Conditions Of Routine Clinical Practice Research Articles

Inhibitor development, safety, and efficacy of Advate® in previously untreated patients with hemophilia A in a postmarketing surveillance in Japan.

Rurioctocog alfa (recombinant Factor VIII: AdvateⓇ) is available for the control of bleeding in patients with hemophilia A in Japan. To evaluate the immunogenicity, safety, and efficacy of prophylactic and on-demand use of rurioctocog alfa, postmarketing surveillance was conducted on 114 previously untreated Japanese patients aged 0-82years with ≤ 3 exposure days under the conditions of routine clinical practice. A post-hoc comparison of mean annualized bleeding rates between patients in the regular prophylaxis group (7.4 bleeds/year) and in the on-demand treatment group (15.7 bleeds/year) using a negative binomial model found a statistically significant difference (P = 0.0164) in the subset of patients with severe hemophilia A. Favorable prophylactic and on-demand hemostatic efficacy ("excellent" or "good") was shown in 71.4-88.5% across all treatment regimens. A total of 31 events of adverse drug reactions were reported. Of 114 patients, 21 (18.4%) developed de novo FVIII inhibitor; of these, 17 occurred within 50 exposures. One death was reported. A family history of positive inhibitors was significantly associated with inhibitor development (Fisher exact P value = 0.0004); no other risk factors were identified. Rurioctocog alfa was found to be well-tolerated and effective in previously untreated Japanese patients with hemophilia A in this postmarketing surveillance of routine clinical practice.

One-Year Safety and Effectiveness of Insulin Degludec in Patients with Diabetes Mellitus in Routine Clinical Practice in India—TRUST (Tresiba Real-World Use Study)

Insulin degludec (degludec) is a basal insulin with an ultra-long duration of action and low day-to-day variability in the glucose-lowering effect. The aim of this non-interventional, multicentric, prospective, post-authorization safety study (PASS) was to evaluate the long-term (1 year) safety and effectiveness of insulin degludec in patients with diabetes mellitus (DM) requiring insulin therapy on routine clinical practice conditions, as required by the Indian regulatory authority. Eligible patients who were started with degludec treatment as per the physician’s discretion were followed up and data was collected at baseline (BL), 3, 6 and 12 months in the time periods after degludec initiation. Values are expressed as mean (SD). A total of 1057 adult patients with DM (5 with T1D and 1052 with T2D) were included. In total, 59.6% were male, mean age 55.9 (11.5) years, duration of diabetes 11.4 (7.6) years, body weight 71.6 (13.7) kg and HbA1c 9.6 (1.9)%]. Majority of the subjects (81.83%) were insulin-naïve at BL. At 12 months follow-up, 44 adverse events (AEs) were reported in 2.6% of the subjects and 2 AEs were serious. HbA1c decreased significantly compared to BL by 1.8% (1.68) (p<0.0001). Daily degludec dose increased from a starting dose of 14.8 (8.0) U to 18.01 (9.45) U and body weight increased from 71.68 (13.43) kg (BL) to 72.24 (12.88) kg. Hypoglycemia was reported in 5% of the subjects (8.5 events/ 100PYE) during the 12 months treatment period. The two most common reasons for prescribing degludec were to improve HbA1c (83.8%) and for control of fasting glucose (63.7%). In conclusion, this PASS confirms the long-term safety of treatment with degludec with improvement in glycemic control and low risk of hypoglycemia in patients with T2D on routine clinical care. Disclosure J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. L. Murthy: None. B.D. Saboo: None. S. Yalamanchi: None. B. Ramanathan: Speaker's Bureau; Self; Novo Nordisk India Private Limited, Eli Lilly and Company, Boehringer Ingelheim, Sanofi-Aventis, Zydus Pharmaceuticals, USV Private Limited, DR.REDDY'S LABORATORIES, AstraZeneca, Biocon, Johnson and Johnson, MSD, Novartis, Glenmark, Abbott. S. Gupta: Speaker's Bureau; Self; Novo Nordisk India Private Limited, MSD, AstraZeneca, Novartis, USV Private Limited, Abbott. S. Chatterjee: None. M. Revanna: Employee; Self; Novo Nordisk India Private Limited. H. Kasetty: Employee; Self; Novo Nordisk India Private Limited.

