Cash Transfers may Increase the No-show Rate for Surgical Patients in Low-resource Settings: A Randomized Controlled Trial.

BACKGROUND: Over two-thirds of the world's population cannot access surgery when needed. Interventions to address this gap have primarily focused on surgical training and ministry-level surgical planning. However, patients more commonly cite cost-rather than governance or surgeon availability-as their primary access barrier. We undertook a randomized, controlled trial (RCT) to evaluate the effect on compliance with scheduled surgical appointments of addressing this barrier through a cash transfer. METHODS: 453 patients who were deemed surgical candidates by a nursing screening team in Guinea, West Africa, were randomized into three study arms: control, conditional cash transfer, and labeled unconditional cash transfer. Patients in the conditional cash transfer group were given a cash transfer to cover their transportation costs once they had been discharged from care. Patients in the unconditional arm were given a cash transfer to cover their transportation costs before they left their homes to get care. Arrival to a scheduled surgical appointment was the primary outcome. The study was performed in conjunction with Mercy Ships. RESULTS: The overall no-show rate was five-fold lower in Guinea than previously published estimates, likely due to changes in the patient selection and retention process, leading to an underpowered study. In a post-hoc analysis, which included non-randomized patients, patients in the control group and the conditional cash transfer group demonstrated no effect from the cash transfer. Patients in the unconditional cash transfer group were significantly less likely to arrive for their scheduled appointment. Subgroup analysis suggested that actual receipt of the unconditional cash transfer, instead of a lapse in the transfer mechanism, was associated with failure to show. CONCLUSION: We find that cash transfers are feasible for surgical patients in a low-resource setting, but that unconditional transfers may have negative effects on compliance. Although demand-side barriers are large for surgical patients in low-resource settings, interventions to address them must be designed with care. CONTEXTE: Plus des deux tiers de la population mondiale n'ont pas accès à la chirurgie lorsqu'ils en ont besoin. Les interventions visant à combler cette lacune ont principalement sur la formation chirurgicale et la planification chirurgicale au niveau ministériel. Cependant, les patients citent plus souvent le coût - plutôt que la gouvernance ou la disponibilité des chirurgiens - comme étant leur principal obstacle à l'accès. Nous avons entrepris un essai contrôlé randomisé (ECR) pour évaluer l'effet sur le respect des rendez-vous chirurgicaux programmés en s'attaquant à cet barrière par un transfert d'argent. MÉTHODES: 453 patients considérés comme des candidats à la chirurgie par une équipe de dépistage infirmière en Guinée, Afrique de l'Ouest, ont été répartis de manière aléatoire dans trois bras d'étude : contrôle, transfert monétaire conditionnel et transfert monétaire non transfert monétaire inconditionnel. Les patients du groupe de transfert monétaire conditionnel ont reçu un transfert d'argent pour couvrir leurs frais de transport une fois qu'ils étaient sortis des soins. Les patients du groupe de transfert inconditionnel recevaient un transfert en espèces pour couvrir leurs frais de transport avant de quitter leur domicile pour recevoir des soins. L'arrivée à un rendez-vous chirurgical programmé était le résultat principal. L'étude a été réalisée en collaboration avec Mercy Ships. RÉSULTATS: Le taux global de non-présentation était cinq fois inférieur en Guinée que les estimations publiées précédemment, probablement en raison de changements dans le processus de sélection et de rétention des patients, ce qui a conduit à une étude insuffisamment puissante. Dans une analyse post-hoc, qui incluait des patients non randomisés, les patients dans le groupe de contrôle et dans le groupe de transfert conditionnel n'ont montré aucun effet du transfert d'argent. Les patients du groupe de transfert d'argent sans condition étaient significativement moins susceptibles d'arriver pour leur rendez-vous prévu. L'analyse des sous-groupes suggère que la réception effective du transfert monétaire inconditionnel plutôt d'un erreur en mécanisme de transfert, était associé à l'absence de rendez-vous. CONCLUSION: Nous constatons que les transferts d'argent sont possibles pour les patients chirurgicaux dans un environnement à faibles ressources, mais que les transferts inconditionnels peuvent avoir des effets négatifs sur l'observance. Bien que les obstacles liés à la demande sont importants pour les patients opérés dans des contextes à faibles ressources, les doivent être conçues avec soin. MOTS-CLÉS: Transferts monétaires, Chirurgie, Chirurgie globale, Guinée, Interventions financières, Utilisation chirurgicale, Essai contrôlé randomisé.

