A core domain set for pyoderma gangrenosum trial outcomes: an international eDelphi and consensus study from the UPGRADE initiative.

BACKGROUND: Pyoderma gangrenosum (PG) is a rare ulcerative skin condition with no current standardized outcomes or outcome measures. With a rich investigational therapeutic pipeline, standardization of outcomes and improvement of data quality and interpretability will promote the appropriate and consistent evaluation of potential new therapies. Core outcome sets (COS) are agreed, standardized sets of outcomes that represent the minimum that should be measured and reported in all clinical trials of a specific condition. OBJECTIVES: To identify and reach a consensus on which domains (what to be measured) should be included in the Understanding Pyoderma Gangrenosum: Review and Analysis of Disease Effects (UPGRADE) core domain set for clinical trials in PG. METHODS: Collaborative discussions between patients and PG experts, and a systematic review of the literature identified items and prospective domains. A three-round international eDelphi exercise was performed to prioritize the domains and refine the provisional items (consensus: ≥ 70% of participants rating a domain as 'extremely important' and < 15% of participants voting 'not important'), followed by an international meeting to reach consensus on the core domain set (consensus: < 30% disagreement). Item-generation discussions and consensus meetings were hosted via online videoconferences. The eDelphi exercise and consensus voting were performed using Qualtrics survey software. Participants were adults with PG, healthcare professionals, researchers and industry representatives. RESULTS: Collaborative discussions and systematic reviews yielded 115 items, which were distilled into 15 prospective domains. The eDelphi exercise removed the three lowest-priority domains ('laboratory tests', 'treatment costs' and 'disease impact on family') and ranked 'pain', 'quality of life' and 'physical symptoms' as the highest-priority prospective domains. Consensus was reached on the domains of 'pain', 'quality of life' and 'clinical signs'. The domain of 'disease course/disease progression' narrowly failed to reach consensus for inclusion in the core set (32% of participants voted 'no'). Refinement of this domain definition will be required and presented for consideration at future consensus meetings. CONCLUSIONS: The UPGRADE core domain set for clinical trials in PG has been agreed by international multistakeholder consensus. Future work will develop and/or select outcome measurement instruments for these domains to establish a COS.

WHS guidelines for the treatment of pressure ulcers-2023 update.

The major populations at risk for developing pressure ulcers are older adults who have multiple risk factors that increase their vulnerability, people who are critically ill and those with spinal cord injury/disease. The reported prevalence of pressure ulcers in the United States is 2.5 million. However, this estimate is derived from acute care facilities and does not include people who are living at home or in nursing facilities. Despite the implementation of hospital and facility-based preventive measures, the incidence of pressure ulcers has not decreased in decades. In addition to the burden of pain, infection and death, it is estimated that hospital-acquired pressure ulcers cost the health system $26.8 billion annually with over 50% of the cost attributed to treating Stage 3 and 4 pressure injuries. Thus, it is critical to examine the literature and develop guidelines that will improve the outcomes of this complex and costly condition. This guideline update is a compendium of the best available evidence for the treatment of Pressure Ulcers published since the last update in 2015 and includes a new section based on changing demographics entitled 'Palliative wound care for seriously ill patients with pressure ulcers'. The overall goal of the Wound Healing Society Guideline project is to present clear, concise and commercial free guidelines that clinicians can use to guide care, that researchers can use to develop studies that will improve treatment and that both clinicians and researchers can use to understand the gaps in our knowledge base.

Surgical Reconstruction of Stage 3 and 4 Pressure Injuries: A Literature Review and Proposed Algorithm from an Interprofessional Working Group.

