Consensus-Based Recommendations for Comprehensive Clinical Assessment in Prosthetic Care: A Delphi Study

Abstract

Background/Objective: The most effective strategy for addressing users’ prosthetic needs is a comprehensive clinical assessment that provides a holistic understanding of the individual’s symptoms, health, function, and environmental barriers and facilitators. A standardized evaluation form would provide guidance for a structured approach to comprehensive clinical assessments of people with LLA. The objective of this study was to determine a list of relevant elements to be included in prosthetic evaluation for adults with lower limb amputation. Methods: Three independent focus group discussions were conducted with prosthetists (n = 15), prosthesis users (n = 11), and decision makers (n = 4) to identify all relevant elements that should be included in the clinical assessment of prosthetic services. The final content was then determined using the Delphi technique, with 35 panelists (18 prosthetists and decision makers, and 17 prosthesis users) voting in each round. Results: A total of 91 elements were identified through the focus group, of which 78 were included through the Delphi process. The identified elements are mostly related to the physical health of the prosthesis user (e.g., mobility, pain, and medical information), while others address personal or psychosocial aspects (e.g., activities of daily living, goals, and motivation) or technical aspects (prosthesis-related). Conclusions: Through a Delphi consensus, a list of relevant elements to be included in a prosthetic evaluation was generated. These results will inform the development of a standardized clinical prosthetic assessment form. This form has the potential to improve the quality of clinical evaluations, guide interventions, and enhance the well-being of prosthetic users.

1. Introduction

Approximately 86% of individuals with a major (i.e., at or proximal to the ankle) lower limb amputation (LLA) are fitted with a prosthesis to optimize mobility, and social participation [1,2]. Prosthetists and orthotists design and fabricate these prosthetic devices. Adults with LLA require ongoing prosthetic services throughout their lives to ensure proper maintenance of the prosthesis, accommodate technological advancements, and address evolving needs, functional abilities, and goals [3]. The most effective strategy for addressing users’ prosthetic needs is a comprehensive clinical assessment that provides a holistic understanding of the individual’s symptoms, health, function, and environmental barriers and facilitators [4,5,6]. Clinical outcome measures, which quantify the changes in health resulting directly from healthcare interventions [7], should be evaluated through various sources, including standardized testing, on an individual basis. This approach improves clinical decision making by allowing the monitoring of users’ progress over time and informing prosthetic adjustments [8]. Regular monitoring of clinical outcomes in practice settings is essential, as these measures reflect users’ functional capacity in their environment [9].

The lack of standardized assessments in prosthetics and orthotics services has been reported in various developed countries [6,7,10,11,12]. For example, Young et al. [13] found that only 28% of prosthetists and orthotists in the United Kingdom were routine users of health outcome measures, and Gaunard et al. [10] showed that only 38% did so in the United States. The lack of systematic measurement of clinical outcomes in clinical settings has multifaceted causes. A lack of knowledge about different outcome measures and their administration procedures, the burden of data collection and management have been identified as barriers to use [7,12]. Few initiatives have been taken in recent years to promote and support the use of outcome measures in clinical prosthetics settings. Examples include restructuring educational curricula around important clinical reasoning variables for orthotics and prosthetics students [14], and offering prosthetists interactive training in tests administration [10].

These strategies have been shown to improve prosthetists’ confidence in administering outcome measures [10], but other strategies are needed to overcome the challenges of data collection and management [7,11]. Prosthetists have expressed that a lack of clinical time is a significant barrier to using outcome measures. They have suggested that developing efficient strategies for collecting and managing outcome data is a potential solution [7,11].

