Search

Aims: A set of indicators to assess the quality of care for patients hospitalized for heart failure was developed by an expert working group of the Italian Health Ministry. Because a better performance profile measured using these indicators does not necessarily translate to better outcomes, a study to validate these indicators through their relationship with measurable clinical outcomes and healthcare costs supported by the Italian National Health System was carried out. Methods and results: Residents of four Italian regions (Lombardy, Marche, Lazio, and Sicily) who were newly hospitalized for heart failure (irrespective of stage and New York Heart Association class) during 2014–2015 entered in the cohort and followed up until 2019. Adherence to evidence‐based recommendations [i.e. renin–angiotensin–aldosterone system (RAS) inhibitors, beta‐blockers, mineralocorticoid receptor antagonists (MRAs), and echocardiograms (ECCs)] experienced during the first year after index discharge was assessed. Composite clinical outcomes (cardiovascular hospital admissions and all‐cause mortality) and healthcare costs (hospitalizations, drugs, and outpatient services) were assessed during the follow‐up. The restricted mean survival time at 5 years (denoted as the number of months free from clinical outcomes), the hazard of clinical outcomes (according to the Cox model), and average annual healthcare cost (expressed in euros per person‐year) were compared between adherent and non‐adherent patients. A non‐parametric bootstrap method based on 1000 resamples was used to account for uncertainty in cost‐effectiveness estimates. A total of 41 406 patients were included in this study (46.3% males, mean age 76.9 ± 9.4 years). Adherence to RAS inhibitors, beta‐blockers, MRAs, and ECCs were 64%, 57%, 62%, and 20% among the cohort members, respectively. Compared with non‐adherent patients, those who adhered to ECCs, RAS inhibitors, beta‐blockers, and MRAs experienced (i) a delay in the composite outcome of 1.6, 1.9, 1.6, and 0.6 months and reduced risks of 9% (95% confidence interval, 2–14%), 11% (7–14%), 8% (5–11%), and 4% (−1–8%), respectively; and (ii) lower (€262, €92, and €571 per year for RAS inhibitors, beta‐blockers, and MRAs, respectively) and higher costs (€511 per year for ECC). Adherence to RAS inhibitors, beta‐blockers, and MRAs showed a delay in the composite outcome and a saving of costs in 98%, 84%, and 93% of the 1000 bootstrap replications, respectively. Conclusions: Strict monitoring of patients with heart failure through regular clinical examinations and drug therapies should be considered the cornerstone of national guidelines and audits. [ABSTRACT FROM AUTHOR]

Introduction: The identification of dementia cases through routinely collected health data represents an easily accessible and inexpensive method to estimate the prevalence of dementia. In Italy, a project aimed at the validation of an algorithm was conducted. Methods: The project included cases (patients with dementia or mild cognitive impairment [MCI]) recruited in centers for cognitive disorders and dementias and controls recruited in outpatient units of geriatrics and neurology. The algorithm based on pharmaceutical prescriptions, hospital discharge records, residential long-term care records, and information on exemption from health-care co-payment, was applied to the validation population. Results: The main analysis was conducted on 1110 cases and 1114 controls. The sensitivity, specificity, and positive and negative predictive values in discerning cases of dementia were 74.5%, 96.0%, 94.9%, and 79.1%, respectively, whereas in detecting cases of MCI these values were 29.7%, 97.5%, 92.2%, and 58.1%, respectively. The variables associated with misclassification of cases were also identified. Discussion: This study provided a validated algorithm, based on administrative data, which can be used to identify caseswith dementia and, with lower sensitivity, also early onset dementia but not cases withMCI. [ABSTRACT FROM AUTHOR]

