Pill Count Research Articles

Effect of yoga as add-on therapy in migraine (CONTAIN): A randomized clinical trial.

To evaluate the effectiveness of yoga as an adjuvant to conventional medical management on clinical outcomes in patients with migraine. CONTAIN was a prospective, randomized, open-label superiority trial with blinded endpoint assessment carried out at a single tertiary care academic hospital in New Delhi, India. Patients enrolled were aged 18-50 years with a diagnosis of episodic migraine and were randomized into medical and yoga groups (1:1). Randomization was computer-generated with a variable block size and concealed. A predesigned yoga intervention was given for 3 months. Outcomes were recorded by a blinded assessor. The primary endpoint was a decrease in headache frequency, headache intensity, and Headache Impact Test (HIT)-6 score. Secondary outcomes included change in Migraine Disability Assessment (MIDAS) score, pill count, and proportion of headache free patients. Between April 2017 and August 2018, 160 patients with episodic migraine were randomly assigned to medical and yoga groups. A total of 114 patients completed the trial. Baseline measures were comparable except for a higher mean headache frequency in the yoga group. Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54]; p < 0.0001), headache intensity (1.31 [0.60-2.01]; p = 0.0004), HIT score (8.0 [4.78-11.22]; p < 0.0001), MIDAS score (7.85 [4.98-10.97]; p < 0.0001), and pill count (2.28 [1.06-3.51]; p < 0.0003). Yoga as an add-on therapy in migraine is superior to medical therapy alone. It may be useful to integrate a cost-effective and safe intervention like yoga into the management of migraine. CTRI/2017/03/008041. This study provides Class III evidence that for patients with episodic migraine, yoga as adjuvant to medical therapy improves headache frequency, intensity, impact, and disability.

Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial

BackgroundTo address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended that countries maximize the use of digital adherence technologies. Sub-Saharan Africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered TB care. This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness of the intervention from the patient and provider perspectives.MethodsThis is a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. The study is designed to enroll 144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to start the standard 6-month first-line anti-TB regimen. Participants in the intervention arm (n = 72) will receive 15 days of HRZE—isoniazid, rifampicin, pyrazinamide, and ethambutol—fixed-dose combination therapy in the evriMED500 medication event reminder monitor device for self-administration. When returned, providers will count any remaining tablets in the device, download the pill-taking data, and refill based on preset criteria. Participants can consult the provider in cases of illness or adverse events outside of scheduled visits. Providers will handle participants in the control arm (n = 72) according to the standard in-person DOT. Both arms will be followed up throughout the 2-month intensive phase. The primary outcomes will be medication adherence and sputum conversion. Adherence to medication will be calculated as the proportion of patients who missed doses in the intervention (pill count) versus DOT (direct observation) arms, confirmed further by IsoScreen urine isoniazid test and a self-report of adherence on eight-item Morisky Medication Adherence Scale. Sputum conversion is defined as the proportion of patients with smear conversion following the intensive phase in intervention versus DOT arms, confirmed further by pre-post intensive phase BACTEC MGIT TB liquid culture. Pre-post treatment MGIT drug susceptibility testing will determine whether resistance to anti-TB drugs could have impacted culture conversion. Secondary outcomes will include other clinical outcomes (treatment not completed, death, or loss to follow-up), cost-effectiveness—individual and societal costs with quality-adjusted life years—and acceptability and usability of the intervention by patients and providers.DiscussionThis study will be the first in Ethiopia, and of the first three in sub-Saharan Africa, to determine whether electronic pillbox-enabled SAT improves adherence to TB medication and treatment outcomes, all without affecting the inherent dignity and economic wellbeing of patients with TB.Trial registrationClinicalTrials.gov, NCT04216420. Registered on 2 January 2020.

