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Microprocessor-controlled prosthetic knee: Exploring clinicians’ experience of prescription processes in different regions in Sweden : A qualitative study

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Microprocessor-controlled

prosthetic knee: Exploring

clinicians’ experience of

prescription processes in

different regions in Sweden

PAPER WITHIN Prosthetics and Orthotics AUTHOR: Henrik Ottosson and Saga Tortela TUTOR:Saffran Möller

JÖNKÖPING April 2021

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Sammanfattning

Syfte: Syftet med denna studie var att undersöka vad kliniker upplever påverkar förskrivningsprocessen

av mikroprocesstyrd knäkomponent (MPK) i de olika regionerna i Sverige.

Metod: Kvalitativ analys med semistrukturerade intervjuer genomfördes. Intervjuerna genomfördes

och spelades in med Zoom eller Teams programvara och data analyserades sedan tematiskt.

Resultat: 9 legitimerade ortopedingenjörer samt en legitimerad fysioterapeut från åtta olika regioner

deltog i studien. Under dataanalysen identifierades fyra huvudteman samt 10 underteman. Huvudteman var: utvärdering av patientens lämplighet för MPK, utmaningar med att beräkna patientutfall, förskrivningsbarriärer och externa påverkande faktorer. Deltagarna upplevde att beräkning av patientutfall, budgetrestriktioner och att vara beroende av subjektiva bedömningar av patienter som stora utmaningar med förskrivningsprocessen av en MPK.

Slutsats: Deltagarna upplevde att förskrivningsprocessen av MPK påverkas av flertal olika faktorer;

från regionala budgetar och ansökningsprocesser, till deltagarnas erfarenhet och förmåga att bedöma lämpliga MPK-kandidater. Deltagarna uttryckte utmaningar med att förskrivningsprocessen var känslobaserad och till stor del beroende av subjektiva och generella utvärderingar av patienten. Detta gjorde att ett stort ansvar av bedömningen om vem som bör få ett MPK förskrivet, låg på deltagarna själva, vilket ansågs kan bidra till inkonsekventa patientbehandlingar. Deltagarna upplevde att ett nationellt förskrivningssystem möjligen hade kunnat bidra till att processen var mer rättvis för patienterna samt underlätta processen för de själva.

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Summary

Purpose: The study investigates clinicians’ experience of what is affecting the prescription of

microprocessor-controlled prosthetic knees (MPKs) in different regions in Sweden.

Method: Qualitative analysis with semi-structured interviews were conducted. The interviews were

conducted and recorded using Zoom or Teams software and data was thereafter thematically analysed.

Results: 9 certified prosthetists and a certified physiotherapist from eight different regions

participated. During data analysis four main themes were identified along with ten subthemes. The key themes were: assessing candidate for MPK, challenges in estimating outcomes, barriers to prescribing and external influencing factors. Estimating patient outcomes, budget limitations and being dependent on subjective patient evaluations were expressed as major factors affecting the prescription of MPKs.

Conclusion: The prescription of MPKs was found to be affected by several factors; from regional

budgets and application processes to clinicians’ experience in assessing suitable MPK-candidates. The clinicians expressed challenges in that the prescribing process was emotionally based and relied on subjective and generalised patient assessments. This made decision-making regarding who to prescribe an MPK to, highly dependent on the clinicians’ own experience and knowledge which according to them, could lead to inconsistent treatments. Clinicians felt that a national prescription system could possibly ensure fairer patient evaluations and make the process easier for themselves.

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Table of Contents

1. Introduction ... 1

2. Background ... 2

2.1 Amputation population ... 2

2.2 Ageing population and health ... 2

2.3 International Classification of Functioning, Disability and Health ... 2

2.4 Prosthetic rehabilitation and componentry ... 2

2.5 Microprocessor controlled prosthetic knees ... 3

2.6 Falls and financial costs in relation to MPKs ... 4

2.7 Guidelines for MPK prescription ... 4

2.8 Healthcare equality in relation to MPK prescription ... 5

3. Intention ... 6

4. Methods ... 6

4.1 Sampling strategy ... 6

4.2 Ethical considerations ... 6

4.3 Data collection methods ... 8

4.4 Data processing... 8

5. Results ... 9

5.1 Demographics... 9

5.2 Identified themes ... 9

5.3 Assessing candidate for MPK ... 10

5.4 Challenges in estimating outcomes ... 10

5.5 Barriers to prescribing ... 11

5.6 External influencing factors ... 12

6. Discussion ... 13

6.1 Limitations ... 14

7. Conclusion ... 16

References ... 17

Appendices ... 22

Appendix A ... 22 Appendix B ... 23 Appendix C ... 24

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1. Introduction

The process of prosthetic componentry selection differs between countries (Sansam, O’Connor, Neumann & Bhakta, 2014) and to the authors knowledge, there are no national guidelines in Sweden for clinicians to follow when it comes to prescribing prosthetic componentry. This has led to prescribing processes being mainly dependent on the clinician's own experiences, observations and use of evidence to determine the most suitable solution for the patient rather than on a systematic and quantifiable prescription method (Van der Linde, Hofstad, Van Limbeek, Postema & Geertzen, 2005; Morgenroth, 2013; Sansam et al., 2014).

The global population continues to grow along with increased life expectancy, leading to increased healthcare related issues and costs (Yu, Ravelo, Wagner & Barnett, 2004). In Sweden, the mean age of the population has continuously increased over the past 50 years and currently has a higher average life expectancy than Europe and Africa (World Health Organisation [WHO], 2021). These figures correlate to the older amputee population in Sweden (Swedeamp, 2020).

When prescribing a prosthesis there are several aspects that needs to be taken into consideration and as current prescribing processes depend mainly on the clinician’s previous experiences and values, there is the risk of inconsistent and subjective decision-making (Sansam et al., 2014). Due to the significant cost of MPKs, clinicians are faced with the challenge of having to value patient preferences (Mundell, Maradit Kremers, Visscher, Hoppe & Kaufman, 2017). To avoid the risk of unfair treatments, prescription guidelines have been found to be a helpful tool in guiding clinicians in making more objective and fair judgements and thereby improve the overall quality of prosthetic prescription (Van Der Linde, Geertzen, Hofstad, Van Limbeek & Postema, 2003; Van Der Linde, Geertzen, Hofstad, Van Limbeek & Postema, 2004; Van der Linde et al. 2005; Sansam et al., 2014; Sedki & Fisher, 2015).

Several studies have documented the benefits of MPKs, including improved quality of life and perception of themselves and reduced symptoms of depression, compared to using a non-MPK (Şen, Aydın, Buğdaycı & Kesiktaş, 2020). However, most of these studies have been done on the younger population (Sawers & Hafner, 2013), which is an indication that this is the patient group commonly receiving MPKs to date. However, studies have been made documenting that the low-active geriatric population would also benefit from the technically advanced MPK as it significantly reduces the risk of falling (Fuenzalida Squella, Kannenberg & Benetti, 2018; Burnfield, Eberly, Gronely, Perry, Yule & Mulroy, 2012). Falls in the general population is a major global public health problem, and older patients are at a higher risk of falling compared to individuals of the same age in the general population (WHO, 2021). With more than 50% of lower limb prosthetic users reporting falling at least once a year, indicates that MPKs should be provided more often to this patient group (Kim, Major, Hafner & Sawyer, 2019).