A standardized evaluation form would provide guidance for a structured approach to comprehensive clinical assessments of people with LLA, ensuring that all important data, including outcome measures, are collected efficiently and systematically. However, such forms do not currently exist in clinical settings in Quebec, Canada. Moreover, integrating an evaluation form into a digital platform has several advantages, including the incorporation of clinician-reported measures, performance-based measures, and patient-reported outcome measures (PROMs). Integrating more PROMs into the platform is an efficient strategy for reducing the time needed for clinical assessments [11]. It could provide prosthetists with real-time information about patients’ goals, prosthetic-related symptoms (e.g., pain), identification of problems (e.g., prosthesis-related), and patient functioning. Electronic capture of clinical information allows prosthetists to assess and monitor changes in a patient’s functional ability following a prosthetic intervention [15,16]. Sharing this information with patients could promote shared decision making and support a patient-centered treatment plan aligned with the users’ values and preferences [15]. This information could also be used by prosthetists to justify the funding or reimbursement for prosthetic devices [10].

The aim of our research is to develop an online interactive platform for clinical assessment and follow-up in prosthetic service settings. This interactive platform will be developed in collaboration with prosthetists, prosthetic users, and decision makers [6,7,17] (i.e., managers), to ensure that it meets the needs of the target population. Multiple steps are needed to develop this digital tool, including determining the content, developing the platform, and evaluating the feasibility of its implementation [17]. This article presents the first step in this process: determining the relevant content to include in the standardized evaluation form. While measurement of clinical outcomes is important, sociodemographic data [6], patient objectives and preferences [7], physical and mental health indicators [6], and psychosocial and social factors [6] may also be important elements to consider, as they may be potential barriers or facilitators to prosthesis use [6].

2. Methods

2.1. Study Design

To ensure comprehensive inclusion of relevant information, the elements to be included should be determined from the perspective of the stakeholders [18]. First, three independent focus group discussions were conducted with prosthetists, prosthesis users, and decision makers to identify all relevant elements that should be included in the clinical assessment of prosthetic services. Then, a three-round electronic Delphi study was conducted [19]. This study is reported according to the Accurate Consensus Reporting Document (ACCORD), a reporting guideline for consensus methods in biomedicine [18]. Ethical approval was obtained from the CRIR Research Ethics Committee on Rehabilitation and Physical Impairment (CRIR-1476-0320 2023-5-31).

2.2. Participants

The participants included prosthetists, prosthesis users with LLA, and decision makers. The prosthetists and decision makers were recruited via email from six public prosthetic clinics in the province of Quebec. The inclusion criterion was having at least two years of professional experience, and the sample was formed using convenience sampling. Prosthesis users with LLA were recruited from the same clinics by referral from their prosthetist or from lists of patients who had previously consented to being contacted for research projects. Purposive sampling was used to include people with different types of amputation (i.e., tibial or femoral), different causes of amputation (i.e., traumatic, vascular, or cancer), and different durations of prosthesis use, with the goal of achieving diverse representation of prosthesis users. All participants provided written consent to participate in this study.

2.3. Focus Groups

Three independent focus group discussions were conducted with prosthetists (n = 15), prosthesis users (n = 11), and decision makers (n = 4). Topic guides were developed and adapted for each participant category. Topics covered included current clinical assessments and documentation, and important clinical aspects to be assessed when providing prosthetic care and services. The objective was to identify all relevant elements (including socio-demographic information, clinical tests, etc.) that should be included in the clinical assessment of prosthetic services and in the online interactive platform. The focus groups were recorded and transcribed verbatim. An inductive thematic analysis approach was used to identify relevant elements [20,21].

2.4. The Delphi Process

After this initial step, a list of elements was generated. An environmental scan was then conducted to identify additional elements from the Compendium of Orthotics and Prosthetics Canada and the Association of Orthotists and Prosthetists of Quebec. These two professional organizations are responsible for defining professional standards and ensuring patient safety.

A Delphi panel consisting of prosthetists (n = 13), prosthetic users (n = 17), and decision makers (n = 5) was presented with the complete list of elements. The Delphi technique is a method used to gather opinions and achieve consensus among a group of experts on a specific topic. It involves multiple rounds of anonymous questionnaires and feedback, which allows participants to refine their views based on others’ input. This technique is particularly relevant in our study because the stakeholders involved in prosthetic care are dispersed across different locations and have diverse areas of expertise. Additionally, this technique allows participants to contribute anonymously, which can help prevent one group of experts from dominating the consensus process [22].

