The application, character, and effectiveness of person-centred care with service-users, and the community within the discipline of podiatry: a scoping review

The protocol was developed using the preferred reporting items for systematic reviews and meta-analysis (PRISMA) checklist, agreed with the research team [9] and registered with the Open Science Framework retrospectively on 07.02.2021 (Registration number: osf.io/egjsd). The scoping review uses Arksey and Malley’s five stage framework to provide an overview of the literature leading to summary, synthesis and reporting [10].

A librarian specialising in health was consulted to ensure a comprehensive review of research databases and grey literature. The searches were conducted electronically within the following databases: AMED, CINAHL, EMBASE, Cochrane database of systematic reviews, SocINDEX, British Education Index, Business Source Complete, and MEDLINE (EBSCO). United Kingdom (UK) doctoral theses were accessed via EThOS and the ‘Global electronic thesis and dissertation’ repository. A secondary search within Prospero was conducted to identify systematic reviews. Finally, the reference lists of the review papers were searched to identify further publications. The search terms used can be viewed in Appendix 1.

A data analysis mapping matrix was developed outlining the objectives of the scoping review and a data extraction table with the data types for collection. The data mapping matrix confirmed that each objective had at least one data extraction type mapped to it and indicated the types of data that might be found within the studies. A decision was made to record ‘types of person-centred care’ based upon the definitions stated by National Health Service (NHS) England within the Comprehensive Model of Personalised Care [12]. These definitions are not used beyond England but provide categories for the types of person-centred care using an easily interpreted description.

Citations, abstracts, and full-text papers were independently reviewed by three investigators (SA/PH/KA) against the inclusion criteria. Any disagreements arising between reviewers were resolved through discussion. The study selection process is displayed in the PRISMA flow diagram (Fig. 1).

The data extraction table was piloted to agree definitions and data extracted as follows: geographical location, setting, study aim, research methodology and demographic data of the recipient group. Intervention characteristics and outcomes including intervention type, delivery format, management of the intervention, evidence of effectiveness, efficiency, resourcing, cost implications, reasons for engagement, challenges and barriers encountered, and conclusions were also recorded.

No standardised definition exists for self-care and self-management and is used interchangeably in the literature to refer to separate concepts [13]. We define self-care as activities that promote general health (physical and mental) based on the individual’s choice, whilst self-management are activities guided by the support of others such as family or a health professional.

The Hawker et al. [14] critical appraisal tool was used to systematically assess research articles with differing study designs to assign a total score based on the quality of each research article. This was divided into category scores of low (9 to 17), fair (18 to 26), and high (27 to 36).

Following a search of the databases, 622 citations were identified with a further 27 yielded from additional sources. Duplicates resulted in 54 citations being removed leaving 595 from which a further 119 were excluded following review of the title and abstract. Searches were concluded by 1.3.21. Upon full text reading a further 89 papers were removed and a further 12 removed upon critical review by authors, KA, PH and SA leaving 18 papers included in the scoping review (Fig. 1). The primary reasons for excluding studies at the full-text reviewing stage were: conference abstracts only available, no intervention, not related to person-centred care or did not meet the standards of proficiency set by the HCPC [11]. Table 1 displays the characteristics of the studies included in this review. However, information, such as age or gender are missing. The missing data was either not reported by the study or not applicable.

Geographical distribution represents countries where data were collected for each study (Fig. 2). Of the 18 studies, 11% were multi-sites. Australia [15, 18, 21, 26‐28] contributed 33% of the papers and the United Kingdom 22%, representing 55% of the research undertaken in the area of person-centred care.

A variety of settings were represented with 41% at multiple sites [4, 16, 21, 26, 27, 29, 30]. Community settings accounted for 27% [15, 17‐19, 28] with a further 6% in the home [25], and 16% at podiatry clinics or medical centres [23, 24, 31]. Eleven percent of the studies did not state the context or setting of the study [28, 29].

Diabetes was the main focus of 72% of the studies reviewed [15, 16, 18‐20, 23‐25, 27, 29, 30], with 6% focusing on patients with PVD [5], 6% on patient with chronic disease [28] and 12% on those with visual impairment [24, 25]. None of the studies specifically used the term person-centred care (or a similar term) within their aims. There was, however, reference to ‘foot self-care and self-exam’ by one study [30], but these terms were not defined. ‘Foot examination’ using touch and smell alongside usual care was clearly outlined by one study [25]. The aims relating to diabetes varied from reducing amputation rates 6% [16], prevention, or early identification, of ulceration at 22% [20, 24, 29, 30]. One study looked at the prevention of falls in an older population with disabling foot pain (6%). Comparison of effectiveness of different education methods in relation to changes in foot health behaviours and attitudes was considered by one study (6%). Two studies (11%) focused specifically on Aboriginal and Torres Strait Island people. Chuter et al. [27] undertook a systematic review to consider ‘programmes’ which had successful outcomes in terms of foot related complications due to diabetes and Hu et al. [28] considered the differences between those who undertook a programme designed to support better chronic disease management and those who did not. Four studies (22%) undertook a service or pathway development approach [4, 17, 19, 26] in relation to how the service was operationalised [17, 19, 26], the feasibility of an integrated service [4] and cost-effectiveness and service improvement benefiting patients and clinicians [17].

