Reactive, self-administered malaria treatment against asymptomatic malaria infection: results of a cluster randomized controlled trial in The Gambia.

BACKGROUND: Selectively targeting and treating malaria-infected individuals may further decrease parasite carriage in low-burden settings. Using a trans-disciplinary approach, a reactive treatment strategy to reduce Plasmodium falciparum prevalence in participating communities was co-developed and tested. METHODS: This is a 2-arm, open-label, cluster-randomized trial involving villages in Central Gambia during the 2017 and 2018 malaria transmission season. Villages were randomized in a 1:1 ratio using a minimizing algorithm. In the intervention arm, trained village health workers delivered a full course of pre-packed dihydroartemisinin-piperaquine to all residents of compounds where clinical cases were reported while in the control arm, compound residents were screened for infection at the time of the index case reporting. All index cases were treated following national guidelines. The primary endpoint was malaria prevalence, determined by molecular methods, at the end of the intervention period. RESULTS: The trial was carried out in 50 villages: 34 in 2017 and 16 additional villages in 2018. At the end of the 2018 transmission season, malaria prevalence was 0.8% (16/1924, range 0-4%) and 1.1% (20/1814, range 0-17%) in the intervention and control arms, respectively. The odds of malaria infection were 29% lower in the intervention than in the control arm after adjustment for age (OR 0.71, 95% CI 0.27-1.84, p = 0.48). Adherence to treatment was high, with 98% (964/979) of those treated completing the 3-day treatment. Over the course of the study, only 37 villages, 20 in the intervention and 17 in the control arm, reported at least one clinical case. The distribution of clinical cases by month in both transmission seasons was similar and the odds of new clinical malaria cases during the trial period did not vary between arms (OR 1.04, 95% CI 0.57-1.91, p = 0.893). All adverse events were classified as mild to moderate and resolved completely. CONCLUSION: The systematic and timely administration of an anti-malarial treatment to residents of compounds with confirmed malaria cases did not significantly decrease malaria prevalence and incidence in communities where malaria prevalence was already low. Treatment coverage and adherence was very high. Results were strongly influenced by the lower-than-expected malaria prevalence, and by no clinical cases in villages with asymptomatic malaria-infected individuals. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, NCT02878200. Registered 25 August 2016. https://clinicaltrials.gov/ct2/show/NCT02878200 .

Eliminating Use of Home Oral Antibiotics in Pediatric Complicated Appendicitis.

BACKGROUND: Postoperative oral antibiotic management at discharge for perforated appendicitis varies by institution. A prior study at our institution led to a decrease in antibiotic therapy in patients without leukocytosis. A subsequent protocol change eliminated the white blood cell count check and oral antibiotics if discharge criteria were met by postoperative day seven. We hypothesized this change could be made without an increase in abscess or readmission rates. METHODS: We conducted a retrospective review of patients with perforated appendicitis over two 1-year periods after institutional review board approval (262061). In the pre-protocol group, a white blood cell count was checked at discharge and patients with leukocytosis were prescribed oral antibiotics to complete a total of 7 d. In the post-protocol group, no white blood cell count was checked and patients were discharged home without antibiotics. RESULTS: There were a total of 174 patients with complicated appendicitis in the two 1-year periods with 129 (74%) patients with perforated appendicitis discharged before postoperative day seven. The pre-protocol group included 71 children, and post-protocol included 58 children. There were no differences between mean postoperative days to discharge (2.57 versus 3, P = 0.0896), postoperative abscess rate (12.7% versus 12.1%, P = 1.0000), or readmission rate (12.7% versus 17.2%, P = 0.6184). None of the patients in the post-protocol group were discharged home with oral antibiotics compared with 22.5% in the pre-protocol group (P < 0.001). CONCLUSIONS: For pediatric patients with perforated appendicitis discharged before postoperative day seven, stopping antibiotics at the time of discharge significantly decreased our home antibiotic use without an increase in postoperative morbidity.

Patient/parent administered epinephrine in acute anaphylaxis.

