Making Clinical Practice Guidelines Pragmatic: How Big Data and Real World Evidence Can Close the Gap

Abstract

Clinical practice guidelines (CPGs) have become ubiquitous in every field of medicine today but there has been limited success in implementation and improvement in health outcomes. Guidelines are largely based on the results of traditional randomised controlled trials (RCTs) which adopt a highly selective process to maximise the intervention’s chance of demonstrating efficacy thus having high internal validity but lacking external validity. Therefore, guidelines based on these RCTs often suffer from a gap between trial efficacy and real world effectiveness and is one of the common reasons contributing to poor guideline adherence by physicians. “Real World Evidence” (RWE) can complement RCTs in CPG development. RWE—in the form of data from integrated electronic health records—represents the vast and varied collective experience of frontline doctors and patients. RWE has the potential to fill the gap in current guidelines by balancing information about whether a test or treatment works (efficacy) with data on how it works in real world practice (effectiveness). RWE can also advance the agenda of precision medicine in everyday practice by engaging frontline stakeholders in pragmatic biomarker studies. This will enable guideline developers to more precisely determine not only whether a clinical test or treatment is recommended, but for whom and when. Singapore is well positioned to ride the big data and RWE wave as we have the advantages of high digital interconnectivity, an integrated National Electronic Health Record (NEHR), and governmental support in the form of the Smart Nation initiative. Key words: Guideline adherence, Real world data, Physicians' practice patterns

Effectiveness of Extrafine Single Inhaler Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) in Germany – The TriOptimize Study

“…Based on COPD treatment history, prior treatment was classified in three groups: ICS+LABA+LAMA (multiple inhalers), ICS/LABA or LAMA/LABA (single or two inhalers). CAT scores were grouped in four categories: low (<10), moderate (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20), high (21)(22)(23)(24)(25)(26)(27)(28)(29)(30), and very high (>30). CAT responders were defined as patients with a ≤ 2-point decrease in total CAT score.…”

“…[14][15][16]18 As COPD patients are a highly heterogeneous population, which may not be adequately represented in randomized controlled trials, studies reflecting real-world situation are necessary. [19][20][21] Important aspects of everyday care such as treatment adherence are not representatively captured in clinical trials as adherence is usually ensured by default. 19 The aim of this prospective non-interventional study was to assess changes in HRQoL, COPD specific symptoms, lung function and treatment adherence after six months of treatment with efSITT in patients with moderate-to-severe COPD under conditions of routine clinical practice in Germany.…”

Evaluation of Citation Inaccuracies in Surgical Literature by Journal Type, Study Design, and Level of Evidence: Towards Safeguarding the Peer-Review Process

“…In fact, RCTs had a citation inaccuracy rate of 17.37% compared to case series and low-quality cohort studies which had a citation inaccuracy rate of 15.3%. These findings are considerable, as the results of RCTs are often used in the implementation of clinical practice guidelines 18 and thus have a direct impact on the field of medicine and patient care. Studies with such an impact will likely disseminate their findings rapidly and to a broad audience, reinforcing the importance of accurate citation practices.…”

Development of a real-world database for asthma and COPD: The SingHealth-Duke-NUS-GSK COPD and Asthma Real-World Evidence (SDG-CARE) collaboration

“…Firstly, the Master List is used to extract the ID for patients of interest. Then with this list of IDs, the other subject areas are used to extract the rest of the data elements of interest 2 Problem list conditions were based on SNOMED Clinical Terms (SNOMED-CT) coding 3 Visits details includes details such as visit date, visit location, and visit provider 4 Diagnosis conditions were based on 10th revision of the International Classification of Diseases (ICD-10) coding 5 Rescue therapy is a protocol-based bronchodilator intervention administered at the polyclinic for patients assessed to have asthma exacerbation 6 Referrals made from SingHealth Polyclinics to tertiary hospitals, including Singapore General Hospital 7 Patient history, physical examination findings and management plan were captured as free-text data 8 For influenza and pneumococcal vaccinations only…”

“…RWD can be used to generate real-world evidence (RWE) [1]. The potential uses of RWE are broad, ranging from clinical guidelines development to enabling precision medicine in clinical practice [2][3][4]. With the adoption of electronic health records (EHR) and recent legislations such as the 21st Century Cures Act [5], there has been an increasing interest in using real-world evidence (RWE) to satisfy the needs of the evolving healthcare industry [5,6].…”