ABSTRACT
Background: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life. Objectives: To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children. Design: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years. Setting: Twelve secondary and four primary care centres. Participants: Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery. Interventions: Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation. Main outcome measures: Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness. Results: One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; p = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires. Limitations: Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes. Conclusions: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context. Future research: To pool similar studies in an individual patient data meta-analysis. Trial registration: This trial is registered as ISRCTN21528841. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in Health Technology Assessment; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.
Eczema is a troublesome itchy skin condition affecting 1 in 5 children and 1 in 10 UK adults. There is no cure and affected children are more likely to develop food allergies. We wanted to see if we could prevent eczema by protecting the skin of babies at higher risk of developing eczema (with an immediate relative with eczema, asthma or hay fever) with moisturisers used to treat dry skin. Previous research suggested that protecting the skin barrier might also prevent food allergy. One thousand three hundred and ninety-four families took part in a study; half of them were asked to apply moisturiser every day to their newborn baby for the first year and half to look after their baby's skin in the normal way. At the age of 2 years, we did not see any difference in how common eczema was between the two groups: 23% had eczema in the moisturiser group and 25% in the normal care group. It did not matter how we defined eczema whether examined by a researcher or parent report. We did not find any differences in related conditions like asthma or hay fever either. We found that children using moisturisers had seen their doctor slightly more often for mild skin infections. There was a hint that food allergy might have been increased in the moisturiser group, but there was not enough data to be sure. We followed up the children to age 5 years, but we still did not find any benefits from using moisturisers in early life. Since this study, other similar research has been done using newer types of moisturisers, but their results are the same. This study shows that using daily moisturisers on healthy babies with a high risk of eczema does not prevent eczema. It is one less thing for busy families to worry about.
Subject(s)
Cost-Benefit Analysis , Eczema , Emollients , Humans , Emollients/therapeutic use , Female , Male , Infant , Infant, Newborn , Eczema/prevention & control , United Kingdom , Child, Preschool , Quality-Adjusted Life Years , Quality of Life , Technology Assessment, Biomedical , Dermatitis, Atopic/prevention & controlABSTRACT
BACKGROUND: Cow's milk allergy (CMA) overdiagnosis in young children appears to be increasing and has not been well characterised. We used a clinical trial population to characterise CMA overdiagnosis and identify individual-level and primary care practice-level risk factors. METHODS: We analysed data from 1394 children born in England in 2014-2016 (BEEP trial, ISRCTN21528841). Participants underwent formal CMA diagnosis at ≤2 years. CMA overdiagnosis was defined in three separate ways: parent-reported milk reaction; primary care record of milk hypersensitivity symptoms; and primary care record of low-allergy formula prescription. RESULTS: CMA was formally diagnosed in 19 (1.4%) participants. CMA overdiagnosis was common: 16.1% had parent-reported cow's milk hypersensitivity, 11.3% primary care recorded milk hypersensitivity and 8.7% had low-allergy formula prescription. Symptoms attributed to cow's milk hypersensitivity in participants without CMA were commonly gastrointestinal and reported from a median age of 49 days. Low-allergy formula prescriptions in participants without CMA lasted a median of 10 months (interquartile range 1, 16); the estimated volume consumed was a median of 272 litres (26, 448). Risk factors for CMA overdiagnosis were high practice-based low-allergy formula prescribing in the previous year and maternal report of antibiotic prescription during pregnancy. Exclusive formula feeding from birth was associated with increased low-allergy formula prescription. There was no evidence that practice prescribing of paediatric adrenaline auto-injectors or anti-reflux medications, or maternal features such as anxiety, age, parity and socioeconomic status were associated with CMA overdiagnosis. CONCLUSION: CMA overdiagnosis is common in early infancy. Risk factors include high primary care practice-based low-allergy formula prescribing and maternal report of antibiotic prescription during pregnancy.
