Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

Fragility of Statistically Significant Outcomes in Colonic Diverticular Disease Randomized Trials: A Systematic Review.

BACKGROUND: The p value has been criticized as an oversimplified determination of whether a treatment effect exists. One alternative is the fragility index. It is a representation of the minimum number of nonevents that would need to be converted to events to increase the p value above 0.05. OBJECTIVE: To determine the fragility index of randomized controlled trials assessing the efficacy of interventions for patients with diverticular disease since 2010 to assess the robustness of current evidence. DESIGN: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to August 2022. SETTINGS: Articles were eligible for inclusion if they were randomized trials conducted between 2010 and 2022 with parallel, superiority designs evaluating interventions in patients with diverticular disease. Only randomized trials with dichotomous primary outcomes with an associated p value of <0.05 were considered for inclusion. PARTICIPANTS: Any surgical or medical intervention for patients with diverticular disease. MAIN OUTCOME MEASURES: The fragility index was determined by adding events and subtracting nonevents from the groups with the smaller number of events. Events were added until the p value exceeded 0.05. The smallest number of events required was considered the fragility index. RESULTS: After screening 1271 citations, 15 randomized trials met the inclusion criteria. Nine of the studies evaluated surgical interventions and 6 evaluated medical interventions. The mean number of patients randomly assigned and lost to follow-up per randomized controlled trial was 92 (SD 35.3) and 9 (SD 11.4), respectively. The median fragility index was 1 (range, 0-5). The fragility indices for the included studies did not correlate significantly with any study characteristics. LIMITATIONS: Small sample, heterogeneity, and lack of inclusion of studies with continuous outcomes. CONCLUSIONS: The randomized trials evaluating surgical and medical interventions for diverticular disease are not robust. Changing a single-outcome event in most studies was sufficient to make a statistically significant study finding not significant. See Video Abstract . FRAGILIDAD DE LOS RESULTADOS ESTADSTICAMENTE SIGNIFICATIVOS EN ENSAYOS ALEATORIOS DE ENFERMEDAD DIVERTICULAR DEL COLON UNA REVISIN SISTEMTICA: ANTECEDENTES:El valor p ha sido criticado por una determinación demasiado simplificada de si existe un efecto del tratamiento. Una alternativa es el Índice de Fragilidad. Es una representación del número mínimo de no eventos que deberían convertirse en eventos para aumentar el valor p por encima de 0,05.OBJETIVO:Determinar el IF de ensayos controlados aleatorios que evalúan la eficacia de las intervenciones para pacientes con enfermedad diverticular desde 2010 para evaluar la solidez de la evidencia actual.FUENTES DE DATOS:Se realizaron búsquedas en MEDLINE, Embase y CENTRAL desde el inicio hasta agosto de 2022.SELECCIÓN DE ESTUDIOS:Los artículos eran elegibles para su inclusión si eran ensayos aleatorizados realizados entre 2010 y 2022 con diseños paralelos de superioridad que evaluaran intervenciones en pacientes con enfermedad diverticular. Sólo se consideraron para su inclusión los ensayos aleatorizados con resultados primarios dicotómicos con un valor de p asociado menor que 0,05.INTERVENCIÓNES:Cualquier intervención quirúrgica o médica para pacientes con enfermedad diverticular.PRINCIPALES MEDIDAS DE VALORACIÓN:El índice de fragilidad se determinó sumando eventos y restando no eventos de los grupos con el menor número de eventos. Se agregaron eventos hasta que el valor p superó 0,05. El menor número de eventos requeridos se consideró índice de fragilidad.RESULTADOS:Después de examinar 1271 citas, 15 ensayos aleatorios cumplieron los criterios de inclusión. Nueve de los estudios evaluaron intervenciones quirúrgicas y seis evaluaron intervenciones médicas. El número medio de pacientes aleatorizados y perdidos durante el seguimiento por ECA fue 92 (DE 35,3) y 9 (DE 11,4), respectivamente. La mediana del índice de fragilidad fue 1 (rango: 0-5). Los índices de fragilidad de los estudios incluidos no se correlacionaron significativamente con ninguna característica del estudio.LIMITACIONES:Muestra pequeña, heterogeneidad y falta de inclusión de estudios con resultados continuos.CONCLUSIONES:Los ensayos aleatorios que evalúan las intervenciones quirúrgicas y médicas para la enfermedad diverticular no son sólidos. Cambiar un solo evento de resultado en la mayoría de los estudios fue suficiente para que un hallazgo estadísticamente significativo del estudio no fuera significativo. (Traducción- Dr. Ingrid Melo ).

Duodeno-ileal diversion with self-forming magnets in a sutureless neodymium anastomosis procedure (SNAP) for weight recidivism after sleeve gastrectomy: feasibility and 9-month results.

