Using a modified Delphi methodology to gain consensus on the use of dressings in chronic wounds management

Objective: Managing chronic wounds is associated with a burden to patients, caregivers, health services and society and there is a lack of clarity regarding the role of dressings in improving outcomes. This study aimed to provide understanding on a range of topics, including: the definition of chronicity in wounds, the burden of illness, clinical outcomes of reducing healing time and the impact of early interventions on clinical and economic outcomes and the role of matrix metalloproteinases (MMPs) in wound healing. Method: A systematic review of the literature was carried out on the role of dressings in diabetic foot ulcer (DFU), and venous leg ulcer (VLU) management strategies, their effectiveness, associated resource use/cost, and quality of life (QoL) impact on patients. From this evidence-base statements were written regarding chronicity in wounds, burden of illness, healing time, and the role of MMPs, early interventions and dressings. A modified Delphi methodology involving two iterations of email questionnaires followed by a face-to-face meeting was used to validate the statements, in order to arrive at a consensus for each. Clinical experts were selected, representing nurses, surgeons, podiatrists, academics, and policy experts. Results: In the first round, 38/47 statements reached or exceeded the consensus threshold of 80% and none were rejected. According to the protocol, any statement not confirmed or rejected had to be modified using the comments from participants and resubmitted. In the second round, 5/9 remaining statements were confirmed and none rejected, leaving 4 to discuss at the meeting. All final statements were confirmed with at least 80% consensus. Conclusion: This modified Delphi panel sought to gain clarity from clinical experts surrounding the use of dressings in the management of chronic wounds. A full consensus statement was developed to help clinicians and policy makers improve the management of patients with these conditions

Self-monitoring of lower leg skin temperature: accuracy of self-reported data and adherence to a cooling protocol for the prevention of venous leg ulcers

Teresa J Kelechi, Mohan Madisetti, Martina Mueller, Mary Dooley, Margaret Prentice College of Nursing, Medical University of South Carolina, Charleston, SC, USA Background: For intervention studies that require the use of participant self-reports, the quality and accuracy of recorded data and variability in participant adherence rates to the treatment can cause significant outcome bias.Purpose: To assess the quality and accuracy of participant documentation of daily self-monitoring of leg skin temperature, adherence to a graduated cooling treatment protocol to prevent venous leg ulcers, and the potential for bias in treatment effect in a randomized controlled trial that included a population with chronic venous disease.Methods: Individuals were randomized to a leg cooling intervention or placebo treatment group to daily self-monitor and record lower leg skin temperature over a 9-month period on monthly paper study logs. Returned study logs for the first 100 completed participants (n=54 cooling intervention, n=46 control) were reviewed for quality and accuracy. Adherence was determined from evaluating the accuracy of participant documentation. To examine potential outcome bias in treatment effect, mean between group and within group comparisons of the before and after treatment differences were conducted using an intention-to-treat (ITT) versus a modified intention-to-treat (mITT) analysis approach with an 85% accuracy cut-off rate. Data were collected in 2011–2014.Results: Of the expected 900 study logs, 91.8% (826/900) were returned and 8.2% (74/900) were not. Non-mutually exclusive main error types in returned documentation included: 59.2% (489/826) white-outs, cross-off and/or overwrites, 34.9% (288/826) entries omitted, 29.4% (243/826) no performance of daily self-monitoring, 28.7% (237/826) no performance of the treatment intervention per the prescribed protocol regime, 26.8% (221/826) extraneous data, 8.6% (71/826) suspected fabrication, and 7.6% (63/826) questionable validity. Under ITT analysis, 38.4% (346/900) of all returned logs were <85% accurate, 25.0% (225/900) were 85%–99% accurate, and 36.6% (329/900) were 100% accurate. Mean overall participant adherence rates were: 22.0% at <85% accuracy, 53.0% at 85%–99% accuracy, and 25.0% at 100% accuracy. Under the mITT analysis, 54.0% (483/900) of returned logs were deemed adherent with ≥85% accuracy. Conclusion: This study found good rates of adherence. Under ITT analysis, 78.0% of participants were deemed adherent to the study protocol with ≥85% accuracy in documenting daily self-monitoring of skin temperatures in response to a topically applied experimental cooling cuff intervention for the prevention of venous leg ulcers. Keywords: self care, lower leg, symptoms, prevention intervention, diary logs, chronic illnes

Exploring the influence of a cooling treatment on quality of life in patients with chronic venous disease

Teresa J Kelechi, Martina Mueller, Mohan Madisetti, Margie A Prentice, Mary J Dooley College of Nursing, Medical University of South Carolina, Charleston, SC, USA Purpose: The study aimed to evaluate the influence of a self-administered cooling intervention on quality of life (QOL) associated with chronic venous disease (CVD), stages clinical, etiological, anatomical, pathophysiological (CEAP) C4 (skin damage) and C5 (healed ulcer). Study design and subjects: A sample of 276 individuals was randomized to receive a cooling (n=138) or placebo control cuff (n=138) applied to the leg skin affected by CVD. Both groups also received standard of care that included compression, leg elevation, and physical activity. QOL was measured with the venous insufficiency epidemiological and economic study (VEINES)-QOL and symptom (Sym) subscale Questionnaire at 5 time points during the 9-month study. Relationships between treatment outcomes and demographics were analyzed. Results: Cooling and control groups had significant increases from baseline in mean change VEINES-QOL scores (13.5 vs 12.8, p<0.0001) and Sym scores (10.4 vs 6.7, p<0.0001). No significant difference was observed for VEINES-QOL between the groups (Δ =0.67, p=0.58); however, the difference was significant for Sym for cooling (Δ =3.7, p=0.015). Overall QOL improvements were significant for females compared to males (p<0.001), not employed full-time (p<0.001), living in rural areas (p<0.002), and less effective for larger calf circumference (p=0.042). For age groups ≥65 years, cooling produced significant improvements in QOL (10.8 vs 4.5, p<0.0004); the control group symptoms worsened during the study (–1.0 vs 8.1, p<0.0001). Conclusion: This cooling intervention improved QOL. The greatest improvements were observed in older individuals, females, those who were married, not working full time, and living in rural areas. CVD remains a poorly controlled chronic condition and has a major negative influence on QOL. Keywords: chronic venous disease, quality of life, cooling therapy, negative symptoms, ­cryotherapy, venous disorder

Sistema especialista para apoiar a decisão na terapia tópica de úlceras venosas

Apesar de o tratamento das úlceras venosas exigir um conjunto de conhecimentos específicos, os enfermeiros não especialistas desconhecem as terapias adequadas, o que constitui uma dificuldade na terapia tópica dessas lesões de pele. Este artigo tem como objetivo apresentar um sistema especialista para apoiar o processo de decisão dos enfermeiros na terapia tópica das úlceras venosas. Trata-se de uma pesquisa de desenvolvimento, operacionalizada em cinco etapas: modelagemdo sistema, aquisição do conhecimento, representação do conhecimento a partir de regras de produção, implementação e avaliação do sistema. O conjunto das regras é apresentado, assim como casos que simulam o comportamento do sistema especialista, mostrando a viabilidade da sua utilização na prática do enfermeiro. O sistema poderá auxiliar na tomada de decisão sobre as condutas tópicas em úlceras venosas, porém, a avaliação da úlcera deve ser realizada de forma correta, a fim de que o sistema forneça sugestões adequadas, permitindo melhor organização e planejamento da assistência