1.4.1

Complete description of a therapeutic patient education program for patients after amputation

Very few rigorous studies on TPE programs for amputees are found in the literature. Studies mainly describe tools associated to another therapeutic intervention, classic TPE methods such as Metaplan™ and brainstorming. The first is used for group animation and communication model. It consists in developing opinions, constructing a common comprehension and formulating objectives, recommendations and action plans before focusing on the problem and its possible solutions. The second method involves the spontaneous contribution of ideas from all members of the group, stimulating creativity to find solutions in order to solve a problem. The goal is to generate as many ideas as possible in a minimum of time on a given theme without judging or criticizing others. This group method of generating ideas privileges quantity, spontaneity and imagination. Only one study with a good methodological quality (level 2) evaluated the acceptance and effectiveness of a TPE program aimed at improving the quality of life of patients after limb loss. This prospective, comparative, cluster randomised study from the United States was published in 2009. Its main objectives were to reduce pain and depressive disorders, improve positive moods while promoting self-management capacities in the patient. Secondary objectives were to improve the patients’ functional status and quality of life.

Wegener et al. used support groups for patients with limb loss, which were already in place in the American National Health System in order to randomize and test a TPE program. All participants involved in these groups for at least 4 months and who underwent amputation of at least one limb (upper or lower limbs) were invited to join the study.

There was no significant difference between the control group and the study group regarding: age (56.9 ± 13.3 vs. 55.5 ± 13.8), gender (59% men vs. 55%), amputation etiologies (vascular/diabetes 34.8% vs. 37.1%, trauma-related 36.1% vs. 39.3%, neoplastic conditions 10.6% vs. 5.5%, congenital 1.8% vs. 3.6% and others) . Very few upper-limb amputees participated in the study (11 in the control group, i.e. 4.9% vs. 20 in the study group, i.e. 7.3%) .

When we look at the TPE approach described by the HAS, an educational diagnosis was not found in this study. The content of the program is not specifically described, but includes general presentation of TPE, pain management, psychological support (building positive emotions and managing negative thoughts), hygiene guidelines (lifestyle, stump, prosthetic) and finally interaction with family and the outside world.

The multidisciplinary education team included nurses, prosthetics/orthotics professionals and American veterans.

Patients were seen in group sessions, with a maximum of 10 persons per group. The meeting location was not indicated: it was the usual meeting place of the support group. The dedicated time was 90 minutes per session. Frequency was 1 session per week for 8 weeks followed by another session 2 weeks later. Validated scales were used to evaluate the efficacy of the program on the symptoms: pain was evaluated with the Brief Pain Inventory, depressive syndrome by the Major Depressive Disorder Scale (CESD), mood evolution by the Positive and Negative Affect Schedule and Positive States of Mind scales and finally self-management was assessed by the Modified Self-Efficacy scale.

Secondary criteria were also evaluated: improvement of the functional status was evaluated by the Musculoskeletal Function Assessment – Short Form and quality of life by the Satisfaction With Life Scale (SWLS).

The final evaluation of TPE program implementation consisted in open questions on behavioral changes. In this study, the TPE program was proposed to all patients regardless of the amputation level and clinical type.

Authors noted significant improvements on depression, mood, self-management and functional status lingering for 6 months after the end of the program. However, no significant improvement was recorded for pain and quality of life. A subgroup analysis (amputation < 3 years, age < 65 years) showed a significant improvement on all the parameters including pain and quality of life.

To our knowledge, this represents the first and only prospective, cluster randomized study evaluating the efficacy of a TPE program in patients after limb loss. It validates the grade B level of evidence of TPE program in amputees (HAS).

1.4.2

Content of TPE program and evaluation of amputee needs

The design of the various TPE program should be based on the needs brought up by patients. Five studies have been published on the needs for information and education of amputees (one level 3 study and four level 4 studies). The three first studies published in 1988 , 1989 and 1998 evaluated and discussed the role of nurses in amputee support groups while giving details on the program themes.

A 1991 study evaluated the education needed for children with bilateral limb amputation regarding personal hygiene.

Finally, a recent study published in 2009 , with a better methodological level (level 3), presented and discussed the results of an evaluation on lower-limb amputee needs assessment held in Seattle and Washington on October 30–31, 2007. Klute et al. conducted a qualitative study with a focus group approach which had three objectives: on the one hand evaluating on a qualitative level the needs, worries, interests and opinions of prosthetic users on the performances of their prosthetics; on the other hand evaluating the hypothesis that the needs of vascular and diabetic amputees are different than trauma-related amputees; and finally conducting open discussions on emerging issues that could shape the future directions of research and development for the various professions represented.

Three other studies have been published on the needs of patients faced with stump pain, phantom limb pain and musculoskeletal pain (one level 3 study and two level 4 studies). A first study from 2006 described the advances in pain management through prevention programs. A second study from 2001 found a greater prevalence of low back pain in amputees (52%) than in the general population (15 to 25%). Finally, a third study from 2000 found a similar incidence of phantom limb pain and stump pain in over 70% of amputees. Other studies (total of 8: including three level 3 studies and five level 4 studies) showed the interest of patients and healthcare professionals for the following: stump hygiene , falls prevention , prevalence and management of depression disorders and finally the relevance of physical activity on the patient’s future functional status .

