scholarly journals Intravenous or oral antibiotic treatment in adults and children with cystic fibrosis and Pseudomonas aeruginosa infection: the TORPEDO-CF RCT

2021 ◽  
Vol 25 (65) ◽  
pp. 1-128
Author(s):  
Simon C Langton Hewer ◽  
Alan R Smyth ◽  
Michaela Brown ◽  
Ashley P Jones ◽  
Helen Hickey ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Health Technology ◽  
Intravenous Therapy ◽  
Intravenous Antibiotics ◽  
Oral Group ◽  
Secondary Outcomes ◽  
The Cost

Background People with cystic fibrosis are susceptible to pulmonary infection with Pseudomonas aeruginosa. This may become chronic and lead to increased mortality and morbidity. If treatment is commenced promptly, infection may be eradicated through prolonged antibiotic treatment. Objective To compare the clinical effectiveness, cost-effectiveness and safety of two eradication regimens. Design This was a Phase IV, multicentre, parallel-group, randomised controlled trial. Setting Seventy UK and two Italian cystic fibrosis centres. Participants Participants were individuals with cystic fibrosis aged > 28 days old who had never had a P. aeruginosa infection or who had been infection free for 1 year. Interventions Fourteen days of intravenous ceftazidime and tobramycin or 3 months of oral ciprofloxacin. Inhaled colistimethate sodium was included in both regimens over 3 months. Consenting patients were randomly allocated to either treatment arm in a 1 : 1 ratio using simple block randomisation with random variable block length. Main outcome measures The primary outcome was eradication of P. aeruginosa at 3 months and remaining free of infection to 15 months. Secondary outcomes included time to reoccurrence, spirometry, anthropometrics, pulmonary exacerbations and hospitalisations. Primary analysis used intention to treat (powered for superiority). Safety analysis included patients who had received at least one dose of any of the study drugs. Cost-effectiveness analysis explored the cost per successful eradication and the cost per quality-adjusted life-year. Results Between 5 October 2010 and 27 January 2017, 286 patients were randomised: 137 patients to intravenous antibiotics and 149 patients to oral antibiotics. The numbers of participants achieving the primary outcome were 55 out of 125 (44%) in the intravenous group and 68 out of 130 (52%) in the oral group. Participants randomised to the intravenous group were less likely to achieve the primary outcome; although the difference between groups was not statistically significant, the clinically important difference that the trial aimed to detect was not contained within the confidence interval (relative risk 0.84, 95% confidence interval 0.65 to 1.09; p = 0.184). Significantly fewer patients in the intravenous group (40/129, 31%) than in the oral group (61/136, 44.9%) were hospitalised in the 12 months following eradication treatment (relative risk 0.69, 95% confidence interval 0.5 to 0.95; p = 0.02). There were no clinically important differences in other secondary outcomes. There were 32 serious adverse events in 24 participants [intravenous: 10/126 (7.9%); oral: 14/146 (9.6%)]. Oral therapy led to reductions in costs compared with intravenous therapy (–£5938.50, 95% confidence interval –£7190.30 to –£4686.70). Intravenous therapy usually necessitated hospital admission, which accounted for a large part of this cost. Limitations Only 15 out of the 286 participants recruited were adults – partly because of the smaller number of adult centres participating in the trial. The possibility that the trial participants may be different from the rest of the cystic fibrosis population and may have had a better clinical status, and so be more likely to agree to the uncertainty of trial participation, cannot be ruled out. Conclusions Intravenous antibiotics did not achieve sustained eradication of P. aeruginosa in a greater proportion of cystic fibrosis patients. Although there were fewer hospitalisations in the intravenous group during follow-up, this confers no advantage over the oral therapy group, as intravenous eradication frequently requires hospitalisation. These results do not support the use of intravenous antibiotics to eradicate P. aeruginosa in cystic fibrosis. Future work Future research studies should combine long-term follow-up with regimens to reduce reoccurrence after eradication. Trial registration Current Controlled Trials ISRCTN02734162 and EudraCT 2009-012575-10. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 65. See the NIHR Journals Library website for further project information.