Correlation of Knowledge and Beliefs to Adherence with Antibiotic Use in Adult Patients at a Private Hospital in Sidoarjo

Infectious diseases are one of the top ten causes of death in the world. Antibiotic therapy is administered for infectious diseases, but if bacteria are exposed to antibiotics continuously, then the bacteria are able to adapt to the medication, thereby resulting in antibiotic resistance. This condition results in an increase in mortality, long hospitalization period, and increased cost of antibiotic therapy and health services. Adherence to using antibiotics may be influenced by knowledge and beliefs about them. This study aimed to understand correlation between knowledge and belief with adherence to antibiotic use at a private hospital in Sidoarjo. This cross-sectional study, the data collected in three months period, was conducted with a questionnaire for assessment knowledge and belief. A pill count method was applied for assessment adherence to using antibiotics prescribed by doctors. The study results show that knowledge of the respondents was adequate for 76 people (69.7%), belief was adequate for 74 people (67.9%), and adherence to antibiotic use for 79 people (72%). Regression analysis showed that the variable that significantly influenced the adherence of patients in using antibiotics was perceived threat (p-value = 0,029). Sex, age, education, income, occupation, and marital status have no contribution to antibiotic knowledge, belief, and adherence.

Coverage of Sex Acts by Event-Driven Pre-exposure Prophylaxis: A Sub-Study of the ANRS IPERGAY Trial

We assessed the coverage of sex acts by event-driven pre-exposure prophylaxis (ED-PrEP) over a 2-month period in 54 participants in the open label phase of the ANRS Ipergay trial. Participants received an electronic monitoring system device to record bottle openings. Self-questionnaires collected daily information on PrEP intake and sexual behavior. Intake was also estimated through returned pill counts. Full coverage of sex acts was defined as at least one pill taken both within 24h before and within 48h following sex. There was a strong correlation (r = - 0.92) between the number of bottle openings and returned pill counts. During the study, 42 participants (78%) practiced ED-PrEP and 12 (22%) daily PrEP with bottle openings at least 5days/week whatever their sexual activity. Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.

A single-arm feasibility cohort study of rivaroxaban in antiphospholipid syndrome

BackgroundThere is uncertainty regarding the safety and effectiveness of direct oral anticoagulant agents in patients with antiphospholipid syndrome (APS). We performed a multicenter feasibility study to examine our ability to identify and obtain consent from eligible APS patients and to obtain 95% adherence with daily rivaroxaban administration, in order to inform and power a larger study. Clinical outcomes of bleeding and thrombosis were also collected.MethodsAPS patients with prior venous thromboembolism (VTE) were recruited over 2 years (Oct 2014–Sept 2016) and followed for ≥ 1 year. Patients were assessed clinically every 3 months and had pill counts performed every 6 months. Numbers of patients fulfilling study criteria, as well as those consenting to participate, were tracked, and percentage adherence based on pill counts was recorded. These data were compared against the feasibility endpoints. Rates of thrombosis and bleeding were calculated. Criterion for feasibility was obtaining consent from 135 of 150 identified APS patients over 2 years.ResultsNinety-six eligible patients were identified, and 14 declined participation. Eighty-two patients were followed for a mean of 19 months, representing 129.8 patient-years. Average rivaroxaban adherence was 95.0%. During follow-up, there were 4 thromboembolic events (2 cerebrovascular and 2 VTE). There were no episodes of major bleeding.ConclusionsAdequately powered comparative trials using patient-important outcomes in APS are unlikely to be successful due to inability to recruit sufficient numbers of study subjects. This study does not reveal a higher than expected risk of recurrent thromboembolic disease compared to historical cohorts; however, this is an uncontrolled study in relatively low-risk APS patients.Trial registrationThe study was registered with clinicaltrials.gov, identifier NCT02116036, April 16, 2014.

