What Are Patients Told About Innovative Surgical Procedures? A Qualitative Synthesis of 7 Case Studies in the United Kingdom.

OBJECTIVES: To investigate how information about innovative surgical procedures is communicated to patients. BACKGROUND: Despite the national and international guidance that patients should be informed whether a procedure is innovative and has uncertain outcomes, little is known about current practice. METHODS: This qualitative study followed 7 "case studies" of surgical innovation in hospitals across the United Kingdom. Preoperative interviews were conducted with clinician innovators (n=9), preoperative real-time consultations between clinicians and patients were audio-recorded (n=37). Patients were interviewed postoperatively (n=30). Data were synthesized using thematic analytical methods. RESULTS: Interviews with clinicians demonstrated strong intentions to inform patients about the innovative nature of the procedure in a neutral manner, although tensions between fully informing patients and not distressing them were raised. In the consultations, only a minority of clinicians actually made explicit statements about, (1) the procedure being innovative, (2) their limited clinical experience with it, (3) the paucity of evidence, and (4) uncertainty/unknown outcomes. Discussions about risks were generalized and often did not relate to the innovative component. Instead, all clinicians optimistically presented potential benefits and many disclosed their own positive beliefs. Postoperative patient interviews revealed that many believed that the procedure was more established than it was and were unaware of the unknown risks. CONCLUSIONS: There were contradictions between clinicians' intentions to inform patients about the uncertain outcomes of innovative and their actual discussions with patients. There is a need for communication interventions and training to support clinicians to provide transparent data and shared decision-making for innovative procedures.

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations' policies in England and Wales.

OBJECTIVE: To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds). DESIGN: A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales. SETTING: NHS trusts in England and health boards in Wales, UK. PARTICIPANTS: Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review. RESULTS: From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure's novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon's experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included. CONCLUSIONS: Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients' and clinicians' views is required to address variability around information provision/consent for innovative procedures.

Using qualitative research methods to understand how surgical procedures and devices are introduced into NHS hospitals: the Lotus study protocol.

INTRODUCTION: The 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 ANALYSIS: This 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 DISSEMINATION: The 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.

Discussing surgical innovation with patients: a qualitative study of surgeons' and governance representatives' views.

OBJECTIVES: Little 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. DESIGN: Qualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically. PARTICIPANTS: 42 interviews were conducted (26 surgeons and 16 governance representatives). SETTING: Surgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK. RESULTS: Participants 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. CONCLUSIONS: This 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.

Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study).

INTRODUCTION: Rigorous 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 ANALYSIS: A 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 DISSEMINATION: Ethical 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.

Introduction and adoption of innovative invasive procedures and devices in the NHS: an in-depth analysis of written policies and qualitative interviews (the INTRODUCE study protocol).

INTRODUCTION: Innovation is key to improving outcomes in healthcare. Innovative pharmaceutical products undergo rigorous phased research evaluation before they are introduced into practice. The introduction of innovative invasive procedures and devices is much less rigorous and phased research, including randomised controlled trials, is not always undertaken. While the innovator (usually a surgeon) may introduce a new or modified procedure/device within the context of formal research, they may also be introduced by applying for local National Health Service (NHS) organisation approval alone. Written policies for the introduction of new procedures and/or devices often form part of this local clinical governance infrastructure; however, little is known about their content or use in practice. This study aims to systematically investigate how new invasive procedures and devices are introduced in NHS England and Wales. METHODS AND ANALYSIS: An in-depth analysis of written policies will be undertaken. This will be supplemented with interviews with key stakeholders. All acute NHS trusts in England and Health Boards in Wales will be systematically approached and asked to provide written policies for the introduction of new invasive procedures and devices. Information on the following will be captured: (1) policy scope, including when new procedures should be introduced within a formal research framework; (2) requirements for patient information provision; (3) outcome reporting and/or monitoring. Data will be extracted using a standardised form developed iteratively within the study team. Semistructured interviews with medical directors, audit and governance leads, and surgeons will explore views regarding the introduction of new invasive procedures into practice, including knowledge of and implementation of current policies. ETHICS AND DISSEMINATION: In-depth analysis of written policies does not require ethics approval. The University of Bristol Ethics Committee (56522) approved the interview component of the study. Findings from this work will be presented at appropriate conferences and will be published in peer-reviewed journals.

