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Prominent positioning and food swaps are effective interventions to reduce the saturated fat content of the shopping basket in an experimental online supermarket: A randomized controlled trial
© 2019 The Author(s). Background: Interventions to reduce the saturated fat (SFA) content of food purchases may help reduce SFA consumption and lower cardiovascular risk. This factorial RCT aimed to examine the effect of altering the default order of foods and being offered a swap on the SFA content of food selected during an online shopping experiment. Methods: UK adults who were the primary grocery shoppers for their household were recruited online and invited to select items in a custom-made experimental online supermarket using a 10-item shopping list. Participants were randomly allocated to one of four groups (i) to see products within a category ranked in ascending order of SFA content, (ii) receive an offer to swap to a product with less SFA, (iii) a combination of both interventions, or (iv) no intervention. The primary outcome was the difference in percentage energy from SFA in the shopping basket between any of the four groups. The outcome assessors and statistician were blinded to intervention allocation. Results: Between March and July 2018, 1240 participants were evenly randomised and 1088 who completed the task were analysed (88%). Participants were 65% female and aged 38y (SD 12). Compared with no intervention (n = 275) where the percentage energy from SFA was 25.7% (SD 5.6%), altering the order of foods (n = 261) reduced SFA by [mean difference (95%CI)] -5.0% (- 6.3 to - 3.6) and offering swaps (n = 279) by - 2.0% (- 3.3 to - 0.6). The combined intervention (n = 273) was significantly more effective than swaps alone (- 3.4% (- 4.7 to - 2.1)) but not different than altering the order alone (- 0.4% (- 1.8 to 0.9)), p = 0.04 for interaction. Conclusions: Altering the default order to show foods in ascending order of SFA and offering a swap with lower SFA reduced percentage energy from SFA in an experimental online supermarket. Environmental-level interventions, such as altering the default order, may be a more promising way to improve food purchasing than individual-level ones, such as offering swaps. Trial registration: ISRCTN13729526 https://doi.org/10.1186/ISRCTN13729526 26th February 2018.
Validation of ultrasound strategies to assess tumor extension and to predict high-risk endometrial cancer in women from the prospective IETA (International Endometrial Tumour Analysis) 4 cohort.
OBJECTIVES: To validate ultrasound measurements and subjective ultrasound assessment (SA) to detect deep myometrial invasion (MI), and cervical stromal invasion (CSI) in patients with endometrial cancer and to compare their performance between low and high-grade endometrial cancer, and to validate published prediction models to identify high-risk endometrial cancer (grade 3 endometrioid or non-endometrioid cancer and/or deep MI and/or CSI). METHODS: The study comprises 1538 patients from the prospective IETA4 multicenter study with endometrial cancer undergoing standardized expert transvaginal ultrasound examination. SA and ultrasound measurements were used to predict deep MI and CSI. We assessed the diagnostic accuracy of the Tumor/Uterine anteroposterior (AP) ratio to detect deep MI and the distance from the lower margin of the tumor to outer cervical os (Dist-OCO) to detect CSI, and validated two 2-step strategies to predict high-risk cancer. In the 2-step strategies the first step consists of biopsy grade 3/non-endometrioid cancers were classified as high-risk cancer, and the second step encompasses application of a mathematical model on the remaining tumors. The "subjective model" included biopsy grade (1 versus 2) and subjective assessment of deep MI/CSI (deep MI or CSI: yes or no), the "objective model" includes biopsy grade (1 versus 2) and minimal tumor-free margin. The two 2-step strategies were compared to simply classifying patients as high-risk if either deep MI or CSI was suspected based on SA or if biopsy showed grade 3/non-endometroid histotype (combining SA with biopsy grade). Histological assessment from hysterectomy was considered the reference standard. RESULTS: Among patients with measurable lesions (n=1275), SA had a sensitivity and specificity of 70% and 80% to detect deep MI in grade 1-2 tumors versus 76% and 64% in grade 3/non endometrioid tumors. The corresponding percentages for detection of CSI were 51% and 94% versus 50% and 91%. Tumor AP diameter and Tumor/Uterine AP ratio were the best ultrasound measurements to predict deep MI, and Dist-OCO was best to predict CSI (area under receiver operating characteristics curve(AUC) of 0.77 and 0.72). The proportion of patients correctly classified as having high-risk cancer was 80% for simply combining SA with biopsy grade versus 80% and 74% for the subjective and objective 2-step strategies, respectively. The subjective and objective models had AUC of 0.76 and 0.75 when applied to grade 1-2 endometrioid tumors. CONCLUSIONS: In the hands of experienced ultrasound examiners SA was superior to taking measurements for prediction of deep MI and CSI of endometrial cancer especially in grade 1-2 tumors. The mathematical models for prediction of high-risk cancer performed as expected. The best strategy to predict high-risk endometrial cancer was either to simply combine SA with biopsy grade or to use the subjective 2-step strategy, both having an accuracy of 80%. This article is protected by copyright. All rights reserved.
