Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- A prospective MAPPWrQoL patient registry.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Non-industry based Medical Affairs Pharmaceutical Physicians
- •Not able to comply with the study schedule
- •Not able to read, write, and converse in English.
结局指标
主要结局
A prospective MAPPWrQoL patient registry.
时间窗: 12 months
Implementation of the developed MAPPWrQoL instrument as the core dataset in the associated patient registry (MAPPWrQoLReg).
Development and validation of MAPPWrQoL instrument.
时间窗: 3 months.
The design and creation of a work-related quality of life measure to be self-administered by medical affairs pharmaceutical physicians.
次要结局
未报告次要终点