Department of Periodontology and Operative Dentistry, Faculty of Dentistry, University Hospital Münster, Münster, Germany.
Cancer Med. 2024 Apr;13(8):e7036. doi: 10.1002/cam4.7036.
To assess the frequency of patient-reported outcomes (PROs) and non-PROs in randomized controlled trials (RCTs) addressing head/neck cancers.
We included RCTs about interventions to treat head/neck cancers. PubMed was searched on September 16, 2022 and included studies published during three periods (2000-2002, 2010-2012, and 2020-2022). Data on types of outcomes and instruments to measure them were extracted and organized into PROs and non-PROs, and temporal trends for reporting outcomes were determined.
There was a reduction in the frequency of non-PROs (40% to 22%) and an increase in PROs (5% to 19%) over 20 years. The frequency of reporting both non-PROs and PROs seemed to be stable over the same period (55% to 58%). A great variety of instruments to measure PROs and non-PROs was identified.
There has been a growth in the types of PROs in more recent years, and they were more frequently reported in RCTs. However, head/neck cancer trials with a combination of PROs and non-PROs were the most prevalent.
评估针对头颈部癌症的随机对照试验(RCT)中患者报告的结局(PROs)和非患者报告的结局(non-PROs)的频率。
我们纳入了关于治疗头颈部癌症干预措施的 RCT。于 2022 年 9 月 16 日在 PubMed 上进行检索,纳入了三个时期(2000-2002 年、2010-2012 年和 2020-2022 年)发表的研究。提取了关于结局类型和用于测量它们的工具的数据,并将其组织为 PROs 和 non-PROs,确定了报告结局的时间趋势。
20 年来,非 PROs 的频率(40%降至 22%)减少,PROs 的频率(5%升至 19%)增加。在同一时期,报告非 PROs 和 PROs 的频率似乎保持稳定(55%至 58%)。确定了大量用于测量 PROs 和 non-PROs 的工具。
近年来,PROs 的种类有所增加,并且在 RCT 中更频繁地报告。然而,同时报告 PROs 和 non-PROs 的头颈部癌症试验最为普遍。