OBJECTIVE: Stage 3 and 4 pressure injuries (PIs) present an enormous societal burden with no clearly defined interventions for surgical reconstruction. The authors sought to assess, via literature review and a reflection/evaluation of their own clinical practice experience (where applicable), the current limitations to the surgical intervention of stage 3 or 4 PIs and propose an algorithm for surgical reconstruction. METHODS: An interprofessional working group convened to review and assess the scientific literature and propose an algorithm for clinical practice. Data compiled from the literature and a comparison of institutional management were used to develop an algorithm for the surgical reconstruction of stage 3 and 4 PIs with adjunctive use of negative-pressure wound therapy and bioscaffolds. RESULTS: Surgical reconstruction of PI has relatively high complication rates. The use of negative-pressure wound therapy as adjunctive therapy is beneficial and widespread, leading to reduced dressing change frequency. The evidence for the use of bioscaffolds both in standard wound care and as an adjunct to surgical reconstruction of PI is limited. The proposed algorithm aims to reduce complications typically seen with this patient cohort and improve patient outcomes from surgical intervention. CONCLUSIONS: The working group has proposed a surgical algorithm for stage 3 and 4 PI reconstruction. The algorithm will be validated and refined through additional clinical research.

Chronic wounds: Treatment consensus.

The Wound Healing Foundation (WHF) recognised a need for an unbiased consensus on the best treatment of chronic wounds. A panel of 13 experts were invited to a virtual meeting which took place on 27 March 2021. The proceedings were organised in the sub-sections diagnosis, debridement, infection control, dressings, grafting, pain management, oxygen treatment, outcomes and future needs. Eighty percent or better concurrence among the panellists was considered a consensus. A large number of critical questions were discussed and agreed upon. Important takeaways included that wound care needs to be simplified to a point that it can be delivered by the patient or the patient's family. Another one was that telemonitoring, which has proved very useful during the COVID-19 pandemic, can help reduce the frequency of interventions by a visiting nurse or a wound care center. Defining patient expectations is critical to designing a successful treatment. Patient outcomes might include wound specific outcomes such as time to heal, wound size reduction, as well as improvement in quality of life. For those patients with expectations of healing, an aggressive approach to achieve that goal is recommended. When healing is not an expectation, such as in patients receiving palliative wound care, outcomes might include pain reduction, exudate management, odour management and/or other quality of life benefits to wound care.

'I'll put up with things for a long time before I need to call anybody': Face work, the Total Institution and the perpetuation of care inequalities.

Failures in fundamental care (e.g. nutrition or pain-relief) for hospitalised patients can have serious consequences, including avoidable deaths. Policy rhetoric of 'shared decision-making' fails to consider how structural constraints and power dynamics limit patient agency in nursing staff-patient interactions. Goffman's concepts of face work, the presentation of self and the Total Institution shaped our analysis of interview and focus group data from hospital patients. Patients avoided threatening 'good' patient and staff face by only requesting missed care when staff face was convincing as 'caring' and 'available' ('engaged'). Patients did not request care from 'distracted' staff ('caring' but not 'available'), whilst patient requests were ignored in Total Institution-like 'dismissive' interactions. This meant patients experienced missed care with both 'distracted' and 'dismissive' staff. Patients with higher support needs were less able to carry out their own missed care to protect staff face, so experienced more serious care omissions. These findings show that many elements of the Total Institution survive in modern healthcare settings despite attempts to support individualised care. Unless nursing staff can maintain face as 'engaged' (despite organisational constraints that can reduce their capacity to do so) patient participation in care decisions will remain at the level of rhetoric.

Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft.

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single-blinded, multi-centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub-studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P = .0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P = .009), decreased time to healing (54 days vs 64 days; P = .009), and improved local neuropathy (118% vs 11%; P = .028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub-studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non-healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.

Nanomedicine in Healing Chronic Wounds: Opportunities and Challenges.