BACKGROUND: The sleeve gastrectomy (SG) has become the most common bariatric procedure worldwide. However, insufficient weight loss or weight recidivism is frequent, which may require effective and safe revisional procedures. OBJECTIVE: To determine the technical feasibility and safety of a minimally invasive, duodeno-ileal side-to-side anastomosis using a Sutureless Neodymium Anastomosis Procedure (SNAP) for patients with weight recidivism or inadequate weight loss following SG. METHODS: This is a prospective, single-arm, open-label pilot study that enrolled patients with obesity to assist in weight reduction following an SG performed > 12 months prior. For the SNAP, self-assembling magnets were deployed into the ileum (laparoscopically) and duodenum (per-oral endoscopy). Magnets were coupled under laparoscopic and fluoroscopic guidance to create a compression anastomosis. The primary endpoints were technical feasibility, weight loss, and rate of serious adverse events (SAEs). RESULTS: Successful duodeno-ileal diversions were created with SNAP in 27 participants (mean age: 50.6 ± 9.1, mean BMI: 38.1 ± 4.6 kg/m2) with no device-related serious adverse events. Upper endoscopy at 3 months confirmed patent, healthy anastomoses in all patients. At 9 months, patients (n = 24) experienced 11.9 ± 6.2%, 14.5 ± 10.8%, and 17.0 ± 13.9% TBWL at 3, 6, and 9 months, respectively. There were no device-related SAEs. CONCLUSION: The SNAP is technically feasible and relatively safe, with all patients presenting widely patent anastomosis at 3 months. Patients experienced a progressive, clinically meaningful weight loss. Further studies are needed to confirm our findings.

Arthroscopic stabilization surgery for first-time anterior shoulder dislocations: a systematic review and meta-analysis.

BACKGROUND: The optimal management of first-time anterior shoulder dislocations (FTASDs) remains controversial. Therefore, the purpose of this study was to assess the efficacy of arthroscopic stabilization surgery for FTASDs through a systematic review and meta-analysis of existing literature. METHODS: MEDLINE, Embase, and Web of Science were searched from inception to December 18, 2022, for single-arm or comparative studies assessing FTASDs managed with arthroscopic stabilization surgery following first-time dislocation. Eligible comparative studies included studies assessing outcomes following immobilization for an FTASD, or arthroscopic stabilization following recurrent dislocations. Eligible levels of evidence were I to IV. Primary outcomes included rates of shoulder redislocations, cumulative shoulder instability, and subsequent shoulder stabilization surgery. RESULTS: Thirty-four studies with 2222 shoulder dislocations were included. Of these, 5 studies (n = 408 shoulders) were randomized trials comparing immobilization to arthroscopic Bankart repair (ABR) after a first dislocation. Another 16 studies were nonrandomized comparative studies assessing arthroscopic Bankart repair following first-time dislocation (ABR-F) to either immobilization (studies = 8, n = 399 shoulders) or arthroscopic Bankart repair following recurrent dislocations (ABR-R) (studies = 8, n = 943 shoulder). Mean follow-up was 59.4 ± 39.2 months across all studies. Cumulative loss to follow-up was 4.7% (range, 0%-32.7%). A composite rate of pooled redislocation, cumulative instability, and reoperations across ABR-F studies was 6.8%, 11.2%, and 6.1%, respectively. Meta-analysis found statistically significant reductions in rates of redislocation (odds ratio [OR] 0.09, 95% confidence interval [CI] 0.04-0.3, P < .001), cumulative instability (OR 0.05, 95% CI 0.03-0.08, P < .001), and subsequent surgery (OR 0.08, 95% CI 0.04-0.15, P < .001) when comparing ABR-F to immobilization. Rates of cumulative instability (OR 0.32, 95% CI 0.22-0.47, P < .001) and subsequent surgery rates (OR 0.27, 95% CI 0.09-0.76, P = .01) were significantly reduced with ABR-F relative to ABR-R, with point estimate of effect favoring ABR-F for shoulder redislocation rates (OR 0.59, 95% CI 0.19-1.83, P = .36). Return to sport rates to preoperative levels or higher were 3.87 times higher following ABR-F compared to immobilization (95% CI 1.57-9.52, P < .001), with limited ABR-R studies reporting this outcome. The median fragility index of the 5 included randomized controlled trials (RCTs) was 2, meaning reversing only 2 outcome events rendered the trials' findings no longer statistically significant. CONCLUSION: Arthroscopic stabilization surgery for FTASDs leads to lower rates of redislocations, cumulative instability, and subsequent stabilization surgery relative to immobilization or arthroscopic stabilization surgery following recurrence. Although a limited number of RCTs have been published on the subject matter to date, the strength of their conclusions is limited by a small sample size and statistically fragile results.

The Reverse Fragility Index for Mortality End Points in Randomized Trials Comparing Uncemented and Cemented Hemiarthroplasty for Intracapsular Hip Fractures.