Replacing meat with alternative plant-based products (RE-MAPs): Protocol for a randomised controlled trial of a behavioural intervention to reduce meat consumption
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. Introduction Reducing meat consumption could contribute towards preventing some chronic conditions and protecting the natural environment. This study will examine the effectiveness of a behavioural intervention to reduce meat consumption. Methods and analyses Replacing meat with alternative plant-based product is a randomised controlled trial comparing a behavioural intervention to reduce meat consumption with a no intervention control condition. Eligible volunteers will be recruited from the general public through advertisement and randomised in a 1:1 ratio to receive no intervention or a 4-week intervention comprising the provision of free plant-based meat alternatives, written information on the health and environmental benefits of eating less meat, success stories of people who reduced their meat consumption and recipes. The primary outcome is the change in meat consumption at 4 weeks (T1) from baseline. Secondary and exploratory outcomes include changes in meat consumption at 8 weeks (T2) from baseline and changes from the baseline to both follow-up in other aspects of participants diet, putative psychosocial determinants of eating a low meat diet and of using meat substitutes and biomarkers of health risk, including blood lipid profiles, blood pressure, weight and body composition. Linear models will be employed to explore whether the changes in each of the aforementioned outcomes differ significantly between the control and intervention group. Qualitative interviews on a subsample of participants receiving the intervention will evaluate their experiences of the intervention and help to identify the mechanisms through which the intervention reduced meat consumption or the barriers preventing the intervention to aid this dietary transition. Ethics and dissemination The trial has been granted ethical approval by the Medical Sciences Interdivisional Research Ethics Committee (IDREC) of the University of Oxford (Ref: R54329/RE001). All results originating from this study will be submitted for publication in scientific journals and presented at meetings and through the media. Trial registration number ISRCTN13180635;Pre-recruitment.
Smith J, Dopson S, Davies B, Wartolowska K, Karp J, Carr A, Brindley D: Borderline Regulation of Stem Cell Technologies: Therapies, Devices and Combination Products. Chapter 19 in Global Medical Device Regulatory Strategy. Regulatory Affairs Professionals Society, 2016. Regulatory Affairs Professionals Society
BACKGROUND: It is plausible that night shift work could affect breast cancer risk, possibly by melatonin suppression or circadian clock disruption, but epidemiological evidence is inconclusive. METHODS: Using serial questionnaires from the Generations Study cohort, we estimated hazard ratios (HR) and 95% confidence intervals (95%CI) for breast cancer in relation to being a night shift worker within the last 10 years, adjusted for potential confounders. RESULTS: Among 102,869 women recruited in 2003-2014, median follow-up 9.5 years, 2059 developed invasive breast cancer. The HR in relation to night shift work was 1.00 (95%CI: 0.86-1.15). There was a significant trend with average hours of night work per week (P = 0.035), but no significantly raised risks for hours worked per night, nights worked per week, average hours worked per week, cumulative years of employment, cumulative hours, time since cessation, type of occupation, age starting night shift work, or age starting in relation to first pregnancy. CONCLUSIONS: The lack of overall association, and no association with all but one measure of dose, duration, and intensity in our data, does not support an increased risk of breast cancer from night shift work in women.
Identifying change processes in group-based health behaviour-change interventions: Development of the Mechanisms of Action in Group-based Interventions (MAGI) framework.
Group-based interventions are widely used to promote health-related behaviour change. While processes operating in groups have been extensively described, it remains unclear how behaviour change is generated in group-based health-related behaviour-change interventions. Understanding how such interventions facilitate change is important to guide intervention design and process evaluations. We employed a mixed-methods approach to identify, map and define change processes operating in group-based behaviour-change interventions. We reviewed multidisciplinary literature on group dynamics, taxonomies of change technique categories, and measures of group processes. Using weight-loss groups as an exemplar, we also reviewed qualitative studies of participants' experiences and coded transcripts of 38 group sessions from three weight-loss interventions. Finally, we consulted group participants, facilitators and researchers about our developing synthesis of findings. The resulting "Mechanisms of Action in Group-based Interventions" (MAGI) framework comprises six overarching categories: (1) group intervention design features, (2) facilitation techniques, (3) group dynamic and development processes, (4) inter-personal change processes, (5) selective intra-personal change processes operating in groups, and (6) contextual influences. The framework provides theoretical explanations of how change occurs in group-based behaviour-change interventions and can be applied to optimise their design and delivery, and to guide evaluation, facilitator training and further research.
