A Temperature-Monitoring Vaginal Ring for Measuring Adherence

Background

Product adherence is a pivotal issue in the development of effective vaginal microbicides to reduce sexual transmission of HIV. To date, the six Phase III studies of vaginal gel products have relied primarily on self-reporting of adherence. Accurate and reliable methods for monitoring user adherence to microbicide-releasing vaginal rings have yet to be established.

Methods

A silicone elastomer vaginal ring prototype containing an embedded, miniature temperature logger has been developed and tested in vitro and in cynomolgus macaques for its potential to continuously monitor environmental temperature and accurately determine episodes of ring insertion and removal.

Results

In vitro studies demonstrated that DST nano-T temperature loggers encapsulated in medical grade silicone elastomer were able to accurately and continuously measure environmental temperature. The devices responded quickly to temperature changes despite being embedded in different thickness of silicone elastomer. Prototype vaginal rings measured higher temperatures compared with a subcutaneously implanted device, showed high sensitivity to diurnal fluctuations in vaginal temperature, and accurately detected periods of ring removal when tested in macaques.

Conclusions

Vaginal rings containing embedded temperature loggers may be useful in the assessment of product adherence in late-stage clinical trials.

Predictors of adherence to treatment in bronchiestasis

Objectives

We aimed to determine if beliefs about treatment, clinical factors and quality of life predicted adherence to treatment in patients with bronchiectasis.

Methods

We recruited participants with confirmed bronchiectasis to a one-year study. We calculated adherence to treatment using medication possession ratios and self-report. Baseline Beliefs about Medicines, clinical, demographic and Quality of Life Questionnaire-Bronchiectasis data were collected. We used logistic regression to determine predictors of adherence to treatment during the subsequent year.

Results

Seventy-five participants were recruited. Beliefs about harm, age and total number of prescribed medications were predictors of adherence to inhaled antibiotics. Concerns about medication, age and Quality of Life Questionnaire-Bronchiectasis Treatment Burden were predictors of adherence to other respiratory medicines. Beliefs about necessity of airway clearance and age were predictors of adherence to airway clearance.

Conclusion

Beliefs about treatment, age, number of prescribed medications and perceived treatment burden predicted subsequent adherence in bronchiectasis, thereby, providing potential targets for future interventions in this population. Clinicians can use these data to identify patients with bronchiectasis who might be at risk of non-adherence i.e. those who are younger, have concerns about medications, who do not think airway clearance is necessary or who are prescribed numerous medications.

Defining the content and delivery of an intervention to Change AdhereNce to treatment in BonchiEctasis (CAN-BE): a qualitative approach incorporating the Theoretical Domains Framework, behavioural change techniques and stakeholder expert panels

Background
Low patient adherence to treatment is associated with poorer health outcomes in bronchiectasis. We sought to use the Theoretical Domains Framework (TDF) (a framework derived from 33 psychological theories) and behavioural change techniques (BCTs) to define the content of an intervention to change patients’ adherence in bronchiectasis (Stage 1 and 2) and stakeholder expert panels to define its delivery (Stage 3).

Methods
We conducted semi-structured interviews with patients with bronchiectasis about barriers and motivators to adherence to treatment and focus groups or interviews with bronchiectasis healthcare professionals (HCPs) about their ability to change patients’ adherence to treatment. We coded these data to the 12 domain TDF to identify relevant domains for patients and HCPs (Stage 1). Three researchers independently mapped relevant domains for patients and HCPs to a list of 35 BCTs to identify two lists (patient and HCP) of potential BCTs for inclusion (Stage 2). We presented these lists to three expert panels (two with patients and one with HCPs/academics from across the UK). We asked panels who the intervention should target, who should deliver it, at what intensity, in what format and setting, and using which outcome measures (Stage 3).

Results
Eight TDF domains were perceived to influence patients’ and HCPs’ behaviours: Knowledge, Skills, Beliefs about capability, Beliefs about consequences, Motivation, Social influences, Behavioural regulation and Nature of behaviours (Stage 1). Twelve BCTs common to patients and HCPs were included in the intervention: Monitoring, Self-monitoring, Feedback, Action planning, Problem solving, Persuasive communication, Goal/target specified:behaviour/outcome, Information regarding behaviour/outcome, Role play, Social support and Cognitive restructuring (Stage 2). Participants thought that an individualised combination of these BCTs should be delivered to all patients, by a member of staff, over several one-to-one and/or group visits in secondary care. Efficacy should be measured using pulmonary exacerbations, hospital admissions and quality of life (Stage 3).

