Postoperative outcomes for Indigenous Peoples in Canada: a systematic review.

BACKGROUND: Substantial health inequities exist for Indigenous Peoples in Canada. The remote and distributed population of Canada presents unique challenges for access to and use of surgery. To date, the surgical outcome data for Indigenous Peoples in Canada have not been synthesized. METHODS: We searched 4 databases to identify studies comparing surgical outcomes and utilization rates of adults of First Nations, Inuit or Métis identity with non-Indigenous people in Canada. Independent reviewers completed all stages in duplicate. Our primary outcome was mortality; secondary outcomes included utilization rates of surgical procedures, complications and hospital length of stay. We performed meta-analysis of the primary outcome using random effects models. We assessed risk of bias using the ROBINS-I tool. RESULTS: Twenty-eight studies were reviewed involving 1 976 258 participants (10.2% Indigenous). No studies specifically addressed Inuit or Métis populations. Four studies, including 7 cohorts, contributed adjusted mortality data for 7135 participants (5.2% Indigenous); Indigenous Peoples had a 30% higher rate of death after surgery than non-Indigenous patients (pooled hazard ratio 1.30, 95% CI 1.09-1.54; I 2 = 81%). Complications were also higher for Indigenous Peoples, including infectious complications (adjusted OR 1.63, 95% CI 1.13-2.34) and pneumonia (OR 2.24, 95% CI 1.58-3.19). Rates of various surgical procedures were lower, including rates of renal transplant, joint replacement, cardiac surgery and cesarean delivery. INTERPRETATION: The currently available data on postoperative outcomes and surgery utilization rates for Indigenous Peoples in Canada are limited and of poor quality. Available data suggest that Indigenous Peoples have higher rates of death and adverse events after surgery, while also encountering barriers accessing surgical procedures. These findings suggest a need for substantial re-evaluation of surgical care for Indigenous Peoples in Canada to ensure equitable access and to improve outcomes. PROTOCOL REGISTRATION: PROSPERO-CRD42018098757.

WITHDRAWN: Flossing for the management of periodontal diseases and dental caries in adults.

BACKGROUND: Good oral hygiene is thought to be important for oral health. This review is to determine the effectiveness of flossing in addition to toothbrushing for preventing gum disease and dental caries in adults. OBJECTIVES: To assess the effects of flossing in addition to toothbrushing, as compared with toothbrushing alone, in the management of periodontal diseases and dental caries in adults. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 17 October 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), MEDLINE via OVID (1950 to 17 October 2011), EMBASE via OVID (1980 to 17 October 2011), CINAHL via EBSCO (1980 to 17 October 2011), LILACS via BIREME (1982 to 17 October 2011), ZETOC Conference Proceedings (1980 to 17 October 2011), Web of Science Conference Proceedings (1990 to 17 October 2011), Clinicaltrials.gov (to 17 October 2011) and the metaRegister of Controlled Clinical Trials (to 17 October 2011). We imposed no restrictions regarding language or date of publication. We contacted manufacturers of dental floss to identify trials. SELECTION CRITERIA: We included randomised controlled trials conducted comparing toothbrushing and flossing with only toothbrushing, in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias for the included studies and extracted data. We contacted trial authors for further details where these were unclear. The effect measure for each meta-analysis was the standardised mean difference (SMD) with 95% confidence intervals (CI) using random-effects models. We examined potential sources of heterogeneity, along with sensitivity analyses omitting trials at high risk of bias. MAIN RESULTS: Twelve trials were included in this review, with a total of 582 participants in flossing plus toothbrushing (intervention) groups and 501 participants in toothbrushing (control) groups. All included trials reported the outcomes of plaque and gingivitis. Seven of the included trials were assessed as at unclear risk of bias and five were at high risk of bias.Flossing plus toothbrushing showed a statistically significant benefit compared to toothbrushing in reducing gingivitis at the three time points studied, the SMD being -0.36 (95% CI -0.66 to -0.05) at 1 month, SMD -0.41 (95% CI -0.68 to -0.14) at 3 months and SMD -0.72 (95% CI -1.09 to -0.35) at 6 months. The 1-month estimate translates to a 0.13 point reduction on a 0 to 3 point scale for Loe-Silness gingivitis index, and the 3 and 6 month results translate to 0.20 and 0.09 reductions on the same scale.Overall there is weak, very unreliable evidence which suggests that flossing plus toothbrushing may be associated with a small reduction in plaque at 1 or 3 months.None of the included trials reported data for the outcomes of caries, calculus, clinical attachment loss, or quality of life. There was some inconsistent reporting of adverse effects. AUTHORS' CONCLUSIONS: There is some evidence from twelve studies that flossing in addition to toothbrushing reduces gingivitis compared to toothbrushing alone. There is weak, very unreliable evidence from 10 studies that flossing plus toothbrushing may be associated with a small reduction in plaque at 1 and 3 months. No studies reported the effectiveness of flossing plus toothbrushing for preventing dental caries.