Background and purpose: Multiple sclerosis (MS) is a complex chronic, autoimmune inflammatory disease involving multidisciplinary assessments and interventions. Access to outpatient specialist and home healthcare services was explored during the pandemic outbreak and the lockdown amongst MS patients in the Lazio region. Adherence to disease‐modifying therapies (DMTs) is also described. Methods: A population‐based study was conducted using regional healthcare administrative databases. A validated algorithm was used to identify MS cases over the period 2011–2018. The numbers of specialist and home‐based services were compared between 2019 and 2020. The medication possession ratio was used to measure adherence to DMTs. Results: A total of 9380 MS patients were identified (68% women). A decline in the number of outpatient care services between March and June 2020 compared to the previous year was observed, in particular for rehabilitation (−82%), magnetic resonance imaging (−56%) and neurological specialist services (−91%). Important year‐to‐year variations were observed in May and June 2020 in home‐based nursing and medical care (−91%) and motor re‐education services (−74%). Adherence to DMTs was higher in the first 4 months of 2019 compared to the same period of 2020 (67.1% vs. 57.0%). Conclusions: A notable disruption of rehabilitative therapy and home‐based services as well as in DMT adherence was observed. Since the pandemic is still ongoing and interruption of healthcare services could have a major impact on MS patients, it is necessary to monitor access of MS patients to healthcare resources in order to ensure adequate treatments, including rehabilitative therapies. [ABSTRACT FROM AUTHOR]

Introduction and Aims: To corroborate protective effects of a range of drug treatment modalities against overdose mortality risk. Design and Methods: Nested case–control study, with incidence density sampling, selecting controls retrospectively at each case event. Cases and controls came from a sub‐cohort of opioid‐dependent patients (n = 4444) from two Italian regions (Lazio and Piedmont). From 1998 to 2005, there were 91 overdose deaths (cases) matched to 352 controls. The primary outcome was overdose mortality and the primary exposure was drug treatment: opioid agonist treatment (OAT), opioid detoxification, residential community, psychosocial and other pharmacological treatment. Conditional logistic regression models generated intervention effects comparing mortality risk in and out of treatment, adjusting for confounding variables. Results: Overall, drug treatment reduced overdose mortality risk by 80% [adjusted odds ratio (AOR) 0.18, 95% confidence interval (CI) 0.10–0.33, P < 0.001] compared to being out of treatment. There was a particularly strong protective effect of OAT on overdose mortality (AOR 0.08, 95% CI 0.03–0.23, P < 0.001) compared to being out of treatment. There was evidence of a substantially elevated risk of overdose in the first month of leaving treatment (AOR 23.50, 95% CI 7.84–70.19, P < 0.001) compared to being in treatment. Discussion and Conclusions: The nested case–control design strengthened earlier findings that OAT in Italy has strong protective effects on overdose mortality risk, much stronger than has been previously seen in other Western European settings. [ABSTRACT FROM AUTHOR]

Purpose To analyse the drug use pattern in women with psoriasis before, during and after pregnancy. Methods: All children born (2009‐2016) in a central Italian region (Lazio) to mothers with a diagnosis of psoriasis were identified. Drug use patterns (biologicals, systemic, and topical), and discontinuation and switching of drug therapies before, during, and after pregnancy were studied. Findings were compared with data from a population exposed to similar drug therapies (eg, antirheumatic drugs). Results: Among 3499 deliveries by women affected by psoriasis, 1876 (53.6%) were diagnosed with this condition before the Last Menstrual Period (LMP). Of these, 525 (27.9%) had at least one drug prescription for psoriasis therapy during 6 months before LMP. For each class of drugs considered, there was a general decrease in its use during pregnancy. Considering the two trimesters preceding LMP and the three trimesters of pregnancy, the following percentages of prescriptions were observed: from 10.5% to 0% for biologicals, 7.2% to 2.5% for the conventional systemic drugs, and 51.1% to 9.4% for the topical treatments. After delivery, previous treatments were resumed. Similar results were observed for rheumatoid arthritis, a chronic condition. Conclusions: Majority of drugs come with warnings regarding potential embryo‐fetotoxicity, which might play a role in the decision to continue treatments during pregnancy. According to our study pregnancy appears to have a significant influence on drug prescriptions of different pharmacological treatments for psoriasis. [ABSTRACT FROM AUTHOR]

