Optimizing patient safety remains a key priority for health care systems across the world, including the United Kingdom’s National Health Service (NHS). When looking at the frequency of patient safety incidents, surgical care settings typically emerge as the most risky, with higher rates of adverse events than other hospital departments or specialties [1-3]. This is likely attributable to the complexity of surgical environments and the risk profile of surgical patients, but it may also reflect higher incident reporting rates by surgical teams.

Numerous tools have been introduced to surgical settings to increase reliability and improve safety, ranging from safety checklists to electronic devices for counting swabs [4,5]. Although these clinical and team-based interventions are critical, the call to deliver more patient-focused interventions in health care is equally important. This is set in the context of an ongoing movement across the NHS and internationally, toward greater patient and public involvement (PPI) and empowerment, working on the concept that, where appropriate, patients should be encouraged to take an active role in the management of their own health and facilitated in participating more meaningfully in their care [6-8]. This focus on patient involvement extends into the world of health care research and evaluation, with patients and the public increasingly being included in all phases of research, from conception, through design and data collection, to dissemination [9]. However, the evidence suggests that PPI efforts, particularly in the world of patient safety, have tended to be atheoretical, exclusive, and tokenistic in nature, with few addressing issues of equality and diversity in their involvement strategies [10-12].

In parallel to the patient empowerment movement, the industry of health care is being called to take on another challenge—to better embrace the potential of digital technology for transforming care. In 2016, the Nuffield Trust released a report highlighting the possibilities offered by digital technology and how best to grasp them, putting health care at least a decade behind other industries in terms of incorporation and use of information technology [13]. Smartphones, with their ever-increasing accessibility, have emerged as a key device for communicating knowledge at scale and for improving patient empowerment [14]. Around 85% of the UK population own or have access to a smartphone, including 71% of 55 to 75-year olds, and between 45,000 and more than 300,000 medical health apps are available to download (depending on the platform used) [15-17]. In the context of surgical safety, given their accessibility, smartphone apps could constitute an effective means of mobilizing knowledge to patients about risk and empowering them to play a role in optimizing the safety of their care.

In 2017, the NHS released an online App Library with the aim of providing “trusted digital tools to patients and the public to manage and improve their health.” To be listed on the library, an app must meet the NHS quality standards for clinical effectiveness, safety, usability, and accessibility and have evidence to support its use. Therefore, it should be tested with the relevant stakeholder groups [18]. There are currently 76 apps available in the library, falling into the following categories: first aid; living with cancer; mental health and well-being; pre- and postnatal care; welfare and lifestyle; advice, management, and support for long-term conditions; and prescription and appointment management. Although all the apps aim to empower and educate patients in some manner, none of them have a specific focus on involving patients in the effort to improve patient safety. Outside of the NHS, there are apps available that have a greater focus on patient safety. The majority are designed for clinicians or hospital management, for example, digital patient safety manuals, or patient safety solutions for hospitals (eg, the Patient Safety Solutions app). Others, designed for patients, have a broad focus on patient education and empowerment (eg, eg, providing information about procedures, conditions, complications, and processes of care; keeping track of upcoming appointments; and informing patients about how to interact and ask questions; eg, the Empowered Patient, Manage my Surgery, and Patient Aider apps) and include some safety-relevant information as part of this. With their broader scope, these apps do not focus specifically on the key evidence-based safety risks present in any particular specialty or pathway.

MySurgery is a smartphone app that aims to empower patients to help optimize the safety of their care when having a surgical procedure. The app was developed for the context of the United Kingdom’s NHS and was created by a multidisciplinary team of clinicians, patient safety experts, and patient/public representatives. It has been available for free download on the Apple App Store since 2015 (located under apps for iPhones)—to date, it has been downloaded by more than 6000 people. MySurgery mobilizes evidence around safety in surgery into a format that is easily digestible by patients and their carers. It is an animated app combining simple, jargon-free information and is structured around 10 specific areas of risk to safety: preparing for surgery, personal details and consent, hand hygiene, deep vein thrombosis, falls, pressure ulcers, medications, wound care, nutrition, and going home. For each area of risk, MySurgery provides practical step-by-step advice on the actions that patients and their carers can take—including warning signs to look out for, information to provide, and questions to ask. The app also includes a short introduction (to inform users of its objectives and how it was developed), a Top 10 Things to Remember tab (highlighting 10 key behaviors that patients should always aim to engage in), and a link to a survey for evaluating the app (Figure 1) [19]. Until now, formal evaluation of the MySurgery app has not been possible because of funding cessation. However, new funding has recently been secured from the National Institute for Health Research (NIHR), United Kingdom, to evaluate the app over a 3-year program of work. On completion of this work, MySurgery would offer a novel contribution to the NHS App Library and an approach to improving patient safety that is both patient focused and embraces the call for better digital technology solutions to care problems.