MP83-12 EFFECTS OF A REDUCED OPIATE PRESCRIPTION PROTOCOL ON POST-DISCHARGE PILL CONSUMPTION

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Quality Improvement & Patient Safety IV (MP83)1 Apr 2020MP83-12 EFFECTS OF A REDUCED OPIATE PRESCRIPTION PROTOCOL ON POST-DISCHARGE PILL CONSUMPTION Kristian Stensland*, Peter Chang, Aaron Berkenwald, Adrian Waisman Malaret, Kortney Robinson, Gabriel Brat, Sarah Hyde, Kyle McAnally, Catrina Crociani, Brian Holliday, Analeesa Baraka, Jodi Mechaber, Marc Manganiello, David Canes, Alireza Moinzadeh, and Andrew Wagner Kristian Stensland*Kristian Stensland* More articles by this author , Peter ChangPeter Chang More articles by this author , Aaron BerkenwaldAaron Berkenwald More articles by this author , Adrian Waisman MalaretAdrian Waisman Malaret More articles by this author , Kortney RobinsonKortney Robinson More articles by this author , Gabriel BratGabriel Brat More articles by this author , Sarah HydeSarah Hyde More articles by this author , Kyle McAnallyKyle McAnally More articles by this author , Catrina CrocianiCatrina Crociani More articles by this author , Brian HollidayBrian Holliday More articles by this author , Analeesa BarakaAnaleesa Baraka More articles by this author , Jodi MechaberJodi Mechaber More articles by this author , Marc ManganielloMarc Manganiello More articles by this author , David CanesDavid Canes More articles by this author , Alireza MoinzadehAlireza Moinzadeh More articles by this author , and Andrew WagnerAndrew Wagner More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000975.011AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prescribing fewer opiates may lead to less narcotic use and fewer excess pills in the community. We employed a multiphase opiate reduction protocol to assess baseline use, change prescribing protocols, and assess the impact of the change. METHODS: Patients prospectively recorded home pain pill use in a written log after robotic radical prostatectomy (RALP) and robotic partial nephrectomy (RPN) at 2 institutions from 7/2016 to 7/2019. Log accuracy was validated by independent phone contact in a subset of patients. We extracted in-hospital narcotic use, POD1 visual analog scale (VAS) pain scores, and patient comorbidities from our EMRs. In 7/2018, we instituted new prescribing guidelines to meet an estimated 80% of patients’ opiate requirements. RESULTS: Phone survey pill counts exactly matched written logs in 69% of patients and varied by only 1-2 pills in 93% of patients. Of the 193 RALP patients, 137 (71%) were in the pre-intervention group (20-30 pills), and 56 (29%) were in the post-intervention group (5 pills). In the pre-intervention RALP group, 64/137 (47%) patients took no opiates post-discharge, and 90/137 (66%) took <= 2 pills. In the post intervention group, 23/56 (41%) took no opiates post-discharge, and 37/56 (66%) took <= 2 pills. Of the 73 RPN patients, 56 (77%) were in the pre-intervention (20-30 pills), and 17 patients (23%) were in the post-intervention group (15 pills). In the pre-intervention PN, group, 17/56 (30%) patients took no opiates post-discharge. In the post-intervention PN group (15 pills), 3/17 (18%) of patients took no opiate pills post-discharge. After intervention, our new guidelines reduced the number of pills prescribed by 1,655 pills for these 73 patients, compared to what would have been prescribed in prior protocols. 0 and 2 additional prescriptions were filled in the pre- and post-intervention groups, respectively. CONCLUSIONS: Reducing quantity of opiates prescribed tailored by validated institutional data allowed for decreased excess pills with minimal impact on absolute number of pills taken and the number of additional requested prescriptions. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1260-e1260 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kristian Stensland* More articles by this author Peter Chang More articles by this author Aaron Berkenwald More articles by this author Adrian Waisman Malaret More articles by this author Kortney Robinson More articles by this author Gabriel Brat More articles by this author Sarah Hyde More articles by this author Kyle McAnally More articles by this author Catrina Crociani More articles by this author Brian Holliday More articles by this author Analeesa Baraka More articles by this author Jodi Mechaber More articles by this author Marc Manganiello More articles by this author David Canes More articles by this author Alireza Moinzadeh More articles by this author Andrew Wagner More articles by this author Expand All Advertisement PDF downloadLoading ...

Implementation of a patient-specific tapering protocol at discharge decreases total opioid dose prescribed for 6 weeks after elective primary spine surgery

Background and objectivesAt our institution, we developed an individualized discharge opioid prescribing and tapering protocol for joint replacement patients and implemented the same protocol for neurosurgical spine patients. We then...

