The creation of operative reports is a tedious documentation task that increases administrative burden, which is a potential driver of burnout. Additionally, operative reports are inherently subjective and may contain inaccuracies and incomplete information. Recent advances in artificial intelligence (AI) technology have enabled computer vision systems to accurately detect operative steps on surgical video. We aim to develop a platform for the automated creation of video-based AI surgical operative reports in robotic-assisted radical prostatectomy.

An AI computer vision algorithm was used to automatically detect surgical steps. Each step detected on video was mapped to prespecified text, which was then compiled into a narrative AI operative report. The accuracy of the AI operative reports was compared with operative reports written by surgeons, using expert review of raw surgical video footage as the ground truth.

A total of 158 cases from a tertiary referral center were included. In surgeon operative reports, 84 cases (53.2%) had at least 1 discrepancy between the operative report and surgical video. Of these, 43 cases (27.2%) had a clinically significant discrepancy based on expert video review. In AI operative reports, 46 cases (29.1%) had at least 1 discrepancy between the operative report and surgical video. Of these, 20 cases (12.7%) had a clinically significant discrepancy. Overall accuracy was higher for AI operative reports compared with surgeon operative reports (87.3% vs 72.8%, p = 0.001).

Operative reports created by AI achieved higher accuracy than those written by surgeons. To our knowledge, this is the first report of automated video-based AI surgical documentation. Future studies are warranted to explore the potential for this novel tool to reduce documentation burden, improve operative report accuracy, promote surgical transparency, and decrease subjectivity in surgical documentation.

To systematically review and characterize the literature on using the pragmatic-explanatory continuum indicator summary (PRECIS) tools in low- and middle-income countries (LMICs), focusing on successes, challenges, and potential improvements to enhance applicability across diverse settings.

A systematic search of PubMed to identify peer-reviewed articles applying PRECIS tools to LMIC-based research. Data extraction focused on trial characteristics, modifications, and use of PRECIS tools. Narrative synthesis was used to outline successes, challenges, and recommendations.

A total of 40 articles met the selection criteria. The PRECIS tools were mostly (n = 39, 97.5%) used for purposes other than trial design. Significant variation was seen in methods of use and reporting. Most (n = 32, 80%) used PRECIS-2, valued for its reliability, ability to quantify pragmatism, assess trial design, and identify research gaps. Challenges included the tools' subjectivity, absence of information needed for scoring, interpretation of scores, and application to non-Western contexts and multinational trials. Recommendations for improvement included refining scoring criteria, translating guidance, and developing additional educational resources.

The PRECIS tools have successfully supported research globally and are perceived as reliable research tools with multiple strengths. Further guidance and refinement would enable consistent application and reporting, particularly as the tools have frequently been used for purposes other than their original intention. Most challenges were similar to high-income settings; however, translation and application of the tools to traditional medicine, international trials, and research-naïve settings were highlighted as LMIC-focused issues requiring consideration.

The pragmatic-explanatory continuum indicator summary (PRECIS) tools were created to help researchers design better studies. The tools were developed mainly by researchers from developed Western nations. Therefore, it is possible that the PRECIS tools are not as relevant to other places. To help improve the usefulness of the tools in all settings, our team wanted to learn from the experiences of people who had already used PRECIS in low- and middle-income countries. We systematically searched for academic papers on this topic published before May 2022 and found 40 relevant articles. The articles showed that the PRECIS tools had been successfully used in many, often unexpected, ways to support research. Some researchers struggled with using the tool to assess research conducted by others, as relevant information was not available. Researchers recommended translating the tools to other languages and asked for more guidance to use the tool in specific circumstances, such as Chinese herbal medicine and large international research projects. Advice on the best ways to use the PRECIS tools and report the findings would also be beneficial. We share these findings to help those designing the next version of the tool make it useful for researchers working in all parts of the world.

Prospective Observational Propensity Score.

Randomization may lead to bias when the treatment is unblinded and there is a strong patient preference for treatment arms (such as in spinal device trials). This report describes the rationale and methods utilized to develop a propensity score (PS) model for an investigational device exemption (IDE) trial (NCT03115983) to evaluate decompression and stabilization with an investigational dynamic sagittal tether (DST) vs decompression and Transforaminal Lumbar Interbody Fusion (TLIF) for patients with symptomatic grade I lumbar degenerative spondylolisthesis with spinal stenosis.

Twenty-five baseline covariates were selected for their expected relationship to patient outcomes or enrollment bias. Subclassification by PS quintiles was used to design a sample of investigational DST patients and TLIF controls with excellent covariate balance in which to estimate causal treatment effects. Additionally, balance in PS covariates was compared to available matching covariates from seven randomized spine IDE trials.

The PS subclassification design resulted in excellent balance across baseline covariates, as evidenced by small standardized mean differences and no significant between group differences after accounting for the PS design (all P ≥ 0.768). Differences in SMDs among covariates of randomized spine IDE trials were not significant (P = 0.396).

The PS subclassification design achieved excellent covariate balance between DST investigational and TLIF control participants. This PS designed sample shows covariate balance similar to that observed in published studies in which patients were randomized to investigational or control arms.Clinical trial registered with https://www.clinicaltrials.gov (NCT03115983).

