Intensive Treatment Group Research Articles

First-Session Therapeutic Relationship and Outcome in High Risk Adolescents Intensive Group Psychotherapeutic Programme.

BackgroundAn important determinant of therapy outcome is the quality of the therapeutic relationship. This study evaluated the association between the client’s assessment of first-session therapeutic relationship (FSTR) and outcome in an intensive treatment for adolescents with personality disorders.MethodPatients (N = 92) were measured weekly during intensive group treatment. The therapeutic relationship was measured with the Child version of the Session Rating Scale (C-SRS) that was completed after each group therapy session by the patient. Outcome was measured with the Child version of the Outcome Rating Scale (C-ORS). Reliable change index (RCI) was calculated for the both instruments to determine significant changes in therapeutic relationship and outcome.ResultsA good FRST gave twice as much chance of a significantly better outcome. Especially for those with moderate FSTR, establishing and maintaining a good working relationship during treatment could increase the chances of a good outcome considerably. In contrast, adolescents with low FSTR had little chance of positive outcome regardless of any improvement in the therapeutic relationship.ConclusionAdolescents assessment of FRST is indicative of the chance of a good outcome.

INTENSIVE SYSTOLIC BLOOD PRESSURE TARGET IN OLDER HYPERTENSIVE PATIENTS - IS IT BENEFICIAL?

Objective: The prevalence of hypertension increases with age, and the treatment in older patients is more challenging due to their comorbidities and frailty. The ideal target for systolic blood pressure (SBP) remains unclear. This study analysed how intensive blood-pressure control in older patients reflects cardiovascular events and hypertensive-mediated organ damage (HMOD) reversion. Design and method: We present a descriptive and retrospective study, including patients over 60 years, followed in a central hospital hypertension clinic over two years. One group had an SBP target < 130mmHg (intensive treatment), while the other had a more lenient target. Stroke, acute coronary syndromes, acute decompensated heart failure or death from cardiovascular causes were the evaluated cardiovascular events. The analysed HMOD included microalbuminuria, echocardiographic left ventricular hypertrophy (LVH) and chronic kidney disease (CKD). Results: 150 of 296 patients were selected. 30% were over 80 years old. Cardiovascular events occurred in 9% of patients with SBP < 130mmHg and in 7% of patients with > 130mmHg. More than half of patients (64%) had HMOD. LVH was the most frequent HMOD (78%), followed by microalbuminuria (44,8%) and CKD (37,5%). 61% of patients in intensive treatment had HMOD versus 66% with SBP target > 130mmHg. Reversion of HMOD occurred in 83% of patients with standard treatment compared with 17,6% in the intensive treatment group. Regarding previous cardiovascular events in the studied population, stroke was the most prevalent (56%), followed by acute coronary syndrome (41%). The majority (59%) of these very high cardiovascular risk patients presented an SBP target < 130mmHg. Conclusions: In this study, intensive treatment in older patients did not appear to benefit cardiovascular events prevention and HMOD reversion. However, the HMOD reversion might have been underestimated due to patient discharge prior to further evaluation. In patients with previous cardiovascular events, a tendency to select an intensive treatment seems evident.

Efficacy of INtensive Treatment vs. Standard Treatment of COmpound DanshEn Dripping Pills in Refractory Angina Patients With Incomplete Revascularization (INCODER Study): Study Protocol for a Multicenter, Double-Blind, Randomized Controlled, Superiority Trial.

IntroductionPatients with incomplete revascularization (ICR) tend to develop refractory angina despite optimal medical therapy. The Compound Danshen Dripping Pills (CDDP) is a widely used antianginal drug in China and is shown to significantly alleviate myocardial ischemia. Previous studies showed dose-efficacy tendency when increasing doses of CDDP. This study aims to investigate the efficacy and safety of intensive doses of CDDP in patients with refractory angina with ICR.Methods and AnalysisThe INCODER study is a multicenter, double-blind, randomized controlled, superiority trial. We plan to recruit 250 patients aged 18–85 years with a diagnosis of refractory angina with ICR. Patients will be randomized (1:1) to intensive treatment group (CDDP 20 pills three times per day) or standard treatment group (10 pills CDDP and 10 pills placebo three times per day). Patients will have a 6-week medication period and be followed up every 2 weeks. The primary endpoint is the change of total exercise time from baseline to week 6 as assessed by cardiopulmonary exercise testing (CPET). Secondary endpoints include changes in the frequency of angina, Canadian Cardiovascular Society angina class, nitroglycerin use, Seattle Angina Questionnaire scores, peak oxygen uptake (VO2 peak) and other parameters as measured by CPET, and the levels of plasma C-reactive protein, homocysteine, and N-terminal pro-B-type natriuretic peptide. Safety events related to CDDP use will be monitored.Ethics and DisseminationThe research had been approved by the Clinical research and laboratory animal ethics committee of the First Affiliated Hospital, Sun Yat-sen University ([2019]65). The results will be reported through peer-reviewed journals, seminars, and conference presentations.Trial Registration Numberwww.chictr.org.cn (ChiCTR2000032384). Registered on 27 April 2020.

