BACKGROUND: In contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to estimate the effectiveness and cost-effectiveness of a perpetrator programme for men. METHODS: Pragmatic two-group individually randomised controlled trial (RCT) with embedded process and economic evaluation. Five centres in southwest England and South Wales aim to recruit 316 (reduced from original target of 366) male domestic abuse perpetrators. These will be randomised 2:1 to a community-based domestic abuse perpetrator programme (DAPP) or usual care comparator with 12-month follow-up. Female partners/ex-partners will be invited to join the study. The intervention for men comprises 23 weekly sessions of a group programme delivered in voluntary sector domestic abuse services. The intervention for female partners/ex-partners is one-to-one support from a safety worker. Men allocated to usual care receive no intervention; however, they are free to access other services. Their partners/ex-partners will be signposted to support services. Data is collected at baseline, and 4, 8 and 12 months' follow-up. The primary outcome is men's self-reported abusive behaviour measured by the Abusive Behaviour Inventory (ABI-29) at 12 months. Secondary measures include physical and mental health status and resource use alongside the abuse measure ABI (ABI-R) for partners/ex-partners and criminal justice contact for men. A mixed methods process evaluation and qualitative study will explore mechanisms of effectiveness, judge fidelity to the intervention model using interviews and group observations. The economic evaluation, over a 1-year time horizon from three perspectives (health and social care, public sector and society), will employ a cost-consequences framework reporting costs alongside economic outcomes (Quality-Adjusted Life Years derived from EQ-5D-5L, SF-12 and CHU-9D, and ICECAP-A) as well as the primary and other secondary outcomes. DISCUSSION: This trial will provide evidence of the (cost)effectiveness of a DAPP. The embedded process evaluation will further insights in the experiences and contexts of participants and their journey through a perpetrator programme, and the study will seek to address the omission in other studies of economic evaluations. TRIAL REGISTRATION: ISRCTN15804282, April 1, 2019.
Domestic Violence , Quality of Life , Female , Male , Humans , Cost-Benefit Analysis , England , Domestic Violence/prevention & control , Qualitative Research , Randomized Controlled Trials as Topic
Background: Globally, healthcare professionals (HCPs) are increasingly asked to identify and respond to domestic violence and abuse (DVA) among patients. However, their own experiences of DVA have been largely ignored.Aim: To determine the prevalence of current and lifetime DVA victimisation among HCPs globally, and identify risk markers, consequences and support-seeking for DVA.Method: PubMed, EMBASE, PsycINFO, CINAHL ASSIA and ProQuest were searched. Studies about HCPs' personal experience of any type of DVA from any health service/country were included. Meta-analysis and narrative synthesis were adopted.Results: Fifty-one reports were included. Pooled lifetime prevalence was 31.3% (95% CI [24.7%, 38.7%] p < .001)) and past-year prevalence was 10.4% (95% CI [5.8%, 17.9%] p <.001). Pooled lifetime prevalence significantly differed (Qb=6.96, p < .01) between men (14.8%) and women (41.8%), and between HCPs in low-middle income (64.0%) and high-income countries (20.7%) (Qb = 31.41, p <.001). Risk markers were similar to those in the general population, but aspects of the HCP role posed additional and unique risks/vulnerabilities. Direct and indirect consequences of DVA meant HCP-survivors were less able to work to their best ability. While HCP-survivors were more likely than other HCPs to identify and respond to DVA among patients, doing so could be distressing. HCP-survivors faced unique barriers to seeking support. Being unable to access support - which is crucial for leaving or ending relationships with abusive people - leaves HCP-survivors entrapped.Conclusion: Specialised DVA interventions for HCPs are urgently needed, with adaptations for different groups and country settings. Future research should focus on developing interventions with HCP-survivors.
