Responsiveness of the PROMIS physical function measure in orthopaedic trauma patients.

OBJECTIVES: To compare the responsiveness of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) to the 36-Item Short Form Survey Physical Component Score (SF36-PCS) in orthopaedic trauma patients from pre-injury to one year recovery. DESIGN AND SETTING: Prospective cohort study at a Level 1 trauma centre. PARTICIPANTS: Patients over the age of 18 with orthopaedic trauma injuries to the pelvis, lower extremity or upper extremity between 2017 and 2018. MAIN OUTCOMES MEASUREMENTS: The PROMIS-PF and SF36-PCS assessments were conducted at baseline, 3 months, 6 months and 12 months. Responsiveness of each measure was assessed between time points by calculating the standardized response mean (SRM), the proportions of patients exceeding minimal clinically important difference (MCID), and the floor and ceiling effects. RESULTS: Sixty-eight patients with completed assessments at every timepoint were included: mean age 44.7 years, 39 were male and mean Injury Severity Score (ISS) was 7.4 (range: 4-16). Mean time of completion for the SF-36 at all the time points was 5.6 min vs 1.7 min for the PROMIS-PF (p<0.01). The SRM was comparable between measures at all the time points. Although a greater proportion of patients achieved MCID for SF36-PCS between all the time points, this only approached statistical significance between the 6- and 12-month assessments (47.1% vs 33.8%; p = 0.15). There was a significant ceiling effect demonstrated with the PROMIS-PF at baseline and 12-month assessments, with 34 (50.0%) patients and 7 (10.3%) patients achieving the maximum scores at each time point, respectively. DISCUSSION AND CONCLUSIONS: PROMIS-PF has a more favourable responder burden based on lower time to completion and comparable responsiveness to the SF-36 PCS. However, there are limitations in responsiveness with the PROMIS-PF in patients who are higher functioning as demonstrated by the ceiling effects in patients at baseline pre-injury and at 12 months post-injury timepoints.

Comparing the responsiveness of a generic and a musculoskeletal specific functional outcome measure in orthopaedic patients with operative fixation of pelvic ring, acetabulum, or tibia fractures: a comparison between single injury and multiply injured patients.

OBJECTIVES: This study compares the responsiveness, or the ability to detect clinical change in a disease, between the generic Short Form-36 (SF-36) and musculoskeletal specific Short Musculoskeletal Functional Assessment (SMFA) patient-reported outcome measures (PROMs) in the orthopaedic trauma population. Stratified analysis was performed to compare whether responsiveness differs between patients with single or multiple orthopaedic injuries. DESIGN: Prospective case series. SETTING: Level 1 Trauma Center. PATIENTS: A total of 659 patients with orthopaedic trauma injuries to the pelvis, acetabulum, or tibia were included for analysis. There were 485 patients with a single isolated injury and 174 patients with multiple orthopaedic injuries. INTERVENTION: None. MAIN OUTCOME MEASUREMENTS: Responsiveness was calculated through the standard response mean (SRM), the proportion meeting a minimal clinically important difference, and floor and ceiling effects. RESULTS: Between baseline and 6 months the magnitude of the SRM for SF-36 was consistently greater than that of SMFA in patients with single (P < .01) and multiple injuries (P < .01). Between 6 and 12 months, there were no differences in SRM across all cohorts. The proportion of patients who achieved minimal clinically important difference was consistently higher when assessed with SF-36 compared with SMFA between baseline and 6 months (81.8% vs 68.1%, P < .0001) and between 6 and 12 months (63.3% vs 55.4%, P = .01).A ceiling effect was only observed at baseline for the SMFA with 16.6% of patients achieving the maximal level of functioning detectable. No floor effects were seen in either PROM. CONCLUSION: This study demonstrates that SF-36 has superior responsiveness versus SMFA in both polytrauma and isolated injury patients and supports the collection of SF-36 as the primary PROM in prospective orthopaedic trauma studies irrespective of whether the patient has an isolated injury or multiple injuries.

Predicting completion of follow-up in prospective orthopaedic trauma research.

