Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg)

NCT05123846 | Recruiting

• 1 other identifier: KCL Asset 10 and 11
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Existing evidence has shown that medical affairs pharmaceutical physicians (MAPPs), are a core function within the pharmaceutical industry. Despite their expertise, there are ongoing concerns about recognition and respect for the MAPP's role within the pharmaceutical industry. Anecdotal evidence further suggests that this lack of recognition and respect for the valuable contribution of this specialised group of medical doctors may impact their quality of life, resulting in stress, anxiety, depression and occupational burnout. Hence, participants are likely to use NHS services as patients, when experiencing the physical, mental, and emotional issues associated with occupational burnout, an internationally recognised condition (ICD-11 code QD85) resulting from chronic occupational stress. This observational study will recruit participants to contribute data to creating a MAPP work-related participant-reported outcome measure on the impact of work-related performance on quality of life (QoL). The created MAPP work-related participant-reported measure will be used longitudinally with study participants to measure their QoL monthly for 12 months. In total, up to 180 Medical Affairs Pharmaceutical Physicians are expected to be recruited to the study. The study will be conducted in two main phases, involving three online surveys.

Conditions

Quality of Life

Keywords

Quality of Life; Jandhyala Method; Medical Affairs; Occupational burnout; Stress; Anxiety

Outcome Measures

Primary Outcomes (2)

• Development and validation of MAPPWrQoL instrument.

  The design and creation of a work-related quality of life measure to be self-administered by medical affairs pharmaceutical physicians.

  3 months.

• A prospective MAPPWrQoL patient registry.

  Implementation of the developed MAPPWrQoL instrument as the core dataset in the associated patient registry (MAPPWrQoLReg).

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant are medical affairs pharmaceutical physicians, with pharmaceutical industry-based work experience.

You may qualify if:

• Phase one and Phase two: Participants will be eligible to take part in Phase One based on the following criteria:
• Qualification as a Medical Affairs Pharmaceutical Physician (qualified by medical degree).
• Previous or current work experience within a pharmaceutical company (industry-based).
• The participant can provide informed consent.
• The participant can read, write, and converse in English.
• The participant can comply with the study schedule.
• years and above.

You may not qualify if:

• Non-industry based Medical Affairs Pharmaceutical Physicians
• Not able to comply with the study schedule
• Not able to read, write, and converse in English.

Sponsors & Collaborators

• Medialis Ltd.: lead

Study Sites (1)

Medialis

Oxford, OX16 0AH, United Kingdom

RECRUITING

Related Publications (1)

• Jandhyala R. Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument. Curr Med Res Opin. 2023 Dec;39(12):1567-1574. doi: 10.1080/03007995.2023.2174747. Epub 2023 Feb 8.

  PMID: 36719367 DERIVED

Related Links

• Publication
• Publication

MeSH Terms

Conditions

Burnout, Professional; Anxiety Disorders

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Ravi Jandhyala

  Medialis Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omolade Femi-Ajao, PhD

CONTACT

+447502228066; research@medialis.co.uk

Ravi Jandhyala

CONTACT

+447717 448656; ravi@medialis.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 3, 2021
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

GB (1)