Introduction to Surgical Trials

5,6 Por muitos anos, a intervenção mecânica da IM secundária (cirúrgica ou percutânea) foi restrita a casos refratários ao tratamento clínico convencional,7,8 com evidência respaldada principalmente por dois importantes estudos do grupo Cardiothoracic Surgical Trials Network.

The growing notion that inadequate training may affect the outcomes in surgical trials further underscores the necessity of validated training programs and courses.

In this review a group with experience in trials in congenital and adult cardiac and thoracic surgery discusses the key issues with surgical trials and suggest potential solutions.

As blinding is more difficult in surgical trials it is important to determine whether this applies to them.

Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients.

However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials.

Importance Knowledge on the frequency and severity of complications in surgical trials for rhegmatogenous retinal detachment (RRD) is essential to determine whether surgical procedures are developed and compared adequately, taking into account not only efficacy but also harms.

We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.

Risks of associated procedures and novel neurosurgical trials are discussed, together with the ethical challenges they pose.

MATERIALS AND METHODS A questionnaire survey of currently practising UK consultant general surgeons was carried out by the North West Surgical Research Collaborative, using a secure web-based database maintained by the North West Surgical Trials Centre.

OBJECTIVES To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials.

The medical applications include complex medical procedures with clinical and surgical trials.

Such paucity of surgical trials is a cause for concern, and prompted us to explore the recent landscape of surgical trials in India.

Involvement of low- and middle-income countries will lead to capacity building in these countries, fast recruitment for surgical trials, and more generalizability of trial results.

Low SBNET incidence, long event-times, and variability in disease burden, surgical technique, and institutional treatment preferences remain obstacles to conducting randomized surgical trials for SBNETs.

Due to clinical heterogeneity among surgical trials, the random-effects model should be used as a default.

No differences were found in the mean 5-, 8-, and 10-year index scores or their distributions within surgical trials.

We aimed to determine if the proportion of patient‐important outcomes in surgical trials has changed over the last decade, and to determine whether patient‐important outcomes are more likely to be specified as primary outcomes.

We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.

BACKGROUND The evidence-based management of melanoma patients with a positive sentinel lymph node biopsy (SLNB) has undergone a dramatic shift following publication of practice-changing surgical trials demonstrating no melanoma-specific survival advantage for completion lymph node dissection (CLND) in this scenario.

As a case study, this was applied to a COS project for surgical trials in gastric cancer to translate a Delphi survey into 7 target languages from regions active in gastric cancer research.

Their results indirectly suggest that surgical innovation is alive and well and that surgeons are overcoming barriers to conducting surgical trials.

CONCLUSION A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals.

The first framework learns to predict final skill scores of surgical trials with two auxiliary tasks.

Methods Databases including MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched (last update on 27 April 2020) to include published phase II and phase III non-inferiority surgical trials.

METHODS We performed a post-hoc analysis of a trial by the Cardiothoracic Surgical Trials Network, which randomized patients with POAF after cardiac surgery to rate control or rhythm control with amiodarone/cardioversion.

These findings enhance our understanding of the factors that influence parents’ decision-making and should be used to inform the design and conduct of future paediatric surgical trials.

Robinson et al, in their article “Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020: A Systematic Review,”1 use various tools and approaches to summarize key quality measures for all surgical trials (n = 388) published in 8 leading journals during the study period.

Aims To recommend a list of complications of glaucoma surgery to be used in future glaucoma surgery research and reporting by exploring the spectrum of complications’ names, the variety of definitions and time frames used for reporting them in glaucoma surgical trials.

In this descriptive review, we focus on how PROs can be used in cardiac clinical trials, with an emphasis on cardiac surgical trials for patients with coronary heart disease and heart failure.

As a case study this was applied to a COS project for surgical trials in gastric cancer to translate a Delphi survey into 7 target languages from regions active in gastric cancer research.

Methods: MVs were obtained by the Cardiothoracic Surgical Trials Network from 17 patients with ischemic mitral regurgitation (IMR).