BACKGROUND: Among patients with a known peanut allergy, previous studies suggest low carrying rates of epinephrine auto-injectors (EAIs) and hesitancy to self-administer epinephrine upon anaphylaxis onset. Given the high prescription rates of epinephrine and prevalence of peanut allergies, it is important to identify rates of on-scene EAI use and affecting factors. METHODS: The electronic medical records of 217 patients-either with an ED diagnosis of peanut anaphylaxis or diagnosis of anaphylaxis with a known epinephrine prescription from 2010 through May 2020--were reviewed for physician notes and demographic factors. RESULTS: Epinephrine was administered on-scene by 25.3% of anaphylaxis patients. Of the 6 health care professionals identified, 100% administered epinephrine on-scene. Females (32.2%) were administered epinephrine on-scene more frequently than males (19.8%; p = 0.04). Rate of epinephrine administration increased from 2010 through 2019 (p = 0.005). CONCLUSION: This study selected for individuals diagnosed with anaphylaxis, meaning EAI use should have been observed nearly 100% of the time. An administration rate of 22.6% observed among individuals not identified as health care professionals suggests that the majority of patients prescribed epinephrine have not used their EAIs, even when presented an opportunity for application. The administration rate of 100% observed among health care professionals indicates that comfort with EAIs facilitates willingness to administer on-scene. EAIs can range up to $900 in expense, thus physicians should employ EAI training devices and other training strategies.

Adherence to Oral Anticancer Therapeutics in the Gynecologic Oncology Population.

INTRODUCTION: To gain a better understanding of gynecologic oncology patient adherence to oral anticancer agents through both a cross-sectional survey of adherence and qualitative interviews with patients and clinicians regarding their experience with these medications. METHODS: Eligible participants completed a survey for this cross-sectional study that included an assessment of adherence, distress, quality of life, and health literacy. Any woman taking an oral anticancer agent for a gynecologic malignancy at a tertiary academic medical center for 30 days or more was eligible. Semi-structured qualitative interviews (n=14) were then conducted to explore experiences with oral anticancer agents. We also conducted a qualitative group interview with physicians and nurse practitioners. RESULTS: One hundred women taking oral anticancer agents were enrolled. Fifty-four percent reported perfect adherence to their medication, 21% reported equivocal adherence (demonstrating at least one nonadherent behavior in the previous 7 days), and 25% reported nonadherence (demonstrating more than one nonadherent behavior in the previous 7 days). Qualitative analysis identified five major themes: ease of use compared with traditional therapy; the mental burden of self-administrated medication; perceived importance of the medication; management of side effects; and the desire for consistent physician communication. Common misperceptions expressed in the health care professional interviews included high adherence to oral medications and a belief that cost was the biggest barrier to adherence. CONCLUSION: Almost half of the patients surveyed reported equivocal or nonadherence to their oral anticancer agent. The qualitative interviews identified several important themes, many of which were not recognized by physicians and nurse practitioners. These findings highlight the need for patient and health care professional interventions to improve patient adherence.

Availability of over-the-counter antibiotics in Guatemalan corner stores.

Widespread availability of antibiotics without prescription potentially facilitates overuse and contributes to selection pressure for antimicrobial resistant bacteria. Prior to this study, anecdotal observations in Guatemala identified corner stores as primary antibiotic dispensaries, where people purchase antibiotics without prescriptions. We carried out a cross sectional study to document the number and types of antibiotics available in corner stores, in four study areas in Guatemala. A total of 443 corner stores were surveyed, of which 295 (67%) sold antibiotics. The most commonly available antibiotics were amoxicillin, found in 246/295 (83%) stores, and tetracycline, found in 195/295 (66%) stores. Over the counter sales result from laissez-faire enforcement of antibiotic dispensing regulations in Guatemala combined with patient demand. This study serves as a baseline to document changes in the availability of antibiotics in informal establishments in light of new pharmacy regulations for antibiotic dispensing, which were adopted after this study was completed.

Subjective health, general medicine beliefs and social desirability response among older hospital outpatients in Hong Kong.

