ORCID Profile
0000-0003-3121-6050
Current Organisations
京都大学 / Kyoto University
,
University of Oxford
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Publisher: CMA Joule Inc.
Date: 11-04-2006
DOI: 10.1503/CMAJ.060171
Publisher: Elsevier BV
Date: 09-2023
Publisher: Elsevier BV
Date: 02-2023
DOI: 10.1016/J.KINT.2022.09.026
Abstract: In this multi-center longitudinal cohort study conducted in Australia and New Zealand, we assessed the trajectories of health-related quality of life (HRQoL) in children with chronic kidney disease (CKD) over time. A total of 377 children (aged 6-18 years) with CKD stages 1-5 (pre-dialysis), dialysis, or transplant, were followed biennially for four years. Multi Attribute Utility (MAU) scores of HRQoL were measured at baseline and at two and four years using the McMaster Health Utilities Index Mark 3 tool, a generic multi-attribute, preference-based system. A multivariable linear mixed model was used to assess the trajectories of HRQoL over time in 199 children with CKD stage 1-5, 43 children receiving dialysis and 135 kidney transplant recipients. An interaction between CKD stage at baseline and follow-up time indicated that the slopes of the HRQoL scores differed between children by CKD stage at inception. Over half of the cohort on dialysis at baseline had received a kidney transplant by the end of year four and the MAU scores of these children increased by a meaningful amount averaging 0.05 (95% confidence interval 0.01 to 0.09) per year in comparison to those who were transplant recipients at baseline. The mean difference between baseline and year two MAU scores was 0.09 (95% confidence interval -0.05, 0.23), (Cohen's d effect size 0.31). Thus, improvement in HRQoL over time of children on dialysis at baseline was likely to have been driven by their transition from dialysis to transplantation. Additionally, children with CKD stage 1-5 and transplant recipients at baseline had no changes in their disease stage or treatment modality and experienced stable HRQoL over time.
Publisher: BMJ
Date: 11-2004
Publisher: BMJ
Date: 12-2018
DOI: 10.1136/BMJOPEN-2018-025428
Abstract: To undertake an assessment of preferences as to how, where and by whom ultrasounds (US) should be performed in: (1) patients undergoing surveillance of abdominal aortic aneurysm (AAA) size (AAA group) and (2) patients being scanned for general abdominal conditions (general group). A discrete choice experiment (DCE) questionnaire was administered to patients attending US appointments. Analysis of questionnaire responses used conditional logit models and included validity checks. West Midlands, England. 524 patients (223 in the AAA group and 301 in the general group) were recruited from the US outpatient department at University Hospital Coventry and Warwickshire. Coefficients for attributes in relation to their reference levels. The AAA group preferred to have their US performed in hospital while the general group had a preference for portable US at general practice surgeries. All patients had a strong preference for scanning by specialists, devices with a lower risk of underdiagnosis and receiving their results at the appointment where the scan takes place. The general group had a strong preference for the person performing the scan to know their medical history. Patients being scanned for general abdominal conditions prefer to be scanned in a general practice by practitioners who know their medical history. Patients undergoing surveillance of AAA size prefer to be scanned in a hospital setting. Both groups would prefer to be informed of the scan results as soon as possible. Further research is required to explore the clinical scenarios in which targeted scanning by community practitioners would be of benefit to patients.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: Elsevier BV
Date: 02-2006
DOI: 10.1016/J.EARLHUMDEV.2006.01.002
Abstract: Previous assessments of the economic impact of preterm birth focussed on short term health service costs across the broad spectrum of prematurity. To estimate the societal costs of extreme preterm birth during the sixth year after birth. Unit costs were applied to estimates of health, social and broader resource use made by 241 children born at 20 through 25 completed weeks of gestation in the United Kingdom and Republic of Ireland and a comparison group of 160 children born at full term. Societal costs per child during the sixth year after birth were estimated and subjected to a rigorous sensitivity analysis. The effects of gestational age at birth on annual societal costs were analysed, first in a simple linear regression and then in a multiple linear regression. Mean societal costs over the 12 month period were 9541 pounds sterling (standard deviation 11,678 pounds sterling) for the extreme preterm group and 3883 pounds sterling (1098 pounds sterling) for the term group, generating a mean cost difference of 5658 pounds sterling (bootstrap 95% confidence interval: 4203 pounds sterling, 7256 pounds sterling) that was statistically significant (P<0.001). After adjustment for clinical and sociodemographic covariates, sex-specific extreme preterm birth was a strong predictor of high societal costs. The results of this study should facilitate the effective planning of services and may be used to inform the development of future economic evaluations of interventions aimed at preventing extreme preterm birth or alleviating its effects.
Publisher: Wiley
Date: 12-2003
DOI: 10.1046/J.1523-536X.2003.0251A.X
Abstract: Studies that measure benefits of health care interventions in natural or physical units cannot incorporate the several health changes that might occur within a single measure, and they overlook in iduals' preferences for those health changes. This paper discusses and critically appraises the application of preference-based approaches to the measurement of the benefits of perinatal care that have developed out of economic theory. These include quality adjusted life year (QALY)-based approaches, monetary-based approaches, and discrete choice experiments. QALY-based approaches use scaling techniques, such as the rating scale, standard gamble approach, and time trade-off approach, or multi-attribute utility measures, to measure the health-related quality of life weights of health states. Monetary-based approaches include the revealed preference approach, which involves observing decisions that in iduals actually make concerning health risks, and the willingness-to-pay approach, which provides a framework for investigating in iduals' willingness to pay for benefits of health care interventions. Discrete choice experiments describe health care interventions in terms of their attributes, and elicit preferences for scenarios that combine different levels of those attributes. Empirical ex les are used to illustrate each preference-based approach to benefit measurement, and several methodological issues raised by the application of these approaches to the perinatal context are discussed. Particular attention is given to identifying the relevant attributes to incorporate into the measurement instrument, appropriate respondents for the measurement exercise, potential sources of bias in description and valuation processes, and the practicality, reliability, and validity of alternative measurement approaches. The paper's conclusion is that researchers should be explicit and rigorous in their application of preference-based approaches to benefit measurement in the context of perinatal care.
Publisher: Springer Science and Business Media LLC
Date: 16-01-2020
DOI: 10.1038/S41366-020-0529-3
Abstract: Overweight and obesity in children is associated with poor health-related quality of life (HRQoL), but the nuances of this relationship across different age and socio-demographic groups are not well-established. The aim of this study is to examine how the association between weight status and HRQoL changes with age and socioeconomic position (SEP) throughout childhood and adolescence. We used data from the Longitudinal Study of Australian Children (LSAC), a cohort study in which children were interviewed biennially from ages 4 to 17 years over seven waves of data. Measurements of HRQoL (using PedsQL Age was a significant modifier of the association between weight status and HRQoL, with adjustment for known predictors of HRQoL (P 0.05). Our results demonstrate that the relationship between overweight and obesity status and poor HRQoL is strengthened with increasing age through childhood and adolescence, but is not affected by SEP. Paediatricians, researchers and carers of children with obesity should acknowledge HRQoL outcomes, particularly for older children and adolescents.
Publisher: Springer Science and Business Media LLC
Date: 03-10-2023
Publisher: Wiley
Date: 02-2001
DOI: 10.1111/J.1471-0528.2001.00044.X
Abstract: To carry out a systematic review of the literature relating to economic aspects of alternative modes of delivery. A comprehensive literature search of the years 1990-1999 was conducted of electronic and non-electronic sources using a tested search strategy. Papers considered to contain useful cost or resource use data were read in full and classified according to their relevance to the review and their methodological quality. Relevant cost and resource use data were converted to pound sterling and inflated to 1998-1999 price levels. The literature search resulted in 975 papers, 49 of which met criteria for the review. Thirty-two papers were from the USA where the organisation, structure and costs of health care are significantly different from that of other industrialised countries. The aggregate costs of different modes of delivery reported in these American studies were between four and five times higher than costs reported in other studies. The majority of included studies were of poor quality. Data from the better quality studies demonstrated that caesarean section costs a health service substantially more than other modes of delivery. The range of costs of an uncomplicated vaginal delivery were 629 pound sterling - 1,298 pound sterling compared with1,238 pound sterling - 3,551 pound sterling for a caesarean section. However, papers have so far only considered short term health service costs. Research is required to estimate the cost and resource use attributable to alternative modes of delivery. Future research should investigate the long term health service costs and the costs that arise outside the health service which are likely to vary according to mode of delivery.
