Oncology Centre, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
School for Public Health and Primary Care (CAPHRI) Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, The Netherlands.
BMC Med Inform Decis Mak. 2017 Aug 1;17(1):112. doi: 10.1186/s12911-017-0505-6.
A patient decision aid (PtDA) can support shared decision making (SDM) in preference-sensitive care, with more than one clinically applicable treatment option. The development of a PtDA is a complex process, involving several steps, such as designing, developing and testing the draft with all the stakeholders, known as alpha testing. This is followed by testing in 'real life' situations, known as beta testing, and then finalising the definite version. Our aim was developing and alpha testing a PtDA for primary treatment of early stage breast cancer, ensuring that the tool is considered relevant, valid and feasible by patients and professionals.
Our qualitative descriptive study applied various methods including face-to-face think-aloud interviews, a focus group and semi-structured telephone interviews. The study population consisted of breast cancer patients facing the choice between breast-conserving therapy with or without preceding neo-adjuvant chemotherapy and mastectomy, and professionals involved in breast cancer care in dedicated multidisciplinary breast cancer teams.
A PtDA was developed in four iterative test rounds, taking nearly 2 years, involving 26 patients and 26 professionals. While the research group initially opted for simplicity for the sake of implementation, the clinicians objected that the complexity of the decision could not be ignored. Other topics of concern were the conflicting views of professionals and patients regarding side effects, the amount of information and how to present it.
The development was an extensive process, because the professionals rejected the simplifications proposed by the research group. This resulted in the development of a completely new draft PtDA, which took double the expected time and resources. The final version of the PtDA appeared to be well-appreciated by professionals and patients, although its acceptability will only be proven in actual practice (beta testing).
NTR TC 5721 .
患者决策辅助工具（PtDA）可支持偏好敏感型医疗中具有多种临床适用治疗选择的共同决策（SDM）。PtDA 的开发是一个复杂的过程，涉及多个步骤，例如与所有利益相关者共同设计、开发和测试草案，即 alpha 测试。随后在“真实生活”情境中进行测试，称为 beta 测试，然后最终确定最终版本。我们的目标是开发一种用于早期乳腺癌初始治疗的 PtDA，并确保患者和专业人员认为该工具具有相关性、有效性和可行性。
我们的定性描述性研究应用了多种方法，包括面对面的出声思维访谈、焦点小组和半结构化电话访谈。研究人群包括面临选择保乳治疗加或不加新辅助化疗与乳房切除术的乳腺癌患者，以及参与专门的多学科乳腺癌团队中乳腺癌护理的专业人员。
经过近 2 年的 4 个迭代测试轮次，PtDA 得以开发，共涉及 26 名患者和 26 名专业人员。虽然研究小组最初出于实施的考虑选择了简单性，但临床医生认为不能忽视决策的复杂性。另一些关注的问题包括专业人员和患者对副作用、信息量和呈现方式的看法存在冲突。
由于专业人员反对研究小组提出的简化方案，因此开发过程非常广泛。这导致了一个全新的 PtDA 草案的开发，所花费的时间和资源是预期的两倍。尽管其可接受性将仅在实际实践（beta 测试）中得到证明，但最终版本的 PtDA 似乎受到专业人员和患者的好评。
NTR TC 5721。