ABSTRACT
BACKGROUND: Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. OBJECTIVE: To determine the cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children at 2 years from a health service perspective. We also considered a 5-year time horizon as a sensitivity analysis. METHODS: A within-trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost-effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost-effectiveness analysis. Secondary analysis, undertaken as a cost-utility analysis, reports incremental cost per Quality-Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU-9D at 2 years. RESULTS: At 2 years, the adjusted incremental cost was £87.45 (95% CI -54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI -0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI -0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, -£106.89 (95% CI -354.66, 140.88) and the proportion without eczema was -0.0329 (95% CI -0.0659, 0.0002). The 5-year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group. CONCLUSIONS: In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high-risk children does not appear cost-effective.
Subject(s)
Dermatitis, Atopic , Eczema , Humans , Infant , Cost-Effectiveness Analysis , Dermatitis, Atopic/prevention & control , Dermatitis, Atopic/drug therapy , Eczema/prevention & control , Emollients/therapeutic use , Quality of Life , Treatment OutcomeABSTRACT
BACKGROUND: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and atopic conditions to age 5 years. METHODS: 1394 term infants with a family history of atopic disease were randomized (1:1) to daily emollient plus standard skin-care advice (693 emollient group) or standard skin-care advice alone (701 controls). Long-term follow-up at ages 3, 4 and 5 years was via parental questionnaires. Main outcomes were parental report of a clinical diagnosis of atopic dermatitis and food allergy. RESULTS: Parents reported more frequent moisturizer application in the emollient group through to 5 years. A clinical diagnosis of atopic dermatitis between 12 and 60 months was reported for 188/608 (31%) in the emollient group and 178/631 (28%) in the control group (adjusted relative risk 1.10, 95% confidence interval 0.93 to 1.30). Although more parents in the emollient group reported food reactions in the previous year at 3 and 4 years, cumulative incidence of doctor-diagnosed food allergy by 5 years was similar between groups (92/609 [15%] emollients and 87/632 [14%] controls, adjusted relative risk 1.11, 95% confidence interval 0.84 to 1.45). Findings were similar for cumulative incidence of asthma and hay fever. CONCLUSIONS: Daily emollient application during the first year of life does not prevent atopic dermatitis, food allergy, asthma or hay fever.
Subject(s)
Asthma , Dermatitis, Atopic , Eczema , Food Hypersensitivity , Rhinitis, Allergic, Seasonal , Infant , Humans , Child, Preschool , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/epidemiology , Dermatitis, Atopic/prevention & control , Emollients/therapeutic use , Rhinitis, Allergic, Seasonal/drug therapy , Food Hypersensitivity/prevention & control , Asthma/drug therapy , Treatment OutcomeABSTRACT
BACKGROUND: Palmar hyperlinearity is a feature of ichthyosis vulgaris, the monogenic skin disorder caused by FLG loss-of-function mutations. OBJECTIVE: To investigate how well the presence or absence of hyperlinear palms (HLP) detect FLG genotype in children. METHODS: STARD criteria are used to report this diagnostic accuracy study. Phenotype and genotype data (four most prevalent FLG null mutations) were obtained from a total of 3656 children in three studies: the UK CLOTHES trial (children 1-5 years with moderate-severe atopic eczema); UK BEEP trial (2 year olds at high risk of developing atopic eczema); UK-Irish eczema case collection (0-16 year olds with atopic eczema). All participants included in analyses of HLP as the index test and FLG genotype as the reference were of white European ancestry. RESULTS: Thirty-two percent of participants (1159/3656) had FLG null mutation(s) and 37% (1347/3656) had HLP. In 13% (464/3656), HLP was recorded as 'unsure' or not recorded. The sensitivity and specificity of HLP for detecting FLG mutations in each of the studies was: 67% (95% CI 55-78%) and 75% (67-82%) in CLOTHES; 46% (36-55%) and 89% (86-91%) in BEEP; 72% (68-75%) and 60% (57-62%) in the UK-Irish case collection. Positive and negative likelihood ratios were: 2.73 (1.95-3.81) and 0.44 (0.31-0.62) in CLOTHES; 4.02 (2.99-5.40) and 0.61 (0.52-0.73) in BEEP; 1.79 (1.66-1.93) and 0.47 (0.42-0.53) in the UK-Irish collection. DISCUSSION: Trained observers were able to define palmar hyperlinearity in the majority (3191/3656, 87%) of cases. The presence of HLP is not a reliable sign to detect FLG mutations, but the absence of HLP excludes FLG null genotype with a reasonable degree of certainty.
