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  ::  Introduction
  ::  Methods
  ::  Results
  ::  Discussion
 ::  References
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  Table of Contents     
REVIEW ARTICLE
Year : 2023  |  Volume : 69  |  Issue : 3  |  Page : 153-158

Low degree of patient involvement in contemporary surgical research: A scoping review


Center for Perioperative Optimization, Department of Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark

Date of Submission02-Feb-2023
Date of Decision02-May-2023
Date of Acceptance03-May-2023
Date of Web Publication19-Jun-2023

Correspondence Address:
Dr. Z M Mojadeddi
Center for Perioperative Optimization, Department of Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen
Denmark
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpgm.jpgm_83_23

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 :: Abstract 


Background: Patient and public involvement in research was introduced a few decades ago. However, there is still a lack of knowledge of the degree of patient involvement, particularly in surgical research. The aim of this review was to characterize the use of patient/public involvement in contemporary surgical research and to describe how patients were involved, if they gained authorships, and which countries studies came from.
Methods: In this scoping review, original studies and reviews about surgery were included that had patient/public involvement regarding study planning, conducting the study, and/or revising the manuscript. Screening was performed in the issues from 2021 of five general medicine journals with high-impact factors, also classically called “the big five,” and in the ten surgical journals with the highest impact factor.
Results: Of the 808 studies, 12 studies from three journals had patient involvement, corresponding to 1.7%. Patients were involved as participants in nine of the studies either in the designing of the study and/or in revising or approving the protocol; and in four studies in revising and/or approving the manuscript. One patient fulfilled the ICMJE authorship criteria and received a group authorship. Studies with patient involvement originated from six countries namely, Australia, Canada, Netherlands, Norway, USA, and UK; with five studies from the UK.
Conclusion: Patient involvement is very low in contemporary surgical research. It is primarily in the study planning phase, authorship is almost non-existent and few countries publish such studies.


Keywords: Patient and public involvement, public health, surgery


How to cite this article:
Mojadeddi Z M, Öberg S, Rosenberg J. Low degree of patient involvement in contemporary surgical research: A scoping review. J Postgrad Med 2023;69:153-8

How to cite this URL:
Mojadeddi Z M, Öberg S, Rosenberg J. Low degree of patient involvement in contemporary surgical research: A scoping review. J Postgrad Med [serial online] 2023 [cited 2023 Sep 23];69:153-8. Available from: https://www.jpgmonline.com/text.asp?2023/69/3/153/379143





 :: Introduction Top


The acknowledgment that patients could contribute to research started only a few decades ago because of patients' eagerness to influence the research on HIV.[1] However, awareness and implementation regarding patient involvement increased in the new millennium when certain countries and their health sectors began to focus on patient involvement.[2],[3] INVOLVE from the United Kingdom (UK) was one of the first organizations that focused on patient and public engagement. It is a government-funded organization that was established in 1996 by the National Institute for Health Research (NIHR).[2] INVOLVE has since April 2020 been disbanded and taken over by the NIHR Centre for Engagement and Dissemination.[4] In 2010, the nonprofit nongovernmental organization Patient Centered Outcome Research Institute (PCORI) was established by the United States of America (USA) congress,[3] which advocate for patient and public involvement.[2],[3] Patient involvement should not be understood as patients being participants in a study but that patients are involved in the research process, which encompasses all stages of the research from the study idea to critically reviewing the article.

The increased focus on patient and public involvement has led some journals to instruct authors to have a mandatory patient and public involvement statement in articles. Some of these journals include the British Medical Journal (BMJ)[5] and the 18 journals of BMJ's portfolio,[6] Journal of Occupational Therapy,[7] and Research Involvement and Engagement.[8] Another initiative regarding patient and public involvement was the launching of an editorial board consisting solely of patients by the Journal of Neurology, Neurosurgery and Psychiatry in 2019.[9] The literature has shown several positive effects of patient involvement in research, including changes in researchers' perception of the research process[10],[11] and contributions to the way of thinking and planning.[10] A review has also shown that patient and public involvement led to high recruitment of participants in studies.[11] However, challenges regarding patient and public involvement also exist. A systematic review showed that the involvement of patient and public in research could lead to a divergence from the scientific methods and could possibly cause ethical dilemmas.[12] Even though there are systematic reviews about patient and public involvement,[13],[14] the current knowledge is limited since this research method is relatively new.