Effectiveness of Intensively Applied Mirror Therapy in Older Patients with Post-Stroke Hemiplegia: A Preliminary Trial

Introduction: The present work was carried out to determine the effectiveness of neuromuscular stimulation triggered by mirror therapy (MT) in older patients with post-stroke hemiplegia by two different intervention protocols, either intensively or spaced. Methods: A preliminary trial conducted on Spanish rehabilitation centres was conducted. Forty older patients (>70 years) with diagnosed post-stroke hemiplegia were randomly distributed to intensive intervention group (5 times/week for 6 weeks) or to spaced intervention group (3 times/week for 10 weeks), which underwent a similar number of MT sessions (n = 30). Muscle strength and activity were measured at baseline and at the end of treatment. Functional ability was also evaluated. Results: Although both interventions improved muscle activity parameters, intensive MT showed a significantly and statistically higher intervention effect on electromyographic activity (p < 0.001) and muscle strength (p < 0.001) than the spaced over time protocol. Attending to the Barthel Index scores, the effect on functionality was also greater in the intensive therapy group (p < 0.001), although the functional improvement measured by the Fugl-Meyer test was similar (p = 0.235). The effect of the interventions was independent of age and clinical antecedents. Conclusion: Intensive MT appears to be more effective than a more spaced over time therapy; therefore, at least in the older adults, this treatment protocol should be recommended in the post-stroke recovery of these patients. Further studies will confirm with certainty whether this treatment is the most suitable guideline for to treat these patients.

Association of Intensive Blood Pressure Control and Living Arrangement on Cardiovascular Outcomes by Race

Living alone, a key proxy of social isolation, is a risk factor for cardiovascular disease. In addition, Black race is associated with less optimal blood pressure (BP) control than in other racial or ethnic groups. However, it is not clear whether living arrangement status modifies the beneficial effects of intensive BP control on reduction in cardiovascular events among Black individuals. To examine whether the association of intensive BP control with cardiovascular events differs by living arrangement among Black individuals and non-Black individuals (eg, individuals who identified as Alaskan Native, American Indian, Asian, Native Hawaiian, Pacific Islander, White, or other) in the Systolic Blood Pressure Intervention Trial (SPRINT). This secondary analysis incorporated data from SPRINT, a multicenter study of individuals with increased risk for cardiovascular disease and free of diabetes, enrolled at 102 clinical sites in the United States between November 2010 and March 2013. Race and living arrangement (ie, living alone or living with others) were self-reported. Data were collected between November 2010 and March 2013 and analyzed from January 2021 to October 2021. The SPRINT participants were randomized to a systolic BP target of either less than 120 mm Hg (intensive treatment group) or less than 140 mm Hg (standard treatment group). Antihypertensive medications were adjusted to achieve the targets in each group. Cox proportional hazards model was used to investigate the association of intensive treatment with the incident composite cardiovascular outcome (by August 20, 2015) according to living arrangement among Black individuals and other individuals. Transportability formula was applied to generalize the SPRINT findings to hypothetical external populations by varying the proportion of Black race and living arrangement status. Among the 9342 total participants, the mean (SD) age was 67.9 (9.4) years; 2793 participants [30%] were Black, 2714 [29%] lived alone, and 3320 participants (35.5%) were female. Over a median (IQR) follow-up of 3.22 (2.74-3.76) years, the primary composite cardiovascular outcome was observed in 67 of 1001 Black individuals living alone (6.7%), 76 of 1792 Black individuals living with others (4.2%), 108 of 1713 non-Black individuals living alone (6.3%), and 311 of 4836 non-Black individuals living with others (6.4%). The intensive treatment group showed a significantly lower rate of the composite cardiovascular outcome than the standard treatment group among Black individuals living with others (hazard ratio [HR], 0.53 [95% CI, 0.33-0.85]) but not among those living alone (HR, 1.07 [95% CI, 0.66-1.73]; P for interaction = .04). The association was observed among individuals who were not Black regardless of living arrangement status. Using transportability, we found a smaller or null association between intensive control and cardiovascular outcomes among hypothetical populations of 60% Black individuals or more and 60% or more of individuals living alone. Intensive BP control was associated with a lower rate of cardiovascular events among Black individuals living with others and individuals who were not Black but not among Black individuals living alone. ClinicalTrials.gov Identifier: NCT01206062.