Subject(s)
Diagnostic Tests, Routine , Filaggrin Proteins , Adolescent , Child , Child, Preschool , Genetic Predisposition to Disease , Genotype , Humans , Infant , Intermediate Filament Proteins/genetics , MutationABSTRACT
BACKGROUND: Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT). METHODS: Parents of babies included in the host trial were randomised to (1) short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18 months versus no SMS notification and (2) a £10 voucher sent with the invitation letter for the primary follow-up visit at 24 months or given at the visit. The two co-primary outcomes were collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24 months during a home/clinic visit with a research nurse. RESULTS: Between November 2014 and November 2016, 1394 participants were randomised: 350 to no SMS + voucher at visit, 345 to SMS + voucher at visit, 352 to no SMS + voucher before visit and 347 to SMS + voucher before visit. Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS versus none 1.02, 95% CI 0.83 to 1.25). Host trial primary outcome data was collected at a visit for 557 (80%) allocated to the voucher before the visit in the invitation letter and for 566 (81%) whose parents were allocated to receive the voucher at the visit (OR before versus at visit 0.89, 95% CI 0.69 to 1.17). CONCLUSION: There was no evidence of a difference in retention according to SMS notification or voucher timing. Future synthesis of SWAT results is required to be able to detect small but important incremental effects of retention strategies. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN21528841. Registered on 25 July 2014. SWAT Repository Store ID 25.
Subject(s)
Follow-Up Studies , Patient Participation/statistics & numerical data , Reward , Text Messaging/statistics & numerical data , Adult , Female , Humans , Logistic Models , Surveys and QuestionnairesABSTRACT
BACKGROUND: Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children. METHODS: We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment. FINDINGS: 1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09). INTERPRETATION: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn. FUNDING: National Institute for Health Research Health Technology Assessment.
Subject(s)
Dermatitis, Atopic/drug therapy , Eczema/prevention & control , Emollients/therapeutic use , Dose-Response Relationship, Drug , Drug Administration Schedule , Eczema/drug therapy , Female , Follow-Up Studies , Humans , Infant , Infant, Newborn , Male , Reference Values , Risk Assessment , Treatment Outcome , United KingdomABSTRACT
BACKGROUND: People with multiple sclerosis have problems with memory and attention. The effectiveness of cognitive rehabilitation has not been established. OBJECTIVES: The objectives were to assess the clinical effectiveness and cost-effectiveness of a cognitive rehabilitation programme for people with multiple sclerosis. DESIGN: This was a multicentre, randomised controlled trial in which participants were randomised in a ratio of 6 : 5 to receive cognitive rehabilitation plus usual care or usual care alone. Participants were assessed at 6 and 12 months after randomisation. SETTING: The trial was set in hospital neurology clinics and community services. PARTICIPANTS: Participants were people with multiple sclerosis who had cognitive problems, were aged 18-69 years, could travel to attend group sessions and gave informed consent. INTERVENTION: The intervention was a group cognitive rehabilitation programme delivered weekly by an assistant psychologist to between four and six participants for 10 weeks. MAIN OUTCOME MEASURES: The primary outcome was the Multiple Sclerosis Impact Scale - Psychological subscale at 12 months. Secondary outcomes included results from the Everyday Memory Questionnaire, the 30-Item General Health Questionnaire, the EuroQol-5 Dimensions, five-level version and a service use questionnaire from participants, and the Everyday Memory Questionnaire - relative version and the Modified Carer Strain Index from a relative or friend of the participant. RESULTS: Of the 449 participants randomised, 245 were allocated to cognitive rehabilitation (intervention group) and 204 were allocated to usual care (control group). Of these, 214 in the intervention group and 173 in the control group were included in the primary analysis. There was no clinically