Kidney transplantation is the ultimate treatment for end-stage kidney disease. Function of the kidney graft is not only dependent on medical factors but also on a complication-free surgical procedure. In the event of major surgical complications, the kidney graft is potentially lost and the patient will return to the waiting list which may be long. To optimise peri-operative care and reduce complications, robot-assisted kidney transplantation (RAKT) has been introduced as an alternative to open kidney transplantation (OKT), but to our knowledge, no randomised clinical trials (RCT) have compared RAKT to OKT. In this study, we will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.

This is a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation recruited from Copenhagen University Hospital - Rigshospitalet, Denmark. The study plans to include 106 participants who will be randomised in a 1:1 manner between OKT and RAKT. Primary outcomes are vascular- and major surgical complications at 30 days post-operatively. Participants will be followed for 2 years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses will follow intention-to-treat principles.

Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify replacing an open approach with a robot-assisted one. Ultimately, the introduction of new surgical techniques should be as vigorously tested as any other new treatments. However, reducing surgical complications that compromise graft viability could lead to improved patient care and survival.

The trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.

Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery.

Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as 'adequate', 'inadequate', or 'no information'; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews.

We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 61 (6.7%) were inadequate, 410 (44.7%) lacked information, and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT.

There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs.

The authors conducted a comprehensive review and integration of insights from 4 webinars hosted by the International Society for the Advancement of Spine Surgery (ISASS) to arrive at recommendations for best clinical practices for guideline development for endoscopic spine surgery. This perspective article discusses the limitations of traditional surgical trials and amalgamates surgeons' experience and research on various cutting-edge techniques.

Data were extracted from surveys conducted during each webinar session involving 3639 surgeons globally. The polytomous Rasch model was employed to analyze responses, ensuring a robust statistical assessment of surgeon endorsements and educational impacts and focusing on operative nuances and experience-based outcomes. Bias detection was performed using the differential item functioning test.

The ISASS webinars provided a dynamic platform for discussing advances in endoscopic spine surgery, identifying a range of high-value procedures from basic discectomies to complex lumbar interbody fusions. Each high-value endoscopic spine surgery was highlighted in separate peer-reviewed publications, which form the basis for this summary document that synthesizes key takeaways from these webinars. High-value clinical applications of endoscopic spine surgery, primarily defined as higher-intensity endorsement transformation from the pre- to postwebinar survey with a shift to higher mean logit locations of test items both with unbiased and orderly threshold progression, were: (a) Percutaneous interlaminar endoscopic decompression for lateral canal stenosis, (b) transforaminal debridement of low-grade degenerative spondylolisthesis, (c) transforaminal full-endoscopic interbody fusion for hard disc herniation, (d) endoscopic standalone lumbar interbody fusion, (e) endoscopic debridement of spondylolytic spondylolisthesis, and (f) posterior cervical foraminotomy for herniated disc and bony stenosis.

The ISASS webinar series has significantly impacted surgeons' education and contributed to the identification of high-value endoscopic spine surgery practices that may serve as a cornerstone for surgeon training standards, policy, and guidelines development. Ongoing research on technological advancements and expansions of clinical indications combined with systematic review is expected to refine the recommendations on high-value endoscopic spinal surgeries recommended for enhanced reimbursement.

Assessing surgeon confidence and acceptance of endoscopic spinal surgeries using polytomous Rasch analysis.

Level 2 (inferential) and 3 (observational) evidence because Rasch analysis provides statistical validation of instruments rather than direct clinical outcomes.

Gastric cancer (GC) is the leading diagnosed malignancy worldwide, especially in China. Radical surgery is the cornerstone of GC treatment. We reviewed previous clinical trials and aimed to provide an update on the factors related to the surgical treatment of GC. The number of registered clinical trials in the field of GC surgery is rapidly increasing. With the development and popularization of endoscopic, laparoscopic, and robotic techniques, GC surgery has gradually entered a new era of precise minimally invasive surgery. Postoperative quality of life has become a major issue in addition to surgical oncological safety. Although great progress has been made in clinical research on GC in China, there are still deficiencies. Many studies enrolled large numbers of patients, but the research data were not of high quality. The characteristics of GC in China include a high incidence, large population, and large proportion of patients with advanced GC, which provides sufficient reason for studying this disease. There is still a need for well-designed, large, randomized clinical trials to improve our knowledge of the surgical treatment of GC.

Robot-assisted minimally invasive gastrectomy (RAMIG) is increasingly used as a surgical approach for gastric cancer. This study assessed the effectiveness of RAMIG and studied which stages of the IDEAL-framework (1 = Idea, 2A = Development, 2B = Exploration, 3 = Assessment, 4 = Long-term follow-up) were followed.

The Cochrane Library, Embase, Pubmed, and Web of Science were searched for studies on RAMIG up to January 2023. Data collection included the IDEAL-stage, demographics, number of participants, and study design. For randomized controlled trials (RCTs) and long-term studies, data on intra-, postoperative, and oncologic outcomes, survival, and costs of RAMIG were collected and summarized.

Of the 114 included studies, none reported the IDEAL-stage. After full-text reading, 18 (16%) studies were considered IDEAL-2A, 75 (66%) IDEAL-2B, 4 (4%) IDEAL-3, and 17 (15%) IDEAL-4. The IDEAL-stages were followed sequentially (2A-4), with IDEAL-2A studies still ongoing. IDEAL-3 RCTs showed lower overall complications (8.5-9.2% RAMIG versus 17.6-19.3% laparoscopic total/subtotal gastrectomy), equal 30-day mortality (0%), and equal length of hospital stay for RAMIG (mean 5.7-8.5 days RAMIG versus 6.4-8.2 days open/laparoscopic total/subtotal gastrectomy). Lymph node yield was similar across techniques, but RAMIG incurred significantly higher costs than laparoscopic total/subtotal gastrectomy ($13,423-15,262 versus $10,165-10,945). IDEAL-4 studies showed similar or improved overall/disease-free survival for RAMIG.

