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Article ; Online: Diagnosis of childhood obesity using BMI: potential ethicolegal implications and downstream effects: a response.

Simmonds, M / Llewellyn, A / Owen, C G / Woolacott, N

Obesity reviews : an official journal of the International Association for the Study of Obesity

2017 Volume 18, Issue 3, Page(s) 382–383

Language	English
Publishing date	2017-03
Publishing country	England
Document type	Letter
ZDB-ID	2147980-X
ISSN	1467-789X ; 1467-7881
ISSN (online)	1467-789X
ISSN	1467-7881
DOI	10.1111/obr.12510
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Article ; Online: Strimvelis

South, Emily / Cox, Edward / Meader, Nick / Woolacott, Nerys / Griffin, Susan

PharmacoEconomics - open

2018 Volume 3, Issue 2, Page(s) 151–161

Abstract: The Centre for Reviews and Dissemination and Centre for Health Economics Technology Assessment Group at the University of York was commissioned by the National Institute for Health and Care Excellence (NICE) Highly Specialised Technologies (HST) ... ...

Abstract	The Centre for Reviews and Dissemination and Centre for Health Economics Technology Assessment Group at the University of York was commissioned by the National Institute for Health and Care Excellence (NICE) Highly Specialised Technologies (HST) programme to act as the independent Evidence Review Group (ERG) for an appraisal of Strimvelis
Language	English
Publishing date	2018-10-17
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2874287-4
ISSN	2509-4254 ; 2509-4262
ISSN (online)	2509-4254
ISSN	2509-4262
DOI	10.1007/s41669-018-0102-3
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Article ; Online: Systematic review of patient preference and adherence to the correct use of graduated compression stockings to prevent deep vein thrombosis in surgical patients.

Wade, Ros / Paton, Fiona / Woolacott, Nerys

Journal of advanced nursing

2016 Volume 73, Issue 2, Page(s) 336–348

Abstract: Aim: The aim of this study was to explore patient preference and adherence to thigh and knee length graduated compression stockings for the prevention of deep vein thrombosis in surgical patients.: Background: Hospitalised patients are at risk of ... ...

Abstract	Aim: The aim of this study was to explore patient preference and adherence to thigh and knee length graduated compression stockings for the prevention of deep vein thrombosis in surgical patients. Background: Hospitalised patients are at risk of developing deep vein thrombosis. Mechanical methods of prophylaxis include compression stockings, available as knee or thigh length. Patient adherence to correct stocking use is of critical importance to their effectiveness. Design: Systematic review of quantitative evidence. Data sources: Eleven databases were searched from inception to 2013 for systematic reviews of compression stockings. Reviews were screened for relevant primary studies and update searches of eight electronic sources were undertaken (2010-2014). Review methods: Randomised controlled trials and observational studies of surgical patients using compression stockings were quality assessed and data were extracted on patient adherence and preference. A narrative summary is presented. Results: Nine randomised controlled trials and seven observational studies were included in the systematic review. There was substantial variation between studies in terms of patient characteristics, interventions and methods of outcome assessment. Conclusion: Patient adherence was generally higher with knee length than thigh length stockings. However, the studies reflect patient adherence in a hospital setting only, where patients are observed by healthcare professionals; it is likely that adherence reduces once patients have been discharged from hospital. Patients preferred knee length stockings over thigh length stockings. In many clinical settings, any difference in efficacy between thigh length and knee length stockings may be rendered irrelevant by patient preference for and likely better adherence to knee length stockings.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Middle Aged ; Observational Studies as Topic ; Patient Compliance ; Patient Preference ; Postoperative Care/methods ; Postoperative Complications/prevention & control ; Postoperative Complications/psychology ; Randomized Controlled Trials as Topic ; Stockings, Compression ; Treatment Outcome ; Venous Thrombosis/prevention & control ; Venous Thrombosis/psychology ; Young Adult
Language	English
Publishing date	2016-10-09
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	197634-5
ISSN	1365-2648 ; 0309-2402
ISSN (online)	1365-2648
ISSN	0309-2402
DOI	10.1111/jan.13148
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Article ; Online: Predicting adult obesity from childhood obesity: a systematic review and meta-analysis.

Simmonds, M / Llewellyn, A / Owen, C G / Woolacott, N

Obesity reviews : an official journal of the International Association for the Study of Obesity

2016 Volume 17, Issue 2, Page(s) 95–107

Abstract: A systematic review and meta-analysis was performed to investigate the ability of simple measures of childhood obesity such as body mass index (BMI) to predict future obesity in adolescence and adulthood. Large cohort studies, which measured obesity both ...