important difference in the Multiple Sclerosis Impact Scale - Psychological subscale score between the two groups at the 12-month follow-up (adjusted difference in means -0.6, 95% confidence interval -1.5 to 0.3; p = 0.20). There were no important differences between the groups in relation to cognitive abilities, fatigue, employment, or carer strain at follow-up. However, there were differences, although small, between the groups in the Multiple Sclerosis Impact Scale - Psychological subscale score at 6 months (adjusted difference in means -0.9, 95% confidence interval -1.7 to -0.1; p = 0.03) and in everyday memory on the Everyday Memory Questionnaire as reported by participants at 6 (adjusted difference in means -5.3, 95% confidence interval -8.7 to -1.9) and 12 months (adjusted difference in means -4.4, 95% confidence interval -7.8 to -0.9) and by relatives at 6 (adjusted difference in means -5.4, 95% confidence interval -9.1 to -1.7) and 12 months (adjusted difference in means -5.5, 95% confidence interval -9.6 to -1.5) in favour of the cognitive rehabilitation group. There were also differences in mood on the 30-Item General Health Questionnaire at 6 (adjusted difference in means -3.4, 95% confidence interval -5.9 to -0.8) and 12 months (adjusted difference in means -3.4, 95% confidence interval -6.2 to -0.6) in favour of the cognitive rehabilitation group. A qualitative analysis indicated perceived benefits of the intervention. There was no evidence of a difference in costs (adjusted difference in means -£574.93, 95% confidence interval -£1878.93 to £729.07) or quality-adjusted life-year gain (adjusted difference in means 0.00, 95% confidence interval -0.02 to 0.02). No safety concerns were raised and no deaths were reported. LIMITATIONS: The trial included a sample of participants who had relatively severe cognitive problems in daily life. The trial was not powered to perform subgroup analyses. Participants could not be blinded to treatment allocation. CONCLUSIONS: This cognitive rehabilitation programme had no long-term benefits on quality of life for people with multiple sclerosis. FUTURE WORK: Future research should evaluate the selection of those who may benefit from cognitive rehabilitation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN09697576. 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. 24, No. 4. See the National Institute for Health Research Journals Library website for further project information.
Cognitive (or mental processing) problems, particularly those affecting memory and attention, are common in people with multiple sclerosis. Multiple sclerosis is a condition that affects the brain and causes nerve damage. Cognitive rehabilitation can involve: retraining cognitive skills, which are the core skills your brain uses to think, read, learn, remember, reason and concentrateteaching strategies to cope in daily life. Cognitive rehabilitation is rarely provided for people with multiple sclerosis. A trial was carried out to determine whether or not providing a group cognitive rehabilitation programme improved quality of life more than usual clinical care, which did not involve any cognitive rehabilitation. The effects on daily memory problems, mood, fatigue and employment were examined and also the cost-effectiveness of the treatment. A total of 449 people with multiple sclerosis took part in the trial. They all agreed to be part of the research trial, had cognitive problems, were aged 1869 years and could travel to attend group sessions. Participants were then allocated to receive cognitive rehabilitation or not, on the basis of chance (i.e. randomly). All participants were followed up for 1 year. Although both groups showed no differences in quality of life after 1 year, those who received cognitive rehabilitation had fewer memory problems in daily life and reported better mood than those who received only their usual clinical care. There were no differences in their levels of fatigue or disability, or in employment status. The qualitative results indicated that participants found the intervention useful. Treatment cost slightly less than usual care but had modest benefits. Overall, the results suggest that there may be modest short-term benefits of cognitive rehabilitation, and future studies will consider how such benefits can be maintained and whether or not some people benefit more than others.
