Reporting of Patient And Public Involvement (PPI) In Clinical Trials Published In Three Leading Nursing Science Journals: A Scientiometric Study

Background: Patient and Public Involvement (PPI) in identifying research questions, designing trials, and collecting, interpreting, and publishing results may positively affect the relevance, quality and impact of research. The extent of patient and public involvement in nursing clinical trials has not been previously studied. Methods: A Scientiometric study of PPI in clinical trials published in three leading nursing science journals. Randomised controlled clinical trials published in the International Journal of Nursing Studies, the Journal of Clinical Nursing, and the Journal of Advanced Nursing between January and April 2021 were identied by searching the SCOPUS database. Journal author guidelines were also review. Data were extracted against the ve items of the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) reporting checklist. Results: None of the journals required authors to include a patient and public involvement statement in submitted papers or to thank participants in the acknowledgement section of the paper. We included 23 randomised controlled clinical trials, of which half were conducted in Europe and 12 were supported by external grants. Authors thanked participants in the acknowledgement section often (43%) trials. There was no statement or evidence of patient and public involvement in any of the included trials. Conclusion: There was no evidence of PPI in trials published in nursing science journals. Researchers, funders, and journals need to collaborate to change cultural expectations to ensure that PPI is an emended part of clinical research.


Introduction
Patient and public involvement (PPI) in research can be de ned as research carried out 'with' or 'by' members of the public rather than 'to', 'about' or 'for' them (NIHR, n.d.). There is a clear consensus that patient and public involvement in research improves the relevance, quality, and impact of the work (Price, Albarqouni, et al., 2018;Vale et al., 2012). In PPI, consumers are active partners in all aspects of research, from generating the research question, writing the grant application, developing the study protocol, collecting data, analysing and interpreting results and co-authoring publications (Vale et al., 2012).
Major research funding bodies are, to a varying degree, encouraging of PPI. In the United Kingdom, for example, the National Institute for Health Research (NIHR) -the major funding body for health research -has taken a notably forthright position, requiring researchers applying for funding to "describe how they have involved the public in the design and planning of their study as well as their plans for further involvement throughout the research, including plans for evaluating impact" (NIHR, n.d.). In Australia National Health and Medical Research Council encourages researchers to involve patients in all stages of the research process (NHMRC, 2016).
While researchers are seemingly, generally optimistic about involving patients in research, they struggle to achieve this objective (Boaz et al., 2016). Authors of a qualitative exploration of 36 researchers' experiences of PPI, for example, found that participants expressed a combination of ambivalence, cynicism and enthusiasm about PPI (Boylan et al., 2019). Further, Boylan et al. (2019) report that participants described PPI as both rewarding and burdensome, requiring practical and social support. Bowers et al. (2020) argue that PPI in research is time-consuming and more challenging for patients, the public and researchers than is often argued.
We have identi ed four studies that have examined the extent to which PPI has been integrated into research (Jones et al., 2015;Owyang et al., 2021;Patel et al., 2021;Price, Schroter, et al., 2018). Owyang et al. (2021) report a systematic review examining the prevalence and quality of PPI in randomised controlled trials in orthopaedics. The authors reviewed 475 studies and identi ed two trials where there was some evidence of meaningful PPI. In one, PPI was used to inform the research question, choice of outcome and the dissemination of ndings. In the second trial, PPI informed the study design.
The British Medical Journal (BMJ) has been in uential in promoting PPI through its Patient Partnership Strategy. In 2014 the BMJ implemented a policy requiring authors to make a PPI deceleration in the methods section of submitted manuscripts. Authors that had not involved patients were asked to state this in the paper explicitly. This policy aimed to increase PPI in research by shifting cultural expectations.  report the frequency of PPI in research published in the BMJ before and after implementing the consumer involvement policy. Of 152 papers -reporting any study design -published in the year following the implementation of the policy, there was an increase from less than 1-11% of authors reporting PPI, an important improvement but suggesting that consumer involvement in research is still infrequent. reporting patient and public involvement in research. The authors used the EQUATOR method for developing reporting guidelines: a three-round Delphi study and consensus statement. GRIPP2 identi ed key concepts that authors should report in their papers to describe PPI in their research. The short-form version of the guideline addresses ve topics: a. the aim of PPI in the study, b. methods used for PPI, c. results of PPI in the study, d. extent to which PPI in uenced the study overall, e. re ections. The authors suggest that journal editors can use the GRIPP2 checklist to set reporting expectations for submitted manuscripts.
The extent to which PPI is demonstrated in clinical trials in nursing has not been previously examined. We undertook a scientiometric study to show to what extent nurses involve consumers in randomised controlled clinical trials reported in nursing science journals.

