A Literature Review of the Quality of Life, Health Status and Prosthesis Satisfaction in Older Patients With A Trans-tibial Amputation

BACKGROUND: Several reviews have been published regarding quality of life (QoL) and Health Status (HS) in persons with lower limb amputation (LLA). However, little has been discussed in the literature with respect to older populations (i.e. age>60 years) with trans-tibial amputation. Furthermore, the perceived satisfaction with prosthesis is another important aspect for consideration in the amputees’ life. OBJECTIVE: The purpose of this review was to evaluate the impact of trans-tibial amputation on the QoL, HS and prosthesis satisfaction, in order to determine the appropriate intervention to improve these aspects in older population of trans-tibial amputees (TTA). METHODS: Research articles, published between January 2000 to March 2019, were found using Scopus, PubMed and Google Scholar databases. The methodological quality of the selected articles was assessed using the Critical Review Form-Quantitative Studies checklist. RESULTS: Ten articles that met the inclusion criteria were selected. In these papers, we can summarize that people with trans-tibial amputation have a better QoL compared to those with above knee amputation. Moreover, physical functioning and mobility are the most influencing factors for QoL and HS in older people with lower limb amputation. Finally, the prosthesis weight reduction may improve satisfaction with the prosthetic limb. CONCLUSION: Efforts have to be made in order to improve mobility in older population with transtibial amputation for better QoL and HS. This can be accomplished by means of adequate rehabilitation, pain management and an accurate choice of appropriate prosthetic components. We observed that the quality of evidence in the literature available is inadequate and future research would benefit from more prospective observational cohort studies with appropriate inclusion criteria and larger sample sizes to better understand the QoL and HS in this population.

Health Status has the goal of evaluating a persons' perception of his or her disease influenced by the complex interactions of social, emotional and physical functioning. 6 The evaluation of QoL and HS, by means of reliable questionnaires, might determine which are the most influencing factors and thereby helping the rehabilitation team or the healthcare services to improve care of persons with limb amputation. 7 A proper investigation of QoL in people with amputation could rely on the use of specific instruments developed for this purpose, such as: Trinity Amputation and Prosthesis Experience Scales (TAPES) 8 that investigate these domains: psychosocial adjustment; social, functional and athletic restriction; prosthesis satisfaction; pain and other medical problems, or the Prosthesis Evaluation Questionnaire (PEQ) 9 which investigates ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility and well-being.
A comfortable prosthetic device allows amputees to walk and carry out daily activities without pain and could increases their satisfaction, independence and activity level. 10 Even an aesthetically acceptable prosthetic device might favourably influence the social reintegration of the patient. A comprehensive life assessment of people with lower limb amputation must take into account their satisfaction with the prosthesis. Those satisfaction aspects are included in some items of TAPES and PEQ. Furthermore, the SAT-PRO (satisfaction with prosthesis) was developed specifically for this purpose. 11 Many studies have investigated functional outcome, functional status, mobility level and the predictor factors in LLA. 12,13 However, rarely those data are associated with QoL, HS or satisfaction with the prosthesis. Moreover, studies rarely focus on different populations of LLA, in a way that the results can be differentiate between elderly or younger people with trans-tibial or trans-femoral amputation. 14 It should be noted that poor QoL in a person with lower limb amputation may depend not only on physical disability but also on pain, in particular low back pain or artrithis 15,16 or phantom pain. 17 In addition, traumatic amputation at young age is associated with better QoL. 18 Some reviews about QoL and HS are available, however they are related exclusively to a general sample of LLA. 14,19,20 This literature review was undertaken with a purpose to support or refute any or all of the following assumptions: a) TTA have better mobility capacity than TFA 21 ; b) people above 65 years old present lower physical performance than younger patients; and c) the performance status of older patients after amputation is generally poor. 22 With these observations in mind, the aim of this review was to analyse the QoL, HS and satisfaction with the prosthesis in a specific group of trans-tibial amputees (i.e. age>60y).

Search strategy
Two authors, SB and CB, independently conducted a search in the spring 2019 to find related research articles using Scopus, PubMed and Google Scholar databases. The electronic literature search included articles published from January 2000 to March 2019, using the keywords "amputee", "lower limb amputation", "trans-tibial", "belowknee", "health status," "quality of life", "outcome" and "satisfaction". We have included the keyword "outcome" as sometimes the keyword of a study was the functional outcome and the QoL or HS described only as secondary aims. Moreover, "SF-36", "WHO QOL-BREF", "PEQ", "PPA (Prosthetic Profile for Amputee 23 )" and "TAPES-R", have also been searched as these are the most used tools for the measurements of QoL or HS in LLA. Combinations of keywords were made in order to refine the search results by using Boolean terms 'AND' and 'OR'.