A system for solution-orientated reporting of errors associated with the extraction of routinely collected clinical data for research and quality improvement
Background: We have used routinely collected clinical data in epidemiological and quality improvement research for over 10 years. We extract, pseudonymise and link data from heterogeneous distributed databases; inevitably encountering errors and problems. Objective: To develop a solution-orientated system of error reporting which enables appropriate corrective action. Method: Review of the 94 errors, which occurred in 2008/9. Previously we had described failures in terms of the data missing from our response files; however this provided little information about causation. We therefore developed a taxonomy based on the IT component limiting data extraction. Results: Our final taxonomy categorised errors as: (A) Data extraction Method and Process; (B) Translation Layer and Proxy Specification; (C) Shape and Complexity of the Original Schema; (D) Communication and System (mainly Software-based) Faults; (E) Hardware and Infrastructure; (F) Generic/Uncategorised and/or Human Errors. We found 79 distinct errors among the 94 reported; and the categories were generally predictive of the time needed to develop fixes. Conclusions: A systematic approach to errors and linking them to problem solving has improved project efficiency and enabled us to better predict any associated delays. © 2010 IMIA and SAHIA. All rights reserved.
Aims To conduct a systematic review to identify types and implications of incorrect or incomplete coding or classification within diabetes or between diabetes and other conditions; also to determine the availability of evidence regarding frequency of occurrence. Methods Medical Subject Headings (MeSH) and free-text terms were used to search relevant electronic databases for papers published to the end of August 2008. Two researchers independently reviewed titles and abstracts and, subsequently, the full text of potential papers. Reference lists of selected papers were also reviewed and authors consulted. Three reviewers independently extracted data. Results Seventeen eligible studies were identified, including five concerned with distinguishing between Type 1 and Type 2 diabetes. Evidence was also identified regarding: the distinction between diabetes and no-diabetes, failure to specify type of diabetes, and diagnostic errors or difficulties involving maturity-onset diabetes of the young, latent autoimmune diabetes in adults, pancreatic diabetes, persistence of foetal haemoglobin and acquired immune deficiency syndrome (AIDS). The sample was too heterogeneous to derive accurate information about frequency, but our findings suggested that misclassification occurs most commonly in young people. Implications relating to treatment options and risk management were highlighted, in addition to psychological and financial implications and the potential impact on the validity of quality of care evaluations and research. Conclusions This review draws attention to the occurrence and implications of incorrect or incomplete coding or classification of diabetes, particularly in young people. A pragmatic and clinically relevant approach to classification is needed to assist those involved in making decisions about types of diabetes. © 2010 Diabetes UK.
Using an open source observational tool to measure the influence of the doctor's consulting style and the computer system on the outcomes of the clinical consultation
Computerization of general practice is an international phenomenon. Many of the Electronic Patient Record (EPR) systems have developed organically with considerable variation in their interface and functionality. Consequently they have differing impact on the clinical consultation. There is a dearth of tools available to study their impact on the consultation. The objective is to use ALFA to film and analyze a simulated clinical consultation. We used the ALFA (Activity Log File Aggregation) open source toolkit, to make video based observation and analysis of the computer mediated consultation. ALFA enables precise comparison of core elements of EPR systems. It allows multiple video channels including screen capture, data about computer use, and verbal interactions to be synchronized, timed and navigated through for analysis. The toolkit is free and can be downloaded under an open source license from www.biomedicalinformatics.info/alfa/. Its outputs, which include Unified Modelling Language (UML), provide the evidence-base for assessing the impact of the computer on the consultation the designing of EPR systems. ALFA has been used to compare different brands of primary care computer systems; nurse case-load selection and consultation in psychiatry. © 2009 European Federation for Medical Informatics.
