Pilot Feasibility Stud
Pilot Feasibility Stud
Pilot Feasibility Stud
PMCID: PMC5674799
PMID: 29142758
Abstract
Background
Aim of study
Methods
Results
Conclusions
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Background
Patients’ perceptions of care have been reported to influence functional clinical outcomes
following orthopedic trauma. Patients’ belief systems have been suggested to predict the
recovery after whiplash injuries, back pain, hand injuries, tibia fractures, and mangled lower
extremity injuries [1–5]. Although the impact of patients’ perceptions on the functional recovery
after orthopedic trauma seems to be widely accepted, the topic has received limited attention in
the orthopedic literature. Detailed knowledge of patients’ beliefs towards their orthopedic
injuries appears crucial for understanding of disparities in clinical outcomes. Increased
understanding of factors that influence outcomes may allow orthopedic surgeons to establish
protocols for recognizing and more appropriately addressing patients’ perceptions to improve the
functional clinical outcomes following orthopedic trauma.
It is well documented that various ethnic and racial disparities are associated with patients’
perceptions towards their healthcare [6–9]. For example, Hispanic patients appear to be less
willing to participate in cancer screening due to mistrust of healthcare providers, fear of “being a
guinea pig,” and fear of embarrassment [6]. In addition, Hispanic immigrants may be more likely
to use alternative medicine as a first line of care and feel that they have less control over their
own health, fatalism [7]. A recently published study recorded that fatalistic attitudes and medical
system mistrust were more prevalent among minority men [10]. Furthermore, these attributes
were associated with poorer physical and emotional well-being. This study data offers some
insight into Hispanic perceptions of healthcare in general. However, these data cannot be
extrapolated to examine the barriers and facilitators for orthopedic trauma patients. Anecdotal
reports have also suggested that Hispanic patients with musculoskeletal injuries have a higher
prevalence of posttraumatic stress disorder symptoms than non-Hispanic whites [9]. However,
the underlying factors contributing to this health disparity remain unclear.
Given Hispanics represent the fastest growing ethnic population in the USA, increasing by 15.2
million (43%) between 2000 and 2010. By 2050, the Hispanic population is expected to almost
double in size from 16 to 30% of the entire USA population [11]. These growth trends
emphasize the urgent need for detailed knowledge on characteristics of the Hispanic patient
population.
This pilot study compared patients’ perceptions towards isolated orthopedic injuries in a sample
of Hispanic and non-Hispanic white patients. The purpose of this pilot study is to explore
whether Hispanic patients with isolated orthopedic injuries will demonstrate different
perceptions towards their injury as compared to non-Hispanic white patients.
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Methods
The study was performed at a university-based level-1 trauma center in San Antonio, Texas. The
population within the city of San Antonio includes approximately 60% Hispanics and
approximately 30% non-Hispanic whites (https://www.sanantonio.gov). The protocol was
approved by the Institutional Review Board (IRB) of the University of Texas Health Science
Center at San Antonio. A total of 43 consecutive patients (31 Hispanics and 12 non-Hispanic
whites) were enrolled in this cross-sectional observational study. Patients were identified by their
treating physician at the orthopedic trauma clinic at our university-based level-1 trauma center.
Patients who met the following inclusion criteria were eligible for participation in this study: (1)
had an isolated orthopedic injury requiring surgical fracture treatment, (2) six-week follow-up
visit following their most recent surgical fracture treatment, (3) between the age of 18 and
65 years, (4) willing to provide informed consent, and (5) self-reported ethnicity of Hispanic or
non-Hispanic white. The following patients were excluded from the study: (1) patients with
significant non-orthopedic injuries (abbreviated injury scale [12] > 2), (2) patients with more
than one orthopedic injury requiring surgical fracture treatment, (3) a history of mental illness,
(4) decisional impairment, or (5) unable to read and/or write either English or Spanish.
Study questionnaire
The study questionnaire was a compilation of valid and reliable scoring systems including the
Questionnaire of Perceived Injustice (QPI), a wording modification of the Injustice Experience
Questionnaire [14, 15], Short-Form 36 Health Survey (SF-36v2) [16], the Pain Catastrophizing
Scale (PCS) [17], and Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Cultural Competence (CC) item set [18]. Additional questions on the patient’s self-reported
ethnicity, native language, country of birth, and social history (smoking, alcohol, drug abuse,
educational level, income level) were included in the study questionnaire.
