The Effect of Practitioner Empathy on Patient Satisfaction : A Systematic Review of Randomized Trials.

BACKGROUND: Practitioners who deliver enhanced empathy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival. PURPOSE: To evaluate the effect of health care practitioner empathy on patient satisfaction, using a systematic review of randomized trials. DATA SOURCES: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023. STUDY SELECTION: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale. DATA EXTRACTION: Data extraction, risk-of-bias assessments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus. DATA SYNTHESIS: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogeneous in terms of geographic locations (North America, Europe, Asia, and Africa), settings (hospital and primary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials suggested a positive change in patient satisfaction, inadequate reporting hindered the ability to draw definitive conclusions about the overall effect size. LIMITATIONS: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence. CONCLUSION: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction. PRIMARY FUNDING SOURCE: Stoneygate Trust. (PROSPERO: CRD42023412981).

Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention.

OBJECTIVES: We developed a guided self-help intervention (Supporting Weight Management during COVID-19, "SWiM-C") to support adults with overweight or obesity in their weight management during the COVID-19 pandemic. This parallel, two-group trial (ISRCTN12107048) evaluated the effect of SWiM-C on weight and determinants of weight management over twelve months. METHODS: Participants (≥18 years, body-mass-index ≥25 kg/m2) were randomised to the SWiM-C intervention or to a standard advice group (unblinded). Participants completed online questionnaires at baseline, four months, and twelve months. The primary outcome was change in self-reported weight from baseline to twelve months; secondary outcomes were eating behaviour (uncontrolled eating, emotional eating, cognitive restraint of food intake), experiential avoidance, depression, anxiety, stress, wellbeing and physical activity. INTERVENTIONS: SWiM-C is based on acceptance and commitment therapy (ACT). Participants had access to an online web platform with 12 weekly modules and email and telephone contact with a trained, non-specialist coach. Standard advice was a leaflet on managing weight and mood during the COVID-19 pandemic. RESULTS: 388 participants were randomised (SWiM-C: n = 192, standard advice: n = 196). The baseline-adjusted difference in weight change between SWiM-C (n = 119) and standard advice (n = 147) was -0.81 kg (95% CI: -2.24 to 0.61 kg). SWiM-C participants reported a reduction in experiential avoidance (-2.45 [scale:10-70], 95% CI: -4.75 to -0.15), uncontrolled eating (-3.36 [scale: 0-100], 95% CI: -5.66 to -1.06), and emotional eating (-4.14 [scale:0-100], 95% CI: -7.25 to -1.02) and an increase in physical activity (8.96 [MET-min/week], 95% CI: 0.29 to 17.62) compared to standard advice participants. We found no evidence of an effect on remaining outcomes. No adverse events/side effects were reported. CONCLUSIONS: Whilst we were unable to conclude that the intervention had an effect on weight, SWiM-C improved eating behaviours, experiential avoidance and physical activity. Further refinement of the intervention is necessary to ensure meaningful effects on weight prior to implementation in practice. TRIAL REGISTRATION NUMBER: ISRCTN 12107048.

The impact of changing risk thresholds on the number of people in England eligible for urgent investigation for possible cancer: an observational cross-sectional study.

BACKGROUND: Expediting cancer diagnosis may be achieved by targeted decreases in referral thresholds to increase numbers of patients referred for urgent investigation. METHODS: Clinical Practice Research Datalink data from England for 150,921 adults aged ≥40 were used to identify participants with features of possible cancer equating to risk thresholds ≥1%, ≥2% or ≥3% for breast, lung, colorectal, oesophago-gastric, pancreatic, renal, bladder, prostatic, ovarian, endometrial and laryngeal cancers. RESULTS: The mean age of participants was 60 (SD 13) years, with 73,643 males (49%). In 2016, 8576 consultation records contained coded features having a positive predictive value (PPV) of ≥3% for any of the 11 cancers. This equates to a rate of 5682/100,000 patients compared with 4601/100,000 Suspected Cancer NHS referrals for these cancers from April 2016-March 2017. Nine thousands two hundred ninety-one patient-consultation records had coded features equating to a ≥2% PPV, 8% more than met PPV ≥ 3%. Similarly, 19,517 had features with a PPV ≥ 1%, 136% higher than for PPV ≥ 3%. CONCLUSIONS: This study estimated the number of primary-care patients presenting at lower thresholds of cancer risk. The resource implications of liberalising this threshold to 2% are modest and manageable. The details across individual cancer sites should assist planning of English cancer services.