This study represents the first phase of this program of work, in which we present results from some pilot testing of MySurgery with surgical patients. To further strengthen the study design, the research was also conducted in partnership with a study being carried out by JO who was funded by the Health Foundation and aimed to understand how best to incorporate diverse PPI into the testing of patient safety interventions. The research objectives are 2-fold:

The research team was formulated using a participatory action research (PAR) approach, which is appropriate when seeking to solve problems and effect improvement [20,21]. PAR is particularly relevant to the development of PPI as it is a methodology that seeks to empower its research subjects and to create more equal partnerships in the research process [22,23]. We used PAR to enable collaborative working within the project by creating a research steering group. This consisted of 5 public representatives (AL, HO, JOT, JT, and SW), alongside 4 researchers (SR, ZL, NS, and JO). The public representatives were recruited following attendance at a focus group on the design of the app. They all had some experience of surgery and were selected to represent a diverse range of backgrounds (1 male/4 females; 2 white British/3 black, Asian, or minority ethnic [BAME] group British; 1 with a disability/4 with no disability; and 2 aged <55 years/3 aged >55 years). Steering group members attended face-to-face meetings at 3 key time points across the project and maintained regular communication via email and telephone. In line with PAR, all steering group members were treated as coresearchers and were involved equally in decision making around the design and planning of the project (including development of research tools and recruitment strategy), analysis of the findings (extraction of themes from qualitative data), and write up and review of this manuscript (4 of the 5 public representatives are involved as authors; 1 public representative chose to opt out of authorship but is acknowledged). Owing to time limitations in gaining Disclosure and Barring Service approval, we were not able to involve the public members in collecting the data.

To evaluate MySurgery, the steering group agreed upon a prospective mixed methods design. Both quantitative (survey) and qualitative (reflective notes) methods were used to evaluate patient perspectives of the app with a sample of individuals undergoing surgery recruited from community networks across England. The study ran as a pilot to test the feasibility of the procedure and research tools before future evaluation of MySurgery with a larger cohort of patients. Ethical approval was granted by the King’s College London Research Ethics Review Board (Reference LRS-17/18-5697).

Individuals meeting the following inclusion criteria were eligible to participate:

Given the narrow time frame and inclusion criteria, we recruited participants using an opportunistic approach via a range of channels, including social media (Facebook and Twitter); bimonthly calls for research participants generated by King’s College London; the Call for Participants open Web-based platform ; specialist and nonspecialist local community centers; community-based networks of the steering group; and other community voluntary and charitable organizations, including disability groups. We also formulated a structured diversity approach as this objective was central to the study (Textbox 1).

Research participants completed the following:

All members of the research steering group completed a written self-reflection tool as part of the research process to enable critical thinking both about the research process and their involvement in it (findings are highlighted in the Results section).

A study advert (Multimedia Appendix 1) outlining the study aims and inclusion and diversity criteria was distributed via email (to the community networks and organizations), face to face (at community centers), and via social media promotion. Eligible individuals expressed their interest to the research team and received a Participant Information Sheet (that detailed the study procedure), a consent form, and an EOM form to complete by email or in the post. On receipt of the completed forms, they were offered a phone call to explain the procedure further and answer questions. Consenting participants were assigned a unique identifier and were asked to download and refer to the MySurgery app before (preferably before their preoperative appointment), during, and up to 2 weeks following their surgery. They were asked to keep their reflective notes throughout the time they were using the app and to complete the embedded questionnaire following their surgery. On completion and return of the questionnaire and reflective notes, they received a £25 shopping voucher. Data collection took place in May and June 2018.

Quantitative analyses were completed using Statistics 24 Software (IBM). Participant characteristics and survey data were summarized using descriptive statistics. To examine the relationship between perceptions of MySurgery and participant characteristics, independent-samples t tests were computed—the sample was split according to sex (male/female), disability (yes/no), ethnicity (white/BAME), age (either side of median), length of hospital stay (day surgery/1 or more nights), and general perceptions of patient involvement in hospital care for the 3 relevant questionnaire items (agree/other).

Participant’s reflective notes were divided randomly between members of the steering group for inductive thematic analysis. At the final face-to-face steering group meeting, emergent themes were discussed and cross-checked before collectively agreeing on a list of themes that represented the reflections as a whole. Furthermore, 2 of the researchers (SR and JO) analyzed the steering group self-reflections in a similar manner to extract themes regarding perceptions of the research process and involvement strategy. No software was used for the qualitative analyses.