The aim of this study was formed based on this background and wanting to explore clinicians’ perceptions of what is affecting the prescription of MPKs in different regions in Sweden. To the authors knowledge, no national prescription guidelines for prescribing MPK exist in Sweden, therefore the authors wanted to explore what factors influence the clinicians’ judgement regarding who they should prescribe an MPK to and why. In Sweden, the law “Patientlagen (2014:821)” states that everyone has the right to equal care and that every region relies on their own set of additional regulations, meaning that prescription processes may vary across Sweden. The authors wanted to investigate this and explore what clinicians perceive as affecting the prescription of MPKs across regions in Sweden.

Investigating this is of clinical relevance as patients with the same clinical problem ought to receive the same treatment regardless of where they live or which clinician they meet. Exploring clinicians’ perceptions of what is affecting the prescription of MPKs may further provide an indication whether there is a need for national prescription guidelines or not. To investigate this topic, semi-structured qualitative interviews were conducted remotely using Teams or Zoom with ten clinicians from eight regions in Sweden. The interviews were recorded, and thematic data analysis was done.

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2. Background

2.1 Amputation population

Lower limb amputation (LLA) can be a consequence of diabetes and/or peripheral arterial disease and between 1000 and 1100 new amputees can be expected in Sweden each year (Johannesson, 2009). One sixth of individuals who are amputated through or above the knee in Sweden, are fitted with a prosthesis (Swedeamp, 2020). 22 302 individuals went through a LLA between the years 2005 and 2014 in Sweden, with number of incidences varying between 33 and 70 individuals per 100 000 in each region (Jarl & Johannesson, 2016). The amputation level varied between regions, where amputation through or above the knee accounted for 31-67 percent of amputation of the total LLAs while below the knee accounted for 23-60 percent (Jarl & Johannesson, 2016). According to Johannesson, Larsson, Ramstrand, Turkiewicz, Wiréhn and Atroshi (2009), the occurrence of vascular amputation at, or proximal to, the transmetatarsal level is eight times higher for diabetic individuals compared to non-diabetics when looking at the general population aged 45 years or older. Furthermore, up to 25% of diabetic amputees go through reamputation and/or amputation of the contralateral side (Johannesson et al. 2009). The mean age of amputees in Sweden is 78 years for females and 75 years for males (Swedeamp, 2020).

2.2 Ageing population and health

Populations across the world continue to grow in both number and age, leading to increased need for healthcare services (WHO, 2019). In Sweden, the mean age of the population has continuously increased over the past 50 years; from a mean age of 37.18 years in 1970 to 41.43 years in 2020 (Statistikmyndigheten SCB [SCB], 2021). Today, 5.4 percent of Sweden’s total population is over 80 years, and the average life expectancy is 80.6 years for male and 84.3 for female (SCB, 2021). These numbers are higher when compared to the average life expectancy of 78 for Europe and 64 for Africa (WHO, 2021). In developing countries including Ghana, Nigeria, Kenya and Somalia, less than 0.4 percent of their total population is above the age of 80 (WHO, 2021).

Increased life expectancy implies increased healthcare related costs, both long- and short-term (Yu et al., 2004). In Sweden, the governmental expenditure on healthcare has increased yearly over the past decade, with a current general government expenditure on health being approximately 19 percent of Sweden’s total government expenditure (WHO, 2014). Regardless of economic condition, religion, race, age, political view or health condition, every individual has the right to the highest attainable health care (WHO, 2017).

2.3 International Classification of Functioning, Disability and Health

Disability is a complex concept and researchers from social and health sciences have found themselves questioning its true definition (WHO, 2011). To achieve a more uniform understanding and definition of disability, WHO created the International Classification of Functioning, Disability and Health (ICF). This framework works to measure health and disability in individuals and populations by assessing disability at a personal, society and body level (WHO, 2013).

According to WHO (2011), disabled individuals include those with long-term impairments relating to their physical, mental, intellectual, or sensory state of being that in some way limit their ability to participate in society on the same basis as others. In today’s world, an individual’s disability is not defined by their bodily condition, but by how society views them and how other environmental factors may hinder them from participation (WHO, 2011). A more person-centred approach of treating patients is recommended to allow the patients themselves to explore their own ideas of health and disability (Cross, 2020).

2.4 Prosthetic rehabilitation and componentry

There are several aspects involved in the rehabilitation process of patients following an LLA. Initially, a decision needs to be made whether a prosthesis should be prescribed or not, and if so, further decision needs to be made regarding which type of prothesis to provide (Sansam et al., 2014). To ensure the best outcome, the prosthetist must initially take a thorough anamnesis, find out about their background, previous activity level and physical function (Uustal, 2009). Patient education is an important aspect during the rehabilitation process and prosthetic prescription, as it ensures that realistic goals are set (Uustal, 2009). Choosing the right prosthetic design and componentry is essential as it directly affects the patient’s ambulation ability (Uustal, 2009). Prescribing patients with the optimal prosthetic knee is

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largely dependent on the clinician's experience and use of evidence to determine the best solution for the patient (Morgenroth, 2013). Several other factors are taken into consideration when determining which knee unit a patient should receive, including the patients’ own goals, preferences, activity level, motivation and financial resources available to cover the prosthetic componentry costs (Morgenroth, 2013; Sedki & Fisher, 2015).

The process of prosthetic componentry selection differs between countries (Sansam et al., 2014). In the US, patients’ ability to mobilise with a prosthesis is classified into actual or potential ability using the Medicare Functional Classification Level (MFCL) which is used to assist clinicians in selecting prosthetic components. In the UK, on the other hand, the prosthetic prescription is predominantly influenced by the clinicians’ own experience and observations (Sansam et al., 2014).

In Sweden, there are no national guidelines to follow when it comes to prescribing prosthetic componentry and to the authors’ knowledge no research to date have evaluated the prosthetic componentry selection process in Sweden. There are various regulations and prescription guidelines in place, however, they do not focus on the actual selection process of prosthetic componentry (Socialstyrelsen, 2016; Västra Götalandsregionen, 2019). Some regions follow prescription guidelines set by Stockholm Region which includes quantifiable tests and questionnaires to assist the prescriber in the decision-making regarding what intervention to prescribe (Vårdgivarguiden, 2021). Other regions refer to a process designed from the regulations from the National Social Board of Sweden which puts emphasis on the competence of the prescriber, stating that they should decide what intervention suits best for the patient's needs (Socialstyrelsen, 2016).