Ultrasound Fissure Observation: Assessment of Lung by Pleural-Hub Affiliates

Lung ultrasound examination is becoming an even more important part of pulmonologists' clinical routine. As indicated in the literature, the coordinates of any findings on lung parenchyma are based on surface landmarks or conventional quadrants. In our experience we have noticed that lung fissures are clearly detectable as interruptions of the pleural line, but this has never been investigated previously. The aim of this study was to evaluate whether lung fissures are detectable under normal conditions in routine clinical practice. Ten operators were enrolled from Pleural-Hub, a scientific discussion group. After compiling a prestudy survey to investigate whether they had observed fissures previously, they were asked to note if the following fissures were detectable: posterior right (PR) and left (PL), lateral right (LR) and left (LL), anterior right (AR), and anterolateral left (AL). Enrollment was competitive, aiming to reach 100 case subjects. We found that general fissure detection was 61.3%, in particular: PR, 59%; LR, 75%; AR, 69%; PL, 45%; LL, 64%; AL, 56%. Single operators yielded different detection rates ranging from 90%to 25%, showing strong operator dependency. Before being made aware of general results operators indicated operator's skill and rib shadow artifacts as the principal factors affecting fissure detection. Lung fissures may be detected with ultrasound once adequate training is provided. This may allow the clinician a more precise anatomical delineation of pathology identified by lung ultrasound.

Protocol for the BRECAR study: a prospective cohort follow-up on the impact of breast reconstruction timing on health-related quality of life in women with breast cancer

IntroductionThe completion of postmastectomy breast reconstruction (BR) in women with breast cancer can last from months to years, and to our knowledge, there is a lack of studies that analyse...

Routine urinary detection of antihypertensive drugs for systematic evaluation of adherence to treatment in hypertensive patients.

Nonadherence to antihypertensive therapy is an important cause of poor blood pressure control. However, to date, few effective and accurate tools exist to routinely evaluate drug nonadherence. In this observational study, performed under conditions of routine clinical practice, we included 174 patients (aged 67 ± 11 years) with treated essential hypertension who attended the outpatient hypertension clinic of a university hospital. Adherence to antihypertensive treatment was measured by using ultraperformance liquid chromatography-tandem mass spectrometry in spot urine at the time of clinical appointment and blood pressure measurement. Patients were also asked to report their adherence using a validated questionnaire (four-item Morisky Medication Adherence Scale). The prevalence of directly measured nonadherence by urine drug detection was approximately 10%. Compared with adherent patients, those who did not adhere to their treatment (n = 15) had a higher number of antihypertensive pills and drugs (P = 0.02), cotreatment with cardiovascular drugs (P < 0.05), and total concurrent medications and pills (P < 0.01). After adjustment for age, SBP and DBP were higher in nonadherent than adherent group (SBP: 146 ± 18 vs. 131 ± 14, respectively, P < 0.01; and DBP: 77 ± 15 vs. 73 ± 9, respectively, P < 0.01). There was no significant association between four-item Morisky Medication Adherence Scale score and directly measured nonadherence. A longitudinal analysis, performed in a subpopulation of 105 patients after a median follow-up of 11 months, showed that the adherence status remained unchanged in 88% of patients. These results indicate a good adherence to antihypertensive drugs in patients attending the outpatient clinics of a university hospital. They suggest that urine detection of antihypertensive drugs by ultraperformance liquid chromatography-tandem mass spectrometry is an accurate and practical tool for directly monitoring adherence. This direct information is not overlapping with self-report questionnaire.

An evaluation of the effectiveness of psychological therapy in reducing general psychological distress for adults with autism spectrum conditions and comorbid mental health problems.

