Mapi Values, Adelphi Mill, Bollington, Macclesfield, Cheshire, UK.
Patient. 2011;4(4):227-40. doi: 10.2165/11595280-000000000-00000.
This review investigates whether the development and implementation of treatment satisfaction instruments during a product's lifecycle are informed by their purpose. A basic literature review was performed between 2000 and 2010 using electronic databases (PubMed, PsycINFO®, and EMBASE) and the keywords 'satisfaction' and 'questionnaire' and 'medication' or 'drug'. Relevant articles were reviewed to extract the following information: type of study; study objectives; treatment satisfaction instrument used; clinical condition/indication; purpose of instrument; development of instrument; association of satisfaction with other endpoint measures; and main results and conclusions. Of 875 abstracts, 80 articles were further considered. Treatment satisfaction instruments were most commonly used in observational studies and interventional clinical trials. The review indicated similarities regarding the development and validation of satisfaction instruments, such as using patient input to derive the items and exploring classical measurement properties specific to the target population. Although some differences were apparent between instruments intended for use in clinical trials and clinical practice (e.g. the approaches used to enable the interpretation of satisfaction scores), the specificities of the implementation of treatment satisfaction during a product's lifecycle were rarely considered. By 'keeping the end in mind', data from treatment satisfaction instruments can help at three key stages: (i) product access to market: generating evidence as part of an overall value proposition to facilitate product reimbursement at a national level; (ii) market access to product: making the product available at a local level (e.g. local hospital formularies); and (iii) clinical practice: enhancing market penetration and product expansion after launch, and demonstrating value for prescribers. Furthermore, the development, validation, and interpretation of scores from treatment satisfaction instruments should be sensitive to the intended purpose. By considering the stage in the product lifecycle when an instrument is to be used, treatment satisfaction instruments can be developed with the specific research purpose and target audience in mind - whether it be patients, payers, or prescribers. In the future, treatment satisfaction instruments will become increasingly important for informing decisions at the individual level, giving patients a voice towards their overall management and care, and enhancing the relationship between doctor and patient.
本综述探讨了治疗满意度工具在产品生命周期中的开发和实施是否与其目的相关。在 2000 年至 2010 年期间，我们使用电子数据库（PubMed、PsycINFO®和 EMBASE）和关键词“满意度”和“问卷”和“药物”或“药物”进行了基本文献综述。回顾了相关文章，以提取以下信息：研究类型；研究目标；使用的治疗满意度工具；临床情况/适应症；工具的目的；工具的开发；满意度与其他终点测量的关联；以及主要结果和结论。在 875 篇摘要中，进一步考虑了 80 篇文章。治疗满意度工具最常用于观察性研究和干预性临床试验。该综述表明，满意度工具的开发和验证存在相似之处，例如使用患者的投入来得出项目，并探索针对目标人群的特定经典测量特性。尽管临床试验和临床实践中使用的满意度工具之间存在一些差异（例如，用于解释满意度评分的方法），但在产品生命周期中实施治疗满意度的特殊性很少被考虑。通过“牢记目标”，治疗满意度工具的数据可以在三个关键阶段提供帮助：（i）产品进入市场：作为整体价值主张的一部分生成证据，以促进国家层面的产品报销；（ii）产品进入市场：在当地层面提供产品（例如，当地医院处方集）；（iii）临床实践：提高上市后的市场渗透率和产品扩张，并为处方医生展示价值。此外，治疗满意度工具的开发、验证和评分解释应考虑到其预期目的。通过考虑在产品生命周期中使用工具的阶段，可以根据特定的研究目的和目标受众开发治疗满意度工具——无论是患者、支付者还是处方医生。在未来，治疗满意度工具将在为个人层面的决策提供信息方面变得越来越重要，让患者对其整体管理和护理有发言权，并加强医患关系。