A total of 42 participants took part in the study. Their age ranged from 20 to 70 years (mean age=40 years), with a good split between males and females. Participants were treated at 27 different hospitals across England for 25 different kinds of surgical procedures under a total of 11 surgical specialties, with the majority (31/42, 74%) staying in hospital for a night or longer. Just under half of the participants were from a white background—the remaining were from a BAME background. In addition, 41% (17/42) of the sample reported having a disability (Table 1).

One participant failed to complete the questionnaire. The sample as a whole was positive about MySurgery (Table 2). A large majority agreed that it was acceptable and appealing, it was useful and informative, it was easy to use, it provided new information, it made them better able to become involved in conversations and ask questions about their care, it changed the way they behaved, it should be recommended to patients, it would make surgery more successful, and that they intended to use it in future. Participants were more unsure about the potential impact the app could have on safety per se and whether or not it was applicable to all surgical patients. In general, patients felt the app contained the right amount of information, but of those who disagreed with this statement (7/41, 17%), all but 1 felt it contained too little information. A third (14/41, 34%) of the sample encountered technical difficulties when using the app, which were all related to problems downloading it onto an iPad. Over half of the sample (25/41, 60%) said that they would support an option to incorporate audio into the app and availability of an easy-read version, and more patients (30/41, 71%) said that they would like to know how to access support in using MySurgery.

There were no significant differences in perceptions of MySurgery according to sex, participants’ age, ethnicity, or length of stay.

Those with a disability were significantly less likely to agree that MySurgery was easy to use (t₃₉=2.22; P<.04) and that they would recommend it to others having surgery (t₃₉=2.45; P=.02).

Those who had experienced at least one previous operation were significantly more positive about MySurgery for 5 of the 18 questionnaire items that related to perceptions of the app than those who had not had a previous operation. They were more likely to approve of it (t₃₉=2.27; P=.03), to find it appealing (t₃₉=2.48; P=.02), to feel it contained the right amount of information (t₃₉=2.87; P<.001), suggest that it should be recommended to all patients (t₃₉=2.69; P<.001), and suggest that it would make them feel safer (t₃₉=2.56; P=.01).

Participants’ views about being involved in conversations and decisions around their care in general had the most striking impact on their views of MySurgery. Those who agreed that they were confident to play an active role in conversations around their care (n=15), that they could help to reduce errors by being involved (n=23), and that it is best for patients to be involved in decisions around treatment and safety (n=30) were significantly more positive about the app for a large number of questionnaire items than those who disagreed or neither agreed nor disagreed with these statements (ts range: 1.0-4.3; Ps range <.001-.04).

Overall, 8 themes were extracted from the analysis of participants’ reflections (Table 3).

Key themes that emerged from the self-reflections of the steering group were as follows:

MySurgery is a novel smartphone app that works on the premise of educating and involving patients and their carers in behaviors that are known to contribute toward surgical safety and to increase resource in the health care system for preventing safety incidents. It has the potential for inclusion in surgical care pathways in the NHS and the NHS App Library should the data be there to support its use and effectiveness.

We gathered views regarding MySurgery from a diverse group of patients undergoing a range of surgical procedures in hospitals across England. Using a survey combined with reflective notes, we were able to conduct a critical analysis of participants’ perceptions of the app that can inform improvements to the app itself and areas to probe in the next phase of evaluation. Overall, the feedback was positive, and there was a strong sense of support for MySurgery. It was reported to act as a useful reminder of steps to take in preparing for surgery, it empowered patients to engage in conversation with clinicians and prompted questions to ask, it promoted confidence in caring for surgical wounds, it reduced anxiety about the surgical process, it was reported to be easy to use, and it would be recommended to others in its current form by 76% (31/41) of participants. This feedback, particularly in relation to promoting greater patient empowerment, shows that the perceived impact of MySurgery was in line with the objectives of the app.

Those who had undergone previous surgery were more positive about MySurgery in a number of respects. Perhaps having more knowledge and experience of the surgical process, and reflecting from previous as well as current experience, allowed participants a greater appreciation of the potential virtues of the app. However, the strongest predictor of perceptions was individuals’ views about whether they personally felt confident to be involved in conversations around their care and whether they thought patients should be involved in health care conversations and decisions making. Those who felt uncomfortable to engage in health care conversations and did not feel that they could have an impact on the occurrence of error were less supportive of the app (although not entirely unsupportive). This suggests that MySurgery will likely be more appealing to those who already feel that they are able to play a role in their care or think it is appropriate to do so. It also highlights how some patients are unclear about the role patients can play or may need more support becoming involved.