To investigate the effectiveness of psychological therapy in reducing psychological distress for adults with autism spectrum conditions (ASC) and co-morbid mental health conditions in routine clinical practice. To explore the effect of individual characteristics and service factors on change in general distress. In a specialist psychological therapies service for adults with ASC, the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) self-report questionnaire of psychological distress is completed by clients at start and end of therapy. Change over time and reliable and clinical change was assessed for 81 of a total of 122 clients (66.4%). Factors which may influence change over time were explored using available clinical information. Overall, there was a significant reduction in CORE-OM score during therapy with a small effect size. Most clients showed an improvement in psychological distress over therapy (75.4% improved, with 36.9% of these showing reliable changes). Significant and comparable reductions from pre-therapy to post-therapy were seen across the sample, showing that individual differences did not mediate therapy effectiveness. CORE-OM scores mediate the association between age of ASD diagnosis and hours of therapeutic input required, with greater age at diagnosis and higher distress associated with longer therapy duration. Our preliminary findings suggest that psychological therapy may be effective in reducing general distress for clients with ASC and co-morbid mental health conditions and should be routinely offered. Individuals who are diagnosed with ASD in adulthood are likely to require a longer course of therapy when their general distress scores are high.

Clinical management, expectations, and satisfaction of patients with moderate to severe allergic rhinoconjunctivitis treated with SQ-standardized grass-allergen tablet under routine clinical practice conditions in Spain

BackgroundSublingual immunotherapy has been proven as a well-tolerated and effective treatment for allergic rhinitis. Within this type of treatment, GRAZAX® is the most documented product in terms of safety and efficacy. The objective of this study was to identify the patients’ expectations and level of treatment satisfaction, as well as the clinical management of patients with moderate/severe allergic rhinoconjunctivitis treated with GRAZAX®.MethodsThis was a non-interventional, observational, multi-centre, open-label study involving a total of 131 adult patients aged 18–66 years with confirmed diagnosis of grass-allergy and initiated treatment with GRAZAX® between June 2010 and April 2011.ResultsIn the pollen season after starting treatment, 56.6% of patients stated that their symptoms were much less/less intense, 86% needed less symptomatic medication for control of their symptoms, and 74.4% manifested to have improved (quite/a lot) as regards their allergic disease since treatment was initiated as compared with previous grass pollen season. The patient satisfaction with GRAZAX® was measured using a visual analogue scale (VAS) between 0 (minimum satisfaction) and 100 (maximum satisfaction) comprising five different items: effectiveness, tolerability, cost, convenience and overall satisfaction. The results obtained for each item were [mean (SD)]: 74.7 (18.1), 70.3 (36.1), 39.3 (25.8), 86.2 (12.6), 78.4 (15.8) respectively. The patient’s level of satisfaction is highly influenced, especially in terms of assessment of effectiveness, tolerability and convenience, by the information provided by the specialist.ConclusionsIn summary, it can be concluded that improved communication leads to increased patient knowledge, greater patient compliance, and increased patient satisfaction.

Tratamiento de la esclerosis múltiple remitente recurrente con fingolimod en la práctica clínica habitual

Fingolimod is a selective immunosuppressant that targets the S1P receptor, and is indicated in the treatment of aggressive relapsing-remitting multiple sclerosis (RRMS) and following treatment failure with first-order drugs. To investigate the safety and effectiveness of fingolimod under the conditions of routine clinical practice. We conducted an observational study with prospective follow-up of patients with RRMS who received fingolimod from January 2011 until February 2014. Data assessed were the annualised relapse rate (ARR), disability measured by the Expanded Disability Status Scale (EDSS), magnetic resonance activity and the appearance of side effects. Our sample consisted of 122 patients, 79.5% of them females and with a mean age of 26.8 years. They were classified, according to the last treatment received, as being: naive (aggressive RRMS; n = 17), previous treatment failure (n = 67) and withdrawal of natalizumab due to risk of progressive multifocal leukoencephalopathy (n = 38). After a mean follow-up of 29.9 ± 15.9 months, the ARR and the appearance of new lesions with gadolinium enhancement were reduced in both the naive and the previous treatment failure groups. There were no differences between the various subgroups as regards the progression of EDSS or the time elapsed until the first attack or treatment failure. The risk of treatment failure is higher with a baseline EDSS > 3 (hazard ratio: 4.24; p = 0.001) and presence of IgM oligoclonal bands (hazard ratio: 2.45; p < 0.022). Fingolimod is an effective and well-tolerated drug under conditions of routine clinical practice. Having a baseline EDSS > 3 and IgM oligoclonal bands is predictive of a poor response to fingolimod.

