Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research.

This review focused on psoriasis RCTs published in the 96 dermatology journals recognized by the 2025 Journal Citation Reports. The selection of PubMed and the Cochrane Database was based on their comprehensive coverage of the relevant dermatology literature. We therefore searched these two databases for studies published between January 2020 and July 2025. The detailed search strategy and journal list are provided in the online Supplementary material.

We used EndNote 21 to screen and exclude studies. Two investigators (ZX and YL) independently screened the titles and abstracts based on predetermined eligibility criteria. This was followed by independent full-text reviews conducted by two additional researchers (ZL and YQ). Discrepancies during the screening process were re-solved through consensus discussions between two senior investigators (ZP and PS). The study selection process is detailed in the PRISMA flow diagram. For the purpose of screening, a record was considered “full text unavailable” (and thus excluded) if, after exhaustive efforts, the complete manuscript could not be retrieved. Primary reasons for unavailability were: (1) paywall restrictions not covered by our institutional subscriptions; (2) database limitations providing only an abstract without a full-text link; and (3) unavailability after direct requests to corresponding authors. Our search was conducted in English databases without language filters.

Eligibility criteria for RCT inclusion, followed the population, intervention, comparator, outcome, study type (PICOS) framework.

Population: Patients with various forms of psoriasis (plaque, erythrodermic, pustular), excluding psoriatic arthritis, as psoriatic arthritis represents a distinct rheumatic immune disease requiring fundamentally different efficacy assessment approaches from cutaneous psoriasis.

Interventions: Any medical intervention (pharmacological/non-pharmacological) for treating or preventing non-articular psoriasis.

Comparator(s): Any

Outcome(s): All outcomes measuring treatment safety in psoriasis were included without restriction.

Study type: 1. Original randomized controlled trials.

2. Studies excluded non-randomized investigations (e.g., observational studies, single-arm trials), secondary analyses of RCTs, and extensions including but not limited to long-term extension studies, post-hoc analyses, pre-specified or non-pre-specified subgroup analyses, pooled analyses, meta-analyses, and patient-level data reanalyses.

Data extraction was performed independently by two investigators (ZX and YL) using a standardized form pre-designed in Microsoft Office Excel. The extracted information encompassed study characteristics and variables related to AE reporting.

The extracted study characteristics included publication year, journal impact factor, funding source, sample size, disease subtype, and center type. To comprehensively characterize adverse event reporting practices, we extracted data for 20 reporting items aligned with the CONSORT-Harms 2022 guidelines. These items encompass key domains of AE collection, analysis, and presentation, including assessor identity, confirmation methods, timing, severity grading, management measures, outcomes, statistical analysis, pre-specification, and coding systems (See Supplementary Table S1).

All data were extracted from the main text and Supplementary material of each included article. Any discrepancies between reviewers were resolved through discussion to reach consensus, with arbitration by a senior investigator (SY) when necessary.

To mitigate potential conceptual overlap between individual AE reporting items and the study outcomes, a composite index was constructed to quantify the overall completeness of AE reporting.

The primary outcome measure was the Adverse Event Reporting Completeness Index–Core (AERCI-Core). This index comprises 12 specific harm items, selected based on explicit reviewer endorsements and their alignment with the core elements of the CONSORT-Harms checklist. These items encompass the fundamental components of adverse event reporting, including: identification of the AE assessor(s), methods for AE confirmation, time of onset, severity grading, management measures, outcome or resolution, discontinuations due to AEs, explicit reporting of serious AE types, reporting of adverse events of special interest, between-group statistical comparison, pre-specification of harm outcomes in the study protocol or trial registry, and the use of a standardized AE coding system (e.g., MedDRA or WHO-ART)(See items 1–12 in Supplementary Table S1).

Additionally, an extended index (AERCI-Extended) was developed. This index incorporates eight supplementary items recommended by the CONSORT-Harms 2022 statement and was employed specifically in sensitivity analyses to assess the robustness of the findings under varying definitions of reporting completeness (See items 13–20 in Supplementary Table S1).

Each item was scored dichotomously (1 = adequately reported; 0 = not reported or unclearly reported). The total AERCI-Core score ranges from 0 to 12, and the AERCI-Extended score from 0 to 20, with higher scores reflecting greater completeness and transparency in adverse event reporting. The total AERCI-Core scores were categorized into three groups: low (≤the 25th percentile), moderate (interquartile range, between the 25th and 75th percentiles), and high (≥ the 75th percentile). All items were extracted independently by two investigators (ZX and YL) using a standardized data abstraction form. Discrepancies were resolved by a senior researcher (SY).

