Koes B W, Bouter L M, Knipshild P G, Van Mameren H, Essers A, Houben J P, Verstegen G M, Hofhuizen D M
Department of Epidemiology and Biostatistics, University of Limburg, The Netherlands.
J Manipulative Physiol Ther. 1991 Nov-Dec;14(9):498-502.
There are strong arguments for publishing research protocols before the results are available. First, it permits a critical judgment of the design unbiased by knowledge of the results, and second it may prevent publication bias. We present the design of a randomized trial on the effectiveness of manual therapy, physiotherapy, (continued) treatment by the general practitioner and a placebo treatment for patients (n = 300) with chronic (more than 6 wk) nonspecific back and neck complaints. In designing this trial in close cooperation with manual therapists and physiotherapists, special attention has been given to inclusion and exclusion criteria, (blinded) outcome measurements and control (placebo) treatment(s). Outcome measures include severity of complaints rated by a blinded research assistant, global perceived effect assessed by the patient, pain severity, functional status, range of motion (ROM) of the spine and recurrence. Measurements are carried out at baseline and after 3 wk, 6 wk, 3 months, 6 months and 1 yr.
在研究结果出来之前发表研究方案有充分的理由。首先，这样可以在不受结果影响的情况下对研究设计进行批判性评估，其次，这可能会防止发表偏倚。我们展示了一项关于手法治疗、物理治疗、全科医生治疗以及安慰剂治疗对300例患有慢性（超过6周）非特异性颈背痛患者有效性的随机试验设计。在与手法治疗师和物理治疗师密切合作设计该试验时，特别关注了纳入和排除标准、（盲法）结局测量以及对照（安慰剂）治疗。结局测量包括由盲法研究助理评定的症状严重程度、患者评估的总体感知效果、疼痛严重程度、功能状态、脊柱活动范围（ROM）以及复发情况。测量在基线时以及3周、6周、3个月、6个月和1年后进行。
