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Article

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

1
Center for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris), CIUSSS de la Capitale-Nationale, 525 boulevard Wilfrid-Hamel, Québec, QC G1M 2S8, Canada
2
School of Rehabilitation Sciences, Faculty of Medicine, Université Laval, Québec, QC G1V 0A6, Canada
3
Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal (IURDPM), Centre Intégré Universitaire de Santé et de Services Sociaux du Centre-Sud-de-l’Île-de-Montréal, Montreal, QC H3S 2J4, Canada
4
School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, QC H3T 1J4, Canada
5
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Montreal, QC H3S 1M9, Canada
*
Author to whom correspondence should be addressed.
Prosthesis 2025, 7(4), 92; https://doi.org/10.3390/prosthesis7040092 (registering DOI)
Submission received: 26 May 2025 / Revised: 11 July 2025 / Accepted: 14 July 2025 / Published: 1 August 2025
(This article belongs to the Section Orthopedics and Rehabilitation)

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).

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.
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). 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.

Author Contributions

D.Z., B.S. and C.A. developed the protocol of this study. D.Z. moderated the focus group. D.Z. and M.P. analyzed the results. F.D. prepared the original draft of the manuscript and performed data synthesis. All authors have read and agreed to the published version of the manuscript.

Funding

Programme de recherche clinique du Réseau provincial de recherche en adaptation-réadaptation, supported by the Fonds de recherche du Québec–secteur Santé (FRQS).

Institutional Review Board Statement

Ethical approval was obtained from the CRIR Research Ethics Committee on Rehabilitation and Physical Impairment (CRIR-1476-0320).

Informed Consent Statement

All participants provided informed written consent.

Data Availability Statement

Anonymized data set will be available upon request to the corresponding author.

Acknowledgments

The authors would like to thank all the participants who took part in this study.

Conflicts of Interest

The authors declare no conflicts of interest.

Abbreviations

ACCORDAccurate Consensus Reporting Document.
LLALow limb amputation.
PROMSPatient-reported outcome measures.