The paper presents an analysis of how EFMI disseminates new knowledge and the active medical informatics journals in EFMI member countries was carried out as an outcome of the EFMI Council meeting in London in 2008. The analysis identifies eight active major informatics journals and a several other publications. Most are subscription-based and are published at least quarterly. There is a possibility for the editors to meet regularly and form a community of practice with the aim of further improving their effectiveness in disseminating new knowledge and best practice in medical informatics. It is feasible to share expertise and it may be possible to harmonise several aspects of preparation and submission of manuscripts so that some identified barriers in publishing are reduced. © 2009 European Federation for Medical Informatics.
© M. Courtenay and M. Grifths 2010 and Cambridge University Press, 2010. Introduction. This chapter sets out the rationale for improving prescribing safety, namely the high rate of deaths, unnecessary hospital admissions and illness caused by unsafe prescribing; and what practical steps prescribers should take to reduce the risk of issuing an unsafe prescription. The tragedy in Northwick Park in 2006 when healthy volunteers suffered catastrophic consequences, albeit in the first test of a new drug, highlighted how pharmaceuticals need to be treated with caution and respect (Sunthralingham, 2006). However, it is not just new drugs which can be unsafe; drugs which have become established after many years of clinical use can also cause problems (Lasser et al., 2002). For example, after several years of use, a widely used non-steroidal anti-inflammatory drug was found to be associated with an increased risk of myocardial infarction (Solomon et al., 2004). The first part of this chapter describes why prescribing safety is so important and this is addressed under the following four themes: (1) Key issues for safe prescribing at the point of care. Theme one explores the safety issues that should be considered by an individual prescriber before issuing a prescription. A key message for prescribers is that they need to have the necessary information to hand at the point of prescribing: an understanding of the patient's wishes; access to a comprehensive medical record; and access to information about the drug they are about to prescribe. […]
Assessing the impact of recording quality target data on the gp consultation using multi-channel video
Background: In the UK routinely collected computerized clinical data is used to assess progress towards financially incentivised quality targets for chronic disease management including hypertension. Objective: To develop a method for assessing the impact of recording quality target data in the clinical consultation. Methods: Raters were trained how to rate a multi-channel video of a simulated clinical consultation for interaction between actors, computer use, non-verbal communication. Results: 25% of consultation time is computer use and a median of 4 to 5 items were coded per consultation mainly items related to the hypertension quality target. Intraclass correlation coefficient showed good inter-rater reliability ( > 0.9; p < 0.001). Conclusion: We have successfully piloted a novel technique for observing the influence of the computer on the consultation. Despite increasing computer use to record quality target data the over whelming proportion of the consultation remains doctor patient interaction. © 2007 The authors. All rights reserved.
Background: Ethnicity data in general practice (GP) computerized medical records can be utilized to audit equity in health care. Methods: We evaluated a patient profiling project targeted to improve ethnicity recording. Results: Data extracted from 16 practices showed an increase in ethnicity recording from <1% before the intervention to 48% after. Recorded codes could be mapped onto the basic national statistics six-category ethnicity classification headings, and their proportions were similar to the 2001 census values. Conclusion: Recording of data using multiple coding hierarchies has reduced the utility of data as clinically important ethnic subgroups cannot be identified. Practitioners should be encouraged to use the single recommended ethnicity coding hierarchy. © The Author 2006, Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved.
Using UMLS to map from a library to a clinical classification: Improving the functionality of a digital library
The Metathesaurus of the Unified Medical Language System (UMLS) offers the possibility of mapping between various medical vocuabularies. The Primary Care Electronic Library (PCEL) contains a database of over six thousand Medical Subject Headings (MeSH terms) describing the resources of the electronic library. We were interested to know if it was possible to map from MeSH to the Systemized Nomenclature of Medicine Clinical Terms (SNOMED CT). Such a mapping would aid healthcare professionals to retrieve relevant data from our digital library as it would enable links between clinical systems and indexed material.
: Background: Medical Subject Headings (MeSH) are a hierarchical taxonomy of over 42 000 descriptors designed to classify scientific literature; it is hierarchical with generic high order headings and specific low order headings. Over 1,000 resources in the Primary Care Electronic Library (PCEL-www.pcel.info) were classified with MeSH. Methods: Each of the entries or resources in the primary care digital library was assigned up to five MeSH terms. We compared whether the most generic or specific MeSH term ascribed to each resource best predicted user preferences. Results: over the four month period analysed statistically significant differences were found for resources according to specific key MeSH terms they were classified by. This result was not repeated for generic key MeSH terms. Conclusions: Analysis of the use of specific MeSH terms reveals user preferences that would have otherwise remained obscured. These preferences are not found if more generic MeSH terms are analysed. © 2006 Organizing Committee of MIE 2006.