Conclusions
Twelve BCTs form the intervention content. An individualised selection from these 12 BCTs will be delivered to all patients over several face-to-face visits in secondary care. Future research should focus on developing physical materials to aid delivery of the intervention prior to feasibility and pilot testing. If effective, this intervention may improve adherence and health outcomes for those with bronchiectasis in the future.

Methotrexate polyglutamates as a potential marker of adherence to long-term therapy in children with juvenile idiopathic arthritis and juvenile dermatomyositis: an observational, cross-sectional study

Introduction: Methotrexate (MTX) is a cornerstone of treatment in a wide variety of inflammatory conditions, including juvenile idiopathic arthritis (JIA) and juvenile dermatomyositis (JDM). However, owing to its narrow therapeutic index and the considerable interpatient variability in clinical response, monitoring of adherence to MTX is important. The present study demonstrates the feasibility of using methotrexate polyglutamates (MTXPGs) as a biomarker to measure adherence to MTX treatment in children with JIA and JDM.
Methods: Data were collected prospectively from a cohort of 48 children (median age 11.5 years) who received oral or subcutaneous (SC) MTX therapy for JIA or JDM. Dried blood spot samples were obtained from children by finger pick at the clinic or via self- or parent-led sampling at home, and they were analysed to determine the variability in MTXPG concentrations and assess adherence to MTX therapy.
Results: Wide fluctuations in MTXPG total concentrations (>2.0-fold variations) were found in 17 patients receiving stable weekly doses of MTX, which is indicative of nonadherence or partial adherence to MTX therapy. Age (P = 0.026) and route of administration (P = 0.005) were the most important predictors of nonadherence to MTX treatment. In addition, the study showed that MTX dose and route of administration were significantly associated with variations in the distribution of MTXPG subtypes. Higher doses and SC administration of MTX produced higher levels of total MTXPGs and selective accumulation of longer-chain MTXPGs (P < 0.001 and P < 0.0001, respectively).
Conclusions: Nonadherence to MTX therapy is a significant problem in children with JIA and JDM. The present study suggests that patients with inadequate adherence and/or intolerance to oral MTX may benefit from SC administration of the drug. The clinical utility of MTXPG levels to monitor and optimise adherence to MTX in children has been demonstrated.Trial Registration: ISRCTN Registry identifier: ISRCTN93945409 . Registered 2 December 2011.

High-dose therapy and autologous stem cell transplantation in first relapse for diffuse large B cell lymphoma in the rituximab era:an analysis based on data from the European Blood and Marrow Transplantation Registry

Autologous stem cell transplantation (ASCT) consolidation remains the treatment of choice for patients with relapsed diffuse large B cell lymphoma. The impact of rituximab combined with chemotherapy in either first- or second-line therapy on the ultimate results of ASCT remains to be determined, however. This study was designed to evaluate the benefit of ASCT in patients achieving a second complete remission after salvage chemotherapy by retrospectively comparing the disease-free survival (DFS) after ASCT for each patient with the duration of the first complete remission (CR1). Between 1990 and 2005, a total of 470 patients who had undergone ASCT and reported to the European Blood and Bone Transplantation Registry with Medical Essential Data Form B information were evaluated. Of these 470 patients, 351 (74%) had not received rituximab before ASCT, and 119 (25%) had received rituximab before ASCT. The median duration of CR1 was 11 months. The median time from diagnosis to ASCT was 24 months. The BEAM protocol was the most frequently used conditioning regimen (67%). After ASCT, the 5-year overall survival was 63% (95% confidence interval, 58%-67%) and 5-year DFS was 48% (95% confidence interval, 43%-53%) for the entire patient population. Statistical analysis showed a significant increase in DFS after ASCT compared with duration of CR1 (median, 51 months versus 11 months; P < .001). This difference was also highly significant for patients with previous exposure to rituximab (median, 10 months versus not reached; P < .001) and for patients who had experienced relapse before 1 year (median, 6 months versus 47 months; P < .001). Our data indicate that ASCT can significantly increase DFS compared with the duration of CR1 in relapsed diffuse large B cell lymphoma and can alter the disease course even in patients with high-risk disease previously treated with rituximab.

