Assessor-blinded Study Research Articles

A patient- and assessor-blinded randomized controlled trial of axillary reverse mapping (ARM) in patients with early breast cancer

BackgroundAxillary lymph node dissection (ALND) in breast cancer patients is infamous for its accompanying morbidity. Selective preservation of upper extremity lymphatic drainage and accompanying lymph nodes crossing the axillary basin - currently resected during a standard ALND - has been proposed as a valuable surgical refinement. MethodsPeroperative Axillary Reversed Mapping (ARM) was used for selective preservation of upper extremity lymphatic drainage. A multicentre patient- and assessor-blinded randomized study was performed in clinical node negative, sentinel node positive early breast cancer patients. Patients were randomized to undergo either standard-ALND or ARM-ALND. Primary outcome was the presence of surgery-related lymphedema at six, 12 and 24 months post-operatively. Secondary outcomes included patient reported and objective signs and symptoms of lymphedema, pain, paraesthesia, numbness, loss of shoulder mobility, quality of life and axillary recurrence risk. ResultsNo significant differences were found between both groups using the water displacement method with respect to measured lymphedema. ARM-ALND resulted in less reported complaints of lymphedema at six, 12 and 24 months postoperatively (p < 0.05). No axillary recurrence was found in both groups. ConclusionsIn contrast to results of volumetric measurement, patient reported outcomes support selective sparing of the upper extremity lymphatic drainage using ARM as valuable surgical refinement in case of ALND in clinically node negative, sentinel node positive early breast cancer. If completion ALND in clinically node negative, sentinel node positive early breast cancer is considered, selective sparing of upper extremity axillary lymphatics by implementing ARM should be carried out in order to reduce morbidity.

Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomised controlled trial

Metabolic syndrome is a predisposing factor for cardiovascular and metabolic disease, but also has socioeconomic relevance by affecting the health and productivity of workers. We tested the effect of regular telemonitoring-supported physical activity on metabolic syndrome severity and work ability in company employees. This was a prospective, randomised, parallel-group, and assessor-blind study done in workers in the main Volkswagen factory (Wolfsburg, Germany). Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria were randomly assigned (1:1) to a 6-month lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length. Participants in the exercise group received individual recommendations for exercise at face-to-face meetings and via a smartphone application, with the aim of doing 150 min physical activity per week. Activities were supervised and adapted using activity-monitor data, which were transferred to a central database. Participants in the control group continued their current lifestyle and were informed about the possibility to receive the supervised intervention after study completion. The primary outcome was the change in metabolic syndrome severity (metabolic syndrome Z score) after 6 months in the intention-to treat population. This trial is registered with ClinicalTrials.gov, number NCT03293264, and is closed to new participants. 543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8]) were randomly assigned to receive the intervention (n=160; exercise group) or to a waiting list (n=154; control group). The mean metabolic syndrome Z score for the exercise group was significantly reduced after the 6-month intervention period (0·93 [SD 0·63] before and 0·63 [0·64] after the intervention) compared with the control group (0·95 [0·55] and 0·90 [0·61]; difference between groups -0·26 [95% CI -0·35 to -0·16], p<0·0001). We documented 11 adverse events in the exercise group, with only one event (a twisted ankle) regarded as directly caused by the intervention. A 6-month exercise-focused intervention using telemonitoring systems reduced metabolic syndrome severity. This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease. Audi BKK health insurance and the German Research Foundation through the Cluster of Excellence REBIRTH.

Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible

IntroductionOsteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the...

A Touch-Observation and Task-Based Mirror Therapy Protocol to Improve Sensorimotor Control and Functional Capability of Hands for Patients With Peripheral Nerve Injury.

