scholarly journals Positive behaviour support training for staff for treating challenging behaviour in people with intellectual disabilities: a cluster RCT

2018 ◽  
Vol 22 (15) ◽  
pp. 1-110 ◽  
Author(s):  
Angela Hassiotis ◽  
Michaela Poppe ◽  
Andre Strydom ◽  
Victoria Vickerstaff ◽  
Ian Hall ◽  
...  
Keyword(s):  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
Service Users ◽  
Challenging Behaviour ◽  
The Mean ◽  
Secondary Outcomes ◽  
Positive Behaviour Support

Background Preliminary studies have indicated that training staff in Positive Behaviour Support (PBS) may help to reduce challenging behaviour among people with intellectual disability (ID). Objective To evaluate whether or not such training is clinically effective in reducing challenging behaviour in routine care. The study also included longer-term follow-up (approximately 36 months). Design A multicentre, single-blind, two-arm, parallel-cluster randomised controlled trial. The unit of randomisation was the community ID service using an independent web-based randomisation system and random permuted blocks on a 1 : 1 allocation stratified by a staff-to-patient ratio for each cluster. Setting Community ID services in England. Participants Adults (aged > 18 years) across the range of ID with challenging behaviour [≥ 15 Aberrant Behaviour Checklist – Community total score (ABC-CT)]. Interventions Manual-assisted face-to-face PBS training to therapists and treatment as usual (TAU) compared with TAU only in the control arm. Main outcome measures Carer-reported changes in challenging behaviour as measured by the ABC-CT over 12 months. Secondary outcomes included psychopathology, community participation, family and paid carer burden, family carer psychopathology, costs of care and quality-adjusted life-years (QALYs). Data on main outcome, service use and health-related quality of life were collected for the 36-month follow-up. Results A total of 246 participants were recruited from 23 teams, of whom 109 were in the intervention arm (11 teams) and 137 were in the control arm (12 teams). The difference in ABC-CT between the intervention and control arms [mean difference –2.14, 95% confidence interval (CI) –8.79 to 4.51; p = 0.528] was not statistically significant. No treatment effects were found for any of the secondary outcomes. The mean cost per participant in the intervention arm was £1201. Over 12 months, there was a difference in QALYs of 0.076 in favour of the intervention (95% CI 0.011 to 0.140 QALYs) and a 60% chance that the intervention is cost-effective compared with TAU from a health and social care cost perspective at the threshold of £20,000 per QALY gained. Twenty-nine participants experienced 45 serious adverse events (intervention arm, n = 19; control arm, n = 26). PBS plans were available for 33 participants. An independent assessment of the quality of these plans found that all were less than optimal. Forty-six qualitative interviews were conducted with service users, family carers, paid carers and service managers as part of the process evaluation. Service users reported that they had learned to manage difficult situations and had gained new skills, and carers reported a positive relationship with therapists. At 36 months’ follow-up (n = 184), the mean ABC-CT difference between arms was not significant (–3.70, 95% CI –9.25 to 1.85; p = 0.191). The initial cost-effectiveness of the intervention dissipated over time. Limitations The main limitations were low treatment fidelity and reach of the intervention. Conclusions Findings from the main study and the naturalistic follow-up suggest that staff training in PBS as delivered in this study is insufficient to achieve significant clinical gains beyond TAU in community ID services. Although there is an indication that training in PBS is potentially cost-effective, this is not maintained in the longer term. There is increased scope to develop new approaches to challenging behaviour as well as optimising the delivery of PBS in routine clinical practice. Trial registration This study is registered as NCT01680276. 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. 22, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study

2016 ◽  
Vol 20 (64) ◽  
pp. 1-86 ◽  
Author(s):  
Rebecca K Simmons ◽  
Knut Borch-Johnsen ◽  
Torsten Lauritzen ◽  
Guy EHM Rutten ◽  
Annelli Sandbæk ◽  
...  
Keyword(s):  
Risk Factors ◽  
Patient Reported Outcomes ◽  
Cost Effective ◽  
Well Being ◽  
Health Technology ◽  
Patient Reported ◽  
All Cause Mortality

BackgroundIntensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain.ObjectiveTo quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes.DesignPragmatic, multicentre, cluster-randomised, parallel-group trial.SettingThree hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK.ParticipantsIndividuals aged 40–69 years with screen-detected diabetes.InterventionsScreening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol.Main outcome measuresThe primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3;©Isis Innovation Ltd 2010; seewww.dtu.ox.ac.uk/outcomesmodel(accessed 27 January 2016)].ResultsWe included 3055 (RC,n = 1377; IT,n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient.ConclusionsCompared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted.Trial registrationClinicalTrials.gov NCT00237549.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

scholarly journals Evaluation of efficacy and safety of terbinafine and itraconazole in superficial mycoses: a prospective, randomized, controlled and cost-effective analysis study

