Systematic Reviews Must Evolve: From Retraction Alerts to Recovery-Oriented Design
Dear Editor,
Xu et al.’s VITALITY study rightly highlights the structural risks that retracted RCTs pose to meta-analyses and clinical guidelines. This is a crucial first step in illuminating the fragility of our current evidence ecosystem.
Yet the core issue lies not only in whether a trial is retracted, but in the very architecture by which evidence is constructed. From a phenomenological perspective, current RCT paradigms risk becoming overly formalistic and insufficiently attuned to the lived complexity of patient experience.
The REAL study offers a compelling contrast. Targeting individuals with complex mental health needs, it assessed not only the efficacy of interventions but also recovery-oriented outcomes, social functioning, and cost-effectiveness—demonstrating that richly contextualised designs can yield clinically relevant insights.
We must move beyond the idea that a “trustworthy RCT” or “high-quality meta-analysis” can be judged solely by formal criteria. Design coherence—alignment among question, context, and method—should be treated as a central metric of evidence validity.
Future GRADE and systematic review frameworks therefore need an additional dimension: not only detecting retracted trials, but evaluating the structure of meaningful inquiry itself. As Benner and Wrubel argue, healthcare is not merely technical intervention but an “attunement” to the patient’s world.¹ Without integrating such human-centred perspectives, we risk producing evidence that is technically robust yet epistemically hollow.
The call is thus not just for stricter policing of misconduct, but for more meaningful science.
Sincerely,
Kenjiro Shiraishi
Tanashi Kitaguchi Acupuncture and Moxa Clinic, Tokyo, Japan
Nozaki Building 301, 2-9-6 Tanashi-chō, Nishi-Tokyo-shi, Tokyo 188-0011
ORCID: https://orcid.org/0009-0003-2550-7385
References
1. Benner P, Wrubel J. The Primacy of Caring: Stress and Coping in Health and Illness. Menlo Park, CA: Addison-Wesley; 1989.
2. Killaspy H, et al. The Rehabilitation Effectiveness for Activities for Life (REAL) study. NIHR Journals Library; 2017.
3. Neumann I, Santesso N, Guyatt G, et al. Core GRADE 1: overview of the Core GRADE approach. BMJ 2025;389:e081903. doi:10.1136/bmj-2024-081903
Competing interests:
No competing interests
06 May 2025
Kenjiro Shiraishi
acupuncturist ana resarcher
Nozaki Building 301, 2‑9‑6 Tanashi‑chō, Nishi‑Tokyo‑shi, Tokyo 188‑0011
Rapid Response:
Systematic Reviews Must Evolve: From Retraction Alerts to Recovery-Oriented Design
Dear Editor,
Xu et al.’s VITALITY study rightly highlights the structural risks that retracted RCTs pose to meta-analyses and clinical guidelines. This is a crucial first step in illuminating the fragility of our current evidence ecosystem.
Yet the core issue lies not only in whether a trial is retracted, but in the very architecture by which evidence is constructed. From a phenomenological perspective, current RCT paradigms risk becoming overly formalistic and insufficiently attuned to the lived complexity of patient experience.
The REAL study offers a compelling contrast. Targeting individuals with complex mental health needs, it assessed not only the efficacy of interventions but also recovery-oriented outcomes, social functioning, and cost-effectiveness—demonstrating that richly contextualised designs can yield clinically relevant insights.
We must move beyond the idea that a “trustworthy RCT” or “high-quality meta-analysis” can be judged solely by formal criteria. Design coherence—alignment among question, context, and method—should be treated as a central metric of evidence validity.
Future GRADE and systematic review frameworks therefore need an additional dimension: not only detecting retracted trials, but evaluating the structure of meaningful inquiry itself. As Benner and Wrubel argue, healthcare is not merely technical intervention but an “attunement” to the patient’s world.¹ Without integrating such human-centred perspectives, we risk producing evidence that is technically robust yet epistemically hollow.
The call is thus not just for stricter policing of misconduct, but for more meaningful science.
Sincerely,
Kenjiro Shiraishi
Tanashi Kitaguchi Acupuncture and Moxa Clinic, Tokyo, Japan
Nozaki Building 301, 2-9-6 Tanashi-chō, Nishi-Tokyo-shi, Tokyo 188-0011
ORCID: https://orcid.org/0009-0003-2550-7385
References
1. Benner P, Wrubel J. The Primacy of Caring: Stress and Coping in Health and Illness. Menlo Park, CA: Addison-Wesley; 1989.
2. Killaspy H, et al. The Rehabilitation Effectiveness for Activities for Life (REAL) study. NIHR Journals Library; 2017.
3. Neumann I, Santesso N, Guyatt G, et al. Core GRADE 1: overview of the Core GRADE approach. BMJ 2025;389:e081903. doi:10.1136/bmj-2024-081903
Competing interests: No competing interests