Daily Medication Use Research Articles

No impact of a prescription booklet on medication consumption in nursing home residents from 2011 to 2014: a controlled before\u2013after study

BackgroundOlder persons are particularly exposed to adverse events from medication. Among the various strategies to reduce polypharmacy, educational approaches have shown promising results. We aimed to evaluate the impact on medication consumption, of a booklet designed to aid physicians with prescriptions for elderly nursing home residents.MethodsAmong 519 nursing homes using an electronic pill dispenser, we recorded the daily number of times that a drug was administered for each resident, over a period of 4 years. The intervention group comprised 113 nursing homes belonging to a for-profit geriatric care provider that implemented a booklet delivered to prescribers and pharmacists and specifically designed to aid with prescriptions for elderly nursing home residents. The remaining 406 nursing homes where no such booklet was introduced comprised the control group. Data were derived from electronic pill dispensers. The effect of the intervention on medication consumption was assessed with multilevel regression models, adjusted for nursing home status. The main outcomes were the average daily number of times that a medication was administered and the number of drugs with different presentation identifier codes per resident per month.Results96,216 residents from 519 nursing homes were included between 1 January 2011 and 31 December 2014. The intervention group and the control group both decreased their average daily use of medication (− 0.05 and − 0.06). The booklet did not have a statistically significant effect (exponentiated difference-in-differences coefficient 1.00, 95% confidence interval 0.99–1.02, P = .45).ConclusionWe observed an overall decrease in medication consumption in both the control and intervention groups. Our analysis did not provide any evidence that this reduction was related to the use of the booklet. Other factors, such as national policy or increased physician awareness, may have contributed to our findings.

A Clinical Prediction Model of Medication Adherence in Hypertensive Patients in a Chinese Community Hospital in Beijing.

Hypertension remains a global health problem. Since, there is a significant positive correlation between antihypertensive medication adherence and blood pressure control, it is therefore of great importance to elucidate the determinants of adherence to antihypertensive medications among hypertensive patients. Hereby, we retrospectively analyzed the medical records of a hypertensive cohort recruited from a community hospital in Beijing, China, to investigate the factors affecting adherence to antihypertensive medications using decision trees. In addition, all data were assigned into a training set (75%) and testing set (25%) by the random number seed method to build and validate a compliance predictive model. We identified that how many times patients became nonadherent to antihypertensive medications in the year before the first prescription, types of antihypertensive drugs used in the year before the first prescription, body weight, smoking history, total number of hospital visits in the past year, total number of days of medication use in the year before enrollment, age, total number of outpatient follow-ups in the year after the first prescription, and concurrent diabetes greatly affected the compliance to antihypertensive medications. The compliance predictive model we built showed a 0.78 sensitivity and 0.69 specificity for the prediction of the compliance to antihypertensive medications, with an area under the representative operating characteristics curve of 0.810. Our data provide new insights into the improvements of the compliance to antihypertensive medications, which is beneficial for the management of hypertension, and the compliance predictive model may be used in community-based hypertension management.

Observational study of adverse reactions related to articaine and lidocaine.

This study determined the frequency of adverse reactions related to the administration of local dental anesthesia with 4% articaine compared with 2% lidocaine, both associated with epinephrine 1:100,000. The null hypothesis was that there is no difference between the administrations of both dental local anesthesia. From a total of 727 patients in an emergency service, 338 and 389 patients were subjected to local anesthesia with lidocaine and articaine, respectively. A questionnaire was completed for each patient that contained patient data, the local anesthesia applied, and any reactions. The overall frequency of adverse reactions was 3.71%, with sweating and pallor being the most frequently observed. There was an association between adverse reactions and the use of daily medication by patients anesthetized with articaine (p = 0.0266). In contrast, in patients anesthetized with lidocaine, there was an association among the duration of the procedure (p = 0.0423), the type of procedure (p = 0.0146), and first anesthesia exposure (p = 0.0448). The low frequency of adverse reactions with use of articaine and lidocaine led to the conclusion that both solutions are safe for use in dentistry.