OBJECTIVES: The aim of this study was to investigate any association between self-rated health (SRH) and general perception about medicines using the Beliefs About Medicine Questionnaire-General (BMQ-G) in Hong Kong hospital outpatients. Moreover, the study aims to demonstrate any association between social desirability bias or response (SDR) and BMQ-G, SRH reporting in this population. METHODS: Seven hundred and sixty-nine outpatients, who satisfied the selection criteria, were cordially invited to participate in this study by completing a combined questionnaire of demographic information, BMQ-G, SRH and SDR Set-5 in person, while waiting to collect their medications outside a Hong Kong hospital pharmacy. Results were analysed statistically. KEY FINDINGS: The number of valid questionnaires returned for statistical analysis was 698. Logistic regressions indicated age groups, gender and SRH were significant predictors for BMQ-G reporting. Patients aged over 62, male or those with high SRH were less likely to present high BMQ-G scores, compared to patients aged under 45, female or those with low SRH, respectively (OR 0.43, 0.73 and 0.66, respectively, all CIs 95%). Logistic regressions also demonstrated overall BMQ-G, and SRH reporting was unlikely to be associated with SDR (all P > 0.05) although age was a significant predictor for SDR reporting (OR = 1.10; CI 95%). CONCLUSIONS: This study illustrated age groups, gender and self-rated health significantly associated with general medicine beliefs reporting. The possible association between socially desirable bias and general medicine beliefs or self-rated health reporting was insignificant.

Analgesic Outcomes in a Danish Acute Care Hospital Following Electronic Prescribing and Analgesic Self-Administration.

BACKGROUND: Despite the long-term consequences of poorly controlled postoperative pain, inadequate pain control remains a problem. AIMS: To improve the quality of postoperative pain management, the study site, an acute care hospital in Denmark, introduced electronic prescribing with standard order-sets, and allowed patients to self-administer analgesia. This study aimed to describe analgesic prescribing, prescriptions for multimodal analgesia, analgesic administration, and patients' pain experience, in this context. DESIGN: Point-prevalence survey. SETTINGS: One Danish regional hospital. PARTICIPANTS: Consecutive sample of 286 surgical inpatients comprising 65 orthopaedic, 41 gynaecological, 57 urology and 123 gastrointestinal patients. METHODS: We evaluated the quality of postoperative pain management on four postoperative surgical wards using: (1) the Revised American Pain Society Patient Outcome Questionnaire; and (2) patient chart audit. RESULTS: Overall, 89.2% of patients were prescribed a fixed analgesic and 71.7% were prescribed fixed analgesics in multimodal combination. Patterns of multimodal prescribing and administration varied significantly across surgical groups. Patients received 87.7% of available fixed prescriptions and 22.5% of available analgesics prescribed 'as needed'. However, patients' worst pain intensity was high (mean = 5.8/10, SD = 2) and 73.4% reported moderate-to-severe worst pain during the previous 24-hours. Patients who self-administered medications used significantly more fixed-schedule paracetamol (p = .018), non-steroidal anti-inflammatory drugs (p = .001), weak (p = .035) and strong (p < .001) opioids. CONCLUSIONS: The availability of multimodal analgesia was high following the introduction of electronic prescribing. However, gaps remain in the administration of both fixed and 'as needed' analgesics for postoperative patients. Findings suggested that allowing patients to self-administer analgesia may increase compliance with fixed schedule prescriptions.

Detection of hearing problems in Aboriginal and Torres strait islander children: a comparison between clinician-administered and self-administrated hearing tests.

