The assessment and management of sesamoiditis: a focus group study of podiatrists in Aotearoa New Zealand.

BACKGROUND: Sesamoiditis is a common inflammatory condition affecting the sesamoid bones at the plantar aspect of the first metatarsophalangeal joint (1MTPJ). However, there are currently no recommendations or clinical guidelines to support podiatrists in their assessment or management of sesamoiditis. The aim of this study was to explore the views of podiatrists in Aotearoa New Zealand on their approaches to the assessment and management of patients with sesamoiditis. METHODS: This qualitative study included focus group discussions with registered podiatrists. Focus groups took place online via Zoom and were guided by a detailed focus group question schedule. The questions were designed to encourage discussion around assessment approaches used in the diagnosis of sesamoiditis and the treatment tools used to manage patients with sesamoiditis. Focus groups were audio-recorded and transcribed verbatim. Reflexive thematic analysis was used to analyse the data. RESULTS: A total of 12 registered podiatrists participated in one of three focus groups. Four themes were constructed relating to the assessment of sesamoiditis: (1) obtaining a patient history; (2) recreating patient symptoms; (3) determining contributing biomechanical factors; and (4) ruling out differential diagnoses. Seven themes were constructed relating to the management of sesamoiditis: (1) consideration of patient factors; (2) patient education; (3) cushioning of the sesamoids to allow more comfortable weightbearing of the 1MTPJ; (4) pressure redistribution and offloading of the sesamoids; (5) immobilisation of the 1MTPJ and sesamoids; (6) facilitating efficient sagittal plane motion during gait; (7) referring to other health professionals to find different ways to treat or manage patient symptoms. CONCLUSION: Podiatrists in Aotearoa New Zealand demonstrate an analytical approach in the assessment and management of patients with sesamoiditis based on their clinical experience and knowledge of lower limb anatomy. A range of assessment and management techniques are selected based on the practitioners personal preferences, as well as the patient's social factors, symptomology, and lower limb biomechanics.

Patients' awareness of the prevention and treatment of the selected podiatry diseases.

BACKGROUND: The lower limbs are an essential element of the structure of our body, bearing the weight and responsible for the correct motor skills. Defects in the functioning of the lower limbs and nails or foot skin can significantly affect the quality of life and limit full mobility. Due to the multitude of causes of podiatry changes, we consider their prevention and treatment interdisciplinary. AIMS: This study aimed to examine the patient's awareness of selected podiatry units' prevention and treatment methods. PATIENTS/METHODS: The study was an anonymous questionnaire consisting of 23 questions. The survey was carried out from November 4, 2020, to March 3, 2021. 516 questionnaires were collected. RESULTS: The results indicate that pain in the area of the feet is common. It was shown that patients do not have enough awareness and knowledge about proper foot care, yet the vast majority, mainly using Internet sources, try to solve the problem independently. In turn, a definite minority uses the services of a professional (eg, podiatrist) in this matter. The most commonly observed biological conditions are corns, cracked heels, ingrown toenails, and calluses. CONCLUSION: Patients, despite low awareness of proper care and the risk of complications, rarely decide to seek the help of a specialist in the field of podiatry diseases, even though appropriate care constantly improves foot motor skills. This problem is significant among people chronically ill with somatic diseases that often cause symptoms in the feet and thus reduce the patient's quality of life.

Prevalence of musculoskeletal injury and pain of UK-based podiatrists and the impact of enforced altered working practices.

BACKGROUND: Occupational musculoskeletal injuries are prevalent in healthcare workers and are reported to be profession-specific. There is, however, a paucity of information around the injuries sustained from working as a podiatrist. This paper looks at the incidence of injury from working as a podiatrist, the aggravating factors to sustain these injuries and whether the changes in workload due to the COVID-19 pandemic altered the incidence. METHODS: A modified work based musculoskeletal injury questionnaire was distributed in the UK via podiatry led social media platforms. Open and Closed questions explored the demographics of the sample, perceived injury 12 months prior to the COVID-19 pandemic and then 6 months into the lockdown. Pre and post COVID-19 data were analysed for differences and thematic analysis was included to categorise reported experiences. RESULTS: 148 podiatrists representing 3 % of HCPC registered practitioners responded to the questionnaire. Employment status altered as a result of the COVID-19 pandemic with a 13 % reduction in those working full time. Environments also changed with domiciliary and telehealth significantly increasing (p > 0.00) and non-clinical roles being extended (p > 0.002). Pain frequency and intensity significantly (p > 0.04) increased as a result of the pandemic with shoulder pain being most frequent before lockdown altering to the neck during the lockdown. Two main themes were identified that were attributed to the causes of pain including physical demands and working in awkward spaces. CONCLUSIONS: Work-related musculoskeletal pain in podiatrists is common with the shoulder and neck being the most frequently affected. Changes in work practices due to the restrictions enforced from the COVID-19 pandemic increased the frequency and intensity of pain mostly associated with increased domiciliary and telehealth working environments.

