Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia.

BACKGROUND: An effective, affordable, multivalent meningococcal conjugate vaccine is needed to prevent epidemic meningitis in the African meningitis belt. Data on the safety and immunogenicity of NmCV-5, a pentavalent vaccine targeting the A, C, W, Y, and X serogroups, have been limited. METHODS: We conducted a phase 3, noninferiority trial involving healthy 2-to-29-year-olds in Mali and Gambia. Participants were randomly assigned in a 2:1 ratio to receive a single intramuscular dose of NmCV-5 or the quadrivalent vaccine MenACWY-D. Immunogenicity was assessed at day 28. The noninferiority of NmCV-5 to MenACWY-D was assessed on the basis of the difference in the percentage of participants with a seroresponse (defined as prespecified changes in titer; margin, lower limit of the 96% confidence interval [CI] above -10 percentage points) or geometric mean titer (GMT) ratios (margin, lower limit of the 98.98% CI >0.5). Serogroup X responses in the NmCV-5 group were compared with the lowest response among the MenACWY-D serogroups. Safety was also assessed. RESULTS: A total of 1800 participants received NmCV-5 or MenACWY-D. In the NmCV-5 group, the percentage of participants with a seroresponse ranged from 70.5% (95% CI, 67.8 to 73.2) for serogroup A to 98.5% (95% CI, 97.6 to 99.2) for serogroup W; the percentage with a serogroup X response was 97.2% (95% CI, 96.0 to 98.1). The overall difference between the two vaccines in seroresponse for the four shared serogroups ranged from 1.2 percentage points (96% CI, -0.3 to 3.1) for serogroup W to 20.5 percentage points (96% CI, 15.4 to 25.6) for serogroup A. The overall GMT ratios for the four shared serogroups ranged from 1.7 (98.98% CI, 1.5 to 1.9) for serogroup A to 2.8 (98.98% CI, 2.3 to 3.5) for serogroup C. The serogroup X component of the NmCV-5 vaccine generated seroresponses and GMTs that met the prespecified noninferiority criteria. The incidence of systemic adverse events was similar in the two groups (11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group). CONCLUSIONS: For all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine. NmCV-5 also elicited immune responses to serogroup X. No safety concerns were evident. (Funded by the U.K. Foreign, Commonwealth, and Development Office and others; ClinicalTrials.gov number, NCT03964012.).

Pharmaco-virological outcomes and genotypic resistance profiles among children and adolescents receiving a DTG-based regimen in Togo.

BACKGROUND: Few data are available on the real-world efficacy of receiving tenofovir-lamivudine-dolutegravir (DTG) as HIV treatment, particularly among young people in West Africa. Here, we evaluated pharmaco-virological outcomes and resistance profiles among Togolese children and adolescents. METHODS: A cross-sectional study was conducted in Lomé, Togo, enrolling antiretroviral-treated people with HIV aged from 18 months to 24 years. Plasma HIV-1 viral load and antiretroviral concentrations were measured. Next-Generation Sequencing (NGS) of protease, Reverse Transcriptase (RT) and integrase was performed on all samples with viral load >200 c/mL. Drug resistance mutations (DRMs) were identified and interpreted using the ANRS-MIE algorithm. RESULTS: 264 participants were enrolled (median age=17 years), 226 received a DTG-based regimen for a median of 20.5 months. Among them, virological suppression at the 200 c/mL threshold in 80.0% of the participants. Plasma DTG concentrations were adequate (i.e., >640 ng/mL), suboptimal and below the limit of quantification in 74.1%, 6.7% and 19.2% of participants receiving DTG, respectively. Overall, viruses resistant to any of Nucleoside RT Inhibitors, Non-NRTIs, and protease inhibitors were found in 52%, 66% and 1.6% of participants, respectively. A major integrase inhibitor DRM was observed in 9.4% (n=3/32, R263K, E138A-G140A-Q148R, and N155H) of participants with a viral load >200 c/mL. CONCLUSIONS: These first findings in such a large series of adolescents in a low-income country, showed a good virological response of 80% and the presence of an integrase DRM in 9.4% of the virological failures, supporting the need to monitor DTG drug resistance to reduce the risk of resistance acquisition.

Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers.

