Anne‐Maree Keenan

Background Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP. Objectives To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP. Methods A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1–12, monthly during months 4–12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0–10 numeric rating scale) between baseline and the average over 6–12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1–12, ii) pain at 6 and 12 months, and monthly from 3–12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout. Discussion The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP. Trial registration ISRCTN 12418153. Registration date 06 December 2022 https://doi.org/10.1186/ISRCTN12418153.

Background: Children and young people with symptomatic pes planus (flat feet) often seek treatment from healthcare professionals. There are various treatment options, but there is a lack of high-quality evidence about which is most effective. Objectives: To assess the clinical and cost-effectiveness of prefabricated orthoses, plus exercise and advice, compared with exercise and advice alone on physical function, measured using the physical domain of the Oxford Ankle Foot Questionnaire for Children, among children with symptomatic pes planus. Design and methods: A pragmatic, multicentre, two-armed individually randomised controlled trial with an internal pilot, economic evaluation and qualitative study. Setting and participants: Children and young people aged 6–14 years with symptomatic flat feet were recruited from hospital or community healthcare facilities in England and Wales. Participants were randomised 1 : 1 using a secure web-based randomisation system and followed up for up to 12 months. Interventions: We planned to provide all participants with advice and exercises, with the intervention group also receiving a prefabricated orthosis. Due to the nature of the study treatments, blinding of participants or the research team was not possible. Main outcome measures: The primary outcome was the physical domain subscale of the Oxford Ankle Foot Questionnaire for Children over the 12-month follow-up. Secondary outcomes included the physical domain subscale at 3, 6 and 12 months, and the ‘School and Play’ and ‘Emotional’ domains of the Oxford Ankle Foot Questionnaire, pain scores, healthcare resource use, EQ-5D-Y and Child Health Utility 9D at all time points. The qualitative study drew on health literacy and health belief perspectives and examined fidelity and explored the experiences of being in the trial for those receiving and delivering the study treatments. Results: COVID-19 severely delayed trial set-up and recruitment and the study closed before meeting its recruitment target. Of 549 participants assessed for eligibility, 134 were randomised (intervention n = 70, control n = 64). The mean age of participants was 10.6 years (range 6.3–14.8) and 55.2% were male. No adverse events were reported. The planned statistical and health economic analyses could not be fully conducted due to the limited data. The qualitative study identified pain, posture and gait as the most common concerns by participants with pain relief as the primary motivator for seeking health care. Participants generally reported little understanding of their condition with barriers including misattribution (e.g. growing pains). Misinformation was common emphasising a need for accessible accurate education materials and structured follow-up care. There was a common belief that orthoses were superior to exercises leading to high levels of adherence, satisfaction and outcomes with orthoses compared with poor adherence, and low perceived efficacy with exercises linked to challenges incorporating these into daily routines. Limitations: We could not deliver the study objectives as planned. Due to the limited data available, we were unable to undertake the planned analysis. Conclusions: The COVID-19 pandemic significantly impacted trial set-up and recruitment. Extending the study was not feasible due to cost and time constraints. Future work: The evidence for the clinical and cost-effectiveness of orthotics for the treatment of symptomatic flat feet in children remains inconclusive and an area for further research. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR127510.

Background: Computerised decision support systems (CDSS) are widely used by nurses and allied health professionals but their effect on clinical performance and patient outcomes is uncertain. Objectives: Evaluate the effects of clinical decision support systems use on nurses’, midwives’ and allied health professionals’ performance and patient outcomes and sense-check the results with developers and users. Eligibility criteria: Comparative studies (randomised controlled trials (RCTs), non-randomised trials, controlled before-and-after (CBA) studies, interrupted time series (ITS) and repeated measures studies comparing) of CDSS versus usual care from nurses, midwives or other allied health professionals. Information sources: Nineteen bibliographic databases searched October 2019 and February 2021. Risk of bias: Assessed using structured risk of bias guidelines; almost all included studies were at high risk of bias. Synthesis of results: Heterogeneity between interventions and outcomes necessitated narrative synthesis and grouping by: similarity in focus or CDSS-type, targeted health professionals, patient group, outcomes reported and study design. Included studies: Of 36,106 initial records, 262 studies were assessed for eligibility, with 35 included: 28 RCTs (80%), 3 CBA studies (8.6%), 3 ITS (8.6%) and 1 non-randomised trial, a total of 1318 health professionals and 67,595 patient participants. Few studies were multi-site and most focused on decision-making by nurses (71%) or paramedics (5.7%). Standalone, computer-based CDSS featured in 88.7% of the studies; only 8.6% of the studies involved ‘smart’ mobile or handheld technology. Care processes – including adherence to guidance – were positively influenced in 47% of the measures adopted. For example, nurses’ adherence to hand disinfection guidance, insulin dosing, on-time blood sampling, and documenting care were improved if they used CDSS. Patient care outcomes were statistically – if not always clinically – significantly improved in 40.7% of indicators. For example, lower numbers of falls and pressure ulcers, better glycaemic control, screening of malnutrition and obesity, and accurate triaging were features of professionals using CDSS compared to those who were not. Evidence limitations: Allied health professionals (AHPs) were underrepresented compared to nurses; systems, studies and outcomes were heterogeneous, preventing statistical aggregation; very wide confidence intervals around effects meant clinical significance was questionable; decision and implementation theory that would have helped interpret effects – including null effects – was largely absent; economic data were scant and diverse, preventing estimation of overall cost-effectiveness. Interpretation: CDSS can positively influence selected aspects of nurses’, midwives’ and AHPs’ performance and care outcomes. Comparative research is generally of low quality and outcomes wide ranging and heterogeneous. After more than a decade of synthesised research into CDSS in healthcare professions other than medicine, the effect on processes and outcomes remains uncertain. Higher-quality, theoretically informed, evaluative research that addresses the economics of CDSS development and implementation is still required. Future work: Developing nursing CDSS and primary research evaluation. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in Health and Social Care Delivery Research; 2023. See the NIHR Journals Library website for further project information. Registration: PROSPERO 1 [number: CRD42019147773].