Based on prior literature and a priori hypotheses, the following study-level characteristics were evaluated as potential predictors of AE reporting completeness: funding source (industry, institutional, mixed, personal, or none), disease subtype (plaque psoriasis, psoriasis in special areas, pustular psoriasis), journal impact factor (continuous variable), publication year (continuous variable), and sample size (continuous variable). These variables were selected as they may plausibly influence trial design, safety monitoring procedures, and reporting practices.

To assess whether the publication of the CONSORT-Harms 2022 guidelines influenced researcher adherence to its items, a subgroup analysis was conducted to compare the rates of item adherence in RCT reports published before vs. after the guideline release. Specifically, RCTs were dichotomized into two periods based on their publication date relative to the release of the CONSORT-Harms 2022 statement: the pre-guideline period (studies published 2020–2022) and the post-guideline period (studies published 2023–2025). For each reporting item, the proportion of studies that reported “yes” (i.e., fulfilled the item's requirement) was calculated separately for each period. Differences in these proportions were compared for statistical significance using the Chi-square test or Fisher's exact test, as appropriate. Categorical variables are summarized as frequency and percentage. The normality of continuous variables was assessed using the Shapiro–Wilk test. Normally distributed data are presented as mean ± standard deviation, while non-normally distributed data are presented as median (interquartile range).

The primary analysis employed multiple linear regression, with the AERCI-Core score as the dependent variable, to investigate associations between study characteristics and the completeness of core adverse event reporting. Initial univariable analyses were followed by the construction of a multivariable model incorporating all prespecified covariates. Results are reported as regression coefficients (β) with their corresponding 95% confidence intervals (CIs).

Multicollinearity among covariates was assessed using variance inflation factors (VIFs), with a VIF value ≥5 indicating potential collinearity concerns. No severe multicollinearity was detected. For categorical variables, the following reference categories were specified: “none” for funding source and “plaque psoriasis” for disease classification.

Sensitivity analyses were conducted to evaluate the robustness of the findings. First, the AERCI-Core score was categorized into tertiles (low, medium, high) and analyzed using ordinal logistic regression. Second, the primary multivariate analysis was repeated using the AERCI-Extended score as the outcome variable. Third, the analysis was repeated after excluding studies with a sample size below 30. The consistency in the direction and magnitude of associations across these analyses was considered evidence of robust results.

All statistical analyses were performed using R software (version 4.4.2). A two-sided P-value of < 0.05 was considered statistically significant.

Table 1 presents the general characteristics of the included studies. The publication years were evenly distributed, with the highest number of studies published in 2024 (38 studies, 20.3%) and the lowest in 2025 (22 studies, 11.8%). Among the 187 studies, 110 (58.8%) were multicenter trials, 128 (68.5%) were published in JIF Q1 journals, and 136 (72.7%) reported a trial registration number. The mean impact factor was 5.89 (3.54). Institutional funding supported 133 studies (71.1%), and the majority of studies (105 studies, 56.2%) had no more than 10 authors. Regarding sample size distribution, 92 studies (49.2%) enrolled between 101 and 1,000 participants. Plaque psoriasis was the pre-dominant disease category (145 studies, 77.5%). In terms of control groups, 62 studies (33.2%) used a placebo control, while 79 studies (42.2%) employed an active comparator.

The relationship between the reporting rate of adverse events and the year of publication is presented in Figure 2.

Table 3 details a total of 1,645 adverse events were recorded across the 153 studies that reported specific adverse event types. These events are categorized into 22 distinct classes based on the affected organ systems and etiological mechanisms, each subjected to separate statistical analysis. Diseases of the skin and subcutaneous tissue were the most frequently reported adverse events (360 cases, 21.9%), with pruritus (38 cases) and exacerbation of psoriasis (22 cases) representing the predominant manifestations. Gastrointestinal disorders were the second most common category (236 cases, 14.3%), primarily characterized by diarrhea (56 cases) and nausea (47 cases). Respiratory, thoracic, and mediastinal disorders (233 cases, 14.2%) constituted another frequently reported category, mainly comprising upper respiratory tract infections (59 cases) and nasopharyngitis (58 cases). (When an event was attributable to multiple categories, it was counted only once).