During worldwide RAMIG implementation, the IDEAL-framework was followed in sequential order. IDEAL-3 and 4 long-term studies showed that RAMIG is similar or even better to conventional surgery in terms of hospital stay, lymph node yield, and overall/disease-free survival. In addition, RAMIG showed reduced postoperative complication rates, despite higher costs.

Comparative studies on surgical treatments with time-to-event endpoints have provided substantial evidence for clinical practice, but the accurate use of survival data analysis and the control of confounding bias remain big challenges.

This was a survey of surgical studies with survival outcomes published in four general medical journals and five general surgical journals in 2021. The two most concerned statistical issues were evaluated, including confounding control by propensity score analysis (PSA) or multivariable analysis and testing of proportional hazards (PH) assumption in Cox model.

A total of 74 studies were included, comprising 63 observational studies and 11 randomized controlled trials. Among the observational studies, the proportion of studies utilizing PSA in surgical oncology and non-oncology studies was similar (40.9 % versus 36.8 %, P = 0.762). However, the former reported a significantly lower proportion of PH assumption assessments compared to the latter (13.6 % versus 42.1 %, P = 0.020). Twenty-five observational studies (25/63) used PSA methods, but two-thirds of them (17/25) showed unclear balance of baseline data after PSA. And the proportion of PH assumption testing after PSA was slightly lower than that before PSA, but the difference was not statistically significant (24.0 % versus 28.0 %, P = 0.317). Comprehensive suggestions were given on confounding control in survival analysis and alternative resolutions for non-compliance with PH assumption.

This study highlights suboptimal reporting of PH assumption evaluation in observational surgical studies both before and after PSA. Efforts and consensus are needed with respect to the underlying assumptions of statistical methods.

To evaluate the quantity and quality of randomized controlled trials (RCTs) in hepatobiliary surgery and for identifying gaps in current evidences.

A systematic search was conducted in MEDLINE (via PubMed), Web of Science, and Cochrane Controlled Register of Trials (CENTRAL) for RCTs of hepatobiliary surgery published from inception until the end of 2023. The quality of each study was assessed using the Cochrane risk-of-bias (RoB) tool. The associations between risk of bias and the region and publication date were also assessed. Evidence mapping was performed to identify research gaps in the field.

The study included 1187 records. The number and proportion of published randomized controlled trials (RCTs) in hepatobiliary surgery increased over time, from 13 RCTs (.0005% of publications) in 1970-1979 to 201 RCTs (.003% of publications) in 2020-2023. There was a significant increase in the number of studies with a low risk of bias in RoB domains (p < .01). The proportion of RCTs with low risk of bias improved significantly after the introduction of CONSORT guidelines (p < .001). The evidence mapping revealed a significant research focus on major and minor hepatectomy and cholecystectomy. However, gaps were identified in liver cyst surgery and hepatobiliary vascular surgery. Additionally, there are gaps in the field of perioperative management and nutrition intervention.

The quantity and quality of RCTs in hepatobiliary surgery have increased over time, but there is still room for improvement. We have identified gaps in current research that can be addressed in future studies.

Loss to follow-up (LTFU) distorts results of randomized controlled trials (RCTs). Understanding trial characteristics that contribute to LTFU may enable investigators to anticipate the extent of LTFU and plan retention strategies. The objective of this systematic review and meta-analysis was to investigate the extent of LTFU in surgical RCTs and evaluate associations between trial characteristics and LTFU.

MEDLINE, Embase, and PubMed Central were searched for surgical RCTs published between January 2002 and December 2021 in the 30 highest impact factor surgical journals. Two-hundred eligible RCTs were randomly selected. The pooled LTFU rate was estimated using random intercept Poisson regression. Associations between trial characteristics and LTFU were assessed using metaregression.

The 200 RCTs included 37,914 participants and 1307 LTFU events. The pooled LTFU rate was 3.10 participants per 100 patient-years (95% confidence interval [CI] 1.85-5.17). Trial characteristics associated with reduced LTFU were standard-of-care outcome assessments (rate ratio [RR] 0.17; 95% CI 0.06-0.48), surgery for transplantation (RR 0.08; 95% CI 0.01-0.43), and surgery for cancer (RR 0.10; 95% CI 0.02-0.53). Increased LTFU was associated with patient-reported outcomes (RR 14.21; 95% CI 4.82-41.91) and follow-up duration ≥ three months (odds ratio 10.09; 95% CI 4.79-21.28).

LTFU in surgical RCTs is uncommon. Participants may be at increased risk of LTFU in trials with outcomes assessed beyond the standard of care, surgical indications other than cancer or transplant, patient-reported outcomes, and longer follow-up. Investigators should consider the impact of design on LTFU and plan retention strategies accordingly.

Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.

The aim was to analyze the learning curves of minimal invasive liver surgery(MILS) and propose a standardized reporting.

MILS offers benefits compared to open resections. For a safe introduction along the learning curve, formal training is recommended. However, definitions of learning curves and methods to assess it lack standardization.

