Development of a preliminary conceptual model of the patient experience of chronic kidney disease: a targeted literature review and analysis

BackgroundPatient-reported outcome (PRO) instruments should capture the experiences of disease and treatment that patients consider most important in order to inform patient-centred care and product development. The aim of this study was to develop a preliminary conceptual model of patient experience in chronic kidney disease (CKD) based on a targeted literature review and to characterize existing PRO instruments used in CKD.MethodsPubMed, EMBASE and Cochrane databases and recent society meetings were searched for publications reporting signs/symptoms and life impacts of CKD. Concepts identified in the literature review were used to develop a preliminary conceptual model of patient experience of CKD, overall, and within patient subpopulations of differing CKD causes, severities and complications. PRO instruments, identified from PRO databases, CKD literature and CKD clinical trials, were assessed for content validity, psychometric strength and coverage of concepts in the literature review.ResultsIn total, 100 publications met criteria for analysis; 56 signs/symptoms and 37 life impacts of CKD were identified from these sources. The most frequently mentioned signs/symptoms were pain/discomfort (57% of publications) and tiredness/low energy/lethargy/fatigue (42%); the most commonly reported life impacts were anxiety/depression (49%) and decrements in physical functioning (43%). Signs/symptoms and life impacts varied across the subpopulations and were more frequent at advanced CKD stages. The preliminary conceptual model grouped signs/symptoms into seven domains (pain/discomfort; energy/fatigue; sleep-related; gastrointestinal-related; urinary-related; skin-/hair-/nails-related; and other) and life impacts into six domains (psychological/emotional strain; cognitive impairment; dietary habit disruption; physical function decrements; interference with social relationships; and other). Eleven PRO instruments were considered to be promising for use in CKD; all had limitations.ConclusionsAlthough preliminary, the proposed conceptual model highlights key PROs for people with CKD and is intended to spur development of more tailored PRO instruments to assess these concepts

HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol

Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. INTRODUCTION: Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease worldwide and a major cause of premature mortality in diabetes mellitus (DM). While improvements in care have reduced the incidence of kidney disease among those with DM, the increasing prevalence of DM means that the number of patients worldwide with DKD is increasing. Improved understanding of the biology of DKD and identification of novel therapeutic targets may lead to new treatments. A major challenge to progress has been the heterogeneity of the DKD phenotype and renal progression. To investigate the heterogeneity of DKD we have set up The East and North London Diabetes Cohort (HEROIC) Study, a secondary care-based, multiethnic observational study of patients with biopsy-proven DKD. Our primary objective is to identify histological features of DKD associated with kidney endpoints in a cohort of patients diagnosed with type 1 and type 2 DM, proteinuria and kidney impairment. METHODS AND ANALYSIS: HEROIC is a longitudinal observational study that aims to recruit 500 patients with DKD at high-risk of renal and cardiovascular events. Demographic, clinical and laboratory data will be collected and assessed annually for 5 years. Renal biopsy tissue will be collected and archived at recruitment. Blood and urine samples will be collected at baseline and during annual follow-up visits. Measured glomerular filtration rate (GFR), echocardiography, retinal optical coherence tomography angiography and kidney and cardiac MRI will be performed at baseline and twice more during follow-up. The study is 90% powered to detect an association between key histological and imaging parameters and a composite of death, renal replacement therapy or a 30% decline in estimated GFR. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Bloomsbury Research Ethics Committee (REC 18-LO-1921). Any patient identifiable data will be stored on a password-protected National Health Services N3 network with full audit trail. Anonymised imaging data will be stored in a ISO27001-certificated data warehouse.Results will be reported through peer-reviewed manuscripts and conferences and disseminated to participants, patients and the public using web-based and social media engagement tools as well as through public events

Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting

Aim: This study aimed to identify from different stakeholders the benefits and obstacles of implementing precision medicine in diabetic kidney disease (DKD) and to build consensus about a way forward in order to treat, prevent, or even reverse this disease. Methods: As part of an ongoing effort of moving implementation of precision medicine in DKD forward, a two-day consensus-building meeting was organized with different stakeholders involved in drug development and patient care in DKD, including patients, patient representatives, pharmaceutical industry, regulatory agencies representatives, health technology assessors, healthcare professionals, basic scientists, and clinical academic researchers. The meeting consisted of plenary presentations and discussions, and small group break-out sessions. Discussion topics were based on a symposium, focus groups and literature search. Benefits, obstacles and potential solutions toward implementing precision medicine were discussed. Results from the break-out sessions were presented in plenary and formed the basis of a broad consensus discussion to reach final conclusions. Throughout the meeting, participants answered several statement and open-ended questions on their mobile device, using a real-time online survey tool. Answers to the statement questions were analyzed descriptively. Results of the open-ended survey questions, the break-out sessions and the consensus discussion were analyzed qualitatively. Results and conclusion: Seventy-one participants from 26 countries attended the consensus-building meeting in Amsterdam, April 2019. During the opening plenary on the first day, the participants agreed with the statement that precision medicine is the way forward in DKD (n = 57, median 90, IQR [75–100]). Lack of efficient tools for implementation in practice and generating robust data were identified as significant obstacles. The identified benefits, e.g., improvement of the benefit-risk ratio of treatment, offer substantive incentives to find solutions for the identified obstacles. Earlier and increased multi-stakeholder collaboration and specific training may provide solutions to alter clinical and regulatory guidelines that lie at the basis of both obstacles and solutions. At the end of the second day, the opinion of the participants toward precision medicine in DKD was somewhat more nuanced (n = 45, median 83, IQR [70–92]) and they concluded that precision medicine is an important way forward in improving the treatment of patients with DKD