The results of the univariate and multivariate linear regression analyses are presented in Table 4. In the univariable linear regression analysis, several factors were associated with higher AERCI–Core scores: journal impact factor [β = 0.34, 95% CI (0.21, 0.46), P < 0.001], institutional funding [β = 1.57, 95% CI (0.43, 2.71), P = 0.007], and sample size (β < 0.01, P = 0.001). Based on the multivariate linear regression model adjusting for publication year, sample size, funding source, and disease category, each one-unit increase in journal impact factor[β = 0.27, 95% CI (0.13, 0.40), P < .001] and pustular psoriasis [β = 1.85, 95% CI (0.10, 3.60), P = .038] with plaque psoriasis as the reference were independently and positively associated with higher adverse event reporting completeness scores. By contrast, publication year [β = −0.18, 95% CI (-0.44, 0.08), P = .167], sample size [β = 0.00, 95% CI (-.00,.00), P = .101], funding source (including individual, institutional, mixed, and unreported categories; all p>.05), and psoriasis in special areas [β = −0.10, 95% CI (-1.31, 1.11), P = .866] did not demonstrate statistically significant associations. Furthermore, the variance inflation factor (VIF) for all independent variables was below 2, indicating the absence of multicollinearity in the model. The variance inflation factors for all variables are detailed in Supplementary Table S2.

The results remained robust across all sensitivity analyses. When the AERCI-Core scores were stratified into tertiles and analyzed using ordinal logistic regression, the direction and strength of the associations were consistent with the primary linear regression model. A similar pattern of associations was observed when the analysis was repeated using the extended 20-item index (AERCI-Extended), including the positive correlation between journal impact factor and reporting completeness. Additional analyses conducted after excluding trials with a sample size below 30 did not substantially alter the results (Supplementary Tables S3–S5).

Guided by the latest CONSORT-Harms (2022) guideline, this study has developed and applied for the first time a structured assessment instrument—AERCI-Core (12 items)—to systematically evaluate the quality of safety reporting in psoriasis RCTs published between 2020 and 2025. The key findings are summarized as follows:

First, our analysis identified significant deficiencies in the overall quality of adverse event reporting among psoriasis RCTs. The AERCI-Core scores (median 6, IQR 2–8, total possible score 0–12) revealed that only approximately one-quarter of studies (26.2%) achieved a high-quality threshold (≥8 points), nearly half (47.1%) were of moderate quality, and over one-quarter (26.7%) were categorized as low quality. Particularly noteworthy is the finding that only three studies (1.6%) reported adherence to all 12 core items. This result aligns with findings by Beytout et al. (14) in dermatology, who used an earlier CONSORT framework and reported a median compliance of 9 checklist items (range 0–18). It is also consistent with the broader literature documenting the generally suboptimal quality of safety reporting across other medical specialties (9, 16–21). These findings collectively reinforce the existence of a gap between reporting guidelines and current practice in this field.

Second, an item-by-item analysis of the AERCI-Core revealed systemic underreporting of critical information. The identity of the adverse event assessor and the method for event confirmation were reported in only 42.2% and 63.1% of trials, respectively, posing challenges for evaluating data objectivity. Information directly pertinent to clinical risk assessment, such as the timing of adverse events (reported in 20.3% of trials), specific management strategies implemented (16.0%), and their subsequent outcomes (26.7%), was documented at alarmingly low rates. Furthermore, reporting rates for the specific types of serious adverse events, adverse events of special interest, and the use of standardized coding systems (e.g., MedDRA) were all below 50% (39.0%, 37.4%, and 31.6%, respectively), substantially impeding the meaningful aggregation and comparison of safety data. The low reporting rates for these specific items represent a substantial deviation from the standards set by CONSORT-Harms 2022 and directly limit the utility of the safety data for informing clinical decision-making.

Further subgroup analysis indicated that, in the period following the publication of the CONSORT-Harms 2022 guideline (2023–2025), compliance rates for most reporting items showed no statistically significant improvement compared to the preceding period (2020–2022). Notably, adherence to several critical items, such as “identity of the adverse event assessor,” exhibited a significant downward trend. This finding suggests that the publication of the guideline did not, by itself, prompt a widespread immediate improvement in reporting practices.