Objective: This study evaluated the agreement of self-administered tests with clinician-administered tests in detecting hearing loss and speech-in-noise deficits in Aboriginal & Torres Strait Islander children.Design: Children completed clinician-administered audiometry, self-administered automatic audiometry (AutoAud), clinician-administered Listening in Spatialised Noise - Sentences test and self-administered tablet-based hearing game Sound Scouts. Comparisons were made between tests to determine the agreement of the self-administered tests with clinician-administered tests in detecting hearing loss and speech-in-noise deficits.Study sample: Two hundred and ninety seven Aboriginal and Torres Strait Islander children aged 4-14 years from three schools.Results: Acceptable threshold differences of ≤5 dB between AutoAud and manual audiometry hearing thresholds were found for 88% of thresholds, with a greater agreement for older than for younger children. Consistent pass/fail results on the Sound Scouts speech-in-quiet measure and manual audiometry were found for 81% of children. Consistent pass/fail results on the Sound Scouts speech-in-noise measure and LiSN-S high-cue condition were found for 73% of children.Conclusions: This study shows good potential in using self-administered applications as initial tests for hearing problems in children. These tools may be especially valuable for children in remote locations and those from low socio-economic backgrounds who may not have easy access to healthcare.

Risk Factors for Medication Nonadherence to Self-Injectable Biologic Therapy in Adult Patients With Inflammatory Bowel Disease.

BACKGROUND: In inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), nonadherence to biologic therapy increases risk of disease flare. The aim of this study was to identify risk factors for nonadherence. METHODS: This was a single-center retrospective study evaluating patients with IBD treated at a tertiary care center and prescribed self-injectable biologic therapy using the center's specialty pharmacy. Adherence was defined using medication possession ratio (MPR). Nonadherence was defined as MPR <0.86. RESULTS: Four hundred sixty patients (n = 393 with CD and n = 67 with UC) were evaluated with mean MPR (interquartile range) equaling 0.89 (0.48-1). Overall, 69% of patients were adherent (defined as MPR ≥0.86), 66% of patients with CD and 87% of patients with UC. In univariate analysis, several factors increased risk of nonadherence: CD diagnosis, insurance type, psychiatric history, smoking, prior biologic use, and narcotic use (P < 0.05). In multivariable analysis, Medicaid insurance (odds ratio [OR], 5.5; 95% confidence interval [CI], 1.85-15.6) and CD diagnosis (OR, 2.8; 95% CI, 1.3-6.0) increased risk of nonadherence. In CD, as the number of risk factors increased (narcotic use, psychiatric history, prior biologic use, and smoking), the probability of nonadherence increased. Adherence was 72% in patients with 0-1 risk factors, decreasing to 62%, 61%, and 42% in patients with 2, 3, and 4 risk factors, respectively (P < 0.05). CONCLUSIONS: This study identified risk factors for nonadherence to biologic therapy. In patients with CD, the probability of nonadherence increased as the number of risk factors increased.

Is non-traditional therapy for multiple sclerosis overwhelming in Saudi Arabia.

OBJECTIVE: To describe the prevalence, knowledge and attitudes about complementary and alternative medicine (CAM) use and the proportion that seek advice from their physician about CAM use. METHODS: This cross-sectional observational study was performed in multiple sclerosis (MS) clinic of King Fahd Hospital of Universityin Alkhobar, Kingdom of Saudi Arabia from January-June 2017. A total of 133 patients have completed the survey. RESULTS: The mean age of patients was 32.3+/-7.6 years and 84 (63.2%) were female. Approximately 83.5% of the patients reported the use of CAM. Among all the reported forms of CAM, vitamins were the most prevalent form, followed by cupping, special prayers and meditation. The majority of patients (62%) obtained knowledge of CAM through social media. A significant number of patients (75.6%) did not disclose the use of CAM to their physician. There was a trend for using CAM more in highly educated, older age, and female patients. The most commonly reported rationale to use CAM was overall improvement in health status. CONCLUSION: The use of CAM among Saudi patients with MS is highly prevalent, without disclosure of its use to physicians. These factors should be taken into account in the doctor-patient consultation to avoid adverse events.

Trends in Medical Aid in Dying in Oregon and Washington.

