Checklist for planning IDEAL Stage 4: Long term monitoring – what you need to consider before beginning.
Title
Identification of the novel technique/device being investigated and the type of long term study conducted i.e whether it is based on a registry or other specifically designed prospective database, or on interrogation of data collected for admin, clinical care or other purposes.
Background and objectives
Review literature on the topic, including reference to earlier IDEAL stage reports in previous publications, if applicable. State specific objectives which may include recognizing late or uncommon safety outcomes, identifying changes in the use of procedure/device, risk adjustment, quality assurance, and effectiveness
Methods – What are you planning to do?
About the study (consider PICO elements – (P)atients, (I)ntervention, (C)omparator, (O)utcomes where relevant)
- Describe study design (e.g. registry, analysis of real-world data, etc)
- Describe the dataset used/developed, including who designed and funds it and who curates and manages it, addressing possible conflicts of interest. Describe whether the dataset was purposely designed for research or collected for other purposes
- (P) Provide a detailed account of inclusion and exclusion criteria for subjects
- (I) Describe or reference the intervention/device being monitored,
- (C)and comparator if applicable
- (O) What are the pre-specified primary and secondary outcome measures selected and how they will be assessed, including patient reported outcome measures, when appropriate, utilising those measures that are standardised and validated, when available and applicable. When these are not available, provide rationale for the outcome measure used
Consider what data you will collect and how you will report/analyze it
- What statistical methods will you use to describe and assess patient characteristics and outcomes, including methods of additional analysis (e.g. pre-specified subgroup analysis), and methods to minimize confounding, where appropriate. Explanation of how missing data will be addressed
- Baseline data – What are important patient demographic and clinical characteristics, and hospital/centre/operator characteristics
- Indicate extent of missing data for each variable of interest, if appropriate
- Be able to report main pre-specified outcome measures, including outcome variations among pre-specified subgroups and adjustments for confounders, when applicable
- Transparent account of all harms or unintended effects reported
By the end of the study you will be able to:
- Interpret results and discuss limitations, addressing sources of potential bias, known confounders, missing data, and secular trends, including a discussion of the implications of using data that was not originally collected to answer the specific research question, where appropriate
- Clarify relevance, including a discussion of the overall interpretation of results, the external validity, and any implications for policy and practice.