OBJECTIVE: Orthopaedic trauma studies that collect long-term outcomes are expensive and maintaining high rates of follow-up can be challenging. Knowing what factors influence completion of follow-up could allow interventions to improve this. We aimed to assess which factors influence completion of follow-up in the 12 months following surgery in prospective orthopaedic trauma research. DESIGN: Prospective Cohort Study. SETTING: Level 1 Trauma Center, Vancouver, Canada. PARTICIPANTS: Eight hundred seventy patients recruited to 4 prospective studies investigating the outcomes of operatively treated lower extremity fractures. MAIN OUTCOME MEASUREMENTS: Completion of follow-up defined as completion of all outcome measures at all time points up to 12 months following injury. RESULTS: Univariate analysis and subsequent analysis by building a reductive multivariate regression model allowed for estimation of the influence of factors in completion of follow-up.Eight hundred seventy patients with complete data had previously been recruited and were included in the analysis. Seven hundred seven patients (81.2%) completed follow-up to 12 months. Factors associated with completion of follow up included higher physical component score of SF-36 at baseline, not being on social assistance at the time of injury, being married and having a higher level of educational attainment. CONCLUSIONS: Our study has demonstrated several important factors identifiable at baseline which are associated with a failure to complete follow-up. Although these factors are not modifiable themselves, we advocate that researchers designing studies should plan for additional follow-up resources and interventions for at risk patients. LEVEL OF EVIDENCE: Level IV.

Outcome measures in major trauma care: a review of current international trauma registry practice.

Multiple reports over the past 20 years have criticised the care delivered to major trauma patients in England. The setting up of regional trauma networks is well underway to address these deficiencies. Outcomes currently collected in major trauma are restricted to mortality rates and process measures; however, many patients are left with long-term disabilities and reduced quality of life (QoL), which are not measured at present. Trauma systems need to develop outcome measures that capture this important information to judge the quality of care and influence the development of services. This review aimed to identify the current practice of international trauma registries with regard to outcome measurement and review the literature surrounding these measures. An internet-based search of international trauma registry websites including data dictionaries and annual reports was carried out as well as a literature review to determine what outcome measures are routinely collected by trauma registries. All registries were found to look at mortality and process measures, but only one registry routinely collected morbidity outcome measures for both adults and children. There is a considerable amount of disability and reduced QoL in survivors of major trauma that lasts for years following the injury. At present only the Victorian State Trauma Registry collects outcome measures that evaluate the extent of this. English regional trauma networks and the Trauma Audit and Research Network have the opportunity to learn from this experience and routinely start to collect measures of outcome that can drive service improvement and reduce patient morbidity.

Gastroprotection in trauma patients receiving non-steroidal anti-inflammatory drugs.

BACKGROUND: NSAIDs are commonly used analgesic agents in the orthopaedic trauma setting. Evidence-based guidelines recommend that patients with one or more risk factors for NSAID-associated gastrointestinal (GI) ulcer complications should be prescribed gastroprotective agents to minimise the risk of serious ulcer complications, including gastrointestinal haemorrhage. The purpose of the present audit was to evaluate and improve the adherence to these guidelines in new-NSAID users in a trauma unit at a district general hospital. METHODS: A retrospective observational cohort study was conducted over an 18-week period to assess pre-intervention practice. Subsequently, an awareness programme, including prescriber and pharmacist education and the use of reminder posters, was implemented. Following this, data were collected prospectively over 9 weeks to assess any change in performance. Assessment involved review of case-notes and prescription charts of all adults (aged ≥ 18 years) who were commenced on regular NSAIDs on or during admission to the Trauma Unit. Patients were risk-stratified according to the number of risk factors, which were defined as age ≥ 65 years, major comorbidity, oral steroids, anticoagulation, history of upper gastrointestinal ulceration or bleeding and prescription above the normal recommended dose of NSAIDs. The American College of Rheumatology guidelines recommend the use of gastroprotective agents when one or more risk factors was present. Prescription of gastroprotective drugs was recorded to measure adherence to evidence-based guidelines. RESULTS: A total of 644 patients were reviewed over the study period, 451 pre-intervention and 193 post-intervention. 100 patients fulfilled the inclusion criteria pre-intervention and 49 post-intervention. Before intervention, the proportion of high-risk NSAID-receivers co-prescribed gastroprotection was low at 25.3%, although the likelihood of adherence improved with the number of risk factors; overall adherence rate improved significantly following intervention at 73.1% (chi² = 18.8, p < 0.001). Furthermore, a smaller proportion of NSAID-receivers fell into the high-risk category from 75% to 56.5% (chi² = 7.25, p < 0.05). CONCLUSIONS: (1) The majority of trauma admissions are at high risk for developing gastrointestinal haemorrhage. (2) Initial adherence to national guidelines for safe prescription of NSAIDs in our trauma unit was poor (25.3%) but improved significantly (73.1%) following an awareness programme which included education of prescribers and pharmacists. (3) A lower proportion of NSAID-receivers had multiple risk factors following our awareness programme. (4) Awareness of gastroprotection guidelines must be raised in trauma units to prevent undertreatment and hence minimise the risk of GI haemorrhage.