Abstract	A systematic review and meta-analysis was performed to investigate the ability of simple measures of childhood obesity such as body mass index (BMI) to predict future obesity in adolescence and adulthood. Large cohort studies, which measured obesity both in childhood and in later adolescence or adulthood, using any recognized measure of obesity were sought. Study quality was assessed. Studies were pooled using diagnostic meta-analysis methods. Fifteen prospective cohort studies were included in the meta-analysis. BMI was the only measure of obesity reported in any study, with 200,777 participants followed up. Obese children and adolescents were around five times more likely to be obese in adulthood than those who were not obese. Around 55% of obese children go on to be obese in adolescence, around 80% of obese adolescents will still be obese in adulthood and around 70% will be obese over age 30. Therefore, action to reduce and prevent obesity in these adolescents is needed. However, 70% of obese adults were not obese in childhood or adolescence, so targeting obesity reduction solely at obese or overweight children needs to be considered carefully as this may not substantially reduce the overall burden of adult obesity.
MeSH term(s)	Adolescent ; Adult ; Age of Onset ; Body Mass Index ; Child ; Child, Preschool ; Humans ; Longitudinal Studies ; Obesity/epidemiology ; Prospective Studies ; Public Health
Language	English
Publishing date	2016-02
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2147980-X
ISSN	1467-789X ; 1467-7881
ISSN (online)	1467-789X
ISSN	1467-7881
DOI	10.1111/obr.12334
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Article ; Online: Childhood obesity as a predictor of morbidity in adulthood: a systematic review and meta-analysis.

Llewellyn, A / Simmonds, M / Owen, C G / Woolacott, N

Obesity reviews : an official journal of the International Association for the Study of Obesity

2016 Volume 17, Issue 1, Page(s) 56–67

Abstract: Obese children are at higher risk of being obese as adults, and adult obesity is associated with an increased risk of morbidity. This systematic review and meta-analysis investigates the ability of childhood body mass index (BMI) to predict obesity- ... ...

Abstract	Obese children are at higher risk of being obese as adults, and adult obesity is associated with an increased risk of morbidity. This systematic review and meta-analysis investigates the ability of childhood body mass index (BMI) to predict obesity-related morbidities in adulthood. Thirty-seven studies were included. High childhood BMI was associated with an increased incidence of adult diabetes (OR 1.70; 95% CI 1.30-2.22), coronary heart disease (CHD) (OR 1.20; 95% CI 1.10-1.31) and a range of cancers, but not stroke or breast cancer. The accuracy of childhood BMI when predicting any adult morbidity was low. Only 31% of future diabetes and 22% of future hypertension and CHD occurred in children aged 12 or over classified as being overweight or obese. Only 20% of all adult cancers occurred in children classified as being overweight or obese. Childhood obesity is associated with moderately increased risks of adult obesity-related morbidity, but the increase in risk is not large enough for childhood BMI to be a good predictor of the incidence of adult morbidities. This is because the majority of adult obesity-related morbidity occurs in adults who were of healthy weight in childhood. Therefore, targeting obesity reduction solely at obese or overweight children may not substantially reduce the overall burden of obesity-related disease in adulthood.
MeSH term(s)	Adolescent ; Adult ; Body Mass Index ; Child ; Child, Preschool ; Coronary Disease/etiology ; Coronary Disease/prevention & control ; Diabetes Mellitus, Type 2/etiology ; Diabetes Mellitus, Type 2/prevention & control ; Humans ; Hypertension/etiology ; Hypertension/prevention & control ; Neoplasms/etiology ; Neoplasms/prevention & control ; Pediatric Obesity/complications ; Pediatric Obesity/metabolism ; Pediatric Obesity/prevention & control ; Risk Factors
Language	English
Publishing date	2016-01
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2147980-X
ISSN	1467-789X ; 1467-7881
ISSN (online)	1467-789X
ISSN	1467-7881
DOI	10.1111/obr.12316
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Article ; Online: Simple tests for the diagnosis of childhood obesity: a systematic review and meta-analysis.

Simmonds, M / Llewellyn, A / Owen, C G / Woolacott, N

Obesity reviews : an official journal of the International Association for the Study of Obesity

2016 Volume 17, Issue 12, Page(s) 1301–1315

Abstract: There is a need to accurately quantify levels of adiposity in order to identify overweight and obesity in children. This systematic review aimed to identify all diagnostic accuracy studies evaluating simple tests for obesity and adiposity, including body ...

