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A Proposed Road Map for the Ethical Evaluation of Sham (Placebo) Surgery
Vittoradolfo Tambone1, Dario Sacchini, Antonio G Spagnolo
1*Institute of Philosophy of Scientific and Technological Activity, University Campus Bio-Medico of Rome, Italy; Via Alvaro del Portillo 21, Rome, Italy †Institute of Bioethics and Medical Humanities, "A. Gemelli" School of Medicine and Surgery, Università Cattolica del Sacro Cuore; Largo Francesco Vito 1, Rome, Italy ‡Faculty of Medicine and Surgery, University Campus Bio-Medico of Rome, Italy; Via Alvaro del Portillo 21, Rome, Italy §School of Law, University of Camerino; Piazza Cavour 19, Camerino (MC), Italy **Department of Engineering, University Campus Bio-Medico of Rome, Italy; Via Alvaro del Portillo 21, Rome, Italy ||Istituto Superiore di Sanità, Rome, Italy.
Objective:
The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice.
Background:
Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group. The use of sham surgery is controversial from an ethical point of view.
Methods:
This evaluation system is set up according to ICH/GCP, World Medical Association Declaration of Helsinki, CONSORT 2010 standards. The proposed roadmap is based on the following 4 steps/levels: safety/clinical indications; adequacy of trial methodology/design adopted for a sham surgery CT; specific informed consent, and economic issues.
Results:
A flowchart is proposed which can be used at two levels: as a basic guideline for the design of a surgical protocol representing a benchmark level of care; and a multiaxial assessment considering the first two sources of morality of human acts according to Aristotelian ethics: the object of the act (step 1) and some of its circumstances (steps 2-4).
Conclusions:
The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.
Insights
This study introduces a roadmap for ethically assessing sham surgery clinical trials (CTs), addressing a gap in practical tools. It ensures patient safety and prevents bias in surgical research.
Area of Science:
- Medical Ethics
- Clinical Trial Design
- Surgical Research Methodology
Background:
- Surgical procedures often lack rigorous, controlled studies compared to drug/device trials.
- Sham surgery clinical trials (CTs) aim for legitimate control groups but raise ethical concerns.
- Ethical considerations are paramount for placebo use in surgical research.
Purpose of the Study:
- To propose a practical roadmap for the ethical assessment of sham surgery clinical trials (CTs).
- To address the lack of established ethical assessment tools for surgical placebo controls.
- To enhance the methodological rigor and ethical integrity of surgical research.
Main Methods:
- Developed a 4-step roadmap based on ICH/GCP, Declaration of Helsinki, and CONSORT 2010 standards.
- The roadmap addresses safety, clinical indications, trial methodology, informed consent, and economic factors.
- A flowchart is proposed for protocol design and ethical assessment.
Main Results:
- The proposed roadmap provides a structured approach to ethical evaluation.
- A flowchart serves as a guideline for surgical protocols and a multiaxial ethical assessment.
- The system considers ethical principles related to the act's object and circumstances.
Conclusions:
- Implementing placebo and double-blind controls in surgery CTs can improve results quality.
- An accurate ethical assessment procedure is crucial for patient safety and preventing bias.
- The study outlines future testing for the proposed ethical assessment flowchart.
