flap failure) and proportion healed at one year. Results are compared by "radiographic apparent bone gap" of <2.5 or ≥2.5 cm. RESULTS: The estimated conditional probability of bone grafting within one year given graft-free at 90 days was 44% and 47% in the <2.5 cm and ≥2.5 cm groups, respectively. An estimated infection risk of 14% was observed in both groups [adjusted hazard ratio (HR) 0.98, 95% confidence interval (CI): 0.33-2.92], estimated amputation risk was 9% (<2.5 cm) and 4% (≥2.5 cm) (unadjusted HR 0.66, 95% CI: 0.13-3.29), and estimated flap failure risk (among those with flaps) was 10% and 13%, respectively (unadjusted HR 1.71, 95% CI: 0.24-12.25). There was no appreciable difference in the proportion healed at one year between defect sizes [adjusted HR: 1.07 (95% CI, 0.63-1.82)]. CONCLUSIONS: Larger size bone defects were not associated with higher number of secondary procedures to promote healing or a lower overall one-year healing rate. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Assuntos
Fixação Intramedular de Fraturas , Fraturas Expostas , Fraturas da Tíbia , Pinos Ortopédicos , Fixação Intramedular de Fraturas/métodos , Consolidação da Fratura , Fraturas Expostas/cirurgia , Humanos , Estudos Retrospectivos , Tíbia , Fraturas da Tíbia/cirurgia , Resultado do TratamentoRESUMO
OBJECTIVE: To compare the retrospective decision of an expert panel who assessed likelihood of acute compartment syndrome (ACS) in a patient with a high-risk tibia fracture with decision to perform fasciotomy. DESIGN: Prospective observational study. SETTING: Seven Level 1 trauma centers. PATIENTS/PARTICIPANTS: One hundred eighty-two adults with severe tibia fractures. MAIN OUTCOME MEASUREMENTS: Diagnostic performance (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and receiver-operator curve) of an expert panel's assessment of likelihood ACS compared with fasciotomy as the reference diagnostic standard. SECONDARY OUTCOMES: The interrater reliability of the expert panel as measured by the Krippendorff alpha. Expert panel consensus was determined using the percent of panelists in the majority group of low (expert panel likelihood of ≤0.3), uncertain (0.3-0.7), or high (>0.7) likelihood of ACS. RESULTS: Comparing fasciotomy (the diagnostic standard) and the expert panel's assessment as the diagnostic classification (test), the expert panel's determination of uncertain or high likelihood of ACS (threshold >0.3) had a sensitivity of 0.90 (0.70, 0.99), specificity of 0.95 (0.90, 0.98), PPV of 0.70 (0.50, 0.86), and NPV of 0.99 (0.95, 1.00). When a threshold of >0.7 was set as a positive diagnosis, the expert panel assessment had a sensitivity of 0.67 (0.43, 0.85), specificity of 0.98 (0.95, 1.00), PPV of 0.82 (0.57, 0.96), and NPV of 0.96 (0.91, 0.98). CONCLUSION: In our study, the retrospective assessment of an expert panel of the likelihood of ACS has good specificity and excellent NPV for fasciotomy, but only low-to-moderate sensitivity and PPV. The discordance between the expert panel-assessed likelihood of ACS and the decision to perform fasciotomy suggests that concern regarding potential diagnostic bias in studies of ACS is warranted. LEVEL OF EVIDENCE: Diagnostic Level I. See Instructions for Authors for a complete description of levels of evidence.
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Síndromes Compartimentais , Adulto , Síndromes Compartimentais/diagnóstico , Síndromes Compartimentais/epidemiologia , Síndromes Compartimentais/cirurgia , Fasciotomia , Humanos , Incidência , Reprodutibilidade dos Testes , Estudos RetrospectivosRESUMO
LEVEL OF EVIDENCE: Prognostic Level II.
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Ortopedia , Humanos , Medidas de Resultados Relatados pelo PacienteRESUMO
SUMMARY: Optimal timing and procedure selection that define staged treatment strategies can affect outcomes dramatically and remain an area of major debate in the treatment of multiply injured orthopaedic trauma patients. Decisions regarding timing and choice of orthopaedic procedure(s) are currently based on the physiologic condition of the patient, resource availability, and the expected magnitude of the intervention. Surgical decision-making algorithms rarely rely on precision-type data that account for demographics, magnitude of injury, and the physiologic/immunologic response to injury on a patient-specific basis. This study is a multicenter prospective investigation that will work toward developing a precision medicine approach to managing multiply injured patients by incorporating patient-specific indices that quantify (1) mechanical tissue damage volume; (2) cumulative hypoperfusion; (3) immunologic response; and (4) demographics. These indices will formulate a precision injury signature, unique to each patient, which will be explored for correspondence to outcomes and response to surgical interventions. The impact of the timing and magnitude of initial and staged surgical interventions on patient-specific physiologic and immunologic responses will be evaluated and described. The primary goal of the study will be the development of data-driven models that will inform clinical decision-making tools that can be used to predict outcomes and guide intervention decisions.
