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Lucy Chapman

Can we adapt the way we do research when involving healthcare staff as research participants?

Can we adapt the way we do research when involving healthcare staff as research participants?

Dr Raabia Sattar, Dr Jane Heyhoe & Professor Rebecca Lawton

NHS staff live the health system every day and have much to offer research about healthcare (Marjanovic et al., 2019). Their first-hand experience and insight means that staff have a unique role in applied health research that seeks to improve the delivery of care and support staff wellbeing.  Applied health research is beneficial for patients, healthcare staff, and organisations. A review by Harding et al (2107) found that staff participation in research was associated with increased organisation level patient satisfaction, improved efficiency of care, and lower staff turnover. Increased levels of research engagement by healthcare staff may improve the processes of care (Boaz et al., 2015).

While NHS healthcare staff can make important contributions to research, there are a number of barriers to staff taking part.  These include a lack of time to participate in research (Marjanaovic et al., 2019), a lack of funding to support engagement (Bryant., 2014; Brereton, L., et al., 2017), and a lack of support by leadership (Evanst et al., 2013; French et al., 2016; Mitchell et al., 2015). While research has been at the centre of an effective response to Covid-19, pressures on staff have only increased during the last two years, meaning that staff ability to be involved in research as participants is also under pressure. At the same time, the Covid-19 crisis and the associated changes in practice, work pressures and emotional toll mean that now more than ever the voices of NHS staff need to be heard. This is vital if we are to learn from and respond to their first-hand experiences of delivering care during these unprecedented times and to ensure the development of the most appropriate interventions, policies and frameworks to continue to improve healthcare.

The traditional ways of including staff in research have involved methods such as face-face interviews, focus groups and questionnaires, as well as observations of the work as done via ethnographic studies. Undoubtedly, these types of research techniques are needed to address certain research questions. However, as researchers, it is important that we take into account that when we ask healthcare staff take part in such research activities, they are away from their clinical duties and responsibilities. We must also consider, what are we offering staff in return for their time? Can we adapt the way we involve participants in our research so that there is greater participant gain? Below, we provide an example of an alternative participation approach we have used for one of our research projects.

An example of an innovative approach: CASE (Conversations About Safety and Emotions)
How we express emotion and interpret emotion in others is integral to important aspects of healthcare such as decision making, team functioning and effective leadership.  Healthcare professionals are required to make clinical decisions in contexts that are emotionally charged and require healthcare staff to actively manage their own and others emotions (Kozlowski et al, 2017). Although there is now increasing recognition that emotions play an important role in staff wellbeing, patient experience and the delivery of safe care, research within this area is limited. Therefore, the aim of this study was to explore the role of emotion in maternity practice within hospital settings.

 

We were planning this study during the initial months of Covid-19, and we quickly realised that healthcare staff within the NHS were now being faced by immense service pressures. After discussions with a member of our team, a consultant obstetrician, we started to think more about reciprocity as part of the research contract. Most research groups provide feedback to participants about the findings of their research and make recommendations that can be used to improve practice, but benefits associated with the ‘process’ of being a participant in research are less frequently deliberated. This notion of benefits of participation was central to our research design. We worked with our clinical partners to develop a workshop series focusing on delivering evidence and supporting staff to think about the evidence on emotion and safety. The series – Conversations About Safety and Emotion was delivered during scheduled training time (Friday afternoons). Whilst delivering the workshop we planned to collect data by recording the break out room discussions which we ran as short focus groups. Using this innovative approach allowed us as researchers to capture the data we required for our study, whilst also offering healthcare staff training.

This study is now underway and takes the form of a programme of four online interactive training workshops, with a mixture of teaching and group discussions. These workshops are multi-disciplinary in nature, and include maternity clinicians including midwives and obstetricians as well as senior leaders. The workshops are delivered by psychologists and a consultant obstetrician. We have delivered the first workshop which focused on feeling psychologically safe in teams, to a mixture of 37 midwives and obstetricians. All participants signed up and consented to the recording and analysis of discussions during the workshops, at least 24 hours in advance of the training workshop.  Feedback on the experience from staff was that they were supported and encouraged to engage in discussions about challenging issues in a safe space and that both the formal presentation and the discussions contributed to their learning. We believe this is a mutually beneficial method of delivering research, as we are able to collect research data, whilst also providing healthcare staff with evidence-based training and knowledge which they are able to apply to real life settings within their NHS workplace.