Importance: The combined 28 years of data of medical aid in dying (MAID) between Oregon (OR) and Washington (WA) are the most comprehensive in North America. No reports to date have compared MAID use in different US states. Objective: To evaluate and compare patterns of MAID use between the states with the longest-running US death with dignity programs. Design, Setting, and Participants: A retrospective observational cohort study of OR and WA patients with terminal illness who received prescriptions as part of their states' legislation allowing MAID. All published annual reports, from 1998 to 2017 in OR and from 2009 to 2017 in WA, were reviewed. A total of 3368 prescriptions were included. Main Outcomes and Measures: Number of deaths from self-administration of lethal medication vs number of prescriptions written. Results: A combined 3368 prescriptions were written in OR and WA, with 2558 patient deaths from lethal ingestion (76.0%). Of the 2558 patients, most were male (1311 [51.3%]), older than 65 years (1851 [72.4%]), and non-Hispanic white (2426 [94.8%]). The most common underlying illnesses were cancer (1955 [76.4%]), neurologic illness (261 [10.2%]), lung disease (144 [5.6%]), and heart disease (117 [4.6%]). Loss of autonomy (2235 [87.4%]), impaired quality of life (2203 [86.1%]), and loss of dignity (1755 [68.6%]) were the most common reasons for pursuing MAID. Time between drug intake to coma ranged from 1 to 660 minutes and time from drug intake to death ranged from 1 to 6240 minutes. In the 1557 patients for whom rates of complications were reported, 1494 (96.0%) did not experience a complication (592 of 626 [94.6%] in OR and 902 of 931 [96.8%] in WA). Eight patients (<0.5%) regained consciousness after drug ingestion in OR. Annual rates per year for percentage of patients who received a prescription ingesting the prescribed medication ranged from 48% to 87%, with no significant time trend in OR (adjusted odds ratio per year, 1.01; 95% CI, 0.99-1.02; P = .59) but with an increase over time in WA (adjusted odds ratio per year, 1.13; 95% CI, 1.08-1.19; P < .001). In both OR and WA there were increases in the number of patient deaths due to MAID per 1000 deaths over time. Conclusions and Relevance: In this study, MAID results in Oregon and Washington were similar, although MAID use measured as a percentage of patients prescribed lethal medications and then self-administering them increased only in WA. Most patients who acquired lethal prescriptions had cancer or terminal illnesses that are difficult to palliate and lead to loss of autonomy, dignity, and quality of life.

Improving adrenaline autoinjector adherence: A psychologically informed training for healthcare professionals.

BACKGROUND: Clinicians draw on instructional approaches when training patients with anaphylaxis to use adrenaline autoinjectors, but patient use is poor. Psychological barriers to these behaviours exist but are not considered routinely when training patients to use autoinjectors. Health Psychology principles suggest exploring these factors with patients could improve their autoinjector use. OBJECTIVE: To evaluate the impact of a 90-minute workshop training clinicians in strategies and techniques for exploring and responding to psychological barriers to autoinjector use with patients. Attendees' knowledge, confidence and likelihood of using the strategies were expected to improve. METHODS: Impact was evaluated using a longitudinal mixed-method design. Twenty-nine clinicians (general and specialist nurses, general practitioners, and pharmacists) supporting patients with anaphylaxis in UK hospitals and general practice attended. Self-rated knowledge, confidence, and likelihood of using the strategies taught were evaluated online 1 week before, 1 to 3, and 6 to 8 weeks after the workshop. Clinicians were invited for telephone interview after attending to explore qualitatively the workshop impact. RESULTS: χ2 analyses were significant in most cases (P < .05), with sustained (6-8 weeks) improvements in knowledge, confidence, and likelihood of using the strategies taught. Thematic analysis of interview data showed the workshop enhanced attendees' knowledge of the care pathway, understanding of patient's experience of anaphylaxis as psychological not purely physical, and altered their communication with this and other patient groups. However, interviewees perceived lack of time and organisational factors as barriers to using the strategies and techniques taught in clinical contexts. CONCLUSION: Training clinicians in psychologically informed strategies produce sustained improvements in their confidence and knowledge around patient autoinjector education, and their likelihood of using strategies in clinical practice. CLINICAL RELEVANCE: Exploring psychological barriers should be part of training patients with anaphylaxis in autoinjector use.

Effectiveness and Safety of Physician-Led Versus Patient-Led Titration of Insulin Glargine in Indian Patients with Type 2 Diabetes Mellitus: A Subanalysis of the Asian Treat to Target Lantus Study (ATLAS).

