Keywords
patient reported outcome measures - foot and ankle surgery
Introduction
Patient-reported outcomes measures (PROMs) are standardized tools aimed at learning
the patient's perspective regarding their health status, functionality, or well-being.[1] These results can be measured in different fields, such as quality of life, mobility,
pain or ability to perform activities of daily living,[2] and they enable the assessment of the quality of the health care provided.[3] These questionnaires were designed to be used in the clinical practice, but, currently,
they are also used in research because they enable the systematic collection of information
and the comparison of clinical outcomes in different contexts.[4]
Three fields covered by this type of questionnaire are applicable to traumatology
and orthopedics: the first one corresponds to quality of life, the second, to the
evaluation of a specific anatomical segment (such as the hand, hip, knee, ankle and
foot), and the third one refers to the evaluation of a specific pathology (Achilles
tendinopathy, osteoarthritis etc.).
In ankle and foot surgery, a wide spectrum of self-reported questionnaires is used
by patients, and we have identified up to 139 different measures used in the main
journals of the subspecialty, with no consensus on which is the ideal measure to apply
in the clinical practice.[2]
[5]
During the last 25 years, the interest in these questionnaires has grown exponentially,
which has generated new questionnaires and expanded these tools to different languages
and cultures, helping in the decision-making process regarding specific patients and
public health in general.[6]
[7]
Patient-reported outcome measures must be validated in the specific population on
whom they will be applied; thus, the questionnaires must be translated and culturally-adapted
in order to preserve the measuring properties of the tool. Otherwise, one cannot be
sure that the questionnaire measures what it is supposed to measure, or that it is
capable of detecting changes in the patient's health status; therefore, they should
not be used or reported.[8]
At present, there are PROMs validated for the Chilean population that can be used
in ankle and foot surgery, but we do not know how they are being used in our field,
nor which questionnaires are used most frequently, which makes communication among
Chilean surgeons difficult.
The primary objective of the present study is to describe the use of PROMs in the
field of ankle and foot traumatology and orthopedics in Chile. The secondary objectives
are to know the purpose, format, the people in charge of management during their application,
and the type of questionnaires used.
Materials and methods
The present is an observational, cross-sectional study in which traumatologists dedicated
to ankle and foot surgery according to the registry of Sociedad Chilena de Ortopedia
y Traumatología (Chilean Society of Orthopedics and Traumatology, SCHOT, in Spanish)
were invited to participate. A survey was designed in digital format by the research
team and was reviewed by ten specialist traumatologists to corroborate adequate understanding.
It consisted of 16 questions, 4 of them intended to explore the social and professional
characteristics of the respondents, 1 question to categorize whether the respondents
have used these questionnaires or not, 7 questions that inquire about the year they
have begun using PROMs, the purpose, the format, the people in charge of management
during the application, the category of the PROM, and the specific questionnaires
used. For those who have not used PROMs, three questions were asked about the factors
that limit or prevent their use. Finally, everyone was asked if they were interested
in increasing their knowledge regarding this type of questionnaire ([Table 1]). In 7 questions, choosing more than one alternative was allowed.
Table 1
|
Item
|
Question
|
|
Use of PROMs
|
Do you normally use PROMs in your clinical practice?
|
|
Yes, I do
|
|
|
Begining of use
|
When did you first use PROMs?
|
|
Purpose
|
For what purpose have you used PROMs?
|
|
Format
|
Which PROM formats have you used?
|
|
Person in charge
|
Which professionals are in charge of applying these questionnaires in you work team?
|
|
Category
|
Indicate which of the following categories of PROMs you have used
|
|
Questionnaire
|
Indicate which of the following PROM(s) you have used
|
|
No, I don't
|
|
|
Limitations
|
What have been the limitations to implement the application of these questionnaires?
|
|
Interest
|
Are you interested in applying this type of tool to your patients?
|
An invitation was sent to the email address registered in the SCHOT database in June
2020, and a reminder was subsequently sent to the respondents who still had not responded
at 2 and 3 weeks. Data collection was closed one month after the initial invitation.
Incomplete forms were excluded from the data analysis. All responses were anonymous.
The data was tabulated in Excel (Microsoft Corp., Redmond, WA, US) spreadsheets, and
a descriptive analysis, in which absolute and relative frequencies were reported,
was performed using the Stata (StataCorp LLC, College Station, TX, US) software, version
14.
The present study was approved by the scientific ethics committee of our institution
(ID: 200520004).
[Table 1]: Items and questions of the survey applied to the participants
Results
Characteristics of Respondents
The survey was answered by 73 of the 110 traumatologists invited. In total, 94% (n = 70)
of the respondents were male, with a median age of 39 years, a minimum age of 29 years,
and a maximum age of 64 years. Overall, 67% (n = 49) of the sample had formal training
or a fellowship in ankle and foot surgery. The respondents were affiliated to hospitals
belonging to the governmental health services, university hospitals, hospitals dependent
on mutual insurance associations, and private clinics. Of those surveyed, 52% (n = 38)
reported working in more than one center.