2.5 Microprocessor controlled prosthetic knees

Prosthetic componentry and technical advancements are continuously developing, especially when it comes to prosthetic knees (Bellman, Schmalz & Blumentritt 2010; Şen et al., 2020; Sedki & Fisher, 2015). MPKs are designed to closely resemble a natural gait pattern and allow for a more complex and sophisticated method of controlling a prosthetic knee compared to a non-MPK (Şen et al., 2020). The main function of an MPK is to ensure continuous and instantaneous control of the flexion and extension of the knee joint to allow for smooth and stable transition between different cadence and best imitate the function of an intact limb (Şen et al., 2020). The continuous adaptation of the knee joint can be achieved thanks to the microdata system inside the knee (Şen et al., 2020).

Several studies have documented the benefits of MPKs, stating that they have the potential to increase the patient’s functional abilities as well as increase their positive body perception and decrease symptoms of depression, when compared to using a non-MPK (Şen et al., 2020). In a study by Möller, Hagberg, Samulesson and Ramstrand (2018), the correlation between self-efficacy and prosthetic usage was studied, looking at prosthetic functions and challenges, and relating the findings to the patients’ quality of life. They found that when there was a higher self-efficacy, it effected not only the physical aspects of the patient's everyday life but also the psychological. The higher the self-efficacy, the more likely the patient was to use the prosthesis (Möller et al., 2018). Şen et al. (2020) found that patients using an MPK had increased quality of life and perception of themselves, as well as reduced symptoms of depression, compared to using a non-MPK.

Activity level significantly affects a patients’ opportunity to receive an MPK and a functional classification system, referred to as K-levels, is often used to describe lower limb amputees’ functional abilities and assist clinicians in determining the necessary functions of the prosthetic components (Gailey, Roach, Applegate, Cho, Cunniffe, Licht, Maguire & Nash, 2002). The rating system has five functional levels, from K0 to K4, and is used by insurance companies in the US to assess eligibility for payments or reimbursements of prosthetic componentry (Gailey et al., 2002). According to Kaufman, Bernhardt and Symms (2018), current medical policies often only cover costs of MPKs provided to amputees with an activity level of K3 or K4. K3 level is described as “typical of the community ambulator who has the ability to traverse most environmental barriers” and K4 as “having the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels” (Gailey et al., 2002). Several studies have found that patients with lower activity levels such as K2, who are limited community ambulators with ability to transverse low-level environmental barriers, would also benefit from MPKs in terms of safety, mobility, function and satisfaction (Burnfield et al., 2012; Hafner & Smith, 2009; Theeven, Hemmen, Rings, Meys, Brink, Smeets & Seelen, 2011). They also suggest that an MPK could improve a K2 patient’s functional ability and increase their activity level to K3.

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Although studies have been done to investigate how the older limited community ambulators would benefit from an MPK, most studies documenting MPK usage have been on the younger amputee population (Sawers & Hafner, 2013). In a systematic review of MPK usage by Sawers and Hafner (2013), 27 studies were investigated and the average age of the participants in each study ranged from 30 to 54.7 years. As benefits have been recorded of limited community ambulators using MPKs, including increased activity level and significant reduction in falls, it could be beneficial not only for the geriatric population but also for the society to reduce health care costs (Kaufman et al., 2018).

2.6 Falls and financial costs in relation to MPKs

Falls in the general population is a major global public health problem and it is estimated that 684 000 fatal falls occur yearly, making it the second leading cause of unintentional injury death after road traffic injuries (WHO, 2021). Individuals with LLA are at a higher risk of falling compared to individuals of the same age in the general population and according to Kim et al. (2019), more than 50% of lower limb prosthetic users report falling at least once a year. This increased risk of falling may result in an increased fear of falling, lower mobility and reduced quality of life (Mundell et al., 2017; Kim et al., 2019). Several studies have found that patients fitted with an MPK significantly lowers their risk of falling compared to being fitted with a non-MPK, highlighting that uncontrolled falls can be reduced by up to 80% (Fuenzalida Squella et al., 2018; Burnfield et al., 2012; Hafner & Smith, 2009; Theeven et al., 2011).

Despite the benefits of MPKs and potential cost-savings in preventing falls, they are often associated with significant financial costs, making their prescription more difficult to justify in comparison to non-MPKs (Sedki & Fisher, 2015). On the other hand, Clarke, Dillon and Shiell (2019) highlight that there are issues in the way that health economic evaluations have been conducted in the field of prosthetics. They state that current evaluation focus on specific component costs rather than on the broader service provided by prosthetists, contributing to unclear policy decisions and potential unfair treatments of patients (Clarke et al., 2019).

Mundell et al. (2017), investigated the direct costs involved in accidental falls and hospitalisation of transfemoral (TF) amputees and compared them to the cost involved in prescribing an MPK. Their study highlights the importance of policy makers to take the costs of falls into consideration when deciding prosthetic componentry as the cost of an MPK can be small compared to the cost of hospitalization due to a fall. Furthermore, they found that falls in the TF amputee population can be compared to the cost of falling in the general elderly population (Mundell et al., 2017).

Highsmith, Kahle, Bongiorni, Sutton, Groer & Kaufman (2010) investigated the cost-effectiveness aspect of a type of MPK, named C-leg, and found that it was more cost-effective than a non-MPK. This was especially evident from a societal cost perspective, highlighting that the increased production costs were compensated by lower costs in caretaking and household assistance (Highsmith et al., 2010). Furthermore, Brodtkorb, Henriksson, Johannesen-Munk and Thidell (2008), stress the importance of providing health care decision makers with the relevant data and information and developed a cost-to-health outcome ratio to be used when evaluating if an MPK treatment is cost-effective or not. The conclusion was made that using an MPK yields a positive health outcome within a reasonable price range (Brodtkorb et al., 2008).

2.7 Guidelines for MPK prescription

Research done by Mühlbacher and Juhnke (2013) highlight difficulties in balancing patient preferences with clinician’s judgement in healthcare decision making. Although it is essential to include the patient’s needs and wants in the treatment, receiving an MPK is unfortunately not always a possibility (Morgenroth, 2013). Due to the significant costs involved in the prescription of MPKs, prosthetists and other clinicians are faced with the challenge of valuing patient preferences when deciding on what prosthetic components to provide (Mundell et al., 2017). Current prosthetic prescription for lower limb amputees relies primarily on the prosthetist's empirical knowledge rather than on an optimized, systematic and quantifiable prescription method (Van der Linde et al., 2005; Morgenroth, 2013; Sansam et al., 2014).

Several studies have addressed the need of national clinical guidelines to improve quality and equality of prosthetic prescription (Van Der Linde et al., 2003; Van Der Linde et al., 2004; Van der Linde et al. 2005; Sansam et al., 2014; Sedki & Fisher, 2015). Sansam et al. (2014) investigated clinicians’ perspectives on factors that influence decision-making when it comes to prosthetic componentry. The participating

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clinicians considered patient choice, estimating outcome, difficulties predicting outcome and barriers to prescribing to be the most significant influencing factors during decision-making (Sansam et al., 2014). Van der Linde et al. (2004) and Van der Linde et al. (2005), investigated the prosthetic prescription process and looked at developing guidelines for prosthetic prescription in the Netherlands. Both studies stated that activity level played a significant role when prescribing a prothesis, however neither study presented how this conclusion was established. There was furthermore no clear association between the activity level and choice of prosthetic component prescribed (Van der Linde et al., 2004; Van der Linde et al., 2005).