A systematic review of PubMed, Web of Science, and CENTRAL databases identified studies on learning curves in MILS. The primary outcome was the number needed to overcome the learning curve. Secondary outcomes included endpoints defining learning curves, and characterization of different learning phases(competency, proficiency and mastery).

60 articles with 12'241 patients and 102 learning curve analyses were included. The laparoscopic and robotic approach was evaluated in 71 and 18 analyses and both approaches combined in 13 analyses. Sixty-one analyses (60%) based the learning curve on statistical calculations. The most often used parameters to define learning curves were operative time (n=64), blood loss (n=54), conversion (n=42) and postoperative complications (n=38). Overall competency, proficiency and mastery were reached after 34 (IQR 19-56), 50 (IQR 24-74), 58 (IQR 24-100) procedures respectively. Intraoperative parameters improved earlier (operative time: competency to proficiency to mastery: -13%, 2%; blood loss: competency to proficiency to mastery: -33%, 0%; conversion rate (competency to proficiency to mastery; -21%, -29%), whereas postoperative complications improved later (competency to proficiency to mastery: -25%, -41%).

This review summarizes the highest evidence on learning curves in MILS taking into account different definitions and confounding factors. A standardized three-phase reporting of learning phases (competency, proficiency, mastery) is proposed and should be followed.

Systematic review.

To determine if the natural experiment design is a useful research methodology concept in spinal trauma care, and to determine if this methodology can be a viable alternative when randomized controlled trials are either infeasible or unethical.

A Medline, Embase and Cochrane database search was performed between 2004 and 2023 for studies comparing different treatment modalities of spinal trauma. All observational studies with a natural experiment design comparing different treatment modalities of spinal trauma were included. Data extraction and quality assessment with the MINORS criteria was performed.

Four studies with a natural experiment design regarding patients with traumatic spinal fractures were included. All studies were retrospective, one study collected follow-up data prospectively. Three studies compared different operative treatment modalities, whereas one study compared different antibiotic treatment strategies. Two studies compared preferred treatment modalities between expertise centers, one study between departments (neuro- and orthopedic surgery) and one amongst surgeons. For the included retrospective studies, MINORS scores (maximum score 18) were high ranging from 12-17 and with a mean (SD) of 14.6 (1.63).

Since 2004 only four studies using a natural experiment design have been conducted in spinal trauma. In the included studies, comparability of patient groups was high emphasizing the potential of natural experiments in spinal trauma research. Natural experiments design should be considered more frequently in future research in spinal trauma as they may help to address difficult clinical problems when RCT's are infeasible or unethical.

Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical.

Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials.

We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods.

Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment.

Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

A greater than 1 mm tumour-free resection margin (R0 >1 mm) is a prognostic factor in upfront-resected pancreatic ductal adenocarcinoma. After neoadjuvant treatment (NAT); however, the prognostic impact of resection margin (R) status remains controversial.

Randomised and non-randomised studies assessing the association of R status and survival in resected pancreatic ductal adenocarcinoma after NAT were sought by systematic searches of MEDLINE, Web of Science and CENTRAL. Hazard ratios (HR) and their corresponding 95% CI were collected to generate log HR using the inverse-variance method. Random-effects meta-analyses were performed and the results presented as weighted HR. Sensitivity and meta-regression analyses were conducted to account for different surgical procedures and varying length of follow-up, respectively.

Twenty-two studies with a total of 4929 patients were included. Based on univariable data, R0 greater than 1 mm was significantly associated with prolonged overall survival (OS) (HR 1.76, 95% CI 1.57-1.97; P<0.00001) and disease-free survival (DFS) (HR 1.66, 95% CI 1.39-1.97; P<0.00001). Using adjusted data, R0 greater than 1 mm was significantly associated with prolonged OS (HR 1.65, 95% CI 1.39-1.97; P<0.00001) and DFS (HR 1.76, 95% CI 1.30-2.39; P=0.0003). Results for R1 direct were comparable in the entire cohort; however, no prognostic impact was detected in sensitivity analysis including only partial pancreatoduodenectomies.

After NAT, a tumour-free margin greater than 1 mm is independently associated with improved OS as well as DFS in patients undergoing surgical resection for pancreatic cancer.

Laparoscopic incisional hernia repair is increasingly performed worldwide and expected to be superior to conventional open repair regarding hospital stay and quality of life (QoL). The INCisional Hernia-Trial was designed to test this hypothesis.

A multicenter parallel randomized controlled open-label trial with a superiority design was conducted in six hospitals in the Netherlands. Patients with primary or recurrent incisional hernias were randomized by computer-guided block-randomization to undergo either conventional open or laparoscopic repair. Primary endpoint was postoperative length of hospital stay in days. Secondary endpoints included QoL, complications, and recurrences. Patients were followed up for at least 5 years.

Hundred-and-two patients were recruited and randomized. In total, 88 patients underwent surgery and were included in the intention-to-treat analysis (44 in the open group, 44 in the laparoscopic group). Mean age was 59.5 years, gender division was equal, and BMI was 28.8 kg/m. The trial was concluded early for futility after an unplanned interim analysis, which showed that the hypothesis needed to be rejected. There was no difference in primary outcome: length of hospital stay was 3 (range 1-36) days in the open group and 3 (range 1-12) days in the laparoscopic group (p = 0.481). There were no significant between-group differences in QoL questionnaires on the short and long term. Satisfaction was impaired in the open group. Overall recurrence rate was 19%, of which 16% in the open and 23% in the laparoscopic group (p = 0.25) at a mean follow-up of 6.6 years.