Energy Detection based Spectrum Sensing over Two-wave with Diffuse Power Fading Channels

One of the most important factors that affects the performance of energy detection (ED) is the fading channel between the wireless nodes. This article investigates the performance of ED-based spectrum sensing, for cognitive radio (CR), over two-wave with diffuse power (TWDP) fading channels. The TWDP fading model characterizes a variety of fading channels, including well-known canonical fading distributions, such as Rayleigh and Rician, as well as worse than Rayleigh fading conditions modeled by the two-ray fading model. Novel analytic expressions for the average probability of detection over TWDP fading that account for single-user and cooperative spectrum sensing as well as square law selection diversity reception are derived. These expressions are used to analyze the behavior of ED-based spectrum sensing over moderate, severe and extreme fading conditions, and to investigate the use of cooperation and diversity as a means of mitigating the fading effects. Our results indicate that TWDP fading conditions can significantly degrade the sensing performance; however, it is shown that detection performance can be improved when cooperation and diversity are employed. The presented outcomes enable us to identify the limits of ED-based spectrum sensing and quantify the trade-offs between detection performance and energy efficiency for cognitive radio systems deployed within confined environments such as in-vehicular wireless networks.

EU water framework directive: will the nitrate load reduction from diffuse sources produce the same results in all estuaries?

The impact of urban waste-water and non-point nitrate discharges in estuarine and near-shore coastal waters are analyzed. The study is focused on the effects of applying the European directives 91/271/EEC and 91/676/EEC to these systems. 4 Portuguese estuaries and two coastal lagoons with different characteristics are studied. A modelling system is applied and calibrated in each system. Three nitrate load scenarios are examined. It is shown that the morphologic and hydrodynamic characteristics of the domain largely control the ecological processes in these systems. The primary production limitation factors are split into “biologic” and “hydrodynamic” components. The physical limitation due to hydrodynamic and residence time is the most important factor. The combined limitation of “biologic” factors (temperature, light and nutrients availability) control productivity only in the systems where physical limitation is not important.

Pharmacist intervention on adherence to therapy in the elderly

Background: Non-adherence to therapy contributes to the increase in hospitalizations, admissions to nursing homes, decreased quality of life and consequent increased morbimortality in the elderly. Aim: To assess whether pharmacist intervention contributes to the adherence to medical prescription by elderly patients.

A Retrospective Claims Analysis of Medication Adherence and Persistence Among Patients Taking Antidepressants for the Treatment of Major Depressive Disorder (MDD)

Thesis (Master's)--University of Washington, 2015

Cardiorespiratory fitness is negatively associated with metabolic risk factors independently of the adherence to a healthy dietary pattern

Background and aim: Cardiorespiratory fitness (CRF) and diet have been involved as significant factors towards the prevention of cardio-metabolic diseases. This study aimed to assess the impact of the combined associations of CRF and adherence to the Southern European Atlantic Diet (SEADiet) on the clustering of metabolic risk factors in adolescents. Methods and Results: A cross-sectional school-based study was conducted on 468 adolescents aged 15-18, from the Azorean Islands, Portugal. We measured fasting glucose, insulin, total cholesterol (TC), HDL-cholesterol, triglycerides, systolic blood pressure, waits circumference and height. HOMA, TC/HDL-C ratio and waist-to-height ratio were calculated. For each of these variables, a Z-score was computed by age and sex. A metabolic risk score (MRS) was constructed by summing the Z scores of all individual risk factors. High risk was considered when the individual had 1SD of this score. CRF was measured with the 20 m-Shuttle-Run- Test. Adherence to SEADiet was assessed with a semi-quantitative food frequency questionnaire. Logistic regression showed that, after adjusting for potential confounders, unfit adolescents with low adherence to SEADiet had the highest odds of having MRS (OR Z 9.4; 95%CI:2.6e33.3) followed by the unfit ones with high adherence to the SEADiet (OR Z 6.6; 95% CI: 1.9e22.5) when compared to those who were fit and had higher adherence to SEADiet.

Characteristics of HIV patients referred to a medication adherence program in Switzerland.

