Research (NIHR), was set up in 1993. It produces high-quality research information on the effecti... more Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in the NHS, from the public and consumer groups and from professional bodies such as royal colleges and NHS trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service users). The HTA programme then commissions the research by competitive tender. Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme commissions bespoke reports, principally for NICE, but also for other policy-makers. TARs bring together evidence on the value of specific technologies. Some HTA research projects, including TARs, may take only months, others need several years. They can cost from as little as £40,000 to over £1 million, and may involve synthesising existing evidence, undertaking a trial, or other research collecting new data to answer a research problem. The final reports from HTA projects are peer reviewed by a number of independent expert referees before publication in the widely read journal series Health Technology Assessment.
Health technology assessment (Winchester, England), 2015
Alcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patient... more Alcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patients who have been drinking to excess for prolonged periods, which is characterised by jaundice and liver failure. Severe disease is associated with high short-term mortality. Prednisolone and pentoxifylline (PTX) are recommended in guidelines for treatment of severe AH, but trials supporting their use have given heterogeneous results and controversy persists about their benefit. The aim of the clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis trial was to resolve the clinical dilemma on the use of prednisolone or PTX. The trial was a randomised, double-blind, 2 × 2 factorial, multicentre design. Sixty-five gastroenterology and hepatology inpatient units across the UK. Patients with a clinical diagnosis of AH who had a Maddrey's discriminant function value of ≥ 32 were randomised into four arms: A, placebo/placebo; B, placebo/prednisolon...
Uptake of preschool vaccinations is less than optimal. Financial incentives and quasi-mandatory p... more Uptake of preschool vaccinations is less than optimal. Financial incentives and quasi-mandatory policies (restricting access to child care or educational settings to fully vaccinated children) have been used to increase uptake internationally, but not in the UK. To provide evidence on the effectiveness, acceptability and economic costs and consequences of parental financial incentives and quasi-mandatory schemes for increasing the uptake of preschool vaccinations. Systematic review, qualitative study and discrete choice experiment (DCE) with questionnaire. Community, health and education settings in England. Qualitative study - parents and carers of preschool children, health and educational professionals. DCE - parents and carers of preschool children identified as 'at high risk' and 'not at high risk' of incompletely vaccinating their children. Qualitative study - focus groups and individual interviews. DCE - online questionnaire. The review included studies exploring the effectiveness, acceptability or economic costs and consequences of interventions that offered contingent rewards or penalties with real material value for preschool vaccinations, or quasi-mandatory schemes that restricted access to 'universal' services, compared with usual care or no intervention. Electronic database, reference and citation searches were conducted. Systematic review - there was insufficient evidence to conclude that the interventions considered are effective. There was some evidence that the quasi-mandatory interventions were acceptable. There was insufficient evidence to draw conclusions on economic costs and consequences. Qualitative study - there was little appetite for parental financial incentives. Quasi-mandatory schemes were more acceptable. Optimising current services was consistently preferred to the interventions proposed. DCE and questionnaire - universal parental financial incentives were preferred to quasi-mandatory interventions, which were preferred to targeted incentives. Those reporting that they would need an incentive to vaccinate their children completely required around £110. Those who did not felt that the maximum acceptable incentive was around £70. Systematic review - a number of relevant studies were excluded as they did not meet the study design inclusion criteria. Qualitative study - few partially and non-vaccinating parents were recruited. DCE and questionnaire - data were from a convenience sample. There is little current evidence on the effectiveness or economic costs and consequences of parental financial incentives and quasi-mandatory interventions for preschool vaccinations. Universal incentives are likely to be more acceptable than targeted ones. Preferences concerning incentives versus quasi-mandatory interventions may depend on the context in which these are elicited. Further evidence is required on (i) the effectiveness and optimal configuration of parental financial incentive and quasi-mandatory interventions for preschool vaccinations - if effectiveness is confirmed, further evidence is required on how to communicate this to stakeholders and the impact on acceptability; and (ii) the acceptability of parental financial incentive and quasi-mandatory interventions for preschool vaccinations to members of the population who are not parents of preschool children or relevant health professionals. Further consideration should be given to (i) incorporating reasons for non-vaccination into new interventions for promoting vaccination uptake; and (ii) how existing services can be optimised. This study is registered as PROSPERO CRD42012003192. The National Institute for Health Research Health Technology Assessment programme.