Abstract	There is a need to accurately quantify levels of adiposity in order to identify overweight and obesity in children. This systematic review aimed to identify all diagnostic accuracy studies evaluating simple tests for obesity and adiposity, including body mass index (BMI), skin-fold thickness and waist circumference, compared against high-quality reference tests. Twenty-four cohort studies including 25,807 children were included. BMI had good performance when diagnosing obesity: a sensitivity of 81.9% (95% confidence interval [CI]: 73.0 to 93.8) for a specificity of 96.0% (95% CI: 93.8 to 98.1). It was less effective at diagnosing overweight (sensitivity: 76.3%, 95% CI: 70.2 to 82.4; specificity: 92.1% 95% CI: 90.0 to 94.3). When diagnosing obesity, waist circumference had similar performance (sensitivity: 83.8%; specificity: 96.5%). Skin-fold thickness had slightly poorer performance (sensitivity: 72.5%; specificity: 93.7%). Few studies considered any other tests. There was no conclusive evidence that any test was generally superior to the others. BMI is a good simple diagnostic test for identifying childhood adiposity. It identifies most genuinely obese and adipose children while misclassifying only a small number as obese. There was no conclusive evidence that any test should be preferred to BMI, and the extra complexity of skin-fold thickness tests does not appear to improve diagnostic accuracy.
MeSH term(s)	Adiposity ; Body Mass Index ; Child ; Humans ; Overweight/diagnosis ; Pediatric Obesity/diagnosis ; Sensitivity and Specificity ; Waist Circumference
Language	English
Publishing date	2016-12
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Review
ZDB-ID	2147980-X
ISSN	1467-789X ; 1467-7881
ISSN (online)	1467-789X
ISSN	1467-7881
DOI	10.1111/obr.12462
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Article ; Online: Ustekinumab for Treating Moderately to Severely Active Crohn's Disease after Prior Therapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

Hodgson, Robert / Walton, Matthew / Biswas, Mousumi / Mebrahtu, Teumzghi / Woolacott, Nerys

PharmacoEconomics

2017 Volume 36, Issue 4, Page(s) 387–398

Abstract: As part of the single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited Janssen to submit evidence on the clinical and cost effectiveness of their drug ustekinumab, an interleukin-12/23 inhibitor, ... ...

Abstract	As part of the single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited Janssen to submit evidence on the clinical and cost effectiveness of their drug ustekinumab, an interleukin-12/23 inhibitor, for treating moderate-to-severe active Crohn's disease (CD). The Centre for Reviews and Dissemination (CRD) and Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the Company's submission, the ERG's critical review of submitted evidence, and the resulting NICE guidance. The main supporting clinical evidence was derived from four well conducted, randomised controlled trials, comparing ustekinumab with placebo in two sub-populations (conventional care failure and anti-TNFα failure patients) of adults with moderate-to-severe CD. Three trials assessed treatment induction over 8 weeks, while the fourth recruited successfully induced patients into a maintenance trial for 1 year. These trials showed ustekinumab to be more effective than placebo in terms of its ability to induce and maintain clinical response and remission. In the absence of any direct head-to-head data, the Company conducted a network meta-analysis (NMA), which synthesised induction trial data on ustekinumab and relevant comparators (vedolizumab, adalimumab and infliximab) using placebo data as a common comparator. This analysis found ustekinumab to be of comparable efficacy to previously approved biologics in treatment induction. A 'treatment sequence analysis' compared long-term treatment efficacy, finding ustekinumab to be comparable in maintaining treatment response and remission to the three other biologic therapies. However, the ERG had identified many limitations and potential bias in this analysis, and urged caution when interpreting the results. The Company's economic model estimated ustekinumab to be dominant in both sub-populations compared with conventional care; however, the ERG's preferred base-case estimated an incremental cost-effectiveness ratio of £109,279 in the conventional care failure sub-population, and £110,967 in the anti-TNFα failure sub-population when compared with conventional care. However, the ERG identified significant failings in both the model structure and data inputs, which could not be addressed without complete restructuring. The ERG considered that the economic analysis presented by the Company failed to adequately address the decision problem specified in NICE's scope. The NICE Appraisal Committee recommended ustekinumab within its market authorisation, on the grounds of sufficiently similar efficacy and costs to previously recommended biologic therapies. However, the ERG's analyses demonstrated that all currently recommended biologics are unlikely to be cost effective relative to conventional care, raising broader questions regarding the appropriateness of cost-comparison exercises for decision making.
MeSH term(s)	Anti-Inflammatory Agents, Non-Steroidal/economics ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Cost-Benefit Analysis ; Crohn Disease/drug therapy ; Crohn Disease/economics ; Drug Resistance ; Humans ; Meta-Analysis as Topic ; Models, Economic ; Randomized Controlled Trials as Topic/statistics & numerical data ; Technology Assessment, Biomedical/statistics & numerical data ; Treatment Outcome ; United Kingdom ; Ustekinumab/economics ; Ustekinumab/therapeutic use
Chemical Substances	Anti-Inflammatory Agents, Non-Steroidal ; Ustekinumab (FU77B4U5Z0)
Language	English
Publishing date	2017-11-30
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1100273-6
ISSN	1179-2027 ; 1170-7690
ISSN (online)	1179-2027
ISSN	1170-7690
DOI	10.1007/s40273-017-0593-2
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Article ; Online: Innovative regenerative medicines in the EU: a better future in evidence?

