Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease

BACKGROUND: Varenicline and bupropion are effective smoking cessation treatments, but there are concerns about their safety in smokers with COPD. OBJECTIVE: To investigate whether varenicline and bupropion are associated with serious adverse cardiovascular and neuropsychiatric events in smokers with COPD. METHODS: In a retrospective cohort study, we used data from 14 350 patients with COPD included in the QResearch database, which holds data from 753 National Health Service general practices across England. We identified patients with COPD who received a prescription of nicotine replacement therapy (NRT; N=10 426; reference group), bupropion (N=350) or varenicline (N=3574) in the period between January 2007 and June 2012. Patients were followed up for 6 months to compare incident cardiovascular (ie, ischaemic heart disease, stroke, heart failure, peripheral vascular disease and cardiac arrhythmias) and neuropsychiatric (ie, depression and self-harm) events using Cox proportional hazards models, adjusted for potential confounders. Propensity score analysis was used as an additional approach to account for potential confounding by indication. We also modelled the effects of possible unmeasured confounders. RESULTS: Neither bupropion nor varenicline showed an increased risk of adverse events compared with NRT. Varenicline was associated with a significantly reduced risk of heart failure (HR=0.56, 95% CI 0.34 to 0.92) and depression (HR=0.73, 95% CI 0.61 to 0.86). Similar results were obtained from the propensity score analysis. Modelling of unmeasured confounding provided additional evidence that an increased risk of these adverse events was very unlikely. CONCLUSION: In smokers with COPD, varenicline and bupropion do not appear to be associated with an increased risk of cardiovascular events, depression or self-harm in comparison with NRT

Effect of a workplace-based group training programme combined with financial incentives on smoking cessation:a cluster-randomised controlled trial

Prevention, Population and Disease management (PrePoD)Public Health and primary car

Antibiotics versus placebo for acute bacterial conjunctivitis

Background Acute bacterial conjunctivitis is an infection of the conjunctiva and is one of the most common ocular disorders in primary care. Antibiotics are generally prescribed on the basis that they may speed recovery, reduce persistence, and prevent keratitis. However, many cases of acute bacterial conjunctivitis are self‐limited, resolving without antibiotic therapy. This Cochrane Review was first published in The Cochrane Library in 1999, then updated in 2006, 2012, and 2022. Objectives To assess the benefits and side effects of antibiotic therapy in the management of acute bacterial conjunctivitis. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2022, Issue 5), MEDLINE (January 1950 to May 2022), Embase (January 1980 to May 2022), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases in May 2022. Selection criteria We included randomized controlled trials (RCTs) in which any form of antibiotic treatment, with or without steroid, had been compared with placebo/vehicle in the management of acute bacterial conjunctivitis. This included topical and systemic antibiotic treatments. Data collection and analysis Two authors independently reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies and determined the included RCTs, which were further assessed for risk of bias using Cochrane methodology. We performed data extraction in a standardized manner and conducted random‐effects meta‐analyses using RevMan Web. Main results We included 21 eligible RCTs, 10 of which were newly identified in this update. A total of 8805 participants were randomized. All treatments were topical in the form of drops or ointment. The trials were heterogeneous in terms of their eligibility criteria, the nature of the intervention (antibiotic drug class, which included fluoroquinolones [FQs] and non‐FQs; dosage frequency; duration of treatment), the outcomes assessed and the time points of assessment. We judged one trial to be of high risk of bias, four as low risk of bias, and the others as raising some concerns

Antibiotics versus placebo for acute bacterial conjunctivitis: Findings from a Cochrane systematic review

Purpose To summarize key findings from a Cochrane review of the benefits and safety of antibiotic therapy compared with placebo (or vehicle) for acute bacterial conjunctivitis. Design Systematic review and meta-analysis. Methods We included placebo-controlled randomized controlled trials (RCTs) that compared topical antibiotics with placebo. We followed Cochrane methods for trial selection, data extraction, risk of bias assessment, and evidence synthesis. Results Twenty-one RCTs involving 8805 participants with acute bacterial conjunctivitis were included. Fifteen (71%) RCTs examined fluoroquinolone (FQ) drops, 3 tested macrolides, alone or in combination with steroids, and another 3 compared other non-FQ antibiotics. Intention-to-treat estimates suggested that compared with placebo, antibiotics may increase clinical recovery by 26% (risk ratio [RR]: 1.26; 95% confidence interval [CI]: 1.09-1.46) at the end of therapy (5 RCTs, 1474 participants). Modified intention-to-treat estimates, in which only participants with laboratory-confirmed bacterial conjunctivitis were analyzed, indicated that antibiotics were associated with 53% higher likelihood of microbiological cure as compared with placebo (RR: 1.53; 95% CI: 1.34-1.74; 10 RCTs, 2827 participants). Non-FQs (RR: 4.05; 95% CI: 1.36-12.00), but not FQs (RR: 0.70; 95% CI: 0.54-0.90), were likely to increase treatment-associated ocular complications such as eye pain, discomfort, and allergic reactions; the certainty of level of evidence was very low. Conclusions Moderate level certainty of evidence suggested that antibiotics may increase the likelihood of clinical recovery and microbiological clearance compared with placebo. Very low-level certainty of evidence suggested that antibiotics may be associated with potential harm in patients with acute bacterial conjunctivitis, but the potential risk of bias from study design, inconsistency in outcome measurement, and reporting limit the evidence to very low certainty