Appendix A. Results Round 1

ElementsProsthetists and Decision Makers
Mean Score (Median)
Prosthetic Users
Mean Score (Median)
% Prosthetists and Decision Makers Who Voted ≥ 7% Prosthetic Users Who Voted ≥ 7
General information of prosthetic users
Name8.9 (9.0)7.47 (9.0)10070.6
Date of birth8.3 (9.0)7.18 (7.0)88.964.7
Sex5.8 (6.0)4.8 (4.0)44.429.4
Healthcare insurance number7.9 (9.0)6.82 (8.0)77.870.6
Address7.9 (9.0)5.82 (6.0)77.847.1
Phone number8.2 (9.0)7.2 (8.0)94.482.4
E-mail address6.7 (7.0)7.3 (7.0)61.176.5
Paying agent8.7 (9.0)7.2 (7.0)10076.5
Shoe size8.0 (9.0)7.3 (7.0)83.376.5
Reason for consultation8.7 (9.0)7.8 (8.0)10082.4
Client’s goals7.8 (8.0)8.6 (9.0)88.9100
Client’s motivation7.7 (8.0)8.1 (9.0)77.888.8
Medical and rehabilitation information
Deterioration history of the amputated limb7.3 (7.0)8.5 (9.0)77.894.1
Date of last amputation7.5 (7.0)8.3 (9.0)88.994.1
Amputation hospital4.3 (4.0)6.1 (6.0)16.741.2
Referring physician6.4 (7.0)7.2 (7.0)61.182.4
Family doctor4.8 (4.5)6.7 (7.0)27.864.7
Cause of amputation8.2 (9.0)8.4 (9.0)94.488.8
Level of amputation8.4 (9.0)8.7 (9.0)10094.1
Amputation side8.2 (9.0)8.2 (9.0)88.988.8
Smoking status5.8 (6.0)6.4 (7.0)33.364.7
Alcohol use5.5 (6.0)6.2 (7.0)33.358.8
Drug use (including cannabis)5.4 (5.0)6.0 (7.0)33.358.8
Presence of intermittent claudication7.2 (7.0)7.8 (8.0)83.388.8
Visual or hearing impairment7.1 (7.00)8.1 (8.0)72.294.1
Patient weight without prosthesis7.7 (8.0)7.8 (8.0)94.488.8
Patient height7.1 (7.0)7.3 (7.0)72.276.5
Common comorbidities (e.g., vascular disease, diabetes, hypertension, etc.)7.8 (8.0)8.2 (9.0)88.994.1
Allergies7.2 (7.0)7.4 (8.0)77.882.4
Follow-up(s) with other health care professionals6.9 (7.0)7.7 (8.0)66.782.4
Current medications6.9 (7.0)7.8 (9.0)61.170.6
Place of rehabilitation5.5 (6.0)7.8 (8.0)33.382.4
Date of rehabilitation admission 5.8 (6.0)7.8 (9.0)44.482.4
Date of rehabilitation discharge 5.8 (6.0)7.5 (9.0)38.982.4
Treating physiatrist7.2 (7.5)8.4 (9.0)66.782.4
Environmental context
Type of housing5.6 (6.0)7.9 (9.0)33.382.4
Stairs in the home7.1 (7.0)8.2 (9.0)77.894.1
Living alone or not6.8 (7.0)7.7 (8.0)66.788.8
Presence of current support (social services, family and/or friends)7.0 (7.0)7.9 (8.0)77.888.8
Availability of help from a relative for donning and removing the prosthesis7.4 (7.0)8.4 (9.0)83.3100
Prosthetic history
Description of prosthetic components (socket, suspension, knee, foot, etc.)7.9 (8.0)7.7 (8.0)94.482.4
Integrity of prosthetic components (to be replaced or not)7.6 (8.0)7.9 (8.0)83.382.4
Hygiene of the sleeve and prosthesis7.4 (7.0)8.1 (9.0)72.288.8
Prosthetic history, if applicable (what worked and what didn’t work with previous prostheses)8.0 (8.0)8.7 (9.0)94.494.1
Problems (current and known recurring) with current prosthesis8.4 (9.0)8.9 (9.0)100100
Prosthesis use (h/day, number of days/week)7.6 (8.0)8.7 (9.0)83.394.1
Reasons for not using prosthesis (if applicable)7.8 (7.5)8.7 (9.0)94.4100
Satisfaction and comfort with prosthesis7.9 (8.0)8.9 (9.0)100100
Pain
Phantom pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)7.2 (8.0)8.4 (9.0)72.294.1
Pain in residual limb (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)8.0 (8.0)8.7 (9.0)94.4100
Pain in contralateral limb (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)7.3 (7.0)8.5 (9.0)83.3194.1
Low back pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)6.7 (7.0)8.5 (9.0)66.7100
Other pain with description of intensity, frequency, interference with activities, factors that increase or decrease pain, etc.6.9 (7.0)8.4 (9.0)72.294.1
Pain when walking without prosthesis (residual limb, contralateral limb)7.4 (8.0)8.5 (9.0)77.8100
Pain while walking with prosthesis (residual limb, contralateral limb)7.7 (7.5)8.5 (9.0)83.3100
Activities and participation (other than mobility)
Number of falls in the past month7.6 (8.0)8.4 (9.0)83.3100
Autonomy to donn and doff prosthesis8.1 (8.0)8.7 (9.0)100100
Driving6.7 (7.0)8.1 (9.0)72.2100
Independence in activities of daily living7.8 (8.0)8.4 (9.0)77.894.1
Use of technical mobility aids before amputation6.9 (7.5)8.2 (9.0)61.182.4
Type(s) of technical mobility aid(s) used7.6 (8.0)8.6 (9.0)94.494.1
Current main occupation7.8 (7.5)8.3 (7.0)94.470.6
Physical activities and main leisure activities7.6 (7.0)7.7 (8.0)10088.8
Autonomy to manage finances, bills, etc. (cognitive skills)5.6 (6.0)6.4 (7.0)38.958.8
Autonomy with activities of daily living (ADLs) (e.g., cooking, housework/laundry, shopping, transportation)7.1 (7.0)7.9 (9.0)77.882.4
Physical examination and measures
Skin integrity (wounds, scar tissue/skin grafts/skin problems on residual limb and non-amputee limb, scar mobility)8.3 (9.0)8.8 (9.0)100100
Assessment of color/temperature of residual limb and non-amputee limb7.4 (7.5)8.5 (9.0)72.294.1
Presence and location of neuroma on residual limb7.8 (8.0)8.7 (9.0)100100
Presence and measurement of contractures (especially hip and knee flexors)8.5 (9.0)8.2 (9.0)10088.8
Assessment of sensitivity of residual limb and non-amputee limb (e.g., light touch, prick sensation test)7.0 (7.0)7.9 (8.0)66.788.8
Lower limb muscle strength7.7 (7.5)7.9 (9.0)88.982.4
Upper limb muscle strength6.8 (6.5)6.7 (7.0)5058.8
Lower limb joint amplitude8.0 (8.0)7.9 (9.0)94.482.4
Joint amplitude of upper limbs6.4 (6.0)6.7 (7.0)38.958.8
Anthropometric measurements: residual limb length, edema7.9 (8.0)7.0 (9.0)10082.4
Type and use of compression method (e.g., elastic bandage)7.3 (7.0)7.7 (8.0)66.770.6
Level of autonomy for compression method7.4 (7.5)7.3 (8.0)66.770.6
Mobility without prosthesis
Standing balance (static and dynamic)7.4 (8.0)8.1 (9.0)77.894.1
Transfer autonomy (e.g., sit-stand; wheelchair-bed)6.8 (7.0)8.1 (9.0)72.282.4
Unipodal walking autonomy8.2 (9.0)7.8 (9.0)66.770.6
Technical aids used7.1 (7.0)8.3 (9.0)88.988.8
Maximum walking distance5.9 (6.0)7.5 (9.0)55.670.6
Mobility with prosthesis
Standing balance (static and dynamic)7.4 (8.0)8.5 (9.0)77.894.1
Transfer autonomy (e.g., sit-stand; wheelchair-bed)6.8 (7.0)8.2 (9.0)61.188.8
Prosthetic alignment (static and dynamic)8.2 (9.0)8.7 (9.0)94.4100
Description of gait pattern 7.1 (7.0)8.5 (9.0)66.7100
Walking speed5.9 (6.0)7.5 (8.0)27.870.6
Technical mobility aids used7.4 (8.0)8.2 (9.0)83.388.8
Autonomy in locomotor activities (e.g., stairs, slopes, sidewalks, transferring to and from the floor, walking on uneven surfaces, etc.).7.8 (7.5)8.4 (9.0)10094.1
List of priority problems8.0 (8.0)8.4 (9.0)94.4100
Prosthetic treatment plan8.4 (8.5)8.3 (9.0)10094.1
Prosthesis 07 00092 i001: inclusion consensus. Prosthesis 07 00092 i002: no consensus. Prosthesis 07 00092 i003: Exclusion consensus (No item obtained an exclusion consensus for round 1).