Optimal Dosing of Cyclosporine and Tacrolimus to Improve Medication Adherence after Heart Transplantation

The number of daily tablets is shown to be crucial for medical adherence of patients after heart transplantation (HTx) to improve long-term outcome. In this study we identified two methods to reduce the daily count of tablets: substitution of innovator-Tacrolimus (TAC) with generic-TAC, which offer various dosages, and simplification and systematic adjustment of Cyclosporine A (CsA) intake. A retrospective study of the immunosuppressive therapy was conducted on 63 patients who received a HTx in our center from 2009 to 2014. The daily dosage was recorded and the daily tablet amount was counted. In a theoretic model, innovator-TAC was replaced by generic drug, which is available with five different dosages, with the same daily TAC-dosage. For ideal CsA-dosing, we established 3 models, namely model A, with systematic and targeted adjustment of partial CsA-dosages but keeping the same cumulative daily dose, and model B and C, with lowest daily pill count by allowing the change of cumulative daily dose within 5% and 10%, respectively. Then we compared the daily tablet amount and costs over the study period. Our patient population was comparable to current international and national databases. The average innovator-TAC dosage was 4.8±3.3mg/d, and the daily innovator-TAC pill count was 4.1±1.7. The replacement of innovator-TAC by generic-TACcould lead to a 20.8% volume reduction of TAC tablets. The number of TAC tablets could be significantly decreased to an average of 3.3±1.1mg/day. Furthermore, an annually cost reduction of 19.2% (528 193.01€) could be achieved. The average CsA dosage was 148.9±42.6mg/day; the daily pill count was 4.3±1.1. Using model A, a 24.4% reduction of daily tablets intake could be achieved. Allowing an average change of the cumulative daily dose of 1.3±1.1% (model B) or 1.4±1.2% (model C) could result in a 34.3% and 39.2% reduction of daily tablet-count of CsA, respectively. In this study we were able to show that the replacement of innovator-TAC by generic-TAC with multiple available dosages, and the simplification and systematic adjustment of CsA dosing could significantly reduce the daily tablet count, and even the total amount of cost. The reduction of the daily tablets could, therefore, increase medication adherence and help to improve outcome after HTx.

Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial.

BackgroundAs people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission.ObjectiveThis study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore.MethodsWe conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device—Medication Event Monitoring System (MEMS)—and a mobile app—MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention.ResultsAll participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results.ConclusionsAlthough MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app–assisted intervention RCTs in the future.Trial RegistrationClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648

The effectiveness of treatment supporter interventions in antiretroviral treatment adherence in sub-Saharan Africa: a systematic review and meta-Analysis

ABSTRACTThis systematic review and meta-analysis evaluated the effectiveness of treatment supporter interventions (TSI) in improving ART adherence and viral suppression among adults living with HIV (PLWH) in sub-Saharan Africa. This review included ten randomized controlled trials (RCT) and six cohort studies comparing treatment support interventions to the standard of care (SOC). Primary outcomes include pill count ART adherence and viral load suppression (VLS). Pooled relative risk ratios (PRR) with 95% confidence intervals were generated using random-effects models. Stratified analyses and meta-regressions were conducted to determine the effect of study type, follow-upperiod, and patient treatment supporters on ART adherence. Treatment supporters included partners, friends, family members, trained community health workers, and HIV positive peers. TSIs were associated with a 7.6% higher ART adherence compared to the SOC group (PRR = 1.076, [95% CI = 1.005, 1.151]). VLS was 5% higher in the treatment group compared to the SOC group (PRR = 1.05, [95% CI = 1.061, 1.207]). There was a significant, positive association between TSIs and VLS in community-based delivery settings but not in facility-based settings. TSIs were statistically significant for VLS in cohort study designs (RR = 1.073, [95% CI = 1.028, 1.121]) but not in RCTs. Findings suggest that TSIs critical in facilitating optimal ART adherence and VLS among PLWHs.

Smartphone use and primary headache: A cross-sectional hospital-based study.