An Analysis of Substandard Propofol Detected in Use in Zambian Anesthesia.

BACKGROUND: In early 2015, clinicians throughout Zambia noted a range of unpredictable adverse events after the administration of propofol, including urticaria, bronchospasm, profound hypotension, and most predictably an inadequate depth of anesthesia. Suspecting that the propofol itself may have been substandard, samples were procured and sent for testing. METHODS: Three vials from 2 different batches were analyzed using gas chromatography-mass spectrometry methods at the John L. Holmes Mass Spectrometry Facility. RESULTS: Laboratory gas chromatography-mass spectrometry analysis determined that, although all vials contained propofol, its concentration differed between samples and in all cases was well below the stated quantity. Two vials from 1 batch contained only 44% ± 11% and 54% ± 12% of the stated quantity, whereas the third vial from a second batch contained only 57% ± 9%. The analysis found that there were no hexane-soluble impurities in the samples. CONCLUSIONS: None of the analyzed vials contained the stated amount of propofol; however, our analysis did not detect additional contaminants that would explain the adverse events reported by clinicians. Our results confirm the presence of substandard propofol in Zambia; however, anecdotal accounts of substandard anesthetic medicines in other countries abound and warrant further investigation to provide estimates of the prevalence and scope of this global problem.

Access to controlled medicines for anesthesia and surgical care in low-income countries: a narrative review of international drug control systems and policies.

PURPOSE: This article describes the functioning of the international drug control system, its integration into national legislation and policy, and the collective impact on access to medicines. SOURCE: We conducted a review of the three international drug control conventions, peer-reviewed articles, and grey literature known to the authors that describes national and international drug control systems and their impact on access to controlled medicines. This review was supplemented with literature derived from a structured search of MEDLINE® for articles relating to medical uses of ketamine in low- and middle-income countries conducted to strengthen an advocacy campaign. We illustrate the impact of the drug control system on access to medicines through an analysis of current levels of availability of opioids in many countries as well as through a description of the ongoing advocacy work to ensure the availability of ketamine for medical care in low-income countries. PRINCIPAL FINDINGS: The complexity of the international drug control system, along with health providers' lack of knowledge regarding key provisions, presents a barrier to improving access to safe anesthesia care in low- and middle-income countries. Fifteen of the 46 essential medicines of potential relevance to perioperative care are listed under one or more of the schedules of the three international drug control conventions and, subsequently, are required to be under national controls, potentially decreasing their availability for medical use. CONCLUSION: Improving the capacity and quality of anesthesia care in low- and middle-income countries requires attention to improving access to controlled medicines. Anesthesiologists and others involved in global health work should collaborate with policymakers and others to improve national and international drug control legislation to ensure that attempts to thwart illicit drug trafficking and use do not compromise availability of controlled medicines.

Fatal Bacterial Meningitis Possibly Associated with Substandard Ceftriaxone--Uganda, 2013.

The burden of disease from bacterial meningitis is highest in low-income countries (1). Early initiation of antibiotic therapy is important in reducing the risk for mortality. Current treatment guidelines recommend the use of an expanded-spectrum cephalosporin (cefotaxime or ceftriaxone) (2), but these therapies increasingly are limited by drug resistance, and are threatened by the proliferation of substandard and falsified medicines (3,4). In February 2013, a case of bacterial meningitis following a middle ear infection was diagnosed in an adolescent at the Mulago National Referral Hospital in Kampala, Uganda. Once-daily treatment with 2 g of intravenous ceftriaxone administered according to guidelines failed, and the patient died. To determine whether the patient's treatment failure and subsequent death might be related to the ceftriaxone product administered, a sealed vial similar to the one administered to the patient was analyzed at the University of Ottawa, Canada, and was found to contain only 0.455 g of the drug, not 1 g as stated by the manufacturer. This would have resulted in subtherapeutic dosing. Substandard medicines are a global problem that disproportionately affects low-income countries, leading to fatal consequences and promoting the emergence of drug resistance (4).

Issues postopératoires chez les Autochtones au Canada: revue systématique.