Crime Victims , Domestic Violence , Female , Humans , Male , Delivery of Health Care , Health Personnel , Prevalence
Introduction: COVID-19 restrictions created barriers to "business as usual" in healthcare but also opened the door to innovation driven by necessity. This manuscript (1) describes how ADVANCE, an in-person group perpetrator program to reduce intimate partner violence (IPV) against female (ex)partners by men in substance use treatment, was adapted for digitally-supported delivery (ADVANCE-D), and (2) explores the feasibility and acceptability of delivering ADVANCE-D to men receiving substance use treatment. Methods: Firstly, the person-based approach and mHealth development framework were used to iteratively adapt ADVANCE for digitally-supported delivery including conceptualization, formative research, and pre-testing. Then, a non-randomized feasibility study was conducted to assess male participants' eligibility, recruitment, and attendance rates and uptake of support offered to their (ex)partners. Exploratory analyses on reductions in IPV perpetration (assessed using the Abusive Behavior Inventory; ABI) and victimization (using the revised ABI; ABI-R) at the end of the program were performed. Longitudinal qualitative interviews with participants, their (ex)partners, and staff provided an understanding of the program's implementation, acceptability, and outcomes. Results: The adapted ADVANCE-D program includes one goal-setting session, seven online groups, 12 self-directed website sessions, and 12 coaching calls. ADVANCE-D includes enhanced risk management and support for (ex)partners. Forty-five participants who had perpetrated IPV in the past 12 months were recruited, forty of whom were offered ADVANCE-D, attending 11.4 (SD 9.1) sessions on average. Twenty-one (ex)partners were recruited, 13 of whom accepted specialist support. Reductions in some IPV perpetration and victimization outcome measures were reported by the 25 participants and 11 (ex)partners interviewed pre and post-program, respectively. Twenty-two participants, 11 (ex)partners, 12 facilitators, and 7 integrated support service workers were interviewed at least once about their experiences of participation. Overall, the program content was well-received. Some participants and facilitators believed digital sessions offered increased accessibility. Conclusion: The digitally-supported delivery of ADVANCE-D was feasible and acceptable. Remote delivery has applicability post-pandemic, providing greater flexibility and access. Given the small sample size and study design, we do not know if reductions in IPV were due to ADVANCE-D, time, participant factors, or chance. More research is needed before conclusions can be made about the efficacy of ADVANCE-D.
Qualitative and feminist researchers aim to build rapport, show empathy, be non-judgemental, and equalise power imbalances. A crucial challenge researchers face is how to navigate and balance competing aims and values when interacting with and interviewing participants who have perpetrated intimate partner violence and abuse towards women. In this article, four female researchers evaluating perpetrator programmes for abusive men use reflexive analysis to identify the tensions encountered in such research. We outline how these tensions affected us and the data produced, and end with recommendations, which we hope will help prepare researchers, particularly women, for conducting interviews with violent/abusive men.
BACKGROUND: Compared to men in the general population, men in substance use treatment are more likely to perpetrate intimate partner abuse (IPA). The ADVANCE group intervention for men in substance use treatment is tailored to address substance use and IPA in an integrated way. In a feasibility trial pre-COVID, men who received the ADVANCE intervention via face-to-face group delivery showed reductions in IPA perpetration. Due to COVID-19, ADVANCE was adapted for remote digital delivery. METHODS/DESIGN: This mixed-methods non-randomised feasibility study, with a nested process evaluation, will explore the feasibility and acceptability of delivering the ADVANCE digital intervention to men in substance use treatment who have perpetrated IPA towards a female partner in the past year. Sixty men will be recruited from seven substance use treatment services in Great Britain. The ADVANCE digital intervention comprises a preparatory one-to-one session with a facilitator to set goals, develop a personal safety plan, and increase motivation and a preparatory online group to prepare men for taking part in the intervention. The core intervention comprises six fortnightly online group sessions and 12 weekly self-directed website sessions to recap and practise skills learned in the online group sessions. Each website session is followed by a one-to-one video/phone coaching session with a facilitator. Men will also receive their usual substance use treatment. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Outcome measures for men and women will be sought post intervention (approximately 4 months post male baseline interview). Feasibility parameters to be estimated include eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates. In-depth interviews or focus groups will explore the intervention's acceptability to participants, facilitators and ISS workers. A secondary focus of the study will estimate pre-post-differences in outcome measures covering substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts and quality of life. DISCUSSION: Findings will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE digital intervention for reducing IPA. TRIAL REGISTRATION: The feasibility study was prospectively registered: ISRCTN66619273 .