Conclusion
Involving NHS healthcare staff within research is fundamental to improving patient care, staff wellbeing and patient safety. However, due to the immense work pressures healthcare staff are facing, as researchers, we must adapt the way we involve staff in our research to ensure that they benefit from taking part. We are keen to hear from others about how they have adapted research so that healthcare staff benefit from the process of being engaged in that research. We also welcome the views of healthcare staff on how they would like to be involved in research and what we, as researchers, can do to reduce the burden and increase the benefits.

Please comment below.

From Kingston to Yorkshire: An Internship in Patient Safety

By Kayley Perfetto, Ph.D. Student, Queen’s University, Kingston, Ontario, Canada

 

In March 2020, I was faced with a choice. I was nearing the end of the second semester of my first year in my Ph.D. program in Health Quality (HQ) and the following semester I was expected to begin an internship. In order to apply the knowledge and skills gained during two semesters of course work, first-year Ph.D. HQ students are required to complete a 200-hour internship at a location that aligns with their areas of interest. Based upon a suggestion from my Ph.D. supervisor, planning had been underway since November 2019 and I was excitedly preparing for a trip to Yorkshire, England. I had been looking forward to spending two weeks on-site with the Yorkshire Quality and Safety Research (YQSR) Group which hosts the NIHR Yorkshire and Humber Patient Safety Translational Research Centre (YH PSTRC), assisting with two pre-determined research projects. Unfortunately, at that time the COVID-19 pandemic had started to take hold of the world and my carefully laid out plans had to be abandoned and I needed to decide what to do next. The faculty at Queen’s provided my classmates and I the option of completing, what was supposed to be an in-person internship, virtually, or delaying our internships for a year, and hope for the best that international travel could occur in a year’s time.

To provide a bit of context, I will share a little bit about Queen’s University and the HQ program that I am fortunate to be a part of. Queen’s University is located in beautiful Kingston, Ontario, Canada, a city with a population of 136 000, along Lake Ontario. Queen’s University is Canada’s oldest University as it predates the founding of Canada by 28 years. The university was modeled after universities in Edinburgh and Glasgow.

My PhD colleagues and I onsite during our intensive week in beautiful snowy Kingston, January 2020

I live in London, Ontario, a city that is roughly four hours from Kingston and therefore my Ph.D. is being completed virtually. The HQ Graduate programs are designed for individuals like myself, health care professionals who are working in the field, who want to further their education in quality and patient safety. I am a physiotherapist by training, and I am currently working as a Patient Safety Specialist in a hospital organization in London, Ontario.

 

 

Lovely Queen’s University

Lovely Queen’s University

After careful consideration and meetings with my supervisor and the YQSR team to discuss whether my internship could be made virtual, I decided to give it a go and hope for the best. Utilizing a variety of virtual technologies and many emails, I have been able to contribute to three research projects, (one of which I am currently contributing to) one of which used qualitative data to understand the experiences of patients with learning disabilities and how these experiences impacted patient safety. The other project was a scoping review, completed as the first phase of a large five-phase study, which explored the current involvement of patient and family members in serious incident investigations. Both projects are ongoing at this time and both will be submitted for publication within the next few months. I was invited to present the key learnings from my internship at a virtual YQSR staff meeting in March 2021 and I shared my experiences at the academic series held at Queen’s University.