CONTEXTE: Il existe d'importantes iniquités en matière de santé chez les populations autochtones au Canada. La faible densité de la population canadienne et les populations en région éloignée posent un problème particulier à l'accès et à l'utilisation des soins chirurgicaux. Aucune synthèse des données sur les issues chirurgicales chez les Autochtones au Canada n'avait été publiée jusqu'à maintenant. MÉTHODES: Nous avons interrogé 4 bases de données pour recenser les études comparant les issues chirurgicales et les taux d'utilisation chez les adultes des Premières Nations, inuits et métis et chez les adultes non autochtones au Canada. Des évaluateurs indépendants ont réalisé toutes les étapes en parallèle. L'issue primaire était la mortalité; les issues secondaires comprenaient le taux d'utilisation des chirurgies, les complications et la durée du séjour à l'hôpital. Nous avons effectué une méta-analyse pour l'issue primaire à l'aide d'un modèle à effets aléatoires. Nous avons évalué les risques de biais à l'aide de l'outil ROBINS-I. RÉSULTATS: Vingt-huit études ont été analysées, pour un total de 1 976 258 participants (10,2 % d'Autochtones). Aucune étude ne portait précisément sur les populations inuites et métisses. Quatre études portant sur 7 cohortes ont fourni des données corrigées sur la mortalité pour 7135 participants (5,2 % d'Autochtones); les Autochtones présentaient un risque de décès après une intervention chirurgicale 30 % plus élevé que les patients non autochtones (rapport de risque combiné 1,30; IC à 95 % 1,09­1,54; I 2 = 81 %). Les complications étaient aussi plus fréquentes chez le premier groupe, notamment les infections (RC corrigé 1,63; IC à 95 % 1,13­2,34) et les pneumonies (RC 2,24; IC à 95 % 1,58­3,19). Les taux de différentes interventions chirurgicales étaient plus faibles, notamment pour les transplantations rénales, les arthroplasties, les chirurgies cardiaques et les accouchements par césarienne. INTERPRÉTATION: Les données disponibles sur les issues postopératoires et le taux d'utilisation de la chirurgie chez les Autochtones au Canada sont limitées et de faible qualité. Elles suggèrent que les Autochtones ont de plus hauts taux de décès et d'issues négatives postchirurgicales et qu'ils font face à des obstacles dans l'accès aux interventions chirurgicales. Ces conclusions indiquent qu'il y a un besoin de réévaluer en profondeur les soins chirurgicaux prodigués aux Autochtones au Canada pour leur assurer un accès équitable et améliorer les issues. NUMÉRO D'ENREGISTREMENT DU PROTOCOLE: PROSPERO-CRD42018098757.

Staffing patterns of respiratory therapists in critical care units of Canadian teaching hospitals.

BACKGROUND: The optimal level of respiratory therapy staffing in Canadian intensive care units (ICUs) has not been described in the literature. An examination of practice patterns is an essential first step in developing an understanding of the contribution of respiratory therapists (RTs) to both short- and long-term patient outcomes in this context. OBJECTIVE: To identify the ratio of mechanically ventilated patients to respiratory therapist (Vent:RT ratio) in the ICUs of Canadian teaching hospitals and the factors that influence this ratio. METHODS: The present observational study investigated all adult ICUs (n=38) of the primary teaching hospital associated with each Canadian medical school. An electronic survey was administered at three intervals over a period of three months to control for seasonal variation. Data collected included the hours worked by all RTs, the number of mechanically ventilated patients receiving care, ICU characteristics and the practice patterns of the RTs. Data were used to calculate the Vent:RT ratio, and repeated measures ANOVA examined for variation between findings of each of the data collection points. Correlation analyses between key variables were performed and identified associations were further explored using the t test. Approval for the study was granted by the University of Manitoba Research Ethics Board (Winnipeg, Manitoba). RESULTS: A mean (± SD) Vent:RT ratio of 5.1:1±2.818 was determined. Repeated measures ANOVA demonstrated no significant differences between findings of the three data collection points (F [1.7,30.5]=0.695; P=0.492). Several variables were associated with a significant difference in the Vent:RT ratio including ICUs where RTs insert arterial monitoring lines (4.05±2.89 versus 6.97±2.85; t[17.6]=-2.64; P=0.02), neurological ICUs (4.04±2.76 versus 6.40±3.35; t[30]=-2.092; P=0.04) and coronary care units (5.72±2.80 versus 3.10±1.88; t[35]=2.72; P=0.01). Significant differences were also identified in the mean number of RT hours worked in ICUs where RTs intubated (31.40±9.71 versus 60.54±47.20; t(13)=-2.17; P=0.049) and procured arterial blood gases (41.68±30.85 versus 77.33±46.22; t[35]=-2.79; P=0.01). CONCLUSIONS: The present study is the first to report the Vent:RT ratio and RT practice patterns in Canadian adult ICUs. The results serve as a baseline for comparison of staffing norms and will enlighten future research on the impact of RT staffing and practice patterns on patient outcomes.

