scholarly journals Adding emollient bath additives to standard eczema management for children with eczema: the BATHE RCT

2018 ◽  
Vol 22 (57) ◽  
pp. 1-116 ◽  
Author(s):  
Miriam Santer ◽  
Kate Rumsby ◽  
Matthew J Ridd ◽  
Nick A Francis ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Intervention Group ◽  
Additive Group ◽  
Health Technology ◽  
Control Group ◽  
Open Label ◽  
Secondary Outcomes ◽  
Bath Additives

BackgroundChildhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema.DesignPragmatic, randomised, open-label, multicentre superiority trial with two parallel groups.SettingNinety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically.ParticipantsChildren aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation.InterventionsThe intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required.Main outcome measuresThe primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding.ResultsFrom December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group,n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping.LimitationsSimple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups.ConclusionThis trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema.Future workFurther research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.FundingThis project was funded by the NIHR Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

scholarly journals Behavioural activation versus guided self-help for depression in adults with learning disabilities: the BeatIt RCT

2018 ◽  
Vol 22 (53) ◽  
pp. 1-130 ◽  
Author(s):  
Andrew Jahoda ◽  
Richard Hastings ◽  
Chris Hatton ◽  
Sally-Ann Cooper ◽  
Nicola McMeekin ◽  
...  
Keyword(s):  
Learning Disabilities ◽  
Health Technology Assessment ◽  
Learning Disability ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Health Technology ◽  
Behavioural Activation ◽  
Self Help ◽  
Adults With Learning Disabilities ◽  
Secondary Outcomes

Background Depression is the most prevalent mental health problem among people with learning disabilities. Objective The trial investigated the clinical effectiveness and cost-effectiveness of behavioural activation for depression experienced by people with mild to moderate learning disabilities. The intervention was compared with a guided self-help intervention. Design A multicentre, single-blind, randomised controlled trial, with follow-up at 4, 8 and 12 months post randomisation. There was a nested qualitative study. Setting Participants were recruited from community learning disability teams and services and from Improving Access to Psychological Therapies services in Scotland, England and Wales. Participants Participants were aged ≥ 18 years, with clinically significant depression, assessed using the Diagnostic Criteria for Psychiatric Disorders for use with Adults with Learning Disabilities. Participants had to be able to give informed consent and a supporter could accompany them to therapy. Interventions BeatIt was a manualised behavioural activation intervention, adapted for people with learning disabilities and depression. StepUp was an adapted guided self-help intervention. Main outcome measures The primary outcome measure was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD). Secondary outcomes included carer ratings of depressive symptoms and aggressiveness, self-reporting of anxiety symptoms, social support, activity and adaptive behaviour, relationships, quality of life (QoL) and life events, and resource and medication use. Results There were 161 participants randomised (BeatIt, n = 84; StepUp, n = 77). Participant retention was strong, with 141 completing the trial. Most completed therapy (BeatIt: 86%; StepUp: 82%). At baseline, 63% of BeatIt participants and 66% of StepUp participants were prescribed antidepressants. There was no statistically significant difference in GDS-LD scores between the StepUp (12.94 points) and BeatIt (11.91 points) groups at the 12-month primary outcome point. However, both groups improved during the trial. Other psychological and QoL outcomes followed a similar pattern. There were no treatment group differences, but there was improvement in both groups. There was no economic evidence suggesting that BeatIt may be more cost-effective than StepUp. However, treatment costs for both groups were approximately only 4–6.5% of the total support costs. Results of the qualitative research with participants, supporters and therapists were in concert with the quantitative findings. Both treatments were perceived as active interventions and were valued in terms of their structure, content and perceived impact. Limitations A significant limitation was the absence of a treatment-as-usual (TAU) comparison. Conclusions Primary and secondary outcomes, economic data and qualitative results all clearly demonstrate that there was no evidence for BeatIt being more effective than StepUp. Future work Comparisons against TAU are required to determine whether or not these interventions had any effect. Trial registration Current Controlled Trials ISRCTN09753005. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 53. See the NIHR Journals Library website for further project information.

