The use of antimicrobial dressings for the management of diabetic foot ulcers: A survey of podiatrists in Aotearoa New Zealand.

INTRODUCTION: Diabetic foot ulcers (DFUs) are commonly contaminated with pathogenic organisms and precede most diabetes-related amputations. Antimicrobial dressings are used in the treatment of DFUs; however, recent guidelines do not support their use. There are no data describing the experience of antimicrobial dressing use among podiatrists in Aotearoa New Zealand (AoNZ). This study aimed to (i) determine which antimicrobial dressings podiatrists in AoNZ use for the management of diabetic foot ulcers; and (ii) determine what factors influence AoNZ podiatrists' use of antimicrobial dressing when managing DFUs. METHODS: An anonymous cross-sectional web-based survey was undertaken. Participants were AoNZ registered podiatrists who managed DFUs in their practice. The survey included questions relating to personal and professional demographic characteristics and DFU management and dressing practices. Descriptive statistics were computed to address the research aims. RESULTS: Responses from 43 AoNZ podiatrists were included. Participants reported both cadexomer iodine and silver dressings were the most common antimicrobial dressings used, with honey dressings being the least frequently used. The most influential factors in choosing antimicrobial dressings when managing DFUs were the presence of current infection, ulcer exudate and ability to prevent future infection. The least influential factors in choosing antimicrobial dressings when managing DFUs were patient preferences, cost of dressings and comfort of dressing/pain on removal. CONCLUSIONS: AoNZ podiatrists managing DFUs primarily use antimicrobial dressings containing cadexomer iodine or silver as active ingredients, while lower-cost options, such as honey and povidone iodine are less often used. Current recommendations highlight the lack of evidence to support positive outcomes from any particular antimicrobial dressing over another and advocate that exudate control, comfort and cost be prioritised in decision-making. As cost has been an increasing burden to our healthcare funding, clinicians and organisations may consider this before purchasing and stocking expensive dressings.

Burnout among the podiatry profession: A survey of podiatrists in Aotearoa New Zealand.

INTRODUCTION: Burnout and occupational stress have not yet been explored within the Aotearoa New Zealand (AoNZ) podiatry workforce despite research suggesting an increased risk among this population. This study aimed to: (i) determine the prevalence and severity of burnout risk and occupational stress among AoNZ podiatrists; (ii) determine the factors associated with burnout risk and occupational stress among AoNZ podiatrists; and (iii) examine the relationship between burnout risk and occupational stress. METHODS: A cross-sectional online survey study was undertaken involving registered podiatrists practicing in AoNZ. Personal and professional demographic characteristics were captured. Participants also completed the Maslach Burnout Inventory (assessing three domains of emotional exhaustion, depersonalisation and personal accomplishment) and the Workplace Stress Scale as measures of burnout risk and occupational stress, respectively. Descriptive statistics, multiple regression analyses and correlation analyses were performed to address the research aims. RESULTS: Responses from 112 AoNZ podiatrists were included in the analyses. High levels of emotional exhaustion were identified in 43.8% of practitioners and were associated with physical activity status, sector of work, working in isolation and work hours (R2 = 0.304, F (8, N = 110) = 5.519, p < 0.001). High levels of depersonalisation were seen in 13.4% of practitioners and were associated with patient caseload and work hours, (R2 = 0.183, F (4, N = 108) = 5.770, p < 0.001). Low levels of personal accomplishment were observed in 8.9% of practitioners and associated with ethnicity, physical activity status and patient caseload, (R2 = 0.152, F (5, N = 106) = 3.577, p < 0.005). A total of 27.7% of practitioners exhibited an overall moderate to high risk of developing burnout. Over a fifth of practitioners exhibited stress at severe or dangerous levels. Stress levels were significantly associated with physical activity status, sector of work and management responsibility, (R2 = 0.282, F (5, N = 47) = 3.218, p = 0.15). A strong positive relationship was found between emotional exhaustion and stress (rho = 0.59, p < 0.001). CONCLUSIONS: The findings reflect a moderate to severe risk of developing burnout within the workforce, with high workloads and collegial isolation constituting the primary modifiable factors driving burnout development. To maintain retention and well-being within the workforce, mitigation strategies must be implemented to address this issue.

The development of recommendations for the assessment and management of sesamoiditis by podiatrists: A Delphi and content validity study.