To determine the association of smartphone use with occurrence of new-onset headache and/or increased severity of headaches in patients with primary headache. In a cross-sectional study between June 2017 and December 2018, patients with primary headache were divided into 2 groups: smartphone users (SUs) and non-smartphone users (NSUs). A questionnaire was administered for headache characteristics and treatment taken. The primary objective was to determine the association of smartphone use with new-onset headache or increase severity. The secondary objective was to determine any differences in the requirement of acute medication and prophylaxis. Four hundred patients were included in the study, of which 194 were NSUs and 206 were SUs. The NSUs were older with lower education and socioeconomic status. The headache characteristics were similar in both the groups, except for higher occurrence of aura (NSUs: 15 [7.7%] vs SUs: 36 [17.5%]; p = 0.003) in the SU group. There was, however, higher proportion of patients taking analgesics (NSUs: 157 [80.9%] vs SUs: 197 [95.6%]; p < 0.001), with less relief in headache with medication in the SU group. This was driven by increased pill count (low SUs: 5.0 [3.0; 10.0] vs high SUs: 10.0 [5.0; 15.0]; p = 0.007) and poor response to medication in the high SU group. The use of smartphone was associated with increase in requirement of acute medication and less relief with acute medication. Longitudinal studies may be required to confirm these findings.

Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Feasibility Randomized Controlled Trial.

BackgroundProblems with prospective memory, which refers to the ability to remember future intentions, cause deficits in basic and instrumental activities of daily living, such as taking medications. Older adults show minimal deficits when they rely on mostly preserved and relatively automatic associative retrieval processes. On the basis of this, we propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, we developed the Medication Ambient Display (MAD), a system that unobtrusively presents relevant information (unless it requires the users’ attention) and uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence.ObjectiveThis study aimed to assess the adoption and effect of external cues provided through ambient displays on medication adherence in older adults.MethodsA total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique.ResultsThe treatment group improved their adherence behavior from 80.9% at baseline to 95.97% using the MAD in the intervention phase. This decreased to 76.71% in the postintervention phase when the MAD was no longer being used. Using a one-way repeated measures analysis of variance and a post hoc analysis using the Tukey honestly significant difference test, we identified a significant statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002). In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. Our qualitative results showed that the most useful cues were the auditory reminders, followed by the stylized representations of medication adherence. We also found that the MAD’s external cues not only improved older adults’ medication adherence but also mediated family caregivers’ involvement.ConclusionsThe findings of this study demonstrate that using ambient modalities for implementing external cues is useful for drawing the attention of older adults to remind them to take medications and to provide immediate awareness on adherence behavior.Trial RegistrationClinicalTrials.gov NCT04289246; https://tinyurl.com/ufjcz97

Frequency and predictors of compliance among patients taking antihypertensive medicines

IntroductionMedication compliance, an important aspect in the treatment of chronic disease research, is often assessed using pill count method. The patient perception is usually not addressed objectively. The present study was conducted to assess patient cognizance, prevalence and predictors of compliance towards antihypertensive therapy in Indian patients. MethodsAdult patients taking antihypertensive medicines were included from the cardiology and geriatric OPDs of a tertiary care hospital in India. Socio-demographic data and disease awareness information was collected. Hill-Bone high blood pressure compliance scale was administered for compliance score. ResultsFor the 452 participants, mean age was 54.6 ± 13.7 years with approximate 2:1 ratio of males to females. Cronbach's alpha value of 0.7 for Hill Bone compliance scale showed good internal consistency. More than 80% participants had a score of ≥80%, showing good compliance among Indian patients. Factors that were significantly associated with uncontrolled blood pressure with correlation analysis were age, gender and awareness regarding disease. ConclusionThe study suggests that Hill-Bone high blood pressure compliance scale may be useful for assessing compliance in Indian population. An age appropriate intervention for continued compliance should be considered to improve compliance and hence, reduce long term sequelae of hypertension.

Medication Adherence During Adjunct Therapy With Statins and ACE Inhibitors in Adolescents With Type 1 Diabetes.

