Consent in pregnancy: A qualitative study of the experiences of ethnic minority women.

OBJECTIVE: Consent in ante-natal and birthing contexts is often challenging, controversial and poorly understood. Increasing evidence indicates that ethnic minority women's overall experiences of ante-natal care are unsatisfactory, but little is known about their involvement in the consent process. This study aims to explore the views and experiences of ethnic minority women when making decisions requiring their consent. DESIGN: Qualitative interview study SETTING: A national study conducted in the UK SAMPLE: Seventeen self-selecting ethnic minority women who had given birth in a UK hospital in the previous 12 months. METHODS: In-depth telephone interviews with seventeen women. A thematic analysis was conducted with a focus on women's experiences of the consent process. RESULTS: Three themes were identified. 1. Compromised choice: women experienced limited choice; some women were not asked for their consent at all, or consent was presumed. 2. Pressured consent and silencing: women reported feeling undermined and 'othered' based on their ethnicity. 3. Impersonal consent: discussions were impersonal and not tailored to women as individuals; some women suggested that healthcare professionals ignored cultural concerns which were important to them. PRACTICE IMPLICATIONS: There is an urgent need for healthcare professionals to be supported in actively facilitating consent consultations which enable women from ethnic minority backgrounds to freely voice their concerns and priorities without censure. CONCLUSIONS: This exploratory study is a first step towards understanding how consent is experienced by ethnic minority women. Many women's experiences reflected failure of healthcare professionals to support genuine choice-making which was perceived to be further undermined by negativity related to women's ethnicity and cultural identity. There is a need for further research focusing on the consent experiences of specific ethnic minority groups.

Consent practices in midwifery: A survey of UK midwives.

OBJECTIVE: To explore midwives' knowledge and understanding of the law and practice of consent in the post-Montgomery world. DESIGN: Cross-sectional online survey. Descriptive statistical analysis of midwives' survey responses. SETTINGS: Social media: Instagram, Facebook and Twitter. Survey distribution was via the UCL Opinio survey platform. PARTICIPANTS: A total of 402 midwives, surveyed over a four month period between 2nd March and 2nd July 2021. MEASUREMENTS: Knowledge of legal consent, 'sureness' of meeting current legal requirements and competence to gain consent. FINDINGS: 91% of participants acknowledged correctly that consent must be voluntary. 91% reported that women must be informed of all the risks associated with their care, although 26% reported that women should be informed of some of the risks associated with their care. Most participants were 'sure' that their discussions of consent meet current legal requirements (91%). 21% rated their competence to gain consent as 'excellent', 71% rated themselves as 'very good', whilst 1% rated their competence as 'poor'. Deficiencies in fundamental knowledge of consent were noted in some participants rating themselves highest in 'sureness' of meeting legal requirements and competence to consent. KEY CONCLUSIONS: Fundamental gaps in midwives' knowledge of legal consent were identified. Participants demonstrated uncertainty regarding the extent of risk disclosure and discussion of alternative care options. Participants generally rated themselves highly in their consenting practices, despite lacking in basic knowledge of legal consent, revealing a discrepancy between midwives' self-perceptions and their actual knowledge. IMPLICATIONS FOR PRACTICE: The overconfidence displayed by some participants is concerning for clinical midwifery practice. Professional education and guidance for midwives on legal consent in keeping with Montgomery is urgently required to ensure that midwives are legally compliant in their consenting practices.

Women's experiences of consent to induction of labour: A qualitative study.