La dotation en thérapeutes respiratoires dans les unités de soins intensifs des hôpitaux universitaires canadiens. HISTORIQUE: Les publications ne décrivent pas le taux de dotation optimal des thérapeutes respiratoires dans les unités de soins intensifs (USI) canadiennes. À cet effet, il est essentiel de commencer par examiner les profils d'exercice pour comprendre l'apport des thérapeutes respiratoires (TR) aux résultats cliniques des patients à court et à long terme. OBJECTIF: Déterminer le ratio entre les patients sous ventilation mécanique et les TR (ratio Vent:TR) dans les USI des hôpitaux universitaires canadiens et les facteurs qui influent sur ce ratio. MÉTHODOLOGIE: La présente étude d'observation a porté sur toutes les USI pour adultes (n=38) de l'hôpital universitaire de soins de première ligne associé à chaque faculté de médecine canadienne. Les chercheurs ont envoyé un sondage virtuel à trois reprises sur une période de trois mois pour controller la variation saisonnière. Ils ont recueilli les heures travaillées par tous les TR, le nombre de patients sous ventilation mécanique traités, les caractéristiques des USI et les profils d'exercice des TR. Ils ont utilisé les données pour calculer le ratio Vent:TR et examiné les mesures de variance répétées pour établir la variation entre les observations à chaque moment de la collecte des données. Ils ont effectué des analyses de corrélation entre les principals variables et examiné de manière plus approfondie les associations établies au moyen du test t. Le comité d'éthique de la recherche de l'université du Manitoba, à Winnipeg, a approuvé l'étude. RÉSULTATS: Un ratio Vent:TR moyen (± ÉT) de 5,1:1±2,818 a été établi. Les mesures de variance répétées n'ont démontré aucune différence significative entre les observations à trois moments de la collecte de données (F [1,7, 30,5]=0,695; P=0,492). Plusieurs variables s'associaient à une différence importante du ratio Vent:TR, y compris les USI où les TR insèrent les cathéters intra-artériels (4,05±2,89 par rapport à 6,97±2,85; t[17,6]=−2,64; P=0,02), les USI en neurologie (4,04±2,76 par rapport à 6,40±3,35; t[30]=−2,092; P=0,04) et les unités de soins coronariens (5,72±2,80 par rapport à 3,10±1,88; t[35]=2,72; P=0,01). Les chercheurs ont également constaté des différences significatives en matière de nombre moyen d'heures-TR travaillées dans les USI où les TR procédaient à des intubations (31,40±9,71 par rapport à 60,54±47,20; t(13)=−2,17; P=0,049) et celles où ils effectuaient des gaz artériels (41,68±30,85 par rapport à 77,33±46,22; t[35]=−2,79; P=0,01). CONCLUSIONS: La présente étude est la première à rendre compte du ratio Vent:TR et des profils d'exercice des TR dans les USI pour adultes canadiennes. Les résultats sont un point de départ pour comparer les normes de dotation en personnel et pour éclairer les futures recherches sur les répercussions du nombre de TR et des profils d'exercice sur les résultats cliniques des patients.

A needs assessment to determine the need for respiratory therapy in complex continuing care: A methods paper.

BACKGROUND: There is an emerging demand for complex continuing care for patients who are too ill to safely return home, but for whom hospitalization in an acute care environment is unnecessary or inappropriate. Despite the need and medical complexity of these patients, few respiratory therapists are practising in this environment, and little evidence exists to guide the implementation of respiratory therapy services in this setting. OBJECTIVE: In response to a perceived need for greater respiratory services at Saint Vincent Hospital (Ottawa, Ontario), a needs assessment was undertaken to assess the prevalence of respiratory diseases and for increased respiratory therapist coverage at this complex continuing care hospital. METHODS: An initial literature review was conducted to guide the assessment, and identified only one tool of relevance, which was obtained and formed the basis of the further development of tools for collecting data at the hospital level and on patient care units at the facility. This needs assessment tool was expanded to include priority areas of relevance that fall within the scope of practice of respiratory therapists, and was supplemented by the analysis of administrative databases and qualitative data gathered through unit walkthroughs and unstructured key informant interviews. A health systems framework was used to structure recommendations for the development of interventions and programs for this patient population. RESULTS: The burden of respiratory disease was significant, and included a high prevalence of inhaled medication and oxygen use, and a significant workload that could be attributed to addressing the respiratory needs of patients. CONCLUSION: A range of tools and methods are needed to conduct needs assessments for respiratory therapy in complex continuing care. Using multiple data sources, a significant burden of respiratory diseases was present at the Saint Vincent Hospital; further studies in other complex continuing care hospitals are needed to understand the significance of these findings among this patient population more generally.