Publisher: Springer Science and Business Media LLC
Date: 23-11-2011
Publisher: Elsevier BV
Date: 2019
DOI: 10.1016/J.DRUGALCDEP.2018.08.044
Abstract: There is growing interest in the provision of parenting support to substance misusing parents. This pragmatic, multi-center randomized controlled trial compared an intensive one-to-one parenting program (Parents under Pressure, PuP) with Treatment as Usual (TAU) in the UK. Parents were engaged in community-based substance misuse services and were primary caregivers of children less than 2.5 years of age. The primary outcome was child abuse potential, and secondary outcomes included measures of parental emotional regulation assessed at baseline, 6 and 12-months. A prospective economic evaluation was also conducted. Of 127 eligible parents, 115 met the inclusion criteria, and subsequently parents were randomly assigned to receive PuP (n = 48) or TAU (n = 52). Child abuse potential was significantly improved in those receiving the PuP program while those in TAU showed a deterioration across time in both intent-to-treat (p < 0.03) and per-protocol analyses (p < 0.01). There was also significant reliable change (recovery/improvement) in 30.6% of the PuP group compared with 10.3% of the TAU group (p < 0.02), and deterioration in 3% compared with 18% (p < 0.02). The probability that the program is cost-effective was approximately 51.8% if decision-makers are willing to pay £1000 for a unit improvement in the primary outcome, increasing to 98.0% at a £20,000 cost-effectiveness threshold for this measure. Up to one-third of substance dependent parents of children under 3-years of age can be supported to improve their parenting, using a modular, one-to-one parenting program. Further research is needed.
Publisher: BMJ
Date: 04-2020
DOI: 10.1136/BMJOPEN-2019-033520
Abstract: Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches. Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019. ISRCTN79708100 .
Publisher: Elsevier BV
Date: 02-2013
Publisher: Springer Science and Business Media LLC
Date: 24-01-2022
Publisher: SAGE Publications
Date: 06-2000
DOI: 10.1136/JMS.7.2.59
Abstract: A systematic review of recent economic evaluations of antenatal screening was conducted. Relevant studies were identified from a number of sources including computerised databases, bibliographies of economic evaluations, and searches of unpublished manuscripts. Each study identified by the literature searches was categorised on the basis of its title and abstract. Studies considered relevant to the systematic review were obtained from libraries. The methodology, results, and policy implications of studies categorised as economic evaluations upon full review were documented.A total of 566 studies were identified by the literature searches, 41 of which were categorised as economic evaluations upon full review. The economic evaluations covered a range of antenatal screening practices, aimed mainly at the prevention of infectious diseases and fetal anomalies. The review highlighted the poor methodological quality of the bulk of economic evaluations of antenatal screening. The study design, data collection methods, and analysis and interpretation of results frequently violated methodological guidelines adopted by health economists. The review also highlighted the narrow definition of benefits adopted by this body of literature, with most studies reporting outcomes in terms of cases detected, cases of particular disorders prevented or, most often, costs averted.The conclusions arrived at differed by area of antenatal screening. There appeared to be clear economic arguments in favour of some forms of antenatal screening, for ex le, triple test screening for Down's syndrome. Other economic evaluations pertained to specific locations, which suggests that the results may not necessarily be generalisable to different settings. For all areas of antenatal screening, an updating of published economic evaluations may be required to account for evolving economic, epidemiological, and clinical effectiveness evidence.
Publisher: American Academy of Pediatrics (AAP)
Date: 02-2009
Abstract: BACKGROUND. Infants born preterm are at increased risk of adverse health and developmental outcomes. Mortality and morbidity after preterm birth impose a burden on finite public sector resources. This study considers the economic consequences of preterm birth from birth to adult life and compares the costs accruing to those born preterm with those born at term. METHODS. A decision-analytic model was constructed to estimate the costs to the public sector over the first 18 years after birth, stratified by week of gestational age at birth. Costs were discounted and reported in UK pounds at 2006 prices. Probabilistic sensitivity analysis was used to examine uncertainty in the model parameters and generate confidence intervals surrounding the cost estimates. RESULTS. The model estimates the costs associated with a hypothetical cohort of 669601 children and is based on live birth and preterm birth data from England and Wales in 2006. The total cost of preterm birth to the public sector was estimated to be £2.946 billion (US $4.567 billion), and an inverse relationship was identified between gestational age at birth and the average public sector cost per surviving child. The incremental cost per preterm child surviving to 18 years compared with a term survivor was estimated at £22885 (US $35471). The corresponding estimates for a very and extremely preterm child were substantially higher at £61781 (US $95760) and £94740 (US $146847), respectively. CONCLUSIONS. Despite concerns about ongoing costs after discharge from perinatal services, the largest contribution to the economic implications of preterm birth are hospital inpatient costs after birth, which are responsible for 92.0% of the incremental costs per preterm survivor.
Publisher: Springer Science and Business Media LLC
Date: 03-05-2023
Publisher: Elsevier BV
Date: 09-2010
DOI: 10.1111/J.1524-4733.2010.00731.X
Abstract: To estimate the cost-effectiveness (CE) of total body hypothermia plus intensive care versus intensive care alone to treat neonatal encephalopathy. Decision analytic modeling was used to synthesize mortality and morbidity data from three randomized controlled trials, the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), National Institute of Child Health and Human Development (NICHD), and CoolCap trials. Cost data inputs were informed by TOBY, the sole source of prospectively collected resource utilization data for encephalopathic infants. CE was expressed in terms of incremental cost per disability-free life year (DFLY) gained. Probabilistic sensitivity analysis was performed to generate CE acceptability curves (CEACs). Cooling led to a cost increase of £3787 (95% confidence interval [CI]: -2516, 12,360) (€5115 95% CI: -3398-16,694 US$5344 95% CI: -3598, 26,356 using 2006 Organisation for Economic Co-operation and Development (OECD) purchasing power parities) and a DFLY gain of 0.19 (95%CI: 0.07-0.31) over the first 18 months after birth. The incremental cost per DFLY gained was £19,931 (€26,920 US$28,124). The baseline CEAC showed that if decision-makers are willing to pay £30,000 for an additional DFLY, there is a 69% probability that cooling is cost-effective. The probability of CE exceeded 99% at this threshold when the throughput of infants was increased to reflect the national incidence of neonatal encephalopathy or when the time horizon of the economic evaluation was extended to 18 years after birth. The probability that cooling is a cost-effective treatment for neonatal encephalopathy is finely balanced over the first 18 months after birth but increases substantially when national incidence data or an extended time horizon are considered.
Publisher: BMJ
Date: 09-1212
DOI: 10.1136/BMJOPEN-2020-037516
Abstract: The ‘Oxford Pain, Activity and Lifestyle’ (OPAL) Cohort is a longitudinal, prospective cohort study of adults, aged 65 years and older, living in the community which is investigating the determinants of health in later life. Our focus was on musculoskeletal pain and mobility, but the cohort is designed with flexibility to include new elements over time. This paper describes the study design, data collection and baseline characteristics of participants. We also compared the OPAL baseline characteristics with nationally representative data sources. We randomly selected eligible participants from two stratified age bands (65–74 and 75 and over years). In total, 5409 in iduals (42.1% of eligible participants) from 35 general practices in England agreed to participate between 2016 and 2018. The majority of participants (n=5367) also consented for research team to access their UK National Health Service (NHS) Digital and primary healthcare records. Mean participant age was 74.9 years (range 65–100) 51.5% (n=2784/5409) were women. 94.9% of participants were white, and 28.8% lived alone. Over 83.0% reported pain in at least one body area in the previous 6 weeks. Musculoskeletal symptoms were more prevalent in women (86.4%). One-third of participants reported having one or more falls in the last year. Most participants were confident in their ability to walk outside. The characteristics of OPAL Cohort participants were broadly similar to the general population of the same age. Postal follow-up of the cohort is being undertaken at annual intervals, with data collection ongoing. Linkage to NHS hospital admission data is planned. This English prospective cohort offers a large and rich resource for research on the longitudinal associations between demographic, clinical, and social factors and health trajectories and outcomes in community-dwelling older people.
Publisher: National Institute for Health and Care Research
Date: 02-2022
DOI: 10.3310/FXII0508
Abstract: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery or with physiotherapist-led conservative care. To compare the clinical effectiveness and cost-effectiveness of hip arthroscopy with best conservative care. The UK FASHIoN (full trial of arthroscopic surgery for hip impingement compared with non-operative care) trial was a pragmatic, multicentre, randomised controlled trial that was carried out at 23 NHS hospitals. Participants were included if they had femoroacetabular impingement, were aged ≥ 16 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy. Participants were randomly allocated (1 : 1) to receive hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an in idualised physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre using a central telephone randomisation service. Outcome assessment and analysis were masked. The primary outcome was hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed by intention to treat. Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited. In total, 171 participants were allocated to receive hip arthroscopy and 177 participants were allocated to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% ( N = 319 hip arthroscopy, n = 157 personalised hip therapy, n = 162). At 12 months, mean International Hip Outcome Tool (iHOT-33) score had improved from 39.2 (standard deviation 20.9) points to 58.8 (standard deviation 27.2) points for participants in the hip arthroscopy group, and from 35.6 (standard deviation 18.2) points to 49.7 (standard deviation 25.5) points for participants in personalised hip therapy group. In the primary analysis, the mean difference in International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre, was 6.8 (95% confidence interval 1.7 to 12.0) points in favour of hip arthroscopy ( p = 0.0093). This estimate of treatment effect exceeded the minimum clinically important difference (6.1 points). Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment and one serious adverse event in the personalised hip therapy group was not. Thirty-eight (24%) personalised hip therapy patients chose to have hip arthroscopy between 1 and 3 years after randomisation. Nineteen (12%) hip arthroscopy patients had a revision arthroscopy. Eleven (7%) personalised hip therapy patients and three (2%) hip arthroscopy patients had a hip replacement within 3 years. Study participants and treating clinicians were not blinded to the intervention arm. Delays were encountered in participants accessing treatment, particularly surgery. Follow-up lasted for 3 years. Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months. This study does not demonstrate cost-effectiveness of hip arthroscopy compared with personalised hip therapy within the first 12 months. Further follow-up will reveal whether or not the clinical benefits of hip arthroscopy are maintained and whether or not it is cost-effective in the long term. Current Controlled Trials ISRCTN64081839. 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. 26, No. 16. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 10-2018
DOI: 10.1136/BMJOPEN-2018-022205
Abstract: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target s le size is a minimum of 402. The BOOST programme consists of an in idual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three in idual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study. Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. ISRCTN12698674 Pre-results.