BACKGROUND: Neisseria meningitidis serogroups A, B, C, W, X, and Y cause outbreaks of meningococcal disease. Quadrivalent conjugate vaccines targeting the A, C, W, and Y serogroups are available. A pentavalent vaccine that also includes serogroup X (NmCV-5) is under development. METHODS: We conducted a phase 2, observer-blinded, randomized, controlled trial involving Malian children 12 to 16 months of age. Participants were assigned in a 2:2:1 ratio to receive nonadjuvanted NmCV-5, alum-adjuvanted NmCV-5, or the quadrivalent vaccine MenACWY-D, administered intramuscularly in two doses 12 weeks apart. Participants were followed for safety for 169 days. Immunogenicity was assessed with an assay for serum bactericidal antibody (SBA) with rabbit complement on days 0, 28, 84, and 112. RESULTS: A total of 376 participants underwent randomization, with 150 assigned to each NmCV-5 group and 76 to the MenACWY-D group; 362 participants received both doses of vaccine. A total of 1% of the participants in the nonadjuvanted NmCV-5 group, 1% of those in the adjuvanted NmCV-5 group, and 4% of those in the MenACWY-D group reported local solicited adverse events; 6%, 5%, and 7% of the participants, respectively, reported systemic solicited adverse events. An SBA titer of at least 128 was seen in 91 to 100% (for all five serotypes) of the participants in the NmCV-5 groups and in 36 to 99% (excluding serogroup X) of those in the MenACWY-D group at day 84 (before the second dose); the same threshold was met in 99 to 100% (for all five serotypes) of the participants in the NmCV-5 groups and in 92 to 100% (excluding serogroup X) of those in the MenACWY-D group at day 112. Immune responses to the nonadjuvanted and adjuvanted NmCV-5 formulations were similar. CONCLUSIONS: No safety concerns were identified with two doses of NmCV-5. A single dose of NmCV-5 elicited immune responses that were similar to those observed with two doses of MenACWY-D. Adjuvanted NmCV-5 provided no discernible benefit over nonadjuvanted NmCV-5. (Funded by the U.K. Foreign, Commonwealth, and Development Office; ClinicalTrials.gov number, NCT03295318.).

SARS-CoV-2 antibody seroprevalence in Togo: a national cross-sectional household survey, May-June, 2021.

BACKGROUND: The extent of SARS-CoV-2 circulation in African countries is still unclear. Seroprevalence studies are a common approach to epidemiological surveillance, allowing estimation of the proportion of people who have had contact with the virus. We aimed at estimating the seroprevalence of anti-SARS-CoV-2 antibodies and associated factors in Togo at the national level in 2021 according to age groups, gender, and place of residence (rural or urban). METHODS: From 15 May to 31 June 2021, we conducted a nationally representative cross-sectional serological survey in 12 health districts (two districts per health region) in the > 5 years old population in Togo. The Wantai SARS-CoV-2 total antibody assay S protein receptor-binding domain-based ELISA (Wantai Biological Pharmacy Enterprise Co.; Beijing, China) was used to determine the presence of SARS-CoV-2 total antibodies in plasma. Crude and weighted seroprevalences (weighted by age, sex and place of residence) were calculated and then weighted seroprevalences were adjusted according to sensitivity and specificity of the ELISA test. Finally, logistic regression models were performed in order to describe factors associated. RESULTS: Of the 7593 participants, the overall weighted and adjusted seroprevalence of total anti-SARS-CoV-2 antibodies was 65.5% (CI95%: 18.9-21.1). Urban dwellers, young adults (30-49 years) and vaccinated individuals were significantly more likely to be seropositive. CONCLUSION: The high seroprevalence we observed is consistent with observations across West Africa. Quantification of the level of immunity in the population is needed to know how close we are to herd immunity. In the meantime, vaccination against the COVID-19 remains necessary.

Comparison of Thromboelastography Devices TEG®6S Point of Care Device vs. TEG®5000 in Pediatric Patients Undergoing Cardiac Surgery.