Prevalence of prescription medication use in preschool-age children seen in pediatric otolaryngology

ObjectiveTo examine the prevalence of daily medication use and prescribing patterns in preschool aged children presenting to otolaryngology clinics. Study designRetrospective summary of prescription-related data from PEDSnet database of two tertiary care children's hospitals within single health system. MethodsAll new patients between birth and 5 years of age seen in otolaryngology clinics from October 1, 2016 through September 30, 2017 were included. Existing diagnoses, active prescriptions at time of visit, prescription dates, and demographics were abstracted. Summary analysis was performed on medication prevalence, quantity and duration of use, comparing all variables between age, gender, and geographical regions. ResultsOf 7532 patient encounters, 20% presented with active daily medication use. Eustachian tube dysfunction and otitis media were the most common diagnoses regardless of daily medication usage. Corticosteroids, specifically hydrocortisone (Delaware) and Flovent (Florida), were the most common medication prescribed. The number of medications strongly correlated with the number of encounter diagnoses. Overall, patients in Delaware were 4.5 times more likely to have at least one prescription prior to encounter (p < 0.05, 95% CI 3.2–4.8). This pattern was preserved across age and gender. Patients with medication in Delaware and Florida had a median of 2 (IQR 3.0–1.0) and 1 prescriptions (IQR 2.0–1.0), respectively (p < 0.001). There were no differences based on insurance type and no correlations between medication count and age or gender. ConclusionChildren in Delaware presented to otolaryngology clinics with significantly more prescribed medications than in Florida. Regional differences were consistent across age and gender. Most children were on these medications for a significant duration.

Guessability of U.S. pharmaceutical pictograms in Iranian prospective users.

Objective:This study examined the gueassability of US pharmaceutical pictograms as well as associated demographic factors and cognitive design features among Iranian adults.Methods:A total of 400 participants requested to guess the meaning of 53 US pharmaceutical pictograms using the open-ended method. Moreover, the participants were asked to rate the cognitive design features of each pictorial in terms of familiarity, concreteness, simplicity, meaningfulness and semantic closeness on a scale of 0-100.Results:The average guessability score (standard deviation) was 66.30 (SD=24.59). Fifty-five percent of pharmaceutical pictograms understudy met the correctness criteria of 67% specified by ISO3864, while only 30% reached the criterion level of 85% set by ANSIz535.3. Low literate participants with only primary school education had substantial difficulty in the interpretation of pharmaceutical pictograms compared to those completed higher education levels. Younger adults of <30 years significantly performed better in the interpretation of pharmaceutical pictograms as compared to >31 years old participants. ‘Home patient care’ and ‘daily medication use’ had no effect on guessability performance. Concerning cognitive design features, meaningfulness better predict geussability score compared to the others.Conclusions:Several USP pictograms fail to be correctly interpreted by Iranian users and need to be redesigned respecting cognitive design features. Interface designers are recommended to incorporate more familiar and concrete elements into their graphics in order to create more meaningful pictorial symbols and to avoid any misinterpretation by the user. Much effective medication use is expected to be achieved by means of this approach, through the improvement of the communication property of pharmaceutical pictograms.

Willingness to use PrEP among female university students in Lesotho.

Oral pre-exposure prophylaxis (PrEP) for HIV-negative individuals at high risk was introduced in Lesotho in April 2016. To assess the feasibility and acceptability of PrEP in Lesotho and to study the attitudes and beliefs around HIV risk and prevention measures among young women, between September and December 2016 we asked 302 female university students at fourteen higher education institutions in Lesotho about their sexual behavior, experiences of sexual coercion and abuse, HIV risk perception, willingness to use PrEP, as well as their attitudes toward condom use and self-administration of daily medications. Overall, 57.3% of the sample reported perceiving themselves at risk of acquiring HIV and 32.1% reported being strongly willing to use PrEP if it were available in their community. In a multivariate mediation analysis, perceived HIV risk was associated with 11.5 percentage points increase in likelihood of using PrEP (p = 0.041). Multiple concurrent sexual partnership was associated with 16.1 percentage points increase in likelihood of self-perceived HIV risk (p = 0.007), while having sexual partners in polygamous relationships was associated with 17.8 percentage points increase in likelihood of self-perceived HIV risk (p = 0.002) and the mediated indirect effect accounted for 18.2% of its total effect. Those who reported strong adherence to antibiotics were 23.1 percentage points more likely to express willingness to use PrEP than those who did not (p = 0.004), and those who reported to dislike condoms were 19.1 percentage points more likely to be willing to use PrEP than those who did not report aversion to condom use: these effect were direct and not mediated by HIV risk perception. Intimate partner violence (IPV) in the network of peers was also directly associated with willingness to use PrEP and its effect was not significantly mediated by HIV risk perception: those who had friends who experienced intimate partner violence were 14.9 percentage points more likely to be willing to use PrEP than those who did not report IPV in their network of peers (p = 0.009). These findings support the inclusion of individuals with multiple concurrent sexual partners among the key populations for PrEP provision and confirm that willingness to use PrEP is not solely driven by HIV risk perception. They also indicate that the presence of IPV in peer networks is related to one’s willingness to use PrEP. PrEP service provision may generate synergies with IPV prevention programs when offered within this framework.

Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia

Sleep and opioid medications used to treat insomnia and chronic pain are associated with adverse side effects (falls and cognitive disturbance). Although behavioural treatments such as cognitive behavioral therapy for insomnia (CBT-I) and pain (CBT-P) improve sleep and clinical pain, their effects on sleep and opioid medication use are unclear. In this secondary analysis of published trial data, we investigated whether CBT-I and CBT-P reduced reliance on sleep/opioid medication in patients with fibromyalgia and insomnia (FMI). Patients with FMI (n=113, Mage =53.0, SD=10.9) completed 8 weeks of CBT-I (n=39), CBT-P (n=37) or waitlist control (WLC; n=37). Participants completed 14 daily diaries at baseline, post-treatment and 6-month follow-up, assessing sleep and opioid medication usage. Multilevel modelling examined group by time effects on days of medication use. A significant interaction revealed CBT-P reduced the number of days of sleep medication use at post-treatment, but usage returned to baseline levels at follow-up. There were no other significant within- or between-group effects. CBT-P led to immediate reductions in sleep medication usage, despite lack of explicit content regarding sleep medication. CBT-I and CBT-P may be ineffective as stand-alone treatments for altering opioid use in FMI. Future work should explore CBT as an adjunct to other behavioural techniques for opioid reduction.

The Efficacy and Safety of Fluticasone/Salmeterol Compared to Fluticasone in Children Younger Than Four Years of Age

The combination of inhaled corticosteroid (ICS) and long-acting β-2 agonist (LABA) is widely used as maintenance therapy for children with asthma. However, use in young children has not been well studied. This study investigates the efficacy and safety of combination therapy with fluticasone propionate 50 µg and salmeterol xinafoate 25 µg in children up to 4 years of age.Study participants were children aged 6 months to 4 years with asthma diagnosed according to the Japanese Pediatric Guideline for the Treatment and Management of Asthma 2012 and in whom ICS and LABA was considered necessary by their physician.This 27-week double-blind, randomized controlled trial was conducted from May 2014 to October 2016 in 70 Japanese pediatric centers. The study consisted of 4 time intervals: (1) a 2-week run-in period, during which all children received inhaled fluticasone propionate twice daily; (2) an 8-week randomized treatment period, during which fluticasone only or fluticasone and salmeterol was administered twice daily; (3) a 16-week open-label period, during which all children received fluticasone and salmeterol twice daily; and (4) a 1-week follow-up period, during which children received care that the investigator felt was appropriate. Children <2 years received 1 inhalation per dose, whereas children 2 years or older received 1 to 2 inhalations per dose, according to the investigator’s judgment. The number of inhalations remained consistent during the run-in and treatment phases but could be adjusted during the open-label phase, if appropriate. As needed, salbutamol 100 µg was allowed as a rescue inhaler. Study endpoints and compliance were assessed via twice-daily recordings in a patient diary by the parent or legal guardian.A total of 300 patients were randomized 1:1 to the double-blind period, of whom 148 completed treatment with ICS and LABA, and 142 completed treatment with ICS only. The study was completed by 268 patients. In both treatment groups, boys predominated, and the majority (≥90%) of patients had moderate or severe persistent asthma. Both groups showed reduction in total asthma symptom scores; however, the primary end point of mean change in total asthma symptom scores from baseline to the last 7 days of the treatment period was not significantly different between the 2 groups (−3.97 for ICS and LABA versus −3.01 for ICS only, P = .21). Secondary outcome analysis showed fewer exacerbations in the ICS and LABA group (3% vs 5% in the ICS group) and statistically greater mean change from baseline in Japanese Pediatric Asthma Control scores in the ICS and LABA group (0.4 points vs −0.3 points for ICS only, P = .04). Little change from baseline in daily rescue medication use or percentage of rescue-free days was seen, with no statistically significant differences between the groups. Incidence of adverse effects was virtually identical between the ICS and LABA (74%) and ICS only (73%) groups and was not associated with age or number of inhalations. No new safety concerns were identified during the open-label period. Decreased plasma cortisol was reported in 6 children during the open-label and follow-up periods, although most values normalized on recheck. No serious adverse effects were considered by the investigators to be drug related.Combination therapy with ICS and LABA showed similar safety profiles to ICS alone in children with asthma up to 4 years of age. Although combination therapy improved total asthma symptom scores, it did not show superior efficacy to ICS alone.Asthma management in young children is challenging because of inability to perform pulmonary function tests and the intermittent nature of symptoms, with many children being clinically well in between exacerbations. Importantly, this study provides new evidence regarding the safety of ICS and LABA use in young children. Regarding efficacy, statistically significant differences were seen for some secondary outcomes, which may suggest better symptom control with ICS and LABA, although it is unclear if these differences warrant the use of ICA and LABA over ICS only in this age group. Further studies are needed to make this determination and support the findings in this study.