Some themes underlined in the needs expressed by amputees are common to all these studies and are unquestionable: stump pain management ( Table 1 ) phantom limb pain management ( Table 1 ), musculoskeletal pain and disorders ( Table 1 ), stump ( Table 1 ) and prosthetic hygiene ( Table 1 ), grieving for the lost limb ( Table 1 ), information and education workshop on the various types of prosthetics and their modalities of use ( Table 1 ). Patients also wanted to learn about the perception of amputation and changes in social life . Daily needs were also important: couple relationship and sexuality , professional life and transportation . Patients were also in demand for more technical education regarding fitting and cleaning their prosthetic socket as well as prosthetic alignment . Other themes have been identified and should not be overlooked when designing a TPE program such as falls prevention ( Table 1 ), managing depression ( Table 1 ) and possible sports and physical activities ( Table 1 ).

The main actors of TPE programs found in the literature differ according to the year of the publications. The first studies insisted on the role of nurses, who are close to patients and have the type of relationship enabling the implementation of TPE programs but not necessarily in PM&R departments . More recent articles have focused on other actors involved in multidisciplinary care in PM&R departments: occupational therapists , physiotherapists but also adapted physical activity (APA) teachers and psychologists .

1.4.3

Different TPE stages for amputees

Four education stages characterize the amputation care management process :

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  preoperative care (for vascular and diabetic amputees);

  
  
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  hospitalization in the surgical department;

  
  
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  hospitalization in the PM&R department;

  
  
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  finally returning home to an active life.

Proposals formulated by Klute et al. underline the need for a targeted therapeutic education at each stage of the care management process of an amputee, including on the long-term as reminder sessions. Finally, it is interesting to note that the study did not unveil any difference between the needs and expectations of vascular/diabetic amputees and trauma-related amputees, and thus it would make sense to propose common TPE sessions.

1.4.4

SOFMER workgroup recommendations

These recommendations from the “TPE and amputee” SOFMER workgroup, based on the professional experience of experts, are quite similar to the themes found in the literature. In fact, 11 themes emerged from the discussions:

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  stump contention;

  
  
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  stump/prosthetic hygiene and skin issues;

  
  
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  amputee pain;

  
  
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  prosthetic fitting and managing stump volume variations;

  
  
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  technical maintenance of the prosthetic;

  
  
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  specificity of the upper limb;

  
  
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  safe use of the prosthetic and preventing falls;

  
  
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  physical activities and leisure activities;

  
  
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  managing cardiovascular risk factors;

  
  
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  body representation and amputation experience;

  
  
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  and finally conducting a review of all the educational supports already available.

The collection and validation of experts’ opinions took place in a plenary session where everyone could propose a theme, which needed to be validated by all experts in attendance ( Appendix 1 ). Thus, the review of the literature legitimates the choice of these different themes underlined by the professional experience of experts ( Table 1 ).

1.4.5

Need for pre-amputation (non-traumatic) TPE

To conduct TPE programs before surgery, it is essential to identify the factors that could influence the patient’s personal decision (outside of a medical indication). Three studies have been published on the decision-making process of patients before amputation (one level 3 study and 2 level 4 studies). A first study dating from 2000 focused on training former patients (at a distance from their amputation) to visit patients during the preoperative period to help them with their decision-making process and answer the questions they might have. A second level 4 study from 2012 identified the decision-making factors in a qualitative manner via a standardized, retroactive, open questionnaire. Finally, one last qualitative study from 2011 listed other decision-making factors collected via standardized open-ended interviews and prospective targeted questionnaires. The aim of these studies was to understand the decision-making process of patients who chose amputation in order to help physicians and healthcare professionals provide better support and advice to their future patients.

Three key factors emerged from the two qualitative studies: pain , loss of limb function and participation restriction . Three factors were considered as being of little importance: body representation , physical identity and opinion of others . Most participants were not interested in the opinion of health care professionals and insisted that the decision was a personal one . However, participants found the information given to them useful for their decision-making process and in setting up expectations regarding their future prosthetic . Finally authors’ recommendations underlined the fact that amputation should not be viewed as a failure of previous medical treatments but as the best mean to free the patients from years of pain and suffering.

1.4.6

Therapeutic education tools

The literature offers very few descriptions of TPE tools. Regarding TPE sessions, they were all group sessions with a limited number of participants (less than 10) . The topic of the session was brought up through open questions followed by a discussion between patients and the educational staff .

Various tools were used: descriptive information sheets with illustrations on stump bandaging to hand out to patients , slide presentations to illustrate the discussions , practical workshop for prosthetic socket fitting or for using technical aids for personal hygiene .

Pain management workshops use mock prescriptions to evaluate the patient’s understanding of a medical prescription . TPE programs’ contents must by adapted to users while abiding by HAS guidelines. To our knowledge, in the literature, there is no study on the experience of French teams with description of TPE tools for amputees.

Internet has become an essential tool for informing and educating patients. To our knowledge, there is no website of reference, in French or in English, for TPE in amputees, but only information sites managed by patients’ associations.

1.4.7

Evaluation TPE tools

Therapeutic patient education programs must abide by the French national guidelines. To be implemented at a local level, these programs must first be authorized by the regional health agencies that recommend the implementation of a TPE evaluation. No tool specific to TPE in amputees has been found for this review. The TPE guide proposed by the SOFMER group will require frameworks for each therapeutic workshop but also the implementation of validated evaluation tools for each theme and these tools will be described in the guide ( Table 2 ).