Thromboelastography (TEG) can predict bleeding in pediatric patients undergoing cardiac surgery. We hypothesized that results obtained from TEG®5000 correlate with the new point-of-care TEG®6S system and that TEG®6S rewarming maximum amplitude (MA) is associated with surrogate endpoints for perioperative bleeding in pediatric patients who underwent complex cardiac surgery. We describe a retrospective study of pediatric (≤18 years) patients who underwent complex cardiac surgery on cardiopulmonary bypass. Citrate whole-blood samples were used to compared TEG®5000 vs.TEG®6S and TEG®6S-FLEV (with fibrinogen measurement) vs. Clauss-fibrinogen methods. TEG®6S parameters obtained during rewarming were compared to the surrogate endpoints for perioperative bleeding using linear regression analysis. Among 100 patients, 225 TEG®5000 vs.TEG®6S comparisons and 54 TEG®6S-FLEV were analyzed. Good correlation was observed for all parameters comparing TEG®5000 to TEG®6S and TEG®6S-FLEV to the Clauss-fibrinogen method (Pearson r ≥ .7). Similar to rewarming TEG®5000 MA, rewarming TEG®6S MA was the only parameter independently associated with risk for perioperative bleeding (median [interquartile range {IQR}] in bleeding vs. nonbleeding patients: 35 [29, 48] vs. 37 [32, 55]; p = .02). A platelet transfusion calculator was developed based on TEG®6S results by determining the relationship between platelet transfusion volume (mL/kg) and percent change in MA using linear regression analysis. TEG®6S is a good alternative point-of-care method to analyze a patient's coagulation profile and it is comparable to TEG®5000 in pediatric patients undergoing cardiac surgery on cardiopulmonary bypass. Lower TEG®6S MA during rewarming is associated with increased risk for perioperative bleeding. TEG analysis during rewarming may be useful in customizing platelet transfusion therapy by reducing the risk of bleeding while minimizing excessive blood product transfusions.

Stratification of Bleeding Risk Using Thromboelastography in Children on Extracorporeal Membrane Oxygenation Support.

OBJECTIVES: Patients undergoing extracorporeal membrane oxygenation are at high risk for bleeding and thrombotic complications. Current laboratory methods for assessing the coagulation system may be imprecise and complicate clinical decision-making. We hypothesize that thromboelastography may be more strongly associated with bleeding events than traditional methods and can aid extracorporeal membrane oxygenation coagulation management. DESIGN: In a retrospective study, 40 patients with congenital heart disease requiring extracorporeal membrane oxygenation support yielded a total of 159 patient days of data for thromboelastography analysis. SETTING: Pediatric cardiac ICU at a single institution. SUBJECTS: Pediatric patients (≤ 18 yr) with congenital heart disease requiring extracorporeal membrane oxygenation support. INTERVENTIONS: None. METHODS: Thromboelastography was performed on whole blood samples collected 6-12 hours following extracorporeal membrane oxygenation initiation and daily for the duration of extracorporeal membrane oxygenation. Bleeding during each 24-hour period was defined as need for re-exploration or need for blood transfusion. Associations between thromboelastography variables and bleeding over each 24-hour period (bleeding vs nonbleeding days) were assessed using mixed effects logistic regression and classification and regression tree analysis. MEASUREMENTS AND MAIN RESULTS: Bleeding occurred in 25 patients (63%), contributing 87 bleeding days (55% extracorporeal membrane oxygenation days) for analysis. The probability of bleeding within the 24-hour period was not associated with activated partial thromboplastin time (p = 0.6) or anti-Xa levels (p = 0.3) on that day. The strongest correlate of bleeding was a maximum amplitude less than 55.4 mm on thromboelastography (odds ratio, 3.28; 95% CI, 1.63-6.60; p < 0.001). Bleeding occurred on 73% versus 35% of extracorporeal membrane oxygenation days for maximum amplitude less than 55.4 mm versus greater than or equal to 55.4 mm, respectively. Bleeding occurred on all days when a combination of maximum amplitude less than 55.4 mm and a reaction time greater than 12.9 minutes was present. The lowest risk of bleeding (28% of patient days) was associated with maximum amplitude greater than or equal to 55.4 mm and plasma fibrinogen greater than 345 mg/dL. CONCLUSIONS: Thromboelastography-derived variables maximum amplitude and reaction time, along with plasma fibrinogen levels, can help predict bleeding events in children on extracorporeal membrane oxygenation support. Research based on larger patient samples is needed to confirm the specific thresholds identified for bleeding risk stratification for extracorporeal membrane oxygenation anticoagulation management.