Background: End‐stage ankle osteoarthritis typically causes severe pain and impaired function. Surgical treatment involves total ankle replacement (TAR) or ankle fusion. Definitive evidence about which procedure is optimal is lacking. No previous studies have thoroughly explored patients' experiences across the entire TAR/ankle fusion pathway. This study aimed to address this gap by exploring perceptions of surgery, education, rehabilitation and outcomes among patients who had undergone TAR or ankle fusion.Methods: Seven participants were purposively selected from an orthopaedic centre in northern England (3 females, 4 males). Participants had undergone primary TAR without revision (n = 2), TAR requiring revision (n = 3) or ankle fusion (n = 2). Each participant completed a single semi‐structured interview. Interviews were digitally recorded, transcribed verbatim and analysed thematically.Results: Three themes, each with two subthemes, were identified: decision‐making (seeking help; surgical options), perceptions of support (information/education; clinical support) and impact on the individual (personal circumstances and beliefs; post‐operative outcomes). Pain affecting participants' valued activities was key to their decision to seek help. Participants' decision between TAR and ankle fusion was influenced by multiple factors. Concerns regarding the lack of joint flexibility following fusion were highlighted, with some participants perceiving TAR as a “proper ankle” that would enable them to avoid limping. Participants obtained information from various sources, with most feeling that the education from their care team was inadequate. Participants' individual circumstances and beliefs influenced their decision‐making and perceptions of their post‐operative outcomes. Finally, whilst most participants were pleased with their outcomes, some experienced substantial ongoing problems such as difficulty walking and chronic pain.Conclusions: This study demonstrates the importance of providing adequate education about TAR and ankle fusion to enable patients to make informed decisions. Most participants felt that the education and clinical support they received did not fully meet their needs. Participants' personal circumstances and beliefs had a strong influence on their decision‐making and perceptions of their post‐operative outcomes, highlighting the need to personally tailor education and clinical support. Future work with a larger sample of patients and other key stakeholders is required to develop consensus‐based guidelines on pre‐ and post‐operative support for patients undergoing TAR/ankle fusion.

Background: Medical imaging can be used to assist with the diagnosis of plantar heel pain. The aim of this study was to synthesise medical imaging features associated with plantar heel pain.Methods: This systematic review and meta‐analysis conducted searches in MEDLINE, CINAHL, SPORTDiscus, Embase and the Cochrane Library from inception to 12th February 2021. Peer‐reviewed articles of cross‐sectional observational studies written in English that compared medical imaging findings in adult participants with plantar heel pain to control participants without plantar heel pain were included. Study quality and risk of bias was assessed using the National Institutes of Health quality assessment tool for observational cohort and cross‐sectional studies. Sensitivity analyses were conducted where appropriate to account for studies that used unblinded assessors.Results: Forty‐two studies (2928 participants) were identified and included in analyses. Only 21% of studies were rated ‘good’ on quality assessment. Imaging features associated with plantar heel pain included a thickened plantar fascia (on ultrasound and MRI), abnormalities of the plantar fascia (on ultrasound and MRI), abnormalities of adjacent tissue such as a thickened loaded plantar heel fat pad (on ultrasound), and a plantar calcaneal spur (on x‐ray). In addition, there is some evidence from more than one study that there is increased hyperaemia within the fascia (on power Doppler ultrasound) and abnormalities of bone in the calcaneus (increased uptake on technetium‐99 m bone scan and bone marrow oedema on MRI).Conclusions: People with plantar heel pain are more likely to have a thickened plantar fascia, abnormal plantar fascia tissue, a thicker loaded plantar heel fat pad, and a plantar calcaneal spur. In addition, there is some evidence of hyperaemia within the plantar fascia and abnormalities of the calcaneus. Whilst these medical imaging features may aid with diagnosis, additional high‐quality studies investigating medical imaging findings for some of these imaging features would be worthwhile to improve the precision of these findings and determine their clinical relevance.

Over the past decade, the role of nurses, midwives and allied health professionals (NMAHPs) have been transformed within the UK research community. Assisted by new funding opportunities and a recognition of their role in interdisciplinary working, NMAHPs are driving innovative patient care. Challenges still remain to maximise the potential of NHAMPs in clinical research; signposting opportunities to become involved in research, promoting clear career pathways and developing innovative roles with the NHS to attract and retain this community are critical.