Pre-registration
The methodology for this study was registered with the Open Science Framework and can be accessed via this link: https://osf.io/x2bqv Ethical considerations Ethical approval for this study was not required because data were extracted from publicly available sources or published research.

Consumer academic involvement
The study was instigated by RG, who does not identify as a consumer researcher. AN and CB are employed as teaching and research academics and identify as consumers. Both are committed to consumer and stakeholder engagement and were involved across all stages of this project.

Study design
We conducted a scientiometric study of PPI in randomised controlled clinical trials published between January and May 2021 in the leading nursing science journals.

Journal author guidelines
Two researchers read the journal author guidelines -and any other supplementary documents -to identify any requirements to report patient and public involvement in submitted manuscripts. We also checked if authors were instructed to thank patients involved in studies in the acknowledgement section of the manuscript.

Sample
We identi ed a sample of papers reporting the results of randomised controlled clinical trials published in three leading (publish more than 200 documents per year) general nursing science Journals: the International Journal of Nursing Studies (IJNS), the Journal of Advanced Nursing (JAN) and the Journal of Clinical Nursing (JCN) from 1 January 2021 through 31 April 2021. Trials testing an educational intervention or did not involve a clinical population were excluded. Our decision to focus on randomised clinical trials was informed by the impact this high level of evidence would have on patient care and treatment. We also considered that it was more likely that randomised controlled trials were more likely to have received funding where PPI was a requirement.

Search strategy
All documents published in the IJNS, JAN and JCN, were identi ed using the "sources" function in SCOPUS, entering the journal title and accessing the "SCOPUS content coverage" tab. We then restricted documents to those published in 2021. Title and abstract and full-text screening of all documents published (including the early view) between 1 January 2021 and 31 April 2021 was completed by two researchers to determine those that met our inclusion criteria.

Data extraction
Included papers were read in full -including footnotes and acknowledgements -by two researchers who independently extracted the following information: citation, summary of the trial, country where eldwork was conducted, if any authors identi ed as being a lived experience researcher, a summary of PPI reported in the manuscript, if participants were thanked in the acknowledgement section, source(s) of funding (coded: a. charity, b. government, c. University, d. own account, e. student project). Additionally, information against the ve GRIPP2 short-form items was also extracted.

PPI requirement of funding bodies
We checked the website of organisations identi ed in included manuscripts as funding trials to determine if PPI was a recommendation or requirement of funding applications.

Journal author guidelines
The author guidelines of the three participating journals neither implicitly nor explicitly required authors to report how patients were involved in the research submitted to the journal. All three journals required that authors follow relevant reporting guidelines listed on the EQUATOR network but did not mention GRIPP Both the Journal of Clinical Nursing and the Journal of Advanced Nursing has identical text about what information authors should include in the acknowledgement section and make no mention of thanking study participants. Section 2.9 of the author guidelines for the International Journal of Nursing Studies is the only section that deals with acknowledgements but is entirely focused on authorship.
Included studies Figure 1 shows the ow of papers through the study. As of the end of April 2021, the IJNS, JCN and JAN had published 691 documents, of which 23 (3%) were papers reporting the results of a randomised controlled clinical trial. A complete list of included trials has been made available via an online data repository that can be accessed via this link: (https://doi.org/10.26181/60bf1eac7eb64). Table 1 summarises the information extracted from the included studies. Almost half of the corresponding authors were based in Europe (n = 11, 48%) most studies were focused on medical patients (n = 13, 57%), half (n = 12, 52%) were funded by an external charity (n = 4, 17%), government (n = 5, 22%) or University (n = 3, 13%) grant. None of the researchers listed as authors on included studies identi ed as lived experience or patient researchers.
Authors of most (n = 13, 57%) of the included studies did not thank participants for their contribution to the research in the acknowledgement section of the manuscript.
A summary of patient and public involvement was not reported in any of the included manuscripts. There was no evidence of patient or public involvement in any of the included studies; consequently, we could not rate any of the GRIPP2 short-form items.

PPI requirements of funding bodies
We searched the websites of 16 funding bodies that had supported included but could not nd any evidence that PPI was recommended or a requirement of funding being awarded. All of the websites had an English language version except two that were exclusively in French.