Infection Control Behavior at Home During the COVID-19 Pandemic: Observational Study of a Web-Based Behavioral Intervention (Germ Defence).

BACKGROUND: To control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors. OBJECTIVE: This study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved. METHODS: This was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors. RESULTS: Current behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31). CONCLUSIONS: Self-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.

Improving Empathy in Healthcare Consultations-a Secondary Analysis of Interventions.

A recent systematic review of randomised trials suggested that empathic communication improves patient health outcomes. However, the methods for training healthcare practitioners (medical professionals; HCPs) in empathy and the empathic behaviours demonstrated within the trials were heterogeneous, making the evidence difficult to implement in routine clinical practice. In this secondary analysis of seven trials in the review, we aimed to identify (1) the methods used to train HCPs, (2) the empathy behaviours they were trained to perform and (3) behaviour change techniques (BCTs) used to encourage the adoption of those behaviours. This detailed understanding of interventions is necessary to inform implementation in clinical practice. We conducted a content analysis of intervention descriptions, using an inductive approach to identify training methods and empathy behaviours and a deductive approach to describe the BCTs used. The most commonly used methods to train HCPs to enhance empathy were face-to-face training (n = 5), role-playing (n = 3) and videos (self or model; n = 3). Duration of training was varied, with both long and short training having high effect sizes. The most frequently targeted empathy behaviours were providing explanations of treatment (n = 5), providing non-specific empathic responses (e.g. expressing understanding) and displaying a friendly manner and using non-verbal behaviours (e.g. nodding, leaning forward, n = 4). The BCT most used to encourage HCPs to adopt empathy behaviours was "Instruction on how to perform behaviour" (e.g. a video demonstration, n = 5), followed by "Credible source" (e.g. delivered by a psychologist, n = 4) and "Behavioural practice" (n = 3 e.g. role-playing). We compared the effect sizes of studies but could not extrapolate meaningful conclusions due to high levels of variation in training methods, empathy skills and BCTs. Moreover, the methods used to train HCPs were often poorly described which limits study replication and clinical implementation. This analysis of empathy training can inform future research, intervention reporting standards and clinical practice.

Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.

BACKGROUND: Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients' concerns. OBJECTIVE: This study aimed to test the effects of PoP, compared with a control website, on people's knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial. METHODS: A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions). RESULTS: After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001). CONCLUSIONS: In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.

Is it worth it? Patient and public views on the impact of their involvement in health research and its assessment: a UK-based qualitative interview study.

BACKGROUND: There are mounting calls for robust, critical evaluation of the impact of patient and public involvement (PPI) in health research. However, questions remain about how to assess its impact, and whether it should be assessed at all. The debate has thus far been dominated by professionals. OBJECTIVE: To explore the views of PPI contributors involved in health research regarding the impact of PPI on research, whether and how it should be assessed. DESIGN: Qualitative interview study. SETTING AND PARTICIPANTS: Thirty-eight PPI contributors involved in health research across the UK. RESULTS: Participants felt that PPI has a beneficial impact on health research. They described various impactful roles, which we conceptualize as the 'expert in lived experience', the 'creative outsider', the 'free challenger', the 'bridger', the 'motivator' and the 'passive presence'. Participants generally supported assessing the impact of PPI, while acknowledging the challenges and concerns about the appropriateness and feasibility of measurement. They expressed a range of views about what impacts should be assessed, by whom and how. Individual feedback on impact was seen as an important driver of improved impact and motivation to stay involved. CONCLUSIONS: While there appears to be widespread support for PPI impact assessment among PPI contributors, their views on what to assess and how are diverse. PPI contributors should be involved as equal partners in debates and decisions about these issues. Individual feedback on impact may increase PPI contributors' potential impact and their motivation to stay involved.

