Vuorinen 2003.
| Methods | Randomised controlled trial | |
| Participants | 30 patients were enrolled from a single university hospital between 1993 to 1996. Inclusion criteria were radiologically malignant supratentorial glioma, Karnofsky Performance Status greater than or equal to 60 (error in the methods section of the paper, where as it states greater than 60), patients older than 65 years of age, informed consent to participate in the study. Symptoms/evidence of raised intracranial pressure was not an exclusion criterion. No stratification for age or performance status. | |
| Interventions | Stereotactic biopsy versus open craniotomy and resection. A pre‐randomisation brain scan (CT or MRI) was performed. Procedures were performed by an experienced neurosurgeon. An estimate of extent of resection was made from a postoperative brain scan in those undergoing resection between days 1 and 3. Clinical evaluation was performed 1 week after surgery, and Karnofsky Performance Score was evaluated. | |
| Outcomes | Primary: survival. Secondary: time to deterioration, quality of life, morbidity and mortality. Statistical tests were: non‐parametric Kaplan‐Meier method compared non‐parametric log rank Chi2 test. | |
| Notes | 4 exclusions from resection group (1 withdrew consent, 1 each of lymphoma, haematoma, and infarct) and 3 exclusions from the biopsy group (2 metastases and 1 haematoma). No intention‐to‐treat analysis. Total resection rate was 20%. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Data awaited from author. |
| Allocation concealment (selection bias) | High risk | The signs associated with a craniotomy and resection of a tumour would be difficult to disguise. |
| Blinding (performance bias and detection bias) All outcomes | High risk | The signs associated with a craniotomy and resection of a tumour would be difficult to disguise. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All prespecified outcome criteria had 100% completion for the treatment groups, but this was not an intention‐to‐treat analysis. |
| Selective reporting (reporting bias) | Unclear risk | No intention‐to‐treat analysis; 7 participants excluded from final analysis |
| Other bias | Low risk | No industry sponsorship declared. |
CT: computed tomography MRI: magnetic resonance imaging