To develop a practical program in the early phase after nerve repair for more rapid return of function. To investigate the effects of touch-observation and task-based mirror therapy on the sensorimotor outcomes of patients with nerve repair. An assessor-blinded study with a randomized controlled design. University hospital. We recruited 12 patients with median or ulnar nerve repair between the level of midpalm and elbow referred by the plastic surgeons. The patients were randomized into touch-observation and task-based mirror therapy or control groups, and both groups received training for 12 wk. The Semmes-Weinstein monofilament (SWM) test, two-point discrimination test, Purdue Pegboard Test (PPT), Minnesota Manual Dexterity Test (MMDT), and pinch-holding-up activity test were assessed at pretreatment, immediately after treatment, and 12 wk after the last treatment. The experimental group showed greater improvements in the results of the pinch-holding-up activity test and the PPT Unilateral Pin Insertion, Bilateral Pin Insertion, and Assembly subtests. However, change on the SWM test revealed no significant difference between the two groups. Touch-observation and task-based mirror therapy is an effective but low-cost treatment protocol to optimize sensorimotor control and functional capability of the upper limb in patients with peripheral nerve injury.

The effect of cognitive behavioral therapy for insomnia in schizophrenia patients with sleep Disturbance: A non-randomized, assessor-blind trial

This non–randomized, assessor blind study evaluated the effects of cognitive behavioral therapy for insomnia (CBT-I) delivered in a group format on insomnia symptoms as well as psychotic, depressive, and anxiety symptoms in schizophrenia patients (n = 63) recruited from residential or rehabilitative facilities in Seoul, South Korea. Thirty-one patients received four sessions of CBT-I in groups of 2–9 patients in addition to usual care, while the control group (n = 32) received no additional intervention. The Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI), Psychotic Symptoms Rating Scale (PSYRATS), Anxiety Sensitivity Index (ASI), and Beck Depression Inventory (BDI) were administered at baseline, week 4, and week 8. Both groups showed significant time-group interactions on the ISI and PSQI. Post hoc testing showed that, compared to the control group, the CBT-I group showed significant reductions in ISI and PSQI at both week 4 and week 8. For the PSYRATS, ASI, and BDI scores, the CBT-I and control groups showed significant time-group interactions, but post hoc testing revealed no significant group differences at either week 4 or week 8. Therefore, CBT-I was effective for reducing insomnia symptoms in patients with schizophrenia and the effect lasted for 4 weeks after the intervention.

Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults

BackgroundFrailty is a multidimensional geriatric syndrome associated with functional loss. The Senior Chef (SC, nutrition) and SAYGO (strength and balance exercise) programmes are well accepted among older adults but the impact of each, or a combination of both, on the frailty syndrome in pre-frail older adults is unknown.AimsTo determine the effectiveness and cost-effectiveness of a complex intervention consisting of the SC and/or SAYGO programmes to prevent progression of frailty in pre-frail older adults.MethodsA multi-centre randomised controlled assessor-blinded study. The four intervention groups are SC, an 8-week nutrition education and cooking class; SAYGO, a 10-week strength and balance exercise class; SC plus SAYGO, and a social group (Control). Community-dwelling adults aged 75+ (60 + Māori and Pasifika) in New Zealand are recruited through health providers. Participants are not terminally ill or with advanced dementia, and have a score of 1 or 2 on the FRAIL questionnaire. Baseline assessments are completed using standardised questionnaires prior to randomisation. Four follow-up assessments are completed: immediately after intervention, 6, 12 and 24 months post-intervention. The primary outcome is frailty score, secondary outcomes are falls, physical function, quality of life, food intake, physical activity, and sustainability of the strategy. Study outcomes will be analysed using intention-to-treat approach. Cost analyses will be completed to determine if interventions are cost effective relative to the control group.DiscussionThis trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people. If successful, this will generate valuable information about effectiveness of this nutrition and exercise strategy, and provide insights for their implementation.Trial registrationAustralian and New Zealand Clinical Trials Registry number—ACTRN12614000827639.

Comparative Evaluation of Dexmedetomidine versus Midazolam as Premedication to Propofol Anesthesia in Endoscopic Retrograde Cholangiopancreatography.

