The PodPAD project: a podiatry-led integrated pathway for people with peripheral arterial disease in the UK – a pilot study

The PodPAD project: a podiatry-led integrated pathway for people with peripheral arterial disease... Background: Peripheral arterial disease affects the lower limb and is associated with diabetes, high cholesterol, smoking and obesity. It increases the risk of cardiovascular morbidity and mortality. It can be symptomatic causing intermittent claudication, but often there are few clinical signs. Podiatrists are able to detect the presence of peripheral arterial disease as part of their lower limb assessment and are well placed to give advice on lifestyle changestohelpreduce disease progression.Thisisimportant to improve healthoutcomesand is offeredasa prevention/public health intervention. Method: We describe the clinical and patient-centred outcomes of patients attending a podiatry-led integrated care pathway in a multi-use clinic situated in a venue supported by the National Centre for Sports and Exercise Medicine in the UK. At the baseline appointment, patients were given a full assessment where symptoms of intermittent claudication using the Edinburgh Intermittent Claudication Questionnaire, foot pulses, Doppler sounds, Ankle Brachial Pressure Indices, glycated haemoglobin (HbA1c) and cholesterol levels, and smoking status were recorded. A tailored treatment plan was devised, including referral to an exercise referral service, smoking cessation programmes (if applicable) and each participant was also seen by a dietician for nutritional advice. Participants were followed up at 3 and 6 months to assess any improvement in vascular status and with each completing the EQ-5D quality of life questionnaire and a simple satisfaction questionnaire at the end of the study. As this was a complex intervention a pilot study design was adopted to evaluate if the method and outcomes were suitable and acceptable to participants the results of which will then inform the design of a larger study. Results: Data was collected on 21 individuals; 15 men (71.4%) and 6 women (28.6%) across the 6-month study period. Eleven participants were referred onto the exercise referral service; 16 participants saw the dietician for nutritional advice at baseline and had one-to-one or telephone follow-up at 3 months. Five out of 14 participants had reduced scores from baseline of intermittent claudication during the study period. No evidence for substantive changes in Doppler sounds or ABPI measurements was revealed. Quality of life scores with the EQ-5D improved in 15 participants; this was statistically significant (p = 0.007) with 14 participants who completed the simple satisfaction questionnaire expressing a positive view of the programme. Of the four people who were smokers, two stopped smoking cigarettes and moved to e-cigarettes as part of smoking cessation advice. (Continued on next page) * Correspondence: Lisa.farndon@nhs.net Sheffield Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 2 of 11 (Continued from previous page) Conclusion: As this was a pilot study the sample sizewas low, butsomestatistically significant improvements with some measures were observed over the 6-month study. Podiatrists are able to provide a comprehensive vascular assessment of the lower limb and accompanying tailored advice on lifestyle changes includingsmoking cessation andexercise. Locating clinics in National Centres for Sports and Exercise Medicine enables easy access to exercise facilities to encourage the adoption of increased activity levels, though the long term sustainability of exercise programmes still requires evaluation. This study was reviewed and approved by London Brent Ethics Committee IRAS ID 204611 and received research governance approval from the sponsor, Sheffield Teaching Hospitals NHS Foundation Trust Research and Innovation Office STH19410. Keywords: Peripheral arterial disease, Activity, Intermittent claudication, Quality of life, Integrated pathway, Podiatry led, National Centres for sports and exercise medicine, Public health Background examining the feet and legs for evidence of any lesions/ Peripheral Arterial Disease (PAD) is a long-term condition ulcerations, examining pulses in the lower limb by characterised by atherosclerotic obstruction of the lower palpation and Doppler ultrasound and calculate the extremity arteries [1], and is a marker of patients who are ankle brachial pressure index (ABPI). Diagnosis is con- at increased risk of cardiovascular events, including myo- firmed with reduced, absent or monophasic pulse cardial infarction and stroke. The incidence in the sounds with a Doppler and an ABPI < 0.9. over-60s is approximately 20%; increasing with age and This study was funded to support allied health profes- other factors, including: smoking, diabetes and existing sions in public health in the UK [6] and to support coronary arterial disease [2]. Globally, 202 million people podiatry assessment and treatment to prevent mortality had PAD in 2010, with a 28% increase in low and moder- and amputation [7]. Significant gains in wellbeing for ate income countries and 13% in high-income countries individual patients and cost savings from preventing in the preceding decade [3]. In the lower limb, PAD may interventions can be achieved from improved population be symptomatic with intermittent claudication or asymp- level health outcomes [5]. These clinical interventions tomatic and can lead to, foot ulceration and critical limb align to the evidence and to the implementation of pre- ischaemia; all of which can result in amputation. Heavy vention strategies in podiatry services [9]. smokers are four times more likely to develop intermittent claudication compared to non-smokers [4]. Intermittent Treatment claudication is also associated with reduced quality of life Early identification of both asymptomatic and symp- and depression [5]. tomatic PAD allows for early intervention: slowing As clinicians of the lower limb, podiatrists are able to disease progression and decreasing the risk of lower assess patients for signs of PAD; offering treatment, limb amputation and cardiovascular morbidity and surveillance, advice and follow on referral to the vascular mortality [8]. The overall aim is to sustain or improve surgery team if needed. The clinical evidence base sug- mobilityand qualityoflife. Keyareas to themanage- gests that this intervention (foot care and advice on diet, ment of symptoms include: smoking cessation, weight exercise and smoking) is highly effective at reducing the management and increased activity. Regular exercise progression into acute care and can reduce the incidence can reduce cardiovascular mortality by 50% [9]and is of amputation by 60% [6]. Strict pharmacological man- an effective treatment for PAD [10, 11]. Other treat- agement of cardiovascular risks specifically in people ments include lipid modification and statin therapy, with diabetes and foot ulceration has been shown to the prevention, management of diabetes (if applic- reduce mortality rates [7]. It is recommended that all able), management of high blood pressure (if applic- commissioners and providers should have a clear path- able) and antiplatelet therapy (if required). If way for patients suspected of PAD in the UK [6]. conservative treatments are not effective patients can National Institute for Health and Care Excellence develop more severe PAD where a surgical interven- (NICE) guidelines [2] recommend that people who are tion in the form of angioplasty or bypass graft may at risk or have symptoms of PAD, including those who be required [12]. The aim of this study was to inves- have diabetes and non-healing wounds, or have unex- tigate the feasibility of a podiatry-led integrated care plained leg pain should be given a full assessment. This pathway in the UK, utilising advice on diet, activity should involve documenting the presence and severity of and smoking cessation for people with PAD and symptoms of intermittent claudication and rest pain, measuring the clinical and patient centred outcomes. Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 3 of 11 Methods Peripheral arterial disease The study was located at a UK National Centre for Symptoms of PAD were assessed by means of the Sports and Exercise Medicine, in which health care Edinburgh Intermittent Claudication Questionnaire clinics are situated in existing leisure/sports facilities. (EICQ). This questionnaire comprised 5 questions, all of This allowed easy access to gym facilities for partici- which could be answered with a “yes” or “no”. The first pants, if they agreed to this as part of their activity question was the following screening question: programme. Outcomes considered to be favourable were: improvement in symptoms of PAD (reduction in Do you get pain or discomfort in your legs when intermittent claudication pain if present), improved you walk? ABPI readings, increase in number of pedal pulses pal- If participants answered “yes” to this question, they were pated or a change in Doppler sounds from monophasic then requested to answer the following further 4 to bi or tri-phasic, decrease in cholesterol and HbA1c questions: levels (if applicable) and the success of any smoking ces- sation and activity programmes. Quality of life and pa- 1. Does the pain ever begin when you are standing tient satisfaction with the programme was also assessed. still or sitting? Patients were excluded if they were unable to give in- 2. Do you get this pain if you walk uphill or when you formed consent due to lack of mental