制定复杂干预措施实施研究报告标准(StaRI):一项系统评价和电子德尔菲法

Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi.

作者信息

Pinnock Hilary, Epiphaniou Eleni, Sheikh Aziz, Griffiths Chris, Eldridge Sandra, Craig Peter, Taylor Stephanie J C

机构信息

Asthma UK Centre for Applied Research, Allergy and Respiratory Research Group, Centre for Population Health Sciences, University of Edinburgh, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, Scotland, UK.

Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK.

出版信息

Implement Sci. 2015 Mar 30;10:42. doi: 10.1186/s13012-015-0235-z.

Abstract

BACKGROUND

Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other study types has been improved by the introduction of reporting standards (e.g. CONSORT). We are therefore developing guidelines for reporting implementation studies (StaRI).

METHODS

Using established methodology for developing health research reporting guidelines, we systematically reviewed the literature to generate items for a checklist of reporting standards. We then recruited an international, multidisciplinary panel for an e-Delphi consensus-building exercise which comprised an initial open round to revise/suggest a list of potential items for scoring in the subsequent two scoring rounds (scale 1 to 9). Consensus was defined a priori as 80% agreement with the priority scores of 7, 8, or 9.

RESULTS

We identified eight papers from the literature review from which we derived 36 potential items. We recruited 23 experts to the e-Delphi panel. Open round comments resulted in revisions, and 47 items went forward to the scoring rounds. Thirty-five items achieved consensus: 19 achieved 100% agreement. Prioritised items addressed the need to: provide an evidence-based justification for implementation; describe the setting, professional/service requirements, eligible population and intervention in detail; measure process and clinical outcomes at population level (using routine data); report impact on health care resources; describe local adaptations to the implementation strategy and describe barriers/facilitators. Over-arching themes from the free-text comments included balancing the need for detailed descriptions of interventions with publishing constraints, addressing the dual aims of reporting on the process of implementation and effectiveness of the intervention and monitoring fidelity to an intervention whilst encouraging adaptation to suit diverse local contexts.

CONCLUSIONS

We have identified priority items for reporting implementation studies and key issues for further discussion. An international, multidisciplinary workshop, where participants will debate the issues raised, clarify specific items and develop StaRI standards that fit within the suite of EQUATOR reporting guidelines, is planned.

REGISTRATION

The protocol is registered with Equator: http://www.equator-network.org/library/reporting-guidelines-under-development/#17 .

摘要

背景

目前,实施研究报告质量参差不齐,阻碍了医疗保健干预措施的推广和实施。通过引入报告标准(如CONSORT),其他研究类型的报告质量得到了提高。因此,我们正在制定实施研究报告指南(StaRI)。

方法

我们采用既定的卫生研究报告指南制定方法,系统回顾文献以生成报告标准清单项目。然后,我们招募了一个国际多学科专家小组进行电子德尔菲共识构建活动,该活动包括一个初始开放轮次,以修订/建议在随后两轮评分中进行评分的潜在项目清单(1至9分制)。事先将共识定义为80%的人同意7、8或9分的优先分数。

结果

我们从文献综述中确定了8篇论文,从中得出36个潜在项目。我们招募了23名专家加入电子德尔菲小组。开放轮次的评论导致了修订,47个项目进入评分轮次。35个项目达成了共识:19个项目达成了100%的一致。优先项目满足了以下需求:为实施提供基于证据的理由;详细描述背景、专业/服务要求、合格人群和干预措施;在人群层面测量过程和临床结果(使用常规数据);报告对医疗保健资源的影响;描述对实施策略的本地调整,并描述障碍/促进因素。自由文本评论中的总体主题包括在满足干预措施详细描述需求与出版限制之间取得平衡,解决报告实施过程和干预措施有效性以及监测干预措施保真度的双重目标,同时鼓励进行调整以适应不同的本地情况。

结论

我们确定了实施研究报告的优先项目以及有待进一步讨论的关键问题。计划举办一次国际多学科研讨会,参与者将在会上讨论提出的问题、澄清具体项目并制定符合EQUATOR报告指南套件的StaRI标准。

注册情况

该方案已在Equator注册:http://www.equator-network.org/library/reporting-guidelines-under-development/#17

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/493c/4393562/3c1d46a52388/13012_2015_235_Fig1_HTML.jpg

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