scholarly journals Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men

2017 ◽  
Vol 21 (19) ◽  
pp. 1-150 ◽  
Author(s):  
Iain K Crombie ◽  
Kathryn B Cunningham ◽  
Linda Irvine ◽  
Brian Williams ◽  
Falko F Sniehotta ◽  
...  
Keyword(s):  
Primary Care ◽  
Liver Disease ◽  
Alcohol Consumption ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Intervention Group ◽  
Health Technology ◽  
Control Group ◽  
Increased Risk

BackgroundObese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease.ObjectivesTo develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness.Design of the interventionThe intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods.SettingMen were recruited from the community, from primary care registers and by time–space sampling (TSS). The intervention was delivered in community settings such as the participant’s home, community centres and libraries.ParticipantsMen aged 35–64 years who had a body mass index (BMI) of > 30 kg/m2and who drank > 21 units of alcohol per week.ResultsThe screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital.InterventionThe intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high.ConclusionsThis feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention.Future workA RCT to test the effectiveness and cost-effectiveness of the intervention.Trial registrationCurrent Controlled Trials ISRCTN55309164.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. 19. See the NIHR Journals Library website for further project information.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

scholarly journals Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT

2018 ◽  
Vol 22 (63) ◽  
pp. 1-136 ◽  
Author(s):  
David Kessler ◽  
Alison Burns ◽  
Debbie Tallon ◽  
Glyn Lewis ◽  
Stephanie MacNeill ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Technology Assessment ◽  
Usual Care ◽  
Reuptake Inhibitor ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Health Technology ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression

Background Depression is usually managed in primary care and antidepressants are often the first-line treatment, but only half of those treated respond to a single antidepressant. Objectives To investigate whether or not combining mirtazapine with serotonin–noradrenaline reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants results in better patient outcomes and more efficient NHS care than SNRI or SSRI therapy alone in treatment-resistant depression (TRD). Design The MIR trial was a two-parallel-group, multicentre, pragmatic, placebo-controlled randomised trial with allocation at the level of the individual. Setting Participants were recruited from primary care in Bristol, Exeter, Hull/York and Manchester/Keele. Participants Eligible participants were aged ≥ 18 years; were taking a SSRI or a SNRI antidepressant for at least 6 weeks at an adequate dose; scored ≥ 14 points on the Beck Depression Inventory-II (BDI-II); were adherent to medication; and met the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, criteria for depression. Interventions Participants were randomised using a computer-generated code to either oral mirtazapine or a matched placebo, starting at a dose of 15 mg daily for 2 weeks and increasing to 30 mg daily for up to 12 months, in addition to their usual antidepressant. Participants, their general practitioners (GPs) and the research team were blind to the allocation. Main outcome measures The primary outcome was depression symptoms at 12 weeks post randomisation compared with baseline, measured as a continuous variable using the BDI-II. Secondary outcomes (at 12, 24 and 52 weeks) included response, remission of depression, change in anxiety symptoms, adverse events (AEs), quality of life, adherence to medication, health and social care use and cost-effectiveness. Outcomes were analysed on an intention-to-treat basis. A qualitative study explored patients’ views and experiences of managing depression and GPs’ views on prescribing a second antidepressant. Results There were 480 patients randomised to the trial (mirtazapine and usual care, n = 241; placebo and usual care, n = 239), of whom 431 patients (89.8%) were followed up at 12 weeks. BDI-II scores at 12 weeks were lower in the mirtazapine group than the placebo group after adjustment for baseline BDI-II score and minimisation and stratification variables [difference –1.83 points, 95% confidence interval (CI) –3.92 to 0.27 points; p = 0.087]. This was smaller than the minimum clinically important difference and the CI included the null. The difference became smaller at subsequent time points (24 weeks: –0.85 points, 95% CI –3.12 to 1.43 points; 12 months: 0.17 points, 95% CI –2.13 to 2.46 points). More participants in the mirtazapine group withdrew from the trial medication, citing mild AEs (46 vs. 9 participants). Conclusions This study did not find convincing evidence of a clinically important benefit for mirtazapine in addition to a SSRI or a SNRI antidepressant over placebo in primary care patients with TRD. There was no evidence that the addition of mirtazapine was a cost-effective use of NHS resources. GPs and patients were concerned about adding an additional antidepressant. Limitations Voluntary unblinding for participants after the primary outcome at 12 weeks made interpretation of longer-term outcomes more difficult. Future work Treatment-resistant depression remains an area of important, unmet need, with limited evidence of effective treatments. Promising interventions include augmentation with atypical antipsychotics and treatment using transcranial magnetic stimulation. Trial registration Current Controlled Trials ISRCTN06653773; EudraCT number 2012-000090-23. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 63. See the NIHR Journals Library website for further project information.

