Evidence map›Paper›PMID 36386444›Full record

ArticleBMJ medicine2022

Designing and conducting adaptive trials to evaluate interventions in health services and implementation research: practical considerations.

Julie C Lauffenburger, Niteesh K Choudhry, Massimiliano Russo, Robert J Glynn, Steffen Ventz, Lorenzo Trippa

Open access · goldAbstract read
In one paragraph

Article in BMJ medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
5.7field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Re-defining the future of cancer peer support: implementation, research, and policy considerations.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  11. Proof of concept studies in mental health systems research: strategy and steps.International journal of mental health systems · 2025
    Review
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  13. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Julie C LauffenburgerCenter for Healthcare Delivery Science and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Niteesh K ChoudhryCenter for Healthcare Delivery Science and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Massimiliano RussoDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Department of Data Science, Dana-Farber Cancer Institute.
Robert J GlynnCenter for Healthcare Delivery Science and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Steffen VentzDepartment of Data Science, Dana-Farber Cancer Institute, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Lorenzo TrippaDepartment of Data Science, Dana-Farber Cancer Institute, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Brigham and Women's Hospital · USDana-Farber Cancer Institute · US

Funding

The Roybal Center for TherapeuticOptimization using BehavioralScienceP30AG064199 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI Julie Christine Lauffenburger · 2019 to 2026
$8.3M
Optimizing electronic health record prompts with behavioral economics to improve prescribing for older adultsR33AG057388 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI CHOUDHRY, NITEESH K, LAUFFENBURGER, JULIE CHRISTINE · 2019 to 2021
$2.2M
Statistical Methods and Validation Analyses for the Integration of External Data in Clinical TrialsR01LM013352 · NLM · DANA-FARBER CANCER INST · PI TRIPPA, LORENZO · 2021 to 2024
$1.5M
Development of a novel medication adherability tool to improve cardiovascular disease managementK01HL141538 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI LAUFFENBURGER, JULIE CHRISTINE · 2018 to 2022
$718k
NHLBI NIH HHS K01 HL141538NIA NIH HHS P30 AG064199NIA NIH HHS R33 AG057388NLM NIH HHS R01 LM013352
6 · The paper itself

Abstract

Randomized controlled clinical trials are widely considered the gold standard for evaluating the efficacy or effectiveness of interventions in health care. Adaptive trials incorporate changes as the study proceeds, such as modifying allocation probabilities or eliminating treatment arms that are likely to be ineffective. These designs have been widely used in drug discovery studies but can also be useful in health services and implementation research and have been minimally used. As motivating examples, we use an ongoing adaptive trial and two completed parallel group studies and highlight potential advantages, disadvantages, and important considerations when using adaptive trial designs in health services and implementation research. In addition, we investigate the impact on power and the study duration if the two completed parallel-group trials had instead been conducted using adaptive principles. Compared with traditional trial designs, adaptive designs can often allow one to evaluate more interventions, adjust participant allocation probabilities (e.g., to achieve covariate balance), and identify participants who are likely to agree to enroll. These features could reduce resources needed to conduct a trial. However, adaptive trials have potential disadvantages and practical aspects that need to be considered, most notably outcomes that can be rapidly measured and extracted (e.g., long-term outcomes that take significant time to measure from data sources can be challenging), minimal missing data, and time trends. In conclusion, adaptive designs are a promising approach to help identify how best to implement evidence-based interventions into real-world practice in health services and implementation research.

Indexed as

adaptive trialbehavioral scienceclinical trialhealth services researchimplementation science

Identifiers

PMID36386444
PMCPMC9650931
OpenAlexW4285809704

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.