Search

BACKGROUND: Value-based healthcare models aim to incentivize healthcare providers to offer interventions that address determinants of health. Understanding patient priorities for physical and socioeconomic recovery after injury can help determine which services and resources are most useful to patients. QUESTIONS/PURPOSES: (1) Do trauma patients consistently identify a specific aspect/domain of recovery as being most important at 6 weeks, 6 months, and 12 months after an injury? (2) Does the relative importance of those domains change within the first year after injury? (3) Are differences in priorities greater between patients than for a given patient over time? (4) Are different recovery priorities associated with identifiable biopsychosocial factors? METHODS: Between June 2018 and December 2018, 504 adult patients with fractures of the extremities or pelvis were surgically treated at the study site. For this prospective longitudinal study, we purposefully sampled patients from 6 of the 12 orthopaedic attendings' postoperative clinics. The participating surgeons surgically treated 243 adult patients with fractures of the extremities or pelvis. Five percent (11 of 243) of patients met inclusion criteria but missed their appointments during the 6-week recruitment window and could not be consented. We excluded 4% (9 of 243) of patients with a traumatic brain injury, 1% (2) of patients with a spinal cord injury, and 5% (12) of non-English-speaking patients (4% Spanish speaking [10]; 1% other languages [2]). Eighty-six percent of eligible patients (209 of 243) were approached for consent, and 5% (11 of 209) of those patients refused to participate. All remaining 198 patients consented and completed the baseline survey; 83% (164 of 198 patients) completed at least 6 months of follow-up, and 68% (134 of 198 patients) completed the 12-month assessment. The study participants' mean age was 44 ± 17 years, and 63% (125 of 198) were men. The primary outcome was the patient's recovery priorities, assessed at 6 weeks, 6 months, and 12 months after fracture using a discrete choice experiment. Discrete choice experiments are a well-established method for eliciting decisional preferences. In this technique, respondents are presented with a series of hypothetical scenarios, described by a set of plausible attributes or outcomes, and asked to select their preferred scenario. We used hierarchical Bayesian modeling to calculate individual-level estimates of the relative importance of physical recovery, work-related recovery, and disability benefits, based on the discrete choice experiment responses. The hierarchical Bayesian model improves upon more commonly used regression techniques by accounting for the observed response patterns of individual patients and the sequence of scenarios presented in the discrete choice experiment when calculating the model estimates. We computed the coefficient of variation for the three recovery domains and compared the between-patient versus within-patient differences using asymptotic tests. Separate prognostic models were fit for each of the study's three recovery domains to assess marginal changes in the importance of the recovery domain based on patient characteristics and factors that remained constant over the study (such as sex or preinjury work status) and patient characteristics and factors that varied over the study (including current work status or patient-reported health status). We previously published the 6-week results. This paper expands upon the prior publication to evaluate longitudinal changes in patient recovery priorities. RESULTS: Physical recovery was the respondents' main priority at all three timepoints, representing 60% ± 9% of their overall concern. Work-related recovery and access to disability benefits were of secondary importance and were associated with 27% ± 6% and 13% ± 7% of the patients' concern, respectively. The patients' concern for physical recovery was 6% (95% CrI 4% to 7%) higher at 12 months after fracture that at 6 weeks postfracture. The mean concern for work-related recovery increased by 7% (95% CrI 6% to 8%) from 6 weeks to 6 months after injury. The mean importance of disability benefits increased by 2% (95% CrI 1% to 4%) from 6 weeks to 6 months and remained 2% higher (95% CrI 0% to 3%) at 12 months after the injury. Differences in priorities were greater within a given patient over time than between patients as measured using the coefficient of variation (physical recovery [245% versus 7%; p < 0.001], work-related recovery [678% versus 12%; p < 0.001], and disability benefits [620% versus 33%; p < 0.001]. There was limited evidence that biopsychosocial factors were associated with variation in recovery priorities. Patients' concern for physical recovery was 2% higher for every 10-point increase in their Patient-reported Outcome Measure Information System (PROMIS) physical health status score (95% CrI 1% to 3%). A 10-point increase in the patient's PROMIS mental health status score was associated with a 1% increase in concern for work-related recovery (95% CrI 0% to 2%). CONCLUSION: Work-related recovery and accessing disability benefits were a secondary concern compared with physical recovery in the 12 months after injury for patients with fractures. However, the importance of work-related recovery was elevated after the subacute phase. Priorities were highly variable within a given patient in the year after injury compared with between-patient differences. Given this variation, orthopaedic surgeons should consider assessing and reassessing the socioeconomic well-being of their patients throughout their continuum of care. LEVEL OF EVIDENCE: Level II, therapeutic study.