I am ready to see you now, Doctor! A mixed-method study of the Let's Discuss Health website implementation in Primary Care.

BACKGROUND: Let's Discuss Health (LDH) is a website that encourages patients to prepare their health-care encounters by providing communication training, review of topics and questions that are important to them. OBJECTIVE: To describe LDH implementation during primary care (PC) visits for chronic illnesses. METHODS: Design: Descriptive mixed-method study. SETTING: 6 PC clinics. PARTICIPANTS: 156 patients and 51 health-care providers (HCP). INTERVENTION: LDH website implementation. OUTCOME MEASURES: Perceived quality and usefulness of LDH; perceived quality of HCP-patient communication; patient activation; LDH integration in routine PC practices and barriers to its use. RESULTS: Patients reported a positive perception of the website in that it helped them to adopt an active role in the encounters; recall their visit agenda and reduce encounter-related stress; feel more confident to ask questions, feel more motivated to prepare their future medical visits and improve their chronic illness management. However, a certain disconnect emerged between HCP and patient perceptions as to the value of LDH in promoting a sense of partnership and collaboration. The main barriers to the use of LDH are HCP lack of interest, limited access to technology, lack of time and language barriers. CONCLUSION: Our findings indicate that it is advantageous for patients to prepare their medical encounters. However, the study needs to be replicated in other medical environments using larger and more diverse samples. PATIENT AND PUBLIC CONTRIBUTION: Patient partners were involved in the conduct of this study.

Epidemiology, Risk Factors, and Outcomes of Respiratory Syncytial Virus Infections in Newborns in Bamako, Mali.

BACKGROUND: Few studies describe the respiratory syncytial virus (RSV) burden in African populations, and most have utilized hospital-based surveillance. In Mali, no community-based studies exist of the incidence or epidemiology of RSV infection. This study provides the first estimates of RSV incidence in Mali. METHODS: In a cohort of infants enrolled in a clinical trial of maternal influenza vaccination, we estimate incidence of RSV-associated febrile illness in the first 6 months of life and identify risk factors for RSV infection and progression to severe disease. Infants (N = 1871) were followed from birth to 6 months of age and visited weekly to detect pneumonia and influenza-like illness. Baseline covariates were explored as risk factors for RSV febrile illness and RSV pneumonia or hospitalization. RESULTS: Incidence of RSV illness was estimated at 536.8 per 1000 person-years, and 86% (131/153) of RSV illness episodes were positive for RSV-B. RSV illness was most frequent in the fifth month of life and associated with having older mothers and with lower parity. The incidence of RSV-associated hospitalizations was 45.6 per 1000 person-years. Among infants with RSV illness, males were more likely to be hospitalized. The incidence of RSV pneumonia was 29 cases per 1000 person-years. CONCLUSIONS: In the first 6 months of life, Malian infants have a high incidence of RSV illness, primarily caused by RSV-B. Prevention of early RSV will require passive protection via maternal immunization in pregnancy. Mali is the first country where RSV-B has been identified as the dominant subtype, with potential implications for vaccine development.

Platelet Inhibition With IV Glycoprotein IIb/IIIa Inhibitor to Prevent Thrombosis in Pediatric Patients Undergoing Aortopulmonary Shunting.

