Compression for preventing recurrence of venous ulcers.

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. Most leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or damaged valves. Venous ulcer prevention and treatment typically involves the application of compression bandages/stockings to improve venous return and thus reduce pressure in the legs. Other treatment options involve removing or repairing veins. Most venous ulcers heal with compression therapy, but ulcer recurrence is common. For this reason, clinical guidelines recommend that people continue with compression treatment after their ulcer has healed. This is an update of a Cochrane review first published in 2000 and last updated in 2014. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) for preventing recurrence of venous leg ulcers. SEARCH METHODS: In August 2023, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, three other databases, and two ongoing trials registries. We also scanned the reference lists of included studies and relevant reviews and health technology reports. There were no restrictions on language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected studies, assessed risk of bias, and extracted data. Our primary outcome was reulceration (ulcer recurrence anywhere on the treated leg). Our secondary outcomes included duration of reulceration episodes, proportion of follow-up without ulcers, ulceration on the contralateral leg, noncompliance with compression therapy, comfort, and adverse effects. We assessed the certainty of evidence using GRADE methodology. MAIN RESULTS: We included eight studies (1995 participants), which were published between 1995 and 2019. The median study sample size was 249 participants. The studies evaluated different classes of compression (UK class 2 or 3 and European (EU) class 1, 2, or 3). Duration of follow-up ranged from six months to 10 years. We downgraded the certainty of the evidence for risk of bias (lack of blinding), imprecision, and indirectness. EU class 3 compression stockings may reduce reulceration compared with no compression over six months (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.76; 1 study, 153 participants; low-certainty evidence). EU class 1 compression stockings compared with EU class 2 compression stockings may have little or no effect on reulceration over 12 months (RR 1.70, 95% CI 0.67 to 4.32; 1 study, 99 participants; low-certainty evidence). There may be little or no difference in rates of noncompliance over 12 months between people using EU class 1 stockings and people using EU class 2 stockings (RR 1.22, 95% CI 0.40 to 3.75; 1 study, 99 participants; low-certainty evidence). UK class 2 hosiery compared with UK class 3 hosiery may be associated with a higher risk of reulceration over 18 months to 10 years (RR 1.55, 95% CI 1.26 to 1.91; 5 studies, 1314 participants; low-certainty evidence). People who use UK class 2 hosiery may be more compliant with compression treatment than people who use UK class 3 hosiery over 18 months to 10 years (RR for noncompliance 0.69, 95% CI 0.49 to 0.99; 5 studies, 1372 participants; low-certainty evidence). There may be little or no difference between Scholl UK class 2 compression stockings and Medi UK class 2 compression stockings in terms of reulceration (RR 0.77, 95% CI 0.47 to 1.28; 1 study, 166 participants; low-certainty evidence) and noncompliance (RR 0.97, 95% CI 0.84.1 to 12; 1 study, 166 participants; low-certainty evidence) over 18 months. No studies compared different lengths of compression (e.g. below-knee versus above-knee), and no studies measured duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. AUTHORS' CONCLUSIONS: Compression with EU class 3 compression stockings may reduce reulceration compared with no compression over six months. Use of EU class 1 compression stockings compared with EU class 2 compression stockings may result in little or no difference in reulceration and noncompliance over 12 months. UK class 3 compression hosiery may reduce reulceration compared with UK class 2 compression hosiery; however, higher compression may lead to lower compliance. There may be little to no difference between Scholl and Medi UK class 2 compression stockings in terms of reulceration and noncompliance. There was no information on duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. More research is needed to investigate acceptable modes of long-term compression therapy for people at risk of recurrent venous ulceration. Future trials should consider interventions to improve compliance with compression treatment, as higher compression may result in lower rates of reulceration.

1/f Noise Mitigation in an Opto-Mechanical Sensor with a Fabry-Pérot Interferometer.

Low-frequency and 1/f noise are common measurement limitations that arise in a variety of physical processes. Mitigation methods for these noises are dependent on their source. Here, we present a method for removing 1/f noise of optical origin using a micro-cavity Fabry-Pérot (FP) interferometer. A mechanical modulation of the FP cavity length was applied to a previously studied opto-mechanical sensor. It effectively mimics an up-conversion of the laser frequency, shifting signals to a region where lower white-noise sources dominate and 1/f noise is not present. Demodulation of this signal shifts the results back to the desired frequency range of observation with the reduced noise floor of the higher frequencies. This method was found to improve sensitivities by nearly two orders of magnitude at 1 Hz and eliminated 1/f noise in the range from 1 Hz to 4 kHz. A mathematical model for low-finesse FP cavities is presented to support these results. This study suggests a relatively simple and efficient method for 1/f noise suppression and improving the device sensitivity of systems with an FP interferometer readout.