Background:Endoscopic retrograde cholangiopancreatography (ERCP) is used to diagnose and treat pancreaticobiliary diseases. It is a potentially uncomfortable procedure that needs to be performed under conscious sedation. Safe and effective sedation protocol is the need of an hour.Aims:This study aims to evaluate the requirement of propofol using midazolam and dexmedetomidine as premedication for ERCP. The degree of comfort experienced by endoscopist and the patients was also assessed.Materials and Methods:A total of sixty patients were enrolled in a randomized, assessor-blinded study in the age group of 40–80 years, American Society of Anesthesiologists physical class II–III undergoing elective ERCP procedures. They were divided into two groups of 30 each. Group D (n = 30): Dexmedetomidine (100 μg/mL + 18 mL saline) loading dose at 1 μg/kg intravenous (IV) over 10 min followed by 0.5 μg/kg/h infusion, and Group M (n = 30): Midazolam at 0.05 mg/kg IV bolus over 10 min followed by normal saline infusion under hemodynamic monitoring. Satisfaction scores, total propofol requirement, and complications such as gagging, restlessness, agitation, postoperative nausea and vomiting were noted and analyzed statistically.Statistical Analysis:Statistical analysis was performed using SSPS 17.0 software (SPSS Inc., 233 South Wacker Drive, Chicago, USA). The Chi-square test was applied for nonparametric data and parametric numerical data, unpaired t-test for intergroup comparison, and repeated measures ANOVA for intragroup comparison. Results were expressed as a mean ± standard deviation. Value of P < 0.05 was considered statistically significant and <0.001 as highly significant.Results:Surgeons and patients were more satisfied and comfortable along with less requirement of propofol in the dexmedetomidine group. The incidence of complications was also less in the dexmedetomidine group as compared to that of midazolam group.Conclusion:Both dexmedetomidine and midazolam can be safely administered as an anesthetic adjuvant to propofol for short procedures like ERCP's. Dexmedetomidine provided intense and better sedation quality along with lesser requirement of propofol doses. Moreover, it provided stable hemodynamic conditions and good recovery characteristics as compared to midazolam group.

A Patient- and Assessor-Blinded Randomized Controlled Trial of Axillary Reverse Mapping (ARM) in Patients with Early Breast Cancer

Background: Axillary lymph node dissection (ALND) in breast cancer patients is infamous for its accompanying morbidity. Selective preservation of upper extremity lymphatic drainage and accompanying lymph nodes crossing the axillary basin - currently resected during a standard ALND - has been proposed as a valuable surgical refinement. Methods: Peroperative Axillary Reversed Mapping (ARM) was used for selective preservation of upper extremity lymphatic drainage. A multicentre patient- and assessor-blinded randomised study was performed in clinical node negative, sentinel node positive early breast cancer patients. Patients were randomized to undergo either standard-ALND or ARM-ALND. Primary outcome was the presence of surgery-related lymphedema at six, 12 and 24 months post-operatively, measured by the water displacement method. Secondary outcomes included patient reported and objective signs and symptoms of lymphedema, pain, paraesthesia, numbness, loss of shoulder mobility, quality of life and axillary recurrence risk. Results: No significant differences were found between both groups using the water displacement method with respect to measured lymphedema. ARM-ALND resulted in less reported complaints of lymphedema at six, 12 and 24 months postoperatively (p<0.05). Postoperative numerical differences of arm/shoulder pain, necessity to wear a compressive arm sleeve favouring ARM-ALND were only significant at six months (p=0.039 and p=0.043 respectively) as compared to 24 months (p=0.076 and p=0.066). No axillary recurrence was found in both groups. Interpretation: In contrast to results of volumetric measurement, patient reported outcomes support selective sparing of the upper extremity lymphatic drainage using ARM as valuable surgical refinement in case of ALND in clinically node negative, sentinel node positive early breast cancer. If completion ALND in clinically node negative, sentinel node positive early breast cancer is considered, selective sparing of upper extremity axillary lymphatics by implementing ARM should be carried out in order to reduce morbidity. Trial Registration Number: The trial is registered in the Dutch trial registration (TC 3698). Funding Statement: Pink Ribbon foundation (currently KWF) and the Maurits and Anna the Kock foundation Declaration of Interests: The authors have no financial of non-financial competing interest to declare. Ethics Approval Statement: Ethical approval for this study was provided by the medical ethics committee (METC) of Maxima Medisch Centrum, Veldhoven, The Netherlands. Informed consent was obtained from each participant prior to the operation. This study was carried out in compliance with the Helsinki Declaration.

Incidence of adverse events attributable to bupivacaine liposome injectable suspension or plain bupivacaine for postoperative pain in pediatric surgical patients: A retrospective matched cohort analysis.