Background Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure.

As few as half of initiated surgical trials reach their recruitment target, and failure to recruit is cited as the most frequent reason for premature closure of surgical RCTs.

Key Points Question How have the design, conduct, and reporting of surgical randomized clinical trials changed from 2008 to 2020? Findings In this systematic review of 388 randomized clinical trials, the sizes of surgical trials were small and the focus was on minor clinical events.

STUDY DESIGN Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage 2 or greater POP who underwent surgical POP repair and had sufficient follow-up in one of 4 multi-center surgical trials conducted by the NICHD Pelvic Floor Disorders Network.

The results of this study propose the likelihood of using etomidate as an anesthetic agent for short surgical trials in the chickens that can be augmented and improved by using xylazine to yield balanced anesthesia.

In our opinion, more should be invested in randomized controlled surgical trials, in quality development measures such as learning from “positive outliers”, and in the collection of patient-reported functional outcomes in routine cancer care.

In surgical trials, a lack of experience and comfort with the experimental technique will typically result in a high crossover rate to the control arm.

At the same time, the placebo response appears to have increased in pharmacological trials and marked placebo effects are found in neurostimulation and surgical trials, thereby posing the question whether non-pharmacological interventions should be placebo-controlled to a greater extent.

, multicenter surgical trials enrolling 1321 women with pelvic organ prolapse.

Should they have considered hypothetical agents that alter the genotypic-defined predilection for diverticulitis and how might that be achieved? Until there are some answers to those questions, medical therapy remains the tragic opera once used to describe surgical trials (full of promise and hope but ultimately disappointing).

CONCLUSION There is large disparity in the number of surgical trials in emergency surgery, which are primarily focused on high-volume conditions.

Background and aimsHistorically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders.

BackgroundSurgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fractures of the proximal humerus in adults.

The implications of surgical trials (American College of Surgeons Oncology Group [ACOSOG] Z011 and ACOSOG Z1071) on imaging protocols for the axilla are reviewed, in conjunction with the American Joint Committee on Cancer nodal staging guidelines.

In addition, surgical trials have often been associated with poor methodological quality.

OBJECTIVE The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151).

In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury.

However, large surgical trials of craniotomy have not demonstrated definitive improvement in clinical outcomes.

Surgical trials are notoriously difficult to perform without the risk of bias in the results.

A total of 9 studies consisting of 2 randomized parallel-arm trials, 4 crossover trials, and 3 nonrandomized clinical or surgical trials were included.

The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial.

1 Patients refractory to physical therapy have increasingly been treated with arthroscopic sub‐acromial decompression (ASAD), although the benefit to patients has recently been challenged by evidence from randomized placebo‐controlled surgical trials.

Surgery and radiotherapy being the mainstay of the treatment of these fragile patients, clinical and surgical trials are required to determine which patients will benefit most from these treatments when affected by metastatic epidural spinal cord compression.

In an era of escalating drug discovery costs, shifting priorities within the pharmaceutical industry, and longstanding challenges in central nervous system drug delivery, surgical trials offer an avenue to identify promising agents with demonstrable tumor penetration and molecular effects.

Objective: To use novel statistical methods for analyzing the effect of lesion set on (long‐standing) persistent atrial fibrillation (AF) in the Cardiothoracic Surgical Trials Network trial of surgical ablation during mitral valve surgery (MVS).

Methods This is a secondary analysis of two surgical trials; concomitant AR was performed at surgeon's discretion.

Patients tend to choose less effective but less invasive treatments, whereas most surgical trials report effectiveness as the most important end-point.

Historically, adverse events in surgical trials have been poorly reported.

COIs do not appear to significantly influence the outcome of randomized neurosurgical trials.

This article will discuss the past and current surgical trials in MPM, the limitations of these and what evidence we can draw upon for current clinical practice.

Results Core themes of: (1) surgical oncology trials; (2) placebo-controlled surgical trials; (3) research funding; (4) medical student involvement in research; (5) emergency care; (6) patient and public involvement.