The Injustice Experience Questionnaire is a 12-item scoring system that has been validated and
used in both the English and Spanish language [14, 15]. A minimal important difference (MID)
has not been defined for this outcome measure. The SF-36v2 is a standardized scoring system
that has been used in numerous clinical trials [16]. It is divided into two main categories,
physical component summary score and the mental component summary score. It can also be
subdivided into eight subscales. The Spanish version of the SF-36v2 has been validated and has
been widely used in clinical studies [19, 20]. A MID of 3 has been identified for the physical and
mental component summary scores of the SF-36 [21, 22]. The PCS is a 13-item questionnaire
that has been validated in the English and Spanish language [17]. To our best knowledge, the
MID has not been determined for the PCS.
The CC item set of the CAHPS is a validated system that has been validated in the English and
Spanish language [18]. It allows for calculation of two composites: (1) Providers are caring and
inspire trust (five items), and (2) Providers are polite and considerate (three Items). It also
includes a Likert scale from 0 to 10 for trust in the healthcare provider. The composite of
“provider caring and inspiring trust” includes the following five items: (1) In the last 12 months,
did you feel you could tell this provider anything, even things that you might not tell anyone
else? (2) In the last 12 months, did you feel you could trust this provider with your medical care?
(3) In the last 12 months, did you feel that this provider always told you the truth about your
health, even if there was bad news? (4) In the last 12 months, did you feel this provider cared as
much as you do about your health? and (5) In the last 12 months, did you feel this provider really
cared about you as a person? The composite of “providers polite and considerate” consists of the
following three items: (1) In the last 12 months, how often did this provider talk too fast when
talking with you? (2) In the last 12 months, how often did this provider use a condescending,
sarcastic, or rude tone or manner with you? and (3) In the last 12 months, how often did this
provider interrupt you when you were talking? The response options for each of these items
include “never”, “sometimes”, “usually”, and “always”. The items were scored using the top box
score method which calculates the rate of respondents who chose the most favorable response,
e.g., “In the last 12 months, how often did this provider use a condescending, sarcastic, or rude
tone or manner with you?” (most favorable response: never); “In the last 12 months, did you feel
you could trust this provider with your medical care?” (most favorable response: always). The
score for a composite represents the rate of most favorable responses for all items within the
respective composite.
Statistics
All statistical analysis was performed using Stata 14 (StataCorp, College Station, TX). Patients
were divided into Hispanics versus non-Hispanic whites according to their self-reported
ethnicity. No sample size calculation had been performed for the purpose of this pilot study as no
comparable data was available in the current literature. The chi-square test was used to compare
gender and smoking, between Hispanics and non-Hispanic whites. The Fisher’s exact test was
used to compare the educational level and income between the two groups. The T test was used
to compare age. Based on the results of this pilot investigation, a power analysis was performed
in order to calculate how many patients would have to be included in a potential future trial in
order to have 80% power to find a difference at the level of p = 0.05 for the QPI.
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Results
A summary of the demographic data is provided in Table 1. The isolated orthopedic injuries in
these patients included various anatomic regions including injuries to the distal humerus, both
bone forearm, distal radius, acetabulum, pelvic ring, hip, femoral shaft, distal femur, patella,
tibial plateau, tibial shaft, pilon, ankle, calcaneus, and midfoot. No differences by demographic
or clinical characteristics between the two groups were found.
Table 1
Demographic variable comparing Hispanic versus non-Hispanic white patients
Age in years, mean (SD) 41.9 (12.4) 44.7 (15.3) 42.7 (13.1) 0.58
Smoking history % (n) 19.4% (6) 41.7% (5) 25.6% (11) 0.13
Hispanics Non-Hispanic whites Total p
(n = 31) (n = 12) (n = 43)
Less than $20,000 44.8% (13) 16.7% (2) 35% (14) 0.09
Some high school but did not 9.7% (3) 0% (0) 7.0% (3)
graduate
High school graduate or GED 38.7% (12) 50% (6) 41.9% (18)
Hispanics Non-Hispanic whites Total p
(n = 31) (n = 12) (n = 43)
Some college or 2-year degree 29% (9) 25% (3) 27.9% (12)
More than 4-year college degree 3.2% (1) 16.7% (2) 7.0% (3)
The QPI, SF-36, and PCS were completed by all 43 patients enrolled in this study (Table 2). The
QPI was found to point towards worse outcomes in Hispanic versus non-Hispanic white patients
(mean difference [MD] 5.4, 95%; confidence interval [CI] − 4.4, 15.2). Hispanic patients showed
a trend towards better physical component summary scores of the SF-36 (MD 4.7, 95%; CI 0.2,
9.3), while the mental component summary score of the SF-36 trended lower in Hispanics
patients (MD − 6.8, 95%; CI − 15.0, 1.4). The magnitude of the differences for the SF-36
summary scores was greater than the MID of 3. The PCS did not show any trends between
Hispanic patients.