Surgical wound infiltration with local anesthetics is common as part of multimodal analgesia and enhanced recovery pathways in pediatric surgical patients. Liposomal bupivacaine can provide up to 92hours of pain relief, and was approved by the U.S Food and Drug Administration for local infiltration in adults. It is also commonly used by pediatric surgeons, but its safety profile in this age group has not been described. The aim of this study was to describe the incidence of local anesthetic systemic toxicity syndrome in pediatric surgical patients receiving liposomal bupivacaine compared to plain bupivacaine for surgical wound infiltration. We conducted a retrospective, single center, assessor blinded cohort study of pediatric surgical inpatients having open or laparoscopic surgery in the Cleveland Clinic between 2013 and 2017 and receiving wound infiltration with local anesthetics. We compared the incidence of local anesthetic systemic toxicity among those who received any dose of liposomal bupivacaine and those who received plain bupivacaine. Groups were matched 1:2 according to procedure type, age, and physical status score. Local anesthetic systemic toxicity was primarily defined as at least two signs or symptoms possibly related to anesthetic toxicity, as judged by two independent adjudicators blinded to the type of local anesthetic. A sensitivity analysis compared the incidence of a single sign/symptom possibly related to anesthetic toxicity. A total of 924 surgical cases were included in the final analysis (356 liposomal bupivacaine and 568 plain bupivacaine cases). The primary outcome did not occur in any patient. The sensitivity analysis found three cases in the liposomal bupivacaine group and two cases in the plain bupivacaine group having a single sign/symptom possibly related to local anesthetic administration (relative risk 2.4, 95% CI 0.4-14.0, P=0.38). In a cohort of pediatric surgical patients receiving wound infiltration with either plain or liposomal bupivacaine, we identified no cases of local anesthetic systemic toxicity syndrome, and only few patients with any sign or symptom that could potentially be related to local anesthetic toxicity.

Comparison of a novel, endoscopic chest tube insertion technique versus the standard, open technique performed by novice users in a human cadaver model: a randomized, crossover, assessor-blinded study

BackgroundThe technique of tube thoracostomy has been standardized for years without significant updates. Alternative procedural methods may be beneficial in certain prehospital and inpatient environments with limited resources. We sought to compare the efficacy of chest tube insertion using a novel, endoscopic device (The Reactor™) to standard, open tube thoracostomy.MethodsNovice users were randomly assigned to pre-specified sequences of six chest tube insertions performed on a human cadaver model in a crossover design, alternating between the Reactor™ and standard technique. All subjects received standardized training in both procedures prior to randomization. Insertion site, which was randomly assigned within each cadaver’s hemithorax, was marked by the investigators; study techniques began with skin incision and ended with tube insertion. Adequacy of tube placement (intrapleural, unkinked, not in fissure) and incision length were recorded by investigators blinded to procedural technique. Insertion time and user-rated difficulty were documented in an unblinded fashion. After completing the study, participants rated various aspects of use of the Reactor™ compared to the standard technique in a survey evaluation.ResultsSixteen subjects were enrolled (7 medical students, 9 paramedics) and performed 92 chest tube insertions (n = 46 Reactor™, n = 46 standard). The Reactor™ was associated with less frequent appropriate tube positioning (41.3% vs. 73.9%, P = 0.0029), a faster median insertion time (47.3 s, interquartile range 38–63.1 vs. 76.9 s, interquartile range 55.3–106.9, P < 0.0001) and shorter median incision length (28 mm, interquartile range 23–30 vs. 32 mm, interquartile range 26–40, P = 0.0034) compared to the standard technique. Using a 10-point Likert scale (1-easiest, 10-hardest) participants rated the ease of use of the Reactor™ no different from the standard method (3.8 ± 1.9 vs. 4.7 ± 1.9, P = 0.024). The Reactor™ received generally favorable scores for all parameters on the post-participation survey.ConclusionsIn this randomized, assessor-blinded, crossover human cadaver study, chest tube insertion using the Reactor™ device resulted in faster insertion time and shorter incision length, but less frequent appropriate tube placement compared with the standard technique. Additional studies are needed to evaluate the efficacy, safety and potential advantages of this novel device.