Sustainable healthcare - Time for 'Green Podiatry'.

BACKGROUND: Healthcare aims to promote good health and yet demonstrably contributes to climate change, which is purported to be 'the biggest global health threat of the 21st century'. This is happening now, with healthcare as an industry representing 4.4% of global carbon dioxide emissions. MAIN BODY: Climate change promotes health deficits from many angles; however, primarily it is the use of fossil fuels which increases atmospheric carbon dioxide (also nitrous oxide, and methane). These greenhouse gases prevent the earth from cooling, resulting in the higher temperatures and rising sea levels, which then cause 'wild weather' patterns, including floods, storms, and droughts. Particular vulnerability is afforded to those already health compromised (older people, pregnant women, children, wider health co-morbidities) as well as populations closer to equatorial zones, which encompasses many low-and-middle-income-countries. The paradox here, is that poorer nations by spending less on healthcare, have lower carbon emissions from health-related activity, and yet will suffer most from global warming effects, with scant resources to off-set the increasing health care needs. Global recognition has forged the Paris agreement, the United Nations sustainable developments goals, and the World Health Organisation climate change action plan. It is agreed that most healthcare impact comes from consumption of energy and resources, and the production of greenhouse gases into the environment. Many professional associations of medicine and allied health professionals are advocating for their members to lead on environmental sustainability; the Australian Podiatry Association is incorporating climate change into its strategic direction. CONCLUSION: Podiatrists, as allied health professionals, have wide community engagement, and hence, can model positive environmental practices, which may be effective in changing wider community behaviours, as occurred last century when doctors stopped smoking. As foot health consumers, our patients are increasingly likely to expect more sustainable practices and products, including 'green footwear' options. Green Podiatry, as a part of sustainable healthcare, directs us to be responsible energy and product consumers, and reduce our workplace emissions.

Exploring the use of musculoskeletal ultrasound imaging by podiatrists: an international survey.

BACKGROUND: Podiatrists, in musculoskeletal services, are demonstrating an expansion of their practice skills through the use of ultrasound imaging. There is an assumption that this practice is beneficial within the context of patient care and health systems. The aim of this research was to further investigate the use of musculoskeletal ultrasound (MSUS) by podiatrists within their clinical setting and gain additional insights into the impact that they perceive use of MSUS has on their approaches to management of musculoskeletal foot and ankle problems. METHOD: An international study utilising a cross-sectional design and an internet-based platform was undertaken. The survey was developed and implemented through three phases: 1. survey development, 2. face validity agreement via questionnaire review, and 3. survey distribution and data collection. Twenty-two survey questions were developed and set as a two-step approach collecting quantitative data (part 1) and qualitative free text data (part 2). Data was exported from SurveyMonkey and analysed using Microsoft Excel software. Counts and frequencies were calculated for responses to all twenty closed questions. Responses to the two final open-ended questions were analysed using thematic analysis to search for patterns related to podiatrists' perceptions of impact. RESULTS: Two hundred and thirty-two eligible participants consented to complete the survey. The majority (n = 159) of respondents were from the UK and Spain. Commonly MSUS has been used in practice for (i) diagnosing pathology, (ii) supporting rehabilitation, (iii) supporting interventions or (iv) research purposes. Most frequently, MSUS was used to assist in the diagnosis of injury/pathology (84%). A range of free text comments were received from the participants in response to the question relating to their thoughts on the impact of using MSUS imaging in their practice (n = 109) and on their perceptions of how the use of MSUS has influenced their approaches to management of their patients' musculoskeletal foot and ankle problems (n = 108). Thematic analysis of the free text comments generated four themes: (i) diagnosis, (ii) delivery and access of care, (iii) patient education and engagement, and (iv) patient empowerment. CONCLUSION: The perceived benefit podiatrists indicated in using MSUS as part of their practice is the perceived improvement in patient journeys through tighter, focused management plans and reduced waiting times. An additional novel finding was that MSUS provided the capacity for podiatrists to better inform patients of their diagnosis, which they believed led to improved engagement and consequent empowerment of patients in their treatment plans. We propose further investigation of patient experiences as well as testing of the model that embeds podiatrists' use of MSUS as a key skill in musculoskeletal foot and ankle services.