Combined inhaled therapy in chronic obstructive pulmonary disease (COPD) is commonly used, but its benefits remain controversial. We assessed the effect of tiotropium in reducing COPD exacerbations when combined with long-acting β2 agonists (LABA) and/or inhaled corticosteroids (ICS). This new-user cohort study is based on administrative data from 3 Italian regions. We identified adults hospitalized for COPD from 2006 to 2009 who were newly prescribed a fixed LABA/ICS combination (double therapy). We classified patients according to whether tiotropium was also prescribed (triple therapy), using both intention-to-treat and as-treated approaches, and followed them for 1 year. COPD exacerbations were measured as outcomes. Multivariate and propensity score-adjusted hazard ratios (HRs, 95%CI) were calculated with Cox regression models. We identified 5717 new users of LABA/ICS of which 31.9% initiated triple therapy. In the intention-to-treat analysis, the multivariate adjusted HR for moderate, severe, and any exacerbations were 1.02 (95%CI 0.89-1.16), 0.92 (95%CI 0.76-1.12), and 1.08 (95%CI 0.91-1.28), respectively. The propensity score adjustment produced similar results. In the subcohort of patients with previous exacerbations, triple therapy was significantly associated with reduced risk of moderate exacerbations, compared to double therapy (HR 0.68, 95%CI 0.48-0.98 in intention-to-treat approach). In conclusion, the addition of tiotropium to LABA/ICS did not reduce COPD exacerbations compared to LABA/ICS alone. A protective role for moderate exacerbations was found in patients at risk of frequent exacerbations. Given the impact of exacerbations on health status and prognosis, it is crucial to target COPD patients for optimal treatment. [ABSTRACT FROM AUTHOR]

