招募过程对肠易激综合征随机饮食试验的挑战。
Challenges of recruitment processes to a randomized dietary trial in irritable bowel syndrome.
机构信息
Department of Internal Medicine, Skåne University Hospital, Malmö, 20502, Sweden.
Clinical Sciences, Lund University, Malmö, 20502, Sweden.
出版信息
F1000Res. 2024 Jun 24;13:323. doi: 10.12688/f1000research.147710.2. eCollection 2024.
BACKGROUND
Irritable bowel syndrome (IBS) is common with a global prevalence of 4%. Dietary regimes with a low content of fermentable oligo-, di-, and monosaccharides and polyol (FODMAP) or a starch- and sucrose-reduced diet (SSRD) have proven to be efficient. The aim of the present study was to describe the recruitment process for a randomized dietary trial with low FODMAP or SSRD for 4 weeks with a follow-up period of 5 months. The results of the dietary trial itself are not included in this paper but will be presented in another publication.
METHODS
The County of Skåne, with 1,41 million inhabitants, was used as a base to perform a dietary trial in which IBS patients, age 18-70 years, were randomized to either low FODMAP or SSRD for 4 weeks. The estimated number of IBS patients in the actual age span was approximately 32,000. The trial was announced through lectures, letters to all primary healthcare centers (n=203), social media (two campaigns), and invitations to IBS patients identified in medical records (n=744).
RESULTS
Three referrals arrived from the healthcare system, 17 patients contacted the investigators in person after receiving information from their healthcare center, and four patients contacted the investigators after recommendations from friends. Of these, 14 were enrolled in the study. From social media, 218 names were delivered, of which 93 fulfilled the study criteria and were willing to participate when contacted by the investigators (42.7%). Of the 3587 identified IBS patients in medical records in close proximity to the hospital, 744 were randomly contacted. Forty-eight patients (6.5 %) were willing to be included in the study. Thus, 155 patients with IBS were included in this study.
CONCLUSIONS
The inclusion rate for dietary intervention was very low considering the large population informed about the study. Announcements on social media seem to be the best way to recruit patients for intervention.
TRIAL REGISTRATION
NCT05192603, 29/11/2021, ClinicalTrials.gov. The PRS URL is https://register.clinicaltrials.gov.
背景
肠易激综合征（IBS）在全球的患病率为 4%，较为常见。低含量可发酵寡糖、二糖和单糖及多元醇（FODMAP）或淀粉和蔗糖减少饮食（SSRD）的饮食方案已被证明是有效的。本研究旨在描述一项为期 4 周的低 FODMAP 或 SSRD 随机饮食试验的招募过程，随访期为 5 个月。该饮食试验本身的结果不在本文中，将在另一篇出版物中呈现。
方法
斯科讷县拥有 141 万居民，以此作为基地进行饮食试验，将年龄在 18-70 岁的 IBS 患者随机分为低 FODMAP 或 SSRD 组，进行 4 周饮食干预。在实际年龄范围内，估计 IBS 患者的数量约为 32000 人。该试验通过讲座、向所有初级保健中心（n=203）发出信函、社交媒体（两次活动）以及向医疗记录中识别出的 IBS 患者发出邀请（n=744）进行宣传。
结果
从医疗系统收到了 3 个转介，17 名患者在从他们的医疗中心收到信息后亲自联系了研究者，4 名患者在朋友的推荐后联系了研究者。其中 14 名患者被纳入研究。从社交媒体收到了 218 个名字，其中 93 名符合研究标准，并在被研究者联系时愿意参与（42.7%）。在医院附近的医疗记录中识别出的 3587 名 IBS 患者中，随机联系了 744 名。48 名患者（6.5%）愿意参与研究。因此，共有 155 名 IBS 患者纳入本研究。
结论
考虑到告知的研究人群庞大，饮食干预的纳入率非常低。社交媒体上的公告似乎是招募干预患者的最佳方式。
试验注册
NCT05192603，2021 年 11 月 29 日，ClinicalTrials.gov。PRS 网址为 https://register.clinicaltrials.gov。
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