In a randomized controlled trial, short- and long-term outcomes after laparoscopic incisional hernia repair were not superior to open surgery. The persisting high recurrence rates, reduced QoL, and suboptimal satisfaction warrant the need for patient's expectation management in the preoperative process and individualized surgical management.

Netherlands Trial Register NTR2808.

Randomized controlled clinical trials (RCTs) are at the heart of "evidence-based" medicine. Conducting well-designed RCTs for surgical procedures is often challenged by inadequate recruitment accrual, blinding, or standardization of the surgical procedure, as well as lack of funding and evolution of the treatment strategy during the many years over which such trials are conducted. In addition, most clinical trials are performed in academic high-volume centers with highly selected patients, which may not necessarily reflect a "real-world" practice setting. Large databases provide easy and inexpensive access to data on a large and diverse patient population at a variety of treatment centers. Furthermore, large database studies provide the opportunity to answer questions that would be impossible or very arduous to answer using RCTs, including questions regarding health policy efficacy, trends in surgical practice, access to health care, the impact of hospital volume, and adherence to practice guidelines, as well as research questions regarding rare disease, infrequent surgical outcomes, and specific subpopulations. Prospective data registries may also allow for quality benchmarking and auditing. There are several high-quality RCTs providing evidence to support current practices in hepatopancreatobiliary (HPB) oncology. Evidence from big data bridges the gap in several instances where RCTs are lacking. In this article, we review the evidence from RCTs and big data in HPB oncology identify the existing lacunae, and discuss the future directions of research in HPB oncology.

We aimed to evaluate the renoprotective effects of remote ischemic preconditioning (RIPC) in patients undergoing robot-assisted laparoscopic partial nephrectomy (RAPN). Data from 59 patients with solitary renal tumors who underwent RAPN with RIPC comprising three cycles of 5-min inflation to 200 mmHg of a blood pressure cuff applied to one lower limb followed by 5-min reperfusion by cuff deflation, from 2018 to 2020 were analyzed. Patients who underwent RAPN for solitary renal tumors without RIPC between 2018 and 2020 were selected as controls. The postoperative estimated glomerular filtration rate (eGFR) at the nadir during hospitalization and the percentage change from baseline were compared using propensity score matching analysis. We performed a sensitivity analysis with imputations for missing postoperative renal function data weighted by the inverse probability of the data being observed. Of the 59 patients with RIPC and 482 patients without RIPC, 53 each were matched based on propensity scores. No significant differences in the postoperative eGFR in mL/min/1.73 m2 at nadir (mean difference 3.8; 95% confidence interval [CI] - 2.8 to 10.4) and its percentage change from baseline (mean difference 4.7; 95% CI - 1.6 to 11.1) were observed between the two groups. Sensitivity analysis also indicated no significant differences. No complications were associated with the RIPC. In conclusion, we found no significant evidence of the protective effect of RIPC against renal dysfunction after RAPN. Further research is required to determine whether specific patient subgroups benefit from RIPC.Trial registration number: UMIN000030305 (December 8, 2017).

RCTs are essential in guiding clinical decision-making but are difficult to perform, especially in surgery. This review assessed the trend in volume and methodological quality of published surgical RCTs over two decades.

PubMed was searched systematically for surgical RCTs published in 1999, 2009, and 2019. The primary outcomes were volume of trials and RCTs with a low risk of bias. Secondary outcomes were clinical, geographical, and funding characteristics.

Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The most common subspecialty in 2019 was gastrointestinal surgery (50.7 per cent). The volume of surgical RCTs increased mostly in Asia (61, 159, and 199 trials), especially in China (7, 40, and 81). In 2019, countries with the highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect.

The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs.

This analysis was conducted to characterize contemporary randomized controlled trials (RCTs) in cardiothoracic surgery.

We selected randomized controlled trials published in the journals with the highest impact factor in medicine, general surgery, and cardiothoracic surgery and published between 2008 and 2020. Trial characteristics as well as measures of reporting and quality were summarized and compared.

Ninety-three trials were included; 44 (47.3%) were prospectively registered and 14 (31.8%) had a discrepancy between the registered and published primary outcome. Most trials (n = 83 [89.1%]) used a superiority design, a composite primary outcome (n = 82 [88.2%]), and a major clinical event as the primary end point (n = 67 [72.0%]). Blinding was used infrequently, and most trials did not control for surgeon experience (n = 74 [79.5%]) or monitor the intervention (n = 90 [96.7%]). Twenty-four (25.8%) trials had high risk of bias. Twenty-one (27.3%) trials were funded by industry. A median 1.62% of patients (interquartile range, 0.00-3.70) crossed over between trial arms. Most trials reported a favorable outcome (n = 53 [58.9%]). For eligible trials, the median fragility index was 2.0 (interquartile range, 0.0-4.0), meaning the change of 2 patient outcomes would render the significant result insignificant. Spin, or distortion in reporting, was identified in 9 of 53 trials (17.0%). The median number of citations was 25 (10-56).

Contemporary trials in cardiothoracic surgery are pragmatic with low rates of loss to follow-up and crossover. Few trials implemented measures to ensure quality of the intervention, and the presence of spin was infrequent.

