{
  "abstract": "Introduction Recent data indicate that approximately one in three randomized controlled trials (RCTs) involving patients with connective tissue diseases fail to reach their target enrollment, resulting in substantial waste of resources. Regarding scleroderma (SSc), the pace of patient recruitment for RCTs has remained slow, with no significant improvement over the past 25 years. We performed this study to evaluate the completeness of reporting of pre-randomization patient’ flow in systemic sclerosis (SSc) randomized controlled trials (RCTs), and to estimate the extent and reasons for screening failure.Material and Methods We searched SSc-RCTs indexed in PubMed from 2000 to 2024. We recorded key trial features and checked whether they provided information on patient’ flow before randomization. We collected information on the adequacy of reporting of pre-randomization phase, the number of patients screened, and the extent and reasons of screening failure. Data were summarized as number (percentage) for qualitative variables and median (interquartile range) for continuous variables.Results Of the 127 SSc-RCTs retrieved, 52.9% reported patient flow before randomization, 21.2% of those published before 2011 and 65.1% of those published after. The most commonly used terms were ‘screened’ in 33 (50%), and ‘assessed for eligibility,’ in 29 studies (44%). Of 10,043 patients screened, 5,147 (51%) were considered screening failure. The median proportion of screening failures was 36% (IQR 20%–58%), with higher rates in studies testing non-pharmacologic interventions, lacking industry funding, lacking double-blinding, or not including a placebo arm. Main reasons for screening failure were reported for 3,510 patients (68.2%). The most common causes were not meeting eligibility criteria (72.5%) and patient refusal (20.1%). The vast majority of trials did not provide details on the reasons underlying patients’ refusal to participate. The overall rate of screening failure remained stable over time.Conclusions Reporting of screening procedures in SSc-RCTs has improved over time. Most screening failures are due to patient ineligibility, followed by patient refusal, which continues to represent a significant barrier to enrollment. Understanding the extent of the impact of poorly justified exclusion criteria on patient recruitment, as well as to explore the factors behind patient’s refusal is a priority. Gaining these insights could be instrumental in reducing trial-related costs, minimizing the burden associated with screen failures, and ultimately promoting greater participation of SSc patients in clinical research.Abstract P.269 Figure 1",
  "authors": [
    {
      "affiliations": [
        "Division of Rheumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland"
      ],
      "name": "Delphine Courvoisier"
    },
    {
      "affiliations": [
        "Division of Dermatology and Venereology, University Hospitals of Geneva, Geneva, Switzerland"
      ],
      "name": "Barbara Russo"
    },
    {
      "affiliations": [
        "University of Medicine and Pharmacy Carol Davila, Bucharest, Romania"
      ],
      "name": "Iulia-Simona Chirica"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland"
      ],
      "name": "Michele Iudici"
    }
  ],
  "title": "P.269 Screening failure in systemic sclerosis randomized trials: reporting, rates, causes, and trends over time",
  "uid": "25a43c74-c8dd-5c4f-88a6-fbeece2572d7"
}