The expansion of primary care and community-based service delivery systems is intended to meet emerging needs, reduce the costs of hospital-based ambulatory care and prevent avoidable hospital use by the provision of more appropriate care. Great emphasis has been placed on the role of self-management in the complex process of care of patient with long-term conditions. Several studies have determined that nurses, among the health professionals, are more recommended to promote health and deliver preventive programs within the primary care context. The aim of this systematic review and meta-analysis is to assess the efficacy of the nurse-led self-management support versus usual care evaluating patient outcomes in chronic care community programs. Systematic review was carried out in MEDLINE, CINAHL, Scopus and Web of Science including RCTs of nurse-led self-management support interventions performed to improve observer reported outcomes (OROs) and patients reported outcomes (PROs), with any method of communication exchange or education in a community setting on patients >18 years of age with a diagnosis of chronic diseases or multi-morbidity. Of the 7,279 papers initially retrieved, 29 met the inclusion criteria. Meta-analyses on systolic (SBP) and diastolic (DBP) blood pressure reduction (10 studies—3,881 patients) and HbA1c reduction (7 studies—2,669 patients) were carried-out. The pooled MD were: SBP -3.04 (95% CI -5.01—-1.06), DBP -1.42 (95% CI -1.42—-0.49) and HbA1c -0.15 (95% CI -0.32–0.01) in favor of the experimental groups. Meta-analyses of subgroups showed, among others, a statistically significant effect if the interventions were delivered to patients with diabetes (SBP) or CVD (DBP), if the nurses were specifically trained, if the studies had a sample size higher than 200 patients and if the allocation concealment was not clearly defined. Effects on other OROs and PROs as well as quality of life remain inconclusive.

ObjectiveTo evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes), directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both.DesignProspective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up.Data SourcesDirect contact and structured questionnaires by phone or via internet.MethodsAdults (30–75 years) were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers), users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers), or smokers of both tobacco and e-cigarettes (dual smokers). Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence.Main Outcome MeasuresSustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily.Data SynthesisWe used linear and logistic regression, with region as cluster unit.ResultsFollow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%). All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35–8.02), whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall).ConclusionsAdding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e-cigarettes alone may facilitate quitters remaining so.Registration NumberNCT01785537.

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI −0.05; 0.08) for soft outcomes; −0.06 (−0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (−0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40–7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.Electronic supplementary materialThe online version of this article (doi:10.1007/s10654-015-0104-8) contains supplementary material, which is available to authorized users.

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Given the rapid development of genetic tests, an assessment of their benefits, risks, and limitations is crucial for public health practice. We performed a systematic review aimed at identifying and comparing the existing evaluation frameworks for genetic tests. We searched PUBMED, SCOPUS, ISI Web of Knowledge, Google Scholar, Google, and gray literature sources for any documents describing such frameworks. We identified 29 evaluation frameworks published between 2000 and 2017, mostly based on the ACCE Framework (n = 13 models), or on the HTA process (n = 6), or both (n = 2). Others refer to the Wilson and Jungner screening criteria (n = 3) or to a mixture of different criteria (n = 5). Due to the widespread use of the ACCE Framework, the most frequently used evaluation criteria are analytic and clinical validity, clinical utility and ethical, legal and social implications. Less attention is given to the context of implementation. An economic dimension is always considered, but not in great detail. Consideration of delivery models, organizational aspects, and consumer viewpoint is often lacking. A deeper analysis of such context-related evaluation dimensions may strengthen a comprehensive evaluation of genetic tests and support the decision-making process.

ObjectiveTo evaluate the safety and effectiveness of e-cigarettes, by comparing users of only e-cigarettes, smokers of only tobacco cigarettes and dual users.DesignProspective cohort study. We update previous 12-month findings and report the results of the 24-month follow-up.Data sourcesDirect contact and questionnaires by phone or via internet.MethodsAdults (30–75 years) were classified as: (1) tobacco smokers, if they smoked ≥1 tobacco cigarette/day, (2) e-cigarette users, if they inhaled ≥50 puffs/week of any type of e-cigarette and (3) dual users, if they smoked tobacco cigarettes and also used e-cigarettes. Carbon monoxide levels were tested in 50% of those declaring tobacco smoking abstinence. Hospital discharge data were used to validate possibly related serious adverse events in 46.0% of the sample.Main outcome measuresSustained abstinence from tobacco cigarettes and/or e-cigarettes after 24 months, the difference in the number of tobacco cigarettes smoked daily between baseline and 24 months, possibly related serious adverse events.ResultsData at 24 months were available for 229 e-cigarette users, 480 tobacco smokers and 223 dual users (overall response rate 68.8%). Of the e-cigarette users, 61.1% remained abstinent from tobacco (while 23.1% and 26.0% of tobacco-only smokers and dual users achieved tobacco abstinence). The rate (18.8%) of stopping use of either product (tobacco and/or e-cigarettes) was not higher for e-cigarette users compared with tobacco smokers or dual users. Self-rated health and adverse events were similar between all groups. Among those continuing to smoke, there were no differences in the proportion of participants reducing tobacco cigarette consumption by 50% or more, the average daily number of cigarettes and the average self-rated health by baseline group. Most dual users at baseline abandoned e-cigarettes and continued to smoke tobacco. Those who continued dual using or converted from tobacco smoking to dual use during follow-up experienced significant improvements in the 3 outcomes compared with those who continued or switched to only smoking tobacco (p<0.001).ConclusionsE-cigarette use alone might support tobacco quitters remaining abstinent from smoking. However, dual use did not improve the likelihood of quitting tobacco or e-cigarette use, but may be helpful to reduce tobacco consumption. Adverse event data were scarce and must be considered preliminary.Trial registration numberNCT01785537.

Objective To evaluate the extent of non-publication or delayed publication of registered randomized trials on vaccines, and to investigate potential determinants of delay to publication. Design Survey.Data sources Trials registry websites, Scopus, PubMed, Google. Main outcome measures Publication status of trial results and time from completion to publication in peer reviewed journals. Study selectionData synthesis Cox proportional hazards regression was used to evaluate potential predictors of publication delay. ResultsWe analysed 384 trials (85% sponsored by industry). Of 355 trials (404 758 participants) that were completed, 176 (n=151 379) had been published in peer reviewed journals. Another 42 trials (total sample 62 765) remained unpublished but reported results in ClinicalTrials.gov. The proportion of trials published 12, 24, 36, and 48 months after completion was 12%, 29%, 53%, and 73%, respectively. Including results posted in ClinicalTrials.gov, 48 months after study completion results were available for 82% of the trials and 90% of the participants. Delay to publication between non-industry and industry sponsored trials did not differ, but non-industry sponsored trials were 4.42-fold (P=0.008) more likely to report negative or mixed findings. Negative results were reported by only 2% of the published trials.Conclusions Most vaccine trials are published eventually or the results posted in ClinicalTrials.gov, but delays to publication of several years are common. Actions should focus on the timely dissemination of data from vaccine trials to the public.

Targeted educational programs are needed to improve the expertise of physicians, and, ultimately, to enhance the appropriate use of genetic tests in clinical practice.