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Development and Pilot Testing of an International Knowledge Assessment of Prosthetic Management for Patients Using Lower-Limb Prostheses

Goodworth, Adam D. PhD; Veneri, Diana A. PT, EdD, NCS; Burger, John CPO; Lee, Daniel J. PT, DPT, GCS

JPO: Journal of Prosthetics and Orthotics: January 2017 - Volume 29 - Issue 1 - p 28–34
doi: 10.1097/JPO.0000000000000117
Original Research Article
Free

Introduction Individuals using a lower-limb prosthesis need knowledge about many aspects of management to maximize use and comfort and minimize secondary complications. Knowledge assessments are used in other health fields, yet no assessment has been published in prosthetics. Therefore, a knowledge assessment was developed for international use and pilot tested in the United States and East Africa.

Materials and Methods The assessment contained 36 questions and was written at a 4.7-grade reading level. Content was based on professional input and literature. The assessment was pilot tested with 16 prosthetic users in the United States, 19 prosthetic users in East Africa, and 24 nonprosthetic users in the United States. Assessment scores were analyzed across questions, between prosthetic users and nonprosthetic users, and correlated with patient demographics.

Results We found the assessment was understandable among all subject groups. United States prosthesis users scored higher than nonprosthesis users. Prosthetic experience was positively correlated with assessment scores in the United States and negatively correlated with assessment scores in East Africa.

Conclusions Clinicians can use this knowledge assessment to identify gaps or misunderstanding and track progress in comprehension with their patients. Clinicians can adapt questions to their local context, individual needs and componentry, and time constraints.

ADAM D. GOODWORTH, PhD; and DIANA A. VENERI, PT, EdD, NCS, are affiliated with the University of Hartford, West Hartford, Connecticut.

JOHN BURGER, CPO, is affiliated with the New England Orthotics and Prosthetics.

DANIEL J. LEE, PT, DPT, GCS, is affiliated with the University of Hartford, West Hartford, Connecticut.

Disclosure: The authors declare no conflict of interest.

Correspondence to: Adam Goodworth, PhD, University of Hartford, Dana Hall 408A, 200 Bloomfield Ave, West Hartford, CT 06117; email: goodworth@hartford.edu

There are currently no diagnostic tools available for the assessment of patient knowledge in prosthetics. Patient knowledge is critical to limit the risk of developing preventable secondary complications such as skin breakdown, musculoskeletal impairments, falls, and subsequent reamputation.1,2 For example, in the United States alone, it is estimated that hospital costs associated with amputations can cost approximately $8.3 billion per year.3 While providing some form of therapeutic education is routine in many clinics, without an objective knowledge assessment tool, the effectiveness and understandability of education interventions cannot be evaluated. In developing countries, patient education may be even more critical as the incidence of amputation is even higher, prosthetic rehabilitation is minimal, and patients have limited access to health care opportunities.4,5 Because we developed the first knowledge assessment for prosthetic users, a pilot study was the most appropriate method of evaluation. The current pilot study focused on the assessment of patient knowledge with the ultimate goal of supporting clinicians in delivering patient-centric self-management education.

In the management of complex medical conditions, a knowledge assessment is performed to guide targeted therapeutic educational interventions and self-management strategies.6–8 Studies have shown that knowledge assessment and therapeutic education are foundational to managing conditions such as diabetes that require patients to problem solve on a daily basis.2,6–10 In developing countries, assessments and questionnaires are also used to identify gaps in knowledge about health concepts.11,12 Because lack of knowledge or self-management skills can lead to devastating secondary complications,1,2,7,8,10 individuals with lower-limb loss should have a homogenous understanding of several key topics (hygiene, donning/doffing, emergency scenarios, physical rehabilitation, etc.).2,13–15