The scoping review considered who the person-centred care intervention was aimed at, which was categorised as ‘person/carer’ (56%) [15, 18, 20, 21, 23‐25, 29‐31], ‘practitioner’ zero studies, and ‘service’ one study [19]. The remaining studies combined ‘person/carer’ and ‘practitioner’ (6%) [22], ‘person/carer’ and ‘service’ (17%) [4, 17, 26] or all three categories (17%) [16, 27, 28].

The data extracted was analysed using descriptive qualitative analysis [32, 33] and initially coded by author, SA. Emergent categories were noted and subsequently checked for coherence by the authors, KA and SA (Table 2) leading to three overarching categories.

This theme describes a concept where an intervention made a structural change to service delivery for the purposes of person-centred care and has three sub-themes. The sub-theme ‘referral pathways to access assessment/care’ describes increased access to a range of services for patients with diabetes [16] and improvements for access to podiatry services via self-referral [17]. The sub-theme ‘multidisciplinary approaches’ describes changes to care delivery where a group of healthcare professionals combined their expertise for the assessment and treatment of an individual patient [16, 29]. ‘Clinician empowerment’ was represented by one study which described giving more control over prescribing choices to clinicians to improve patient outcomes [19]; however, this paper did not specify from where power was transferred.

The theme ‘direct clinician participation’ describes a concept where the intervention is directly delivered by the clinician to the patient and has six sub-themes. This could be a treatment intervention, a person-centred care activity or referral to another clinician based on the patient’s needs. It is an activity that is instigated and led by the clinician. The sub-theme, ‘teaching via educator’, includes clinicians giving educational information to patients during consultations, and educational sessions/groups set up outside of the consultation [15, 20, 23, 30]. ‘Self-care reminders’ describes a mobile phone app reminding patients to engage with self-care activities [18]. ‘Standard monitoring and usual treatment protocols’ captures studies where participants received their usual care alongside the study intervention [20, 21, 27, 29]. ‘Referrals to promote health change behaviours’ describes those studies which included interventions designed to promote healthy behaviour changes such as smoking cessation, weight loss and exercise regimes [4, 26, 28]. The sub-theme ‘motivational interviewing’ represents two interventions: one utilising motivational interviewing [23] and one utilising motivational interviewing plus focused counselling to influence self-care behaviours [31]. ‘Education digitally-based’ describes online education utilising a web-based online toolkit for supporting informed footwear choices [22].

‘Patient instigated participation’ reflects interventions where patient initiation was required outside of the influence of the clinician and has four sub-themes. The sub-theme ‘self-care’ represents those studies which required the patient to undertake self-care of their feet between consultations [15, 29, 30]. Two studies [16, 21] incorporated paper-based education resources such as leaflets, and are represented in sub-theme ‘education paper-based’ [15, 16]. The ‘telehealth’ sub-theme includes mobile phone apps, and the use of a temperature mat to detect daily changes in foot temperature [18, 24]. ‘Non-visual foot exam’ represents one study focusing on individuals with significant sight problems utilising smell and touch to identify potential foot issues [25].

It was not always clear how interventions were delivered (28%) [4, 20, 25, 27, 30]. Five of the studies (28%) provided ‘face to face education’ [19, 23, 26, 29, 31], with three (17%) providing ‘educational literature’ such as leaflets [15, 16, 21], and one study using audio-visual sessions (digital education) [15]. ‘Health technology’, such as mobile phone apps [18], an online toolkit [22] and remote temperature measuring [24] were utilised by 17% of studies. One study utilised a ‘prescribed therapy’ such as orthotic issue combined with a footwear voucher [21] with patients undertaking a ‘self-administered’ exercise programme at home [21]. Finally, one study used an online referral system to deliver the intervention [17].

Types of person-centred care were identified based on the definitions outlined previously: supports self-management (78%) [15, 16, 18, 20‐31], personalised care and support plans (17%) [4, 19, 22], enabling choice (6%) [17], and shared decision making (6%).