Efficacy and safety of condylectomy with minimally invasive surgery in the treatment of interdigital corns of the lesser toes compared to conservative treatment.

BACKGROUND: Minimally invasive surgery (MIS) procedures cause less trauma to the patient and might improve recovery. This study aimed to determine the efficacy and safety of condylectomy with MIS to treat interdigital corns of the lesser toes. METHODS: This prospective cohort study was conducted in seven podiatry centers. Patients with interdigital corns of the lesser toes, progressing for more than a year, with one or more recurrences in the last year following conservative treatments were eligible. The recruited patients were classified according to their treatment: conservative or surgical (condylectomy with MIS) and were compared. Patient satisfaction, pain, the clinical and functional status of the foot and the appearance of sequelae were assessed at 3 and 6 months after treatment. RESULTS: At 6 months, patients in the surgical treatment group showed no pain on pressure, which significantly differed from the conservative treatment group (p <  0.001). They also improved clinical and functional status of the foot, reaching values comparable to those of the standard population. No paresthesia, joint stiffness or instability, toe malalignment, or corn transfer to a contiguous site resulted from the surgical treatment. CONCLUSIONS: Condylectomy with MIS is effective and safe to treat interdigital corns of the lesser toes.

Semi-automatic measurements of foot morphological parameters from 3D plantar foot scans.

BACKGROUND: Foot healthcare research is focusing increasingly on personalized orthotic and prosthetic devices to address patient-specific morphology and ailments. Customization requires advanced 3D image processing tools to assess foot and leg geometrical parameters and alterations. The aim of this study is to present a new software for the measurement of the foot shape from 3D scans of the foot plantar surface. METHODS: A Kinect-based scanning device was used to acquire the 3D foot shape of 44 healthy subjects. A software was developed in Matlab to measure the foot main morphological parameters from foot scans. Principal Component Analysis was used to orientate the foot scans with respect to the same reference system. Accuracy, via percentage errors and Bland-Altman plots, and correlation of the software-based foot parameters were assessed against manual measurements. A normalized Arch Volume Index (nAVI) was proposed and correlated to the traditional Arch Index. Test-retest Intraclass Correlation Coefficient was used to assess the inter-session repeatability of foot measurements. RESULTS: The average percentage error between software and manual measurements was 1.2 ± 0.8% for foot length, 9.1 ± 3.7% for foot width, 22.3 ± 13.5% for arch height and 23.1 ± 12.7% for arch depth. Very strong correlations were observed for foot length (R = 0.97) and foot width (R = 0.83), and strong correlations for arch height (R = 0.62) and arch depth (R = 0.74). nAVI was negatively correlated to the Arch Index (R = -0.54). A small difference was found between software and manual measurements of foot length (Δ = 0.92 mm), a software overestimation of foot width (Δ = 8.6 mm) and underestimation of arch height (Δ = -1.4%) and arch depth (Δ = -11%). Moderate to excellent repeatability was observed for all measurements (0.67-0.99). CONCLUSIONS: The present software appears capable to estimate the foot main morphological parameters without the need for skin markers or for identification of anatomical landmarks. Moreover, measurements are not affected by the foot orientation on the scanning device. The good accuracy and repeatability of measurements make the software a potentially useful operator-independent tool for the assessment of foot morphological alterations and for orthotics customization. nAVI may be used for a more realistic classification of foot types when 3D foot images are available.

Effects of training podiatrists to use imagery-based motivational interviewing when treating people with diabetes-related foot disease: a mixed-methods pilot study.