Our first aim was to develop an assessment of basic prosthetic knowledge of individuals using a lower-limb prosthesis. The second aim was to complete a descriptive study of field testing the assessment in both the United States and East Africa. East Africa was selected because our clinical collaborators have ongoing projects in Uganda and Kenya and their past experience indicated we would have a high probability of reliable data collection and larger sample sizes compared with their other sites. As part of the testing, we investigated the hypothesis that prosthetic experience would be correlated with assessment scores and that prosthetic users would score higher than nonprosthetic users. Ultimately, the assessment aims to provide clinicians with an easy means to identify and fill in knowledge gaps, to remind patients of key concepts, and to improve outcomes and reduce health care costs.3,10,16,17

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METHODS

The motivation to create an international knowledge assessment was initiated by our partnership with LIMBS International and our associated needs assessment meetings. LIMBS International works in over 12 countries providing prosthetic care and training via low-cost components. LIMBS International identified the need for improved patient feedback and outcomes and more patient education in rehabilitation. A team of researchers at the University of Hartford responded with the development of low-literacy education materials and a knowledge assessment. Together with LIMBS International, our work has been multifaceted, including clinical care, education, and research. Our partnership has been sustained since 2011. This study describes the creation and testing of the knowledge assessment tool.

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DEVELOPMENT

We developed the knowledge assessment to provide an objective measure of patient knowledge on key topics and to facilitate patient-clinician education sessions. The tool can be administered via verbal clinician-patient exchange or completed by the patient in written form. The tool contains basic concepts that are applicable to nearly all individuals with a lower-limb prosthesis. The test format was chosen to increase objectivity because self-assessments can be biased and prone to subjectivity.18,19 The test format also bypasses the anecdotal reporting of many international relief organizations that appreciative patients tend to overrate their satisfaction, comfort, and knowledge with/of a product or service that they receive.

A review of prosthetic literature was used to ensure consistency with clinical practice in developing a preliminary set of questions.13,14,16,20–22 Preliminary questions were distributed to health professionals for feedback. These professionals included 10 certified prosthetists and rehabilitation specialists across the United States with international prosthetics and rehabilitation relief experience, and three non–United States professionals who work full time at clinics in low- and middle-income countries. After examining the final set of questions, the research team agreed that many questions could be naturally grouped into the same domain and that grouping questions into domains could better guide patient feedback. We agreed to four domains: problem solving (PS), return to clinic (RC), hygiene/skin care (H), and exercise/rehabilitation (ER). By consensus, each question was placed into one of the domains and then several clinicians reviewed the categorization. To accommodate potential low cognition and literacy skills of test populations,23,24 questions were written with dichotomous answers (yes or no) to increase understandability and the average question was written at a 4.7-grade level using Flesch-Kincaid.25 Thirty-six total questions were included and can be found in Appendix A for more details.

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SUBJECTS

Sixteen subjects in United States using a lower-limb prosthesis, 24 subjects in United States without a prosthesis (i.e., controls) and 19 subjects in East Africa using a lower-limb prosthesis (Kenya = 6 and Uganda = 13), n = 59, participated. Demographics are summarized in Table 1.

Table 1

Table 1

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PROTOCOL

Before testing, all subjects agreed to an informed consent. All testing was completed in accordance with the institutional review board at the University of Hartford and international partnerships. Inclusion criteria for the prosthetic users were having either transtibial or transfemoral amputation and being older than 18 years. Exclusion criterion for prosthetic users was pregnancy, because mobility tests were performed in the United States. Inclusion criterion for controls was older than 18 years. Exclusion criterion for controls was any special knowledge concerning prosthetics (rehabilitation specialist, being a close relative of prosthetic user, etc.).