Central mechanisms of real and sham electroacupuncture in the treatment of chronic low back pain: study protocol for a randomized, placebo-controlled clinical trial

BackgroundChronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action remain poorly understood. Evidence suggests that pain regulatory mechanisms (particularly the ascending and secondarily the descending pain modulatory pathways) and psychological mechanisms (e.g., expectations, pain catastrophizing and self-efficacy) may be involved in the pathogenesis of CLBP and its response to treatments. We will examine these mechanisms in the treatment of CLBP by electroacupuncture (EA).MethodsWe present the aims and methods of a placebo-controlled, participant-blinded and assessor-blinded mechanistic study. Adult patients with CLBP will be randomized to receiving 16 sessions of real (active) or sham (placebo) EA over the course of 8 weeks. The primary pain regulatory measure for which the study was powered is temporal summation (TS), which approximates ascending pain facilitation. Conditioned pain modulation (CPM), representing a descending pain modulatory pathway, will be our secondary pain regulatory measure. The primary psychological measure is expectations of benefit, and the secondary psychological measures are pain catastrophizing and self-efficacy in managing pain. Main clinical outcomes are back pain bothersomeness on a 0–100 visual analog scale (primary), Roland Morris Disability Questionnaire (secondary), and relevant items from the National Institutes of Health (NIH) Patient-Reported Outcome Measures Information System (secondary). We hypothesize that compared to sham, real EA will lead to greater reduction in TS after 8 treatment sessions (4 weeks); and that reduction in TS (and secondarily, increase in CPM) after 8 treatment sessions will mediate reduction in back pain bothersomeness from baseline to week 10 (clinical response) to EA. We also hypothesize that the three psychological factors are moderators of clinical response. With 100 treatment completers, the study is designed to have 80% power to detect a medium-sized between-group effect (d = 0.5) on temporal summation.DiscussionTo the best of our knowledge, this is the first appropriately powered, placebo-controlled clinical trial evaluating mechanisms of EA in the treatment of CLBP.Trial registrationClinicalTrials.gov, NCT02503475. Registered on 15 July 15 2015. Retrospectively registered.

The beach chair position for shoulder surgery in intravenous general anesthesia and controlled hypotension: Impact on cerebral oxygenation, cerebral blood flow and neurobehavioral outcome

Study objectivesThe aim of this study was to assess the impact of intravenous general anesthesia and controlled hypotension on cerebral saturation (rScO2), cerebral blood flow measured as middle cerebral artery blood flow velocity (Vmax MCA) and neurobehavioral outcome in patients scheduled for shoulder surgery in beach chair position. DesignProspective, assessor-blinded observational study. SettingUniversity hospital, shoulder surgery operating room. PatientsForty ASA I-II patients scheduled for shoulder surgery in beach chair position and controlled hypotension. InterventionsNeurological and neurobehavioral tests were performed prior and the day after surgery. The baseline data for near-infrared spectroscopy, bispectral index, cerebral blood flow, PaCO2 and invasive blood pressure (radial artery) were taken prior anesthesia and after anesthesia induction, after beach chair positioning and all 20 min after surgery start until discharge of the patient. MeasurementsNeurological and neurobehavioral tests, cerebral saturation (rScO2) using near-infrared spectroscopy, BIS, cerebral blood flow using Doppler of the middle cerebral artery (Vmax MCA), PaCO2 and invasive blood pressure assessed at heart and at the external acoustic meatus level. Main resultsThe incidence of cerebral desaturation events (CDEs) was 25%. The blood pressure drop 5 min after beach chair position measured at the acoustic meatus level in the CDE group was higher compared to patients without CDEs (p = 0.009) as was the rScO2 (p = 0.039) and the Vmax MCA (p = 0.002). There were no neurological deficits but patients with CDEs showed a greater negative impact on neurobehavioral tests 24 h after surgery compared to patients without CDEs (p = 0.001). ConclusionsIn ASA I-II patients intravenous general anesthesia and controlled hypotension in the beach chair position affects cerebral blood flow and cerebral oxygenation with impact on the neurobehavioral outcome.