Surgery is central to the cure of most solid cancers and an integral part of modern multimodal cancer management for early and advanced stage cancers. Decisions made by surgeons and multidisciplinary team members are based on best available knowledge for the defined clinical situation at hand. While surgery is both an art and a science, good decision-making requires data that are robust, valid, representative and, applicable to most if not all patients with a specific cancer. Such data largely comes from clinical observations and registries, and more preferably from trials conducted with the specific purpose of arriving at new answers. As part of the ESSO core curriculum development an increased focus has been put on the need to enhance research literacy among surgical candidates. As an expansion of the curriculum catalogue list and to enhance the educational value, we here present a set of principles and emerging concepts which applies to surgical oncologist for reading, understanding, planning and contributing to future surgeon-led cancer trials.

Surgical studies evaluating a device or technology in comparison to an established surgical technique should accurately report all the important components of the surgical technique in order to reduce the risk of intervention bias. In the debate of visualization of the recurrent laryngeal nerve alone (VONA) versus intraoperative nerve monitoring (IONM) during thyroidectomy, surgical technique plays a key role in both strategies. Our aim was to investigate whether the surgical technique was considered as a risk of intervention bias by relevant meta-analyses and reviews and if steps of surgical intervention were described in their included studies.

We searched PUBMED, CENTRAL-Cochrane library, PROSPERO and GOOGLE for reviews and meta-analyses focusing on the comparison of IONM to VONA in primary open thyroidectomy. Τhen, primary studies were extracted from their reference lists. We developed a typology for surgical technique applied in primary studies and a framework approach for the evaluation of this typology by the meta-analyses and reviews.

Twelve meta-analyses, one review (388,252 nerves at risk), and 84 primary studies (128,720 patients) were included. Five meta-analyses considered the absence of typology regarding the surgical technique as a source of intervention bias; 48 primary studies (57.14%) provided information about at least one item of the typology components and only 1 for all of them.

Surgical technique of thyroidectomy in terms of a typology is underreported in studies and undervalued by meta-analyses comparing VONA to IONM. This missing typology should be reconsidered in the comparative evaluation of these two strategies.

Pragmatic clinical trials (PCTs) are designed to reflect how an investigational treatment would be applied in clinical practice. As such, unlike their explanatory counterparts, they measure therapeutic effectiveness and are capable of generating high-quality real-world evidence. However, the conduct of PCTs remains extremely rare. The scarcity of such studies has contributed to the emergence of the efficacy-effectiveness gap and has led to calls for launching more of them, including in the field of oncology. This analysis aimed to identify self-labelled pragmatic trials of antineoplastic interventions and to evaluate whether their use of this label was justified.

We searched PubMed® and Embase® for publications corresponding with studies that investigated antitumor therapies and that were tagged as pragmatic in their titles, abstracts and/or index terms. Subsequently, we consulted all available source documents for the included trials and extracted relevant information from them. The data collected were then used to appraise the degree of pragmatism displayed by the PCTs with the help of the validated PRECIS-2 tool.

The literature search returned 803 unique records, of which 46 were retained upon conclusion of the screening process. This ultimately resulted in the identification of 42 distinct trials that carried the 'pragmatic' label. These studies examined eight different categories of neoplasms and were mostly randomized, open-label, multicentric, single-country trials sponsored by non-commercial parties. On a scale of one (very explanatory) to five (very pragmatic), the median PCT had a PRECIS-2 score per domain of 3.13 (interquartile range: 2.57-3.53). The most and least pragmatic studies in the sample had a score of 4.44 and 1.57, respectively. Only a minority of trials were described in sufficient detail to allow them to be graded across all domains of the PRECIS-2 instrument. Many of the studies examined also had features that arguably precluded them from being pragmatic altogether, such as being monocentric or placebo-controlled in nature.

PCTs of antineoplastic treatments are generally no more pragmatic than they are explanatory.

Surgical innovations are necessary to improve patient care. After an initial exploratory phase, novel surgical technique should be compared with alternative options or standard care in randomized controlled trials (RCTs). However, surgical RCTs have unique methodological challenges. Our study sought to investigate key aspects of the design, conduct, and reporting of RCTs of novel surgeries.

Systematic review.

The protocol was prospectively registered in PROSPERO (CRD42021253297). RCTs evaluating novel surgeries for cataract, vitreoretinal, glaucoma, and corneal diseases were included. Medline, EMBASE, Cochrane Library, and Clinicaltrials.gov were searched. The search period was January 1, 2016, to June 16, 2021.

A total of 52 ophthalmic surgery RCTs were identified in the fields of glaucoma (n = 12), vitreoretinal surgery (n = 5), cataract (n = 19), and cornea (n = 16). A description defining the surgeon's experience or level of expertise was reported in 30 RCTs (57%) and was presented in both control and intervention groups in 11 (21%). Specification of the number of cases performed in the particular surgical innovation being assessed prior to the trial was reported in 10 RCTs (19%) and an evaluation of quality of the surgical intervention in 7 (13%). Prospective trial registration was recorded in 12 RCTs (23%) and retrospective registration in 13 (25%); and there was no registration record in the remaining 28 (53%) studies.

Important aspects of the study design such as the surgical learning curve, surgeon's previous experience, quality assurance, and trial registration details were often missing in novel ophthalmic surgical procedures. The Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework aims to improve the quality of study design.