Each question was read to the subject and answers were recorded by a researcher. Subjects were encouraged to describe their interpretation of each question and notations were made. After the test, US subjects were asked to circle the three questions that they believed were most important. In US testing, we determined if any correlation existed between knowledge and mobility skills by performing the Amputee Mobility Predictor Pro (AMP-pro), a standardized mobility test for subjects with lower-limb amputation.26

In Uganda, researchers traveled to subjects' homes for testing to ease the burden of travel on patients and to serve as a follow-up visit. In Kenya, testing occurred in two clinics during regular patient visits. In East Africa, English skills were mixed (5 were fluent, 5 spoke a little, and 9 knew none, Table 1). A local clinician verbally delivered all tests in the subjects' native language. Because of cultural considerations and time constraints, adaptations to the knowledge assessment were made in East Africa. After reviewing our first 2 days of testing in Uganda, four professionals selected a subset of 20 questions (two of which were reworded, Appendix B) based on perceived importance and elimination of redundancy. The AMP-pro was not performed in East Africa because of time constraints and variability in available surfaces that subjects would have walked upon during the test.

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STUDY DESIGN

Assessment scores were compared across domains, between subject groups, and correlated with demographic information. Additional measures included patient perception of the most important questions and qualitative feedback on his/her interpretation of questions. Mixed methods analyses were used as quantitative results were interpreted with qualitative feedback and cultural influences.

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STATISTICS

Correlations were quantified using the Pearson correlation coefficient. To compare scores across domains, repeated-measures analysis of variance (ANOVA) and Tukey's HSD for post hoc testing were used in SAS JMP V10 software (Cary, NC, USA). T-tests were used to compare scores between US prosthetic users and US controls. A p value of less than 0.05 was considered significant.

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RESULTS

The knowledge assessment is included in Appendix A. A description of how local adaptations were made for testing in East Africa is included in Appendix B. Field testing results are described below.

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US QUANTITATIVE TESTING

For US prosthetic users, scores on hygiene questions (98%) were significantly higher than exercise (87.5%), and exercise was significantly higher than return to clinic (77.5%). Controls scored on average approximately 10% lower than prosthetic users. Prosthetic users scored significantly higher than controls in three of the four domains (p < 0.0024) (Figure 1A), and there was a significant positive correlation between experience and score (R = 0.51; p = 0.037) (Figure 1B), supporting our hypothesis. In this correlation analysis, the mean control score was included and considered to have zero months of experience. Neither age nor education was significantly correlated with scores in US prosthetic users (Figure 1B). Additional correlations were investigated, but none were found significant. These additional investigations in prosthetic users included AMP-pro versus score, age versus education, age versus experience, and AMP-pro versus age; additional investigations in controls included age versus education, age versus score, and education versus score.

Figure 1

Figure 1

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US QUALITATIVE TESTING

Qualitative data from US prosthetic users pointed to a few important themes. First, many subjects reported hygiene questions to be the most important. Second, when describing normal versus abnormal skin color (such as “If my limb is red for 3 minutes and then it goes away, I should go to the clinic” in RC2), one needs to consider the variability of skin color of a person's residual limb when it is not irritated. Third, answers to question PS8 (related to how long it is permissible to wear prosthesis) will differ between prosthestic users as new users and those with acute skin problems will have shorter wearing times. Fourth, questions related to socks were not applicable to subjects using a suction socket. Similarly, some questions in the exercise/rehab domain were not applicable to everyone. Specifically, ER6 (addressing the proper use of cane) and ER7 (addressing mobility strategies for difficult hills) were not applicable for subjects with high mobility.

Two questions were notably misunderstood more than others. The first was question RC4 (“When walking with my prosthesis and my foot turns in or out, I should go to the clinic?”), and the second was H5 (“It is OK to put on a wet liner at the start of the day?”). H5 intended to address “putting on” a wet liner, but some subjects were confused because they considered the presence of sweat while using their prosthesis.

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EAST AFRICAN TESTING

For East African prosthetic users, scores on hygiene questions were higher than other domains, consistent with US prosthetic users (Figure 2A). The lowest score on any single question was PS11 at 50%. This question addressed the need to add a sock to avoid “bottoming out” in a socket. Bottoming out is when the distal end of the residual limb is contacting the liner or socket too much, causing excessive wear on the liner and/or excessive pressure on the residual limb. Consistent with this low score on PS11, excessive wear on the bottom of the liner was a common observation during testing in East Africa, thus suggesting the need for patient education.