The objective was to reach consensus through iterative rounds with feedback on the relevant elements to be included. An electronic Delphi (e-Delphi, LimeSurvey, Hamburg, Germany) was used to facilitate panelist participation throughout the province of Quebec. All panelists received an individualized link by email to access the list of elements. For each round, panelists were instructed to rate the relevance of each item in the evaluation and follow-ups of prosthetic users’, using a 9-point Likert scale (from 1 = least relevant; to 9 = most relevant) [21,23]. Panelists were given the opportunity to suggest additional elements for inclusion. If a suggestion was made, it was added to the next round. In case of missing responses, reminders were sent via email.

A mean score was calculated for each item, for both panelist subgroups (Group 1: prosthetists/decision makers and Group 2: prosthesis users). Mean scores ≤ 3 were grouped and rated as not relevant, scores ranging from 4 to 6 were rated as undefined, and scores ≥ 7 to 9 were rated as relevant. For each item, consensus was reached for inclusion if: (1) both groups rated the item as relevant (i.e., prosthesis users and prosthetists/decision makers), and (2) if ≥ 75% of panelists in both groups rated the item as relevant. Exclusion consensus was achieved when: (1) the mean score of the item was ≤3 and both groups rated it as such, and (2) ≥75% of panelists in both groups rated the item as not relevant. Items that met these criteria were either included or excluded and not presented in the next round.

Any item that did not reach a consensus was presented again in the second round. This process was repeated for the third round. After the third round, elements that still lacked consensus were included if one of the two groups (prosthetists/decision makers or prosthesis users) met the inclusion criteria, i.e., if (1) the mean score of the item was rated as relevant and if (2) at least 75% of the panelists rated the item as relevant. Items for which neither group met these criteria were excluded.

3. Results

Demographic characteristics of the panelists are presented in

Table 1. Panelists’ sociodemographic characteristics.

Characteristics	Prosthetists and Decision Makers n = 18	Prosthetic Users n = 17
Age, mean (SD)	44 (7)	60 (10)
Gender, %
Men	2 (11)	9 (53)
Women	16 (89)	8 (47)
Years of clinical experience, mean (SD)	21 (9)	-
Amputation, %
Unilateral	-	16 (94)
Bilateral	-	1 (6)
Level of amputation
Transfemoral	-	5 (29)
Transtibial	-	11 (65)
Other	-	1 (6)
Time since amputation (years), mean (SD)		22 (19)
Cause of amputation, n (%)
Infection	-	1 (6)
Dysvascular	-	2 (12)
Trauma	-	11 (64)
Cancer	-	1 (6)
Other	-	2 (12)
Highest certificate, diploma or degree obtained, n (%)
Highschool or equivalent	0 (0)	5 (29)
Professional degree or college	15 (83)	5 (29)
Bachelor	2 (11)	4 (24)
Master or doctorate	1 (6)	3 (18)

.

After analyzing the interviews and focus groups, 91 elements were identified for inclusion in the Delphi process. The initial list was sent to the panelists on 21 November 2023, and all panelists in both groups completed it. After the first round, 51 elements reached consensus and were included. The remaining elements were returned to the panelists on 11 March 2023, for the second round. In the second round, one panelist in the prosthetist/decision maker group did not respond (n = 1/18 lost to follow-up). All panelists in the prosthesis user group completed the Delphi survey. After the second round, 16 elements met the inclusion criteria, for a total of 67/91 elements. The remaining 18 elements were returned to the panelists on 15 April 2023, for the third and final round, with no additional loss to follow-up (n = 17/18 prosthetists/decision makers, n = 17/17 prosthesis users). Eleven elements met the inclusion criteria for Round 3, for a total of 78/91 elements to be included (Figure 1,

Table 2. Final list of elements included (n = 78).