Multiparametric Magnetic Resonance Imaging Allows Non-Invasive Functional and Structural Evaluation of Diabetic Kidney Disease

BackgroundWe sought to develop a novel non-contrast multi-parametric MRI (mpMRI) protocol employing several complementary techniques in a single scan session for a comprehensive functional and structural evaluation of diabetic kidney disease (DKD).MethodsIn the cross-sectional part of this prospective observational study, 38 subjects aged 18‒79 years with type 2 diabetes and DKD (estimated glomerular filtration rate [eGFR] 15‒60 ml/min/1.73 m2), and 20 age- and gender-matched healthy volunteers (HV) underwent mpMRI. Repeat mpMRI was performed in 23 DKD subjects and 10 HV. By measured GFR (mGFR), 2 DKD subjects had GFR stage G2, 16 stage G3, and 20 stage G4/5. A wide range of MRI-biomarkers associated with kidney hemodynamics, oxygenation, and macro/micro-structure were evaluated. Their optimal sensitivity, specificity and repeatability to differentiate diabetic versus healthy kidneys, and categorize various stages of disease as well as their correlation with mGFR/albuminuria was assessed.ResultsSeveral MRI-biomarkers differentiated diabetic from healthy kidneys and distinct GFR stages (G3 versus G4/5); mean arterial flow (MAF) was the strongest predictor (sensitivity = 0.94 and 1.0, specificity = 1.00 and 0.69, p = 0.04 and 0.004, respectively). Parameters significantly correlating with mGFR were specific measures of kidney hemodynamics, oxygenation, microstructure and macrostructure, with MAF being the strongest univariate predictor (r = 0.92, p<0.0001).ConclusionsA comprehensive and repeatable non-contrast mpMRI protocol was developed that as a single, non-invasive tool allows functional and structural assessment of DKD, which has the potential to provide valuable insights into underlying pathophysiology, disease progression and analysis of efficacy/mode of action of therapeutic interventions in DKD

Akutsjukhus, rätt vårdnivå? En studie av ej inlagda prio 3 patienter

Resultat från olika studier av ambulanstransporterade patienter visar ett allt större behov av att kunna selektera patienter utifrån behov av vårdinsats. I nuvarande sjukvårdsorganisation saknas information samt verktyg för att kunna göra denna selektering ur ett patientsäkerhetsperspektiv. Prio 3 är en av ambulanssjukvårdens larmkriterier vilket innebär att patienten misstänks vara akut sjuk men ej vara i behov av omedelbar akutsjukvård. Denna studie beskriver de patienter vilka transporterades in av ambulans som prio 3 uppdrag men som bedömdes inte ha behov av att kvarstanna för vård efter att ha träffat läkare eller annan sjukvårdspersonal på akutmottagning. För att kunna selektera patienter till annan vårdnivå, skulle man hitta dessa i prioriteringsgrupp 3 vad det gäller bedömning samt behandling på akutsjukhus?Studien baseras på en retrospektiv journalgranskning av ambulansjournalsystemet AmbuLink samt patientjournalsystemet MELIOR. Data som analyserats beskriver patienter ur olika aspekter utifrån uppgifter såsom ålder, kön, symptom, bedömning, behandling, tid på dygnet med flera.Resultatet ger en viss hänvisning om symptomdiagnoser vilka skulle kunna ge en fingervisning om olika patientgrupper som skulle kunna få den vård som krävs utan att behöva belasta akutsjukhusets resurser. Nivåer för sådan vård och behandling skulle kunna vara inom kommunsjukvård, primärvård samt framtida ambulanssjukvårdsorganisation. Studien visar även att stora delar av patienterna har behov av att kunna göra utvidgade bedömningar vilka endast kan ges på akutsjukhus. Men med bra bedömningsverktyg, utbildning samt befogenhet skulle ambulanspersonal kunna stå för stora delar av den initiala patientstyrningen