Figure 2

Figure 2

Contrary to our hypothesis, in East Africa testing, there was a negative correlation that was significant between experience and knowledge scores (R = −0.67; p = 0.0019) (Figure 2B). Demographics may have contributed to this finding. Older subjects in East Africa had more experience with a prosthetic device than younger subjects, but they had less education than younger subjects and lower knowledge assessment scores. Specifically, age had a negative correlation with knowledge scores (R = −0.56; p = 0.012) (Figure 2C), age had a negative correlation with education (R = −0.47; p = 0.047), and age had a positive correlation with experience (R = 0.67; p = 0.0017).

To understand the role of English proficiency on assessment scores, subjects rated their level of English before each test as 0 (“almost none”), 1 (“a little”), and 2 (“fluent”) (Table 1). Based on this scale, there was no significant effect of English proficiency and assessment scores, suggesting that English was not a major factor in the performance among East Africans.

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DISCUSSION

IMPLICATIONS AND USEFULNESS OF THE KNOWLEDGE ASSESSMENT TOOL

In both the United States and East Africa, nearly all questions on the knowledge assessment were understandable for subjects, implying the assessment has international applicability. Scores in the hygiene domain were highest for all groups and hygiene questions were often selected as the most important by US prosthetic users. This finding implies that patient education should emphasize hygiene topics and is consistent with a focus group study that identified priorities in prosthetic users.15 However, the high scores in the hygiene domain may also imply that the questions were easy to answer. One way to circumvent this and retain the content would be to reword the questions to be open-ended.27,28 While open-ended questions may reduce objective measures, they allow the clinician to see what patients can bring to mind without any options presented to them.

Usefulness of the assessment tool was evident. In the United States, the knowledge assessment aimed to offer distinct information from mobility scores alone. This was supported by the lack of correlation between knowledge assessment scores and the AMP-pro. Furthermore, the lack of correlation between assessment scores and other demographics in the United States implies that the tool was not biased toward age and education level in the United States. In East Africa, the importance of identifying and remediating gaps in patient knowledge is underscored by the difficulty and reduced rate of clinical visits. Subjects' travel time to clinic (Table 1) was much longer than in the United States. Most of the subjects visited in Uganda (82%) had a prosthesis that needed repair or were in need of significant physical rehabilitation. Finally, the relationship between low scores on the “bottoming out” question (PS11) in East Africa and the clinical observation that many subjects were in fact “bottoming out” is an example of how the assessment provided clinical benefit. The concept of adding socks to avoid “bottoming out” is not intuitive but should be taught to prevent undue stress of the distal end of the limb and unnecessary wear of the liner.

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HYPOTHESIS TESTING

Our hypothesis was supported in the United States, as assessment scores positively correlated with experience (Figure 1B) and prosthetic users' were scores significantly greater than controls. However, in East Africa, the relationship between prosthetic experience and assessment scores was reversed (Figure 2B). In the United States, prosthetic users with more experience have greater exposure to education materials, teaching, and time in the clinic,4,5 as well as problem solving opportunities at home. Furthermore, US prosthetic users are more likely to have health care insurance and have prosthetic devices that fit well and are repaired immediately. Prosthetic users in the United States are also regularly exposed to new technological advancements. The East African prosthetic users in this study were amputated at a relatively early age (~28.3 years [13.3 SD]) due to causes that would all be considered traumatic or congenital. In contrast to the United States, East African prosthetic users with the greatest experience were the oldest and had the least number of years in school; these older prosthetic users may have had inadequate initial training as many of the clinicians making and fitting prostheses in the 1970s and 1980s in East Africa had a different level of training compared with clinicians now. Also in developing countries, cultural and economic factors can reduce patients initiating follow-up visits (note the large median travel time to clinic, Table 1). As such, older subjects' training may not have been sufficiently reinforced through regular follow-up visits. The implication is that in East Africa, the prosthetic user's age and education level should be considered when estimating the time needed for prosthetic education. More frequent contact with clinicians and use of the knowledge assessment tool will minimize gaps in prosthetic users' knowledge.2 Community-based rehabilitation programs may help in East Africa as well as other geographical regions with similar circumstances and characteristics.28,29

