https://orcid.org/0000-0002-5398-6200
Abstract
For many patients including those with psoriasis, scientific manuscripts comprising clinical outcomes including psoriasis area severity index (PASI) and/or physician global assessment (PGA) may be difficult to understand. However, most patients can relate to images at baseline and follow-up, particularly for dermatological diseases. This study aimed to assess the proportion of shared clinical images in psoriasis trials. A systematic review adhering to the PRISMA guidelines was performed. The review was limited to randomized controlled trials, and among these, only investigations involving biological agents for treatment of psoriasis were included. The Embase, MEDLINE and Scopus databases were searched for eligible studies published from inception to October 26, 2021. In total, 152 studies were included. When combining these, 62,871 patients were randomized. Overall, 203 images were shared depicting 60 patients in the manuscripts yielding an overall sharing rate of 0.1%. Patient images are seldom incorporated in clinical trial manuscripts which impairs interpretation for patients. Inclusion of image material would strengthen the patients’ perspective and understanding on what treatment effects that can be expected. As such, this systematic review should be an invitation to the pharmaceutical industry, other sponsors, and editorial offices to improve easy transfer of information to patients using image data.
Introduction
Psoriasis is one of the most prevalent immune-mediated inflammatory diseases and is characterized by cutaneous plaques (Citation1). The disease may have significant impact on quality of life and is associated with several comorbidities including psoriatic arthritis, depression and cardiovascular disease (Citation2,Citation3). The treatment options for patients with psoriasis is rapidly expanding and during the past two decades several biologics have been introduced (Citation4,Citation5). Despite expiring patents and the introduction of biosimilars (Citation6–9), these drugs are costly and have a considerable impact on health care budgets worldwide.
In randomized prospective clinical trials involving patients with psoriasis, the most often used primary outcome is based on improvement of baseline psoriasis area severity index (PASI) and physician global assessment (PGA). PASI is an old scoring system introduced in the 1970s, and is a composite score for redness, scaling, induration and distribution in predefined body areas (Citation10). Thus, higher scores do not simply correlate with disease distribution, and PASI correlates poorly with quality of life impact in psoriasis (Citation11,Citation12). In a Delphi consensus meeting arranged by the International Psoriasis Council, the use of body surface area, along with disease involving special sites and failure to topical therapy was the preferred measures to define those patients that would require systemic treatment. The debate regarding what should be the preferred primary clinical outcome in psoriasis trials is ongoing (Citation13,Citation14).
Shared decision making is a collaborative process in which a healthcare professional works together with a patient to reach a decision about care (Citation15). In contemporary medicine, shared decision making should be the norm. For many patients, scientific manuscripts, and scores such as PASI are often hard to understand. Moreover, scientific manuscripts have traditionally not been tailored for patients. However, most patients can relate to images at baseline and during follow-up. Inclusion of image material along with the original manuscript certainly strengthens the patients’ perspective and understanding on what treatment effects that can be expected and could be an integral part of future patient decision aids.
The aim of this systematic review was to investigate at what proportion clinical images are shared in randomized prospective clinical trials including patient with psoriasis and biological treatments.
Materials and methods
A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for all applicable items (Citation16). The PRISMA checklist is available in the supplementary material (Appendix S1). Prior the initiation, the review protocol (CRD42021286077) was published and registered at the PROSPERO platform (October 26, 2021) (Citation17).
Eligibility criteria
Population: no geographic restriction was imposed.
Psoriasis type: all psoriasis types except pustular subtypes.
Study design: randomized controlled trials published within the specified time frame, from the inception of selected databases until October 26, 2021.
Study drugs: biological treatment options.
Exclusion criteria
Investigations only in psoriatic arthritis (PsA).
Patients <18 years at inclusion (i.e. pediatric indication).
Follow-up, post-hoc or extension investigations.
Pustular palmoplantar psoriasis.
Non-English investigations.
Information sources and search strategy
The Embase (Ovid), MEDLINE (PubMed) and Scopus databases were searched for eligible studies published from inception to October 26, 2021. The search strings used (Appendix S2) were constructed in collaboration with medical librarians. A standard method was used to identify and remove duplicates (Citation18).
Selection and data collection process
Two reviewers (SP and FA) screened the titles and abstracts of all studies. In case of disagreement in the title/abstract screening the investigation was included in the full-text screening phase. All full texts were reviewed independently by both authors. Any disagreement about eligibility was resolved using a third reviewer (AE). The data obtained from the included investigations were verified by SP and FA.
Data items
The following items were extracted from included studies: first author; year of publication; journal; digital object identifier (DOI)-link (if available); primary outcome (if available); time to primary outcome (if available); number of randomized patients, number of patients depicted and number of available images in the manuscript (including all supplementary material). If an investigation included ≥2 stages, only the number of patients adding up to the primary outcome was included in the calculation. A data extraction work sheet was used to systematically address all data points above (Table S1).
