Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses

OBJECTIVES: This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured. DESIGN: Systematic review of systematic reviews (umbrella review). DATA SOURCES: Cochrane Database of Systematic Reviews. ELIGIBILITY CRITERIA: Systematic reviews attempt to compare surgical to drug interventions. DATA EXTRACTION: We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review. SYNTHESIS: The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger's test and excess significance were assessed. RESULTS: Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance. CONCLUSIONS: Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed

Quality of Life Considerations in Endoscopic Endonasal Management of Anterior Cranial Base Tumors

Considering quality of life (QOL) is critical when discussing treatment options for patients undergoing endoscopic endonasal skull base surgery (EESBS) for cancers at the base of the skull. Several questionnaires have been developed and validated in the last 20 years to explore QOL in this patient population, including the Anterior Skull Base Questionnaire, Skull Base Inventory, EESBS Questionnaire, and the Sino-Nasal Outcome Test for Neurosurgery. The Sino-Nasal Outcomes Test-22 and Anterior Skull Base Nasal Inventory-12 are other tools that have been used to measure sinonasal QOL in anterior cranial base surgery. In addition to pathology-related perturbations in QOL endoscopic surgical options (transsellar approaches, anterior cranial base surgery, and various reconstructive techniques) all have unique morbidities and QOL implications that should be considered. Finally, we look ahead to new and emerging techniques and tools aimed to help preserve and improve QOL for patients with anterior cranial base malignancies

Quality of Life Considerations in Endoscopic Endonasal Management of Anterior Cranial Base Tumors

Considering quality of life (QOL) is critical when discussing treatment options for patients undergoing endoscopic endonasal skull base surgery (EESBS) for cancers at the base of the skull. Several questionnaires have been developed and validated in the last 20 years to explore QOL in this patient population, including the Anterior Skull Base Questionnaire, Skull Base Inventory, EESBS Questionnaire, and the Sino-Nasal Outcome Test for Neurosurgery. The Sino-Nasal Outcomes Test-22 and Anterior Skull Base Nasal Inventory-12 are other tools that have been used to measure sinonasal QOL in anterior cranial base surgery. In addition to pathology-related perturbations in QOL endoscopic surgical options (transsellar approaches, anterior cranial base surgery, and various reconstructive techniques) all have unique morbidities and QOL implications that should be considered. Finally, we look ahead to new and emerging techniques and tools aimed to help preserve and improve QOL for patients with anterior cranial base malignancies

Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews

An overview aiming to examine across the entire Cochrane Library how many reviews have attempted to compare surgical to medical interventions, how many of them did find suitable trials for such comparisons, and what the results of these comparisons for the primary outcomes of interest were. PRISMA contains all the necessary PRISMA checklists as well as the flowchart. Supplement 1 is a spreadsheet of all found studies categorized according to specialty and data availabilit

Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses

Objectives This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured.Design Systematic review of systematic reviews (umbrella review).Data sources Cochrane Database of Systematic Reviews.Eligibility criteria Systematic reviews attempt to compare surgical to drug interventions.Data extraction We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review.Synthesis The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger’s test and excess significance were assessed.Results Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance.Conclusions Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed

Timing of postoperative oral feeding after head and neck mucosal free flap reconstruction.

ObjectiveFistula remains a common complication of upper aerodigestive tract reconstruction. Optimal timing of oral feeding is unknown and the impact of early feeding on swallow function and fistula rates remains controversial. The purpose of this study is to better understand the effects of "early feeding" on fistula rate and swallow in patients with free flap reconstruction of upper aerodigestive tract defects.MethodsRetrospective cohort study. One hundred and four patients undergoing free flap reconstruction of mucosalized head and neck defects. Two groups, early feeding (oral intake on or before postoperative day 5) and late-feeding (oral intake after postoperative day 5). Primary outcome was incidence of salivary fistula. Secondary outcomes included Functional Oral Intake Scale scores.ResultsFistula rate was 16.5% in late-feeding group and 0% in early-feeding group (P = .035). Patients who were fed early had an association with progression to a full oral diet by 30 days (P = .027).DiscussionThis cohort analysis suggests that in properly selected patients with free flap reconstruction for mucosal defects, early feeding may not increase risk of salivary fistula and may improve swallow functional outcomes earlier. Level of Evidence: 3