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LIMITATIONS AND FUTURE WORK

Several questions had answers that were too obvious to be considered discriminatory (e.g., M2, M9, R3, R6, H4, H7, and E2). These questions were initially created, and still have value, because they serve as reminders of important concepts and increase patient confidence and comfort with the assessment.30 The protocol in East Africa was limited because a few questions were not answered by some subjects, standardized mobility tests could not be completed, and subjects did not provide feedback on their interpretation and importance of the questions. Limitations like these are often inherent to testing in developing nations.31 Finally, because some questions could fit within more than one domain, clinicians and patients should be aware that the domains are not completely independent. The most prominent example is the “return to clinic” domain, which overlaps with “problem solving” and “hygiene.” Based on input from international clinicians, we deemed it important to have a separate domain for “return to clinic” because delayed follow-up visits are a common problem.

Because no other assessments of knowledge currently exist, this pilot study demonstrates the clinical relevance of the tool developed and directs future studies. To transform the assessment into a valid and reliable outcome measure of knowledge, one challenge will be identifying a “gold standard” to compare against. Future studies may also wish to test the assessment in other regions, and potentially expand for local social support topics and prosthetic componentry because culture and local resources can influence the importance of concepts.29

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CLINICAL USE

This study presents an assessment that clinicians can use to identify gaps or misunderstandings in patient knowledge about lower-limb prostheses. The assessment is intended to complement and guide conversations regarding prosthesis management. Ideally, the knowledge assessment can be administered to patients before receiving their prosthesis in either verbal or in written form. Clinicians can discuss answers with their patients and track knowledge gained in subsequent visits. The ready-made list of questions simplifies the assessment phase of the education process.

Clinicians can also adapt questions to their local context, individual patient needs, prosthetic componentry, and time constraints (such as open-ended questions) as needed. For example, in East Africa, several local professionals and workers read through the questions, selected a subset and reworded some, given local considerations. In other international clinics, it may be appropriate to add questions, and it is always important to include patients in the decision-making process.29,32 The two questions most often misunderstood (RC4 and H5) could be clarified or omitted. Finally, our test results reinforce the importance of follow-up visits and that the knowledge assessment is a useful tool to facilitate clinician-patient exchange of information.

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CONCLUSIONS

The current study presents the first assessment of patient knowledge in prosthetic management. Our motivation was based on the documented use of knowledge assessments in other health fields and on a needs assessment from our partnership with an international prosthetic relief organization. Testing suggested that nearly all questions were understood by everyone. The United States scores indicated that the tool was sensitive to prosthetic experience. Testing in East Africa modeled an approach for local adaptation of the assessment and results demonstrated usefulness of the assessment and emphasized the importance of cultural awareness and follow-up visit education.

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ACKNOWLEDGMENTS

The authors thank the assistance of LIMBS International, Max Acamun at Great Lakes Rehabilitation in Uganda, New England Orthotics and Prosthetics, and Hanger Clinics for their collaboration with data collection. The work was supported by a University of Hartford Institute for Translational Research Sprout Grant.

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4. World Health Organization. Guidelines for Training Personnel in Developing Countries for Prosthetics and Orthotics Services. Scotland, UK. World Health Organization. 2005. ISBN 92 4 159267 2. 2005.
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Appendix A

The Knowledge Assessment

Before administering, abnormal pain should be distinguished from pressure. Abnormal pain can be considered pain, which inhibits the user from putting on the prosthesis and walking with it or using it.