Diagnosis, treatment, and outcome of primary CNS lymphoma—a single-center experience

Primary CNS lymphoma (PCNSL) is a highly aggressive non-Hodgkin lymphoma (NHL) that occurs in the CNS (e.g. brain, meninges, spinal cord, cerebrospinal fluid, or intraocular involvement) in the absence of systemic NHL. Tumor resection does not improve survival, and neurosurgical intervention is generally limited to stereotactic biopsy to provide a histopathological diagnosis. The objective of this single-center study was to evaluate the management and outcome of PCNSL patients diagnosed by biopsy, using overall survival and progression-free survival as endpoints. At our department of neurosurgery, 140 patients were diagnosed with PCNSL by biopsy between January 1, 2009, and December 31, 2018. Of these, 37 patients were included in the study and were divided into three groups according to their postoperative therapy. Median OS was 35.7months for the intensive treatment group, 29.5months for the moderate treatment group, and 8.6months for the palliative treatment group. The intensive and moderate treatment groups had similar progression-free survival, while the palliative treatment group had poor overall and progression-free survival. Six patients were long-term survivors (> 80months). Age under 65years was the main significant parameter affecting overall survival. In this cohort, patients with PCNSL had an overall fair prognosis if they (1) were under 65years old, (2) had a performance score < 2 at the time of diagnosis, and (3) received either intensive or moderate chemotherapeutic treatment. Biopsy is still the primary diagnostic tool; other methods have been investigated but are not yet recommended.

Association of Intensive vs Standard Blood Pressure Control With Cerebral Blood Flow

Antihypertensive treatments benefit cerebrovascular health and cognitive function in patients with hypertension, but it is uncertain whether an intensive blood pressure target leads to potentially harmful cerebral hypoperfusion. To investigate the association of intensive systolic blood pressure (SBP) control vs standard control with whole-brain cerebral blood flow (CBF). This substudy of the Systolic Blood Pressure Intervention Trial (SPRINT) randomized clinical trial compared the efficacy of 2 different blood pressure-lowering strategies with longitudinal brain magnetic resonance imaging (MRI) including arterial spin labeled perfusion imaging to quantify CBF. A total of 1267 adults 50 years or older with hypertension and increased cardiovascular risk but free of diabetes or dementia were screened for the SPRINT substudy from 6 sites in the US. Randomization began in November 2010 with final follow-up MRI in July 2016. Analyses were performed from September 2020 through December 2021. Study participants with baseline CBF measures were randomized to an intensive SBP target less than 120 mm Hg or standard SBP target less than 140 mm Hg. The primary outcome was change in whole-brain CBF from baseline. Secondary outcomes were change in gray matter, white matter, and periventricular white matter CBF. Among 547 participants with CBF measured at baseline, the mean (SD) age was 67.5 (8.1) years and 219 (40.0%) were women; 315 completed follow-up MRI at a median (IQR) of 4.0 (3.7-4.1) years after randomization. Mean whole-brain CBF increased from 38.90 to 40.36 (difference, 1.46 [95% CI, 0.08-2.83]) mL/100 g/min in the intensive treatment group, with no mean increase in the standard treatment group (37.96 to 37.12; difference, -0.84 [95% CI, -2.30 to 0.61] mL/100 g/min; between-group difference, 2.30 [95% CI, 0.30-4.30; P = .02]). Gray, white, and periventricular white matter CBF showed similar changes. The association of intensive vs standard treatment with CBF was generally similar across subgroups defined by age, sex, race, chronic kidney disease, SBP, orthostatic hypotension, and frailty, with the exception of an indication of larger mean increases in CBF associated with intensive treatment among participants with a history of cardiovascular disease (interaction P = .05). Intensive vs standard antihypertensive treatment was associated with increased, rather than decreased, cerebral perfusion, most notably in participants with a history of cardiovascular disease. ClinicalTrials.gov Identifier: NCT01206062.

Longitudinal Electronic Cigarette Use Among Patients Recently Diagnosed With Cancer Enrolled in a Smoking Cessation Trial.