356 Mucosal Ablation and Suturing at the Esophagogastric Junction (MASE): A Novel Procedure for the Management of Gastroesophageal Reflux Disease in Altered Anatomy Patients

INTRODUCTION: Gastroesophageal reflux disease (GERD) is caused by reflux of gastric contents into the esophagus. For patients with esophageal or gastric surgery there are limited options for endoscopic or surgical therapy for GERD. There has recently been introduced an endoscopic suturing platform that allows for full thickness suturing. We created a technique called Mucosal Ablation and Suturing at the Esophagogastric Junction (MASE) to anatomically correct the GEJ in patients where other surgical or endoscopic options may not be possible. METHODS: This is a single-center prospective observational study. The standardized procedure involved APC ablation below the GE junction to improve tissue apposition prior to suturing. Three sutures were placed along the lesser curvature of the cardia immediately below the EGJ. This creates a tightening and tissue bulge that acts as a barrier to reflux. The primary outcome evaluated was 30% improvement in reflux disease questionnaire (RDQ) and GERD Health Related Quality of Life Questionnaire. The secondary outcomes evaluated were reduction in PPI use, procedure tolerance and safety. RESULTS: 10 patients with a mean age of 63 years with altered anatomy: Fundoplication (N = 5), Billroth II (N = 1), Roux-en-Y (N = 3), and Sleeve gastrectomy (N = 1) underwent MASE procedure. The RDQ and HRQL questionnaires were recorded for each patient before and after MASE. Mean follow-up time was 113 days. Primary outcome of 30% improvement in RDQ and GERD HRQL were achieved for all patients (Figure 1). There was a 90 % reduction in PPI use in the study group; 6 patients (66%) were able to discontinue PPI use, and 2 patients (22%) reduced their dose. The most common side effect was self-limited post-procedure epigastric pain (9%). CONCLUSION: The MASE procedure represents a novel endoscopic treatment option for management of GERD in patients with altered anatomy. Altered anatomy patients have limited treatment options once they fail standard PPI therapy. The MASE procedure can reduce GERD symptoms in this difficult to treat patient population and reduce reliance of daily anti-secretory medication use. Further studies need to be performed to determine longevity of this procedure.

Development and Validation of a Clinical Prediction Score for Poor Postoperative Pain Control Following Elective Spine Surgery

Abstract INTRODUCTION Approximately, 30% to 64% of people suffer from poorly controlled pain following spine surgery leading to patient dissatisfaction and poor outcomes. The ability to identify these patients before surgery may be useful to facilitate patient education and the development of personalized clinical-care pathways to improve postoperative pain management. METHODS Adult patients were consecutively enrolled through the Canadian Spine Outcomes and Research Network registry and were included if they underwent inpatient elective cervical or thoracolumbar spine surgery. The outcome was poor postoperative pain control defined as the mean numeric rating scale for pain &gt;4 in the first 24-h after surgery. A split-sample design was used to develop and validate the prediction model. The prediction model was transformed into a risk-based score and simplified to a 3-tier Calgary Postoperative Pain after Spine Surgery (CAPPS) score to maximize clinical utility. RESULTS Of 1300 patients, 57% had poorly controlled pain following spine surgery. Seven significant predictors were associated with poor pain control: younger age, female sex, preoperative daily opioid medication use, higher preoperative neck or back pain intensity, higher PHQ-9 depression score, &gt; = 3 motion segment operation, and fusion surgery. Notably, chronic pain and minimally invasive surgery were not associated with pain control status. The model was discriminative (c-statistics 0.74 [95% CI = 0.71-0.77]) and accurate (Hosmer-Lemeshow goodness-of-fit, P = .99) at predicting the outcome. Patients classified to low-, high-, and extreme-risk groups by the CAPPS score had 32%, 63%, and 85% predicted probability of developing poor postoperative pain control, respectively. This closely mirrored the observed probability of 37%, 62%, and 81% in the same risk-groups for poor pain control in the validation cohort. CONCLUSION This internally validated CAPPS score based on 7 easily acquired characteristics accurately predicted the probability of developing poor pain control after spine surgery. This score can be used to develop personalized preoperative and perioperative treatment strategies to improve pain outcomes.

Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery.

Objective: Opioid pain medications are commonly prescribed postsurgically for pain. Few studies have investigated the effects of Battlefield Acupuncture (BFA) on postsurgical pain and pain-medication use. To date, no studies have investigated BFA's effectiveness for reducing postoperative shoulder pain and pain-medication use post surgery. The objective of this study was to determine if adding BFA to a rehabilitation protocol was effective for reducing pain and use of prescribed pain medications, compared to that protocol alone after shoulder surgery. Materials and Methods: Forty Department of Defense beneficiaries (ages 17-55) were randomized to either a standard-of-care group or a standard-of-care + BFA group prior to shoulder surgery. The standard BFA protocol was administered with semipermanent acupuncture needles emplaced on the subjects' ears for 3-5 days within 24 hours after shoulder surgery in an outpatient physical therapy setting. BFA was reapplied, as needed, up to 6 weeks postsurgically for pain management in the intervention group. The primary outcomes were visual analogue scale (VAS) pain rating and daily pain medication use by each subject. Secondary outcome measures were the Global Rating of Change and Patient Specific Functional scale. Outcome measures were obtained at 24 hours, 72 hours, 1 week, 2 weeks, and 6 weeks post surgery. Results: Significant differences in average and worst VAS pain change scores were noted between baseline and 7 days (P < 0.05). The main effect for time was significant (average and worst VAS pain) at all timepoints (P < 0.05), without time-group interactions seen. No significant differences between the groups in pain-medication use were observed (P > 0.05) Conclusions: BFA reduced postsurgical shoulder pain significantly between the groups' average and worst pain change scores between baseline and 7 days despite similar opioid and nonsteroidal anti-inflammatory drug use between the groups.

Determinants of Pain and Predictors of Pain Relief after Ulnar Shortening Osteotomy for Ulnar Impaction Syndrome.

Background The purpose of this study is to characterize patient- and surgery-specific factors associated with perioperative pain level in patients undergoing ulnar shortening osteotomy (USO) for ulnar impaction syndrome (UIS). We hypothesize that preoperative opiate consumption, tobacco utilization, and severity of ulnar variance will be associated with less postoperative pain relief. Methods All cases of USO between January 2010 and December 2016 for management of UIS were retrospectively reviewed. Patient demographics, smoking status, type of labor, and opioid utilization before surgery were recorded. Radiographic measurements for ulnar variance, radial tilt and inclination, as well as triangular fibrocartilage complex and distal radial-ulnar joint (DRUJ) morphology were assessed. Pre- and postoperative pain score were recorded. Regression analysis was performed to determine predictors of pain scores. Results A total of 69 patients were included for the final analysis with a mean age of 44 years (range 17-73 years). Seventeen patients reported use of daily opioid medications at the time of surgery (25%). Patients who used opioid analgesics daily, active laborers, smokers, and patients involved in worker compensation claims had significantly less pain relief after surgery. Patients with osteotomy performed at the metaphysis had significantly more pain relief than patients that had diaphyseal osteotomy. Regression analysis identified tobacco utilization and anatomic site of osteotomy as independent predictors of postoperative pain. Conclusion The results from this study identified smoking and location of osteotomy as independent predictors of postoperative pain relief. While smoking cessation is paramount to prevent delayed/nonunion it may also help improve pain relief following USO. The potential to achieve greater shortening with a metaphyseal osteotomy suggests that in addition to the mechanical unloading the carpus, pain relief after USO may also stem from tensioning the ulnar collateral ligaments of the wrist, the ECU subsheath, and the radioulnar ligaments. Level of Evidence This is a Level III, therapeutic study.

Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot and Feasibility Randomized Controlled Trial.

BackgroundAsthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use. However, WAAPs are typically written at a seventh- to ninth-grade reading level, which can be a barrier to young people in understanding their treatment, having confidence in using a WAAP, and engaging with asthma education.ObjectiveUtilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the Take Action for Asthma Control study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in comparison with a standard WAAP and assess the feasibility and acceptability of the asthma action plan (AAP) intervention and study procedures. The study has 3 aims: (1) estimate the effect sizes of PAAPs compared with WAAPs on outcomes (eg, AAP knowledge and medication adherence), (2) evaluate feasibility and acceptability of AAP intervention and RCT procedures from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes.MethodsThis feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6 months in duration. At baseline, participants will be randomly assigned to receive a PAAP or WAAP generated for them and reviewed with them by their asthma physician. Study procedures will take place over 4 separate time points: a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point, data will be collected related to the main outcomes: AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up to 60 participants (aged 8-17 years) will be recruited. Feasibility and acceptability data will be collected via one-to-one qualitative interviews with providers involved in the study and a subgroup of families that participate in the study.ResultsRecruitment and data collection began in May 2017 and were completed in October 2018.ConclusionsThis pilot and feasibility study will test the potential efficacy, feasibility, and acceptability of an AAP intervention and study procedures. The findings will inform the design and delivery of a future definitive trial to assess the efficacy of PAAPs versus WAAPs in supporting asthma self-management among children and adolescents.International Registered Report Identifier (IRRID)DERR1-10.2196/11733

Experiences with the daily use of medications among chronic hepatitis C patients.

Subjective experiences with medication use are individual experiences that can impact health outcomes by contributing to problems related to such use. The aim of the present study was to understand the experiences of chronic hepatitis C patients who were taking chronic medications, based on the phenomenology proposed by Merleau-Ponty and connection among this experience with the essential structures of the experience. Data were gathered from interviews conducted with ten individuals taking long-term medications at the Viral Hepatitis Outpatient Clinic of the Alfa Gastroenterology Institute of the Hospital das Clínicas, Federal University of Minas Gerais, Brazil. The content of field diaries kept during the interviews were also used. Thematic analysis was employed, enabling the identification of the ways in which individuals experienced their medication routines, which were then reorganized to encompass the essential structures of the experience. The researchers identified four ways patients experience daily medication use, all anchored in corporeality: resolution, adversity, ambiguity, and irrelevance. The first three were based on the perspective that daily medication use is more than a mere mechanical action, involving changes in the phenomenal body, relieving, eliminating or causing symptoms in the physical body, normalizing life and symbolizing the disease. The present study allowed the researchers to infer that the same individual can even simultaneously experience daily medication use in different ways, depending on the disease and the medication in question. It also allowed for the understanding of the cyclical nature of experience with daily medication use, being that the introduction of a new medication can give rise to a new experience. The results point to the complexity of this experience, which requires formal education and places health professionals as responsible for this aspect of care.

Daily patient-reported health status assessment improvements with benralizumab for patients with severe, uncontrolled eosinophilic asthma.

BackgroundPatients with severe, uncontrolled asthma experience debilitating symptoms that result in meaningful reductions to health-related quality of life. Benralizumab is an interleukin-5 receptor alpha–directed cytolytic monoclonal antibody that reduces exacerbations and improves asthma symptoms for patients with severe, uncontrolled eosinophilic asthma.ObjectiveThe objective of this study was to evaluate improvements in daily asthma-related health status outcomes following treatment with benralizumab.MethodsPooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) Phase III studies were analyzed. Patients aged 12–75 years with severe, uncontrolled asthma, and blood eosinophil counts (BEC) ≥300 and ≥150 cells/µL were evaluated. Patients received subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W, first three doses Q4W) or placebo and completed a daily diary reporting rescue medication use, night-time awakening requiring rescue medication use, perceived tiredness, and asthma-related activity impairment. Outcome measures were compared across treatment arms from baseline to end of treatment (EOT) using a mixed-effect model for repeated measures analyses.ResultsPatients with BEC ≥300 cells/µL receiving benralizumab Q8W had greater improvements in all patient-reported outcomes at EOT relative to baseline than patients receiving placebo (all nominal P≤0.013). Effects were reported as early as 3 days following the initial dose and sustained throughout treatment for daily and night-time rescue medication use and night-time awakenings requiring rescue medication. For patients with BEC ≥300 and ≥150 cells/ µL, sustained improvements in activity impairment items (all nominal P<0.05) were achieved with benralizumab Q8W at week 2.ConclusionBenralizumab produces sustained reductions by as early as 3 days in rescue medication use and activity impairment for patients with severe, uncontrolled eosinophilic asthma.