Third, having established the current state of reporting quality and its lack of improvement post-guideline, we further investigated its potential determinants through multivariate regression analysis. The results identified journal impact factor as a key independent predictor of reporting completeness, underscoring the pivotal role of journals in the practical implementation of reporting guidelines. Regression analysis demonstrated that journal impact factor [β = 0.27, 95% CI (0.13, 0.40), P < .001] and the pustular psoriasis subtype [β = 1.850, 95% CI (0.10, 3.60), P = .038] were independent positive predictors of the AERCI-Core score. It is noteworthy that institutional funding and sample size, which were significant in the univariate analysis, were no longer significant in the multivariate model. This suggests their effects may be mediated through journal impact factor—for example, institutionally funded or larger-scale trials may be more likely to be published in higher-impact journals (22, 23), where stringent editorial and peer-review processes directly promote reporting rigor (24).

This finding, complementary to the results of the subgroup analysis, indicates that the publication of the CONSORT-Harms 2022 guideline has not led to a significant improvement in the quality of adverse event reporting in psoriasis RCTs. On the one hand, subgroup analysis showed no statistically significant increase in compliance rates for most items after the guideline's publication; on the other hand, publication year did not exhibit a significant positive association in the regression model. Taken together, these results consistently indicate that reporting quality has not improved automatically over time or following the introduction of the guideline. Within this context, the independent predictive role of journal impact factor underscores the critical function of journal editorial and peer-review standards in driving the practical adoption of reporting guidelines.

The aforementioned conclusions, of course, should be interpreted with caution. Impact factor is a journal-level metric and does not fully equate to the quality of individual studies; moreover, the analysis may be susceptible to publication bias (25, 26). Future research should further dissect the specific mechanisms by which journals promote reporting quality, focusing on editorial policies, the practical use of manuscript checklists, and the author revision process.

In summary, the AERCI instrument developed in this study provides, for the first time, a structured framework for the quantitative assessment of adverse event reporting quality in RCTs. The assessment clearly identified deficiencies across multiple dimensions of safety reporting in the field of psoriasis, and the release of the CONSORT-Harms 2022 guideline did not significantly alter this landscape in the short term. Although journal impact factor demonstrated a potential positive influence, substantial room for improvement remains in overall reporting quality. Future research efforts, journal editors, and reviewers should place greater emphasis on the implementation of the CONSORT-Harms guidelines, particularly for the key items identified in this study as having low reporting rates. We recommend that journals explicitly mandate adherence to CONSORT-Harms within their author guidelines and systematically verify key safety reporting items during peer review. This approach would translate guideline recommendations into actionable publishing standards, thereby improving the reporting quality of future studies.

This study identified deficiencies in adverse event reporting within psoriasis RCTs that extend beyond incomplete adherence to the CONSORT-Harms guidelines. These shortcomings permeate four interrelated dimensions—data collection processes, the selection of reported content, and the format of presentation—collectively undermining the reliability of the safety evidence.

This systematic evaluation reveals systemic deficiencies in the current safety reporting of psoriasis RCTs, spanning overall quality, adherence to key checklist items, and multiple facets of data collection, presentation, and analysis. These shortcomings compromise the reliability and clinical utility of the safety evidence. Therefore, future research in this field should not be limited to superficial compliance with reporting checklists (such as CONSORT-Harms) but should strive to establish a fully transparent system encompassing the entire process—from data collection and the selection of core outcomes to data presentation and statistical analysis. Only through such systemic improvement can high–quality safety evidence—sufficient to support robust clinical risk–benefit assessment—be generated.

Several limitations of this study should be acknowledged. First, our analysis was restricted to randomized controlled trials published in dermatology specialty journals indexed in the Web of Science. Adverse event reporting practices in general medical journals or journals from other specialties may differ, potentially limiting the generalizability of our findings. Second, adverse event reporting was assessed based on information available in published articles and Supplementary material; safety data documented exclusively in trial protocols, registries, or regulatory submissions may not have been fully captured. Third, although we applied a standardized checklist aligned with the CONSORT-Harms (2022) guideline, the assessment inevitably involved a degree of subjectivity, and the dichotomous scoring approach could not fully capture qualitative differences in reporting depth. Finally, as a cross-sectional meta-epidemiological study, this work is inherently a descriptive analysis of the published literature and cannot establish causal relationships between the observed reporting deficiencies and specific elements of trial design, conduct, or editorial processes. Fifth, the exclusion of studies with unavailable full texts may have introduced selection bias, as these studies (e.g., those behind paywalls or only published as abstracts) might be systematically different in their reporting completeness. This could potentially lead to an overestimation of the reporting quality in our sample. Furthermore, the restriction of our inclusion criteria to English-language publications from the past 5 years (2020–2025) may limit the generalizability of our findings to earlier periods or to the non-English literature, precluding an assessment of longitudinal trends in reporting practices.