Many cancer patients who smoke report concurrent e-cigarette use. Using a mixed-methods approach, we aimed to (1) describe longitudinal e-cigarette use over 6 months after a cancer diagnosis and (2) assess the association between e-cigarette use and smoking cessation, among cancer patients in a smoking cessation trial. Data were from a 2-site randomized controlled trial of Standard (brief counseling) versus Intensive treatment (sustained counseling plus smoking cessation medication) in individuals who smoke recently diagnosed with cancer. Participants (n = 303) reported e-cigarette use at baseline, 3 months, and 6 months. Biochemically-verified past 7-day cigarette abstinence was collected at 6 months. Qualitative interviews at 6 months explored factors related to e-cigarette use. E-cigarette use prevalence was highest between baseline and 3 months (16%) and declined over time. Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily. Multivariable analyses found no significant association between follow-up e-cigarette use and 6-month cigarette abstinence. E-cigarette use at follow-up was higher in the Standard versus Intensive treatment group (p = .003 and .001 at 3 and 6 mo, respectively). Smoking cessation and health concerns were primary reasons for using e-cigarettes. Among individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence. Individuals who chose to use e-cigarettes were less likely to be receiving intensive cessation support as part of the trial. Further studies are needed to evaluate the association between e-cigarette use and smoking cessation in cancer patients. E-cigarette use was not associated with cigarette abstinence at 6 months among adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial. Individuals with easier access to evidence-based smoking cessation treatment may be less likely to use e-cigarettes.

Body Weight Variability and Risk of Cardiovascular Outcomes and Death in the Context of Weight Loss Intervention Among Patients With Type 2 Diabetes

Body weight fluctuation is associated with greater risks of adverse health outcomes. Whether intensive weight loss interventions affect the association of variability in adiposity measures with adverse health outcomes in individuals with type 2 diabetes has not been studied previously. To evaluate the associations of long-term variability in adiposity indices with cardiovascular disease (CVD) outcomes and whether these associations are affected by an intensive lifestyle intervention among adults with type 2 diabetes. This prospective cohort study included participants in the Action for Health in Diabetes (Look AHEAD) trial without CVD at baseline (August 2001 to April 2004). The Look AHEAD study included 16 centers in the United States. Data analysis was performed from December 2020 to June 2021. Variability of body mass index (BMI) and waist circumference (WC) across 4 annual visits, assessed using the coefficient of variation (CV), variability independent of the mean (VIM), and standard deviation (SD). Main outcomes were (1) all-cause mortality, (2) cardiovascular deaths (deaths from myocardial infarction [MI] or stroke), and (3) CVD events (MI, stroke, and/or death from cardiovascular causes). Among 3604 study participants (mean [SD] age, 58.4 [6.6] years; 2240 [62.3%] women; 1364 [37.7%] Black participants; 2404 [66%] White participants), there were 216 CVD events, 33 CVD deaths, and 166 deaths over a median of 6.7 years. In the control group, the hazard ratios (HRs) for the highest quartile (quartile 4) compared with the lowest quartile (quartile 1) of CV of BMI were 4.06 (95% CI, 2.17-7.57), 15.28 (95% CI, 2.89-80.90), and 2.16 (95% CI, 1.21-3.87) for all-cause mortality, CVD mortality, and cardiovascular events, respectively. In the intervention group, the corresponding HRs were 0.99 (95% CI, 0.45-2.16), 1.14 (95% CI, 0.12-10.53), and 0.77 (95% CI, 0.40-1.49) for quartile 4 vs quartile 1. Regarding WC, in the control group, HRs for quartile 4 vs quartile 1 were 1.84 (95% CI, 1.01-3.35), 6.46 (95% CI, 1.16-36.01), and 1.28 (95% CI, 0.72-2.29). In the intervention group, HRs were 1.23 (95% CI, 0.61-2.46), 0.55 (95% CI, 0.15-2.11), and 0.70 (95% CI, 0.39-1.25) for quartile 4 vs quartile 1. In this cohort study of individuals with type 2 diabetes, higher variability of adiposity indices was associated with significantly increased risk of CVD outcomes and death in the control group but not in the intensive lifestyle intervention group.

Time to benefit for stroke reduction after blood pressure treatment in older adults: A meta-analysis.

BackgroundHypertension treatment in older adults can decrease mortality, cardiovascular events, including heart failure, cognitive impairment, and stroke risk, but may also lead to harms such as syncope and falls. Guidelines recommend targeting preventive interventions with immediate harms and delayed benefits to patients whose life expectancy exceeds the intervention's time to benefit (TTB). Our objective was to estimate a meta‐analyzed TTB for stroke prevention after initiation of more intensive hypertension treatment in adults aged ≥65 years.MethodsStudies were identified from two Cochrane systematic reviews and a search of MEDLINE and Google Scholar for subsequent publications until August 31, 2021. We abstracted data from randomized controlled trials comparing standard (untreated, placebo, or less intensive treatment) to more intensive treatment groups in older adults (mean age ≥ 65 years). We fit Weibull survival curves and used a random‐effects model to estimate the pooled annual absolute risk reduction (ARR) between control and intervention groups. We applied Markov chain Monte Carlo methods to determine the time to ARR thresholds (0.002, 0.005, and 0.01) for a first stroke.ResultsNine trials (n = 38,779) were identified. The mean age ranged from 66 to 84 years and study follow‐up times ranged from 2.0 to 5.8 years. We determined that 1.7 (95%CI: 1.0–2.9) years were required to prevent 1 stroke for 200 persons (ARR = 0.005) receiving more intensive hypertensive treatment. Heterogeneity was found across studies, with those focusing on tighter systolic blood pressure control (SBP < 150 mmHg) showing longer TTB. For example, in the SPRINT study (baseline SBP = 140 mmHg, achieved SBP = 121 mmHg), the TTB to avoid 1 stroke for 200 patients treated was 5.9 years (95%CI: 2.2–13.0).ConclusionsMore intensive hypertension treatment in 200 older adults prevents 1 stroke after 1.7 years. Given the heterogeneity across studies, the TTB estimates from individual studies may be more relevant for clinical decision‐making than our summary estimate.