The poor healing associated with chronic wounds affects millions of people worldwide through high mortality rates and associated costs. Chronic wounds present three main problems: First, the absence of a suitable environment to facilitate cell migration, proliferation, and angiogenesis; second, bacterial infection; and third, unbalanced and prolonged inflammation. Unfortunately, current therapeutic approaches have not been able to overcome these main issues and, therefore, have limited clinical success. Over the past decade, incorporating the unique advantages of nanomedicine into wound healing approaches has yielded promising outcomes. Nanomedicine is capable of stimulating various cellular and molecular mechanisms involved in the wound microenvironment via antibacterial, anti-inflammatory, and angiogenetic effects, potentially reversing the wound microenvironment from nonhealing to healing. This review briefly discusses wound healing mechanisms and pathophysiology and then highlights recent findings regarding the opportunities and challenges of using nanomedicine in chronic wound management.

Restoring Endogenous Repair Mechanisms to Heal Chronic Wounds with a Multifunctional Wound Dressing.

Current treatment of chronic wounds has been critically limited by various factors, including bacterial infection, biofilm formation, impaired angiogenesis, and prolonged inflammation. Addressing these challenges, we developed a multifunctional wound dressing-based three-pronged approach for accelerating wound healing. The multifunctional wound dressing, composed of nanofibers, functional nanoparticles, natural biopolymers, and selected protein and peptide, can target multiple endogenous repair mechanisms and represents a promising alternative to current wound healing products.

Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 3: The Patient Survey.

The 2006 U.S. Food and Drug Administration Guidance for Industry emphasizes wound closure as the primary outcome for clinical trials in wound healing. Wound care professionals understand that complete wound healing is not always achievable when evaluating new treatments. FDA, Association for the Advancement of Wound Care, and Wound Healing Society are working collaboratively to identify scientifically achievable, clinically relevant, and patient-centered endpoints with sufficient support to serve as primary outcomes for clinical trials. The Opinion Survey from People with Wounds presented here addresses an important but understudied issue: the gap between clinician, healthcare insurance companies, government agencies, and patient perspectives regarding clinically meaningful and scientifically achievable primary endpoints for wound care. The survey, adapted from the clinician survey with adjustment for health literacy, was pilot tested and revised based on a limited number of patients in a single clinic. After central IRB approval, the on-line survey was administered in English and Spanish and submitted anonymously to a server with the cooperation of multiple wound clinics and societies. Four hundred and thirty-eight patients and caregivers from across the United States responded over a 10-month period. Based on this survey, the most valuable clinical endpoints were reduced infection, recurrence, and amputation. The most valuable quality of life outcomes were increased independence, reduced social isolation, and pain. The top five endpoints in terms of usefulness for measuring clinical trial success were time to heal, wound size, infection, recurrence, and pain. Narrative responses from wound patients emphasized the inability to perform activities of daily living and pain as major factors that impacted their daily lives. Engagement of patients in clinical trials and evaluation of potential treatments is critical to improving wound care. This survey provides insight into the needs of patients with wounds and provides a roadmap for structuring future clinical trials to better meet those needs.

Lemur catta in small forest fragments: Which variables best predict population viability?

Habitat fragmentation is an increasingly serious issue affecting primates in most regions where they are found today. Populations of Lemur catta (ring-tailed lemur) in Madagascar's south-central region are increasingly restricted to small, isolated forest fragments, surrounded by grasslands or small-scale agriculture. Our aim was to evaluate the potential for population viability of L. catta in nine forest fragments of varying sizes (2-46 ha, population range: 6-210 animals) in south-central Madagascar, using a set of comparative, quantitative ecological measures. We used Poisson regression models with a log link function to examine the effects of fragment size, within-fragment food availability, and abundance of matrix resources (food and water sources) on L. catta population sizes and juvenile recruitment. We found a strong association between overall population size and (a) fragment size and (b) abundance of key food resources Melia azedarach and Ficus spp. (per 100 m along transect lines). Juvenile recruitment was also associated with fragment size and abundance of the two above-mentioned food resources. When the largest population, an outlier, was removed from the analysis, again, the model containing fragment size and abundance of M. azedarach and Ficus spp. was the best fitting, but the model that best predicted juvenile recruitment contained only fragment size. While our results are useful for predicting population presence and possible persistence in these fragments, both the potential for male dispersal and the extent of human disturbance within most fragments play crucial roles regarding the likelihood of long-term L. catta survival. While seven of the nine fragments were reasonably protected from human disturbance, only three offered the strong potential for male dispersal, thus the long-term viability of many of these populations is highly uncertain.