BACKGROUND: Over two million adults experience domestic violence and abuse (DVA) in England and Wales each year. Domestic homicide reviews often show that health services have frequent contact with victims and perpetrators, but healthcare professionals (HCPs) do not share information related to DVA across healthcare settings and with other agencies or services. AIM: We aimed to analyse and highlight the commonalities, inconsistencies, gaps and ambiguities in English guidance for HCPs around medical confidentiality, information sharing or DVA specifically. SETTING: The English National Health Service. DESIGN AND METHOD: We conducted a desk-based review, adopting the READ approach to document analysis. This approach is a method of qualitative health policy research and involves four steps for gathering, and extracting information from, documents. Its four steps are: (1) Ready your materials, (2) Extract data, (3) Analyse data and (4) Distill your findings. Documents were identified by searching websites of national bodies in England that guide and regulate clinical practice and by backwards citation-searching documents we identified initially. RESULTS: We found 13 documents that guide practice. The documents provided guidance on (1) sharing information without consent, (2) sharing with or for multiagency risk assessment conferences (MARACs), (3) sharing for formal safeguarding and (4) sharing within the health service. Key findings were that guidance documents for HCPs emphasise that sharing information without consent can happen in only exceptional circumstances; documents are inconsistent, contradictory and ambiguous; and none of the documents, except one safeguarding guide, mention how coercive control can influence patients' free decisions. CONCLUSIONS: Guidance for HCPs on sharing information about DVA is numerous, inconsistent, ambiguous and lacking in detail, highlighting a need for coherent recommendations for cross-speciality clinical practice. Recommendations should reflect an understanding of the manifestations, dynamics and effects of DVA, particularly coercive control.
Domestic Violence , State Medicine , Adult , Delivery of Health Care , Domestic Violence/prevention & control , Health Personnel , Humans , Qualitative Research
Despite consistent evidence that substance use is a contributory risk factor for perpetration of intimate partner abuse (IPA), little evidence exists for effective interventions for male IPA perpetrators who use substances. The Advance intervention aimed to meet this need. This 16-week intervention addressed both IPA and substance use, and was for men accessing substance use treatment who had perpetrated IPA toward a female (ex-)partner within the last 12 months. Two key theories underpinned the intervention: goal theory and self-regulation theory. In this article, we aim to illustrate the views of men and substance use treatment staff on men's motivations to change, the ways in which men and staff said that men had changed their behavior, and the aspects of the intervention that they reported were key in the process of change. Using framework analysis, we analyzed data from 12 men who took part in the intervention as well as 31 staff members from substance use treatment services. Our five overarching themes were personal goal setting and motivation; recognition of IPA and the substance using lifestyle; improved self-regulation; considering the impact on others; and learning together in a group. Men and staff valued having a program that integrated IPA and substance use and thought the program was unique and much needed. Moreover, our findings suggest that goal theory, self-regulation, and more broadly, motivational and strengths-based approaches with practice-based activities, may be beneficial for effecting change in the substance using perpetrator population. However, further research is needed to determine the effectiveness of the intervention. Overall, our findings highlight the value of using qualitative outcome measures of perpetrator programs to complement quantitative measures of impact.
Intimate Partner Violence , Substance-Related Disorders , Female , Humans , Male , Men , Motivation , Risk Factors , Substance-Related Disorders/epidemiology , Substance-Related Disorders/therapy
BACKGROUND: Substance use is a risk factor for intimate partner abuse (IPA) perpetration. Delivering perpetrator interventions concurrently with substance use treatment shows promise. METHODS: The feasibility of conducting an efficacy and cost-effectiveness trial of the ADVANCE 16-week intervention to reduce IPA by men in substance use treatment was explored. A multicentre, parallel group individually randomised controlled feasibility trial and formative evaluation was conducted. Over three temporal cycles, 104 men who had perpetrated IPA towards a female (ex) partner in the past year were randomly allocated to receive the ADVANCE intervention + substance use treatment as usual (TAU) (n = 54) or TAU only (n = 50) and assessed 16-weeks post-randomisation. Participants' (ex) partners were offered support and 27 provided outcome data. Thirty-one staff and 12 men who attended the intervention participated in focus groups or interviews that were analysed using the framework approach. Pre-specified criteria assessed the feasibility of progression to a definitive trial: 1) ≥ 60% of eligible male participants recruited; 2) intervention acceptable to staff and male participants; 3) ≥ 70% of participants followed-up and 4) levels of substance use and 5) IPA perpetrated by men in the intervention arm did not increase from average baseline level at 16-weeks post-randomisation. RESULTS: 70.7% (104/147) of eligible men were recruited. The formative evaluation confirmed the intervention's acceptability. Therapeutic alliance and session satisfaction were rated highly. The overall median rate of intervention session attendance (of 14 compulsory sessions) was 28.6% (range 14.3-64.3% by the third cycle). 49.0% (51/104) of men and 63.0% (17/27) of their (ex) partners were followed-up 16-weeks post-randomisation. This increased to 100% of men and women by cycle three. At follow-up, neither substance use nor IPA perpetration had worsened for men in the intervention arm. CONCLUSIONS: It was feasible to deliver the ADVANCE intervention in substance use treatment services, although it proved difficult to collect data from female (ex)partners. While some progression criteria were met, others were not, although improvements were demonstrated by the third cycle. Lessons learned will be implemented into the study design for a definitive trial of the ADVANCE intervention. TRIAL REGISTRATION: ISRCTN79435190 prospectively registered 22nd May 2018.