OBJECTIVE: Induction of labour (IOL) does not require formal written consent, and little is known about how consent operates in this context. This prospective study explores pregnant women's experiences of the IOL consent process. METHODS: Qualitative study using semi-structured, interviews with thirteen women admitted to hospital for IOL. Data were analysed using thematic analysis. RESULTS: Three themes emerged: 1) Voluntary nature of consent: Some women experienced genuine choice; others perceived pressure to prioritise their baby. 2) Understanding the why and how, risks and benefits: Information provision and explanation was often minimal, particularly regarding risks and alternatives to induction. The possibility of IOL failing was not discussed 3) Non-personalised information process: Few women received information specific and relevant to their circumstance. PRACTICE IMPLICATIONS: There is an urgent need for healthcare professionals to be supported in actively facilitating consent consultations which enable women undergoing IOL to make a fully autonomous, informed choice. CONCLUSIONS: Women did not always experience choice about whether to be induced. This sense of disempowerment was sometimes exacerbated by inadequate information provision. The study reveals a practice imperative to address consent in IOL and we suggest there is an urgent need for HCPs to be offered high quality training specific to IOL.

Choice in episiotomy - fact or fantasy: a qualitative study of women's experiences of the consent process.

BACKGROUND: Consent to episiotomy is subject to the same legal and professional requirements as consent to other interventions, yet is often neglected. This study explores how women experience and perceive the consent process. METHODS: Qualitative research in a large urban teaching hospital in London. Fifteen women who had recently undergone episiotomy were interviewed using a semi-structured interview guide and data was analysed using thematic analysis. RESULTS: Three themes captured women's experiences of the episiotomy consent process: 1) Missing information - "We knew what it was, so they didn't give us details," 2) Lived experience of contemporaneous, competing events - "There's no time to think about it," and 3) Compromised volitional consent - "You have no other option." Minimal information on episiotomy was shared with participants, particularly concerning risks and alternatives. Practical realities such as time pressure, women's physical exhaustion and their focus on the baby's safe delivery, constrained consent discussions. Participants consequently inferred that there was no choice but episiotomy; whilst some women were still happy to agree, others perceived the choice to be illusory and disempowering, and subsequently experienced episiotomy as a distressing event. CONCLUSIONS: Consent to episiotomy is not consistently informed and voluntary and more often takes the form of compliance. Information must be provided to women in a more timely fashion in order to fulfil legal requirements, and to facilitate a sense of genuine choice.

Patient-centred consent in women's health: does it really work in antenatal and intra-partum care?

BACKGROUND: Legal and social changes mean that information sharing and consent in antenatal and intrapartum settings is contentious, poorly understood and uncertain for healthcare professionals. This study aimed to investigate healthcare professionals' views and experiences of the consent process in antenatal and intrapartum care. METHODS: Qualitative research performed in a large urban teaching hospital in London. Fifteen healthcare professionals (obstetricians and midwives) participated in semi-structured in-depth interviews. Data were collectively analysed to identify themes in the experiences of the consent process. RESULTS: Three themes were identified: (1) Shared decision-making and shared responsibility -engaging women in dialogue is often difficult and, even when achieved, women are not always able or do not wish to share responsibility for decisions (2) Second-guessing women - assessing what is important to a woman is inherently difficult so healthcare professionals sometimes feel forced to anticipate a woman's views (3) Challenging professional contexts - healthcare professionals are disquieted by consent practice in the Labour ward setting which is often at odds with legal and professional guidance. CONCLUSIONS: Results suggest that there is a mismatch between what is required of healthcare professionals to effect an antenatal or intrapartum consent process concordant with current legal and professional guidance and what can be achieved in practice. If consent, as currently articulated, is to remain the barometer for current practice, healthcare professionals need more support in ways of enabling women to make decisions which healthcare professionals feel confident are autonomous whatever the circumstances of the consultation.

Consent on the labour ward: A qualitative study of the views and experiences of healthcare professionals.