Defining complete wound closure: Closing the gap in clinical trials and practice.

We investigate how wound closure is determined in recent randomized controlled wound trials and real-world studies, identify solutions to the current limitations of wound assessment, and propose a standard methodology to define and assess wound healing in research. We searched PubMed for randomized clinical trials using the terms "complete wound closure" and "wound healing rate" and for real-world studies using the terms "real-world wound healing," "real-world wound data," and "wound registries" dating from March 2010 through March 2018. We selected studies that had "complete wound closure" or "healed wound" as an endpoint. Sixty-five trial articles and 10 real-world articles met our criteria, from which we extracted the wound type studied, definition of healed wound used, wound assessment method, the number of weeks assessed, the number of wounds, and the percent of healed wounds in the study group(s) and control group. There were 7,194 trial wounds included. The most common definition of healing used by 26 studies (40.6%) was complete/full/100% (re)epithelialization or closure without discharge, drainage/scab, and/or dressing. Fifty-two studies (81.2%) used blinded wound assessment, and at least 10 studies (15.6%) used blinded adjudication. The real-world studies analyzed more than 901,396 wounds. Only three studies (33.3%) defined a healed/closed wound, two of which used "complete epithelialization." Eight studies (88.9%) did not define the wound assessment method; none indicated a blinded assessment. We support the Food and Drug Administration definition: 100% reepithelialization of the wound surface with no discernable exudate and without drainage or dressing, confirmed at two visits 2 weeks apart, and we recommend blinded adjudication for wound assessment. The widespread adoption of a standard wound healing definition and assessment method in wound care research would allow for stronger comparisons of treatment effects across studies to improve the evidence base and strengthen the treatment decision-making process in clinical practice.

Pressure ulcer summit 2018: An interdisciplinary approach to improve our understanding of the risk of pressure-induced tissue damage.

Pressure ulcers (PrUs) affect approximately 2.5 million patients and account for 60,000 deaths annually. They are associated with an additional annual cost of $43,000 per related hospital stay and a total cost to the US health care system as high as $25 billion. Despite the implementation of national and international PrU prevention guidelines and toolkits, rates of facility-acquired PrU s and PrUs in people with spinal cord injury are still high. A new paradigm is needed that distinguishes between prevention and treatment research methods and includes not only the causative factors of pressure and tissue deformation but also patient-specific anatomical differences and the concomitant biological cellular processes, including reperfusion injury, toxic metabolites, ischemia, cell distortion, impaired lymphatic drainage, and impaired interstitial fluid flow that compound existing tissue damage. The purpose of this article is to summarize the highlights from the first annual Pressure Ulcer Summit held February 9-10, 2018 in Atlanta, Georgia (sponsored by the Association for the Advancement of Wound Care in partnership with multiple professional organizations). This international, interdisciplinary summit brought together key stakeholders in wound care and PrU prevention and management to highlight advances in pathophysiology of pressure-induced tissue damage; explore challenges in current terminologies, documentation, and data collection; describe innovations in clinical care; and identify research opportunities to advance the science of PrU prevention and management.

Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 2. Literature survey.