Use of PROMs
Of the total number of respondents, 75.3% (n = 55) reported having used PROMs at some
point, and 49.1% (n = 27) of those reported using them regularly.
Year they have started using PROMs
When asked about the year in which they began to use the questionnaires, we observed
that 4 respondents (7.3%) had begun to use these tools prior to 2000, 10 (18.2%),
between 2000 and 2010, and 41 (74.5 %), between 2010 and 2020.
Purpose
In total, 16.4% (n = 9) of the PROM users do so for clinical purposes, and 34.6% (n = 19),
for research. And 49.1% (n = 27) of the PROM users reported using them simultaneously
for clinical and research purposes.
Data Collection Format
Overall, 61.8% (n = 34) of the respondents apply the PROMs in an analog way, while
5.5% (n = 3) do so digitally; 32.7% (n = 18) of the respondents apply them using both
methods.
Management of Questionnaire Application
In 52.7% (n = 29) of the cases, the treating traumatologist is in charge of the management
of the application of these questionnaires. In 41.8% (n = 23) of the cases, this work
is shared between the doctor and other members of the team, mainly nurses or kinesiologists.
Only in 5.5% (n = 3) of the cases there are other professionals who exclusively manage
the application of these questionnaires (kinesiologists, clinical psychologists, and
administrative personnel).
Specific Categories and Questionnaires
Regarding their purpose and design, PROMs were grouped into 3 categories ([table 2]): 87% of the questionnaires are on quality of life, 51%, on the ankle and foot,
and 23%, on specific pathologies. We identified 17 different questionnaires used in
our field ([table 3]), and the most used is the Visual Analog Scale (VAS), the American Orthopaedic Foot
and Ankle Society's (AOFAS) Ankle-Hindfoot Score, the 36-item Short Form Health Survey
(SF-36), and the Foot and Ankle Outcome Score (FAOS).
Table 2
|
PROM category
|
n (%)
|
|
Quality of life or general
|
58 (87.3%)
|
|
Specific segment of ankle and foot
|
51 (92.7%)
|
|
Specific pathology
|
13 (23.6%)
|
Table 3
|
Questionnaire
|
n
|
%
|
|
Visual Analog Scale (VAS)
|
51
|
92.7
|
|
American Orthopaedic Foot and Ankle Society's (AOFAS) Ankle-Hindfoot Scale
|
45
|
81.8
|
|
36-item Short Form Health Survey (SF-36)
|
33
|
60.0
|
|
Foot and Ankle Outcome Score (FAOS)
|
16
|
29.1
|
|
Foot and Ankle Ability Measure (FAAM)
|
15
|
27.3
|
|
12-item Short Form Survey (SF-12)
|
9
|
16.4
|
|
Victorian Institute of Sport Assessment-Achilles Questionnaire (VISA-A)
|
8
|
14.5
|
|
Short Musculoskeletal Function Assessment (SMFA)
|
7
|
12.7
|
|
Achilles tendon rupture score
|
7
|
12.7
|
|
EuroQol 5 Dimensions (EQ-5D)
|
4
|
7.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
|
3
|
5.5
|
|
Ankle osteoarthritis scale
|
3
|
5.5
|
|
Foot and Ankle Disability Index (FADI)
|
3
|
5.5
|
|
Musculoskeletal Function Assessment (MFA)
|
2
|
3.6
|
|
The Manchester–Oxford Foot Questionnaire (MOXFQ)
|
1
|
1.8
|
|
Cumberland Ankle Instability Tool (CAIT)
|
1
|
1.8
|
|
The Lower Extremity Functional Scale (LEFS)
|
1
|
1.8
|
[Table 2]: Categories and proportion of use of PROMs in our field
[Table 3]: Questionnaire and rate of use
A total of 24.7% (n = 18) of the ankle and foot surgeons surveyed stated that they
did not use PROMs. When asked about their interest in using them, 83.3% (n = 15) reported
being interested, and 61.1% (n = 11) had already discussed the implementation of these
questionnaires with their work team.
Respondents who had not used these questionnaires pointed out the lack of information,
time, and personnel to carry out this task as the main limitations ([Figure 1]), and 93.2% (n = 68) of the respondents are interested in deepening their knowledge
of these questionnaires.
Fig. 1 Limitations to the use of PROMs according to respondents who do not use them.Número
de encuestados= Number of respondentsLimitantes para el uso de PROMs= Limitations
to the use of PROMsFalta de tiempo= Lack of timeFalta de información= Lack of informationFalta
de personal= Lack of personnelFalta de infraestrutura= Lack of infrastructureFalta
de interés= Lack of interestOtros= Other
[Figure 1]: Limitations for the use of PROMs according to respondents who do not use them
Discussion
The objective of the present study was to describe the use of PROMs in ankle and foot
traumatology and orthopedics in Chile. The survey was answered by 73 professionals,
mainly of whom male, and 67% (n = 49) with formal training or a fellowship in ankle
and foot surgery.