BACKGROUND: Self-care in diabetes related foot disease (DFD) is challenging and contributes to poor outcomes. Motivational Interviewing (MI) can engage people in self-care and modifying it by integrating imagery may further improve its outcomes. No previous studies have trained podiatrists in using MI to address DFD self-care. This was the first study on training podiatrists to conduct imagery-based motivational interviewing (MI) when treating people with DFD, and to examine impacts on MI related skills, job satisfaction and subjective experiences in a mixed-methods pilot study. METHODS: Eleven recruited podiatrists (median age: 35 years, 9 female and 2 male) received two 4-h training sessions, and three received subsequent mentoring. MI and imagery skills were rated using validated tools during two clinical sessions per participant at baseline, and 2- and 12-weeks post-training. Job satisfaction was assessed at baseline and 12 weeks. Semi-structured interviews at 12 weeks were analysed using the framework approach. RESULTS: Significant improvements over time (p = .006-.044) with substantial effect sizes (η2 = .50-.67) were found in three of four global MI related communication skills and two of four MI behaviours. However, effects on these indices were not sustained to 12 weeks, and imagery was rarely used. Job satisfaction was high at baseline and unchanged at follow-up (p = 0.34, η2 = .100). In qualitative interviews, MI training and skills were valued, but significant challenges in using MI when treating people with DFD were reported. CONCLUSION: Training podiatrists in MI may have potential but more training, observation and mentoring appear needed to obtain sustained communication changes in practice.

Put PEP in your step with a Podiatric Enhanced Recovery After Surgery Protocol in the outpatient adult population: a best practice implementation project.

OBJECTIVE: The goal of this implementation project was to improve postoperative outcomes in the Day Surgery Podiatric patient population with the implementation of an enhanced recovery after surgery (ERAS) protocol at a large urban health system in the northeastern United States. We aimed to improve postoperative patient pain scores and reduce patient length of stay (LOS) with the implementation of the podiatric ERAS protocol (PEP). INTRODUCTION: ERAS provides an evidence-based interdisciplinary approach to the preparation and care of surgical patients. The core goals of ERAS promote accelerated patient recovery after surgery by incorporating broad patient education with strategies to reduce the physiologic stress associated with surgery and anesthesia. This strategy has been applied to many major surgical specialties but has not been established in podiatric patients. METHODS: The PEP evidence implementation initiative integrates two Joanna Briggs Institute tools: the Getting Research into Practice audit and feedback tool, and Practical Application of Clinical Evidence System, by incorporating proactive planning and data analyses. Baseline electronic health record data were collected in July 2019, followed by interdisciplinary PEP review, revision, implementation, and three data collection cycles. Strategic education was provided to stakeholders throughout data collection cycles. RESULTS: This use of ERAS in the outpatient podiatric surgery population demonstrated excellence in compliance with best practice recommendations. The proactive multimodal approach of PEP revealed improvement in four measures of patient pain, with improvement from 83 to 100% of patients having a pain goal higher than their admission postoperative pain score. Patient pain goal greater than discharge pain score was also found but not sustained. Baseline data collection established that 29% of podiatric patients had a LOS less than 90 min, which improved to 42% with PEP. This finding was also not sustained in the third cycle of audit data. Missing data may have influenced these results, reinforcing the need for further study. CONCLUSION: The use of ERAS in orthopedic patients has an established empirical basis for use, demonstrating a reduction in both postoperative pain and LOS. This novel use of ERAS in a podiatric surgery outpatient population has similar findings but was not sustained in all audit criteria. PEP demonstrated promising reductions in postoperative pain and LOS; however, further implementation replication is needed to confirm this expansion of ERAS and the promising results.

Technology-enabled remote management of diabetes foot disease and potential for reduction in associated health costs: a pilot study.

Diabetes-related foot disease, particularly when associated with amputation, affects quality of life and has a significant impact on health care costs. A pilot study using enhanced technology to facilitate remote access and video conferencing from rural locations to the diabetes MDT through a new service pathway confirmed high levels of patient satisfaction with 89% of foot ulcers improved or stable and only two minor amputations. A health economic analysis suggested potential for significant cost savings if this was scaled up regionally. Further evaluation of an integrated pathway, impact on lower limb amputation rates and full health economic assessment is recommended.

Joint Initiative Between Infectious Diseases and Podiatry in Outpatient Settings Improves Outcomes and Adherence to Treatment.