Background: Titration of basal insulin led by either the physician or the patient is not well understood in India. This analysis of Indian subset of Asian Treat to Target Lantus Study (ATLAS) compared effectiveness of patient-led with physician-led titration of once-daily insulin glargine 100 U/mL (Glargine-U-100) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetes drug (OAD). Methods: In this open-label parallel group study, randomized patients (either physician-led or patient-led [self-titration] group) followed the same dose titration algorithm (fasting blood glucose [FBG] target 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led group versus the physician-led group. Results: Patients (40-75 years) were randomized to either the physician-led group (n = 39) or the patient-led group (n = 36). At week 24, self-titration led to a greater decline in HbA1c than physician-led titration (-1.3% vs. -1.1%). Mean decrease in FBG was more in the patient-led group than in the physician-led group (-53.7 mg/dL vs. -35.5 mg/dL). Mean daily dose of Glargine-U-100 at week 24 was higher in the patient-led group than in the physician-led group (30.0 U vs. 23.8 U). At any time during the study, 30.6% and 7.7% of patients in the patient-led and physician-led groups, respectively, showed target HbA1c level of <7.0% without severe hypoglycemia. Treatment satisfaction and quality of life improved in both groups. Overall, treatment was safe and well tolerated, and none of the events led to treatment discontinuation. Conclusion: Patient-led adjustment of Glargine-U-100 in outpatient setting can be a safe and effective method for glycemic control in Indian patients with T2DM uncontrolled on OADs.

[The medical aspect of using anabolic androgenic steroids in males attending gyms of Saint-Petersburg].

BACKGROUND: Anabolic androgenic steroids (AASs) are often used by individuals engaged in physical recreational activity. AASs inhibit the hypothalamus-pituitary-gonad axis and can cause erectile dysfunction and reduced fertility. There is no data on the use of AASs in this category of people in the Russian Federation; therefore, a study exploring the rate and patterns of using steroids for non-medical purposes is topical. Aim - of this study was to investigate the rate and patterns of using AASs in males attending gyms in Saint Petersburg. MATERIAL AND METHODS: We used individual anonymous postal survey of males attending gyms. We analyzed demographic and anthropometric data, information on the use of AASs, awareness of their side effects, used agents, patterns and duration of their use, and rehabilitation therapy. RESULTS: Out of 1,815 sent questionnaires, we received back 762 ones. The criteria were met by 550 questionnaires. The mean age was 29.3±7.4 years. The use of AASs was reported by 30.4% of respondents. The main AAS (74.3%) consumers were males aged 22 to 35 years. The most popular drug was Testosterone Propionate (51.5%); the drug was often combined with Oxandrolone (19.7%). In 70.6% of cases, drugs were administered by injection or injection combined with tablet intake. The injectable testosterone dose ranged from 500 to 2,000 mg/week and above. The most common dose was 1,000 mg/week (23.9%). AAS administration for more than 1 year was reported in 16.1% of males. Anastrozole (55%), hCG (51.3%), Clomiphene (41.3%), and Tamoxifen (30.5%) were used during the recovery period. The main source of information on AASs, doses, and dosage patterns was the Internet (48.7%). A negative attitude towards AASs was found in 17.3% of respondents. The desire to receive qualified information about AASs and their impact on health was reported by 54.8% of the surveyed respondents. CONCLUSION: Almost every fourth gym visitor has experience in using AASs. These are males of an optimal reproductive age. The common pattern of using AASs is an aggressive steroid course followed by a recovery period. The list of used drugs and their doses indicate a significant pharmacological intervention and a high risk to health.

Impact of a SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Feasibility Study.

