Factors Associated With Loss to Follow-Up in Surgical Trials: A Systematic Review and Meta-Analysis.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Variability in risk tolerance and adherence to guidelines in "go or no-go" decisions among anesthetists in Saudi Arabia.

BACKGROUND: Anesthetists deal with many situations where they decide whether proceeding with anesthesia is safe or not. These are termed "go or no-go" decisions. Although guidelines have been developed to ensure safe anesthesia, many factors affect anesthetists' decision in practice. Therefore, we aimed to assess the variability in risk tolerance when making "go or no-go" decisions among anesthetists in Saudi Arabia. MATERIALS AND METHOD: A questionnaire-based study that included anesthetists practicing in Saudi Arabia from 1--14th October 2017 was conducted. The questionnaire presented 11 clinical scenarios that involved deviation from guidelines, followed by four questions where the participants were asked to decide whether they would proceed with administering anesthesia, write a comment explaining their decision, to predict whether a colleague would make the same decision, and if they had a previous similar experience. RESULTS: A total of 124 anesthetists responded, of which 56.5% were consultants. There was no absolute consensus over the decision to proceed in any scenario. Most of the respondents who would proceed (67.35%) expected a colleague to make the same decision. Anesthetists who encountered a previous similar experience were more likely to proceed (P = 0.000). There was no significant difference among the respondents' decisions according to years of experience (P = 0.121). Analysis of the comments showed that procedure urgency and presence of alternatives to deficient resources were the most frequent factors that dictated anesthetists' decision. CONCLUSION: There is a wide variation in risk tolerance among anesthetists. Further simulation-based studies are needed to identify and address factors that affect anesthetists' decisions.

Systematic review of anorectal leiomyosarcoma: Current challenges and recent advances.

BACKGROUND: The anorectal leiomyosarcoma (LMS) is an aggressive malignant neoplasm. Owing to the rarity of LMSs, an optimal treatment modality has yet to be determined. AIM: To collect all published data on anorectal LMS characteristics, explore current treatment options, and review recent cases of postradiation LMS. METHODS: A literature search of the PubMed electronic database was conducted using the MeSH terms "rectal neoplasms", "anus neoplasms" and "gastrointestinal neoplasms" combined with "leiomyosarcoma". The search was limited to English language and human studies. All available case reports and case series of anal or rectal LMSs that were published from the beginning of January 1996 to May 2017 were included if the diagnosis of LMS had been confirmed by histopathologic examination. Data were analyzed using simple statistics (mean, median, and standard deviation). Independent sample t-test was used to compare means for continuous variables. RESULTS: A total of 27 articles reporting on 51 cases of anorectal LMS were identified. Among these cases, 11.7% had undergone previous pelvic radiotherapy (developing LMS at 13-35 years afterwards). Anorectal LMS affected the rectum in 92.2% of the cases, and no sex-based predominance was observed. Surgical resection with negative margins remains the mainstay of treatment, which can be accomplished with wide local excision or radical resection. The local recurrence rate was higher among cases who received wide local excision (30%), as compared to radical resection (20%); however, the overall rate of metastasis was 51.61% regardless of the treatment approach. The use of neoadjuvant radiation lowers the risk of local recurrence compared to adjuvant radiotherapy, and facilitates R0 resection of the tumor. Cases treated with adjuvant chemotherapy showed better rates of distant recurrence and overall survival. Nonetheless, multidisciplinary team discussion is necessary to determine the optimal management plan whilst considering patient- and disease-related factors. CONCLUSION: A multidisciplinary team approach, considering the underlying patient- and disease- related factors, is necessary for optimal management of these complex tumors.