scholarly journals Use of Featforward Mobile Phone App Associated with Decreased Cardiometabolic Risk Factors in Patients with Chronic Conditions (Preprint)

2018 ◽  
Author(s):  
Sara B Golas ◽  
Ramya Palacholla ◽  
Amanda Centi ◽  
Odeta Dyrmishi ◽  
Stephen Agboola ◽  
...  
Keyword(s):  
Physical Activity ◽  
Mobile Phone ◽  
Chronic Conditions ◽  
Primary Outcome ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Step Count ◽  
Control Group ◽  
Activity Trackers ◽  
Secondary Outcomes

BACKGROUND Physical inactivity is one of the leading risk factors contributing to rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. FeatForward is a mobile phone app designed to encourage patients with cardiometabolic risk (CMR) factors to increase their levels of physical activity. OBJECTIVE To evaluate the effect of the FeatForward mobile phone app on physical activity levels (primary outcome) and global CMR factors (secondary outcomes) in patients with chronic conditions. METHODS In this 6-month, 2-arm randomized controlled trial, adult participants endorsing at least 1 study-eligible condition (obesity, [pre-]diabetes, [pre-]hypertension) were enrolled and assigned to either the intervention group (FeatForward app and standard care) or control group (standard care only). The primary and secondary outcomes were, respectively, change from baseline in physical activity (step count) and CMR factors (weight, body mass index [BMI], waist circumference, glycated hemoglobin [HbA1c], fasting blood glucose, systolic/diastolic blood pressures, serum lipids, C-reactive protein [CRP]). CMR data were collected at 3 time-points: baseline, 3 months, and 6 months. Step count data were recorded continuously by patients’ study-issued activity trackers and collected in batches at 3 and 6 months. At study end, patients’ weekly average step counts (WAS) were calculated as total steps taken divided by days of step data (0-7) for each of 26 study weeks. Mixed-effects linear regression models evaluated change over time between groups for the primary outcome and secondary outcomes. All models controlled for baseline values. The step count model additionally controlled for proportion of days without data, defined as (7 – days of data) / 7. Analyses were conducted for both groups overall, and by disease cohort (obesity, diabetes, hypertension). RESULTS Step count and CMR data were analyzed for 128 intervention and 133 control patients. There were no demographic differences between groups. While there was an overall downward trend in WAS for both groups, the intervention group decreased significantly less than the control group, with a slope of -29.3 steps per week compared to controls’ -57.9 (P=.02). Intervention patients with obesity slightly increased their step count overtime, differing significantly from controls (slope of 0.9 vs -90.2; P<.001). Intervention patients significantly lowered their BMI per study month compared to controls (slopes -0.23 vs -0.02; P=.04). Additionally, intervention patients with hypertension significantly decreased weight (P=.003), BMI (P=.002), and CRP (P=.03) per month compared to the control group. Waist circumference, HbA1c, fasting blood glucose, blood pressure, and lipids did not differ significantly by group or disease cohort over time. CONCLUSIONS While it is common for patient engagement with physical activity trackers to decrease over the course of a study, patients using the FeatFoward app had a slower decline in physical activity compared to controls. Intervention patients experienced a reduction in their BMI from a mean of 34.3 to 33.4, compared to controls’ 34.8 to 35.0. Patients with hypertension experienced significant decreases in BMI, weight, and CRP compared to controls. Future analyses will evaluate the impact of app engagement levels on step counts and CMR factors for the intervention group.