 

Screen shot of an interview with Professor. Jane O’Hara and Dr. Abigail Albutt (and me)

Through the guidance and support from the YQSR team, this internship allowed me to gain a deeper understanding of my substantive area of interest, patient and family involvement in patient safety, the knowledge that has been invaluable as I develop my thesis. During my internship, I was able to (and continue to!) work alongside and network with some renowned researchers in the field, learn more about their current projects and hear their perspectives on the direction research in this area is heading. Being part of these three projects, allowed me to consolidate what I learned in my first year Ph.D. courses, gaining an increased understanding of the practical aspects of conducting research.

This internship provided me with so many opportunities, but what I feel most fortunate about is having the opportunity to meet such wonderful people. The team at YQSR was warm and welcoming and was genuine in the desire to make this experience a success. They provided resources and experiences that they felt would be helpful for me and shared information about themselves and their experiences going through the pandemic. This internship was possible due to the commitment and collaboration between the team at YQSR and Ph.D. HQ team. When my original plans were unexpectedly altered by COVID-19, both groups worked together to ensure that I was able to continue with and benefit from my internship. For their dedication to ensuring that I had the best experience possible, I offer a heartfelt thank you and hope someday soon I have the opportunity to thank you in person.

 

World Patient Safety Day 2021: Yorkshire Quality and Safety Group

World Patient Safety Day 2021: Yorkshire Quality and Safety Group

The third annual World Patient Safety Day takes place on 17th September 2021. Established by the World Health Assembly[1], the day is all about increasing public awareness and understanding and working towards global solidarity and action on patient safety. Each year, the World Health Organization (WHO) selects a theme to highlight a priority area for action. This year’s theme is ‘Safe maternal and newborn care’, with the WHO encouraging us to ‘Act now for safe and respectful childbirth!’.

Every day 810 women and 6700 newborns lose their lives. While the greatest burden of these deaths is in low- and middle-income countries, confidential enquiry reports in the UK highlight that maternal mortality is higher in older women, those living in the most deprived areas and amongst women from ethnic minority groups[2]. Most of these deaths are preventable through the provision of safe, effective and high quality care. Although coverage of evidence-based interventions such as antenatal care and skilled birth attendance have increased rapidly, the quality and safety of care provided to mothers and babies is often lacking. Reducing the safety risks during pregnancy and around the time of birth is critical for maternal and newborn survival.

In this blog we outline some of the work being carried out by researchers in the Yorkshire Quality and Safety Research group (YQSR), based at Bradford Royal Infirmary, which contributes to our understanding, and implementation, of safe maternal and newborn health care and services. We work closely with colleagues in the Patient Safety Collaborative, and the Improvement Academy, to facilitate translation of research findings into a range of initiatives to improve safety for mothers and newborns. Read their World Patient Safety Day blog here.

Strong teams lead to safer births

Rising birth rates and increasing complexity of births in UK maternity services has led to increasingly multi-disciplinary teams of healthcare staff, particularly during childbirth. Failures in teamwork and communication continue to be identified as substantial contributors to compromised patient safety in both research and in high profile inquiries into maternity services3 4.

Dr Siobhan McHugh (Research Fellow, YQSR Group) explored the use of video reflexive ethnography (VRE) as a tool for the improvement of communication at the multi-disciplinary clinical handover on labour ward. Using video footage of the handover captured in situ to prompt discussion, multi-disciplinary staff groups were prompted to collaboratively identify areas for change or improvement, and ideas to address these areas. Siobhan has worked closely with two local maternity units (St. James’ Hospital, Leeds Teaching Hospitals NHS Trust and Bradford Royal Infirmary, Bradford Teaching Hospitals Foundation Trust) supporting them to use VRE to improve the multi-disciplinary handover on labour ward. Both projects resulted in staff-led changes to the structure of the handover. For the team at St. James’ Hospital this meant re-designing the handover to meet the different needs of obstetric and theatre teams better, ensuring theatre staff felt better prepared for any emergent safety concerns. For the team at Bradford Royal Infirmary, the work led to re-designing the handover to ensure multi-disciplinary input was welcomed, rather than a single one-way flow of information, allowing for more extensive discussion and awareness of emergent safety concerns or risk. Staff at both sites also reported improvements in clinical confidence, timely escalation of high risk cases, staff well-being and multi-disciplinary team culture. You can find out more about Siobhan’s research on Twitter (@YH_PSTRC, @yqsrdotorg, @skmc84). She has also presented a short snapshot video on her use of VRE in healthcare improvement which is available here.