HISTORIQUE: La demande de soins continus complexes auprès des patients trop malades pour rentrer chez eux en toute sécurité, mais pour qui l'hospitalisation en soins aigus est inutile ou inappropriée commence à émerger. Malgré les besoins et la complexité médicale de ces patients, peu d'inhalothérapeutes exercent dans ce contexte, et il existe peu de données pour orienter la mise en œuvre de services d'inhalothérapie dans ce milieu. OBJECTIF: En réponse à l'impression qu'il fallait accroître les services respiratoires à l'Hôpital Saint-Vincent d'Ottawa, en Ontario, l'auteur a procédé à une évaluation des besoins pour examiner la prévalence de maladies respiratoires et l'augmentation nécessaire du nombre d'inhalothérapeutes dans cet hôpital de soins continus complexes. MÉTHODOLOGIE: L'auteure a effectué une première analyse bibliographique pour orienter l'évaluation et n'a relevé qu'un outil pertinent, qu'il a utilisé pour préparer d'autres outils afin de colliger des données à l'hôpital et dans les unités de patients de l'établissement. Il en a élargi le champ d'application pour inclure les secteurs prioritaires dans la portée de pratique des inhalothérapeutes et l'a complété par l'analyse de bases de données administratives et de données qualitatives amassées lors de la revue des unités et d'entrevues non structurées avec des témoins privilégiés. Il s'est fié à un cadre du système de santé pour structurer ses recommandations sur l'élaboration d'interventions et de programmes à l'intention de cette population de patients. RÉSULTATS: Le fardeau des maladies respiratoires était important et exigeait une forte prévalence de médicaments inhalés et d'oxygénothérapie, de même qu'une importante charge de travail pour répondre aux besoins respiratoires des patients. CONCLUSION: Un éventail d'outils et de méthodes s'imposent pour effectuer une évaluation des besoins d'inhalothérapie en soins continus complexes. D'après de multiples sources de données, l'Hôpital Saint-Vincent présentait un fardeau important de maladies respiratoires. Des études plus approfondies dans d'autres hôpitaux de soins continus complexes devront être réalisées pour comprendre le sens plus général de ces observations au sein de cette population de patients.

Liberian surgical and anesthesia infrastructure: a survey of county hospitals.

BACKGROUND: There is a significant burden of disease in low-income countries that can benefit from surgical intervention. The goal of this survey was to evaluate the current ability of the Liberian health care system to provide safe surgical care and to identify unmet needs in regard to trained personnel, equipment, infrastructure, and outcomes measurement. METHODS: A comprehensive survey tool was developed to assess physical infrastructure of operative facilities, education and training for surgical and anesthesia providers, equipment and medications, and the capacity of the surgical system to collect and evaluate surgical outcomes at district-level hospitals in Africa. This tool was implemented in a sampling of 11 county hospitals in Liberia (January 2011). Data were obtained from the Ministry of Health and by direct government-affiliated hospital site visits. RESULTS: The total catchment area of the 11 hospitals surveyed was 2,313,429--equivalent to roughly 67 % of the population of Liberia (3,476,608). There were 13 major operating rooms and 34 (1.5 per 100,000 population) physicians delivering surgical, obstetric, or anesthesia care including 2 (0.1 per 100,000 population) who had completed formal postgraduate training programs in these specialty areas. The total number of surgical cases for 2010 was 7,654, with approximately 43 % of them being elective procedures. Among the facilities that tracked outcomes in 2010, a total of 11 intraoperative deaths (145 per 100,000 operative cases) were recorded for 2009. The 30-day postoperative mortality at hospitals providing data was 44 (1,359 per 100,000 operative cases). Metrics were also used to evaluate surgical output, safety of anesthesia, and the burden of obstetric disease. CONCLUSIONS: A significant volume of surgical care is being delivered at county hospitals throughout Liberia. The density and quality of appropriately trained personnel and infrastructure remain critically low. There is strong evidence for continued development of emergency and essential surgical services, as well as improved surgical outcomes tracking, at county hospitals in Liberia. These results serve to inform the international community and donors of the ongoing global surgical and anesthesia crisis.

Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children.

BACKGROUND: Respiratory syncytial virus (RSV) is one of the most important viral pathogens causing acute respiratory infections in children. It results in about 3.4 million hospitalisations annually in children under five. Palivizumab is an anti-RSV monoclonal antibody, administered intramuscularly at a dose of 15 mg/kg once every 30 days. The efficacy and safety of palivizumab has been evaluated in multicentre, randomised controlled trials (RCTs) and a large number of economic evaluations (EEs) have tested its cost-effectiveness. OBJECTIVES: To assess the effectiveness and safety of palivizumab prophylaxis compared with placebo, or another type of prophylaxis, in reducing the risk of complications (hospitalisation due to RSV infection) in high-risk infants and children. To assess the cost-effectiveness (or cost-utility) of palivizumab prophylaxis compared with no prophylaxis in infants and children in different risk groups. SEARCH METHODS: We searched CENTRAL 2012, Issue 7, MEDLINE (1996 to July week 4, 2012), EMBASE (1996 to August 2012), CINAHL (1996 to August 2012) and LILACS (1996 to August 2012) for studies of effectiveness and safety. We searched the NHS Economic Evaluations Database (NHS EED 2012, Issue 4), Health Economics Evaluations Database (HEED, 9 August 2012) and Paediatric Economic Database Evaluations (PEDE, 1980 to 2009), MEDLINE (1996 to July week 4, 2012) and EMBASE (1996 to August 2012) for economic evaluations. SELECTION CRITERIA: We included RCTs comparing palivizumab prophylaxis with a placebo, no prophylaxis or another type of prophylaxis in preventing serious lower respiratory tract disease caused by RSV in paediatric patients at high risk. We included cost-effectiveness analyses and cost-utility analyses comparing palivizumab prophylaxis with no prophylaxis. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias for the included studies and extracted data for both the RCTs and EEs. We calculated risk ratios (RRs) and their associated 95% confidence intervals (CIs) for dichotomous outcomes and for adverse events (AEs). We provided a narrative summary of results for continuous outcomes, due to missing data on standard deviations. We performed fixed-effect meta-analyses for the estimation of pooled effects whenever there was no indication of heterogeneity between included RCTs. We summarised the results reported in included EEs, such as incremental costs, incremental effectiveness, and incremental cost-effectiveness and/or cost-utility ratios (ICERs), and we calculated ICER present values in 2011 Euros for all studies. MAIN RESULTS: Of the seven available RCTs, three compared palivizumab with a placebo in a total of 2831 patients, and four compared palivizumab with motavizumab in a total of 8265 patients. All RCTs were sponsored by the drug manufacturing company. The overall quality of RCTs was good, but for most of the outcomes assessed only data from two studies contributed to the analysis. Palivizumab prophylaxis was associated with a statistically significant reduction in RSV hospitalisations (RR 0.49, 95% CI 0.37 to 0.64) when compared to placebo. When compared to motavizumab, palivizumab recipients showed a non-significant increase in the risk of RSV hospitalisations (RR 1.36, 95% CI 0.97 to 1.90). In both cases, the proportion of children with any AE or any AE related to the study drug was similar between the two groups.In terms of economic evidence, we included 34 studies that reported cost-effectiveness and/or cost-utility data for palivizumab prophylaxis compared with no prophylaxis, in high-risk children with different underlying medical conditions. The overall quality of EEs was good, but the variations in modelling approaches were considerable across the studies, leading to big differences in cost-effectiveness results. The cost-effectiveness of palivizumab prophylaxis depends on the consumption of resources taken into account by the study authors; and on the cost-effectiveness threshold set by the healthcare sector in each country. AUTHORS' CONCLUSIONS: There is evidence that palivizumab prophylaxis is effective in reducing the frequency of hospitalisations due to RSV infection, i.e. in reducing the incidence of serious lower respiratory tract RSV disease in children with chronic lung disease, congenital heart disease or those born preterm.Results from economic evaluations of palivizumab prophylaxis are inconsistent, implying that economic findings must be interpreted with caution. ICER values varied considerably across studies, from highly cost-effective to not cost-effective. The availability of low-cost palivizumab would reduce its inequitable distribution, so that RSV prophylaxis would be available to the poorest countries where children are at greatest risk.