OBJECTIVE: Consent on the labour ward is a complex and controversial topic which is poorly understood. Consenting labouring women is recognised as challenging and problematic, and thus, it is uncertain that pregnant women experience true informed consent during labour. This project aims to explore healthcare professionals' views and experiences of consent practice on the labour ward. DESIGN: Qualitative research performed in a tertiary hospital labour ward in Central London with 5500 patients annually. Eleven obstetricians and seven midwives participated. In-depth one-on-one semi-structured interviews were conducted, and the data were analysed by thematic analysis. RESULTS: Three themes were identified: 1) The value of women's choice: healthcare professionals framed consent as an agreement process rather than an exercise of choice. Implicit paternalism was evident with some healthcare professionals imposing their own recommendations upon patients. 2) Communicating risk: many participants viewed full risk communication, including extremely rare risk disclosure as their duty to ensure the validity of obstetric consent despite the risk of overwhelming women. 3) Law and professional practice: many healthcare professionals lacked knowledge of the implications to practice of current law. CONCLUSION: Healthcare professionals' experiences of consent on the labour ward reflect uncertainties and ambiguities in consent practice such that it sometimes falls short of legal and professional requirements. Difficulties in discussing risk with women in an appropriate way at an appropriate time threatens the lawfulness of consent. If consent is to remain as the legal standard of autonomy, we recommend the provision of specialist training to assist professionals in providing timely consultation dialogues which endorse women's right to choose.

Consent in pregnancy - an observational study of ante-natal care in the context of Montgomery: all about risk?

BACKGROUND: How to best support pregnant women in making truly autonomous decisions which accord with current consent law is poorly understood and problematic for them and their healthcare professionals. This observational study examined a range of ante-natal consultations where consent for an intervention took place to determine key themes during the encounter. METHODS: Qualitative research in a large urban teaching hospital in London. Sixteen consultations between pregnant women and their healthcare professionals (nine obstetricians and three midwives) where ante-natal interventions were discussed and consent was documented were directly observed. Data were collectively analysed to identify key themes characterising the consent process. RESULTS: Four themes were identified: 1) Clinical framing - by framing the consultation in terms of the clinical decision to be made HCPs miss the opportunity to assess what really matters to a pregnant woman. For many women the opportunity to feel that their previous experiences had been 'heard' was an important but sometimes neglected prelude to the ensuing consultation; 2) Clinical risk dominated narrative - all consultations were dominated by information related to risk; discussion of reasonable alternatives was not always observed and women's understanding of information was seldom verified making compliance with current law questionable; 3) Parallel narrative - woman-centred experience - for pregnant women social factors such as the place of birth and partner influences were as or more important than considerations of clinical risk yet were often missed by HCPs; 4) Cross cutting narrative - genuine dialogue - we observed variably effective interaction between the clinical (2) and patient (3) narratives influenced by trust and empathy and explicit empowering language by HCPs. CONCLUSION: We found that ante-natal consultations that include consent for interventions are dominated by clinical framing and risk, and explore the woman-centred narrative less well. Current UK law requires consent consultations to include explicit effort to gauge a woman's preferences and values, yet consultations seem to fail to achieve such understanding. At the very least, consultations may be improved by the addition of opening questions along the lines of 'what matters to you most?'

Mental capacity assessment: a descriptive, cross-sectional study of what doctors think, know and do.

BACKGROUND: The Mental Capacity Act (MCA) (2005) was enacted in 2007 in England and Wales, but the assessment of mental capacity still remains an area of professional concern. Doctors' compliance with legal and professional standards is inconsistent, but the reasons for poor compliance are not well understood. This preliminary study investigates doctors' experiences of and attitudes toward mental capacity assessment (MCAx). METHODS: This is a descriptive, cross-sectional study where a two-domain, study-specific structured questionnaire was developed, piloted and digitally disseminated to doctors at differing career stages employed in a large, multi-site National Health Service Trust in London over 4 months in 2018. Descriptive statistics and frequency tables adjusted for missing data were generated and secondary analysis was conducted. RESULTS: Participants (n=92) were predominantly UK trained (82%), female (58%) and between the ages of 30 and 44 years (45%). Less than half (45%) of the participants reported receiving formal MCAx training. Only one-third (32%) of the participants self-rated themselves as very competent (29%) or extremely competent (4%). Self-reported MCA confidence was significantly affected by career stage with Consultants with over 10 years of experience reporting lowest confidence (p=0.001). CONCLUSIONS: This study describes significant variation in practice by doctors and low self-confidence in the practice of MCAx. These results raise concerns that MCAx continues to be inconsistently performed by doctors despite appropriate awareness of the law and professional guidance on best practice.