scholarly journals Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

2021 ◽  
Vol 25 (77) ◽  
pp. 1-190
Author(s):  
Kamlesh Khunti ◽  
Simon Griffin ◽  
Alan Brennan ◽  
Helen Dallosso ◽  
Melanie Davies ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Health Technology ◽  
Accelerometer Data ◽  
Ambulatory Activity ◽  
Steps Per Day

Background Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives To investigate whether or not Walking Away from Diabetes (Walking Away) – a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes – leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting Primary care and the community. Participants Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval –290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval –282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration Current Controlled Trials ISRCTN83465245. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

Translational delivery of Cool Little Kids to prevent child internalising problems: Randomised controlled trial

2017 ◽  
Vol 52 (2) ◽  
pp. 181-191 ◽  
Author(s):  
Jordana K Bayer ◽  
Ruth Beatson ◽  
Lesley Bretherton ◽  
Harriet Hiscock ◽  
Melissa Wake ◽  
...  
Keyword(s):  
Standard Deviation ◽  
Confidence Interval ◽  
Anxiety Disorders ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Controlled Trial ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Internalising Problems

Objective: To determine whether a population-delivered parenting programme assists in preventing internalising problems at school entry for preschool children at-risk with temperamental inhibition. Methods: Design: a randomised controlled trial was used. Setting: the setting was 307 preschool services across eight socioeconomically diverse government areas in Melbourne, Australia. Participants: a total of 545 parents of inhibited 4-year-old children: 498 retained at 1-year follow up. Early intervention: Cool Little Kids parenting group programme was implemented. Primary outcomes: the primary outcomes were child DSM-IV anxiety disorders (assessor blind) and internalising problems. Secondary outcomes: the secondary outcomes were parenting practices and parent mental health. Results: At 1-year follow up (mean (standard deviation) age = 5.8 (0.4) years), there was little difference in anxiety disorders between the intervention and control arms (44.2% vs 50.2%; adjusted odds ratio = 0.86, 95% confidence interval = [0.60, 1.25], p = 0.427). Internalising problems were reduced in the intervention arm (Strengths and Difficulties Questionnaire: abnormal – 24.2% vs 33.0%; adjusted odds ratio = 0.56, 95% confidence interval = [0.35, 0.89], p = 0.014; symptoms – mean (standard deviation) = 2.5 (2.0) vs 2.9 (2.2); adjusted mean difference = –0.47, 95% confidence interval = [–0.81, –0.13], p = 0.006). Parents’ participation in the intervention was modest (29.4% attended most groups, 20.5% used skills most of the time during the year). A priori interaction tests suggested that for children with anxious parents, the intervention reduced anxiety disorders and internalising symptoms after 1 year. Conclusion: Offering Cool Little Kids across the population for inhibited preschoolers does not impact population outcomes after 1 year. Effects may be emerging for inhibited children at highest risk with parent anxiety. Trial outcomes will continue into mid-childhood.

Efficacy of intravitreal conbercept injection in the treatment of retinopathy of prematurity

2018 ◽  
Vol 103 (4) ◽  
pp. 494-498 ◽  
Author(s):  
Yichen Bai ◽  
Huanjie Nie ◽  
Shiyu Wei ◽  
Xiaohe Lu ◽  
Xiaoyun Ke ◽  
...  
Keyword(s):  
Retinopathy Of Prematurity ◽  
Laser Photocoagulation ◽  
Primary Outcome ◽  
Safety And Efficacy ◽  
Postmenstrual Age ◽  
Zone Ii ◽  
The Mean ◽  
Secondary Outcomes ◽  
Number Of Injections

