Letter to the Editor: The appropriateness of screening for amblyopia is an emotive issue, both wi... more Letter to the Editor: The appropriateness of screening for amblyopia is an emotive issue, both within the United Kingdom (UK) and worldwide. Recommendations within the UK state that children should be screened for visual impairment; yet there is evidence to suggest that such programmes are not cost-effective. We aim to identify possible reasons as to why clinicians find the prospect of removing screening programmes unacceptable.
This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmerc... more This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
The Leeds Beckett repository holds a wide range of publications, each of which has been checked f... more The Leeds Beckett repository holds a wide range of publications, each of which has been checked for copyright and the relevant embargo period has been applied by the Research Services team. We operate on a standard take-down policy. If you are the author or publisher of an output and you would like it removed from the repository, please contact us and we will investigate on a case-by-case basis.
IntroductionAchieving glycemic targets and optimizing quality of life (QoL) are important goals o... more IntroductionAchieving glycemic targets and optimizing quality of life (QoL) are important goals of type 1 diabetes care. Hypoglycemia is a common barrier to achieving targets and can be associated with significant distress. However, the impact of hypoglycemia on QoL is not fully understood. The aim of this study was to explore how adults with type 1 diabetes are impacted by hypoglycemia in areas of life that are important to their overall QoL.Research design and methodsParticipants responded to a web-based qualitative survey involving a novel ‘Wheel of Life’ activity. Responses were analyzed using reflexive thematic analysis.ResultsThe final sample included 219 adults with type 1 diabetes from Denmark, Germany, the Netherlands, and the UK. They had a mean±SD age of 39±13 years and diabetes duration of 20±14 years. Participants identified eight areas of life important to their overall QoL, including relationships and social life, work and studies, leisure and physical activity, every...
There has been growing international interest in the role that wellbeing measures could play with... more There has been growing international interest in the role that wellbeing measures could play within policy making in health and social care. This project explored the opinions of a sample of UK decision-makers on the relevance of wellbeing and subjective wellbeing (by which we mean good and bad feelings or overall evaluations of life, such as life satisfaction) for resource allocation decisions within health and social care. Through these discussions we draw out the perceived advantages and the potential concerns that decision-makers have about broadening out to wellbeing and subjective wellbeing rather than just measuring health. Three focus groups were conducted: with members of the National Institute for Health and Care Excellence (NICE) Citizen’s Council, with a Health and Wellbeing Board at a Local Authority and with Public Health England. In addition, eleven semi-structured interviews were held with staff from NHS England and members of a range of NICE committees. We identifie...
ObjectiveBased on concerns about existing patient-reported outcome measures (PROMs) for assessing... more ObjectiveBased on concerns about existing patient-reported outcome measures (PROMs) for assessing quality of life (QoL) in Duchenne muscular dystrophy (DMD), we describe the mixed methods development of a new QoL PROM for use in boys and men with DMD: the DMD-QoL.MethodsThe DMD-QoL was developed in 3 stages. First, draft items were generated from 18 semistructured qualitative interviews with boys and men with DMD, analyzed using framework analysis. Second, cognitive debriefing interviews with patients (n = 10), clinicians (n = 8), and patients' parents (n = 10) were undertaken, and a reduced item set was selected and refined. Third, psychometric data on the draft items from a cross-sectional online survey (n = 102) and stakeholder input from patients and patients' parents were used to produce the final questionnaire. Patient and public involvement and engagement was embedded throughout the process.ResultsFrom an initial draft of 47 items, a revised set of 27 items was produc...
Economic evaluation combines costs and benefits to support decision-making when assessing new int... more Economic evaluation combines costs and benefits to support decision-making when assessing new interventions using preference-based measures to measure and value benefits in health or health-related quality of life. These health-focused instruments have limited ability to capture wider impacts on informal carers or outcomes in other sectors such as social care. Sector-specific instruments can be used but this is problematic when the impact of an intervention straddles different sectors.An alternative approach is to develop a generic preference-based measure that is sufficiently broad to capture important cross-sector outcomes. We consider the options for the selection of domains for a cross-sector generic measure including how to identify domains, who should provide information on the domains and how this should be framed. Beyond domain identification, considerations of criteria and stakeholder needs are also identified.This paper sets out the case for an approach that relies on the ...