Importance Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, –3.4%; 95% CI, –6.9% to 0.1%;P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, –3.7%; 95% CI, –6.7% to –0.8%;P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, –1.6% to 2.1%;P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration ClinicalTrials.gov Identifier:NCT02227446

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.

Objectives To determine whether using topical vancomycin powder in fracture surgery may result in low levels of vancomycin in the serum and not result in nephrotoxicity. Design Prospective observational at a single site as a substudy of the VANCO trial. Setting Single, large urban level I trauma center. Patients/participants Fifty-eight patients with tibial plateau and pilon fractures randomized to the treatment arm at the principal investigator's site. Intervention Topical vancomycin powder (1000 mg) applied directly in the wound over all metal implants at the time of wound closure. Main outcome measurements Serum vancomycin levels at 1 hour and 6-8 hours after surgery. Secondary outcomes included serum creatinine before surgery, a day after surgery, and at 2 weeks postoperatively and complete blood count at 2 weeks postoperatively. Results Except in 2 patients who also received intravenous vancomycin, none of the study patients had detectable (>5 µg/mL) serum vancomycin levels at 1 hour and 6-8 hours after surgery. One patient with a history of elevation of serum creatinine had a minor increase of serum creatinine but had undetectable vancomycin levels. None of the other patients had a clinically significant increase in creatinine levels. Conclusions Despite its relatively widespread usage, little data exist regarding the systemic levels and nephrotoxicity associated with the topical use of vancomycin powder in orthopaedic fracture surgery. These prospective data indicate that there seems to be little clinical concern regarding toxicity associated with systemic absorption of vancomycin powder in this specific clinical application. Level of evidence Therapeutic Level IV. See instructions for authors for a complete description of levels of evidence.

Author(s): Pogorzelski, David; Nguyen, Uyen; McKay, Paula; Thabane, Lehana; Camara, Megan; Ramsey, Lolita; Seymour, Rachel; Goodman, J Brett; McGee, Sheketha; Fraifogl, Joanne; Hudgins, Andrea; Tanner, Stephanie L; Bhandari, Mohit; Slobogean, Gerard P; Sprague, Sheila; PREP-IT Investigators Executive Committee:; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; McMaster University Methods Center; University of Maryland School of Medicine Administrative Center; University of Maryland School of Pharmacy, The PATIENTS Program; PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE); Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee | Abstract: IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p l 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

OBJECTIVE To determine the risk factors for knee stiffness surgery after tibial plateau fixation. DESIGN Retrospective observational cohort study. SETTING Academic Level I trauma center. PATIENTS/PARTICIPANTS A study group of 110 patients who underwent knee stiffness surgery (manipulation while under anesthesia, arthroscopic lysis of adhesion, or quadricepsplasty) at a time remote from open reduction and internal fixation of tibial plateau fractures and a control group of 319 patients with tibial plateau fractures treated with open reduction and internal fixation who did not undergo knee stiffness surgery and who had either a minimum of 1 year of follow-up or clearly documented range of motion ≥110 degrees with a minimum of 90 days of follow-up. INTERVENTION Each case was assessed from the time of index admission through study event, end of minimum follow-up, or achievement of ≥110 degrees range of motion. MAIN OUTCOME MEASUREMENTS Knee stiffness surgery. RESULTS Total number of weeks in an external fixator (odds ratio, 1.5 per week; 95% confidence interval, 1.3-1.7; P < 0.001) and the presence of bilateral tibial plateau fractures (odds ratio, 3.3; 95% confidence interval, 1.2-9.1; P = 0.02) were significant predictors of knee stiffness intervention. CONCLUSION Clinicians should be aware that the time spent in external fixation and the presence of bilateral tibial plateau injuries are strong risk factors for requiring subsequent surgery to treat knee stiffness. LEVEL OF EVIDENCE Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Orthopedic trauma patients are often treated with venous thromboembolism (VTE) chemoprophylaxis with aspirin or low molecular weight heparin (LMWH) after discharge from their index admission, but adherence patterns are not known. We hypothesized that overall adherence would be moderate and greater with aspirin compared to LMWH.We conducted a randomized controlled trial of adult trauma patients with an operative extremity fracture or any pelvic/acetabular fracture requiring VTE prophylaxis. Patients were randomized to receive either LMWH 30 mg BID or aspirin 81 mg BID. Patients prescribed outpatient prophylaxis were contacted between 10 and 21 days after discharge to assess adherence measured by the validated Morisky Medication Adherence Scale (MMAS-8). Adherence scores were compared between the two treatment arms with similar results for intention-to-treat and as-treated analyses. As-treated multivariable logistic regression was performed to determine factors associated with low-medium adherence scores.One hundred fifty patients (64 on LMWH, 86 on aspirin) on chemoprophylaxis at time of follow-up completed the questionnaire. As-treated analysis showed that adherence was high overall (mean MMAS 7.2 out of 8, SD 1.5) and similar for the two regimens (LMWH: 7.4 vs. aspirin: 7.0, p = 0.13). However, patients on LMWH were more likely to feel hassled by their regimen (23% vs. 9%, p = 0.02). In a multivariable model, low-medium adherence was associated with taking LMWH as the prophylaxis medication (aOR 2.34, CI 1.06-5.18, p = 0.04), having to self-administer the prophylaxis (aOR 4.44, CI 1.45-13.61, p0.01), being of male sex (aOR 2.46, CI 1.10-5.49, p = 0.03), and of younger age (aOR 0.72 per additional 10 years of age, CI 0.57-0.91, p0.01).Overall post-discharge adherence with VTE prophylaxis was high. Several factors, including prophylaxis by LMWH, were associated with decreased adherence. These factors should be considered when managing patients and designing efficacy trials.Therapeutic, level II.