Purpose Whether inhaled medications improve long-term survival in Chronic Obstructive Pulmonary Disease (COPD) is an open question. The purpose of this study is to assess the impact of adherence to inhaled drug use on 5-year survival in COPD. Methods A population-based cohort study in three Italian regions was conducted using healthcare linked datasets (hospitalization, mortality, drugs). Individuals (45+ years) discharged after COPD exacerbation in 2006-2009 were enrolled. Inhaled drug daily use during 5-year follow-up was determined through Proportion of Days Covered on the basis of Defined Daily Doses. Five levels of time-dependent exposure were identified: (i) long-acting β2 agonists and inhaled corticosteroids (LB/ICS) regular use; (ii) LB/ICS occasional use; (iii) LB regular use; (iv) LB occasional use; and (v) respiratory drugs other than LB. Cox regression models adjusted for baseline (socio-demographic, comorbidities, drug use) and time-dependent characteristics (COPD exacerbations, cardiovascular hospitalizations, cardiovascular therapy) were performed. Results A total of 12 124 individuals were studied, 46% women, mean age 73,8 years. Average follow-up time 2,4 year. A total of 3415 subjects died (mortality rate = 11.9 per 100 person years). In comparison to LB/ICS regular use, higher risks of death for all remaining treatments were found, the highest risk for respiratory drugs other than LB category (HR = 1.63, 95%CI 1.43-1.87). Patients with regular LB use had higher survival than those with LB/ICS occasional use (HR = 0.89, 95%CI 0.79-0.99). Conclusions These findings support clinical guidelines and recommendations for the regular use of inhaled drugs to improve health status and prognosis among moderate-severe COPD patients. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Purpose Long-acting bronchodilators, i.e. beta-2-agonists (LABA) and tiotropium are commonly used in COPD treatment. Choice of a specific agent is based on effectiveness and safety. Evidence yields controversial results with respect to mortality. The present study compared one-year mortality associated to treatment with tiotropium versus LABA. Methods A population-based cohort study using data from Italian health information systems was performed. Patients aged 45+ years, discharged with COPD diagnosis in 2006-2009 were identified. Through record linkage with drug claims, patients who received a first prescription of LABA or tiotropium within 6 months after discharge were enrolled. The main analysis was restricted to naïve users (no prior use of either LABA or tiotropium). We used 'intention to treat' (ITT) and 'as treated' (AT) approaches. We followed patients for a maximum of 12 months. Hazard ratios (HRs) were calculated by Cox regression including quintiles of propensity score. In sensitivity analysis patients receiving tiotropium + LABA combination were included in the tiotropium group. Results Among the 33 891 enrolees, 28% were exposed to Tio, 56% to LABA, 16% to both. Overall mean age was 74 years and the mortality rate was 122/1000 person-years (py) at the ITT analysis and 108/1000 py at the AT analysis. The adjusted HR for tiotropium only compared with LABA only was 1.06 (95%CI: 0.94-1.20) at the ITT analysis and 1.00 (95%CI: 0.93-1.08) at the AT analysis. Results were robust in sensitivity analysis. Conclusions In this real-world study use of tiotropium was not associated with an increased risk of one-year mortality compared with LABA. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background and Aims The World Health Organization ( WHO), and a growing number of other organizations, have adopted the Grading of Recommendations, Assessment, Development and Evaluation ( GRADE) system in order to both assess the quality of research evidence and develop clinical practice guidelines. In 2009 WHO published a guideline on psychosocially assisted pharmacological treatment of opioid dependence, based on the results of Cochrane Reviews summarized using the GRADE methodology. The main features of this system are an a priori definition of outcomes and their relevance, and distinction between the quality of evidence (also referred to as confidence in the estimate of intervention effect) and the strength of recommendations. We consider how successful this approach has been. Analysis and Evidence We discuss the merits and limitations of using Cochrane Reviews and GRADE framework in developing guidelines in the field of drug addiction. In 2009 a panel of multi-disciplinary international experts identified 15 clinical questions and eight relevant outcomes. Cochrane reviews were available for each clinical question and four outcomes. The panel formulated 15 recommendations. Eight recommendations were classified as strong, two of which were based on high-quality evidence and three on very low-quality evidence. For example, the strong recommendation to use methadone in adequate doses in preference to buprenorphine was based on high-quality evidence, while the strong recommendation not to use the combination of opioid antagonists with heavy sedation in the management of opioid withdrawal was based on low-quality evidence. Conclusions An explicit stepwise process of moving from evaluation of the quality of evidence to the definition of the strength of recommendations is important in providing practical and clear clinical guidance for practitioners and policy-makers in addiction. [ABSTRACT FROM AUTHOR]

Background and Objective The Cochrane Drugs and Alcohol Group aims to produce, update, and disseminate systematic reviews on the prevention, treatment, and rehabilitation of problematic drug and alcohol use. This paper describes what the Group has done since the 1990s to produce evidence to guide policy, practice, and research. Method We analyze the coverage of topics by our reviews, the body of studies they have included, and the evidence produced. Results By July 2013, the Group had published 67 reviews, with 376 authors from 25 different countries. These reviews included 906 studies, of 3061 studies considered for inclusion. Most (90%) included studies were randomized trials. Considering the 'Implications for practice' section of each review, 41% interventions were classified as 'do it', 15% as 'do not do', and 44% as 'do only in research'. These proportions varied according to the type of substance of abuse studied. The proportion of 'do it' interventions were 46% for alcohol, 40% for opioids, 20% for psychostimulants, 40% for polydrugs, and 62% for prevention. Conclusion Cochrane Reviews produced by the Drugs and Alcohol Group provide evidence on the effectiveness of several interventions, and identify areas of uncertainty where new research is needed. [ABSTRACT FROM AUTHOR]