A narrative review of the epidemiology and economics of chronic wounds.

Chronic wounds have a debilitating effect on the quality of life of many individuals, and the large economic impact on health system budgets warrants greater attention in policy making and condition management than is currently evident. The aim of this narrative review is to summarize the nature and extent of the chronic wound problem that confronts health systems across the world. The first section is used to highlight the underlying epidemiology relating to chronic wounds, while the second explores the economic costs associated with them and the relative efficiency of measures designed to manage them.

Utility of a Low-Cost, Dense Sensor Network for the Study of Air Quality Impact Upon Human Health in Urban and Rural Areas.

The chemical composition of air changes from moment to moment. While the atmosphere may appear clear and cloudless to the human eye, gases, aerosols, and particulates are in constant interaction with Earth's surface under the influence of meteorological conditions. The recent emergence of low-cost, dense environmental air quality monitoring networks suggests growing interest in highly granular temporospatial exposure assessments by scientists and citizens. This chapter describes the utility of leveraging partnerships and resources to collocate a dense network of low-cost air quality sensors with meteorological sensors across a predominantly rural state located in the southeastern U.S. Construction of the network will improve knowledge on the daily, diurnal, and seasonal variations of pollutant exposures in rural and urban areas, the public health impact of extreme climatological and atmospheric events, and socioeconomic factors that heighten risk of exposures and health outcomes.

Burden of medically attended influenza infection and cases averted by vaccination - United States, 2013/14 through 2015/16 influenza seasons.

BACKGROUND: In addition to preventing hospitalizations and deaths due to influenza, influenza vaccination programs can reduce the burden of outpatient visits for influenza. We estimated the incidence of medically-attended influenza at three geographically diverse sites in the United States, and the cases averted by vaccination, for the 2013/14 through 2015/16 influenza seasons. METHODS: We defined surveillance populations at three sites from the United States Influenza Vaccine Effectiveness Network. Among these populations, we identified outpatient visits laboratory-confirmed influenza via active surveillance, and identified all outpatient visits for acute respiratory illness from healthcare databases. We extrapolated the total number of outpatient visits for influenza from the proportion of surveillance visits with a positive influenza test. We combined estimates of incidence, vaccine coverage, and vaccine effectiveness to estimate outpatient visits averted by vaccination. RESULTS: Across the three sites and seasons, incidence of medically attended influenza ranged from 14 to 54 per 1000 population. Incidence was highest in children aged 6 months to 9 years (33 to 70 per 1000) and lowest in adults aged 18-49 years (21 to 27 per 1000). Cases averted ranged from 9 per 1000 vaccinees (Washington, 2014/15) to 28 per 1000 (Wisconsin, 2013/14). DISCUSSION: Seasonal influenza epidemics cause a considerable burden of outpatient medical visits. The United States influenza vaccination program has caused meaningful reductions in outpatient visits for influenza, even in years when the vaccine is not well-matched to the dominant circulating influenza strain.

Cost-effectiveness of yoga for managing musculoskeletal conditions in the workplace.