Discussion
This study aimed to investigate the reporting of patient and public involvement in clinical trials published in the leading journals in nursing science. We found no evidence of PPI in any of the 23 trials that we reviewed. None of the three nursing science journals we included in this review required authors to report PPI in the papers they publish. Again, authors of studies in other disciplines reported similar ndings. For example, in the study of PPI in orthodontic research, Patel et al. (2021) reported that none of the four journals that they included had guidance on PPI. The exception is the British Medical Journal that actively promotes PPI in papers they publish. The BMJ introduced a policy in 2014 requiring authors submitting manuscripts to the journal to include a PPI declaration in their methods section (Price, Schroter, et al., 2018).
Trials published in nursing science journals were seemingly not supported by funding bodies that required PPI as part of the grant application process. Our observation is somewhat discrepant with other disciplines; for example, Patel et al. (2021) reported in their study of PPI that of nine funding agencies that they reviewed, only two (the National Institute for Health Research and Health Care Research Wales) required applicants to demonstrate PPI as part of the application process.
It is part of the BMJ patient partner strategy that authors should thank the patients that participated in the research in the acknowledgement section of their manuscript (Price, Schroter, et al., 2018). Expressing gratitude to people giving freely of their time in the advancement of knowledge seems to us important. It is the least that researchers can do, particularly as published research articles are often inaccessible to consumers as they are either behind a paywall or jargon-heavy and challenging for the general public to understand. That over half of the included nursing trials did not thank patients for their contribution is disappointing.

Limitations
It may be that researchers are involving patients in their research and then not reporting this in the published manuscript. In their study of PPI rates, Patel et al.
(2021) attempted to check -by emailing authors -if there was PPI in the trial, but this had not been reported in the manuscript. Only 14% responded to the researcher's request, suggesting that directly contacting authors may not be an effective way to check unreported PPI (Patel et al., 2021). Based on this observation, we concluded that there was little merit in contacting authors to check unreported PPI. It may be that qualitative interviews with researchers may be a more productive approach to addressing this issue.
Identifying if authors of included studies were consumer researchers was problematic. We assumed that it would be evident in the author a liation if this were the case. However, none of the three included journals asks authors to report job titles in papers, and this is probably how we would most likely identify lived experience authors. We also note that there is a culture in academia not to identify as lived experience academics. So even though authors may have an academic a liation, they may still be a lived experience academic, but we would not know.
We note that it was di cult to determine if some funding bodies required PPI because different terms were used, also some of the websites were not in English, making it di cult for us to be con dent that PPI was not a requirement of funding.

Generalisability
The generalisability of our observation is limited by the small number of journals that we included and our decision to only focus on papers reporting clinical trials. We included three leading nursing journals that publish -between them -around 1,000 papers a year and are all ranked in the top 25 nursing science journals (Journal Citation Report) Impact Factor. It may be that there are higher levels of PPI reported in papers in more specialist nursing journals. For example, we are aware that the Journal of Psychiatric and Mental Health Nursing has a speci c section on lived experience narratives. We focused on clinical trials because this design because is likely to have a direct impact on patient care, making PPI, arguably, more important. It may be that PPI is more prevalent in observational and qualitative research and systematic reviews.
Nurses may publish their research in non-nursing journals because they may perceive them as more prestigious or subject relevant. It is plausible that these studies are more likely to report meaningful PPI engagement to those in nursing journals. Consequently, we cannot generalise our observations to all trials by nurses, instead to those published in nursing science journals.
Consumer academic perspectives (NG CB) on the study ndings The original premise and intent of PPI in research is to ensure that the resulting work bene ts the community it serves. Partnerships with various stakeholders in research are critical to co-design and develop solutions that are more likely to be implemented and used within practice. Patients and the general public need to be seen a stakeholder as important as clinicians and policymakers who are often included in research design and implementation.
Results from this study highlight that while there is a slow culture change to acknowledge patients and the public as important equals in research, there is still much to be done across journals and research institutions alike. It is not surprising that researchers often focus on the barriers when it comes to PPI in research, which is perhaps the next knot to untangle in embracing PPI.

Consumer academic (NG, CB) experiences of involving patients and the public in research
Including PPI in research provides a different perspective from researchers and clinicians when it comes to tackling issues in healthcare. Patients and the public are privy to the challenges they face when navigating the healthcare system that may be unbeknownst or considered by researchers or clinicians. However, it can be challenging to nd patients and the public who can speak freely amongst the research team, particularly when hierarchical systems are in place. Additionally, while PPI can be embedded in research grants, it can sometimes be done in a tokenistic manner, diminishing the value of true PPI and increasing cynicism in patients to be involved with future projects.

Conclusions
Despite agreement about the value of PPI in improving the relevance and impact of research, we found no evidence that nurses had meaningfully engaged consumers in clinical trials. Further, authors frequently did not thank patients for their contribution to the research in the acknowledgement section of their manuscripts. Unlike their medical counterparts, the editorial leading nursing journals have not implemented policies to promote patient engagement in research. Researchers, funding agencies and Journals need to engage in strategies to promote meaningful PPI across all aspects of the research process.

Supplementary Files
This is a list of supplementary les associated with this preprint. Click to download. GRIPP2shortform.docx