Background There is an unmet need for treatment options in intermediate age-related macular degen... more Background There is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical endpoints need to be developed. Thus, the MACUSTAR study aims to develop and evaluate functional, structural, and patient-reported candidate endpoints for use in future iAMD trials. Methods The protocol describes a low-interventional clinical multicenter study employing a novel two-part design. The cross-sectional part (total duration, 1 month) and the longitudinal part (total duration, 36 months) include participants with iAMD and control groups with early/late/no AMD. The cross-sectional part’s primary objective is a technical evaluation of functional, structural, and patient-reported candidate outcomes. The longitudinal part’s primary objective is to assess the prognostic power of changes in functional, structural, and patient-reported outcomes for progression from ...
Background Amblyopia screening can target reduced visual acuity (VA), its refractive risk factors... more Background Amblyopia screening can target reduced visual acuity (VA), its refractive risk factors, or both. VA testing is imprecise under 4 years of age, so automated risk-factor photoscreening appears an attractive option. This review considers photoscreening used in community services, focusing on costs, cost-effectiveness and scope of use, compared with EUSCREEN project Country Reports describing how photo- and automated screening is used internationally. Methods A systematic narrative review was carried out of all English language photoscreening literature to September 10th 2018, using publicly available search terms. Where costs were considered, a CASP economic evaluation checklist was used to assess data quality. Results Of 370 abstracts reviewed, 55 reported large-scale community photoscreening projects. Five addressed cost-effectiveness specifically, without original data. Photoscreening was a stand-alone, single, test event in 71% of projects. In contrast, 25 of 45 EUSCREEN...
Purpose: To develop a pediatric disease-specific health related quality of life (HRQOL) instrumen... more Purpose: To develop a pediatric disease-specific health related quality of life (HRQOL) instrument for amblyopia. Methods: In a development phase, 59 children (age 45-119 months, average 6 years 3 months) with amblyopia were interviewed. Interview transcripts were analysed to identify items and levels for the descriptive system. These were used in a piloting phase which was completed by 32 children who were undergoing amblyopia treatment. Ranking exercises and cognitive debriefing were used to modify the developed descriptive system. Results: Following the cognitive debriefing and ranking exercise, the draft questionnaire was modified. Eleven items were identified relating to the health-related implications of amblyopia treatment. Seven versions of the Children’s Amblyopia Treatment Quality of Life Questionnaire (CAT-QoL) were developed (patch; drops; glasses; patch and drops; patch and glasses; glasses and drops; glasses, patch and drops). Conclusions: Children were able to identif...
Objectives: Foot orthoses are commonly prescribed as an intervention for people with rheumatoid a... more Objectives: Foot orthoses are commonly prescribed as an intervention for people with rheumatoid arthritis. Data relating to the cost-effectiveness of foot orthoses in people with RA is limited. The aim was to evaluate the clinical and cost effectiveness of two foot orthoses in people with established RA. Methodology: A single-blind randomised controlled trial was undertaken to compare customised foot orthoses and simple insoles in 41 people with established RA. The Foot Function Index measured foot pain, disability and functional limitation. Costs were estimated from the perspective from the UK National Health Service, societal (patient and family) perspective and secondary care resource use in terms of the intervention and staff time. Effects were assessed in terms of health gain expressed as quality adjusted life years (QALYS). Results: At baseline, 20 participants received the customised foot orthoses and 21 participants received a simple insole. After 16 weeks foot pain improved in the custom-made foot orthoses (p=0.000) and simple insoles (p<0.01). Custom-made foot orthoses improved disability scores (p<0.001) but not for simple insoles (p=0.40). The cost effectiveness results demonstrated no difference in cost between the arms (custom-made foot orthoses: £159.10; simple insole: £79.10 p=0.35), with the customised foot orthoses being less effective in terms of cost per QALY gain (p<0.001). Conclusions: In people with established RA, semi-rigid customised foot orthoses can improve pain and disability scores in comparison to simple insoles. From a cost effectiveness perspective the customised foot orthoses were far more expensive to manufacture, with no significant cost per QALY gain.
This is a repository copy of Reducing the burden of hypoglycaemia in people with diabetes through... more This is a repository copy of Reducing the burden of hypoglycaemia in people with diabetes through increased understanding : design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo RESOLVE) project- .