Appendix B. Results, Round 2

ElementsProsthetists and Decision Makers
Mean Score (Median)
Prosthetic Users
Mean Score (Median)
% Prosthetists and Decision Makers Who Voted ≥ 7% Prosthetic Users Who Voted ≥ 7
General information of prosthetic users
Name8.8 (9.0)7.6 (9.0)100.082.4
Date of birth8.5 (9.0)7.4 (8.0)100.070.6
Sex5.7 (6.0)6.7 (8.0)42.152.9
Healthcare insurance number8.5 (9.0)7.2 (9.0)94.776.5
Address8.2 (9.0)6.1 (7.0)89.552.9
E-mail address6.2 (6.0)7.2 (7.0)36.876.5
Medical and rehabilitation information
Amputation hospital4.1 (4.0)6.5 (6.0)0.047.1
Referring physician7.0 (7.0)7.7 (8.0)73.776.5
Family doctor5.5 (6.0)5.9 (6.0)31.641.2
Smoking status5.7 (6.0)6.8 (7.0)36.858.8
Alcohol use5.6 (6.0)6.5 (7.0)31.658.8
Drug use (including cannabis)5.3 (6.0)6.7 (7.0)21.158.8
Visual or hearing impairment7.7 (8.0)8.3 (8.0)94.794.1
Patient height7.1 (7.0)7.3 (7.0)72.276.5
Follow-up(s) with other health care professionals6.7 (7.0)7.7 (8.0)57.976.5
Current medications7.0 (7.0)7.7 (8.0)73.776.5
Place of rehabilitation6.3 (7.0)7.5 (8.0)52.676.5
Date of rehabilitation admission 6.5 (7.0)7.2 (7.0)57.970.6
Date of rehabilitation discharge 6.0 (6.0)7.3 (7.0)52.676.5
Treating physiatrist7.6 (8.0)8.0 (8.0)84.288.2
Environmental context
Type of housing6.9 (7.0)7.3 (8.0)68.476.5
Living alone or not6.9 (7.0)7.9 (8.0)68.4100.0
Pain
Phantom pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)7.9 (8.0)8.1 (8.0)94.7100.0
Low back pain (e.g., intensity, frequency, interference with activities, factors that increase or decrease pain)7.5 (8.0)8.2 (8.0)89.594.1
Other pain with description of intensity, frequency, interference with activities, factors that increase or decrease pain, etc.8.0 (8.0)8.2 (8.0)94.7100.0
Activities and participation (other than mobility)
Current main occupation7.8 (8.0)8.1 (8.0)100.094.1
Driving7.1 (7.0)7.9 (8.0)63.2100.0
Autonomy to manage finances, bills, etc. (cognitive skills)6.4 (7.0)6.4 (6.0)52.647.1
Use of technical mobility aids before amputation7.5 (7.0)8.0 (8.0)84.288.2
Physical examination and measures
Assessment of color/temperature of residual limb and non-amputee limb8.2 (8.0)8.4 (8.0)100.0100.0
Assessment of sensitivity of residual limb and non-amputee limb (e.g., light touch, prick sensation test)7.9 (8.0)8.1 (8.0)94.794.1
Upper limb muscle strength7.4 (7.0)7.4 (7.0)84.264.7
Joint amplitude of upper limbs6.7 (7.0)7.2 (7.0)57.964.7
Type and use of compression method (e.g., elastic bandage)7.8 (8.0)7.8 (8.0)100.094.1
Level of autonomy for compression method7.5 (8.0)7.7 (7.0)94.794.1
Mobility without prosthesis
Transfer autonomy (e.g., sit-stand; wheelchair-bed)7.4 (7.0)8.0 (8.0)84.288.2
Unipodal walking autonomy7.3 (8.0)7.7 (8.0)78.988.2
Maximum walking distance6.9 (7.0)8.0 (8.0)73.788.2
Mobility with prosthesis
Transfer autonomy (e.g., sit-stand; wheelchair-bed)7.1 (7.0)7.7 (8.0)73.788.2
Description of gait pattern5.5 (6.0)7.4 (8.0)57.970.6
Walking speed7.7 (8.0)8.3 (9.0)89.594.1
Prosthesis 07 00092 i001: inclusion consensus. Prosthesis 07 00092 i002: no consensus. Prosthesis 07 00092 i003: Exclusion consensus (No item obtained an exclusion consensus for round 2).