BACKGROUND: A joint infectious disease-podiatry clinic (JIDPC) in which an infectious diseases physician and a podiatrist see patients with diabetic foot infections together once a week was initiated in January 2017. This study was designed to investigate if the JIDPC can improve patient adherence and reduce recurrent infections. METHODS: A retrospective analysis of patients with diabetic foot infection admitted to Wheeling Hospital from March 2013 to December 2018 was performed. Initially, the patients were followed by infectious diseases and podiatry in their clinics separately (preintervention group). Beginning January 2017, they were followed together at the JIDPC (postintervention group). Recurrent infection, mortality, and loss to follow-up were compared using logistic regression models. RESULTS: Surgeries were performed in 52.5% of preintervention group participants (n = 99) and 81.9% of postintervention group participants (n = 55; P < .001). The preintervention group was more likely to be lost to follow-up (30.3% vs 9.1%; odds ratio [OR], 4.35 [confidence interval (CI), 1.58-11.99]), but the association was attenuated with further adjustment for surgery (OR 3.35 [CI, 1.17-9.62]). The risk of infection recurrence in 6 months was significantly higher in the preintervention group (36.1% vs 20.8%; OR, 2.16 [CI, 0.99-4.71]), but with further adjustment for surgery, this was not significant (P = .067; OR, 2.17 [CI, 0.95-4.94]). Mortality and 90-day readmission were not significantly different. CONCLUSIONS: Implementation of JIDPCs may decrease the incidence of recurrent infections among patients with diabetic foot infections.

Foot Examination for Older Adults.

The foot changes with age. Foot disorders in older adults are associated with falls, lower limb ulcers, and pain. Physical examination of the feet as part of the routine assessment of older adults is imperative to detect foot problems. Foot pain and pathologies are common in older adults. Regular foot care is important to prevent these issues. However, some older adults may find it difficult to complete foot care, including cutting toenails. Regular foot examination can detect common foot problems, functional decline, and is recommended for preventing falls. We describe a technique for performing a focused examination of the feet for older adults. This review addresses current podiatric issues in older patient populations and describes a method for foot examination to address the needs of older adults that can be incorporated into patient assessments in any clinical setting.

Application of tele-podiatry in diabetic foot management: A series of illustrative cases.

BACKGROUND AND AIMS: Telemedicine had been proposed as a tool to manage diabetes, but its role in management of diabetic foot ulcer is still evolving. The COVID-19 pandemic and related social restrictions have necessitated the use of telemedicine in the management of diabetic foot disease (tele-podiatry), particularly of patients classified as low-risk. MATERIALS AND METHODS: We present a report of three cases of varied diabetic foot problems assessed during the present pandemic using different forms of telemedicine for triaging, management of low-risk cases and for follow-up. RESULTS: Tele-podiatry was effective in the management of low-risk subjects with diabetic foot ulcer, and also useful in referral of high-risk subjects for hospital/clinic visit, facilitating proper management. It also helped in the follow-up of the cases. CONCLUSION: Telemedicine is a good screening tool for diagnosing and managing low-risk subjects with diabetic foot problems, and also enables a triaging system for deciding on hospital visits and hospitalization. Telemedicine offers several benefits in the management of diabetic foot disease, although it also has some limitations. Based on our experience during the pandemic, we recommend its judicious use in the triaging of patients of diabetic foot disease and management of low-risk cases. Future innovation in technology and artificial intelligence may help in better tele-podiatry care in the time to come.

The Application of Forensic Podiatry to Clinical Practice.

The practice of the clinical podiatrist traditionally focuses on the diagnosis and treatment of conditions of the foot, ankle, and related structures of the leg. Clinical podiatrists are expected to be mindful of "the principles and applications of scientific enquiry." This includes the evaluation of treatment efficacy and the research process. In contrast, the forensic podiatrist specializes in the analysis of foot-, ankle-, and gait-related evidence in the context of the criminal justice system. Although forensic podiatry is a separate, specialized field, many aspects of this discipline can be useful in the clinical treatment and management of foot and ankle problems. The authors, who are forensic podiatrists, contend that the clinical podiatrist can gain significant insights from the field of forensic podiatry. This article aims to provide clinical podiatrists with an overview of the principles and methods that have been tested and applied by forensic podiatrists in their practice, and suggests that the clinical practice of the nonforensic foot practitioner may benefit from such knowledge.

Podiatrists' views of assessment and management of pain in diabetes-related foot ulcers: a focus group study.