Effectiveness, efficiency and efficacy in the multidimensional treatment of schizophrenia: Rethinking project

Schizophrenia is a clinically heterogeneous syndrome affecting multiple dimensions of patients’ life. Therefore, its treatment might require a multidimensional approach that should take into account the efficacy (the ability of an intervention to get the desired result under ideal conditions), the effectiveness (the degree to which the intended effect is obtained under routine clinical practice conditions or settings) and the efficiency (value of the intervention as relative to its cost to the individual or society) of any therapeutic intervention. In a first step of the process, a group of 90 national experts from different areas of health-care and with a multidimensional and multidisciplinary perspective of the disease, defined the concepts of efficacy, effectiveness and efficiency of established therapeutic interventions within 7 key dimensions of the illness: symptomatology; comorbidity; relapse and adherence; insight and subjective experience; cognition; quality of life, autonomy and functional capacity; and social inclusion and associated factors. The main conclusions and recommendations of this stage of the work are presented herein.

Spanish Registry of Patients With Alpha-1 Antitrypsin Deficiency: Database Evaluation and Population Analysis

Introduction and ObjectiveREDAAT, the Spanish Registry of Patients with Alpha-1 Antitrypsin Deficiency, was set up in order to improve knowledge of this disease. This study is an evaluation of the registry and an analysis of its patient population. MethodsThe registry has a database hosted on the website www.redaat.es. It collects clinical and functional data on patients with PiSZ, ZZ phenotypes and other rare variants. ResultsThanks to the collaboration of 124 physicians, the registry currently contains information on 511 individuals from 103 healthcare centers. Of these 511, 348 (74.2%) are Pi*ZZ homozygotes, and 100 (19.5%) are Pi*SZ heterozygotes. More cases are seen in tertiary level hospitals. A total of 81% of the cases have respiratory disease, and a lower proportion of AATD cases were detected by family screening or liver disease. Follow-up data are available for 45% of the cases, and 35% received alpha-1 antitripsin replacement therapy. ConclusionsThe REDAAT registry is a useful tool for obtaining quality information about this minority disease in routine clinical practice conditions, although it is difficult to obtain follow-up data, and the representativeness of the sample included cannot be determined.

Diagnostic Prevalence of Ankylosing Spondylitis Using Computerized HealthCare Data, 1996 to 2009: Underrecognition in a US Health Care Setting

Few studies have assessed the prevalence and features of axial spondyloarthritis (axSpA) and ankylosing spondylitis in diverse, population-based, community settings. We used computerized diagnoses to estimate the prevalence of axSpA and ankylosing spondylitis in Kaiser Permanente Northern California (KPNC). We identified persons aged 18 years or older with 1 or more International Classification of Diseases, Ninth Revision (ICD-9) diagnosis Code 720.X (ankylosing spondylitis and other inflammatory spondylopathies) in clinical encounter data from 1996 through 2009 to estimate the prevalence of axSpA and ankylosing spondylitis. We reviewed medical records to confirm the diagnosis in a random sample and estimated the positive predictive value of computerized data to identify confirmed cases using various case definitions. In the computerized data, 5568 adults had diagnostic codes indicating axSpA. On the basis of our case-finding approach using a single physician diagnosis code for ICD-9 720.X, the point prevalence of these conditions, standardized to the 2000 US Census, was 2.26 per 1000 persons for axSpA and 1.07 per 1000 for ankylosing spondylitis. Less than half of suspected cases saw a rheumatologist. The most specific algorithm for confirmed ankylosing spondylitis required 2 or more computerized diagnoses assigned by a rheumatologist, with 67% sensitivity (95% confidence interval, 64%-69%) and 81% positive predictive value (95% confidence interval, 79%-83%). Observed prevalence in the KPNC population, compared with national estimates for axSpA and ankylosing spondylitis, suggests there is substantial underrecognition of these conditions in routine clinical practice. However, use of computerized data is able to identify true cases of ankylosing spondylitis, facilitating population-based research.