Subject(s)
Cognitive Dysfunction , Multiple Sclerosis/therapy , Psychotherapy, Group , Quality of Life/psychology , Technology Assessment, Biomedical , Adult , Aged , Cost-Benefit Analysis , Female , Humans , Male , Memory , Middle Aged , Multiple Sclerosis/complications , Surveys and Questionnaires , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time-consuming, carry some risk and may, therefore, not be acceptable to all study participants. OBJECTIVE: To design and evaluate an algorithm for detecting IgE-mediated food allergy in clinical study participants who do not undergo OFC. METHODS: An algorithm for trial participants in the Barrier Enhancement for Eczema Prevention (BEEP) study who were unwilling or unable to attend OFC was developed. BEEP is a pragmatic, multi-centre, randomized-controlled trial of daily emollient for the first year of life for primary prevention of eczema and food allergy in high-risk infants (ISRCTN21528841). We built on the European iFAAM consensus guidance to develop a novel food allergy diagnosis algorithm using available information on previous allergenic food ingestion, food reaction(s) and sensitization status. This was implemented by a panel of food allergy experts blind to treatment allocation and OFC outcome. We then evaluated the algorithm's performance in both BEEP and Enquiring About Tolerance (EAT) study participants who did undergo OFC. RESULTS: In 31/69 (45%) BEEP and 44/55 (80%) EAT study control group participants who had an OFC the panel felt confident enough to categorize children as "probable food allergy" or "probable no food allergy". Algorithm-derived panel decisions showed high sensitivity 94% (95%CI 68, 100) BEEP; 90% (95%CI 72, 97) EAT and moderate specificity 67% (95%CI 39, 87) BEEP; 67% (95%CI 39, 87) EAT. Sensitivity and specificity were similar when all BEEP and EAT participants with OFC outcome were included. CONCLUSION: We describe a new algorithm with high sensitivity for IgE-mediated food allergy in clinical study participants who do not undergo OFC. CLINICAL RELEVANCE: This may be a useful tool for excluding food allergy in future clinical studies where OFC is not conducted.
Subject(s)
Algorithms , Food Hypersensitivity/diagnosis , Food Hypersensitivity/immunology , Immunoglobulin E/immunology , Child , Female , Humans , Infant , MaleABSTRACT
OBJECTIVE: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. DESIGN: Multicentre, pragmatic, randomized controlled trial. SETTING: Community. PARTICIPANTS: People with multiple sclerosis aged 18-69 years, who reported cognitive problems in daily life and had cognitive problems on standardized assessment. INTERVENTIONS: A group cognitive rehabilitation programme delivered in 10 weekly sessions in comparison with usual care. MAIN MEASURES: The primary outcome was the Multiple Sclerosis Impact Scale Psychological subscale at 12 months after randomization. Secondary outcomes included measures of everyday memory problems, mood, fatigue, cognitive abilities and employment at 6 and 12 months after randomization. RESULTS: In all, 245 participants were allocated to cognitive rehabilitation and 204 to usual care. Mean Multiple Sclerosis Impact Scale Psychological at 12 months was 22.2 (SD = 6.1) for cognitive rehabilitation and 23.4 (SD = 6.0) for usual care group; adjusted difference -0.6, 95% confidence interval (CI) = -1.5 to 0.3, P = 0.20. No differences were observed in cognitive abilities, fatigue or employment. There were small differences in favour of cognitive rehabilitation for the Multiple Sclerosis Impact Scale Psychological at 6 months and everyday memory and mood at 6 and 12 months. There was no evidence of an effect on costs (-£808; 95% CI = -£2248 to £632) or on quality-adjusted life year gain (0.00; 95% CI = -0.01 to 0.02). CONCLUSION: This rehabilitation programme had no long-term benefits on the impact of multiple sclerosis on quality of life, but there was some evidence of an effect on everyday memory problems and mood.
