Beč kao formativni prostor Branka Gavelle

Model used for data simulation. The Hussey and Hughes [8] mixed model and a simplified version corresponding to the parameters chosen for our data simulations. (DOCX 13 kb

Investigating harms of testing for ovarian cancer – psychological outcomes and cancer conversion rates in women with symptoms of ovarian cancer:A cohort study embedded in the multicentre ROCkeTS prospective diagnostic study

Objective: To investigate psychological correlates in women referred with suspected ovarian cancer via the fast‐track pathway, explore how anxiety and distress levels change at 12 months post‐testing, and report cancer conversion rates by age and referral pathway. Design: Single‐arm prospective cohort study. Setting: Multicentre. Secondary care including outpatient clinics and emergency admissions. Population: A cohort of 2596 newly presenting symptomatic women with a raised CA125 level, abnormal imaging or both. Methods: Women completed anxiety and distress questionnaires at recruitment and at 12 months for those who had not undergone surgery or a biopsy within 3 months of recruitment. Main outcome measures: Anxiety and distress levels measured using a six‐item short form of the State–Trait Anxiety Inventory (STAI‐6) and the Impact of Event Scale – Revised (IES‐r) questionnaire. Ovarian cancer (OC) conversion rates by age, menopausal status and referral pathway. Results: Overall, 1355/2596 (52.1%) and 1781/2596 (68.6%) experienced moderate‐to‐severe distress and anxiety, respectively, at recruitment. Younger age and emergency presentations had higher distress levels. The clinical category for anxiety and distress remained unchanged/worsened in 76% of respondents at 12 months, despite a non‐cancer diagnosis. The OC rates by age were 1.6% (95% CI 0.5%–5.9%) for ag

COVID 19:Seroprevalence and vaccine responses in UK dental care professionals

Dental care professionals (DCPs) are thought to be at enhanced risk of occupational exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, robust data to support this from large-scale seroepidemiological studies are lacking. We report a longitudinal seroprevalence analysis of antibodies to SARS-CoV-2 spike glycoprotein, with baseline sampling prior to large-scale practice reopening in July 2020 and follow-up postimplementation of new public health guidance on infection prevention control (IPC) and enhanced personal protective equipment (PPE). In total, 1,507 West Midlands DCPs were recruited into this study in June 2020. Baseline seroprevalence was determined using a combined IgGAM enzyme-linked immunosorbent assay and the cohort followed longitudinally for 6 mo until January/February 2021 through the second wave of the coronavirus disease 2019 pandemic in the United Kingdom and vaccination commencement. Baseline seroprevalence was 16.3%, compared to estimates in the regional population of 6% to 7%. Seropositivity was retained in over 70% of participants at 3- and 6-mo follow-up and conferred a 75% reduced risk of infection. Nonwhite ethnicity and living in areas of greater deprivation were associated with increased baseline seroprevalence. During follow-up, no polymerase chain reaction–proven infections occurred in individuals with a baseline anti–SARS-CoV-2 IgG level greater than 147.6 IU/ml with respect to the World Health Organization international standard 20-136. After vaccination, antibody responses were more rapid and of higher magnitude in those individuals who were seropositive at baseline. Natural infection with SARS-CoV-2 prior to enhanced PPE was significantly higher in DCPs than the regional population. Natural infection leads to a serological response that remains detectable in over 70% of individuals 6 mo after initial sampling and 9 mo from the peak of the first wave of the pandemic. This response is associated with protection from future infection. Even if serological responses wane, a single dose of the Pfizer-BioNTech 162b vaccine is associated with an antibody response indicative of immunological memory

The impact of an intervention to increase uptake to structured self-management education for people with type 2 diabetes mellitus in primary care (the embedding package), compared to usual care, on glycaemic control: study protocol for a mixed methods study incorporating a wait-list cluster randomised controlled trial