Suboptimal adherence to insulin treatment is a main issue in adolescents with type 1 diabetes. However, to date, there are no available data on adherence to adjunct noninsulin medications in this population. Our aim was to assess adherence to ACE inhibitors and statins and explore potential determinants in adolescents with type 1 diabetes. There were 443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs-an ACE inhibitor and a statin-as well as combinations of both or placebo for 2-4 years. Adherence was assessed every 3 months with the Medication Event Monitoring System (MEMS) and pill count. Median adherence during the trial was 80.2% (interquartile range 63.6-91.8) based on MEMS and 85.7% (72.4-92.9) for pill count. Adherence based on MEMS and pill count dropped from 92.9% and 96.3%, respectively, at the first visit to 76.3% and 79.0% at the end of the trial. The percentage of study participants with adherence ≥75% declined from 84% to 53%. A good correlation was found between adherence based on MEMS and pill count (r = 0.82, P < 0.001). Factors associated with adherence were age, glycemic control, and country. We report an overall good adherence to ACE inhibitors and statins during a clinical trial, although there was a clear decline in adherence over time. Older age and suboptimal glycemic control at baseline predicted lower adherence during the trial, and, predictably, reduced adherence was more prevalent in subjects who subsequently dropped out.

Adherence to endocrine therapy and its relation to disease-free survival among breast cancer patients visiting an out-patient clinic at Khartoum Oncology Hospital, Sudan.

Adherence to endocrine therapy provides substantial reduction in breast cancer (BC) relapses and improve survival. Hence, non-adherence remains an under reported issue mainly in developing countries. The aim of this study is to evaluate the adherence to endocrine therapy (tamoxifen [TAM] and aromatase inhibitors [AIs]) among BC patients visiting an out-patient clinic (2015-2016) in Khartoum Oncology Hospital, Sudan. Adherence was assessed using pills count and self-reporting methods. A total of 172 patients were interviewed. Also, records were reviewed for demographic and other cancer characteristics. The patients' mean age at diagnosis was 53 years, with the highest frequency at (41-60) years. Invasive ductal carcinoma 69.2% formed the main pathological diagnosis. T2 tumour size (51.2%) and lymph node involvement (N1) (31.4%) were most evident. Also, the majority of patients were stage III (45.9%) and grade II (48%). The studied women were postmenopausal (49.4%) and premenopausal (47.7%). Regarding hormonal receptors, about 68% were oestrogen (ER)+/progesterone (PR)+ and 23.3% were ER+/PR-. Studying adherence, almost (93%) of the studied group were ≥80% adherent to TAM and AIs. The hormonal therapy persistence mean was 27.2 ± 22.5 months (40-96). While adherence percentage mean was 93.7 ± 13.6% (0%-100%). Also disease-free survival (DFS) mean was 36.3 ± 32.7 months (4-312). Adherence to hormonal therapy and persistence were significantly correlated (P < .000). Also, statistically significant association was found between hormonal therapy adherence (≥80%) and patient poor to average economic status (P = .006), and the marital status "married" (P = .008). A high rate of adherence (93%) to endocrine therapy was estimated in the present study. Also, a positive association was found between the hormonal therapy persistence, and the DFS year's groups (P = .000), and the hormonal therapy types (P = .000). Adherence to hormonal therapy and persistence were significantly correlated (P < .000).

Opioid Consumption After Gender-Affirming Mastectomy and Two Other Breast Surgeries

BackgroundThere are few studies that evaluate patient-reported opioid consumption after discharge from surgery. In addition, there has been a call for “special care in prescribing opioids” for lesbian, gay, bisexual, transgender, questioning patients. Here, we evaluate if patients undergoing gender-affirming mastectomy (GAM) require different amounts of opioids for pain management after discharge compared alongside two surgeries with similar surgical exposure. Materials and methodsFrom October 2017 to July 2018, patients undergoing oncologic mastectomy without reconstruction, mammoplasty reduction, or gender-affirming mastectomy at a single institution were enrolled in a phone survey study to quantify opioids consumed after discharge from surgery. Patient information was captured from the medical record. A total of 170 patients were called between 14 and 30 d after discharge and were asked to count unused pills from their opioid prescription. ResultsA total of 99 patients participated and provided pill counts. There were differences between prescribed and consumed opioids within each surgery. Patients who underwent oncologic mastectomy were prescribed and consumed the lowest amounts of opioids. There were significantly more opioids prescribed to patients with GAM than mammoplasty reduction, but consumption was not statistically different. Patients with oncologic mastectomy, mammoplasty reduction, and GAM consumed a median of 0, 10, and 15 five mg oxycodone equivalent tablets, respectively. ConclusionsDespite similar approaches, surgeries had different opioid prescribing and use profiles. Generally, all patients were overprescribed opioids. Overprescribing may be especially problematic in patients with known higher risk of misuse and substance abuse. Granular data on patient consumption, demographics, and preoperative risk factors for opioid misuse may improve prescribing practices.