Sedki and Fisher (2015) aimed to quantify and structure the prescription process of MPKs and develop guidelines for clinicians to use when deciding whether to prescribe an MPK or not. Guidelines were created with the help of experts and professionals in the prosthetics field. The guidelines allowed for a more justified decision-making and ensured a more unified approach to the prescription of MPKs across different clinics. The study highlighted the importance of current evidence and ensuring to update and improve the guidelines as research progresses and more evidence becomes available (Sedki & Fisher, 2015).

Current evidence provides information regarding the benefits of using MPKs (Highsmith et al., 2010; Şen et al., 2020), however, without uniform MPK prescription guidelines, clinicians are faced with challenges in knowing when prescribing an MPK is most suitable. Manufacturers of prosthetics components evidently indicate the benefits of using the component, however there is often a lack of information provided about contraindications for use and other information regarding when the component is most suitable (Sedki & Fisher, 2015). As stated, developing guidelines is seen as a useful tool in making healthcare more efficient and consistent and could promote fairness and best outcomes for all parties involved (Van der Linde et al., 2003; Van der Linde et al., 2005).

2.8 Healthcare equality in relation to MPK prescription

In Sweden, the law “Patientlagen (2014:821)” state that all citizens should be treated on the same premises when it comes to healthcare (Sveriges Riksdag, n.d). However, beyond national regulations, each region confines to their own set of additional regulations (Patientlag, 2014). Sweden is divided into 21 regions where each region covers a large geographical area (Sveriges Kommuner och Regioner [SKR], 2021). Regions have been formed to manage larger economical resources such as healthcare and taking care of tasks considered too expensive for smaller communities to manage (SKR, 2021). The regions are funded by tax money from the inhabitants in the region and the regions can make their own decisions about what to spend the money on (SKR, 2021), hence the amount of funds allocated towards healthcare may differ between regions.

There is indication of varying data across Sweden in relation to LLA. The national register Swedeamp (2020), have reported that the level of amputation and total number of amputations varies per region. The region of Skåne has registered 1570 amputations while the region of Stockholm only has 840 amputations registered, despite Stockholm having over one million more inhabitants than Skåne (Swedeamp, 2020; SCB, n.d.). Moreover, the percentage ratio between transtibial (TT) amputation over knee disarticulation (KD) and TF amputation differs across Sweden. The region of Skåne report 55 TT amputations and 45 amputations through or above the knee, while Östergötland report 35/65, Stockholm 74/26 and Uppsala 81/19 (Swedeamp, 2020). These varying numbers indicate that patients with the same clinical problem may receive different surgical treatments in different regions.

To the authors knowledge no national prescribing guidelines are available in Sweden. However, all healthcare providers are obliged to present and offer all feasible intervention options whenever possible, and the patient should be a part of the decision-making process regarding their own treatment (Patientlag, 2014). Clinicians’ experience of the prescription process of MPKs in Sweden has not been studied. However, it is possible that patients who have identical clinical problems, receive different treatment depending on their clinician, hospital or region in which they live (Van der Linde et al., 2003; Van der Linde et al., 2005).

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3. Intention

The aim of this study was to explore clinicians’ perceptions of what is affecting the prescription of MPKs in different regions in Sweden.

4. Methods

A qualitative study was conducted with prosthetists and a physiotherapist with experience in prescribing lower limb prostheses. The qualitative approach allowed the authors to get a thorough insight of the clinicians’ perceptions and reasoning on what is affecting the prescribing process of MPKs (Denny & Weckesser, 2019). Semi-structured interviews were used which, according to McIntosh and Morse (2015), allow for an in-depth understanding of the subject matter. This form of interview allows the interviewer to ask follow-up questions during the interviews (Carl & Ravitch, 2018), and is designed to promote subjective responses from the participants relating to the research aim in question (McIntosh & Morse, 2015).

The interviews were conducted and recorded remotely using Zoom or Teams software. The interviews were then transcribed and analysed using thematic analysis. According to Braun and Clarke (2014), thematic analysis provides an accessible systematic framework of analysing and presenting qualitative data and is well suited for research relating to clinical settings.

4.1 Sampling strategy

Criterion sampling was done where the authors were responsible for the recruitment of clinicians based on the authors’ assumption that they have knowledge and experience with MPK prescription (Palinkas, Horwitz, Green, Wisdom, Duan & Hoagwood, 2015). Criterion sampling is a type of purposeful sampling strategy commonly used in qualitative research as it allows for identification of rich information related to the research topic (Palinkas et al., 2015). The subjects of this study were prosthetists from different regions who had at least three years of experience in prescribing lower limb prosthetics and one physiotherapist who had one-year experience in prescribing lower limb prosthetics. All participating clinicians had to be able to communicate in Swedish or English. The sample size was determined based on findings by Dworkin (2012) who suggests that sample size in qualitative studies can range from 5-50 participants to reach a sufficient level of data saturation. The sample size was determined based on the scope of the study and considering factors such as the time, authors’ experience, aim of the study and chosen methodology (Dworkin, 2012).

4.2 Ethical considerations

A self-assessment of ethical issues was conducted according to instructions from Jönköping University and submitted for review at the local, School of Health and Welfare, ethical review board. There is no requirement for ethical approval for a degree project as it is not considered research and can therefore not be reviewed by the Swedish Ethical Review Authority (Jönköping University, 2020). Interviewing clinicians about their perception of what is affecting the prescribing process of MPKs in Sweden is also not considered relevant for ethical examining under the Swedish law “Lag (2003:460) om etikprövning av forskning som avser människor” (Sveriges Rikstad, 2003).

Despite not being required to obtain ethical approval for this study, careful considerations were made to ensure that participating individuals were not subject to any form of physical or psychological violation or exploitation. The participants were adult clinicians and not considered to be a vulnerable group in society nor in a dependent relationship to the investigators. The authors ensured that the clinicians were informed about the aim of the study and about their right to stop and withdraw from the study at any given time. Prior to participation, the individuals received a written explanation about the study and a consent form was developed based on World Health Organization’s informed consent form for qualitative research (WHO, 2021) (see appendix C). Consent was provided via email. While the interview questions were not considered sensitive in nature, the clinicians were informed that they did not have to answer questions if they did not wish to do so.

Data collected was treated confidentially and only used for research purposes. Individuals were not identifiable from any material published about the study and all data collected was stored securely. To avoid over- or under-representation of a certain region, only clinicians from one clinic in each region was chosen to participate. Due to some regions only having one practicing prosthetics clinic, careful measures

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were taken to prevent regions, clinics and participating clinicians from being exploited in any way as a result of their participation.