scholarly journals Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial

2017 ◽  
Vol 21 (34) ◽  
pp. 1-92 ◽  
Author(s):  
William Jeffcoate ◽  
Frances Game ◽  
Vivienne Turtle-Savage ◽  
Alison Musgrove ◽  
Patricia Price ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Technology ◽  
Control Group ◽  
Advisory Panel ◽  
Health Economic Analysis ◽  
Randomised Controlled

Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. Design A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. Setting Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2–4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. Participants In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm2 [interquartile range (IQR) 104–683 mm2] in the intervention group and 206 mm2 (IQR 77–649 mm2) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. Interventions The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant’s ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. Main outcome measures The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). Results Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. Limitations Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. Conclusions There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. Future work It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. Trial registration Current Controlled Trials ISRCTN62524796. 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. 21, No. 34. See the NIHR Journals Library website for further project information.

scholarly journals Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT

2019 ◽  
Vol 23 (39) ◽  
pp. 1-166 ◽  
Author(s):  
Barnaby C Reeves ◽  
Leila Rooshenas ◽  
Rhiannon C Macefield ◽  
Mark Woodward ◽  
Nicky J Welton ◽  
...  
Keyword(s):  
Abdominal Surgery ◽  
Surgical Site Infection ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Value Of Information ◽  
Primary Outcome ◽  
Health Technology ◽  
Controlled Trials ◽  
Site Infection ◽  
Pilot Rct

Background Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. Objective To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. Design Phase A – semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B – pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. Setting Usual NHS care. Participants Patients undergoing elective/non-elective abdominal surgery, including caesarean section. Interventions Phase A – none. Phase B – simple dressing, glue-as-a-dressing (tissue adhesive) or ‘no dressing’. Main outcome measures Phase A – pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B – participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. Data sources Phase A – interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B – participants and HCPs in five hospitals. Results Phase A – we interviewed 102 participants. HCPs interpreted ‘dressing’ variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a ‘no dressing’ group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B – from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients’ understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test–retest and Cronbach’s alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. Limitations Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. Conclusions A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4–8 weeks. Trial registration Phase A – Current Controlled Trials ISRCTN06792113; Phase B – Current Controlled Trials ISRCTN49328913. 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. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

scholarly journals Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT

2019 ◽  
Vol 23 (38) ◽  
pp. 1-92 ◽  
Author(s):  
Matthew Scarborough ◽  
Ho Kwong Li ◽  
Ines Rombach ◽  
Rhea Zambellas ◽  
A Sarah Walker ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Joint Infection ◽  
Health Technology ◽  
Definitive Treatment ◽  
Open Label ◽  
Bone And Joint Infection ◽  
Intravenous Antibiotics ◽  
Significant Difference

Background Management of bone and joint infection commonly includes 4–6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes. Objective To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection. Design Parallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%. Setting Twenty-six NHS hospitals. Participants Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively). Interventions Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm. Main outcome measure The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data. Results Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was –1.38% (90% confidence interval –4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial. Limitations The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded. Conclusions PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy. Future work Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics. Trial registration Current Controlled Trials ISRCTN91566927. 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. 38. See the NIHR Journals Library website for further project information.

scholarly journals Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT

2020 ◽  
Vol 24 (49) ◽  
pp. 1-130
Author(s):  
Nadine E Foster ◽  
Kika Konstantinou ◽  
Martyn Lewis ◽  
Reuben Ogollah ◽  
Benjamin Saunders ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Technology Assessment ◽  
Usual Care ◽  
Technology Assessment ◽  
Fast Track ◽  
Primary Outcome ◽  
Health Technology ◽  
Care Pathways ◽  
Care Model ◽  
Stratified Care

Background Sciatica has a substantial impact on patients and society. Current care is ‘stepped’, comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. Objectives The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. Design This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. Setting Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. Participants Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. Interventions In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. Main outcome measures The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost–utility analysis was undertaken over 12 months. A qualitative study explored patients’ and clinicians’ views of the fast-track care pathway to a spinal specialist. Results A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. Conclusions The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. Limitations Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. Future work Other approaches to stratified care may provide superior outcomes for sciatica. Trial registration Current Controlled Trials ISRCTN75449581. 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. 24, No. 49. See the NIHR Journals Library website for further project information.