Subject(s)
Attention , Cognitive Behavioral Therapy , Memory Disorders/therapy , Memory , Multiple Sclerosis/psychology , Multiple Sclerosis/rehabilitation , Adolescent , Adult , Affect , Aged , Cognition , Cost-Benefit Analysis , Female , Humans , Male , Memory Disorders/etiology , Middle Aged , Multiple Sclerosis/complications , Quality of Life , Quality-Adjusted Life Years , Young AdultABSTRACT
OBJECTIVE: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING: Community. PARTICIPANTS: People with memory problems following traumatic brain injury, aged 18-69 years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS: A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES: The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12 months post randomization. RESULTS: We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5, p = 0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION: This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.
Subject(s)
Brain Injuries, Traumatic/psychology , Brain Injuries, Traumatic/rehabilitation , Memory Disorders/rehabilitation , Psychotherapy, Group/economics , Psychotherapy, Group/methods , Adolescent , Adult , Aged , Brain Injuries, Traumatic/economics , Cost-Benefit Analysis , England , Female , Humans , Male , Memory Disorders/economics , Memory Disorders/etiology , Middle Aged , Quality of Life , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI. DESIGN: Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken. SETTING: Community settings in nine sites in England. PARTICIPANTS: Participants were aged 18-69 years, had undergone a TBI > 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent. RANDOMISATION AND BLINDING: Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded. INTERVENTIONS: In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only. MAIN OUTCOME MEASURES: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire - patient version (EMQ-p) at 6 months' follow-up. Secondary outcomes: Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied. RESULTS: We randomised 328 participants (memory rehabilitation, n = 171; usual care, n = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5; p = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months' follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months' follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be £26.89 cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported. LIMITATIONS: As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the sample. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation. CONCLUSIONS: The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN65792154. 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. 16. See the NIHR Journals Library website for further project information.
People with brain injuries often report memory problems. These difficulties can continue long after the injury, causing complications in daily life. Many people do not receive specific help for these memory problems after leaving hospital. Our study explored whether receiving 'memory rehabilitation' (a group treatment to help people deal with memory difficulties) was better than the treatment that people usually receive to help reduce the frequency of forgetting in daily life. We recruited 328 people who had memory problems following brain injury. About half were allocated at random to receive memory rehabilitation and half did not have any extra memory treatments, but everyone continued to receive their usual care. Those who had memory rehabilitation were offered 10 group sessions at which strategies were taught to help them cope with memory problems. We asked all participants to complete memory tests and questionnaires at the start of the study and again 6 and 12 months afterwards to find out whether the memory rehabilitation had any effect. Some participants were also interviewed about the study. At the 6- and 12-month assessments, there were no differences between those who received memory rehabilitation and those who did not in terms of how often participants reported memory problems in their daily lives or how well they performed on memory tests. We also did not find any differences in participants' mood or quality of life. However, individual goals set by the participants at the start of the study were a little better met by those who received memory rehabilitation than by those who did not. The memory rehabilitation did not represent value for money. In interviews, participants reported positive experiences of taking part in the study and of attending the group sessions. This group memory rehabilitation programme is unlikely to help people with memory problems following a brain injury more than the usual treatment that people receive. Some people may benefit more from memory rehabilitation than others, but this needs further investigation.
Subject(s)
Brain Injuries, Traumatic/psychology , Brain Injuries, Traumatic/rehabilitation , Memory , Rehabilitation/organization & administration , Adolescent , Adult , Aged , Brain Injuries, Traumatic/physiopathology , Cluster Analysis , England , Female , Follow-Up Studies , Humans , Male , Middle Aged , Quality of Life , Quality-Adjusted Life Years , State Medicine , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis). METHODS: This is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24 months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18 months with a face-to-face visit at 24 months. Long-term follow-up until 60 months will be via annual questionnaires. DISCUSSION: This trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases. TRIAL REGISTRATION: ISRCTN registry; ID: ISRCTN21528841 . Registered on 25 July 2014.