The purpose of the current study was to examine the feasibility and acceptability of a SystemCHANGE™ intervention in improving medication adherence in older adults with heart failure (HF). Adults age ≥50 years with HF who self-administered diuretics were screened for 2 months using electronic monitoring to determine baseline adherence scores. Participants were randomized into the SystemCHANGE™ or attention-control group if adherence scores were <88%. The SystemCHANGE™ intervention focuses on changing the individual's environment by including medication taking into existing routines, receiving support from individuals who impact routines, and using small experiments with feedback. Challenges were noted by participants in using the electronic medication monitor technology during the screening phase. Lessons learned from this study emphasize the need to revise recruitment procedures and include multiple sites. Education and counseling should be adapted to the cognitive level of the participant and address technology challenges. [Journal of Gerontological Nursing, 45(4), 15-19.].

Adherence to intermittent preventive treatment for malaria in Papua New Guinean infants: A pharmacological study alongside the randomized controlled trial.

BACKGROUND: The intermittent preventive treatment in infants (IPTi) trial that took place in Papua New Guinea showed an overall reduction of 29% of the risk of malaria when delivering single-dose sulfadoxine-pyrimethamine (SP) associated to 3 days of amodiaquine (AQ) every three months to children during the first year of life. The aim of the present study was to assess if the last two doses of AQ were truly administered as prescribed by the parents at home based on drug level measurement and PK modelling, which is a good proxy of medication adherence. It provides also important information to discuss the efficacy of the intervention and on feasibility of self-administered preventive malaria treatment. METHODS AND FINDINGS: During the three-arm randomized double-blinded IPTi trial, each child was prescribed one dose of SP (day 0) and 3 doses of either AQ or artesunate (AS) at day 0, 1 & 2 adjusted to weight or placebo. Treatments were given at 3, 6, 9 and 12 months of age. The first day of treatment was delivered by nursing staff (initiation under directly observed treatment (DOT)) and the two last doses of AQ or AS by parents at home without supervision. For this cross-sectional study, 206 consecutive children already involved in the IPTi trial were enrolled over a 2-month period. At the time of the survey, allocation of the children to one of the three arms was not known. Blood samples for drug level measurement were collected from finger pricks one day after the planned last third dose intake. Only children allocated to the SP-AQ arm were included in the present analysis. Indeed, the half-life of AS is too short to assess if drugs were given on not. Because of the short half-life of AQ, desethyl-AQ (metabolite of AQ (DAQ)) measurements were used to investigate AQ medication adherence. Two PK (PK) models from previously published studies in paediatric populations were applied to the dataset using non-linear mixed effect modelling (NONMEM) to estimate the number of doses really given by the parents. The study nurse reported the administration time for the first AQ dose while it was estimated by the parents for the remaining two doses. Out of 206 children, 64 were in the SP-AQ arm. The adjusted dosing history for each individual was identified as the one with the lowest difference between observed and individual predicted concentrations estimated by the two PK models for all the possible adherence schemes. The median (range) blood concentration AQ in AQ arm was 9.3 ng/mL (0-1427.8 ng/mL), (Quartiles 1-3: 2.4 ng/mL -22.2 ng/mL). The median (range) for DAQ was 162.0 ng/mL (0-712 ng/mL), (Quartiles 1-3: 80.4 ng/mL-267.7 ng/mL). Under the assumption of full adherence for all participants, a marked underprediction of concentrations was observed using both PK models. Our results suggest that only 39-50% of children received the three scheduled doses of AQ as prescribed, 33-37% two doses and 17-24% received only the first dose administered by the study nurse. Both models were highly congruent to classify adherence patterns. CONCLUSIONS: Considering the IPTi intervention, our results seem to indicate that medication adherence is low in the ideal trial research setting and is likely to be even lower if given in day-to-day practice, questioning the real impact that this intervention might have. More generally, the estimation of the number of doses truly administered, a proxy measure of adherence and an assessment of the feasibility of the mode of administration, should be more thoroughly studied when discussing the efficacy of the interventions in trials investigating self-administered malaria preventive treatments.

Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial.