In total, 75.3% of those surveyed reported having used PROMs at some point, a scenario
similar to the 83% reported by Zwiers et al.[9] in 2018, and higher than the 55% reported by Lau et al.[10] in 2005. In our sample, we were able to observe that most of those who use these
questionnaires began to do so in the last decade, which seems to be in line with the
aforementioned studies and with the increase in publications on patient-reported outcomes.
In the present study, we observed that these questionnaires are used in our field
mainly for clinical and research purposes. It has been reported in the literature[7] that most surgeons use these questionnaires for research purposes (72%) and, to
a lesser extent, for clinical support (34%), or to assess the quality of care (34%).
It is important to mention that these questionnaires are designed mainly for clinical
purposes, which is why international associations such as the AOFAS recommend the
use of PROMs in all patients, mainly for clinical purposes.[5]
Regarding the application and recording of PROMs, we observed that surgeons prefer
to use analog methods (61.8%, n = 34). It has been shown[7] that the use of digital methods, such as ‘cloud’ platforms, facilitates access to
information to carry out research and implement improvements in hospital practices.
Also, storing analog records poses a risk of loss of information as there is no digital
backup, and it more time is spent in case there is a need to transfer the information
to digital formats to be applied for research or other purposes. Regarding this, there
is need for improvement in application and record system of these tools in our environment.
Regarding the people in charge of managing the application, we observed that it is
mainly the doctors who collect patients' answers. These questionnaires are designed
to be filled out by the patient; therefore, this process could be optimized through
automatic systems. The shorter the survey, the easier it is to understand, and the
fewer interruptions to the process, the better the adherence of the patient regarding
its use.[2] Zwiers et al.[9] investigated the reason that leads users to choose a certain PROM over others, and
the main reason was speed and ease of use (71%), followed by extensive use in the
literature (68%). Therefore, this process must be planned with the aim of optimizing
time in patient care, and offering care adapted to their needs.
We identified 17 PROMs used in our field, and the 5 most used are the VAS, the AOFAS
score, the SF-36, the FAOS, and the Foot and Ankle Ability Measure (FAAM). Regarding
the category of the questionnaires used, a clear predominance was observed in the
use of tools that evaluate a specific segment (ankle and foot) and quality of life
over those that evaluate outcomes regarding a specific pathology. These results are
similar to those reported by other authors,[6] and up to 89 different ankle and foot measures have been identified, and the most
used are the AOFAS score, the SF-12, the SF-36, the FAOS, the FAAM, and the Manchester–Oxford
Foot Questionnaire (MOXFQ).
Many questionnaires are used in our field, which makes communication and scientific
collaboration difficult. Achieving agreement on the measures to be used in our context
would enable the standardization of the compilation of patient-reported outcomes and,
therefore, monitoring over time in order to increase their use.[11]
It is important to mention that, to use a PROM in the clinical practice or for research,
it must first undergo a cultural validation process regarding the country where it
will be used; this is necessary to ensure that the tool is capable of measuring what
is expected. Overall, 12 questionnaires applicable in ankle and foot surgery have
been translated into Spanish,[12]
[13]
[14]
[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22] and, of these, only the EuroQol 5 Dimensions (EQ-5D), the SF-12, the FAOS and the
Victorian Institute of Sport Assessment-Achilles Questionnaire (VISA-A) have undergone
a cultural adaptation process that enables them to be used safely in Chile.[16]
[19]
[23] Translation, cross-cultural adaptation and validation can be long, difficult or
expensive processes; however, they are essential when using a PROM in the clinical
practice.[11]
We observed that the second most used questionnaire in our field is the AOFAS score;
although it still is one of the most used in the world, it presents several issues.
Therefore, in 2011, the AOFAS advised against its use.[24] This questionnaire contains a section to be filled out exclusively by the doctor,
which hinders it from being classified as self-reported. In addition, not has not
been translated into Spanish nor culturally-adapted for Chile, so it should not be
used in our field either.
Within the group that does not use PROMs, their interest in learning about the use
of these questionnaires stands out. There is an opportunity to improve the use of
these questionnaires, emphasizing the promotion of information on the advantages and
usefulness of these tools. In turn, it is important to search for means to reduce
the time involved in the application of PROMs, since this was the main barrier identified.
The main limitations of the present work are the selection of participants, since
there is no national registry of ankle and foot subspecialists, which is why traumatologists
affiliated to SCHOT were invited to participate. Other limitations include the low
response rate (66%, 73 of 110) and the use of an unvalidated tool.
Conclusion
The main advantage in the use of PROMs is the ability to objectify the clinical outcomes
of different treatments in patients and compare them objectively within a given population,
as well as the ability to extend this comparison to other countries. In the present
study, 75% (n = 55) of traumatologists dedicated to ankle and foot surgery in Chile
have used PROMs in their clinical practice, and there is a wide variety of questionnaires
applied in our setting. Most of them are interested in continuing to learn about the
use and usefulness of these questionnaires, which is a potential area of research.