Does increasing packing density using larger caliber coils improve angiographic results of embolization of intracranial aneurysms at 1 year: A randomized trial

© 2020 American Society of Neuroradiology. All rights reserved. BACKGROUND AND PURPOSE: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year. MATERIALS AND METHODS: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 6 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils. RESULTS: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528–1.644; P = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981–1.022; P = .879). CONCLUSIONS: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results

Risk of malnutrition and health-related quality of life in community-living elderly men and women: The Tromsø study

Purpose To explore the association between risk of malnutrition as well as current body mass index (BMI) and health-related quality of life (HRQoL) in elderly men and women from the general population. Methods In a cross-sectional population survey including 1,632 men and 1,654 women aged 65 to 87 years from the municipality of Tromsø, Norway, we assessed HRQoL by using the EuroQol (EQ-5D) instrument in three risk groups of malnutrition and in different categories of BMI. The Malnutrition Universal Screening Tool (‘MUST’) was used to evaluate the risk of malnutrition. Results We found a significant reduction in HRQoL with an increasing risk of malnutrition, and this was more pronounced in men than in women. The relationship between BMI and HRQoL was dome shaped, with the highest score values in the BMI category being 25–27.5 kg/m2. Conclusions HRQoL was significantly reduced in elderly men and women at risk of malnutrition. The highest HRQoL was seen in moderately overweight individuals

Changes in the composition of cannabis from 2000-2017 in Denmark:Analysis of confiscated samples of cannabis resin

Globally, recent studies report increases in Δ-9-tetrahydrocannabinol (THC) concentration in seized samples of cannabis for human consumption. This is important, because use of cannabis with a high concentration of THC has been linked to a number of adverse health outcomes. The objective of this study was to assess recent changes in the composition of seized cannabis resin in Denmark by (a) examining THC concentration in samples from Danish forensic laboratories from 2000 to 2017 ( N = 430) and (b) examining cannabidiol (CBD) concentration and the THC:CBD concentration ratio in samples from the forensic laboratory in Western Denmark from 2008 to 2017 ( N = 147). Cannabis resin samples were analyzed using a gas chromatographic analysis with flame ionization detection quantifying the total THC and CBD concentration. Results showed that the THC concentration increased 3-fold from 2000 (mean: 8.3%) to 2017 (mean: 25.3%). Significant increases occurred in all areas of Denmark. After 2011, we found a dramatic increase in cannabis resin samples with high THC concentration and the near disappearance of cannabis resin samples with medium- and low THC concentration. Furthermore, the THC:CBD concentration ratio increased significantly from 1.4 in 2008 to 4.4 in 2017. Whereas THC concentration increased, CBD concentration remained stable at ∼6%. In conclusion, the THC concentration of cannabis resin, and THC:CBD concentration ratio, have increased dramatically in Denmark, potentially leading to higher risk of harm to users. Policymakers, treatment professionals, and educators should be aware of this change. (PsycINFO Database Record (c) 2019 APA, all rights reserved). </p

Methods for specifying the target difference in a randomised controlled trial : the Difference ELicitation in TriAls (DELTA) systematic review

Peer reviewedPublisher PD

Does patient satisfaction of general practice change over a decade?