The impact of pill counting on resource-limited health facilities: a thematic qualitative analysis in eSwatini.

Research on health systems in resource-limited settings has garnered considerable attention, but the dispensing of individual prescriptions has not been thoroughly explored as a specific bottleneck to effective delivery of care. The rise of human immunodeficiency virus/tuberculosis prevalence and non-communicable diseases in the Kingdom of eSwatini has introduced significant pressures on health facilities to meet patient demands for lifelong medications. Because automated pill counting methods are impracticable and expensive, most prescriptions are made by means of manually counting individual prescriptions using a plastic dish and spatula. The aim of this work was to examine the perceptions of health providers of causes for pill counting errors, and pill counting's impact on clinic workflow. Our study took place in 13 randomly selected public health facilities in eSwatini, stratified by three groups based on monthly patient volumes. Thirty-one participants who count pills regularly and 13 clinic supervisors were interviewed with semi-structured materials and were audio-recorded for later transcription. Interviews were thematically analysed with inductive coding and three major themes emerged: workflow, counting error causes and effect on clinic function. Findings demonstrate large variety in how facilities manage pill counting for prescription making. Due to patient demands, most facilities utilize all available personnel, from cleaners to nurses, to partake in prescription making. Major causes for pill counting errors were distractions, exhaustion and being hurried. Participants mentioned that patients said that they had initially received the wrong quantity of pills and this affected medication adherence measurements based off pill counts. Most participants described how efforts put into pill counting detracted from their work performance, wasted valuable time and increased patient wait times. Future research is needed to quantify prescription accuracy, but our data suggest that interventions directly alleviating the burden of pill counting could lead to improved clinic quality and possibly improve patient outcomes.

Abstract P1-14-01: Feasibility study of moderate dose omega 3 fatty acid supplementation in premenopausal women at high risk for breast cancer considering future pregnancy

Abstract Background: 11% of women developing breast cancer are pre-menopausal women of childbearing potential under the age of 45. Pregnancy and breast feeding provide long term protection for breast cancer when they occur at an early age. The reasons for protection are poorly understood but likely involve both changes in the immune microenvironment and ductal and lobular epithelial differentiation. This pilot study is addressing a potential prevention strategy in a population otherwise excluded from breast cancer prevention trials and not eligible for standard of care chemoprevention. Methods: Eligible individuals included pre-menopausal women ages 21-40 that were considering future pregnancy and are at high risk for breast cancer based on family history, prior precancerous biopsy, or 5-year Gail model risk estimate of ≥ 1.7% or 10-year Tyrer-Cuzick risk of 2x population risk as listed in the model. Participants were enrolled and baseline tissue collection included random periareolar fine-needle aspiration (RPFNA) of breast, as well as collection of blood, urine and stool. Women were asked to take two capsules of Omega-3-Acid Ethyl Esters daily (a total of 750 mg DHA and 930 mg EPA) for six months. Post-intervention visit included repeat tissue collection. If women were pregnant at time of post-intervention visit, RPFNA was not done. Baseline and post-intervention DHA Food Frequency Questionnaire (FFQ) and the BCPT Questionnaire were administered. The intervention length was shortened for some participants due to the study ending. Objectives: 1) To determine feasibility of a breast cancer prevention intervention study in this cohort of pre-menopausal women at high risk for breast cancer and considering future pregnancy, 2) measure compliance with the omega-3 fatty acid supplement in this population, 3) identify novel biomarkers modulated by moderate dose omega-3 fatty acids in this population. Results: Ten women were successfully enrolled at an average rate of 1.5/month from a single center high risk breast clinic. Of the ten women enrolled, median age was 33 years (range 22-37, ±5.04 stdev), 70% married, 80% Non-Hispanic White, 10% of Ashkenazi Jewish descent and 40% reported having a genetic mutation. Feasibility was achieved with 80% (8 out of 10) of participants returning for post-intervention visit. Reasons given for discontinuation of study were (n=1) side effect from supplement (bloating) and (n=1) scheduling conflicts. Of the eight women who completed the off study visit, two chose not to undergo the off study RPFNA due to discomfort with initial procedure or time commitment. Self-reported pill count showed an average of three missed pills/month. Grade 1 related adverse events reported included odor, nausea and flatulence. Post-intervention, more participants reported diarrhea, vaginal discharge and bleeding, weight gain, general aches and dizziness on BCPT items compared to baseline. Change in benign breast tissue biomarkers will be reported including breast tissue cytomorphology, Ki67, fatty acid analysis and selected gene expression. Conclusion: It is feasible to recruit premenopausal women considering future pregnancy to a breast cancer prevention trial with a minimally invasive sampling procedure. Results from this trial will inform a larger randomized prevention trial. Citation Format: Lauren E Nye, Jennifer R Klemp, Kandy R Powers, Anne P O'Dea, Kendra A Cruz, Amy L Kreutzjans, Trina Metheny, Teresa A Phillips, Susan E Carlson, Bruce F Kimler, Carol J Fabian. Feasibility study of moderate dose omega 3 fatty acid supplementation in premenopausal women at high risk for breast cancer considering future pregnancy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-14-01.