There were risks involved in conducting interviews via Zoom and Teams which were taken into consideration (Johnson, Scheitle & Ecklund, 2019). Johnson et al. (2019) suggest that the richness of the data collected from interviews conducted remotely via videoconference technologies is often inferior to information collected from in-person interviews. They highlighted that there are fewer conversational turns and less word-dense transcripts from interviews conducted via video compared to in-person interview (Johnson et al., 2019). Johnson et al. (2019) also raises the issue of scheduled time frame for interviews conducted remotely, highlighting that the researcher who conduct remote interviews, might be less inclined to ask for more information out of concern for the time limit. The authors allocated 30 minutes for each interview, as it was believed to be sufficient to cover all questions and convenient for the clinicians to plan into their work schedule.

Despite the benefits of in-person interviews, conducting them remotely via Teams and Zoom was necessary due to Covid-19 and it was considered the most convenient mode for interviews considering the study time frame, cost and clinicians’ geographical location (McIntosh & Morse, 2015). Vogl (2013) states that face-to-face interviews, whether they be conducted in-person or digitally, are superior to telephone interviews when the interviewers have limited interviewing skills.

Another risk is related to the experience of the authors in conducting interviews, as interview skills can influence the overall quality of the interview and findings (Roulston, 2010). According to Roulston (2010), the ability of the authors to demonstrate their expertise as researchers can increase the validation and quality of the study. How the questions are asked effects the quality of the interviewing, therefore, it is important for the interviewers to find effective ways to ask the questions to ensure that data relevant to the research aim can be produced (Roulston, 2010). To minimize this risk, the authors conducted a test interview with one clinician, who was not included as a participant. This allowed the authors to get feedback regarding the questions, gain experience in asking questions, familiarize themselves with the technology and determine the approximate time needed for the interview.

To minimize the risk of misinterpretation during data analysis and increase the validity of the findings, researchers can maintain regular contact with the clinicians and check in with them during data analysis to see if emerging themes and interpretations were correct (Curtin & Fossey, 2007). Sending the interview transcripts to the clinicians for review prior to data analysis or having another interview with them to verify the findings could also minimize this risk and increased validity of the study (Curtin & Fossey, 2007). However, due to time limit of the study, the authors did not have the opportunity to conduct these activities.

Being an experienced interviewer also involves taking on a neutral role during the interview, ask relevant questions and take careful consideration to minimize bias (Roulston, 2010). Careful considerations were made to avoid the risk of bias. One participating clinician worked together with one of the authors and to avoid the potential for researcher bias, the interview with that clinician was conducted alone by the other author. According to Ravitch (2018), the degree of influence an interviewer may have depends on the roles in the interview setting, social identities and the position that the interviewer and participant has in relation to the research question. These aspects can influence the participants expectations of the interview and possibly bias the data which could affect its validity (Ravitch, 2018). In this case, having the role as co-workers in the interview setting was avoided by letting the other author conduct that interview alone. In terms of the positionality in the study, the clinicians knew that the authors were students within the same field of work and that the research findings would be made available on a public platform. This meant that there was risk of participating clinicians feeling hesitant towards sharing information about certain aspects of the prescribing process or feeling resistant in expressing their true experience. To minimize this risk, the authors ensured the clinicians that they were in a safe and non-judgmental space and that they would not be identifiable from the data and careful considerations were taken to prevent participating clinicians from being exploited in any way (Carl & Ravitch, 2018).

Having individual and pair interviews further minimized the risk of the clinician being influenced by others and allowed them to speak freely about the topic without having to consider competitors or judgement of others (Carl & Ravitch, 2018). Conducting interviews allowed for in-depth discussion regarding the clinicians’ experiences of what is affecting the prescription of MPKs in their region (Carl & Ravitch, 2018). To improve the quality of the research and validate the clinicians’ statements, Morgenroth (2013) suggests including multiple data collection methods. However, survey was not considered a

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suitable method for this study as it focuses on statistical analyses and does not provide in-depth answers around the subject to the same extend as qualitative interviews (Roulston, 2010). Focus groups was not considered appropriate as clinicians work at competing clinics and are likely to feel more comfortable with sharing information about their clinical practices in a more confidential environment. According to Stewart (2018), one of the risks with focus groups is that the data collected may be biased as group members may be influenced by one another.

4.3 Data collection methods

Semi-structured interviews were conducted using primarily open-ended questions (see appendix A for English and appendix B for Swedish). Interview questions were formulated by the researchers and based on previous findings from Clarke et al. (2019), Sedki and Fisher (2015), as well as expert opinion from a prosthetist. A try-out interview was conducted with a certified prosthetist prior to the official interviews which allowed the authors to evaluate the questions and receive feedback. The study focused on expert opinion of prosthetists and one physiotherapist who were involved with prescribing MPKs in Sweden. The researchers informed the clinicians and invited them to participate. Each clinician was asked the questions, where some were open-ended giving them the opportunity to speak freely around the questions while others were more structured. Each interview took approximately 30 minutes to conduct and were all conducted in Swedish.

4.4 Data processing

Both authors transcribed the data collected from the interviews equally and thereafter thematic analysis of the data was done. This qualitative analytic method involved exploring similarities and relationships between different parts of the data. It provided a detailed thematic description of the entire data set, allowing the authors to get an understanding of the predominant and important themes in relation to the aim (Braun & Clarke, 2006). The grounded theory method is another qualitative data analysis method that seeks to describe patterns in the collected data, however it differs from thematic analysis as it involves a more comparative approach with the aim to construct a theory (Bryant & Charmaz, 2007). Data collection and analysis occurs simultaneously, encouraging the researchers’ to constantly interact with their data and keep track of emerging analyses, which can be more demanding and time consuming compared to thematic analysis (Bryant & Charmaz, 2007). Due to the authors lack of experience in conducting data analysis and due to time limitation, thematic analysis was chosen as it is a simpler method to learn and use, while still providing a thorough and systematic reflection and analysis of the data (Braun & Clarke, 2014).

The first step involves familiarising oneself with the data; reading the transcribed material and identifying patterns that bear meaning and relate to the research question. Both authors began by analysing the data individually and distinguished the meaning units considered important and relevant in relation to the aim. Thereafter, they came together to discuss the findings and correlations made. All the identified meaning units were then condensed until both authors agreed on the most significant ones. The next step was to code and label the identified units and thereafter search for themes within the data set based on the codes. The authors sort the coded units in accordance to how they relate to one another and in doing so, different themes emerged for further discussion and investigation. A theme must be complete and mutually exclusive and included data must not fall between two themes nor be present in more than one. Data considered irrelevant for the research purpose was excluded. Once the themes were identified, reviewed, and defined, they were used to produce the report and support the research aim (Braun & Clarke, 2006).

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5. Results

5.1 Demographics

Ten clinicians from eight prosthetic clinics in eight different regions across Sweden were interviewed between the 16th of March and 6th of April 2021. Two of the interviews were conducted with two

representatives from the same clinic. Out of the ten interviewees, nine were certified prosthetists and one was a certified physiotherapist. The physiotherapist was chosen to be included in the study as this person worked closely together with the prosthetist and was involved during the prescription process of an MPK. The prosthetists had 3-38 years of experience in working as a prosthetist, and the physiotherapist had one-year experience working with MPK prescription. Three of the clinicians were female and the clinicians’ overall experience in prescribing MPKs ranged from 1-20 prescriptions each. Sweden consists of 21 regions, eight were represented in the study. Four of the regions had a population size larger than 380,000. The number of clinicians specialized in lower limb prosthetics varied between clinics. One clinic had only one prosthetist specialized in lower limb prosthetics while others had up to four. The number of MPKs prescribed yearly per clinic ranged from 1-4, with a mean of 3.