BackgroundTo evaluate the safety and efficacy of intravitreal conbercept (IVC) injection in the treatment of retinopathy of prematurity (ROP).MethodsPatients with ROP who underwent IVC injection in Zhujiang Hospital from June 2015 to July 2016 were studied retrospectively. The primary outcome was defined as the regression of plus disease. The secondary outcomes were defined as the presence of recurrence, number of injections and the final regression of disease.ResultsA total of 48 eyes of 24 patients with ROP were included. Among them, 9 eyes of 5 patients had zone I ROP, 35 eyes of 18 patients had zone II ROP and 4 eyes of 2 patients had aggressive posterior ROP. The mean gestational age was 28.5±1.6 weeks, the mean birth weight was 1209.6±228.6 g, the mean postmenstrual age of first injection was 34.2±1.9 weeks and the mean follow-up period was 31.0±4.7 weeks. Forty of 48 eyes (83.3%) received IVC only once, and the regression of plus disease occurred at an average of 3.5±1.5 weeks after the first injection of conbercept. For eight recurrent eyes (16.7%), four eyes received a second IVC and the remaining four eyes received laser photocoagulation, and the regression of plus disease occurred in 3 weeks. No lens opacity, vitreous haemorrhage, entophthalmia or retinal detachment was observed during follow-up.ConclusionIVC injection is an effective treatment for ROP.

scholarly journals A Virtual Reality-Based Self-Help Intervention for Dealing with the Psychological Distress Associated with the COVID-19 Lockdown: An Effectiveness Study with a Two-Week Follow-Up

2021 ◽  
Vol 18 (15) ◽  
pp. 8188
Author(s):  
Giuseppe Riva ◽  
Luca Bernardelli ◽  
Gianluca Castelnuovo ◽  
Daniele Di Lernia ◽  
Cosimo Tuena ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Psychological Distress ◽  
Outcome Measures ◽  
Perceived Stress ◽  
Social Connectedness ◽  
Primary Outcome ◽  
Post Intervention ◽  
Stress Levels ◽  
Secondary Outcomes

The aim of this study is to investigate the effectiveness of a novel self-administered at-home daily virtual reality (VR)-based intervention (COVID Feel Good) for reducing the psychological burden experienced during the COVID-19 lockdown in Italy. A total of 40 individuals who had experienced at least two months of strict social distancing measures followed COVID Feel Good between June and July 2020 for one week. Primary outcome measures were depression, anxiety, and stress symptoms, perceived stress levels, and hopelessness. Secondary outcomes were the experienced social connectedness and the level of fear experienced during the COVID-19 pandemic. Linear mixed-effects models were fitted to evaluate the effectiveness of the intervention. Additionally, we also performed a clinical change analysis on primary outcome measures. As concerning primary outcome measures, participants exhibited improvements from baseline to post-intervention for depression levels, stress levels, general distress, and perceived stress (all p < 0.05) but not for the perceived hopelessness (p = 0.110). Results for the secondary outcomes indicated an increase in social connectedness from T0 to T1 (p = 0.033) but not a significant reduction in the perceived fear of coronavirus (p = 0.412). Among these study variables, these significant improvements were maintained from post-intervention to the 2-week follow-up (p > 0.05). Results indicated that the intervention was associated with good clinical outcomes, low-to-no risks for the treatment, and no adverse effects or risks. Globally, evidence suggests a beneficial effect of the proposed protocol and its current availability in 12 different languages makes COVID Feel Good a free choice for helping individuals worldwide to cope with the psychological distress associated with the COVID-19 crisis, although large scale trials are needed to evaluate its efficacy.

scholarly journals Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services

2020 ◽  
Vol 77 (7) ◽  
pp. 454-461 ◽  
Author(s):  
Marijke Keus van de Poll ◽  
Lotta Nybergh ◽  
Caroline Lornudd ◽  
Jan Hagberg ◽  
Lennart Bodin ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Mental Disorders ◽  
Occupational Health ◽  
Sickness Absence ◽  
Primary Outcome ◽  
Common Mental Disorders ◽  
Significant Group ◽  
Secondary Outcomes

ObjectivesCommon mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.MethodsRandomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee’s manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.ResultsA statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.ConclusionPSI was effective in reducing sickness absence which was the primary outcome in this study.