Patients with wounds bear significant clinical, personal, and economic burdens yet complete wound healing is the only United States Food and Drug Administration (FDA) recognized primary clinical trial end point. The overall goal of this project is to work with FDA to expand the list of acceptable primary end points, recognizing that new and innovative treatments, devices, and drugs may not have complete healing as the focus. Part 1 of the project surveyed 628 wound care experts who identified and content-validated 15 end points most relevant to clinical practice and benefitting patients' lives as primary outcomes in clinical trials. Part 2 is focused on critical appraisal of the evidence in the wound care literature supporting FDA criteria to qualify these 15 end points as primary end points in clinical trials. Further research involved systematic review of the literature regarding the most promising end points. Forty volunteer, interdisciplinary, wound healing experts in fields related to the end points compiled evidence from systematic MEDLINE searches and society databases supporting the FDA criteria of reliability, clinical construct validity, capacity to detect concurrent or longitudinal change, and responder analysis. The search revealed 485 references involving over 462,000 subjects supporting FDA-required parameters for all 15 end points More than 50 references supported FDA-required parameters qualifying the following outcomes for use in clinical trials supporting interventions for FDA clearance: Pain reduction, Physical function and ambulation, Infection reduction, Time to heal, and Percent wound area reduction in 4-8 weeks. Among these, only Time to heal is currently recognized by the FDA as a primary wound outcome in clinical trials. These results suggest that wound science is already serving patients and professionals by improving these content-validated outcomes that merit regulatory consideration.

Effects of osteoarthritis on age-at-death estimates from the human pelvis.

OBJECTIVES: This study examined the degree of error in age-at-death estimates when osteoarthritis (OA) is present in three separate pelvic joint areas: (1) the pubic symphysis, (2) the auricular surface, and (3) the acetabulum from a modern known-age European cemetery sample of adults. MATERIALS AND METHODS: Age-at-death ranged from 17 to 79 years (x̄ =50.9 years; n = 252). OA in the pelvic joints was evaluated using standard ranked categorical scoring. Composite OA scores were derived through principal component analysis. Blind age assessments and all analyses were performed separately by region. Error between adult age groups (young, middle, old) and between OA severity groups (low, middle, high) was evaluated using one-way ANOVAs with post-hoc testing, ordinary least squares regression, and transition analysis with a cumulative probit model. Ages-at-transition were compared with Nphases2. RESULTS: Three significant results emerge. First, OA severity has an effect on the accuracy of age estimates from os coxa joints in this sample. Second, this influence is most significant for different age cohorts in each joint region, demonstrating that varied rates of arthritic trait progression occur between the auricular surface, pubic symphyses, and acetabulum. Third, those with OA appear to be aging faster, a consistent trend among the os coxa regions. CONCLUSIONS: These results have significant consequences for understanding the rate of bone remodeling in relation to disease, aging, and the evaluation of skeletal age indicators.

A comparison of the clinical effectiveness and cost of specialised individually delivered parent training for preschool attention-deficit/hyperactivity disorder and a generic, group-based programme: a multi-centre, randomised controlled trial of the New Forest Parenting Programme versus Incredible Years.

The objective of this study is to compare the efficacy and cost of specialised individually delivered parent training (PT) for preschool children with attention-deficit/hyperactivity disorder (ADHD) against generic group-based PT and treatment as usual (TAU). This is a multi-centre three-arm, parallel group randomised controlled trial conducted in National Health Service Trusts. The participants included in this study were preschool children (33-54 months) fulfilling ADHD research diagnostic criteria. New Forest Parenting Programme (NFPP)-12-week individual, home-delivered ADHD PT programme; Incredible Years (IY)-12-week group-based, PT programme initially designed for children with behaviour problems were the interventions. Primary outcome-Parent ratings of child's ADHD symptoms (Swanson, Nolan & Pelham Questionnaire-SNAP-IV). Secondary outcomes-teacher ratings (SNAP-IV) and direct observations of ADHD symptoms and parent/teacher ratings of conduct problems. NFPP, IY and TAU outcomes were measured at baseline (T1) and post treatment (T2). NFPP and IY outcomes only were measured 6 months post treatment (T3). Researchers, but not therapists or parents, were blind to treatment allocation. Analysis employed mixed effect regression models (multiple imputations). Intervention and other costs were estimated using standardized approaches. NFPP and IY did not differ on parent-rated SNAP-IV, ADHD combined symptoms [mean difference - 0.009 95% CI (- 0.191, 0.173), p = 0.921] or any other measure. Small, non-significant, benefits of NFPP over TAU were seen for parent-rated SNAP-IV, ADHD combined symptoms [- 0.189 95% CI (- 0.380, 0.003), p = 0.053]. NFPP significantly reduced parent-rated conduct problems compared to TAU across scales (p values < 0.05). No significant benefits of IY over TAU were seen for parent-rated SNAP, ADHD symptoms [- 0.16 95% CI (- 0.37, 0.04), p = 0.121] or parent-rated conduct problems (p > 0.05). The cost per family of providing NFPP in the trial was significantly lower than IY (£1591 versus £2103). Although, there were no differences between NFPP and IY with regards clinical effectiveness, individually delivered NFPP cost less. However, this difference may be reduced when implemented in routine clinical practice. Clinical decisions should take into account parental preferences between delivery approaches.