Previous systematic reviews have had a broad focus by including clinical trials without a focus on different specialties.[13],[14] Therefore, the primary aim of this study was to show the number of studies that have involved patients and/or the public in surgical papers from high-impact medical and surgical journals. The secondary aim was to determine how patients were involved, how many gained authorships, and which countries studies came from.


 :: Methods Top


This scoping review is reported according to the preferred reporting items for reviews and meta-analysis extensions for scoping reviews (PRISMA-ScR).[15] Furthermore, a protocol was registered a priori to data extraction at Open Science Framework (OSF) with the registration number 10.17605/OSF.IO/KJV2S.[16]

This review included studies with patients or layperson who were involved in the study according to authorship criterion one or two of the International Committee of Medical Journals Editors (ICMJE) criteria. Criteria one is defined as “substantial contribution to the conception of the design of the work; or the acquisition, analysis, or interpretation of the data for the work” and criteria two as “drafting the work; or revising it critically for important intellectual content.”[17] All original studies and reviews about surgery in the specified journals [Table 1] published in 2021 were included. Excluded studies were editorials, case reports, viewpoints, conference abstracts, correspondences, comments, and corrigendums. Furthermore, studies were excluded if patient or layperson involvement was not used for the study according to criteria one or two of the ICMJE criteria, for example face validation of questionnaires with no other involvement.
Table 1: Screened journals and their impact factor

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The primary outcome was to assess the number of surgical studies with patient or layperson involvement. Secondary outcomes were to determine the type of involvement, which ICMJE criteria that were fulfilled, and if authorship was achieved. Among the included studies, we also investigated which countries that utilized involvement, if fundings promoted patient and layperson involvement, and which journals the included surgical studies with patient and layperson involvement were published in.

In collaboration with a professional research librarian, search strategies in PubMed, Embase, and Cochrane CENTRAL were conducted. However, the database search strategy was abandoned since not all the relevant studies were captured by the title and abstract screening. The reason for this was that studies were not necessarily indexed in databases under patient and layperson involvement, and many studies only mention involvement in the manuscript. Therefore, the only way to assess the aim was to access full text studies. The new search strategy was to choose specific journals and then screen title and abstracts directly from the journals' webpages. We chose to screen five general and internal medicine journals with high-impact factors, classically known as “the big five,” and the ten surgical journals with highest impact factor [Table 1]. The impact factor was found through journal citation report.[18] Only issues from 2021 were screened.

The first author screened title and abstracts, and the full text screening was done independently by two authors in an Excel sheet. Disagreements or uncertainties during title/abstract as well as full text screening were solved orally within the author team. When there was unclarity regarding data, authors of studies were contacted by mail for clarification. Data extraction was done by first creating a pilot Excel sheet that was tested for two studies and discussed within the author group. Thereafter, the first author extracted data twice for each study. Doubts were solved orally within the author group through the whole data extracting process.

Finally, data were verified collaboratively by the author group.

Data extracted on study characteristics were first author, publication year, journal, countries, type of procedure, surgical specialties, funding, characteristics of involved patients, and their relation to the procedure. Regarding outcome characteristics, data we extracted were about patient and layperson involvement in the research process, fulfillment of ICMJE criteria one or two, and if the involved persons gained authorship. Another characteristic was where involvement was mentioned in the study. All data are presented in numbers and percentages and described narratively.