Health technology assessment (Winchester, England), 2008
To determine the clinical effectiveness and cost utility of procedures alternative to TURP (trans... more To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments. Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs). Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Cost-effectiveness was assessed using a Markov model reflecting likely care pathways. 156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12-234). TURP provided consistent, high-level, long-term symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation o...
Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patie... more Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patients meeting specific criteria. Approximately 12% of eligible patients in England, Wales and Northern Ireland received thrombolysis in the first quarter of 2013, yet as many as 15% are eligible to receive treatment. Suboptimal use of thrombolysis may have been largely attributable to structural factors; however, with the widespread implementation of 24/7 hyper acute stroke services, continuing variation is likely to reflect differences in clinical decision-making, in particular the influence of ambiguous areas within the guidelines, licensing criteria and research evidence. Clinicians' perceptions about thrombolysis may now exert a greater influence on treatment rates than structural/service factors. This research seeks to elucidate factors influencing thrombolysis decision-making by using patient vignettes to identify (1) patient-related and clinician-related factors that may help to...
To determine whether internal limiting membrane (ILM) peeling is effective and cost effective com... more To determine whether internal limiting membrane (ILM) peeling is effective and cost effective compared with no peeling in patients with idiopathic stage 2 or 3 full-thickness maculay hole (FTMH). This was a pragmatic multicenter randomized controlled trial. Eligible participants from nine centers were randomized to ILM peeling or no peeling (1:1 ratio) in addition to phacovitrectomy, including detachment and removal of the posterior hyaloid and gas tamponade. The primary outcome was distance visual acuity (VA) at 6 months after surgery. Secondary outcomes included hole closure, distance VA at other time points, near VA, contrast sensitivity, reading speed, reoperations, complications, resource use, and participant-reported health status, visual function, and costs. Of 141 participants randomized in nine centers, 127 (90%) completed the 6-month follow-up. Nonstatistically significant differences in distance visual acuity at 6 months were found between groups (mean difference, 4.8; 95% confidence interval [CI], -0.3 to 9.8; P = 0.063). There was a significantly higher rate of hole closure in the ILM-peel group (56 [84%] vs. 31 [48%]) at 1 month (odds ratio [OR], 6.23; 95% CI, 2.64-14.73; P < 0.001) with fewer reoperations (8 [12%] vs. 31 [48%]) performed by 6 months (OR, 0.14; 95% CI, 0.05-0.34; P < 0.001). Peeling the ILM is likely to be cost effective. There was no evidence of a difference in distance VA after the ILM peeling and no-ILM peeling techniques. An important benefit in favor of no ILM peeling was ruled out. Given the higher anatomic closure and lower reoperation rates in the ILM-peel group, ILM peeling seems to be the treatment of choice for idiopathic stage 2 to 3 FTMH. (Clinical Trials.gov number, NCT00286507.).
Background: Access and equity in children's therapy services may be improved by directing clinici... more Background: Access and equity in children's therapy services may be improved by directing clinicians' use of resources toward specific goals that are important to patients. A practice-change intervention (titled 'Good Goals') was designed to achieve this. This study investigated uptake, adoption, and possible effects of that intervention in children's occupational therapy services.