Subject(s)
Dermatitis, Atopic/economics , Dermatitis, Atopic/prevention & control , Drug Costs , Emollients/administration & dosage , Emollients/economics , Organic Chemicals/administration & dosage , Organic Chemicals/economics , Administration, Cutaneous , Child, Preschool , Clinical Protocols , Community Health Services , Cost-Benefit Analysis , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/genetics , Emollients/adverse effects , England , Female , Filaggrin Proteins , Humans , Infant , Infant, Newborn , Male , Organic Chemicals/adverse effects , Research Design , Secondary Care , Surveys and Questionnaires , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Atopic 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. OBJECTIVES: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease. DESIGN: Parallel-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. SETTING: Secondary care and the community in five UK centres. PARTICIPANTS: Children aged 1-15 years with moderate or severe AE. INTERVENTIONS: Participants 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 MEASURES: Primary 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. RESULTS: A 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. LIMITATIONS: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes. CONCLUSIONS: The 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 WORK: Non-pharmacological interventions for the management of AE remain a research priority among patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365. 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. 16. See the NIHR Journals Library website for further project information.
Subject(s)
Clothing , Dermatitis, Atopic/therapy , Silk/therapeutic use , Child, Preschool , Chronic Disease , Cost-Benefit Analysis , Humans , Qualitative Research , Quality of Life , Severity of Illness Index , Standard of Care , Surveys and Questionnaires , Technology Assessment, BiomedicalABSTRACT
BACKGROUND: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. METHODS AND FINDINGS: This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 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 units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. CONCLUSIONS: Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365.
Subject(s)
Clothing , Eczema/therapy , Silk , Standard of Care , Adolescent , Child , Child, Preschool , Eczema/pathology , Female , Humans , Infant , Male , Severity of Illness Index , Single-Blind Method , Treatment OutcomeABSTRACT
BACKGROUND: One in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delirium and dementia (the Medical and Mental Health Unit, MMHU) was developed and then tested in a randomised controlled trial where it delivered significantly higher quality of, and satisfaction with, care, but no significant benefits in terms of health status outcomes at three months. OBJECTIVE: To examine the cost-effectiveness of the MMHU for older people with delirium and dementia in general hospitals, compared with standard care. METHODS: Six hundred participants aged over 65 admitted for acute medical care, identified on admission as cognitively impaired, were randomised to the MMHU or to standard care on acute geriatric or general medical wards. Cost per quality adjusted life year (QALY) gained, at 3-month follow-up, was assessed in trial-based economic evaluation (599/600 participants, intervention: 309). Multiple imputation and complete-case sample analyses were employed to deal with missing QALY data (55%). RESULTS: The total adjusted health and social care costs, including direct costs of the intervention, at 3 months was £7714 and £7862 for MMHU and standard care groups, respectively (difference -£149 (95% confidence interval [CI]: -298, 4)). The difference in QALYs gained was 0.001 (95% CI: -0.006, 0.008). The probability that the intervention was dominant was 58%, and the probability that it was cost-saving with QALY loss was 39%. At £20,000/QALY threshold, the probability of cost-effectiveness was 94%, falling to 59% when cost-saving QALY loss cases were excluded. CONCLUSIONS: The MMHU was strongly cost-effective using usual criteria, although considerably less so when the less acceptable situation with QALY loss and cost savings were excluded. Nevertheless, this model of care is worthy of further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01136148.
Subject(s)
Delirium/economics , Dementia/economics , Health Services for the Aged/economics , Aged , Aged, 80 and over , Cost-Benefit Analysis , Health Services for the Aged/organization & administration , Hospitals, General , Humans , Quality-Adjusted Life YearsABSTRACT
BACKGROUND: Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. METHODS/DESIGN: Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete. Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365 (registered 11 November 2013).
