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Randomized Controlled Trials
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Fung et al. (2022)
22
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The trial protocol was registered The main findings are clearly described with appropriate measures of variability (95% CI) and exact P values unless < 0.001 Patients who were recruited and who participated may have been representative of the entire population from which they were recruited No patients appear to have been lost to follow-up The staff, places, and facilities may have been representative of the treatment majority of the patients received Those providing treatment, the investigators and the data collectors were blinded to the treatment received for each participant Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Intention to treat approach was used Patients from intervention and comparator groups were recruited from the same population over the same period of time Randomization process and concealment was clearly described Sufficient power calculations were used to determine adequate sample size Authors declared receiving no funding or conflicts of interest
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It is unclear if all important adverse events were reported Patients were not blinded to the treatment received due to the nature and safety of the intervention It is unclear if analysis was adjusted for different lengths of follow-up
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Kvaslerud et al. (2022)
23
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The main findings are clearly described with appropriate measures of variability (95% CI) and exact P values unless < 0.001 Characteristics of patients lost to follow-up was described Patients who were recruited and who participated may have been representative of the entire population from which they were recruited Patients, investigators, and data collectors were blinded to treatment Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Intention to treat approach was used Patients from intervention and comparator groups were recruited from the same population over the same period of time Randomization process and concealment was clearly described Sufficient power calculations were used to determine adequate sample size Authors declared funding and potential conflicts of interest
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It is unclear if trial protocol was registered It is unclear if all important adverse events were reported It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received It is unclear if there were any protocol deviations It is unclear if analysis was adjusted for different lengths of follow-up or if lost to follow-up would have affected the results
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Shokri et al. (2022)
24
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The trial protocol was registered The main findings are clearly described with appropriate measures of variability (mean difference with standard deviation) and exact P values unless < 0.001 No patients appear to have been lost to follow-up Patients who were recruited and who participated may have been representative of the entire population from which they were recruited The staff, places, and facilities may have been representative of the treatment majority of the patients received and treatment was provided by the same surgical team Those providing treatment, the investigators and the data collectors were blinded to the treatment received for each participant Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Intention to treat approach was used Patients from intervention and comparator groups were recruited from the same population over the same period of time Randomization process and concealment was clearly described Sufficient power calculations were used to determine adequate sample size Authors declared receiving no funding or conflicts of interest
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It is unclear if all important adverse events were reported It is unclear if patients were blinded to the treatment received It is unclear if there were any protocol deviations It is unclear if analysis was adjusted for different lengths of follow-up
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Thin et al. (2021)
25
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The trial protocol was registered The main findings are clearly described with appropriate measures of variability (standard deviation) and exact P values No patients appear to have been lost to follow-up Patients who were recruited and who participated may have been representative of the entire population from which they were recruited Randomization process was clearly described Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Patients from intervention and comparator groups were recruited from the same population over the same period of time Authors declared funding and potential conflicts of interest
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It is unclear if all important adverse events were reported It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received Patients, those administering the treatment, investigators, or data collectors were not blinded to the treatment allocation It is unclear if randomization was concealed to individuals or investigators It is unclear if analysis was adjusted for different lengths of follow-up It is unclear if power calculations were conducted to establish adequate sample size It is unclear if there were any protocol deviations
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Non-Randomized Studies
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Ploug et al. (2022)
26
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The study received ethical approval The main findings are clearly described with appropriate measures of variability (interquartile range) and exact P values unless < 0.001 Patient data used may have been representative of the entire population from which they were recruited Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Patient data from intervention and comparator groups were from the same population over the same period of time Authors declared study funding sources
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It is unclear if all important adverse events were reported Principle confounders between comparison group was not clearly outlined It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received Patient loss to follow-up was likely not captured due to study design (retrospective cohort study) As this is a non-randomized study, there was no blinding or randomization and therefore confounding factors may impact findings It is unclear if confounding factors were accounted for in analysis It is unclear if sufficient power calculations were used to determine adequate sample size Authors did not declare any potential conflicts of interest
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Abdullah et al. (2021)
27