The inadequate treatment of pain: collateral damage from the war on drugs.

Jason Nickerson and Amir Attaran examine the vast inequities in medical pain relief around the world and argue that the global control of licit narcotics be shifted from the International Narcotic Control Board to WHO.

Surgical care during humanitarian crises: a systematic review of published surgical caseload data from foreign medical teams.

OBJECTIVE: Humanitarian surgery is often organized and delivered with short notice and limited time for developing unique strategies for providing care. While some surgical pathologies can be anticipated by the nature of the crisis, the role of foreign medical teams in treating the existing and unmet burden of surgical disease during crises is unclear. The purpose of this study was to examine published data from crises during the years 1990 through 2011 to understand the role of foreign medical teams in providing surgical care in these settings. METHODS: A literature search was completed using PubMed, MEDLINE, and EMBASE databases to locate relevant manuscripts published in peer-reviewed journals. A qualitative review of the surgical activities reported in the studies was performed. RESULTS: Of 185 papers where humanitarian surgical care was provided by a foreign medical team, only 11 articles met inclusion criteria. The reporting of surgical activities varied significantly, and pooled statistical analysis was not possible. The quality of reporting was notably poor, and produced neither reliable estimates of the pattern of surgical consultations nor data on the epidemiology of the burden of surgical diseases. The qualitative trend analysis revealed that the most frequent procedures were related to soft tissue or orthopedic surgery. Procedures such as caesarean sections, hernia repairs, and appendectomies also were common. As length of deployment increased, the surgical caseload became more reflective of the existing, unmet burden of surgical disease. CONCLUSIONS: This review suggests that where foreign medical teams are indicated and requested, multidisciplinary surgical teams capable of providing a range of emergency and essential surgical, and rehabilitation services are required. Standardization of data collection and reporting tools for surgical care are needed to improve the reporting of surgical epidemiology in crisis-affected populations.

Emergency surgery data and documentation reporting forms for sudden-onset humanitarian crises, natural disasters and the existing burden of surgical disease.

Following large-scale disasters and major complex emergencies, especially in resource-poor settings, emergency surgery is practiced by Foreign Medical Teams (FMTs) sent by governmental and non-governmental organizations (NGOs). These surgical experiences have not yielded an appropriate standardized collection of data and reporting to meet standards required by national authorities, the World Health Organization, and the Inter-Agency Standing Committee's Global Health Cluster. Utilizing the 2011 International Data Collection guidelines for surgery initiated by Médecins Sans Frontières, the authors of this paper developed an individual patient-centric form and an International Standard Reporting Template for Surgical Care to record data for victims of a disaster as well as the co-existing burden of surgical disease within the affected community. The data includes surgical patient outcomes and perioperative mortality, along with referrals for rehabilitation, mental health and psychosocial care. The purpose of the standard data format is fourfold: (1) to ensure that all surgical providers, especially from indigenous first responder teams and others performing emergency surgery, from national and international (Foreign) medical teams, contribute relevant and purposeful reporting; (2) to provide universally acceptable forms that meet the minimal needs of both national authorities and the Health Cluster; (3) to increase transparency and accountability, contributing to improved humanitarian coordination; and (4) to facilitate a comprehensive review of services provided to those affected by the crisis.

Patent "Evergreening" of Medicine-Device Combination Products: A Global Perspective.

Background: Patenting medicine-delivery devices (inhalers and pens) is controversial when it extends market protections beyond that of the underlying therapeutic agent. We evaluated how common device patenting is, internationally. Method: Using a product sample (n = 88) and an international patent database, we assessed the issue's scope. Results: When comparing the 88 patent portfolios for each product in each country, Canada was found to be among the most impacted, with 90% of the portfolios containing at least one device patent and 35% of the portfolios containing device patents exclusively. Conclusion: Patenting of delivery devices impacts major pharmaceutical manufacturing centres worldwide. International consensus among stakeholders (regulators and payors) is needed on which device modifications represent meaningful clinical value.

Postoperative outcomes for Nunavut Inuit at a Canadian quaternary care centre: a retrospective cohort study.