Publisher: Elsevier BV
Date: 11-2016
Publisher: Springer Science and Business Media LLC
Date: 18-06-2018
Publisher: BMJ
Date: 09-02-2023
DOI: 10.1136/ARCHDISCHILD-2022-324763
Abstract: To examine the association between gestational age at birth and hospital admission costs from birth to 8 years of age. Population-based, record linkage, cohort study in England. National Health Service (NHS) hospitals in England, UK. 1 018 136 live, singleton births in NHS hospitals in England between 1 January 2005 and 31 December 2006. Hospital admission costs from birth to age 8 years, estimated by gestational age at birth ( , 28–29, 30–31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 and 42 weeks). Both birth admission and subsequent admission hospital costs decreased with increasing gestational age at birth. Differences in hospital admission costs between gestational age groups diminished with increasing age, particularly after the first 2 years following birth. Children born extremely preterm ( weeks) and very preterm (28–31 weeks) still had higher average hospital admission costs (£699 (95% CI £419 to £919) for weeks £434 (95% CI £305 to £563) for 28–31 weeks) during the eighth year of life compared with children born at 40 weeks (£109, 95% CI £104 to £114). Children born extremely preterm had the highest 8-year cumulative hospital admission costs per child (£80 559 (95% CI £79 238 to £82 019)), a large proportion of which was incurred during the first year after birth (£71 997 (95% CI £70 866 to £73 097)). The association between gestational age at birth and hospital admission costs persists into mid-childhood. The study results provide a useful costing resource for future economic evaluations focusing on preventive and treatment strategies for babies born preterm.
Publisher: Springer Science and Business Media LLC
Date: 12-2015
Publisher: Oxford University Press (OUP)
Date: 12-2002
DOI: 10.1093/HUMREP/17.12.3090
Abstract: Approximately one in six couples experiences problems with their fertility at some point in their reproductive lives. The economic implications of the use of assisted reproductive techniques require consideration. Herein, the health economics research in this area are critically appraised. Multiple strategies were used to identify relevant studies. Each title and abstract was independently reviewed by two members of the study team and categorized according to perceived relevance. The selected papers were then assessed for quality and data were extracted, converted to UK pounds sterling at 1999/2000 prices, tabulated and critically appraised. A total of 2547 papers was identified through the searches this resulted in 30 economic evaluations, 22 cost studies and five economic benefit studies that met the selection criteria. The quality of these studies was mixed many failed to disaggregate costs, discount future costs or conduct sensitivity analyses. Consistent findings included the following: initiating treatment with intrauterine insemination appeared to be more cost-effective than IVF vasectomy reversal appeared to be more cost-effective than ICSI factors associated with poor prognosis decreased the cost-effectiveness of interventions. The cost-effectiveness of different interventions should be considered when making decisions about treatment. Future economic appraisals of assisted reproductive techniques would benefit from more robust methodology than is evident in much of the published literature to date.
Publisher: Elsevier BV
Date: 05-2021
Publisher: Elsevier BV
Date: 12-2022
DOI: 10.1016/J.JOCA.2022.08.016
Abstract: To investigate trends in the incidence rate and the main indication for revision knee replacement (rKR) over the past 15 years in the UK. Repeated national cross-sectional study from 2006 to 2020 using data from the National Joint Registry (NJR). Crude incidence rates were calculated using population statistics from the Office for National Statistics. Annual total counts of rKR increased from 2,743 procedures in 2006 to 6,819 procedures in 2019 (149% increase). The incidence rate of rKR increased from 6.3 per 100,000 adults in 2006 (95% CI 6.1 to 6.5) to 14 per 100,000 adults in 2019 (95% CI 14 to 14) (122% increase). Annual increases in the incidence rate of rKR became smaller over the study period. There was a 43.6% reduction in total rKR procedures in 2020 (during the Covid-19 pandemic) compared to 2019. Aseptic loosening was the most frequent indication for rKR overall (20.7% procedures). rKR for aseptic loosening peaked in 2012 and subsequently decreased. rKR for infection increased incrementally over the study period to become the most frequent indication in 2019 (2.7 per 100,000 adults [95% CI 2.6 to 2.9]). Infection accounted for 17.1% first linked rKR, 36.5% second linked rKR and 49.4% third or more linked rKR from 2014 to 2019. Recent trends suggest slowing of the rate of increase in the incidence of rKR. Infection is now the most common indication for rKR, following recent decreases in rKR for aseptic loosening. Infection was prevalent in re-revision KR procedures.
Publisher: Wiley
Date: 15-07-2021
DOI: 10.1111/AJO.13405
Abstract: Preterm birth is the greatest cause of death up to five years of age and an important contributor to lifelong disability. There is increasing evidence that a meaningful proportion of early births may be prevented, but widespread introduction of effective preventive strategies will require financial support. This study estimated the economic cost to the Australian government of preterm birth, up to 18 years of age. A decision‐analytic model was developed to estimate the costs of preterm birth in Australia for a hypothetical cohort of 314 814 children, the number of live births in 2016. Costs to Australia’s eight jurisdictions included medical expenditures and additional costs to educational services. The total cost of preterm birth to the Australian government associated with the annual cohort was estimated at $1.413 billion (95% CI 1047‒1781). Two‐thirds of the costs were borne by healthcare services during the newborn period and one‐quarter of the costs by educational services providing special assistance. For each child, the costs were highest for those born at the earliest survivable gestational age, but the larger numbers of children born at later gestational ages contributed heavily to the overall economic burden. Preterm birth leaves many people with lifelong disabilities and generates a significant economic burden to society. The costs extend beyond those to the healthcare system and include additional educational needs. Assessments of economic costs should inform economic evaluations of interventions aimed at the prevention or treatment of preterm birth.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2016
Publisher: Springer Science and Business Media LLC
Date: 22-02-2021
Publisher: BMJ
Date: 08-2016
Publisher: Elsevier BV
Date: 12-2022
DOI: 10.1016/J.JCLINEPI.2022.09.002
Abstract: The aim of this study is to develop and validate two models to predict 2-year risk of self-reported mobility decline among community-dwelling older adults. We used data from a prospective cohort study of people aged 65 years and over in England. Mobility status was assessed using the EQ-5D-5L mobility question. The models were based on the outcome: Model 1, any mobility decline at 2 years Model 2, new onset of persistent mobility problems over 2 years. Least absolute shrinkage and selection operator logistic regression was used to select predictors. Model performance was assessed using C-statistics, calibration plot, Brier scores, and decision curve analyses. Models were internally validated using bootstrapping. Over 18% of participants who could walk reported mobility decline at year 2 (Model 1), and 7.1% with no mobility problems at baseline, reported new onset of mobility problems after 2 years (Model 2). Thirteen and 6 out of 31 variables were selected as predictors in Models 1 and 2, respectively. Models 1 and 2 had a C-statistic of 0.740 and 0.765 (optimism < 0.013), and Brier score = 0.136 and 0.069, respectively. Two prediction models for mobility decline were developed and internally validated. They are based on self-reported variables and could serve as simple assessments in primary care after external validation.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: National Institute for Health and Care Research
Date: 2017
DOI: 10.3310/HTA21010
Abstract: Effective programmes to help children manage their weight are required. ‘Families for Health’ focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. Three sites in the West Midlands, England, UK. Children aged 6–11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. Joint primary outcome measures were change in children’s BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months’ follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. The study recruited 115 families (128 children 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the ‘usual-care’ control arm. There was 80% retention of families at 3 months (Families for Health, 46 families usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) –0.001 to 0.229 p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (–0.118, 95% CI –0.203 to –0.034 p = 0.007), but not in the Families for Health arm (–0.005, 95% CI –0.085 to 0.078 p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548 p 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators’, parents’ and children’s experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6–11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. Current Controlled Trials ISRCTN45032201. 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. 1. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 04-2016
DOI: 10.3310/HTA20320