Laboratory assessment of the anti-feeding effect for up to 12 months of a slow release deltamethrin collar (Scalibor\xae) against the sand fly Phlebotomus perniciosus in dogs

BackgroundLeishmaniosis/leishmaniasis consists of a wide group of diseases, caused by different Leishmania species and having different hosts. Leishmaniosis caused by Leishmania infantum, a disease primarily of dogs and humans, occurs after susceptible hosts are exposed to the feeding behavior of infected sand flies. A one-year laboratory study in dogs was designed to determine the 364-day anti-feeding efficacy of a slow release deltamethrin collar against the sand fly P. perniciosus, a common host of L. infantum in the Mediterranean basin.MethodsIn this assessor-blinded study, 16 Beagle dogs were randomized into two groups using P. perniciosus engorgement rates from a Day -7 challenge. On Day 0, dogs in Group 1 received a placebo collar, while dogs in Group 2 received a deltamethrin collar (Scalibor® Protector Band). All dogs were caged, sedated and then exposed for 1 h to 85 (± 10) female and 15 (± 5) male P. perniciosus on Day 7 and every 28 days through Day 364. All flies, alive and dead, were aspirated from cages and from dogs, immediately counted and then frozen for assessment of blood engorgement. Anti-feeding efficacy was determined by comparing the arithmetic means of engorged female flies (alive, dead and moribund) in the deltamethrin group to the control group means. Insecticidal efficacy at the time flies were retrieved was assessed by comparisons between groups of mean live female fly counts.ResultsIn the deltamethrin group, relative to the control group, there was a significant reduction in arithmetic mean numbers of engorged P. perniciosus of 94–98% from Day 7 through Day 364. On Day 28, in the treated group relative to the control group, there was a 74% reduction in mean live fly counts, with between-group differences significant from Days 7 through 196, although insecticidal activity remained less than 50% from Day 56.ConclusionDeltamethrin collar application to dogs reduced sand fly feeding by ≥ 94%, relative to unprotected control dogs, for 364 days. Thus, one collar applied to a dog can prevent or reduce the risk of sand fly transmission of Leishmania for one full year.

Efficacy and tolerability in skin chronophotoaging of a glycolic, retinoids, and vitamin E cream: A prospective assessor-blinded study

Efficacy and tolerability in skin chronophotoaging of a glycolic, retinoids, and vitamin E cream: A prospective assessor-blinded study

Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study

IntroductionHome-based self-rehabilitation programmes combined with botulinum toxin injections (BTIs) appear to be a relevant approach to increase the recommended intensive rehabilitation of patients with spasticity following a stroke. The literature...

Is aberrant affective cognition an endophenotype for affective disorders? - A monozygotic twin study.

Identification of endophenotypes can improve prevention, detection and development of new treatments. We therefore investigated whether aberrant affective cognition constitutes an endophenotype for affective disorders by being present in monozygotic (MZ) twins with unipolar or bipolar disorder in partial remission (i.e. affected) and their unaffected co-twins (i.e. high-risk) relative to twins with no family history of affective disorder (i.e. low-risk). We conducted an assessor blind cross-sectional study from 2014 to 2017 of MZ twins using Danish population-based registers in recruitment. Twins attended one test session involving neurocognitive testing, clinical ratings and questionnaires. Main outcomes were attention to and recognition of emotional facial expressions, the memory of emotional self-referential words, emotion regulation and coping strategies. Participants were 103 affected, 44 high-risk and 36 low-risk MZ twins. Groups were demographically well-balanced and showed comparable non-affective cognitive performance. We observed no aberrant affective cognition in affected and high-risk relative to low-risk twins. However, high-risk twins displayed attentional avoidance of emotional faces (ps ⩽ 0.009) and more use of task-oriented coping strategies (p = 0.01) compared with affected twins. In contrast did affected twins show more emotion-oriented coping than high- and low-risk twins (ps ⩽ 0.004). Our findings provide no support of aberrant affective cognition as an endophenotype for affective disorders. High-risk twins' attentional avoidance of emotional faces and greater use of task-oriented coping strategies may reflect compensatory mechanisms.

The reverse remodeling response to sacubitril/valsartan therapy in heart failure with reduced ejection fraction.