INTRODUCTION: Sesamoiditis is a common, and often painful, musculoskeletal pathology frequently encountered by podiatrists. However, there are currently no recommendations to guide podiatrists in the assessment and management of people with sesamoiditis. The aim of this study was to develop consensus-driven clinical recommendations on the assessment and management of people with sesamoiditis. METHODS: A four-round online Delphi survey was conducted with a panel of New Zealand and Australian podiatrists. In the first round, panellists answered open-ended questions that were used to create statements. In round two, the panellists scored the statements from 1 to 9 (1 = not at all important, 9 = absolutely essential). Consensus was defined using the RAND/University of California Los Angles Disagreement Index. Panellists were asked to reconsider statements that did not achieve consensus in round three. In the final round, content validity and acceptability of the statements for inclusion in clinical recommendations were determined using content validity ratios and the Content Validity Index (CVI). RESULTS: Eighteen panellists completed round one with 16 (89%) completing all four rounds. A total of 118 statements were generated following round one. Following rounds two and three, 78 statements were accepted by panellists as being important, with 62 statements achieving sufficient content validity for inclusion in clinical recommendations. The CVI for these 62 statements was 0.58. These recommendations provide guidance on subjective assessment (pain characteristics/symptomology, activity/sports/training history and medical history) objective assessment (establishing a diagnosis, identifying contributing biomechanical factors, footwear/orthoses, ruling out differential diagnoses) and management (temporary padding/strapping, education, footwear, foot orthoses and when to consider referral). CONCLUSION: This consensus exercise has provided a set of consensus-based recommendations for the assessment and management of people with sesamoiditis. In the current absence of research-based evidence in this area, these recommendations are intended to support clinicians. The recommendations may also serve as a basis for future clinical trials evaluating the efficacy of conservative interventions for people with sesamoiditis.

Objective grading of rib eye traits using the Q-FOM™ camera in Australian beef carcasses.

The objective of this study was to develop calibration models against rib eye traits and independently validate the precision, accuracy, and repeatability of the Frontmatec Q-FOM™ Beef grading camera in Australian carcasses. This study compiled 12 different research datasets acquired from commercial processing facilities and were comprised of a diverse range of carcass phenotypes, graded by industry identified expert Meat Standards Australia (MSA) graders and sampled for chemical intramuscular fat (IMF%). Calibration performance was maintained when the device was independently validated. For continuous traits, the Q-FOM™ demonstrated precise (root mean squared error of prediction, RMSEP) and accurate (coefficient of determination, R2) prediction of eye muscle area (EMA) (R2 = 0.89, RMSEP = 4.3 cm2, slope = 0.96, bias = 0.7), MSA marbling (R2 = 0.95, RMSEP = 47.2, slope = 0.98, bias = -12.8) and chemical IMF% (R2 = 0.94, RMSEP = 1.56%, slope = 0.96, bias = 0.64). For categorical traits, the Q-FOM™ predicted 61%, 64.3% and 60.8% of AUS-MEAT marbling, meat colour and fat colour scores equivalent, and 95% within ±1 classes of expert grader scores. The Q-FOM™ also demonstrated very high repeatability and reproducibility across all traits.

An updated systematic review and meta-analysis of randomised controlled trials on the effects of urate-lowering therapy initiation during a gout flare.

BACKGROUND: There is uncertainty about the optimal time to start urate-lowering therapy (ULT) in the setting of a gout flare. The aim was to perform a systematic review and meta-analysis of randomised controlled trials (RCTs) assessing the effects of ULT initiation during a gout flare. METHODS: This systematic review was conducted in accordance with PRISMA methodology. MEDLINE, EMBASE and The Cochrane Library were searched for studies published between database inception to 1 March 2023. RCTs published in English that examined ULT initiation during a gout flare in adults ≥18 years were included. The quality of included studies was assessed using the revised Cochrane Risk of Bias tool 2.0. Data were extracted for the following outcomes: patient-rated pain score, duration of gout flare, recurrent gout flares, time to achieve target serum urate, adherence to ULT, patient satisfaction with treatment and adverse events. Meta-analyses were performed using Review Manager v5.4. This study is registered on PROSPERO, number CRD42023404680. RESULTS: A total of 972 studies were identified and of these, six RCTs met the criteria for inclusion in the analysis. Three studies were assessed as having high risk of bias, one study as having some concerns, and two studies as having low risk of bias. In total, there were 445 pooled participants; 226 participants randomised to early initiation of ULT and 219 to placebo or delayed initiation of ULT. Allopurinol was used in three studies, febuxostat in two studies and probenecid in one study. Few participants (n = 62, 13.9 %) had tophaceous gout. Participants with renal impairment were excluded from most studies. There were no differences in patient-rated pain scores at baseline, days 3-4, days 7-8, day 10 or days 14-15 (p ≥ 0.42). Additionally, there was no significant difference in time to resolution of gout flare (standardised mean difference 0.77 days; 95 % CI -0.26 to 1.79; p = 0.14) or the risk of recurrent gout flare in the subsequent 28 to 30 days (RR 1.06; 95 % CI 0.59 to 1.92; p = 0.84). Adverse events were similar between groups. The included studies did not report time to achieve target serum urate, long-term adherence to ULT, or patient satisfaction with treatment. CONCLUSION: There appears to be no evidence for harm or for benefit to initiating ULT during a gout flare. These findings have limited applicability to patients with tophaceous gout, or those with renal impairment.