Letter to the Editor: The appropriateness of screening for amblyopia is an emotive issue, both wi... more Letter to the Editor: The appropriateness of screening for amblyopia is an emotive issue, both within the United Kingdom (UK) and worldwide. Recommendations within the UK state that children should be screened for visual impairment; yet there is evidence to suggest that such programmes are not cost-effective. We aim to identify possible reasons as to why clinicians find the prospect of removing screening programmes unacceptable.
This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmerc... more This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
The Leeds Beckett repository holds a wide range of publications, each of which has been checked f... more The Leeds Beckett repository holds a wide range of publications, each of which has been checked for copyright and the relevant embargo period has been applied by the Research Services team. We operate on a standard take-down policy. If you are the author or publisher of an output and you would like it removed from the repository, please contact us and we will investigate on a case-by-case basis.
IntroductionAchieving glycemic targets and optimizing quality of life (QoL) are important goals o... more IntroductionAchieving glycemic targets and optimizing quality of life (QoL) are important goals of type 1 diabetes care. Hypoglycemia is a common barrier to achieving targets and can be associated with significant distress. However, the impact of hypoglycemia on QoL is not fully understood. The aim of this study was to explore how adults with type 1 diabetes are impacted by hypoglycemia in areas of life that are important to their overall QoL.Research design and methodsParticipants responded to a web-based qualitative survey involving a novel ‘Wheel of Life’ activity. Responses were analyzed using reflexive thematic analysis.ResultsThe final sample included 219 adults with type 1 diabetes from Denmark, Germany, the Netherlands, and the UK. They had a mean±SD age of 39±13 years and diabetes duration of 20±14 years. Participants identified eight areas of life important to their overall QoL, including relationships and social life, work and studies, leisure and physical activity, every...
There has been growing international interest in the role that wellbeing measures could play with... more There has been growing international interest in the role that wellbeing measures could play within policy making in health and social care. This project explored the opinions of a sample of UK decision-makers on the relevance of wellbeing and subjective wellbeing (by which we mean good and bad feelings or overall evaluations of life, such as life satisfaction) for resource allocation decisions within health and social care. Through these discussions we draw out the perceived advantages and the potential concerns that decision-makers have about broadening out to wellbeing and subjective wellbeing rather than just measuring health. Three focus groups were conducted: with members of the National Institute for Health and Care Excellence (NICE) Citizen’s Council, with a Health and Wellbeing Board at a Local Authority and with Public Health England. In addition, eleven semi-structured interviews were held with staff from NHS England and members of a range of NICE committees. We identifie...
ObjectiveBased on concerns about existing patient-reported outcome measures (PROMs) for assessing... more ObjectiveBased on concerns about existing patient-reported outcome measures (PROMs) for assessing quality of life (QoL) in Duchenne muscular dystrophy (DMD), we describe the mixed methods development of a new QoL PROM for use in boys and men with DMD: the DMD-QoL.MethodsThe DMD-QoL was developed in 3 stages. First, draft items were generated from 18 semistructured qualitative interviews with boys and men with DMD, analyzed using framework analysis. Second, cognitive debriefing interviews with patients (n = 10), clinicians (n = 8), and patients' parents (n = 10) were undertaken, and a reduced item set was selected and refined. Third, psychometric data on the draft items from a cross-sectional online survey (n = 102) and stakeholder input from patients and patients' parents were used to produce the final questionnaire. Patient and public involvement and engagement was embedded throughout the process.ResultsFrom an initial draft of 47 items, a revised set of 27 items was produc...
Economic evaluation combines costs and benefits to support decision-making when assessing new int... more Economic evaluation combines costs and benefits to support decision-making when assessing new interventions using preference-based measures to measure and value benefits in health or health-related quality of life. These health-focused instruments have limited ability to capture wider impacts on informal carers or outcomes in other sectors such as social care. Sector-specific instruments can be used but this is problematic when the impact of an intervention straddles different sectors.An alternative approach is to develop a generic preference-based measure that is sufficiently broad to capture important cross-sector outcomes. We consider the options for the selection of domains for a cross-sector generic measure including how to identify domains, who should provide information on the domains and how this should be framed. Beyond domain identification, considerations of criteria and stakeholder needs are also identified.This paper sets out the case for an approach that relies on the ...