How does communication affect patient safety? Protocol for a systematic review and logic model.

INTRODUCTION: One in 10 patients are harmed in healthcare, more than three million deaths occur annually worldwide due to patient safety incidents, and the economic burden of patient safety incidents accounts for 15% of hospital expenditure. Poor communication between patients and practitioners is a significant contributor to patient safety incidents. This study aims to evaluate the extent to which patient safety is affected by communication and to provide a logic model that illustrates how communication impacts patient safety. METHODS AND ANALYSIS: We will conduct a systematic review of randomised and non-randomised studies, reported in any language, that quantify the effects of practitioner and patient communication on patient safety. We will search MEDLINE, CINAHL, APA PsychINfo, CENTRAL, Scopus and ProQuest theses and dissertations from 2013 to 7 February 2024. We will also hand-search references of included studies. Screening, data extraction and risk of bias assessment will be conducted by two independent reviewers. Risk of bias will be assessed using the Cochrane Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) for non-randomised studies, and the Cochrane Risk of Bias V.2 (RoB2) for randomised controlled trials. If appropriate, results will be pooled with summary estimates and 95% confidence intervals (CIs); otherwise, we will conduct a narrative synthesis. We will organise our findings by healthcare discipline, type of communication and type of patient safety incident. We will produce a logic model to illustrate how communication impacts patient safety. ETHICS AND DISSEMINATION: This systematic review does not require formal ethics approval. Findings will be disseminated through international conferences, news and peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42024507578.

Preventing urinary tract infection in older people living in care homes: the 'StOP UTI' realist synthesis.

BACKGROUND: Urinary tract infection (UTI) is the most diagnosed infection in older people living in care homes. OBJECTIVE: To identify interventions for recognising and preventing UTI in older people living in care homes in the UK and explain the mechanisms by which they work, for whom and under what circumstances. METHODS: A realist synthesis of evidence was undertaken to develop programme theory underlying strategies to recognise and prevent UTI. A generic topic-based search of bibliographic databases was completed with further purposive searches to test and refine the programme theory in consultation with stakeholders. RESULTS: 56 articles were included in the review. Nine context-mechanism-outcome configurations were developed and arranged across three theory areas: (1) Strategies to support accurate recognition of UTI, (2) care strategies for residents to prevent UTI and (3) making best practice happen. Our programme theory explains how care staff can be enabled to recognise and prevent UTI when this is incorporated into care routines and activities that meet the fundamental care needs and preferences of residents. This is facilitated through active and visible leadership by care home managers and education that is contextualised to the work and role of care staff. CONCLUSIONS: Care home staff have a vital role in preventing and recognising UTI in care home residents.Incorporating this into the fundamental care they provide can help them to adopt a proactive approach to preventing infection and avoiding unnecessary antibiotic use. This requires a context of care with a culture of personalisation and safety, promoted by commissioners, regulators and providers, where leadership and resources are committed to support preventative action by knowledgeable care staff.

Potential donor family behaviours, experiences and decisions following implementation of the Organ Donation (Deemed Consent) Act 2019 in England: A qualitative study.