Systematic reviews (22%) [20, 27, 29, 30] and randomised controlled trials (22%) were the most utilised methods. The types of RCT implemented differed across studies, such as ‘parallel group randomised controlled trial’, ‘pilot randomised controlled trial design’ and ‘quasi-randomised trial’ [21, 23, 25, 31]. The most utilised primary data collection method were questionnaires (28%) [4, 15, 17, 28, 31] and observing health data (28%). Three studies used a combination of diaries, focus groups, questionnaires and observation of health data [4, 25, 28].

The main findings centred around four areas: improvements in participants’ health status, health behaviour change, clinician practice changes, and improved service delivery. It is important to note that these findings should be approached with caution due to methodological flaws as revealed by the Hawker tool (see ‘Quality assessment of included studies’ section).

The majority of the studies reported improvements in participants’ health status in the following areas: reduced amputations [16], reduced admission rates [19] number of days hospitalised [16], better metabolic control for those with type 1 and 2 diabetes [4, 19] and delayed microvascular complications [19]. A reduction in falls was seen in older people suffering with severe foot pain [21] with increased patient satisfaction scores relating to a new diabetic foot service [16].

Health behaviour change was identified in 28% of the studies. Participants with diabetic foot ulcers reported they engaged more in their ulcer care using the mobile phone app [18], foot temperature monitoring was found to be beneficial in preventing foot ulceration [20], and non-visual foot checking was higher than conventional foot checking techniques in the visually impaired [25]. Collaborative approaches to education, include active listening and recognising the patient as the expert in their own care, increased knowledge retention and self-care behaviours utilising counselling and motivational interviewing strategies as part of the education [31]. Finally, a systematic review by Navarro Flores et al. [30] suggests that behavioural changes such as promoting better hygiene habits, moisturizing, selecting the correct type of shoes and adequate foot care, support better metabolic control in diabetes and reduction in amputation rates.

Clinician practice changes characterised 18% of the studies, with two focusing on educational changes and one on motivational interviewing. The educationally centred studies reported that effective foot care education required both written and audio-visual elements [15], and that footwear advice required inclusion of four aspects: practicalities, personal choice, purpose and pressure [22]. Motivational interviewing was used to support footwear adherence, however, this produced only a short term clinically relevant effect (not statistically significant) increase after one week, with levels returning to baseline over time [23].

Improved service delivery represented 18% of the studies. Improved accuracy in patient triage and patient satisfaction [17] was observed in one service evaluation, with increased quality of life scores for those with PVD following the introduction of a new integrated pathway pilot study [4]. Evaluation of an integrated service, with access to allied healthcare professionals at no extra cost, was made available to those with type 2 diabetes, which was felt by patients to increase their knowledge and to support adherence to self-manage their condition [26]. Finally, a systematic review to identify the provision of programmes seeking to reduce diabetic foot related complications in Aboriginal and Torres Islander Australians found that no such programme existed [27].

Three (17%) of the studies produced findings that had more than one element of the categories outlined above. The use of technology to support self-monitoring using thermometry requiring both a change in clinician practice and behaviour change in the patient. This was a small case series pilot study where the initial findings were positive. Three of the four cases developed ulceration which was detected using thermometry, suggesting requirement for a larger scale research project [24]. A further study considered the introduction of a self-management of chronic disease programme for Aboriginal and Torres Islander Australians (service change) demonstrating increased uptake of other healthcare services by the participants (behaviour change [28]). However, the outcome of these contacts with other healthcare services and information regarding the patients’ disease progression is not reported. Finally, a systematic review determined a strong relationship between the use of thermometry and therapeutic footwear in the prevention of recurrent foot ulceration, but that the evidence for some other widely used practices, such as foot-related exercises, single sessions of education and foot surgery to reduce ulcer recurrence was weak [29].

Pre/post data outcome measures were used by 44% of the studies using tools such as: the Nottingham assessment of functional foot care [15], amputation rates and number of days in hospital [16], pain and function sub-scales [21], quality of life surveys [4, 28], the Edinburgh intermittent claudication questionnaire [4], footwear adherence and step count [23] a post-intervention survey of an online referral system [17] and knowledge, self-care and self-efficacy behaviour questionnaires [31]. A further 33% studies recorded biomarkers such as body mass index (BMI), haemoglobin A1c (HbA1c) and muscle strength [4, 19, 21, 23, 24, 28]. Four studies (22%) used a combination of biomarkers and pre-post data outcome measures. Those studies undertaking systematic reviews (22%) produced a narrative synthesis [20, 27, 29, 30], and 16% of studies solely used qualitative data [18, 22, 26]. One study undertook a baseline ‘podiatric check’ and repeated this at three and six months, but no details of the assessment were provided [25].

Effectiveness was viewed as a measure of the extent to which a specific intervention achieved its aim for a specified population. A range of disparate interventions were reported in nine studies and are shown in Table 3.