Background The Patient Participation Program (PPP) was a patient satisfaction survey endorsed by the Royal Australian College of General Practitioners and designed to assist general practitioners in continuous quality improvement (CQI). The survey was been undertaken by 3500 practices and over a million patients between 1994 and 2003. This study aimed to use pooled patient questionnaire data to investigate changes in satisfaction with primary care over time. Methods The results of 10 years of the PPP surveys were analyzed with respect to 10 variables including the year of completion, patient age, gender, practice size, attendance at other doctors, and whether the practice had previously undertaken the survey. Comparisons were made using Logistic Generalized Estimating Equations (LGEE). Results There was a very high level of satisfaction with general practice in Australia (99% of respondents). An independent indicator of satisfaction was created by pooling the results of 12 questions. This new indicator had a greater variance than the single overall satisfaction question. Participants were shown to have higher levels of satisfaction if they were male, older, did not attend other practitioners or the practice was small in size. A minimal improvement in satisfaction was detected in this pooled indicator for the second or third survey undertaken by a practice. There was however no statistically significant change in pooled satisfaction with the year of survey. Conclusion The very high level of satisfaction made it difficult to demonstrate change. It is likely that this and the presentation of results made it difficult for GPs to use the survey to improve their practices. A more useful survey would be more sensitive to detect negative patient opinions and provide integrated feedback to GPs. At present, there are concerns about the usefulness of the PPP in continuous quality improvement in general practice.James Allan, Peter Schattner, Nigel Stocks and Emmae Ramsa

Does patient satisfaction of general practice change over a decade?

Background The Patient Participation Program (PPP) was a patient satisfaction survey endorsed by the Royal Australian College of General Practitioners and designed to assist general practitioners in continuous quality improvement (CQI). The survey was been undertaken by 3500 practices and over a million patients between 1994 and 2003. This study aimed to use pooled patient questionnaire data to investigate changes in satisfaction with primary care over time. Methods The results of 10 years of the PPP surveys were analyzed with respect to 10 variables including the year of completion, patient age, gender, practice size, attendance at other doctors, and whether the practice had previously undertaken the survey. Comparisons were made using Logistic Generalized Estimating Equations (LGEE). Results There was a very high level of satisfaction with general practice in Australia (99% of respondents). An independent indicator of satisfaction was created by pooling the results of 12 questions. This new indicator had a greater variance than the single overall satisfaction question. Participants were shown to have higher levels of satisfaction if they were male, older, did not attend other practitioners or the practice was small in size. A minimal improvement in satisfaction was detected in this pooled indicator for the second or third survey undertaken by a practice. There was however no statistically significant change in pooled satisfaction with the year of survey. Conclusion The very high level of satisfaction made it difficult to demonstrate change. It is likely that this and the presentation of results made it difficult for GPs to use the survey to improve their practices. A more useful survey would be more sensitive to detect negative patient opinions and provide integrated feedback to GPs. At present, there are concerns about the usefulness of the PPP in continuous quality improvement in general practice.James Allan, Peter Schattner, Nigel Stocks and Emmae Ramsa

Clinical Phenotypes and Comorbidity in European Sleep Apnoea Patients

BackgroundClinical presentation phenotypes of obstructive sleep apnoea (OSA) and their association with comorbidity as well as impact on adherence to continuous positive airway pressure (CPAP) treatment have not been established.MethodsA prospective follow-up cohort of adult patients with OSA (apnoea-hypopnoea index (AHI) of >= 5/h) from 17 European countries and Israel (n = 6,555) was divided into four clinical presentation phenotypes based on daytime symptoms labelled as excessive daytime sleepiness ("EDS") and nocturnal sleep problems other than OSA (labelled as "insomnia"): 1) EDS (daytime+/nighttime-), 2) EDS/insomnia (daytime+/nighttime+), 3) non-EDS/noninsomnia (daytime-/nighttime-), 4) and insomnia (daytime-/nighttime+) phenotype.ResultsThe EDS phenotype comprised 20.7%, the non-EDS/non-insomnia type 25.8%, the EDS/insomnia type 23.7%, and the insomnia phenotype 29.8% of the entire cohort. Thus, clinical presentation phenotypes with insomnia symptoms were dominant with 53.5%, but only 5.6% had physician diagnosed insomnia. Cardiovascular comorbidity was less prevalent in the EDS and most common in the insomnia phenotype (48.9% vs. 56.8%, p<0.001) despite more severe OSA in the EDS group (AHI 35.0 +/- 25.5/h vs. 27.9 +/- 22.5/h, p<0.001, respectively). Psychiatric comorbidity was associated with insomnia like OSA phenotypes independent of age, gender and body mass index (HR 1.5 (1.188-1.905), p<0.001). The EDS phenotype tended to associate with higher CPAP usage (22.7 min/d, p = 0.069) when controlled for age, gender, BMI and sleep apnoea severity.ConclusionsPhenotypes with insomnia symptoms comprised more than half of OSA patients and were more frequently linked with comorbidity than those with EDS, despite less severe OSA. CPAP usage was slightly higher in phenotypes with EDS