capacity and if hurry? they were unable to participate in increased activity due 3. Do you get this pain when you walk at an ordinary to other co-morbidities. pace on the level? Inclusion criteria: Patients who were on the podiatry 4. Does the pain disappear when you rest for less than service PAD caseload were purposively sampled to take 10 min? part in this pilot study. Anyone wishing to take part was given an information sheet, and an appointment was The respective responses Yes, No, Yes, Yes, Yes were arranged for a baseline assessment. taken as likely indicators of the presence of intermittent Exclusion criteria: housebound patients, patients claudication (IC). A score was derived for each partici- who had poor mobility and would be unable to take pant with 1 point being awarded for each instance of a part in any activity programme and patients who were response corresponding to a likely indicator of the pres- not able to give informed consent. At baseline med- ence of IC due to PAD (excluding presence of IC due to ical history was recorded, with any symptoms associ- causes other than PAD, such as spinal stenosis). Hence ated with PAD assessed using the Edinburgh scores could range from 0 (no IC; given to those who Intermittent Claudication Questionnaire [13]; and ab- answered “no” to the first question) to 5 (highly likely sence or presence of lower limb pulses on palpation, presence of IC) per participant. tri-, bi- or mono-phasic lower limb pulse sounds with a Doppler and ABPIs assessed with a Dopplex Ability Pulse measurements System®. The EQ-5D questionnaire was given to each Left and right posterior tibial, anterior tibial, dorsalis participant to complete to assess quality of life [13]. pedis and popliteal pulse measurements were obtained Clinical measurements were taken by experienced from participants at each time point, amounting to 8 research podiatrists with training in vascular assess- measurements in total per visit. A score was derived ment. Based on this assessment, the research podia- for each participant, with 1 point being awarded for trists tailored a treatment plan, which included advice each palpable pulse reading; scores could range from about smoking cessation and local support services to 0 (indicating no pulses were palpable) to 8 (all pulses support stopping smoking and weight loss (if applic- were palpable). able), recommendation to the physical activity referral scheme and participants were also given the oppor- Doppler readings tunity to meet with a dietician who was present in an Doppler sound readings were also taken of left and right adjoining clinic room to get advice about nutrition lower limb pulses from all participants at each time and weight loss (again, if applicable). point, amounting to 8 measurements in total. Sound readings were classified as triphasic, biphasic or mono- phasic; with triphasic considered to be the optimum Data collection status. Several outcome measures were recorded on participants at three time points: baseline; 3 months and 6 months. HbA1c and cholesterol Changes from baseline to 6 months were considered to be Glycated haemoglobin (HbA1c) and cholesterol readings the primary comparisons of interest. (if applicable) were recorded from the electronic patient Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 4 of 11 record as near to each appointment time point as pos- feedback on the study design and patient information sible if these were available. sheet. ABPI readings Results Left and right ABPI readings were obtained from each Data was collected on 21 individuals; 15 men (71.4%) participant at each time point using the Dopplex ability. and 6 women (28.6%). At baseline, 4 participants (19.0%) Overall values were calculated for each participant for reported themselves to be smokers; 17 participants each time point. Values < 0.9 are an indication of PAD, (81.0%) were non-smokers, of these 9 were ex-smokers with lower values indicating greater severity of disease. and 8 had never smoked. Participants also reported a number of co-morbidities Quality of life and patient satisfaction at baseline; nine (42.9%) had hypertension; 15 (71.4%) The EQ-5D was administered to participants at each had diabetes; 4 (19.0%) had hyperlipidaemia; 4 (19.0%) appointment. This instrument consists of 5 questions, had kidney disease; 3 (14.3%) had a previous stroke or relating to: mobility; self-care; usual activities; pain/dis- transient ischaemic attack; 4 (19.0%) had ischemic heart comfort; and anxiety/depression. All questions were disease (IHD) and 5 (23.8%) had a previous myocardial 5-point Likert-style items, with a score of 1 representing infarction (MI). no problems, and 5 representing extreme problems. Additionally, participants rated their overall quality of Assessment of peripheral arterial disease life on a 10-point visual analogue scale (VAS), with All 21 participants provided responses to the Edinburgh higher scores representing higher quality of life. A sim- Intermittent Claudication Questionnaire (EICQ) at the ple satisfaction questionnaire consisting of 5 questions baseline assessment, ranging from 0 to 5. The mean with a free text section at the end was administered at baseline score was 2.62 (SD 1.80). At the 3-month the 6 month appointment. assessment, 16 participants provided responses, again ranging from 0 to 5, and the mean score was 2.38 (SD Statistical analysis 1.59). At the 6-month assessment, 14 participants The sample was summarised descriptively; with gender, provided responses, again ranging from 0 to 5 and the smoking status and co-morbidities reported for all mean score was 2.36 (SD 1.78). patients. Additional qualitative information for partici- Fourteen participants provided data both at baseline pant satisfaction was also collected and summarised. and at the final 6-month assessment. The EICQ score of All outcome measures were summarised at each of the 5 participants reduced over this time period; whilst the three measured time points. Patterns of missingness and EICQ score of 2 participants increased. The scores of the effect of missing data values were assessed where the remaining 7 participants was unchanged. A paired appropriate. Paired samples t-tests were conducted on the samples t-test conducted on the respondents who pro- full EICQ scores, pulse measurements, ABPI measure- vided data both at baseline and at 6 months found a ments, HbA1c levels and cholesterol levels and overall mean reduction of 0.643 points (SD 1.34). A 95% confi- quality of life scores to assess the significance of the change dence interval for the difference between baseline and in these measures from baseline to the 6-month 6-month data was given by (− 0.129, 1.41). The differ- post-baseline assessment. Effect sizes and associated 95% ence, though substantive, was not significant at the 5% confidence intervals were also reported for these measures. significance level (t = 1.80; p = 0.095) (Fig. 1). Further analysis was conducted on the EICQ screening There was no evidence that missing EICQ data was question to investigate any trends over time in the propor- not missing completely at random (MCAR) according to tion of participants with IC. Similar procedures were con- Little’s MCAR test (χ = 4.41; p = 0.220). (3) ducted on the proportions of participants recording ABPI Further analysis was conducted on the response to the measurements in either or both legs below a critical value. first question alone; which was taken as a likely indicator Overall trends in the proportions of participants with tri-, of the presence of IC. At baseline, 12 participants bi- and monophasic Doppler readings were also investi- (57.1%) were assessed to have IC. Of these 11 had other gated. Individual EQ-5D item scores were analysed using signs of PAD such as some absent pulses on palpation multivariate methods. and or monophasic Doppler sounds. Only 1 participant had no other signs of PAD, so their pain may have been Ethical permissions neurological in origin. Eight participants completed their Ethical and research governance approval was given 3-month assessment, of which 7 (87.5% of those com- prior to commencement of the project and Patient and pleting the 3-month assessment) were assessed to still Public Involvement (PPI) was sought from a Citizens have IC. Nine participants completed their 6-month Reference Group and a local hospital panel. Both gave assessment (one participant who missed their 3-month Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 5 of 11 Fig. 1 EICQ scores at baseline and at 6 months, with 95% confidence intervals assessment returned for the 6-month assessment). Of twotimepoints was givenby(− 0.562, 2.10). The difference these, 6 were assessed to still have IC (66.7%) and 3 were was not significant at the 5% significance level (t = 1.26; not. p =0.232) (Fig. 2). Hence overall at 6 months, 6 participants out of 12 (50.0%) were assessed to have IC; with a net change of 2 Doppler sound readings patients moving from the group with IC to the group At baseline, participants recorded on average 3.52 mono- without IC. phasic readings (SD 2.60); 4.38 biphasic readings (SD Of the 8 participants assessed not to have IC at base- 2.50) and 0.10 triphasic readings (SD 0.30). At 3 months, line, 5 completed their 3-month assessment. Four were participants recorded on average 2.47 monophasic read- assessed to still not have IC; 1 participant was assessed ings (SD 2.45); 5.00 biphasic readings (SD 2.07) and 0.27 to have IC at 6 months. triphasic readings (SD 0.59). At 6 months, participants re- corded on average 2.47 monophasic readings (SD 2.77); Pulse measurements 5.07 biphasic readings (SD 2.69) and 0.27 triphasic read- All 21 participants provided pulse measurements at the ings (SD 0.59). baseline assessment, with scores ranging from 0 to 8 Hence no clear trends in recordings were observed (mean 5.33 (SD 2.67)). At the 3-month assessment, 15 over the three measured time points; however, the pro- participants provided responses, ranging from 2 to 8 portion of triphasic readings increased slightly from (mean 6.07 (SD 2.05)). At the 6-month assessment, 14 baseline to 3 months; with negligible further changes in participants provided responses, ranging from 1 to 8 any proportions between 3 and 6 months. (mean 6.69 (SD 2.02)). Thirteen participants provided pulse readings both at ABPI readings baseline and at the 6-month assessment. Of these, the At baseline, ABPI data was obtained from 17 partici- scores of 7 participants increased over this time period; pants; of whom 6 (35.3%) had overall ABPI values below whilst scores of 2 participants reduced, with scores of 4 0.90 in one or both legs (range from 0.56 to 1.45). The unchanged. A paired samples t-test conducted on the re- mean value for all participants providing a reading at spondents who provided data both at baseline and at this time point was 0.998 (SD 0.229) in the left leg and 6 months found a mean increase of 0.769 points (SD 2.20). 