Atlantic Healthcare (United Kingdom)

Chronic kidney disease (CKD) is traditionally viewed as a condition marked by a progressive reduction in kidney function leading to the need for kidney dialysis or transplantation. The estimated prevalence of CKD in adults in Puerto Rico is ~20% higher than that of the overall United States (US). To address the disproportionately high rate of CKD in Puerto Rico, we created a multidisciplinary chronic disease management (CDM) program targeting CKD and diabetes mellitus (DM), the leading CKD risk factor. Over 7200 eligible enrollees in a Puerto Rico-Managed Medicare Program participated in a CDM program targeting individuals with CKD or DM as determined by administrative review. Evaluations were conducted on 4068 program participants with baseline glomerular filtration rate (eGFR) and codifying CKD stage by eGFR. A dietitian/nurse team provided dietary and lifestyle recommendations to the patient/family and a nephrologist/endocrinologist made diabetes and CKD recommendations to the primary care provider. Findings on 2095 participants with Stages 1-3 CKD with follow-up eGFR at least 6 months but less than 2 years after baseline are presented. At baseline, the mean age was 74 years (range 30-101), 59% of patients were female and mean duration of follow-up from initial evaluation to second evaluation was 407 days (±159 days SD). Most participants had Stage 2 CKD (34.8%), followed by CKD Stage 1 and 3 (33.5 and 31.7%). During the follow-up period, 55.9% of participants with Stage 1 CKD remained in Stage 1, 84.9% of patients with Stage 2 remained in Stage 2 or regressed to Stage 1, while 96.1% of patients with Stage 3 remained in Stage 3 or regressed to Stage 2. Only 15.1% of patients in Stage 2 progressed to Stage 3 and 3.9% of patients in Stage 3 progressed to Stage 4 or 5. A secondary analysis comparing all 665 CDM Stage 3 participants to 117,249 historical controls found CDM participants demonstrated a higher rate of regression (20.3% vs. 15.2%; absolute difference +5.1 percentage points; p = <0.01) and a lower rate of progression (3.9% vs. 15.3%; absolute difference -11.4 percentage points; p < 0.001). Early findings of a multidisciplinary CDM intervention indicate that 79% of participants with CKD Stages 1-3 by eGFR had stabilized or improved CKD status. Comparison to a randomized control group to better assess for causality and longer-term CDM program follow-up on CKD status and clinical outcomes is warranted.

Fullick, James MBChB, FRCA, BSc(Hons); Fullick, Thomas Ma(Cantab), BSc(Hons), MRSB Author Information

Patient-reported outcomes (PROs) are an emerging paradigm in clinical research and healthcare, aiming to capture the patient's self-assessed health status in order to gauge efficacy of treatment from their perspective. As these patient-generated health data provide insights into the effects of healthcare processes in real-life settings beyond the clinical setting, they can also be viewed as a resolution beyond what can be gleaned directly by the clinician. To this end, patients are identified as a key stakeholder of the healthcare decision making process, instead of passively following their doctor's guidance. As this joint decision-making process requires constant and high-quality communication between the patient and his/her healthcare providers, novel methodologies and tools have been proposed to promote richer and preemptive communication to facilitate earlier recognition of potential complications. To this end, as PROs can be used to quantify the patient impact (especially important for chronic conditions such as cancer), they can play a prominent role in providing patient-centric care. In this paper, we introduce the MyPal platform that aims to support adults suffering from hematologic malignancies, focusing on the technical design and highlighting the respective challenges. MyPal is a Horizon 2020 European project aiming to support palliative care for cancer patients via the electronic PROs (ePROs) paradigm, building upon modern eHealth technologies. To this end, MyPal project evaluate the proposed eHealth intervention via clinical studies and assess its potential impact on the provided palliative care. More specifically, MyPal platform provides specialized applications supporting the regular answering of well-defined and standardized questionnaires, spontaneous symptoms reporting, educational material provision, notifications etc. The presented platform has been validated by end-users and is currently in the phase of pilot testing in a clinical study to evaluate its feasibility and its potential impact on the quality of life of palliative care patients with hematologic malignancies.

Palliative care is offered along with primary treatment to improve the quality of life of the patient by relieving the symptoms and stress of a serious illness such as cancer. As per modern definitions, palliative care is appropriate at any age and at any stage of the illness, regardless of the eventual outcome. Patient-reported outcomes (PRO), i.e., health status measurements reported directly by the patients or their proxies, and especially their availability in electronic form (ePROs), are gradually gaining popularity as building blocks of innovative palliative care interventions. This paper presents MyPal, an EC-funded collaborative research project that aims to exploit advanced eHealth technologies to develop and evaluate two novel ePRO-based general palliative care interventions for cancer patients. In particular, the paper presents: (1) a short overview of MyPal; (2) the target populations, i.e., adults suffering from chronic lymphocytic leukemia (CLL) or myelodysplastic syndromes (MDS), and children with solid or hematologic malignancies; (3) the ePRO-based interventions being designed for the target populations, (4) the eHealth platform for delivering the interventions under development, and (5) the international, multi-center clinical studies to be conducted for assessing these interventions, i.e., a randomized controlled trial (RCT) and an observational study for adults and children, respectively.

The antisense ICAM-1 inhibitor alicaforsen has been studied in four phase 2 studies in ulcerative colitis (UC). Recruited patients varied as to the extent of their colitis and in the severity of disease at entry. To investigate the efficacy of alicaforsen enema in specific UC populations. Efficacy was analysed for short-term (week 6-10) and long-term (week 30) outcomes compared with either placebo or a high-dose mesalazine (mesalamine) enema in patients with disease extent up to 40cm from the anal verge in patients with moderate or severe disease, and in patients with both of these features. Individual patient data meta-analyses of 200 patients from four phase 2 studies evaluating nightly alicaforsen 240mg enema and comparators. Patient data were pooled and analysed in a single data set. Continuous outcomes were evaluated using anova; dichotomous outcomes were evaluated using Pearson chi-square or Fisher's exact tests. Alicaforsen showed superior efficacy vs. placebo in: patients with disease extent up to 40cm, patients with moderate and severe disease and especially when both those conditions were satisfied. In these patient groups, mesalazine also showed short-term efficacy. At week 30, however, the efficacy of mesalazine waned and alicaforsen became significantly more efficacious. This post hoc meta-analysis showed that alicaforsen is effective in patients with active UC, especially in patients with distal disease, which is of moderate/severe activity. The efficacy of alicaforsen was durable in these sub-groups, suggesting a disease-modifying effect. This analysis suggests that alicaforsen enema may offer an effective, potentially durable response in moderate/severe distal active UC.