Critical appraisal 

Title and Abstract

The title should be an accurate reflection of the article’s content and be easy to understand.⁶ The Alger et al.⁵ title conveys the main theme of the article; however, it could be made clearer and more concise by reducing the word count. Abstracts provide an overview of the study to help readers determine its relevance⁶—in original research articles, they are usually 200–300 words long.^7–9 The unusually lengthy 344-word structured abstract by Alger et al.⁵ is disproportionately distributed across subheadings, with a large proportion given to the background and insufficient information in the methods and results sections to describe how the study was conducted. 

Three points of discussion are mentioned in the abstract: to discuss the importance of patient and public involvement and engagement (PPIE) in shaping advanced dose-finding trial designs; to share insights from patients on integrating patient-reported outcomes (PROs) to inform treatment tolerability; and to present a template for meaningful patient involvement in trial design development. However, the purpose of the study is not clearly stated, indicating that the authors may not have had a clear idea of the knowledge gap of concern or their research objectives. Additionally, the participant selection process is not described. In the abstract, the last sentence of the methods section belongs in the conclusion, and the conclusion is not supported by the results.

Background

The background should provide a brief review of the literature to identify the knowledge gap that the study aims to address and provide a rationale for the study.⁶ As the Alger et al.⁵ abstract does not clearly state the study’s purpose, the reader must assume that the three points of discussion, referred to above, are designed to address a knowledge gap. However, the Alger et al.⁵ background only revisits one of these points, namely the integration of PROs to assess treatment tolerability. The article mentions previous dose-finding oncology trials, but without references, the reader cannot identify the specific studies or determine if they support the discussion point around PPIE in trial design. Moreover, although Alger et al.⁵ claim that their article provides a template to support organisations with PPIE involvement in trial design, it does not offer advice on how to utilise it, either in the background or elsewhere in the article. Finally, the poorly formulated research question does not specify the study population.

Methods

The methods section should clearly describe how the research was conducted to enable replication and ensure reproducible results.⁶ The Alger et al.⁵ methodology is unclear and does not specify a study design, but rather that the study utilised a “virtual PPIE session”, in addition to a “PowerPoint presentation and Zoom polls” for study participants to answer—the reader is left to assume that the poll was presented during the virtual session. 

Participant details are not presented in a logical order and appear before the recruitment process is described. The sample size is small, with no explanation of how it was calculated. There is insufficient information on participants to help the reader determine how generalisable the findings are.

According to the methods, there were nine participants included in the study. The subsequent mention of including advocates suggests there were more than nine participants; however, the results section refers to nine only. To make this clearer for the reader, the advocate's text could appear before stating there were nine participants. Furthermore, the number of participants belongs in the results section, rather than in the methods. 

The questionnaire used in the study does not appear to have been validated and is not adequately described or included for the reader’s review. The methods section mentions statistical methodology and the involvement of a statistician but does not explain what “statistical methodology” entails, or specify the methods of statistical analysis used in the study. Additionally, statistical methodology does not feature in the study points for discussion or aims. 

Results

The results section should reflect the aims and outcomes described in the methods section and provide a basis for the discussion.⁶ The Alger et al.⁵ study results are not presented in a logical order and do not align with the methods—subheadings, including “PPIE insights”, “Assessing patient adverse events”, “Patient tolerability levels”, and “Toxicity vs. tolerability”, appear without any context or explanation. Results of the zoom polls are not presented—instead, quotes from participants are provided, accompanied by vague phrases such as “it was generally thought”, “it was also suggested that “, and “many participants agreed that”. In terms of PPIE insights, the text states, “we defined PROs and current limitations to tolerability assessment”, but it fails to tell the reader what these are. Therefore, stating whether participants agreed or disagreed with these definitions lacks meaning. 

The descriptions of participants in each subgroup are unclear, and some of the numbers do not add up. According to Table 1 and the text, there were three distinct subgroups: “participants with experience in clinical trials (n=6)”, “participants with experience in Phase 1 clinical trials (n=4)”, and “participants with experience as a partner in Phase 1 clinical trials (n=9)”. However, as there were only nine participants, the reader must spend time reviewing the subgroups and assume that the first two groups are the patient partners, with some crossover between them. The use of a phrase such as “of which” would have provided clarity in this instance. 

The text mentions “two experienced patient advocates”, and the testimonials in Figure 2 are provided by “a patient advocate with lived experience of a Phase 1 trial” and “an experienced patient advocate who has contributed substantially to Phase 1 trial processes”. However, Table 1 lists one advocate only. Furthermore, the term “experienced patient advocate” is not found in the table, and it is not clear how “substantially” has been qualified.

Lastly, there is a small discrepancy in the proportion of female patients mentioned in the text (55.5%) and in Table 1 (55.6%), and the text in the results that is referenced and discursive, such as that under the “Patient tolerability levels” subheading, belongs in the discussion.

Discussion and Conclusion 

The discussion should present and review any new knowledge found through conducting the study.⁶ Several statements are made in the Alger et al.⁵ discussion that are not supported by the results. The discussion of the study results is limited to two paragraphs before moving on to “Future research directions”, implying that the study results may not warrant extensive discussion. 

The two testimonials in Figure 2 are not mentioned in the discussion, and so, it is not clear what they contribute to the study's conclusions. There is a section in the discussion dedicated to “PPIE in statistical methodology”, but as mentioned above, this is not defined in the article, making it difficult to ascertain how the study addressed this. 