Expert Review of Pharmacoeconomics & Outcomes Research, 2009
The goal of improving the health status of people living in developing countries has received inc... more The goal of improving the health status of people living in developing countries has received increasing priority in recent years. To achieve this goal, evidence is needed regarding methods for optimal allocation of expenditure within particular program areas. Among several competing programs, a commitment has been made to improve maternal health as part of the Millennium Development Goal targets. While there is a growing body of cost-effectiveness evidence relating to maternal healthcare programs, underutilization of services is still pervasive, especially among poorer groups of the population. A major reason for such underutilization lies in underlying adverse socioeconomic factors, or barriers, which impede healthcare use. This article reviews the evidence from studies that have conducted multivariate analyses to quantify the effects of education, economic status and distance barriers on service use. It is concluded that it is not possible to state categorically whether one particular barrier is more important than others and that efforts should continue to consider demand-side barriers more fully, along with supply-side barriers.
To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no ... more To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no peeling for patients with an idiopathic stage 2 or 3 full-thickness macular hole. A cost-effectiveness analysis was performed alongside a randomised controlled trial. 141 participants were randomly allocated to receive macular-hole surgery, with either ILM peeling or no peeling. Health-service resource use, costs and quality of life were calculated for each participant. The incremental cost per quality-adjusted life year (QALY) gained was calculated at 6 months. At 6 months, the total costs were on average higher (£424, 95% CI -182 to 1045) in the No Peel arm, primarily owing to the higher reoperation rate in the No Peel arm. The mean additional QALYs from ILM peel at 6 months were 0.002 (95% CI 0.01 to 0.013), adjusting for baseline EQ-5D and other minimisation factors. A mean incremental cost per QALY was not computed, as Peeling was on average less costly and slightly more effective. A stochastic analysis suggested that there was more than a 90% probability that Peeling would be cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Although there is no evidence of a statistically significant difference in either costs or QALYs between macular hole surgery with or without ILM peeling, the balance of probabilities is that ILM Peeling is likely to be a cost-effective option for the treatment of macular holes. Further long-term follow-up data are needed to confirm these findings.
Purpose To validate the predictive power for determining breast cancer risk of an automated breas... more Purpose To validate the predictive power for determining breast cancer risk of an automated breast density measurement system with full-fi eld digital mammography (FFDM). Materials and methods Two hundred cancers and 200 controls were imaged with FFDM. Density was measured separately on MLO and CC images using an integral automated volumetric breast density measurement system (Hologic, Quantra). For each cancer, the contralateral mammogram was used. Each cancer was matched to a control case by date of birth, age at examination and laterality of mammogram used for density determination. Breast density (percentage of fi broglandular tissue) was analyzed by Quantra. Data were analyzed by conditional logistic regression to determine the eff ect on breast cancer risk. Results The percentage of breast density ranged from 6% to 63%. Density declined signifi cantly with age (P <0.001). Overall, there was no signifi cant association of density with risk of breast cancer (P = 0.4). There was a suggestive increase in risk with dense volume higher than 35% (OR = 1.80, 95% CI = 0.96 to 3.39, P = 0.07). There was signifi cant heterogeneity by age in the eff ect of density on risk (P = 0.04). In women aged <50, density was signifi cantly associated with increased risk (P = 0.02), with odds ratios of 6.06, 3.98 and 10.59 for density volumes of 15 to 24%, 25 to 34% and ≥35% respectively, relative to those with <15%. In women aged ≥50 years there was no association of density with risk (P = 0.5). Conclusions Quantra automated volumetric breast density measurement is strongly associated with breast cancer risk in women aged under 50, but not in women aged ≥50 years or over.
BJOG: An International Journal of Obstetrics & Gynaecology, 2009
Objective: To provide evidence on outcomes of importance to women who have stress urinary inconti... more Objective: To provide evidence on outcomes of importance to women who have stress urinary incontinence (SUI). The secondary aim was to identify additional outcomes that ought to be collected in future primary studies or in systematic reviews of the literature.