Dementia care in the age of COVID-19: Community resources for nurses.

ABSTRACT: The COVID-19 pandemic and related measures, such as social distancing, have adversely impacted persons with dementia (PWD) and their caregivers. Nurses must be able to identify the care needs of PWD and their caregivers and intervene with relevant resources.

Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol).

BACKGROUND: A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. AIM: The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. METHODS: Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control.

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof-of-concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score-matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi-layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow-up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan-Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ2 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.

A Model for Recruiting Clinical Research Participants With Anxiety Disorders in the Absence of Service Provision: Visions, Challenges, and Norms Within a Canadian Context.

High-quality research in clinical psychology often depends on recruiting adequate samples of clinical participants with formally diagnosed difficulties. This challenge is readily met within the context of a large treatment center, but many clinical researchers work in academic settings that do not feature a medical school, hospital connections, or an in-house clinic. This article describes the model we developed at the University of Waterloo Centre for Mental Health Research for identifying and recruiting large samples of people from local communities with diagnosable mental health problems who are willing to participate in research but for whom treatment services are not offered. We compare the diagnostic composition, symptom profile, and demographic characteristics of our participants with treatment-seeking samples recruited from large Canadian and American treatment centers. We conclude that the Anxiety Studies Division model represents a viable and valuable method for recruiting clinical participants from the community for psychopathology research.

Distinguishing the roles of trait and state anxiety on the nature of anxiety-related attentional biases to threat using a free viewing eye movement paradigm.

Although attentional biases to threatening information are thought to contribute to the development and persistence of anxiety disorders, it is not clear whether an attentional bias to threat (ABT) is driven by trait anxiety, state anxiety or an interaction between the two. ABT may also be influenced by "top down" processes of motivation to attend or avoid threat. In the current study, participants high, mid and low in trait anxiety viewed high threat-neutral, mild threat-neutral and positive-neutral image pairs for 5 seconds in both calm and anxious mood states while their eye movements were recorded. State anxiety alone, but not trait anxiety, predicted greater maintenance of attention to high threat images (relative to neutral) following the first fixation (i.e., delayed disengagement) and over the time course. Motivation was associated with the time course of attention as would be expected, such that those motivated to look towards negative images showed the greatest ABT over time, and those highly motivated to look away from negative images showed the greatest avoidance. Interestingly, those ambivalent about where to direct their attention when viewing negative images showed the greatest ABT in the first 500 ms of viewing. Implications for theory and treatment of anxiety disorders, as well as areas for further study, are discussed.

The use of actigraphy to objectively define motion and function before and after shoulder arthroplasty.

Introduction: Actigraphy is a quantitative means of measuring activity data that has proven viable in post-surgery recovery analysis for arthroplasties in lower extremities, but scant literature has been published on the utilization actigraphy to evaluate shoulder motion and function before and after shoulder arthroplasty. The purpose of this prospective cohort study is to identify if actigraphy can serve as a valid means for objective evaluation of shoulder function and motion before and after shoulder arthroplasty. Secondarily, the data collected by the actigraphy can be analyzed with standard patient-reported outcomes to report correlations between the subjective and objective methods used in this study. Materials and methods: Sixty-four subjects wore an actigraphy device for one day at pre-op, six, twelve and twenty-four weeks. In addition, subjects completed three patient-reported outcome surveys at each time-point. Student t-tests were used to compare percent activity preoperatively with 24-weeks and to compare PROs preoperatively with 24-week results; categorical variables were compared with one-way ANOVAs. Results: All Patient reported outcome scores significantly improved following arthroplasty (p-value<0.001). The percent of physical activity was highly correlated with vector magnitude (p-value<0.001), but neither percent activity or the vector magnitude were correlated with any of the PROs: UCLA Pain p-value = 0.656, SANE p-value = 0.328, UCLA Function p-value = 0.532. Conclusions: Actigraphy results from this study mirror findings in previous literature utilizing the technology in similar manners and demonstrate its potential for motion and function analysis before and after total shoulder arthroplasties. Despite both being suitable methods independently for the evaluation of shoulder function, there was no significant correlation between standard actigraphy measurements and PROs at 24-weeks. Future research to determine clinical utility and an overall broader scope for actigraphy monitoring could benefit from improved technology, such as increased battery life for prolonged durations of data collection during observation periods.

Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instrument.

BACKGROUND: Patient-reported outcome (PRO) data are integral to patient care, policy decision making and healthcare delivery. PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes. Further, there are no pressure ulcer PRO instruments available. METHODS: We used gold-standard methods to develop and evaluate a new PRO instrument for people with pressure ulcers (the PU-QOL instrument). Firstly a conceptual framework was developed forming the basis of PU-QOL scales. Next an exhaustive item pool was used to produce a draft instrument that was pretested using mixed methods (cognitive interviews and Rasch Measurement Theory). Finally, we undertook psychometric evaluation in two parts. This first part was item reduction, using PU-QOL data from 227 patients. The second part was reliability and validity evaluation of the item-reduced version using both Traditional and Rasch methods, on PU-QOL data from 229 patients. RESULTS: The final PU-QOL contains 10 scales for measuring symptoms, physical functioning, psychological well-being and social participation specific to pressure ulcers. It is intended for administration and patients rate the amount of "bother" attributed during the past week on a 3-point response scale. Scale scores are generated by summing items, with lower scores indicating better outcome. The PU-QOL instrument was found to be acceptable, reliable (Cronbach's alpha values ranging 0.89-0.97) and valid (hypothesised correlations between PU-QOL and SF-12 scores (r>0.30) and PU-QOL scales and sociodemographic variables (r<0.30) were consistent with predictions). CONCLUSIONS: The PU-QOL instrument provides a standardised method for assessing PROs, reflecting the domains in a pressure ulcer-specific conceptual framework. It is intended for evaluating patient orientated differences between interventions and in particular the impact from the perspective of patients.

Exploring support, experiences and needs of older women and health professionals to inform a self-management package for urinary incontinence: a qualitative study.

OBJECTIVES: Many women attempt to manage urinary incontinence (UI) independently with variable success while health professionals may be unaware of their needs. This study aimed to (1) understand older women's experiences of UI, their self-management strategies and support needs; (2) explore health professionals' experiences of supporting women and providing relevant services and (3) combine their experiences contribute to development of a theory-based and evidence-based self-management package for UI. DESIGN: Qualitative semi-structured interviews were conducted with 11 older women with UI and 11 specialist health professionals. Data were analysed independently using the framework approach, then synthesised in a triangulation matrix to identify implications for content and delivery of the self-management package. SETTING: Community centres, community continence clinic and urogynaecology centre of a local teaching hospital in northern England. PARTICIPANTS: Women aged 55 years and over who self-reported symptoms of UI and health professionals delivering UI services. RESULTS: Three overarching themes emerged. Older women see UI as a 'fact of life' but many struggle with it: women typically considered UI as part of ageing yet expressed annoyance, distress, embarrassment and had made significant lifestyle changes. Access to information and limited high-quality professional support: health professionals provided specialist UI care and information. Yet less than half of women accessed specialist services, those who had, highly valued these services. 'Trial and error' with different self-management strategies: women had tried or were using different strategies (continence pads, pelvic floor exercises, bladder management and training, fluid management and medication), with mixed success. Health professionals provided evidence-based, personalised support and motivation. CONCLUSIONS: Findings informed the content of the self-management package that focused on providing facts, acknowledging challenges of living with/self-managing UI, sharing others' experiences, using motivational strategies and self-management tools. Delivery preferences were independent use by women or working through the package with a health professional.

Structural Evolution of Ultrathin SrFeO3-δ Films during Oxygen Evolution Reaction Revealed by In Situ Electrochemical Stress Measurements.

We report the electrochemical stress analysis of SrFeO3-δ (SFO) films deposited on Au substrates during oxygen evolution reactions (OERs). Our in situ analysis of Au reveals conversion reactions from Au to Au(OH)3, AuOOH, and AuOx during the OER. Au reactions cause a monotonic compressive stress on surfaces assigned to the formation of Au hydroxides and oxides. Electrochemical stress analysis of SrFeO3-δ/Au shows a dramatically different behavior during the OER, which we attribute to structural evolutions and conversion reactions, such as the conversion of SFO to iron (oxy)hydroxides. Interestingly, electrochemical stress analysis of SrFeO3-δ/Au shows a tensile trend, which evolves with cycling history. Electrochemical stress analysis of SFO films before the onset of the OER shows in situ changes, which cause tensile stresses when cycling to 1.2 V. We attribute these stresses to the formation of Fe2+δOδ(OH)2-δ (0 ≤ δ ≤ 1.5)-type materials where δ approaches 1.5 at higher potentials. At potentials higher than 1.2 V and during OER, surface stress response is rather stable, which we assign to the full conversion of SFO to iron (oxy)hydroxides. This analysis provides insight into the reaction mechanism and details of in situ structural changes of iron perovskites during the OER in alkaline environments.