Intimate Partner Violence , Substance-Related Disorders , Cost-Benefit Analysis , Feasibility Studies , Female , Humans , Intimate Partner Violence/prevention & control , Male , Substance-Related Disorders/therapy
BACKGROUND: Domestic violence and abuse (DVA) is common and damaging to health. UK national guidance advocates a multi-agency response to DVA, and domestic homicide reviews consistently recommend improved information-sharing between agencies. Identification of patients experiencing DVA in general practice may come from external information shared with the practice, such as police incident reports and multi-agency risk assessment conference (MARAC) reports. The aim of this study was to explore the views of general practitioners (GPs) and the police about sharing reports about DVA with GPs. METHODS: Qualitative semi-structured interviews were conducted with GPs, police staff and a partnership manager. Participants were located across England and Wales. Thematic analysis was undertaken. RESULTS: Interviews were conducted with 23 GPs, six police staff and one former partnership manager. Experiences of information-sharing with GPs about DVA varied. Participants described the relevance and value of external reports to GPs to help address the health consequences of DVA and safeguard patients. They balanced competing priorities when managing this information in the electronic medical record, namely visibility to GPs versus the risk of unintended disclosure to patients. GPs also spoke of the judgements they made about exploring DVA with patients based on external reports, which varied between abusive and non-abusive adults and children. Some felt constrained by short general practice consultations. Some police and GPs reflected on a loss of control when information about DVA was shared between agencies, and the risk of unintended consequences. Both police and GPs highlighted the importance of clear information and a shared understanding about responsibility for action. CONCLUSION: GPs regarded external reports about DVA as relevant to their role, but safely recording this information in the electronic medical record and using it to support patients required complex judgements. Both GPs and police staff emphasised the importance of clarity of information and responsibility for action when information was shared between agencies about patients affected by DVA.
Domestic Violence , Information Dissemination , Interprofessional Relations , Law Enforcement , Physical Abuse , Primary Health Care/methods , Adult , Child , Domestic Violence/ethics , Domestic Violence/legislation & jurisprudence , Domestic Violence/prevention & control , Domestic Violence/statistics & numerical data , Electronic Health Records/statistics & numerical data , Female , General Practitioners , Humans , Information Dissemination/ethics , Information Dissemination/legislation & jurisprudence , Information Dissemination/methods , Interdisciplinary Communication , Law Enforcement/ethics , Law Enforcement/methods , Male , Physical Abuse/ethics , Physical Abuse/legislation & jurisprudence , Physical Abuse/prevention & control , Physical Abuse/statistics & numerical data , Physician's Role , Police , Psychosocial Support Systems , Risk Assessment/methods , United Kingdom
BACKGROUND: Strong evidence exists that substance use is a contributory risk factor for intimate partner abuse (IPA) perpetration. Men in substance use treatment are more likely to perpetrate IPA than men from the general population. Despite this, referral pathways are lacking for this group. This trial will assess the feasibility of conducting an evaluation trial of a tailored integrated intervention to address substance use and IPA perpetration to men in substance use treatment. METHODS/DESIGN: ADVANCE is a multicentre, parallel-group individually randomised controlled feasibility trial, with a nested formative evaluation, comparing an integrated intervention to reduce IPA + substance use treatment as usual (TAU) to TAU only. One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited. ADVANCE is a manualised intervention comprising 2-4 individual sessions (2 compulsory) with a keyworker to set goals, develop a personal safety plan and increase motivation and readiness, followed by a 12-session weekly group intervention delivered in substance use services. Men will be randomly allocated (ratio 1:1) to receive the ADVANCE intervention + TAU or TAU only. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Regular case management meetings between substance use and ISS will manage risk. Outcome measures will be obtained at the end of the intervention (approximately 4 months post-randomisation) for all male and female participants. The main objective of this feasibility trial is to estimate parameters required for planning a definitive trial including rates of consent, recruitment, and follow-up by site and group allocation. Nested formative evaluation including focus groups and in-depth interviews will explore the intervention's acceptability to participants, group facilitators, keyworkers and ISS workers. Secondary outcomes include substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life. DISCUSSION: Findings from this feasibility trial will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE intervention for reducing IPA and improving the well-being of female (ex)partners. TRIAL REGISTRATION: ISRCTN79435190.
