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• W2428588886 abstract "The ideal situation for healthcare policymakers is to have knowledge about the real-world effectiveness of all medical interventions available for a certain condition to choose the one with the best cost–effectiveness. However, most research is poorly suited to answer such questions. Unlike in everyday medicine, research is often performed in a highly specialized environment, with participating doctors who are highly motivated. Furthermore, patients found suitable for inclusion in a clinical trial may not be comparable with the plethora of patient profiles with the condition in the community. Finally, where two or more competing interventions are available, research is often lacking about the comparative effectiveness of the two. In 1979, Marvin Zelen1 published a new concept for randomized trials with a standard of care control group (not placebo or sham), to determine the real-world comparative effectiveness of different interventions, the so-called Zelen design. Zelen proposed to include study participants more representative of the large pool of individuals with a condition by first randomizing eligible individuals and then request consent only from those randomized to receive the experimental treatment or intervention. When analyzing such trials according to the intention to treat principle, real-world effectiveness can be estimated with more validity as compared with conventional clinical trials in which patients first consent, and are then randomized (provided that compliance with the assigned treatment is comparable in the trial and in clinical practice). However, Zelen’s design has been criticized for leaving individuals included in the standard care control group uninformed about their participation in the trial. In 2010, Relton and coworkers2 described the cohort multiple randomized controlled trial (RCT), as a way to efficiently gain real-world comparative effectiveness evidence. The concept builds on Zelen’s design and extends it to establish a longitudinal everyday practice patient cohort which serves as the pool for conducting multiple RCTs. In the current issue of EPIDEMIOLOGY, Young-Afat and coworkers3 propose a refined consent and information procedure for cohort multiple RCTs. As it appears, the work was motivated by discussions with ethics committees when planning cohort multiple RCTs in the Netherlands. The requirement that patients should provide fully “informed consent” is a very high bar to reach in clinical research. A recent meta-analysis found that only 52% to 76% of patients participating in clinical trials understood the information in the consent form.4 Information about the concepts and rationales for randomization and use of placebo were most difficult to grasp. The cohort multiple RCT concept might introduce particular challenges with regards to providing informed consent, since the study process is stepwise in time, and the patient might not fully understand what he or she has consented to at the different stages. Introducing a structured consent procedure as proposed by Young-Afat and coworkers3 can be a way to relieve the information challenge in cohort multiple RCTs. The three distinct phases—consent to data collection; consent to randomization and to serve as controls; and finally consent to specific experimental interventions—are clearly defined and may thus increase clarity for patients. The separation of the two first consent steps (data collection; randomization and agreeing to serve as controls) may seem superfluous at first sight. But given the particular difficulties in conveying information about randomization and the possibility of being offered nonexperimental interventions (as is the case in a control group) this is a step forward. Furthermore, it might also help researchers to better understand the selection mechanisms into participation in randomized trials and thus increase the external validity of trials performed in the cohort multiple RCT framework. If one believes that the Zelen design is ethically challenging, the concepts described by Relton and Young-Afat represent a step forward because they address patient consent and maintain the advantage of the original method which lies in its greater external validity for real-world clinical practice as compared with designs in which patients are first asked to participate in a clinical trials, and only those who reply “yes” are randomized to intervention or control group. However, we question the existence of the problem that Relton and Young-Afat, respectively, try to overcome. In our view, the Zelen design is not related to substantial ethical concerns. In fact, an increasing number of healthcare systems, such as the Scandinavian public healthcare systems, already routinely include important features of the Zelen and cohort multiple RCT concepts: all individuals are traceable via unique personal identifiers, specific patient groups can be identified in patient registries, and patient outcomes are routinely reported to national registries such as cause of death registry, cancer registry, and other clinical registries. In these systems, health-related information is routinely tracked and used both in planning of future resources, quality assurance of the healthcare system, and in research. Thus, these systems are comparable with the cohorts of the cohort multiple RCT concept, the cohort being all citizens of the country or region. In such systems, randomization before consent for an intervention, and not requesting consent from standard of care control groups, is ethically acceptable. In these societies, an implicit and informed contract exists between all inhabitants and the authorities that individual health data might be used for research purposes. Importantly, the contract must include the recognition of a particular responsibility of researchers to secure personal integrity of patient data, and public access to obtained data. We believe that the Scandinavian approach is feasible, advantageous and ethically sound, and may serve as an example for others. We have performed several large-scale randomized trials in colorectal cancer screening,5–7 using Zelen’s design.1 In these trials, participants are randomly selected from the population registry and randomized to a screening intervention or care as usual. Endpoints are ascertained from public registries to which reporting is mandatory for all citizens. Thus, no actions have been taken toward control individuals in the trials, and they have received the same health care as the Norwegian population. Inclusion of this nonconsent control group in such trials is not different from nonconsent inclusion of the same individuals in an observational study based on public registries, a practice that is widespread in several countries, and which has recently been approved by European Union regulatory authorities.8 The advantage of the data obtained in such trials is that they provide real-world effectiveness evidence. The Norwegian government has recently introduced the same concept for the introduction of a national colorectal cancer-screening program (ClinicalTrials.gov identifier: NCT01538550). The program has been organized as a platform for comparative effectiveness research, randomizing individuals (without prior consent) to undergo screening with flexible sigmoidoscopy or fecal occult blood testing. Informed consent is asked after randomization. The plan is to expand the program to also cover other screening modalities, such as colonoscopy. In Sweden, a similar initiative has recently started (ClinicalTrials.gov identifier NCT02078804). The Zelen design was visionary and ahead of time when it was published in 1979. Although the cohort-multiple RCT concept of Relton and Young-Afat is appreciated, it is now time to move on and rediscuss the ethical concerns Zelen had to fight. We believe they may not be valid. ABOUT THE AUTHORS The authors are MDs with clinical backgrounds in internal medicine, surgery, and gastroenterology, respectively. They work in the Clinical Effectiveness Research Group at the University of Oslo in Oslo, Norway. Their main interests include large-scale randomized trials and observational studies in the areas of cancer screening, colorectal polyps, breast cancer, inflammatory bowel disease, and gastrointestinal endoscopy; and development and evaluation of scientific methodology in clinical epidemiology." @default.
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