Lewin Simon, Glenton Claire, Oxman Andrew D
Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London WC1E 7HT.
BMJ. 2009 Sep 10;339:b3496. doi: 10.1136/bmj.b3496.
To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions.
Review of randomised controlled trials of interventions to change professional practice or the organisation of care.
Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group.
Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done.
30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable.
Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.
研究定性方法与复杂医疗保健干预随机试验同时使用的情况。
对旨在改变专业实践或护理组织方式的干预措施的随机对照试验进行综述。
从Cochrane有效实践与护理组织综述小组登记册中系统抽取100项以英文发表的试验。
通过数据库检索和与作者联系，确定与随机对照试验相关的已发表和未发表的定性研究。两名评审员使用标准表格从每项研究中提取数据。我们提取了描述随机对照试验和定性研究的数据、这些研究的质量，以及定性和定量研究结果（若有）是如何结合的。对研究结果进行了叙述性综合分析。
100项试验中有30项有相关的定性研究工作，其中19项为已发表研究。14项定性研究在试验前进行，9项在试验期间进行，4项在试验后进行。13项研究报告了明确的理论基础，11项明确了其方法学方法。抽样和数据分析方法的描述欠佳。在大多数情况下（n = 20），我们发现在分析或解释层面没有定性和定量研究结果整合的迹象。定性研究的质量差异很大。
即使在评估相对复杂的干预措施时，随机对照试验同时开展定性研究的情况仍然不常见。大多数定性研究是在试验前或试验期间进行的，很少有研究用于解释试验结果。定性研究的结果似乎与试验结果整合得很差，且往往存在重大的方法学缺陷。
