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评价案例报告中呈现的改良 Naranjo 标准,以评估临床结局归因于顺势疗法干预的因果关系。

Evaluation of the Modified Naranjo Criteria for Assessing Causal Attribution of Clinical Outcome to Homeopathic Intervention as Presented in Case Reports.

机构信息

Central Council for Research in Homoeopathy, New Delhi, India.

Scientific Advisory Board, Central Council for Research in Homoeopathy, New Delhi, India.

出版信息

Homeopathy. 2020 Nov;109(4):191-197. doi: 10.1055/s-0040-1701251. Epub 2020 Mar 25.

DOI:10.1055/s-0040-1701251
PMID:32215892
Abstract

OBJECTIVES

The objective of this study was to establish the reliability and content validity of the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory" as a tool for attributing a causal relationship between the homeopathic intervention and outcome in clinical case reports.

METHODS

Purposive sampling was adopted for the selection of information-rich case reports using pre-defined criteria. Eligible case reports had to fulfil a minimum of nine items of the CARE Clinical Case Reporting Guideline checklist and a minimum of three of the homeopathic HOM-CASE CARE extension items. The Modified Naranjo Criteria for Homeopathy Inventory consists of 10 domains. Inter-rater agreement in the scoring of these domains was determined by calculating the percentage agreement and kappa (κ) values. A κ greater than 0.4, indicating fair agreement between raters, in conjunction with the absence of concerns regarding the face validity, was taken to indicate the validity of a given domain. Each domain was assessed by four raters for the selected case reports.

RESULTS

Sixty case reports met the inclusion criteria. Inter-rater agreement/concordance per domain was "perfect" for domains 1 (100%, κ = 1.00) and 2 (100%, κ = 1.00); "almost perfect" for domain 8 (97.5%, κ = 0.86); "substantial" for domains 3 (96.7%, κ = 0.80) and 5 (91.1%, κ = 0.70); "moderate" for domains 4 (83.3%, κ = 0.60), 7 (67.8%, κ = 0.46) and 9 (99.2%, κ = 0.50); and "fair" for domain 10 (56.1%, κ = 0.38). For domains 6A (46.7%, κ = 0.03) and 6B (50.3%, κ = 0.18), there was "slight agreement" only. Thus, the validity of the Modified Naranjo Criteria for Homeopathy tool was established for each of its domains, except for the two that pertain to direction of cure (domains 6A and 6B).

CONCLUSION

The MO: dified NAR: anjo C: riteria for H: omeopathy-Causal Attribution Inventory was identified as a valid tool for assessing the likelihood of a causal relationship between a homeopathic intervention and clinical outcome. Improved wordings for several criteria have been proposed for the assessment tool, under the new acronym "MONARCH". Further assessment of two MONARCH domains is required.

摘要

目的

本研究旨在确立“修正版顺势疗法因果归因量表”(以下简称“修正版 Naranjo 顺势疗法因果归因量表”)作为一种工具的可靠性和内容效度,用于归因于临床病例报告中顺势疗法干预与结局之间的因果关系。

方法

采用目的性抽样,根据预先设定的标准选择信息丰富的病例报告。合格的病例报告必须至少满足 CARE 临床病例报告指南检查表的 9 项标准和顺势疗法 HOM-CASE CARE 扩展项的 3 项标准。修正版 Naranjo 顺势疗法因果归因量表共包含 10 个领域。通过计算百分比一致性和κ(κ)值来确定这些领域评分的评分者间一致性。κ 值大于 0.4,表明评分者间存在适度一致,且不存在对表面效度的担忧,则表明该特定领域具有有效性。为选定的病例报告,每个领域由 4 名评分者进行评估。

结果

60 份病例报告符合纳入标准。每个领域的评分者间一致性/符合率为:领域 1(100%,κ=1.00)和 2(100%,κ=1.00)为“完美”;领域 8(97.5%,κ=0.86)为“几乎完美”;领域 3(96.7%,κ=0.80)和 5(91.1%,κ=0.70)为“显著”;领域 4(83.3%,κ=0.60)、7(67.8%,κ=0.46)和 9(99.2%,κ=0.50)为“中度”;领域 10(56.1%,κ=0.38)为“尚可”。对于领域 6A(46.7%,κ=0.03)和 6B(50.3%,κ=0.18),仅存在“轻微一致”。因此,除了与治疗方向相关的两个领域(领域 6A 和 6B)之外,修正版 Naranjo 顺势疗法因果归因量表的每个领域的有效性均已确立。

结论

修正版 Naranjo 顺势疗法因果归因量表被确定为一种评估顺势疗法干预与临床结局之间因果关系可能性的有效工具。已经为评估工具提出了几个标准的改进措辞,缩写为“MONARCH”。需要进一步评估 MONARCH 的两个领域。

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