0.947 (SD 0.220) in the right leg. At 3 months, data was A 95% confidence interval for the difference between the obtained from 9 participants, of whom 5 (55.6%) had Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 6 of 11 Fig. 2 Pulse readings representing good circulation at baseline and at 6 months, with 95% confidence intervals overall ABPI values below 0.90 in one or both legs difference was significant at the 5% significance level (range from 0.77 to 1.29). The mean value for all partici- (t =3.66; p = 0.006). Of these 9 participants, 7 had pants providing a reading at this time point was 0.948 dietetic consultation and were referred to the exercise (SD 0.210) in the left leg and 0.921 (SD 0.195) in the referral service. right leg. At 6 months, data was obtained from 10 par- There was no evidence that missing HbA1c data was ticipants; of which 4 (40.0%) had overall ABPI values not missing completely at random (MCAR) according to below 0.90 (range from 0.75 to 1.20). The mean value Little’s MCAR test (χ = 8.32; p = 0.140) (Fig. 3). (5) for all participants providing a reading at this time point was 0.967 (SD 0.166) in the left leg and 0.958 (SD 0.149) in the right leg (Fig. 3). Cholesterol levels There was no evidence that missing ABPI data was At baseline, cholesterol data was obtained from 13 par- not missing completely at random (MCAR) according to ticipants (range 2.20 to 5.70 mmol/l; mean 3.75 mmol/ Little’s MCAR test (χ = 6.93; p = 0.226). l; SD 1.05). At 3 months, data was obtained from 5 par- (5) ticipants (range 2.30 to 5.10 mmol/l; mean 3.26 mmol/ HbA1c levels l; SD 1.18). At 6 months, data was obtained from 8 par- At baseline, HbA1c data was obtained from 13 partici- ticipants (range 2.40 to 4.20 mmol/l; mean 3.33 mmol/ pants (range 35.0 to 75.0 mmol/l; mean 57.0 mmol/l; l; SD 0.654). Hence no clear trend in HbA1c levels with SD 10.6). At 3 months, data was obtained from 6 par- time was apparent. ticipants (range 42.0 to 70.0 mmol/l; mean 55.5 mmol/ Eight participants provided data both at baseline and l; SD 10.7). At 6 months, data was obtained from 9 par- at the final 6-month assessment. A paired sample t-test ticipants (range 45.0 to 63.0 mmol/l; mean 51.4 mmol/ found a mean reduction of 0.050 mmol/l (SD 0.414). A l; SD 5.55). Hence a monotonic reduction in HbA1c 95% confidence interval for the difference between base- levels with time was apparent. line and 6-month data was given by (− 0.296, 0.369), the Nine participants provided data both at baseline and difference was not significant at the 5% significance level at the final 6-month assessment. A paired samples t-test (t = 0.342; p = 0.743). found a mean reduction of 9.22 mmol/l (SD 7.56). A There was no evidence that missing cholesterol data 95% confidence interval for the difference between base- was not missing completely at random (MCAR) accord- line and 6-month data was given by (3.41, 15.0). The ing to Little’s MCAR test (χ = 3.14; p = 0.678) (Fig. 4). (5) Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 7 of 11 Fig. 3 HbA1c levels at baseline and at 6 months, with 95% confidence intervals Quality of life not being significantly or substantively associated with Eighteen participants provided responses to overall the analysis time point. The reduction in pain of 0.50 EQ-5D quality of life (VAS item) at the baseline assess- points (from 2.37 points to 1.87 points) corresponded to ment (range 3.0 to 9.0; mean 5.93; SD 1.79). At the a 21.1% reduction from the baseline value (Fig. 6). 3-month assessment, 11 participants provided responses (range 3.80 to 9.0; mean 7.34; SD 1.36). At the 6-month Other outcomes assessment, 15 participants provided responses (range Eleven participants agreed to be referred onto the exer- 4.0 to 9.0; mean 7.10; SD 1.28). cise referral service situated in the same venue and 16 Fifteen participants provided data both at baseline and participants saw the dietician for nutritional advice at at the final 6-month assessment. A paired samples t-test baseline and had one to one or telephone follow ups at found a mean increase of 1.11 points (SD 1.37). A 95% 3 months. Of the four people who were smokers, two confidence interval for the difference between baseline stopped smoking cigarettes and moved to e-cigarettes as and 6-month data was given by (0.352, 1.88). The differ- part of smoking cessation advice given during the study. ence was significant at the 5% significance level (t =3.13; Seven participants had painful neuropathic symptoms at p =0.007) (Fig. 5). baseline and were referred either to their GP or to the There was no evidence that missing overall EQ-5D painful neuropathy clinic for a medication review or fur- data was not missing completely at random (MCAR) ac- ther management options. cording to Little’s MCAR test (χ = 6.53; p = 0.163). (4) Nineteen participants provided responses to the individ- Qualitative responses ual item scores at the baseline, 11 at 3 months and 15 at Fourteen patients completed a simple patient satisfaction the 6-month assessment. questionnaire; all of whom responded that they felt they Multivariate analysis conducted on baseline data and could discuss their symptoms of PAD with the podia- data collected at the final 6-month assessment revealed trist, they felt involved with the treatment plan, they a substantive effect (partial-η = 0.548) of time point on were satisfied with the service and they would recom- the measures assessed jointly (Wilk’s Λ = 0.452; F = mend this service to a friend. When asked to rate their 4,11 3.30; p = 0.051). Follow-up univariate analyses revealed PAD symptoms after completing the programme; 9 time-related differences to be based primarily in the pain respondents felt that they symptoms were better and the measure (F = 12.3; p = 0.004); with other measures remaining 5 said that they had remained the same. 1,14 Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 8 of 11 Fig. 4 Cholesterol levels at baseline and at 6 months, with 95% confidence intervals Fig. 5 Overall EQ-5D quality of life score at baseline and at 6 months, with 95% confidence intervals Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 9 of 11 Fig. 6 EQ-5D pain scores at baseline and at 6 months, with 95% confidence intervals Some comments were made on individual experiences development of a larger study. As 7 participants had during the study, one participant said: “I was referred to painful neuropathic symptoms at baseline, improve- the exercise referral service, this has proved to be a dra- ments in pain scores could also be associated with other matic change to my general wellbeing, especially the interventions such as medication that was prescribed circulation in my legs.” Another said that: during the study period. Whilst a substantial proportion of participants were current or former smokers, the level “I have felt comfortable explaining my problems to the of concurrent co-morbidities reported was not excessive; podiatry team and consider them to have understood suggesting that the apparent beneficial effect of the and been able to diagnose where my problem lies. The programme has not been over-stated due to regression information I have been given is a comfort and the to the mean effects; i.e. there is no evidence that partici- advice that losing weight will help is well received. The pants were skewed towards the lower end of the health facility and service I have found excellent with patient spectrum to be found in the parent population, with and friendly staff that one can be easily with in their correspondingly greater likelihood of natural improve- company.” However another participant had more ment over time. A certain amount of attrition was ob- difficulty: “Struggled to complete exercises at the gym served; in general this took place between baseline and due to knee pain. Ok with arm, back and chest the 3-month assessment. Many patients who did not exercises.” complete a 3-month assessment returned for a 6-month assessment. One patient died during the course of the study. Limitations As this was a pilot study there was no control group Discussion which gives some limitations on the internal validity of Though this was a small pilot study, some