Consent in pregnancy: A qualitative study of the views and experiences of women and their healthcare professionals.

OBJECTIVE: Consent in antenatal settings is contentious, poorly understood and recognised as problematic for pregnant women. This study aimed to investigate participants' views and experiences of the consent process. DESIGN: Qualitative research performed in a large urban teaching hospital in London. Sixteen pregnant women and fifteen healthcare professionals (obstetricians and midwives) participated. Consent consultations were observed and in-depth interviews carried out with healthcare professionals and pregnant women using semi-structured interview guides. Data were collectively analysed to identify themes in the experiences of the consent process. RESULTS: Four themes were identified: 1) Choice and shared decision-making. Pregnant women do not always experience consent in a choice-making way and often do not understand information provided to them. 2) Contextualising information disclosure. What is important to women is not only the information but the relational context in which consent is obtained. 3) Quality of HCP-woman relationship. Trust in their healthcare professional sometimes makes women seek less information and conversely. Individualised information is desired by women but professionals found it difficult to ensure that women receive this in practice. 4) Law and professional practice. Doctors are more aware of legal developments in consent related to the Montgomery case than their midwifery colleagues, but they are not always certain of the implications. CONCLUSION: Results suggest that an effective antenatal consent process which empowers pregnant women requires their understanding of provided information to be elicited. There is a delicate balance to be struck between the trust of a patient in their professional and information-based consent, rather than a simple focus on improving information provision. Whilst recognising women's desire for bespoke consent professionals acknowledged the difficulty of ensuring this in practice. If consent is to remain the legal yardstick of autonomous choice-making, women's understanding and that shared with their healthcare professional needs to be more explicitly addressed.

Between Scylla and Charybdis: Charting the Wicked Problem of Reusing Health Data for Clinical Research Informatics.

OBJECTIVES: Recognising dilemmas posed by the sharing and reuse of health data as a classic wicked problem and uncover some current key challenges to clinical research informatics. METHODS: A modified thematic review process including identification of agreed critical research questions, appropriate query terms and search strategy, identification of relevant papers in accordance with inclusion criteria, and authors' co-review of full text papers. RESULTS: Queries returned 4,779 papers published between January 2014 and November 2017. A shortlist of 197 abstracts was analysed and 18 papers were finally selected for review. Thematic assessment of findings revealed four key challenges: (1) uncertain reliability of consent as a cornerstone of trust due to the limits to understanding and awareness of data sharing; (2) ethical challenges around equity and autonomy; (3) ambitious overly theoretical governance frameworks lacking practical validity; and (4) a clear desire for further public and individual engagement to achieve clearer and more nuanced knowledge dissemination around data sharing practice and governance frameworks. CONCLUSIONS: Understanding the wicked problem of reusing clinically acquired health data for research purposes is essential if clinical research is to benefit from informatics advances. A lack of understanding around the context of data acquisition and sharing undermines the foundations of patient-professional trust. Efforts to protect privacy, where tailoring to specific contexts is a key driver, should support the development of solutions which more adequately honour privacy needs, justify access, and protect equity and autonomy.

Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research.

In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns.

Legal and professional implications of shared care: a case study in oral anticoagulation stroke prevention therapy.

