The CORALIE study: improving patient education to help new users better understand their oral contraceptive

Abstract

Objectives: Combined oral contraceptives (COCs) are the most widely used contraceptive method in Europe. Paradoxically, rates of unintended pregnancy and abortion are still remarkably high. A lack of knowledge about COCs is often reported to lead to poor adherence, suggesting an unmet need for adequate contraceptive counselling. Our objective was to investigate the impact on the knowledge level of users of a structured approach to deliver contraceptive information for a first COC prescription.

Methods: The Oral Contraception Project to Optimise Patient Information (CORALIE) is a multicentre, prospective, randomised study conducted in France between March 2009 and January 2013. The intervention involved providing either an ‘essential information’ checklist or unstructured counselling to new COC users. The outcome measure was a questionnaire that assessed whether the information provided to the new user by the gynaecologist had been correctly understood.

Results: One hundred gynaecologists and an expert committee used the Delphi method to develop an ‘essential information’ checklist, after which 161 gynaecologists were randomised to two groups. Group I (n = 81) used the checklist with 324 new COC users and group II (n = 80) delivered unstructured information to 307 new COC users. The average score for understanding the information delivered during the visit was significantly higher in women in group I than in the women in group II, even after adjustment for age and previous history of pregnancy: 16.48/20 vs 14.27/20 (p < 0.0001).

Conclusion: Delivering structured information for a first COC prescription is beneficial for understanding contraception. Our tool could ultimately contribute to increased adherence and should be investigated in a prospective study of long-term outcomes.

Chinese abstract

目的: 复方口服避孕药（COCs）是欧洲使用最广泛的避孕方法。奇怪的是, 意外妊娠率和流产率仍然很高。报道常认为对COC知识的缺乏导致使用者依从性差, 表明充分的避孕咨询需求尚未得到满足。我们的目的是调查第一次开COC处方时提供避孕信息的结构化方法对使用者知识水平的影响。

方法: 优化患者信息的口服避孕项目（CORALIE）是2009年3月到2013年1月在法国进行的一项多中心、前瞻性的随机研究。干预措施为新的COC使用者提供一个基本信息的清单或非结构化咨询。测量结果是一份问卷, 评估由妇产科医生提供给新用户的信息是否被正确理解。

结果: 100名妇产科医生和一个专家委员会采用德尔菲法建立一个基本信息的清单, 此后, 161名妇产科医生随机被分为两组。组I（n=81）对324名新的COC使用者采用清单法, 组II（n=80）向307名新的COC使用者提供非结构化信息。在随访期间传递的对信息理解的平均分组I仍明显高于组II, 即使矫正年龄及妊娠史因素以后差异仍存在: 16.48/20 VS14.27/20（P＜0.0001）。

结论: 第一次开COC处方时提供结构化信息有利于了解避孕知识。我们的工具最终可能有助于增加患者的依从性, 应对其长期结果进行前瞻性研究调查。

Keywords:

• Adherence
• combined oral contraceptives
• counselling
• patient information

Acknowledgements

The manuscript was prepared with writing and editorial assistance from Jean-Louis Carsol, PhD, Racquel N. Cooper, PhD, Tristan Blundell and Daniel Loniewski, MD, all employed by ‘Publicis Life Brands International’.

Disclosure statement

Pia de Reilhac, Geneviève Plu Bureau, David Serfaty, Jean Gondry and Sophie Christin-Maitre report that they have no conflicts of interest. Brigitte Letombe has been lecturer for Conceptus and EFFIK.