Problem Solving

PS1. If I have pain in my missing limb (phantom or nerve pain) I could rub it. I could also put a sock on it to get rid of the pain.

PS2. Should I take the prosthesis off to go to sleep?

PS3. If I feel pressure in a new spot, I should put the prosthesis on again.

PS4. It is OK if the size of my limb gets bigger or smaller during the day.

PS5. A feeling of pressure is normal, but not feelings of pain.

PS6. If my socket feels loose, it is OK to add a sock.

PS7. It is normal for my limb to hurt everywhere when touched.

PS8. I should wear my prosthesis from when I get out of bed to when I go back to bed.

PS9. Gentle touching of the limb should not produce pain.

PS10. I should always take off my prosthesis after using for 2 hours.

PS11. If I feel pressure at the end of my limb, I should try to put on a sock.

PS12. If my socket feels tight, it is OK to add a sock.

Return to Clinic

RC1. If I have new redness on my leg that does not go away, I should go back to the clinic.

RC2. If my limb is red for 3 minutes and then it goes away, I should go to the clinic.

RC3. If I cannot wear my prosthesis due to pain, I should go to the clinic.

RC4. When walking with my prosthesis and my foot turns in or out I, should go to the clinic.

RC5. If I change shoes, I may not be able to walk properly with my prosthesis.

RC6. If a screw comes out of the prosthesis, I should get it checked out as soon as possible.

RC7. If the socket cracks, I can use tape to fix it and then go to the clinic as soon as possible.

RC8. If my leg hurts in a part of my leg that is missing (i.e., phantom pain), I should go to the clinic because this is not normal.

RC9. If I feel pressure at the end of my limb when I'm wearing my prosthesis, I should go straight to the clinic.

RC10. If my limb is red for more than 20 minutes, I should go to the clinic.

Hygiene

H1. When I have a new wound on my limb, I should always continue using my prosthesis.

H2. I should clean my socket at least 3 times per day.

H3. If I have a wound on my limb, I should keep it clean, dry, and stop using the prosthesis.

H4. I should clean my limb at least once a day.

H5. It is OK to put on a wet liner at the start of the day.

H6. I should clean my liner or sock every day.

H7. It is OK if my leg smells really bad or has pus.

Exercise and Rehabilitation

ER1. When walking up steps or a hill, I should start with my prosthetic limb.

ER2. It is a good idea to stretch every day.

ER3. It is normal to fall during common daily activities.

ER4. I should be able to put the same weight on both legs when standing.

ER5. When I stand up, my hips should be in line and my feet in front of me.

ER6. I should hold a cane with the arm closest to my prosthesis.

ER7. It is safe to walk sideways down a hill, stepping first with prosthetic my leg.

Answers to Assessment

PS1: Y; PS2: Y; PS3: Y; PS4: Y; PS5: Y; PS6: Y; PS7: N; PS8: Y; PS9: Y; PS10: N; PS11: Y; PS12: N; RC1: Y; RC2: N; RC3: Y; RC4: Y; RC5: Y; RC6: Y; RC7: N; RC8: N; RC9: N; RC10: Y; H1: N; H2: N; H3: Y; H4: Y; H5: N; H6: Y; H7: N; ER1: N; ER2: Y; ER3: N; ER4: Y; ER5: Y; ER6: N; ER7: Y

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Appendix B

Testing in East Africa

The 20 questions selected for East Africa included: PS1, PS2, PS3, PS6, PS7, PS10, PS11, PS12, RC1, RC3, RC4, RC6, RC7, H1, H3, H5, H7, ER1, ER4, and ER6. Of these 20 questions, two were reworded, indicated by brackets and strikethrough below.

RC1. If I have new redness, [abrasion, or wound] on my leg that does not go away, I should go back to the clinic.

RC7. If the socket cracks, I [should] go to the clinic as soon as possible.

Keywords:

knowledge; assessment; patient education; prosthesis; international; prosthetic management

© 2017 by the American Academy of Orthotists and Prosthetists.