Only a limited number of studies have specifically sought to analyse and try to understand sex di... more Only a limited number of studies have specifically sought to analyse and try to understand sex differences in willingness to pay (WTP). To identify the role of sex in determining monetary values placed upon improvements in maternal health in Burkina Faso, West Africa. A contingent valuation survey using the bidding game method was conducted in the district of Nouna in 2005; a sample of 409 male heads of households and their spouses were asked their WTP for a reduction in the number of maternal deaths in the Nouna area. Ordinary least squares regression analysis was employed to examine the determinants of WTP. Men were willing to pay significantly more than women (3127 vs 2273 West African francs), although this represented a significantly smaller proportion of their annual income (4% vs 11%). In the multivariate analyses of all respondents there was a significant positive relationship between WTP values and both starting bid and whether there had been a previous maternal complication in the respondent&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s household. However, there was a significant negative relationship between WTP and female sex. Once interactions between sex and income were taken into account, income did affect valuations, with a positive relationship between higher-income women and WTP values. In absolute terms, men were willing to pay more than women, while women were willing to pay a greater proportion of their income. Differences between men and women in their WTP, both in absolute terms and in terms of proportion of income, can be explained by a household effect. Future studies should distinguish between individual income and command over decision making with respect to use of individual and household income, and gain further insight into the strategies used by respondents in answering bidding game questions.
Clean intermittent self-catheterisation is an important management option for people who cannot e... more Clean intermittent self-catheterisation is an important management option for people who cannot empty their bladder effectively. Recurrent urinary tract infections are common in these patients. Data from recent studies suggest that antibiotic prophylaxis may be beneficial in reducing infection risk, but the effectiveness of this intervention remains uncertain. This is a 52-site, patient randomised superiority trial set in routine care comparing an experimental strategy of once daily antibiotic prophylaxis for 12 months against a control strategy of no prophylaxis in people who carry out self-catheterisation and suffer recurrent urinary tract infections. The primary outcome is number of urinary tract infections during a 12-month treatment period. Both groups will otherwise receive usual care including on demand treatment courses of antibiotics for urinary tract infection. Participants and their clinicians will not be blinded to the allocated intervention, but central trial staff mana...
Research (NIHR), was set up in 1993. It produces high-quality research information on the effecti... more Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in the NHS, from the public and consumer groups and from professional bodies such as royal colleges and NHS trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service users). The HTA programme then commissions the research by competitive tender. Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme commissions bespoke reports, principally for NICE, but also for other policy-makers. TARs bring together evidence on the value of specific technologies. Some HTA research projects, including TARs, may take only months, others need several years. They can cost from as little as £40,000 to over £1 million, and may involve synthesising existing evidence, undertaking a trial, or other research collecting new data to answer a research problem. The final reports from HTA projects are peer reviewed by a number of independent expert referees before publication in the widely read journal series Health Technology Assessment.
Health technology assessment (Winchester, England), 2015
Alcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patient... more Alcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patients who have been drinking to excess for prolonged periods, which is characterised by jaundice and liver failure. Severe disease is associated with high short-term mortality. Prednisolone and pentoxifylline (PTX) are recommended in guidelines for treatment of severe AH, but trials supporting their use have given heterogeneous results and controversy persists about their benefit. The aim of the clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis trial was to resolve the clinical dilemma on the use of prednisolone or PTX. The trial was a randomised, double-blind, 2 × 2 factorial, multicentre design. Sixty-five gastroenterology and hepatology inpatient units across the UK. Patients with a clinical diagnosis of AH who had a Maddrey's discriminant function value of ≥ 32 were randomised into four arms: A, placebo/placebo; B, placebo/prednisolon...
