Abstract
Background: Long-term monitoring is important in chronic condition management. Despite considerable costs of monitoring, there is no or poor evidence on how, what and when to monitor. The aim of this study was to improve understanding, methods, evidence base and practice of clinical monitoring in primary care, focusing on two areas: Chronic kidney disease and chronic heart failure.
Objectives: The research questions were as follows: Does the choice of test affect better care while being affordable to the NHS? Can the number of tests used to manage individuals with early-stage kidney disease, and hence the costs, be reduced? Is it possible to monitor heart failure using a simple blood test? Can this be done using a rapid test in a general practitioner consultation? Would changes in the management of these conditions be acceptable to patients and carers?
Design: Various study designs were employed, including cohort, feasibility study, Clinical Practice Research Datalink analysis, seven systematic reviews, two qualitative studies, one cost-effectiveness analysis and one cost recommendation.
Setting: This study was set in UK primary care.
Data sources: Data were collected from study participants and sourced from UK general practice and hospital electronic health records, and worldwide literature.
Participants: The participants were NHS patients (Clinical Practice Research Datalink: 4.5 million patients), chronic kidney disease and chronic heart failure patients managed in primary care (including 750 participants in the cohort study) and primary care health professionals.
Interventions: The interventions were monitoring with blood and urine tests (for chronic kidney disease) and monitoring with blood tests and weight measurement (for chronic heart failure).
Main outcome measures: The main outcomes were the frequency, accuracy, utility, acceptability, costs and cost-effectiveness of monitoring.
Results: Chronic kidney disease: Serum creatinine testing has increased steadily since 1997, with most results being normal (83% in 2013). Increases in tests of creatinine and proteinuria correspond to their introduction as indicators in the Quality and Outcomes Framework. The Chronic Kidney Disease Epidemiology Collaboration equation had 2.7% greater accuracy (95% confidence interval 1.6% to 3.8%) than the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate. Estimated annual transition rates to the next chronic kidney disease stage are ≈ 2% for people with normal urine albumin, 3–5% for people with microalbuminuria (3–30 mg/mmol) and 3–12% for people with macroalbuminuria (> 30 mg/mmol). Variability in estimated glomerular filtration rate-creatinine leads to misclassification of chronic kidney disease stage in 12–15% of tests in primary care. Glycaemiccontrol and lipid-modifying drugs are associated with a 6% (95% confidence interval 2% to 10%) and 4% (95% confidence interval 0% to 8%) improvement in renal function, respectively. Neither estimated glomerular filtration rate-creatinine nor estimated glomerular filtration rate-Cystatin C have utility in predicting rate of kidney function change. Patients viewed phrases such as ‘kidney damage’ or ‘kidney failure’ as frightening, and the term ‘chronic’ was misinterpreted as serious. Diagnosis of asymptomatic conditions (chronic kidney disease) was difficult to understand, and primary care professionals often did not use ‘chronic kidney disease’ when managing patients at early stages. General practitioners relied on Clinical Commissioning Group or Quality and Outcomes Framework alerts rather than National Institute for Health and Care Excellence guidance for information. Cost-effectiveness modelling did not demonstrate a tangible benefit of monitoring kidney function to guide preventative treatments, except for individuals with an estimated glomerular filtration rate of 60–90 ml/minute/1.73 m2, aged < 70 years and without cardiovascular disease, where monitoring every 3–4 years to guide cardiovascular prevention may be cost-effective. Chronic heart failure: Natriuretic peptide-guided treatment could reduce all-cause mortality by 13% and heart failure admission by 20%. Implementing natriuretic peptide-guided treatment is likely to require predefined protocols, stringent natriuretic peptide targets, relative targets and being located in a specialist heart failure setting. Remote monitoring can reduce all-cause mortality and heart failure hospitalisation, and could improve quality of life. Diagnostic accuracy of point-of-care N-terminal prohormone of B-type natriuretic peptide (sensitivity, 0.99; specificity, 0.60) was better than point-of-care B-type natriuretic peptide (sensitivity, 0.95; specificity, 0.57).Within-person variation estimates for B-type natriuretic peptide and weight were as follows: Coefficient of variation, 46% and coefficient of variation, 1.2%, respectively. Point-of-care N-terminal prohormone of B-type natriuretic peptide within-person variability over 12 months was 881 pg/ml (95% confidence interval 380 to 1382 pg/ml), whereas between-person variability was 1972 pg/ml (95% confidence interval 1525 to 2791 pg/ml). For individuals, monitoring provided reassurance; future changes, such as increased testing, would be acceptable. Point-of-care testing in general practice surgeries was perceived positively, reducing waiting time and anxiety. Community heart failure nurses had greater knowledge of National Institute for Health and Care Excellence guidance than general practitioners and practice nurses. Health-care professionals believed that the cost of natriuretic peptide tests in routine monitoring would outweigh potential benefits. The review of cost-effectiveness studies suggests that natriuretic peptide-guided treatment is cost-effective in specialist settings, but with no evidence for its value in primary care settings.