Defining Sickle Cell Disease Severity Among Adults Hospitalized with Vaso-Occlusive Crisis

Background: While there is no uniform definition of sickle cell disease (SCD) severity, vaso-occlusive crises (VOC) are the leading cause of emergency department (ED) visits and hospital admissions among adults with SCD and those with frequent hospital admissions constitute a subgroup more likely to have SCD-related complications. New patient-reported outcomes measures, such as the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Medical History Checklist (MHC), were developed in ambulatory populations to describe SCD severity based on patient-reported medical history. However, similar tools have not been used in adults with SCD hospitalized for VOC. We describe the development and performance of a medical history checklist, modeled off of the ASCQ-Me MHC, to assess disease severity among adults with SCD hospitalized with VOC.Methods: This retrospective cohort study consists of 41 adults with SCD hospitalized with VOC at a US-based academic medical center between 2013 and 2016. For the current analysis, the first hospitalization for VOC within the study window for each patient was selected.Demographic and SCD characteristics were abstracted from the electronic medical record (EMR) by trained research staff, and all SCD-complications were reviewed by two study hematologists.We utilized a 9-item checklist of SCD-related complications (history of lung damage, avascular necrosis, spleen damage, stroke, retinopathy, kidney disease, leg ulcers) and treatments (daily use of pain medication, receipt of an outpatient blood transfusion protocol) in accordance with a prior study by Keller et al. (Health and Quality of Life Outcomes, 2017; 15:117). However, rather than collecting information by patient self-report, we relied on abstraction of checklist items from EMR documentation of history of SCD-related complications in the year prior to the selected hospitalization, documentation of an outpatient transfusion protocol with receipt of transfusions within 3 months prior to hospitalization, and the admission reconciliation record of home pain medications.In the absence of a standard definition of SCD severity, we drew from ASCQ-Me methodology and scored the checklist as the sum of items from 0-9 and also categorized scores as low (<2 points), medium (=2 points), and high (>2 points) severity (Keller et al. Health and Quality of Life Outcomes, 2017; 15:117). Data were described with summary statistics (means, standard deviations, frequencies, percentiles).Results: The mean age was 26.8 years (SD 8.4) with 68% females. Patients were 71% black, non-Hispanic and 29% Hispanic. 90% of patients were publicly insured with 37% on disability (as indicated by Medicare insurance and age <65 years). The most common genotype was Hemoglobin (Hb) SS (71%), followed by Hb SC (19%) and Hb SB+ thalassemia (10%). 68% of patients were prescribed hydroxyurea.Nearly all patients were taking pain medication for SCD every day prior to hospital admission and most patients had documentation of lung damage (Table). The checklist mean score was 2.8 (SD 1.0, range 1-5), reflecting severe SCD among this hospitalized cohort of adults, with 64% of patients categorized as having high disease severity (checklist scores >2) at time of hospital admission for VOC.Conclusions: The high severity scores among this cohort supports the validity of employing a medical history checklist as a measure of disease severity, reflecting the cumulative end organ damage due to SCD and near universal need for daily pain medication among patients requiring inpatient admission for VOC. Two-thirds of patients were categorized as having high disease severity, driven primarily by daily pain medication use prior to hospitalization and pulmonary complications, consistent with a known subgroup of adults with SCD-related complications who are more likely to have lower health-related quality of life and account for higher healthcare utilization. Leveraging information readily available in the EMR, this type of checklist can yield a uniform and informative definition of SCD severity. In turn, this information can help identify the most severely affected patients as well as potential gaps in the delivery of quality care (e.g. pain medication, transfusions) to improve health outcomes among this vulnerable population. [Display omitted] DisclosuresParsons:Seattle Genetics: Research Funding.

RESCUE MEDICATION USE REDUCTION WITH BENRALIZUMAB FOR PATIENTS WITH SEVERE, UNCONTROLLED EOSINOPHILIC ASTHMA

Introduction We investigated the effect of benralizumab, an interleukin-5 receptor alpha–directed cytolytic monoclonal antibody, on rescue medication use by patients with severe, uncontrolled asthma with eosinophilic inflammation. Methods We analyzed pooled data from two Phase III studies, SIROCCO (NCT01928771; 48 weeks [N=1,204]) and CALIMA (NCT01914757; 56 weeks [N=1,306]). Patients aged 12–75 years with severe, uncontrolled asthma, ≥2 exacerbations in the year before enrollment, and blood eosinophil counts ≥300 cells/μL were evaluated. Patients received benralizumab 30 mg every 8 weeks (Q8W; first three doses every 4 weeks) or placebo with their existing high-dosage inhaled corticosteroids and long-acting β2-agonists. Daily, daytime, and night-time rescue medication use and night-time awakenings requiring rescue medication use were evaluated at Day 1, Day 3, Day 7, and at end of treatment. Results By Day 3 with benralizumab Q8W, reductions in daily and night-time rescue medication use and in night-time awakenings requiring rescue medication use were observed for patients with blood eosinophil counts ≥300 cells/μL. Reductions in daytime rescue medication use were obtained by Day 7 (all nominal prequiring rescue medication use relative to baseline compared with patients receiving placebo (all nominal p≤0.013) (table). Conclusions Benralizumab Q8W reduced daily rescue medication use by patients with severe, uncontrolled asthma with eosinophilic inflammation as early as Day 3, and treatment effects were sustained until end of treatment.