Introduction: Activity pacing is considered a key component of rehabilitation programmes for chronic pain/fatigue. However, there are no widely used guidelines to standardize how pacing is delivered. This study aimed to undertake the first stage in developing a comprehensive evidence‐based activity pacing framework.Methods: An online survey across pain/fatigue services in English National Health Service trusts explored healthcare professionals' opinions on the types/uses of pacing, aims, facets and perceived effects. Data were analysed using descriptive statistics for closed‐ended questions and thematic analysis for open‐ended questions. Purposeful recruitment with a snowball effect engaged 92 healthcare professionals (physiotherapists, occupational therapists, nurses, doctors and psychologists) to the study.Results: Pacing was highly utilized, with perceived long‐term benefits for patients (n = 83, 90.2% healthcare professionals instructed pacing). The most endorsed aim of pacing was “achievement of meaningful activities” (24.5% of ranked votes). The least endorsed aim was “to conserve energy” (0.1% of ranked votes). The most frequently supported facet of pacing was “breaking down tasks” (n = 91, 98.9%). The least supported facet was “stopping activities when symptoms increase” (n = 6, 6.5%). Thematic analysis showed recurring themes that pacing involved flexibility and sense of choice.Conclusions: Pacing is a multidimensional coping strategy and complex behaviour. The message is clear that pacing should enable increases in meaningful activities, as opposed to attempting to avoid symptoms. The survey findings have informed the development of an activity pacing framework to guide healthcare professionals on the multiple components of pacing. This will help to standardize and optimize treatments for chronic pain/fatigue and enable future investigations.

Background: Guidelines recommend foot orthoses for people with both early (< 2 years) and established rheumatoid arthritis (RA). While prefabricated foot orthoses are cheaper and can exhibit comparable effects to customised devices, the available evidence for their effectiveness is inconsistent. Little is known about what types of foot orthoses clinicians prescribe. This study describes the foot orthoses prescription habits of podiatrists for people with rheumatoid arthritis.Methods: One hundred and eighty‐three podiatrists from the United Kingdom (UK) (n = 88), Australia (n = 68) and New Zealand (n = 27) completed a self‐administered, online survey regarding the types of foot orthoses prescribed in clinical practice for people with RA. This study forms part of a wider international survey exploring foot orthosis prescription habits.Results: UK respondents were more likely to prescribe prefabricated orthoses for early RA (n = 47, 53%) and customised orthoses for established RA (n = 47, 53%). Respondents in Australia were more likely to prescribe customised orthoses for both early (n = 32, 47%) and established (n = 46, 68%) RA, whilst respondents in New Zealand were more likely to prescribe prefabricated orthoses for both early (n = 16, 59%) and established (n = 10, 37%) disease.Irrespective of disease stage, the use of foam impression boxes was more prevalent in the UK and New Zealand when capturing a model of the feet prior to manufacturing customised orthoses. In contrast, electronic scanning and plaster of Paris were more common in Australia. Computer aided manufacture was utilised more frequently among respondents in Australia than in the UK and New Zealand. Respondents in all three countries specified more flexible shell materials for established RA, compared to early disease. Cushioning top covers (e.g. PORON® or polyurethane) were most frequently specified in all countries for both disease stages.Conclusions: Considerable variation was seen in the self‐reported foot orthoses prescription habits of respondents for people with RA. Variation between countries and disease stage was seen in type of orthoses, specific brands, manufacturing methods, and materials prescribed. The results allow podiatrists and broader health service providers to compare their practice against reported national and international patterns.

Background: While the prevalence and impact of musculoskeletal problems are high, most attention has been directed towards the back, knee and hip disorders. Foot pain is known to be common in older adults and accounts for a significant burden on health services. The aim of this study was to assess the impact of foot and ankle joint pain, considering age, presence of co‐morbidities and other site joint pain, in a large community sample.Methods: In the North Yorkshire Health study, 16,222 people over 55 years participated in a detailed survey of the prevalence and impact of lower limb joint problems. Self‐assessment of overall body pain and functional activities of daily living were assessed. Participants indicated the presence of joint pain, stiffness or swelling during the last 3 months which had lasted for more than 6 weeks on a manikin: data were captured on the foot and the ankle.Results: The prevalence of self‐reported foot and ankle joint pain was substantial: 184.33 per 1000, second only to knee problems. While foot pain was common, it was mostly associated with joint pain at other sites; only 1 in 11 of those with foot and ankle pain reported it only in the foot. Logistic regression modeling revealed while established factors such as co‐morbidities, knee and hip problems contributed to functional impairment, foot and ankle problems contributed to an additional increased risk of having difficulty standing and walking by two fold (OR = 2.314, 95%CI 2.061–2.598), going up and down stairs by 71% (OR = 1.711, 95%CI 1.478–1.980) and getting up from a seated position by 44% (OR = 1.438, 95%CI 1.197–1.729).Conclusion: These results suggest that not only are foot problems in the over 55 age group extremely prevalent, they have a considerable impact on functional abilities.