Quality of LifeNCT05123846
Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg)
An observational study of Quality of Life, run by Medialis Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2021to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant are medical affairs pharmaceutical physicians, with pharmaceutical industry-based work experience.
Who may be able to join
- 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.
- 18 years and above.
Who cannot join
- Non-industry based Medical Affairs Pharmaceutical Physicians
- Not able to comply with the study schedule
- Not able to read, write, and converse in English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Medialis
Oxford, OX16 0AH
Ravi Jandhyala, 44(0)1744865, ravi@medialis.co.uk
About this study
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.
Read the detailed description
Phase One - the development of a MAPP work-related participant-reported quality of life (MAPPWrQoL) measure
The study will recruit between nine and 15 participants in this phase. Firstly, a novel method, the Jandhyala Method [16], will be used to elicit medical affairs pharmaceutical physicians' preferences for a QoL tool addressing work-related performance.
Below is the outline of activities to be completed during Phase One:
- Awareness Round survey (first survey, hosted on Survey Monkey) - asking for areas of their life which the participants feel have been impacted by work-related performance, including details and examples of those impacts.
- The research team will collate and code these responses and generate a list of statements based on the information provided by participants.
- Consensus Round survey (second survey, hosted on Survey Monkey) - the list of statements will be sent to participants. Participants will be asked to rate their agreement or disagreement with the inclusion of these areas in a MAPP work-related QoL tool.
- The research team will collate this information, group it into relevant domains and develop a weighting tool.
- Weighting tool (online Microsoft excel template) - participants will be asked to assign a percentage value (as weights) to the individual items and domains for the finalised MAPP work-related QoL tool using an online excel spreadsheet template.
- The research team will use this information to develop the finalised MAPP work-related QoL measure to be completed by participants and to develop the system to score this tool.
The research team expect the Awareness Round survey (first survey) to be completed within a month. Following this, two weeks will be allocated for the research team to analyse and finalise the survey to be used during the Consensus Round (second survey). The consensus Round survey will be open for two weeks, and participants will be prompted after one week if yet to complete the survey. We will send five reminder emails to the participants. The research team will have two weeks to complete the weighting tool, and participants will be given another two weeks to complete this. The research team will have an additional two weeks to finalise the MAPP work-related QoL at this stage. Thus, it is expected that Phase one activities will take up to 3 months to complete.
Phase two - the longitudinal completion of the quality of life tool by Medical Affairs Pharmaceutical Physicians each month for 12 months - observational patient study (MAPPWrQoLReg)
Following the MAPP work-related QoL tool development, the research team will recruit additional participants to complete the developed tool monthly for 12 months. The research team will aim to recruit a maximum of 165 study participants for this phase. Participants involved in Phase one will have the option to continue to Phase two. However, participation in Phase two is not a criterion for participation in Phase one. Recruitment will remain open for phase two for a minimum of one year and then reviewed, with another year following this to gain the full 12 months of data from participants.
The finalised MAPP work-related QoL measure will be hosted on a secure online system (Survey Monkey), and participants will be allocated an identification (ID) record number. Participants will be asked to complete this measure at monthly intervals for 12 months. Statistical methods for this phase will be finalised when the measure has been completed at the end of phase one by the Biostatistician Team at Medialis Ltd.
- Conditions
- Quality of Life
- Keywords
- Quality of Life, Jandhyala Method, Medical Affairs, Occupational burnout, Stress, Anxiety
- Medical subject headings
- Burnout, Professional, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months.
A prospective MAPPWrQoL patient registry.
Implementation of the developed MAPPWrQoL instrument as the core dataset in the associated patient registry (MAPPWrQoLReg).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start3 Nov 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medialis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Jandhyala, Principal investigator, Medialis Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123846
- Sponsor's protocol ID
- KCL Asset 10 and 11
- Status last verified
- Oct 2023
- First submitted
- 5 Nov 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36719367
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg)
- ClinicalTrials.gov ID
- NCT05123846
- Acronym / sponsor ID
- KCL Asset 10 and 11
- Conditions
- Quality of Life
- Keywords
- Quality of Life, Jandhyala Method, Medical Affairs, Occupational burnout, Stress, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medialis Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase One - the development of a MAPP work-related participant-reported quality of life (MAPPWrQoL) measure
The study will recruit between nine and 15 participants in this phase. Firstly, a novel method, the Jandhyala Method [16], will be used to elicit medical affairs pharmaceutical physicians' preferences for a QoL tool addressing work-related performance.
Below is the outline of activities to be completed during Phase One:
- Awareness Round survey (first survey, hosted on Survey Monkey) - asking for areas of their life which the participants feel have been impacted by work-related performance, including details and examples of those impacts.
- The research team will collate and code these responses and generate a list of statements based on the information provided by participants.
- Consensus Round survey (second survey, hosted on Survey Monkey) - the list of statements will be sent to participants. Participants will be asked to rate their agreement or disagreement with the inclusion of these areas in a MAPP work-related QoL tool.
- The research team will collate this information, group it into relevant domains and develop a weighting tool.
- Weighting tool (online Microsoft excel template) - participants will be asked to assign a percentage value (as weights) to the individual items and domains for the finalised MAPP work-related QoL tool using an online excel spreadsheet template.
- The research team will use this information to develop the finalised MAPP work-related QoL measure to be completed by participants and to develop the system to score this tool.
The research team expect the Awareness Round survey (first survey) to be completed within a month. Following this, two weeks will be allocated for the research team to analyse and finalise the survey to be used during the Consensus Round (second survey). The consensus Round survey will be open for two weeks, and participants will be prompted after one week if yet to complete the survey. We will send five reminder emails to the participants. The research team will have two weeks to complete the weighting tool, and participants will be given another two weeks to complete this. The research team will have an additional two weeks to finalise the MAPP work-related QoL at this stage. Thus, it is expected that Phase one activities will take up to 3 months to complete.
Phase two - the longitudinal completion of the quality of life tool by Medical Affairs Pharmaceutical Physicians each month for 12 months - observational patient study (MAPPWrQoLReg)
Following the MAPP work-related QoL tool development, the research team will recruit additional participants to complete the developed tool monthly for 12 months. The research team will aim to recruit a maximum of 165 study participants for this phase. Participants involved in Phase one will have the option to continue to Phase two. However, participation in Phase two is not a criterion for participation in Phase one. Recruitment will remain open for phase two for a minimum of one year and then reviewed, with another year following this to gain the full 12 months of data from participants.
The finalised MAPP work-related QoL measure will be hosted on a secure online system (Survey Monkey), and participants will be allocated an identification (ID) record number. Participants will be asked to complete this measure at monthly intervals for 12 months. Statistical methods for this phase will be finalised when the measure has been completed at the end of phase one by the Biostatistician Team at Medialis Ltd.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant are medical affairs pharmaceutical physicians, with pharmaceutical industry-based work experience.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Non-industry based Medical Affairs Pharmaceutical Physicians
- Not able to comply with the study schedule
- Not able to read, write, and converse in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development and validation of MAPPWrQoL instrument.
Time frame: 3 months.
The design and creation of a work-related quality of life measure to be self-administered by medical affairs pharmaceutical physicians.
A prospective MAPPWrQoL patient registry.
Time frame: 12 months
Implementation of the developed MAPPWrQoL instrument as the core dataset in the associated patient registry (MAPPWrQoLReg).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 36719367Jandhyala 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.
- PublicationLink provided by the sponsor.
- PublicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Jandhyala principal investigator
Medialis Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Medialis Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omolade Femi-Ajao, PhD (+447502228066, research@medialis.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and validation of MAPPWrQoL instrument. (time frame: 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.