Previous observational studies and meta-analyses have recommended augmentation with a fibular allograft (FA) during the treatment of proximal humeral fractures with locking plates (LPs). However, to our knowledge, randomized controlled trials comparing open reduction and internal fixation (ORIF) with and without FA have not been performed to date.

This was a randomized controlled trial in which adults with a medial column comminuted proximal humeral fracture were randomly allocated to undergo ORIF with an LP (the LP group) or with an LP augmented with an FA (the FA group). Patients were followed for 24 months. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score at 12 months after the surgical procedure. The secondary outcomes included the DASH score at other time points, shoulder function, pain score, satisfaction, complications, and changes in neck-shaft angle and humeral head height.

From October 20, 2016, to December 24, 2019, 80 patients were randomized. There were 52 women (65%), and the mean patient age (and standard deviation) was 65 ± 14 years. Of the 80 patients, 39 were allocated to the FA group and 41 were allocated to the LP group. At the primary time point (12 months), the unadjusted mean between-group difference in DASH score was -1.2 (95% confidence interval [CI], -7.3 to 5.0; p = 0.71) favoring the FA group, and, with adjustment for smoking, alcohol drinking, and diabetes, the between-group difference was -1.4 (95% CI, -7.7 to 5.0; p = 0.67) favoring FA. No significant differences between the 2 groups were found among the secondary outcomes.

No additional benefit was found for FA augmentation in treating medial column comminuted proximal humeral fractures.

Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

Aging is associated with a decline in the regenerative potential of stem cells. In recent years, several clinical trials have been launched in order to evaluate the efficacy of mesenchymal stem cell interventions to slow or reverse normal aging processes (aging conditions). Information concerning those clinical trials was extracted from national and international databases (United States, EU, China, Japan, and World Health Organization). Mesenchymal stem cell preparations were in development for two main aging conditions: physical frailty and facial skin aging. With regard to physical frailty, positive results have been obtained in phase II studies with intravenous Lomecel-B (an allogeneic bone marrow stem cell preparation), and a phase I/II study with an allogeneic preparation of umbilical cord-derived stem cells was recently completed. With regard to facial skin aging, positive results have been obtained with an autologous preparation of adipose-derived stem cells. A further sixteen clinical trials for physical frailty and facial skin aging are currently underway. Reducing physical frailty with intravenous mesenchymal stem cell administration can increase healthy life expectancy and decrease costs to the public health system. However, intravenous administration runs the risk of entrapment of the stem cells in the lungs (and could raise safety concerns). In addition to aesthetic purposes, clinical research on facial skin aging allows direct evaluation of tissue regeneration using sophisticated and precise methods. Therefore, research on both conditions is complementary, which facilitates a global vision.

The reverse fragility index (RFI) describes the number of event conversions needed to convert a statistically nonsignificant dichotomous outcome to a significant one. The objective of the present study was to assess the RFI of vascular surgery randomized controlled trials (RCTs) comparing endovascular vs open surgery for the treatment of abdominal aortic aneurysms (AAAs), carotid artery stenosis (CAS), and peripheral artery disease (PAD).

MEDLINE and Embase were searched for RCTs that had investigated AAAs, CAS, or PAD with statistically nonsignificant binary primary outcomes. The primary outcome for the present study was the median RFI. Calculation of the RFI was performed by creating two-by-two contingency tables and subtracting events from the group with fewer events and adding nonevents to the same group until a two-tailed Fisher exact test had produced a statistically significant result (P ≤ .05).

Of 4187 reports, 49 studies reporting 103 different primary end points were included. The overall median RFI was 7 (interquartile range [IQR], 5-13). The specific RFIs for AAA, CAS, and PAD were 10 (IQR, 6-15.5), 6 (IQR, 5-9.5), and 7 (IQR, 5.5-10), respectively. Of the 103 end points, 42 (47%) had had a loss to follow-up greater than the RFI, of which 10 were AAA trials (24%), 23 were CAS trials (55%), and 9 were PAD trials (21%). The Pearson correlation demonstrated a significant positive relationship between a study's RFI and the impact factor of its publishing journal (r = 0.38; 95% confidence interval [CI], 0.20-0.54; P < .01), length of follow-up (r = 0.43; 95% CI, 0.26-0.58; P < .01), and sample size (r = 0.28; 95% CI, 0.09-0.45; P < .01).

A small number of events (median, 7) was required to change the outcome of negative RCTs from statistically nonsignificant to significant, with 47% of the studies having missing data that could have reversed the finding of its primary outcome. Reporting of the RFI relative to the loss to follow-up could be of benefit in future trials and provide confidence regarding the robustness of the P value.

There is an ongoing debate whether coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) provide better results for the treatment of coronary artery disease (CAD). We aimed to evaluate the impact of CABG or PCI on long-term survival based on local reports from different regions in the world. We systematically searched MEDLINE selecting studies that compared outcomes for CABG or PCI as a treatment for CAD in the last 10 years. Reports without all-cause mortality, multi-national cohorts, hybrid revascularization populations were excluded. Qualifying studies were statistically compared, and their geographic location visualized on a world map. From 5126 studies, one randomized and twenty-two observational studies (19 risk-adjusted) met the inclusion criteria. The mean follow-up was 4.7 ± 7 years and 18 different countries were included. In 17 studies, CABG was associated with better survival during follow-up, six studies showed no significant difference, and no study favored PCI. Periprocedural mortality was not different in seven, lower with PCI in one, lower with CABG in three and not reported in 12 studies. In regional registry-type comparisons, CABG is associated with better long-term survival compared to PCI in most regions of the world without evidence for higher periprocedural mortality.