Effect of smoke-free legislation on the incidence of sudden circulatory arrest in the Netherlands

Objective To investigate whether smoke-free legislation in the Netherlands led to a decreased incidence of out-of-hospital sudden circulatory arrest (SCA). Smoke-free legislation was implemented in two phases: a workplace ban in 2004 and an extension of this ban to the hospitality sector on 1 July 2008. Design Weekly incidence data on SCA were obtained from the ambulance registry of South Limburg, the Netherlands. Three time periods were distinguished: the pre-ban period (1 January 2002-1 January 2004), the first post-ban period (1 January 2004-1 July 2008) and the second post-ban period (1 July 2008-1 May 2010). Trends in absolute SCA incidence were analysed using Poisson regression, adjusted for population size, ambient temperature, air pollution and influenza rates. Results A total of 2305 SCA cases were observed (mean weekly incidence 5.3 +/- 2.3 SD). The adjusted Poisson regression model showed a small but significant increase in SCA incidence during the pre-ban period (+0.20% cases per week, p = 0.044). This trend changed significantly after implementation of the first ban (with -0.24% cases per week, p = 0.043), translating into a 6.8% (22 cases) reduction in the number of SCA cases after 1 year of smoke-free legislation. No further decrease was seen after the second smoking ban. Conclusions After introduction of a nationwide workplace smoking ban in 2004, a significant decrease in the incidence of out-of-hospital SCA was seen in South Limburg. Poor enforcement of the 2008 hospitality sector ban may account for the fact that no further decrease in the incidence of SCA was seen at this time

Follow-up care by patient's own general practitioner after contact with out-of-hours care. A descriptive study

BACKGROUND: Little is known about the care process after patients have contacted a GP cooperative for out-of-hours care. The objective of this study was to determine the proportion of patients who seek follow-up care after contact with a GP cooperative for out-of-hours care, and to gain insight into factors that are related to this follow-up care. METHODS: A total of 2805 patients who contacted a GP cooperative for out-of-hours care were sent a questionnaire. They were asked whether they had attended their own GP within a week after their contact with the cooperative, and for what reason. To investigate whether other variables are related to follow-up care, a logistic regression analysis was applied. Variables that entered in this analysis were patient characteristics (age, gender, etc.) and patient opinion on correctness of diagnosis, urgency and severity of the medical complaint. RESULTS: The response rate was 42%. In total, 48% of the patients received follow-up care from their own GP. Only 20% were referred or advised to attend their own GP. Others attended because their medical condition worsened or because they were concerned about their complaint. Variables that predicted follow-up care were the patient's opinion on the correctness of the diagnosis, patient's health insurance, and severity of the medical problem. CONCLUSION: Almost half of all patients in this study who contacted the GP cooperative for out-of-hours care attended their own GP during office hours within a week, for the same medical complaint. The most important factor that predicted follow-up care from the patient's own GP after an out-of-hours contact was the patient's degree of confidence in the diagnosis established at the GP cooperative. Despite the limited generalisability, this study is a first step in providing insight into the dimension of follow-up care after a patient has contacted the GP cooperative for out-of-hours primary care

Out-of-hours primary care. Implications of organisation on costs

BACKGROUND: To perform out-of-hours primary care, Dutch general practitioners (GPs) have organised themselves in large-scale GP cooperatives. Roughly, two models of out-of-hours care can be distinguished; GP cooperatives working separate from the hospital emergency department (ED) and GP cooperatives integrated with the hospital ED. Research has shown differences in care utilisation between these two models; a significant shift in the integrated model from utilisation of ED care to primary care. These differences may have implications on costs, however, until now this has not been investigated. This study was performed to provide insight in costs of these two different models of out-of-hours care. METHODS: Annual reports of two GP cooperatives (one separate from and one integrated with a hospital emergency department) in 2003 were analysed on costs and use of out-of-hours care. Costs were calculated per capita. Comparisons were made between the two cooperatives. In addition, a comparison was made between the costs of the hospital ED of the integrated model before and after the set up of the GP cooperative were analysed. RESULTS: Costs per capita of the GP cooperative in the integrated model were slightly higher than in the separate model (ε 11.47 and ε 10.54 respectively). Differences were mainly caused by personnel and other costs, including transportation, interest, cleaning, computers and overhead. Despite a significant reduction in patients utilising ED care as a result of the introduction of the GP cooperative integrated within the ED, the costs of the ED remained the same. CONCLUSION: The study results show that the costs of primary care appear to be more dependent on the size of the population the cooperative covers than on the way the GP cooperative is organised, i.e. separated versus integrated. In addition, despite the substantial reduction of patients, locating the GP cooperative at the same site as the ED was found to have little effect on costs of the ED. Sharing more facilities and personnel between the ED and the GP cooperative may improve cost-efficiency