Corbett, Mark S / Webster, Andrew / Hawkins, Robert / Woolacott, Nerys

BMC medicine

2017 Volume 15, Issue 1, Page(s) 49

Abstract: Background: Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in ...

Abstract	Background: Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future. Discussion: Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice. Conclusions: Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations might also offer a possible antidote to the innovation crisis in the pharmaceutical industry.
MeSH term(s)	Biomedical Research ; Cell- and Tissue-Based Therapy/standards ; Costs and Cost Analysis ; Drug Industry ; European Union ; Forecasting ; Humans ; Regenerative Medicine/legislation & jurisprudence ; Regenerative Medicine/standards ; Translational Medical Research
Language	English
Publishing date	2017-03-08
Publishing country	England
Document type	Journal Article
ISSN	1741-7015
ISSN (online)	1741-7015
DOI	10.1186/s12916-017-0818-4
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Article ; Online: Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

Woolacott, Nerys / Corbett, Mark / Jones-Diette, Julie / Hodgson, Robert

Journal of clinical epidemiology

2017 Volume 90, Page(s) 108–118

Abstract: Background: Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology ... ...

Abstract	Background: Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. Methods: We examined these methodological challenges through a pragmatic review of the available literature. Results: Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Conclusion: Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented.
MeSH term(s)	Clinical Trials as Topic ; Cost-Benefit Analysis ; Decision Making ; Endpoint Determination ; Evidence-Based Medicine ; Health Services Accessibility ; Health Services Needs and Demand ; Humans ; Research Design ; Technology Assessment, Biomedical ; Time Factors ; Uncertainty
Language	English
Publishing date	2017-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2017.07.002
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Article ; Online: Hyperhidrosis quality of life measures: review and patient perspective.

Wade, Ros / Jones-Diette, Julie / Wright, Kath / Layton, Alison M / Woolacott, Nerys

The Journal of dermatological treatment

2018 Volume 30, Issue 3, Page(s) 303–308

Abstract: Purpose: To identify the tools that have been used to measure quality of life in hyperhidrosis research and obtain patient insight on commonly used tools.: Methods: Twelve databases were searched to identify studies that reported measuring quality of ...

Abstract	Purpose: To identify the tools that have been used to measure quality of life in hyperhidrosis research and obtain patient insight on commonly used tools. Methods: Twelve databases were searched to identify studies that reported measuring quality of life or described a quality of life tool in the context of hyperhidrosis. Data on the use of the tools were tabulated and hyperhidrosis-specific and dermatology-specific measures were summarized. A workshop was held to obtain the patients' perspective on the most commonly used tools and the newly developed HidroQoL tool. Results: One hundred and eighty-two studies were included in the review. Twenty-two quality of life tools were identified; two or more tools were often used in combination. The most commonly used tools were the Hyperhidrosis Disease Severity Scale, the Dermatology Quality of Life Index and the Hyperhidrosis Quality-of-Life Questionnaire. Patient advisors preferred the new HidroQoL tool, which was considered to be easy to complete and most relevant to hyperhidrosis patients. Conclusions: There are several tools available for assessing quality of life in hyperhidrosis patients; disease specific measures are widely used and appear suitable. It is unclear which tool is the most reliable, although the HidroQoL tool was preferred by a small group of patient advisors.
MeSH term(s)	Adult ; Female ; Humans ; Hyperhidrosis ; Male ; Middle Aged ; Quality of Life ; Surveys and Questionnaires ; Treatment Outcome
Language	English
Publishing date	2018-09-12
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1036299-x
ISSN	1471-1753 ; 0954-6634
ISSN (online)	1471-1753
ISSN	0954-6634
DOI	10.1080/09546634.2018.1506080
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