BACKGROUND: Interpreting clinical relevance of randomized clinical trials (RCTs) is challenging when P-values are marginally above or below the P = .05 threshold. This study examined the robustness of statistically insignificant mortality events from RCTs comparing hemiarthroplasty femoral fixation for displaced intracapsular hip fractures through the reverse fragility index (RFI). METHODS: RCTs were identified using Pubmed, OVID/Medline, and Cochrane databases. Mortality endpoints were stratified into 3 categories: (1) within 30-days, (2) within 90-days, and (3) at latest follow-up. The RFI was derived by manipulating reported mortality events utilizing a contingency table while maintaining a constant number of participants. The reverse fragility quotient (RFQ) was quantified by dividing the RFI by the study sample. RESULTS: Eight RCTs (2,494 participants) were included. The median RFI and RFQ within 30-days was 3.0 (interquartile range [IQR]: 3.0 to 6.0) and 0.016 (IQR: 0.015 to 0.021), suggesting nonsignificant findings were contingent on 1.6 mortality events/100 participants. The median RFI and RFQ within 90-days was 6.0 (IQR: 4.0 to 7.0) and 0.028 (IQR: 0.024 to 0.038), suggesting nonsignificant findings were contingent on 2.8 mortality events/100 participants. At latest follow-up, the median RFI and RFQ was 7.0 (IQR: 6.0 to 12.0) and 0.038 (IQR: 0.029 to 0.054), suggesting nonsignificant findings were contingent on only 3.8 mortality events/100 participants. Median loss to follow-up was 16.0 (IQR: 11.0 to 58.0; 228% greater than RFI), and exceeded the RFI in 6/7(85.7%) studies. CONCLUSIONS: A small number of events (median of 7) was required to convert a statistically nonsignificant finding to one that is significant for the endpoint of mortality. The median loss to follow-up exceeded the median RFI by greater than 200%, suggesting methodological limitations such as patient allocation could alter conclusions.

Best practice approach for redo-surgeries after sleeve gastrectomy, an expert's modified Delphi consensus.

BACKGROUND: Sleeve gastrectomy (SG) is the most common metabolic and bariatric surgical (MBS) procedure worldwide. Despite the desired effect of SG on weight loss and remission of obesity-associated medical problems, there are some concerns regarding the need to do revisional/conversional surgeries after SG. This study aims to make an algorithmic clinical approach based on an expert-modified Delphi consensus regarding redo-surgeries after SG, to give bariatric and metabolic surgeons a guideline that might help for the best clinical decision. METHODS: Forty-six recognized bariatric and metabolic surgeons from 25 different countries participated in this Delphi consensus study in two rounds to develop a consensus on redo-surgeries after SG. An agreement/disagreement ≥ 70.0% on statements was considered to indicate a consensus. RESULTS: Consensus was reached for 62 of 72 statements and experts did not achieve consensus on 10 statements after two rounds of online voting. Most of the experts believed that multi-disciplinary team evaluation should be done in all redo-procedures after SG and there should be at least 12 months of medical and supportive management before performing redo-surgeries after SG for insufficient weight loss, weight regain, and gastroesophageal reflux disease (GERD). Also, experts agreed that in case of symptomatic GERD in the presence of adequate weight loss, medical treatment for at least 1 to 2 years is an acceptable option and agreed that Roux-en Y gastric bypass is an appropriate option in this situation. There was disagreement consensus on efficacy of omentopexy in rotation and efficacy of fundoplication in the presence of a dilated fundus and GERD. CONCLUSION: Redo-surgeries after SG is still an important issue among bariatric and metabolic surgeons. The proper time and procedure selection for redo-surgery need careful considerations. Although multi-disciplinary team evaluation plays a key role to evaluate best options in these situations, an algorithmic clinical approach based on the expert's consensus as a guideline can help for the best clinical decision-making.

What Is the Prevalence of Intimate Partner Violence and Traumatic Brain Injury in Fracture Clinic Patients?

