HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

BACKGROUND: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery. METHODS/DESIGN: The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR3617).

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial.

BACKGROUND: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. METHODS/DESIGN: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR2025).

Effect of the Dutch Hip Fracture Audit implementation on mortality, length of hospital stay and time until surgery in elderly hip fracture patients; a multi-center cohort study.

BACKGROUND: In 2040 the estimated number of people with a hip fracture in the Netherlands will be about 24,000. The medical care for this group of patients is complicated and challenging. Multidisciplinary approaches aim to improve clinical outcome. Quality indicators that gain insight in the treatment and outcome of hip fracture patients may help to optimize and monitor the standard of medical care. The Dutch Hip Fracture Audit (DHFA) is a new multidisciplinary quality indicator that is implemented in the Dutch hospitals in 2017. AIM: The aim of this study was to determine the effect of the implementation of the DHFA on 30-day mortality, length of hospital stay and time until surgery in elderly with a hip fracture in the Netherlands. METHODS: A multicenter retrospective comparative cohort study was conducted and data were extracted from the Dutch Nationwide Trauma Registration (LTR). Included were patients aged 60 years and older with a hip fracture (femoral neck and trochanteric) and admitted in one of the ten participating hospitals registered in 2015 and 2017. Data from 2015, before implementation of DHFA, were compared with data from 2017, when the DHFA was implemented. The primary outcome was 30-day mortality; secondary outcomes were length of hospital stay and time until surgery. Multivariable regression models were used to compare outcomes between groups. RESULTS: 3808 patients were included, 1839 in the 2015 cohort and 1969 in the 2017 cohort. 29% was male; mean age 82 years. The multilevel analysis showed a positive non-significant difference between groups on the primary outcome30-day mortality (OR adjusted 1.23, 95%CI 0.93 - 1.63). The secondary outcomes length of hospital stay (adjusted effect estimates -0.002, 95%CI -0.03 - 0.03) and time until surgery (adjusted effect estimates 0.292, 95%CI -2.68 - 3.26) showed no differences between groups. CONCLUSIONS: Implementation of the DHFA quality indicator does have a positive non-significant trend on 30-day mortality, but showed no impact on length of hospital stay and time until surgery. More research on relevant quality indicators seems therefore mandatory.

Epidemiology of injuries, treatment (costs) and outcome in burn patients admitted to a hospital with or without dedicated burn centre (Burn-Pro): protocol for a multicentre prospective observational study.

INTRODUCTION: The Emergency Management of Severe Burns (EMSB) referral criteria have been implemented for optimal triaging of burn patients. Admission to a burn centre is indicated for patients with severe burns or with specific characteristics like older age or comorbidities. Patients not meeting these criteria can also be treated in a hospital without burn centre. Limited information is available about the organisation of care and referral of these patients. The aims of this study are to determine the burn injury characteristics, treatment (costs), quality of life and scar quality of burn patients admitted to a hospital without dedicated burn centre. These data will subsequently be compared with data from patients with<10% total bodysurface area (TBSA) burned who are admitted (or secondarily referred) to a burn centre. If admissions were in agreement with the EMSB, referral criteria will also be determined. METHODS AND ANALYSIS: In this multicentre, prospective, observational study (cohort study), the following two groups of patients will be followed: 1) all patients (no age limit) admitted with burn-related injuries to a hospital without a dedicated burn centre in the Southwest Netherlands or Brabant Trauma Region and 2) all patients (no age limit) with<10% TBSA burned who are primarily admitted (or secondarily referred) to the burn centre of Maasstad Hospital. Data on the burn injury characteristics (primary outcome), EMSB compliance, treatment, treatment costs and outcome will be collected from the patients' medical files. At 3 weeks and at 3, 6 and 12 months after trauma, patients will be asked to complete the quality of life questionnaire (EuroQoL-5D), and the patient-reported part of the Patient and Observer Scar Assessment Scale (POSAS). At those time visits, the coordinating investigator or research assistant will complete the observer-reported part of the POSAS. ETHICS AND DISSEMINATION: This study has been exempted by the medical research ethics committee Erasmus MC (Rotterdam, The Netherlands). Each participant will provide written consent to participate and remain encoded during the study. The results of the study are planned to be published in an international, peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR6565.

Long-term survival after non-small cell lung cancer surgery: development and validation of a prognostic model with a preoperative and postoperative mode.

OBJECTIVE: At present, there is no prognostic model that is specific for prediction of survival after non-small cell lung cancer surgery. We aimed to develop a prognostic model that can be used to estimate the postoperative survival of individual patients. METHODS: A total of 766 patients underwent resection for primary non-small cell lung cancer. Comorbid conditions were scaled according to the Charlson comorbidity index (CCI). Cox proportional hazard analyses were used to determine risk factors for survival. A prognostic model for survival with a preoperative and postoperative mode was established. Performance of the prognostic model, the CCI, and pathologic tumor stage were quantified by a concordance statistic to indicate discriminative ability. RESULTS: The factors associated with an impaired survival were male sex, age, chronic obstructive pulmonary disease, congestive heart failure, any prior tumor, moderate-to-severe renal disease (preoperative and postoperative mode), clinical tumor stage (preoperative mode), type of resection, and pathologic tumor stage (postoperative mode). The discriminative performance was poor for the CCI (c = 0.55), better for pathologic tumor stage (c = 0.60) and for the preoperative mode (c = 0.61), and best for the postoperative mode (c = 0.65). The discriminative performance of the postoperative mode was better than the discriminative performance of the CCI (P < .0001), the preoperative mode (P < .0002), and pathologic tumor stage (P < .0001). The discriminative performance of the preoperative mode was better than the discriminative performance of the CCI (P < .0001) and similar (P = .90) to a model that only included pathologic tumor stage. CONCLUSIONS: The prognostic model, particularly the postoperative mode, successfully estimates long-term survival of individual patients and could help clinicians in clinical decision-making and treatment tailoring.