Abstract: Background: Approximately 425 million people globally have diabetes, with ~ 90% of these having Type 2 Diabetes Mellitus (T2DM). This is a condition that leads to a poor quality of life and increased risk of serious health complications. Structured self-management education (SSME) has been shown to be effective in improving glycaemic control and patient related outcome measures and to be cost-effective. However, despite the demonstrated benefits, attendance at SSME remains low. An intervention has been developed to embed SSME called the ‘Embedding Package’. The intervention aims to address barriers and enhance enablers to uptake of SSME at patient, healthcare professional and organisational levels. It comprises a marketing strategy, user friendly and effective referral pathways, new roles to champion SSME and a toolkit of resources. Methods: A mixed methods study incorporating a wait-list cluster randomised trial and ethnographic study, including 66 UK general practices, will be conducted with two intervention start times (at 0 and 9 months), each followed by an active delivery phase. At 18 months, the intervention will cease to be actively delivered and a 12 month observational follow-up phase will begin. The intervention, the Embedding Package, aims to increase SSME uptake and subsequent improvements in health outcomes, through a clear marketing strategy, user friendly and effective referral pathways, a local clinical champion and an ‘Embedder’ and a toolkit of resources for patients, healthcare professionals and other key stakeholders. The primary aim is, through increasing uptake to and attendance at SSME, to reduce HbA1c in people with T2DM compared with usual care. Secondary objectives include: assessing whether there is an increase in referral to and uptake of SSME and improvements in biomedical and psychosocial outcomes; an assessment of the sustainability of the Embedding Package; contextualising the process of implementation, sustainability of change and the ‘fit’ of the Embedding Package; and an assessment of the cost-effectiveness of the Embedding Package. Discussion: This study will assess the effectiveness, cost-effectiveness and sustainability of the Embedding Package, an intervention which aims to improve biomedical and psychosocial outcomes of people with T2DM, through increased referral to and uptake of SSME. Trial registration: International Standard Randomised Controlled Trials Number ISRCTN23474120. Assigned 05/04/2018. The study was prospectively registered. On submission of this manuscript practice recruitment is complete, participant recruitment is ongoing and expected to be completed by the end of 2019

Increasing uptake of structured self-management education programmes for type 2 diabetes in a primary care setting: a feasibility study

Abstract: Background: Structured self-management education (SSME) for people with type 2 diabetes mellitus (T2DM) improves biomedical and psychological outcomes, whilst being cost-effective. Yet uptake in the UK remains low. An ‘Embedding Package’ addressing barriers and enablers to uptake at patient, health care professional and organisational levels has been developed. The aim of this study was to test the feasibility of conducting a subsequent randomised controlled trial (RCT) to evaluate the Embedding Package in primary care, using a mixed methods approach. Methods: A concurrent mixed methods approach was adopted. Six general practices in the UK were recruited and received the intervention (the Embedding Package). Pseudonymised demographic, biomedical and SSME data were extracted from primary care medical records for patients recorded as having a diagnosis of T2DM. Descriptive statistics assessed quantitative data completeness and accuracy. Quantitative data were supplemented and validated by a patient questionnaire, for which two recruitment methods were trialled. Where consent was given, the questionnaire and primary care data were linked and compared. The cost of the intervention was estimated. An integrated qualitative study comprising ethnography and stakeholder and patient interviews explored the process of implementation, sustainability of change and ‘fit’ of the intervention. Qualitative data were analysed using a thematic framework guided by the Normalisation Process Theory (NPT). Results: Primary care data were extracted for 2877 patients. The primary outcome for the RCT, HbA1c, was over 90% complete. Questionnaires were received from 423 (14.7%) participants, with postal invitations yielding more participants than general practitioner (GP) prompts. Ninety-one percent of questionnaire participants consented to data linkage. The mean cost per patient for the Embedding Package was £8.94, over a median follow-up of 162.5 days. Removing the development cost, this reduces to £5.47 per patient. Adoption of ethnographic and interview methods in the collection of data was appropriate, and the use of NPT, whilst challenging, enhanced the understanding of the implementation process. The need to delay the collection of patient interview data to enable the intervention to inform patient care was highlighted. Conclusions: It is feasible to collect data with reasonable completeness and accuracy for the subsequent RCT, although refinement to improve the quality of the data collected will be undertaken. Based on resource use data collected, it was feasible to produce cost estimates for each individual component of the Embedding Package. The methods chosen to generate, collect and analyse qualitative data were satisfactory, keeping participant burden low and providing insight into potential refinements of the Embedding Package and customisation of the methods for the RCT. Trial registration: ISRCTN, ISRCTN21321635, Registered 07/07/2017—retrospectively registered

