De conventionele RCT voor trauma- en orthopedisch chirurgen: geen heilige graal

Abstract: Conventionele RCT’s voor trauma- en orthopaedisch chirurgisch onderzoek zijn moeilijk uitvoerbaar door chirurg- en patiënt gerelateerde redenen. Grote regionale cohortstudies en (quasi-) experimentele designs met vooraf gedefinieerde uitkomst parameters en een fulltime onderzoeker bieden een oplossing. De conventionele RCT kan dan worden ingezet voor specifiek gedefinieerde problemen die voortkomen uit de resultaten van deze studies

Natural Experiments as a Study Method in Spinal Trauma Surgery:A Systematic Review

Study Design: Systematic review. Objectives: To determine if the natural experiment design is a useful research methodology concept in spinal trauma care, and to determine if this methodology can be a viable alternative when randomized controlled trials are either infeasible or unethical. Methods: A Medline, Embase and Cochrane database search was performed between 2004 and 2023 for studies comparing different treatment modalities of spinal trauma. All observational studies with a natural experiment design comparing different treatment modalities of spinal trauma were included. Data extraction and quality assessment with the MINORS criteria was performed. Results: Four studies with a natural experiment design regarding patients with traumatic spinal fractures were included. All studies were retrospective, one study collected follow-up data prospectively. Three studies compared different operative treatment modalities, whereas one study compared different antibiotic treatment strategies. Two studies compared preferred treatment modalities between expertise centers, one study between departments (neuro- and orthopedic surgery) and one amongst surgeons. For the included retrospective studies, MINORS scores (maximum score 18) were high ranging from 12-17 and with a mean (SD) of 14.6 (1.63). Conclusions: Since 2004 only four studies using a natural experiment design have been conducted in spinal trauma. In the included studies, comparability of patient groups was high emphasizing the potential of natural experiments in spinal trauma research. Natural experiments design should be considered more frequently in future research in spinal trauma as they may help to address difficult clinical problems when RCT’s are infeasible or unethical.</p

Natural Experiments as a Study Method in Spinal Trauma Surgery:A Systematic Review

Study Design: Systematic review. Objectives: To determine if the natural experiment design is a useful research methodology concept in spinal trauma care, and to determine if this methodology can be a viable alternative when randomized controlled trials are either infeasible or unethical. Methods: A Medline, Embase and Cochrane database search was performed between 2004 and 2023 for studies comparing different treatment modalities of spinal trauma. All observational studies with a natural experiment design comparing different treatment modalities of spinal trauma were included. Data extraction and quality assessment with the MINORS criteria was performed. Results: Four studies with a natural experiment design regarding patients with traumatic spinal fractures were included. All studies were retrospective, one study collected follow-up data prospectively. Three studies compared different operative treatment modalities, whereas one study compared different antibiotic treatment strategies. Two studies compared preferred treatment modalities between expertise centers, one study between departments (neuro- and orthopedic surgery) and one amongst surgeons. For the included retrospective studies, MINORS scores (maximum score 18) were high ranging from 12-17 and with a mean (SD) of 14.6 (1.63). Conclusions: Since 2004 only four studies using a natural experiment design have been conducted in spinal trauma. In the included studies, comparability of patient groups was high emphasizing the potential of natural experiments in spinal trauma research. Natural experiments design should be considered more frequently in future research in spinal trauma as they may help to address difficult clinical problems when RCT’s are infeasible or unethical.</p

Complications after plate fixation and elastic stable intramedullary nailing of dislocated midshaft clavicle fractures: a retrospective comparison

PURPOSE: The incidence of operative treatment of dislocated midshaft clavicle fractures (DMCF) is rising due to unsatisfactory results after non-operative treatment. Knowledge of complications is important for selection of the surgical technique and preoperative patient counselling. The aim of this study is to compare complications after plate fixation and elastic stable intramedullary nailing (ESIN) with a titanium elastic nail (TEN) for DMCF. METHODS: A retrospective analysis of our surgical database was performed. From January 2005 to January 2010, 90 patients with DMCF were treated with plate fixation or ESIN. Complications were evaluated in both treatment groups and subsequently compared. RESULTS: Seven implant failures occurred in six patients (14 %) of the plate group and one implant failure (2.1 %) was seen in the ESIN group (p = 0.051). Major revision surgery was performed in five cases in the plate group (11.6 %) and in one case (2.1 %) in the ESIN group (p = 0.100). Three refractures (7.0 %) were observed in the plate group after removal of the implant against none in the ESIN group (p = 0.105). Six minor revisions (13 %) were reported in the ESIN group and none were reported in the plate group (p = 0.027). CONCLUSIONS: Compared to other studies we report higher rates of refracture (7.0 %), major revision surgery (11.6 %) and implant failure (14.0 %) after plate fixation. The frequency of implant failures differed almost significantly for patients treated with plate fixation compared to ESIN. Furthermore, a tendency towards refracture after implant removal and major revision surgery after plate fixation was observed

When to perform urodynamics before mid-urethral sling surgery for female stress urinary incontinence?