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The study received ethical approval A propensity matched case-control approached was used, which may help control for confounding factors The main findings are clearly described with appropriate measures of variability (standard deviation) and exact P values unless < 0.001 Patient data used may have been representative of the entire population from which they were recruited Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Patient data from intervention and comparator groups were from the same population over the same period of time Sufficient power calculations were used to determine adequate sample size Authors declared funding and potential conflicts of interest
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It is unclear if all important adverse events were reported Patient loss to follow-up was likely not captured due to study design (retrospective cohort study) It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received As this is a non-randomized study, there was no blinding or randomization and therefore confounding factors may impact findings It is unclear if confounding factors were accounted for in the analysis despite the study design approach (propensity matched case-control)
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Evans et al. (2021)
28
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The objective, outcomes, inclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The main findings are clearly described with appropriate measures of variability (interquartile range, standard deviation, and 95% CI) and exact P values unless < 0.001 Patient data used may have been representative of the entire population from which they were recruited Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Patient data from intervention and comparator groups were from the same population over the same period of time Authors declared potential conflicts of interest
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It is unclear if the study received ethical approval Patient exclusion criteria was not clearly defined It is unclear if all important adverse events were reported Patient loss to follow-up was likely not captured due to study design (retrospective cohort study) Principle confounders between comparison group was not clearly outlined It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received As this is a non-randomized study, there was no blinding or randomization and therefore confounding factors may impact findings It is unclear if confounding factors were accounted for in analysis It is unclear if sufficient power calculations were used to determine adequate sample size Authors did not report study funding sources
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Peel et al. (2021)
29
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The objective, outcomes, inclusion and exclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The study received ethical approval Missing data variable in >25% of patient data was removed from modelling Principle confounders were identified, and regression models were used to account for possible confounding factors in the analysis The main findings are clearly described with appropriate measures of variability (standard deviation and 95% CI) and exact P values unless < 0.0001 Patient data used may have been representative of the entire population from which they were recruited The staff, places, and facilities may have been representative of the treatment majority of the patients received Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Patient data from intervention and comparator groups were from the same population over the same period of time Authors declared funding and potential conflicts of interest
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It is unclear if all important adverse events were reported Patient loss to follow-up was likely not captured due to study design (retrospective cohort study) As this is a non-randomized study, there was no blinding or randomization and therefore confounding factors may impact findings It is unclear if sufficient power calculations were used to determine adequate sample size
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Quarterman et al. (2021)
30
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The objective, outcomes, inclusion criteria, interventions, and patient characteristics were clearly defined in the introduction and methods The study received ethical approval The main findings are clearly described with appropriate measures of variability (interquartile range) and exact P values unless < 0.001 Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Patient data from intervention and comparator groups were from the same population over the same period of time Authors declared potential conflicts of interest
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Patient exclusion criteria was not clearly defined It is unclear if all important adverse events were reported Patient loss to follow-up was likely not captured due to study design (retrospective cohort study) Principle confounders between comparison group was not clearly outlined It is unclear is patient data used may have been representative of the entire population from which they were recruited because of a change in administration policy after the study was complete It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received As this is a non-randomized study, there was no blinding or randomization and therefore confounding factors may impact findings It is unclear if confounding factors were accounted for in analysis It is unclear if sufficient power calculations were used to determine adequate sample size Authors did not report study funding sources
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Triphaus et al. (2021)
31
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The trial protocol was registered The objective, outcomes, inclusion criteria, and interventions were clearly defined in the introduction and methods Patient characteristics were available in supplemental information The main findings are clearly described with appropriate measures of variability (interquartile range and standard deviation) and exact P values Appropriate statistical tests were used to assess main outcomes and main outcome measures used were valid and reliable Compliance with intervention was reliable Authors declared potential conflicts of interest
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Patient exclusion criteria was not clearly defined It is unclear if all important adverse events were reported It is unclear if patient loss to follow up was accounted for in the analysis and characteristics of any patients lost to follow up were not clearly described Principle confounders between comparison group was not clearly outlined It is unclear is patient data used may have been representative of the entire population from which they were recruited because recruitment was done using multiple centres It is unclear if the staff, places, and facilities may have been representative of the treatment majority of the patients received As this is a non-randomized study, there was no blinding or randomization and therefore confounding factors may impact findings It is unclear if confounding factors were accounted for in analysis It is unclear if sufficient power calculations were used to determine adequate sample size It is unclear if patient data from intervention and comparator groups were from the same population over the same period of time Authors did not report study funding sources
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