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.

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.

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.

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.

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.

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.

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.

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).

Using microbiological data to improve the use of antibiotics for respiratory tract infections: A protocol for an individual patient data meta-analysis.

BACKGROUND: Resistance to antibiotics is rising and threatens future antibiotic effectiveness. 'Antibiotic targeting' ensures patients who may benefit from antibiotics receive them, while being safely withheld from those who may not. Point-of-care tests may assist with antibiotic targeting by allowing primary care clinicians to establish if symptomatic patients have a viral, bacterial, combined, or no infection. However, because organisms can be harmlessly carried, it is important to know if the presence of the virus/bacteria is related to the illness for which the patient is being assessed. One way to do this is to look for associations with more severe/prolonged symptoms and test results. Previous research to answer this question for acute respiratory tract infections has given conflicting results with studies has not having enough participants to provide statistical confidence. AIM: To undertake a synthesis of IPD from both randomised controlled trials (RCTs) and observational cohort studies of respiratory tract infections (RTI) in order to investigate the prognostic value of microbiological data in addition to, or instead of, clinical symptoms and signs. METHODS: A systematic search of Cochrane Central Register of Controlled Trials, Ovid Medline and Ovid Embase will be carried out for studies of acute respiratory infection in primary care settings. The outcomes of interest are duration of disease, severity of disease, repeated consultation with new/worsening illness and complications requiring hospitalisation. Authors of eligible studies will be contacted to provide anonymised individual participant data. The data will be harmonised and aggregated. Multilevel regression analysis will be conducted to determine key outcome measures for different potential pathogens and whether these offer any additional information on prognosis beyond clinical symptoms and signs. TRIAL REGISTRATION: PROSPERO Registration number: CRD42023376769.

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 perceptions of empathy in primary care telephone consultations: A mixed methods study.

OBJECTIVE: Clinical empathy can enhance patient outcomes. This study examined patients' perceptions of empathy in primary care consultations delivered by telephone. METHODS: A mixed methods study was nested in a larger feasibility study conducted May-October 2020. Adults reporting a UK primary care consultation in the previous 2 weeks completed an online survey. A sample of survey respondents participated in a semi-structured qualitative interview. Interviews were analysed thematically. RESULTS: Survey respondents (n = 359) rated practitioners as between 'good' and 'very good' at established patient-reported indicators of clinical empathy. Telephone consultations were rated slightly lower than face-to-face or other consultations. 30 survey respondents were interviewed. Three qualitative themes identified how telephone consultations can shape clinical empathy: setting for an empathic encounter; feeling connected; being acknowledged. CONCLUSION: Primary care patients typically perceive good levels of clinical empathy in telephone consultations; specific features of telephone consultations may facilitate and/or hinder clinical empathy. PRACTICE IMPLICATIONS: To ensure patients feel listened to, acknowledged and understood, practitioners may need to increase their empathic verbalisations in telephone consultations. By using verbal responses to demonstrate active listening and by clearly describing and/or implementing next steps in management, practitioners may be able to enhance clinical empathy in telephone consultations.

Post-consultation acute respiratory tract infection recovery: a latent class-informed analysis of individual patient data.

BACKGROUND: There is a lack of evidence regarding post-consultation symptom trajectories for patients with respiratory tract infections (RTIs) and whether patient characteristics can be used to predict illness duration. AIM: To describe symptom trajectories in patients with RTIs, and assess baseline characteristics and adverse events associated with trajectories. DESIGN AND SETTING: The study included data about 9103 adults and children from 12 primary care studies. METHOD: A latent class-informed regression analysis of individual patient data from randomised controlled trials and observational cohort studies was undertaken. Post-consultation symptom trajectory (severity and duration), re-consultation with same or worsening illness, and admission to hospital were assessed. RESULTS: In total, 90% of participants recovered from all symptoms by 28 days, regardless of antibiotic prescribing strategy (none, immediate, and delayed antibiotics). For studies of RTI with cough as a dominant symptom (n = 5314), four trajectories were identified: 'rapid (6 days)' (90% of participants recovered within 6 days) in 52.0%; 'intermediate (10 days)' (28.9%); 'slow progressive improvement (27 days)' (12.5%); and 'slow improvement with initial high symptom burden (27 days)' (6.6%). For cough, being aged 16-64 years (odds ratio [OR] 2.57, 95% confidence interval [CI] = 1.72 to 3.85 compared with <16 years), higher presenting illness baseline severity (OR 1.51, 95% CI = 1.12 to 2.03), presence of lung disease (OR 1.78, 95% CI = 1.44 to 2.21), and median and above illness duration before consultation (≥7 days) (OR 1.99, 95% CI = 1.68 to 2.37) were associated with slower recovery (>10 days) compared with faster recovery (≤10 days). Re-consultations and admissions to hospital for cough were higher in those with slower recovery (ORs: 2.15, 95% CI = 1.78 to 2.60 and 7.42, 95% CI = 3.49 to 15.78, respectively). CONCLUSION: Older patients presenting with more severe, longer pre-consultation symptoms and chronic lung disease should be advised they are more likely to experience longer post-consultation illness durations, and that recovery rates are similar with and without antibiotics.