BACKGROUND: Individuals in violent intimate relationships are at a high risk of sustaining both orthopaedic fractures and traumatic brain injury (TBI), and the fracture clinic may be the first place that concurrent intimate partner violence (IPV) and TBI are recognized. Both IPV and TBI can affect all aspects of fracture management, but prevalence of TBI and comorbid TBI and IPV is unknown. QUESTIONS/PURPOSES: (1) What are the previous-year and lifetime prevalence of IPV and TBI in women presenting to an outpatient orthopaedic fracture clinic? (2) What are the conditional probabilities of TBI in the presence of IPV and the reverse, to explore whether screening for one condition could effectively identify patients with the other? (3) Do patients with TBI, IPV, or both have worse neurobehavioral symptoms than patients without TBI and IPV? METHODS: The study was completed in the fracture clinic at a community Level 1 trauma center in Southern Ontario from July 2018 to March 2019 and included patients seen by three orthopaedic surgeons. Inclusion criteria were self-identification as a woman, age 18 years or older, and the ability to complete forms in English without assistance from the person who brought them to the clinic (for participant safety and privacy). We invited 263 women to participate: 22 were ineligible (for example, they were patients of a surgeon who was not on the study protocol), 87 declined before hearing the topic of the study, and data from eight were excluded because the data were incomplete or lost. Complete data were obtained from 146 participants. Participants' mean age was 52 ± 16 years, and the most common diagnosis was upper or lower limb fracture. Prevalence of IPV was calculated as the number of women who answered "sometimes" or "often" to direct questions from the Woman Abuse Screening Tool, which asks about physical, emotional, and sexual abuse in the past year or person's lifetime. The prevalence of TBI was calculated as the number of women who reported at least one head or neck injury that resulted in feeling dazed or confused or in loss of consciousness lasting 30 minutes or less on the Ohio State University Traumatic Brain Injury Identification Method, a standardized procedure for eliciting lifetime history of TBI through a 3- to 5-minute structured interview. Conditional probabilities were calculated using a Bayesian analysis. Neurobehavioral symptoms were characterized using the Neurobehavioral Symptom Inventory, a standard self-report measure of everyday emotional, somatic, and cognitive complaints after TBI, with total scores compared across groups using a one-way ANOVA. RESULTS: Previous-year prevalence of physical IPV was 7% (10 of 146), and lifetime prevalence was 28% (41 of 146). Previous-year prevalence of TBI was 8% (12 of 146), and lifetime prevalence was 49% (72 of 146). The probability of TBI in the presence of IPV was 0.77, and probability of IPV in the presence of TBI was 0.36. Thus, screening for IPV identified proportionately more patients with TBI than screening for TBI, but the reverse was not true. Neurobehavioral Symptom Inventory scores were higher (more symptoms) in patients with TBI only (23 ± 16) than those with fractures only (12 ± 11, mean difference 11 [95% CI 8 to 18]; p < 0.001), in those with IPV only (17 ± 11) versus fractures only (mean difference 5 [95% CI -1 to -11]; p < 0.05), and in those with both TBI and IPV (25 ± 14) than with fractures only (mean difference 13 [95% CI 8 to 18]; p < 0.001) or those with IPV alone (17 ± 11, mean difference 8 [95% CI -1 to 16]; p < 0.05). CONCLUSION: Using a brief screening interview, we identified a high self-reported prevalence of TBI and IPV alone, consistent with previous studies, and a novel finding of high comorbidity of IPV and TBI. Given that the fracture clinic may be the first healthcare contact for women with IPV and TBI, especially mild TBI associated with IPV, we recommend educating frontline staff on how to identify IPV and TBI as well as implementing brief screening and referral and universal design modifications that support effective, efficient, and accurate communication patients with TBI-related cognitive and communication challenges. LEVEL OF EVIDENCE: Level II, prognostic study.

Failure to disclose industry funding impacts outcomes in randomized controlled trials of platelet-rich plasma.

PURPOSE: Platelet-rich plasma (PRP) represents a highly profitable biological therapy. Platelet-rich plasma is widely used to treat musculoskeletal disorders despite mixed evidence of its efficacy. As evidenced by literature from other domains, industry funding may influence the results of clinical trials. The objective of the current study was to determine the association between industry funding and positive results for randomized controlled trials (RCTs) assessing the efficacy of PRP in musculoskeletal disorders. METHODS: A search of four databases was conducted. Included studies were RCTs comparing PRP to any non-PRP comparator in adults (18 years old or over) with musculoskeletal disorders and had full text available in English. Studies were excluded if they were published before 2016 or were non-human trials. A multivariate binomial logistic regression model was created to explore predictors of statistically significant findings. Covariates included the presence of industry funding, sample size, and length of study follow-up. 1440 records were screened with 87 trials included in the final analysis. RESULTS: Of the 87 studies, 61 (70%) reported a statistically significant primary outcome. The presence of industry funding was not predictive of a statistically significant primary outcome [OR = 0.36, 95% CI 0.096-1.36, (n.s.)]. Studies that did not state whether industry funding was present had a higher chance of reporting a statistically significant primary outcome (OR = 3.61, 95% CI 1.1-11.9, p = 0.035). Sample size and length of follow-up were not predictive of a statistically significant primary outcome. CONCLUSION: The results of the current study conclude that industry funding had no impact on the reporting of positive results for RCTs investigating PRP in musculoskeletal disorders. However, not disclosing sources of funding was associated with a higher likelihood of reporting positive results. The results of trials that fail to disclose funding sources should be interpreted with caution in the PRP literature. LEVEL OF EVIDENCE: I.

Trend of female first authorship in Journal of Orthopaedic Science, the official journal of the Japanese orthopaedic association from 2001 to 2021: An observational study.

BACKGROUND: Women are underrepresented in orthopaedic surgery, especially in Japan. Authorship is associated with representation and career advancement, but the academic representation of women in Japanese orthopaedic surgery has not been elucidated. This study aimed to elucidate the proportion of female first authorship and its associating factors, as well as trends in the Journal of Orthopaedic Science (JOS), the official journal of the Japanese Orthopaedic Association. METHODS: The study reviewed original articles published in JOS from 2002 to 2021 using data from PubMed on March 16, 2022. The gender of the first and last authors was determined using genderize. io, an online gender detection tool and manual search. The study used multivariable logistic regression to identify the factors associated with female first authorship and visualized the trend of predicted probability using restricted cubic spline curve. RESULTS: Among 2272 original articles, 148 (6.5%) and 79 (3.5%) had female first and last authors, respectively. Compared with 2002-2006, female first authorship significantly increased in 2012-2016 (adjusted odds ratio [aOR], 2.04; 95% confidence interval [CI], 1.09-4.05; p = 0.03) and 2017-2021 (aOR, 2.72; 95% CI, 1.46-5.276; p = 0.002). Affiliation with an institution in Japan (aOR, 0.51; 95% CI, 0.35-0.74; p < 0.001) and affiliation in orthopaedics (aOR, 0.16; 95% CI, 0.11-0.23; p < 0.001) were negatively associated with female first authorship. Around 2020, the trend showed a gradual then rapid increase in women with non-orthopaedic affiliations. Only a very small increase was observed in women with an orthopaedic affiliation. CONCLUSIONS: Female first authorship in JOS has been increasing. However, the proportion of female authors remains low. Authors outside of Japan and not affiliated with orthopaedics largely affect female authorship statistics. The results indicate the persistent gender gap in the academic representation of women in Japanese orthopaedic publications.

Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations?

BACKGROUND: Patients with a tibial shaft fracture experiencing their first postoperative complication following treatment with intramedullary nails may be at greater risk of subsequent complications than the whole population. We aimed to determine whether the initial method of nail insertion influences outcome in patients with a tibial shaft fracture requiring multiple reoperations. METHODS: Using the Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures trial data, we categorized patients as those not requiring reoperation, those requiring a single reoperation and those requiring multiple reoperations, and we compared them by nail insertion technique (reamed v. unreamed) and fracture type (open v. closed). We then determined the number of patients whose first reoperation was in response to infection, and we compared other clinical outcomes between the reamed and unreamed groups. RESULTS: Among 1226 patients included in this analysis, 175 (14.27%) experienced a single reoperation and 44 patients (3.59%) underwent multiple reoperations. Nail insertion techniques (reamed v. unreamed) did not play a role in the need to perform multiple reoperations. Seventy-five percent of patients requiring multiple reoperations had open tibial shaft fractures. An equal number of these were reamed and unreamed insertions. The majority of patients had their course complicated by infection and almost 50% of patients whose first reoperation was for infection required more than 2 reoperations for management. The rest required multiple procedures for nonunion or bone loss. CONCLUSION: Our findings corroborate those of other studies, in which open fracture type rather than nail insertion technique was found to be the cause of morbidity following intramedullary nailing of tibial fractures. CLINICAL TRIAL REGISTRATION: www. CLINICALTRIALS: gov, no. NCT00038129.

Use of population-based electronic databases for the identification of patients with synchronous colorectal cancer and liver metastases potentially eligible for a surgical trial.

BACKGROUND: Some population-based recruitment methods, such as registries and databases, have been used to increase enrolment in clinical trials by identifying eligible participants based on baseline characteristics; however; these methods have not been tested in surgical trials, in which accrual occurs before surgery. We evaluated the use of population-based electronic databases to identify patients who potentially could be accrued to the Simultaneous Resection of Colorectal Cancer with Synchronous Liver Metastases (RESECT) trial and compared it to the traditional methods used to accrue patients (e.g., multidisciplinary rounds, letters to community surgeons) for that same trial during the same period. METHODS: An electronic database (ePath) was interrogated every 2 weeks for patients diagnosed with colorectal cancer from Feb. 1, 2017, to Mar. 30, 2019. A radiologic image database (OneView) was reviewed to identify those with liver metastases (level 1 screening). Reports were interrogated to identify potentially eligible patients for the RESECT trial (level 2 screening). A hepatobiliary surgeon reviewed radiology images to identify eligible patients for the trial (level 3 screening). The primary outcome was patient eligibility for the ongoing RESECT trial. RESULTS: The population-based method identified 90 (11.2%) of 803 patients diagnosed with colorectal cancer over the study period. Among the 90 patients, level 2 screening identified 60 (67%) potentially eligible patients for the RESECT trial. Of the 90 patients, 18 (20%) were eligible after radiographic image review (level 3 screening). Traditional accrual methods identified 38 patients with liver metastases, 27 (71%) of whom were identified as potentially eligible on level 2 screening, and 14 (37%) of whom were deemed to be eligible on level 3 screening. Twenty-six patients were identified by both methods. Twelve patients were identified by population-based methods alone, and 8 patients by traditional methods alone. Six eligible patients were identified by both methods. Baseline characteristics were similar between the 2 groups. CONCLUSION: A population-based electronic database method of patient accrual was able to identify eligible participants for the RESECT trial. However, optimal accrual likely requires the use of traditional methods as well.

Evidence-based treatment of Achilles tendon rupture.

The treatment of Achilles tendon rupture has recently seen a shift toward non-operative management, as supported by the literature, yet many surgeons continue to treat these injuries operatively. The evidence clearly supports non-operative management of these injuries except for Achilles insertional tears and for certain patient groups, such as athletic patients, for whom further research is warranted. This nonadherence to evidence-based treatment may be explained by patient preference, surgeon subspecialty, surgeon era of practice or other variables. Further research to understand the reasons behind this nonadherence would help to promote conformity in the surgical community across all specialties and adherence to evidence-based approaches.

Four-year outcomes for endoscopic sleeve gastroplasty from a single centre in India.