OBJECTIVES: Shunt thrombosis, a potential complication of aortopulmonary shunting, is associated with high mortality. Commonly used oral antiplatelet drugs such as aspirin demonstrate variable absorption and inconsistent antiplatelet effect in critically ill patients early after surgery. IV glycoprotein IIb/IIIa inhibitors are antiplatelet agents with rapid and reproducible effect that may be beneficial as a bridge to oral therapy. DESIGN: Retrospective review of pediatric patients undergoing treatment with IV tirofiban. Discarded blood samples were used to determine pharmacokinetic parameters. SETTING: Pediatric cardiac ICU at a single institution. PATIENTS: Fifty-two pediatric patients (< 18 yr) undergoing surgical aortopulmonary shunt procedure who received tirofiban infusion as a bridge to oral aspirin. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Primary outcome measures were shunt thrombosis and bleeding events, whereas secondary outcomes included measurement of platelet inhibition by thromboelastography with platelet mapping and pharmacokinetic analysis (performed in a subset of 15 patients). Shunt thrombosis occurred in two of 52 patients (3.9%) after prophylaxis treatment with tirofiban; both thrombosis events occurred after discontinuation of the drug. One patient (1.9%) experienced bleeding complication during the infusion. A tirofiban bolus of 10 µg/kg and infusion of 0.15 µg/kg/min resulted in significantly increased platelet inhibition via adenosine diphosphate pathway (median 66% [43-96] pre-tirofiban compared with 97% [92-99%] at 2 hr; p < 0.05). Half-life of tirofiban in plasma was 142 ± 1.5 minutes, and the average steady-state concentration was 112 ± 62 ng/mL. Age and serum creatinine were significant covariates associated with systemic clearance. Dosing simulations were generated based upon one compartment model. CONCLUSIONS: IV glycoprotein IIb/IIIa inhibitor as a bridge to oral antiplatelet therapy is safe in pediatric patients after aortopulmonary shunting. Dosing considerations should include both age and renal function. Randomized trials are warranted to establish efficacy compared with current anticoagulation practices.

Family medicine rotations and medical students' intention to pursue family medicine: Descriptive study.

OBJECTIVE: To identify specific factors occurring during family medicine (FM) rotations that were associated with a change in intention to pursue FM. DESIGN: Transversal descriptive study. A self-administered questionnaire was distributed on SurveyMonkey between September 2015 and April 2016. SETTING: Family medicine rotation sites affiliated with the University of Montreal in Quebec. PARTICIPANTS: Medical students who were conducting their rotations at participating sites and who had not yet chosen their residency specialty. MAIN OUTCOME MEASURES: Specific factors occurring during a rotation that influenced medical students' intention to pursue FM in residency. RESULTS: In the sample population, it was found that the FM rotation was generally highly appreciated by study participants, and that it improved the FM specialty's image while positively influencing the participants' intention to pursue FM. The degree of exposure to different areas of practice, overall atmosphere, the presence of role models, and the desire to return to the rotation site to practise were all moderately associated with a positive change in intention to pursue FM. There was a weak association between pursuing FM and participants' perception of physicians' interest in their work, rural rotation sites, positive interactions with physicians, perceptions of the rotation's level of difficulty, and degree of satisfaction with the final assessment. The results for other factors were not statistically significant. Concerning a negative change in the intention to pursue FM in residency, 2 factors were identified: the absence of a role model and lack of interest in returning to the rotation site. New positive factors were identified: overall atmosphere and the desire to return to the rotation site to practise. CONCLUSION: Several factors related to the FM rotations appeared to act as prime motivators for change toward pursuing FM. This could support the development of an assessment tool and the improvement of FM rotations.

Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants.

Background: Rotavirus vaccines given to infants are safe and efficacious. A booster dose of rotavirus vaccine could extend protection into the second year of life in low-resource countries. Methods: We conducted an open-label, individual-randomized trial in Bamako, Mali. We assigned 600 infants aged 9-11 months to receive measles vaccine (MV), yellow fever vaccine (YFV), and meningococcal A conjugate vaccine (MenAV) with or without pentavalent rotavirus vaccine (PRV). We assessed the noninferiority (defined as a difference of ≤10%) of seroconversion and seroresponse rates to MV, YFV, and MenAV. We compared the seroresponse to PRV. Results: Seroconversion to MV occurred in 255 of 261 PRV recipients (97.7%) and 246 of 252 control infants (97.6%; difference, 0.1% [95% confidence interval {CI}, -4.0%-4.2%]). Seroresponse to YFV occurred in 48.1% of PRV recipients (141 of 293), compared with 52.2% of controls (153 of 293; difference, -4.1% [95% CI, -12.2%-4.0%]). A 4-fold rise in meningococcus A bactericidal titer was observed in 273 of 292 PRV recipients (93.5%) and 276 of 293 controls (94.2%; difference, -0.7% [95% CI, -5.2%-3.8%]). Rises in geometric mean concentrations of immunoglobulin A and immunoglobulin G antibodies to rotavirus were higher among PRV recipients (118 [95% CI, 91-154] and 364 [95% CI, 294-450], respectively), compared with controls (68 [95% CI, 50-92] and 153 [95% CI, 114-207], respectively). Conclusions: PRV did not interfere with MV and MenAV; this study could not rule out interference with YFV. PRV increased serum rotavirus antibody levels. Clinical Trials Registration: NCT02286895.