Abstract 38: Magnitude Of Blood Pressure Change After Endovascular Therapy And Outcomes: Insight From Bp Target Trial

Background: To assess the association between systolic blood pressure change (ΔSBP) at different time intervals after successful reperfusion with radiographic and clinical outcomes. Methods: This is a post hoc analysis of the Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP TARGET) multicenter trial. ΔSBP was defined as end of procedure SBP minus mean SBP at different time intervals (15-60 minutes, 1-6 hours, 6-24 hours post-procedure). The primary outcome was the poor functional outcome (90-day modified Rankin Scale 3-6). Results: We included a total of 267 patients (130 in the intensive treatment group). Compared to patients with favorable outcome, patients with poor outcome had lower ΔSBP (less SBP reduction) at all times intervals. After adjusting for potential confounders including baseline SBP, both ΔSBP 15-60M and ΔSBP 6-24H were associated with lower odds of poor outcome (adjusted odds ratio [aOR] per 5mmHg SBP reduction, 0.89; 95% confidence interval [CI] 0.81 to 0.99, and aOR 0.82; 95% CI 0.73 to 0.92, respectively). Concerning safety outcomes, patients with intraparenchymal hemorrhage (IPH) had lower ΔSBP at all time intervals. ΔSBP 15-60M was associated with lower odds of any IPH (aOR per 5mmHg SBP reduction 0.91, 95% CI 0.83 to 0.99). Conversely, ΔSBP was not associated with mortality or neurological deterioration at any time interval. Conclusion: After successful reperfusion, ΔSBP had a linear relationship with poor outcome and the risk of poor outcome was higher with less reduction from the baseline SBP.

A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes.

Aims Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored whether these interventions could revert prediabetes to normal glycemic status as the primary outcome. Interventions that may revert prediabetes back to normal glucose status would be of great clinical importance. Materials and Methods We conducted a randomized, multicenter, 2 × 2 factorial designed study to examine whether intensive lifestyle intervention and/or pioglitazone could revert prediabetes to normal glucose tolerance. The participants were followed up for three years unless they reverted to normal glucose state or developed diabetes at the annual oral glucose tolerance test (OGTT). Reversion to normal glucose tolerance was confirmed on the basis of the results of OGTT. Results In our study, 1945 eligible patients were ultimately randomized into four groups. In this three-year follow-up study, overall, 60.0%, 50.3%, 56.6% and 65.1% reverted back to normoglycemic state over 3 years of follow-up in the conventional lifestyle intervention plus placebo, intensive lifestyle intervention plus placebo, conventional lifestyle intervention plus pioglitazone, and intensive lifestyle intervention plus pioglitazone groups, respectively. Compared to the conventional lifestyle intervention plus placebo group, all the other three groups did not show any significant benefit in terms of reverting back to normoglycemic state. Conclusion In our study, for patients with prediabetes, neither intensive lifestyle intervention nor pioglitazone had led to a higher reversion rate to normal glucose state. Trail registration.http://www.chictr.org.cn: ChiCTR-PRC-06000005.

Post–residential treatment outpatient care preferences: Perspectives of youth with opioid use disorder

IntroductionWe know little about what youth with opioid use disorders (OUD) think about outpatient substance use treatment and 12-step meetings following discharge from residential substance use treatment. This study explores youths' preferences between intensive outpatient treatment (IOP) and community-based 12-step groups. MethodThe study recruited youth (n = 35) from a larger randomized trial (N = 288) that examined the effectiveness of extended-release naltrexone versus treatment-as-usual. This study asked the youth to participate in semi-structured qualitative interviews at baseline, 3 months, and 6 months post-residential treatment discharge. Qualitative interviews probed youths' key decision points during the six-months following residential treatment for OUD, including medication and counseling, and 12-step continuation in the community. ResultsQualitative analyses revealed three overarching themes related to youths' preferences for either IOP or 12-step meetings: structure of recovery support, mechanisms of accountability, and relationships. ConclusionDespite varying preferences, this analysis highlights the complexity of benefits that youth report receiving from each approach. Research has yet to determine the degree to which these approaches are complementary or supplementary for this population.