ABSTRACT Purpose There are some methodological concerns regarding results from observational studies about the effectiveness of evidence-based (EB) drug therapy in secondary prevention after myocardial infarction. The present study used a nested case-control approach to address these major methodological limitations. Methods A cohort of 6880 patients discharged from hospital after acute myocardial infarction (AMI) in 2006-2007 was enrolled and followed-up throughout 2009. Exposure was defined as adherence to each drug in terms of the proportion of days covered (cutoff ≥ 75%). Composite treatment groups, that is, groups with no EB therapy or therapy with one, two, three, or four EB drugs), were analyzed. Outcomes were overall mortality and reinfarction. Nested case-control studies were performed for both outcomes, matching four controls to every case (841 deaths, 778 reinfarctions) by gender, age, and individual follow-up. The association between exposure to EB drug therapy and outcomes was analyzed using conditional logistic regression, adjusting for revascularization procedures, comorbidities, duration of index admission, and use of the study drugs prior to admission. Results Mortality and reinfarction risk decreased with the use of an increasing number of EB drugs. Combinations of two or more EB drugs were associated with a significant protective effect ( p < 0.001) versus no EB drugs (mortality: 4 EB drugs: ORadj = 0.35; 95%CI: 0.21-0.59; reinfarction: 4 EB drugs: ORadj = 0.23; 95%CI: 0.15-0.37). Conclusions These findings of the beneficial effects of EB polytherapy on mortality and morbidity in a population-based setting using a nested case-control approach strengthen existing evidence from observational studies. Copyright © 2013 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article discusses a study by Minozzi and colleagues who concluded that addiction rates among people prescribed opioids for pain relief are very low. It mentions that evidence base on which to make such an assertion is very limited about iatrogenic addiction and how to measure it. It states that there are many methodological shortcomings in existing research and therefore addiction scientists must reassess and re-evaluate research in this area.

Aims To assess the incidence or prevalence of opioid dependence syndrome in adults (with and without previous history of substance abuse) following treatment with opioid analgesics for pain relief. Methods Medline, Embase, CINHAL and the Cochrane Library were searched up to January 2011. Systematic reviews and primary studies were included if they reported data about incidence or prevalence of opioid dependence syndrome (as defined by DSM-IV or ICD-10) in patients receiving strong opioids (or opioid-type analgesics) for treatment of acute or chronic pain due to any physical condition. The data were abstracted, and the methodological quality was assessed using validated checklists. Results Data were extracted from 17 studies involving a total of 88 235 participants. The studies included three systematic reviews, one randomized controlled trial, eight cross-sectional studies and four uncontrolled case series. Most studies included adult patients with chronic non-malignant pain; two also included patients with cancer pain; only one included patients with a previous history of dependence. Incidence ranged from 0 to 24% (median 0.5%); prevalence ranged from 0 to 31% (median 4.5%). Conclusions The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence. [ABSTRACT FROM AUTHOR]

Objective To evaluate whether reporting of hospital performance was associated with a change in quality indicators in Italian hospitals. Data Sources/Study Setting Nationwide Hospital Information System for 2006-2009. Study Design We performed a pre-post evaluation in Lazio (before and after disclosure of the Regional Outcome Evaluation Program P.Re.Val.E.) and a comparative evaluation versus Italian regions without comparable programs. We analyzed risk-adjusted proportions of percutaneous coronary intervention ( PCI), hip fractures operated on within 48 hours, and cesarean deliveries. Data Collection/Extraction Methods Using standardized ICD-9- CM coding algorithms, we selected 381,053 acute myocardial infarction patients, 250,712 hip fractures, and 1,736,970 women who had given birth. Principal Findings In Lazio PCI within 48 hours changed from 22.49 to 29.43 percent following reporting of the P.Re.Val.E results (relative increase, 31 percent; p < .001). In the other regions this proportion increased from 22.48 to 27.09 percent during the same time period (relative increase, 21 percent; p < .001). Hip fractures operated on within 48 hours increased from 11.73 to 15.78 percent (relative increase, 34 percent; p < .001) in Lazio, and not in other regions (29.36 to 28.57 percent). Cesarean deliveries did not decrease in Lazio (34.57-35.30 percent), and only slightly decreased in the other regions (30.49-28.11 percent). Conclusions Reporting of performance data may have a positive but limited impact on quality improvement. The evaluation of quality indicators remains paramount for public accountability. [ABSTRACT FROM AUTHOR]