BACKGROUND: In May 2020, England implemented "deemed consent" legislation, to make it easier for individuals to donate their organs and convey their decision when alive. Families are supposed to support the decision but can still override it if they disagree. We aimed to learn more about this changed role when families were approached about organ donation. METHODS: A qualitative study using semi-structured interviews with families, feedback from nurses, comparisons with audit data, and public involvement. We used framework analysis with a health systems perspective and utilitarian theory to explore if the law worked. FINDINGS: 103 participants were interviewed representing 83 potential donation cases. In 31/83 (37%) cases donation was fully supported, in 41/83 (49%) cases families supported retrieval of some organs, tissues and procedures, and in 11/83 (13%) cases families declined completely. Themes explaining why the law was not (yet) working included: Understanding and agreeing the family's role, confusion about deemed consent, not supporting the deceased expressed decisions, organ donation as too much of a harm, the different experiences of donation pathways, transition from end-of-life to organ donation discussions, experiences of 'consent', paperwork and processes. Families frequently questioned if their relative wanted to have a surgery rather than supporting the person who died to save lives. CONCLUSION: Families use the unique experience of their relative dying in intensive care to create alternate narratives whereby the outcome satisfies their own utility and not necessarily those of the potential donor. New public ongoing media campaigns crafted to be more supportive of organ donation as a benefit to transplant recipients could help families overcome the many difficulties they encounter at the bedside. IMPLICATIONS FOR CLINICAL PRACTICE: The soft opt-out policy has not empowered nurses to help families at their most vulnerable to increase their support for and consent to deceased organ donation.

Trends in organ donation in England, Scotland and Wales in the context of the COVID-19 pandemic and 'opt-out' legislation.

BACKGROUND: In May 2020, England implemented soft 'opt-out' or 'deemed consent' for deceased donation with the intention of raising consent rates. However, this coincided with the COVID-19 pandemic, making it difficult to assess the early impact of the law change. Wales and Scotland changed their organ donation legislation to implement soft opt-out systems in 2015 and 2021 respectively. This study provides a descriptive analysis of changes in consent and transplant rates for deceased organ donation in England, Scotland and Wales. METHODS: Logistic regression and descriptive trend analysis were employed to assess the probability of a patient who died in critical care becoming a donor, and to report consent rates using data, respectively, from the Intensive Care National Audit and Research Centre (ICNARC) in England from 1 April 2014 to 30 September 2021, and from the Potential Donor Audit for England, Scotland and Wales from April 2010 to June 2023. RESULTS: The number of eligible donors in April-June 2020 were 56.5%, 59.3% and 57.6% lower in England, Scotland and Wales relative to April-June 2019 (pre-pandemic). By April-June 2023, the number of eligible donors had recovered to 87.4%, 64.2% and 110.3%, respectively, of their levels in 2019. The consent rate in England, Scotland and Wales reduced from 68.3%, 63.0% and 63.6% in April-June 2019 to 63.2%, 60.5% and 56.3% in April-June 2023. CONCLUSIONS: While the UK organ donation system shows signs of recovery from the COVID-19 pandemic, the number of eligible potential donors and consent rates remain below their pre-pandemic levels.

Why did England change its law on deceased organ donation in 2019? The dynamic interplay between evidence and values.

In the three years since the law on adult deceased organ donation consent in England changed to include an opt-out system, there has been no discernible change to donation rates. The lack of a positive impact on donation rates was predicted by many of those who took part in debates before and during the passage of the Bill through Parliament. This invites the question as to why England moved to an opt-out system for organ donation despite equivocal evidence of likely benefit and opposition from expert health professional organisations. To address this question qualitative analyses of Parliamentary debates on organ donation was undertaken. This revealed a shift from a dominant position, which gave primacy to the evidence of likely effects, towards a more normative position where a deemed consent option was viewed as the 'correct thing to do' and the limited and conflicting evidence viewed in a positive light. By 2017, following Wales's move to an opt-out system, together with continued lobbying for similar changes for England by professional and patient groups, alongside sustained public popularity for organ donation, the balance of opinion had shifted towards a system where deemed consent would become the default position for most English adults.

Strategies for older people living in care homes to prevent urinary tract infection: the StOP UTI realist synthesis.