BACKGROUND: Structural aspects of health care systems, such as limited access to specialized surgical and perioperative care, can negatively affect the outcomes and resource use of patients undergoing elective and emergency surgical procedures. The aim of this study was to compare postoperative outcomes of Nunavut Inuit and non-Inuit patients at a Canadian quaternary care centre. METHODS: We conducted a retrospective cohort study involving adult (age ≥ 18 yr) patients undergoing inpatient surgery from 2011 to 2018 at The Ottawa Hospital, the quaternary referral hospital for the Qikiqtaaluk Region of Nunavut. The study was designed and conducted in collaboration with Nunavut Tunngavik Incorporated. The primary outcome was a composite of in-hospital death or complications.Secondary outcomes included postoperative length of stay in hospital, adverse discharge disposition, readmissions within 30 days and total hospitalization costs. RESULTS: A total of 98 701 episodes of inpatient surgical care occurred among patients aged 18 to 104 years; 928 (0.9%) of these involved Nunavut Inuit, and 97 773 involved non-Inuit patients. Death or postoperative complication occurred more often among Nunavut Inuit than non-Inuit patients (159 [17.2%] v. 15 691 [16.1%]), which was significantly different after adjustment for age, sex, surgical specialty, risk and urgency (odds ratio [OR] 1.25, 95% confidence interval [CI] 1.03-1.51). This association was most pronounced in cases of cancer (OR 1.63, 95% CI 1.03-2.58) and elective surgery (OR 1.58, 95% CI 1.20-2.10). Adjusted rates of readmission, adverse discharge disposition, length of stay and total costs were significantly higher for Nunavut Inuit. INTERPRETATION: Nunavut Inuit had a 25% relative increase in their odds of morbidity and death after surgery at a major quaternary care hospital in Canada compared with non-Inuit patients, while also having higher rates of other adverse outcomes and resource use. An examination of perioperative systems involving patients, Inuit leadership, health care providers and governments is required to address these differences in health outcomes.

Flossing for the management of periodontal diseases and dental caries in adults.

BACKGROUND: Good oral hygiene is thought to be important for oral health. This review is to determine the effectiveness of flossing in addition to toothbrushing for preventing gum disease and dental caries in adults. OBJECTIVES: To assess the effects of flossing in addition to toothbrushing, as compared with toothbrushing alone, in the management of periodontal diseases and dental caries in adults. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 17 October 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), MEDLINE via OVID (1950 to 17 October 2011), EMBASE via OVID (1980 to 17 October 2011), CINAHL via EBSCO (1980 to 17 October 2011), LILACS via BIREME (1982 to 17 October 2011), ZETOC Conference Proceedings (1980 to 17 October 2011), Web of Science Conference Proceedings (1990 to 17 October 2011), Clinicaltrials.gov (to 17 October 2011) and the metaRegister of Controlled Clinical Trials (to 17 October 2011). We imposed no restrictions regarding language or date of publication. We contacted manufacturers of dental floss to identify trials. SELECTION CRITERIA: We included randomised controlled trials conducted comparing toothbrushing and flossing with only toothbrushing, in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias for the included studies and extracted data. We contacted trial authors for further details where these were unclear. The effect measure for each meta-analysis was the standardised mean difference (SMD) with 95% confidence intervals (CI) using random-effects models. We examined potential sources of heterogeneity, along with sensitivity analyses omitting trials at high risk of bias. MAIN RESULTS: Twelve trials were included in this review, with a total of 582 participants in flossing plus toothbrushing (intervention) groups and 501 participants in toothbrushing (control) groups. All included trials reported the outcomes of plaque and gingivitis. Seven of the included trials were assessed as at unclear risk of bias and five were at high risk of bias.Flossing plus toothbrushing showed a statistically significant benefit compared to toothbrushing in reducing gingivitis at the three time points studied, the SMD being -0.36 (95% CI -0.66 to -0.05) at 1 month, SMD -0.41 (95% CI -0.68 to -0.14) at 3 months and SMD -0.72 (95% CI -1.09 to -0.35) at 6 months. The 1-month estimate translates to a 0.13 point reduction on a 0 to 3 point scale for Loe-Silness gingivitis index, and the 3 and 6 month results translate to 0.20 and 0.09 reductions on the same scale.Overall there is weak, very unreliable evidence which suggests that flossing plus toothbrushing may be associated with a small reduction in plaque at 1 or 3 months.None of the included trials reported data for the outcomes of caries, calculus, clinical attachment loss, or quality of life. There was some inconsistent reporting of adverse effects. AUTHORS' CONCLUSIONS: There is some evidence from twelve studies that flossing in addition to toothbrushing reduces gingivitis compared to toothbrushing alone. There is weak, very unreliable evidence from 10 studies that flossing plus toothbrushing may be associated with a small reduction in plaque at 1 and 3 months. No studies reported the effectiveness of flossing plus toothbrushing for preventing dental caries.