Refaja Ziekenhuis

BackgroundBiomechanical reduction techniques for shoulder dislocations have demonstrated high reduction success rates with a limited pain experience for the patient. We postulated that the combination of biomechanical reduction techniques with the shortest length of stay would also have the lowest pain experience and the highest first reduction success rate.MethodsA randomized multicenter clinical trial was performed to compare different biomechanical reduction techniques in treating anterior shoulder dislocations without the use of invasive pain relief. Patients who were able to perform adduction of the arm were randomly assigned to Cunningham, the modified Milch, and the scapular manipulation technique. Those who were not able to do so were randomly assigned to modified Milch and the scapular manipulation technique. Primary outcomes were emergency department length of stay and pain experienced during the reduction process, measured by the numeric pain rating scale. Secondary outcomes were reduction time, reduction success, use of analgesics or sedatives, and complications.ResultsThree hundred eight patients were included, of whom 134 were in the adduction group. In both groups, no differences in emergency department length of stay and experienced pain were observed between the treatment arms. In the adduction group, the modified Milch technique had the highest first reduction success rates 52% (p = 0.016), within protocol 61% (p = 0.94), and with sedation in the ED 100% ( −). In the no-adduction group, the modified Milch was also the most successful primary reduction technique with 51% success (p = 0.040), within protocol 66% (p = 0.90), and with sedation in the ED 98% (p = 0.93). No complications were recorded in any of the techniques.ConclusionA combination of biomechanical techniques resulted in a similar length of stay in the emergency department and showed similar pain scores with an overall high success rate of reduction. In both groups, the modified Milch had the highest first-reduction success rate.Trial registrationNetherlands Trial Register NTR5839—1 April 2016. Ethical committee Noord-Holland with the CCMO-number NL54173.094.15

The aim of this study was to investigate the effect of treat-to-target combination therapy with intensification at 13 weeks in early RA. Early RA patients were classified as being at high or low risk of worsening RA based on disease activity and prognostic factors. High-risk patients received COBRA-light (prednisolone 30 mg/day tapered to 7.5 mg/day, MTX increasing to 25 mg/week), and low-risk patients received MTX monotherapy increasing to 25 mg/week. The primary outcome (target) was DAS44 < 1.6 or EULAR good response at 26 weeks. At 13 weeks, non-responders were randomized to (open-label) intensification [high-risk patients: prednisolone 60 mg/day tapered to 7.5 mg/day, addition of SSZ (2 g/day) and HCQ (400 mg/day); low-risk patients: prednisolone 30 mg/day tapered to 7.5 mg/day] or continuation. In the high-risk group (n = 150), 110 patients (73%) reached the target at 13 weeks, and 9 dropped out. Non-responders were randomized to intensification (n = 15) or continuation (n = 16), and after 26 weeks, 12 (80%) vs 7 (44%) of these, respectively, reached the target [difference: 36%, (95% CI 2%, 71%); P = 0.04]. In the low-risk group (n = 40), 17 (43%) reached the target. Non-responders were randomized to intensification (n = 8) or continuation (n = 7); 4 vs 3, respectively, reached the target.Adverse event rates were higher in the high-risk group, and higher in the intensification subgroup of that group. Serious adverse events were rare. Protocol violations were frequent and mostly led to mitigation of actual treatment intensification. Initial combination therapy was very successful in high-risk RA, and early intensification was beneficial in patients not reaching the strict target. The low-risk group was too small for drawing conclusions. In routine practice, adherence to early intensification based on strict targets is difficult. Netherlands Trial Register (NTR), NL4393, https://www.trialregister.nl/.

Decision-making on management of proximal femoral fractures in frail patients with limited life expectancy is challenging, but surgical overtreatment needs to be prevented. Current literature provides limited insight into the true outcomes of nonoperative management and operative management in this patient population. To investigate the outcomes of nonoperative management vs operative management of proximal femoral fractures in institutionalized frail older patients with limited life expectancy. This multicenter cohort study was conducted between September 1, 2018, and April 25, 2020, with a 6-month follow-up period at 25 hospitals across the Netherlands. Eligible patients were aged 70 years or older, frail, and institutionalized and sustained a femoral neck or pertrochanteric fracture. The term frail implied at least 1 of the following characteristics was present: malnutrition (body mass index [calculated as weight in kilograms divided by height in meters squared] <18.5) or cachexia, severe comorbidities (American Society of Anesthesiologists physical status class of IV or V), or severe mobility issues (Functional Ambulation Category ≤2). Shared decision-making (SDM) followed by nonoperative or operative fracture management. The primary outcome was the EuroQol 5 Dimension 5 Level (EQ-5D) utility score by proxies and caregivers. Secondary outcome measures were QUALIDEM (a dementia-specific quality-of-life instrument for persons with dementia in residential settings) scores, pain level (assessed by the Pain Assessment Checklist for Seniors With Limited Ability to Communicate), adverse events (Clavien-Dindo classification), mortality, treatment satisfaction (numeric rating scale), and quality of dying (Quality of Dying and Death Questionnaire). Of the 172 enrolled patients with proximal femoral fractures (median [25th and 75th percentile] age, 88 [85-92] years; 135 women [78%]), 88 opted for nonoperative management and 84 opted for operative management. The EQ-5D utility scores by proxies and caregivers in the nonoperative management group remained within the set 0.15 noninferiority limit of the operative management group (week 1: 0.17 [95% CI, 0.13-0.29] vs 0.26 [95% CI, 0.11-0.23]; week 2: 0.19 [95% CI, 0.10-0.27] vs 0.28 [95% CI, 0.22-0.35]; and week 4: 0.24 [95% CI, 0.15-0.33] vs 0.34 [95% CI, 0.28-0.41]). Adverse events were less frequent in the nonoperative management group vs the operative management group (67 vs 167). The 30-day mortality rate was 83% (n = 73) in the nonoperative management group and 25% (n = 21) in the operative management group, with 26 proxies and caregivers (51%) in the nonoperative management group rating the quality of dying as good-almost perfect. Treatment satisfaction was high in both groups, with a median numeric rating scale score of 8. Results of this study indicated that nonoperative management of proximal femoral fractures (selected through an SDM process) was a viable option for frail institutionalized patients with limited life expectancy, suggesting that surgery should not be a foregone conclusion for this patient population.