Abstract: Femoroacetabular impingement (FAI) is a syndrome of hip or groin pain associated with shape abnormalities of the hip joint. Treatments include arthroscopic surgery and conservative care. This study explored the feasibility of a randomised controlled trial to compare these treatments. The objectives of this study were to estimate the number of patients available for a full randomised controlled trial (RCT) to explore clinician and patient willingness to participate in such a RCT to develop consensus on eligibility criteria, surgical and best conservative care protocols to examine possible outcome measures and estimate the s le size for a full RCT and to develop trial procedures and estimate recruitment and follow-up rates. Pre-pilot work: we surveyed all UK NHS hospital trusts ( n = 197) to identify all FAI surgeons and to estimate how much arthroscopic FAI surgery they performed. We interviewed a purposive s le of 18 patients, 36 physiotherapists, 18 surgeons and two sports physicians to explore attitudes towards a RCT and used consensus-building methods among them to develop treatment protocols and patient information. Pilot RCT: we performed a pilot RCT in 10 hospital trusts. Patients were randomised to receive either hip arthroscopy or best conservative care and then followed up at 3, 6 and 12 months using patient-reported questionnaires for hip pain and function, activity level, quality of life, and a resource-use questionnaire. Qualitative recruitment intervention: we performed semistructured interviews with all researchers and clinicians involved in the pilot RCT in eight hospital trusts and recorded and analysed diagnostic and recruitment consultations with eligible patients. We identified 120 surgeons who reported treating at least 1908 patients with FAI by hip arthroscopy in the NHS in the financial year 2011/12. There were 34 hospital trusts that performed ≥ 20 arthroscopic FAI operations in the year. We found that clinicians were positive about a RCT: only half reported equipoise, but most said that they would be prepared to randomise patients. Patients strongly supported a RCT, but expressed concerns about its design these were used to develop patient information for the pilot RCT. We developed a surgical protocol and showed that this could be used in a RCT. We developed a physiotherapy-led exercise-based package of best conservative care called ‘personalised hip therapy’ and showed that this was practicable. In the pilot RCT, we recruited 42 out of 60 eligible patients (70%) across nine sites. The mean duration and recruitment rate across all sites were 4.5 months and one patient per site per month, respectively. The lead site recruited for the longest period (9.3 months) and accrued the largest number of patients (2.1 patients per month). We recorded and analysed 84 diagnostic and recruitment consultations in 60 patients and used these to develop a model for an optimal recruitment consultation. We identified the International Hip Outcome Tool at 12 months as an appropriate outcome measure and estimated the s le size for a full trial as 344 participants: a number that could be recruited in 25 centres over 18 months. We have demonstrated that it is feasible to perform a RCT to establish the clinical effectiveness of hip arthroscopy compared with best conservative care for FAI. We have designed a full trial and developed and tested procedures for it, including an innovative approach to recruitment. We propose that a full trial be implemented. The National Institute for Health Research Health Technology Assessment programme.
Publisher: Springer Science and Business Media LLC
Date: 14-02-2022
Publisher: National Institute for Health and Care Research
Date: 02-2022
DOI: 10.3310/JKNZ2003
Abstract: Upper limb problems are common after breast cancer treatment. To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis the unit of randomisation was the in idual (allocated ratio 1 : 1). Breast cancer centres, secondary care. Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants’ mean age was 58.1 years (standard deviation 12.1 years range 28–88 years). Most participants had undergone axillary node clearance surgery (327/392 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of –7.81, 95% confidence interval –12.44 to –3.17 p = 0.001) and complier-average causal effect analyses (adjusted mean difference –8.74, 95% confidence interval –13.71 to –3.77 p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04 p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (–£387, 95% CI –£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. Postal follow-up was lower than estimated however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. This trial is registered as ISRCTN35358984. 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. 26, No. 15. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 04-2021
DOI: 10.3310/HTA25250
Abstract: Adrenaline has been used as a treatment for cardiac arrest for many years, despite uncertainty about its effects on long-term outcomes and concerns that it may cause worse neurological outcomes. The objectives were to evaluate the effects of adrenaline on survival and neurological outcomes, and to assess the cost-effectiveness of adrenaline use. This was a pragmatic, randomised, allocation-concealed, placebo-controlled, parallel-group superiority trial and economic evaluation. Costs are expressed in Great British pounds and reported in 2016/17 prices. This trial was set in five NHS ambulance services in England and Wales. Adults treated for an out-of-hospital cardiac arrest were included. Patients were ineligible if they were pregnant, if they were aged 16 years, if the cardiac arrest had been caused by anaphylaxis or life-threatening asthma, or if adrenaline had already been given. Participants were randomised to either adrenaline (1 mg) or placebo in a 1 : 1 allocation ratio by the opening of allocation-concealed treatment packs. The primary outcome was survival to 30 days. The secondary outcomes were survival to hospital admission, survival to hospital discharge, survival at 3, 6 and 12 months, neurological outcomes and health-related quality of life through to 6 months. The economic evaluation assessed the incremental cost per quality-adjusted life-year gained from the perspective of the NHS and Personal Social Services. Participants, clinical teams and those assessing patient outcomes were masked to the treatment allocation. From December 2014 to October 2017, 8014 participants were assigned to the adrenaline ( n = 4015) or to the placebo ( n = 3999) arm. At 30 days, 130 out of 4012 participants (3.2%) in the adrenaline arm and 94 out of 3995 (2.4%) in the placebo arm were alive (adjusted odds ratio for survival 1.47, 95% confidence interval 1.09 to 1.97). For secondary outcomes, survival to hospital admission was higher for those receiving adrenaline than for those receiving placebo (23.6% vs. 8.0% adjusted odds ratio 3.83, 95% confidence interval 3.30 to 4.43). The rate of favourable neurological outcome at hospital discharge was not significantly different between the arms (2.2% vs. 1.9% adjusted odds ratio 1.19, 95% confidence interval 0.85 to 1.68). The pattern of improved survival but no significant improvement in neurological outcomes continued through to 6 months. By 12 months, survival in the adrenaline arm was 2.7%, compared with 2.0% in the placebo arm (adjusted odds ratio 1.38, 95% confidence interval 1.00 to 1.92). An adjusted subgroup analysis did not identify significant interactions. The incremental cost-effectiveness ratio for adrenaline was estimated at £1,693,003 per quality-adjusted life-year gained over the first 6 months after the cardiac arrest event and £81,070 per quality-adjusted life-year gained over the lifetime of survivors. Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest. The estimate for survival with a favourable neurological outcome is imprecise because of the small numbers of patients surviving with a good outcome. Adrenaline improved long-term survival, but there was no evidence that it significantly improved neurological outcomes. The incremental cost-effectiveness ratio per quality-adjusted life-year exceeds the threshold of £20,000–30,000 per quality-adjusted life-year usually supported by the NHS. Further research is required to better understand patients’ preferences in relation to survival and neurological outcomes after out-of-hospital cardiac arrest and to aid interpretation of the trial findings from a patient and public perspective. Current Controlled Trials ISRCTN73485024 and EudraCT 2014-000792-11. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 25. See the NIHR Journals Library website for further project information.
Publisher: American Academy of Pediatrics (AAP)
Date: 04-2006
Abstract: OBJECTIVE. The objective of this study was to estimate the economic costs of bilateral permanent childhood hearing impairment (PCHI) in the preceding year of life for children aged 7 to 9 years. METHODS. A cost analysis was conducted by using a birth cohort of children born between 1992 and 1997 in 8 districts of Southern England, of which half had been born into populations exposed to universal newborn screening (UNS). Unit costs were applied to estimates of health, social, and broader resource use made by 120 hearing-impaired children and 63 children in a normally hearing comparison group. Associations between societal costs per child and severity of hearing impairment, language ability score, exposure to UNS, and age of confirmation were analyzed, including adjustment for potential confounders in a linear regression model. RESULTS. The mean societal cost in the preceding year of life at 7 to 9 years of age was £14092.5 for children with PCHI, compared with £4206.8 for the normally hearing children, a cost difference of £9885.7. After adjusting for severity and other potential confounders in a linear regression model, mean societal costs among children with PCHI were reduced by £2553 for each unit increase in the z score for receptive language. Using similar regression models, exposure to a program of UNS was associated with a smaller cost reduction of £2213.2, whereas costs were similar between children whose PCHI was confirmed at & or & months. CONCLUSIONS. The study provides rigorous evidence of the annual health, social, and broader societal cost of bilateral PCHI in the preceding year of life at 7 to 9 years of age and shows that it is related to its severity and has an inverse relationship with language abilities after adjustment for severity.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 28-03-2023
DOI: 10.1212/WNL.0000000000201518
Abstract: Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches. This was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension–type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management program, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material. The primary outcome was headache related-quality of life using the Headache Impact Test (HIT)-6 at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data. Between April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyzed for primary outcome. There was no between-group difference in HIT-6 (adjusted mean difference = −0.3, 95% CI −1.23 to 0.67) or headache days (0.9, 95% CI −0.29 to 2.05) at 12 months. The Chronic Headache Education and Self-management Study intervention generated incremental adjusted costs of £268 (95% CI, £176–£377) (USD383 [95% CI USD252–USD539]) and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI −0.005 to 0.063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained. These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension–type headache with episodic migraine. Registered on the International Standard Randomized Controlled Trial Number registry, ISRCTN79708100 16th December 2015 0.1186/ISRCTN79708100. The first enrollment was April 24, 2017. This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine.