Table 2
Outcome scores comparing Hispanics versus non-Hispanic whites
SF-36
Trust with doctor (0–10) 8.9 (0.4) 9.9 (2.1) − 1.0 (− 1.9,− 0.1)
The CC item set of the CAHPS was completed by a total of 34 patients (27 Hispanics and 7 non-
Hispanic whites). This was attributed to the length of the questionnaire and the wording of some
questions that allowed skipping certain items. Hispanic patients seemed less likely to choose the
top box score within the composite of “providers caring and inspiring trust” as compared to non-
Hispanic whites, 64.8 versus 80% (odds ratio [OR] 2.21, 95%; CI 0.90, 5.43). No trends were
observed for the composite score of “providers polite and considerate” with top box scores in
79% of Hispanics versus 81% in non-Hispanics whites (OR 1.13, 95%; CI 0.34, 3.80). In
addition, Hispanic patients indicated less trust with their doctor on a scale from 0 to 10 (MD
− 1.0, 95%; CI − 1.9, − 0.1).
A power analysis was performed for sample size estimation based on our pilot data. The QPI as
our primary outcome was used for sample size estimation. The power analysis determined that
87 subjects would be needed in each arm to have an 80% chance of detecting a statistically
significant difference between the QPI scores of Hispanics vs. non-Hispanic whites at the level
of p = 0.05.
The following parametric formula was used to calculate the sample size:
n = 2 ([α + β]2[σ]2) / (μ 1-μ 2)2.
α = 1.96 (z-score for a two-sided test with an alpha of 0.05).
β = .84 (z-score for 80% power).
σ = 12.66 (calculated from pooled standard deviation formula using the means, standard
deviations, and sample sizes for the QPI. The pooled version of the formula was used since the
Hispanic and non-Hispanic groups had different sample sizes).
μ 1 = 22.7 (the mean QPI score for the Hispanic group).
μ 2 = 17.3 (the mean QPI score for the non-Hispanic group).
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Discussion
It has been widely suggested that patients’ perceptions may have a significant influence on
functional recovery following orthopedic injuries [1–5]. While in other areas of medicine, ethnic
and racial disparities with regard to patients’ perceptions towards their healthcare have been
observed, patient perceptions have not been a focus of research in the orthopedic literature. In
this pilot study, we aimed to collect data to identify whether ethnic differences in patients’
perceptions towards isolated orthopedic injuries should be further examined. Among Hispanic
patients with isolated orthopedic injuries, we identified a trend towards slower mental recovery,
greater perceived injustice, and less trust in the healthcare provider despite a favorable physical
recovery. We believe that the study methodology and outcome measures used to explore the
impact on clinical outcomes were shown to be feasible for larger clinical investigations. The
QPI, SF-36, and PCS demonstrated a high rate of completion. We also conclude that patients
may require assistance when completing the CAHPS.
Our study has both strengths and limitations. We chose a patient population that was
homogenous with regard to the diagnosis of an isolated orthopedic injury requiring surgical
treatment. However, we included a broad spectrum of orthopedic injuries that included various
injured anatomic areas. Future investigations may focus on one particular type of injury in order
to further improve the homogeneity of the study population. We believe that, overall, the
outcome measures used in this study were appropriate and useful to answer the study question.
