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Use of a single global assessment to reduce missing data in a clinical trial with follow-up at one year.

机译:在一年的随访中,使用一项全球评估来减少临床试验中丢失的数据。

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We conducted a randomized controlled trial (ISRCTN96537534) to assess the effects of acupuncture on migraine and chronic tension headache. Patients (n=401) completed a diary of headache severity four times a day for 4 weeks at baseline, immediately following a 3-month treatment period and 1 year after randomization. During the trial, it appeared that dropout might be higher than expected. We therefore obtained a rapid global assessment of headache from participants to aid imputation of missing data. Patients were contacted by telephone and asked to rate current and baseline headache on a 0-10 scale. Use of global assessment reduced the number of patients from whom we obtained no follow-up headache data from 69 (17%) to 24 (6%). Analysis of patients who provided both a diary and a global assessment demonstrated excellent properties of global assessment, with very similar results to the full diary. We therefore used the global assessment to help impute missing 1-year diary scores. Rapid global assessmentcan be easily implemented in any trial and aids imputation of missing data, though it should not be used instead of more intensive methods of assessment. Further research might usefully examine the value of global assessment for imputation of missing data in a variety of different settings.
机译:我们进行了一项随机对照试验(ISRCTN96537534),以评估针灸对偏头痛和慢性紧张性头痛的影响。患者(n = 401)在治疗3个月后和随机分组后1年立即每天基线完成4次头痛头痛日记,连续4周。在试验过程中,辍学率似乎比预期的要高。因此,我们从参与者那里获得了快速的全球头痛评估,以帮助估算丢失的数据。通过电话与患者联系,并要求以0-10的等级对当前和基线头痛进行评估。全球评估的使用将我们没有获得随访头痛数据的患者人数从69(17%)减少到24(6%)。对既提供日记又提供整体评估的患者的分析表明,整体评估具有出色的性能,其结果与完整日记非常相似。因此,我们使用全局评估来帮助估算缺失的1年日记成绩。快速全球评估可以在任何试验中轻松实现,并有助于估算缺失的数据,尽管不应该使用它来代替更密集的评估方法。进一步的研究可能会有用地检查全局评估在各种不同情况下估算缺失数据的价值。

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