Interventions impacting directly on services represented 28% of the studies. Effectiveness was reported in all cases in the following areas: reduced amputation rates [16], improved quality of care [16], reduced cost to services [16], improved patient access to appropriate care [17, 26, 28], increased patient knowledge and disease awareness [26], reduced hospital admission rates [19], and improved patient satisfaction [16].

A systematic review focusing on patient education and regular monitoring treatment found these interventions to be mostly ineffective in prevention of diabetic foot ulcers, although plantar foot temperature guided avoidance therapy was reported as having potential utility due to the robust study design [20]. Arad et al. (2011) conducted a systematic review examining the effectiveness of foot health programmes to reduced diabetic foot related complications for Aboriginal and Torres Strait Island people and found inconclusive findings due to a lack of clarity of some studies reviewed [27]. A systematic review by van Netten et al. (2016) supporting the use of specific self-management and footwear intervention for the prevention of recurrent plantar foot ulcers was identified [29]. Strategies aimed at behavioural changes were found to be effective for the metabolic control of diabetes and reduction of amputations, but methodological flaws suggested that the effectiveness should be treated with caution [30].

Efficiency was defined as reducing the cost of delivering a service as a direct result of the intervention. Most studies did not discuss efficiency (78%). One service improvement plan reported multiple interventions leading to a decrease in the number of days in hospital for patients and a 45% reduction per year in major and minor amputation rates resulting in a £300,000 saving per annum [16]. Another service improvement project improved triage via self-referral and reported the potential for reduced service costs and savings in relation to general practitioners (GPs) not being consulted unnecessarily [17]. Distiller et al. [19] reported reduced rates of admissions for patients with diabetes but no related cost savings. Primary care integrated service with allied professionals and GPs was reported as ‘cost efficient’ [26]. Of the 18 studies reviewed only one study provided costs relating to a footwear subsidy valued at $A100/£65 [21].

No explanations were provided.

Fifty-six percent did not report any challenges or barriers to participation [15, 17, 19, 20, 22, 24, 26‐28, 30]. Low participation engagement reported by 28% [4, 16, 23, 25, 29] and 17% ceased participation due to death, injury, illness, and lack of time to engage [4, 21, 31]. Attrition was described as ‘external issues to the study’ by 6% [23], difficulties using technology by 6% [18], and a fear of developing wounds whilst undertaking prescribed exercise 6% [23]. Of these studies, 11% reported more than one of these experiences occurring [4, 23].

Overall, there were 30 grants awarded across the studies. Of the studies reviewed 61% [4, 15, 18, 20, 21, 26‐28] received funding, 6% [24] stated that they received no funding and 33% [16, 17, 19, 23, 25, 30] did not make a statement about funding. None of the studies stated the value of the funding received. There were three main funding streams: biopharmaceutical or health related companies, Universities, and Government enterprises. Company funding was the most utilised, with 17 separate grants [15, 20, 29, 31]. One study accounts for 12 of the grants within this category [29]. Five grants came from University funding [18, 21, 22, 27]; one study gained two grants from different faculties [28]. A further five studies received Government funding [4, 15, 21, 26, 29]. Of those studies, one received three Government funded grants [4] and another received two grants [29].

Six studies (33%) did not discuss areas for future research or gaps in research [4, 15, 17, 18, 20, 24, 27], and 6% study stated nil research gaps [16]. Further investigation, development of the research question or understanding of the mechanism of effect was cited by 33% [4, 23, 26, 28‐30] and 17% suggested further testing with a different population [20], setting [21] or larger cohort [24]. Development of technology (6%) [18] and testing the effectiveness of a toolkit developed during the study (6%) [22] was also cited.

Some authors’ reiterated their findings (61%) [4, 15, 17‐20, 24, 27‐30]. A further 33% added to their findings by discussing the potential for podiatrists to reduce falls [21], implementation of motivational interviewing for patients with diabetes [23] and teaching non-visual foot examination for the visually impaired [25]. Three studies commented upon the podiatrist’s role in; increasing patients making the right footwear choices [4], potential for employers to provide training to increase effectiveness of patient education to increase self-management [31]; and understanding complex relationships with other healthcare professionals as part of an integrated model of care [26]. Finally, one study commented on the need for more than service structures to be in place to reduce amputation rates but did not elucidate further [16].

Using the Hawker disparate data tool [14] the majority of the studies were deemed fair quality (53%), 29% high quality and 18% studies low quality. Studies considered “fair” was based upon a lack of consideration for ethics and potential bias in their study design, sampling reporting and where statements of generalisability were unclear. Coherent abstracts and titles, clear reporting of findings and implications led to ‘high’ categorisation. Studies categorised as “low” lacked information/clarity in their abstract, methods, sampling, analysis, generalisability, ethics and bias consideration.