Division of Infection & Immunity, Cardiff University, Cardiff, UK.
BS Medical College of Georgia, Augusta, GA, USA.
Br J Dermatol. 2022 Dec;187(6):846-854. doi: 10.1111/bjd.21821. Epub 2022 Sep 4.
Pain is the most common and bothersome symptom experienced by people with hidradenitis suppurativa (HS) and has been prioritized as an outcome domain by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC).
To perform a scoping review of pain measurement in randomized control trials (RCTs) of painful skin conditions (PSCs) and use of the pain numerical rating scale (NRS) and visual analogue scale (VAS) in rheumatoid arthritis RCTs, to inform the efforts of HISTORIC to reach consensus on how to measure pain intensity in HS trials.
A search was conducted on several publication databases. Inclusion criteria were RCTs with a minimum of 10 participants that measured pain intensity.
Pain NRS and VAS were used in 68% of PSC trials. Respectively, 77% and 87% of PSC and rheumatoid arthritis RCTs did not specify the recall window. The commonest recall window in PSCs when specified was 24 h. In total, 33% of PSC trials assessed maximum pain intensity and 3% average pain intensity, while 87% of rheumatoid arthritis trials did not provide details. Pain data were reported as mean difference by 76% of PSC trials and 75% of rheumatoid arthritis trials. Respectively, 10% and 11% of PSC and rheumatoid arthritis studies reported pain as the percentage of patients reaching a desirable state and only 1% and 2% reported number needed to treat.
While pain NRS and VAS are standard methods to measure pain intensity in PSCs, key details such as the recall window are often omitted and there is no consensus on how to report pain NRS data. What is already known about this topic? Pain is the most burdensome symptom experienced by patients with hidradenitis suppurativa and has been prioritized as an outcome domain by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). What does this study add? Our review shows substantial variation in how pain numerical rating scale (NRS) and visual analogue scale are utilized in clinical trials. This variation restricts meta-analysis of pain intensity results. There is a need for consensus regarding the recall window for pain NRS and maximum vs. average pain, and whether current pain should be measured.
疼痛是患有化脓性汗腺炎（HS）的人群最常见和最困扰的症状，已被 Hidradenitis SuppuraTiva cORe outcomes set International Collaboration（HISTORIC）作为一个优先的结局领域。
对疼痛评估在随机对照试验（RCTs）中的应用进行范围界定综述，评估疼痛数字评分量表（NRS）和视觉模拟量表（VAS）在类风湿关节炎 RCTs 中的应用，并为 HISTORIC 努力达成共识提供信息，以确定如何在 HS 试验中测量疼痛强度。
在多个出版物数据库中进行了搜索。纳入标准为至少有 10 名参与者的 RCT，且需评估疼痛强度。
在 PSC 试验中，疼痛 NRS 和 VAS 的使用率分别为 68%和 77%。分别有 77%和 87%的 PSC 和类风湿关节炎 RCT 未指定回忆窗。在指定的情况下，PSC 中最常见的回忆窗是 24 小时。共有 33%的 PSC 试验评估了最大疼痛强度，3%评估了平均疼痛强度，而 87%的类风湿关节炎试验未提供详细信息。76%的 PSC 试验和 75%的类风湿关节炎试验报告疼痛数据为平均差异。分别有 10%和 11%的 PSC 和类风湿关节炎研究报告了达到理想状态的患者百分比，只有 1%和 2%报告了需要治疗的人数。
尽管疼痛 NRS 和 VAS 是评估 PSC 中疼痛强度的标准方法，但关键细节（如回忆窗）经常被忽略，并且如何报告疼痛 NRS 数据尚未达成共识。
关于这个主题已知的内容是什么？疼痛是化脓性汗腺炎患者最困扰的症状，已被 Hidradenitis SuppuraTiva cORe outcomes set International Collaboration（HISTORIC）作为一个优先的结局领域。
本研究增加了什么新内容？我们的综述表明，疼痛数字评分量表（NRS）和视觉模拟量表在临床试验中的应用存在很大差异。这种差异限制了疼痛强度结果的荟萃分析。需要就疼痛 NRS 的回忆窗、最大与平均疼痛以及当前疼痛是否需要测量达成共识。