Registro español de pacientes con déficit de alfa-1 antitripsina: evaluación de la base de datos y análisis de la población incluida

Introduction and objectiveREDAAT, the Spanish Registry of Patients with Alpha-1 Antitrypsin Deficiency, was set up in order to improve knowledge of this disease. This study is an evaluation of the registry and an analysis of its patient population. MethodsThe registry has a database hosted on the website www.redaat.es. It collects clinical and functional data on patients with PiSZ, ZZ phenotypes and other rare variants. ResultsThanks to the collaboration of 124 physicians, the registry currently contains information on 511 individuals from 103 healthcare centers. Of these 511, 348 (74.2%) are Pi*ZZ homozygotes, and 100 (19.5%) are Pi*SZ heterozygotes. More cases are seen in tertiary level hospitals. A total of 81% of the cases have respiratory disease, and a lower proportion of AATD cases were detected by family screening or liver disease. Follow-up data are available for 45% of the cases, and 35% received alpha-1 antitripsin replacement therapy. ConclusionsThe REDAAT registry is a useful tool for obtaining quality information about this minority disease in routine clinical practice conditions, although it is difficult to obtain follow-up data, and the representativeness of the sample included cannot be determined.

Pragmatic Clinical Trials: Implementation Opportunity, or Just Another Fad?

Clinical trials have been characterized as either explanatory or pragmatic in nature based on whether the major objective of the trial is to prioritize internal or external validity.1 Explanatory trials prioritize internal validity by minimizing clinician and patient biases, but, in doing so, they are generalizable only to “ideal” conditions. In contrast, pragmatic trials prioritize external validity by studying interventions in the context of broadly based and routine clinical practice conditions. The term pragmatic was coined for research trials in the 1960s2; however, since that time, alternative descriptors have been used to define trial designs in which generalizability is the primary goal, including practical trials, large simple trials, real-world trials, management trials, and effectiveness trials.1 Although there is considerable overlap in these labels, “pragmatic” has come to the forefront primarily for 2 reasons: (1) the advent of the Pragmatic Explanatory Continuum Indicator Summaries (PRECIS),3,4 an intuitive tool to characterize a clinical trial on an explanatory-pragmatic spectrum, and (2) reporting standards for pragmatic clinical trials that have been formalized through an extended version of the Consolidated Reporting Trials (CONSORT).5 The PRECIS tool comprehensively dissects a clinical trial by eligibility criteria, recruitment methods, settings, clinician expertise, intervention delivery flexibility, adherence strategies, intensity of follow-up, relevancy of outcomes, and primary analysis strategies and characterizes each category on an explanatory-pragmatic spectrum. Although lack of detail in trial reporting makes true quantitative analyses difficult,6 attempts at quantifying the percentage of published trials that are pragmatic indicate that pragmatic trials are infrequent—less than 2% of trials, according …

Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India.