Prevalence and Correlates of Autism Spectrum Disorders in Quebec: Prévalence et corrélats des troubles du spectre de l'autisme au Québec.

OBJECTIVE: To estimate the prevalence, comorbidities, and service use of people with autism spectrum disorders (ASDs) based on data from Quebec Integrated Chronic Diseases Surveillance System (QICDSS). METHODS: We included all residents up to age 24 eligible for health plan coverage who were in Quebec for at least 1 day from January 1, 1996, to March 31, 2015. To be considered as having an ASD, an individual had to have had at least 1 physician claim or hospital discharge abstract from 2000 to 2015 indicating one of the following ASD diagnosis codes: ICD-9 codes 299.0 to 299.9 or their ICD-10 equivalents. RESULTS: The QICDSS shows that the prevalence of ASD has risen steadily over the past decade to approximately 1.2% ( n = 16,940) of children and youths aged 1 to 17 years in 2014 to 2015. The same prevalence was obtained using Ministry of Education data. Common medical comorbidities included congenital abnormalities of the nervous system, particularly in the first year of life. Psychiatric comorbidity was much more highly prevalent, especially common mental disorders like anxiety and attention-deficit/hyperactivity disorder. Children and youths with ASDs made on average 2.3 medical visits per year compared with 0.2 in the general population. Between 18 and 24 years old, the mental health needs of individuals with ASDs were met less by medical specialists and more by general practitioners. CONCLUSION: Information derived from this database could support and monitor development of better medical services coordination and shared care to meet the continuous and changing needs of patients and families over time.

Drug samples in family medicine teaching units: a cross-sectional descriptive study: Part 2: portrait of drug sample management in Quebec.

OBJECTIVE: To draw a portrait of drug sample management in academic primary health care settings and assess conformity to existing Canadian guidelines. DESIGN: Descriptive cross-sectional survey. SETTING: All 33 family medicine teaching units (FMTUs) in Quebec that kept drug samples. PARTICIPANTS: Health care professionals or FMTU staff who managed drug samples (ie, managers). MAIN OUTCOME MEASURES: Drug sample managers completed a self-administered questionnaire between February and December 2013. Questionnaires inquired about sample selection, procurement, reception, storage, inventory, and disposal. Results were compared with the Canada's Research-Based Pharmaceutical Companies Code of Ethical Practices (2012) and the Canadian Medical Association Guidelines for Physicians in Interactions with Industry (2007). RESULTS: All 33 FMTUs responded to the questionnaire. According to managers, no FMTUs had written selection criteria to guide sample choice. Almost one-third (30%) of FMTUs had uncontrolled access to drug sample cabinets. Even though pharmaceutical companies must distribute drug samples to authorized professionals only, these professionals were involved in the procurement and the reception of samples in 79% and 56% of FMTUs, respectively. Only 15% of FMTUs kept track of samples distributed, 82% checked expiration dates, and 85% ensured proper disposal as recommended. CONCLUSION: The management of drug samples in the FMTUs in Quebec is heterogeneous, with many FMTUs and pharmaceutical companies not following Canadian guidelines.

Drug samples in family medicine teaching units: a cross-sectional descriptive study: Part 3: availability and use of drug samples in Quebec.