The article presents a study on patients treated with evidence-based drugs after acute myocardial infarction (AMI) in absence of prescribed daily doses (PDD). It defines those patients treated with such alternative drugs and examines the impact of the different drug use measures on risk factors estimation related to drug use. It also points the need to develop and validate methodologies in absence of PDD.

Issues. Cross-sectional surveys have revealed that cannabis is the most widely used illicit substance in Western countries. Cannabis intoxication can lead to acute, transient psychotic symptoms and the short-term exacerbation of pre-existing psychotic symptoms. However, controversy exists about whether cannabis can actually cause long-term psychosis. Approach. We summarised the findings of systematic reviews on the association between cannabis use and psychosis, searching MEDLINE, EMBASE and CINAHL up to August 2007. We assessed the methodological quality, selected the better quality reviews and analysed reasons for discordant results. Key Findings. We included five systematic reviews. Four of the reviews performed a meta-analysis and showed a consistent association between cannabis use and psychosis; the fifth review considered psychological problems more broadly, did not perform a meta-analysis and reported an inconsistent association. The reasons for discordance were: different outcomes (psychosis vs. psychological problems), different inclusion criteria for primary studies and different methods for summarising the results. Implications. This overview shows a consistent association between cannabis use and psychotic symptoms, though it is not possible to draw firm conclusions about a causal relationship. Reverse causality and residual confounding cannot be excluded. An interaction with other environmental and genetic factors is difficult to ascertain. Conclusion. We conclude that there is insufficient knowledge to determine the level of risk associated with cannabis use in relation to psychotic symptoms and that more information is needed on both the risks of cannabis use and the benefits of preventive interventions to support evidence-based approaches in this area.[Minozzi S, Davoli M, Bargagli AM, Amato L, Vecchi S, Perucci CA. An overview of systematic reviews on cannabis and psychosis: Discussing apparently conflicting results. Drug Alcohol Rev 2009] [ABSTRACT FROM AUTHOR]

Background Specialist drug treatment is critical to overdose prevention; methadone maintenance is effective, but we lack evidence for other modalities. We evaluate the impact of a range of treatments for opiate dependence on overdose mortality. Methods Prospective cohort study of 10 454 heroin users entering treatment 1998–2001 in Italy followed-up for 10 208 person-years in treatment and 2914 person-years out of treatment. Standardized overall mortality ratios (SMR) estimate excess mortality risk for heroin users in and out of treatment compared to the general population. Cox models compare the hazard ratio (HR) of overdose between heroin users in treatment and out of treatment. Results There were 41 overdose deaths, 10 during treatment and 31 out of treatment, generating annual mortality rates of 0.1% and 1.1% and SMRs of 3.9 [95% confidence interval (CI) 2.8–5.4] and 21.4 (16.7–27.4), respectively. Retention in any treatment was protective against overdose mortality (HR 0.09 95% CI 0.04–0.19) compared to the risk of mortality out of treatment, independent of treatment type and potential confounders. The risk of a fatal overdose was 2.3% in the month immediately after treatment and 0.77% in the subsequent period; compared to the risk of overdose during treatment the HR was 26.6 (95% CI 11.6–61.1) in the month immediately following treatment and 7.3 (3.3–16.2) in the subsequent period. Conclusions We demonstrate that a range of treatments for heroin dependence reduces overdose mortality risk. However, the considerable excess mortality risk in the month following treatment indicates the need for greater health education of drug users and implementation of relapse and overdose death prevention programmes. Further investigation is needed to measure and weigh the potential benefits and harms of short-term therapies for opiate use. [ABSTRACT FROM AUTHOR]

With the breadth of new psychoactive substances and international policy changes, an analysis of specific responses in all areas of drug supply and demand is beyond the resources of a single country. The Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction calls for a strengthening of global monitoring and evidence synthesis and a renewed vigour in collaborative efforts to expand training, research and the quality and comparability of data across Europe and beyond.