Establish a safety culture in which healthcare workers are not afraid to speak up

Maternity is a high-risk environment and adverse events can have an impact on the affected women, partners and/or families and the midwives, doctors and others involved. An important element in managing the aftermath of these events is disclosure. Dr Raabia Sattar (Research Fellow, YQSR) focused on this topic for her PhD, specifically focusing on the support needed by healthcare professionals to do disclosure well.

The systematic review, conducted as part of Raabia’s PhD, highlights key elements of disclosure that are valued by patients. These include relevant information about the adverse event, accountability and an apology, and commitment to preventing future recurrences of the event. The review also found that health workers face a number of barriers when trying to disclose events to patients. To address this, Raabia and colleagues have developed a disclosure training workshop and top tips on how to do disclosure, hosted on our second victim website.

Led by Professor Jane O’Hara, the Patient and Family Involvement in Serious Incident Investigations (PFI SII) project aims to co-design guidance to support more meaningful involvement of patients and their families in serious incident investigations following adverse events in healthcare. The PFI SII team have worked with patients, families, healthcare staff, investigators and policy makers to co-design guidance to sit alongside Trust investigation policies. Starting in October 2021, the team will work with four participating NHS Trusts and the Healthcare Safety Investigation Branch (HSIB), to test this guidance during serious incident investigations. With the HSIB, the PFI SII team will focus specifically on investigations following serious adverse events during active childbirth. The aim of the guidance is to support investigators to more meaningfully involve patients, families and healthcare staff in investigations to enable better learning following healthcare harm.

Build trust, and engage and empower all women

Dr Gemma Louch (Senior Research Fellow, YQSR) and colleagues have been reviewing the evidence on patient safety for people with learning disabilities in acute hospital settings. A key finding in their recent scoping review, was that women with learning disabilities are more likely to experience complications of pregnancy and birth, including pre-eclampsia, pre-term birth, caesarean birth and small for gestational age babies. The NIHR, along with other national policy and funding bodies, recognises the lack of evidence about how maternity services are experienced by parents with learning disabilities. Gemma and colleagues aim to address this research gap with future research on how maternity services support parents with learning disabilities to identify what improvements are needed.

Setting and implementing global standards for safe and respectful maternal and newborn care

Dr Helen Smith (Senior Research Fellow, YQSR) has been committed to improving quality and safety of maternity care throughout her career and has valued the opportunity to work with WHO on guidelines that set standards for maternal and new-born care. WHO’s guidelines aim to promote health, prevent harm, and encourage evidence-based clinical practice and policy. Helen has worked with WHO’s Department for Maternal, Child and Adolescent Health and Ageing on guidelines for health promotion interventions for maternal and newborn health, interventions to manage health complications of FGM, home-based records for maternal, newborn and child health, implementing Maternal Death Surveillance and Response (MDSR) and postnatal care (forthcoming).

Supporting policy makers and health workers to implement safe and effective interventions requires just as much if not more effort than producing the recommendations. Helen has a special interest in implementation of safe, effective and respectful childbirth care. She helped set up the Better Births Initiative which had strong regional reach in Africa, and more recently has worked on factors that affect implementation of interventions for maternal and newborn health. Helen has recently been working with the WHO team to prepare a new implementation toolkit alongside the forthcoming postnatal care guidelines. The toolkit will help countries to adapt the recommendations to their context, update their policies, and identify factors that are likely to influence implementation of safe and effective postnatal care interventions.

We hope this blog has given you an indication of the research conducted within YQSR. As a multidisciplinary group we are committed to conducting high quality research on NHS and patient priorities, across a range of specialities including maternal and newborn health. We develop and evaluate innovative solutions to patient safety problems and deliver research that makes healthcare safer. We work closely with the Improvement Academy to facilitate translating research findings into practice. You can read more about their work to support high quality, safe maternity care here.