Identifying determinants of adherence to adjuvant endocrine therapy following breast cancer: A systematic review of reviews.

BACKGROUND: In oestrogen-receptor positive breast cancer, daily oral adjuvant endocrine therapy (ET) for at least 5 years significantly reduces risks of recurrence and breast cancer-specific mortality. However, many women are poorly adherent to ET. Development of effective adherence support requires comprehensive understanding of influences on adherence. We undertook an umbrella review to identify determinants of ET adherence. METHODS: We searched PubMed, Embase, CINAHL, PsycINFO, Cochrane and PROSPERO (inception to 08/2022) to identify systematic reviews on factors influencing ET adherence. Abstracted determinants were mapped to the World Health Organization's dimensions of adherence. Reviews were quality appraised and overlap assessed. RESULTS: Of 5732 citations screened, 17 reviews were eligible (9 quantitative primary studies; 4 qualitative primary studies; 4 qualitative or quantitative studies) including 215 primary papers. All five WHO dimensions influenced ET non-adherence: The most consistently identified non-adherence determinants were patient-related factors (e.g. lower perceived ET necessity, more treatment concerns, perceptions of ET 'cons' vs. 'pros'). Healthcare system/healthcare professional-related factors (e.g. perceived lower quality health professional interaction/relationship) were also important and, to a somewhat lesser extent, socio-economic factors (e.g. lower levels of social/economic/material support). Evidence was more mixed for medication-related and condition-related factors, but several may be relevant (e.g. experiencing side-effects, cost). Potentially modifiable factors are more influential than non-modifiable/fixed factors (e.g. patient characteristics). CONCLUSIONS: The evidence-base on ET adherence determinants is extensive. Future empirical studies should focus on less well-researched areas and settings. The determinants themselves are numerous and complex in indicating that adherence support should be multifaceted, addressing multiple determinants.

Virtual Reality for Pain Management During High-Resolution Manometry: A Randomized Clinical Trial.

OBJECTIVE: High-resolution esophageal manometry (HRM) is the gold standard for the diagnosis of esophageal motility disorders. HRM is typically performed in the office with local anesthesia only, and many patients find it unpleasant and painful. The aim of this study was to examine the effects of the use of a virtual reality (VR) headset on pain and anxiety outcomes in patients with dysphagia undergoing HRM. METHODS: Patients with dysphagia were prospectively recruited and randomized to undergo HRM with and without VR distraction. Data collected included the State-Trait Anxiety Inventory-6 (STAI-6), the Short-Form McGill Pain Questionnaire, heart rate, and galvanic skin response (GSR) tracings. RESULTS: Forty subjects completed the study, including 20 subjects in the intervention arm and 20 in the control arm. There was evidence of a significant positive effect of VR on calmness (p = 0.0095) STAI-6 rating, as well as on physiologic measures of pain with significantly decreased GSR rise time (p = 0.0137) and average rate of change of conductance change (p = 0.0035). CONCLUSION: The use of VR during HRM catheter insertion increased calmness compared to control. Change of skin conductance was also reduced in the VR group, suggesting decreased physiologic pain. This study supports the consideration of the use of VR as a distraction tool to improve patient comfort during HRM. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:1118-1126, 2024.

Time-Series Analysis of First-Time Pediatric Speech Delays From 2018 to 2022.