The effects of trait and state anxiety on attention to emotional images: an eye-tracking study.

Attentional biases for threatening stimuli have been implicated in the development of anxiety disorders. However, little is known about the relative influences of trait and state anxiety on attentional biases. This study examined the effects of trait and state anxiety on attention to emotional images. Low, mid, and high trait anxious participants completed two trial blocks of an eye-tracking task. Participants viewed image pairs consisting of one emotional (threatening or positive) and one neutral image while their eye movements were recorded. Between trial blocks, participants underwent an anxiety induction. Primary analyses examined the effects of trait and state anxiety on the proportion of viewing time on emotional versus neutral images. State anxiety was associated with increased attention to threatening images for participants, regardless of trait anxiety. Furthermore, when in a state of anxiety, relative to a baseline condition, durations of initial gaze and average fixation were longer on threat versus neutral images. These findings were specific to the threatening images; no anxiety-related differences in attention were found with the positive images. The implications of these results for future research, models of anxiety-related information processing, and clinical interventions for anxiety are discussed.

Avoidance of mild threat observed in generalized anxiety disorder (GAD) using eye tracking.

Attentional biases towards threat are assumed to be a causal factor in the development of anxiety disorders, including generalized anxiety disorder (GAD). However, findings have been inconsistent, and studies often examine single time-point bias during threat exposure, instead of across time. Attention to threat may shift throughout exposure (e.g., from initial engagement to avoidance), and research suggests that threat intensity and state anxiety influence attentional biases. No studies to our knowledge have examined biases across time and with varying threat intensity and state anxiety. Participants with GAD (n=38) and non-anxious controls (n=25) viewed emotional (high threat, mild threat, and positive) and neutral image pairs under calm and anxious mood states while their eye movements were tracked. Participants showed an initial orientation to emotional images, and, under the anxious mood induction, demonstrated a bias towards threatening images at first fixation and over time. Results suggest it may be normative to attend to threat cues over other stimuli while in an anxious state. Individuals with GAD uniquely showed a bias away from mild (but not high) threat images over time relative to controls. Implications for theories of attentional biases to threat and clinical implications for GAD and anxiety disorders broadly are discussed.

Non-erotic thoughts, attentional focus, and sexual problems in a community sample.

According to Barlow's model of sexual dysfunction, anxiety in sexual situations leads to attentional focus on sexual performance at the expense of erotic cues, which compromises sexual arousal. This negative experience will enhance anxiety in future sexual situations, and non-erotic thoughts (NETs) relevant to performance will receive attentional priority. Previous research with student samples (Purdon & Holdaway, 2006; Purdon & Watson, 2010) has found that people experience many types of NETs in addition to performance-relevant thoughts, and that, consistent with Barlow's model, the frequency of and anxiety evoked by these thoughts is positively associated with sexual problems. Extending this previous work, the current study found that, in a community sample of women (N = 81) and men (N = 72) in long-term relationships, women were more likely to report body image concerns and external consequences of the sexual activity, while men were more likely to report performance-related concerns. Equally likely among men and women were thoughts about emotional consequences of the sexual activity. Regardless of thought content, experiencing more frequent NETs was associated with more sexual problems in both women and men. Moreover, as per Barlow's model, greater negative affect in anticipation of and during sexual activity predicted greater frequency of NETs and greater anxiety in response to NETs was associated with greater difficulty dismissing the thoughts. However, greater difficulty in refocusing on erotic thoughts during sexual activity uniquely predicted more sexual problems above the frequency and dismissability of NETs. Together, these data support the cognitive interference mechanism implicated by Barlow's causal model of sexual dysfunction and have implications for the treatment of sexual problems.

Systematics of the combtooth blenny clade Omobranchus (Blenniidae: Omobranchini), with notes on early life history stages.