Background: Bariatric endoscopy has emerged for non-surgical treatment of obesity, providing a treatment option for weight loss and associated comorbidities. Outcomes of endoscopic sleeve gastroplasty (ESG) of 12 months have been published by our team and there is a need for longer follow-up period understanding the effects of ESG techniques. Aim: This report emphasises on weight loss pattern in follow-up time points and monitors the post-procedure improvement in comorbidities with minimum 4-year follow-up of patients undergoing ESG at a single academic centre in India. Subjects and Methods: This was a prospective cohort study. All procedures were performed by the same surgeon. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities) underwent ESG for treatment of obesity. Patients were systematically followed yearly after their procedure. Data collected on the primary outcome and secondary outcomes were analysed and presented. Results: 612 patients (69.3% female) with a mean age of 40.70 ± 12.66 years and mean body mass index of 34.30 ± 5.05 kg/m2 underwent ESG. Out of 612 patients, follow-up rates for a 1-2-3 and 4 years were 93.1%, 90.2%, 81.7% and 81.9%, respectively. The mean percentage total body weight loss was 18.19% (95% confidence interval [CI]: 17.72-18.57) and %EWL was 49.30% (95% CI: 48.91-49.68) with 90% of participants-maintaining a percentage of total weight loss of ≥5% and 70% of patients maintaining an EWL of ≥25% at 4 years, respectively. Resolution/improvement of comorbidities was 51.2% cases of T2DM, 65.8% cases of hypertension, 73.6% cases of dyslipidaemia and 89.9% remission were in obstructive sleep apnoea. No patient required an emergency intervention, and there was no mortality or significant morbidity. Conclusions: This study shows acceptable results with ESG at 4 years in our unit. Regular monitoring by a multidisciplinary nurtures weight loss, resolution or improvement of comorbidities and improvement of quality of life with low perioperative complications. There is a need for more reports with this approach to determine the amount and duration of weight loss outcome and medical intervention.

Postoperative mortality in the COVID-positive hip fracture patient, a systematic review and meta-analysis.

PURPOSE: The extent to which concomitant COVID-19 infection increases short-term mortality following hip fracture is not fully understood. A systemic review and meta-analysis of COVID-19 positive hip fracture patients (CPHFPs) undergoing surgery was conducted to explore the association of COVID-19 with short-term mortality. METHODS: Review of the literature identified reports of short-term 30-day postoperative mortality in CPHFPs. For studies including a contemporary control group of COVID-19 negative patients, odds ratios of the association between COVID-19 infection and short-term mortality were calculated. Short-term mortality and the association between COVID-19 infection and short-term mortality were meta-analyzed and stratified by hospital screening type using random effects models. RESULTS: Seventeen reports were identified. The short-term mortality in CPHFPs was 34% (95% C.I., 30-39%). Short-term mortality differed slightly across studies that screened all patients, 30% (95% C.I., 22-39%), compared to studies that conditionally screened patients, 36% (95% C.I., 31-42%), (P = 0.22). The association between COVID-19 infection and short-term mortality produced an odds ratio of 7.16 (95% C.I., 4.99-10.27), and this was lower for studies that screened all patients, 4.08 (95% C.I., 2.31-7.22), compared to studies that conditionally screened patients, 8.32 (95% C.I., 5.68-12.18), (P = 0.04). CONCLUSION: CPHFPs have a short-term mortality rate of 34%. The odds ratio of short-term mortality was significantly higher in studies that screened patients conditionally than in studies that screened all hip fracture patients. This suggests mortality prognostication should consider how COVID-19 infection was identified as asymptomatic patients may fare slightly better.

Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture.

BACKGROUND: Globally, hip fractures are among the top 10 causes of disability in adults. For displaced femoral neck fractures, there remains uncertainty regarding the effect of a total hip arthroplasty as compared with hemiarthroplasty. METHODS: We randomly assigned 1495 patients who were 50 years of age or older and had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. All enrolled patients had been able to ambulate without the assistance of another person before the fracture occurred. The trial was conducted in 80 centers in 10 countries. The primary end point was a secondary hip procedure within 24 months of follow-up. Secondary end points included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health end points. RESULTS: The primary end point occurred in 57 of 718 patients (7.9%) who were randomly assigned to total hip arthroplasty and 60 of 723 patients (8.3%) who were randomly assigned to hemiarthroplasty (hazard ratio, 0.95; 95% confidence interval [CI], 0.64 to 1.40; P = 0.79). Hip instability or dislocation occurred in 34 patients (4.7%) assigned to total hip arthroplasty and 17 patients (2.4%) assigned to hemiarthroplasty (hazard ratio, 2.00; 99% CI, 0.97 to 4.09). Function, as measured with the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score, modestly favored total hip arthroplasty over hemiarthroplasty. Mortality was similar in the two treatment groups (14.3% among the patients assigned to total hip arthroplasty and 13.1% among those assigned to hemiarthroplasty, P = 0.48). Serious adverse events occurred in 300 patients (41.8%) assigned to total hip arthroplasty and in 265 patients (36.7%) assigned to hemiarthroplasty. CONCLUSIONS: Among independently ambulating patients with displaced femoral neck fractures, the incidence of secondary procedures did not differ significantly between patients who were randomly assigned to undergo total hip arthroplasty and those who were assigned to undergo hemiarthroplasty, and total hip arthroplasty provided a clinically unimportant improvement over hemiarthroplasty in function and quality of life over 24 months. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov number, NCT00556842.).

