A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain.
A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain.
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DOI：
10.1186/1472-6882-14-16
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发表时间：
2014-01-13
影响因子：
--
通讯作者：
Polissar N
中科院分区：
文献类型：
--
作者：
Haas M;Vavrek D;Neradilek MB;Polissar N
医患接触（DPE）和相关的患者期望是治疗效果的开放标签随机试验中的潜在混杂因素。因此，评估 DPE 对研究结果的影响非常重要。 400 名患有慢性腰痛 (LBP) 的参与者被随机分为四个剂量组：由脊椎按摩师进行 0、6、12 或 18 次脊柱推拿治疗。参与者每周接受三次治疗，持续六周。当未安排按摩时，他们在就诊时接受轻度按摩控制。治疗脊椎按摩师被要求对两种干预措施抱有同样的热情。进行路径分析以确定剂量、患者对治疗成功的期望和 DPE 对护理结束时（6 周）和主要终点（12 周）的 LBP 强度（100 分制）的影响。计算直接、间接和总标准化效应（βtotal）。期望和 DPE 采用李克特量表进行评估。 DPE 的评估是患者对脊椎按摩师的热情、信心、护理舒适度和花费时间的评价。 DPE 成功地实现了跨组平衡，基线预期也是如此。主要发现是，DPE 在 6 周和 12 周时对 LBP 的影响程度（|β|total = 0.22 和 0.15，p < .05）与当时操作剂量的影响相当（|β|total = 0.11 和 0.12，p< .05）。此外，基线预期对后续腰痛没有显着影响。随后的预期受到 LBP、DPE 和剂量的影响 (p< .05)。 DPE 可以对治疗效果的开放标签随机试验的结果产生相对重要的影响。因此，应尝试平衡治疗组之间的 DPE，并在研究出版物中报告成功程度。我们通过对治疗提供者进行最少的培训来平衡各组的 DPE。 ClinicalTrials.gov NCT00376350
The doctor-patient encounter (DPE) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy. It is therefore important to evaluate the effects of the DPE on study outcomes. Four hundred participants with chronic low back pain (LBP) were randomized to four dose groups: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for six weeks. They received light massage control at visits when manipulation was not scheduled. Treating chiropractors were instructed to have equal enthusiasm for both interventions. A path analysis was conducted to determine the effects of dose, patient expectations of treatment success, and DPE on LBP intensity (100-point scale) at the end of care (6 weeks) and primary endpoint (12 weeks). Direct, indirect, and total standardized effects (βtotal) were computed. Expectations and DPE were evaluated on Likert scales. The DPE was assessed as patient-rated perception of chiropractor enthusiasm, confidence, comfort with care, and time spent. The DPE was successfully balanced across groups, as were baseline expectations. The principal finding was that the magnitude of the effects of DPE on LBP at 6 and 12 weeks (|β|total = 0.22 and 0.15, p < .05) were comparable to the effects of dose of manipulation at those times (|β|total = 0.11 and 0.12, p < .05). In addition, baseline expectations had no notable effect on follow-up LBP. Subsequent expectations were affected by LBP, DPE, and dose (p < .05). The DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy. Therefore, attempts should be made to balance the DPE across treatment groups and report degree of success in study publications. We balanced the DPE across groups with minimal training of treatment providers. ClinicalTrials.gov NCT00376350
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影响因子：
--
作者：
Cherkin, Daniel C.;Sherman, Karen J.;Avins, Andrew L.;Erro, Janet H.;Ichikawa, Laura;Barlow, William E.;Delaney, Kristin;Hawkes, Rene;Hamilton, Luisa;Pressman, Alice;Khalsa, Partap S.;Deyo, Richard A.
通讯作者：
Deyo, Richard A.
影响因子：
3
作者：
Furlan, Andrea D.;Pennick, Victoria;van Tulder, Maurits
通讯作者：
van Tulder, Maurits
DOI：
10.1093/rheumatology/16.1.34
发表时间：
1977-01-01
期刊：
RHEUMATOLOGY AND REHABILITATION
影响因子：
--
作者：
ANDERSON, JAD
通讯作者：
ANDERSON, JAD
DOI：
10.1016/0197-2456(94)00031-w
发表时间：
1995-02-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
MOHER, D;JADAD, AR;WALSH, S
通讯作者：
WALSH, S
影响因子：
7.4
作者：
Farrar, JT;Young, JP;Poole, RM
通讯作者：
Poole, RM