Background: Back pain and musculoskeletal conditions negatively affect the health-related quality of life (HRQL) of employees and generate substantial costs to employers. Aims: To assess the cost-effectiveness of yoga for managing musculoskeletal conditions. Methods: A randomized controlled trial evaluated an 8-week yoga programme, with a 6-month follow-up, for National Health Service (NHS) employees. Effectiveness in managing musculoskeletal conditions was assessed using repeated-measures generalized linear modelling for the Roland-Morris Disability Questionnaire (RDQ) and the Keele STarT Back Screening Tool. Cost-effectiveness was determined using area-under-the-curve linear regression for assessing HRQL from healthcare and societal perspectives. The incremental cost per quality-adjusted life year (QALY) was also calculated. Sickness absence was measured using electronic staff records at 6 months. Results: There were 151 participants. At 6 months, mean differences between groups favouring yoga were observed for RDQ [-0.63 (95% CI, -1.78, 0.48)], Keele STarT [-0.28 (95% CI, -0.97, 0.07)] and HRQL (0.016 QALY gain). From a healthcare perspective, yoga yielded an incremental cost-effectiveness ratio of £2103 per QALY. Given a willingness to pay for an additional QALY of £20 000, the probability of yoga being cost-effective was 95%. From a societal perspective, yoga was the dominant treatment compared with usual care. At 6 months, electronic staff records showed that yoga participants missed a total of 2 working days due to musculoskeletal conditions compared with 43 days for usual care participants. Conclusions: Yoga for NHS employees may enhance HRQL, reduce disability associated with back pain, lower sickness absence due to musculoskeletal conditions and is likely to be cost-effective.

Clustering high-dimensional mixed data to uncover sub-phenotypes: joint analysis of phenotypic and genotypic data.

The LIPGENE-SU.VI.MAX study, like many others, recorded high-dimensional continuous phenotypic data and categorical genotypic data. LIPGENE-SU.VI.MAX focuses on the need to account for both phenotypic and genetic factors when studying the metabolic syndrome (MetS), a complex disorder that can lead to higher risk of type 2 diabetes and cardiovascular disease. Interest lies in clustering the LIPGENE-SU.VI.MAX participants into homogeneous groups or sub-phenotypes, by jointly considering their phenotypic and genotypic data, and in determining which variables are discriminatory. A novel latent variable model that elegantly accommodates high dimensional, mixed data is developed to cluster LIPGENE-SU.VI.MAX participants using a Bayesian finite mixture model. A computationally efficient variable selection algorithm is incorporated, estimation is via a Gibbs sampling algorithm and an approximate BIC-MCMC criterion is developed to select the optimal model. Two clusters or sub-phenotypes ('healthy' and 'at risk') are uncovered. A small subset of variables is deemed discriminatory, which notably includes phenotypic and genotypic variables, highlighting the need to jointly consider both factors. Further, 7 years after the LIPGENE-SU.VI.MAX data were collected, participants underwent further analysis to diagnose presence or absence of the MetS. The two uncovered sub-phenotypes strongly correspond to the 7-year follow-up disease classification, highlighting the role of phenotypic and genotypic factors in the MetS and emphasising the potential utility of the clustering approach in early screening. Additionally, the ability of the proposed approach to define the uncertainty in sub-phenotype membership at the participant level is synonymous with the concepts of precision medicine and nutrition. Copyright © 2017 John Wiley & Sons, Ltd.

Electrical impedance tomography for non-invasive assessment of stroke volume variation in health and experimental lung injury.

BACKGROUND: Functional imaging by thoracic electrical impedance tomography (EIT) is a non-invasive approach to continuously assess central stroke volume variation (SVV) for guiding fluid therapy. The early available data were from healthy lungs without injury-related changes in thoracic impedance as a potentially influencing factor. The aim of this study was to evaluate SVV measured by EIT (SVVEIT) against SVV from pulse contour analysis (SVVPC) in an experimental animal model of acute lung injury at different lung volumes. METHODS: We conducted a randomized controlled trial in 30 anaesthetized domestic pigs. SVVEIT was calculated automatically analysing heart-lung interactions in a set of pixels representing the aorta. Each initial analysis was performed automatically and unsupervised using predefined frequency domain algorithms that had not previously been used in the study population. After baseline measurements in normal lung conditions, lung injury was induced either by repeated broncho-alveolar lavage (n=15) or by intravenous administration of oleic acid (n=15) and SVVEIT was remeasured. RESULTS: The protocol was completed in 28 animals. A total of 123 pairs of SVV measurements were acquired. Correlation coefficients (r) between SVVEIT and SVVPC were 0.77 in healthy lungs, 0.84 after broncho-alveolar lavage, and 0.48 after lung injury from oleic acid. CONCLUSIONS: EIT provides automated calculation of a dynamic preload index of fluid responsiveness (SVVEIT) that is non-invasively derived from a central haemodynamic signal. However, alterations in thoracic impedance induced by lung injury influence this method.