OBJECTIVE: To draw a portrait of drug sample distribution and to assess the concordance between drug samples distributed and the medical problems encountered in the ambulatory primary health care setting. DESIGN: Descriptive cross-sectional survey. A self-administered questionnaire was distributed to all health care professionals (HCPs) in family medicine teaching units (FMTUs) that kept drug samples between February and December 2013. Dispensers were defined as HCPs reporting the use of drug samples. Concurrently, an inventory log sheet was completed by managers of drug samples to document the contents of sample cabinets. Data from the Canadian Disease and Therapeutic Index were used as the criterion standard to assess the consistency between the drug samples found in the cabinets and the profile of the most frequent health problems encountered in primary care. SETTING: All 33 FMTUs that kept drug samples in Quebec. PARTICIPANTS: Health care professionals authorized to hand out drug samples (practising physicians, residents, pharmacists, and nurses), and managers of drug sample cabinets. MAIN OUTCOME MEASURES: Dispensing practices of HCPs; number of doses of each drug contained in the sample cabinets; total market value of the samples; concordance between the drug sample categories made available and the most common medical problems encountered in primary care; and data on safe handling, ethical issues, effect of the pharmaceutical industry on prescribing behaviour, and inventory of samples. RESULTS: Among 859 HCPs, 579 (67%) reported dispensing drug samples. A large proportion of dispensers (88%) were unable to find the specific drug they sought and half of them (51%) provided the patients with a drug sample even if it was not their first choice for treatment. The drug sample cabinet inventory revealed products from 292 different companies and identified a total of 382 363 medication doses for a total value of $201 872. We found gaps among types of drugs provided to patients, those the HCPs would consider useful, and those available in the cabinets. CONCLUSION: Drug samples available in FMTUs do not meet the needs of many patients and HCPs, suggesting that the main driving force for drug sample distribution is not patient care. Policies on drug samples in FMTUs should be uniform across the province, and management should be as strict as in community pharmacies. Otherwise, prohibiting their use should be considered.

Drug samples in family medicine teaching units: a cross-sectional descriptive study: Part 1: drug sample management policies and the relationship between the pharmaceutical industry and residents in Quebec.

OBJECTIVE: To determine the existence and the level of health care professional (HCP) knowledge of local policies regarding drug sample use and the relationship between residents and the pharmaceutical industry in academic primary health care settings. DESIGN: Descriptive cross-sectional survey. Health care providers were invited to complete a self-administered questionnaire on drug sample use between February and December 2013. Managers of drug samples were also asked to complete a specific questionnaire on drug sample management and policies and an inventory log sheet. Data about the existence of written policies were validated with health and social services centre (HSCC) directors or pharmacy departments and family medicine teaching unit (FMTU) directors between February and June 2014. SETTING: All 42 FMTUs in Quebec. PARTICIPANTS: All HCPs in the FMTUs authorized to hand out drug samples (practising physicians, residents, pharmacists, and nurses). Dispensers were defined as those who reported using drug samples. Managers were defined as HCPs or staff members who managed drug samples. MAIN OUTCOME MEASURES: Existence of written policies on drug sample use in HSCCs and FMTUs; whether FMTUs applied the HSCC policies if they existed; whether dispensers were aware of the existence of the policies; and whether policies on the relationships between residents and pharmaceutical companies existed. RESULTS: Among the 42 FMTUs, 33 (79%) kept drug samples. Of these, 30% (10 of 33) did not have policies about drug samples in the FMTU or in the HSCC. A total of 67% (579 of 859) of HCPs from these FMTUs reported using drug samples. Most dispensers did not know if a policy existed in their FMTU (n = 297; 51%) or their HSCC (n = 420; 73%). Eleven (26%) of the 42 FMTU directors reported having a policy regarding relationships between residents and the pharmaceutical industry. Most drug sample dispensers were not aware whether such a policy existed (n = 310; 54%). CONCLUSION: Many FMTUs did not have policies regarding drug samples or relationships between residents and the pharmaceutical industry. Variation in use and management of drug samples and the lack of knowledge of HCPs about the existence of policies point to the need to implement uniform policies in all FMTUs in Quebec.

Temporal Trends in the Prevalence and Incidence of Diagnosed ADHD in Children and Young Adults between 1999 and 2012 in Canada: A Data Linkage Study.

OBJECTIVE: There is a need for the routine monitoring of treated attention-deficit hyperactivity disorder (ADHD) for timely policy making. The objective is to report and assess over a decade the prevalence and incidence of diagnosed ADHD in Canada. METHODS: Administrative linked patient data from the provinces of Manitoba, Ontario, Quebec, and Nova Scotia were obtained from the same sources as the Canadian Chronic Diseases Surveillance Systems to assess the prevalence and incidence of a primary physician diagnosis of ADHD ( ICD-9 and ICD-10 codes: 314, F90.x) for consultations in outpatient and inpatient settings (Med-Echo in Quebec, the Canadian Institute of Health Information Discharge Abstract Database in the 3 other provinces, plus the Ontario Mental Health Reporting System). Dates of service, diagnosis, and physician specialty were retained. The estimates were presented in yearly brackets between 1999-2000 and 2011-2012 by age and sex groups. RESULTS: The prevalence of ADHD between 1999 and 2012 increased in all provinces and for all groups. The prevalence was approximately 3 times higher in boys than in girls, and the highest prevalence was observed in the 10- to 14-year age group. The incidence increased between 1999 and 2012 in Manitoba, Quebec, and Nova Scotia but remained stable in Ontario. Incident cases were more frequently diagnosed by general practitioners followed by either psychiatrists or paediatricians depending on the province. CONCLUSION: The prevalence and incidence of diagnosed ADHD did not increase similarly across all provinces in Canada between 1999 and 2012. Over half of cases were diagnosed by a general practitioner.