Appendix C. Results, Round 3

ElementsProsthetists and Decision Makers
Mean Score (Median)
Prosthetic Users
Mean Score (Median)
% Prosthetists and Decision Makers Who Voted ≥ 7% Prosthetic Users Who Voted ≥ 7
General information of prosthetic users
Date of birth8.3 (8.0)7.1 (8.0)100.082.4
Sex4.5 (5.0)6.2 (7.0)26.752.9
Address7.9 (8.0)6.6 (7.0)87.152.9
E-mail address5.7 (6.0)6.7 (7.0)26.776.5
Medical and rehabilitation information
Amputation hospital4.0 (4.0)5.5 (5.0)13.323.5
Referring physician7.5 (7.0)7.2 (7.0)86.782.4
Family doctor5.2 (5.0)6.6 (6.0)26.747.1
Smoking status5.2 (5.0)6.8 (7.0)33.370.6
Alcohol use4.7 (5.0)6.5 (6.0)13.341.2
Drug use (including cannabis)5.0 (5.0)6.6 (6.0)20.047.1
Patient height7.1 (7.0)7.3 (7.0)72.276.5
Follow-up(s) with other health care professionals7.3 (7.0)7.5 (7.0)86.788.2
Current medications6.9 (7.0)7.8 (7.0)80.0100.0
Place of rehabilitation5.3 (6.0)7.3 (7.0)26.782.4
Date of rehabilitation admission 5.5 (6.0)7.0 (7.0)33.364.7
Date of rehabilitation discharge 5.4 (6.0)6.6 (7.0)33.352.9
Environmental context
Type of housing7.5 (8.0)7.3 (7.0)87.188.2
Living alone or not7.7 (8.0)7.8 (7.0)100.094.1
Driving6.9 (7.0)7.9 (8.0)73.3100.0
Activities and participation (other than mobility)
Autonomy to manage finances, bills, etc. (cognitive skills)6.2 (6.0)6.6 (7.0)40.064.7
Physical examination and measures
Upper limb muscle strength7.3 (7.0)8.1 (8.0)87.194.1
Joint amplitude of upper limbs7.1 (7.0)7.7 (8.0)66.788.2
Mobility without prosthesis
Maximum walking distance6.6 (7.0)7.6 (8.0)66.788.2
Mobility with prosthesis
Transfer autonomy (e.g., sit-stand; wheelchair-bed)7.6 (7.0)7.9 (8.0)100.0100.0
Description of gait pattern4.9 (5.0)6.6 (7.0)20.064.7
Prosthesis 07 00092 i001: inclusion consensus. Prosthesis 07 00092 i003: Exclusion consensus.