2020 ◽  
Vol 9 (8) ◽  
pp. 1222
Author(s):  
D. Aruna ◽  
M. Padmaja ◽  
S. P. Vijayalakshmi
Keyword(s):  
Cost Effective ◽  
Clinical Score ◽  
Study Groups ◽  
Fungal Culture ◽  
Open Label ◽  
Superficial Mycoses ◽  
Significant Difference ◽  
The Mean

Background: Superficial mycoses are common worldwide. Dermatophytic infections can greatly affect quality of life. Several newer antimycotic agents, have been reported effective and safe. Hence this study was planned to analyse effectiveness as well as cost effectiveness of these treatments.Methods: It were a prospective, randomized, parallel, open label, comparative study. Fifty patients were included in the study and divided into 2 groups. They were randomized to receive either oral terbinafine 250 mg or itraconazole 100 mg once daily for 4 weeks. Scaling, erythema and pruritus were rated as clinical score 0 to 3: 0 - absent, 1 - mild, 2 - moderate, and 3 - severe for the above three target symptoms. Total symptom score was assessed. Pruritus was also graded on visual analogue scale (VAS). Mycological cure was assessed by skin scraping with KOH mounts and fungal culture. Clinical efficacy scoring and VAS were assessed before the study and at each follow up visit at 2 and 4 weeks. Patients were followed up for another 4 weeks after completion of the treatment.Results: There was highly significant decrease p<000.1 in the mean total symptoms scores in both the study groups from baseline. No significant difference in the mean total symptoms score was observed when compared between groups. ADRs were more in terbinafine group.Conclusions: Both terbinafine and itraconazole are effective and safe against superficial mycoses, but adverse effects are more with terbinafine. Itraconazole was found to be cost effective compared to terbinafine.

scholarly journals Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT

2019 ◽  
Vol 23 (29) ◽  
pp. 1-140
Author(s):  
Melissa Kapoor ◽  
Will Storrar ◽  
Lara Balls ◽  
Thomas P Brown ◽  
Adel Mansur ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Severe Asthma ◽  
Cost Effective ◽  
Health Technology ◽  
Active Device ◽  
Asthma Exacerbations ◽  
Severe Allergic Asthma ◽  
Secondary Outcomes

Background Severe asthma exacerbations are costly to patients and the NHS, and occur frequently in severely allergic patients. Objective To ascertain whether or not nocturnal temperature-controlled laminar airflow (TLA) device usage over 12 months can reduce severe exacerbations and improve asthma control and quality of life compared with a placebo device, while being cost-effective and acceptable to adults with severe allergic asthma. Design A pragmatic, multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial with qualitative interviews. The trial included an internal pilot with qualitative focus groups. Setting Fourteen hospitals in the UK that manage patients with severe asthma. Participants Adults (16–75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen. Intervention Nocturnal, home-based TLA treatment using an Airsonett® (Airsonett AB, Ängelholm, Sweden) device. The comparator was a placebo device that was identical to the active device except that it did not deliver the laminar airflow. Participants were allocated 1 : 1 to TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second. Main outcome measures Primary outcome – frequency of severe asthma exacerbations occurring within the 12-month follow-up period, defined as worsening of asthma requiring systemic corticosteroids [≥ 30 mg of prednisolone or equivalent daily (or ≥ 50% increase in dose if on maintenance dose of ≥ 30 mg of prednisolone)] for ≥ 3 days. Secondary outcomes – changes in asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness. Results Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised (n = 119 in the treatment group and n = 121 in the placebo group); all were analysed. In total, 202 participants (84%) reported use of the device for 9–12 months. Qualitative analyses showed high levels of acceptability. The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616]. There were no significant differences in secondary outcomes for lung function, except for a reduction in mean daily peak expiratory flow [mean (SD) difference 14.7 l/minute (7.35 l/minute), 95% CI 0.32 to 29.1 l/minute; p = 0.045) for those in the active device group. There were no differences in asthma control or airway inflammation and no serious harms related to the device. No significant difference between the groups in quality-adjusted life-years gained over 1 year was observed. In addition, there was no difference in generic or disease-specific health-related quality of life overall, although statistically significant higher quality of life at month 6 was observed. Increases in quality of life were not sufficient to offset the annual costs associated with use of the TLA device. Limitations Missing outcome data could have resulted in an underestimation of exacerbations and rendered the study inconclusive. Conclusions Within the limits of the data, no consistent benefits of the active device were demonstrated, and the differences observed were not sufficient to make the device cost-effective. The types of patients who may benefit from the TLA device, and the reasons for large reductions in exacerbation frequency in severe asthma trials, which also incorporate other methods of recording exacerbations, need to be explored. Trial registration Current Controlled Trials ISRCTN46346208. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 29. See the NIHR Journals Library website for further project information.