BACKGROUND: Health services are often the first point of professional contact for people who have experienced domestic violence and abuse. We report on the evaluation of a multi-site, hospital-based advocacy intervention for survivors of domestic violence and abuse. Independent Domestic Violence Advisors (IDVAs), who provide survivors with support around safety, criminal justice, and health and wellbeing, were located in five hospitals in England between 2012 and 2015 in emergency departments and maternity services. We present views about IDVAs' approaches to tackling domestic violence and abuse, how the IDVA service worked in practice, and factors that hindered and facilitated engagement with survivors. METHODS: We adopted a convenience sampling approach and invited participation from all who offered to take part within the study timeframe. Sixty-four healthcare professionals, IDVAs, IDVA service managers, and commissioners at all sites were interviewed. Interviews were analysed using a thematic approach: familiarising ourselves with the data through repeated readings and noting initial ideas; generating initial codes through double coding notable features of the data across the dataset; collating codes into potential themes; and reviewing themes to ensure they captured the essence of the data. RESULTS: Two key themes emerged. The first was Hospital-based IDVAs fulfil several crucial roles. This theme highlighted that healthcare professionals thought the hospital-based IDVA service was valuable because it enhanced their skills, knowledge, and confidence in asking about domestic violence and abuse. It enabled them to immediately refer and provide support to patients who might have otherwise been lost along a referral pathway. It also reached survivors who might otherwise have remained hidden. The second theme was Success hinges on a range of structural factors. This theme illustrated the importance of ongoing domestic violence and abuse training for staff, the IDVA having private and dedicated space, and the service being embedded in hospital infrastructure (e.g. featuring it in hospital-wide policies and enabling IDVAs access to medical records). CONCLUSION: Hospital-based IDVAs offer a unique and valued way to respond to domestic violence and abuse in a healthcare setting. Further work must now be done to explore how to implement the service sustainably.
Domestic Violence/prevention & control , Hospitals , Patient Advocacy , Adult , Diagnostic Tests, Routine , Emergency Service, Hospital , England , Female , Health Services Research , Humans , Male , Pregnancy , Qualitative Research , Survivors/psychology , Survivors/statistics & numerical data , Taboo
The 100,000 Genomes Project (100kGP)-a hybrid clinical-research initiative-was set up to analyse whole-genome sequences (WGS) from patients living with a rare disease or cancer. The project positioned participant consent as being of central importance, but consent in the context of genomic testing raises challenging issues. In this mixed method study, we surveyed 1337 100kGP participants regarding their experiences of taking part in the project and conducted in-depth interviews with 24 survey respondents to explore these findings further. Survey responses were analysed using descriptive statistics and interview data were analysed thematically. The consent approach of the 100kGP resulted in a proportion of our study's participants not understanding the complexities of the project and what types of results they might receive; for example, 20% of participants who we surveyed from the cancer arm did not recall what decisions they had made regarding additional findings. It is not surprising that a project such as this, with such diverse aims and participant groups, would throw up at least some challenges. However, participants reported being satisfied with their experience of the project to date. Our study highlights that in the context of consent for more complex endeavours, such as the 100kGP, it is important to assess (and document) an agreement to take part, but complicated decisions about what and when to communicate may need revisiting over time in response to changing contexts. We discuss the implications of our findings with reference to participants of the 100kGP and the newly formed NHS Genomic Medicine Service.