References

  1. Rommers, G.M.; Vos, L.D.W.; Groothoff, J.W.; Eisma, W.H. Clinical rehabilitation of the amputee: A retrospective study. Prosthet. Orthot. Int. 1996, 20, 72–78. [Google Scholar] [CrossRef] [PubMed]
  2. Raichle, K.A.; Hanley Ma Fau-Molton, I.; Molton I Fau-Kadel, N.J.; Kadel Nj Fau-Campbell, K.; Campbell K Fau-Phelps, E.; Phelps E Fau-Ehde, D.; Ehde D Fau-Smith, D.G.; Smith, D.G. Prosthesis use in persons with lower- and upper-limb amputation. J. Rehabil. Res. Dev. 2008, 45, 7. [Google Scholar] [CrossRef] [PubMed]
  3. Pezzin, L.E.; Dillingham, T.R.; MacKenzie, E.J.; Ephraim, P.; Rossbach, P. Use and satisfaction with prosthetic limb devices and related services. Arch. Phys. Med. Rehabil. 2004, 85, 723–729. [Google Scholar] [CrossRef] [PubMed]
  4. Resnik, L.; Borgia, M. Reliability of Outcome Measures for People With Lower-Limb Amputations: Distinguishing True Change From Statistical Error. Phys. Ther. 2011, 91, 555–565. [Google Scholar] [CrossRef] [PubMed]
  5. Walton, M.K.; Powers, J.H., III; Hobart, J.; Patrick, D.; Marquis, P.; Vamvakas, S.; Isaac, M.; Molsen, E.; Cano, S.; Burke, L.B. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. Value Health 2015, 18, 741–752. [Google Scholar] [CrossRef] [PubMed]
  6. Schaffalitzky, E.; Gallagher, P.; MacLachlan, M.; Wegener, S.T. Developing consensus on important factors associated with lower limb prosthetic prescription and use. Disabil. Rehabil. 2012, 34, 2085–2094. [Google Scholar] [CrossRef] [PubMed]
  7. Hall, N.; Parker, D.; Williams, A. An exploratory qualitative study of health professional perspectives on clinical outcomes in UK orthotic practice. J. Foot Ankle Res. 2020, 13, 49. [Google Scholar] [CrossRef] [PubMed]
  8. Robinson, C.; Fatone, S. You’ve heard about outcome measures, so how do you use them? Integrating clinically relevant outcome measures in orthotic management of stroke. Prosthet. Orthot. Int. 2012, 37, 30–42. [Google Scholar] [CrossRef] [PubMed]
  9. Parker, K.; Kirby, R.L.; Adderson, J.; Thompson, K. Ambulation of People With Lower-Limb Amputations: Relationship Between Capacity and Performance Measures. Arch. Phys. Med. Rehabil. 2010, 91, 543–549. [Google Scholar] [CrossRef] [PubMed]
  10. Gaunaurd, I.; Spaulding, S.E.; Amtmann, D.; Salem, R.; Gailey, R.; Morgan, S.J.; Hafner, B.J. Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program. Prosthet. Orthot. Int. 2014, 39, 314–321. [Google Scholar] [CrossRef] [PubMed]
  11. Morgan, S.J.; Rowe, K.; Fitting, C.C.; Gaunaurd, I.A.; Kristal, A.; Balkman, G.S.; Salem, R.; Bamer, A.M.; Hafner, B.J. Use of Standardized Outcome Measures for People With Lower Limb Amputation: A Survey of Prosthetic Practitioners in the United States. Arch. Phys. Med. Rehabil. 2022, 103, 1786–1797. [Google Scholar] [CrossRef] [PubMed]
  12. Ostler, C.; Scott, H.; Sedki, I.; Kheng, S.; Donovan-Hall, M.; Dickinson, A.; Metcalf, C. From outcome measurement to improving health outcomes following lower limb amputation—A Narrative review exploring outcome measurement from a clinical practice perspective. Prosthet. Orthot. Int. 2021, 46, e341–e350. [Google Scholar] [CrossRef] [PubMed]
  13. Young, J.; Rowley, L.; Lalor, S. Use of Outcome Measures Among Prosthetists and Orthotists in the United Kingdom. J. Prosthet. Orthot. 2018, 30, 152–157. [Google Scholar] [CrossRef]
  14. Spaulding, S.; Yamane, A.; McDonald, C.; Spaulding, S. A conceptual framework for orthotic and prosthetic education. Prosthet. Orthot. Int. 2019, 43, 369–381. [Google Scholar] [CrossRef]
  15. Field, J.; Holmes, M.M.; Newell, D. PROMs data: Can it be used to make decisions for individual patients? A narrative review. Patient Relat. Outcome Meas. 2019, 10, 233–241. [Google Scholar] [CrossRef] [PubMed]
  16. Calvert, M.; Kyte, D.; Price, G.; Valderas, J.M.; Hjollund, N.H. Maximising the impact of patient reported outcome assessment for patients and society. BMJ 2019, 364, k5267. [Google Scholar] [CrossRef] [PubMed]