Uptake of preschool vaccinations is less than optimal. Financial incentives and quasi-mandatory p... more Uptake of preschool vaccinations is less than optimal. Financial incentives and quasi-mandatory policies (restricting access to child care or educational settings to fully vaccinated children) have been used to increase uptake internationally, but not in the UK. To provide evidence on the effectiveness, acceptability and economic costs and consequences of parental financial incentives and quasi-mandatory schemes for increasing the uptake of preschool vaccinations. Systematic review, qualitative study and discrete choice experiment (DCE) with questionnaire. Community, health and education settings in England. Qualitative study - parents and carers of preschool children, health and educational professionals. DCE - parents and carers of preschool children identified as &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;at high risk&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;not at high risk&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; of incompletely vaccinating their children. Qualitative study - focus groups and individual interviews. DCE - online questionnaire. The review included studies exploring the effectiveness, acceptability or economic costs and consequences of interventions that offered contingent rewards or penalties with real material value for preschool vaccinations, or quasi-mandatory schemes that restricted access to &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;universal&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; services, compared with usual care or no intervention. Electronic database, reference and citation searches were conducted. Systematic review - there was insufficient evidence to conclude that the interventions considered are effective. There was some evidence that the quasi-mandatory interventions were acceptable. There was insufficient evidence to draw conclusions on economic costs and consequences. Qualitative study - there was little appetite for parental financial incentives. Quasi-mandatory schemes were more acceptable. Optimising current services was consistently preferred to the interventions proposed. DCE and questionnaire - universal parental financial incentives were preferred to quasi-mandatory interventions, which were preferred to targeted incentives. Those reporting that they would need an incentive to vaccinate their children completely required around £110. Those who did not felt that the maximum acceptable incentive was around £70. Systematic review - a number of relevant studies were excluded as they did not meet the study design inclusion criteria. Qualitative study - few partially and non-vaccinating parents were recruited. DCE and questionnaire - data were from a convenience sample. There is little current evidence on the effectiveness or economic costs and consequences of parental financial incentives and quasi-mandatory interventions for preschool vaccinations. Universal incentives are likely to be more acceptable than targeted ones. Preferences concerning incentives versus quasi-mandatory interventions may depend on the context in which these are elicited. Further evidence is required on (i) the effectiveness and optimal configuration of parental financial incentive and quasi-mandatory interventions for preschool vaccinations - if effectiveness is confirmed, further evidence is required on how to communicate this to stakeholders and the impact on acceptability; and (ii) the acceptability of parental financial incentive and quasi-mandatory interventions for preschool vaccinations to members of the population who are not parents of preschool children or relevant health professionals. Further consideration should be given to (i) incorporating reasons for non-vaccination into new interventions for promoting vaccination uptake; and (ii) how existing services can be optimised. This study is registered as PROSPERO CRD42012003192. The National Institute for Health Research Health Technology Assessment programme.
Health technology assessment (Winchester, England), 2008
To determine the clinical effectiveness and cost utility of procedures alternative to TURP (trans... more To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments. Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs). Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Cost-effectiveness was assessed using a Markov model reflecting likely care pathways. 156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12-234). TURP provided consistent, high-level, long-term symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation o...
Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patie... more Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patients meeting specific criteria. Approximately 12% of eligible patients in England, Wales and Northern Ireland received thrombolysis in the first quarter of 2013, yet as many as 15% are eligible to receive treatment. Suboptimal use of thrombolysis may have been largely attributable to structural factors; however, with the widespread implementation of 24/7 hyper acute stroke services, continuing variation is likely to reflect differences in clinical decision-making, in particular the influence of ambiguous areas within the guidelines, licensing criteria and research evidence. Clinicians' perceptions about thrombolysis may now exert a greater influence on treatment rates than structural/service factors. This research seeks to elucidate factors influencing thrombolysis decision-making by using patient vignettes to identify (1) patient-related and clinician-related factors that may help to...
