Liu 2020.
Study characteristics | ||
Methods | Randomised controlled trial Setting: Peking Union Medical College Hospital, China Study duration: between March 2017 to December 2017. Exercise for 2 weeks preoperative. Assessments performed before and after the intervention, and 30 days postoperative. |
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Participants | 73 participants (mean age: control group: 56 (SD 9) years; exercise group: 56 (SD 10) years; eligibility was aged < 70 years) with newly suspected or confirmed NSCLC, clinical stage I–III, who were scheduled for lobectomy via VATS. 85 participants recruited, 12 were excluded because of not receiving lobectomy surgery (6), failure of follow‐up (5) or final pathology was not NSCLC (1). |
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Interventions | Control (36 participants): usual care consisting of a comprehensive preoperative anaesthesia assessment, perioperative drug recommendations for chronic diseases, smoking cessation and abstinence. No specific recommendations for preoperative exercise, diet or mental health. Exercise (37 participants): 2‐week preoperative multimodal intervention programme. Exercises performed in the home. Programme included:
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Outcomes | Postintervention and 30 days postoperatively
Postoperatively
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Notes | Study registered (NCT03068507). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were then assigned randomly to the prehabilitation or control group according to computer‐generated random numbers". |
Allocation concealment (selection bias) | Low risk | Quote: "assigned randomly to the prehabilitation or control group according to computer‐generated random numbers concealed in sealed envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "A doctor blinded to group allocation assessed all patients". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quotes: "85 were enrolled and randomized. Twelve patients were excluded because of not receiving lobectomy surgery (n = 6), failure of follow‐up (n = 5), or the final pathology was not NSCLC (n = 1). The number of patients excluded in the analyses was balanced, and the reasons for dropping out were comparable between groups". "There were no significant differences between the analyzed population and the patients who were randomized but excluded in terms of demographic and physiological characteristics". Comment: missing outcome data balanced in numbers across groups, with similar reasons for missing data across groups. Attrition rate low (14%). |
Selective reporting (reporting bias) | High risk | Comment: trial registered (NCT03068507). The registry states quality of life was measured but this was not reported in the publication. The publication included data on extra outcomes not specified in the trial registry. The publication included data on lung function, short‐term recovery quality, length of hospital stay, chest tube duration, postoperative complications and mortality, which were not recorded on the registry. |
Other bias | High risk | Quote: "A sample size of 70 (35 per group) was required to detect a statistically significant difference at a 2‐sided significance level of.05 and 90% statistical power. To account for patient dropouts and missing data, we planned to recruit a total of 85 patients". Comment: sample size on trial registry (100 participants) differed to the publication (70 participants). |