Rules of Evidence and Clinical Recommendations on the Use of Antithrombotic Agents

To analyse literature data on vaccine related induction, worsening of the disease and disease reccurrences as well as vaccine safety and efficacy among pediatric patients with acquired inflammatory immune-mediated neuromuscular disorders (NMD).

Medline, Pub Med and Scopus database search from 1975 to 2020 focused on pediatric age was conducted including peer reviews, meta analyses and epidemiological studies on vaccination and Guillain-Barré syndrome (GBS), Bell's palsy, optic neuritis (ON), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and immune-mediated inflammatory myopathy (IM).

s: There are no strong evidence supporting relationship between vaccination with different pediatric vaccines and development of first episodes or reccurrences of GBS, Bell's palsy, optic neuritis (ON), juvenile MG, CIDP, and IM. The vaccination and revaccination with inactivated vaccines is considered safe in children with medical history of GBS, Bell's palsy, ON, MG and IM. Caution when immunization against influenza, quadrivalent conjugated meningococcal vaccine (MCV4) and pneumococcal disease and avoiding tetanus toxoid immunization in CIDP patients is suggested. Patients with immune mediated acquired NMD should be vaccinated with live vaccines before the initiation of immunosupressive treatment. Immunosuppressed patients with low protective antibody titers should be considered for revaccination.

Once a core outcome set (COS) has been defined, it is important to achieve consensus on how these outcomes should be measured. The aims of this systematic review were to gain insight into the methods used to select outcome measurement instruments and to determine whether methods have improved following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)/Core Outcome Measures in Effectiveness Trials (COMET) guideline publication.

Eligible articles, which were identified from the annual COMET systematic review, concerned any COS development studies that provided a recommendation on how to measure the outcomes included in the COS. Data were extracted on the methods used to select outcome measurement instruments in accordance with the COSMIN/COMET guideline.

Of the 118 studies included in the review, 48% used more than one source of information when finding outcome measurement instruments, and 74% performed some form of quality assessment of the measurement instruments. Twenty-three studies recommended one single instrument for each core outcome included in the COS. Clinical experts and public representatives were involved in selecting instruments in 62% and 28% of studies, respectively.

Methods used to select outcome measurement instruments have improved since the publication of the COSMIN/COMET guideline. Going forward, COS developers should ensure that recommended outcome measurement instruments have sufficient content validity. In addition, COS developers should recommend one instrument for each core outcome to contribute to the overarching goal of uniformity in outcome reporting.

The optimal timing for treatment of ruptured brain arteriovenous malformation (BAVM) is still controversial. The present study aims to determine safety of subacute BAVM management in clinically stable patients by identifying the rate of rebleeding.

Patients presenting from 2000 to 2018 with ruptured BAVM who were scheduled for BAVM treatment at least 4 weeks after initial hemorrhage were included in the present study. After neurological rehabilitation of the patient and decreased hemorrhage-induced brain swelling, subacute treatment for the ruptured BAVM was carried out. Primary outcome of the present series was defined as treatment failure resulting from rehemorrhage caused by the ruptured BAVM in patients previously labeled eligible for subacute BAVM treatment. Additionally, we performed a systematic review of the contemporary peer-reviewed literature concerning treatment strategy in patients with ruptured BAVM.

Fifty-five patients suffering from ruptured BAVM were considered eligible for subacute BAVM treatment at our institution. No patient suffered from early rebleeding before definitive BAVM treatment in our institutional group. Our own patient data were then pooled with data from the literature, resulting in 166 patients suffering from ruptured BAVM who underwent subacute BAVM treatment. Of these, 1 patient (0.6%) suffered from rehemorrhage during the recovery period 130 days after initial BAVM rupture.

The present series and systematic review revealed a rehemorrhage rate of 0.6% in patients suffering from ruptured BAVM who underwent subacute treatment. Therefore, subacute treatment of patients with ruptured BAVM seems safe after application of rigorous treatment algorithms to sort out patients with higher risk for rehemorrhage.

