scholarly journals Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

2017 ◽  
Vol 21 (16) ◽  
pp. 1-260 ◽  
Author(s):  
Kim S Thomas ◽  
Lucy E Bradshaw ◽  
Tracey H Sach ◽  
Fiona Cowdell ◽  
Jonathan M Batchelor ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Standard Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
Skin Infections ◽  
Observational Period ◽  
Treatment Allocation ◽  
Patient Reported ◽  
Randomised Controlled

BackgroundAtopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.ObjectivesTo assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.DesignParallel-group, observer-blind, randomised controlled trial of 6 months’ duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.SettingSecondary care and the community in five UK centres.ParticipantsChildren aged 1–15 years with moderate or severe AE.InterventionsParticipants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM(AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM(DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measuresPrimary outcome – AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes – patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility – 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes – number of skin infections and hospitalisations for AE.ResultsA total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07;p = 0.43). This confidence interval is equivalent to a difference of –1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds.LimitationsKnowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.ConclusionsThe addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making.Future workNon-pharmacological interventions for the management of AE remain a research priority among patients.Trial registrationCurrent Controlled Trials ISRCTN77261365.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals A randomised, controlled trial of the effects of a mobile telehealth intervention on clinical and patient-reported outcomes in people with poorly controlled diabetes

2016 ◽  
Vol 23 (2) ◽  
pp. 207-216 ◽  
Author(s):  
Justine S Baron ◽  
Shashivadan Hirani ◽  
Stanton P Newman
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Blood Pressure ◽  
Standard Care ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Objective The objective of this research is to determine the effects of mobile telehealth (MTH) on glycosylated haemoglobin (HbA1c) and other clinical and patient-reported outcomes in insulin-requiring people with diabetes. Methods A nine-month randomised, controlled trial compared standard care to standard care supplemented with MTH (self-monitoring, mobile-phone data transmissions, graphical and nurse-initiated feedback, and educational calls). Clinical (HbA1c, blood pressure, daily insulin dose, diabetes outpatient appointments (DOAs)) and questionnaire data (health-related quality of life, depression, anxiety) were collected. Mean group changes over time were compared using hierarchical linear models and Mann-Whitney tests. Results Eighty-one participants with a baseline HbA1c of 8.98% ± 1.82 were randomised to the intervention ( n = 45) and standard care ( n = 36). The Group by Time effect revealed MTH did not significantly influence HbA1c ( p = 0.228), but p values were borderline significant for blood pressure ( p = 0.054) and mental-health related quality of life ( p = 0.057). Examination of effect sizes and 95% confidence intervals for mean group differences at nine months supported the existence of a protective effect of MTH on mental health-related quality of life as well as depression. None of the other measured outcomes were found to be affected by the MTH intervention. Conclusions Findings from this study must be interpreted with caution given the small sample size, but they do not support the widespread adoption of MTH to achieve clinically significant changes in HbA1c. MTH may, however, have positive effects on blood pressure and protective effects on some aspects of mental health.

scholarly journals Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017931 ◽  
Author(s):  
Tim Kirkpatrick ◽  
Charlotte Lennox ◽  
Rod Taylor ◽  
Rob Anderson ◽  
Michael Maguire ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Standard Care ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Related Quality ◽  
Common Mental Health Problems ◽  
Randomised Controlled ◽  
Drug And Alcohol

IntroductionThe ‘Engager’ programme is a ‘through-the-gate’ intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention.Methods and analysisThe study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders’ mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness.Ethics and disseminationThis study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015–283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations.Trial registration numberISRCTN11707331; Pre-results.

scholarly journals DiPALS: Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis – a randomised controlled trial

2016 ◽  
Vol 20 (45) ◽  
pp. 1-186 ◽  
Author(s):  
Christopher J McDermott ◽  
Mike J Bradburn ◽  
Chin Maguire ◽  
Cindy L Cooper ◽  
Wendy O Baird ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Respiratory Failure ◽  
Standard Care ◽  
Controlled Trial ◽  
Health Technology ◽  
Diaphragm Pacing ◽  
Randomised Controlled ◽  
Lateral Sclerosis