The prescribing process of MPKs differed across regions and although there were similar key aspects, there was no standardised and uniform approach. In some regions the prosthetists received a referral from a doctor with a general prescription for prosthetic provision. The prosthetist thereby became responsible for prescribing the prothesis he or she believed to be the most suitable, without requiring further approval from the doctor. While, in other regions, the orthopaedic doctor was responsible for the prescription. In these regions, the prosthetists were required to apply for approval from the doctor prior to prescribing an MPK to a patient. One region’s prescribing process stood out from the rest in that they had to apply for a formal approval of an MPK prescription at the regional council, which could be done a few times every year. The formality of an MPK prescribing process differed between regions, where some regions had a structured process with standardized functional tests and formal questionaries as a base in the decision process, whereas other regions relied predominantly on the clinicians’ own experiences and judgements.

Decision-making regarding possible candidates for MPKs were made together with the patient and multidisciplinary team at all clinics. The patient assessments were done either at a single appointment with all team members present at once, or separately. To determine whether a patient would benefit from an MPK or not, members of the multidisciplinary team assessed the patients functional and cognitive abilities, activity level as well as motivation and potential to understand how an MPK works. The estimation of outcomes and patient assessments were predominantly based on the prosthetists’ previous experience while one clinic used prescription guidelines that were agreed upon locally and provided a more formal approach to assessing patients’ potential when using an MPK.

5.2 Identified themes

When analysing the data four main themes were identified along with ten subthemes. Assessing patients and valuing their characteristics and goals were found to be factors that affect the clinicians’ prescription of MPKs. Other factors that affected the MPK prescription related to challenges in predicting outcomes, staying within budget limitations, and dealing with application processes and inconsistent procedures. External factors such as the patients’ social circle and media, were found to influence the patients’ expectations of an MPK which could affect the prescription process.

Table 1. Presentation of emerging themes and subthemes.

Themes Subthemes

Assessing candidate for MPK • Valuing patient characteristics • Importance of patient goals • Use of prosthesis

Challenges in estimating outcomes • Subjective evaluation

• Dilemma with trail of MPK prior to approval

Barriers to prescribing • Budget limitations

• Application process and timing • Inconsistent procedures External influencing factors • Social influence

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5.3 Assessing candidate for MPK

Three subthemes were recognized as influencing the clinician’s assessment of possible MPK candidates: valuing patient characteristics, importance of patient goals and use of prothesis.

Valuing patient characteristics. Clinicians experienced difficulties in valuing patient characteristics

when evaluating their suitability for an MPK and determine who to prioritize over others. They described activity level to be one of the most important aspects to consider, highlighting that the patient must be ambulant and have a high activity level to be eligible for an MPK. They did however, express a dilemma in valuing patient characteristics as they knew that patients with lower activity levels, including geriatric patients, would also benefit from the security provided by an MPK. However, due to budget limitations the low active geriatric patients were rarely prescribed an MPK.

” We know that nearly every patient would benefit from an MPK and possibly more so the patients who have less balance and strength, but they are not the ones who receive one. Focus has become on the younger, active patients who often work, they are the ones who will get an MPK prescribed”

The clinicians stated that age was not a determining factor as to who would get an MPK, although there was an agreement that it is often the younger, active and working patients who receive an MPK. Assessing the patients’ ability to work and contribute financially to society, was expressed as affecting the prescription of MPKs. Clinicians felt a need to consider how the prescription of an MPK would influence not only the individual, but also look at it from a socioeconomic perspective and consider where tax revenues are spent.

Importance of patient goals. Clinicians felt that the patient’s own goals were important to consider and

could affect their chances of receiving an MPK. Highlighting that their goals are often linked to their motivation and can provide an indication of how determined they would be towards using an MPK as intended. Clinicians stated that it could be challenging to decline a patient’s wish for an MPK, especially if the patient early on had their mind set on an MPK before even consulting it with their clinicians. Clinicians stated that the patients’ goals, whether it be to improve activity level, walk in stairs or be able to walk without a cane, affects their chances of receiving an MPK and is carefully considered as part of the patient assessment.

Use of prosthesis. Another factor that was found to influence the clinician’s prescription of MPKs was

the extent to which the patient used the prothesis. Clinicians indicated that the patient should preferably be ambulating on the prothesis daily and have an overall high usage frequency. According to the clinicians, the high cost of the MPKs needs to be justified and therefore the patient should be using it regularly and making use of all the functions it has to offer.

5.4 Challenges in estimating outcomes

Two subthemes were recognized as making it difficult for clinicians to predict outcomes and thereby affecting the prescription of MPKs: subjective evaluation and dilemma with trial of MPK prior to approval.

Subjective evaluation. Clinicians mentioned that evaluating aspects such as motivation was challenging

and affected the prescription of MPKs. They highlighted that patients’ compatibility for an MPK was based more on subjective measures rather than objective making it difficult to estimate outcomes. They expressed that without objectively assessing baseline predictive factors, they rely more on their own speculations and general impression of the patient which affects the prescription of MPKs. One clinic differed from the others by having a more formal way of assessing and predicting outcomes by conducting several physical assessment tests and collecting data to support their decision-making.

Dilemma with trial of MPK prior to approval. Challenges relating to the trial of an MPK prior to

approval was a prevalent issue. All clinicians reflected on the dilemma that can occur if a patient is given the opportunity to try an MPK but then get their application denied.

“We often end up in a dilemma where we would like to try an MPK on the patient first to see if they are a suitable candidate and then apply for approval, but the risk is that the patient will become disappointed if we would not get it prescribed.”

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One clinic mentioned that they occasionally do provide patients with an MPK to try prior to receiving approval of prescription, highlighting that they ensure the patient is well aware of the circumstances and that no guarantee is provided regarding the prescription of an MPK. Other clinics ensured that the patient received approval for an MPK prior to starting the trial period to avoid the moral dilemma that might arise if a patient becomes committed to the MPK during the trial period and then has their application rejected.

5.5 Barriers to prescribing

Three subthemes were recognized as barriers to prescribing MPKs, including budget limitations, application process and timing, and inconsistent procedures.

Budget limitations. Regional budget restrictions were found to significantly affect the prescription of

MPKs. Clinicians stated that they would likely prescribe MPKs to additional patients if there was no budget limit.

“The greatest dilemma is the budget. I would have really liked to prescribe MPKs to more and not have to be so tough in the judgement because I feel that they provide so much quality of life.”