This cohort study evaluates changes in pediatric speech delay diagnoses before and after the COVID-19 pandemic.

UK clinicians' attitudes towards the application of molecular diagnostics to guide antibiotic use in ICU patients with pneumonias: a quantitative study.

BACKGROUND: Molecular diagnostic tests may improve antibiotic prescribing by enabling earlier tailoring of antimicrobial therapy. However, clinicians' trust and acceptance of these tests will determine their application in practice. OBJECTIVES: To examine ICU prescribers' views on the application of molecular diagnostics in patients with suspected hospital-acquired and ventilator-associated pneumonia (HAP/VAP). METHODS: Sixty-three ICU clinicians from five UK hospitals completed a cross-sectional questionnaire between May 2020 and July 2020 assessing attitudes towards using molecular diagnostics to inform initial agent choice and to help stop broad-spectrum antibiotics early. RESULTS: Attitudes towards using molecular diagnostics to inform initial treatment choices and to stop broad-spectrum antibiotics early were nuanced. Most (83%) were positive about molecular diagnostics, agreeing that using results to inform broad-spectrum antibiotic prescribing is good practice. However, many (58%) believed sick patients are often too unstable to risk stopping broad-spectrum antibiotics based on a negative result. CONCLUSIONS: Positive attitudes towards the application of molecular diagnostics to improve antibiotic stewardship were juxtapositioned against the perceived need to initiate and maintain broad-spectrum antibiotics to protect unstable patients.

Vesiclepedia 2024: an extracellular vesicles and extracellular particles repository.

Vesiclepedia (http://www.microvesicles.org) is a free web-based compendium of DNA, RNA, proteins, lipids and metabolites that are detected or associated with extracellular vesicles (EVs) and extracellular particles (EPs). EVs are membranous vesicles that are secreted ubiquitously by cells from all domains of life from archaea to eukaryotes. In addition to EVs, it was reported recently that EPs like exomeres and supermeres are secreted by some mammalian cells. Both EVs and EPs contain proteins, nucleic acids, lipids and metabolites and has been proposed to be implicated in several key biological functions. Vesiclepedia catalogues proteins, DNA, RNA, lipids and metabolites from both published and unpublished studies. Currently, Vesiclepedia contains data obtained from 3533 EV studies, 50 550 RNA entries, 566 911 protein entries, 3839 lipid entries, 192 metabolite and 167 DNA entries. Quantitative data for 62 822 entries from 47 EV studies is available in Vesiclepedia. The datasets available in Vesiclepedia can be downloaded as tab-delimited files or accessible through the FunRich-based Vesiclepedia plugin.

Do Dynamic Plantar Pressures Differ Based on Sonographic Evidence of Metatarsophalangeal Joint Synovitis in People With Rheumatoid Arthritis?

OBJECTIVE: The metatarsophalangeal joints (MTPJs) are the most common location for synovitis in people with rheumatoid arthritis (RA), yet their association with plantar foot pressures has received very little attention. This study aimed to determine whether plantar pressures differed based on sonographic evidence of MTPJ synovitis in people with RA. METHOD: Ultrasound was used to assess synovitis (grey scale synovial hypertrophy and power Doppler signal) in MTPJs 1 to 5 using the combined EULAR/Outcome Measures in Rheumatology scoring system. Peak pressure (PP) and pressure time integrals (PTIs) were assessed during barefoot walking for seven plantar foot regions (heel, midfoot, first metatarsal, second metatarsal, third to fifth metatarsals, hallux, lesser toes). Mixed-effects linear regression was used to determine the difference in PP and PTI between MTPJs with none/minimal synovitis and MTPJs with moderate/severe synovitis. RESULTS: Thirty-five participants with RA were included. Mean age was 66.3 years and mean disease duration was 22.2 years. Participants with sonographic evidence of moderate/severe synovitis at the first MTPJ had reduced PTI at the hallux compared with those with none/minimal synovitis at this joint (P = 0.039). Participants with moderate/severe synovitis at the second MTPJ and fourth MTPJ had reduced PP and reduced PTI at lesser toes compared with those with none/minimal synovitis in these joints (all P ≤ 0.048). No significant differences were observed for synovitis in other joints. CONCLUSION: These findings may be suggestive of an inverse relationship between plantar pressure and soft tissue pathology, which is consistent with an offloading strategy and reduced use of the toes during propulsion.