Impact of Traditional Versus Flavored Tongue Depressors on Pediatric Oropharynx Exam

2017 ◽  
Vol 57 (9) ◽  
pp. 1053-1057
Author(s):  
Brian Murray ◽  
Marina Gore ◽  
Nicole R. Leonard ◽  
Nadia M. Pearson ◽  
Jeremiah J. Johnson ◽  
...  
Keyword(s):  
Emergency Department ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Convenience Sample ◽  
Provider Perceptions ◽  
Patient Discomfort ◽  
Tongue Depressor ◽  
Patient Reported ◽  
Secondary Outcomes

We compared patient-reported discomfort associated with oropharynx examination using traditional (unflavored) versus flavored tongue depressors among pediatric patients presenting to the emergency department in a single-blinded, placebo-controlled randomized trial using a convenience sample ages 3 to 12 years. Our primary outcome was patient discomfort. Secondary outcomes included provider perceptions of patient discomfort, provider-reported examination ease, and caregiver perceptions of patient discomfort. Of 96 recruited patients, 92 (95.8%) completed the study. Forty-six (50%) were randomized to a traditional tongue depressor. Mean patient-reported oropharynx examination discomfort scores were 2.3 cm (95% confidence interval = 1.4-3.2 cm) with traditional tongue depressors versus 1.9 cm (95% confidence interval = 1.0-2.8 cm) with flavored tongue depressors ( P = .72). There were similarly no significant differences between the 2 arms with regard to any of the secondary outcomes. We conclude that the use of flavored tongue depressors does not appear to significantly alleviate discomfort associated with examination of the oropharynx in pediatric patients.

scholarly journals Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights from the EMPEROR-Reduced Trial

Circulation ◽  
2020 ◽  
Author(s):  
Faiez Zannad ◽  
João Pedro Ferreira ◽  
Stuart J. Pocock ◽  
Cordula Zeller ◽  
Stefan D. Anker ◽  
...  
Keyword(s):  
Kidney Function ◽  
Primary Outcome ◽  
Cardiovascular Death ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Reduced Ejection Fraction ◽  
Secondary Outcomes ◽  
Kidney Impairment ◽  
Kidney Function Decline

Background: In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes. We aim to study the effect of empagliflozin on cardiovascular and kidney outcomes across the spectrum of kidney function. Methods: In this pre-specified analysis, patients were categorized by the presence or absence of CKD at baseline (eGFR<60ml/min/1.73m 2 or UACR>300mg/g). The primary and key secondary outcomes were (1) a composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope. The direct impact on kidney events was investigated by a prespecified composite kidney outcome (defined as a sustained profound decline in eGFR, chronic dialysis or transplant). The median follow-up was 16 months. Results: 3730 patients were randomized to empagliflozin or placebo, of whom 1978 (53%) had CKD. Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: primary outcome HR=0.78 (95%CI=0.65-0.93) and HR=0.72 (95%CI=0.58-0.90), respectively; interaction P=0.63. Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23-1.98) ml/min/1.73m 2 /year in patients with CKD and by 2.41 (1.49-3.32) ml/min/1.73m2/year in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95%CI=0.31-0.91) and HR=0.46 (95%CI=0.22-0.99), respectively. The effect of empagliflozin on the primary composite outcome and the key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73m 2 . Empagliflozin was well tolerated in CKD patients. Conclusions: In EMPEROR-reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD and regardless of the severity of kidney impairment at baseline. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977

Ruthenium-106 brachytherapy for iris and iridociliary melanomas

2017 ◽  
Vol 102 (8) ◽  
pp. 1154-1159 ◽  
Author(s):  
Marina Marinkovic ◽  
Nanda Horeweg ◽  
Mirjam S Laman ◽  
Jaco C Bleeker ◽  
Martijn Ketelaars ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Local Control ◽  
Primary Outcome ◽  
Low Vision ◽  
Local Failure ◽  
Dry Eyes ◽  
Free Survival ◽  
Secondary Outcomes ◽  
Preservation Rate