The presented data do not justify the conclusions of the study. The conclusion section is uncommonly long at three paragraphs and includes concepts such as reimbursement of patients for their time and incurred expenses, financial considerations, and budgeting, which are not mentioned earlier in the article. There is text in the discussion that belongs in the conclusion, and vice versa. Additionally, the conclusion includes a reference, which is not the usual practice in medical publications.

Strengths of the Article

The inclusion of a plain language summary increases the article’s accessibility for a lay audience. The article includes a limitations section, indicating acknowledgment of the study’s areas of weakness. For instance, the article notes the potential drawbacks of using a virtual instead of a face-to-face PPIE session and recognises the lack of ethnic diversity by having an all-white study population. 

Limitations Not Acknowledged in the Article

The methods section of the Alger et al.⁵ article describes an international study, yet all authors appear to be based in the United Kingdom. The discussion claims that a diverse range of ages was included; however, most participants were aged ≥65 years. The declarations section indicates that ethics approval and consent for participation and publication are not applicable, but does not provide an explanation for this. Submission of PPIE activities to a research ethics committee isn’t always required.^10–12 However, given the ongoing ambiguity surrounding this issue within the academic community,¹³ providing an explanation for the study’s ethics exemption in the article would have offered additional clarity and reassurance.   

Further Points for Consideration

The article uses bold statements such as “development of patient-centric dose-finding trial designs is now essential” and “the session…was incredibly beneficial”, along with multiple instances of “crucial” and “vital”, without providing context or evidence. Avoiding these could enhance the credibility of the messaging. In addition, readers must move back and forth between the background, methods, results, discussion, and conclusion sections to understand the study and decipher the article's message—a more structured and logical flow of information could help to prevent this.

Summary of Critical Appraisal 

Involving and engaging patients and the public in the design and dissemination of clinical trials has become a key focus and relevant topic in current healthcare research. As a result, researchers and medical writers may be inclined to cite articles such as that from Alger et al.⁵, without conducting a critical appraisal. This thorough evaluation of the Alger et al.⁵ study highlights how the lack of a clear research question and methodology, along with insufficient data and numerous errors, may undermine the reader’s confidence in the reported results and conclusions, thus underscoring the importance of critically appraising such an article before citing it.  

References 

1. Faulkner SD, Somers F, Boudes M, Nafria B, Robinson P. Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions. Pharm Med. 2023;37:129–138. https://doi.org/10.1007/s40290-022-00458-4.
2. Harman NL, McGiveron K, Tudur Smith C, Williamson PR, Barrington H. Opening up ideas: an advent calendar for patient and public engagement in clinical trials research. Res Involv Engagem. 2023;9(1):118. https://doi.org/10.1186/s40900-023-00530-6. 
3. Pijuan J, Palau F. Patient involvement in clinical trials: a paradigm shift in research. Orphanet J Rare Dis. 2025;20(1):63. https://doi.org/10.1186/s13023-025-03573-y. 
4. Arumugam A, Phillips LR, Moore A, et al. Patient and public involvement in research: a review of practical resources for young investigators. BMC Rheumatol. 2023;7(1):2. https://doi.org/10.1186/s41927-023-00327-w. 
5. Alger E, Van Zyl M, Aiyegbusi OL, et al. Patient and public involvement and engagement in the development of innovative patient-centric early phase dose-finding trial designs. Research Involvement and Engagement. 2024;10(1):63. https://doi.org/10.1186/s40900-024-00599-7. 
6. Crombie IK. The Pocket Guide to Critical Appraisal. BMJ Publishing Group. 1996.
7. Andrade C. How to write a good abstract for a scientific paper or conference presentation. Indian J Psychiatry. 2011;53(2):172–175. https://doi/10.4103/0019-5545.82558.
8. Cals JW, Kotz D. Effective writing and publishing scientific papers, part II: title and abstract. J Clin Epidemiol. 2013;66(6):585. https://doi.org/10.1016/j.jclinepi.2013.01.005. 
9. Dewan P, Gupta P. Writing the title, abstract and introduction: looks matter!. Indian J Pediatr. 2016;53(3):235–41.  https://doi.org/10.1007/s13312-016-0827-y.
10. National Institute for Health and Care Research (NIHR). Do I need ethical approval to run an involvement activity? Available from: https://www.spcr.nihr.ac.uk/PPI/resources-for-researchers/faq/do-i-need-ethical-approval-to-run-an-involvement-activity. Accessed July 14, 2025.
11. Canadian Institutes of Health Research (CIHR). Ethics Guidance for Developing Partnerships with Patients and Researchers. Available from: https://cihr-irsc.gc.ca/e/51910.html#2. Accessed July 14, 2025. 
12. PPI Ignite Network. PPI Ignite Network Statement on PPI and research ethics approval. Available from: https://ppinetwork.ie/wp-content/uploads/2024/01/REC-approval-statement-Final-Jan2024.pdf. Updated 31 January 2024. Accessed 01 July 2025.
13. Nollett C, Eberl M, Fitzgibbon J, Joseph-Williams N, Hatch S. Public involvement and engagement in scientific research and higher education: the only way is ethics? Res Involv Engagem. 2024;10(1):50. https://doi.org/10.1186/s40900-024-00587-x.

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