Intensive drug therapy versus standard drug therapy for symptomatic intestinal Crohn's disease strictures (STRIDENT): an open-label, single-centre, randomised controlled trial

Strictures are the most common structural complication of Crohn's disease. Surgery and endoscopic balloon dilation are the main treatments; drug therapy has been considered contraindicated. Given that most strictures have an inflammatory component, we aimed to find out whether strictures are responsive to drug treatment and whether intensive drug therapy is more effective than standard drug therapy. This open-label, single-centre, randomised controlled trial was performed in one specialist inflammatory bowel disease centre in Australia. Patients aged 18 years or older with Crohn's disease were included. Eligible patients had a de novo or postoperative anastomotic intestinal stricture on MRI or ileocolonoscopy, symptoms consistent with chronic or subacute intestinal obstruction (postprandial abdominal pain in the presence of a confirmed stricture), and evidence of active intestinal inflammation. Patients were randomly assigned (2:1) to receive intensive high-dose adalimumab (160 mg adalimumab once per week for 4 weeks followed by 40 mg every 2 weeks, with escalation of dose at 4 months and 8 months if assessment of disease activity indicated active inflammation) plus thiopurine (initial dose of azathioprine 2·5 mg/kg or mercaptopurine 1·5 mg/kg, with dose adjustment based on thiopurine metabolite testing) or standard adalimumab monotherapy (160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks) using stratified fixed block randomisation. Stratification factors were stricture dilation at study baseline colonoscopy and current biologic drug use. The primary endpoint was improvement (decrease) in the 14-day obstructive symptom score at 12 months by one or more points compared with baseline. This trial is registered with ClinicalTrials.gov, NCT03220841, and is completed. Between Sept 10, 2017, and Sept 6, 2019, 123 patients were screened and 77 randomly assigned to intensive adalimumab plus thiopurine treatment (n=52) or standard adalimumab treatment (n=25). At 12 months, improvement in obstructive symptom score was noted in 41 (79%) of 52 patients in the intensive treatment group and 16 (64%) of 25 in the standard treatment group (odds ratio [OR] 2·10 [95% CI 0·73-6·01]; p=0·17). Treatment failure occurred in five (10%) patients in the intensive treatment group versus seven (28%) in the standard treatment group (OR 0·27 [95% CI 0·08-0·97]; p=0·045); four patients in each group required stricture surgery (0·44 [0·10-1·92]; p=0·27). Crohn's Disease Activity Index was less than 150 in 36 (69%) patients in the intensive treatment group versus 15 (60%) in the standard treatment group (1·50 [0·56-4·05]; p=0·42). MRI at 12 months showed improvement using the stricture MaRIA score (≥25%) in 31 (61%) of 51 versus seven (28%) of 25 patients (3·99 [1·41-11·26]; p=0·0091). MRI complete stricture resolution was seen in ten (20%) versus four (16%) patients (1·28 [0·36 to 4·57]; p=0·70). Intestinal ultrasound at 12 months showed improvement (>25%) in bowel wall thickness in 22 (51%) of 43 versus seven (33%) of 21 patients (2·10 [0·71 to 6·21]; p=0·18). Faecal calprotectin normalised in 32 (62%) versus 11 (44%) patients (2·04 [0·77-5·36]; p=0·15). Normalisation of CRP was seen in 32 (62%) versus 11 (44%) patients (2·04 [0·77-5·36]; p=0·15). Eight (15%) patients in the intensive treatment group and four (16%) in the standard treatment group reported serious adverse events. No deaths occurred during the study. Crohn's disease strictures are responsive to drug treatment. Most patients had improved symptoms and stricture morphology. Treat-to-target therapy intensification resulted in less treatment failure, a reduction in stricture-associated inflammation, and greater improvement in stricture morphology, although these differences were not significantly different from standard therapy. Australian National Health and Medical Research Council, Gastroenterological Society of Australia Ferring IBD Clinician Establishment Award, Australasian Gastro Intestinal Research Foundation, AbbVie, and the Spotlight Foundation.