Research articles serve not just to inform but also to convince. Consequently, authors may be inclined to employ language to ‘sell’ aspects of their study. Such language may undermine objective and disinterested interpretation and bias readers’ evaluation of new knowledge. Randomized Controlled Trials (RCTs) are a type of study that aims to minimise bias when testing treatments and, in medicine, RCTs are generally regarded as the ‘gold standard’. This study provides quantitative and qualitative descriptions of how authors of RCTs use hyperbolic and/or subjective language to glamorise, promote and/or exaggerate aspects of their research – a phenomenon we refer to as ‘hype’. From a corpus of twenty-four RCTs in orthopaedic medicine we identified 161 hypes which we categorised for functional target and linguistic realization. Hypes in RCTs are most prevalent in Discussion sections and most frequently serve to aggrandize the methodology and sell the paper. Findings are discussed in relation to competition, pressure to publish, and the influence of standardised guidelines. Implications for the producers and consumers of the medical literature are considered.

Partially thrombosed intracranial aneurysms (PTIAs) represent a challenging subgroup of aneurysms, with an organized intraluminal thrombus and a solid mass, in which the optimal therapeutic strategy is discussed controversially because of limited data. We therefore analyzed the results of surgical and endovascular treatment in patients with PTIAs treated in our department and combined the results with a systematic literature review.

Between January 2006 and October 2016, data from 996 patients with intracranial aneurysms were prospectively entered into a database. Twenty-five consecutive patients harbored PTIAs and were treated in the authors' institution. The degree of aneurysm occlusion, the degree of recurrence, and the necessity of aneurysm retreatment were assessed and analyzed. PubMed was searched for published studies of PTIAs to gain a larger population. Multivariate regression models were performed on the pooled data.

Literature data, including the present series, revealed a total of 157 patients. Overall, 64 patients (41%) were treated by clipping, and 93 patients (59%) were treated by endovascular treatment. In the multivariate analysis, surgical treatment of PTIAs was an independent predictor for complete aneurysm occlusion (P < 0.001). In a second multivariate model, endovascular treatment was independently associated with aneurysm recurrence (P < 0.001). In a third multivariate model, endovascular treatment was associated with a higher rate of retreatment (P < 0.001).

In this study, surgical treatment of PTIAs showed superior initial radiologic results and better long-term stability than endovascular treatment. Therefore, surgical treatment should be considered in those patients harboring PTIAs who are qualified as suitable surgical candidates after interdisciplinary consensus.

In patients with systemic lupus erythematosus (SLE), persistent joint activity and treatment with glucocorticoids are associated with musculoskeletal complications. About 30% of these patients become candidates for surgical treatment. The aim of this study was to evaluate postoperative outcomes after total hip arthroplasty (THA) in SLE patients.

We performed a retrospective cohort study at a tertiary care center in Mexico City between 1995 and 2013. All patients with SLE who underwent THA during that period were included (n = 58). They were compared with 2 control groups, one from another inflammatory arthropathy (rheumatoid arthritis, n = 58) and other noninflammatory (osteoarthritis, n = 58), matched by gender and date of surgery. The primary outcome was the frequency of postoperative complications during follow-up.

We included 174 patients who underwent THA during the study period. Patients with SLE were younger (P < .0001), had a longer hospitalization stay (P = .001), and required more transfusions (P = .004). Global complications in THA in patients with SLE were more prevalent than rheumatoid arthritis (36.2% vs 15.5%, P = .029) and osteoarthritis (36.2% vs 5.1%, P < .0001) patients. After multivariate analysis, risk factors for THA complications were: SLE (hazard ratio 2.8, 95% confidence interval 1.2-6.8; P = .018) and low postoperative hemoglobin (hazard ratio 0.77, 95% confidence interval 0.73-0.83; P < .0001). Long-term complications after THA were similar among groups.

This is the largest single-center study regarding clinical outcomes after THA in SLE patients. Our data suggest that SLE is an independent risk factor for adverse postoperative outcomes, mainly immediate complications, but the long-term outcome is good enough to offer surgical treatment that will improve quality of life.