Integrating Intimate Partner Violence Screening and Counseling in a Family Planning Clinic: Evaluation of a Pilot Project in Conakry, Guinea.

Few programs exist to address Intimate Partner Violence (IPV) in Guinea. In 2014, Engender Health, in partnership with the local health authorities in Conakry, Guinea, piloted an integrated approach to IPV screening and counseling, within an existing family planning clinic. This article describes both the process of formulating and implementing this approach, as well as the results of an evaluation of the program. From January to June of 2014, Engender Health staff trained midwives at the Conakry International Planned Parenthood Federation family planning clinic staff in screening and counseling client for IPV. Program evaluators used project records, interview with program staff (n=3), midwives (n=3) and client exit interviews (n=53) to measure the outcomes of this pilot project. Regardless of their IPV status, clients appreciated having a venue in which to discuss IPV. Program staff also felt empowered by the additional training and support for IPV screening. The evaluation yielded valuable suggestions for improvement, including more time for staff training and mock client interview practice, additional skills in counseling, and stronger referral links for women who screen positive for IPV. Integrating IPV screening into family planning services is an important and feasible method for reaching vulnerable women with IPV services.

A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.

BACKGROUND: A safe, affordable, and highly immunogenic meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed to control epidemic group A meningitis in Africa. Documentation of the safety specifications of the PsA-TT vaccine was warranted, with sufficient exposure to detect potential rare vaccine-related adverse reactions. METHODS: This phase 3, double-blind, randomized, active controlled clinical study was designed to evaluate the safety--primarily vaccine-related serious adverse events (SAEs)--up to 3 months after administration of a single dose of the PsA-TT vaccine to subjects aged 1-29 years in Mali. Safety outcomes were also compared to those following a single dose of a licensed meningococcal ACWY polysaccharide vaccine (PsACWY). RESULTS: No vaccine-related SAEs occurred during the 3 months of follow-up of 4004 subjects vaccinated with a single dose of PsA-TT. When compared to PsACWY (1996 subjects), tenderness at the injection site appeared to be more frequent in the PsA-TT group. However, rates of local induration, systemic reactions, adverse events (AEs), and SAEs were similar in both groups, and unsolicited AEs and SAEs were all unrelated to the study vaccines. CONCLUSIONS: The study confirmed on a large scale the excellent safety profile of a single dose of PsA-TT when administered to its entire target population of 1-29 years of age. CLINICAL TRIALS REGISTRATION: PACTR ATMR201003000191317.

Antibody Persistence 1-5 Years Following Vaccination With MenAfriVac in African Children Vaccinated at 12-23 Months of Age.

BACKGROUND: Following mass vaccination campaigns in the African meningitis belt with group A meningococcal conjugate vaccine, MenAfriVac (PsA-TT), disease due to group A meningococci has nearly disappeared. Antibody persistence in healthy African toddlers was investigated. METHODS: African children vaccinated at 12-23 months of age with PsA-TT were followed for evaluation of antibody persistence up to 5 years after primary vaccination. Antibody persistence was evaluated by measuring group A serum bactericidal antibody (SBA) with rabbit complement and by a group A-specific IgG enzyme-linked immunosorbent assay (ELISA). RESULTS: Group A antibodies measured by SBA and ELISA were shown to decline in the year following vaccination and plateaued at levels significantly above baseline for up to 5 years following primary vaccination. CONCLUSIONS: A single dose of PsA-TT induces long-term sustained levels of group A meningococcal antibodies for up to 5 years after vaccination. CLINICAL TRIALS REGISTRATION: ISRTCN78147026.