substantive, the study. However, the consistent and substantive and in some cases, statistically significant improvements improvements recorded across a wide range of outcome with respect to many measures have been observed over measures, in conjunction with lack of evidence for con- the 6-month study period. The extent of intermittent current changes in patient lifestyles over the course of claudication in those participants with these symptoms the study, provides evidence that the programme was (as assessed by the EICQ tool), substantively decreased, acceptable to participants and this will inform the with the proportion of respondents reporting pain or Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 10 of 11 discomfort when walking also decreasing. The propor- to multiple comparisons being conducted. We have not tion of patients providing tri-phasic Doppler sound read- attempted to specify a priori any outcomes as primary ings increased slightly within the context of a small outcomes or correct for inflated Type I errors which overall trend primarily between baseline and 3 months; would be appropriate in a full-scale study. Likewise, the with little further change beyond 3 months until the end size of the sample precludes the consideration of of the study period. No substantive changes in ABPI controlling factors in comparative analyses. between baseline and 6 months post baseline in either leg were revealed. Conclusion A substantive and significant reduction was recorded This small, feasibility study has demonstrated important in HbA1c levels but no changes were observed in chol- effects on health outcomes from a pilot clinical interven- esterol levels. A significant improvement was recorded tion for patients with PAD. The context and intervention in quality of life with improvements in pain scores being are reported as a novel prevention-orientated treatment mainly responsible for the overall improvement as mea- that sought to improve health outcomes. The findings sured by the quality of life instrument. suggest that a larger follow-up study would include a Previous studies have shown that patients with PAD number of specific outcome measures and economic have a much reduced level of physical activity which can assessment to demonstrate the effect of podiatric monitor- be attributed to the pain associated with the disease ing and exercise referral for this population. Further study [14]. However, if patients are persuaded to exercise or is needed to examine associated behaviour change factors increase their activity levels, this can help with the that result from prevention services of this kind, particu- symptoms and progression of the disease, and on-going larly where the professional intervention is designed to compliance can be improved [15]. A large systematic mitigate the effects of chronic wounds, revascularisation review comparing supervised exercise with usual care and amputation, particularly with the diabetic population. for claudication found that exercise resulted in more The study was designed to meet the strategic vision for functional benefits and should be advised as part of a allied health professions to engage in specific public health treatment programme for people with PAD [16]. A Ran- and prevention interventions in the United Kingdom. domised Controlled Trial (RCT) comparing medical care Abbreviations alone, medical care plus supervised exercise and medical ABPI: Ankle Brachial Pressure Index; EICQ: Edinburgh Intermittent care plus stent revascularisation for aortoiliac PAD Claudication Questionnaire; HbA1c: Glycated haemoglobin; IC: Intermittent Claudication; MCAR: Missing Completely at Random; NICE: National Institute found that both exercise and revascularisation resulted for Health and Care Excellence; PAD: Peripheral Arterial Disease; PPI: Patient in improved clinical outcomes and quality of life up to and Public Involvement; SD: Standard Deviation 18 months later [11]. Rather than a prescribed exercise programme, our study referred participants who agreed Acknowledgements to the exercise referral service where tailored one to one Funding advice was given to increase activity levels. This was pro- This study was funded by the National Centre for Sports Exercise Medicine vided on site in a National Centre for Sports and Exer- (NCSEM) in conjunction with Yorkshire and Humber Collaborations for Leadership in Applied Health Research and Care (CLAHRC) and Sheffield cise Medicine which enabled participants’ easy access to Clinical Commissioning Group. sports facilities at reduced rates. Similarly, access to nutritional advice was made easy Availability of data and materials The datasets used and/or analysed during the current 492 study are available by the presence of a dietician on site and most partici- from the corresponding author on reasonable request. pants were happy to discuss their diet as part of the programme. Authors’ contributions LF co-designed and applied for the funding and managed the project. JS Of the four patients who were smokers, two changed analysed the data and contributed to all parts of the manuscript. OB-H and to e-cigarettes as part of a smoking cessation regimen. KK delivered the intervention, collected the data and contributed to all part This follows current guidance from Public Health of the manuscript. SFD co-designed the proposal and application for funding, advised on rationale specifically supporting the policy implementation aspects England [18] which advises e-cigarettes in conjunction and links with NCSEM and contributed to all parts of the manuscript. All authors with smoking cessation services. This combined read and approved the final manuscript. approach has contributed to improved quit success Ethics approval and consent to participate rates. This study was reviewed and approved by London Brent Ethics Committee The significant and substantive associations observed IRAS ID 204611 and received research governance approval from the sponsor, must be considered in the context of the study being Sheffield Teaching Hospitals NHS Foundation Trust Research and Innovation Office STH19410. All participants gave written informed consent before taking formulated as a pilot and as such not powered to detect part in the study. significant effects. Further inferences of significance may be anticipated in a larger follow-up study. Conversely, Competing interests however, the large number of outcome measures has led The authors declare that they have no competing interests. Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 11 of 11 Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Author details Sheffield Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. School of Human & Health Sciences, University of Huddersfield, Huddersfield, UK. Sheffield Hallam University /Combined Community & Acute Care Group, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. Received: 27 March 2018 Accepted: 23 May 2018 References 1. BMJ. Best practice guidelines - Peripheral vascular disease. In: BMJ best practice; 2012. 2. National Institute for Health Clinical Excellence. Lower Limb Peripheral Arterial Disease: diagnosis and management. Clinical Guideline 147. 2012. https://www.nice.org.uk/guidance/cg147. 3. Fowkes FG, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;19(382(9901):1329–40. 4. Norgren L, et al., Inter-society consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg, 2007. 45(Suppl S:S5–67). 5. Regensteiner J, et al. The impact of peripheral arterial disease on health- related quality of life in peripheral arterial disease awareness, risk and treatment: new resources for survival (PARTNERS) program. Vasc Med. 2008; 13:15–24. 6. All Party Parliamentary Group on Vascular Disease. Tackling Peripheral Arterial Disease More Effectively: Saving Limbs. Saving Lives. 2013; 7. Young MJ, et al. Improved survival or diabetic foot ulcer patients 1995-2008. Diabetes Care. 2008;31:2143–7. 8. Walker CM, et al. Multidisciplinary approach to the diagnosis and management of patients with peripheral arterial disease. Clin Interv Aging. 2015;10:1147–53. 9. Powell KE, P M. Physical activity and health. Br Med J (Clin Res Ed). 1996; 313(7050):126–7. 10. Aherne T, et al. Comparing supervised exercise therapy to invasive measures in the Management of Symptomatic Peripheral Arterial Disease. Surgery Research and Practice, 2015. https://doi.org/10.1155/2015/960402. 11. Murphy T, et al. Supervised exercise, stent revascularization, or medical therapy for claudication due to Aortoiliac peripheral artery disease: a randomized clinical trial. J Am Coll Cardiol. 2015;65:999–1009. https://doi. org/10.1016/j.jacc.2014.12.043. 12. Sachs T, et al. Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft. J Vasc Surg. 2011;54(4):1021–31.e.1. 13. Leng G, Fowkes F. The Edinburgh claudication questionnaire: an improved version of the WHO/rose questionnaire for use in epidemiological surveys. J Clin Epidemiol. 1992;45(10):1101–9. 14. Gardner A, et al. Patterns of ambulatory activity in subjects with and without intermittent claudication. J Vasc Surg. 2007;46:1208–14. 15. Haas T, et al. Exercise training and peripheral arterial disease. Compr Physiol. 2012;2:2933–3017. https://doi.org/10.1002/cphy.c110065. 16. Watson L, Ellis B, Leng G. Excercise for intermittent claudication. Cochrane Database Syst Rev. 2008;(4):CD000990. https://doi.org/10.1002/14651858. CD000990.pub2. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Foot and Ankle Research Springer Journals

The PodPAD project: a podiatry-led integrated pathway for people with peripheral arterial disease in the UK – a pilot study

