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for the Improving Evidence-Based Treatment Gaps and Outcomes in Community-Acquired Pneumonia (IMPROVE-GAP) Implementation Team at Western Health IMPORTANCE Community-acquired pneumonia remains a leading cause of hospitalization, mortality, and health care costs worldwide. Randomized clinical trials support the use of adjunctive corticosteroids, early progressive mobilization, antibiotic switching rules, and dietary interventions in improving outcomes. However, it is uncertain whether implementing these interventions will translate into effectiveness under routine health care conditions. OBJECTIVE To evaluate the effectiveness of a bundle of evidence-supported treatments under conditions of routine care in a representative population hospitalized for community-acquired pneumonia. DESIGN, SETTING, AND PARTICIPANTSA double-blind, stepped-wedge, cluster-randomized clinical trial with 90-day follow-up was conducted between August 1, 2016, and October 29, 2017, in the general internal medicine service at 2 tertiary hospitals in Melbourne, Australia, among a consecutive sample of patients with community-acquired pneumonia. The primary analysis and preparation of results took place between May 14 and November 25, 2018.INTERVENTIONS Treating clinical teams were advised to prescribe prednisolone acetate, 50 mg/d, for 7 days (in the absence of any contraindication) and de-escalate from parenteral to oral antibiotics according to standardized criteria. Algorithm-guided early mobilization and malnutrition screening and treatment were also implemented. MAIN OUTCOMES AND MEASURESHospital length of stay, mortality, readmission, and intervention-associated adverse events (eg, gastrointestinal bleeding and hyperglycemia).RESULTS A total of 917 patients were screened, and 816 (351 women and 465 men; mean [SD] age, 76 [13] years) were included in the intention-to-treat analysis, with 401 patients receiving the intervention and 415 patients in the control group. An unadjusted geometric mean ratio of 0.95 (95% CI, 0.78-1.16) was observed for the difference in length of stay (days) between the intervention and control groups. Similarly, no significant differences were observed for the secondary outcomes of mortality and readmission, and the results remained unchanged after further adjustment for sex and age. The study reported higher proportions of gastrointestinal bleeding in the intervention group (9 [2.2%]) compared with the controls (3 [0.7%]), with an unadjusted estimated difference in mean proportions of 0.008 (95% CI, 0.005-0.010). CONCLUSIONS AND RELEVANCEThis bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding. Efficacy of individual interventions demonstrated in clinical trials may not necessarily translate into effectiveness when implemented in combination and may even result in net harm.TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02835040

Background: We conducted a cohort study of adult patients presenting for orthopaedic trauma surgery at a statewide trauma centre, with the aims of determining (i) the incidence and risk factors for severe acute pain in the PACU, and (ii) the incidence and risk factors for persistent post-surgical pain at 3 months. Methods: Data were collected before operation, in the PACU, 72 h after surgery and 3 months after surgery, and included numerical rating scale (NRS) scores for pain, and modified Brief Pain Inventory-Short Form, Kessler Psychological Distress Scale, World Health Organization Disability Assessment Schedule, and Pain Catastrophizing Scale scores. Results: Severe acute pain in the PACU was reported by 171 (56%; 95% confidence interval [CI]: 51%, 62%) of the 303 included patients. Female sex (odds ratio [OR]: 1.86; 95% CI: 1.06, 3.26) and prior post-injury surgery (OR: 2.21; 95% CI: 1.11, 4.41) remained associated with severe acute pain after multivariable adjustment. Persistent post-surgical pain at 3 months was reported by 149 (65%; 95% CI: 59%, 71%) of the 229 included patients. The preoperative NRS score (OR: 1.17; 95% CI: 1.03, 1.32) remained associated with persistent pain after multivariable adjustment. Conclusions: We identified three easy-to-measure risk factors: female sex, prior post-injury surgery for severe acute pain, and preoperative NRS scores for persistent pain. Further research is required to identify pain management strategies and psychosocial interventions to reduce the burden of pain, disability, and distress in these patients.

BackgroundMissing data is a common problem in epidemiological studies, and is particularly prominent in longitudinal data, which involve multiple waves of data collection. Traditional multiple imputation (MI) methods (fully conditional specification (FCS) and multivariate normal imputation (MVNI)) treat repeated measurements of the same time-dependent variable as just another ‘distinct’ variable for imputation and therefore do not make the most of the longitudinal structure of the data. Only a few studies have explored extensions to the standard approaches to account for the temporal structure of longitudinal data. One suggestion is the two-fold fully conditional specification (two-fold FCS) algorithm, which restricts the imputation of a time-dependent variable to time blocks where the imputation model includes measurements taken at the specified and adjacent times. To date, no study has investigated the performance of two-fold FCS and standard MI methods for handling missing data in a time-varying covariate with a non-linear trajectory over time – a commonly encountered scenario in epidemiological studies.MethodsWe simulated 1000 datasets of 5000 individuals based on the Longitudinal Study of Australian Children (LSAC). Three missing data mechanisms: missing completely at random (MCAR), and a weak and a strong missing at random (MAR) scenarios were used to impose missingness on body mass index (BMI) for age z-scores; a continuous time-varying exposure variable with a non-linear trajectory over time. We evaluated the performance of FCS, MVNI, and two-fold FCS for handling up to 50% of missing data when assessing the association between childhood obesity and sleep problems.ResultsThe standard two-fold FCS produced slightly more biased and less precise estimates than FCS and MVNI. We observed slight improvements in bias and precision when using a time window width of two for the two-fold FCS algorithm compared to the standard width of one.ConclusionWe recommend the use of FCS or MVNI in a similar longitudinal setting, and when encountering convergence issues due to a large number of time points or variables with missing values, the two-fold FCS with exploration of a suitable time window.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-017-0372-y) contains supplementary material, which is available to authorized users.