Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03087435 |
| Other study ID # |
HPM 309.712 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2019 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
August 2019 |
| Source |
Hospital Italiano de Buenos Aires |
| Contact |
Diego Giunte, MD |
| Phone |
00541149590200 |
| Email |
diego.giunta[@]hospitalitaliano.org.ar |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
It is necessary and important to design tools to evaluate a central aspect of medical
residents formation. The research group has been working with resident well-being since a few
years in order to improve the global quality of the education and working environment. The
investigators present a plan to develop and validate a tool to assess residents well-being. A
tool designed with this characteristics would be of much importance to monitored as a
security event, managed and actively promoted well being in residents.
Description:
Background:
The residency promotes learning, improves the development of skills, competencies, practices
and attitudes characteristic of each different medical specialty. Just as the health of the
children reflects the health and future of a population, the university and the residency are
likely to reflect the quality of the health system.
Collapsed and overloaded health systems rely on residents as a low-cost human resource. The
residency program should be characterized by a supervised learning system to promote
progressive independence in decision making and clinical reasoning. This learning experience
can be affected by many factors like stress, sleep deprivation, poor learning environments,
relocation issues, vertical structure, excess of administrative tasks and work overload among
others. This characteristics of the learning/working environment have an individual direct
impact on safety, processing, learning and decision-making capacity and a group effect on
safety and quality of patient's care.
Residents are a population of high risk for depression, burnout and social isolation. The
well-being of residents is a key aspect of their training that can be monitored as a security
event, managed and actively promoted. While several strategies are used to measure the degree
of work overload and its impact on training residents, none seems to be holistic and
appropriate to understand the dimensions of this complex phenomenon. The aim is to generate
and validate a tool to measure the well-being of residents considering their multidimensional
features.
Research Question: Is it possible to built a valid instrument to measure well-being in
residents of medical residency programs?
Instrument description: It is planned to develop a paper multidimensional, self-administered,
questionnaire, relative brief, which considers the most important domains of well-being. The
main features of the instrument are shown in figure 2 (domains, format, administration,
score).
The whole process of generation and validation of the instrument of well-being measurement in
residents will be developed according to study protocol. All study participant will give
freely informed consent to participate. The protocol and its informed consent will be
evaluated and approved by an independent research ethics committee before starting the study.
The protocol will be registered in argentinian public database of research protocols and in
clinicaltrials.gov.
Development and validation
1. Well-being instrument development
1.1. Conceptual framework development: The aim of the first meeting is to construct a
simpler conceptual framework about the medical resident well-being considering the
literature review, thoughts, expertise and experience of each participant. In group of
experts in education, residents and medical specialists will develop a group conceptual
framework using the Nominal Group Technique (NGT). This technique is a solving method
designed to provide each member of a group with an equal voice in the resolution of a
particular problem. A complete description of the original technique may be found in Van
de Ven AH, Delbecq AL. The nominal group as a research instrument for exploratory health
studies. Am J Public Health. 1972; 62: 337-342 7.
1.2. Domain selection The domains will be selected according to consensus in a group of
experts in education, residents and medical specialists considering the conceptual
framework defined for the problem in previous meeting. Potential domains to include are
physical, mental, social, role/functional, fatigue/sleep, burnout, work environment,
future potentiality, mistreat/abuse, learning experience/environment, self care, and
resilience.
Previous instruments will be considered, conceptual framework, experience and opinion of
the participating experts, and bibliography on the well-being of residents to decide the
main domains to be represented in the instrument. NGT will be used to make this grupal
decision.
1.3. Item selection to access each domain Each domain will consist of between 5 and 10
items. Likert or pseudo-Likert scales will be used with 5 standard options with a
neutral central value. All the items will be affirmations or statements obtained from
previous instruments that measure similar constructs, previous literature, experience of
the consensus group integrated by residents, specialists in education, medical
specialists.
Initially, all the items that the group considers pertinent per domain will be included.
For the generation of the list of items per domain, the NGT will be used again. For the
design of the items, previous instruments, conceptual framework, experience and opinion
of the participating experts, and bibliography on the well-being of residents should be
considered.
The list of items per domain, will be reduced to contain a minimum of 5 items and a
maximum of 10 items according to group discussion and consensus. The NGT will be used
again to define a group order according to importance Each participant of the consensus
group will order the items of each domain according to order of importance. The items
will be reduced according to the redundancy, difficult for the translation to other
languages, awkward of phrases, excessively idiomatic expressions, difficulty in
understanding or less relative importance with respect to the rest of the items.