Review process
The reference lists of all screened articles were also examined for any potentially eligible studies. Reviews, case reports, congresses abstracts, comments, editorials, guidelines, letters and studies not in English were excluded. Articles that focused on individuals with upper limb amputation or solely on individuals with above knee amputation or on people with mean age<60 were excluded. The authors performed a second screening by reading the full-text of the selected articles, to understand if they could obtain data on QoL, HS or satisfaction with the prosthesis based on the following inclusion criteria: 1) persons diagnosed with TTA; 2) studies investigating QoL and/or HS and/or satisfaction with the prosthesis in persons aged >60 years; 3) use of standardized evaluation measures. As all data was drawn from literature and as such no informed consent or ethical approval was needed for this study.

Study quality
The methodological quality of the selected articles was assessed using the Critical Review Form-Quantitative Studies checklist. 24 The checklist consists of 15 questions pertaining to the quality of reporting, internal validity, external validity, and power of the studies. Higher scores representing better quality. Most questions were answered as "1" for a yes or "0" for a no. Some questions had the option "unable to determine", these questions were excluded from the checklist. 24

Article selection
An initial electronic database search obtained 892 articles. CPOJ articles because they were not investigating the impact of a trans-tibial amputation on the QoL, HS or satisfaction with the prosthetic limb. Eighty-two articles were removed after reviewing the full texts. In total, 10 articles were selected for the purpose of this literature review ( Figure 1).
In our review of literature, no randomized controlled trial studies were found on the topic of interest. The majority were observational studies (n=5) and cross-sectional (n=3) studies while the others were cross-over (n=1) or retrospective studies (n=1). The results of the four studies, 2, 25-27 which evaluated QoL in older TTA are summarized in Table 1. Four studies 17,28-30 evaluated HS in this population and their findings were summarized in Table 2 . Moreover, Table 3 shows two studies on patient level of satisfaction with the prosthesis. 31-32 The only study that investigated both HS and QoL, 27 is included in Table 1, as the main results were related to QoL. The response to the PEQ domains of perceived responses, frustration, social burden, overall well-being and overall satisfaction were above 65% of the midline of the PEQ scores. The domains "ambulation" and "transfer" showed less favorable responses. Statistical study of the relationships between domains showed these correlations: a. "residual limb health" and "prosthetic appearance" with "social burden" "satisfaction" b. less "pain" with "satisfaction". c. "ability to ambulate" with "satisfaction" d. "transfer ability" with "satisfaction" and with decreased "social burden" e. "pain" and "residual limb health" with "ability to ambulate" f. "social burden" with "ambulation"

Patients Characteristics
Only three studies focused on TTA with a mean age>60 years, two of which primarily investigated the effects of a new prosthetic foot. 31,32 Only one study exclusively assessed the QoL of a population of non-traumatic TTA who were successful prosthetic users. 2 In most of the selected studies, the sample consisted in a mixed group of TTA and TFA. In two articles 25,27 the sample also included partial foot amputees and in two other studies 28,30 there was a control group consisting of people with intact lower extremities or foot ulcer.

QoL and HS measurement
The most used tools were the Research and Development Assessing amputees satisfaction with prosthesis using two different prosthetic feet: 1M10 Adjust and SACH in low-mobility TTA Participants showed a significantly higher improvement in SAT-PRO with "1M10 Adjust" than with SACH.

12/13
Abbreviations: TTA: Trans-Tibial Amputee, SAT-PRO: Satisfaction with Prosthesis, SACH: Solid Ankle Cushion Heel, NGF: New Geriatric Foot.  CPOJ Survey 1.0 (RAND-36) (3 times) and the SF-36 (2 times). 34,35 The RAND-36 is a self-reported questionnaire which includes the same items as those of SF-36, but scoring is slightly different in the domains "pain" and "general health". PEQ and TAPES-R questionnaire was used one time (Table 4).

