Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument

Medical affairs pharmaceutical physicians (MAPPs) are at risk for low work-related quality of life (WRQoL). The aim of this study was to develop, validate and implement the first WRQoL instrument for this population. A prospective observational cohort clinical study, the Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg), was registered in November 2021 (NCT05123846). Thirteen MAPPs and 12 non-MAPPs participated in development and validation between December 2021 and January 2022. Development used the Jandhyala method for observing proportional group awareness and consensus. Discriminant validity analysis used the WRQoL Scale as a reference standard and assessed whether the instrument could differentiate between the groups. Twelve MAPPs and 12 non-MAPPs self-reported their WRQoL in the registry each month from February 2022. Recruitment and data collection are ongoing; 6-month data between February 2022 and August 2022 are reported here. Two participants were excluded from the registry. Chi-squared analysis showed a significant difference between the MAPPWRQoL instrument and WRQoL Scale (<i>p</i> = 1.029e-08) with acceptable sensitivity (89.19%) and specificity (75.00%). There were significant between-group differences for total scores at each follow-up (<i>p</i> = .003; <i>n</i> = 6 questions). Chi-squared analysis showed a significant difference between MAPPs’ and non-MAPPs’ ability to answer MAPPWRQoL instrument items (<i>p</i> = .002629), with acceptable sensitivity (91.9%) and near-acceptable specificity (66.7%). MAPPs’ WRQoL did not change significantly over 6 months. Discriminant validity of the 39-item MAPPWRQoL instrument was confirmed. The Jandhyala method successfully developed and validated a specific WRQoL instrument and may be applied to similar populations, such as junior doctors and UK general practitioners.

医药事务医师（Medical Affairs Pharmaceutical Physicians, MAPPs）面临工作相关生活质量（Work-Related Quality of Life, WRQoL）低下的风险。本研究旨在为该人群开发、验证并推行首款工作相关生活质量评估工具。本研究为一项前瞻性观察队列临床研究，名为「医药事务医师工作相关生活质量（MAPPWrQoL）评估工具开发与受试者注册库（MAPPWrQoLReg）」，于2021年11月完成注册（登记号：NCT05123846）。2021年12月至2022年1月期间，共有13名医药事务医师与12名非医药事务医师参与了工具开发与验证工作。工具开发采用詹迪亚拉法（Jandhyala method）开展分组比例意识与共识性观察。区分效度分析以工作相关生活质量量表（WRQoL Scale）为参照标准，评估该工具能否对两组人群进行有效区分。2022年2月起，每月共有12名医药事务医师与12名非医药事务医师通过注册库自行报告其工作相关生活质量状况。目前招募与数据收集工作仍在进行中，本文报告2022年2月至8月的6个月随访数据。已有2名受试者被排除出注册库。卡方检验结果显示，MAPPWrQoL评估工具与WRQoL量表的评估结果存在显著差异（*p* = 1.029×10⁻⁸），且具有可接受的敏感度（89.19%）与特异度（75.00%）。各随访时间点的总分组间差异均具有统计学意义（*p* = 0.003；共纳入6个条目）。卡方检验结果显示，医药事务医师与非医药事务医师对MAPPWrQoL评估工具条目的作答能力存在显著差异（*p* = 0.002629），其敏感度为91.9%（可接受水平），特异度为66.7%（接近可接受水平）。6个月随访期内，医药事务医师的工作相关生活质量未发生显著变化。本研究证实了包含39个条目的MAPPWrQoL评估工具具有良好的区分效度。詹迪亚拉法可成功开发并验证针对性的工作相关生活质量评估工具，该方法亦可推广至类似人群，例如初级医师与英国全科医师。