Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study.

INTRODUCTION: Mental illness is a leading cause of non-fatal disease burden worldwide. Natural health products (NHPs) are sought by patients with mental health conditions as a safer and more 'natural' option than conventional pharmacotherapy; however, the possible adverse events (AE) and interactions between NHPs and prescription medicines are not fully known. OBJECTIVES: The aim of this study was to determine (i) the prevalence of adult patients with mental health conditions taking prescription medications only, NHPs only, NHPs and prescription medications concurrently, or neither, (ii) which prescription medications and NHPs are most commonly used, (iii) AEs (serious and non-serious) experienced in the last 30 days for each product use group. METHODS: Mental health clinics in Alberta and Ontario, Canada, were included in an active surveillance study investigating NHP-drug interactions. On their first clinic visit, adult mental health patients were provided with a form inquiring about prescription drug use, NHP use, and any undesirable health events experienced in the last month. Healthcare professionals were also asked to report AEs. RESULTS: A total of 3079 patients were screened at 11 mental health clinics in Alberta and Ontario. In total, 620 AEs were reported in 447 patients (14.9%). The majority of adverse events were seen in patients using both NHPs and prescription medicines (58.8%), followed by patients taking only prescription medicines (37.1%), NHPs only (3.4%) and neither (0.67%). Combining NHPs and prescription medications increases the likelihood of experiencing AEs (OR 2.1; p < 0.001; 95% CI 1.7-2.6). CONCLUSIONS: Adult patients with mental health conditions who are taking both prescription medications and NHPs are more likely to report an adverse event than patients taking prescription drugs or NHPs alone. Polypharmacy increases the likelihood of an adverse event. Active surveillance is feasible and could contribute to enhanced pharmacovigilance.

Massage therapy for paediatric procedural pain: A rapid review.

BACKGROUND: Pain is a common paediatric problem, and procedural pain, in particular, can be difficult to manage. Complementary therapies are often sought for pain management, including massage therapy (MT). We assessed the evidence for use of MT for acute procedural pain management in children. METHODS: We searched five main databases for (i) primary studies in English, (ii) included children 0 to 18 years of age, (iii) compared MT for procedural pain management to standard care alone or placebo, and (iv) measured pain as the primary or secondary outcome. The data were extracted by one author and verified by a second author. Randomized controlled trials were evaluated using the Cochrane Risk of Bias tool. RESULTS: Eleven paediatric trials of procedural pain in neonatal, burn, and oncology populations, a total of 771 participants, were identified. Eight reported statistically significant reductions in pain after MT compared to standard care. Pain was measured using validated pain scales, or physiologic indicators. The studies were heterogeneous in population, techniques, and outcome measures used. No adverse events associated with MT were identified. CONCLUSION: MT may be an effective nonpharmacologic adjunct for management of procedural pain in children.

Unfractionated heparin versus low molecular weight heparins for avoiding heparin-induced thrombocytopenia in postoperative patients.