How parents perceive screen viewing in their 5-6 year old child within the context of their own screen viewing time: a mixed-methods study.

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 (<2-h per day) versus high SV time. RESULTS: Fifty-three parents were interviewed (94.3% mothers), with 52 interviews analysed. Fifteen parent-child dyads (28.8%) exceeded the 2-h SV threshold on both weekdays and weekend days; 5 parent-child dyads (9.6%) did not exceed this threshold. The remaining 32 dyads reported a combination of parent or child exceeding/not exceeding the SV threshold on either weekdays or weekend days. Three main themes distinguished the 15 parent-child dyads exceeding the SV threshold from the 5 dyads that did not: 1) parents' personal SV-related views and behaviours; 2) the family SV environment; and 3) setting SV rules and limits. Parents in the dyads not exceeding the SV threshold prioritized and engaged with their children in non-SV behaviours for relaxation, set limits around their own and their child's SV-related behaviours, and described an environment supportive of physical activity. Parents in the dyads exceeding the SV threshold were more likely to prioritise SV as a shared family activity, and described a less structured SV environment with minimal rule setting, influenced their child's need for relaxation time. CONCLUSIONS: The majority of parents in this study who exceeded the SV threshold expressed minimal concern and a relaxed approach to managing SV for themselves and their child(ren), suggesting a need to raise awareness amongst these parents about the time they spend engaging in SV. Parents may understand their SV-related parenting practices more clearly if they are encouraged to examine their own SV behaviours. Designing interventions aimed to create environments that are less supportive of SV, with more structured approaches to SV parenting strategies are warranted.

Are parents' motivations to exercise and intention to engage in regular family-based activity associated with both adult and child physical activity?

BACKGROUND/AIM: To examine the associations between parents' motivation to exercise and intention to engage in family-based activity with their own and their child's physical activity. METHODS: Cross-sectional data from 1067 parent-child pairs (76.1% mother-child); children were aged 5-6 years. Parents reported their exercise motivation (ie, intrinsic motivation, identified regulation, introjected regulation, external regulation and amotivation) as described in self-determination theory and their intention to engage in family-based activity. Parents' and children's mean minutes of moderate-to-vigorous-intensity physical activity (MVPA) and mean counts per minute were derived from ActiGraph accelerometers worn for 3 to 5 days (including a mixture of weekdays and weekend days). Multivariable linear regression models, adjusted for parent sex, number of children, indices of multiple deprivation and clustering of children in schools were used to examine associations (total of 24 associations tested). RESULTS: In fully adjusted models, each unit increase in identified regulation was associated with a 6.08 (95% CI 3.27 to 8.89, p<0.001) min-per-day increase in parents' MVPA. Parents' external regulation was associated with children performing 2.93 (95% CI -5.83 to -0.03, p=0.05) fewer minutes of MVPA per day and a 29.3 (95% CI -53.8 to -4.7, p=0.02) accelerometer count-per-minute reduction. There was no evidence of association for the other 21 associations tested. CONCLUSIONS: Future family-based physical activity interventions may benefit from helping parents identify personal value in exercise while avoiding the use of external control or coercion to motivate behaviour.

Sedentary time among spouses: a cross-sectional study exploring associations in sedentary time and behaviour in parents of 5 and 6 year old children.

