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Beliefs About Medicines Predict Side-Effects of Placebo Modafinil

BACKGROUND: Patients receiving placebo in clinical trials often report side-effects (nocebo effects), but contributing factors are still poorly understood. PURPOSE: Using a sham trial of the cognition-enhancing "smart pill" Modafinil we tested whether medication beliefs and other psychological factors predicted detection and attribution of symptoms as side-effects to placebo. METHODS: Healthy students (n = 201) completed measures assessing beliefs about medication, perceived sensitivity to medicines, negative affectivity, somatization, and body awareness; 66 were then randomized to receive Deceptive Placebo (told Modafinil-given placebo, 67 to Open Placebo (told placebo-given placebo, and 68 to No Placebo. Memory and attention tasks assessed cognitive enhancement. Nocebo effects were assessed by symptom checklist. RESULTS: More symptoms were reported in the Deceptive Placebo condition (M = 2.65; SD = 2.27) than Open Placebo (M = 1.92; SD = 2.24; Mann-Whitney U = 1,654, z = 2.30, p = .022) or No Placebo (M = 1.68; SD = 1.75, Mann-Whitney U = 1,640, z = 2.74, p = .006). Participants were more likely to attribute symptoms to Modafinil side-effects if they believed pharmaceuticals to be generally harmful (incidence rate ratio [IRR] = 1.70, p = .019), had higher perceived sensitivity to medicines (IRR = 1.68, p = .011), stronger concerns about Modafinil (IRR = 2.10, p < .001), and higher negative affectivity (IRR = 2.37, p < .001). CONCLUSIONS: Beliefs about medication are potentially modifiable predictors of the nocebo effect. These findings provide insight into side-effect reports to placebo and, potentially, active treatment

Medication nonadherence: health impact, prevalence, correlates and interventions

Nonadherence to medicines is a global problem compromising health and economic outcomes for individuals and society. This article outlines how adherence is defined and measured, and examines the impact, prevalence and determinants of nonadherence. It also discusses how a psychosocial perspective can inform the development of interventions to optimise adherence and presents a series of recommendations for future research to overcome common limitations associated with the medication nonadherence literature. Nonadherence is best understood in terms of the interactions between an individual and a specific disease/treatment, within a social and environmental context. Adherence is a product of motivation and ability. Motivation comprises conscious decision-making processes but also from more 'instinctive', intuitive and habitual processes. Ability comprises the physical and psychological skills needed to adhere. Both motivation and ability are influenced by environmental and social factors which influence the opportunity to adhere as well as triggers or cues to actions which may be internal (e.g. experiencing symptoms) or external (e.g. receiving a reminder). Systematic reviews of adherence interventions show that effective solutions are elusive, partly because few have a strong theoretical basis. Adherence support targeted at the level of individuals will be more effective if it is tailored to address the specific perceptions (e.g. beliefs about illness and treatment) and practicalities (e.g. capability and resources) influencing individuals' motivation and ability to adhere

A systematic review of the prevalence and determinants of nonadherence to phosphate binding medication in patients with end-stage renal disease

<p>Abstract</p> <p>Background</p> <p>Cardiovascular events are the leading cause of death in end stage renal disease (ESRD). Adherence to phosphate binding medication plays a vital role in reducing serum phosphorus and associated cardiovascular risk. This poses a challenge for patients as the regimen is often complex and there may be no noticeable impact of adherence on symptoms. There is a need to establish the level of nonadherence to phosphate binding medication in renal dialysis patients and identify the factors associated with it.</p> <p>Methods</p> <p>The online databases PsycINFO, Medline, Embase and CINAHL were searched for quantitative studies exploring predictors of nonadherence to phosphate binding medication in ESRD. Rates and predictors of nonadherence were extracted from the papers.</p> <p>Results</p> <p>Thirty four studies met the inclusion criteria. There was wide variation in reported rates of non-adherence (22–74% patients nonadherent, mean 51%). This can be partially attributed to differences in the way adherence has been defined and measured. Demographic and clinical predictors of nonadherence were most frequently assessed but only younger age was consistently associated with nonadherence. In contrast psychosocial variables (e.g. patients' beliefs about medication, social support, personality characteristics) were less frequently assessed but were more likely to be associated with nonadherence.</p> <p>Conclusion</p> <p>Nonadherence to phosphate binding medication appears to be prevalent in ESRD. Several potentially modifiable psychosocial factors were identified as predictors of nonadherence. There is a need for further, high-quality research to explore these factors in more detail, with the aim of informing the design of an intervention to facilitate adherence.</p

Medication beliefs predict uptake of preventive therapy in women at increased risk of breast cancer: a Latent Profile Analysis (Abstract only)