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction presenting as a prothrombotic disorder related to antibody-mediated platelet activation. It is a paradoxical immune reaction resulting in thrombin generation in vivo, which leads to a hypercoagulable state and the potential to initiate venous or arterial thrombosis. A number of factors are thought to influence the incidence of HIT including the type and preparation of heparin (unfractionated heparin (UFH) or low molecular weight heparin (LMWH)) and the heparin-exposed patient population, with the postoperative patient population at higher risk.Although LMWH has largely replaced UFH as a front-line therapy, there is evidence supporting a lack of superiority of LMWH compared with UFH regarding prevention of deep vein thrombosis and pulmonary embolism following surgery, and similar frequencies of bleeding have been described with LMWH and UFH. The decision as to which of these two preparations of heparin to use may thus be influenced by harmful effects such as HIT. We therefore sought to determine the relative impact of UFH and LMWH on HIT in postoperative patients receiving thromboembolism prophylaxis. This is an update of a review first published in 2012. OBJECTIVES: The objective of this review was to compare the incidence of heparin-induced thrombocytopenia (HIT) and HIT complicated by venous thromboembolism in postoperative patients exposed to unfractionated heparin (UFH) versus low molecular weight heparin (LMWH). SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Specialised Register (May 2016), CENTRAL (2016, Issue 4) and trials registries. The authors searched Lilacs (June 2016) and additional trials were sought from reference lists of relevant publications. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which participants were postoperative patients allocated to receive prophylaxis with UFH or LMWH, in a blinded or unblinded fashion. Studies were excluded if they did not use the accepted definition of HIT. This was defined as a relative reduction in the platelet count of 50% or greater from the postoperative peak (even if the platelet count at its lowest remained greater than 150 x 109/L) occurring within five to 14 days after the surgery, with or without a thrombotic event occurring in this timeframe. Additionally, we required circulating antibodies associated with the syndrome to have been investigated through laboratory assays. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Disagreements were resolved by consensus with participation of a third author. MAIN RESULTS: In this update, we included three trials involving 1398 postoperative participants. Participants were submitted to general surgical procedures, minor and major, and the minimum mean age was 49 years. Pooled analysis showed a significant reduction in the risk of HIT with LMWH compared with UFH (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.07 to 0.73); low-quality evidence. The number needed to treat for an additional beneficial outcome (NNTB) was 59. The risk of HIT was consistently reduced comparing participants undergoing major surgical procedures exposed to LMWH or UFH (RR 0.22, 95% CI 0.06 to 0.75); low-quality evidence. The occurrence of HIT complicated by venous thromboembolism was significantly lower in participants receiving LMWH compared with UFH (RR 0.22, 95% CI 0.06 to 0.84); low-quality evidence. The NNTB was 75. Arterial thrombosis occurred in only one participant who received UFH. There were no amputations or deaths documented. Although limited evidence is available, it appears that HIT induced by both types of heparins is common in people undergoing major surgical procedures (incidence greater than 1% and less than 10%). AUTHORS' CONCLUSIONS: This updated review demonstrated low-quality evidence of a lower incidence of HIT, and HIT complicated by venous thromboembolism, in postoperative patients undergoing thromboprophylaxis with LMWH compared with UFH. Similarily, the risk of HIT in people undergoing major surgical procedures was lower when treated with LMWH compared to UFH (low-quality evidence). The quality of the evidence was downgraded due to concerns about the risk of bias in the included studies and imprecision of the study results. These findings may support current clinical use of LMWH over UFH as front-line heparin therapy. However, our conclusions are limited and there was an unexpected paucity of RCTs including HIT as an outcome. To address the scarcity of clinically-relevant information on HIT, HIT must be included as a core harmful outcome in future RCTs of heparin.

Quality of reporting in systematic reviews of adverse events: systematic review.

OBJECTIVES: To examine the quality of reporting of harms in systematic reviews, and to determine the need for a reporting guideline specific for reviews of harms. DESIGN: Systematic review. DATA SOURCES: Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE). REVIEW METHODS: Databases were searched for systematic reviews having an adverse event as the main outcome, published from January 2008 to April 2011. Adverse events included an adverse reaction, harms, or complications associated with any healthcare intervention. Articles with a primary aim to investigate the complete safety profile of an intervention were also included. We developed a list of 37 items to measure the quality of reporting on harms in each review; data were collected as dichotomous outcomes ("yes" or "no" for each item). RESULTS: Of 4644 reviews identified, 309 were systematic reviews or meta-analyses primarily assessing harms (13 from CDSR; 296 from DARE). Despite a short time interval, the comparison between the years of 2008 and 2010-11 showed no difference on the quality of reporting over time (P=0.079). Titles in fewer than half the reviews (proportion of reviews 0.46 (95% confidence interval 0.40 to 0.52)) did not mention any harm related terms. Almost one third of DARE reviews (0.26 (0.22 to 0.31)) did not clearly define the adverse events reviewed, nor did they specify the study designs selected for inclusion in their methods section. Almost half of reviews (n=170) did not consider patient risk factors or length of follow-up when reviewing harms of an intervention. Of 67 reviews of complications related to surgery or other procedures, only four (0.05 (0.01 to 0.14)) reported professional qualifications of the individuals involved. The overall, unweighted, proportion of reviews with good reporting was 0.56 (0.55 to 0.57); corresponding proportions were 0.55 (0.53 to 0.57) in 2008, 0.55 (0.54 to 0.57) in 2009, and 0.57 (0.55 to 0.58) in 2010-11. CONCLUSION: Systematic reviews compound the poor reporting of harms data in primary studies by failing to report on harms or doing so inadequately. Improving reporting of adverse events in systematic reviews is an important step towards a balanced assessment of an intervention.