Abstract 10095: Beneficial Effects of Intensive Blood Pressure Control on Cardiovascular Outcomes Are Seen in Cohabitating Black Individuals but Not in Those Living Alone

Introduction: Living alone, a key proxy of social isolation, is a risk factor for cardiovascular disease. In addition, Black race is associated with less optimal blood pressure (BP) control than in other racial/ethnic groups. However, it is not clear whether living arrangement modifies the beneficial effects of intensive BP control on reduction in cardiovascular events among Black individuals. We aimed to examine whether the effects of intensive BP control on cardiovascular events differ by living arrangement among Black and non-Black individuals in the Systolic Blood Pressure Intervention Trial (SPRINT). Methods: This secondary analysis of the SPRINT trial included 9,361 participants (30% Black individuals; 29% living alone) who were randomized to a systolic BP target of either &lt;120mmHg (intensive treatment group) or &lt;140mmHg (standard treatment group). Cox proportional hazards model was used to estimate the effect of intensive treatment on the composite cardiovascular outcome according to living arrangement (i.e., living alone or living with others) among Black and non-Black individuals. Results: At a median follow-up of 3.2 years, the intensive treatment group showed a significantly lower rate of the composite cardiovascular outcome than the standard treatment group among cohabitating Black individuals (hazard ratio [HR], 0.53 [95%CI, 0.33-0.85]) but not among those living alone (HR, 1.07 [95%CI, 0.66-1.73]; p-for-interaction, 0.04). A significant reduction of the composite cardiovascular outcome was observed among non-Black individuals regardless of living arrangement status. Conclusion: Intensive BP control was beneficial to reduce cardiovascular events among Black individuals living with others and non-Black individuals but not among Black individuals living alone. Our findings highlight a potentially important role of assessing living arrangements in tailored approaches to improve cardiovascular health among Black individuals.

Effects of voice rehabilitation in people with MS: A double-blinded long-term randomized controlled trial

Background: Hypophonia is a prevailing problem in people with multiple sclerosis (PwMS). However, evidence supporting the effectiveness of voice rehabilitation is lacking. Objective: The aim of this study was to identify the most effective method to reduce hypophonia. Methods: In this randomized controlled trial, 44 PwMS were randomized to intensive and high-effort voice treatment groups, the LSVT-LOUD®, and conventional treatment group. Subjects received 16 treatments (4 sessions/week) lasting 45 minutes. The primary outcome was voice intensity (dB) in monologue, vocalization, and sentences while voice handicap index (VHI) measured voice self-perception. Outcomes were assessed by a blinded observer at baseline, post-treatment, and 15-month follow-up (FU). Results: Linear models revealed a significant post-intervention between-group mean difference in favor of LSVT-LOUD for monologue: +6.3 dB (95% CI: 2.5 to 10.1); vocalization: +7.4 dB (95% CI: 2.3 to 12.5); and sentences: +9.5 dB (95% CI: 4.7 to 14.3). However, 43.7% PwMS in the LSVT-LOUD and 10% in the conventional treatment group obtained a full recovery of voice intensity (>60 dB) post-treatment, Fisher’s test = 13.3, p < 0.01. However, these improvements were not maintained at FU. Between-group differences at VHI were −10.8 (95% CI: −21.2 to −0.4) and −11.3 (95% CI: −24.3 to −1.7) in favor of LSVT-LOUD at post and FU. Conclusion: LSVT-LOUD can be a valid treatment to increase voice intensity in PwMS. However, results suggest the need for FU interventions targeting maintenance.

The behavior of systolic blood pressure variability indices in the SPRINT trial. A randomized clinical trial

Abstract Background We previously report that intensive hypertension treatment increases visit-to-visit variability in the total SPRINT population and in all subgroups under study, based on coefficient of variation (CV) calculated during all follow-up time, previous to SPRINT primary outcome. It becomes important describes the behavior of other long-term SBP variability indices. Purpose To evaluate the interaction between intensive treatment and systolic blood pressure variability, measured during the first year of follow-up, by coefficient of variation (CV), standard deviation (SD), variability independent of the mean (VIM), and average true variability (ARV), and its contribution to SPRINT primary outcome. Methods We include 9068 SPRINT participants with 128139 repeated SBP measurements. Participants were randomly assigned to intensive (SBP &amp;lt;120 mmHg) vs standard treatment (SBP between 135–139 mmHg). The primary outcome was a composite outcome of myocardial infarction, other acute coronary syndromes, acute decompensated heart failure, stroke, and cardiovascular mortality. The coefficient of variation (CV), standard deviation (SD), variability independent of the mean (VIM), and average true variability (ARV) was calculated taking into account all SBP measurements during the first year of follow-up. Effect of the interaction between intensive treatment and SBP variability indices over the SPRINT primary outcome was calculated in both total population and each SPRINT subgroups. Results All SBP variability indices showed association with increase the risk of the SPRINT primary outcome. However, all interaction terms between treatment and SBP variability were not statistically significant. The ARV of intensive treatment group, showed a tendency to increase the risk in all its quartiles and deciles, being significantly associated with the development of the primary outcome for the fourth, eighth and tenth deciles (see table). Regarding the intensive treatment subgroups, the male subpopulation showed a significant risk of primary outcome in the upper decile of all indices and in the upper quartile of them, except CV. As well as in the subpopulation that was not of black race, the risk was evidenced in the decile and upper quartile of all the indices (see table) Conclusions ARV is the visit-to-visit blood pressure variability index that presented the most significant increase for the development of the primary outcome after the first year of follow-up in the SPRINT study intensive treatment population. Aiming to corroborate the association between intensive treatment and the adverse cardiovascular events risk, is required the evaluation of the visit-to-visit variability indices in other randomized clinical trials with larger populations which compares standard and intensive treatment. Funding Acknowledgement Type of funding sources: None. Hd: higher decile; Hq: higher quartile