Reflections about the impact of MySurgery on safety were also interesting. Almost half of the patients were unclear what was meant by safety, assuming we were referring to procedural success as opposed to reduction in risk of error, and the same proportion felt strongly that safety was a matter for clinicians alone. Many recognized that they had become more involved in safety-relevant behaviors after using MySurgery (eg, checking medication and providing a more thorough history), but they did not describe this in terms of safety per se. This seems to reflect both a lack of awareness about safety issues in health care in general and a lack of insight into the role a patient might be able to play, which highlights a challenge for those working in the area of patient empowerment in terms of how best to promote the scope for patient involvement in safety and how to encourage the formation of working partnerships between clinicians and patients. Interestingly, in this sample, we did not find any difference in the willingness to become involved in safety between those from different backgrounds (in terms of ethnicity and disability), which is an important finding to explore further, given how often these groups are excluded from involvement processes in quality and safety.

There was evidence to suggest that MySurgery may be currently less suited to certain patient groups, which was highlighted by the theme of diversity and inclusivity. Those with a disability reported more issues in using the app and were a key group that would be less likely to recommend it to others. The suggested additions of audio, videos, signposting, easy-read versions, and support in using the app may help here. Likewise, although ethnicity was not related to views of the app in general, there were some limitations identified with regard to a requirement for more nutrition-related information for different cultures (as well as those with restricted diets) and availability of the app in different languages. Finally, a few suggested that MySurgery is likely to be less relevant for certain procedures (eg, dental, eye, or minor procedures with fewer inherent risks).

When introducing a new intervention, it is critical to analyze the potential for unintended consequences. Although MySurgery was deemed to have a beneficial emotional impact by most, 3 participants reported that it made them feel more anxious about their surgery as they became more aware of potential risks/complications. The content of MySurgery was designed to be intentionally nonanxiety provoking; however, this should be explored in future evaluations. One participant inferred that clinicians might be resistant to patients asking more questions, and it would be interesting to explore this further with clinicians. Both potential issues might also highlight areas that will need to be addressed during implementation.

A key strength of the project was the PAR approach taken in setting up the research steering group. Through a process of self-reflection, we were able to demonstrate a number of beneficial impacts, including a richer contribution of perspectives to project design and data analysis and validation of the approach from a more diverse group of decision makers. A second strength was the diversity achieved in the sample. By implementing a structured diversity approach, we were able to include good representation (17/42, 41% and 22/42, 52% of the sample, respectively) from 2 groups with protected characteristics (disability and BAME background) who are often described as seldom heard in health care research. As a result, we have identified steps that can be taken to adapt the app to make it more suitable to these groups.

In terms of limitations, this was a pilot sample totaling 42 participants. Accordingly, although the sample was diverse, the subgroups were relatively small, and formal cross-groups analyses will not be definitive as they lack statistical power. Therefore, any subgroup effects reported in this study (eg, with regard to ethnicity or disability) should be interpreted with caution and will be followed up in the next phase of the study with a larger patient cohort. We did not assess the impact of socioeconomic status or geographic region, which may impact the ability to access the app; this should also be addressed going forward. In addition, we did not assess actual use of MySurgery in real time (eg, via observation) because of the methodological challenges inherent in doing so, and we did not assess clinicians’ views of the app at this stage.

Next steps are to evaluate MySurgery with surgical staff and a larger cohort of patients, using themes identified here to refine the research questions and outcome measures and to test subgroup effects more robustly. Feedback from this pilot study and the next phase of the research will then be used to make improvements to the app. We will also be more formally exploring the design and interface of MySurgery, focusing on user experience, with Mindwave Ventures—UK experts in the design and implementation of digital technology solutions to health care problems. Following improvements to the app, the final objective will be to work with NHS Trusts to explore the best approach to implementing MySurgery into surgical care pathways and to include it on the NHS Apps Library.

MySurgery is a smartphone app that brings together efforts to empower patients and their carers to become involved in their care and, specifically, to play a role in enhancing surgical safety, with the movement to embrace the potential of digital technology to transform health care. Our findings show that MySurgery has particular potential to empower patients to become involved in health care conversations, shared decision making, and safety-related behaviors. Adopting a PAR approach and the use of a diversity strategy also considerably enhanced the research process in terms of gaining diverse participant recruitment and PPI in the process. Further research is needed to explore why some patients felt less comfortable with their involvement in safety issues and to look more closely at how particular groups of patients, such as those with disabilities, can be empowered through use of the MySurgery app.