Methods | Published data for the Indian subset of patients of a multinational International Atomic Energy Agency randomised trial (E13010), that's never been published in full. | |
Participants | N = 31 cancer patients with any primary tumour histology (13 with prostate cancer, 12 with breast cancer, 3 with lung cancer, 3 with other cancers). Metastatic bone lesions confirmed by radionuclide bone scan. Patients had to present a minimum level of pain from the scan‐positive sites (score of 5 to 10 on a 0‐10 VAS ) not relieved by therapy with non‐narcotic analgesia or with narcotic medication. (15 on 89Sr, 16 on 32P). |
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Interventions | 1. 89Sr 4 mCi (148 MBq). 2. 32P 12 mCi. Follow up: 4 months. |
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Outcomes | Pain relief assessed daily by patients through a 0‐10 VAS. Analgesic score based on daily assessed analgesic type and administration frequency (0‐20 range). Mobility score assessed every two weeks by a 4‐points score. Pain flares. Toxicity graded as recommended by the IAEA (White blood cell X 109/L:grade 0> = 4.0; grade 1 = 3.0‐3.9; grade 2 2.0‐2.9; grade 3 = 1.0‐1.9; grade 4 < 1.0. Platelets X 109/L:grade 0 = 150‐400; grade 1 = 75‐149.9; grade 2 = 50.0‐74.9; grade 3 = 25.0‐49.9; grade 4 < 25.0. Absolute granulocyte counts of less than 1000 were considered as significant toxicity). Death. |
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Notes | Summary description of full trial in http://www‐crp.iaea.org/html/rifa‐show‐detail.asp?ProgCode=E13010. It's not clear whether the outcomes were assessed by the patient or their relatives. "A set of data sheets was given to the patient's relatives to fill out and return every 2 weeks". 0 patients lost to follow up or withdrawn. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Low risk | "Randomization of patients to the radionuclide was done at the IAEA, which then informed the center of the radionuclide to be used in a given patient". |
Blinding (performance bias and detection bias) Patients | Unclear risk | "Two responsible relatives of the patient were taken into confidence and the details of treatment, the stage of the disease and the expected outcome were explained". |
Blinding (performance bias and detection bias) Study researchers | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Outcome assessment | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Apparently, all randomised patients were assessed. |