Cholangiocarcinoma(CC)is the second most common primary liver tumour.High-quality guidelines are essential for effective patient stratification and individualised treatment.This study aimed to appraise the methodologi...Cholangiocarcinoma(CC)is the second most common primary liver tumour.High-quality guidelines are essential for effective patient stratification and individualised treatment.This study aimed to appraise the methodological quality of existing guidelines for the resection of CC using the Appraisal of Guidelines for Research&Evaluation(AGREE II)instrument.A systematic search of the literature in Cochrane,PubMed,Google Scholar,and Embase was performed.Assessment of the clinical practice guidelines(CPGs)and consensuses was performed using the AGREE II instrument by four clinicians experienced in surgical practice and the AGREE II appraisal method.Literature searches identified 13 guidelines of highly variable quality according to the AGREE II criteria.The guidelines scored well in certain domains such as scope&purpose(median score across all guidelines;65%),clarity of presentation(76%),and editorial independence(56%).However,they scored poorly for applicability(13%),rigour of development(30%),and stakeholder involvement(39%).None of the 13 guidelines was recommended universally for use without modification.Overall,the methodological quality of guidelines on the surgical management of CC is poor.Future updates should address and modify shortcomings detected by the AGREE II instrument,thereby facilitating better patient stratification and individualised treatment strategies.展开更多
Background:The vast majority of patients with cholangiocarcinoma(CC)have advanced disease at diagnosis and are candidates for palliative treatment only.The robustness of the randomized controlled trials regarding the ...Background:The vast majority of patients with cholangiocarcinoma(CC)have advanced disease at diagnosis and are candidates for palliative treatment only.The robustness of the randomized controlled trials regarding the treatment of CC are assessed.Methods:A systematic review of all randomized control trials(RCT)of treatments for both intra-and extrahepatic CC between 2010 and 2020 was performed.The survival-inferred fragility index(SIFI;the minimum number of reassignments of the best survivors between arms that would overturn the statistical outcomes)was calculated.In addition,the gain,or loss,in survival in RCTs was evaluated by the restricted mean survival time(RMST)difference.Finally,the level of spin i.e.,misrepresentation of study outcomes,was measured in inconclusive studies to assess distorted reporting strategies.Results:Out of 6,167 studies retrieved,11 could be retained for full text revision(7 with both intra-and extrahepatic CC,3 with peri-hilar CC,and 1 with peri-hilar or distal CC).Only 3 studies included resected patients(2 with both intra-and extrahepatic CC and 1 with peri-hilar or distal CC).Nine studies investigated systemic chemotherapy(including 3 after surgical resection),one study evaluated photodynamic therapy,and another investigated the use of an endoscopically inserted stent in the biliary tract.The median SIFI was−2[interquartile range(IQR):−6.25,−0.25]across all studies.Overall,the median RMST difference was 0.56 months(IQR:0.10,0.95).Finally,for inconclusive studies,the level of spin was high,moderate,and low in respectively 12.5%,25%,and 62.5% of the studies.Conclusions:RCTs of CC showed a low degree of robustness with a frequent proportion of associated spin.展开更多
文摘Cholangiocarcinoma(CC)is the second most common primary liver tumour.High-quality guidelines are essential for effective patient stratification and individualised treatment.This study aimed to appraise the methodological quality of existing guidelines for the resection of CC using the Appraisal of Guidelines for Research&Evaluation(AGREE II)instrument.A systematic search of the literature in Cochrane,PubMed,Google Scholar,and Embase was performed.Assessment of the clinical practice guidelines(CPGs)and consensuses was performed using the AGREE II instrument by four clinicians experienced in surgical practice and the AGREE II appraisal method.Literature searches identified 13 guidelines of highly variable quality according to the AGREE II criteria.The guidelines scored well in certain domains such as scope&purpose(median score across all guidelines;65%),clarity of presentation(76%),and editorial independence(56%).However,they scored poorly for applicability(13%),rigour of development(30%),and stakeholder involvement(39%).None of the 13 guidelines was recommended universally for use without modification.Overall,the methodological quality of guidelines on the surgical management of CC is poor.Future updates should address and modify shortcomings detected by the AGREE II instrument,thereby facilitating better patient stratification and individualised treatment strategies.
文摘Background:The vast majority of patients with cholangiocarcinoma(CC)have advanced disease at diagnosis and are candidates for palliative treatment only.The robustness of the randomized controlled trials regarding the treatment of CC are assessed.Methods:A systematic review of all randomized control trials(RCT)of treatments for both intra-and extrahepatic CC between 2010 and 2020 was performed.The survival-inferred fragility index(SIFI;the minimum number of reassignments of the best survivors between arms that would overturn the statistical outcomes)was calculated.In addition,the gain,or loss,in survival in RCTs was evaluated by the restricted mean survival time(RMST)difference.Finally,the level of spin i.e.,misrepresentation of study outcomes,was measured in inconclusive studies to assess distorted reporting strategies.Results:Out of 6,167 studies retrieved,11 could be retained for full text revision(7 with both intra-and extrahepatic CC,3 with peri-hilar CC,and 1 with peri-hilar or distal CC).Only 3 studies included resected patients(2 with both intra-and extrahepatic CC and 1 with peri-hilar or distal CC).Nine studies investigated systemic chemotherapy(including 3 after surgical resection),one study evaluated photodynamic therapy,and another investigated the use of an endoscopically inserted stent in the biliary tract.The median SIFI was−2[interquartile range(IQR):−6.25,−0.25]across all studies.Overall,the median RMST difference was 0.56 months(IQR:0.10,0.95).Finally,for inconclusive studies,the level of spin was high,moderate,and low in respectively 12.5%,25%,and 62.5% of the studies.Conclusions:RCTs of CC showed a low degree of robustness with a frequent proportion of associated spin.