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Medicine & Public Health; Orthopedics; Rehabilitation
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Abstract

Background: Peripheral arterial disease affects the lower limb and is associated with diabetes, high cholesterol, smoking and obesity. It increases the risk of cardiovascular morbidity and mortality. It can be symptomatic causing intermittent claudication, but often there are few clinical signs. Podiatrists are able to detect the presence of peripheral arterial disease as part of their lower limb assessment and are well placed to give advice on lifestyle changestohelpreduce disease progression.Thisisimportant to improve healthoutcomesand is offeredasa prevention/public health intervention. Method: We describe the clinical and patient-centred outcomes of patients attending a podiatry-led integrated care pathway in a multi-use clinic situated in a venue supported by the National Centre for Sports and Exercise Medicine in the UK. At the baseline appointment, patients were given a full assessment where symptoms of intermittent claudication using the Edinburgh Intermittent Claudication Questionnaire, foot pulses, Doppler sounds, Ankle Brachial Pressure Indices, glycated haemoglobin (HbA1c) and cholesterol levels, and smoking status were recorded. A tailored treatment plan was devised, including referral to an exercise referral service, smoking cessation programmes (if applicable) and each participant was also seen by a dietician for nutritional advice. Participants were followed up at 3 and 6 months to assess any improvement in vascular status and with each completing the EQ-5D quality of life questionnaire and a simple satisfaction questionnaire at the end of the study. As this was a complex intervention a pilot study design was adopted to evaluate if the method and outcomes were suitable and acceptable to participants the results of which will then inform the design of a larger study. Results: Data was collected on 21 individuals; 15 men (71.4%) and 6 women (28.6%) across the 6-month study period. Eleven participants were referred onto the exercise referral service; 16 participants saw the dietician for nutritional advice at baseline and had one-to-one or telephone follow-up at 3 months. Five out of 14 participants had reduced scores from baseline of intermittent claudication during the study period. No evidence for substantive changes in Doppler sounds or ABPI measurements was revealed. Quality of life scores with the EQ-5D improved in 15 participants; this was statistically significant (p = 0.007) with 14 participants who completed the simple satisfaction questionnaire expressing a positive view of the programme. Of the four people who were smokers, two stopped smoking cigarettes and moved to e-cigarettes as part of smoking cessation advice. (Continued on next page) * Correspondence: Lisa.farndon@nhs.net Sheffield Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 2 of 11 (Continued from previous page) Conclusion: As this was a pilot study the sample sizewas low, butsomestatistically significant improvements with some measures were observed over the 6-month study. Podiatrists are able to provide a comprehensive vascular assessment of the lower limb and accompanying tailored advice on lifestyle changes includingsmoking cessation andexercise. Locating clinics in National Centres for Sports and Exercise Medicine enables easy access to exercise facilities to encourage the adoption of increased activity levels, though the long term sustainability of exercise programmes still requires evaluation. This study was reviewed and approved by London Brent Ethics Committee IRAS ID 204611 and received research governance approval from the sponsor, Sheffield Teaching Hospitals NHS Foundation Trust Research and Innovation Office STH19410. Keywords: Peripheral arterial disease, Activity, Intermittent claudication, Quality of life, Integrated pathway, Podiatry led, National Centres for sports and exercise medicine, Public health Background examining the feet and legs for evidence of any lesions/ Peripheral Arterial Disease (PAD) is a long-term condition ulcerations, examining pulses in the lower limb by characterised by atherosclerotic obstruction of the lower palpation and Doppler ultrasound and calculate the extremity arteries [1], and is a marker of patients who are ankle brachial pressure index (ABPI). Diagnosis is con- at increased risk of cardiovascular events, including myo- firmed with reduced, absent or monophasic pulse cardial infarction and stroke. The incidence in the sounds with a Doppler and an ABPI < 0.9. over-60s is approximately 20%; increasing with age and This study was funded to support allied health profes- other factors, including: smoking, diabetes and existing sions in public health in the UK [6] and to support coronary arterial disease [2]. Globally, 202 million people podiatry assessment and treatment to prevent mortality had PAD in 2010, with a 28% increase in low and moder- and amputation [7]. Significant gains in wellbeing for ate income countries and 13% in high-income countries individual patients and cost savings from preventing in the preceding decade [3]. In the lower limb, PAD may interventions can be achieved from improved population be symptomatic with intermittent claudication or asymp- level health outcomes [5]. These clinical interventions tomatic and can lead to, foot ulceration and critical limb align to the evidence and to the implementation of pre- ischaemia; all of which can result in amputation. Heavy vention strategies in podiatry services [9]. smokers are four times more likely to develop intermittent claudication compared to non-smokers [4]. Intermittent Treatment claudication is also associated with reduced quality of life Early identification of both asymptomatic and symp- and depression [5]. tomatic PAD allows for early intervention: slowing As clinicians of the lower limb, podiatrists are able to disease progression and decreasing the risk of lower assess patients for signs of PAD; offering treatment, limb amputation and cardiovascular morbidity and surveillance, advice and follow on referral to the vascular mortality [8]. The overall aim is to sustain or improve surgery team if needed. The clinical evidence base sug- mobilityand qualityoflife. Keyareas to themanage- gests that this intervention (foot care and advice on diet, ment of symptoms include: smoking cessation, weight exercise and smoking) is highly effective at reducing the management and increased activity. Regular exercise progression into acute care and can reduce the incidence can reduce cardiovascular mortality by 50% [9]and is of amputation by 60% [6]. Strict pharmacological man- an effective treatment for PAD [10, 11]. Other treat- agement of cardiovascular risks specifically in people ments include lipid modification and statin therapy, with diabetes and foot ulceration has been shown to the prevention, management of diabetes (if applic- reduce mortality rates [7]. It is recommended that all able), management of high blood pressure (if applic- commissioners and providers should have a clear path- able) and antiplatelet therapy (if required). If way for patients suspected of PAD in the UK [6]. conservative treatments are not effective patients can National Institute for Health and Care Excellence develop more severe PAD where a surgical interven- (NICE) guidelines [2] recommend that people who are tion in the form of angioplasty or bypass graft may at risk or have symptoms of PAD, including those who be required [12]. The aim of this study was to inves- have diabetes and non-healing wounds, or have unex- tigate the feasibility of a podiatry-led integrated care plained leg pain should be given a full assessment. This pathway in the UK, utilising advice on diet, activity should involve documenting the presence and severity of and smoking cessation for people with PAD and symptoms of intermittent claudication and rest pain, measuring the clinical and patient centred outcomes. Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 3 of 11 Methods Peripheral arterial disease The study was located at a UK National Centre for Symptoms of PAD were assessed by means of the Sports and Exercise Medicine, in which health care Edinburgh Intermittent Claudication Questionnaire clinics are situated in existing leisure/sports facilities. (EICQ). This questionnaire comprised 5 questions, all of This allowed easy access to gym facilities for partici- which could be answered with a “yes” or “no”. The first pants, if they agreed to this as part of their activity question was the following screening question: programme. Outcomes considered to be favourable were: improvement in symptoms of PAD (reduction in Do you get pain or discomfort in your legs when intermittent claudication pain if present), improved you walk? ABPI readings, increase in number of pedal pulses pal- If participants answered “yes” to this question, they were pated or a change in Doppler sounds from monophasic then requested to answer the following further 4 to bi or tri-phasic, decrease in cholesterol and HbA1c questions: levels (if applicable) and the success of any smoking ces- sation and activity programmes. Quality of life and pa- 1. Does the pain ever begin when you are standing tient satisfaction with the programme was also assessed. still or sitting? Patients were excluded if they were unable to give in- 2. Do you get this pain if you walk uphill or when you formed consent due to lack of mental capacity and if