Análise crítica das novas recomendações para reanimação cardiopulmonar / The new guidelines for cardiopulmonary resuscitation: a critical analysis

OBJETIVO: Descrever as novas recomendações da American Heart Association (AHA), baseado em evidências científicas organizadas pelo Comitê Internacional de Reanimação, endossado e disseminado por entidades norte-americanas e européias. FONTES DOS DADOS: Os guias para suporte básico e avançado de vida em pediatria publicados nas revistas Circulation em novembro de 2005 foram revisados, bem como as subseqüentes publicações sobre o mesmo tópico usando as palavras-chave cardiac arrest, basic life support, advanced life support, cardiopulmonary resuscitation e pediatric resuscitation, através dos métodos de busca PubMed e MEDLINE. SíNTESE DOS DADOS: As maiores alterações foram na área de suporte básico de vida. O novo guia enfatiza a relação compressão torácica/ventilação para os profissionais da saúde treinados, que passa a ser 15:2 em todas as idades, exceto neonatos. É ressaltada a importância das compressões torácicas fortes e rápidas e a necessidade de se evitar a hiperventilação durante e após a parada cardiorrespiratória. O uso de megadoses de adrenalina foi retirado, bem como outras orientações. CONCLUSÃO: O guia mais recente de reanimação em pediatria da AHA tem como foco principal o atendimento básico pré-hospitalar. Está baseado na melhor evidência científica disponível, porém futuras pesquisas são necessárias para corroborar essas mudanças e trazer novas evidências para os futuros protocolos.

OBJECTIVE: To describe the new American Heart Association (AHA) guidelines for pediatric life support, based on the scientific evidence evaluated by the International Liaison Committee on Resuscitation, and endorsed and disseminated by North American resuscitation councils. SOURCES: The guidelines for basic and advanced life support published in Circulation in November 2005 were reviewed together with subsequent publications on the same topics, identified in PubMed and MEDLINE using the keywords cardiac arrest, basic life support, advanced life support, cardiopulmonary resuscitation and pediatric resuscitation. SUMMARY OF THE FINDINGS: The greatest guideline changes are in the area of basic life support. The new guidelines emphasize the new chest compression/ventilation ratio for trained health professionals, which is now 15:2 for all children except neonates. Also emphasized is the need for harder and faster chest compressions, and the need to avoid hyperventilation during and after cardiorespiratory arrest. The use of high-dose epinephrine has been removed, as have some other previous recommendations. CONCLUSIONS: The most recent AHA guidelines for pediatric resuscitation are focused primarily on basic life support care. They are based on the best available scientific evidence, although further research is required to validate these changes and provide new evidence for future guidelines.

Foreign body in children's airways

OBJECTIVE: To determine the clinical characteristics and the results of bronchoscopic treatment of children due to foreign body aspiration in a university hospital. METHOD: Time series of children who underwent bronchoscopies for foreign bodies aspirated into the airway between March 1993 and July 2002. Each patient was analyzed for age, sex, initial clinical diagnosis, nature and location of the foreign body, duration of symptoms between aspiration and bronchoscopy, radiological findings, results of bronchoscopic removal, complications of bronchoscopy and presence of foreign bodies in the airways. RESULTS: Thirty-four children, 20 (59 percent) boys, ages ranging from nine months to nine years (median = 23 months). In 32 (94 percent) children the foreign body was removed by rigid bronchoscope, and two resulted in thoracotomy. Foreign bodies were more frequent in children under three years of age (66 percent). A clinical history of foreign body inhalation was obtained in 27 (80 percent) cases. Most of the foreign bodies removed were organic (65 percent) and more frequently found in the right bronchial tree (59 percent). Foreign bodies were removed within 24 hours in 18 (53 percent) cases. The most frequent radiographic findings were: unilateral air trapping, atelectasis and radiopac foreign body. Major bronchoscopy complications occurred in seven children (22 percent), and there were no deaths. CONCLUSIONS: More attention is necessary to the respiratory symptoms of aspirations, mainly in boys at early ages, with clinical history and compatible radiological findings. Most foreign bodies removed were of organic nature. In this case series, therapeutic rigid bronchoscopy was effective with few complications.