Major classes of medical therapy for heart failure with reduced ejection fraction (HFrEF) induce reverse remodeling. The revere remodeling response to sacubitril/valsartan remains unstudied. We performed a single-center, prospective assessor-blinded study to determine the reverse remodeling response of sacubitril/valsartan therapy in HFrEF patients with a class I indication (New York heart Association [NYHA]-class II-IV, Left ventricular ejection fraction [LVEF] < 35%, optimal dose with Renin-Angiotensin-System-Blocker [RAS-blocker]). Doses of sacubitril/valsartan were optimized to individual tolerance. Echocardiographic images were assessed offline by 2 investigators blinded to both the clinical data and timing of echocardiograms. One-hundred-twenty-five HFrEF patients (66±10years) were prospectively included. The amount of RAS-blocker before and after switch to sacubitril/valsartan was similar(P=.290), indicating individual optimal dosing of sacubitril/valsartan. Over a median(IQR) follow-up of 118(77-160)days after initiation of sacubitril/valsartan, LVEF improved (29.6±6% vs 34.8±6%; P<.001) and Left ventricular end-systolic (LVESV) and end-diastolic volume (LVEDV) decreased (LVESV; 147±57mL vs 129±55mL; P<.001 and LVEDV; 206±71mL vs197±72mL; P=.027). Volumetric remodeling was associated with a reduction in the degree of mitral regurgitation (1.59±1.0 vs 1.11±0.8; P<.001; [scale from 0-4]). Metrics of diastolic function improved; including a drop in the E/A-wave ratio (1.75±1.13 vs 1.38±0.88; P=.002) and diastolic filling time (% of cycle length) prolonged (48±9% vs 52±1%; P=.005). The percent of patients with a restrictive mitral filling pattern dropped from 47% to 23% (P=.004). A dose-dependent effect was noted for changes in LVEF (P<.001) and LVESV (P=.031), with higher doses of sacubitril/valsartan leading to more reverse remodeling. Switching therapy in eligible HFrEF patients from a RAS-blocker to sacubitril/valsartan induces beneficial reverse remodeling of both metrics of systolic as diastolic function.

Feasibility of Ballistic Strength Training in Subacute Stroke: A Randomized, Controlled, Assessor-Blinded Pilot Study

ObjectiveTo establish the feasibility and effectiveness of a 6-week ballistic strength training protocol in people with stroke. DesignRandomized, controlled, assessor-blinded study. SettingSubacute inpatient rehabilitation. ParticipantsConsecutively admitted inpatients with a primary diagnosis of first-ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14 m were screened for eligibility to recruit 30 participants for randomization. InterventionsParticipants were randomized to standard therapy or ballistic strength training 3 times per week for 6 weeks. Main Outcome MeasuresThe primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden, and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power, and quality of life. ResultsA total of 30 participants (11% of those screened) with mean age of 50 years (SD 18) were randomized. The median number of sessions attended was 15 of 18 and 17 of 18 for the ballistic and control groups, respectively. Earlier than expected discharge to home (n=4) and illness (n=7) were the most common reasons for nonattendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (P<.05) between-group changes favoring the ballistic group for comfortable gait velocity (mean difference [MD] 0.31m/s, 95% confidence interval [CI]: 0.08-0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3-13), and peak propulsive velocity (MD 64cm/s, 95% CI: 17-112). ConclusionsBallistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial.

302 - The Efficacy and Safety of Immediate Versus Gradually Increasing Oral Intake of Low-Fat Solid Food after Fasting in the Recovery Phase of Mild Acute Pancreatitis: A Single Center, Assessor-Blinded, Randomized, Parallel-Group and Superiority Study

302 - The Efficacy and Safety of Immediate Versus Gradually Increasing Oral Intake of Low-Fat Solid Food after Fasting in the Recovery Phase of Mild Acute Pancreatitis: A Single Center, Assessor-Blinded, Randomized, Parallel-Group and Superiority Study

What is the effect of prolonged sitting and physical activity on thoracic spine mobility? An observational study of young adults in a UK university setting

ObjectiveSedentary behaviour has long been associated with neck and low back pain, although relatively little is known about the thoracic spine. Contributing around 33% of functional neck movement, understanding the...