Elements
1. General information of prosthetic users	Not included
Name	Sex
Date of birth	Adress
Healthcare insurance number	Email address
Phone number
Paying agent
Shoe size
Reason of consultation
Client’s goals
Client’s motivation
2. Medical and rehabilitation information	Not included
Deterioration history of the amputated limb	Amputation hospital
Date of last amputation	Referring physician
Referring physician	Smoking status
Cause of amputation	Alcohol use
Level of amputation	Drug use (including cannabis)
Amputation side	Date of rehabilitation admission
Presence of intermittent claudication	Date of rehabilitation discharge
Visual or auditory impairment
Patient weight without prosthesis
Patient height
Comorbidities (e.g., vascular, diabetes, hypertension, etc.)
Allergies
Follow-up(s) with other healthcare professionals
Current medications
Place of rehabilitation
Treating physiatrist
3. Environmental context
Type of housing
Stairs in the home
Living alone or not
Presence of current support (social services, family and/or friends)
Availability of help from a relative for donning and removing the prosthesis
4. Current prosthesis and prosthetic history
Description of prosthetic components (socket, suspension, knee, foot, etc.)
Integrity of prosthetic components (to be replaced or not)
Hygiene of the sleeve and prosthesis
Prosthetic history, if applicable (what worked and what didn’t with previous prostheses)
Problems (current and known recurring) with current prosthesis
Prosthesis use (h/day, no. of days/week)
Reasons for not using the prosthesis (if applicable)
Satisfaction and comfort with the prosthesis
5. Pain
Phantom pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)
Residual limb pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)
Pain in contralateral limb (e.g., intensity, frequency, interference with activities, factors increasing or decreasing pain)
Low back pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)
Other pain with description of intensity, frequency, interference with activities, factors increasing or decreasing pain, etc.
Pain when walking with or without prosthesis (residual limb, contralateral limb)
6. Activities and participation (other than mobility)	Not included
Number of falls in the last month	Autonomy to manage finances, bills, etc.
Driving
Independence in activities of daily living
Use of technical mobility aids before amputation
Type(s) of technical mobility aid(s) used
Current main occupation
Physical activities and main leisure activities
Autonomy to don and doff the prosthesis
Autonomy in activities of daily living (ADLs) (e.g., cooking, housework/laundry, shopping, transportation)
7. Physical examination and measures
Skin integrity (wounds, scar tissue/skin grafts/skin problems on residual limb and non-amputee limb, scar mobility)
Assessment of color/temperature of residual limb and non-amputee limb
Presence and location of neuroma on residual limb
Presence and measurement of contractures (especially hip and knee flexors)
Assessment of sensitivity of residual limb and non-amputee limb (e.g., light touch, prick sensation test)
Lower limb muscle strength
Upper limb muscle strength
Lower limb joint amplitude
Joint amplitude of upper limbs
Anthropometric measurements: residual limb length, edema
Type and use of compression method (e.g., elastic bandage)
Level of autonomy for compression method
7.1 Mobility without prosthesis	Not included
Standing balance (static and dynamic)	Maximum walking distance
Transfer autonomy (e.g., sit-stand; wheelchair-bed)
Unipodal walking autonomy
Technical mobility aids used
7.2 Mobility with prosthesis	Not included
Standing balance (static and dynamic)	Description of gait pattern
Transfer autonomy (e.g., sit-stand; wheelchair-bed)
Prosthesis alignment (static and dynamic)
Walking speed
Technical mobility aids used
Autonomy in locomotor activities (e.g., stairs, slopes, sidewalks, transferring to and from the ground, walking on uneven ground, etc.).
8. List of priority problems
9. Prosthetic treatment plan

). Detailed lists of elements for each round are presented in the Appendix files (Appendix A, Appendix B and Appendix C).