Background There is an unmet need for treatment options in intermediate age-related macular degen... more Background There is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical endpoints need to be developed. Thus, the MACUSTAR study aims to develop and evaluate functional, structural, and patient-reported candidate endpoints for use in future iAMD trials. Methods The protocol describes a low-interventional clinical multicenter study employing a novel two-part design. The cross-sectional part (total duration, 1 month) and the longitudinal part (total duration, 36 months) include participants with iAMD and control groups with early/late/no AMD. The cross-sectional part’s primary objective is a technical evaluation of functional, structural, and patient-reported candidate outcomes. The longitudinal part’s primary objective is to assess the prognostic power of changes in functional, structural, and patient-reported outcomes for progression from ...
Background Amblyopia screening can target reduced visual acuity (VA), its refractive risk factors... more Background Amblyopia screening can target reduced visual acuity (VA), its refractive risk factors, or both. VA testing is imprecise under 4 years of age, so automated risk-factor photoscreening appears an attractive option. This review considers photoscreening used in community services, focusing on costs, cost-effectiveness and scope of use, compared with EUSCREEN project Country Reports describing how photo- and automated screening is used internationally. Methods A systematic narrative review was carried out of all English language photoscreening literature to September 10th 2018, using publicly available search terms. Where costs were considered, a CASP economic evaluation checklist was used to assess data quality. Results Of 370 abstracts reviewed, 55 reported large-scale community photoscreening projects. Five addressed cost-effectiveness specifically, without original data. Photoscreening was a stand-alone, single, test event in 71% of projects. In contrast, 25 of 45 EUSCREEN...
Purpose: To develop a pediatric disease-specific health related quality of life (HRQOL) instrumen... more Purpose: To develop a pediatric disease-specific health related quality of life (HRQOL) instrument for amblyopia. Methods: In a development phase, 59 children (age 45-119 months, average 6 years 3 months) with amblyopia were interviewed. Interview transcripts were analysed to identify items and levels for the descriptive system. These were used in a piloting phase which was completed by 32 children who were undergoing amblyopia treatment. Ranking exercises and cognitive debriefing were used to modify the developed descriptive system. Results: Following the cognitive debriefing and ranking exercise, the draft questionnaire was modified. Eleven items were identified relating to the health-related implications of amblyopia treatment. Seven versions of the Children’s Amblyopia Treatment Quality of Life Questionnaire (CAT-QoL) were developed (patch; drops; glasses; patch and drops; patch and glasses; glasses and drops; glasses, patch and drops). Conclusions: Children were able to identif...
Objectives: Foot orthoses are commonly prescribed as an intervention for people with rheumatoid a... more Objectives: Foot orthoses are commonly prescribed as an intervention for people with rheumatoid arthritis. Data relating to the cost-effectiveness of foot orthoses in people with RA is limited. The aim was to evaluate the clinical and cost effectiveness of two foot orthoses in people with established RA. Methodology: A single-blind randomised controlled trial was undertaken to compare customised foot orthoses and simple insoles in 41 people with established RA. The Foot Function Index measured foot pain, disability and functional limitation. Costs were estimated from the perspective from the UK National Health Service, societal (patient and family) perspective and secondary care resource use in terms of the intervention and staff time. Effects were assessed in terms of health gain expressed as quality adjusted life years (QALYS). Results: At baseline, 20 participants received the customised foot orthoses and 21 participants received a simple insole. After 16 weeks foot pain improved in the custom-made foot orthoses (p=0.000) and simple insoles (p<0.01). Custom-made foot orthoses improved disability scores (p<0.001) but not for simple insoles (p=0.40). The cost effectiveness results demonstrated no difference in cost between the arms (custom-made foot orthoses: £159.10; simple insole: £79.10 p=0.35), with the customised foot orthoses being less effective in terms of cost per QALY gain (p<0.001). Conclusions: In people with established RA, semi-rigid customised foot orthoses can improve pain and disability scores in comparison to simple insoles. From a cost effectiveness perspective the customised foot orthoses were far more expensive to manufacture, with no significant cost per QALY gain.
This is a repository copy of Reducing the burden of hypoglycaemia in people with diabetes through... more This is a repository copy of Reducing the burden of hypoglycaemia in people with diabetes through increased understanding : design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo RESOLVE) project- .
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