  17. Innovation Canada. Innovation Canada—Technology Readiness Levels; Innovation, Science and Economic Development Canada: Ottawa, ON, Canada, 2018; Available online: https://ised-isde.canada.ca/site/innovation-canada/en/technology-readiness-levels (accessed on 10 March 2025).
  18. Gattrell, W.; Logullo, P.; van Zuuren, E.; Price, A.; Hughes, E.; Blazey, P.; Winchester, C.C.; Tovey, D.; Goldman, K.; Hungin, A.P.; et al. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024, 21, e1004326. [Google Scholar] [CrossRef] [PubMed]
  19. Barrett, D.; Heale, R. What are Delphi studies? Evid. Based Nurs. 2020, 23, 68. [Google Scholar] [CrossRef] [PubMed]
  20. Hsieh, H.-F.; Shannon, S.E. Three Approaches to Qualitative Content Analysis. Qual. Health Res. 2005, 15, 1277–1288. [Google Scholar] [CrossRef] [PubMed]
  21. Nasa, P.; Jain, R.; Juneja, D. Delphi methodology in healthcare research: How to decide its appropriateness. World J. Methodol. 2021, 11, 116–129. [Google Scholar] [CrossRef] [PubMed]
  22. Boulkedid, R.; Abdoul, H.; Loustau, M.; Sibony, O.; Alberti, C. Using and Reporting the Delphi Method for Selecting Healthcare Quality Indicators: A Systematic Review. PLoS ONE 2011, 6, e20476. [Google Scholar] [CrossRef] [PubMed]
  23. Hasson, F.; Keeney, S.; McKenna, H. Research guidelines for the Delphi survey technique. J. Adv. Nurs. 2000, 32, 1008–1015. [Google Scholar] [CrossRef] [PubMed]
  24. Kahle, J.T.; Highsmith, M.J.; Schaepper, H.; Johannesson, A.; Orendurff, M.S.; Kaufman, K. Redicting walking ability following lower limb amputation: An updated systematic literature review. Technol. Innov. 2016, 18, 125–137. [Google Scholar] [CrossRef] [PubMed]
  25. Shunmuga Sundaram, C.; Campbell, R.; Ju, A.; King, M.T.; Rutherford, C. Patient and healthcare provider perceptions on using patient-reported experience measures (PREMs) in routine clinical care: A systematic review of qualitative studies. J. Patient-Rep. Outcomes 2022, 6, 122. [Google Scholar] [CrossRef] [PubMed]
  26. Foster, A.; Croot, L.; Brazier, J.; Harris, J.; O’Cathain, A. The facilitators and barriers to implementing patient reported outcome measures in organisations delivering health related services: A systematic review of reviews. J. Patient-Rep. Outcomes 2018, 2, 46. [Google Scholar] [CrossRef] [PubMed]
Figure 1. Diagram of Delphi method.
Figure 1. Diagram of Delphi method.
Prosthesis 07 00092 g001
Table 1. Panelists’ sociodemographic characteristics.
Table 1. Panelists’ sociodemographic characteristics.
CharacteristicsProsthetists and Decision Makers
n = 18
Prosthetic Users n = 17
Age, mean (SD)44 (7)60 (10)
Gender, %
  Men2 (11)9 (53)
  Women16 (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 equivalent0 (0)5 (29)
  Professional degree or college 15 (83)5 (29)
  Bachelor 2 (11)4 (24)
  Master or doctorate 1 (6) 3 (18)
Table 2. Final list of elements included (n = 78).
Table 2. Final list of elements included (n = 78).
Elements
1. General information of prosthetic usersNot included
NameSex
Date of birthAdress
Healthcare insurance numberEmail address
Phone number
Paying agent
Shoe size
Reason of consultation
Client’s goals
Client’s motivation
2. Medical and rehabilitation informationNot included
Deterioration history of the amputated limbAmputation hospital
Date of last amputationReferring physician
Referring physicianSmoking status
Cause of amputationAlcohol use
Level of amputationDrug use (including cannabis)
Amputation sideDate of rehabilitation admission
Presence of intermittent claudicationDate 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 monthAutonomy 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 prosthesisNot 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 prosthesisNot 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
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MDPI and ACS Style