Background: Urinary tract infection is the most diagnosed infection in older people. It accounts for more than 50% of antibiotic prescriptions in care homes and is a frequent reason for care home residents being hospitalised. Objective: This realist review developed and refined programme theories for preventing and recognising urinary tract infection, exploring what works, for whom and in what circumstances. Design: The review used realist synthesis to explore existing literature on the detection and prevention of urinary tract infection, complemented by stakeholder consultation. It applies to the UK context, although other healthcare systems may identify synergies in our findings. Data sources: Bibliographic databases searched included MEDLINE, CINAHL, EMBASE, Cochrane Library, Web of Science Core Collection (including the Social Sciences Citation Index), Sociological Abstracts, Bibliomap and National Institute for Health and Care Research Journals Library. Data selection and extraction: Title and abstract screening were undertaken by two researchers independently of each other. Selection and assessment were based on relevance and rigour and cross-checked by a second researcher. Data extracted from the included studies were explored for explanations about how the interventions were considered to work (or not). Evidence tables were constructed to enable identification of patterns across studies that offered insight about the features of successful interventions. Data analysis and synthesis: Programme theories were constructed through a four-stage process involving scoping workshops, examination of relevant extant theory, analysis and synthesis of primary research, teacher-learner interviews and a cross-system stakeholder event. A process of abductive and retroductive reasoning was used to construct context-mechanism-outcome configurations to inform programme theory. Results: The scoping review and stakeholder engagement identified three theory areas that address the prevention and recognition of urinary tract infection and show what is needed to implement best practice. Nine context-mechanism-outcome configurations provided an explanation of how interventions to prevent and recognise urinary tract infection might work in care homes. These were (1) recognition of urinary tract infection is informed by skills in clinical reasoning, (2) decision-support tools enable a whole care team approach to communication, (3) active monitoring is recognised as a legitimate care routine, (4) hydration is recognised as a care priority for all residents, (5) systems are in place to drive action that helps residents to drink more, (6) good infection prevention practice is applied to indwelling urinary catheters, (7) proactive strategies are in place to prevent recurrent urinary tract infection, (8) care home leadership and culture fosters safe fundamental care and (9) developing knowledgeable care teams. Limitations: We adapted our approach and work to online interactions with stakeholders and as a research team because of COVID-19. This also had an impact on bringing stakeholders together at a face-to-face event at the end of the project. Studies focusing on the prevention of urinary tract infection in care home settings were predominantly from the USA and Europe where the regulatory and funding systems for the long-term care of the elderly have some differences, particularly in the USA where national reporting plays a significant role in driving improvements in care. Conclusions: Care home staff have a vital role in the prevention and recognition of urinary tract infection, which can be enabled through integration and prioritisation within the systems and routines of care homes and delivery of person-centred care. Promoting fundamental care as a means of facilitating a holistic approach to prevention and recognition of urinary tract infection helps staff to recognise how they can contribute to antimicrobial stewardship and recognition of sepsis. Challenging assumptions made by staff about the presentation of urinary tract infection is complex and requires education that facilitates 'unlearning' and questioning of low-value practices. Programmes to prevent urinary tract infection need to be co-designed and supported through active and visible leadership by care home managers with support from specialist practitioners. Future work: We will focus on co-designing tools that facilitate implementation of our findings to ensure they fit with the care home context and address some of the challenges faced by care home leaders. This will underpin action at care home and system levels. Further research is needed to better understand the perspectives of residents and family carers, the effectiveness of non-pharmacological, pharmacological and specialist practitioner interventions and non-traditional approaches to training and educating the workforce in care home settings. Study registration: This study is registered as PROSPERO CRD42020201782. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR130396) and is published in full in Health Technology Assessment; Vol. 28, No. 68. See the NIHR Funding and Awards website for further award information.