Background:This 26-week, open-label observational study assessed the incidence and type of adverse events (AEs) associated with liraglutide use according to the standard clinical practice settings and the local label in India.Materials and Methods:A total of 1416 adults with type 2 diabetes (T2D) treated with liraglutide in 125 sites across India were included in the study. Participants were newly diagnosed or already receiving antidiabetic medications. Safety and efficacy data were collected at baseline and at approximately weeks 13 and 26. The primary outcome was incidence and type of AEs while using liraglutide, with events classified by Medical Dictionary for Regulatory Activities system organ class and preferred term. The secondary objective was to assess other clinical parameters related to effective T2D management.Results:Twenty AEs, predominately gastrointestinal, were reported in 1.3% of the study population in scheduled visits up to week 26. No serious AEs, including death, were reported. Hypoglycemic episodes were reported in 7.3% of participants at baseline and 0.7% at week 26. No major hypoglycemic events were reported up to week 26 (baseline: 0.4%). Glycated hemoglobin was reduced from baseline (8.8 ± 1.3%) to week 26 by 1.6 ± 1.1% (P < 0.0001); significant improvements in fasting blood glucose, and 2-h postprandial blood glucose (post-breakfast, -lunch, and -dinner) were also observed. Mean body weight decreased by 8.1 ± 6.5 kg from baseline (92.5 ± 14.6 kg; P < 0.0001).Conclusions:From the number of AEs reported, it is suggested that liraglutide was well tolerated in subjects with T2D treated under standard clinical practice conditions in India. Liraglutide was effective, and no new safety concerns were identified.

Impact of Loss of Work Productivity in Patients with Overactive Bladder Treated with Antimuscarinics in Spain: Study in Routine Clinical Practice Conditions.

Overactive bladder (OAB) is a syndrome characterized by presenting symptoms of urgency, with or without urge incontinence, and normally accompanied by day and night frequency. The aim of this study was to evaluate the impact of lost work productivity [number of days of sick leave] in patients treated with fesoterodine versus tolterodine and solifenacin to treat OAB in Spain. A retrospective, observational study was carried out using the records (digital databases) of actively working patients (2008-2013). The study population comprised of patients from two autonomous communities; 31 primary care centres agreed to participate. Patients who began first treatment with antimuscarinics (fesoterodine, solifenacin or tolterodine) and who met certain inclusion/exclusion criteria were included in the study. Follow-up lasted for 1year. The main outcome measures were comorbidity, medication possession ratio (MPR), treatment persistence, and number of days of sick leave and associated costs. Indirect costs were considered to be those related to lost work productivity (number of days of sick leave, exclusively), (1) due to OAB and (2) overall total. The cost was expressed as the average cost per patient (cost/unit). Multivariate analyses (Cox, ANCOVA) were used to correct the models. A total of 3094 patients were recruited into the study; 43.0% were treated with solifenacin, 29.2% with tolterodine, and 27.8% with fesoterodine. The average age of patients was 54 years (standard deviation 9.2), and 62.2% were women. The comparison of fesoterodine versus solifenacin and tolterodine showed a higher MPR (90.0 vs. 87.0 and 86.1%, respectively), higher treatment persistence (40.2 vs. 34.7 and 33.6%), lower use of sick leave (22.8 vs. 52.9 and 36.7%), total number of days of sick leave (5.1 vs. 9.7 and 9.3days) and costs corrected for covariates (€371 vs. €703 and €683); p<0.05. Despite the possible limitations of this study, active patients who began treatment with fesoterodine to treat OAB (compared with solifenacin or tolterodine) had fewer days of sick leave, resulting in lower costs due to lost productivity.

3106 Open label, multicenter, prospective non-interventional study to monitor the safety and effectiveness of Bevacizumab with chemotherapy in patients with NSCLC under conditions of routine clinical practice in Germany

3106 Open label, multicenter, prospective non-interventional study to monitor the safety and effectiveness of Bevacizumab with chemotherapy in patients with NSCLC under conditions of routine clinical practice in Germany

Risk of Substantial Intraocular Bleeding With Novel Oral Anticoagulants: Systematic Review and Meta-analysis.