BackgroundAmyotrophic lateral sclerosis (ALS) is a neurodegenerative disease resulting in death, usually from respiratory failure, within 2–3 years of symptom onset. Non-invasive ventilation (NIV) is a treatment that when given to patients in respiratory failure leads to improved survival and quality of life. Diaphragm pacing (DP), using the NeuRx/4®diaphragm pacing system (DPS)™ (Synapse Biomedical, Oberlin, OH, USA), is a new technique that may offer additional or alternative benefits to patients with ALS who are in respiratory failure.ObjectiveThe Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis (DiPALS) trial evaluated the effect of DP on survival over the study duration in patients with ALS with respiratory failure.DesignThe DiPALS trial was a multicentre, parallel-group, open-label, randomised controlled trial incorporating health economic analyses and a qualitative longitudinal substudy.ParticipantsEligible participants had a diagnosis of ALS (ALS laboratory-supported probable, clinically probable or clinically definite according to the World Federation of Neurology revised El Escorial criteria), had been stabilised on riluzole for 30 days, were aged ≥ 18 years and were in respiratory failure. We planned to recruit 108 patients from seven UK-based specialist ALS or respiratory centres. Allocation was performed using 1 : 1 non-deterministic minimisation.InterventionsParticipants were randomised to either standard care (NIV alone) or standard care (NIV) plus DP using the NeuRX/4 DPS.Main outcome measuresThe primary outcome was overall survival, defined as the time from randomisation to death from any cause. Secondary outcomes were patient quality of life [assessed by European Quality of Life-5 Dimensions, three levels (EQ-5D-3L), Short Form questionnaire-36 items and Sleep Apnoea Quality of Life Index questionnaire]; carer quality of life (EQ-5D-3L and Caregiver Burden Inventory); cost–utility analysis and health-care resource use; tolerability and adverse events. Acceptability and attitudes to DP were assessed in a qualitative substudy.ResultsIn total, 74 participants were randomised into the trial and analysed, 37 participants to NIV plus pacing and 37 to standard care, before the Data Monitoring and Ethics Committee advised initial suspension of recruitment (December 2013) and subsequent discontinuation of pacing (on safety grounds) in all patients (June 2014). Follow-up assessments continued until the planned end of the study in December 2014. The median survival (interquartile range) was 22.5 months (lower quartile 11.8 months; upper quartile not reached) in the NIV arm and 11.0 months (6.7 to 17.0 months) in the NIV plus pacing arm, with an adjusted hazard ratio of 2.27 (95% confidence interval 1.22 to 4.25;p = 0.01).ConclusionsDiaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure.Future workIt may be that certain population subgroups benefit from DP. We are unable to explain the mechanism behind the excess mortality in the pacing arm, something the small trial size cannot help address. Future research should investigate the mechanism by which harm or benefit occurs further.Trial registrationCurrent Controlled Trials ISRCTN53817913.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 45. See the HTA programme website for further project information. Additional funding was provided by the Motor Neurone Disease Association of England, Wales and Northern Ireland.

scholarly journals TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

2019 ◽  
Author(s):  
Jessica Frost ◽  
J Athene Lane ◽  
Nikki Cotterill ◽  
Mandy Fader ◽  
Lucy Hackshaw-McGeagh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their General Practitioner (GP) in the first instance, with conservative therapies recommended as initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. Methods TRIUMPH is a 2-arm cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) General Practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and health care professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post-consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. Discussion It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care therefore holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic cluster RCT will provide robust evidence in a primary care setting to inform future guidelines.

Patient reported outcomes with remote orthopaedic consultations by telemedicine: A randomised controlled trial

2018 ◽  
Vol 25 (8) ◽  
pp. 451-459 ◽  
Author(s):  
Astrid Buvik ◽  
Einar Bugge ◽  
Gunnar Knutsen ◽  
Arvid Småbrekke ◽  
Tom Wilsgaard
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Remote Consultation ◽  
Video Assisted ◽  
Patient Reported ◽  
Reported Health ◽  
Randomised Controlled ◽  
Eq Vas

Introduction Decentralised services through outreach clinics or modern technology reduce patient travel time and cost to society. Telemedicine consultation through videoconference is one such modality. Here, we compared patient-reported health outcomes and satisfaction between video-assisted remote and standard face-to-face orthopaedic consultations. Methods This randomised controlled trial included two parallel groups: (1) patients receiving video-assisted remote consultation at a regional medical centre (RMC); and (2) patients receiving standard consultation at the orthopaedic outpatient clinic of the University Hospital of North Norway (UNN). This study included patients referred to or scheduled for a consultation at the orthopaedic outpatient clinic. After each consultation, patient satisfaction was determined using patient-completed questionnaires containing questions on patient-reported health (three-level European quality of life five-dimension index (EQ-5D-3L)/European quality of life visual analogue scale (EQ-VAS)) and questions from a validated OutPatient Experiences Questionnaire (OPEQ). Results This study included 389 patients, of which 199 received remote consultation and 190 received standard consultation (total of 559 consultations). In all, 99% RMC-randomised patients and 99% UNN-randomised patients evaluated the consultation as very satisfactory or satisfactory. Moreover, 86% RMC-randomised patients preferred video-assisted consultation as the next consultation. No difference was observed in patient-reported health after 12 months between the two groups. EQ-5D index scores were 0.77 and 0.75 for RMC- and UNN-randomised patients, respectively ( p = 0.42). Discussion We did not observe any difference in patient-reported satisfaction and health (EQ-5D/EQ-VAS) between video-assisted and standard consultations, suggesting that video-assisted remote consultation can be safely offered to some orthopaedic patients. Moreover, a significantly high proportion of patients selected video-assisted remote consultation as their next consultation, thus strengthening the findings of this study. However, economic aspects should be assessed before widely recommending video-assisted consultation.

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