Jandhyala Ravi
Medialis Ltd, Wolverton Mill, Milton Keynes, England, UK.
Centre for Pharmaceutical Medicine Research, King's College University, London, UK.
Curr Med Res Opin. 2023 Dec;39(12):1567-1574. doi: 10.1080/03007995.2023.2174747. Epub 2023 Feb 8.
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 ( = 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 ( = .003; = 6 questions). Chi-squared analysis showed a significant difference between MAPPs' and non-MAPPs' ability to answer MAPPWRQoL instrument items ( = .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.
医学事务制药医师（MAPPs）面临工作相关生活质量（WRQoL）较低的风险。本研究的目的是开发、验证并实施首个针对该人群的WRQoL工具。
一项前瞻性观察性队列临床研究，即医学事务制药医师工作相关生活质量（MAPPWrQoL）工具开发与患者登记研究（MAPPWrQoLReg），于2021年11月注册（NCT05123846）。2021年12月至2022年1月期间，13名MAPPs和12名非MAPPs参与了开发和验证。开发过程采用詹迪亚拉方法观察比例组意识和共识。判别效度分析以WRQoL量表作为参考标准，评估该工具能否区分不同组。从2022年2月起，12名MAPPs和12名非MAPPs每月在登记处自我报告他们的WRQoL。招募和数据收集正在进行；此处报告2022年2月至2022年8月期间的6个月数据。
两名参与者被排除在登记之外。卡方分析显示MAPPWRQoL工具与WRQoL量表之间存在显著差异（=1.029e-08），敏感性（89.19%）和特异性（75.00%）均可接受。每次随访时总分的组间差异均显著（=0.003；=6个问题）。卡方分析显示MAPPs和非MAPPs回答MAPPWRQoL工具项目的能力存在显著差异（=0.002629），敏感性（91.9%）可接受，特异性（66.7%）接近可接受。MAPPs的WRQoL在6个月内没有显著变化。
39项MAPPWRQoL工具的判别效度得到证实。詹迪亚拉方法成功开发并验证了一种特定的WRQoL工具，可应用于类似人群，如初级医生和英国全科医生。