Background Since August 2004, HIV patients who encounter -or are at risk of -problems with their antiretroviral treatment (ART) are referred by their physician to a medication adherence program at the community pharmacy of the Department of Ambulatory Care and Community Medicine in Lausanne (Switzerland). The program combines motivational interviewing and electronic drug monitoring. Objective To compare the demographic and clinical characteristics as well as ART of HIV patients referred to the adherence program versus those of the entire HIV population followed in the same infection disease department in the same time frame. Method Retrospective descriptive cross-sectional study. Study time frame was defined according to the period with the highest number of HIV patients visiting the adherence program. Results Subjects included in the adherence program had more often a protease inhibitor-based regimen (64 %; 95 % CI [52-75 %] vs. 37 %) and lower CD4 cell counts (419 (252.0, 521.0); 95 % CI [305-472] vs. 500 (351.0, 720.0)) than the entire HIV population. A majority of women were included in the adherence program (66 %; 95 % CI [54-76 %] vs. 39% in the entire HIV population). Conclusion Subjects referred to the adherence program were different from the entire HIV population and showed worse clinical outcomes and were more often under salvage therapy. More women than men were included. Reasons for such a difference need to be further explored.

Adherence: the journey of medication taking, are we there yet?

Patient adherence to medications has been an issue challenging healthcare professionals for decades. Adherence rates, causes of non-adherence, barriers and enablers to medication taking, interventions to promote adherence, and the impact of non-adherence on health outcomes, have been extensively studied. In light of this, the area of adherence research has progressed conceptually and practically. This special issue contains a range of articles which focus on different aspects of adherence, from standardising terminology and methods of measurement, to non-adherence in a broad range of patient populations, and to interventions to promote adherence.

Adhésion thérapeutique aux traitements oncologiques oraux et prise en charge interdisciplinaire [Therapeutic adherence to oral cancer therapy and interdisciplinary management].

Medication adherence is a well-known risk factor in internal medicine. However in oncology this dimension is emerging due to the increasing number of oral formulations. First results in the oral oncology literature suggest that patients' ability to cope with medical prescription decreases with time. This might preclude patients from reaching clinical outcomes. Factors impacting on medication adherence to oral oncology treatments have not been yet extensively described neither strategies to address them and support patient's needs. Oncologists and pharmacists in our University outpatient settings performed a pilot study which aimed at measuring and facilitating adherence to oral oncology treatments and at understanding determinants of patient's adherence. The ultimate purpose of such a patient-centered and interdisciplinary collaboration would be to promote patient self-management and complement the standard medical follow-up.

Oral cancer treatments and adherence: medication event monitoring system assessment for capecitabine

Background: Oncological treatments are traditionally administered via intravenous injection by qualified personnel. Oral formulas which are developing rapidly are preferred by patients and facilitate administration however they may increase non-adherence. In this study 4 common oral chemotherapeutics are given to 50 patients, who are still in the process of inclusion, divided into 4 groups. The aim is to evaluate adherence and offer these patients interdisciplinary support with the joint help of doctors and pharmacists. We present here the results for capecitabine. Materials and Methods: The final goal is to evaluate adhesion in 50 patients split into 4 groups according to oral treatments (letrozole/exemestane, imatinib/sunitinib, capecitabine and temozolomide) using persistence and quality of execution as parameters. These parameters are evaluated using a medication event monitoring system (MEMS®) in addition to routine oncological visits and semi-structured interviews. Patients were monitored for the entire duration of treatment up to a maximum of 1 year. Patient satisfaction was assessed at the end of the monitoring period using a standardized questionary. Results: Capecitabine group included 2 women and 8 men with a median age of 55 years (range: 36−77 years) monitored for an average duration of 100 days (range: 5-210 days). Persistence was 98% and quality of execution 95%. 5 patients underwent cyclic treatment (2 out of 3 weeks) and 5 patients continuous treatment. Toxicities higher than grade 1 were grade 2−3 hand-foot syndrome in 1 patient and grade 3 acute coronary syndrome in 1 patient both without impact on adherence. Patients were satisfied with the interviews undergone during the study (57% useful, 28% very useful, 15% useless) and successfully integrated the MEMS® in their daily lives (57% very easily, 43% easily) according to the results obtained by questionary at the end of the monitoring period. Conclusion: Persistence and quality of execution observed in our Capecitabine group of patients were excellent and better than expected compared to previously published studies. The interdisciplinary approach allowed us to better identify and help patients with toxicities to maintain adherence. Overall patients were satisfied with the global interdisciplinary follow-up. With longer follow up better evaluation of our method and its impact will be possible. Interpretation of the results of patients in the other groups of this ongoing trial will provide us information for a more detailed analysis.