The effect of exercise on local and systemic adverse reactions after vaccinations – Outcomes of two randomized controlled trials

IntroductionAn adverse reaction associated with vaccination is considered to be a key barrier to vaccinate, yet little attention has been given to interventions to reduce their occurrence. Exercise is a behavioural adjuvant which may also influence adverse reactions. Here, two randomized controlled trials are reported, examining the effects of exercise on self-reported adverse reactions following vaccination in adolescents and young adults. MethodsStudy one; 116 adolescents receiving the HPV vaccine were randomly allocated to either Control (n = 56) or Pre-vaccine Exercise (n = 60) group (2015–2016). Exercise consisted of 15-minutes upper body exercise. Study two; 78 young adults receiving the influenza vaccine were randomly allocated to either Control (n = 19), or one of 3 exercise groups: Pre-vaccine Arm (n = 19), Pre-vaccine Leg (n = 20) or Post-vaccine Arm (n = 20) (2017). Exercise included 15-minutes of arm or leg exercises prior to or after vaccination. All participants in both studies completed an adverse events diary for seven-days post-vaccination. ResultsStudy one; Reported days of tenderness in female adolescents that exercised were significantly lower than control (p = 0.032), with a similar trend in reported days of pain (p = 0.050). Furthermore, days of feeling ill (p = 0.070) and reduced appetite (p = 0.067) were found to be lower with exercise, although not significant. Overall, female adolescents reported significantly more days of pain (p = 0.003), tenderness (p < 0.001), swelling (p = 0.011), and feeling ill (p = 0.0040). Study two; Exercise groups reported reduced days of swelling (p = 0.018), fever (p = 0.013), and lowered appetite (p = 0.011) across both genders. Furthermore, females reported reduced days of medication use with exercise (p = 0.034), and a trend toward reduced days of swelling (p = 0.052). DiscussionIn two separate trials, a short bout of exercise reduced reported adverse reactions after vaccinations for local and systemic adverse reactions. Gender differences in reported local and systemic adverse reactions were more evident among adolescents than young adults. These findings support the need for further work to examine the potential benefit of exercise in improving vaccination procedures.

Quantity of opioids consumed following an emergency department visit for acute pain: a Canadian prospective cohort study

ObjectivesPrescription opioid diversion is a significant contributor to the opioid misuse epidemic. We examined the quantity of opioids consumed by emergency department (ED) discharged patients after treatment for an acute...

Medication burden attributable to chronic co-morbid conditions in the very old and vulnerable.

ObjectivePolypharmacy is common in older patients but relationships between polypharmacy and common co-morbid conditions have not been elucidated. Our goal was to determine relationships between daily oral medication use and common co-morbid disease dyads and triads using comprehensive medication and diagnostic data from a national sample of nursing homes (NH).DesignRetrospective, cross-sectional study.SettingNationally representative sample of U.S. Nursing Homes.ParticipantsNationally representative sample of long-term stay residents (n = 11734, 75% women) aged 65 years or older.MeasurementsDiagnosis and medication data were analyzed. Proportion of daily oral medication intake attributed to treatment of common two-(dyads) and three-disease (triad) combinations and “health maintenance” agents (vitamins, dietary supplements, stool softeners without related diagnoses) was determined.ResultsOlder NH residents received slightly >8 oral medications/day with the number related to number of medical diagnoses (p < .0001). One third of chronic oral medication intake/day (excluding health maintenance agents) could be attributed to dyad combinations and about half to triad combinations despite an average of 5 other diagnoses. Triads were comprised of hypertension +/- arthritis +/- vascular disease, +/-depression, +/- osteoporosis +/- gastroesophageal reflux disease and +/- diabetes. Health maintenance agents accounted for 15–17% of daily oral medication intake (1.4 medications) such that almost two-thirds of daily oral medications were attributable to disease triads plus health maintenance. Fewer medications were prescribed for NH residents over age 85 (decreased ACE inhibitor and HMG CoA reductase inhibitor USE (p < .001)) while use of Alzheimer medications was higher (p < .01).ConclusionsA large fraction of daily oral medications were attributed to management of common co-morbid disease dyads and triads. Efforts to reduce polypharmacy and unwanted medication interactions could focus on regimens for common co-morbid dyads and triads in varying populations.