scholarly journals VP164 Applying Health Technology Assessment To Pharmacy: The Italian-Medicine-Use-Review-Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 223-224
Author(s):  
Michela Tinelli ◽  
Andrea Manfrin ◽  
Martin Knapp ◽  
Americo Cicchetti ◽  
Andrea Mandelli
Keyword(s):  
Health Technology Assessment ◽  
Community Pharmacy ◽  
Technology Assessment ◽  
Real World ◽  
Cost Effective ◽  
Health Technology ◽  
Health Policies ◽  
Evidence Based ◽  
Medicine Use

INTRODUCTION:There is a lack of Health-Technology-Assessment (HTA) tools in pharmacy practice and the collection of real-world-evidence (RWE) in community pharmacy to populate longer-term-disease-progression-modelling (1). This project is looking at the development and application of a novel Patient-Reported-Outcome- Measure (PROM) in community pharmacy that can enable: the evaluation of the quality of care delivered from the patient perspective in terms of economic impact, patient health outcomes and ‘utilities’; the collection of RWE and evaluate long-term effect of care; to provide different stakeholders with unique evidence-based information that help formulate health policies in community pharmacy that are safe, effective, patient-focused and cost-effective, balancing access to innovation and cost containment.METHODS:Evidence from the Italian-Medicine-Use-Review (I-MUR) trial (2) showed that the I-MUR intervention provided by community pharmacists to asthma patients is effective, cost-saving and cost-effective (3). The trial allowed to model a framework (I-MUR-HTA) that would enable to routinely deliver the intervention, but also collect and analyse PROM data on its clinical-effectiveness, quality-of-life and cost-effectiveness. I-MUR-HTA was discussed within three expert-panel discussions including policy-makers, commissioners, academics, healthcare-professionals and patient-representatives in Italy, United Kingdom and Europe. Current plan include testing the use of the tool in the real world environment.RESULTS:Evidence collected from the panel discussions confirmed that I-MUR-HTA evidence-based information is relevant to meet current National-Health-Care-System plans and this is what is needed to support the evaluation of innovative effective and cost-effective health policies and promote their implementation across nations. Current Italian law on pharmacy services provides the appropriate institutional framework to regulate the introduction of I-MUR-HTA across the territory. Its implementation is underway and a real-world pilot is planned to take place in Italy.CONCLUSIONS:I-MUR-HTA appears to be an innovative tool to promote active patient involvement into policy-decision-making and pharmacy-service.

scholarly journals Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT

2019 ◽  
Vol 23 (24) ◽  
pp. 1-96 ◽  
Author(s):  
Manjit S Gohel ◽  
Francine Heatley ◽  
Xinxue Liu ◽  
Andrew Bradbury ◽  
Richard Bulbulia ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Cost Effective ◽  
Compression Therapy ◽  
Health Technology ◽  
Free Time ◽  
Venous Reflux ◽  
Venous Ulceration ◽  
Endovenous Ablation

Background Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objectives To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. Setting Secondary care vascular centres in England. Participants Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). Main outcome measures The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. Results A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240–328] days in the early ablation group and 278 (IQR 175–324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p < 0.001), EuroQol-5 Dimensions index values (p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. Limitations Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. Conclusions Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. Future work Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. Trial registration Current Controlled Trials ISRCTN02335796. 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. 23, No. 24. See the NIHR Journals Library website for further project information.

scholarly journals Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT

2020 ◽  
Vol 24 (61) ◽  
pp. 1-110
Author(s):  
Robert Pickard ◽  
Beatriz Goulao ◽  
Sonya Carnell ◽  
Jing Shen ◽  
Graeme MacLennan ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Urethral Stricture ◽  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
Urinary Symptoms ◽  
Current Evidence ◽  
Endoscopic Urethrotomy

Background Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking. Objectives To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men. Design Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed. Setting UK NHS with recruitment from 38 hospital sites. Participants A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture. Interventions A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group). Main outcome measures The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence. Results The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was –0.36 [95% confidence interval (CI) –1.78 to 1.02; p = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference –0.01, 95% CI –0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective. Limitations We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis. Conclusions The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective. Future work Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics. Trial registration Current Controlled Trials ISRCTN98009168. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 61. See the NIHR Journals Library website for further project information.