hurry? they were unable to participate in increased activity due 3. Do you get this pain when you walk at an ordinary to other co-morbidities. pace on the level? Inclusion criteria: Patients who were on the podiatry 4. Does the pain disappear when you rest for less than service PAD caseload were purposively sampled to take 10 min? part in this pilot study. Anyone wishing to take part was given an information sheet, and an appointment was The respective responses Yes, No, Yes, Yes, Yes were arranged for a baseline assessment. taken as likely indicators of the presence of intermittent Exclusion criteria: housebound patients, patients claudication (IC). A score was derived for each partici- who had poor mobility and would be unable to take pant with 1 point being awarded for each instance of a part in any activity programme and patients who were response corresponding to a likely indicator of the pres- not able to give informed consent. At baseline med- ence of IC due to PAD (excluding presence of IC due to ical history was recorded, with any symptoms associ- causes other than PAD, such as spinal stenosis). Hence ated with PAD assessed using the Edinburgh scores could range from 0 (no IC; given to those who Intermittent Claudication Questionnaire [13]; and ab- answered “no” to the first question) to 5 (highly likely sence or presence of lower limb pulses on palpation, presence of IC) per participant. tri-, bi- or mono-phasic lower limb pulse sounds with a Doppler and ABPIs assessed with a Dopplex Ability Pulse measurements System®. The EQ-5D questionnaire was given to each Left and right posterior tibial, anterior tibial, dorsalis participant to complete to assess quality of life [13]. pedis and popliteal pulse measurements were obtained Clinical measurements were taken by experienced from participants at each time point, amounting to 8 research podiatrists with training in vascular assess- measurements in total per visit. A score was derived ment. Based on this assessment, the research podia- for each participant, with 1 point being awarded for trists tailored a treatment plan, which included advice each palpable pulse reading; scores could range from about smoking cessation and local support services to 0 (indicating no pulses were palpable) to 8 (all pulses support stopping smoking and weight loss (if applic- were palpable). able), recommendation to the physical activity referral scheme and participants were also given the oppor- Doppler readings tunity to meet with a dietician who was present in an Doppler sound readings were also taken of left and right adjoining clinic room to get advice about nutrition lower limb pulses from all participants at each time and weight loss (again, if applicable). point, amounting to 8 measurements in total. Sound readings were classified as triphasic, biphasic or mono- phasic; with triphasic considered to be the optimum Data collection status. Several outcome measures were recorded on participants at three time points: baseline; 3 months and 6 months. HbA1c and cholesterol Changes from baseline to 6 months were considered to be Glycated haemoglobin (HbA1c) and cholesterol readings the primary comparisons of interest. (if applicable) were recorded from the electronic patient Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 4 of 11 record as near to each appointment time point as pos- feedback on the study design and patient information sible if these were available. sheet. ABPI readings Results Left and right ABPI readings were obtained from each Data was collected on 21 individuals; 15 men (71.4%) participant at each time point using the Dopplex ability. and 6 women (28.6%). At baseline, 4 participants (19.0%) Overall values were calculated for each participant for reported themselves to be smokers; 17 participants each time point. Values < 0.9 are an indication of PAD, (81.0%) were non-smokers, of these 9 were ex-smokers with lower values indicating greater severity of disease. and 8 had never smoked. Participants also reported a number of co-morbidities Quality of life and patient satisfaction at baseline; nine (42.9%) had hypertension; 15 (71.4%) The EQ-5D was administered to participants at each had diabetes; 4 (19.0%) had hyperlipidaemia; 4 (19.0%) appointment. This instrument consists of 5 questions, had kidney disease; 3 (14.3%) had a previous stroke or relating to: mobility; self-care; usual activities; pain/dis- transient ischaemic attack; 4 (19.0%) had ischemic heart comfort; and anxiety/depression. All questions were disease (IHD) and 5 (23.8%) had a previous myocardial 5-point Likert-style items, with a score of 1 representing infarction (MI). no problems, and 5 representing extreme problems. Additionally, participants rated their overall quality of Assessment of peripheral arterial disease life on a 10-point visual analogue scale (VAS), with All 21 participants provided responses to the Edinburgh higher scores representing higher quality of life. A sim- Intermittent Claudication Questionnaire (EICQ) at the ple satisfaction questionnaire consisting of 5 questions baseline assessment, ranging from 0 to 5. The mean with a free text section at the end was administered at baseline score was 2.62 (SD 1.80). At the 3-month the 6 month appointment. assessment, 16 participants provided responses, again ranging from 0 to 5, and the mean score was 2.38 (SD Statistical analysis 1.59). At the 6-month assessment, 14 participants The sample was summarised descriptively; with gender, provided responses, again ranging from 0 to 5 and the smoking status and co-morbidities reported for all mean score was 2.36 (SD 1.78). patients. Additional qualitative information for partici- Fourteen participants provided data both at baseline pant satisfaction was also collected and summarised. and at the final 6-month assessment. The EICQ score of All outcome measures were summarised at each of the 5 participants reduced over this time period; whilst the three measured time points. Patterns of missingness and EICQ score of 2 participants increased. The scores of the effect of missing data values were assessed where the remaining 7 participants was unchanged. A paired appropriate. Paired samples t-tests were conducted on the samples t-test conducted on the respondents who pro- full EICQ scores, pulse measurements, ABPI measure- vided data both at baseline and at 6 months found a ments, HbA1c levels and cholesterol levels and overall mean reduction of 0.643 points (SD 1.34). A 95% confi- quality of life scores to assess the significance of the change dence interval for the difference between baseline and in these measures from baseline to the 6-month 6-month data was given by (− 0.129, 1.41). The differ- post-baseline assessment. Effect sizes and associated 95% ence, though substantive, was not significant at the 5% confidence intervals were also reported for these measures. significance level (t = 1.80; p = 0.095) (Fig. 1). Further analysis was conducted on the EICQ screening There was no evidence that missing EICQ data was question to investigate any trends over time in the propor- not missing completely at random (MCAR) according to tion of participants with IC. Similar procedures were con- Little’s MCAR test (χ = 4.41; p = 0.220). (3) ducted on the proportions of participants recording ABPI Further analysis was conducted on the response to the measurements in either or both legs below a critical value. first question alone; which was taken as a likely indicator Overall trends in the proportions of participants with tri-, of the presence of IC. At baseline, 12 participants bi- and monophasic Doppler readings were also investi- (57.1%) were assessed to have IC. Of these 11 had other gated. Individual EQ-5D item scores were analysed using signs of PAD such as some absent pulses on palpation multivariate methods. and or monophasic Doppler sounds. Only 1 participant had no other signs of PAD, so their pain may have been Ethical permissions neurological in origin. Eight participants completed their Ethical and research governance approval was given 3-month assessment, of which 7 (87.5% of those com- prior to commencement of the project and Patient and pleting the 3-month assessment) were assessed to still Public Involvement (PPI) was sought from a Citizens have IC. Nine participants completed their 6-month Reference Group and a local hospital panel. Both gave assessment (one participant who missed their 3-month Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 5 of 11 Fig. 1 EICQ scores at baseline and at 6 months, with 95% confidence intervals assessment returned for the 6-month assessment). Of twotimepoints was givenby(− 0.562, 2.10). The difference these, 6 were assessed to still have IC (66.7%) and 3 were was not significant at the 5% significance level (t = 1.26; not. p =0.232) (Fig. 2). Hence overall at 6 months, 6 participants out of 12 (50.0%) were assessed to have IC; with a net change of 2 Doppler sound readings patients moving from the group with IC to the group At baseline, participants recorded on average 3.52 mono- without IC. phasic readings (SD 2.60); 4.38 biphasic readings (SD Of the 8 participants assessed not to have IC at base- 2.50) and 0.10 triphasic readings (SD 0.30). At 3 months, line, 5 completed their 3-month assessment. Four were participants recorded on average 2.47 monophasic read- assessed to still not have IC; 1 participant was assessed ings (SD 2.45); 5.00 biphasic readings (SD 2.07) and 0.27 to have IC at 6 months. triphasic readings (SD 0.59). At 6 months, participants re- corded on average 2.47 monophasic readings (SD 2.77); Pulse measurements 5.07 biphasic readings (SD 2.69) and 0.27 triphasic read- All 21 participants provided pulse measurements at the ings (SD 0.59). baseline assessment, with scores ranging from 0 to 8 Hence no clear trends in recordings were observed (mean 5.33 (SD 2.67)). At the 3-month assessment, 15 over the three measured time points; however, the pro- participants provided responses, ranging from 2 to 8 portion of triphasic readings increased slightly from (mean 6.07 (SD 2.05)). At the 6-month assessment, 14 baseline to 3 months; with negligible further changes in participants provided responses, ranging from 1 to 8 any proportions between 3 and 6 months. (mean 6.69 (SD 2.02)). Thirteen participants provided pulse readings both at ABPI readings baseline and at the 6-month assessment. Of these, the At baseline, ABPI data was obtained from 17 partici- scores of 7 participants increased over this time period; pants; of whom 6 (35.3%) had overall ABPI values below whilst scores of 2 participants reduced, with scores of 4 0.90 in one or both legs (range from 0.56 to 1.45). The unchanged. A paired samples t-test conducted on the re- mean value for all participants providing a reading at spondents who provided data both at baseline and at this time point was 0.998 (SD 0.229) in the left leg and 6 months found a mean increase of 0.769 points (SD 2.20). 