BACKGROUND: Policy initiatives and technological advances enable the use of integrated shared care models of healthcare delivery whereby the focus of care is moved from the hospital to the community, and also of models where patients take increasing responsibility for monitoring and treatment. Such shifts may or may be perceived to change professional roles and responsibilities with implications to the delivery of a professionally and legally acceptable standard of care. We focus on oral anticoagulation and stroke prevention therapy to examine some possible professional and legal implications of the increasing use of shared care. METHODS: This paper sought to explore how changes in service delivery influence the discharge of professional responsibilities to patients receiving oral anti-coagulation therapy in the context of clinicians' legal and professional duties. We used a case study of the implementation of a distributed care anti-coagulation service. Qualitative data were collected using complementary methods: participant observation, reflective journaling and legal analysis. RESULTS: Concerns identified by this study included a fear of litigation among both hospital and community-based professionals, a reluctance to embrace an extended role, uncertainty among professionals about the extent of their responsibilities and associated difficulties around adequate exchanges of information. These concerns reflected uncertainty among professionals about the legal and professional scope of the duty of care they owed patients. CONCLUSION: The findings from this study emphasise the importance of clear role definition, communication and inter-agency cooperation for the successful implementation of a shared care service in which threats to professional and legal standards of care are minimised.

Laparoscopic adjustable gastric band: how to reduce the early morbidity.

BACKGROUND: Laparoscopic adjustable gastric band insertion is a safe weight reduction procedure, but serious complications can develop. The aim of this study was to evaluate our technique in preventing early band complications. METHODS: Patients were given the choice of procedure according to body mass index, the presence of diabetes, and preference. Weight loss data were not considered, as our aim was to evaluate the morbidity of band surgery using a specific technique. A pars flaccida approach and plication technique were used for all patients. Postoperative follow-up was provided at 1 month, 2 months, and every 3 months for the first year and then yearly for a further 2 years. Thereafter, general practitioners referred patients if late complications arose. RESULTS: From January 2007 to August 2011, 1149 patients (245 men [21.32%], 904 women [78.67%]) underwent laparoscopic adjustable gastric band insertion under the care of a single bariatric surgeon. Patients were hospitalized for 1 night only unless they developed early complications. The primary and secondary outcomes were major and minor band complications, respectively. Patients' age range was 18 to 64 years (mean, 44 years). Body mass index ranged from 33 to 62 kg/m2 (mean, 42 kg/m2). There were 2 band erosions (0.17%), 6 cases of band prolapse (0.52%), 4 port problems (0.34%), 1 band leak (0.08%), 3 tight bands (0.26%), 2 port infections (0.17%), and no deaths. Five procedures (0.43%) were abandoned and excluded from this study, and 1 (0.17%) was converted to minilaparotomy to control abdominal wall bleeding. The duration of follow-up ranged from 16 to 60 months. CONCLUSIONS: A combined pars flaccida and plication technique is associated with a low early complication rate.

Patient experience with gallstone disease in a national health service district hospital.

BACKGROUND: The prevalence of gallstone disease in the community makes it an important area of service in district general hospitals. Laparoscopic surgical techniques in synergy with modern imaging and endoscopic and interventional techniques have revolutionized the treatment of gallstone disease, making it possible to provide prompt and definitive care to patients. METHODS: Patients with gallstone disease were treated based on a predetermined protocol by a special-interest team depending on the patient's mode of presentation. Data were collected and analyzed prospectively. RESULTS: Our team treated 1332 patients with gallstone disease between September 1999 and December 2007. Patients (249) with acute symptoms presented through Accident and Emergency (A&E). Despite varied presentations, laparoscopic treatment was possible in all but 8 patients. The study comprised 696 patients who underwent laparoscopic cholecystectomy (LC) as in-hospital (23 hour) cases in a stand-alone center, and 257 outpatients and 379 inpatients. Sixty-seven patients with acute cholecystitis had their surgery within 96 hours of acute presentation. Seventy patients had laparoscopic subtotal cholecystectomy. The overall morbidity was 2.33% with 3 patients having residual common bile duct stones; 3 patients had biliary leak from cystic or accessory duct stumps and one had idiopathic right segmental liver atrophy; 19 had wound infections, 5 had port-site hernia. No mortalities occurred during the 30-day follow-up. CONCLUSION: We believe that prompt investigation with imaging and endoscopic intervention if needed along with LC at the earliest safe opportunity by a specialized dedicated team represents an effective method for treating gallstone disease in district general hospitals. Our experience with over 1000 patients has offered us the courage of conviction to say that justice is finally here for gallstone sufferers.