Creation of physiologic rhythm by closed loop stimulation in heart failure patients with severe chronotropic incompetence: worldwide first results of a pilot study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  
Keyword(s):  
Heart Rate ◽  
Closed Loop ◽  
Funding Source ◽  
Chronotropic Incompetence ◽  
First Results ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

scholarly journals Utilization of laser interstitial thermotherapy guided by real-time thermal MRI as an alternative to separation surgery in the management of spinal metastasis

2015 ◽  
Vol 23 (4) ◽  
pp. 400-411 ◽  
Author(s):  
Claudio E. Tatsui ◽  
R. Jason Stafford ◽  
Jing Li ◽  
Jonathan N. Sellin ◽  
Behrang Amini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Real Time ◽  
Spinal Cord Compression ◽  
Spinal Metastasis ◽  
Cord Compression ◽  
The Mean ◽  
Interstitial Thermotherapy

OBJECT High-grade malignant spinal cord compression is commonly managed with a combination of surgery aimed at removing the epidural tumor, followed by spinal stereotactic radiosurgery (SSRS) aimed at local tumor control. The authors here introduce the use of spinal laser interstitial thermotherapy (SLITT) as an alternative to surgery prior to SSRS. METHODS Patients with a high degree of epidural malignant compression due to radioresistant tumors were selected for study. Visual analog scale (VAS) scores for pain and quality of life were obtained before and within 30 and 60 days after treatment. A laser probe was percutaneously placed in the epidural space. Real-time thermal MRI was used to monitor tissue damage in the region of interest. All patients received postoperative SSRS. The maximum thickness of the epidural tumor was measured, and the degree of epidural spinal cord compression (ESCC) was scored in pre- and postprocedure MRI. RESULTS In the 11 patients eligible for study, the mean VAS score for pain decreased from 6.18 in the preoperative period to 4.27 within 30 days and 2.8 within 60 days after the procedure. A similar VAS interrogating the percentage of quality of life demonstrated improvement from 60% preoperatively to 70% within both 30 and 60 days after treatment. Imaging follow-up 2 months after the procedure demonstrated a significant reduction in the mean thickness of the epidural tumor from 8.82 mm (95% CI 7.38–10.25) before treatment to 6.36 mm (95% CI 4.65–8.07) after SLITT and SSRS (p = 0.0001). The median preoperative ESCC Grade 2 was scored as 4, which was significantly higher than the score of 2 for Grade 1b (p = 0.04) on imaging follow-up 2 months after the procedure. CONCLUTIONS The authors present the first report on an innovative minimally invasive alternative to surgery in the management of spinal metastasis. In their early experience, SLITT has provided local control with low morbidity and improvement in both pain and the quality of life of patients.

Criteria for Return to Play After Hip Arthroscopy in the Treatment of Femoroacetabular Impingement: A Systematic Review

2021 ◽  
pp. 036354652110389
Author(s):  
Martin S. Davey ◽  
Eoghan T. Hurley ◽  
Matthew G. Davey ◽  
Jordan W. Fried ◽  
Andrew J. Hughes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Operative Management ◽  
Return To Play ◽  
Return To Sports ◽  
Level Of Evidence ◽  
The Mean

Background: Femoroacetabular impingement (FAI) is a common pathology in athletes that often requires operative management in the form of hip arthroscopy. Purpose: To systematically review the rates and level of return to play (RTP) and the criteria used for RTP after hip arthroscopy for FAI in athletes. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review of the literature, based on the PRISMA guidelines, was performed using PubMed, Embase, and Scopus databases. Studies reporting outcomes after the use of hip arthroscopy for FAI were included. Outcomes analyzed were RTP rate, RTP level, and criteria used for RTP. Statistical analysis was performed using SPSS software. Results: Our review found 130 studies, which included 14,069 patients (14,517 hips) and had a mean methodological quality of evidence (MQOE) of 40.4 (range, 5-67). The majority of patients were female (53.7%), the mean patient age was 30.4 years (range, 15-47 years), and the mean follow-up was 29.7 months (range, 6-75 months). A total of 81 studies reported RTP rates, with an overall RTP rate of 85.4% over a mean period of 6.6 months. Additionally, 49 studies reported the rate of RTP at preinjury level as 72.6%. Specific RTP criteria were reported in 97 studies (77.2%), with time being the most commonly reported item, which was reported in 80 studies (69.2%). A total of 45 studies (57.9%) advised RTP at 3 to 6 months after hip arthroscopy. Conclusion: The overall rate of reported RTP was high after hip arthroscopy for FAI. However, more than one-fourth of athletes who returned to sports did not return at their preinjury level. Development of validated rehabilitation criteria for safe return to sports after hip arthroscopy for FAI could potentially improve clinical outcomes while also increasing rates of RTP at preinjury levels.

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