0.947 (SD 0.220) in the right leg. At 3 months, data was A 95% confidence interval for the difference between the obtained from 9 participants, of whom 5 (55.6%) had Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 6 of 11 Fig. 2 Pulse readings representing good circulation at baseline and at 6 months, with 95% confidence intervals overall ABPI values below 0.90 in one or both legs difference was significant at the 5% significance level (range from 0.77 to 1.29). The mean value for all partici- (t =3.66; p = 0.006). Of these 9 participants, 7 had pants providing a reading at this time point was 0.948 dietetic consultation and were referred to the exercise (SD 0.210) in the left leg and 0.921 (SD 0.195) in the referral service. right leg. At 6 months, data was obtained from 10 par- There was no evidence that missing HbA1c data was ticipants; of which 4 (40.0%) had overall ABPI values not missing completely at random (MCAR) according to below 0.90 (range from 0.75 to 1.20). The mean value Little’s MCAR test (χ = 8.32; p = 0.140) (Fig. 3). (5) for all participants providing a reading at this time point was 0.967 (SD 0.166) in the left leg and 0.958 (SD 0.149) in the right leg (Fig. 3). Cholesterol levels There was no evidence that missing ABPI data was At baseline, cholesterol data was obtained from 13 par- not missing completely at random (MCAR) according to ticipants (range 2.20 to 5.70 mmol/l; mean 3.75 mmol/ Little’s MCAR test (χ = 6.93; p = 0.226). l; SD 1.05). At 3 months, data was obtained from 5 par- (5) ticipants (range 2.30 to 5.10 mmol/l; mean 3.26 mmol/ HbA1c levels l; SD 1.18). At 6 months, data was obtained from 8 par- At baseline, HbA1c data was obtained from 13 partici- ticipants (range 2.40 to 4.20 mmol/l; mean 3.33 mmol/ pants (range 35.0 to 75.0 mmol/l; mean 57.0 mmol/l; l; SD 0.654). Hence no clear trend in HbA1c levels with SD 10.6). At 3 months, data was obtained from 6 par- time was apparent. ticipants (range 42.0 to 70.0 mmol/l; mean 55.5 mmol/ Eight participants provided data both at baseline and l; SD 10.7). At 6 months, data was obtained from 9 par- at the final 6-month assessment. A paired sample t-test ticipants (range 45.0 to 63.0 mmol/l; mean 51.4 mmol/ found a mean reduction of 0.050 mmol/l (SD 0.414). A l; SD 5.55). Hence a monotonic reduction in HbA1c 95% confidence interval for the difference between base- levels with time was apparent. line and 6-month data was given by (− 0.296, 0.369), the Nine participants provided data both at baseline and difference was not significant at the 5% significance level at the final 6-month assessment. A paired samples t-test (t = 0.342; p = 0.743). found a mean reduction of 9.22 mmol/l (SD 7.56). A There was no evidence that missing cholesterol data 95% confidence interval for the difference between base- was not missing completely at random (MCAR) accord- line and 6-month data was given by (3.41, 15.0). The ing to Little’s MCAR test (χ = 3.14; p = 0.678) (Fig. 4). (5) Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 7 of 11 Fig. 3 HbA1c levels at baseline and at 6 months, with 95% confidence intervals Quality of life not being significantly or substantively associated with Eighteen participants provided responses to overall the analysis time point. The reduction in pain of 0.50 EQ-5D quality of life (VAS item) at the baseline assess- points (from 2.37 points to 1.87 points) corresponded to ment (range 3.0 to 9.0; mean 5.93; SD 1.79). At the a 21.1% reduction from the baseline value (Fig. 6). 3-month assessment, 11 participants provided responses (range 3.80 to 9.0; mean 7.34; SD 1.36). At the 6-month Other outcomes assessment, 15 participants provided responses (range Eleven participants agreed to be referred onto the exer- 4.0 to 9.0; mean 7.10; SD 1.28). cise referral service situated in the same venue and 16 Fifteen participants provided data both at baseline and participants saw the dietician for nutritional advice at at the final 6-month assessment. A paired samples t-test baseline and had one to one or telephone follow ups at found a mean increase of 1.11 points (SD 1.37). A 95% 3 months. Of the four people who were smokers, two confidence interval for the difference between baseline stopped smoking cigarettes and moved to e-cigarettes as and 6-month data was given by (0.352, 1.88). The differ- part of smoking cessation advice given during the study. ence was significant at the 5% significance level (t =3.13; Seven participants had painful neuropathic symptoms at p =0.007) (Fig. 5). baseline and were referred either to their GP or to the There was no evidence that missing overall EQ-5D painful neuropathy clinic for a medication review or fur- data was not missing completely at random (MCAR) ac- ther management options. cording to Little’s MCAR test (χ = 6.53; p = 0.163). (4) Nineteen participants provided responses to the individ- Qualitative responses ual item scores at the baseline, 11 at 3 months and 15 at Fourteen patients completed a simple patient satisfaction the 6-month assessment. questionnaire; all of whom responded that they felt they Multivariate analysis conducted on baseline data and could discuss their symptoms of PAD with the podia- data collected at the final 6-month assessment revealed trist, they felt involved with the treatment plan, they a substantive effect (partial-η = 0.548) of time point on were satisfied with the service and they would recom- the measures assessed jointly (Wilk’s Λ = 0.452; F = mend this service to a friend. When asked to rate their 4,11 3.30; p = 0.051). Follow-up univariate analyses revealed PAD symptoms after completing the programme; 9 time-related differences to be based primarily in the pain respondents felt that they symptoms were better and the measure (F = 12.3; p = 0.004); with other measures remaining 5 said that they had remained the same. 1,14 Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 8 of 11 Fig. 4 Cholesterol levels at baseline and at 6 months, with 95% confidence intervals Fig. 5 Overall EQ-5D quality of life score at baseline and at 6 months, with 95% confidence intervals Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 9 of 11 Fig. 6 EQ-5D pain scores at baseline and at 6 months, with 95% confidence intervals Some comments were made on individual experiences development of a larger study. As 7 participants had during the study, one participant said: “I was referred to painful neuropathic symptoms at baseline, improve- the exercise referral service, this has proved to be a dra- ments in pain scores could also be associated with other matic change to my general wellbeing, especially the interventions such as medication that was prescribed circulation in my legs.” Another said that: during the study period. Whilst a substantial proportion of participants were current or former smokers, the level “I have felt comfortable explaining my problems to the of concurrent co-morbidities reported was not excessive; podiatry team and consider them to have understood suggesting that the apparent beneficial effect of the and been able to diagnose where my problem lies. The programme has not been over-stated due to regression information I have been given is a comfort and the to the mean effects; i.e. there is no evidence that partici- advice that losing weight will help is well received. The pants were skewed towards the lower end of the health facility and service I have found excellent with patient spectrum to be found in the parent population, with and friendly staff that one can be easily with in their correspondingly greater likelihood of natural improve- company.” However another participant had more ment over time. A certain amount of attrition was ob- difficulty: “Struggled to complete exercises at the gym served; in general this took place between baseline and due to knee pain. Ok with arm, back and chest the 3-month assessment. Many patients who did not exercises.” complete a 3-month assessment returned for a 6-month assessment. One patient died during the course of the study. Limitations As this was a pilot study there was no control group Discussion which gives some limitations on the internal validity of Though this was a small pilot study, some substantive, the