The 12- and 24-Month Effects of Intravitreal Ranibizumab, Aflibercept, and Bevacizumab on Intraocular Pressure: A Network Meta-Analysis.

TOPIC: To investigate the effect of anti-vascular endothelial growth factor (VEGF) therapy on intraocular pressure (IOP) 12 and 24 months after initiation. CLINICAL RELEVANCE: It is unclear whether serial anti-VEGF injections result in sustained IOP increases. METHODS: Randomized controlled trials (RCTs) comparing anti-VEGF agents with each other or with controls for the treatment of neovascular age-related macular degeneration, retinal vein occlusions, or diabetic macular edema were included. Pairwise meta-analysis and Bayesian network meta-analysis examined the proportion of patients whose IOP (1) increased 5 mmHg or more from baseline on consecutive visits, (2) increased 10 mmHg or more from baseline at any visit, (3) was 21 mmHg or more on consecutive visits, (4) was 25 mmHg or more at any visit, (5) was 30 mmHg or more at any visit, (6) prompted initiation of IOP-lowering medications, or (7) increased as per the clinicians' discretion. Grading of Recommendations Assessments, Development, and Evaluations methodology informed the certainty of evidence. RESULTS: Twenty-six RCTs of 12 522 eyes were included. Aflibercept, bevacizumab, ranibizumab (0.3 mg and 0.5 mg), and noninjection controls were analyzed. Eighty-three of 84 network estimates for comparisons between anti-VEGF agents demonstrated no statistically significant difference (low to moderate certainty of evidence). Ranibizumab 0.5 mg showed higher rates than bevacizumab of IOP measurements of 30 mmHg or more at 12 months (low certainty of evidence). Fifty-three of 56 network estimates for comparisons between anti-VEGF agents and controls demonstrated no statistically significant difference (low to moderate certainty of evidence). Ranibizumab 0.5 mg showed higher rates of consecutive IOP increases of 5 mmHg or more at 24 months (low certainty of evidence) and higher rates of IOP increases as per the clinicians' discretion at 12 and 24 months (low and very low certainty of evidence, respectively). The 95% credible intervals in comparisons without statistically significant effects did not rule out important clinical effects. The certainty of evidence in these comparisons is limited by imprecision. CONCLUSION: This network meta-analysis does not show any clear difference in IOP increases 12 and 24 months after treatment initiation between anti-VEGF agents and controls. Imprecision precludes definitive conclusions.

Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial.

BACKGROUND AND OBJECTIVES: We tested the feasibility of a simultaneous resection clinical trial in patients with synchronous colorectal cancer liver metastases to obtain the necessary information to plan a randomized trial. METHODS: Multicenter feasibility single-arm trial enrolling patients with synchronous colorectal cancer liver metastases eligible for simultaneous resection. Prespecified criteria for feasibility were: proportion of eligible patients enrolled ≥66%, and the proportion of enrolled patients who completed simultaneous resection ≥75%. The prespecified 90-day major postoperative complication rate was 30%. RESULTS: Of 61 eligible patients from February 2017 to August 2019, 41 were enrolled (67%; 95% confidence interval [CI], 55%-78%), 32 underwent simultaneous resection (78%; 95% CI, 63%-88%). Four patients were not enrolled due to the surgeon's preference, three were due to the complexity of resection (right hepatectomy and low anterior resection). Intraoperative complications during liver resection (n = 4) and progression of disease (n = 4) were the main reasons for not undergoing simultaneous resection. The 90-day incidence of major complications was 41% (95% CI, 16%-58%) and the 90-day postoperative mortality was 6% (95% CI, 1.7%-20%). CONCLUSION: According to prespecified criteria, enrolling patients with synchronous colorectal cancer liver metastases to a trial of simultaneous resection is feasible; however, it is associated with higher than anticipated 90-day postoperative complications.

Comparative benefits and harms of individual opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised trials.

BACKGROUND: Most systematic reviews of opioids for chronic pain have pooled treatment effects across individual opioids under the assumption they provide similar benefits and harms. We examined the comparative effects of individual opioids for chronic non-cancer pain through a network meta-analysis of randomised controlled trials. METHODS: We searched MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials to March 2021 for studies that enrolled patients with chronic non-cancer pain, randomised them to receive different opioids, or opioids vs placebo, and followed them for at least 4 weeks. Certainty of evidence was evaluated using the GRADE approach. RESULTS: We identified 82 eligible trials (22 619 participants) that evaluated 14 opioids. Compared with placebo, several opioids showed superiority to others for analgesia and improvement in physical function; however, when restricted to pooled-effect estimates supported by moderate certainty evidence, no differences between opioids were evident. Among opioids with moderate certainty evidence, all increased the risk of gastrointestinal adverse events compared with placebo, although no opioids were more harmful than others. Low to very low certainty evidence suggests that extended-release vs immediate-release opioids may provide similar benefits for pain relief and physical functioning, and gastrointestinal harms. CONCLUSIONS: Our findings support the pooling of effect estimates across different types and formulations of opioids to inform effectiveness for chronic non-cancer pain.