International Multicenter Study of Clinical Outcomes of Sinonasal Melanoma Shows Survival Benefit for Patients Treated with Immune Checkpoint Inhibitors and Potential Improvements to the Current TNM Staging System

OBJECTIVES: Sinonasal mucosal melanoma (SNMM) is an extremely rare and challenging sinonasal malignancy with a poor prognosis. Standard treatment involves complete surgical resection, but the role of adjuvant therapy remains unclear. Crucially, our understanding of its clinical presentation, course, and optimal treatment remains limited, and few advancements in improving its management have been made in the recent past. METHODS: We conducted an international multicenter retrospective analysis of 505 SNMM cases from 11 institutions across the United States, United Kingdom, Ireland, and continental Europe. Data on clinical presentation, diagnosis, treatment, and clinical outcomes were assessed. RESULTS: One-, three-, and five-year recurrence-free and overall survival were 61.4, 30.6, and 22.0%, and 77.6, 49.2, and 38.3%, respectively. Compared with disease confined to the nasal cavity, sinus involvement confers significantly worse survival; based on this, further stratifying the T3 stage was highly prognostic (p < 0.001) with implications for a potential modification to the current TNM staging system. There was a statistically significant survival benefit for patients who received adjuvant radiotherapy, compared with those who underwent surgery alone (hazard ratio [HR] = 0.74, 95% confidence interval [CI]: 0.57–0.96, p = 0.021). Immune checkpoint blockade for the management of recurrent or persistent disease, with or without distant metastasis, conferred longer survival (HR = 0.50, 95% CI: 0.25–1.00, p = 0.036). CONCLUSIONS: We present findings from the largest cohort of SNMM reported to date. We demonstrate the potential utility of further stratifying the T3 stage by sinus involvement and present promising data on the benefit of immune checkpoint inhibitors for recurrent, persistent, or metastatic disease with implications for future clinical trials in this field

International multicenter study of clinical outcomes of sinonasal melanoma shows survival benefit for patients treated with immune checkpoint inhibitors and potential improvements to the current TNM staging system

Objectives: Sinonasal mucosal melanoma (SNMM) is an extremely rare and challenging sinonasal malignancy with a poor prognosis. Standard treatment involves complete surgical resection, but the role of adjuvant therapy remains unclear. Crucially, our understanding of its clinical presentation, course, and optimal treatment remains limited, and few advancements in improving its management have been made in the recent past. Methods: We conducted an international multicenter retrospective analysis of 505 SNMM cases from 11 institutions across the United States, United Kingdom, Ireland, and continental Europe. Data on clinical presentation, diagnosis, treatment, and clinical outcomes were assessed. Results One-, three-, and five-year recurrence-free and overall survival were 61.4, 30.6, and 22.0%, and 77.6, 49.2, and 38.3%, respectively. Compared with disease confined to the nasal cavity, sinus involvement confers significantly worse survival; based on this, further stratifying the T3 stage was highly prognostic (p &lt; 0.001) with implications for a potential modification to the current TNM staging system. There was a statistically significant survival benefit for patients who received adjuvant radiotherapy, compared with those who underwent surgery alone (hazard ratio [HR] = 0.74, 95% confidence interval [CI]: 0.57-0.96, p = 0.021). Immune checkpoint blockade for the management of recurrent or persistent disease, with or without distant metastasis, conferred longer survival (HR = 0.50, 95% CI: 0.25-1.00, p = 0.036). Conclusions: We present findings from the largest cohort of SNMM reported to date. We demonstrate the potential utility of further stratifying the T3 stage by sinus involvement and present promising data on the benefit of immune checkpoint inhibitors for recurrent, persistent, or metastatic disease with implications for future clinical trials in this field