Acceptability and feasibility of a Community Outpatient Psychotherapy Engagement Service for Self-harm: COPESS a mixed methods study

Background: Self-harm refers to any intentional self-injury or self-poisoning, with or without the intention to end one’s life. People who self-harm are at high risk of suicide, and often experience a range of social and mental health issues as well as considerable emotional distress. Around 70% of people who self-harm also experience symptoms of depression. There is very little help available from health and mental health services designed specifically for people who self-harm, and many receive no help at all. Most self-harm happens in the community but there have been very few attempts to develop self-harm specific services in community settings, such as GP practices. Readily accessible brief talking therapies show promise in helping people who self-harm, but further evaluation of these approaches is needed. The Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) is a brief talking therapy intervention for depression and self-harm. Objectives: The objectives were to assess the feasibility of conducting a trial of the COPESS intervention in a community setting in relation to participant recruitment, data collection, the acceptability of the intervention and retention in treatment and study. Design: A mixed-method study, using a single-blind randomised controlled trial (RCT), assessing the acceptability and feasibility of the COPESS intervention for people with depression who self-harm, and purposefully collected qualitative data. Setting: GP practices in Northwest England. Participants: Individuals aged >16 years who had depression and self-harmed in previous six months. Interventions: The COPESS intervention is a psychological ‘talking’ therapy designed to help people who self-harm. It is made up of a short course of sessions with a therapist, that are available quickly after self-harm has been identified by that person’s GP. People were randomised 1:1 to receive either COPESS plus treatment-as-usual (TAU) or TAU alone. Main outcome measures: The primary outcome was the feasibility and acceptability of COPESS for people in the community with self-harm and co-existing depression. Secondary outcome measures were assessed at baseline, with follow-up assessments occurring at 1- month, 2-months and 3-months. Results: Findings indicated that COPESS was both acceptable and feasible, with all progression criteria being met. Fifty-seven people were recruited into the trial. Fifty-five were then randomly allocated to receive either the COPESS therapy (28 people) or treatment as usual only (27 people). Primary care staff and COPESS therapists based in a 3 mental health trust reported the intervention fitted and complemented existing services, and patients reported that they favoured the rapid, self-harm focused, person-centred approach of the intervention. The response to the therapy was very positive, with most participants attending all sessions. There were early indications that receiving COPESS may lower levels of depression, general distress and urges to self-harm compared to treatment as usual. Qualitative interviews were completed with participants, therapists, and primary care staff and feedback was positive about the COPESS intervention. Limitations: Due to the COVID-19 pandemic the COPESS intervention was delivered remotely only, therefore the experiences of the patients in the feasibility trial may not be representative of therapy delivered in person. Furthermore, the pandemic and associated disease control measures (i.e., lockdowns) may have had a general impact on outcomes, including recruitment into the study (both GP surgeries and participants), and experiences of participants and therapists. Conclusions: All progression criteria were met supporting further evaluation of the intervention in a full-scale clinical effectiveness trial. COPESS has potential as a brief primary-care based intervention for those struggling with self-harm. Future work: Further work involving stakeholder engagement is needed to refine the delivery of the intervention across multiple sites and conduct a full-scale efficacy trial. Trial registration: NCT04191122. Funding details: This project was funded by the National Institute for Health and Care Research (NIHR200543) Research for Patient Benefit Programme