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.

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.

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.

Analysis of content and online public responses to media articles that raise awareness of the opt-out system of consent to organ donation in England.

Background: Preceded by a national media campaign, in May 2020, England switched to a soft opt-out system of organ donation which rests on the assumption that individuals meeting specific criteria have consented to organ donation unless they have expressed otherwise. We aimed to learn more about how the changes were communicated, how people responded and any discrepancies between key messages and how they were interpreted by the public. Methods: Summative content analysis of 286 stories and related reader-generated comments in leading UK online news sources (April 2019 to May 2021). Further detailed thematic analysis of 21 articles with reader-generated content, complemented by thematic content analysis coding of all 286 stories. Results: Most media coverage on both organ donation and the law change was positive, with little variation over time or between publications. The importance of organ donation, benefits of the law change, and emotive stories (often involving children) of those who had donated an organ described as "superheroes" or those who had received organs as benefiting from a "miracle" were frequently cited. In contrast, reader-generated comments were markedly more negative, for example, focusing on loss of individual freedom and lack of trust in the organ donation system. Commentators wished to be able to choose who their organs were donated to, were dismissive and blaming towards minority ethnic groups, including undermining legitimate worries about the compatibility of organ donation with religious beliefs and end of life cultural norms, understanding and acceptance of brain-stem death and systemic racism. Misinformation including use of inflammatory language was common. Conclusion: The portrayal of donors and recipients as extraordinary is unlikely to help to normalise organ donation. Undermining legitimate concerns, in particular those from ethnic minorities, can alienate and encourage harmful misinformation in underrepresented groups. The discrepancies between the tone of the articles and the readers comments suggests a lack of trust across the public, health, policy and media outlets. Easily accessible, ongoing and tailored sources are needed to mitigate misinformation and disinformation and ensure key messages are better understood and accepted in order to realise the ambitions of soft opt-out organ donation policies.

Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey.

BACKGROUND: The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective 'nocebo' harms. This study aimed to develop principles to improve the composition of information about potential trial intervention benefits and harms within PILs so that variability and avoidable harms are reduced. METHODS: We conducted a two-round modified online Delphi survey, followed by a consensus meeting. For the first round of the survey, 27 statements were developed based on previous research and relevant guidance from the UK, the USA and the World Health Organization. Participants included members from each of the following stakeholder groups: patient and public representatives, research ethics committee members, industry representatives, medico-legal experts, psychologists and trial managers. Each participant was asked to rate their degree of agreement or disagreement with each statement on a 9-point Likert scale. In the second round, participants were invited to reappraise their ratings after reviewing the results of the first round. Finally, two members from each stakeholder group participated in a meeting to confirm those statements for which there was agreement. RESULTS: Two hundred and fifty participants completed round 1, and 201 participants completed round 2. In round 1, consensus was reached for 16 statements. In round 2, consensus was reached for an additional three statements. The consensus meeting confirmed the survey results and consolidated the statements. This process resulted in seven principles: (1) all potential harms of a given intervention should be listed, (2) all potential harms should be separated into serious and less serious, (3) it must be made explicit that not all potential harms are known, (4) all potential benefits should be listed, (5) all potential benefits and harms need to be compared with what would happen if the participant did not take part in the trial, (6) suitable visual representations should be added where appropriate and (7) information regarding potential benefits and harms should not be presented apart by one or more pages. CONCLUSIONS: Our modified Delphi process successfully generated seven principles that can and should be used to guide how information is conveyed to patients in information leaflets regarding potential trial benefits and harms.