Publisher: Springer Science and Business Media LLC
Date: 15-08-2022
DOI: 10.1186/S13063-022-06563-8
Abstract: Adolescent depression can place a young person at high risk of recurrence and a range of psychosocial and vocational impairments in adult life, highlighting the importance of early recognition and prevention. Parents/carers are well placed to notice changes in their child’s emotional wellbeing which may indicate risk, and there is increasing evidence that modifiable factors exist within the family system that may help reduce the risk of depression and anxiety in an adolescent. A randomised controlled trial (RCT) of the online personalised ‘Partners in Parenting’ programme developed in Australia, focused on improving parenting skills, knowledge and awareness, showed that it helped reduce depressive symptoms in adolescents who had elevated symptom levels at baseline. We have adapted this programme and will conduct an RCT in a UK setting. In total, 433 family dyads (parents/carers and children aged 11–15) will be recruited through schools, social media and parenting/family groups in the UK. Following completion of screening measures of their adolescent’s depressive symptoms, parents/carers of those with elevated scores will be randomised to receive either the online personalised parenting programme or a series of online factsheets about adolescent development and wellbeing. The primary objective will be to test whether the personalised parenting intervention reduces depressive symptoms in adolescents deemed at high risk, using the parent-reported Short Mood & Feelings Questionnaire. Follow-up assessments will be undertaken at 6 and 15 months and a process evaluation will examine context, implementation and impact of the intervention. An economic evaluation will also be incorporated with cost-effectiveness of the parenting intervention expressed in terms of incremental cost per quality-adjusted life year gained. Half of mental health problems emerge before mid-adolescence and approximately three-quarters by mid-20s, highlighting the need for effective preventative strategies. However, few early interventions are family focused and delivered online. We aim to conduct a National Institute for Health and Care Research (NIHR) funded RCT of the online personalised ‘Partners in Parenting’ programme, proven effective in Australia, targeting adolescents at risk of depression to evaluate its effectiveness, cost-effectiveness and usability in a UK setting. ISRCTN63358736. Registered 18 September 2019.
Publisher: Wiley
Date: 27-05-2008
Publisher: Springer Science and Business Media LLC
Date: 09-12-2020
DOI: 10.1007/S40273-019-00866-6
Abstract: Our objective was to identify age- and sex-specific utilities for children and adolescents by body mass index (BMI) z-score. We used data from 6822 participants and 12,094 observations from two cohorts and two waves of interviews from the Longitudinal Study of Australian Children. We fit linear models using generalised estimating equations to investigate associations between Child Health Utility 9D and BMI z-score in girls and boys aged 10-17 years. We initially fit models for each sex, fully adjusted for known predictors of health-related quality of life, including socioeconomic position, long-term medical condition and maternal smoking status and also included an interaction between age and BMI z-score to examine age-specific effects. Finally, we derived a minimal model for each sex by eliminating interaction terms with P > 0.01 and predictors with P > 0.05. Our adjusted results show different utility patterns in girls and boys. In girls, utility decrements for each unit increase in BMI z-score changed with age (P < 0.01 for interaction between age and BMI z-score). At age 10 years, the mean utility decrement for each unit increase in BMI z-score was 0.002 (95% confidence interval [CI] 0.011 decrement to 0.006 increment), but, by age 17 years, this utility decrement was 0.023 (95% CI 0.013 to 0.032). In boys, small non-significant decrements were found in utility for each unit increase in BMI z-score, with no observable change with age. Our analyses demonstrated that age and sex should be considered when attributing utility values and decrements to BMI z-scores.
Publisher: BMJ
Date: 10-11-2021
Abstract: To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. 17 UK National Health Service cancer centres. 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132) 23.7 (22.9) usual care (n=138) adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44 P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale −0.68, −1.23 to −0.12 P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) −2.02, −3.11 to −0.93 P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average −£387 (€457 $533) (95% confidence interval −£2491 to £1718 2015 pricing) and was cost effective compared with usual care. The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. ISRCTN Registry ISRCTN35358984 .
Publisher: Springer Science and Business Media LLC
Date: 27-09-2020
DOI: 10.1186/S13054-020-03271-0
Abstract: The ‘Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration In Cardiac Arrest’ (PARAMEDIC2) trial showed that adrenaline improves overall survival, but not neurological outcomes. We sought to determine the within-trial and lifetime health and social care costs and benefits associated with adrenaline, including secondary benefits from organ donation. We estimated the costs, benefits (quality-adjusted life years (QALYs)) and incremental cost-effectiveness ratios (ICERs) associated with adrenaline during the 6-month trial follow-up. Model-based analyses explored how results altered when the time horizon was extended beyond 6 months and the scope extended to include recipients of donated organs. The within-trial (6 months) and lifetime horizon economic evaluations focussed on the trial population produced ICERs of £1,693,003 (€1,946,953) and £81,070 (€93,231) per QALY gained in 2017 prices, respectively, reflecting significantly higher mean costs and only marginally higher mean QALYs in the adrenaline group. The probability that adrenaline is cost-effective was less than 1% across a range of cost-effectiveness thresholds. Combined direct economic effects over the lifetimes of survivors and indirect economic effects in organ recipients produced an ICER of £16,086 (€18,499) per QALY gained for adrenaline with the probability that adrenaline is cost-effective increasing to 90% at a £30,000 (€34,500) per QALY cost-effectiveness threshold. Adrenaline was not cost-effective when only directly related costs and consequences are considered. However, incorporating the indirect economic effects associated with transplanted organs substantially alters cost-effectiveness, suggesting decision-makers should consider the complexity of direct and indirect economic impacts of adrenaline. ISRCTN73485024 . Registered on 13 March 2014.
Publisher: Oxford University Press (OUP)
Date: 27-10-2016
DOI: 10.1093/JHPS/HNW026
Publisher: Springer Science and Business Media LLC
Date: 2014
Publisher: BMJ
Date: 19-04-2012
DOI: 10.1136/BMJ.E2292
Publisher: Research Square Platform LLC
Date: 06-09-2022
DOI: 10.21203/RS.3.RS-1996679/V1
Abstract: Background There is evidence that childhood overweight and obesity impact negatively on health-related quality of life (HRQoL), using measures including the Paediatric Quality of life Inventory Generic Core Scales (PedsQL) and the Child Health Utilities 9 Dimensions (CHU9D). However, no studies have comprehensively established the psychometric properties of these instruments in the context of paediatric overweight and obesity. The aim of this study was to assess the reliability, acceptability, validity and responsiveness of the PedsQL and the CHU9D in the measurement of HRQoL among children and adolescents with overweight and obesity. Subjects/Methods Subjects were 6544 child participants of the Longitudinal Study of Australian Children, with up to 3 repeated measures of PedsQL and CHU9D and aged between 10 and 17 years. Weight and height were measured objectively by trained operators, and weight status determined using World Health Organisation growth standards. We examined reliability, acceptability, known group and convergent validity and responsiveness, using recognised methods. Results Both PedsQL and CHU9D demonstrated good internal consistency reliability, and high acceptability. Neither instrument showed strong convergent validity, but PedsQL appears to be superior to the CHU9D in known groups validity and responsiveness. Compared with healthy weight, mean (95%CI) differences in PedsQL scores for children with obesity were: boys: -5.6 (-6.2, -4.4) girls − 6.7 (-8.1, -5.4) and differences in CHU9D utility were: boys − 0.02 (-0.034, -0.006) girls − 0.035 (-0.054, -0.015). Differences in scores for overweight compared with healthy weight were: PedsQL boys − 2.2 (-3.0, -1.4) and girls − 1.3 (-2.0, -0.6) and CHU9D boys: no significant difference girls − 0.014 (-0.026, -0.003). Conclusion PedsQL and CHU9D overall demonstrated good psychometric properties, supporting their use in measuring HRQoL in paediatric overweight and obesity. CHU9D had poorer responsiveness and did not discriminate between overweight and healthy weight in boys, which may limit its use in economic evaluation.