 :: Results Top


We identified 12,543 records in the 15 journals. Of these records, 808 studies underwent full text screening, and 12 studies met the eligibility criteria.[19],[20],[21],[22],[23],[24],[25],[26],[27],[28],[29],[30] Thus, 1.7% of the surgical papers in the 15 specified high-impact journals in 2021 had patient or layperson involvement. For further details, see flowchart in [Figure 1].
Figure 1: Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram of included and excluded studies. NEJM: New England Journal of Medicine; JAMA: Journal of the American Medical Association; LANCET: The LANCET; BMJ: British Medical Journal; Ann Intern Med: Annals of Internal Medicine; JAMA Surg: Journal of American Medical Association Surgery; Ann Surg: Annals of Surgery; J Neurol Neurosurg Psychiatry: Journal of Neurology, Neurosurgery and Psychiatry; Heart Lung: Journal of Heart and Lung Transplantation; Am J Transplant: American Journal of Transplantation; J Hepatobiliary Pancreat Sci: Journal of Hepato-Biliary-Pancreatic Science; Hepatobiliary Surg Nutr: Hepatobiliary Surgery and Nutrition; Eur J Vasc Endovasc Surg: European Journal of Vascular and Endovascular Surgery; Br J Surg: British Journal of Surgery; ICMJE: International Committee of Medical Journal Editors

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Of the 12 included studies, five were randomized controlled trials (RCT),[19],[20],[23],[25],[28] four were reviews,[22],[24],[26],[27] and three were cohort studies.[21],[29],[30] Specialties and procedures varied, and sometimes multiple specialties were included in a study.[20],[21],[27],[29],[30]

Eight studies included various procedure types, which most commonly involved different orthopedic procedures[19],[20],[21],[23],[25],[27],[28] and a single study involved neurosurgical procedures.[24] The remaining studies involved bilateral salpingo-oophorectomy,[21] bone cancer surgery,[27] gender affirming surgery,[29] and tumor resection.[30]

In eight of the 12 studies,[19],[22],[24],[25],[26],[28],[29],[30] the involved patients suffered from similar conditions as the study participants or were relatives to patients with similar conditions as the study population. Three studies[21],[23],[27] did not provide a description of the involved persons' background. One study[20] referred to another publication about the involvement in the study.[31] This study described that involvement in the research process was made through a patient and partner panel group consisting of eight laypeople but without a description about the relation to the procedure.[31] Further details on patient and layperson characteristics are given in [Table 1].

Involvement in the research process varied in the studies. Nine studies had more than one patient involved,[20],[22],[23],[24],[25],[28],[29],[30] two studies had one patient/layperson involved,[19],[26] and one study did not specify how many were involved.[21] In addition, only one of the 12 studies had sufficient patient involvement to enable patients to achieve authorship.[19] This study had one patient representative who fulfilled IMCJE criteria one and two by contributing to the conception of the study and revision of the article, and this person received a group authorship. In the remaining 11 studies, the involved patients did not achieve authorship since only one of the authorship criteria was fulfilled. Thus, eight of these studies[20],[21],[22],[23] had patient involvement according to ICMJE criterion one and three studies[24],[26],[27] according to criterion two [Table 2].
Table 2: Characteristics of patient involvement

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The 12 studies came from three journals: seven studies[21],[22],[23],[24],[25],[26],[27] were from BMJ, three studies[28],[29],[30] were from Journal of the American Medical Association (JAMA) Surgery, and two studies[19],[20] were from New England Journal of Medicine (NEJM). There was a variation in the description of involvement in the included journals. All BMJ articles had a paragraph of its own for patient involvement, and one study from BMJ also had a statement in the protocol about patient and layperson involvement.[23] JAMA Surgery and NEJM did not have a paragraph of its own but mentioned involvement in the methods section, acknowledgment section, and/or the supplementary appendix. The 12 studies originated from Australia,[28] Canada,[30] Netherlands,[25] Norway,[19] the USA,[20],[26],[29] and the UK [Table 2].[21],[22],[23],[24],[27]

