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

Abstract

Background 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. Methods 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. Results Two participants were excluded from the registry. Chi-squared analysis showed a significant difference between the MAPPWRQoL instrument and WRQoL Scale (p = 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 (p = .003; n = 6 questions). Chi-squared analysis showed a significant difference between MAPPs’ and non-MAPPs’ ability to answer MAPPWRQoL instrument items (p = .002629), with acceptable sensitivity (91.9%) and near-acceptable specificity (66.7%). MAPPs’ WRQoL did not change significantly over 6 months. Conclusion 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.