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To systematically review methods developed and employed to evaluate the diagnostic accuracy of medical test when there is a missing or no gold standard. Articles that proposed or applied any methods to evaluate the diagnostic accuracy of medical test(s) in the absence of gold standard were reviewed. The protocol for this review was registered in PROSPERO (CRD42018089349). Identified methods were classified into four main groups: methods employed when there is a missing gold standard; correction methods (which make adjustment for an imperfect reference standard with known diagnostic accuracy measures); methods employed to evaluate a medical test using multiple imperfect reference standards; and other methods, like agreement studies, and a mixed group of alternative study designs. Fifty-one statistical methods were identified from the review that were developed to evaluate medical test(s) when the true disease status of some participants is unverified with the gold standard. Seven correction methods were identified and four methods were identified to evaluate medical test(s) using multiple imperfect reference standards. Flow-diagrams were developed to guide the selection of appropriate methods. Various methods have been proposed to evaluate medical test(s) in the absence of a gold standard for some or all participants in a diagnostic accuracy study. These methods depend on the availability of the gold standard, its' application to the participants in the study and the availability of alternative reference standard(s). The clinical application of some of these methods, especially methods developed when there is missing gold standard is however limited. This may be due to the complexity of these methods and/or a disconnection between the fields of expertise of those who develop (e.g. mathematicians) and those who employ the methods (e.g. clinical researchers). This review aims to help close this gap with our classification and guidance tools.

Linking routinely collected health care system data records for the same individual across different services and over time has enormous potential for the NHS and its patients. The aims of this data linkage study are to quantify the changes to mental health services utilisation in responses to the COVID-19 pandemic and determine whether these changes were associated with health-related outcomes and wellbeing among people living in the most deprived communities in North East and North Cumbria, England. We will assemble a retrospective cohort of people having referred or self-referred to NHS-funded mental health services or Improving Access to Psychological Therapies (IAPT) services between 23rd March 2019 and 22nd March 2020 in the most deprived areas in England. We will link together data from retrospective routinely collected healthcare data including local general practitioner (GP) practice data, Hospital Episode Statistics admitted patient care outpatients, and A&E, Community Services Data Set, Mental Health Services Data Set, and Improving Access to Psychological Therapies Data Set. We will use these linked patient-level data to 1) describe the characteristics of the cohort prior to the lockdown; 2) investigate changes to mental health services utilised between multiple time periods of the COVID-19 lockdown including out of lockdown; 3) explore the relationship between these changes and health outcomes/wellbeing and factors that confound and mediate this relationship among this cohort. This study comprises a deprived population-based cohort of people having referred or self-referred to NHS-funded secondary mental health services or Improving Access to Psychological Therapies (IAPT) services over an extended period of the lockdown in England (2019-2022).This study will utilise a new longitudinal data resource that will link together detailed data from a cohort of individual participants and retrospective administrative data relating to the use of primary, secondary, and community care services.The study period covers pre-lockdown, different lockdown and post-lockdown, and out of lockdown periods up to March 2022.Routinely collected administrative data contain limited contextual information and represent an underestimate of total health outcomes for these individuals.Routinely collected datasets can often been incomplete or contain missing data, which can make it difficult to accurately analyse the data and draw meaningful conclusions.Intervention and treatment for mental health conditions are not wholly captured across these data sources and may impact health outcomes.

Diabetic retinopathy (DR), a prevalent microvascular complication of diabetes mellitus (DM), can be prevented with early detection and timely intervention. DR is asymptomatic in its early stages, highlighting the importance of screening for accurate referral and effective management. Multiple barriers impede access to diabetic retinopathy screening (DRS), creating significant public health challenges in regions with high DM prevalence. This study explores the perspectives of people with DM (PwDM) and healthcare providers (HCP) on these barriers. A qualitative study using in-depth interviews (IDI) was conducted between October 2022 and January 2023 in Punjab and Chandigarh. Through purposive sampling, IDIs were conducted with 7 PwDM and 19 HCPs, including retina specialists, ophthalmologists, optometrists, medical officers (MO), Community Health Officers (CHO), and ASHA workers from various public health facilities. A semi-structured topic guide facilitated the interviews, and thematic analysis was applied, utilizing the healthcare access barrier (HCAB) model as a framework. The study identified financial barriers due to insurance unawareness and employment constraints. Structural challenges included insufficient DRS infrastructure, untrained staff, the need for accompaniment, and limited access to screening sites. Limited awareness and misconceptions about DR characterized cognitive barriers, while psychological barriers involved mistrust of the health system, anxiety, and frustration from low vision. Addressing these issues is essential to improve DRS uptake and eye health outcomes. Managing diabetes and VTDR is challenging, highlighting the need for community-level DRS. Enhancing DR awareness and promoting public health insurance benefits are crucial for overcoming barriers and improving screening rates.

Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital. We aimed to establish whether short-term routine use of antimicrobial catheters reduced risk of CAUTI compared with standard polytetrafluoroethylene (PTFE) catheterisation. In our parallel, three group, multicentre, randomised controlled superiority trial, we enrolled adults (aged ≥16 years) requiring short-term (≤14 days) catheterisation at 24 hospitals in the UK. Participants were randomly allocated 1:1:1 with a remote computer allocation to receive a silver alloy-coated catheter, a nitrofural-impregnated catheter, or a PTFE-coated catheter (control group). Patients undergoing unplanned catheterisation were also included and consent for participation was obtained retrospectively. Participants and trial staff were unmasked to treatment assignment. Data were collected by trial staff and by patient-reported questionnaires for 6 weeks after randomisation. The primary outcome was incidence of symptomatic urinary tract infection for which an antibiotic was prescribed by 6 weeks. We postulated that a 3·3% absolute reduction in CAUTI would represent sufficient benefit to recommend routine use of antimicrobial catheters. This study is registered, number ISRCTN75198618. 708 (10%) of 7102 randomly allocated participants were not catheterised, did not confirm consent, or withdrew, and were not included in the primary analyses. Compared with 271 (12·6%) of 2144 participants in the control group, 263 (12·5%) of 2097 participants allocated a silver alloy catheter had the primary outcome (difference −0·1% [95% CI −2·4 to 2·2]), as did 228 (10·6%) of 2153 participants allocated a nitrofural catheter (−2·1% [−4·2 to 0·1]). Rates of catheter-related discomfort were higher in the nitrofural group than they were in the other groups. Silver alloy-coated catheters were not effective for reduction of incidence of symptomatic CAUTI. The reduction we noted in CAUTI associated with nitrofural-impregnated catheters was less than that regarded as clinically important. Routine use of antimicrobial-impregnated catheters is not supported by this trial. UK National Institute for Health Research Health Technology Assessment Programme.

It is unclear what biopsychosocial factors influence the impact of NAFLD on health-related quality of life (HRQoL), and if these factors are equally important predictors between different nationalities. HRQoL (CLDQ) was measured in both Southern European (Spain, n = 513) and Northern European (United Kingdom -UK-, n = 224) cohorts of patients with NAFLD in this cross-sectional study. For each cohort, participant data were recorded on histological grade of steatohepatitis, stage of fibrosis and biopsychosocial variables. Regression analysis was used to explore which of these variables predicted HRQoL. Moderated mediation models were conducted using SPSS PROCESS v3.5 macro. Participants with severe fibrosis reported more fatigue, systemic symptoms and worry, and lower HRQoL than those with none/mild fibrosis, regardless of place of origin. In addition, body mass index (BMI) and gender were found to be significant predictors of HRQoL in both Spanish and UK participants. Female gender was associated with worse emotional function, higher BMI and more fatigue, which predicted lower participants' HRQoL. UK participants showed more systemic symptoms and worry than Spanish participants, regardless of liver severity. The negative effects of gender on HRQoL through emotional function, BMI and fatigue were reported to a greater degree in UK than in Spanish participants. UK participants showed a greater impairment in HRQoL as compared to Spanish participants. Higher fibrosis stage predicted lower HRQoL, mainly in the Spanish cohort. Factors such as female gender or higher BMI contributed to the impact on HRQoL in both cohorts of patients and should be considered in future multinational intervention studies in NAFLD.

Background Glioma are infiltrative primary brain tumours, which despite treatment, lead to a substantial reduction in life expectancy. Seizures are a common symptom of glioma, and have a serious impact on patient health related quality of life (HRQoL). Objective The study aimed to estimate health state utility values for different types of seizures related to glioma, a serious type of brain tumour. Methods Vignettes for the different health states were initially developed from the existing literature. The health states were then refined in collaboration with patients with previous experience of seizures and clinicians experienced in treating patients with seizures. The final vignettes represented three types of acute seizure: focal aware, focal impaired awareness and tonic clonic and several different health states which combined these acute seizures with other aspects of HRQoL. These vignettes were evaluated by a sample of the UK general public using an online survey and analysed descriptively using the mean and standard deviation. Results 302 participants, representative of the UK general population in terms of age, sex and geographical region, were included in the estimation sample. For the health states representing acute seizures, the focal aware seizure had the highest mean utility value (0.607), followed by the impaired awareness seizure (0.593) and the tonic clonic seizure (0.522). For the health states that also incorporated wider aspects of HRQoL, the health state utility values ranged from 0.504 (one focal aware seizure per year) to 0.337 (at least one focal impaired awareness seizure per week). Conclusions Seizures may have a major impact of the HRQoL of patients with glioma. The utility values obtained in the study may be used in future economic evaluations of interventions related to glioma where seizures are either a primary clinical outcome or an adverse event.