Background and purposeTo evaluate ruthenium-106 (Ru106) brachytherapy as eye-conserving treatment of iris melanomas (IMs) and iridociliary melanomas (ICMs).Materials and methodsEighty-eight patients received Ru106 brachytherapy between 2006 and 2016. Primary outcome was local control, and secondary outcomes were metastasis, survival, eye preservation, complications and visual acuity (VA).ResultsOverall median follow-up was 36 months. Of 88 patients, 58 (65.9%) had IM and 30 (34.1%) had ICM. ICM were on average larger and more advanced than IM. Local failure-free survival at 3years was 98.9% (SE 1.2%). Metastasis-free survival was 98.2% (SE 1.8%) at 3years; no deaths due to melanoma occurred during follow-up. Eye preservation rate was 97.7%. Treatment-related toxicities were mostly mild and observed in 80.7% of the patients. Common toxicities were worsening of pre-existing or new cataract (51.1%), dry eyes (29.5%) and glaucoma (20.5%). VA was not affected by Ru106 brachytherapy, with only 2.3% having VA <0.33 (low vision) at follow-up.ConclusionsRu106 for IM and ICM yielded excellent local control (98.9%) and eye preservation (97.7%). Toxicities were common, but mostly mild and transient. Moreover, Ru106 did not affect visual acuity.

scholarly journals Multisystemic therapy compared with management as usual for adolescents at risk of offending: the START II RCT

2020 ◽  
Vol 8 (23) ◽  
pp. 1-114
Author(s):  
Peter Fonagy ◽  
Stephen Butler ◽  
David Cottrell ◽  
Stephen Scott ◽  
Stephen Pilling ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Young People ◽  
Multisystemic Therapy ◽  
Self Report ◽  
Second Phase ◽  
Secondary Outcomes ◽  
Start Trial ◽  
The Cost

Background The Systemic Therapy for At Risk Teens (START) trial is a randomised controlled trial of multisystemic therapy (MST) compared with management as usual (MAU). The present study reports on long-term follow-up of the trial (to 60 months). Objectives The primary objective was to compare MST and MAU for the proportion of young people in each group with criminal convictions up to 60 months post baseline. Secondary outcomes included group comparisons of psychological and behavioural factors. An economic analysis was carried out to determine the cost-effectiveness of MST compared with MAU. Two qualitative studies were conducted to better understand the subjective experiences of the participants. Design Primary outcomes (collected up to 60 months) were collected using a centralised police database. Secondary outcomes were evaluated using self-report questionnaires completed by both young people and parents or carers at the 24-, 36- and 48-month follow-ups. Research assistants were blind to treatment allocation. Setting Participants were recruited from participating MST sites in nine areas of England. Secondary outcomes were typically collected within the family home. Participants A total of 684 families were recruited into the START trial and allocated randomly to a treatment group. Of these, 487 remained in the second phase of the trial. Young people were aged, on average, 13.8 years at baseline, with 63% male and 37% female. Interventions MST is a manualised programme for young people exhibiting antisocial behaviour and their families that uses principles from cognitive–behavioural and family therapy to provide an individualised approach. MAU content was not prespecified, but consisted of the standard care offered to young people who met eligibility for the trial. Main outcome measures Young people’s offending was evaluated using the Police National Computer. Secondary measures included validated self-report measures completed by both the young person and their parent or carer. The economic evaluation took a broad perspective and outcomes were assessed in terms of quality-adjusted life-years and offending. Results No significant differences were found in the proportion of offending between the groups (hazard ratio 1.03, 95% confidence interval 0.84 to 1.26; p = 0.78). No differences were found between the groups on secondary outcome measures, with a few exceptions that did not hold up consistently across the follow-up period. The economic analysis did not find evidence to support the cost-effectiveness of MST compared with MAU. Outcomes from the qualitative studies suggest that families mostly felt positive about MST, and that MST was associated with greater maturity in young men. Limitations Some intended evaluations were not possible to deliver. Selective attrition may have influenced the nature of the sample size. It is also unclear how representative the MAU services were of reality. Future research Recommendations are made for the evaluation of MST in populations with more severe behavioural problems, as well as for identifying and testing new moderators. Conclusions The results of the second phase of the START trial do not support the long-term superiority of MST to MAU, but elements of the intervention may be adapted successfully. Trial registration Current Controlled Trials ISRCTN77132214 and London South-East REC registration number 09/H1102/55. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 23. See the NIHR Journals Library website for further project information.

