University of Groningen Trans-tibial prosthesis fitting and prosthesis satisfaction Baars, Erwin

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University of Groningen

Trans-tibial prosthesis fitting and prosthesis satisfaction

Baars, Erwin

DOI:

10.33612/diss.132703991

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Publication date: 2020

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Citation for published version (APA):

Baars, E. (2020). Trans-tibial prosthesis fitting and prosthesis satisfaction. University of Groningen. https://doi.org/10.33612/diss.132703991

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Chapter 4

Biomedical and psychosocial factors influencing trans-tibial prosthesis fit:

a Delphi survey among health care professionals

Baars EC, Schrier E, Geertzen JH, Dijkstra PU Disabil Rehabil 2015;37(21):1946-1954

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Chapter 4

Biomedical and psychosocial factors influencing trans-tibial prosthesis fit:

a Delphi survey among health care professionals

Baars EC, Schrier E, Geertzen JH, Dijkstra PU Disabil Rehabil 2015;37(21):1946-1954

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while the prosthesis is used. The term biomedical refers to the tissue integrity that must be maintained in relation to the biological and physiological processes in the residual limb together with medical conditions that may influence tissue integrity, i.e. skin disease or vascular insuf-ficiency as a result of arteriosclerosis or diabetes. Adequate knee range of motion (ROM), while performing activities such as cycling and climbing stairs, is also related to the biomedical fit of the prosthesis.3_{An amputation and subsequent fitting of a prosthesis have a psychological and}

social impact.4 _{The appearance of the body has changed after the amputation, and uncertainty}

may arise about functioning with a prosthesis at home, at work or during recreational activities. Individuals’ perceptions of themselves, ideas about the prosthesis and the acceptance of the prosthesis as being part of the individual, influences the fit of a prosthesis in a psychosocial sense.4-16_{As such the psychosocial fit of the prosthesis is the way the prosthesis fits a person}

with an amputation, psychologically and socially. Expressing excessive concerns about the ap-pearance of the prosthesis, hiding the residual limb from others and inadequate coping with the change in body image may be signs of poor psychosocial fit.11-13_{Thus a good psychosocial fit}

ensures adequate acceptance of the prosthesis by both the patient and the people in his or her surroundings. Pain reported by people with a transtibial amputation is a complex issue. Pain may be the result of a poor biomedical fit and has a negative psychological and social effect on the prosthesis user. Eighty-seven percent of the people with traumatic limb amputations expe-rience (phantom or residual limb) pain, and they report significantly higher affective distress than do those without pain.14,16_{Pain may also be an expression of dissatisfaction with the}

pros-thesis when no apparent problem with the biomedical fit can be found.16_{In seeking a good}

prosthesis fit, “trial and error”, based on the experience of involved professionals (the certified prosthetist (CPO), the physiatrist and physical therapist), is often the standard.15,17-19 _{A more}

comprehensive and systematic method of assessing prosthesis fit is needed since 65% of people with a transtibial amputation report skin problems of the residual limb that may be related to the biomedical fit.20_{Additionally in people with a trauma-related amputation, 57% were}

dis-satisfied with the comfort of the prosthesis fit and 24% reported skin irritation and wounds.21

This shows that although a good biomedical fit is sought after, it is not always achieved and continues to present a major challenge in prosthetic care.17,18,22-25

Current instruments to evaluate prosthesis fit assess only a limited number of factors.For ex-ample, the socket comfort score has been used to assess solely the comfort of the socket fit in people with a lower limb amputation26_{, while the Trinity Amputation and Prosthesis}

Experi-ence Scales (TAPES), the Prosthetic Profile of the Amputee (PPA) and the Prosthesis

66 Abstract

Purpose: We aimed to reach consensus among professionals caring for prosthesis users, on

definitions of biomedical and psychosocial factors, to assess their influence on fit of a transtibial prosthesis and to identify new factors.

Method: A three round, internet-based Delphi survey was conducted among experts recruited

via the Dutch National Amputee and Prosthesis Work Group. The main outcome measure was consensus among care professionals on statements concerning new and presented biomedical and psychosocial factors that influence transtibial prosthesis fit.

Results: Fifty-four experts participated in the survey and consensus was reached on 67%

(46/69) of all statements. Consensus on statements relevant for good prosthesis fit was reached in most of the statements concerning psychosocial factors and on statements concerning the biomedical factors “prosthesis support and suspension”. Least consensus was reached on state-ments concerning the biomedical factor “skin problems and pain in the residual limb”.

Conclusions: Biomedical and psychosocial factors influence transtibial prosthesis fit.

Consen-sus was reached among care professionals in a majority of the presented statements concerning these factors.

