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

Abstract

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.

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network‐based learning healthcare system

“…Larger trials are needed in wound care. Lazarus et al found that among 63 prospective VLU trials, the median number of participants was a trifling 37 . Recent RCTs from our research network show higher enrollment numbers, with more than 80 patients enrolled, but these enrollment numbers make up less than 10% of the number of patients with VLUs in the consortium (Table ).…”

“…The impetus on the part of the FDA to utilize RWD is an opportunity for the wound care community to overcome the barriers that have, until now, prevented the creation of a LHS focused on wound care. We have been caught in a vicious cycle wherein RCTs exclude real‐world patients, with the result being that the evidence base derived from these studies that does not apply to real‐world patients . Consequently, clinicians, patients, and payers are hindered in their decision making, because limited evidence is available to determine the best treatment for a chronic wound .…”

“…We have been caught in a vicious cycle wherein RCTs exclude real‐world patients, with the result being that the evidence base derived from these studies that does not apply to real‐world patients . Consequently, clinicians, patients, and payers are hindered in their decision making, because limited evidence is available to determine the best treatment for a chronic wound . Currently, the most logical way out of this is to use EHRs to facilitate registry participation and generate RWD.…”

“…The creation of a LHS is even more challenging for wound care, because the field is not recognized as a medical specialty (which affects collaboration, advocacy, and policy), and because federal funding for research on the clinical care of patients with chronic wounds is alarmingly insufficient. In the absence of the leadership usually afforded by a medical specialty society, 2 of our authors (TES and CEF) collaborated with 25 wound care experts and representatives of major wound care organizations in September 2015 on a 24‐point action plan to improve clinical research in the area of leg ulcers . Participants in the consensus meeting strongly supported the creation of a clinical research network for wound care.…”

“…In addition, clinical data reuse by documentation at the POC as captured by a purpose‐built EHR, PRO quality measures made available by a wound registry linked to the EHR, and collaborative learning through CER within our research consortium are discussed. Lazarus et al effectively describe the theoretical framework needed to establish a LHS in wound care; herein we present an already operational example for wound care that is both practical and reproducible.…”