School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland.
BMC Med Res Methodol. 2021 Jan 7;21(1):10. doi: 10.1186/s12874-020-01197-3.
As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques.
Semi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point rating scale for rating the importance of the list of preliminary outcomes.
Four of the eight patient interview derived outcomes were included in the preliminary COS, however, none of these outcomes were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale.
Using patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature did not appear to influence outcome selection in developing the COS in this study. The use of different rating scales in a Delphi survey, however, did appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is warranted.
随着核心结局集（COS）的发展，制定和报告高质量 COS 的指导不断发展；然而，仍存在许多方法学上的不确定性。本研究的目的是：（1）探讨在制定 COS 时纳入患者访谈的影响，（2）检查在 Delphi 共识方法中使用 5 分制与 9 分制对结果选择的影响，以及（3）通过推进 COS 制定技术的证据基础，为 COS 制定方法学提供信息和贡献。
作为骨盆带疼痛核心结局集项目（PGP-COS）的一部分，采用半结构式患者访谈和嵌套随机对照平行组试验。患者访谈是在对先前研究中报告的结果进行系统回顾的基础上进行的，目的是确定纳入 Delphi 共识调查的初步结果。在 Delphi 调查中，参与者被随机（1:1）分配到 5 分制或 9 分制，用于对初步结果清单的重要性进行评分。
从 8 个患者访谈中得出的 4 个结果被纳入初步 COS，但这些结果都没有被纳入最终的 PGP-COS。在 3 轮 Delphi 调查后，5 分制导致的达到共识的结果数量是 9 分制的两倍。使用 5 分制的参与者对最终 PGP-COS 中纳入的所有 5 个结果均达成共识，而使用 9 分制的参与者对其中 4 个结果达成共识。
在本研究中，使用患者访谈来确定初步结果，作为对文献中测量的结果进行系统回顾的辅助手段，似乎并没有影响 COS 的制定。然而，在 Delphi 调查中使用不同的评分量表确实会影响结果的选择。5 分制与最终 PGP-COS 中纳入的结果之间的一致性大于 9 分制。未来的研究需要证实我们的发现，并探索其他评分量表对 COS 制定过程中结果选择的影响。