Restating the Case for a Sharp Population Decline in Lemur catta.

As with many other species in the primate order, ring-tailed lemurs (Lemur catta) are threatened with extinction. Our articles documented declines in wild ring-tailed lemur populations and noted that fewer than 2,500 wild ring-tailed lemurs are known to persist in 32 [Gould and Sauther: Primate Conservation 2016; 30: 89-101] and 34 [LaFleur et al.: Folia Primatologica 2017; 87: 320-330] sites. A criticism of our articles [Murphy et al.: International Journal of Primatology 2017; 38: 623-628] suggested that we have inadequately sampled ring-tailed lemur populations and habitats, and misused the literature. We disagree, and provide both a detailed rebuttal and responses to specific critique points herein. Moreover, we restate our case outlining a dramatic decline of ring-tailed lemurs resulting from anthropogenic pressures (deforestation, severe habitat fragmentation, extraction for the pet and bushmeat trades). We pose several thought-provoking questions as to when is the appropriate time for researchers to "sound the alarm" about a species' decline, and remain committed to understanding the drivers of unsustainable exploitation of this emblematic lemur, and preventing their extinction in the wild.

Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.

Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory evaluation.

Principal component analysis in the evaluation of osteoarthritis.

OBJECTIVES: The purpose of this study is to demonstrate advantages of principal component analysis (PCA) as a standardized procedure in the evaluation of osteoarthritis (OA) in a skeletal series to: (1) compute aggregate scores for joint complexes that accurately capture pathological expression, (2) reveal which variables describe the most sample variation in OA, (3) enable inter- and intra-sample comparison of results, and (4) formulate predictive models from component-based arthritic scores. MATERIALS AND METHODS: The sample (144 males, 145 females) is drawn from a large skeletal cemetery collection of modern Europeans of known sex, age, and occupation. OA data was collected using standard ranked categorical scoring. PCA was conducted separately on lumbar spine, pelvis, and knee regions to generate composite OA scores from eigenequations of the first and second principal components (PC). RESULTS: Results demonstrate that as severity in OA increases, so does the distribution of OA within the joint surface. In each region, PCA produced the same general pattern with eburnation scoring driving significant changes in composite OA scores, representing earlier to later stages of cartilage degeneration. The distribution of arthritic traits determined by PCA produced an OA score that quantifies the expression of joint changes in varied biological joint structures from most moveable to least mobile, the final stage being joint fusion. OA scores are most highly variable in the lumbar region for both males and females, as compared to the pelvis and knee. CONCLUSIONS: PCA is a simple, non-parametric method of extracting relevant information from complex OA datasets and summarizes variation based on correlated multi-attributes to reveal a simplified structure of OA expression. Multivariate techniques like PCA should be used to describe discrete OA samples, and are useful to compute population-specific representative measurements for idiopathic joint OA in a skeletal sample.

Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research.

The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long-term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research.