Background The majority of patient reported outcome measures (PROMs) don’t have population norms in Romania. This is the case with the EQ-5D as well. Therefore, we aimed to estimate population norms for the Romanian versions of the EQ-5D-5L, EQ-5D-3L, their indexes, and the EQ-VAS. Methods A cross-sectional survey was conducted in all regions of Romania from November 2018 to November 2019. A three-stage probability sampling procedure stratified by region and settlement size was used to select a representative sample. Interviews were computer-assisted and conducted in respondents’ homes by trained interviewers. Health status was assessed with the EQ-5D-5L, the EQ-5D-3L and the EQ VAS. Descriptive statistics were used to estimate population norms by age groups and sex for the EQ-5D-5L, the EQ-5D-3L, their indexes and the EQ VAS. Population norms were weighted using survey weights. Indexes for the EQ-5D questionnaires were estimated using the recently developed Romanian value sets. Results Data from 1,649 interviews was analysed in the present study. Survey weights were used so that sex and place of residence ratios for the weighted sample matched the Romanian general population distribution. Participants’ mean age was 47.4 years (SE = 1.157) and 50.3% of them reported being in good health. The dimension for which people reported the highest number of problems for both questionnaires was the pain/discomfort dimension. Men aged 35 plus reported fewer problems with pain/discomfort than women for both the EQ-5D-5L and EQ-5D-3L. Health decreased with age as shown by the decrease from age group 18–24 to age group 75 plus in the indexes of both questionnaires: from 0.977 (SE = 0.005) to 0.765 (SE = 0.017) for EQ-5D-5L and from 0.981 (SE = 0.005) to 0.784 (SE = 0.019) for EQ-5D-3L. There was 29.9 points drop in the EQ VAS score between the youngest and oldest group. Conclusions Population norms for the Romanian versions of the EQ-5D-5L, EQ-5D-3L, their indexes, and the EQ VAS are now available. These can now be used as reference values by healthcare professionals, researchers and decision-makers leading to a further development of health-related quality of life research in Romania.

Background Economic evaluations that include the patient perspective often base their estimates of patient time and travel costs on data collected at a single point in time. This, however, may be inaccurate if the costs of accessing care change substantially over time, as may be the case for young people in transition from paediatric to adult health services. Aims The aim of this study was to explore the differences in these time and travel costs between two data collection points for young individuals in transition between health care services, and thus to provide an insight of whether such costs should be collected more than once. Methods Descriptive statistics and regression modelling were used to estimate the average difference in costs between the two points of data collection, as well as the potential drivers of those cost differences. Results We found a small difference in costs between the two time points, equal to -£45.78 [95% CI: − 89.70 to − 1.86]. The results were largely driven by changes in the unit cost of visits and in the number of attendances. Conclusions A simple and common assumption that patient costs could be collected at a single time point cannot be made in the context of our study. When deciding on the frequency of elicitation of patient costs, future studies should consider the relative impacts of additional data collection on the estimates of efficiency, inequalities and resource implications for collecting new data.

IntroductionWomen and their infants are at increased risk of complications if gestational diabetes mellitus (GDM) or excessive gestational weight gain (GWG) occurs in pregnancy. Weight management interventions in pregnancy, consisting of diet and physical activity components are targeted based on maternal body mass index (BMI). However, the relative effectiveness of interventions targeted based on alternative measures of adiposity to BMI is unclear. This individual patient data (IPD) meta-analysis aims to explore whether interventions are more effective at preventing GDM and reducing GWG in women according to their level of adiposity.MethodsThe International Weight Management in Pregnancy Collaborative Network has a living database of IPD from randomised trials of diet and/or physical activity interventions in pregnancy. This IPD meta-analysis will use IPD from trials identified from systematic literature searches up until March 2021, where maternal adiposity measures (eg, waist circumference) were collected prior to 20 weeks’ gestation. A two-stage random effects IPD meta-analysis approach will be taken for each outcome (GDM and GWG) to understand the effect of early pregnancy adiposity measures on the effect of weight management interventions for GDM prevention and GWG reduction. Summary intervention effects with 95% CIs) will be derived along with treatment covariate interactions. Between-study heterogeneity will be summarised by I2 and tau2 statistics. Potential sources of bias will be evaluated, and the nature of any missing data will be explored and appropriate imputation methods adopted.Ethics and disseminationEthics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42021282036). Results will be submitted to peer-reviewed journals.PROSPERO registration numberCRD42021282036.