We would like to acknowledge that the choice of outcome measures was somewhat limited by
the fact that we needed to use questionnaires that had been validated in both the English and
Spanish language. This precluded us from the use of other interesting outcome tools, such as the
Somatic Pre-Occupation and Coping (SPOC) questionnaire [2]. Future studies investigating
healthcare disparities in other patient populations may tailor their choice of outcome measures
according to the language requirements within their respective patient population. We also would
like to acknowledge that our study is a single time-point study. The six-week follow-up time
point appeared appropriate as it was felt that the patients will be out of the acute pain phase at
that time. Future proposals need to include longitudinal study designs that will allow for
correlating patient perceptions with long-term functional outcomes after orthopedic injuries. We,
therefore, suggest that this pilot study lays the ground for subsequent larger prospective clinical
investigations. We do not have a robust justification for the sample size of this study. We used a
convenience sample based on recommendations from the literature suggesting that this number is
large enough for a pilot study [23]. Yet, the sample size of this pilot study was too small to make
adjustments for potentially confounding demographic and clinical variables, such as age, gender,
educational level, income level, employment status, insurance status, smoking, alcohol, drug
abuse, medical comorbidities, and types of injuries. However, subsequent larger investigations
need to include logistic regression models in order to make adjustments for these potentially
confounding variables. Despite the relatively small sample size, we were able to identify fairly
remarkable trends and differences between Hispanics and non-Hispanic whites. However, the
results of our study must be interpreted with caution and may need to be confirmed in subsequent
larger clinical investigations. Finally, our study focused on differences between Hispanics and
non-Hispanic whites and we cannot make any conclusions about other minority groups. Future
studies may extend this study question to other ethnic and racial groups.
To our best knowledge, the question of ethnic differences in patients’ perceptions towards
isolated orthopedic injuries is novel within the literature. Therefore, the results recorded in this
pilot study are difficult to compare to published literature. Anecdotal reports have suggested a
higher rate of posttraumatic stress disorder among Hispanic polytrauma patients as compared to
non-Hispanic whites [9]. With regard to perceptions towards healthcare, we are only aware of
data from other areas of medicine [6–8]. These investigations have shown for instance that
Hispanic patients are less likely to participate in cancer screening due to mistrust, are more likely
to report fear of “being a guinea pig,” are more likely to report fear of embarrassment, more
frequently use alternative medicine, and feel that they are less in control over their own health.
However, these data cannot be extrapolated to the orthopedic patient population and further
clinical investigations seem necessary.
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Conclusions
Our pilot study showed that the methods of data collection are feasible for our clinical setting.
The study questionnaire showed a satisfactory completion rate in both Hispanic and non-
Hispanic white patients. Our study suggests that ethnic differences in patients’ perceptions
towards isolated orthopedic injuries whereby Hispanic patients may have a slower mental
recovery, may be more likely to express perceived injustice, and may express more mistrust
towards their provider than non-Hispanic whites. These results must be interpreted cautiously
given the limited number of subjects in this pilot examination. However, our study provides a
basis for future clinical investigations. We collected sufficient data to allow a sample size
calculation for a subsequent larger clinical investigation. Future clinical investigations may
determine the influence of ethnic differences in patients’ perceptions towards orthopedic injuries,
identify their impact on the functional outcomes, and establish appropriate patient and provider
intervention strategies.
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Acknowledgements
Not applicable.
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Funding
The study was funded by a research grant from DePuy Synthes.
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Abbreviations
CC Cultural Competence
CI Confidence interval
MD Mean difference
MID Minimal important difference
OR Odds ratio
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Authors’ contributions
BAZ, GS, RJF, MB, and MAV made substantial contributions to conception and design. BAZ,
GS, and DLK made substantial contribution to data analysis. DLK, GS, and DLK contributed for
the acquisition of data. BAZ, GS, DLK, and MAV have been involved in drafting the
manuscript. GS revised the manuscript. RJF, MB, and MAV have critically revised the
manuscript for important intellectual content. All authors made substantial contributions to
interpretation of data; they have given final approval of the version to be published; they have
participated sufficiently in the work to take public responsibility for appropriate portions of the
content; they have agreed to be accountable for all aspects of the work in ensuring that questions
related to the accuracy or integrity of any part of the work are appropriately investigated and
resolved.
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Notes
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Ethics approval and consent to participate
The study was approved by the Institutional Review Board (IRB) of the University of Texas
Health Science Center at San Antonio (Study no. HSC20150109). All patients enrolled in this
study provided informed consent for participation.
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Competing interests
BAZ has received research grants from DePuy Synthes and the Orthopedic Trauma Association.
BAZ has received a speaker honorarium from AO Trauma North America. None of which is
related to this study. MB reports funding received from Smith & Nephew, Stryker, Amgen,
Zimmer, Moximed, Bioventus, Merck, Eli Lilly, Sanofi, Ferring, Conmed, DePuy, and
Bioventus. None of which is related to this article. GS, DLK, RJF, and MAV declare that they
have no conflict of interest.
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