INTRODUCTION AND HYPOTHESIS: Development of a model that can predict in which group of women pre-operative urodynamics can be safely omitted. METHODS: Three hundred and eighty-one uncomplicated women who underwent pre-operative urodynamics were evaluated. A multivariate logistic regression model was developed based on medical history and physical examination predicting a high probability group of women with detrusor overactivity or a low (<20 cm H2O) mean urethral closure pressure and, therefore, are likely to benefit from urodynamics. RESULTS: Women are likely to benefit from pre-operative urodynamics if they (1) are 53 years of age or older or (2) have a history of prior incontinence surgery and are at least 29 years of age or (3) have nocturia complaints and are at least 36 years of age. CONCLUSION: If urogynaecologists omitted pre-operative urodynamics in women in the low probability group, in our population, pre-operative urodynamics would be reduced by 29

Perspectives by patients and physicians on outcomes of mid-urethral sling surgery

Introduction and hypothesis: The aim of this study is to determine patient expectations regarding wanted and unwanted sequels of mid-urethral sling (MUS) procedures and to identify mismatches during the physician-patient information exchange prior to MUS procedures. Methods: A patient preference study (40 patients) and a questionnaire study with 20 experts as control group were conducted. Seventeen different sequels, defined by an expert team, were evaluated. Results: Both patients and expert physicians ranked cure and improvement of stress urinary incontinence as the most important goals of treatment. De novo urge urinary incontinence, requiring post-operative intermittent self-catheterisation and dyspareunia were considered to be the most important complications by patients. Time to resume work after the operation and dyspareunia were among the highest rated sequels in the patient group compared to re-operation and intra-operative complications in the expert group. Conclusions: No differences were found in the five most important outcome parameters. In pre-operative counselling and future clinical trials, time to resume work and dyspareunia should be given more consideration by clinicians

High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures

Background: Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce. Questions/purposes: We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year? Methods: Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30–51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The Qui

Clinical outcomes and end-of-life treatment in 596 patients with isolated traumatic brain injury:a retrospective comparison of two Dutch level-I trauma centers

Purpose: With an increasingly older population and rise in incidence of traumatic brain injury (TBI), end-of-life decisions have become frequent. This study investigated the rate of withdrawal of life sustaining treatment (WLST) and compared treatment outcomes in patients with isolated TBI in two Dutch level-I trauma centers. Methods: From 2011 to 2016, a retrospective cohort study of patients aged ≥ 18 years with isolated moderate-to-severe TBI (Abbreviated Injury Scale (AIS) head ≥ 3) was conducted at the University Medical Center Rotterdam (UMC-R) and the University Medical Center Utrecht (UMC-U). Demographics, radiologic injury characteristics, clinical outcomes, and functional outcomes at 3–6 months post-discharge were collected. Results: The study population included 596 patients (UMC-R: n = 326; UMC-U: n = 270). There were no statistical differences in age, gender, mechanism of injury, and radiologic parameters between both institutes. UMC-R patients had a higher AIShead (UMC-R: 5 [4–5] vs. UMC-U: 4 [4–5], p &lt; 0.001). There was no difference in the prehospital Glasgow Coma Scale (GCS). However, UMC-R patients had lower GCSs in the Emergency Department and used more prehospital sedation. Total in-hospital mortality was 29% (n = 170), of which 71% (n = 123) occurred after WLST. Two percent (n = 10) remained in unresponsive wakefulness syndrome (UWS) state during follow-up. Discussion: This study demonstrated a high WLST rate among deceased patients with isolated TBI. Demographics and outcomes were similar for both centers even though AIShead was significantly higher in UMC-R patients. Possibly, prehospital sedation might have influenced AIS coding. Few patients persisted in UWS. Further research is needed on WLST patients in a broader spectrum of ethics, culture, and complex medical profiles, as it is a growing practice in modern critical care. Level of evidence: Level III, retrospective cohort study.</p

Operative treatment of dislocated midshaft clavicular fractures: Plate or intramedullary nail fixation?: A randomized controlled trial

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