Ambulanssjukvård : Allmänhetens uppfattning och förväntningar

Under senare år har ambulanssjukvården i Sverige genomgått stora förändringar. Kunskaps och kompetensnivån har ökat, framför allt efter 2005, då alla akutambulanser skulle bemannas med minst en sjuksköterska. Denna kunskapsnivå i samband med ett ökat tryck på sjukhusens akutmottagningar skulle kunna ligga till grund för ett förändrat arbetssätt vad det gäller bedömning och prioritering av patient. En möjlighet skulle vara att ambulanssjukvårdpersonal får möjlighet att bedöma vårdnivå hos vissa patientgrupper redan på plats. Syftet med studien var att belysa vad allmänheten har för uppfattning och förväntningar på ambulanssjukvård, samt att få en uppfattning om deras tankar vid eventuell hänvisning till annan vårdnivå samt annat färdsätt än ambulans. Studien genomfördes i enkätform och målgruppen var en yngre och en äldre åldersgrupp (n = 51). Enkäten innefattade slutna frågor med en demografisk del samt frågeformuleringarna om respondenternas uppfattning samt förväntningar av ambulanssjukvård. Enkäten avslutades med en öppen fråga gällande deras inställning till att bli hänvisade till annan vård än sjukhus. Resultatet visade att åldersgruppernas åsikter skilde sig åt på olika punkter. Vad det gäller frågan om hänvisning så svarade övervägande del yngre att de kunde tänka sig att bli hänvisade till annan vårdinstans än sjukhus, medan så inte var fallet i kategorin äldre. De flesta ansåg att ambulanspersonalen kunde göra en första kvalificerad insats redan på plats. Trots att man visat förtroende för ambulanspersonalen infinner sig en tveksamhet när det gäller att bli ifrågasatt. Denna undersökning visar att behovet av information om vad ambulanssjukvård är till för är stort och eftersatt.Program: Fristående kursUppsatsnivå: C</p

Ambulanssjukvård : Allmänhetens uppfattning och förväntningar

Under senare år har ambulanssjukvården i Sverige genomgått stora förändringar. Kunskaps och kompetensnivån har ökat, framför allt efter 2005, då alla akutambulanser skulle bemannas med minst en sjuksköterska. Denna kunskapsnivå i samband med ett ökat tryck på sjukhusens akutmottagningar skulle kunna ligga till grund för ett förändrat arbetssätt vad det gäller bedömning och prioritering av patient. En möjlighet skulle vara att ambulanssjukvårdpersonal får möjlighet att bedöma vårdnivå hos vissa patientgrupper redan på plats. Syftet med studien var att belysa vad allmänheten har för uppfattning och förväntningar på ambulanssjukvård, samt att få en uppfattning om deras tankar vid eventuell hänvisning till annan vårdnivå samt annat färdsätt än ambulans. Studien genomfördes i enkätform och målgruppen var en yngre och en äldre åldersgrupp (n = 51). Enkäten innefattade slutna frågor med en demografisk del samt frågeformuleringarna om respondenternas uppfattning samt förväntningar av ambulanssjukvård. Enkäten avslutades med en öppen fråga gällande deras inställning till att bli hänvisade till annan vård än sjukhus. Resultatet visade att åldersgruppernas åsikter skilde sig åt på olika punkter. Vad det gäller frågan om hänvisning så svarade övervägande del yngre att de kunde tänka sig att bli hänvisade till annan vårdinstans än sjukhus, medan så inte var fallet i kategorin äldre. De flesta ansåg att ambulanspersonalen kunde göra en första kvalificerad insats redan på plats. Trots att man visat förtroende för ambulanspersonalen infinner sig en tveksamhet när det gäller att bli ifrågasatt. Denna undersökning visar att behovet av information om vad ambulanssjukvård är till för är stort och eftersatt.Program: Fristående kursUppsatsnivå: C</p

Evaluation of reproducibility in MRI quantitative volumetric assessment and its role in the prediction of overall survival and progression-free survival in glioblastoma

Background: Residual tumor volume (RTV) and extent of resection (EOR) have previously been shown to affect survival in glioblastoma (GB) patients. Quantitative radiological assessment (QRA) of these factors could potentially affect clinical decision-making in the postoperative period. Purpose: The first aim was to evaluate the reproducibility of different volume estimation methods of RTV and EOR by comparing QRA with subjective visual estimation and with objective volume estimations. The second aim was to clarify whether QRA of RTV and EOR would provide accuracy in predicting progression-free survival (PFS) and overall survival (OS) in GB patients. Material and Methods: Seventy GB patients were studied retrospectively. Reproducibility of QRA was compared to conventional visual analysis. Intra-rater agreement between two repeated measurements of 25 patients was calculated. QRA for RTV and EOR was made for the entire study population. Survival analysis was performed by multivariate cox-regression analysis. Results: QRA of RTV and EOR gave superior intra-rater agreement compared to subjective evaluation. Multivariate survival analysis showed prognostic significance on 18 months PFS (hazard ratio [HR] = 0.44, P = 0.003) and OS (HR = 0.42, P = 0.012) at RTV 96% on PFS (HR = 2.152, P = 0.005) but not on OS (HR = 1.92, P = 0.053). Conclusion: QRA of tumor volumes is more robust compared to standard evaluation methods. Since EOR and RTV are correlated to the prognosis in GB, quantitative analysis of tumor volumes could aid decision-making and patient management postoperatively