BACKGROUND: Sedentary time is associated with obesity and is a risk factor for other adverse health outcomes. We examined how sedentary time and screen viewing (SV) behaviours in parents of young children are associated and whether associations differed for weekdays versus weekend days. METHODS: Data were from a cross sectional study (B-ProAct1v) based in Bristol, UK investigating associations between physical activity and SV in children and parents. Parents were eligible for analysis if they and their partner had both provided valid accelerometer data (290 dyads) or had both provided valid screen-viewing data (325 dyads). Multivariable regression models were used to examine associations of (a) sedentary behaviours and (b) self-reported time spent on weekdays and weekend days watching TV, using a PC, and using a phone in the dyads. Models were adjusted for the number of media items in the house, mothers' age and body mass index, and household index of multiple deprivation. RESULTS: Sedentary behaviour was lower at weekends than on weekdays for fathers and mothers. In contrast, the proportion of parents watching at least 2 h TV was higher on weekend days than on weekdays. Adjusted multivariable linear regression models suggested that 3 min of sedentary time on weekend days in fathers were associated with an additional minute of mothers' sedentary time (B 0.38; 95 % CI 0.26 to 0.49). Logistic regression indicated that mothers' screen use was positively predicted by fathers' use (e.g., the odds of a mother watching more than 2 h TV on a weekend day were increased fivefold if the father also watched this amount OR 5.09, 95 % CI 3.30 to 7.86), except for PC use at weekends where the association was reversed and the odds of mothers using a PC for more than 30 min per weekend day was halved if the father used a PC for this amount of time (OR 0.45, 95 % CI 0.22 to 0.94). CONCLUSIONS: Programmes that encourage at least one adult in the household to decrease sedentary behaviour and become more active, particularly at weekends, should be developed.

"He's probably more Mr. sport than me"--a qualitative exploration of mothers' perceptions of fathers' role in their children's physical activity.

BACKGROUND: Many children do not meet the recommended levels of physical activity. Parents can influence their children's physical activity in a number of ways but little research has focused on the impact of fathers. The current study aimed to explore how mothers perceived fathers to influence children's physical activity. METHODS: Telephone interviews with mothers (n = 50) who took part in a large cross sectional physical activity study were conducted. A strategic sampling method was applied to ensure varying deprivation levels and child physical activity. Interviews were based on children's physical activity and screen viewing behaviours and patterns. A total of 37 interviews included information on fathers and were used for the current study. Deductive content analysis was used to analyse the interviews. RESULTS: Mothers suggested that fathers are directly involved in their child's physical activity though co-participation, whilst additionally playing an important role in encouraging and facilitating physical activity. The results suggest some variation in how mothers and fathers are involved in children's physical activity behaviours. Father availability seems to play a key role in the amount of physical activity involvement. CONCLUSIONS: Fathers play a key role in children's physical activity choices and behaviours and can influence children in a variety of ways. Parents tend to share in the physical activity related tasks of their children but father availability seems to be a factor in their amount of involvement. Health professionals aiming to improve child physical activity may benefit from developing interventions that target both children and fathers.

Understanding the Accuracy of Parental Perceptions of Child Physical Activity: A Mixed Methods Analysis.

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.

Parental control, nurturance, self-efficacy, and screen viewing among 5- to 6-year-old children: a cross-sectional mediation analysis to inform potential behavior change strategies.

BACKGROUND: Children's screen viewing (SV) is associated with higher levels of childhood obesity. Many children exceed the American Academy of Pediatrics guideline of 2 hours of television (TV) per day. There is limited information about how parenting styles and parental self-efficacy to limit child screen time are associated with children's SV. This study examined whether parenting styles were associated with the SV of young children and whether any effects were mediated by parental self-efficacy to limit screen time. METHODS: Data were from a cross-sectional survey conducted in 2013. Child and parent SV were reported by a parent, who also provided information about their parenting practices and self-efficacy to restrict SV. A four-step regression method examined whether parenting styles were associated with the SV of young children. Mediation by parental self-efficacy to limit screen time was examined using indirect effects. RESULTS: On a weekday, 90% of children watched TV for <2 hours per day, decreasing to 55% for boys and 58% for girls at weekends. At the weekend, 75% of children used a personal computer at home, compared with 61% during the week. Self-reported parental control, but not nurturance, was associated with children's TV viewing. Parental self-efficacy to limit screen time was independently associated with child weekday TV viewing and mediated associations between parental control and SV. CONCLUSIONS: Parental control was associated with lower levels of SV among 5- to 6-year-old children. This association was partially mediated by parental self-efficacy to limit screen time. The development of strategies to increase parental self-efficacy to limit screen-time may be useful.