This study was about how interventions to prevent and recognise urinary tract infections might work in care homes to reduce urinary tract infection in older people. We used an approach called realist synthesis. This aims to understand everything that influences how care is delivered to find out what works in particular situations and settings. We did this by talking to care home staff, residents, family carers and other experts about how to reduce urinary tract infection in older people living in care homes. We combined their experiences and ideas with the evidence from the research literature. From this, we developed three areas of focus: care approaches to support accurate recognition of urinary tract infection care approaches to prevent urinary tract infection/catheter-associated urinary tract infection making best practice happen. Our research shows that care staff are best placed to recognise subtle changes in a resident's behaviour or well-being which might indicate an infection. There are several things care staff can do to proactively help residents from developing a urinary tract infection such as prioritising residents' hydration needs and addressing poor fluid intake. Putting in place infection prevention measures such as caring for, or where possible, removing a urinary catheter can also help. Actively monitoring residents to determine reasons for changes in behaviour can increase the focus on preventative activities and help avoid inappropriate treatment. The detection and prevention of urinary tract infection in older people could be improved in several ways, including: education tailored to the roles and work of care home staff leaders of care homes providing a culture of safety and improvement where urinary tract infection is recognised as something preventable rather than unavoidable having a safe and supportive environment where staff are confident to communicate their concerns all care team members, residents and their families and other professionals linked with the home having a common language and shared goals in the recognition, prevention and diagnosis of urinary tract infection. The COVID-19 pandemic required us to adapt our approach and work mainly online both in our interactions with stakeholders and as a research team. While this provided opportunities to extend our reach to a wider group of stakeholders, it also limited some of our engagement work.

Wellbeing Impact Study of High-Speed 2 (WISH2): Protocol for a mixed-methods examination of the impact of major transport infrastructure development on mental health and wellbeing.

Although research has demonstrated that transport infrastructure development can have positive and negative health-related impacts, most of this research has not considered mental health and wellbeing separately from physical health. There is also limited understanding of whether and how any effects might be experienced differently across population groups, whether this differs according to the stage of development (e.g. planning, construction), and how changes to planned infrastructure may affect mental health and wellbeing. This paper presents a protocol for the Wellbeing Impact Study of HS2 (WISH2), which seeks to address these questions using a high-speed rail development in the UK as an applied example. WISH2 is a 10-year, integrated, longitudinal, mixed-methods project using general practices (primary medical care providers in the UK) as an avenue for participant recruitment and for providing a geographically defined population for which aggregated data on mental health indicators are available. The research comprises: (i) a combined longitudinal and repeated cross-sectional cohort study involving multiple waves of survey data collection and data from medical records; (ii) longitudinal, semi-structured interviews and focus groups with residents and community stakeholders from exposed areas; (iii) analysis of administrative data aggregated at the general practice population level; and (iv) health economic analysis of mental health and wellbeing impacts. The study findings will support the development of strategies to reduce negative impacts and/or enhance positive mental health and wellbeing impacts of high-speed rail developments and other large-scale infrastructure projects.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients' musculoskeletal pain and enablement.

INTRODUCTION: Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain. METHODS AND ANALYSIS: A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews. ETHICS APPROVAL AND DISSEMINATION: Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country. TRIAL REGISTRATION NUMBER: ISRCTN18010240.

Incidence of 'Low-Risk but Not No-Risk' Features of Cancer Prior to High-Risk Feature Occurrence: An Observational Cohort Study in Primary Care.

Diagnosing cancer may be expedited by decreasing referral risk threshold. Clinical Practice Research Datalink participants (≥40 years) had a positive predictive value (PPV) ≥3% feature for breast, lung, colorectal, oesophagogastric, pancreatic, renal, bladder, prostatic, ovarian, endometrial or laryngeal cancer in 2016. The numbers of participants with features representing a 1-1.99% or 2-2.99% PPV for same cancer in the previous year were reported, alongside the time difference between meeting the ≥3% criteria and the lower threshold criteria. A total of 8616 participants had a PPV ≥3% feature, of whom 365 (4.2%) and 1147 (13.3%), respectively, met 2-2.99% and 1-1.99% criteria in the preceding year. The median time difference was 131 days (Interquartile Range (IQR) 27 to 256) for the 2-2.99% band and 179 days (IQR 58 to 289) for the 1-1.99% band. Results were heterogeneous across cancer sites. For some cancers, participants may progress from presenting lower- to higher-risk features before meeting urgent referral criteria; however, this was not usually the case. The details of specific features across multiple cancer sites will allow for a tailored approach to future reductions in referral thresholds, potentially improving the efficiency of urgent cancer referrals for the benefit both of individuals and the National Health Service (NHS).

Patient reported outcomes and recruitment rates following the introduction of principled patient information leaflets (PrinciPILs): Protocol for a meta-analysis.