To determine whether internal limiting membrane (ILM) peeling is effective and cost effective com... more To determine whether internal limiting membrane (ILM) peeling is effective and cost effective compared with no peeling in patients with idiopathic stage 2 or 3 full-thickness maculay hole (FTMH). This was a pragmatic multicenter randomized controlled trial. Eligible participants from nine centers were randomized to ILM peeling or no peeling (1:1 ratio) in addition to phacovitrectomy, including detachment and removal of the posterior hyaloid and gas tamponade. The primary outcome was distance visual acuity (VA) at 6 months after surgery. Secondary outcomes included hole closure, distance VA at other time points, near VA, contrast sensitivity, reading speed, reoperations, complications, resource use, and participant-reported health status, visual function, and costs. Of 141 participants randomized in nine centers, 127 (90%) completed the 6-month follow-up. Nonstatistically significant differences in distance visual acuity at 6 months were found between groups (mean difference, 4.8; 95% confidence interval [CI], -0.3 to 9.8; P = 0.063). There was a significantly higher rate of hole closure in the ILM-peel group (56 [84%] vs. 31 [48%]) at 1 month (odds ratio [OR], 6.23; 95% CI, 2.64-14.73; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) with fewer reoperations (8 [12%] vs. 31 [48%]) performed by 6 months (OR, 0.14; 95% CI, 0.05-0.34; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Peeling the ILM is likely to be cost effective. There was no evidence of a difference in distance VA after the ILM peeling and no-ILM peeling techniques. An important benefit in favor of no ILM peeling was ruled out. Given the higher anatomic closure and lower reoperation rates in the ILM-peel group, ILM peeling seems to be the treatment of choice for idiopathic stage 2 to 3 FTMH. (Clinical Trials.gov number, NCT00286507.).
Background: Access and equity in children's therapy services may be improved by directing clinici... more Background: Access and equity in children's therapy services may be improved by directing clinicians' use of resources toward specific goals that are important to patients. A practice-change intervention (titled 'Good Goals') was designed to achieve this. This study investigated uptake, adoption, and possible effects of that intervention in children's occupational therapy services.
Expert Review of Pharmacoeconomics & Outcomes Research, 2009
The goal of improving the health status of people living in developing countries has received inc... more The goal of improving the health status of people living in developing countries has received increasing priority in recent years. To achieve this goal, evidence is needed regarding methods for optimal allocation of expenditure within particular program areas. Among several competing programs, a commitment has been made to improve maternal health as part of the Millennium Development Goal targets. While there is a growing body of cost-effectiveness evidence relating to maternal healthcare programs, underutilization of services is still pervasive, especially among poorer groups of the population. A major reason for such underutilization lies in underlying adverse socioeconomic factors, or barriers, which impede healthcare use. This article reviews the evidence from studies that have conducted multivariate analyses to quantify the effects of education, economic status and distance barriers on service use. It is concluded that it is not possible to state categorically whether one particular barrier is more important than others and that efforts should continue to consider demand-side barriers more fully, along with supply-side barriers.
To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no ... more To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no peeling for patients with an idiopathic stage 2 or 3 full-thickness macular hole. A cost-effectiveness analysis was performed alongside a randomised controlled trial. 141 participants were randomly allocated to receive macular-hole surgery, with either ILM peeling or no peeling. Health-service resource use, costs and quality of life were calculated for each participant. The incremental cost per quality-adjusted life year (QALY) gained was calculated at 6 months. At 6 months, the total costs were on average higher (£424, 95% CI -182 to 1045) in the No Peel arm, primarily owing to the higher reoperation rate in the No Peel arm. The mean additional QALYs from ILM peel at 6 months were 0.002 (95% CI 0.01 to 0.013), adjusting for baseline EQ-5D and other minimisation factors. A mean incremental cost per QALY was not computed, as Peeling was on average less costly and slightly more effective. A stochastic analysis suggested that there was more than a 90% probability that Peeling would be cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Although there is no evidence of a statistically significant difference in either costs or QALYs between macular hole surgery with or without ILM peeling, the balance of probabilities is that ILM Peeling is likely to be a cost-effective option for the treatment of macular holes. Further long-term follow-up data are needed to confirm these findings.
