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IntroductionThe development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of ‘case studies’ of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.Methods and analysisThis qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordings will be audio-recorded, transcribed verbatim and analysed thematically using constant comparison techniques. Video-recordings will be reviewed to deconstruct procedures into key components and document how the procedure evolves. Comparisons will be made between the different data sources.Ethics and disseminationThe study protocol has Health Research Authority (HRA) and Health and Care Research Wales approval (Ref 18/SW/0277). Results will be disseminated at appropriate conferences and will be published in peer-reviewed journals. The findings of this study will provide a better understanding of how innovative invasive procedures and/or devices are introduced into practice.

ObjectivesLittle is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.DesignQualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically.Participants42 interviews were conducted (26 surgeons and 16 governance representatives).SettingSurgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK.ResultsParticipants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that ‘new’ was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own.ConclusionsThis study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and patients’ views of these information exchanges.

Objective Family members have the capacity to influence each other's health behaviours. This study examined whether there were associations in the objectively assessed physical activity and Body Mass Index (BMI) of mothers and fathers. Methods Recruitment took place in Bristol (UK) during 2012/13. Participants were 272 pairs of parents (dyads) that wore an accelerometer for at least 500 min on 3 or more days. Parents provided demographic information and self-reported height and weight. Multi-variable linear and logistic regression models examined the relationships between parents' moderate-to-vigorous physical activity (MVPA) and BMI. Results MVPA minutes (r = 0.26, p, Highlights • Accelerometer derived levels of MVPA in parents are associated. • Every 9 min of father MVPA predicts a 3 minute increase for mothers. • Self-reported BMI scores of mothers and fathers are associated. • Parents accumulated approximately 10 min less MVPA at the weekend. • Behaviour change in one parent may have a knock on effect for a spouse.

Background: Few studies have examined parental perceptions of their child’s screen-viewing (SV) within the context of parental SV time. This study qualitatively examined parents’ perceptions of their 5-6-year-old child’s SV within the context of their own quantitatively measured SV. Methods: A mixed-methods design employed semi-structured telephone interviews, demographic and SV questionnaires, objectively-measured physical activity and sedentary time. Deductive content analysis was used to explore parents’ perceptions of, and concerns about, their child’s SV, and management of their child’s SV. Comparisons were made between parent-child dyads reporting low (

IntroductionRigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation.Methods and analysisA COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s).Ethics and disseminationEthical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.

Background:Interventions to increase children’s physical activity (PA) have achieved limited success. This may be attributed to inaccurate parental perceptions of their children’s PA and a lack of recognition of a need to change activity levels.Methods:Fifty-three parents participated in semistructured interviews to determine perceptions of child PA. Perceptions were compared with children’s measured MVPA (classified as meeting or not meeting UK guidelines) to produce 3 categories: “accurate,” “over-estimate,” and “under-estimate.” Deductive content analysis was performed to understand the accuracy of parental perceptions.Results:All parents of children meeting the PA guidelines accurately perceived their child’s PA; while the majority of parents whose child did not meet the guidelines overestimated their PA. Most parents were unconcerned about their child’s PA level, viewing them as naturally active and willing to be active. Qualitative explanations for perceptions of insufficient activity included children having health problems and preferences for inactive pursuits, and parents having difficulty facilitating PA in poor weather and not always observing their child’s PA level. Social comparisons also influenced parental perceptions.Conclusions:Strategies to improve parental awareness of child PA are needed. Perceptions of child PA may be informed by child “busyness,” being unaware of activity levels, and social comparisons.