Economic evaluation in chronic pain: a systematic review and de novo flexible economic model.

There is unmet need in patients suffering from chronic pain, yet innovation may be impeded by the difficulty of justifying economic value in a field beset by data limitations and methodological variability. A systematic review was conducted to identify and summarise the key areas of variability and limitations in modelling approaches in the economic evaluation of treatments for chronic pain. The results of the literature review were then used to support the development of a fully flexible open-source economic model structure, designed to test structural and data assumptions and act as a reference for future modelling practice. The key model design themes identified from the systematic review included: time horizon; titration and stabilisation; number of treatment lines; choice/ordering of treatment; and the impact of parameter uncertainty (given reliance on expert opinion). Exploratory analyses using the model to compare a hypothetical novel therapy versus morphine as first-line treatments showed cost-effectiveness results to be sensitive to structural and data assumptions. Assumptions about the treatment pathway and choice of time horizon were key model drivers. Our results suggest structural model design and data assumptions may have driven previous cost-effectiveness results and ultimately decisions based on economic value. We therefore conclude that it is vital that future economic models in chronic pain are designed to be fully transparent and hope our open-source code is useful in order to aspire to a common approach to modelling pain that includes robust sensitivity analyses to test structural and parameter uncertainty.

Retrospective Assessment of the Utility of Imaging, Fine-Needle Aspiration Biopsy, and Intraoperative Frozen Section in the Management of Parotid Neoplasms: The Weill Cornell Medical College Experience.

BACKGROUND/AIMS: Preoperative identification of malignant parotid lesions remains challenging, and thus, some surgeons use frozen section (FS) to assist them in their decision making. We evaluated the pathologic and cost benefit of FS after fine-needle aspiration (FNA) at our institution. METHODS: We assessed medical data for 260 patients undergoing parotidectomy with FS. The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were calculated for radiology, FNA, and FS. RESULTS: The sensitivities, specificities, and accuracies of FNA and FS were 75.0, 96.4, and 93.2%, and 75.0, 100, and 96.8%, respectively. FS detected 0% of FNA false negatives and 80% of false positives. The additional pathology charge for FS alone per correctly identified benign lesion after a positive FNA was USD 1,443. CONCLUSION: FNA and FS are more reliable in the prognostication of the final pathology than radiology. At our center, FS appears to be of limited clinical use after benign FNAs, but may be more useful after positive, indeterminate, and nondiagnostic FNAs.

A UK national audit of hereditary and acquired angioedema.

Hereditary angioedema (HAE) and acquired angioedema (AAE) are rare life-threatening conditions caused by deficiency of C1 inhibitor (C1INH). Both are characterized by recurrent unpredictable episodes of mucosal swelling involving three main areas: the skin, gastrointestinal tract and larynx. Swelling in the gastrointestinal tract results in abdominal pain and vomiting, while swelling in the larynx may be fatal. There are limited UK data on these patients to help improve practice and understand more clearly the burden of disease. An audit tool was designed, informed by the published UK consensus document and clinical practice, and sent to clinicians involved in the care of HAE patients through a number of national organizations. Data sets on 376 patients were received from 14 centres in England, Scotland and Wales. There were 55 deaths from HAE in 33 families, emphasizing the potentially lethal nature of this disease. These data also show that there is a significant diagnostic delay of on average 10 years for type I HAE, 18 years for type II HAE and 5 years for AAE. For HAE the average annual frequency of swellings per patient affecting the periphery was eight, abdomen 5 and airway 0·5, with wide individual variation. The impact on quality of life was rated as moderate or severe by 37% of adult patients. The audit has helped to define the burden of disease in the UK and has aided planning new treatments for UK patients.