BACKGROUND: Directly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT. METHODS: We did a multicentre, analyst-blinded, randomised controlled superiority trial in 22 clinics in England (UK). Eligible participants were patients aged at least 16 years with active pulmonary or non-pulmonary tuberculosis who were eligible for DOT according to local guidance. Exclusion criteria included patients who did not have access to charging a smartphone. We randomly assigned participants to either VOT (daily remote observation using a smartphone app) or DOT (observations done three to five times per week in the home, community, or clinic settings). Randomisation was done by the SealedEnvelope service using minimisation. DOT involved treatment observation by a health-care or lay worker, with any remaining daily doses self-administered. VOT was provided by a centralised service in London. Patients were trained to record and send videos of every dose ingested 7 days per week using a smartphone app. Trained treatment observers viewed these videos through a password-protected website. Patients were also encouraged to report adverse drug events on the videos. Smartphones and data plans were provided free of charge by study investigators. DOT or VOT observation records were completed by observers until treatment or study end. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrolment. Intention-to-treat (ITT) and restricted (including only patients completing at least 1 week of observation on allocated arm) analyses were done. Superiority was determined by a 15% difference in the proportion of patients with the primary outcome (60% vs 75%). This trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN26184967. FINDINGS: Between Sept 1, 2014, and Oct 1, 2016, we randomly assigned 226 patients; 112 to VOT and 114 to DOT. Overall, 131 (58%) patients had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. In the ITT analysis, 78 (70%) of 112 patients on VOT achieved ≥80% scheduled observations successfully completed during the first 2 months compared with 35 (31%) of 114 on DOT (adjusted odds ratio [OR] 5·48, 95% CI 3·10-9·68; p<0·0001). In the restricted analysis, 78 (77%) of 101 patients on VOT achieved the primary outcome compared with 35 (63%) of 56 on DOT (adjusted OR 2·52; 95% CI 1·17-5·54; p=0·017). Stomach pain, nausea, and vomiting were the most common adverse events reported (in 16 [14%] of 112 on VOT and nine [8%] of 114 on DOT). INTERPRETATION: VOT was a more effective approach to observation of tuberculosis treatment than DOT. VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective, and cheaper option for supervision of daily and multiple daily doses than DOT. FUNDING: National Institute for Health Research.

Conocimiento, factores condicionantes y características de automedicación en estudiantes de enfermería y medicina / Knowledge, conditionig factors and characteristics of self-medicationin nursing and medicine students

La automedicación es una práctica de deno-minación moral subjetiva muy frecuente en los pacientes ambulatorios, en la cual estos optan por adquirir medicamentos sin pres-cripción médica para el alivio de dolencias, frecuentemente consideradas de baja seve-ridad. Objetivo: Determinar el conocimien-to, factores condicionantes y características de automedicación en los estudiantes de las carreras enfermería y medicina de la Escue-la Universitaria de Ciencias de la Salud de la Universidad Nacional Autónoma de Hondu-ras en el Valle de Sula (EUCS/UNAH-VS) en el primer semestre del 2017. Pacientes y Métodos: Estudio cuantitativo, alcance des-criptivo, transversal, prospectivo, realizado en estudiantes de la carrera de enfermería y medicina de la EUCS/UNAH-VS que cursa-ban el 2do y 3er año el primer semestre del 2017. La muestra fue no probabilística por conveniencia de 55 estudiantes pertene-cientes a cada carrera, en total 110. Resul-tados: Se encontró que 50 (90.9%) estu-diantes de enfermería y 49 (89.09%) de medicina admitieron automedicarse. La mayoría no conocen las indicaciones y/o efectos adversos de los fármacos utilizados para automedicarse. El 45.45% (25) de enfermería y 63.63% (35) ignoran la dosificación. Un 67.27% (37) de enfermería y 61.8% (34) de medicina desconocen los efectos adversos de las dosificaciones exce-sivas. La principal causa de automedicación fue la consideración de malestares como no graves, siendo manejados en casa. Conclu-sión: La mayoría de los estudiantes de ambas carreras desconocen sobre indica-ciones, efectos adversos y dosificación de los medicamentos y los toman considerando los malestares no graves y no por los efec-tos que el medicamento pueda causarles. El principal síntoma que presentaron es la cefalea y el medicamento que más consu-mían fué el acetaminofen...(AU)