To estimate the impact of intravenous drug use (IVDU) on mortality in the general population of young adults in Rome, Italy, the Population Attributable Risk (PAR) was calculated for the overall and cause-specific mortality in the 15-34 years age group. Relative risks were derived from a previous historical cohort study on mortality among 4200 intravenous drug users (IVDUs) in Rome, in which increased mortality from cardiovascular, respiratory, and gastrointestinal diseases as well as from violence, overdose and AIDS had been observed. The prevalence of the risk factor (i.e. the proportion of IVDUs) in the general population was estimated using the 'multiplier formula' and 'capture-recapture' methods. The proportion of all deaths attributable to IVDU in the 15-34 age group in the Roman population was 16% and 9% in males and females, respectively. The cause-specific attributable proportions were 66% for endocarditis and 37% for cirrhosis in males, and 36% for endocarditis and pneumonia in females. These findings further document the relevant health consequences of IVDU on the general population of a large metropolitan area. [ABSTRACT FROM AUTHOR]

The authors reply to commentaries by Corrado Barbui and by Marica Ferri and Sonia Dias addressing their article "The role of Cochrane reviews in informing international guidelines: a case study of using the Grading of Recommendations, Assessment, Development and Evaluation system to develop World Health Organization guidelines for the psychosocially assisted pharmacological treatment of opioid dependence" in the current issue. Topics include the availability of primary treatment studies.

A letter to the editor is presented in response to the article "Comments on the Cochran Review on Alcoholics Anonymous effectiveness," by L.A. Kaskutas.

The author responds to the article "Asking the right questions in the right way: the need for a shift in research on psychological treatments for addiction," by Jim Orford, published within the issue. The author notes that Orford's criticisms of clinical trials of psychological treatments for addiction apply to other areas of clinical medicine as well and highlights the importance of using insight gained in clinical trials to inform medical practice and subsequent research.

Editorial. Provides information on the Cochrane Review Group on Drugs and Alcohol which identifies and make accessible, citations of randomized and clinical controlled trials involving interventions for alcohol and drug misuse. Other aims of the review group; Editors of the Drug and Alcohol Review Group.

Background: Real-time monitoring is used to the ends of postmarketing observational research on newly marketed drugs. We implemented a pilot near-real-time monitoring program on the test case of oral anticoagulants. Specifically, we evaluated the safety and effectiveness of direct oral anticoagulants compared to vitamin K antagonists in nonvalvular atrial fibrillation secondary prevention during 2013-2015 in the Lazio Region, Italy., Methods and Results: A cohort study was conducted using a sequential propensity-score-matched new user parallel-cohort design. Sequential analyses were performed using Cox models. Overall, 10 742 patients contributed to the analyses. Compared with vitamin K antagonists, direct oral anticoagulant use was associated with a reduction of all-cause mortality (0.81; 95% confidence interval [CI] 0.66-0.99), cardiovascular mortality (0.71; 95% CI 0.54-0.93), myocardial infarction (0.67; 95% CI 0.43-1.04), ischemic stroke (0.87; 95% CI 0.52-1.45), hemorrhagic stroke (0.25; 95% CI 0.07-0.88), and with a nonsignificant increase of gastrointestinal bleeding (1.26; 95% CI 0.69-2.30)., Conclusions: The present pilot study is a cornerstone to develop real-time monitoring for new drugs in our region., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)