Publisher: Elsevier BV
Date: 02-2001
Publisher: Springer Science and Business Media LLC
Date: 18-04-2023
DOI: 10.1038/S41366-023-01305-5
Abstract: The Paediatric Quality of life Inventory (PedsQL TM ) Generic Core Scales and the Child Health Utilities 9 Dimensions (CHU9D) are two paediatric health-related quality of life (HRQoL) measures commonly used in overweight and obesity research. However, no studies have comprehensively established the psychometric properties of these instruments in the context of paediatric overweight and obesity. The aim of this study was to assess the reliability, acceptability, validity and responsiveness of the PedsQL and the CHU9D in the measurement of HRQoL among children and adolescents living with overweight and obesity. Subjects were 6544 child participants of the Longitudinal Study of Australian Children, with up to 3 repeated measures of PedsQL and CHU9D and aged between 10 and 17 years. Weight and height were measured objectively by trained operators, and weight status determined using World Health Organisation growth standards. We examined reliability, acceptability, known group and convergent validity and responsiveness, using recognised methods. Both PedsQL and CHU9D demonstrated good internal consistency reliability, and high acceptability. Neither instrument showed strong convergent validity, but PedsQL appears to be superior to the CHU9D in known groups validity and responsiveness. Compared with healthy weight, mean (95%CI) differences in PedsQL scores for children with obesity were: boys −5.6 (−6.2, −4.4) girls −6.7 (−8.1, −5.4) and differences in CHU9D utility were: boys −0.02 (−0.034, −0.006) girls −0.035 (−0.054, −0.015). Differences in scores for overweight compared with healthy weight were: PedsQL boys −2.2 (−3.0, −1.4) and girls −1.3 (−2.0, −0.6) and CHU9D boys: no significant difference girls −0.014 (−0.026, −0.003). PedsQL and CHU9D overall demonstrated good psychometric properties, supporting their use in measuring HRQoL in paediatric overweight and obesity. CHU9D had poorer responsiveness and did not discriminate between overweight and healthy weight in boys, which may limit its use in economic evaluation.
Publisher: Springer Science and Business Media LLC
Date: 04-06-2019
Publisher: National Institute for Health and Care Research
Date: 07-2015
DOI: 10.3310/HTA19550
Abstract: The feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain. The aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites (4) develop, document and assess acceptability and adherence of interventions (5) assess and describe training requirements of physiotherapists and (6) gain user input in all relevant stages of treatment and protocol design. Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial. The randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS. The randomised feasibility study recruited people aged 10–16 years with mild AIS (Cobb angle of 50°). The randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS. The main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities. A UK survey of orthopaedic consultants and physiotherapists indicated a wide variation in current provision of exercise therapy through physiotherapy services. It also found that clinicians from at least 15 centres would be willing to have their patients involved in a full study. A systematic review update found five new studies that were generally of low quality but showed some promise of effectiveness of SSE. The randomised study recruited 58 patients from four NHS trusts over 11 months and exceeded the pre-specified target recruitment rate of 1.4 participants per centre per month, with acceptable 6-month follow-up (currently 73%). Adherence to treatment was variable (56% of participants completed treatment offered). The qualitative study found the exercise programme to be highly acceptable. We learnt important lessons from patient and public involvement during the study in terms of study and intervention presentation, as well as practical elements such as scheduling of intervention sessions. A definitive RCT evaluating clinical effectiveness and cost-effectiveness of SSE for idiopathic scoliosis is warranted and feasible. Such a RCT is a priority for future work in the area. There is a sufficiently large patient base, combined with willingness to be randomised within specialist UK centres. Interventions developed during the feasibility study were acceptable to patients, families and physiotherapists and can be given within the affordability envelope of current levels of physiotherapy commissioning. Current Controlled Trials ISRCTN90480705. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 55. See the NIHR Journals Library website for further project information.
Publisher: American Academy of Pediatrics (AAP)
Date: 08-2006
Publisher: Springer Science and Business Media LLC
Date: 18-03-2019
Publisher: Springer Science and Business Media LLC
Date: 25-03-2016
Publisher: National Institute for Health and Care Research
Date: 06-2023
DOI: 10.3310/PLJL1440
Abstract: Headaches are a leading cause of years lived with disability. For some people, headaches become chronic and disabling, with treatment options being primarily pharmaceutical. Non-pharmacological alternative treatment approaches are worthy of exploration. To develop and test an educational and supportive self-management intervention for people with chronic headaches. To develop and evaluate a brief diagnostic interview to support diagnosis for people with chronic headaches, and then to develop and pilot an education and self-management support intervention for the management of common chronic headache disorders (the CHESS intervention). To select the most appropriate outcome measures for a randomised controlled trial of the CHESS intervention, and then to conduct a randomised controlled trial and economic evaluation of the CHESS intervention with an embedded process evaluation. Developmental and feasibility studies followed by a randomised controlled trial. General practice and community settings in the Midlands and London, UK. For our feasibility work, 14 general practices recruited 131 people with chronic headaches (headaches on ≥15 days per month for months). People with chronic headaches and expert clinicians developed a telephone classification interview for chronic headache that we validated with 107 feasibility study participants. We piloted the CHESS intervention with 13 participants and refined the content and structure based on their feedback. People with chronic headaches contributed to the decisions about our primary outcome and a core outcome set for chronic and episodic migraine. For the randomised controlled trial, we recruited adults with chronic migraine or chronic tension-type headache and episodic migraine, with or without medication overuse headache, from general practices and via self-referral. Our main analyses were on people with migraine. The CHESS intervention consisted of two 1-day group sessions focused on education and self-management to promote behaviour change and support learning strategies to manage chronic headaches. This was followed by a one-to-one nurse consultation and telephone support. The control intervention consisted of feedback from classification interviews, headache management leaflet and a relaxation compact disc. The primary outcome was headache-related quality of life measured using the Headache Impact Test-6 at 12 months. The secondary outcomes included the Chronic Headache Quality of Life Questionnaire headache days, duration and severity EuroQol-5 Dimensions, five-level version Short Form Questionnaire-12 items Hospital Anxiety and Depression Scale and Pain Self-Efficacy Questionnaire scores. We followed up participants at 4, 8 and 12 months. Between April 2017 and March 2019, we randomised 736 participants from 164 general practices. Nine participants (1%) had chronic tension-type headache only. Our main analyses were on the remaining 727 participants with migraine (376 in the intervention arm and 351 in the usual-care arm). Baseline characteristics were well matched. For the primary outcome we had analysable data from 579 participants (80%) at 12 months. There was no between-group difference in the Headache Impact Test-6 at 12 months, (adjusted mean difference –0.3, 95% confidence interval –1.23 to 0.67 p = 0.56). The limits of the 95% confidence interval effectively exclude the possibility of the intervention having a worthwhile benefit. At 4 months there was a difference favouring the CHESS self-management programme on the Headache Impact Test-6 (adjusted mean difference –1.0, 95% confidence interval –1.91 to –0.006 p = 0.049). However, the self-management group also reported 1.5 (95% confidence interval 0.48 to 2.56) more headache days in the previous 28 days. Apart from improved pain self-efficacy at 4 and 12 months, there were few other statistically significant between-group differences in the secondary outcomes. The CHESS intervention generated 0.031 (95% confidence interval –0.005 to 0.063) additional quality-adjusted life-years and increased NHS and Personal Social Services costs by £268 (95% confidence interval £176 to £377), on average, generating an incremental cost-effectiveness ratio of £8617 with an 83% chance of being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. The CHESS intervention was well received and fidelity was good. No process-related issues were identified that would explain why the intervention was ineffective. Only 288 out of 376 (77%) of those randomised to the CHESS intervention attended one or more of the intervention sessions. This short, non-pharmacological, educational self-management intervention is unlikely to be effective for the treatment of people with chronic headaches and migraine. There is a need to develop and test more sustained non-pharmacological interventions for people with chronic headache disorders. Substantial patient and public involvement went into the design, conduct and interpretation of the CHESS programme. This helped direct the research and ensured that the patient voice was embedded in our work. This trial is registered as ISRCTN79708100. This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research Vol. 11, No. 2. See the NIHR Journals Library website for further information.
Publisher: Wiley
Date: 10-07-2009
DOI: 10.1111/J.1471-0528.2009.02236.X
Abstract: To assess the cost-effectiveness of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour. Economic evaluation was conducted alongside a randomised placebo controlled trial (the IMOP trial). Large UK maternity hospital. A total of 350 nulliparous women with a singleton pregnancy, cephalic presentation > or = 37 weeks gestation, requiring cervical ripening prior to induction of labour. Isosorbide mononitrate (n = 177) or placebo (n = 173) self-administered vaginally at home at 48, 32 and 16 hours prior to the scheduled time of admission for induction. Mean health service costs between the period of randomisation and discharge for mother and infant were 1254.86 pound sterling in the IMN group and 1242.88 pound sterling in the placebo group, generating a mean cost difference of 11.98 pound sterling (bootstrap mean cost difference 12.86 pound sterling 95%CI: -106.79 pound sterling, 129.39 pound sterling) that was not statistically significant (P = 0.842). The incremental cost per hour prevented from hospital admission to delivery was 7.53 pound sterling. At the notional willingness to pay threshold of 100 pound sterling per hour prevented from hospital admission to delivery, the probability that IMN is cost-effective was estimated at 0.67. This translated into a mean net monetary benefit of 98.13 pound sterling for each woman given IMN. Although the probability that IMN is cost-effective approaches 0.7 at seemingly low willingness to pay thresholds for an hour prevented from hospital admission to delivery, our results should be viewed in the light of the clinical findings from the IMOP trial.
Publisher: Elsevier BV
Date: 06-2018
Publisher: BMJ
Date: 03-2018
DOI: 10.1136/BMJOPEN-2017-019078
Abstract: Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subs le of 20 participants to explore their experiences of the trial interventions. The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. Version 2.1 dated 11 January 2017 ISRCTN35358984 Pre-results.