Genetic Testing/ethics , Informed Consent , Neoplasms/genetics , Patient Satisfaction , Rare Diseases/genetics , Whole Genome Sequencing/ethics , Adult , Female , Genetic Testing/standards , Genetic Testing/statistics & numerical data , Humans , Male , Middle Aged , Neoplasms/psychology , Rare Diseases/psychology , Whole Genome Sequencing/standards , Whole Genome Sequencing/statistics & numerical data
BACKGROUND: Domestic violence and abuse (DVA) damages the health of survivors and increases use of healthcare services. We report findings from a multi-site evaluation of hospital-based advocacy services, designed to support survivors attending emergency departments and maternity services. METHODS: Independent Domestic Violence Advisors (IDVA) were co-located in five UK hospitals. Case-level data were collected at T1 (initial referral) and T2 (case closure) from survivors accessing hospital (T1 N = 692; T2 N = 476) and community IDVA services (T1 N = 3544; T2 N = 2780), used as a comparator. Measures included indicators of sociodemographic characteristics, experience of abuse, health service use, health and safety outcomes. Multivariate analyses tested for differences in changes in abuse, health and factors influencing safety outcomes. Health service use data in the 6 months pre-and post- intervention were compared to generate potential cost savings by hospital IDVA services. RESULTS: Hospital IDVAs worked with survivors less visible to community IDVA services and facilitated intervention at an earlier point. Hospital IDVAs received higher referrals from health services and enabled access to a greater number of health resources. Hospital survivors were more likely to report greater reductions in and cessation of abuse. No differences were observed in health outcomes for hospital survivors. The odds of safety increased two-fold if hospital survivors received over five contacts with an IDVA or accessed six or more resources / programmes over a longer period of time. Six months preceding IDVA intervention, hospital survivors cost on average £2463 each in use of health services; community survivors cost £533 each. The cost savings observed among hospital survivors amounted to a total of £2050 per patient per year. This offset the average cost of providing hospital IDVA services. CONCLUSIONS: Hospital IDVAs can identify survivors not visible to other services and promote safety through intensive support and access to resources. The co-location of IDVAs within the hospital encouraged referrals to other health services and wider community agencies. Further research is required to establish the cost-effectiveness of hospital IDVA services, however our findings suggest these services could be an efficient use of health service resources.
Crime Victims/statistics & numerical data , Domestic Violence/statistics & numerical data , Emergency Service, Hospital , Hospitals, Maternity , Patient Advocacy , Survivors/statistics & numerical data , Adult , Crime Victims/psychology , Domestic Violence/psychology , Emergency Service, Hospital/organization & administration , Evaluation Studies as Topic , Female , Guidelines as Topic , Hospitals, Maternity/organization & administration , Humans , Male , Survivors/psychology
Technological advances have increased the availability of genomic data in research and the clinic. If, over time, interpretation of the significance of the data changes, or new information becomes available, the question arises as to whether recontacting the patient and/or family is indicated. The Public and Professional Policy Committee of the European Society of Human Genetics (ESHG), together with research groups from the UK and the Netherlands, developed recommendations on recontacting which, after public consultation, have been endorsed by ESHG Board. In clinical genetics, recontacting for updating patients with new, clinically significant information related to their diagnosis or previous genetic testing may be justifiable and, where possible, desirable. Consensus about the type of information that should trigger recontacting converges around its clinical and personal utility. The organization of recontacting procedures and policies in current health care systems is challenging. It should be sustainable, commensurate with previously obtained consent, and a shared responsibility between healthcare providers, laboratories, patients, and other stakeholders. Optimal use of the limited clinical resources currently available is needed. Allocation of dedicated resources for recontacting should be considered. Finally, there is a need for more evidence, including economic and utility of information for people, to inform which strategies provide the most cost-effective use of healthcare resources for recontacting.