Associations between parenting partners' objectively-assessed physical activity and Body Mass Index: A cross-sectional study.

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 < 0.001) and Body Mass Index (r = 0.20, p = 0.002) of parents were correlated. Logistic regression analysis showed that mothers were almost twice (OR 1.87, p < 0.05) as likely to be overweight or obese when fathers were. Linear regression models showed that at the weekend every 9 min of paternal MVPA was associated with 3 min of maternal MVPA (r = 0.34, p < 0.001). CONCLUSIONS: Both physical activity and BMI of parenting partners were associated. Since parents tend to share home environments and often perform activities together or as a family, then behavioural changes in one parent may have a ripple effect for other family members.

Associations between objectively assessed child and parental physical activity: a cross-sectional study of families with 5-6 year old children.

BACKGROUND: A number of studies have suggested that there is a need to increase the physical activity levels of children. Parents are important influences on children's behaviour. There is a lack of information about whether there are associations between the physical activity levels of young children and their parents. The current study examined the associations between the physical activity (PA) of parents and their children at age five to six years old, and determined whether any associations differed by child or parent gender or between week and weekend days. METHODS: Cross-sectional study, with 1267 Year 1 pupils (five to six years of age) and at least one parent from 57 primary schools. Children and parents wore an accelerometer for five days and mean minutes of moderate-to-vigorous intensity physical activity (MVPA) per day were derived. We used multivariable linear regression to investigate whether parental and child time spent in MVPA was associated with each other. Each model was adjusted for age, child gender, parent BMI and neighbourhood deprivation with subgroup analysis by child gender. RESULTS: 80% of parents met PA guidelines, however 29% of boys and 47% of girls aged five to six years failed to meet them. Fully-adjusted analyses suggested weak positive associations of parent's and children's time spent in MVPA. Every 10 additional minutes of parental MVPA were associated with one additional minute of child MVPA. There was no evidence of a difference in associations for boys and girls or between mothers and fathers. CONCLUSIONS: 29% of boys and 47% of girls aged five to six years did not meet PA guidelines indicating that these children would benefit from new approaches that focus on increasing physical activity. There were weak associations between the MVPA of 5-6 year old children and their parents, demonstrating that the time that children are active with their parents is not a major source of physical activity. Clinicians and public health professionals should encourage parents to create opportunities for their children to be active.

Cross-sectional associations between the screen-time of parents and young children: differences by parent and child gender and day of the week.

BACKGROUND: Greater time spent screen-viewing (SV) has been linked to adverse health outcomes. The aim of this study was to examine whether parental SV time is associated with child SV time on week and weekend days. METHODS: Cross-sectional survey of 1078 children aged 5-6 and at least 1 parent. Child and parent SV was reported for weekday and weekend days. Logistic regression examined whether parental SV time was associated with child SV time, with separate analyses for mothers and fathers and interaction terms for child gender. RESULTS: 12% of boys, 8% of girls and 30% of mothers and fathers watched ≥ 2 hours of TV each weekday. On a weekend day, 45% of boys, 43% of girls, 53% of mothers and 57% of fathers spent ≥ 2 hours watching TV. Where parents exceeded 2 hours TV-watching per weekday, children were 3.4 times more likely to spend ≥ 2 hours TV-watching if their father exceeded the threshold with odds of 3.7 for mothers. At weekends, daughters of fathers who exceeded 2 hours watching TV were over twice as likely as sons to exceed this level. Evidence that parent time spent using computers was associated with child computer use was also strongest between fathers and daughters (vs. sons) (OR 3.5 vs. 1.0, p interaction=0.027). CONCLUSIONS: Strong associations were observed between parent and child SV and patterns were different for weekdays versus weekend days. Results show that time spent SV for both parents is strongly associated with child SV, highlighting the need for interventions targeting both parents and children.