In noninferiority trials, novel oral anticoagulants (NOACs), also known as non-vitamin K oral anticoagulants, were at least noninferior to standard care in the prevention of most prothrombotic conditions. However, differences exist in the safety profile of antithrombotic drugs, and little is known about their intraocular bleeding risk. To evaluate the risk of substantial intraocular bleeding associated with NOACs. MEDLINE, Cochrane Library, SciELO collection, and Web of Science databases were searched from inception to November 2014, as well as other systematic reviews and regulatory agencies documentation. All phase 3 randomized clinical trials (RCTs) comparing NOACs with any other control that reported intraocular bleeding events. Data were extracted independently by 2 of the authors and pooled using random-effects meta-analysis. Heterogeneity was assessed with the I2 test. Substantial intraocular bleeding was evaluated with pooled risk ratios (RRs) and 95% CIs. Seventeen RCTs were included. In patients with atrial fibrillation, no difference was identified between NOACs and vitamin K antagonists (RR, 0.84; 95% CI, 0.59-1.19; I2 = 35%; 5 RCTs), and no increased risk was identified compared with acetylsalicylic acid (RR, 14.96; 95% CI, 0.85-262.00; 1 RCT). In patients with venous thromboembolism, no increased risk of substantial intraocular bleeding compared with sequential treatment with low-molecular-weight heparin and a vitamin K antagonist (RR, 0.67; 95% CI, 0.37-1.20; I2 = 0%; 5 RCTs) was identified. Regarding patients who underwent orthopedic surgery, the risk was not different between NOACs and low-molecular-weight heparin (RR, 2.13; 95% CI, 0.22-20.50; I2 = 0%; 5 RCTs). Randomized data suggest that no differences exist in the risk of substantial intraocular bleeding between NOACs and other antithrombotic drugs. However, the number of events was scarce so that additional studies from larger databases that monitor patients under conditions of ophthalmologic routine clinical practice should be performed to better characterize the safety profile of NOACs.

Validity and Applicability of a New Recording Method for Hypertension

Introduction and objectivesBlood pressure measurement methods and conditions are determinants of hypertension diagnosis. A recent British guideline recommends systematic 24-h ambulatory blood pressure monitoring. However, these devices are not available at all health centers and they can only be used by 1 patient per day. The aim of this study was to test a new blood pressure recording method to see if it gave the same diagnostic results as 24-h blood pressure monitoring. MethodsOne-hour blood pressure monitoring under routine clinical practice conditions was compared with standard method of day time recording by analyzing the coefficient of correlation and Bland-Altman plots. The Kappa index was used to calculate degree of agreement. Method sensitivity and specificity were also analyzed. ResultsOf the 102 participants, 89 (87.3%) obtained the same diagnosis regardless of method, with high between-method agreement (κ= 0.81; 95% confidence interval, 0.71-0.91). We observed robust correlations between diastolic (r=0.85) and systolic blood pressure (r=0.76) readings. Sensitivity and specificity for the new method for diagnosing white coat hypertension were 85.2% (95% confidence interval 67.5%-94.1%) and 92% (95% confidence interval, 83.6%-96.3%), respectively. ConclusionsOne-hour blood pressure monitoring is a valid and reliable method for diagnosing hypertension and for classifying hypertension subpopulations, especially in white coat hypertension and refractory hypertension. This also leads to a more productive use of monitoring instruments.

Validez y aplicabilidad de un nuevo método de registro para la hipertensión arterial

Introduction and objectivesBlood pressure measurement methods and conditions are determinants of hypertension diagnosis. A recent British guideline recommends systematic 24-h ambulatory blood pressure monitoring. However, these devices are not available at all health centers and they can only be used by 1 patient per day. The aim of this study was to test a new blood pressure recording method to see if it gave the same diagnostic results as 24-h blood pressure monitoring. MethodsOne-hour blood pressure monitoring under routine clinical practice conditions was compared with standard method of day time recording by analyzing the coefficient of correlation and Bland-Altman plots. The Kappa index was used to calculate degree of agreement. Method sensitivity and specificity were also analyzed. ResultsOf the 102 participants, 89 (87.3%) obtained the same diagnosis regardless of method, with high between-method agreement (κ= 0.81; 95% confidence interval, 0.71-0.91). We observed robust correlations between diastolic (r=0.85) and systolic blood pressure (r=0.76) readings. Sensitivity and specificity for the new method for diagnosing white coat hypertension were 85.2% (95% confidence interval 67.5%-94.1%) and 92% (95% confidence interval, 83.6%-96.3%), respectively. ConclusionsOne-hour blood pressure monitoring is a valid and reliable method for diagnosing hypertension and for classifying hypertension subpopulations, especially in white coat hypertension and refractory hypertension. This also leads to a more productive use of monitoring instruments.Full English text available from:www.revespcardiol.org/en