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Traumatismo Múltiplo , Procedimentos Ortopédicos , Ortopedia , Humanos , Traumatismo Múltiplo/cirurgia , Medicina de Precisão , Estudos ProspectivosRESUMO
SUMMARY: Physical and psychological impairment resulting from traumatic injuries is often significant and affects employment and functional independence. Extremity trauma has been shown to negatively affect long-term self-reported physical function, the ability to work, and participation in recreational activities and contributes to increased rates of anxiety and/or depression. High pain levels early in the recovery process and psychosocial factors play a prominent role in recovery after traumatic lower extremity injury. Cognitive-behavioral therapy pain programs have been shown to mitigate these effects. However, patient access issues related to financial and transportation constraints and the competing demands of treatment focused on the physical sequelae of traumatic injury limit patient participation in this treatment modality. This article describes a telephone-delivered cognitive-behavioral-based physical therapy (CBPT-Trauma) program and design of a multicenter trial to determine its effectiveness after lower extremity trauma. Three hundred twenty-five patients from 7 Level 1 trauma centers were randomized to CBPT-Trauma or an education program after hospital discharge. The primary hypothesis is that compared with patients who receive an education program, patients who receive the CBPT-Trauma program will have improved physical function, pain, and physical and mental health at 12 months after hospital discharge.
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Terapia Cognitivo-Comportamental , Ortopedia , Cognição , Humanos , Extremidade Inferior , Modalidades de FisioterapiaRESUMO
BACKGROUND: Smoking increases the risk of complications and related costs after an orthopaedic fracture. Research in other populations suggests that a one-time payment may incentivize smoking cessation. However, little is known on fracture patients' willingness to accept financial incentives to stop smoking; and the level of incentive required to motivate smoking cessation in this population. This study aimed to estimate the financial threshold required to motivate fracture patients to stop smoking after injury. METHODS: This cross-sectional study utilized a discrete choice experiment (DCE) to elicit patient preferences towards financial incentives and reduced complications associated with smoking cessation. We presented participants with 12 hypothetical options with several attributes with varying levels. The respondents' data was used to determine the utility of each attribute level and the relative importance associated with each attribute. RESULTS: Of the 130 enrolled patients, 79% reported an interest in quitting smoking. We estimated the financial incentive to be of greater relative importance (ri) (45%) than any of the included clinical benefits of smoking cessations (deep infection (ri: 24%), bone healing complications (ri: 19%), and superficial infections (ri: 12%)). A one-time payment of $800 provided the greatest utility to the respondents (0.64, 95% CI: 0.36 to 0.93), surpassing the utility associated with a single $1000 financial incentive (0.36, 95% CI: 0.18 to 0.55). CONCLUSIONS: Financial incentives may be an effective tool to promote smoking cessation in the orthopaedic trauma population. The findings of this study define optimal payment thresholds for smoking cessation programs.
RESUMO
INTRODUCTION: Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients. METHODS AND ANALYSIS: PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections. ETHICS AND DISSEMINATION: The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients. TRIAL REGISTRATION NUMBER: NCT02984384.
Assuntos
Ortopedia , Trombose , Tromboembolia Venosa , Adulto , Anticoagulantes/uso terapêutico , Aspirina/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Tromboembolia Venosa/prevenção & controleRESUMO
BACKGROUND: The quality of health care for older Americans with chronic conditions is suboptimal. OBJECTIVE: To evaluate the effects of "Guided Care" on patient-reported quality of chronic illness care. DESIGN: Cluster-randomized controlled trial of Guided Care in 14 primary care teams. PARTICIPANTS: Older patients of these teams were eligible to participate if, based on analysis of their recent insurance claims, they were at risk for incurring high health-care costs during the coming year. Small teams of physicians and their at-risk older patients were randomized to receive either Guided Care (GC) or usual care (UC). INTERVENTION: "Guided Care" is designed to enhance the quality of health care by integrating a registered nurse, trained in chronic care, into a primary care practice to work with 2-5 physicians in providing comprehensive chronic care to 50-60 multi-morbid older patients. MEASUREMENTS: Eighteen months after baseline, interviewers blinded to group assignment administered the Patient Assessment of Chronic Illness Care (PACIC) survey by telephone. Logistic and linear regression was used to evaluate the effect of the intervention on patient-reported quality of chronic illness care. RESULTS: Of the 13,534 older patients screened, 2,391 (17.7%) were eligible to participate in the study, of which 904 (37.8%) gave informed consent and were cluster-randomized. After 18 months, 95.3% and 92.2% of the GC and UC recipients who remained alive and eligible completed interviews. Compared to UC recipients, GC recipients had twice greater odds of rating their chronic care highly (aOR = 2.13, 95% CI = 1.30-3.50, p = 0.003). CONCLUSION: Guided Care improves self-reported quality of chronic health care for multi-morbid older persons.