Written by: Dr Helen Smith (Senior Research Fellow) and Dr Siobhan McHugh (Research Fellow), Yorkshire Quality and Safety group

[1] The WHA is the decision-making body of WHO; held annually in Geneva and attended by all WHO Member States.

[2] https://www.npeu.ox.ac.uk/mbrrace-uk/reports

3https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/408480/47487_MBI_Accessible_v0.1.pdf

4 https://www.donnaockenden.com/downloads/news/2020/12/ockenden-report.pdf

 

 

 

Networking & building connections as an early career researcher

By Caitlin Wilson (Twitter: @999_Caitlin), Dr Fiona Bell (@fionablairbell) & Professor Julia Williams (@DrJuliaWilliams)

Undertaking a PhD is about developing a researcher identity. Traditionally, this occurred through one-to-one mentor relationships, which often continued throughout a researcher’s career. However, nowadays early career researchers need to gain experience and develop connections with multiple people through networking (Ansmann et al., 2014). In fact, a study by Wolff and Moser (2009) suggests that networking is related to career progression and career satisfaction across a multitude of sectors.

PhDs can often be an isolating experience (Cantor, 2020), something which has undoubtedly been emphasized through the COVID19 pandemic and subsequent working from home, but intentional networking has been key to my PhD journey so far. Within this blog post, I share my experience of networking as an early career researcher, with valuable input from Dr Fiona Bell, Head of Research at Yorkshire Ambulance Service NHS Trust, and Professor Julia Williams, Head of Research at the College of Paramedics.

  1. Social media

Without social media I would not be a PhD student at the NIHR Yorkshire and Humber Patient Safety Translational Research Centre. It was through a re-tweet from @fionablairbell in March 2019 that I became aware of this amazing opportunity. The trick to Twitter and other social media platforms such as ResearchGate, LinkedIn etc., is to follow key people in your area of interest.

  1. Networking with peers

As an experienced clinician, I am fortunate to be surrounded by supportive colleagues, many of whom I would call friends. However, my peer network extends beyond those geographically close to me or those who I work with clinically. Seminars, workshops, conferences, webinars and courses both virtually and face-to-face have allowed me to connect with many people who I would consider peers. I perceive the value of these networking relationships to often be higher than the course content.

  1. Near-to-peer mentoring

In addition to peer-to-peer networking, there is a great benefit to connecting with people who are slightly ahead of you in your journey as an early career researcher. These are the people to contact when you have a question you feel is too trivial for your supervisors or just need a word of encouragement that it is indeed possible to survive your PhD.

  1. Networking with NHS organisations

Expertise, knowledge and enthusiasm for any topic are generally not centrally held in any NHS organisation. NHS ambulance services cover large geographies and have staff spread across their region delivering care in the community. Therefore, networking in this setting is really key to getting to the ‘right’ people to support you research area. It pays to attend internal meetings at the planning stage to get buy-in and engagement with key stakeholders who have existing connections and can advocate for you through established formal or informal connections. Keeping the whole network updated ensures that association is not lost when people or services change, and allows your network to evolve as the project develops.

  1. Networking with networks

Within your area of practice, there will already be formal networks and organisations, which researchers at any level can access to forge links and make new contacts. For me, this was the Research Centre at the College of Paramedics, but also included collaboration across other disciplines and professions, such as within the YH PSTRC. Research is stronger when developed in teams, so get involved in different research-focused organisations wherever and whenever you can. Often opportunities emerge through these contacts, which could help strengthen your networking activities as well as develop your research knowledge and expertise.

To further explore the topic of early career researcher identity and networking, I have been granted an NIHR Short Placement Award for Research Collaboration (SPARC) supervised by Professor Julia Williams, in her capacity as paramedic-lead for the NIHR Incubator for Emergency Care. Although it is a ‘short’ placement award, the virtual nature of the placement is allowing for a more flexible approach throughout 2021/22, during which I plan to establish an online forum for paramedic researchers, where networking, mentoring and collaborating will be encouraged and supported.