The statistical challenge of analysing changes in dual energy computed tomography (DECT) urate volumes in people with gout.

BACKGROUND: Dual energy computed tomography (DECT) allows direct visualization of monosodium urate crystal deposition in gout. However, DECT urate volume data are often highly skewed (mostly small volumes with the remainder considerably larger), making statistical analyses challenging in longitudinal research. The aim of this study was to explore the ability of various analysis methods to normalise DECT urate volume data and determine change in DECT urate volumes over time. METHODS: Simulated datasets containing baseline and year 1 DECT urate volumes for 100 people with gout were created from two randomised controlled trials. Five methods were used to transform the DECT urate volume data prior to analysis: log-transformation, Box-Cox transformation, log(X-(min(X)-1)) transformation; inverse hyperbolic sine transformation, and rank order. Linear regression analyses were undertaken to determine the change in DECT urate volume between baseline and year 1. Cohen's d were calculated as a measure of effect size for each data treatment method. These analyses were then tested in a validation clinical trial dataset containing baseline and year 1 DECT urate volumes from 91 people with gout. RESULTS: No data treatment method successfully normalised the distribution of DECT urate volumes. For both simulated and validation data sets, significant reductions in DECT urate volumes were observed between baseline and Year 1 across all data treatment methods and there were no significant differences in Cohen's d effect sizes. CONCLUSIONS: Normalising highly skewed DECT urate volume data is challenging. Adopting commonly used transformation techniques may not significantly improve the ability to determine differences in measures of central tendency when comparing the change in DECT urate volumes over time.

The Patient Experience of Gout Remission: A Qualitative Study.

OBJECTIVE: Preliminary remission criteria for gout have been developed. However, the patient experience of gout remission has not been described. This qualitative study aimed to understand the patient experience of gout remission and views about the preliminary gout remission criteria. METHODS: Semistructured interviews were conducted. All participants had gout, had not had a gout flare in the preceding 6 months, and were on urate-lowering medication. Participants were asked to discuss their experience of gout remission and views about the preliminary remission criteria. Interviews were audio recorded and transcribed verbatim. Data were analyzed using a reflexive thematic approach. RESULTS: Twenty participants with gout (17 male participants, median age 63 years) were interviewed. Four key themes of the patient experience of remission were identified: 1) minimal or no gout symptoms (absence of pain due to gout flares, good physical function, smaller or no tophi), 2) freedom from dietary restrictions, 3) gout is "not on the mind", and 4) multifaceted management strategies to maintain remission (regular urate-lowering therapy, exercise, healthy eating). Participants believed that the preliminary remission criteria contained all relevant domains but considered that the pain and patient global assessment domains overlapped with the gout flares domain. Participants regarded 12 months as a more suitable time frame than 6 months to measure remission. CONCLUSION: Patients experience gout remission as a return to normality with minimal or no gout symptoms, dietary freedom, and absence of mental load. Patients use a range of management strategies to maintain gout remission.

Variability of toe pressures during haemodialysis: comparison of people with and without diabetes; a pilot study.

BACKGROUND: Diabetes, end stage renal disease (ESRD), and peripheral arterial disease (PAD) are associated with a higher risk of diabetes-related lower limb amputation. Timely identification of PAD with toe systolic blood pressure (TSBP) and toe-brachial pressure index (TBPI) is critical in order to implement foot protection strategies to prevent foot complications in people with ESRD. There is limited evidence describing the effect of haemodialysis on TSBP and TBPI. This study aimed to determine the variability of TSBP and TBPI during haemodialysis in people with ESRD, and to determine whether any observed variability differed between people with and without diabetes. METHODS: TSBP and TBPI were taken before dialysis (T1), one hour into dialysis (T2) and in the last 15 min of dialysis (T3) during a single dialysis session. Linear mixed effects models were undertaken to determine the variability in TSBP and TBPI across the three time points and to determine whether this variability differed between people with and without diabetes. RESULTS: Thirty participants were recruited, including 17 (57%) with diabetes and 13 (43%) with no diabetes. A significant overall reduction in TSBP was observed across all participants (P < 0.001). There was a significant reduction in TSBP between T1 and T2 (P < 0.001) and between T1 and T3 (P < 0.001). There was no significant overall change in TBPI over time (P = 0.62). There was no significant overall difference in TSBP between people with diabetes and people with no diabetes (mean difference [95% CI]: -9.28 [-40.20, 21.64], P = 0.54). There was no significant overall difference in TBPI between people with diabetes and people with no diabetes (mean difference [95% CI]: -0.01 [-0.17, 03.16], P = 0.91). CONCLUSION: TSBP and TBPI are an essential part of vascular assessment of the lower limb. TBPI remained stable and TSBP significantly reduced during dialysis. Given the frequency and duration of dialysis, clinicians taking toe pressures to screen for PAD should be aware of this reduction and consider how this may have an impact on wound healing capacity and the development of foot related complications.

