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. Design Questionnaire survey of a cohort of women with SUI. Setting UK. Sample A total of 188 women with SUI. Methods Areas of importance to women who suffer from SUI were assessed using a patient generated index (PGI). In addition to the PGI, the questionnaire included the King’s Health Questionnaire (KHQ) and the EuroQol‐5D (EQ‐5D). Main outcome measures PGI, EQ‐5D and the KHQ. Results In total, 38 different areas were reported by respondents on the PGI. PGI and EQ‐5D scores were positively correlated and significant. Correlations between the seven domains of the KHQ and PGI were all negative, but only two were statistically significant: personal relationships and severity measures. Conclusions The PGI succeeded in capturing a diverse range of outcomes of importance to women suffering with SUI. Given the limited correlation between the KHQ domains and the PGI and, in addition, that the areas mentioned in the PGI were not found to map well to the EQ‐5D, the PGI in this instance may be capturing concerns of women who suffer from SUI, which are not captured by quality‐of‐life measures such as the EQ‐5D.
Background The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking. Objective The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum. Design This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation. Setting The trial was set in 17 NHS secondary care hospitals in the UK. Participants A total of 378 eligible participants aged > 18 years were recruited. Interventions Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery ( n = 188) or (2) medical management with intranasal steroid spray and saline spray ( n = 190). Main outcome measures The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes – Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements – peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms. Results At the 6-month time point, 307 participants provided primary outcome data (septoplasty, n = 152; medical management, n = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were −20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was 39.5 (95% confidence interval −23.6 to −16.4; p < 0.0001)]. This was confirmed by sensitivity analyses and through the analysis of secondary outcomes. Outcomes were statistically significantly related to baseline severity, but not to gender or turbinate reduction. In the surgical and medical management arms, 132 and 95 adverse events occurred, respectively; 14 serious adverse events occurred in the surgical arm and nine in the medical management arm. On average, septoplasty was more costly and more effective in improving Sino-nasal Outcome Test-22 items scores and quality-adjusted life-years than medical management, but incurred a larger number of adverse events. Septoplasty had a 15% probability of being considered cost-effective at 12 months at a £20,000 willingness-to-pay threshold for an additional quality-adjusted life-year. This probability increased to 99% and 100% at 24 and 36 months, respectively. Limitations COVID-19 had an impact on participant-facing data collection from March 2020. Conclusions Septoplasty, with or without turbinate reduction, is more effective than medical management with a nasal steroid and saline spray. Baseline severity predicts the degree of improvement in symptoms. Septoplasty has a low probability of cost-effectiveness at 12 months, but may be considered cost-effective at 24 months. Future work should focus on developing a septoplasty patient decision aid. Trial registration This trial is registered as ISRCTN16168569 and EudraCT 2017-000893-12. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/226/07) and is published in full in Health Technology Assessment ; Vol. 28, No. 10. See the NIHR Funding and Awards website for further award information.
