Ethics and patient and public involvement with children and young people

Patient and public involvement (PPI) is important both in research and in quality improvement activities related to healthcare services . While PPI activities do not require formal ethical approval, they can raise a number of ethical concerns, through the introduction of complex technical medical concepts, challenging language or sensitive subject areas. There is very little published literature to guide ethical practice in this area. We have been conducting PPI with children and young people throughout a research study in paediatric palliative care. PPI started during the application process and continued to guide and shape the research as it progressed. Ethical issues can arise at any time in PPI work. Although many can be predicted and planned for, the nature of PPI means that researchers can be presented with ideas and concepts they had not previously considered, requiring reflexivity and a reactive approach. This paper describes how we considered and addressed the potential ethical issues of PPI within our research. The approach that emerged provides a framework that can be adapted to a range of contexts and will be of immediate relevance to researchers and clinicians who are conducting PPI to inform their work

An evaluation of the experiences of young people in Patient and Public Involvement for palliative care research

Background: The active involvement of patients and the public in the design and conduct of research (Patient and Public Involvement) is important to add relevance and context. There are particular considerations for involving children and young people in research in potentially sensitive and emotional subject areas such as palliative care. Aim: To evaluate the experiences of young people of Patient and Public Involvement for a paediatric palliative care research study. Design: Anonymous written feedback was collected from group members about their experiences of Patient and Public Involvement in a paediatric palliative care research study. An inductive thematic analysis of the feedback was conducted using NVivo. Setting / Participants: Young people aged 12–22 years who were members of existing advisory groups at a children’s hospital, hospice and the clinical research network in the West Midlands, UK. Results: Feedback was provided by 30 young people at three meetings, held between December 2016 and February 2017. Three themes emerged: (1) Involvement: Young people have a desire to be involved in palliative care research, and recognise the importance of the subject area. (2) Impact: Researchers should demonstrate the impact of the involvement work on the research, by regularly providing feedback. (3) Learning: Opportunities to learn both about the topic and about research more widely were valued. Conclusions: Young people want to be involved in palliative care research, and recognise its importance. A continuous relationship with the researcher throughout the study, with clear demonstration of the impact that their input has on the research plans, are important

Experiences of general practice of children with complex and palliative care needs and their families: a qualitative study

Objectives To investigate the views and experiences of general practice of children with life-limiting and life-threatening conditions, and their family members, through secondary analysis of a qualitative serial interview study. Thematic analysis was conducted on all interview data relating to experiences of primary care. Setting West Midlands, UK. Participants A total of 31 participants (10 children with life-limiting and life-threatening conditions and 21 family members) from 14 families. Study design and setting Secondary thematic analysis of qualitative interview data from a study carried out in the West Midlands, UK. Method 41 serial interviews with 31 participants from 14 families: 10 children aged 5–18 years with life-limiting and life-threatening conditions, and 21 of their family members. Results Three key themes emerged: (1) poor experiences of general practice cause children and families to feel isolated, (2) children and families value support from general practice, and (3) there are practical ways through which general practice has the potential to provide important aspects of care. Children and families reported benefits from fostering their relationship with their general practice in order to access important aspects of care, including the assessment and management of acute illness, chronic disease and medication reviews, and holistic support. Conclusion Children with life-limiting and life-threatening conditions and their families value the involvement of general practice in the care, alongside their paediatric specialists. Ways of developing and providing such support as part of an integrated system of care need to be developed

Timely digital patient-clinician communication in specialist clinical services for young people : a mixed-methods study (the LYNC study)

BACKGROUND: Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. OBJECTIVE: Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. METHODS: We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. RESULTS: Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of therapeutic relationships but can improve trust. The clinical teams studied had not themselves formally evaluated the impact of their intervention. Staff time is the main cost driver, but offsetting savings are likely elsewhere in the health service. Risks include increased dependence on clinicians, inadvertent disclosure of confidential information, and communication failures, which are mostly mitigated by young people and clinicians using common-sense approaches. CONCLUSIONS: As NHS policy prompts more widespread use of digital communication to improve the health care experience, our findings suggest that benefit is most likely, and harms are mitigated, when digital communication is used with patients who already have a relationship of trust with the clinical team, and where there is identifiable need for patients to have flexible access, such as when transitioning between services, treatments, or lived context. Clinical teams need a proactive approach to ethics, governance, and patient safety

An eight-year follow-up national study of medical school and general hospital ethics committees in Japan

<p>Abstract</p> <p>Background</p> <p>Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan.</p> <p>Methods</p> <p>This study consisted of four national surveys sent twice over a period of eight years to two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses.</p> <p>Results</p> <p>Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees.</p> <p>Conclusion</p> <p>Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees.</p

Improving health outcome for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people receiving specialist clinical services:LYNC study protocol.