scholarly journals 490 Right ventricular free wall longitudinal strain negatively impacts prognosis of patients with functional mitral regurgitation undergoing transcatheter edge-to-edge mitral valve repair

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Giuseppe Iuliano ◽  
Angelo Silverio ◽  
Cesare Baldi ◽  
Michele Bellino ◽  
Luca Esposito ◽  
...  
Keyword(s):  
Mitral Valve ◽  
Cardiac Death ◽  
Longitudinal Strain ◽  
Primary Outcome ◽  
P Value ◽  
Free Wall ◽  
Composite Outcome ◽  
Valve Repair ◽  
Secondary Outcomes

Abstract Aims Although right ventricular (RV) systolic dysfunction seems to be associated with adverse outcome after transcatheter edge-to-edge mitral valve repair (TEER) with the MitraClip system, the prognostic value of RV free wall longitudinal strain (RVFWLS) in this setting has not been yet investigated. The aim of this study is to evaluate RVFWLS as predictor of outcome in patients with severe or moderate-to-severe functional MR undergoing TEER and its prognostic role compared with tricuspid annular plane systolic excursion (TAPSE). Methods and results 102 patients [73 (IQR: 66.8–77.0) years, 73 males (71.6%)] were retrospectively selected from March 2012 to February 2021. Echocardiograms were performed by using General Electric machines. RVFWLS was assessed through RV modified apical 4-chamber view, setting the region of interest to minimum size. Values of RVFWLS &gt; −20% were recognized as abnormal. We considered a composite endpoint including rehospitalization for heart failure (HF) and overall death as primary outcome. Secondary outcomes were overall death, cardiac death and rehospitalization for HF. All patients were assessed at the longest available follow-up [median 22.1 (IQR: 9.7–49.3) months]. Baseline clinical and echocardiographic characteristics are listed in Table 1. Primary outcome was found in 60 (58.8%) patients, while secondary outcomes, i.e. overall death, cardiac death and rehospitalization for HF, were found respectively in 50 (50.0%), 31 (30.4%), and 36 (35.3%) patients. Mean TAPSE was 16.7 ± 4.0 mm and mean RVFWLS was −16.9 ± 6.0%. At univariable analysis both TAPSE (HR: 0.907, CI: 0.848–0.970, P-value: 0.004) and RVFWLS (HR: 0.937, CI: 0.897–0.979, P-value: 0.004) were significantly associated with the primary outcome. Kaplan–Meier survival curves showed that patients with TAPSE &lt;17 mm had a lower survival free from the composite outcome compared with those with TAPSE ≥17 mm (Log-Rank = 0.030); patients with RVFWLS value &gt; −20% also showed a lower survival free from the composite outcome compared with patients with RVFWLS ≤ −20% (Log Rank 0.004). Among patients with preserved RV systolic longitudinal function as indicated by TAPSE ≥ 17 mm, subjects with RVFWLS &gt; −20% had a significantly higher incidence of the composite outcome compare with those with RVFWLS ≤ −20% (Log-Rank = 0.008). Conversely, no difference was found among patients with TAPSE &lt;17 mm. Conclusions RV dysfunction assessed either by TAPSE and RVFWLS is associated with poorer outcome in patients with severe or moderate-to-severe functional MR undergoing TEER. Compared with TAPSE, RVFWLS seems to be superior in identifying patients at higher risk of adverse events during follow-up. Our data encourage the use of this speckle tracking-derived echocardiographic parameter in routinely evaluation of patients with functional MR candidate for TEER.

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