Duty to Recontact , Genetic Counseling/ethics , Genetic Testing/ethics , Practice Guidelines as Topic , European Union , Genetic Counseling/legislation & jurisprudence , Genetic Counseling/standards , Genetic Testing/legislation & jurisprudence , Genetic Testing/standards , Humans , Societies, Medical/standards
In this paper, we present findings from a project involving 20 patients with rare diseases, or parents thereof, participating in the 100,000 genomes project (100â¯kGâ¯P). We explored their experiences of, and views about, the project, including why they took part, and their hopes and concerns about the future of genomic medicine. Patients who attended genetic clinics for testing were offered the opportunity to undergo the more extensive whole genome sequencing (WGS) if they agreed to take part in the 100â¯kGâ¯P. Once people had agreed, a specific additional appointment was organised for them. Taking part in the project therefore involved additional travel and appointments ('clinical labour'). We found that interviewees' decisions to participate in 100â¯kGâ¯P were based on interpersonal and institutional trust in the NHS, and on an investment in improving care for the future. Interviewees relied upon receiving good ongoing NHS care for managing their own or their child's rare disease, but they worried about what their relationships with NHS healthcare professionals would be like in future. A few participants worried about whether Genomics England's biorepository would remain protected and an asset of the NHS. To honour and foster participants' trust - which may easily be lost - and their clinical labour, we therefore recommend ongoing public engagement and consultation about how genomics is being integrated more widely across specialties (especially given current funding and staffing constraints in the NHS) within the newly formed NHS Genomic Medicine Service.
Genetics, Medical/methods , Health Knowledge, Attitudes, Practice , Rare Diseases/psychology , Trust , Whole Genome Sequencing , Genetics, Medical/ethics , Humans , Rare Diseases/genetics , United Kingdom
Advances in genomic medicine are improving diagnosis and treatment of some health conditions, and the question of whether former patients should be recontacted is therefore timely. The issue of recontacting is becoming more important with increased integration of genomics in 'mainstream' medicine. Empirical evidence is needed to advance the discussion over whether and how recontacting should be implemented. We administered a web-based survey to genetic services in European countries to collect information about existing infrastructures and practices relevant to recontacting patients. The majority of the centres stated they had recontacted patients to update them about new significant information; however, there were no standardised practices or systems in place. There was also a multiplicity of understandings of the term 'recontacting', which respondents conflated with routine follow-up programmes, or even with post-test counselling. Participants thought that recontacting systems should be implemented to provide the best service to the patients and families. Nevertheless, many barriers to implementation were mentioned. These included: lack of resources and infrastructure, concerns about potential negative psychological consequences of recontacting, unclear operational definitions of recontacting, policies that prevent healthcare professionals from recontacting, and difficulties in locating patients after their last contact. These barriers are also intensified by the highly variable development (and establishment) of the specialties of medical genetics and genetic counselling across different European countries. Future recommendations about recontacting need to consider these barriers. It is also important to reach an 'operational definition' that can be useful in different countries.
Duty to Recontact , Genetic Counseling/trends , Genetic Services/trends , Genetics, Medical/trends , Europe , Genomics/trends , Health Personnel , Humans , Surveys and Questionnaires
Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research-including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional stakeholders involved in 100kGP, we investigate the ethical issues raised by this project's hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.'s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new 'social contract' for research and clinical care in the health service.
Genetics, Medical/ethics , Genome, Human/genetics , Informed Consent/ethics , Professional-Patient Relations/ethics , Rare Diseases/genetics , Clinical Protocols , Community Participation , Evidence-Based Medicine , Genetic Predisposition to Disease , Health Knowledge, Attitudes, Practice , Humans , Moral Obligations , Whole Genome Sequencing
European genetic testing guidelines recommend that healthcare professionals (HCPs) discuss the familial implications of any test with a patient and offer written material to help them share the information with family members. Giving patients these "family letters" to alert any relatives of their risk has become part of standard practice and has gone relatively unquestioned over the years. Communication with at-risk relatives will become an increasingly pressing issue as mainstream and routine practice incorporates broad genome tests and as the number of findings potentially relevant to relatives increases. This study therefore explores problems around the use of family letters to communicate about genetic risk. We conducted 16 focus groups with 80 HCPs, and 35 interviews with patients, recruited from across the UK. Data were analyzed thematically and we constructed four themes: 1) HCPs writing family letters: how to write them and why?, 2) Patients' issues with handing out family letters, 3) Dissemination becomes an uncontrolled form of communication, and 4) When the relative has the letter, is the patient's and HCP's duty discharged? We conclude by suggesting alternative and supplementary methods of communication, for example through digital tools, and propose that in comparison to communication by family letter, direct contact by HCPs might be a more appropriate and successful option.
Genetic Predisposition to Disease , Health Personnel , Communication , Family , Female , Focus Groups , Genetic Testing , Humans , Male , Qualitative Research , Risk Factors