Publisher: American Astronomical Society
Date: 09-05-2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 22-08-2023
Abstract: The purpose of this study was to investigate patient-relevant outcomes following first revision total knee arthroplasties (rTKAs) performed for different indications. This population-based cohort study utilized data from the United Kingdom National Joint Registry, Hospital Episode Statistics Admitted Patient Care, National Health Service Patient-Reported Outcome Measures, and the Civil Registrations of Death. Patients undergoing a first rTKA between January 1, 2009, and June 30, 2019, were included in our data set. Patient-relevant outcomes included implant survivorship (up to 11 years postoperatively), mortality and serious medical complications (up to 90 days postoperatively), and patient-reported outcome measures (at 6 months postoperatively). A total of 24,540 first rTKAs were analyzed. The patient population was 54% female and 62% White, with a mean age at the first rTKA of 69 years. At 2 years postoperatively, the cumulative incidence of re-revision surgery ranged from 2.7% (95% confidence interval [CI], 1.9% to 3.4%) following rTKA for progressive arthritis to 16.3% (95% CI, 15.2% to 17.4%) following rTKA for infection. The mortality rate at 90 days was highest following rTKA for fracture (3.6% [95% CI, 2.5% to 5.1%]) and for infection (1.8% [95% CI, 1.5% to 2.2%]) but was .5% for other indications. The rate of serious medical complications requiring hospital admission within 90 days was highest for patients treated for fracture (21.8% [95% CI, 17.9% to 26.3%]) or infection (12.5% [95% CI, 11.2% to 13.9%]) and was lowest for those treated for progressive arthritis (4.3% [95% CI, 3.3% to 5.5%]). Patients who underwent rTKA for stiffness or unexplained pain had some of the poorest postoperative joint function (mean Oxford Knee Score, 24 and 25 points, respectively) and had the lowest proportion of responders (48% and 55%, respectively). This study found large differences in patient-relevant outcomes among different indications for first rTKA. The rate of complications was highest following rTKA for fracture or infection. Although rTKA resulted in large improvements in joint function for most patients, those who underwent surgery for stiffness and unexplained pain had worse outcomes. Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
Publisher: Springer Science and Business Media LLC
Date: 27-05-2022
Publisher: Springer Science and Business Media LLC
Date: 07-01-2023
DOI: 10.1186/S12883-022-02792-1
Abstract: The Chronic Headache Education and Self-Management Study (CHESS) multicentre randomised trial evaluated the impact a group education and self-management support intervention with a best usual care plus relaxation control for people living with chronic headache disorders (tension type headaches or chronic migraine, with or without medication overuse headache). Here we report the process evaluation exploring potential explanations for the lack of positive effects from the CHESS intervention. The CHESS trial included 736 (380 intervention: 356 control) people across the Midlands and London UK. We used a mixed methods approach. Our extensive process evaluation looked at context, reach, recruitment, dose delivered, dose received, fidelity and experiences of participating in the trial, and included participants and trial staff. We also looked for evidence in our qualitative data to investigate whether the original causal assumptions underpinning the intervention were realised. The CHESS trial reached out to a large erse population and recruited a representative s le. Few people with chronic tension type headaches without migraine were identified and recruited. The expected ‘dose‘of the intervention was delivered to participants and intervention fidelity was high. Attendance (“dose received”) fell below expectation, although 261/380 (69%) received at least at least the pre-identified minimum dose. Intervention participants generally enjoyed being in the groups but there was little evidence to support the causal assumptions underpinning the intervention were realised. From a process evaluation perspective despite our extensive data collection and analysis, we do not have a clear understanding of why the trial outcome was negative as the intervention was delivered as planned. However, the lack of evidence that the intervention causal assumptions brought about the planned behaviour change may provide some insight. Our data suggests only modest changes in managing headache behaviours and some disparity in how participants engaged with components of the intervention within the timeframe of the study. Moving forwards, we need a better understanding of how those who live with chronic headache can be helped to manage this disabling condition more effectively over time. ISRCTN79708100 .
Publisher: Springer Science and Business Media LLC
Date: 11-11-2008
DOI: 10.1007/S10198-008-0131-4
Abstract: The objective of this study was to estimate the economic costs over the first 2 years of life of Group B Streptococcus (GBS) disease occurring in infants less than 90 days of age. A cost analysis was conducted using a prospective cohort of children born between 2000 and 2003 in the Greater London, Oxford, Portsmouth and Bristol areas of England. Unit costs were applied to estimates of the health and social resource use made by 138 infants diagnosed with GBS disease and 305 non-GBS controls matched for birth weight and hospital stay and time of birth. The health and social care costs for infants exposed to GBS disease were analysed in a multiple linear regression model. The mean health and social care cost over the first 2 years of life was estimated at pound11,968.9 for infants with GBS, compared to pound6,260.7 for the non-GBS controls a mean cost difference of pound5,708.1 (bootstrap 95% CI pound2,977.1, pound8,391.2, P=0.03). After adjusting for gestational age and other potential confounders in a multiple linear regression, mean societal costs was pound6,144.7 higher among GBS cases than among non-GBS controls (P<0.001). This study shows that the health and social care costs for infants with GBS disease is, on average, two-fold higher during the first 2 years of life than for infants without GBS disease. These data should be used to inform policy decisions regarding the cost-effectiveness of prevention and treatment strategies for GBS disease during early childhood.
Publisher: BMJ
Date: 21-12-2016
Publisher: Springer Science and Business Media LLC
Date: 27-01-2022
DOI: 10.1007/S10198-021-01426-6
Abstract: Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of in iduals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
Publisher: National Institute for Health and Care Research
Date: 05-2017
DOI: 10.3310/HTA21300
Abstract: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Five NHS acute trusts in England. Participants were patients aged ≥ 18 years with moderately troublesome LBP present ( 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with ‘best usual care’ (BUC) or BUC alone. All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. Poor recruitment was a limiting factor. This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain. Further work is needed to test recruitment from alternative clinical situations. EudraCT 2014-000682-50 and Current Controlled Trials ISRCTN93184143. 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. 30. See the NIHR Journals Library website for further project information.
Publisher: Wiley
Date: 21-07-2009
DOI: 10.1111/J.1469-7610.2009.02124.X
Abstract: There are well-replicated findings that link poor development on a range of communication skills with increased behavioural problems. This paper examines this relationship in children with hearing loss. One hundred and twenty children with hearing loss (67 boys, 53 girls) and 63 hearing children (37 boys, 26 girls) with a mean age of 8 years from eight districts in Southern England were assessed for receptive and expressive language skills. The relationships between these measures and an aggregate of parent- and teacher-reported behaviour problems in the children were investigated. Children with hearing loss had higher levels of behaviour problems compared to hearing children. Once the language abilities of children with hearing loss are taken into account, the negative effects of hearing loss on behaviour disappear. Behaviour problems are found more commonly in children with hearing loss and the level of behaviour problems is highest amongst those children with hearing loss with the least developed language capabilities.
Publisher: Wiley
Date: 21-01-2018
DOI: 10.1111/OBR.12672
Abstract: Rigorous estimates of preference-based utilities are important inputs into economic evaluations of childhood obesity interventions, yet no published review currently exists examining utility by weight status in paediatric populations. A comprehensive systematic literature review and meta-analysis was therefore undertaken, pooling data on preference-based health state utilities by weight status in children using a random-effects model. Tests for heterogeneity were performed, and publication bias was assessed. Of 3,434 potentially relevant studies identified, 11 met our eligibility criteria. Estimates of Cohen's d statistic suggested a small effect of weight status on preference-based utilities. Mean utility values were estimated as 0.85 (95% uncertainty interval [UI] 0.84-0.87), 0.83 (95% UI 0.81-0.85), 0.82 (95% UI 0.79-0.84) and 0.83 (95% UI 0.80-0.86) for healthy weight, overweight, obese and overweight/obese states, respectively. Meta-analysis of studies reporting utility values for both healthy weight and overweight/obese participants found a statistically significant weighted mean difference (0.015, 95% UI 0.003-0.026). A small but statistically significant difference was also estimated between healthy weight and overweight participants (0.011, 95% UI 0.004-0.018). Study findings suggest that paediatric-specific benefits of obesity interventions may not be well reflected by available utility measures, potentially underestimating cost-effectiveness if weight loss in childhood/adolescence improves health or well-being.