Background: Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. Aim: To present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers. Methods: The research involves: 1) Patient and Public Involvement activities with 16-24 year olds with and without long term health conditions; 2) six literature reviews; 3) case studies – the main empirical part of the study – and 4) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data), on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety

Benefits and harms of antenatal and newborn screening programmes in health economic assessments: the VALENTIA systematic review and qualitative investigation.

BACKGROUND: Health economic assessments are used to determine whether the resources needed to generate net benefit from an antenatal or newborn screening programme, driven by multiple benefits and harms, are justifiable. It is not known what benefits and harms have been adopted by economic evaluations assessing these programmes and whether they omit benefits and harms considered important to relevant stakeholders. OBJECTIVES: (1) To identify the benefits and harms adopted by health economic assessments in this area, and to assess how they have been measured and valued; (2) to identify attributes or relevance to stakeholders that ought to be considered in future economic assessments; and (3) to make recommendations about the benefits and harms that should be considered by these studies. DESIGN: Mixed methods combining systematic review and qualitative work. SYSTEMATIC REVIEW METHODS: We searched the published and grey literature from January 2000 to January 2021 using all major electronic databases. Economic evaluations of an antenatal or newborn screening programme in one or more Organisation for Economic Co-operation and Development countries were considered eligible. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist. We identified benefits and harms using an integrative descriptive analysis and constructed a thematic framework. QUALITATIVE METHODS: We conducted a meta-ethnography of the existing literature on newborn screening experiences, a secondary analysis of existing individual interviews related to antenatal or newborn screening or living with screened-for conditions, and a thematic analysis of primary data collected with stakeholders about their experiences with screening. RESULTS: The literature searches identified 52,244 articles and reports, and 336 unique studies were included. Thematic framework resulted in seven themes: (1) diagnosis of screened for condition, (2) life-years and health status adjustments, (3) treatment, (4) long-term costs, (5) overdiagnosis, (6) pregnancy loss and (7) spillover effects on family members. Diagnosis of screened-for condition (115, 47.5%), life-years and health status adjustments (90, 37.2%) and treatment (88, 36.4%) accounted for most of the benefits and harms evaluating antenatal screening. The same themes accounted for most of the benefits and harms included in studies assessing newborn screening. Long-term costs, overdiagnosis and spillover effects tended to be ignored. The wide-reaching family implications of screening were considered important to stakeholders. We observed good overlap between the thematic framework and the qualitative evidence. LIMITATIONS: Dual data extraction within the systematic literature review was not feasible due to the large number of studies included. It was difficult to recruit healthcare professionals in the stakeholder's interviews. CONCLUSIONS: There is no consistency in the selection of benefits and harms used in health economic assessments in this area, suggesting that additional methods guidance is needed. Our proposed thematic framework can be used to guide the development of future health economic assessments evaluating antenatal and newborn screening programmes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42020165236. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127489) and is published in full in Health Technology Assessment; Vol. 28, No. 25. See the NIHR Funding and Awards website for further award information

Diversity and uniformity in genetic responsibility: moral attitudes of patients, relatives and lay people in Germany and Israel

The professional and institutional responsibility for handling genetic knowledge is well discussed; less attention has been paid to how lay people and particularly people who are affected by genetic diseases perceive and frame such responsibilities. In this exploratory study we qualitatively examine the attitudes of lay people, patients and relatives of patients in Germany and Israel towards genetic testing. These attitudes are further examined in the national context of Germany and Israel, which represent opposite regulatory approaches and bioethical debates concerning genetic testing. Three major themes of responsibility emerged from the inter-group and cross-cultural comparison: self-responsibility, responsibility for kin, and responsibility of society towards its members. National contrast was apparent in the moral reasoning of lay respondents concerning, for example, the right not to know versus the duty to know (self-responsibility) and the moral conflict concerning informing kin versus the moral duty to inform (responsibility for kin). Attitudes of respondents affected by genetic diseases were, however, rather similar in both countries. We conclude by discussing how moral discourses of responsibility are embedded within cultural (national, religious) as well as phenomenological (being affected) narratives, and the role of public engagement in bioethical discourse