Background Following primary breast cancer treatment, the early detection of ipsilateral breast tumour recurrence (IBTR) or ipsilateral secondary cancer in the treated breast and detection of new primary cancers in the contralateral breast is beneficial for survival. Surveillance mammography is used to detect these cancers, but the optimal frequency of surveillance and the length of follow-up are unclear. Objectives To identify feasible management strategies for surveillance and follow-up of women after treatment for primary breast cancer in a UK setting, and to determine the effectiveness and cost-effectiveness of differing regimens. Methods A survey of UK breast surgeons and radiologists to identify current surveillance mammography regimens and inform feasible alternatives; two discrete systematic reviews of evidence published from 1990 to mid 2009 to determine (i) the clinical effectiveness and cost-effectiveness of differing surveillance mammography regimens for patient health outcomes and (ii) the test performance of surveillance mammography in the detection of IBTR and metachronous contralateral breast cancer (MCBC); statistical analysis of individual patient data (West Midlands Cancer Intelligence Unit Breast Cancer Registry and Edinburgh data sets); and economic modelling using the systematic reviews results, existing data sets, and focused searches for specific data analysis to determine the effectiveness and cost–utility of differing surveillance regimens. Results The majority of survey respondents initiate surveillance mammography 12 months after breast-conserving surgery (BCS) (87%) or mastectomy (79%). Annual surveillance mammography was most commonly reported for women after BCS or after mastectomy (72% and 53%, respectively). Most (74%) discharge women from surveillance mammography, most frequently 10 years after surgery. The majority (82%) discharge from clinical follow-up, most frequently at 5 years. Combining initiation, frequency and duration of surveillance mammography resulted in 54 differing surveillance regimens for women after BCS and 56 for women following mastectomy. The eight studies included in the clinical effectiveness systematic review suggest surveillance mammography offers a survival benefit compared with a surveillance regimen that does not include surveillance mammography. Nine studies were included in the test performance systematic review. For routine IBTR detection, surveillance mammography sensitivity ranged from 64% to 67% and specificity ranged from 85% to 97%. For magnetic resonance imaging (MRI), sensitivity ranged from 86% to 100% and specificity was 93%. For non-routine IBTR detection, sensitivity and specificity for surveillance mammography ranged from 50% to 83% and from 57% to 75%, respectively, and for MRI from 93% to 100% and from 88% to 96%, respectively. For routine MCBC detection, one study reported sensitivity of 67% and specificity of 50% for both surveillance mammography and MRI, although this was a highly select population. Data set analysis showed that IBTR has an adverse effect on survival. Furthermore, women experiencing a second tumour measuring > 20 mm in diameter were at a significantly greater risk of death than those with no recurrence or those whose tumour was < 10 mm in diameter. In the base-case analysis, the strategy with the highest net benefit, and most likely to be considered cost-effective, was surveillance mammography alone, provided every 12 months at a societal willingness to pay for a quality-adjusted life-year of either £20,000 or £30,000. The incremental cost-effectiveness ratio for surveillance mammography alone every 12 months compared with no surveillance was £4727. Limitations Few studies met the review inclusion criteria and none of the studies was a randomised controlled trial. The limited and variable nature of the data available precluded any quantitative analysis. There was no useable evidence contained in the Breast Cancer Registry database to assess the effectiveness of surveillance mammography directly. The results of the economic model should be considered exploratory and interpreted with caution given the paucity of data available to inform the economic model. Conclusions Surveillance is likely to improve survival and patients should gain maximum benefit through optimal use of resources, with those women with a greater likelihood of developing IBTR or MCBC being offered more comprehensive and more frequent surveillance. Further evidence is required to make a robust and informed judgement on the effectiveness of surveillance mammography and follow-up. The utility of national data sets could be improved and there is a need for high-quality, direct head-to-head studies comparing the diagnostic accuracy of tests used in the surveillance population. Funding The National Institute for Health Research Health Technology Assessment programme.
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.
Direct posterior dental restorations are commonly provided following management of dental caries. Amalgam use has been phased down and the feasibility of a phase-out by 2030 is being explored. Alternative direct restorative materials differ in their outcomes and provision. This research aimed to elicit the UK population’s preferences for different attributes of restorations and their willingness to pay (WTP) for restorative services and outcomes. A discrete choice experiment (DCE) was designed with patient and public involvement and distributed to a representative sample of the UK general population using an online survey. Respondents answered 17 choice tasks between pairs of scenarios that varied in levels of 7 attributes (wait for filling, clinician type, filling color, length of procedure, likely discomfort after filling, average life span of filling, and cost). An opt-out (no treatment) was included. Mixed logit models were used for data analysis. Marginal WTP for attribute levels and relative attribute importance were calculated. In total, 1,002 respondents completed the DCE. Overall, respondents were willing to pay £39.52 to reduce a 6-wk wait for treatment to 2 wk, £13.55 to have treatment by a dentist rather than a therapist, £41.66 to change filling color from silvery/gray to white, £0.27 per minute of reduced treatment time, £116.52 to move from persistent to no postoperative pain, and £5.44 per year of increased restoration longevity. Ability to pay affected willingness to pay, with low-income respondents more likely to opt out of treatment and value restoration color (white) and increased longevity significantly lower than those with higher income. Clinicians should understand potential drivers of restoration choice, so they can be discussed with individual patients to obtain consent. It is important that policy makers consider general population preferences for restorative outcomes and services, with an awareness of how income affects these, when considering the potential phase-out of amalgam restorations.
