Research quality and transparency, outcome measurement and evidence for safety and effectiveness in robot-assisted surgery: systematic review

Abstract

Background: Robot-assisted surgery (RAS) has potential panspecialty surgical benefits. High-quality evidence for widespread implementation is lacking. This systematic review aimed to assess the RAS evidence base for the quality of randomized evidence on safety and effectiveness, specialty 'clustering', and outcomes for RAS research. Methods: A systematic review was undertaken according to PRISMA guidelines. All pathologies and procedures utilizing RAS were included. Studies were limited to RCTs, the English language and publication within the last decade. The main outcomes selected for the review design were safety and efficacy, and study purpose. Secondary outcomes were study characteristics, funding and governance. Results: Searches identified 7142 titles, from which 183 RCTs were identified for data extraction. The commonest specialty was urology (35⋅0 per cent). There were just 76 unique study populations, indicating significant overlap of publications; 103 principal studies were assessed further. Only 64⋅1 per cent of studies reported a primary outcome measure, with 29⋅1 per cent matching their registration/protocol. Safety was assessed in 68⋅9 per cent of trials; operative complications were the commonest measure. Forty-eight per cent of trials reported no significant difference in safety between RAS and comparator, and 11 per cent reported RAS to be superior. Efficacy or effectiveness was assessed in 80⋅6 per cent of trials; 43 per cent of trials showed no difference between RAS and comparator, and 24 per cent reported that RAS was superior. Funding was declared in 47⋅6 per cent of trials. Conclusion: The evidence base for RAS is of limited quality and variable transparency in reporting. No patterns of harm to patients were identified. RAS has potential to be beneficial, but requires continued high-quality evaluation.

The RoboCOS Study: Development of an international core outcome set for the comprehensive evaluation of patient, surgeon, organisational and population level impacts of robotic assisted surgery

“…In addition to the Garfjeld-Roberts et al [ 5 ] systematic review, the literature search identified 81 titles and abstracts for screening from the INAHTA database. A further eight reports were identified by hand-searching and known literature.…”

“…The identified core outcome set identifies a number of core outcomes at the clinical level including the importance of measuring complications and overall effect of treatment on quality of life. These have been widely used in previous trials to date showing the primary importance of measuring the impact of a new technology like robot-assisted surgery on patients [ 5 ]. Other outcomes have, however, been less widely used in evaluations to date.…”

“…A recent systematic review of all previously published RAS randomised controlled trials [ 5 ]. As part of the conduct of that review, the investigators had extracted all outcomes used in the trials and this database of outcomes was made available for this study.…”

“…Any shortcomings or restrictions need to be measured against possible patient, clinician or system-related advantages of RAS, such as increased precision of surgery, or improved learning curve. The problem is compounded by the plethora and heterogeneity of outcomes currently used in clinical evaluations of RAS making comparison across studies difficult [ 5 ]. Given that RAS technology is highly likely to increase, there is an urgent need for healthcare organisations and other stakeholders to be able to make informed judgements of the overall “value” of RAS.…”

Robot‐assisted laparoscopic versus open partial nephrectomy for renal cell carcinoma in patients with severe chronic kidney disease

“…From another perspective, economic benefits may also be considered. In general, robotic surgical platforms are costly in terms of capital expenditure and use of consumables 29,30 . However, the operative times (occupation times of operating theaters) were shorter, and the consumption of human resources per hour were lower, in the RAPN group compared to the OPN group.…”