Key words: amputee care, prosthesis fit, biomedical factors, psychosocial factors List of abbreviations:

ROM: Range of Motion

TAPES: Trinity Amputation and Prosthesis Experience Scale PPA: Prosthetic Profile of the Amputee

PEQ: Prosthesis Evaluation Questionnaire CPO: Certified Prosthetist

Introduction

A good prosthesis fit is a prerequisite for functioning with a prosthesis after an amputation and therefore an important goal in prosthetic care of people with a transtibial amputation.1-3_{A good}

socket fit, the prosthesis-residual limb interface, is not clearly defined but is nonetheless crucial for a good prosthesis fit. It ensures fit of the prosthesis to the residual limb, the biomedical fit. Biomedical fit of the prosthesis should be comfortable and cause no wounds or pain. It main-tains the integrity of the residual limb tissue including skin, muscles, blood vessels and nerves

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The results of each round were gathered by an independent office and sent via e-mail in a Word document (Microsoft Word 2002, Microsoft Office XP Standard 2002) to the first author (EB) for further analysis.

Experts

Physiatrists (consultants in rehabilitation) from the Dutch National Amputee and Prosthesis Work Group, an advisory group of the Netherlands Society for Physical and Rehabilitation Medicine, were asked to participate in the survey. Physiatrists from all health care regions in the Netherlands who have interest and expertise in the care of people with a lower limb ampu-tation and in prosthesis technology are members. These physiatrists were asked to recruit other professionals in prosthesis care. Experts were eligible to participate if they met the following criteria: working in rehabilitation teams specializing in care of people with an amputation and/or engaged in prosthetic research and they had (1) published in international peer reviewed journals and (2) given (inter)national lectures on prosthesis care. All included experts were assigned a unique number to guarantee anonymity during the survey.

Consensus

Prior to the survey, consensus was operationalized as being reached when at least 75% of the experts “completely agreed” with a statement. Statements were discarded when 25% or more of the experts “completely disagreed”. A statement was undecided and adapted for the next round when fewer than 75% of the experts completely agreed and fewer than 25% completely disagreed. This definition of consensus was chosen because it gives clear contrast between dis-agreement and consensus.

Rounds

Rounds were used to give participating experts the chance to contribute new statements and priorities and consider agreeing on statements in a stepwise fashion. In the first round 67 state-ments and 23 questions were presented (Figure 1, Table IV). After each statement, experts were invited to further specify their opinion regarding that statement. Additionally, we invited par-ticipants to add new factors in an open text section. The survey took approximately 90 minutes to complete. Two months were given to respond to the first round and reminder e-mails were sent after 4 and 6 weeks. Non-responders received an extra reminder a few days before the closing of the round. In the first-round analysis, the first author (EB) gathered the results of the

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Evaluation Questionnaire (PEQ) focus mainly on physical functioning with a prosthesis. 9,27,28

Factors supposed to influence prosthesis fit have been described in literature only in general terms and studied to a limited extent, giving insufficient base for a systematic and comprehen-sive assessment of prosthesis fit.2,5,6,8,10,21,28,29-31

The aims of this study were (1) to reach consensus on definitions of biomedical and psychoso-cial factors, (2) to assess their influence on transtibial prosthesis fit, and (3) to identify new factors suggested by experts using the Delphi consensus survey method. A Delphi method was chosen because it provides insight in current opinions of health care professionals regarding factors influencing transtibial prosthesis fit with the aim of reaching consensus. 32-34 _{In this way}

a base is created for systematic fit assessment and improvement. Prior Delhi surveys focused mainly on consensus regarding prosthesis prescription, use and technology. 19,29 _{Ultimately, we}

aim to develop a standardized assessment tool enabling the health care professional to system-atically assess biomedical and psychosocial factors and target them, if necessary, during care of prosthesis users.

Methods

Survey

Biomedical and psychosocial factors that could influence prosthesis fit were identified through literature study and clinical expertise.1-27,29_{All factors identified were used to construct}

state-ments and questions in Dutch by the first author (EB) for the concept version of the Delphi survey. The concept version was assessed by the other authors (ES, JG, PD) and adapted for presentation to an expert panel. The Delphi survey consisted of three rounds.

Design

An electronic questionnaire containing the statements was placed on a specially developed web-site. Participants entered the website after entering a personal code and password. Questions could be answered with “yes” or “no”. Statements could be answered in the first and second round with: “totally agree”, “partially agree”, “totally disagree”, and “I do not feel competent to answer this statement (no expertise)”. This last option was included so that experts who had no expertise concerning a specific statement or question were not forced to answer it. This option was unavailable in the third round to specifically encourage experts to agree or disagree with a statement in this round, stimulating the formation of opinions and obtainment of data.