Trial of Intensive Blood-Pressure Control in Older Patients with Hypertension

BackgroundThe appropriate target for systolic blood pressure to reduce cardiovascular risk in older patients with hypertension remains unclear.MethodsIn this multicenter, randomized, controlled trial, we assigned Chinese patients 60 to 80 years of age with hypertension to a systolic blood-pressure target of 110 to less than 130 mm Hg (intensive treatment) or a target of 130 to less than 150 mm Hg (standard treatment). The primary outcome was a composite of stroke, acute coronary syndrome (acute myocardial infarction and hospitalization for unstable angina), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes.ResultsOf the 9624 patients screened for eligibility, 8511 were enrolled in the trial; 4243 were randomly assigned to the intensive-treatment group and 4268 to the standard-treatment group. At 1 year of follow-up, the mean systolic blood pressure was 127.5 mm Hg in the intensive-treatment group and 135.3 mm Hg in the standard-treatment group. During a median follow-up period of 3.34 years, primary-outcome events occurred in 147 patients (3.5%) in the intensive-treatment group, as compared with 196 patients (4.6%) in the standard-treatment group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.92; P=0.007). The results for most of the individual components of the primary outcome also favored intensive treatment: the hazard ratio for stroke was 0.67 (95% CI, 0.47 to 0.97), acute coronary syndrome 0.67 (95% CI, 0.47 to 0.94), acute decompensated heart failure 0.27 (95% CI, 0.08 to 0.98), coronary revascularization 0.69 (95% CI, 0.40 to 1.18), atrial fibrillation 0.96 (95% CI, 0.55 to 1.68), and death from cardiovascular causes 0.72 (95% CI, 0.39 to 1.32). The results for safety and renal outcomes did not differ significantly between the two groups, except for the incidence of hypotension, which was higher in the intensive-treatment group.ConclusionsIn older patients with hypertension, intensive treatment with a systolic blood-pressure target of 110 to less than 130 mm Hg resulted in a lower incidence of cardiovascular events than standard treatment with a target of 130 to less than 150 mm Hg. (Funded by the Chinese Academy of Medical Sciences and others; STEP ClinicalTrials.gov number, NCT03015311.)

Is Medication Adherence Predictive of Cardiovascular Outcomes and Blood Pressure Control? The Systolic Blood Pressure Intervention Trial (SPRINT).

BACKGROUNDAdherence to study medications is crucial to evaluating treatment effects in clinical trials. To assess whether in the SPRINT trial, adherence and cardiovascular outcomes are associated regardless of intervention assignment. METHODSThis study included 9,361 participants aged ≥50 years, recruited from 102 clinics. Participants were randomized to a Standard Treatment Group (targeted systolic blood pressure [SBP] <140 mm Hg) or an Intensive Treatment Group (targeted SBP <120 mm Hg) and followed for incident cardiovascular events until the study was halted early for benefit. The 8-item Morisky Medication Adherence Scale (MMAS-8) was administered at baseline, and at the 12- and 48-month (or close out) visit.RESULTSAdjusting for covariates, there was no association between the baseline 8-item MMAS-8 and the likelihood of the primary composite endpoint, any of the secondary endpoints, or blood pressure (BP) control. Low adherence was associated with a higher body mass index, SBP, diastolic BP, and Patient Health Questionnaire, and high adherence was associated with a higher Montreal Cognitive Assessment. There was no difference in the MMAS-8 over time by treatment arm assignment. For the primary outcome (a composite of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes), baseline odds ratios (95% confidence intervals) for the Low vs. Medium and vs. High; and, for Medium vs. High MMAS-8 were 1.02 (0.82–1.28), 1.07 (0.85–1.34), and 1.05 (0.88–1.250).CONCLUSIONSIn SPRINT, medication adherence as measured using the MMAS-8 was not associated with outcomes or BP control.

Heart Failure Events in a Clinical Trial on Arterial Hypertension: New Insights Into the SPRINT Trial.

[Figure: see text].