4. Discussion

The aim of this study was to reach a consensus on the most relevant content for a future online clinical evaluation platform for prosthetic services. Through the Delphi method, a consensus was reached on the final content, which included 78 elements, based on stakeholder perspectives to ensure comprehensive inclusion of relevant information [18].

The elements selected as important for assessing the provision of prosthetic services were categorized into different areas, including the collection of personal and medical information, information related to the environmental context, technical elements (prosthetic components, use, comfort, and satisfaction), and the physical health of the prosthesis user (pain and clinical assessment, including mobility with and without the prosthesis) [6,24]. These elements include outcomes and factors that may influence the prescription and use of lower limb prostheses and are consistent with previous research [6,24].

Prior research has reported a lack of systematic assessment in prosthetics and orthotics services [6,7,10,11,12]. Few initiatives have been taken in recent years to promote and support the use of outcome measures in clinical prosthetics settings, mainly through education to students and prosthetics [10,14]. However, with the burden of data collection and management being a barrier to standardized assessment [7,12], strategies are still needed to overcome the challenge of data collection [7,11]. Developing an online standardized evaluation form will provide guidance for standardized clinical assessments of clients, ensuring that important data are collected efficiently. Currently, such forms do not exist in Quebec’s clinical settings, and to the best of our knowledge, no previous studies have reported the clinically relevant elements to include in such a tool. Thus, this study is the first to provide a detailed list of the important elements to include in a standardized clinical prosthetic assessment for adults with LLA, as determined by stakeholders. In addition to informing the development of the online interactive platform, the results can serve as a basis for other prosthetic clinical settings that wish to develop their own clinical tool.

It should be mentioned that this list represents generic elements and is the first step in designing an online, standardized clinical prosthetic assessment for adults with LLA. Therefore, it does not provide guidance on specific measures or response scales to be included. The next steps in the design process will be to identify the most appropriate standardized measures to assess these outcomes in a prosthetic setting. These measures will include performance-based, clinician-reported, and patient-reported measures. Integrating PROMs with clinician and performance-based assessments can improve prosthetic practice efficiency by reducing the time required for in-clinic evaluations [25,26]. To enhance their use, it is essential to select measures that have adequate psychometric properties, minimal administrative burden, and meet the needs of prosthetists and patients. In addition, developing processes for interpreting and acting on the information collected through this assessment will be part of the design phase, as it may impact the implementation and use of this clinical prosthetic assessment [12,26].

This study has several strengths that are worth mentioning. First, the project included representatives of decision makers, prosthetists, and prosthetic users to obtain a comprehensive and global point of view. The elements were included based on a consensus between the two groups. Second, the response rate was good at each round of the Delphi process. Third, panelists could suggest adding items throughout the process to ensure comprehensive methods. However, the Delphi method may present some limitations. For example, the definition of consensus is arbitrary. Nevertheless, we used two criteria: the mean score and a target of 75% of panelists agreeing. We believe this was optimal in this context. We sought to include adults with LLA with different clinical profiles to ensure representation of users with various amputation levels and causes. However, the sample was mainly composed of people with traumatic LLA, due to the low recruitment rate among other aetiologies. The results might have differed slightly in a sample composed mainly of people with vascular LLA if greater importance had been given to elements related to vascular amputation risk factors or common comorbidities. Finally, it should be acknowledged that this Delphi study was conducted in Canada, where prosthetists are professionals with unique role, obligations and independence. It is possible that professional requirements and tasks vary in other contexts, and that these results would not apply or would apply differently.

5. Conclusions

This Delphi study provides the first comprehensive and detailed list of elements that should be included in the prosthetic evaluation of adults with lower limb amputation. These results will inform the development of an online, interactive platform that aims to standardize clinical prosthetic assessments while reducing the burden of data collection and management. This platform has the potential to improve the quality of clinical evaluations, guide interventions, and enhance the well-being of adults with lower limb amputation.