Background: The way potential benefits and harms of trial interventions are shared within patient information leaflets (PILs) varies widely and may cause unnecessary harms ("nocebo effects"). The aim of this meta-analysis will be to evaluate the influence on recruitment rates and early effects on patient reported adverse events of principled patient information leaflets (PrinciPILs) compared with standard PILs. Methods: Eligible studies will include those that report the effects on recruitment and patient reported adverse events of PrinciPILs compared to standard PILs. We will include in this meta-analysis all the standard PILs in studies within trials (SWATs) of PrinciPILs that were developed as part of the Medical Research Council (MRC) funded PrinciPIL project. By publishing this as a living meta-analysis, we will allow the meta-analysis to be updated with future SWATs of PrinciPILs. We will use the Cochrane Risk of Bias tool to evaluate the risk of bias for each outcome. We will report the total number of studies and participants analysed and the characteristics of included studies (including details of intervention, comparators, outcomes). For dichotomous data, we will calculate the risk difference and the risk ratio (RR) and 95% confidence intervals (CIs). For continuous outcomes we will use weighted mean differences with 95% CIs or standardized mean differences with 95% CIs. We will investigate heterogeneity by visually inspecting the forest plot and by considering the I 2 test result. We will assess the certainty warranted for each outcome using the Grading of Recommendations Assessment Development and Evaluation (GRADE). Ethics approval is not applicable since no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations. Discussion: We will discuss the limitations of the meta-analysis including study risk of bias, inconsistency, heterogeneity, and imprecision. A general interpretation of the results and important implications will be provided.

People who take part in randomised trials need to understand the risks as well as the benefits of taking part. Most 'patient information leaflets' (PILs) that describe trial treatments include information about harms. Yet only some PILs contain information about potential benefits. This variation is confusing. Also, the over-emphasis on harms can cause "nocebo" effects, which are the harms caused by expecting something bad to happen. To solve these problems, we have developed seven principles that ensure that information about potential benefits and harms in PILs is balanced and consistent. We will now compare PILs that have been developed according to our principles (we call these 'PrinciPILs') with PILs that have not been developed with our principles. We will test whether PrinciPILs reduce nocebo effects and improve trial recruitment. Here we have described our plans to test the effect of PrinciPILs in a few trials.

Co-production of guidance and resources to implement principled participant information leaflets (PrinciPILs).

Background: The way information about potential benefits and harms of trial is presented within participant information leaflets (PILs) varies widely and may cause unnecessary 'nocebo' effects. The Medical Research Council (MRC) funded a project that developed seven principles to reduce this variation. However, guidance has not been produced to facilitate the implementation of the principles. Stakeholder involvement is recommended to optimise the way these principles are disseminated and explained. To co-produce recommendations for developing: (1) user-friendly guidance for users of the principles; and (2) resources that support the implementation of the principles. Methods: We held a co-production workshop with representation from the following professional groups: the Health Research Authority (HRA), research ethics committee members, and trial managers. Two rounds of discussions focused on generating recommendations for guidance and resources that support the implementation of the seven principles. Extensive low inference style ethnographic notes were taken, and the data were analysed thematically using deductive codes. The data was collected on October 14, 2022. Results: 25 participants attended a hybrid workshop. Participants recommended that both researchers designing PILs and research ethics committee members should use the principles, and that that they should be simple, mention both benefits and harms explicitly, include examples of visual representations, and provide the evidence base for the principles. Conclusions: We were able to co-produce recommendations for developing and implementing the seven principles within PILs. These recommendations can now be implemented to reduce unexplained variation in the way potential benefits and harms are shared within PILs.

Trial participants need to know about the potential benefits and harms of trial interventions to make an informed decision about whether to take part in a clinical trial. Yet the way they are told about these benefits and harms varies widely. We developed seven principles that can reduced this variability. We held a workshop with members of ethics committees and other stakeholders to develop the best way to implement the principles. 25 participants attended the workshop, and we were able to make useful recommendations that will improve the way trial participants are told about risks and benefits of trial treatments.