Microwave therapy for the treatment of plantar warts.

BACKGROUND: Plantar warts, or verrucae plantaris, are common lesions causing considerable pain during weightbearing activity. Although current treatment modalities have low success rates, microwave therapy has been introduced as a promising intervention. This study aimed to determine the effectiveness of microwave therapy for the treatment of plantar warts and to determine the clinical factors associated with plantar wart resolution. METHODS: A retrospective analysis of 150 plantar warts from 45 patients treated with microwave therapy was undertaken. Binomial regression was conducted to explore clinical characteristics (age, gender, immunosuppression, impaired healing, multiple vs single wart, location of lesion, lesion diameter) associated with lesion resolution. RESULTS: Of the total 150 plantar warts treated with microwave therapy, 125 (83.3%) warts resolved and 25 (17%) warts did not resolve. The mean (SD) total treatment sessions for resolved lesions was 2.8 (1.0). Decreasing age (P = 0.046) was the only clinical characteristic associated with resolution. CONCLUSIONS: This retrospective study has shown that plantar warts may be resolved with two to three sessions of microwave therapy, which may be more successful in younger populations.

Proteomic analysis of the small extracellular vesicles and soluble secretory proteins from cachexia inducing and non-inducing cancer cells.

Cancer cachexia is a wasting syndrome characterised by the loss of fat and/or muscle mass in advanced cancer patients. It has been well-established that cancer cells themselves can induce cachexia via the release of several pro-cachectic and pro-inflammatory factors. However, it is unclear how this process is regulated and the key cachexins that are involved. In this study, we validated C26 and EL4 as cachexic and non-cachexic cell models, respectively. Treatment of adipocytes and myotubes with C26 conditioned medium induced lipolysis and atrophy, respectively. We profiled soluble secreted proteins (secretome) as well as small extracellular vesicles (sEVs) released from cachexia-inducing (C26) and non-inducing (EL4) cancer cells by label-free quantitative proteomics. A total of 1268 and 1022 proteins were identified in the secretome of C26 and EL4, respectively. Furthermore, proteomic analysis of sEVs derived from C26 and EL4 cancer cells revealed a distinct difference in the protein cargo. Functional enrichment analysis using FunRich highlighted the enrichment of proteins that are implicated in biological processes such as muscle atrophy, lipolysis, and inflammation in both the secretome and sEVs derived from C26 cancer cells. Overall, our characterisation of the proteomic profiles of the secretory factors and sEVs from cachexia-inducing and non-inducing cancer cells provides insights into tumour factors that promote weight loss by mediating protein and lipid loss in various organs and tissues. Further investigation of these proteins may assist in highlighting potential therapeutic targets and biomarkers of cancer cachexia.

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life.

BACKGROUND: Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. OBJECTIVE: To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. METHODS: Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. RESULTS: The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. CONCLUSIONS: HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness.

Gout Remission as a Goal of Urate-Lowering Therapy: A Critical Review.

Urate-lowering therapies for the management of gout lead to a reduction in serum urate levels, monosodium urate crystal deposition, and the clinical features of gout, including painful and disabling gout flares, chronic gouty arthritis, and tophi. Thus, disease remission is a potential goal of urate-lowering therapy. In 2016, preliminary gout remission criteria were developed by a large group of rheumatologists and researchers with expertise in gout. The preliminary gout remission criteria were defined as: serum urate < 0.36 mmol/L (6 mg/dL); an absence of gout flares; an absence of tophi; pain due to gout < 2 on a 0-10 scale; and a patient global assessment < 2 on a 0-10 scale over a 12-month period. In this critical review, we describe the development of the preliminary gout remission criteria, the properties of the preliminary gout remission criteria, and clinical studies of gout remission in people taking urate-lowering therapy. We also describe a future research agenda for gout remission.