Some clinicians stated that practically all patients with the ability to ambulate with a prosthetic knee, are expected to benefit more from an MPK compared to a non-MPK. The clinicians also highlighted that having to motivate the cost-effectiveness of MPKs to the decision-makers affects the prescription process. Although clinicians stated that they would likely prescribe additional MPKs if the regional budget was larger, there was still a general agreement that all the patients they considered suitable to receive an MPK to date, were in fact provided with one. Many clinicians expressed a dislike towards having to consider costs when prescribing a prosthetic knee, however, they realize it is necessary to ensure that the financial resources are allocated appropriately to cover the costs for all patients requiring prosthetic componentry.

Application process and timing. Clinicians expressed that the requirement to apply for approval as a

barrier for prescribing an MPK. Clinicians working in private clinics felt that they would be more inclined to prescribe additional MPKs if they would have been prescribers themselves, however, still bearing in mind the finite budget. Clinicians at a private clinic described the dilemma of wanting to prescribe additional MPKs whilst not risk coming across as wanting to increase their own clinics’ revenue. They felt that having to consider the risk of their MPK-applications being done for profit-making purposes, was affecting their prescription of MPKs. Clinicians who had to go through an application process also expressed that it increased the prescription time of an MPK. Waiting for answers regarding an application, paperwork requirements and coordinating meetings to be able to present a patient case, were described as time consuming. In some regions, the clinicians felt that the complete process from patient assessment to the patient receiving an MPK was too long and could benefit from being optimized and shortened. Clinicians even suggested that in some cases, it could be beneficial for a patient to move to another region to receive an MPK sooner.

Inconsistent procedures. Some clinicians felt that their prescribing practices and application process for

MPKs were too generalized, which could lead to inconsistency as to who received an MPK. It was also reported that the relationship between the prosthetists and the prescribing doctors could affect the prescription of MPKs, stating that a good trustworthy relationship could make the application process for an MPK more time efficient. The prescribing process was also described as being too emotionally based, highlighting that the prosthetists emotional attachment to the patient could influence the prescribing process. How well the patient expressed their own desire for an MPK was also stated as having a possible effect on the prescribing process, thereby leaving room for inconsistent assessments.

“The prescribing process is very emotionally based and can depend on how well the patient can formulate their request or which orthopaedic doctor they meet... and a lot depends also on how well I, as a prosthetist, can motivate. So, a lot of responsibility is on me as well, which is a disadvantage.”

Clinician expressed a need of a more standardized and quantifiable way of prescribing MPKs and felt positive towards an idea of having national set of guidelines for prescribing MPKs. They felt that it would promote more equal treatment for patients regardless of budget, experience of prosthetist and regardless of where in Sweden they live.

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5.6 External influencing factors

Two subthemes were found when exploring what external factors influence the patients’ expectations of an MPK: opinions of social circle and media.

Social influence. Some clinicians stated that family members and other social influences can have a

negative effect on the prescribing process, especially when someone persistently request an MPK for a patient that is not suitable for one. Some recall instances where family members put unjustified pressure on the clinician to prescribe an MPK when in fact it is not a relevant option for that patient. Overall, clinicians felt that this external pressure influence the prescribing process of MPKs.

Media influence. Clinicians mentioned that media can contribute to the patient having unrealistically

high expectations of an MPK, which could affect the prescription process. They mentioned that patients sometimes come across information in the media about MPKs which contributes to unrealistic expectations about how an MPK can benefit their lives. It then becomes the prosthetist job to address the patients’ expectations, explain why an MPK might not be suitable and inform them about the realistic anticipated outcomes.

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6. Discussion

Four key themes were identified when exploring the clinicians’ perceptions of what was affecting the prescription of MPKs in different regions in Sweden. The identified themes were: assessing candidates for an MPK, challenges in estimating outcomes, barriers to prescribing and external influencing factors. The clinicians experienced similar difficulties in assessing suitable candidates for MPKs, highlighting that valuing patients’ characteristics, and estimating their level of motivation, can affect the prescribing process. According to Morgenroth (2013), motivation plays a significant role in determining whether an MPK is suitable or not, as it gives an indication of how committed the patient will be to learning how to use the MPK optimally. Active patients in their working life, are often the ones getting it prescribed today, given that they meet the physical and cognitive requirements of using an MPK. Although activity level and participation in relation to work, fits well into the ICF framework (WHO, 2013), none of the clinicians mentioned the use of ICF during patient assessment. It was however clear that focus was not only on the patients’ functional mobility but also on their participation in society, specifically when it came to work. The limited budget was found to be a significant barrier to prescribing MPKs. This was in line with previous studies highlighting that the significant financial costs of MPKs make their prescription more difficult to justify when compared to non-MPKs (Sedki & Fisher, 2015). Clinicians felt that they would most likely prescribe additional MPKs if they had increased financial resources. Some clinicians found it challenging to select which patients to prioritize for an MPK. They felt that their choice not only influenced that individual’s life, but also other individuals requiring prosthetic componentry, highlighting the dilemma that if one individual receives an MPK, there will be fewer financial resources for other patients. Some clinicians stated that a national budget for high-cost medical aids, including MPKs, could be beneficial as regional budgets would not be affected to the same extent by MPK-costs. This is the case in Norway where a national public budget exists for medical aids (Regeringskansliet, 2011). Clinicians in Norway are also required to apply for approval of certain prescription of medical device however, the cost is covered by a national budget rather than regional (Regeringskansliet, 2011). Clinicians discussed that, having medical aids funded by the government, rather that the regions individually, could possibly allow for a more uniform and fair process across the country so that patient treatments are not influenced by factors such as budget or clinician’s experience.

Clinicians also felt that the cost-effectiveness of an MPK in the long run was not always considered by the prescribers. They felt that health economic evaluations ought to be done so that the cost of MPKs can be better justified. Clarke et al. (2019) highlighted the importance of looking at the long-term treatment and broader prosthetic services provided to the patient rather than only considering the cost of the device. According to Highsmith et al. (2010), an MPK was found to be more cost-effective than a non-MPK as the increased costs were compensated by reduced medical- and caretaking costs. Fuenzalida Squella et al. (2018) also states that an MPK decreases the likelihood of falls, which can significantly result in cost savings according to Mundell et al. (2017). Sedki and Fisher (2015) and Brodtkorb et al. (2008), also highlighted that looking at the long-term cost savings and health economy impact of using an MPK is important to better evaluate the cost-effectiveness of an MPK as well as better define the added quality of life to the patient.

Age was not described as being a restriction to receiving an MPK, however, clinicians stated that the budget limitation is affecting the prescription process in that the younger, active and working population are the ones prioritized for an MPK over the less active geriatric population. As mentioned, according to WHO (2017), every individual has the right to the highest attainable health care regardless of age, religion, race, political view, social or economic conditions. According to the law “Hälso- och sjukvårdslag (1982:763)”, individuals who have the greatest need for healthcare should take precedence. Whether the geriatric patients have a greater need for an MPK than the younger active populations, was not commented on by the clinicians. However, clinicians stated that the geriatric population would indeed benefit from the security provided by an MPK. Previous studies support this, stating that less active and limited community ambulators would also benefit from an MPK, especially when it comes to safety, mobility and overall patient satisfaction (Fuenzalida Squella et al., 2018; Burnfield et al., 2012; Hafner & Smith, 2009; Theeven et al., 2011). It has also been shown that limited community ambulators who use MPKs may result in uncontrolled falls reducing by up to 80%, which would furthermore be cost-effective from an economic perspective. Although clinicians were aware of the benefits a geriatric patient would have from an MPK, they felt that it was more justifiable from a socioeconomic perspective to provide MPKs to the younger and active patients.

