This study offers proof-of-concept of the feasibility and safety of PRP treatment to inform larger clinical trials in patients with VLUs. Our preliminary results suggest that PRP delivers a safe and effective treatment for VLU care that can be implemented in primary health-care settings.

BackgroundVascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6).DesignWe will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week.DiscussionThe results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care.Trial registrationCurrent Controlled Trials NCT02213952

Purpose: To demonstrate the long term of follow-up of the recurrence rate after conjunctival autograft for pterygium surgery. Methods: A total of 112 patients operated for pterygium with conjunctival autografts and with more than one year follow-up were registered. Patients were called for voluntary examinations of their respective ocular surface statuses. Completing the study was only possible in 44 cases. Seven had bilateral pterygium. (N=51 operated pterygium). Results:The mean follow-up time was 49.06 months. In 29.45% of the cases, attachment was performed using non-absorbable sutures (nylon 10/0), while fibrin glue was used in 70.55% of the cases. Six cases of recurrence (11.76%) were found. The recurrence rate between primary and recurrent pterygium, and between sutures and fibrin glue proved to be not statistically significant; p>0.05. There were no significant differences between women and men with respect to recurrence. The median of age in the recurrence group was 40 years old, in contrast to 55 in the non-recurrence group; p=0.01517. All of these recurrences were associated with patients of Hispanic origins (from Latin America); p=0.001506. Conclusions: After a long follow-up period after autograft pterygium surgery, there were no statistically significant differences in recurrence rates for the application of sutures as opposed to fibrin glue; similarly, there were no statistically significant differences between the use of autograft in primary and recurrent pterygium. The greatest risk factors for recurrence were young age and Hispanic ethnicity.Keywords: Pterigium/surgery; Transplantation, autologous; Conjunctiva/transplantation, Sutures; Fibrin tissue adhesive RESUMO Objetivo: Demonstrar a taxa de recorrência em cirurgia do pterígio com transplante autólogo de conjuntiva após um acompanhamento a longo prazo. Métodos: Cento e doze pacientes operados de pterígio e transplante autólogo de conjuntiva, com mais de um ano de acompanhamento foram registrados. Os pacientes foram chamados para um exame voluntário de estado da superfície ocular. O estudo completo só foi possível em 44 pacientes. Sete deles tinha tido pterígio bilateral. (N=51). Resultados: A média de acompanhamento a partir do momento da cirurgia até o exame foi de 49,06 meses. A sutura não-absorvível (nylon 10/0) foi usada em 29,45% dos casos, enquanto que a cola biológica de fibrina foi usada em 70,55%. A recidiva do pterígio foi detectada apenas em 6 casos (11,76%). As recidivas entre pacientes operados de pterígio primário e recorrente, e entre o uso de suturas ou cola de fibrina não foram significativos (p>0,05). Também não houve diferença significativa na recorrência com relação ao sexo. A idade média no grupo de recidiva foi de 40 anos e no grupo sem recidiva de 55 anos (p=0,01517). Todas essas recorrências ocorreram em pacientes de origem hispânica (América latina) (p=0,001506). Conclusões: A longo prazo da remoção cirúrgica de pterígio utilizando um transplante autólogo de conjuntiva, não há diferença estatisticamente sig...

BackgroundThe optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time.Design/MethodsWe will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance.DiscussionAs well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals.Trial registrationClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.

BackgroundThe lack of proven efficacy of new healthcare interventions represents a problem for health systems globally. It is partly related to suboptimal implementation processes, leading to poor adoption of new interventions. Activation of Stratification Strategies and Results of the interventions on frail patients of Healthcare Services (ASSEHS) EU project (N° 2013 12 04) aims to study current existing health Risk Stratification (RS) strategies and tools on frail elderly patients. This paper aims at identifying variables that make the implementation of population RS tools feasible in different healthcare services.MethodsTwo different methods have been used to identify the key elements in stratification implementation; i) a Scoping Review, in order to search and gather scientific evidence and ii) Semi-structured interviews with six key experts that had been actively involved in the design and/or implementation of RS strategies. It aims to focus the implementation construct on real-life contextual understandings, multi-level perspectives, and cultural influences.ResultsA Feasibility Framework has been drawn. Two dimensions impact the feasibility of RS: (i) Planning, deployment and change management and (ii) Care intervention. The former comprises communication, training and mutual learning, multidisciplinarity of the team, clinicians’ engagement, operational plan and ICT display and functionalities. The latter includes case finding and selection of the target population, pathway definition and quality improvement process.ConclusionsThe Feasibility Framework provides a list of key elements that should be considered for an effective implementation of population risk stratification interventions. It helps to identify, plan and consider relevant elements to ensure a proper RS implementation.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-017-2275-3) contains supplementary material, which is available to authorized users.