 References

Ansmann, L., Flickinger, T.E., Barello, S., Kunneman, M., Mantwill, S., Quilligan, S., Zanini, C. and Aelbrecht, K. 2014. Career development for early career academics: Benefits of networking and the role of professional societies. Patient Education and Counseling. 97(1), pp.132-134.

Cantor, G. 2020. The loneliness of the long-distance (PhD) researcher. Psychodynamic Practice. 26(1), pp.56-67.

Wolff, H.-G. and Moser, K. 2009. Effects of networking on career success: A longitudinal study. Journal of Applied Psychology. 94(1), pp.196-206.

Are medical device regulations safe?

Photo by Svilen Milev from FreeImages

 

Existing provision of regulations for medical devices may be insufficient for the digital age.  In our recent paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards.

National Institute for Care Excellence (NICE) guidance from 2015 promoted the use of QRISK2. This computerised tool calculated someone’s risk of having a heart attack or stroke in the next 10 years. It was designed, developed and approved in accordance with the safety guidelines at the time. But by 2016, the regulatory agency in the UK raised an alert about the use of the computerised tool in some practices.

Thankfully, the errors in the risk calculated by QRISK2 were minimal. The UK’s commitment to electronic health systems were leveraged to track down the source of the problem and follow up with patients. Although the connectivity of the UK’s increasingly-digitised healthcare system helped to remedy some safety concerns, its connectedness can also be a cause for concern.

What’s the problem?

Perhaps the biggest problem faced by regulators of medical devices is that there isn’t just a single problem to solve. Healthcare is an ever-changing and complex system, where not only the parts need to be considered, but their interactions, too. With so many dynamic interacting parts, it can be practically impossible and hubristic to think we can observe and control everything.

Designed by vector_corp, available at Freepik

 

Many standards are available but are not compulsory. For example, decisions made by the European Union in the 1980s separated law and technical standards, which makes it difficult to enforce standards (1). Even if standards were enforceable, they often don’t acknowledge the contemporary systemic and connected ecology of medical devices in the age of digital health and Healthcare 4.0 (2).

Are regulations safe for patients?

It has become increasingly apparent that existing regulation of medical devices is insufficient for the digital age, despite progress in the European Union’s Medical Device Regulation (3). In our paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards (4).

Medical device regulations were initially created for hardware devices rather than software and offer one-shot approvals rather than supporting iterative innovation and learning. Such iterative development has been the keystone to agile methods in product and service innovation that enable timely responsiveness to emerging contexts. A further issue with many medical device regulations is the bias toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful. This often manifests as bias toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system.

What’s being done about it?

Despite the aforementioned concerns, many theoretical and practical strategies have been proposed to improve the provision of effective medical devices in a safe and timely manner. In our paper, we summarise nine recommendations that focus on embedding less-reductionist and stronger systemic perspectives into regulations and standards (4). These recommendations include a Safety II perspective of risk (5), systemic models of accident and safety (6–8), realignment of standards and regulations, and gradual approval of devices. Frameworks like Idea-Development-Exploration-Assessment-Long-term-study (IDEAL) are examples of gradual approval processes that have shown some effectiveness (9).

Advocates for digital health care about its speed, coverage, and capacity but perhaps without considering its own suite of challenges (10) and safety concerns, e.g. underuse, misuse or abuse due to lack of training and improper integration. Future development of regulations should make it easier for clinical and academic institutions like the NIHR PSTRCs to produce healthcare information technology in a way that contributes state-of-the-art patient care and safety science insight.

How can I get involved?

What other recommendations would you like to see? What other ways are there to foster the production of healthcare products that are simultaneously effective and safe? Let us know your thoughts by commenting below or joining in on the conversation on Twitter.