The combtooth blenny (Blenniidae) genus Omobranchus contains small, cryptobenthic fishes common to nearshore habitats throughout the Indo-West Pacific. Recent molecular systematic studies have resolved Omobranchus as monophyletic but little research has been done to resolve species-level relationships. Herein, phylogenetic analyses of one mitochondrial (CO1) and four nuclear (ENC1, myh6, sreb2, and tbr1) genes provide evidence for the monophyly of Omobranchus and support for the elongatus and banditus species group. Sampling of multiple individuals from widespread species (O. ferox, O. punctatus, and O. elongatus) suggested that the Thai-Malay Peninsula is a phylogeographic break that may be a historic barrier to gene flow. Additionally, common meristics and other morphological characters are used to describe an early life history stage of O. ferox and O. punctatus.

CODIFI (Concordance in Diabetic Foot Ulcer Infection): a cross-sectional study of wound swab versus tissue sampling in infected diabetic foot ulcers in England.

OBJECTIVE: To determine the extent of agreement and patterns of disagreement between wound swab and tissue samples in patients with an infected diabetic foot ulcer (DFU). DESIGN: Multicentre, prospective, cross-sectional study. SETTING: Primary and secondary care foot ulcer/diabetic outpatient clinics and hospital wards across England. PARTICIPANTS: Inclusion criteria: consenting patients aged ≥18 years; diabetes mellitus; suspected infected DFU. EXCLUSION CRITERIA: clinically inappropriate to take either sample. INTERVENTIONS: Wound swab obtained using Levine's technique; tissue samples collected using a sterile dermal curette or scalpel. OUTCOME MEASURES: Coprimary: reported presence, and number, of pathogens per sample; prevalence of resistance to antimicrobials among likely pathogens. Secondary: recommended change in antibiotic therapy based on blinded clinical review; adverse events; sampling costs. RESULTS: 400 consenting patients (79% male) from 25 centres.Most prevalent reported pathogens were Staphylococcus aureus (43.8%), Streptococcus (16.7%) and other aerobic Gram-positive cocci (70.6%). At least one potential pathogen was reported from 70.1% of wound swab and 86.1% of tissue samples. Pathogen results differed between sampling methods in 58% of patients, with more pathogens and fewer contaminants reported from tissue specimens.The majority of pathogens were reported significantly more frequently in tissue than wound swab samples (P<0.01), with equal disagreement for S. aureus and Pseudomonas aeruginosa. Blinded clinicians more often recommended a change in antibiotic regimen based on tissue compared with wound swab results (increase of 8.9%, 95% CI 2.65% to 15.3%). Ulcer pain and bleeding occurred more often after tissue collection versus wound swabs (pain: 9.3%, 1.3%; bleeding: 6.8%, 1.5%, respectively). CONCLUSION: Reports of tissue samples more frequently identified pathogens, and less frequently identified non-pathogens compared with wound swab samples. Blinded clinicians more often recommended changes in antibiotic therapy based on tissue compared with wound swab specimens. Further research is needed to determine the effect of the additional information provided by tissue samples. TRIAL REGISTRATION NUMBER: ISRCTN52608451.

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial.

BACKGROUND: PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development of a Category ≥2 pressure ulcer. The current 'gold standard' for the identification of a Category ≥2 pressure ulcer is expert clinical assessment. Due to the appearance of the bed, it is not possible to achieve blinding of the endpoint. This therefore poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including whether patients would agree to photographs; the burden of data collection; the quality of photographs; the completeness of data; and how the use of photographs compares with the current 'gold standard'. This validation sub-study aims to assess and quantify potential bias in the reporting of the trial endpoint. METHODS/DESIGN: Patients will be specifically asked to consent to photographs being taken of their skin sites. Photographs will be taken at first observation or when patients develop a new Category ≥2 pressure ulcer (to assess over-reporting). A 10% random sample of patients will be identified for additional photographs of two skin sites (one torso and one limb) with and without a pressure ulcer (if present) by an independent assessor (to assess the potential for under-reporting). Staff will be trained to take photographs using a standardised camera and photographic technique. A 'grey scale' will be included in the photo to correct white balance. Photographs will be securely transferred for central review. Photographs will have white balance corrected, and the computer monitor will be calibrated prior to review. Analysis will include assessment of under- and over-reporting, acceptability of photography to patients, secure transfer of data, quality of and confidence in blinded photograph review and sensitivity analysis using photograph assessment of primary outcome. DISCUSSION: This study will use photographs to contribute to the primary outcome of the trial. It will inform our understanding of the acceptability of photography for prevention trials and the possibility of other uses of photographic data in clinical work and research. TRIAL REGISTRATION: ISRCTN, ISRCTN01151335 . Registered on 14 May 2013.

Editorial.

Journal of Wound Care awards Lies, damned lies and statistics.