P573Effects of mobile text messaging on glycemic control in patients with coronary heart disease and diabetes mellitus: a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
X H Huo ◽  
H M K Krumholz ◽  
X B Bai ◽  
E S S Spatz ◽  
Q D Ding ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Coronary Heart Disease ◽  
Text Messaging ◽  
Hba1c Level ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Secondary Outcomes

Abstract Background Mobile health interventions hold the prospect to support risk factor and lifestyle modification and are readily scalable in healthcare systems. Purpose We aim to assess whether text messaging program can improve glycemic control in high-risk patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods The study was a multi-centre randomised clinical trial conducted at 34 clinics in China. 502 individuals with both CHD and DM were recruited and randomly assigned to either the text messaging intervention (n=251) or control group (n=251). The control group received 2 thank-you messages per month in addition to usual care. The intervention group received 6 messages per week for 6 months. Messages provided educational and motivational information related to glucose monitoring, BP control, physical activity and lifestyle recommendations. The primary outcome was change in glycemic hemoglobin (HbA1C) from baseline to 6 months. Results Follow-up rate was 99%. At 6 months, HbA1C was significantly lower in intervention group compared to control group (mean HbA1C 6.7% vs. 7.2%, P<0.001), with a mean change of −0.2% and 0.1% from baseline, respectively (mean absolute change −0.3% [95% CI −0.5 to 0.1]; P=0.003). Significantly more participants in intervention group achieved a HbA1c<7% (69.3% vs. 52.6%; P=0.004), and change in FBG was larger in intervention group (−0.5 vs. 0.1 mmol/L; P=0.011). No differences in SBP, LDL-C, BMI and physical activity were observed. Almost all patients reported messages to be easy to understand (97.1%) and useful (94.1%). Table 1. Primary and Secondary Outcomes Analyses at 6 Month Follow-up Parameter Intervention (N=251) Control (N=251) Mean Difference in Change P value for Baseline 6 Months Mean Change Baseline 6 Months Mean Change (95% CI) Difference in Change Primary Outcome HbA1C level, %, mean (SD) 6.9 (1.4) 6.7 (1.3) −0.2 (1.0) 7.1 (1.4) 7.2 (1.5) 0.1 (1.1) −0.3 (−0.5, −0.1) 0.003 Secondary Outcomes HbA1C level<7%, No. (%) 155 (62.0%) 174 (69.3%) – 139 (56.1%) 132 (52.6%) – 1.2 (1.1, 1.3)a 0.004   FBG, mmol/L, mean (SD) 8.1 (2.7) 7.5 (2.7) −0.5 (2.5) 8.5 (3.0) 8.6 (3.3) 0.1 (3.1) −0.6 (−1.1, −0.2) 0.011   SBP, mmHg, mean (SD) 135.9 (18.4) 134.7 (18.7) −1.4 (17.1) 135.9 (18.1) 132.2 (17.7) −3.5 (17.8) 2.4 (−0.8,5.5) 0.144   LDL-C, mmol/L, mean (SD) 2.6 (0.8) 2.5 (0.7) −0.1 (0.7) 2.6 (0.8) 2.5 (0.8) −0.1 (0.7) 0 (−0.1, 0.1) 0.828   BMI, mean (SD) 26.4 (3.2) 26.3 (3.5) −0.1 (2.1) 26.3 (3.2) 26.0 (3.4) −0.4 (2.5) 0.3 (−0.1, 0.7) 0.213   Physical activity (MET min/wk), 1386 1386 177 1386 1386 322 −70.7 0.784     median (IQR) (693–3066) (918–3612) (2840) (693–3066) (693–3002) (2635) (−574.9, 433.5) Conclusion Use of a simple, culturally sensitive mobile text-messaging program could be an effective and scalable way to improve disease self-management among patients with CHD and DM. Acknowledgement/Funding Research Special Fund for Public Welfare Industry of Health (201502009) from the National Health and Family Planning Commission of China

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