References

  1. Altenstetter C. EU and member state medical devices regulation. Int J Technol Assess Health Care. 2003;1(2003):228–48.
  2. Aceto G, Persico V, Pescapé A. Industry 4.0 and Health: Internet of Things, Big Data, and Cloud Computing. J Ind Inf Integr [Internet]. 2020;18(February 2019):100129. Available from: https://doi.org/10.1016/j.jii.2020.100129
  3. Medicines and Healthcare products Regulatory Agency. An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR) [Internet]. 2020. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
  4. McInerney CD, Scott B, Johnson OA. Are regulations safe? Reflections from developing a digital cancer decision support tool. JCO Clin Cancer Informatics. 2021;353–63.
  5. Hollnagel E. Safety-I and safety-II: the past and future of safety management. Ashgate; 2018.
  6. Ravitz AD, Sapirstein A, Pham JC, Doyle PA. Systems approach and systems engineering applied to health care: Improving patient safety and health care delivery. Johns Hopkins APL Tech Dig (Applied Phys Lab. 2013;31(4):354–65.
  7. Underwood P, Waterson P. Systemic accident analysis: Examining the gap between research and practice. Accid Anal Prev [Internet]. 2013;55:154–64. Available from: http://dx.doi.org/10.1016/j.aap.2013.02.041
  8. Leveson NG. A new accident model for engineering safer systems. Saf Sci. 2004;42(4):237–70.
  9. Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, et al. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019;269(2):211–20.
  10. Sittig DF, Wright A, Coiera E, Magrabi F, Ratwani R, Bates DW, et al. Current challenges in health information technology–related patient safety. Health Informatics J. 2020;26(1):181–9.

 

Research Participation Experience

By Isabel Hague and Chloe Grindey –  Research Assistants, NIHR Yorkshire and Humber PSTRC

The Y&H PSTRC has been collaborating with Care Opinion to build a research community of people (patients, carers and other members of the public) who have written stories on the Care Opinion site. We have been trying to understand what people want when they are involved in research to help us plan for how we as researchers can meet these needs. We were also keen to find out if there are existing criteria for assessing the quality of research from a participant’s perspective.

As part of this process, we conducted a rapid review of the literature in this area. The full report can be found here. Here we report a brief summary.

We began by searching Google scholar with the appropriate terms including ‘communicating results to patients’, and ‘health research participation.’ After identifying seemingly relevant articles and searching their reference lists for additional research, thirty-two papers were added to a spreadsheet and subsequently refined by the authors and RL. We excluded those which discussed patient involvement in research design and the disclosure of individual clinical results (as Care Opinion would not be used for the recruitment of patients to clinical trials), which culminated in a final set of eleven papers for review, employing both quantitative and qualitative methods and of which we were confident were pertinent in answering the research questions.

Our analysis revealed strong evidence that patients want to know the findings of research they are involved in. Evidence was less consistent in indicating a preferred means of communication of these findings, although patients generally favoured individualised modes of contact. Literature indicating whether or not patients are interested in knowing the impact of the research was also minimal. In terms of what they want during their involvement, patients emphasised the importance of building a trusting and respectful relationship with the researchers, clear communication throughout the entirety of the investigative process, and quality of care that is at least consistent with standard healthcare practice.

There was an absence of literature that could directly inform the development of criteria to measure the quality of a patient’s research experience. However, we argue that such criteria could be inferred indirectly from the above research. For example, patients often reported an altruistic motivation for involvement in research, so it would make sense to conclude that being informed of the outcome or impact of their involvement would be desirable for them. Although none of the articles we identified included validated measures of patients participation experience, some asked questions of participants that might be useful in future surveys of this kind. For example, one asked if participants would recommend research involvement to a friend or family member and how useful the consent forms were in preparing them for their participation. Another paper used open-ended questions to assess involvement experience, such as ‘How did you find it talking about the issues in this study,’ or ‘How do you feel about research in this area.’ Such questions could be adapted into generalised involvement experience criteria.

This was a rapid review which has obvious limitations. If readers are aware of other literature that is directly relevant to our aims, please do get in touch with Rebecca Lawton at r.j.lawton@leeds.ac.uk or @LawtonRebecca. We will be sure to acknowledge your contribution.