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71 Discussion

Consensus was reached in the first round on all statements regarding biomedical fit that con-cerned prosthesis support and suspension. Consensus was also reached on one of the two state-ments concerning “knee range of motion” (Table II, Table IV). Some experts stated that the prosthesis always limits knee ROM to a certain degree and that therefore prosthesis fit is never optimal, while other experts stated that knee problems may limit knee ROM independent of prosthesis fit. Statements concerning “movement of the residual limb in socket”, were difficult to reach consensus upon (Table IV). Comments were so contradictory that adaptation by us was impossible. For example, in a statement concerning “movements of the residual limb in the socket”, we stated that these movements were in a vertical direction (pistoning), in a lateral direction (tilting) and rotatory. Some experts stated that these movements were indeed the ones the residual limb makes in the socket and that they should be absent at all times. Other experts stated that (some) movement is necessary and preferred when sitting and acceptable if the in-tegrity of the residual limb is not compromised and the fit is comfortable.It was also claimed that movement is largely dependent on the type of prosthesis used. Others stated that muscles and bones in the residual limb always move. Radiographic evaluation has shown that movement of the residual limb in the socket occurs while walking. 24_{Only 3 out of 11 statements, regarding}

“skin problems and pain in residual limb”, could be agreed upon by the experts. Additionally, experts stated that complaints such as stasis of blood or nerve compression may arise when the prosthesis fit is too tight. These opinions are in agreement with the experience of prostheses users, for many of them are not satisfied with the comfort of the prosthesis and complain of tightness and discomfort.2_{Twenty five percent report skin problems as a result of intense}

pros-thesis use and/or misalignment. 21,25_{Additionally, incorrect hygiene, medical conditions}

(dia-betes, vascular insufficiency) and inadequacy of donning and doffing are known to cause skin problems.5,21,35-37 _{The experts in our survey were also of the opinion that these factors were}

important. Professionals and prosthesis users, agree that “residual limb pain”, “residual limb range of motion” and “being able to donn and doff the prosthesis independently” predict pros-thesis use.29

A disproportionately great number of factors was related to psychosocial fit, reflecting the va-riety of factors influencing psychosocial fit and the substantial amount of research concerning these factors in recent years.4,6-16,38,39 _{Consensus was reached on a majority (82%) of the}

psy-chosocial statements. One hundred percent consensus was reached on statements concerning “social support”, meaning the support the patient gets from the people in his or her surroundings

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questionnaires, recorded new factors and analyzed the presented statements for consensus, dis-carding or adapting them when consensus was not yet reached. New statements were con-structed using the newly suggested factors. Next, new and adapted statements were assessed by the other authors (ES, JG, PD) and further refined if necessary. The second round aimed for consensus on the new and adapted statements from the first round. Experts could not add new factors. The results of this round were assessed identically to the first round. The third round consisted of the adapted statements and all comments from the experts on previous statements. Four weeks were given each to complete the second and third round, with reminders sent after 2 weeks and a few days before closing of the round.

Results

Experts

Sixty-seven health care professionals were invited via e-mail to participate in the survey, of whom 54 (81%) agreed. The expert panel consisted of 13 physiatrists, 16 physical therapists, 13 certified prosthetists, 6 psychologists and 6 social workers (Table I). Experts worked in re-habilitation clinics and hospitals in different regions in the Netherlands: 13 (24%) in the north, 19 (35%) in central, 6 (11%) in the south, 9 (17%) in the west and 6 (11%) in the east, and one (2%) expert was a Dutch CPO working in Scotland.

Rounds

In the first round, the response rate was 100% (Figure 1). Consensus was reached on 19 (28%) of the statements (Figure 1, Table II). Eighteen statements (27%) were discarded (Table III) and 30 (45%) were undecided and adapted for the second round (Figure 1). Two new statements were constructed and presented in the second round, based on new factors given by the experts regarding confidence in the rehabilitation team. In the second round, the response rate was 85%, with consensus on 19 (59%) of the statements (Figure 1, Table II); 2 (6%) were discarded (Fig-ure 1, Table III) and 11 (34%) were undecided and adapted for the third round. In the third round, the response rate was 87%, with consensus on 8 (73%) of the statements (Figure 1, Table II). Three (27%) statements were discarded (Figure 1, Table III). In total, consensus was reached on 67% (46/69) of statements (Figure 1, Table II) and 23 were discarded (Figure 1, Table III). The statements most often discarded concerned “movement of the residual limb in the socket” (6 out of 8) and “skin problems and pain in residual limb” (8 out of 11).

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