Schreijenberg M, Luijsterburg P A J, Van Trier Y D M, Rizopoulos D, Koopmanschap M A, Voogt L, Maher C G, Koes B W
Department of General Practice, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands.
Department of Biostatistics, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands.
BMC Musculoskelet Disord. 2018 May 14;19(1):146. doi: 10.1186/s12891-018-2063-1.
The PACE Plus trial was a multi-center, double-blinded, superiority randomized controlled trial (RCT) conducted in patients from Dutch general practice to investigate the efficacy of paracetamol and NSAIDs in acute non-specific low back pain (LBP). Because insufficient numbers of patients could be recruited (only four out of the required 800 patients could be recruited over a period of 6 months), the trial was prematurely terminated in February 2017, 6 months after the start of recruitment. This article aims to transparently communicate the discontinuation of PACE Plus and to make recommendations for future studies.
General Practitioners (GPs) from 36 participating practices received a one-question survey in which they were asked to give the three most important factors that in their opinion contributed to failure of patient recruitment.
GPs of 33 out of 36 (92%) participating practices sent a response. A total of 81 factors were reported. These have been categorized into patient factors (26 out of 81 comments, 32%), GP factors (39 out of 81 comments, 48%) and research factors (16 out of 81 comments, 20%).
Patient recruitment in the PACE Plus trial may have failed due to inefficient medication distribution, recruitment of incident rather than prevalent cases, a design that was too complicated, adequate self-management of LBP, patient expectations different from the trial's scope and lack of time of participating GPs. Substantial differences in design may explain why the preceding PACE trial did manage to successfully complete patient recruitment.
Although the PACE Plus trial was terminated as a result of insufficient patient inclusion, the research questions addressed in this trial remain relevant but unanswered. We hope that lessons learned from the discontinuation of PACE Plus and corresponding recommendations may be helpful in the design of upcoming research projects in LBP in general practice.
Dutch Trial Registration NTR6089, registered September 14th 2016.
PACE Plus试验是一项多中心、双盲、优效性随机对照试验（RCT），在荷兰全科医疗的患者中开展，旨在研究对乙酰氨基酚和非甾体抗炎药治疗急性非特异性腰痛（LBP）的疗效。由于招募的患者数量不足（在6个月的时间里，仅招募到了所需800名患者中的4名），该试验于2017年2月提前终止，即招募开始6个月后。本文旨在透明地传达PACE Plus试验的终止情况，并为未来研究提出建议。
来自36个参与诊所的全科医生（GPs）收到了一份单问题调查问卷，要求他们给出认为导致患者招募失败的三个最重要因素。
36个参与诊所中的33个（92%）的全科医生回复了问卷。共报告了81个因素。这些因素被分为患者因素（81条评论中的26条，32%）、全科医生因素（81条评论中的39条，48%）和研究因素（81条评论中的16条，20%）。
PACE Plus试验中的患者招募失败可能是由于药物分发效率低下、招募新发病例而非现患病例、设计过于复杂、腰痛的充分自我管理、患者期望与试验范围不同以及参与的全科医生时间不足。设计上的显著差异可能解释了之前的PACE试验为何能够成功完成患者招募。
尽管PACE Plus试验因纳入患者不足而终止，但该试验所涉及的研究问题仍然相关但未得到解答。我们希望从PACE Plus试验的终止中吸取的经验教训及相应建议，可能有助于设计未来全科医疗中腰痛的研究项目。
荷兰试验注册NTR6089，于2016年9月14日注册