Background: Preventive therapies such as tamoxifen are a risk reduction option for women at increased risk of breast cancer. Uptake of preventive therapies is low. The Self-Regulatory Framework identifies the role of beliefs about medication and its impact on treatment decisionmaking. We examined whether women at increased risk of breast cancer can be categorised into groups with similar medication beliefs and whether belief group membership was prospectively associated with uptake of preventive therapy. Methods: Women (n =732) attending an appointment at one of 20 centres in England to discuss breast cancer risk were approached; 55.7% (408/732) completed a survey containing the Beliefs about Medicines Questionnaire (BMQ) and the Perceived Sensitivity to Medicines (PSM) questionnaire. Self-reported uptake of tamoxifen at 3-month follow-up was reported in 258 (63.2%). The optimal number of medication belief groups were identified using Latent Profile Analysis (LPA). Results: Uptake of tamoxifen was 14.7% (38/258). The LPA model fit statistics supported a 2-group model. Both groups held weak beliefs about their need for tamoxifen for current and future health. Group 2 (38% of the sample) reported stronger concerns about tamoxifen and medicines in general, and stronger perceived sensitivity to the negative effects of medicines compared with Group 1 (62%). In a multivariable model, women classified into Group 2 (low need, higher concerns) were more likely to be: aged ≥50 years (vs. 36–49 years), OR=0.56, 95% CI: 0.34–0.93, p=.024). Women with low necessity and lower concerns (Group 1) were more likely to initiate tamoxifen (18.3%; 33) than those with low necessity and higher concerns (Group 2) (6.4%; 5). After adjusting for demographic and clinical factors, the OR was 3.37 (95% CI: 1.08 – 10.51, p = .036). Conclusions and implications: In this UK multi-centre study, uptake of breast cancer preventive therapy was low. An important subgroup of women reported low need for preventive therapy and strong medication concerns. These women were less likely to initiate tamoxifen. Understanding subgroup differences in medication beliefs may enable the development of personalised interventional approaches for supporting informed treatment decision-making

A Data-Driven Typology of Asthma Medication Adherence using Cluster Analysis

Asthma preventer medication non-adherence is strongly associated with poor asthma control. One-dimensional measures of adherence may ignore clinically important patterns of medication-taking behavior. We sought to construct a data-driven multi-dimensional typology of medication non-adherence in children with asthma. We analyzed data from an intervention study of electronic inhaler monitoring devices, comprising 211 patients yielding 35,161 person-days of data. Five adherence measures were extracted: the percentage of doses taken, the percentage of days on which zero doses were taken, the percentage of days on which both doses were taken, the number of treatment intermissions per 100 study days, and the duration of treatment intermissions per 100 study days. We applied principal component analysis on the measures and subsequently applied k-means to determine cluster membership. Decision trees identified the measure that could predict cluster assignment with the highest accuracy, increasing interpretability and increasing clinical utility. We demonstrate the use of adherence measures towards a three-group categorization of medication non-adherence, which succinctly describes the diversity of patient medication taking patterns in asthma. The percentage of prescribed doses taken during the study contributed to the prediction of cluster assignment most accurately (84% in out-of-sample data)

Uptake of breast cancer preventive therapy in the UK: results from a multicentre prospective survey and qualitative interviews

Purpose: Uptake of preventive therapy for women at increased breast cancer risk in England is unknown following the introduction of UK clinical guidelines in 2013. Preventive therapy could create socioeconomic inequalities in cancer incidence if it is more readily accepted by particular socio-demographic groups. In this multicentre study, we investigated uptake of tamoxifen and evaluated socio-demographic and clinical factors associated with initiation. We explored women’s experiences of treatment decision-making using qualitative interview data. Methods: Between September 2015 and December 2016, women (n=732) attending an appointment at one of 20 centres in England to discuss breast cancer risk were approached to complete a survey containing socio-demographic details and nulliparity. Of the baseline survey respondents (n=408/732, 55.7% response rate), self-reported uptake of tamoxifen at 3-month follow-up was reported in 258 (63.2%). Sixteen women participated in semi-structured interviews. Results: One in seven (38/258=14.7%) women initiated tamoxifen. Women who had children were more likely to report use of tamoxifen than those without children (OR=5.26; 95%CI: 1.13–24.49, p=0.035). Interview data suggested that women weigh up risks and benefits of tamoxifen within the context of familial commitments, with exposure to significant other’s beliefs and experiences of cancer and medication a basis for their decision. Conclusions: Uptake of tamoxifen is low in clinical practice. There were no socio-demographic differences in uptake, suggesting that the introduction of breast cancer preventive therapy is unlikely to create socioeconomic inequalities in cancer incidence. Women’s decision-making was influenced by familial priorities, particularly having children

Modelling the effect of beliefs about asthma medication and treatment intrusiveness on adherence and preference for once-daily vs. twice-daily medication

We thank the study participants whose data were used in this analysis. Medical writing support in the form of development of a draft outline and manuscript drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, referencing and graphic services was provided by Jennifer Lawton, PhD, of Gardiner-Caldwell Communications, Macclesfield, UK, and was funded by GlaxoSmithKline. Study GHO-10-4705 is sponsored by GSK. These analyses were funded by GlaxoSmithKline (study GHO-10-4705) and supported by Spoonful of Sugar Ltd (A UCL Business spin out company). Sarah Chapman and Peter Dale were Employed by UCL School of Pharmacy at the time of involvement in this study. Gillian Stynes was employed by GSK at the time of involvement in this study. Previous presentations: These data were presented by S.C. in a poster at the European Respiratory Society 2016 Congress, and the abstract has been published: Chapman et al. Eur Respir J. 2016; 48 (Suppl 60): PA5018.Peer reviewedPublisher PD