{"doi":"10.1002/sim.10161","title":"A sequential, multiple assignment, randomized trial design with a tailoring function","abstract":"We present a trial design for sequential multiple assignment randomized trials (SMARTs) that use a tailoring function instead of a binary tailoring variable allowing for simultaneous development of the tailoring variable and estimation of dynamic treatment regimens (DTRs). We apply methods for developing DTRs from observational data: tree-based regression learning and Q-learning. We compare this to a balanced randomized SMART with equal re-randomization probabilities and a typical SMART design where re-randomization depends on a binary tailoring variable and DTRs are analyzed with weighted and replicated regression. This project addresses a gap in clinical trial methodology by presenting SMARTs where second stage treatment is based on a continuous outcome removing the need for a binary tailoring variable. We demonstrate that data from a SMART using a tailoring function can be used to efficiently estimate DTRs and is more flexible under varying scenarios than a SMART using a tailoring variable.","journal":"Statistics in Medicine","year":2024,"id":451572,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9574,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":390400,"name":"Matthew J. Schipper","orcid":"0000-0001-6728-4720","position":1,"is_corresponding":false},{"id":390401,"name":"Kelley M. Kidwell","orcid":"0000-0002-1717-4483","position":2,"is_corresponding":false},{"id":390399,"name":"Holly Hartman","orcid":"0000-0002-9101-4381","position":0,"is_corresponding":true}],"reference_count":20,"raw_metadata":null,"created_at":"2026-07-19T02:02:45.951080Z","pmid":"38973591","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}