Acceptability of Multiparticulate Dosing Using Sympfiny® Delivery System with Children (Age 1-12).

This study investigated multiparticulate formulation administered over a two-week period of time via the Sympfiny® system with children of ages 1-12 years. The study was conducted with parent-child pairs (N = 120 total participants) following a specific dose strategy to mimic PURIXAN's dosing guidelines based upon the child's age. PURIXAN® (mercaptopurine) and Methotrexate have been identified as potential chemotherapy drugs that could benefit from reformulation into multiparticulate. Multiparticulate drugs have advantages as they can be flavorless, and do not require liquid reconstitution and do not require refrigeration. The study included three parts: initial in-person session, 14 days of at-home use, and a final in-person session. The in-person sessions were conducted at HS Design's (HSD) (Morristown, NJ, USA) offices located in Morristown, New Jersey, where a study moderator captured and recorded all subjective comments by participants and observed device use to identify use errors. The participants were instructed to administer a dose (placebo) for the next 14 days and at each dose delivery to fill out a daily survey regarding their experience. Overall, the cumulative survey responses and feedback collected during the in-person sessions suggest that child participants ages 5-12 years old found multiparticulate to be an acceptable formulation and would be willing to take this medication if they were sick. Over time, more children ages 1-4 did not open their mouths; consistently around 15-20% of 1-4 years olds spat the placebo. However, approximately 95% of parents found the Sympfiny® system acceptable and indicated that they would use it to deliver medication to their child.

Monitoring quality of care in hepatocellular carcinoma: A modified Delphi consensus.

Although there are several established international guidelines on the management of hepatocellular carcinoma (HCC), there is limited information detailing specific indicators of good quality care. The aim of this study was to develop a core set of quality indicators (QIs) to underpin the management of HCC. We undertook a modified, two-round, Delphi consensus study comprising a working group and experts involved in the management of HCC as well as consumer representatives. QIs were derived from an extensive review of the literature. The role of the participants was to identify the most important and measurable QIs for inclusion in an HCC clinical quality registry. From an initial 94 QIs, 40 were proposed to the participants. Of these, 23 QIs ultimately met the inclusion criteria and were included in the final set. This included (a) nine related to the initial diagnosis and staging, including timing to diagnosis, required baseline clinical and laboratory assessments, prior surveillance for HCC, diagnostic imaging and pathology, tumor staging, and multidisciplinary care; (b) thirteen related to treatment and management, including role of antiviral therapy, timing to treatment, localized ablation and locoregional therapy, surgery, transplantation, systemic therapy, method of response assessment, and supportive care; and (c) one outcome assessment related to surgical mortality. Conclusion: We identified a core set of nationally agreed measurable QIs for the diagnosis, staging, and management of HCC. The adherence to these best practice QIs may lead to system-level improvement in quality of care and, ultimately, improvement in patient outcomes, including survival.

K-8 Classroom Self-Collection Using XpressCollect Nasal Swab: A Usability and Efficacy Study.

This study demonstrates that students in kindergarten through eighth grade can use the XpressCollect nasal swab to self-collect a specimen under the guidance of a teacher. This phased study was conducted with parents, teachers, and students. Phases 1 and 2 were conducted as interviews with teachers and parents to assess the suitability of the XpressCollect for children in kindergarten through eighth grade. Additionally, teacher and parent feedback was obtained to develop and optimize the instructional materials for subsequent phases. In Phases 3 and 4, teachers guided small groups and full classes of students through the sample collection process with XpressCollect. The samples collected by the students were sent to a laboratory to analyze the effectiveness of specimen self-collection based on the presence of ribonuclease P (RNase P) on each nasal swab. The presence of RNase P enables disease determination; thus, student samples were analyzed for adequate or inadequate sampling. All students in kindergarten through eighth grade are capable of self-collecting an anterior nares specimen with XpressCollect, as the laboratory results identified acceptable RNase P Ct values for the samples collected in a classroom setting.

Twelve weeks' treatment with a polyphenol-rich seaweed extract increased HDL cholesterol with no change in other biomarkers of chronic disease risk in overweight adults: A placebo-controlled randomized trial.

Cardiovascular diseases (CVD) are the leading global cause of death. Strategies to reduce CVD risk are urgently needed. Polyphenols represent a class of bioactive compounds with potential to moderate biochemical risk factors for CVD (cholesterol, triglycerides, glucose, and inflammation). This double-blind, placebo-controlled, randomized parallel-groups trial investigated the effect of a polyphenol-rich seaweed (Fucus vesiculosus) extract on biochemical markers of CVD risk. Thirty-four overweight and obese adults (21 female, 13 male) with elevated low-density lipoprotein cholesterol (>2.0 mmol/L) were randomized to either the seaweed extract (2000 mg/d) or placebo for twelve weeks. Fasting blood samples were collected at baseline, week six and week twelve to assess biochemical markers. Tests of cognitive performance and mood were performed at baseline, week six and week twelve. A 9.5% (-2.3, 12.9) increase in high-density lipoprotein (HDL) cholesterol was identified following the seaweed extract (baseline: mean (SD) 1.28 (0.23) mmol/L, week 12: 1.35 (0.24) mmol/L) which was different to placebo (baseline: 1.38 (0.54) mmol/L, week 12: 1.35 (0.59) mmol/L) (P=.045). No changes were identified in low-density lipoprotein cholesterol, total cholesterol, triglycerides, glucose, insulin, interleukin (IL)-2, IL-6, IL-8, IL-10, or tumour necrosis factor-alpha levels in the blood, or in cognitive performance or mood between the treatment and placebo groups. Despite the small increase observed in HDL cholesterol, the polyphenol-rich seaweed extract did not change CVD risk factors in adults with high fasting lipids. A larger sample size would be required to confirm the clinical relevance of the changes in HDL cholesterol.