Introduction to the Special Series on Booster Sessions and Long-Term Maintenance of Treatment Gains

In 1998, Eyberg and colleagues conducted a review of the literature of booster sessions and other maintenance strategies for enhancing the long-term maintenance of treatment effects for parent training programs. This timely review concluded with a call for more studies examining: 1) the long-term maintenance of treatment effects, and 2) the need to test the incremental benefit of booster sessions using randomized control group designs. Ten years later, an updated review by Eyberg and colleagues (2008) of treatments for disruptive behavior reported that most of the interventions included in that review had shown maintenance of treatment gains for at least a year after treatment had ended, but that many of the follow-up studies included designs that were only modestly rigorous. They suggested the need to explore alternative designs that would permit careful evaluation of disruptive behavior over time to more rigorously document maintenance effects. This special series is a step towards providing a response to this call. All four papers in this special series address the first of these two recommendations (i.e. long-term maintenance of treatment effects) and three specifically test the utility of booster sessions using a randomized control group design. Dishion and colleagues (this issue) report on the long-term maintenance of benefits from yearly Family Check-Ups (FCUs) in a multiethnic sample of high-risk families. Eyberg and colleagues (this issue) examine a continuing care model of maintenance treatment following Parent-Child Interaction Therapy (PCIT) for families of young children. Young children diagnosed with oppositional defiant disorder (ODD) who completed the original treatment were then randomized to PCIT maintenance treatment (MT) or to an assessment-only follow-up condition (AO). Maintenance treatment consisted of monthly telephone contact to monitor progress and provide additional booster support. Lochman and colleagues (this issue) report on a child-oriented booster intervention with children who had previously received an abbreviated version of the Coping Power program in the 5th grade. The booster sessions consisted of non-manualized, brief monthly individual contact. Finally, Kolko and colleagues (this issue) examine the impact of a brief booster treatment that was delivered three years after an acute treatment for clinically referred boys and girls originally diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD). At the conclusion of the acute treatment and three-year follow-up period (i.e., study month 42), the sample was re-randomized into Booster treatment or Enhanced Usual Care and then assessed through two year follow-up. Although these studies vary widely on specific parameters, all share a randomized design and empirical effort to examine the long-term maintenance of treatment/prevention effects and/or the incremental benefit of booster sessions for children with disruptive behavior problems and their families. There are many parameters that are relevant to the evaluation of booster or sessions or maintenance treatment, many of which are represented in the studies described in this special issue. These include the timing of sessions (when to begin booster sessions), frequency of sessions, dose (both number and length of sessions), and modality (e.g. office visits versus phone check-ups). Another important consideration is whether booster sessions should be administered to all participants or a just a subgroup of participants (perhaps those who have failed to maintain their initial treatment gains). Other considerations include whether or not to introduce new treatment content and/or select new or revised treatment goals. For purposes of providing some background on these and other parameters, we have included a description of the key parameters of several early and more recent studies reporting on the effects of treatment maintenance or booster treatment effects in Table 1. These few studies may provide a context for understanding some of the strengths and limitations of the research conducted in this area, as well as for appreciating the four studies included in this series. Table 1 Summary of Studies Examining Treatment Maintenance or Booster Effects Finally, the series includes a commentary by Patrick Tolan (this issue), who has conducted one the few studies designed to evaluate the incremental benefits of a booster intervention for school students that was conducted in the context of a prevention trial with high risk youth (Tolan et al., 2009). He provides an informed perspective on the role of booster or maintenance that incorporates his review of the four papers included in this series and his understanding of the long-term course of disruptive behavior disorders and juvenile delinquency. We hope that this series provides the reader with a clear and comprehensive understanding of the description and evaluation of alternative applications of booster or maintenance interventions with children and adolescents. In addition, we hope that the series helps to frame some of the critical research and practice directions that should be addressed to enhance the careful study and successful incorporation of these conditions in routine clinical practice.