ObjectiveThe study aimed to assess systematic differences in the characteristics of patients that consented for the trial compared with the broader pool of eligible patients in a large, pragmatic orthopaedic trauma trial.DesignA retrospective observational study performed from April 2017 to March 2018.SettingAcademic trauma centre in Baltimore, USA.ParticipantsThere were 642 eligible adult trial participants with an operative fracture to the appendicular skeleton and were indicated for blood clot prophylaxis. The median age of the sample was 50 years (IQR: 31–63), and 60% were male.Primary outcome measureThe primary outcome was the refusal to enrol in the trial. Demographic and injury covariates were included in iterations of latent class models. The final model was selected based on a minimum Bayesian information criterion.ResultsThe final model identified three clusters with five covariates predictive of cluster membership (age, neighbourhood-based socioeconomic status, alcohol use, multiple fractures, multiple surgeries). The three clusters were associated with 22% (Cluster 1), 38% (Cluster 2) and 62% (Cluster 3) refusal rates, respectively. Members of Cluster 3 (n=84) were most commonly between 66 and 80 years of age (49% vs 6% (Cluster 1) and 21% (Cluster 2)), of high neighbourhood-based socioeconomic status (85% vs 63% (Cluster 1) and 8% (Cluster 2)), with isolated fractures (100% vs 80% (Cluster 1) and 92% (Cluster 2)), and were less likely to have multiple surgeries compared with the other clusters (28% vs 47% (Cluster 1) and 35% (Cluster 2)).ConclusionIn this study, the likelihood of refusing to participate in the trial ranged from 22% to 62% in the three identified clusters. Elderly age, high socioeconomic status, and less severe injuries defined the cluster that was most likely to refuse trial participation.Trial registration numberNCT02984384.

Objective Vitamin D is often prescribed as an adjuvant therapy to aid fracture healing due to its biological role in bone health. However, the optimal frequency, dosage and duration of vitamin D supplementation for non-osteoporotic fracture healing has not been established. The objective of this study was to determine patient preferences for fracture healing relative to hypothetical vitamin D supplementation dosing options. Design Discrete choice experiment. Setting Level 1 trauma centre in Baltimore, Maryland, USA. Participants 199 adult (18–60 years) patients with a fracture. Primary outcome measures Parameter estimates of utility for fracture healing relative to dosing regimens were analysed using hierarchical Bayesian modelling. Results A reduced risk of reoperation (34.3%) and reduced healing time (24.4%) were the attributes of greatest relative importance. The highest mean utility estimates were for a one-time supplementation dose (s=0.71, 95% CI 0.41 to 1.00) followed by a reduced risk of reoperation (s=0.41 per absolute % reduction, 95% CI 0.0.36 to 0.46). Supplementation for 24 weeks in duration (s=−0.83, 95% CI −1.00 to −0.67) and a daily supplement (s=−0.29, 95% CI −0.47 to −0.11) had the lowest mean utilities. The ‘no supplement’ option had a large negative value suggesting supplementation was generally desirable in this sample population. Among other possible clinical scenarios, patients expected a 2% reduction in the absolute risk of reoperation or a 3.1-week reduction in healing time from the baseline to accept a treatment regimen requiring two separate doses of supplementation, two blood tests and a cost of $20 within 3 months of injury. Conclusions Patients with orthopaedic trauma demonstrated strong willingness to take a vitamin D supplement that would decrease risk of reoperation and reduce healing time. Furthermore, these findings specify the required decrease in reoperation risk and reduction in healing time patients would expect to adhere to possible vitamin D dosing regimens.