Ten studies reported being funded,[19],[20],[21],[22],[23],[25],[26],[27],[28],[29],[30] while two studies[24],[27] were not funded. Two studies were funded by PCORI in the USA,[20],[28] and three studies were either funded by NIHR[22],[23] from the UK or NIH[26] from the USA. Some studies were funded by several other sources, including hospitals,[19],[20],[21],[22],[23],[24],[25],[26],[27],[28],[29],[30] universities,[22] ministries of health,[19],[24],[25] and others.[19],[22],[28] Funding originating from PCORI, NIHR, and NIH routinely advocates for patient and layperson involvement.[2],[3]


 :: Discussion Top


This scoping review addressed patient and public involvement in surgical research from high-impact journals. Only 1.7% of the surgical studies had patient and/or layperson involvement, which came from only 3 of the 15 screened journals. Furthermore, only one patient from one study received group authorship. Of the countries where the studies originated from, the most prominent was the UK. Lastly, the funding source was dispersed among the studies, and establishments that advocate for patient and public involvement funded about half of the studies.

The strength of this study was that the PRISMA-ScR guideline was followed and a protocol was registered in a public database, thus increasing transparency. In addition, this is the only review about patient and public involvement that focuses on the surgical field. Another strength is that two authors screened full texts and all authors verified the data from the included studies. Since high-impact journals were included, this would make it likely that the sample of publications would consist of some of the most cited and influential studies in surgery and whether they had patient involvement. Other systematic reviews on patient and public involvement have conducted traditional searches in databases like PubMed, CINHAL, Cochrane, and Embase.[13],[32],[33] It would have been unrealistic for them to find all studies with patient involvement because patient involvement is not necessarily mentioned in the title or abstract, which could initially lead to missed studies. Therefore, we conducted an alternative search in selected high-impact journals, which did not put us in the same position where we could potentially miss studies. Limitations of this study were that only one author screened the titles and abstracts. Furthermore, another limitation was the selective process of screening only selected studies, which could potentially introduce bias based on the countries where they were published. Another limitation is that only studies from 2021 were included. Furthermore, a possible limitation is that the year 2021 was severely impacted by the COVID-19 pandemic. This could potentially have led to fewer surgical articles being published and reduced the use of patients in surgical research to prevent the spread of the disease. However, this was the best compromise to ensure that updated studies with patient involvement were included.

Few journals recommend authors to have a statement on patient and public involvement in their author instructions. It is an interesting development that some journals now recommend a separate paragraph[5],[6],[7],[8],[9], and it would be preferable that all journals implement at least a statement in line with “conflicts of interest” and “fundings.” This could lead to increased awareness for authors and readers regarding patient and public involvement. Nonetheless, this does not mean that patient and public involvement are generally absent in medical research. In fact, many journals and researchers are implementing this practice, and we will inevitably see a rise in this new way of engaging patients in research. We also found that the rules for co-authorship were followed in all 12 studies regarding criteria one and two of the ICMJE's authorship criteria, while criteria three and four were not described. Furthermore, it remains to be investigated whether it is beneficial to involve patients to a degree where they receive co-authorship. We assume that there will be a paradigm shift in the fields of medical research, including the surgical field, because of the benefits of patient and public involvement.[11],[34] Moreover, involving patients in the research process has shown to enhance the quality of research[11],[34] and may result in high accrual rates.[11],[35] A qualitative interview study showed that involved patients were positive about the involvement in the research process and would likely participate again.[36] However, there may be factors that prevent involvement, and one study[12] showed that the patients involved were given a fee to cover the expenses when traveling to engage in the research process, thereby removing a bit of the economic pressure from the patients. If possible, this could be a way to ease the engagement in research from patients and public. Furthermore, it may be a good idea that institutions engaged in clinical research have patient boards that can be involved in the research planning process.

In conclusion, a very small fraction of the eligible surgical papers from high-impact journals in the year 2021 had patient involvement. Involvement varied from patients and layperson being involved in reviewing the protocol and/or designing the study to revising the study manuscript. Only one of the involved patients fulfilled the ICMJE authorship criteria one and two and thereby achieved group authorship. Furthermore, the UK was the most prominent country of origin in studies that involved patients or layperson.

Acknowledgements

We thank Malene Højland for helping with the data acquisition.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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