Article type
Abstract
"Background: As the population is ageing, multimorbidity is becoming an increasingly prevalent health problem. Randomized controlled trials (RCTs) in multimorbidity are still scarce and their quality has not been thoroughly assessed. Clear and transparent reporting is necessary in improving the quality of RCTs. Some reporting checklists, like the Consolidated Standards of Reporting Trials (CONSORT) statement, can ensure that the necessary information is adequately reported in RCTs. However, some characteristics of multimorbidity may not be reported in sufficient detail if only standard reporting checklists are followed.
Objectives: To propose additional key points for reporting multimorbidity trials.
Methods: We searched PubMed for RCTs addressing general outcomes in populations with multimorbidity (“health-centered trials”) and interventions for certain selected combinations of diseases (“disease-centered trials”). Based on the findings of the literature search, we formulated an initial set of recommendations. The set was sent to four experts in multimorbidity research for review. Based on their feedback, we revised the recommendations and drafted the final list of items.
Results: The final list includes seven key items that we recommend to report in RCTs related to multimorbidity in addition to the items of CONSORT or another established general checklist (Table 1). Some of the items apply to health-centered trials, some to disease-centered trials, and some to both with slightly differing wording. The items address the declaration of the multimorbidity aspect in the title and keywords; clarification of the aim and target group in terms of the different comorbidities; a clear description of all baseline characteristics relevant to each comorbidity; and a thorough assessment and consideration of the harms associated with the different conditions and their interactions.
Conclusions: The recommendations can support investigators of RCTs to report the multimorbidity-related aspects in a more detailed and transparent way. These suggestions can serve as launch for developing a dedicated reporting checklist for multimorbidity trials, either as extension of CONSORT or as independent statement.
Statement: No public or consumers were involved in this study."
Objectives: To propose additional key points for reporting multimorbidity trials.
Methods: We searched PubMed for RCTs addressing general outcomes in populations with multimorbidity (“health-centered trials”) and interventions for certain selected combinations of diseases (“disease-centered trials”). Based on the findings of the literature search, we formulated an initial set of recommendations. The set was sent to four experts in multimorbidity research for review. Based on their feedback, we revised the recommendations and drafted the final list of items.
Results: The final list includes seven key items that we recommend to report in RCTs related to multimorbidity in addition to the items of CONSORT or another established general checklist (Table 1). Some of the items apply to health-centered trials, some to disease-centered trials, and some to both with slightly differing wording. The items address the declaration of the multimorbidity aspect in the title and keywords; clarification of the aim and target group in terms of the different comorbidities; a clear description of all baseline characteristics relevant to each comorbidity; and a thorough assessment and consideration of the harms associated with the different conditions and their interactions.
Conclusions: The recommendations can support investigators of RCTs to report the multimorbidity-related aspects in a more detailed and transparent way. These suggestions can serve as launch for developing a dedicated reporting checklist for multimorbidity trials, either as extension of CONSORT or as independent statement.
Statement: No public or consumers were involved in this study."