When performing orthopaedic clinical research, alternative study designs can be more appropriate depending on the research question, availability of data, and feasibility. The most common observational study designs in total joint arthroplasty research are cohort and cross-sectional studies. This article describes methodological considerations for different study designs with examples from the total joint arthroplasty literature. We highlight the advantages and feasibility of experimental and observational study designs using real-world examples. We illustrate how to avoid common mistakes, such as incorrect labeling of matched cohort studies as case-control studies. We further guide investigators through a step-by-step design of a case-control study. We conclude with considerations when choosing between alternative study designs. Please visit the followinghttps://youtu.be/Zvce61cMYi8for videos that explain the highlights of the article in practical terms.

To test whether providing relevant clinical trial registry information to peer reviewers evaluating trial manuscripts decreases discrepancies between registered and published trial outcomes.

Stepped wedge, cluster-randomised trial, with clusters comprised of eligible manuscripts submitted to each participating journal between 1 November 2018 and 31 October 2019.

Thirteen medical journals.

Manuscripts were eligible for inclusion if they were submitted to a participating journal during the study period, presented results from the primary analysis of a clinical trial, and were peer reviewed.

During the control phase, there were no changes to pre-existing peer review practices. After journals crossed over into the intervention phase, peer reviewers received a data sheet describing whether trials were registered, the initial registration and enrolment dates, and the registered primary outcome(s) when enrolment began.

The presence of a clearly defined, prospectively registered primary outcome consistent with the primary outcome in the published trial manuscript, as determined by two independent outcome assessors.

We included 419 manuscripts (243 control and 176 intervention). Participating journals published 43% of control-phase manuscripts and 39% of intervention-phase manuscripts (model-estimated percentage difference between intervention and control trials = -10%, 95% CI -25% to 4%). Among the 173 accepted trials, published primary outcomes were consistent with clearly defined, prospectively registered primary outcomes in 40 of 105 (38%) control-phase trials and 27 of 68 (40%) intervention-phase trials. A linear mixed model did not show evidence of a statistically significant primary outcome effect from the intervention (estimated difference between intervention and control=-6% (90% CI -27% to 15%); one-sided p value=0.68).

These results do not support use of the tested intervention as implemented here to increase agreement between prospectively registered and published trial outcomes. Other approaches are needed to improve the quality of outcome reporting of clinical trials.

ISRCTN41225307.

Professional and other organizations, including oral health care organizations, have been developing evidence-based clinical practice guidelines (CPGs) to help providers incorporate the best available evidence into their clinical decision making. Although the rigor of guideline development has increased over time, ongoing challenges prevent the full adoption of CPGs into clinical practices that experience variability in provider expertise and opinion, patient flow pace, and use of electronic dental records. These challenges include lack of relevant evidence, failure to keep guidelines up to date, and failure to adopt strategies aimed at overcoming the barriers preventing implementation into clinical practice.

This article provides a brief overview of strategies that can be used to overcome common challenges to guideline adoption. Such strategies include creating evidence-based CPGs that use additional sources of evidence and methods to inform guideline development and accelerate the guideline updating and dissemination process (that is, evidence directly from clinical practice, big data, patients' values and preferences, and living guidelines) and applying implementation strategies that have been documented as improving translation of CPGs into routine clinical practice (that is, guideline implementability, implementation science, and computable guidelines).

Adopting newer strategies for developing and translating evidence into practice could lead to improvements in patient care and population health.

The COVID-19 pandemic has brought many challenges including barriers to delivering high-quality surgical care and follow-up while minimizing the risk of infection. Telehealth has been increasingly utilized for post-operative visits, yet little data exists to guide surgeons in its use. We sought to determine safety and efficacy of telehealth follow-up in patients undergoing cholecystectomy during the global pandemic at a VA Medical Center (VAMC).

This was a retrospective review of patients undergoing cholecystectomy at a level 1A VAMC over a 2-year period from August 2019 to August 2021. Baseline demographics, post-operative complications, readmissions, emergency department (ED) visits and need for additional procedures were reviewed. Patients who experienced a complication prior to discharge, underwent a concomitant procedure, had non-absorbable skin closure, had new diagnosis of malignancy or were discharged home with drain(s) were ineligible for telehealth follow-up and excluded.

Over the study period, 179 patients underwent cholecystectomy; 30 (17%) were excluded as above. 20 (13%) missed their follow-up, 52 (35%) were seen via telehealth and 77 (52%) followed-up in person. There was no difference between the two groups regarding baseline demographics or intra-operative variables. There was no significant difference in post-operative complications [4 (8%) vs 6 (8%), p > 0.99], ED utilization [5 (10%) vs 7 (9%), p = 0.78], 30-day readmission [3 (6%) vs 6 (8%), p = 0.74] or need for additional procedures [2 (4%) vs 4 (5%), p = 0.41] between telehealth and in-person follow-up.

Telehealth follow-up after cholecystectomy is safe and effective in Veterans. There were no differences in outcomes between patients that followed up in-person vs those that were seen via phone or video. Routine telehealth follow-up after uncomplicated cholecystectomy should be considered for all patients.