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Clinicians felt that their current prescription of MPKs was primarily dependent on subjective measures by the prosthetist, stating that the process is too emotionally based and agreed that a more formal prescription process would be beneficial to promote a more equal and standardised practice for prescribing MPKs. Having a more formal way of assessing and predicting outcomes by conducting physical tests with and without an MPK and collecting more data about the patient would provide great support for the clinicians and allow them to better justify their decisions. Efforts to try to improve upon these aspects has already been tried in other countries (Van der Linde et al., 2004; Van der Linde et al., 2005; Sedki & Fisher 2015). A uniform prescription method could be a solution to make the prescription method more objective and thereby relives pressure on the clinicians, as decisions do not need to be as dependent on their own judgement and experience.

The clinicians brought to light the ethical dilemma regarding initiation of a trial with an MPK prior to approval and stated that this affected the prescribing process. The researchers found no previous studies covering this aspect, but it significantly influences the prescription possibilities of MPK today as individuals who are on the borderline of being prescribed an MPK, are not always provided with a trial due to the uncertainty of not being approved later. The clinicians stated that if an individual on the other, had been given the opportunity to try an MPK first, they may exceed expectations which thereby would strongly support and benefit the application for approval of an MPK for that individual. However, to avoid any possible ethical wrongdoing or moral dilemmas, most clinics required the approval of an MPK prescription prior to providing it to the patient for trial.

Challenges with having to go through an application process for an MPK was found to affect the prescription of MPKs. Aspects of the application process that were expressed as somewhat burdensome involved administration demands, inefficient correspondence with prescribing doctors or waiting time for the opportunity to present the application during a regional meeting. Frossard, Merlo, Quincey, Burkett and Berg (2017), assessed the challenges involved with establishing prescribing guidelines for prosthesis and highlighted difficulties that prosthetic service providers face including governmental control and time-consuming paperwork (Frossard et al. 2017). Frossard et al. (2017) suggests that a systematic procedure regarding prescription of expensive prosthetic componentry should be developed to ensure high quality treatments and control of expenses. Some clinicians stated that if they were prescribers themselves, and not required to apply for approval from a doctor or third-party, they would possibly initiate more MPK trials and prescriptions. Being prescribers themselves, would allow them to have more control of the whole process and not have to spend time convincing someone else about an MPK candidate which could possibly ensure a more efficient overall MPK prescription process.

6.1 Limitations

There are limitations to this study that need to be brought to attention.

The richness of the data collected from interviews differed, where some interviews generated large amount of content and others more limited amount. The authors believe that the richness of the data was to some extent influenced by the mode in which the interviews took place, as conducting interviews remotely via videoconference technologies is often inferior to data collected from in-person interviews (Johnson et al., 2019). Some of the interviews had fewer conversational turns and provided less word-dense transcripts which could also have been due to the interviews being done via videoconference technologies (Johnson et al., 2019). The authors were aware of the limitations involved in conducting the interviews via Zoom and Teams, however it was necessary to do so due to Covid-19 restrictions. It was also seen as the most convenient mode for interviews considering the study time frame and the clinicians’ geographical location.

Although the mode of the interviews worked well, the time allocated for each interview was slightly underestimated. Clinicians were informed that the interviews would take around 30 minutes, hence they often allocated this time for the interview. However, due to having qualitative questions and allowing the clinicians to reflect freely about their experiences, sometimes resulted in longer answers than anticipated. The shortest interview was 17 min long while the longest interview lasted 38 min. Interviews that went beyond 30 minutes were not stopped by the authors but by the clinician when they had other commitments to attend to. Due to having the set scheduled time frame for the interviews, the authors felt less inclined to ask for further elaboration of a question or ask for more information, out of concern for the time limit. This is according to Johnson et al. (2019), a common concern for researchers conducting remote interviews and to avoid the sense of urgency in the questions during interviews, more time could have been scheduled for each interview.

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To further improve the quality of the interviews and produce valid findings, the authors could have undergone training in how to be a skillful interviewer (Roulston, 2010). The authors knew that being able to demonstrate expertise as a researcher could increase the validation and quality of the overall study (Roulston, 2010) and therefore conducted a test interview with one clinician. This clinician was not included as a participant in the study. However, due to time limit, the authors did not have the opportunity to conduct additional test-interviews, which could have been beneficial to learn how to ask questions effectively and ensure that relevant data can be produced (Roulston, 2010). To further increase the quality of the research findings, more interviews could have been conducted to include additional clinicians in additional regions and thereby obtain a broader representation of the clinicians’ perception of what is affecting the prescription of MPKs across Sweden.

Having qualitative interviews allowed the clinicians to speak freely about the topic without having to consider competitors or judgement of others and generated in-depth discussion regarding the clinicians’ experiences of what is affecting the prescription of MPKs. However, it could have been beneficial to include additional health care providers involved with MPK prescription, to gain a better understanding of what is affecting the prescription of MPK in different regions in Sweden. According to Morgenroth (2013), including multiple data collection methods can improve the quality of the study and validate the findings. However, if focus groups were to be used, members of one focus group would be clinicians from the same clinic. Having members of competing clinics in the same focus group would not be considered appropriate as they would most likely feel hesitant towards sharing possible sensitive information about their clinical practices.

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7. Conclusion

In conclusion, clinicians across Sweden expressed several factors that they perceive affect the prescription of MPKs. Budget limitation was found to be a major barrier to prescribing MPKs as it demanded clinicians to make tough judgements and carefully assess which patients to prioritize over others. Clinicians had to rely on their own experiences and knowledge in determining which patient would benefit the most from an MPK while considering the socioeconomic influence of their decision. Having to consider the socioeconomic factor, the patient group most often prescribed an MPK were active and working. However, clinicians stated that practically every ambulating patient, including the older low-active population, would benefit from the advanced technology of an MPK. This raised the question and dilemma of who should really be prioritized for an MPK.

The prescription of MPKs was dependent on subjective evaluations and relied predominantly on the expertise of the clinicians rather than on measurable outcomes. Today clinicians are expected to use their own understanding of patient attributes and goals as well as understand the capabilities and limitations of the available prosthetic componentry. More research on this topic is warranted to further investigate and optimize the prescription of MPKs so that patients are given an equal opportunity to be prescribed the most suitable prosthetic componentry, regardless of where they live or which clinician they meet.

The results of the study can give clinicians an insight in the prescription process of MPKs in clinics across Sweden. With these results, the authors hope to prompt further discussion about the possible ways that clinicians can work towards developing uniform guidelines and thereby further promote equal healthcare and treatment of the amputee population across Sweden.

References

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