The selected items will be refined. They will be phrased in plain language to avoid
ambiguities. With a single concept by affirmation, in short sentences. A 7th grade or
complete primary education (according to the argentinian education system) level will be
used. The use of slang confusing words will be avoided. The time frame for each item to
increase measurement precision and avoid ambiguity will be discussed.
The items will be sorted in order to keep more general and less personal items at the
beginning, and more private items at the end. The items referred to the same time frame
or similar concepts will be order in proximity. The order of the items will not respect
the domains, but will be designed to increase responsiveness, comprehension and
precision. The options will always be evenly arranged to avoid errors in filling.
1.4. Scale and scoring structure design For the scaling of each item on the Likert or
pseudo-Likert scale, a score from 0 for the worst lack of well-being, and 4 for the best
well-being option will be used. In all cases, the highest score will be assigned to the
response that represents the greater well-being situation and the lower score to the
lower well-being.
The results of each questionnaire will be presented as one score per domain and a global
score. Each domain will have a maximum score of 100 and a minimum of 0, as well as the
global score. Each item will be assigned a weighted score according to group consensus
on the importance of the items in each domain. The score of each domain will be obtained
by adding the weighted scores of each item within the domain. Each domain will be
assigned a weighted score according to the global importance of the domain in the whole
construct decided by group consensus. This weights assigned to each domain will be used
to sum a global score for the whole questionnaire.
Once the validation period of the instrument has been finished, the scale will be
applied to a larger population of residents using networks like the Sociedad Argentina
de Medicina (Argentinian Medicine Society). With these results, the averages and
standard deviations will be obtained. This tables will be used to calculate a z-score
(standard deviation units) according to sex and age for each domain and the global
score.
1.5. Preliminary version and pretest A preliminary version that will be pretested with a
group of residents will be presented, medical specialists and specialists in medical
education. Clear instructions should be added in the header on how to complete the
questionnaire and how to solve it in case of mistakes during the answers. A final
thank-you message will be added.
2. Validation
2.1. Content validity and face validity: To evaluate face validity and content validity the
final version of the questionnaire produced during the development phases will be used. Face
validity will be evaluated asking to different participants whether the questionnaire seems
to be valid to represent the construct well-being.
Content validity will be evaluated with instrument inspection and discussion by a group of
experts and residents as describe in the last section of the development phase. The group
discussion will be focused on whether the instrument incorporates the appropriate components
and facets for the measurement of the construct that is intended to represent. Each
participant will answer if all the items included in the questionnaire are essential to
represent the construct resident well-being.
2.2. Criterion validity Criterion validity will be evaluated assessing concurrent validity
and predictive validity using the same sample of residents.
There is no appropriate gold standard to evaluate the concurrent validity as I have not found
any other instrument designed and validated to represent the construct well-being of
residents with the chosen perspective. Two imperfect approximations will be used as gold
standard: the correlation of the global score with the SF36 [20] as a tool to access global
quality of life and the WRQoL scale.
A sample of residents will complete the three questionnaires (SF36, WRQoL and the well-being
in residents questionnaire). Pearson's correlation coefficient will be used to evaluate the
association of the global scale with SF36 and WRQoL. Even though this two scales are not gold
standards for this construct the investigators expect them to be highly correlated to the
global scale of the new instrument.
To evaluate predictive validity the same sample of residents will be used to access if the
new questionnaire is able to predict the occurrence of future events: medical error, level of
stress and depression, alcoholism, drug abuse, and residence abandon.
2.3. Construct validity The evaluation of construct validity implies the accumulation of
evidence that the questionnaire actually measures the construct. To evaluate the construct
validity of the residents well-being questionnaire the convergent and discriminant validity
will be evaluated (Multitrait-Multimethod approach), test hypothesis of association between
the questionnaire scale and different situations and evaluating the behaviour of known
groups. With all this evaluations, the investigators are planning to gather information about
the performance of the questionnaire scale to the conceptual model of hypothesized
relationships.
Convergent and discriminant validity will be tested by measuring in a sample of residents
simultaneously related and not related scales and the well-being questionnaire. To access
convergent validity, physical activity, depression, anxiety will be used. To access
discriminant validity use socio-economical status will be used, SF36 and subscales and the
domains of BMI. The Multitrait-Multimethod Approach will be used to build a matrix of
correlations between the different scales accessed and each domain and global scale of the
well-being questionnaire.
Additionally it is expected to see more well-being related to some specific rotations like
clinical research, and elective rotations compare to night shift or during the excess of
workload of vacation period. The measurements of this instruments will be compared in the
same residents during this specific rotations.