Subject(s)
Clothing , Eczema/therapy , Pruritus/therapy , Silk , Adolescent , Age Factors , Child , Child, Preschool , Clinical Protocols , Combined Modality Therapy , Dermatologic Agents/therapeutic use , Eczema/diagnosis , Eczema/psychology , England , Female , Humans , Infant , Male , Patient Compliance , Pruritus/diagnosis , Pruritus/psychology , Quality of Life , Research Design , Severity of Illness Index , Surveys and Questionnaires , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The Cord Pilot Trial aimed to assess the feasibility of conducting a large UK randomised trial to compare the effects of alternative polices for timing of cord clamping (immediate within 20 seconds or deferred after at least 2 minutes) for very preterm birth before 32 weeks gestation. Initial recruitment was from March 2013 to February 2014, phase 2 was from March 2014 to February 2015. This paper updates the pilot trial protocol (Trials 15(1):258, 2014) and presents the changes for phase 2. METHODS: An electronic randomisation system was introduced at three of the eight pilot sites. For follow-up of children, the Parent Report of Children's Abilities--Revised (PARCA-R) will not be used. For children recruited to the trial during phase 2, follow-up at age 2 years (corrected for gestation at birth) will be by parent completed Ages and Stages Questionnaire (Squire J, Ages and Stages Questionnaires (ASQ), 2009) alone unless funds can be secured for the additional Bayley Scales of Infant Development III (Bayley N, Bayley Scales of Infant and Toddler Development, Third Edition. (Bayley-III), 2005) assessments. To assess accuracy of the cranial ultrasound diagnosis of intraventricular haemorrhage: (i) quality of the scans will be assessed using the British Society of Paediatric Radiology recommendations, and (ii) scan results will be confirmed by independent adjudication. Within and between adjudicator reliability will be assessed. In addition to the analyses planned to assess feasibility of the full trial based on data from the first year of recruitment, data on compliance and outcomes will be presented by allocated group for all women and babies recruited. TRIAL REGISTRATION: ISRCTN21456601, registered on 28 February 2013.
Subject(s)
Infant, Premature , Premature Birth , Umbilical Cord/surgery , Age Factors , Child Development , Child, Preschool , Clinical Protocols , Constriction , Feasibility Studies , Female , Gestational Age , Humans , Infant, Newborn , Intracranial Hemorrhages/diagnostic imaging , Intracranial Hemorrhages/physiopathology , Pilot Projects , Pregnancy , Research Design , Surveys and Questionnaires , Time Factors , Ultrasonography , United KingdomABSTRACT
BACKGROUND: Poor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period. OBJECTIVE: To examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care. METHODS: Economic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained. RESULTS: We undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (5624, $6878) and £4110 (5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold). CONCLUSIONS: The specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed. TRIAL REGISTRATION: ISRCTN registry ISRCTN21800480 http://www.isrctn.com/ISRCTN21800480.
Subject(s)
Cost-Benefit Analysis , Early Medical Intervention/economics , Models, Theoretical , Aged , Aged, 80 and over , Female , Geriatric Assessment , Hospitals, General/economics , Humans , Male , Patient Discharge/economics , Quality-Adjusted Life Years , United KingdomABSTRACT
OBJECTIVES: To identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults. DESIGN: Secondary analysis of data from a randomized controlled trial. SETTING: An 1,800-bed general hospital in England providing the only emergency medical services in its area. PARTICIPANTS: Cognitively impaired individuals aged 65 and older randomly assigned to a specialist unit or standard geriatric or internal medical wards (N = 600) and related caregivers (N = 488). MEASUREMENTS: Patient and caregiver health status was measured at baseline, including delirium, cognitive impairment, behavioral and psychological symptoms, activities of daily living, and caregiver strain. Caregiver satisfaction with quality of care was ascertained after hospital discharge or death. RESULTS: Four hundred sixty-two caregivers completed satisfaction questionnaires. Regardless of assignment, 54% of caregivers were dissatisfied with some aspects of care, but overall 87% were satisfied with care. The main areas of dissatisfaction were communication, discharge planning, and medical management. Dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission, caregiver strain and poor psychological well-being at admission, a diagnosis of delirium, and the relationship between the caregiver and the patient. There was less dissatisfaction from caregivers of patients managed on the specialist Medical and Mental Health Unit than those on standard wards, after controlling for multiple factors. CONCLUSION: Dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care.