Proceedings of the First International Conference on Stepped Wedge Trial Design

(Opening paragraph) The First International Conference on the Stepped Wedge Trial Design was hosted by the York Trials Unit, Department of Health Sciences, University of York on 10 March 2016. The conference brought together national and international delegates with experience, expertise or interest in this design which employs the incremental randomised implementation of an intervention. The design has gained popularity in the health, social and environmental sciences as a tool to enable the evaluation of interventions/policies whilst being rolled out gradually over time. The conference speakers included eminent researchers at the forefront of the development of the design: Professor Richard Lilford (University of Warwick), Professor Jim Hughes (University of Washington, USA), Dr Karla Hemming (University of Birmingham), Mr. Alan Girling (University of Birmingham), and Professor Andrew Forbes (Monash University, Australia). The keynote speaker, Professor Richard Lilford opened the conference by giving the context for classic stepped wedge designs. This was followed by nine oral and eight poster presentations where practitioners, researchers and methodologists shared ideas, best practice and challenges for the design, implementation and analysis of the stepped wedge model. The conference was simultaneously broadcast to remotely attending delegates from the UK and abroad via dedicated online channels. This supplement is a collection of the proceedings of the conference

Improving the feasibility of stepped-wedge cluster randomised trials: a mixed methods enquiry

Stepped-wedge cluster randomised trials are methodologically complex, and can be logistically challenging, due to the staggered implementation of the intervention. These trials may therefore be more likely than other trials, to encounter issues that make them unable to successfully meet their objectives. Consequently, feasibility studies might be particularly useful for stepped-wedge cluster randomised trials. However, it has not been known what specific aspects of this trial design affect its feasibility, nor to what extent the feasibility of these trials has been investigated. The overarching aim of this thesis, was to improve the feasibility of stepped-wedge cluster randomised trials, by: understanding how the feasibility of these trials has been investigated; identifying the aspects of this trial design that affect its feasibility; investigating a solution to an identified issue; and making recommendations to improve the feasibility of trials of this design. This was achieved through a mixed methods enquiry. Feasibility studies, designed to inform stepped-wedge cluster randomised trials, were identified. The objectives of these studies were examined and the quality of reporting of those that had been published was assessed. The objectives of these studies were rarely specific to the chosen study design. Aspects of the stepped-wedge cluster randomised trial design that could affect its feasibility, were identified from individuals with an involvement, or interest, in trials of this design, through an online questionnaire and interview study. The process for stepped-wedge cluster randomised trials, of balancing prognostic covariates during the randomisation, was identified as a cause for concern for those involved in trials of this design. The use of covariate constrained randomisation for stepped-wedge cluster randomised trials, was therefore investigated using a simulation study. Based on the findings of this thesis, recommendations were made to improve the feasibility of future stepped-wedge cluster randomised trials.</div

Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review

OBJECTIVES: To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials. SETTING: Any, not limited to healthcare settings. PARTICIPANTS: Any taking part in an SW-CRT published up to March 2016. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is the variability in cluster sizes, measured by the coefficient of variation (CV) in cluster size. Secondary outcomes include the difference between the cluster sizes assumed during the sample size calculation and those observed during the trial, any reported variability in cluster sizes and whether the methods of sample size calculation and methods of analysis accounted for any variability in cluster sizes. RESULTS: Of the 101 included SW-CRTs, 48% mentioned that the included clusters were known to vary in size, yet only 13% of these accounted for this during the calculation of the sample size. However, 69% of the trials did use a method of analysis appropriate for when clusters vary in size. Full trial reports were available for 53 trials. The CV was calculated for 23 of these: the median CV was 0.41 (IQR: 0.22-0.52). Actual cluster sizes could be compared with those assumed during the sample size calculation for 14 (26%) of the trial reports; the cluster sizes were between 29% and 480% of that which had been assumed. CONCLUSIONS: Cluster sizes often vary in SW-CRTs. Reporting of SW-CRTs also remains suboptimal. The effect of unequal cluster sizes on the statistical power of SW-CRTs needs further exploration and methods appropriate to studies with unequal cluster sizes need to be employed