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

Treatment outcomes for children with multidrug-resistant tuberculosis: a systematic review and meta-analysis

BACKGROUND: Paediatric multidrug-resistant (MDR) tuberculosis is a public health challenge of growing concern, accounting for an estimated 15% of all global cases of MDR tuberculosis. Clinical management is especially challenging, and recommendations are based on restricted evidence. We aimed to assess existing evidence for the treatment of MDR tuberculosis in children. METHODS: We did a systematic review and meta-analysis of published and unpublished studies reporting treatment outcomes for children with MDR tuberculosis. We searched PubMed, Ovid, Embase, Cochrane Library, PsychINFO, and BioMedCentral databases up to Oct 31, 2011. Eligible studies included five or more children (aged ≤16 years) with MDR tuberculosis within a defined treatment cohort. The primary outcome was treatment success, defined as a composite of cure and treatment completion. RESULTS: We identified eight studies, which reported treatment outcomes for a total of 315 patients. We recorded much variation in the characteristics of patients and programmes. Time to appropriate treatment varied from 2 days to 46 months. Average duration of treatment ranged from 6 months to 34 months, and duration of follow-up ranged from 12 months to 37 months. The pooled estimate for treatment success was 81·67% (95% CI 72·54-90·80). Across all studies, 5·9% (95% CI 1·3-10·5) died, 6·2% (2·3-10·2) defaulted, and 39·1% (28·7-49·4) had an adverse event. The most common drug-related adverse events were nausea and vomiting. Other serious adverse events were hearing loss, psychiatric effects, and hypothyroidism. INTERPRETATION: The treatment of paediatric MDR tuberculosis has been neglected, but when children are treated outcomes can be achieved that are at least as good as those reported for adults. Programmes should be encouraged to report outcomes in children to improve the knowledge base for care, especially as new drugs become available. FUNDING: None

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

Evaluation of POSSUM for Patients Undergoing Pancreatoduodenectomy

Comparison of operative morbidity rates after pancreatoduodenectomy between units may be misleading because it does not take into account the physiological variable of the condition of the patients. The aim of the present study was to evaluate the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) for pancreatoduodenectomy patients and to look for risk factors associated with morbidity in a high-volume center. Between January 1993 and April 2006, 652 patients underwent a pancreatoduodenectomy, 502 of them for malignant disease. POSSUM performance was evaluated by assessing the "goodness-of-fit" with the linear analysis method. Overall, 332 of the 652 patients (50.9%) had one or more complication after pancreatoduodenectomy, and 9 patients (1.4%) died. POSSUM had a significant lack of fit using goodness-of-fit analysis. In multivariate analysis, one statistically significant factor associated with morbidity and not incorporated in POSSUM (P < 0.05) was identified: ampulla of Vater adenocarcinoma (OR = 1.73, 95% CI: 1.07-2.80). Overall, there is a lack of calibration of POSSUM among patients who undergo pancreatoduodenectom

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

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

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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