Dupuis, F.; Pichette, M.; Swaine, B.; Auger, C.; Zidarov, D. Consensus-Based Recommendations for Comprehensive Clinical Assessment in Prosthetic Care: A Delphi Study. Prosthesis 2025, 7, 92. https://doi.org/10.3390/prosthesis7040092

AMA Style

Dupuis F, Pichette M, Swaine B, Auger C, Zidarov D. Consensus-Based Recommendations for Comprehensive Clinical Assessment in Prosthetic Care: A Delphi Study. Prosthesis. 2025; 7(4):92. https://doi.org/10.3390/prosthesis7040092

Chicago/Turabian Style

Dupuis, Frédérique, Marion Pichette, Bonnie Swaine, Claudine Auger, and Diana Zidarov. 2025. "Consensus-Based Recommendations for Comprehensive Clinical Assessment in Prosthetic Care: A Delphi Study" Prosthesis 7, no. 4: 92. https://doi.org/10.3390/prosthesis7040092

APA Style

Dupuis, F., Pichette, M., Swaine, B., Auger, C., & Zidarov, D. (2025). Consensus-Based Recommendations for Comprehensive Clinical Assessment in Prosthetic Care: A Delphi Study. Prosthesis, 7(4), 92. https://doi.org/10.3390/prosthesis7040092

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