BACKGROUND: Contrary to the belief that patients with diabetes-related foot ulcers (DRFU) do not experience wound related pain due to the presence of peripheral neuropathy there is increasing evidence that pain can be present. Subsequently, wound-related pain is often underestimated and undertreated. The aim of this study is to describe what influences pain assessment of DRFU. METHODS: A qualitative exploratory study was conducted with podiatrists who managed DRFU. Eight podiatrists were recruited through a professional organisation to participate in a focus group. A thematic analysis was conducted to identify themes that explored the barriers and enablers to pain assessment and management of DRFU. RESULTS: Three themes emerged. Observational and non-verbal cues were the preferred approaches used to assess wound pain. Assumptions and value judgments of the pain patients experienced and the relationships between podiatrists, patients and other health care practitioners were important influencers on the assessment and management of pain. CONCLUSION: The perceived barriers to the assessment and management of wound related pain in DRFU were attitudes and beliefs about pain, lack of DRFU-specific validated assessment tools and lack of knowledge and skills to manage the pain.

Foot health of Aboriginal and Torres Strait Islander Peoples in regional and rural NSW, Australia.

BACKGROUND: Foot health of Aboriginal and Torres Strait Islander Australians' has not been established. Additionally, studies have shown that there is a lack of engagement of this population with general preventive foot care services. The aim of this study was to establish foot health in Aboriginal and Torres Strait Islander people attending two recently developed, culturally safe podiatry services in rural and regional New South Wales (NSW), Australia. Secondarily the relationship between self-perceived foot health and some medical and demographic characteristics was investigated. METHODS: This descriptive cross-sectional study included participants attending the culturally safe foot health care services managed by the University of Newcastle on the Central Coast or in Wellington, both located in NSW, Australia. At the consultation, participants completed the Foot Health Status Questionnaire (FHSQ) with the assistance of an Aboriginal health care worker, underwent basic vascular and neurological screening, and podiatric treatment. RESULTS: A total of 111 Aboriginal and Torres Strait Islander Australians (48 from the Central Coast, and 63 from Wellington) were included. FHSQ scores for pain (75.7 ± 26.8), function (80.2 ± 25.2), footwear (53.9 ± 33.4), and general foot health (62.0 ± 30.9) were generally good, but below the optimal score of 100. The presence of diabetes (n = 39 of 111 participants or 35.1%) was associated with lower levels of self-perceived foot function (r = - 0.20, n = 107, p = 0.04). CONCLUSION: We found that community-based foot health care services that are culturally safe are utilised by Aboriginal and Torres Strait Islander Peoples not currently at high risk of foot complications. This supports the use of culturally safe foot care services to improve engagement with preventative foot care. Future research should continue to be driven by Aboriginal and Torres Strait Islander Peoples and investigate ways to implement additional screening measures and undertake prospective evaluation of the impact of such services on health related outcomes in these communities.

Foot Care Education Among Patients With Diabetes Mellitus in China: A Cross-sectional Study.

PURPOSE: To investigate the foot care knowledge and behavior of patients with diabetes to determine effect and current challenges of foot care education, as a basis to improve education and reduce diabetic foot complications. DESIGN: Quantitative, cross-sectional study. METHODS: A convenience sampling method was used to recruit 200 patients with diabetes from the endocrinology clinic of a tertiary general hospital in Beijing between September 2014 and January 2015. Demographic and disease-related data, foot care education, foot risk stratification status, and knowledge and behavior (K&B) scores were collected using investigator-designed questionnaires. RESULTS: Of the 200 patients, 128 (64.0%) patients received routine diabetes education, and 73 (36.5%) received foot care education. The mean ± standard deviation (SD) for K&B scores were 63.76 ± 14.85, and 59.78 ± 11.17, respectively. The K&B scores of patients who received foot care education (69.54 ± 14.32 and 65.27 ± 11.90) were significantly higher than those who received diabetic education only (60.75 ± 15.27 and 57.54 ± 10.25) and those with no diabetic education (60.21 ± 13.37 and 55.94 ± 8.74) (P < .01). The K&B scores did not differ for patients based on diabetic foot risk strata (P > .05). CONCLUSION: The foot care K&B scores of patients with diabetes were low to moderate levels, particularly on items that pertained to self-foot examination, prompt treatment of foot problems, and regular foot inspection by professionals. Individuals with high risk of developing foot complications did not score higher on the K&B questionnaire. These data suggest there is need for improvement in instruction and patient uptake and application of knowledge. We recommend further study on the effectiveness of the delivery of foot care education based on foot risk stratification, and the implications of foot ulcer prevention in community settings.

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

BACKGROUND: Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. DESIGN: Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. SETTING: Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-to-face or over the telephone. PARTICIPANTS: Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. RESULTS: Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants' views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. CONCLUSIONS: Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011.