Abstract Background Parkinson’s disease (PD) is the second most common neurodegenerative disorder and, according to the Global Burden of Disease estimates in 2015, was the fastest growing neurological disorder globally with respect to associated prevalence, disability, and deaths. Information regarding the awareness, diagnosis, phenotypic characteristics, epidemiology, prevalence, risk factors, treatment, economic impact and lived experiences of people with PD from the African perspective is relatively sparse in contrast to the developed world, and much remains to be learned from, and about, the continent. Methods Transforming Parkinson’s Care in Africa (TraPCAf) is a multi-faceted, mixed-methods, multi-national research grant. The study design includes multiple sub-studies, combining observational (qualitative and quantitative) approaches for the epidemiological, clinical, risk factor and lived experience components, as appropriate, and interventional methods (clinical trial component). The aim of TraPCAf is to describe and gain a better understanding of the current situation of PD in Africa. The countries included in this National Institute for Health and Care Research (NIHR) Global Health Research Group (Egypt, Ethiopia, Ghana, Kenya, Nigeria, South Africa and Tanzania) represent diverse African geographies and genetic profiles, with differing resources, healthcare systems, health and social protection schemes, and policies. The research team is composed of experts in the field with vast experience in PD, jointly led by a UK-based and Africa-based investigator. Discussion Despite the increasing prevalence of PD globally, robust data on the disease from Africa are lacking. Existing data point towards the poor awareness of PD and other neurological disorders on the continent and subsequent challenges with stigma, and limited access to affordable services and medication. This multi-site study will be the first of its kind in Africa. The data collected across the proposed sub-studies will provide novel and conclusive insights into the situation of PD. The selected country sites will allow for useful comparisons and make results relevant to other low- and middle-income countries. This grant is timely, as global recognition of PD and the public health challenge it poses builds. The work will contribute to broader initiatives, including the World Health Organization’s Intersectoral global action plan on epilepsy and other neurological disorders. Trial registration https://doi.org/10.1186/ISRCTN77014546 .
Background Healthy behaviours are important determinants of health and disease, but many people find it difficult to perform these behaviours. Systematic reviews support the use of personal financial incentives to encourage healthy behaviours. There is concern that financial incentives may be unacceptable to the public, those delivering services and policymakers, but this has been poorly studied. Without widespread acceptability, financial incentives are unlikely to be widely implemented. We sought to answer two questions: what are the relative preferences of UK adults for attributes of financial incentives for healthy behaviours? Do preferences vary according to the respondents' socio-demographic characteristics? Methods We conducted an online discrete choice experiment. Participants were adult members of a market research panel living in the UK selected using quota sampling. Preferences were examined for financial incentives for: smoking cessation, regular physical activity, attendance for vaccination, and attendance for screening. Attributes of interest (and their levels) were: type of incentive (none, cash, shopping vouchers or lottery tickets); value of incentive (a continuous variable); schedule of incentive (same value each week, or value increases as behaviour change is sustained); other information provided (none, written information, face-to-face discussion, or both); and recipients (all eligible individuals, people living in low-income households, or pregnant women). Results Cash or shopping voucher incentives were preferred as much as, or more than, no incentive in all cases. Lower value incentives and those offered to all eligible individuals were preferred. Preferences for additional information provided alongside incentives varied between behaviours. Younger participants and men were more likely to prefer incentives. There were no clear differences in preference according to educational attainment. Conclusions Cash or shopping voucher-type financial incentives for healthy behaviours are not necessarily less acceptable than no incentives to UK adults.
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