Prevalence and Perception of Intimate Partner Violence-Related Traumatic Brain Injury.

BACKGROUND: Traumatic brain injury (TBI) is a serious and often undiagnosed consequence of intimate partner violence (IPV). Data on prevalence of TBI among IPV survivors are emerging, but prevalence of IPV among patients presenting to TBI clinics is unknown. Identification of IPV is important to ensure patients with TBI receive appropriate intervention and referrals. OBJECTIVE: To determine the proportion of women 18 years and older presenting to an acquired brain injury (ABI) clinic with confirmed or suspected concussion who reported experiencing IPV in the last 12 months or their lifetime. METHODS: Single-center cross-sectional cohort study. Proportion of IPV-related TBI or head, neck, or facial) injuries were determined using a modified HELPS Brain Injury Screening Tool and the Neurobehavioral Symptom Inventory. RESULTS: Of the 97 women approached, 50 were enrolled in the study. The average age was 46.1 years and 32 women (64.0%) reported a relationship history with a violent partner; 12-month prevalence of IPV was 26.5% and lifetime prevalence was 44.0%. Within their lifetime, all (44.0%) who reported an IPV history reported emotional abuse, 24.0% reported physical abuse, and 18.0% sexual abuse. HELPS responses indicated a high potential of lifetime IPV-related TBI for 29.2%, most commonly from being hit in the face or head (20.8%). CONCLUSION: Implementation of IPV screening in community-based ABI clinics is a pivotal step toward understanding the potential scope of TBI and addressing the wide range of somatic, cognitive, and affective symptoms experienced by IPV survivors. IPV screening also will lead to timely referral and follow-up and increase patient safety after discharge from rehabilitation.

Patients With Femoral Neck Fractures Are at Risk for Conversion to Arthroplasty After Internal Fixation: A Machine-learning Algorithm.

BACKGROUND: Femoral neck fractures are common and are frequently treated with internal fixation. A major disadvantage of internal fixation is the substantially high number of conversions to arthroplasty because of nonunion, malunion, avascular necrosis, or implant failure. A clinical prediction model identifying patients at high risk of conversion to arthroplasty may help clinicians in selecting patients who could have benefited from arthroplasty initially. QUESTION/PURPOSE: What is the predictive performance of a machine-learning (ML) algorithm to predict conversion to arthroplasty within 24 months after internal fixation in patients with femoral neck fractures? METHODS: We included 875 patients from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial. The FAITH trial consisted of patients with low-energy femoral neck fractures who were randomly assigned to receive a sliding hip screw or cancellous screws for internal fixation. Of these patients, 18% (155 of 875) underwent conversion to THA or hemiarthroplasty within the first 24 months. All patients were randomly divided into a training set (80%) and test set (20%). First, we identified 27 potential patient and fracture characteristics that may have been associated with our primary outcome, based on biomechanical rationale and previous studies. Then, random forest algorithms (an ML learning, decision tree-based algorithm that selects variables) identified 10 predictors of conversion: BMI, cardiac disease, Garden classification, use of cardiac medication, use of pulmonary medication, age, lung disease, osteoarthritis, sex, and the level of the fracture line. Based on these variables, five different ML algorithms were trained to identify patterns related to conversion. The predictive performance of these trained ML algorithms was assessed on the training and test sets based on the following performance measures: (1) discrimination (the model's ability to distinguish patients who had conversion from those who did not; expressed with the area under the receiver operating characteristic curve [AUC]), (2) calibration (the plotted estimated versus the observed probabilities; expressed with the calibration curve intercept and slope), and (3) the overall model performance (Brier score: a composite of discrimination and calibration). RESULTS: None of the five ML algorithms performed well in predicting conversion to arthroplasty in the training set and the test set; AUCs of the algorithms in the training set ranged from 0.57 to 0.64, slopes of calibration plots ranged from 0.53 to 0.82, calibration intercepts ranged from -0.04 to 0.05, and Brier scores ranged from 0.14 to 0.15. The algorithms were further evaluated in the test set; AUCs ranged from 0.49 to 0.73, calibration slopes ranged from 0.17 to 1.29, calibration intercepts ranged from -1.28 to 0.34, and Brier scores ranged from 0.13 to 0.15. CONCLUSION: The predictive performance of the trained algorithms was poor, despite the use of one of the best datasets available worldwide on this subject. If the current dataset consisted of different variables or more patients, the performance may have been better. Also, various reasons for conversion to arthroplasty were pooled in this study, but the separate prediction of underlying pathology (such as, avascular necrosis or nonunion) may be more precise. Finally, it may be possible that it is inherently difficult to predict conversion to arthroplasty based on preoperative variables alone. Therefore, future studies should aim to include more variables and to differentiate between the various reasons for arthroplasty. LEVEL OF EVIDENCE: Level III, prognostic study.