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基层医疗中腰痛的单页患者情况说明书:一项随机临床试验。

One-Page Patient Fact Sheets for Low Back Pain in Primary Care: A Randomized Clinical Trial.

作者信息

Longtin Christian, Chang Jeremy R, Hersch Jolyn, Sharma Sweekriti, Ferraro Michael C, Rizzo Rodrigo R N, McBride Jennifer, Wong Arnold Y L, Maher Chris G, Guppy Michelle, McAuley James H, Traeger Adrian C

机构信息

School of Rehabilitation, University of Sherbrooke, Sherbrooke, Quebec, Canada.

Institute for Musculoskeletal Health, Sydney Local Health District, New South Wales, Australia.

出版信息

JAMA Netw Open. 2025 Jul 1;8(7):e2523352. doi: 10.1001/jamanetworkopen.2025.23352.

DOI:10.1001/jamanetworkopen.2025.23352
PMID:40674046
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12272283/
Abstract

IMPORTANCE

Supporting informed decision-making is a fundamental aspect of primary care for low back pain. Two alternative approaches are providing fact sheets that list information about managing back pain or fact sheets that give advice on how to self-manage back pain, the comparative effects of which are unknown.

OBJECTIVE

To determine the effects of 1-page fact sheets on patient-reported preparedness for shared decision-making among people with low back pain.

DESIGN, SETTING, AND PARTICIPANTS: This 2-group parallel randomized clinical trial recruited 1080 adults from April 1, 2023, to April 30, 2024, who had recently seen their physician for uncomplicated low back pain. Participants were randomized to receive 1 of 2 one-page fact sheets. Outcomes were collected immediately after reading the fact sheet.

INTERVENTIONS

The information sheet was a 1-page fact sheet from a reputable medical journal and listed guideline-recommended management options. The advice sheet was a 1-page fact sheet from a recent clinical care standard and provided advice on how to self-manage low back pain.

MAIN OUTCOMES AND MEASURES

The primary outcome was patient-reported preparedness for decision-making, measured by the 100-point Preparation for Decision Making scale (where higher scores indicated higher preparedness for decision-making). Secondary outcomes included intentions for guideline-recommended interventions (staying active, physical therapies, and heat application) and nonrecommended interventions (imaging and opioid medicines). Analysis was performed on an intent-to-treat basis.

RESULTS

The total study sample included 1080 patients (mean [SD] age, 51.9 [14.7] years; 764 women [70.7%]). After reading the fact sheet, mean (SD) scores for preparation for decision-making were 57.6 (26.5) in the information sheet group and 52.9 (26.2) in the advice sheet group (adjusted mean difference, 4.7 points; 95% CI, 1.0-8.5 points; P = .01). A larger effect was observed among participants with chronic low back pain (mean [SD], 58.3 [28.9] points with information sheet vs 51.9 [28.4] points with advice sheet; adjusted mean difference, 6.4 points; 95% CI, 1.7-11.0 points; P = .007) compared with those with acute low back pain (mean [SD], 57.8 [26.0] points with information sheet vs 56.6 [29.2] points with advice sheet; adjusted mean difference, 1.2 points; 95% CI, -4.9 to 7.4 points; P = .70). There were no significant between-group differences in intentions to use guideline-recommended or nonrecommended interventions.

CONCLUSION AND RELEVANCE

In this randomized clinical trial among people who had recently seen their physician for uncomplicated low back pain, an information sheet listing management options was more effective than an advice sheet at preparing patients for shared decision-making. It is uncertain whether this effect is meaningful.

TRIAL REGISTRATION

http://anzctr.org.au Identifier: ACTRN12623000603617.

摘要

重要性

支持明智的决策是腰痛初级护理的一个基本方面。两种替代方法是提供列出腰痛管理信息的情况说明书,或提供关于如何自我管理腰痛建议的情况说明书,其比较效果尚不清楚。

目的

确定单页情况说明书对腰痛患者报告的共同决策准备情况的影响。

设计、设置和参与者:这项两组平行随机临床试验于2023年4月1日至2024年4月30日招募了1080名成年人,他们最近因单纯性腰痛看过医生。参与者被随机分配接受两种单页情况说明书中的一种。在阅读情况说明书后立即收集结果。

干预措施

信息说明书是一份来自著名医学杂志的单页情况说明书,列出了指南推荐的管理选项。建议说明书是一份来自近期临床护理标准的单页情况说明书,提供了如何自我管理腰痛的建议。

主要结果和测量指标

主要结果是患者报告的决策准备情况,通过100分的决策准备量表测量(分数越高表明决策准备程度越高)。次要结果包括指南推荐干预措施(保持活动、物理治疗和热敷)和不推荐干预措施(影像学检查和阿片类药物)的意向。分析采用意向性分析。

结果

总研究样本包括1080名患者(平均[标准差]年龄,51.9[14.7]岁;764名女性[70.7%])。阅读情况说明书后,信息说明书组的决策准备平均(标准差)得分为57.6(26.5)分,建议说明书组为52.9(26.2)分(调整后平均差异,4.7分;95%置信区间[CI],1.0 - 8.5分;P = 0.01)。与急性腰痛患者相比,慢性腰痛患者中观察到更大的效果(信息说明书组平均[标准差]为58.3[28.9]分,建议说明书组为51.9[28.4]分;调整后平均差异,6.4分;95%CI,1.7 - 11.0分;P = 0.007)(信息说明书组急性腰痛患者平均[标准差]为57.8[26.0]分,建议说明书组为56.6[29.2]分;调整后平均差异,1.2分;95%CI,-4.9至7.4分;P = 0.70)。在使用指南推荐或不推荐干预措施的意向方面,两组之间没有显著差异。

结论和相关性

在这项针对近期因单纯性腰痛看过医生的人群的随机临床试验中,列出管理选项的信息说明书在让患者为共同决策做好准备方面比建议说明书更有效。尚不确定这种效果是否有意义。

试验注册

http://anzctr.org.au 标识符:ACTRN12623000603617

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acc9/12272283/e3fd0ef39a16/jamanetwopen-e2523352-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acc9/12272283/de76a0ae8315/jamanetwopen-e2523352-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acc9/12272283/e3fd0ef39a16/jamanetwopen-e2523352-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acc9/12272283/de76a0ae8315/jamanetwopen-e2523352-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acc9/12272283/e3fd0ef39a16/jamanetwopen-e2523352-g002.jpg

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本文引用的文献

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Patient-Directed Education to Promote Deprescribing: A Nonrandomized Clinical Trial.患者导向的药物减量教育:一项非随机临床试验。
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