Objective Quantification of Opioid Usage After Thyroid Surgery.

Introduction It is well established that America is in the midst of an opioid crisis with 46 people dying every day from overdoses involving prescription opioids. In the last 2 years, multiple articles have been published indicating that the amount of opioid pain medication needed after discharge from thyroid and parathyroid surgery is low. Objective To objectively examine the amount of opioid pain medication required by patients in our practice after thyroid surgery. Methods Patients were given a standardized discharge prescription of 30 pills with a combination of 7.5 mg of hydrocodone and 325 mg of acetaminophen after thyroid surgery. They were asked to log the number of pills consumed per day and the level of pain per day using the Wong-Baker faces pain scale. We used in-office pill counts to ensure accuracy of the logs. Results While reaching a similar conclusion, the present study is the first to objectively examine the quantity of opioid pain medication consumed between postoperative discharge and office follow-up. Our study objectively demonstrates that 85% of patients consumed less than 75.0 morphine milligram equivalent (MME) after thyroid surgery using in-office pill counts. Conclusion Recent multimodality anesthesia research appears promising to dramatically reduce or even eliminate the need for opioid prescriptions upon postoperative discharge.

Glucosylsphingosine as a biomarker of disease burden in Gaucher disease

Poor medication adherence is associated with adverse health outcomes and higher costs of care. However, inconsistencies in the assessment of adherence are found in the literature.To evaluate the effect of different measures of adherence in the comparative effectiveness of complex interventions to enhance patients' adherence to prescribed medications.A systematic review with network meta-analysis was performed. Electronic searches for relevant pairwise meta-analysis including trials of interventions that aimed to improve medication adherence were performed in PubMed. Data extraction was conducted with eligible trials evaluating short-period adherence follow-up (until 3 months) using any measure of adherence: self-report, pill count, or MEMS (medication event monitoring system). To standardize the results obtained with these different measures, an overall composite measure and an objective composite measure were also calculated. Network meta-analyses for each measure of adherence were built. Rank order and surface under the cumulative ranking curve analyses (SUCRA) were performed.Ninety-one trials were included in the network meta-analyses. The five network meta-analyses demonstrated robustness and reliability. Results obtained for all measures of adherence were similar across them and to both composite measures. For both composite measures, interventions comprising economic + technical components were the best option (90% of probability in SUCRA analysis) with statistical superiority against almost all other interventions and against standard care (odds ratio with 95% credibility interval ranging from 0.09 to 0.25 [0.02, 0.98]).The use of network meta-analysis was reliable to compare different measures of adherence of complex interventions in short-periods follow-up. Analyses with longer follow-up periods are needed to confirm these results. Different measures of adherence produced similar results. The use of composite measures revealed reliable alternatives to establish a broader and more detailed picture of adherence.