Purpose To validate the predictive power for determining breast cancer risk of an automated breas... more Purpose To validate the predictive power for determining breast cancer risk of an automated breast density measurement system with full-fi eld digital mammography (FFDM). Materials and methods Two hundred cancers and 200 controls were imaged with FFDM. Density was measured separately on MLO and CC images using an integral automated volumetric breast density measurement system (Hologic, Quantra). For each cancer, the contralateral mammogram was used. Each cancer was matched to a control case by date of birth, age at examination and laterality of mammogram used for density determination. Breast density (percentage of fi broglandular tissue) was analyzed by Quantra. Data were analyzed by conditional logistic regression to determine the eff ect on breast cancer risk. Results The percentage of breast density ranged from 6% to 63%. Density declined signifi cantly with age (P <0.001). Overall, there was no signifi cant association of density with risk of breast cancer (P = 0.4). There was a suggestive increase in risk with dense volume higher than 35% (OR = 1.80, 95% CI = 0.96 to 3.39, P = 0.07). There was signifi cant heterogeneity by age in the eff ect of density on risk (P = 0.04). In women aged <50, density was signifi cantly associated with increased risk (P = 0.02), with odds ratios of 6.06, 3.98 and 10.59 for density volumes of 15 to 24%, 25 to 34% and ≥35% respectively, relative to those with <15%. In women aged ≥50 years there was no association of density with risk (P = 0.5). Conclusions Quantra automated volumetric breast density measurement is strongly associated with breast cancer risk in women aged under 50, but not in women aged ≥50 years or over.
BJOG: An International Journal of Obstetrics & Gynaecology, 2009
Objective: To provide evidence on outcomes of importance to women who have stress urinary inconti... more Objective: To provide evidence on outcomes of importance to women who have stress urinary incontinence (SUI). The secondary aim was to identify additional outcomes that ought to be collected in future primary studies or in systematic reviews of the literature.
Only a limited number of studies have specifically sought to analyse and try to understand sex di... more Only a limited number of studies have specifically sought to analyse and try to understand sex differences in willingness to pay (WTP). To identify the role of sex in determining monetary values placed upon improvements in maternal health in Burkina Faso, West Africa. A contingent valuation survey using the bidding game method was conducted in the district of Nouna in 2005; a sample of 409 male heads of households and their spouses were asked their WTP for a reduction in the number of maternal deaths in the Nouna area. Ordinary least squares regression analysis was employed to examine the determinants of WTP. Men were willing to pay significantly more than women (3127 vs 2273 West African francs), although this represented a significantly smaller proportion of their annual income (4% vs 11%). In the multivariate analyses of all respondents there was a significant positive relationship between WTP values and both starting bid and whether there had been a previous maternal complication in the respondent&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s household. However, there was a significant negative relationship between WTP and female sex. Once interactions between sex and income were taken into account, income did affect valuations, with a positive relationship between higher-income women and WTP values. In absolute terms, men were willing to pay more than women, while women were willing to pay a greater proportion of their income. Differences between men and women in their WTP, both in absolute terms and in terms of proportion of income, can be explained by a household effect. Future studies should distinguish between individual income and command over decision making with respect to use of individual and household income, and gain further insight into the strategies used by respondents in answering bidding game questions.
Clean intermittent self-catheterisation is an important management option for people who cannot e... more Clean intermittent self-catheterisation is an important management option for people who cannot empty their bladder effectively. Recurrent urinary tract infections are common in these patients. Data from recent studies suggest that antibiotic prophylaxis may be beneficial in reducing infection risk, but the effectiveness of this intervention remains uncertain. This is a 52-site, patient randomised superiority trial set in routine care comparing an experimental strategy of once daily antibiotic prophylaxis for 12 months against a control strategy of no prophylaxis in people who carry out self-catheterisation and suffer recurrent urinary tract infections. The primary outcome is number of urinary tract infections during a 12-month treatment period. Both groups will otherwise receive usual care including on demand treatment courses of antibiotics for urinary tract infection. Participants and their clinicians will not be blinded to the allocated intervention, but central trial staff mana...
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