A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).

BACKGROUND: Antibiotic-associated diarrhoea (AAD) occurs most commonly in older people admitted to hospital and within 12 weeks of exposure to broad-spectrum antibiotics. Although usually a mild and self-limiting illness, the 15-39% of cases caused by Clostridium difficile infection [C. difficile diarrhoea (CDD)] may result in severe diarrhoea and death. Previous research has shown that probiotics, live microbial organisms that, when administered in adequate numbers, are beneficial to health, may be effective in preventing AAD and CDD. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of a high-dose, multistrain probiotic in the prevention of AAD and CDD in older people admitted to hospital. DESIGN: A multicentre, randomised, double-blind, placebo-controlled, parallel-arm trial. SETTING: Medical, surgical and elderly care inpatient wards in five NHS hospitals in the UK. PARTICIPANTS: Eligible patients were aged ≥ 65 years, were exposed to one or more oral or parenteral antibiotics and were without pre-existing diarrhoeal disorders, recent CDD or at risk of probiotic adverse effects. Out of 17,420 patients screened, 2981 (17.1%) were recruited. Participants were allocated sequentially according to a computer-generated random allocation sequence; 1493 (50.1%) were allocated to the probiotic and 1488 (49.9%) to the placebo arm. INTERVENTIONS: Vegetarian capsules containing two strains of lactobacilli and two strains of bifidobacteria (a total of 6 × 10(10) organisms per day) were taken daily for 21 days. The placebo was inert maltodextrin powder in identical capsules. MAIN OUTCOME MEASURES: The occurrence of AAD within 8 weeks and CDD within 12 weeks of recruitment was determined by participant follow-up and checking hospital laboratory records by research nurses who were blind to arm allocation. RESULTS: Analysis based on the treatment allocated included 2941 (98.7%) participants. Potential risk factors for AAD at baseline were similar in the two study arms. Frequency of AAD (including CDD) was similar in the probiotic (159/1470, 10.8%) and placebo arms [153/1471, 10.4%; relative risk (RR) 1.04; 95% confidence interval (CI) 0.84 to 1.28; p = 0.71]. CDD was an uncommon cause of AAD and occurred in 12/1470 (0.8%) participants in the probiotic and 17/1471 (1.2%) in the placebo arm (RR 0.71; 95% CI 0.34 to 1.47; p = 0.35). Duration and severity of diarrhoea, common gastrointestinal symptoms, serious adverse events and quality of life measures were also similar in the two arms. Total health-care costs per patient did not differ significantly between the probiotic (£8020; 95% CI £7620 to £8420) and placebo (£8010; 95% CI £7600 to £8420) arms. CONCLUSION: We found no evidence that probiotic administration was effective in preventing AAD. Although there was a trend towards reduced CDD in the probiotic arm, on balance, the administration of this probiotic seems unlikely to benefit older patients exposed to antibiotics. A better understanding of the pathogenesis of AAD and CDD and the strain-specific effects of probiotics is needed before further clinical trials of specific microbial preparations are undertaken. Evaluation of the effectiveness of other probiotics will be difficult where other measures, such as antibiotic stewardship, have reduced CDD rates. TRIAL REGISTRATION: This trial is registered as ISRCTN70017204. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 57. See the NIHR Journals Library website for further project information.