DISCUSSION
The intention of this review was to evaluate the impact of trans-tibial amputation on the QoL, HS and prosthesis satisfaction, in order to determine the appropriate intervention to improve these aspects in older trans-tibial amputees. Many studies reported a better QoL and HS in TTA compared to TFA, 26 particularly in the "physical functioning" domain. 29,30 Moreover, TTA also had significantly higher scores for functional independence compared to the TFA. 26 Considering that TTA have better QoL than TFA, we investigated whether these patients could maintain high QoL throughout the aging process.
Indeed, young age at the time of amputation was associated with better QoL in the categories of physical disability, energy level, emotional reactions and social isolation while advanced age was associated with reduced mobility and lower energy level than younger population. 6 However, whether ageing affected QoL is still debated. A recent study stated that quality of life in LLA is significantly influenced by age, 36 while Adegoke and co-workers (2012) reported that the patient' age at the time of amputation did not affect general quality of life. 37 In our review, we found that there are no longitudinal studies that describe changes in the quality of life during ageing. The "physical functioning" appears to be the main factor affecting QoL and satisfaction in older TTA. Indeed, Fortington et al., (2013) found that subjects over 65 years of age had lower outcome than younger amputees only for physical function, while other domains were comparable to population norm values. 29 The walking distance aspect of mobility is one of the main factors to be considered when evaluating QoL after LLA. 17 Elderly TTA with higher mobility scores were more likely to be satisfied with life, 25 and perception of their social burden correlated strongly with their ability to walk using their prosthesis. Fortington et al.,29 reported that walking distance is associated with improved scores in social function. One study identified also that mobility capability was significantly influenced by these risk factors: age>65y, alcohol disorder, hypertension, anxiety or depression. 25 Another aspect that was postulated to interfere with QoL was the level of pain. Rather controversially the results did not confirm this assumption. In fact, in the only study in which TTA alone were enrolled, Harness et al., (2001) 2 found that the ability to walk using the prosthesis was correlated with the presence of pain and residual limb health. 2 Moreover, the same study reported a correlation between the patient's satisfaction and lesser pain level. 2 Even Knežević and co-workers reported no differences between TTA and TFA on role limitations due to pain and physical health. 30 On the contrary, another study described how the presence of phantom pain might imply a poorer health-related quality of life. 17 An important role of pain was described by Boutoille et al.,(2008). 28 The authors compared HS and pain in patients having experienced an amputation due to diabetic foot ulcer and patients suffering for a current foot ulcer with no previous history of amputation. They reported that a transtibial amputation allows similar HS with less pain with respect to a conservative, unsuccessful, treatment for diabetic ulcer.
Two studies focused on the effect of a prosthetic foot in hypomobile older TTA. 31,32 Both studies investigated the performance and satisfaction utilizing different feet compared to the traditional SACH (solid ankle cushion heel) foot. The SACH is considered to be the most appropriate foot for hypomobile TTA and also the most prescribed foot as it is inexpensive, easy to use, and perceived as stable. 39 Delussu et al.,(2016) tested the "1M10 Adjust" foot that is a multi-axial lightweight foot that allows stiffness heel adjustments to adapt to individual needs. 32 In another study a new geriatric foot was evaluated which shape and type of foam in this foot allows to be shorter and lighter compared to SACH. 31 Both studies reported greater patient satisfaction with the tested prosthetic feet. Moreover, the new geriatric foot reduced the mean pressure in the socket and the "1M10 Adjust" showed a statistically significant reduction of the energy cost of walking. 31, 32 The common feature between these two tested prosthetic feet is the lighter weight compared to SACH. This may lead us to hypothesize that lighter prosthetic components for hypomobile mature TTA could positively affect their satisfaction with the prosthesis.

CONCLUSION
Our review has pointed out that there are very few studies that have investigated this particular population of amputees (TTA aged >60 years). Only one study exclusively investigated QoL in older TTA. 2 We have observed authors have rarely used specific tools for measurement of QoL and HS in LLA. In general, the QoL and HS of LLA is influenced mostly by daily activities. 40 Patients with amputation often encounter difficulties in everyday activities because they have lost their independence and must rely on others. This could influence negatively many aspects of their lives, such as social and financial. For this, it is very important, when studying QoL of amputees, to also analyse their social environment. 41 On the basis of the main results of this review we can conclude that efforts have to be taken in order to improve mobility in TTA for a better QoL, by means of adequate rehabilitation, reduction of pain, and appropriate prosthetic components. The literature available on this specific population is insufficient and future research will benefit from more prospective observational cohort studies. Such studies will need to be conducted with appropriate inclusion criteria and larger sample sizes to better understand the QoL and HS in this population.