Study risk of bias assessment
Due to the nature of this systematic review (i.e. dichotomous outcome) we did not use any quality assessments tools or tested for publication bias.
Effect measures and statistics
The measure for this review was binary (i.e. presence or absence of images). The proportion of shared images in each included investigation and for the complete dataset was calculated. Proportion rates was also analyzed for each represented medical journal. Three softwares; EndNote (Clarivate Analytics, Philadelphia, PA, USA), Rayyan (Rayyan Systems Inc., Cambridge, MA, USA) and Mendeley (Elsevier, Amsterdam, the Netherlands) were used throughout to compile and sort the records. All publications including data extraction were handled manually, and no automation software tools were used. The original EndNote libraries used for the review are available on request to the corresponding author. Microsoft Excel (Microsoft, Redmond WA, USA) was used for data tabulation and data extraction. Fisher’s exact test was used to analyze whether more recent publications (from 2017 and onwards) were more predisposed to sharing patient images. The year 2017 was selected since it aligns with the updated requirements for data sharing published by the International Committee of Medical Journal Editors (Citation19).
Results
Of the 1,918 records first identified, 219 investigations were reviewed in full text. Among these, 67 investigations were excluded (Table S2). After exclusions, 152 studies published in the time period of 2001 to 2021 were included in the analysis () (Citation20–171). Overall, 31 medical journals were represented (Table S3).
Figure 1. PRISMA flow chart. PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses. #All excluded reports are available in Table S2. From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.doi: 10.1136/bmj.n71.
When combining the 152 investigations above, 62,871 patients were randomized. In total, 32 investigations included patients image material in the running manuscript and three additional investigations shared patient images in the supplementary material (). When combining these, 203 images were shared depicting 60 patients in the manuscripts (including all supplementary text and video material) yielding an overall sharing rate of 0.1% (range 0.1% to 25.0%; interquartile range 0.3,4.4%). Six investigations included video supplements (Citation26,Citation35,Citation110,Citation136,Citation148,Citation163), but only one of these included patient images (Citation26).
The majority of patients (n = 51,857) were randomized in trials that included PASI75, PASI90, or PASI100 (i.e. 75, 90, or 100% improvement of PASI compared to baseline) in the primary outcome. Among these individuals, 23 patients (0.04%) were depicted. The five medical journals with the highest number of randomized patients included 50,809 individuals which comprised 80.8% of all included individuals in the review. Overall, 32 patients (0.06%) of these patients were depicted ().
Investigations published from 2017 (n = 67) had a lower proportion of depicted patients compared to studies published prior to 2017 (n = 85) (0.065% vs. 0.12%; p < 0.05, Fisher’s exact test).
Table 1. List of investigations (n = 35) with included patient images in running manuscripts and supplements.
Table 2. Proportion of depicted patients in the five journals with most randomized patients.
Discussion
This systematic review highlights that image sharing in randomized controlled trials involving patient with psoriasis and biological treatment occurs very rarely. The majority (77.0%, n = 117) of all included investigations included no patient image material and only 0.1% (n = 60) of all randomized patients (n = 62,871) were depicted in the included manuscripts.
Over the past two decades, the treatment results for biologic treatment agents for patients with psoriasis have improved markedly and the number of treatment options has expanded significantly. However, the structure for reporting of randomized controlled trial data involving this group of patients has not changed much. Importantly, in this time span, digital dissemination of research data and online access has flourished. It is nowadays very easy to add supplementary material, including extensive image material, in the online version of the article. Particularly for clinical trials, data sharing of deidentified individual-patient data is nowadays the norm. In their first proposal, the International Committee of Medical Journal Editors (ICMJE) stated that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk (Citation172). Inclusion of data sharing statements in the clinical trials registration phase was listed as a requirement by the ICMJE in 2017 (Citation19). However, these requirements do not explicitly mention sharing image data. While the overall sharing rate of patient images was low, the proportion of images shared after the ratification of these guidelines was in fact lower compared to older investigations prior to 2017, albeit that most of these investigations were registered long before 2017.
We acknowledge that scientific manuscripts have traditionally not been tailored for our patients. However, in the evolving landscape of healthcare, patient empowerment and advocacy have become increasingly important. Patient advocates are now integral contributors to common care practices, with patient organizations frequently represented at the major dermatology conferences. As a result, there is a growing need to make scientific literature more accessible and patient friendly. This paradigm shift highlights the importance of bridging the gap between complex research findings and patients’ understanding, ensuring that our publications serve as valuable resources for both medical professionals and the patients they aim to help.
