I) Systematically identify and describe most common characterizations of “usual care” interventions in COPD randomized controlled trials. II) Determine how well randomized controlled trials report usual care interventions and the extent to which COPD guideline-recommended components are a part of usual care interventions in trials.
Following a systematic review design, a search of CENTRAL, Clinicaltrials.gov, Embase, Medline, PEDro, PubMed and Scielo was conducted. Two investigators screened all titles/abstracts and full text articles, and independently extracted data. We extracted study characteristics, type of usual care and quality of reporting. We also classified usual care components as validated or unvalidated comparators. We considered comparators as validated if at least one component of the “usual care” intervention was effective based on the recommendations from the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
This ongoing study has screened 6128 references using Covidence software, with 551 studies evaluated for full-text eligibility and data extraction completed for 39 studies. All studies were reported in English. The mean number of participants was 214 (SD:208) and 53% of trials performed multicenter recruitment. Most trials were funded (92%) and conducted in Europe (53%) and North America (30%). The most common type of intervention for usual care groups was non-pharmacological (48%) followed by a combination of pharmacological and non-pharmacological interventions (17%). The characteristics of usual care presented a wide range including continuing care with patient’s doctor (39%), education (23%), adhering to published guidelines (20%), no care at all (5%) or were simply not defined (12%). Most trials failed to report the type of provider for the usual care group (53%), the frequency that “usual care” was delivered (66%), and the setting where care was provided (69%). Only 5 studies (12%) provided a complete description of the usual care intervention. Twenty studies (51%) were considered validated presenting at least one component of GOLD.
There was a lack of consistency with significant variability in reporting and components for usual care comparators in COPD trials. Almost half of the studies did not adhere to any guideline-recommended components.
Our findings emphasize the need for better reporting of usual care interventions and improvement on the validity of COPD trial comparisons. Addressing these issues can improve the reliability of trial outcomes and support more informed clinical decision-making, ultimately leading to improved COPD management and patient care.
Usual care
Randomized clinical trials