Publisher: Springer Science and Business Media LLC
Date: 10-07-2018
DOI: 10.1007/S11136-018-1932-2
Abstract: Few studies focus on the health-related quality of life (HRQoL) of preschool children with overweight or obesity. This is relevant for evaluation of obesity prevention trials using a quality-adjusted life year (QALY) framework. This study examined the association between weight status in the preschool years and HRQoL at age 5 years, using a preference-based instrument. HRQoL [based on parent proxy version of the Health Utilities Index Mark 3 (HUI3)] and weight status were measured in children born in Australia between 2007 and 2009. Children's health status was scored across eight attributes of the HUI3-vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain, and these were used to calculate a multi-attribute utility score. Ordinary least squares (OLS), Tobit and two-part regressions were used to model the association between weight status and multi-attribute utility. Of the 368 children for whom weight status and HUI3 data were available, around 40% had overweight/obesity. After adjusting for child's sex, maternal education, marital status and household income, no significant association between weight status in the preschool years and multi-attribute utility scores at 5 years was found. Alternative approaches for capturing the effects of weight status in the preschool years on preference-based HRQoL outcomes should be tested. The application of the QALY framework to economic evaluations of obesity-related interventions in young children should also consider longitudinal effects over the life-course. Clinical Trial Registration The Healthy Beginnings Trial was registered with the Australian Clinical Trial Registry (ACTRNO12607000168459).
Publisher: Springer Science and Business Media LLC
Date: 31-10-2022
Publisher: BMJ
Date: 12-2017
DOI: 10.1136/BMJOPEN-2017-019929
Abstract: To systematically review the qualitative literature of the lived experience of people with a chronic headache disorder. Chronic headaches affect 3%–4% of the population. The most common chronic headache disorders are chronic migraine, chronic tension-type headache and medication overuse headache. We present a systematic review and meta-ethnographic synthesis of the lived experience of people with chronic headache. We searched seven electronic databases, hand-searched nine journals and used a modified Critical Appraisal Skills Programme checklist to appraise study quality. Following thematic analysis we synthesised the data using a meta-ethnographic approach. We identified 3586 unique citations full texts were examined for 86 studies and 4 were included in the review. Included studies differed in their foci: exploring, patient-centred outcomes, chronic headache as a socially invisible disease, psychological processes mediating impaired quality of life, and the process of medication overuse. Initial thematic analysis and subsequent synthesis gave three overarching themes: ‘headache as a driver of behaviour’ (directly and indirectly), ‘the spectre of headache’ and ‘strained relationships’. This meta-synthesis of published qualitative evidence demonstrates that chronic headaches have a profound effect on people’s lives, showing similarities with other pain conditions. There were insufficient data to explore the similarities and differences between different chronic headache disorders.
Publisher: Elsevier BV
Date: 11-2019
DOI: 10.1016/J.SOCSCIMED.2019.112543
Abstract: Evidence surrounding utilities for health states, derived either directly from the application of preference-based valuation methods or indirectly from the application of preference-based quality of life instruments, is increasingly being utilised to inform the cost-effectiveness of child health interventions. Proxy (parent or health professional) assessments are common in this area. This study sought to investigate the degree of convergence in childhood utilities generated directly or indirectly within dyad child and proxy assessments. A systematic literature review was conducted following PRISMA guidelines. A comprehensive literature search strategy conducted across six search engines (PubMed, Embase, Web of Science, PsychoINFO, EconLit, CINAHL and Cochrane Library). Original peer-reviewed articles that reported utilities derived directly or indirectly using simultaneous dyad child and proxy assessments were extracted. Mean and median utilities, correlation coefficients and levels of agreement were extracted, catalogued and assessed. A total of 35 studies that reported utilities for two or more respondent types were identified. Of these, 29 studies reported dyad childhood self-report and proxy utilities whilst six studies reported levels of agreement and/or correlations only without documenting overall utilities. Proxy assessment was most often conducted by parents with the HUI3 representing the most commonly applied instrument across a range of health conditions. The utilities derived from child and parent proxy assessment were bidirectional with parental proxies tending to underestimate and health professional proxies tending to overestimate relative to child self-reports. Inter-rater agreement between child self-reports and parent-proxy reports were poorer for more subjective attributes (cognition, emotion and pain), relative to physical attributes (mobility, self-care, speech, vision) of health-related quality of life. Childhood utilities derived from children or proxies are not interchangeable. The choice of self or proxy assessor may have potentially significant implications for economic evaluations of child health interventions.
Publisher: BMJ
Date: 16-05-2018
DOI: 10.1136/BMJ.K1675
Abstract: To estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia. Multicentre, pragmatic, investigator masked, randomised controlled trial. National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions. 494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm. Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises. The primary outcome was score on the Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention. The average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference -1.4, 95% confidence interval -2.6 to -0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer's disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m). A moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes. Current Controlled Trials ISRCTN10416500.
Publisher: National Institute for Health and Care Research
Date: 05-2018
DOI: 10.3310/HTA22280
Abstract: Approximately 670,000 people in the UK have dementia. Previous literature suggests that physical exercise could slow dementia symptom progression. To estimate the clinical effectiveness and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD) and carer burden and HRQoL. Intervention development, systematic review, multicentred, randomised controlled trial (RCT) with a parallel economic evaluation and qualitative study. 15 English regions. People with MMD living in the community. A 4-month moderate- to high-intensity, structured exercise programme designed specifically for people with MMD, with support to continue unsupervised physical activity thereafter. Exercises were in idually prescribed and progressed, and participants were supervised in groups. The comparator was usual practice. The primary outcome was the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog). The secondary outcomes were function [as measured using the Bristol Activities of Daily Living Scale (BADLS)], generic HRQoL [as measured using the EuroQol-5 Dimensions, three-level version (EQ-5D-3L)], dementia-related QoL [as measured using the Quality of Life in Alzheimer’s Disease (QoL-AD) scale], behavioural symptoms [as measured using the Neuropsychiatric Inventory (NPI)], falls and fractures, physical fitness (as measured using the 6-minute walk test) and muscle strength. Carer outcomes were HRQoL (Quality of Life in Alzheimer’s Disease) (as measured using the EQ-5D-3L) and carer burden (as measured using the Zarit Burden Interview). The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained from a NHS and Personal Social Services perspective. We measured health and social care use with the Client Services Receipt Inventory. Participants were followed up for 12 months. Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care and 329 to the intervention. The mean age of participants was 77 years [standard deviation (SD) 7.9 years], 39% (193/494) were female and the mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates, with 65% (214/329) attending between 75% and 100% of sessions. Outcome data were obtained for 85% (418/494) of participants at 12 months, at which point a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), with a mean difference of –1.4 [95% confidence interval (CI) –2.62 to –0.17]. There were no treatment effects for any of the other secondary outcome measures for participants or carers: for the BADLS there was a mean difference of –0.6 (95% CI –2.05 to 0.78), for the EQ-5D-3L a mean difference of –0.002 (95% CI –0.04 to 0.04), for the QoL-AD scale a mean difference of 0.7 (95% CI –0.21 to 1.65) and for the NPI a mean difference of –2.1 (95% CI –4.83 to 0.65). Four serious adverse events were reported. The exercise intervention was dominated in health economic terms. In the absence of definitive guidance and rationale, we used a mixed exercise programme. Neither intervention providers nor participants could be masked to treatment allocation. This is a large well-conducted RCT, with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function or HRQoL in people with dementia or on carer burden. Future work should concentrate on approaches other than exercise to influence cognitive impairment in dementia. Current Controlled Trials ISRCTN32612072. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full programme and will be published in full in Health Technology Assessment Vol. 22, No. 28. See the NIHR Journals Library website for further project information. Additional funding was provided by the Oxford NIHR Biomedical Research Centre and the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care.
Publisher: Wiley
Date: 28-06-2008
Publisher: American Academy of Pediatrics (AAP)
Date: 12-2003
Abstract: Objectives. To compare the cumulative use and cost of hospital inpatient services to 5 years of age by in iduals ided into 4 subgroups by gestational age at birth. Design. Costs applied to the hospital service utilization profile of each infant born in 2 areas covered by the Oxford Record Linkage Study during 1970–1993. Setting. Oxfordshire and West Berkshire, southern United Kingdom. Subjects. 239 694 in iduals ided into 4 subgroups by gestational age at birth: & weeks, 28 to 31 weeks, 32 to 36 weeks, ≥37 weeks. Main Outcome Measures. Number and duration of hospital admissions during the first 5 years of life and costs, expressed in £ sterling and valued at 1998–1999 prices, of hospital inpatient services. Results. The total duration of hospital admissions for infants born at & and at 28 to 31 gestational weeks was 85 and 16 times that for term infants, respectively, once duration of life had been taken into account. Hospital inpatient service costs were significantly higher for preterm infants than for term infants, with the cost differences persisting throughout infancy and early and mid-childhood. Over the first 5 years of life, the adjusted mean cost difference was estimated at £14 614 (US $22 798) when infants born at & weeks gestational age were compared with term infants and £11 958 (US $18 654) when infants born at 28 to 31 weeks gestational age were compared with term infants. Independent contributions to total cost came from being born: small for gestational age, a multiple, during the 1970s and early 1980s, to a woman of extreme maternal age or who was hospitalized antenatally, and from experiencing extended survival or childhood disease. However, preterm birth remained the strongest predictor of high cost. Conclusions. Preterm birth is a major predictor of how much an in idual will cost hospital service providers during the first 5 years of life.
Publisher: American Astronomical Society
Date: 28-08-2015
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Stavros Petrou.