We see several important ancillary uses of sharing deidentified patient images. Firstly, they can be used as an external validation of the treatment effects. Secondly, the images have a high educational value for dermatologists including resident physicians and medical students. Thirdly, it increases the usefulness of the data to be used in other research settings, i.e. one recent and important interest in psoriasis research is to identify patient characteristics that may serve useful to predict treatment response. Baseline skin distribution of psoriasis might be one important factor for the selection of the appropriate treatment selection. Moreover, use of machine learning algorithms for evaluation and management of psoriasis is an idea currently pursued by several research groups (Citation173). Finally, these images could be an integral part in the patient decision aids when weighing several treatment options. Essentially, these investigations are all conducted to improve patient care and consequently researchers and trial sponsor have an ethical responsibility to promote shared decision making, which is the norm in contemporary medicine. In other words, we believe it is the research community’s responsibility to implement additional outcomes that can be easily used for patient education.
This review does not address the reason why the sharing rate is so low. We acknowledge that researchers and sponsors might be reluctant to share patient images due to privacy and medicolegal issues. Nonetheless, deidentified patient images of selected body parts illustrating treatment progress could most often be used without exposing patient anonymity. We acknowledge that editorial offices often have a restriction of how many tables and/or figures that are allowed in the running manuscript. Consequently, including a figure representing a curve of how many patients that meet the primary outcome, might be given higher priority compared to selected clinical images. However, it is nowadays very easy to add extensive supporting material, including image material, in online supplements or repositories. Moreover, supporting material that may help the reader to better understand the data presented is most often encouraged by medical journals. Some reviewers and readers in general might frown at representation of images of individual patients in manuscripts. Inclusion of a minority of patient images should of course raise important questions relating to selection bias (i.e. cherry picking). Of course, the mandatory inclusion of all available image material for all patients in supplements would help override this issue. Finally, most modern electronic case report forms enable uploading of images.
Participation in clinical trials is most often a solid commitment and time-consuming. Consequently, we believe that many patients would be interested in sharing selected and appropriately anonymized images of their skin to illustrate treatment effects. Patient consent forms would of course be mandatory, but since patients already signs multiple forms in a clinical trial, this should not be regarded as an obstacle. Since there is no standardized way of obtaining patient images for patients with psoriasis, we recognize that image material will be hard to use as a primary outcome measure. As such this review is an open invitation to such a debate, how to standardize patient images and at what visits images should be obtained. A consensus agreement how to enhance integration of image material would be a much-welcomed contribution to the dermatology community. Ideally whole-body photography should be used but this technique is far from broad implementation in routine healthcare. Nonetheless, the technical details (i.e. body part placement and photography set-up) are beyond the scope of this review. However, we advocate that use of images at baseline and at the timepoint for the primary outcome (most often 12 or 16 weeks) would be realistic and would be a supportive way of communicating the primary message of the manuscript to our patients. Most often patients can pinpoint a body region which has the highest impact on their daily lives. Preferably this body region could be selected. The minutes of extra time spent on photography and amending these images to an electronic clinical trial form stored at a safe server provided by the sponsor would be well invested. Obtaining clinical images is nowadays common practice at most dermatology clinics; it only takes a couple of minutes, and it is inexpensive since most departments already have a dedicated camera device for this purpose.
During the past years, plain language or capsule summaries have become an essential part of original reports. While there are many advantages in explaining the research in an easy way, the main purpose of these is to involve laypersons in the research. However, patient videos along with images illustrating the treatment effect of selected patients would probably convey a much stronger message to our patients. Overall, six investigations included video supplements (Citation26,Citation35,Citation110,Citation136,Citation148,Citation163), but only one included patient images (Citation26).
This study has some limitations. Firstly, for pragmatic reasons we limited the review to patients with psoriasis and biologic treatment options. Nonetheless this research question is of course equally relevant for other dermatological conditions as well as other treatment modalities. Although particularly applicable for dermatology in general, as long as disease severity clearly can be visualized in images, they can be used to illustrate the treatment progress. Secondly, small molecules such as apremilast, ciclosporin, deucravacitinib, dimethylfumarate, and methotrexate, were included only if they were used as comparative study drugs. Finally, we excluded non-English investigations.
To summarize, this review underlines that sharing patient images in clinical trials including patient with psoriasis and biological treatment options is a rare event. Moreover, sharing images has become increasingly rare during the past years despite the increased demand for data sharing in clinical trials. As such this review should be a wake-up call for researchers, sponsors, and other stakeholders to update our layout for clinical randomized trials to make them more useful for our patients.
Supplemental Material
Download PDF (714.2 KB)Acknowledgments
We thank the medical library of Sahlgrenska University Hospital and Linda Hammarbäck and Helen Sjöblom at the Biomedical Library at the University of Gothenburg for helping us generate the search strings used for this investigation.
Disclosure statement
SP: With no relation to the present manuscript, SP has received honoraria as consultant and/or speaker from AbbVie, Amgen, Astra Zeneca, Beiersdorf, Bristol Myers Squibb, Galderma, Janssen Pharmaceuticals, Leo Pharma, Novartis, and Sanofi.
FA: none.
AE: With no relation to the present manuscript, AE has received research funding from Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co., Ltd, Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Galapagos NV, Union Therapeutics, Mylan, Bristol Myers Squibb, and Janssen Pharmaceuticals.
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