Understanding resilience as it affects the transition from the UK Armed Forces to civilian life.

There has been growing interest among policy officials, charity representatives and academic experts in understanding the transition process of UK Service leavers. While recent evidence suggests that resilience is important for a successful transition, no systematic review has been undertaken on this topic before this study. FiMT commissioned RAND Europe to research whether - and how - resilience can affect individual transition pathways and outcomes for UK Service leavers.

Patients' involvement in decisions about medicines: GPs' perceptions of their preferences.

BACKGROUND: Patients vary in their desire to be involved in decisions about their care. AIM: To assess the accuracy and impact of GPs' perceptions of their patients' desire for involvement. DESIGN OF STUDY: Consultation-based study. SETTING: Five primary care centres in south London. METHOD: Consecutive patients completed decision-making preference questionnaires before and after consultation. Eighteen GPs completed a questionnaire at the beginning of the study and reported their perceptions of patients' preferences after each consultation. Patients' satisfaction was assessed using the Medical Interview Satisfaction Scale. Analyses were conducted in 190 patient-GP pairs that identified the same medicine decision about the same main health problem. RESULTS: A total of 479 patients participated (75.7% of those approached). Thirty-nine per cent of these patients wanted their GPs to share the decision, 45% wanted the GP to be the main (28%) or only (17%) decision maker regarding their care, and 16% wanted to be the main (14%) or only (2%) decision maker themselves. GPs accurately assessed patients' preferences in 32% of the consultations studied, overestimated patients' preferences for involvement in 45%, and underestimated them in 23% of consultations studied. Factors protective against GPs underestimating patients' preferences were: patients preferring the GP to make the decision (odds ratio [OR] 0.2 per point on the five-point scale; 95% confidence interval [CI] = 0.1 to 0.4), and the patient having discussed their main health problem before (OR 0.3; 95% CI = 0.1 to 0.9). Patients' educational attainment was independently associated with GPs underestimation of preferences. CONCLUSION: GPs' perceptions of their patients' desire to be involved in decisions about medicines are inaccurate in most cases. Doctors are more likely to underestimate patients' preferred level of involvement when patients have not consulted about their condition before.

Why has antibiotic prescribing for respiratory illness declined in primary care? A longitudinal study using the General Practice Research Database.

BACKGROUND: Antibiotic prescribing by general practitioners (GPs) increased in the 1980s and peaked in 1995. Prescribing volumes subsequently fell by over a quarter between 1995 and 2000, mostly accounted for by reduced antibiotic prescribing for acute respiratory illnesses. We aimed to investigate changes in consultation rates and the proportion of consultations with antibiotics prescribed for different types of respiratory tract infections. METHODS: Data were derived from 108 UK general practices, covering a mean of 642,685 patients, reporting data to the General Practice Research Database (GPRD) continuously between 1994 and 2000. OUTCOME MEASURES: annual age- and sex-standardized consultation rates for 11 different acute respiratory infections per 1000 registered patients and proportions of these consultations resulting in an antibiotic prescription. RESULTS: The standardized consultation rate for 'any respiratory infection' declined by 35 per cent from 422 to 273 per 1000 registered patients, per year. The largest relative reductions in consultation rates were observed for 'common cold' (50 per cent), 'laryngitis' (43 per cent) and 'sore throat' (43 per cent). The standardized proportion of consultations that resulted in an antibiotic prescription for 'any respiratory infection' declined from 79 per cent in 1994 to 67 per cent in 2000. The largest relative reductions in antibiotic prescribing rates occurred in patients recorded as suffering from 'influenza' (52 per cent), 'upper respiratory tract infections' (33 per cent) and 'laryngitis' (30 per cent). Overall, antibiotic prescriptions for all acute respiratory infections declined by 45 per cent. CONCLUSION: The reduction in antibiotic prescribing in common respiratory infections between 1994 and 2000 has occurred partly because GPs are prescribing antibiotics less frequently when patients consult but mainly because there are fewer consultations with these conditions. Further work should aim to understand the reasons for the decline in consultations for respiratory infections and whether further reductions in antibiotic prescribing are feasible.

A systematic review of the research on communication between patients and health care professionals about medicines: the consequences for concordance.

OBJECTIVES: We draw on a systematic review of research on two-way communication between patients and health practitioners about medicines in order to determine the extent to which concordance is, or is not, being put into practice. DATA SOURCES: Six electronic databases were searched using the following categories of search terms: health care professionals, patients/consumers, medicine-taking/prescribing and communication. Articles were also identified from handsearches of journals, article reference lists and the Concordance website. REVIEW METHODS: Studies published between 1991 and 2000 were included. Studies were not excluded on the basis of design, methods or language employed. Abstracts of identified articles were assessed by at least two reviewers and the full articles were assessed by one reviewer and checked by at least one other reviewer. Data on the design, analysis and relevant findings were extracted. RESULTS: A total of 11 801 abstracts were reviewed and 470 full articles were retrieved. Of the 134 articles subsequently included, 116 were descriptive studies. All but 10 of the papers were written in English. There were mixed findings about the extent to which patients feel that their beliefs, experience and preferences about medicines can be shared. Doctors tend to dominate discussions in consultations, although patient participation is associated with positive outcomes. Health care professionals' behaviour can impede as well as enhance patient involvement. CONCLUSIONS: There is little research that examines fundamental issues for concordance such as whether an exchange of views takes place. It is possible that interventions are needed to facilitate the development of concordance in practice.