Personalised medicine aims to tailor medical decisions to the individual patient. A possible approach is to stratify patients according to the risk of adverse outcomes such as exacerbations in chronic obstructive pulmonary disease (COPD). Risk-stratified approaches are particularly attractive for drugs like inhaled corticosteroids or phosphodiesterase-4 inhibitors that reduce exacerbations but are associated with harms. However, it is currently not clear which models are best to predict exacerbations in patients with COPD. Therefore, our aim was to identify and critically appraise studies on models that predict exacerbations in COPD patients. Out of 1382 studies, 25 studies with 27 prediction models were included. The prediction models showed great heterogeneity in terms of number and type of predictors, time horizon, statistical methods and measures of prediction model performance. Only two out of 25 studies validated the developed model, and only one out of 27 models provided estimates of individual exacerbation risk, only three out of 27 prediction models used high-quality statistical approaches for model development and evaluation. Overall, none of the existing models fulfilled the requirements for risk-stratified treatment to personalise COPD care. A more harmonised approach to develop and validate high- quality prediction models is needed to move personalised COPD medicine forward.
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IntroductionChronic obstructive pulmonary disease (COPD) is a highly prevalent chronic disease characterised by persistent respiratory symptoms. A focus of COPD interventional studies is directed towards prevention of exacerbations leading to hospital readmissions. Telehealth as a method of remote patient monitoring and care delivery may be implemented to reduce hospital readmissions and improve self-management of disease. Prior reviews have not systematically assessed the efficacies of various telehealth functionalities in patients with COPD at different stages of disease severity. We aim to evaluate which COPD telehealth interventions, classified by their functionalities, are most effective in improving patient with COPD management measured by both clinical and resource utilisation outcomes.Methods and analysisWe will conduct a systematic review which will include randomised controlled trials comparing the efficacy of telehealth interventions versus standard care in patients with COPD with confirmed disease severity based on forced expiratory volume(%) levels. An electronic search strategy will be used to identify trials published since 2000 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, CINHAL. Telehealth is described as remote monitoring and delivery of care where patient data/clinical information is routinely or continuously collected and/or processed, presented to the patient and transferred to a clinical care institution for feedback, triage and intervention by a clinical specialist. Two authors will independently screen articles for inclusion, assess risk of bias and extract data. We will merge studies into a meta-analysis if the interventions, technologies, participants and underlying clinical questions are homogeneous enough. We will use a random-effects model, as we expect some heterogeneity between interventions. In cases where a meta-analysis is not possible, we will synthesise findings narratively. We will assess the quality of the evidence for the main outcomes using GRADE.Ethics and DisseminationResearch ethics approval is not required. The findings will be disseminated through publication in a peer-reviewed journal.PROSPERO registration numberCRD42018083671.
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