An Online Health Prevention Intervention for Youth with Addicted or Mentally Ill Parents:Experiences and Perspectives of Participants and Providers from a Randomized Controlled Trial

Background: Mental illnesses affect many people around the world, either directly or indirectly. Families of persons suffering from mental illness or addiction suffer too, especially their children. In the Netherlands, 864,000 parents meet the diagnostic criteria for a mental illness or addiction. Evidence shows that offspring of mentally ill or addicted parents are at risk for developing mental disorders or illnesses themselves. The Kopstoring course is an online 8-week group course with supervision by 2 trained psychologists or social workers, aimed to prevent behavioral and psychological problems for children (aged 16 to 25 years) of parents with mental health problems or addictions. The course addresses themes such as roles in the family and mastery skills. An online randomized controlled trial (RCT) was conducted to assess the effectiveness of the Kopstoring course. Objective: The aim was to gain knowledge about expectations, experiences, and perspectives of participants and providers of the online Kopstoring course. Methods: A process evaluation was performed to evaluate the online delivery of Kopstoring and the experiences and perspectives of participants and providers of Kopstoring. Interviews were performed with members from both groups. Participants were drawn from a sample from the Kopstoring RCT. Results: Thirteen participants and 4 providers were interviewed. Five main themes emerged from these interviews: background, the requirements for the intervention, experience with the intervention, technical aspects, and research aspects. Overall, participants and providers found the intervention to be valuable because it was online; therefore, protecting their anonymity was considered a key component. Most barriers existed in the technical sphere. Additional barriers existed with conducting the RCT, namely gathering informed consent and gathering parental consent in the case of minors. Conclusions: This study provides valuable insight into participants' and providers' experiences and expectations with the online preventive intervention Kopstoring. It also sheds light on the process of the online provision of Kopstoring and the accompanying RCT. The findings of this study may partly explain dropout rates when delivering online interventions. The change in the (financial) structure of the youth mental health care system in the Netherlands has financial implications for the delivery of prevention programs for youth. Lastly, there are few RCTs that assess the effectiveness and cost-effectiveness of online prevention programs in the field of (youth) mental health care and not many process evaluations of these programs exist. This hampers a good comparison between online interventions and the expectations and experiences of the participants and providers

Lessons learned from a living lab on the broad adoption of eHealth in primary health care

Background: Electronic health (eHealth) solutions are considered to relieve current and future pressure on the sustainability of primary health care systems. However, evidence of the effectiveness of eHealth in daily practice is missing. Furthermore, eHealth solutions are often not implemented structurally after a pilot phase, even if successful during this phase. Although many studies on barriers and facilitators were published in recent years, eHealth implementation still progresses only slowly. To further unravel the slow implementation process in primary health care and accelerate the implementation of eHealth, a 3-year Living Lab project was set up. In the Living Lab, called eLabEL, patients, health care professionals, small- and medium-sized enterprises (SMEs), and research institutes collaborated to select and integrate fully mature eHealth technologies for implementation in primary health care. Seven primary health care centers, 10 SMEs, and 4 research institutes participated. Objective: This viewpoint paper aims to show the process of adoption of eHealth in primary care from the perspective of different stakeholders in a qualitative way. We provide a real-world view on how such a process occurs, including successes and failures related to the different perspectives. Methods: Reflective and process-based notes from all meetings of the project partners, interview data, and data of focus groups were analyzed systematically using four theoretical models to study the adoption of eHealth in primary care. Results: The results showed that large-scale implementation of eHealth depends on the efforts of and interaction and collaboration among 4 groups of stakeholders: patients, health care professionals, SMEs, and those responsible for health care policy (health care insurers and policy makers). These stakeholders are all acting within their own contexts and with their own values and expectations. We experienced that patients reported expected benefits regarding the use of eHealth for self-management purposes, and health care professionals stressed the potential benefits of eHealth and were interested in using eHealth to distinguish themselves from other care organizations. In addition, eHealth entrepreneurs valued the collaboration among SMEs as they were not big enough to enter the health care market on their own and valued the collaboration with research institutes. Furthermore, health care insurers and policy makers shared the ambition and need for the development and implementation of an integrated eHealth infrastructure. Conclusions: For optimal and sustainable use of eHealth, patients should be actively involved, primary health care professionals need to be reinforced in their management, entrepreneurs should work closely with health care professionals and patients, and the government needs to focus on new health care models stimulating innovations. Only when all these parties act together, starting in local communities with a small range of eHealth tools, the potential of eHealth will be enforced