study. However, the consistent and substantive and in some cases, statistically significant improvements improvements recorded across a wide range of outcome with respect to many measures have been observed over measures, in conjunction with lack of evidence for con- the 6-month study period. The extent of intermittent current changes in patient lifestyles over the course of claudication in those participants with these symptoms the study, provides evidence that the programme was (as assessed by the EICQ tool), substantively decreased, acceptable to participants and this will inform the with the proportion of respondents reporting pain or Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 10 of 11 discomfort when walking also decreasing. The propor- to multiple comparisons being conducted. We have not tion of patients providing tri-phasic Doppler sound read- attempted to specify a priori any outcomes as primary ings increased slightly within the context of a small outcomes or correct for inflated Type I errors which overall trend primarily between baseline and 3 months; would be appropriate in a full-scale study. Likewise, the with little further change beyond 3 months until the end size of the sample precludes the consideration of of the study period. No substantive changes in ABPI controlling factors in comparative analyses. between baseline and 6 months post baseline in either leg were revealed. Conclusion A substantive and significant reduction was recorded This small, feasibility study has demonstrated important in HbA1c levels but no changes were observed in chol- effects on health outcomes from a pilot clinical interven- esterol levels. A significant improvement was recorded tion for patients with PAD. The context and intervention in quality of life with improvements in pain scores being are reported as a novel prevention-orientated treatment mainly responsible for the overall improvement as mea- that sought to improve health outcomes. The findings sured by the quality of life instrument. suggest that a larger follow-up study would include a Previous studies have shown that patients with PAD number of specific outcome measures and economic have a much reduced level of physical activity which can assessment to demonstrate the effect of podiatric monitor- be attributed to the pain associated with the disease ing and exercise referral for this population. Further study [14]. However, if patients are persuaded to exercise or is needed to examine associated behaviour change factors increase their activity levels, this can help with the that result from prevention services of this kind, particu- symptoms and progression of the disease, and on-going larly where the professional intervention is designed to compliance can be improved [15]. A large systematic mitigate the effects of chronic wounds, revascularisation review comparing supervised exercise with usual care and amputation, particularly with the diabetic population. for claudication found that exercise resulted in more The study was designed to meet the strategic vision for functional benefits and should be advised as part of a allied health professions to engage in specific public health treatment programme for people with PAD [16]. A Ran- and prevention interventions in the United Kingdom. domised Controlled Trial (RCT) comparing medical care Abbreviations alone, medical care plus supervised exercise and medical ABPI: Ankle Brachial Pressure Index; EICQ: Edinburgh Intermittent care plus stent revascularisation for aortoiliac PAD Claudication Questionnaire; HbA1c: Glycated haemoglobin; IC: Intermittent Claudication; MCAR: Missing Completely at Random; NICE: National Institute found that both exercise and revascularisation resulted for Health and Care Excellence; PAD: Peripheral Arterial Disease; PPI: Patient in improved clinical outcomes and quality of life up to and Public Involvement; SD: Standard Deviation 18 months later [11]. Rather than a prescribed exercise programme, our study referred participants who agreed Acknowledgements to the exercise referral service where tailored one to one Funding advice was given to increase activity levels. This was pro- This study was funded by the National Centre for Sports Exercise Medicine vided on site in a National Centre for Sports and Exer- (NCSEM) in conjunction with Yorkshire and Humber Collaborations for Leadership in Applied Health Research and Care (CLAHRC) and Sheffield cise Medicine which enabled participants’ easy access to Clinical Commissioning Group. sports facilities at reduced rates. Similarly, access to nutritional advice was made easy Availability of data and materials The datasets used and/or analysed during the current 492 study are available by the presence of a dietician on site and most partici- from the corresponding author on reasonable request. pants were happy to discuss their diet as part of the programme. Authors’ contributions LF co-designed and applied for the funding and managed the project. JS Of the four patients who were smokers, two changed analysed the data and contributed to all parts of the manuscript. OB-H and to e-cigarettes as part of a smoking cessation regimen. KK delivered the intervention, collected the data and contributed to all part This follows current guidance from Public Health of the manuscript. SFD co-designed the proposal and application for funding, advised on rationale specifically supporting the policy implementation aspects England [18] which advises e-cigarettes in conjunction and links with NCSEM and contributed to all parts of the manuscript. All authors with smoking cessation services. This combined read and approved the final manuscript. approach has contributed to improved quit success Ethics approval and consent to participate rates. This study was reviewed and approved by London Brent Ethics Committee The significant and substantive associations observed IRAS ID 204611 and received research governance approval from the sponsor, must be considered in the context of the study being Sheffield Teaching Hospitals NHS Foundation Trust Research and Innovation Office STH19410. All participants gave written informed consent before taking formulated as a pilot and as such not powered to detect part in the study. significant effects. Further inferences of significance may be anticipated in a larger follow-up study. Conversely, Competing interests however, the large number of outcome measures has led The authors declare that they have no competing interests. Farndon et al. Journal of Foot and Ankle Research (2018) 11:26 Page 11 of 11 Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Author details Sheffield Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. School of Human & Health Sciences, University of Huddersfield, Huddersfield, UK. Sheffield Hallam University /Combined Community & Acute Care Group, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. Received: 27 March 2018 Accepted: 23 May 2018 References 1. BMJ. Best practice guidelines - Peripheral vascular disease. In: BMJ best practice; 2012. 2. National Institute for Health Clinical Excellence. Lower Limb Peripheral Arterial Disease: diagnosis and management. Clinical Guideline 147. 2012. https://www.nice.org.uk/guidance/cg147. 3. Fowkes FG, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;19(382(9901):1329–40. 4. Norgren L, et al., Inter-society consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg, 2007. 45(Suppl S:S5–67). 5. Regensteiner J, et al. The impact of peripheral arterial disease on health- related quality of life in peripheral arterial disease awareness, risk and treatment: new resources for survival (PARTNERS) program. Vasc Med. 2008; 13:15–24. 6. All Party Parliamentary Group on Vascular Disease. Tackling Peripheral Arterial Disease More Effectively: Saving Limbs. Saving Lives. 2013; 7. Young MJ, et al. Improved survival or diabetic foot ulcer patients 1995-2008. Diabetes Care. 2008;31:2143–7. 8. Walker CM, et al. Multidisciplinary approach to the diagnosis and management of patients with peripheral arterial disease. Clin Interv Aging. 2015;10:1147–53. 9. Powell KE, P M. Physical activity and health. Br Med J (Clin Res Ed). 1996; 313(7050):126–7. 10. Aherne T, et al. Comparing supervised exercise therapy to invasive measures in the Management of Symptomatic Peripheral Arterial Disease. Surgery Research and Practice, 2015. https://doi.org/10.1155/2015/960402. 11. Murphy T, et al. Supervised exercise, stent revascularization, or medical therapy for claudication due to Aortoiliac peripheral artery disease: a randomized clinical trial. J Am Coll Cardiol. 2015;65:999–1009. https://doi. org/10.1016/j.jacc.2014.12.043. 12. Sachs T, et al. Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft. J Vasc Surg. 2011;54(4):1021–31.e.1. 13. Leng G, Fowkes F. The Edinburgh claudication questionnaire: an improved version of the WHO/rose questionnaire for use in epidemiological surveys. J Clin Epidemiol. 1992;45(10):1101–9. 14. Gardner A, et al. Patterns of ambulatory activity in subjects with and without intermittent claudication. J Vasc Surg. 2007;46:1208–14. 15. Haas T, et al. Exercise training and peripheral arterial disease. Compr Physiol. 2012;2:2933–3017. https://doi.org/10.1002/cphy.c110065. 16. Watson L, Ellis B, Leng G. Excercise for intermittent claudication. Cochrane Database Syst Rev. 2008;(4):CD000990. https://doi.org/10.1002/14651858. CD000990.pub2.

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Journal of Foot and Ankle ResearchSpringer Journals

Published: Jun 4, 2018

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