Effectiveness and cost-effectiveness of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness and cost utility of a universally provided early years parenting programme. DESIGN: Multicentre randomised controlled trial with cost-effectiveness analysis. SETTING: Early years centres in four deprived areas of South Wales. PARTICIPANTS: Families with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control. INTERVENTION: The Family Links Nurturing Programme (FLNP), a 10-week course with weekly 2 h facilitated group sessions. MAIN OUTCOME MEASURES: Negative and supportive parenting, child and parental well-being and costs assessed before the intervention, following the course (3 months) and at 9 months using standardised measures. RESULTS: There were no significant differences in primary or secondary outcomes between trial arms at 3 or 9 months. With '+' indicating improvement, difference in change in negative parenting score at 9 months was +0.90 (95%CI -1.90 to 3.69); in supportive parenting, +0.17 (95%CI -0.61 to 0.94); and 12 of the 17 secondary outcomes showed a non-significant positive effect in the FLNP arm. Based on changes in parental well-being (SF-12), the cost per quality-adjusted life year (QALY) gained was estimated to be £34 913 (range 21 485-46 578) over 5 years and £18 954 (range 11 664-25 287) over 10 years. Probability of cost per QALY gained below £30 000 was 47% at 5 years and 57% at 10 years. Attendance was low: 34% of intervention families attended no sessions (n=48); only 47% completed the course (n=68). Also, 19% of control families attended a parenting programme before 9-month follow-up. CONCLUSIONS: Our trial has not found evidence of clinical or cost utility for the FLNP in a universal setting. However, low levels of exposure and contamination mean that uncertainty remains. TRIAL REGISTRATION: The trial is registered with Current Controlled Trials ISRCTN13919732.

A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the U.K.

BACKGROUND: Tumour gene expression analysis is useful in predicting adjuvant chemotherapy benefit in early breast cancer patients. This study aims to examine the implications of routine Oncotype DX testing in the U.K. METHODS: Women with oestrogen receptor positive (ER+), pNO or pN1mi breast cancer were assessed for adjuvant chemotherapy and subsequently offered Oncotype DX testing, with changes in chemotherapy decisions recorded. A subset of patients completed questionnaires about their uncertainties regarding chemotherapy decisions pre- and post-testing. All patients were asked to complete a diary of medical interactions over the next 6 months, from which economic data were extracted to model the cost-effectiveness of testing. RESULTS: Oncotype DX testing resulted in changes in chemotherapy decisions in 38 of 142 (26.8%) women, with 26 of 57 (45.6%) spared chemotherapy and 12 of 85 (14.1%) requiring chemotherapy when not initially recommended (9.9% reduction overall). Decision conflict analysis showed that Oncotype DX testing increased patients' confidence in treatment decision making. Economic analysis showed that routine Oncotype DX testing costs £6232 per quality-adjusted life year gained. CONCLUSION: Oncotype DX decreased chemotherapy use and increased confidence in treatment decision making in patients with ER+ early-stage breast cancer. Based on these findings, Oncotype DX is cost-effective in the UK setting.

Inferior alveolar nerve injury following orthognathic surgery: a review of assessment issues.

The sensory branches of the trigeminal nerve encode information about facial expressions, speaking and chewing movements, and stimuli that come into contact with the orofacial tissues. Whatever the cause, damage to the inferior alveolar nerve negatively affects the quality of facial sensibility as well as the patient's ability to translate patterns of altered nerve activity into functionally meaningful motor behaviours. There is no generally accepted, standard method of estimating sensory disturbances in the distribution of the inferior alveolar nerve following injury. Assessment of sensory alterations can be conducted using three types of measures: (i) objective electrophysiological measures of nerve conduction, (ii) sensory testing (stimulus) measures and (iii) patient report. Each type of measure with advantages and disadvantages for use are reviewed.

Management of a complex wound in a person with spinal cord injury and mental illness.

This paper highlights the important nexus between physical and mental health by examining a case concerning a patient with a lower spinal cord injury and mental illness who subsequently developed two pressure ulcers. It examines how clinicians can benefit from looking beyond typical assumptions when caring for an individual with complex needs in the community setting. In such circumstances, the need for a holistic and collaborative approach to wound care is vital. This involves taking into account the individual's mental health care needs, which can be overlooked in the first instance. Recommendations for clinical practice centre on involving the patient in his or her dietary, psychological and physical care, thereby helping to build resilience to any mental health problems and promoting a positive physical recovery.