Limitations: No randomised controlled trial evidence was generated. The pathways to the benefit of monitoring chronic kidney disease were unclear.
Conclusions: It is difficult to ascribe quantifiable benefits to monitoring chronic kidney disease, because monitoring is unlikely to change treatment, especially in chronic kidney disease stages G3 and G4. New approaches to monitoring chronic heart failure, such as point-of-care natriuretic peptide tests in general practice, show promise if high within-test variability can be overcome. Future work: The following future work is recommended: Improve general practitioner–patient communication of early-stage renal function decline, and identify strategies to reduce the variability of natriuretic peptide.
Study registration: This study is registered as PROSPERO CRD42015017501, CRD42019134922 and CRD42016046902.
| Original language | English |
|---|---|
| Pages (from-to) | 1-218 |
| Number of pages | 218 |
| Journal | Programme Grants for Applied Research |
| Volume | 9 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Aug 2021 |
Bibliographical note
Funding Information:Declared competing interests of authors: Rafael Perera reports grants from the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme [RP-PG-1210-12012: the early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (the ARCHIE programme)], the British Heart Foundation (PG/17/49/33099), the NIHR School for Primary Care Research (Wittenberg_FR16), the NIHR Oxford Biomedical Research Centre (BRC) (IS-BRC-1215-20008) and the NIHR Community Healthcare MedTech and In Vitro Diagnostics Co-operative (MIC-2016-018) during the conduct of the study. Jeffrey K Aronson has co-authored and edited textbooks and written reviews, commentaries and medicolegal reports on various aspects of prescribing. He has provided expert reports on cases involving adverse drug reactions, most often for coroners, sometimes on behalf of private individuals, and occasionally for pharmaceutical companies. He was previously a member of the NIHR Journals Library Board from 2012 until it was disbanded. Amitava Banerjee reports personal fees from C.H. Boehringer Sohn AG & Ko. KG (Ingelheim am Rhein,, Germany), AstraZeneca plc (Cambridge, UK), Novo Nordisk A/S (Bagsværd, Denmark) and Pfizer Inc. (New York, NY, USA) outside the submitted work, all before 2017. He is a trustee of the South Asian Health Foundation (2014–present) and was a member of the Education Committee of the British Cardiovascular Society (2017–20). Carl Heneghan reports expenses and fees for his media work and expenses from the World Health Organization; and holds grant funding from the NIHR Oxford Biomedical Research Centre and the NIHR School for Primary Care Research Evidence Synthesis Working Group (project 390). He has received financial remuneration from an asbestos case. He receives expenses for teaching evidence-based medicine and is also paid for his general practitioner work in the NHS out of hours. He is Director of the Centre for Evidence-Based Medicine at the University of Oxford, Editor in Chief of the British Medical Journal Evidence-Based Medicine and a NIHR Senior Investigator. FD Richard Hobbs reports grants from a NIHR Professorship (NIHR-RP-R2-12-015) during the conduct of the study; reports personal fees and other from Novartis International AG (Basel Switzerland), C.H. Boehringer Sohn AG & Ko. KG; and reports grants from Pfizer Inc. outside the submitted work. Milena Kurtinecz is a GlaxoSmithKline plc (Brentford, UK) employee and owns company stock. GlaxoSmithKline plc provided access to limited placebo data for some analyses. Louise Locock reports membership of the NIHR Health Services and Delivery Research board during the lifetime of the study (2014–19). Julie McLellan reports occasional expenses for teaching evidence-based medicine. Borislava Mihaylova reports grants from Merck & Co. Inc. (Kenilworth, NJ, USA) outside the submitted work and support from the NIHR Oxford Biomedical Research Centre (IS-BRC-1215-20008) and NIHR HTA (17/140/02). Christopher A O’Callaghan receives standard academic grants from the Novo Nordisk Foundation (NNF15SA0018346), the Medical Research Council (MC_PC_17174), the European Foundation for the Study of Diabetes (grant 96111) and Diabetes Research UK (15/0005171). Annette Plüddemann reports grant funding from the NIHR School for Primary Care Research (SPCR) (NIHR SPCR Evidence Synthesis Working Group project 390) during the conduct of the study, and occasionally receives expenses for teaching evidence-based medicine. Clare J Taylor reports personal fees from Novartis International AG and Vifor Pharma (Glattbrugg, Switzerland), and non-financial support from F. Hoffman-La Roche Ltd (Basel, Switzerland) outside the submitted work. Clare Bankhead reports grants from Cancer Research UK (EDAG committee 27880), the NIHR Oxford BRC (Multimorbidity theme IS-BRC-1215-20008) and the NIHR School for Primary Care Research (Wittenberg_FR16) during the conduct of the study.
Publisher Copyright:
© Queen’s Printer and Controller of HMSO 2021. This work was produced by Perera et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
ASJC Scopus subject areas
- Health Policy
- Health Informatics
- Public Health, Environmental and Occupational Health
Access to Document
- PereraR2021LongTerm
© Queen’s Printer and Controller of HMSO 2021. This work was produced by Perera et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.