An evaluation of a behaviour assessment to determine the suitability of shelter dogs for rehoming.

We evaluated a scheme for assessing shelter dog behaviour, which used 28 tests and rated responses from 0 (positive response) to 5 (fear, tonic immobility, or escape attempts). The assessment was evaluated for 236 dogs, and was repeated by a different assessor for 39 dogs approximately 80 days after rehoming to determine relevance of individual test components. A new owner survey evaluated satisfaction with the dog. A total of 130 of 236 dogs passed (score 80) failed. Scores were mainly unaffected by dog type and environmental variables, but decreased if dog faeces from a previous test was present in the arena during a test. Shelter tests only correlated with repeat tests if there was no direct contact with assessors. Adopters were satisfied with their dogs, despite reporting some behaviour problems. The shelter assessment was therefore robust against most outside influences but did not predict responses to people well.

Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes.

OBJECTIVES: To determine the comparative effectiveness and cost-effectiveness of three dressing products, N-A, Inadine and Aquacel, for patients with diabetic foot ulcers, as well as the feasibility and consequences of less frequent dressing changes by health-care professionals. DESIGN: A multicentre, prospective, observer-blinded, parallel group, randomised controlled trial, with three arms. SETTING: Established expert multidisciplinary clinics for the management of diabetic foot ulcers across the UK. PARTICIPANTS: Patients over age 18 with type 1 or type 2 diabetes with a chronic (present for at least 6 weeks) full-thickness foot ulcer (on or below the malleoli) not penetrating to tendon, periosteum or bone, and with a cross-sectional area between 25 and 2500 mm(2). INTERVENTIONS: Participants were randomised 1:1:1 to treatment with one of N-A (a non-adherent, knitted, viscose filament gauze), Inadine (an iodine-impregnated dressing), both traditional dressings, or Aquacel, a newer product. MAIN OUTCOME MEASURES: The primary outcome measure was the number of ulcers healed in each group at week 24. Secondary measures included time to healing, new ulcerations, major and minor amputations, and episodes of secondary infection. RESULTS: A total of 317 patients were randomised. After 88 withdrawals, 229 remained evaluable. A greater proportion of smaller (25-100 mm(2) ulcers healed within the specified time (48.3% versus 37.3%; p = 0.048). There was, however, no difference between the three dressings in terms of percentage healed by 24 weeks, or in the mean time to healing, whether analysed on the basis of intention to treat (Inadine 44.4%, N-A 38.7%, Aquacel 44.7%; not significant) or per protocol (Inadine 55.2%, N-A 59.4%, Aquacel 63.0%; not significant). There was no difference in the quality of healing, as reflected in the incidence of recurrence within 12 weeks. Likewise, there was no difference in the incidence of adverse events, although a greater proportion of those randomised to the non-adherent dressings were withdrawn from the study (34.9% versus 29.1% Aquacel and 19.4% Inadine; p = 0.038). The only statistically significant difference found in the health economic analysis was the cost associated with the provision of dressings (mean cost per patient: N-A 14.85 pounds, Inadine 17.48 pounds, Aquacel 43.60 pounds). The higher cost of Aquacel was not offset by the fewer dressings required. There was no difference in measures of either generic or condition-specific measures of quality of life. However, there was a significant difference in the change in pain associated with dressing changes between the first and second visits, with least pain reported by those receiving non-adherent dressings (p = 0.012). There was no difference in the costs of professional time, and this may relate to the number of dressing changes undertaken by non-professionals. Fifty-one per cent of all participants had at least one dressing change undertaken by themselves or a non-professional carer, although this ranged from 22% to 82% between the different centres. CONCLUSIONS: As there was no difference in effectiveness, there is no reason why the least costly of the three dressings could not be used more widely across the UK National Health Service, thus generating potentially substantial savings. The option of involving patients and non-professional carers in changing dressings needs to be assessed more formally and could be associated with further significant reductions in health-care costs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78366977.