| Study |
Sequence generation |
Allocation concealment |
Blinding |
Attrition |
Selective reporting |
Risk of Bias |
| OS |
DFS/Tox |
| Airoldi 1987 |
Quote: "i pazienti sono stati stratificati (...) prima di essere randomizzati al trattamento (...)" Comment: sequence generation not reported; no earlier reports from the same investigators found that clearly describe the use of random sequences |
Not reported; prognostic factors similarly distributed |
No blinding reported |
No dropouts or withdrawals |
Comprehensive report of outcomes |
moderate |
moderate ‐ high |
| Bedikian 1984 |
Quote: "Patients (...) were randomized (...)." Comment: sequence generation not reported |
Probably not done: no concealment reported, dissimilarities in baseline prognostic factors |
No blinding reported |
Quote: Three of 49 thymosin patients have been excluded from the subsequent evaluation of response and survival of the thymosin group (...) Comment: differential loss in comparison groups, but extent of possible bias unclear |
No indication for selective reporting |
moderate ‐ high |
high |
| Canovas 1988 |
Quote: "La asignación de los pacientes.....se realizó mediante el sistema de numeros aleatorios." Comment: probably done, table of random numbers used |
Not reported. Equal distribution of characteristics/prognostic factors stated in text, but no detailed data provided |
No blinding reported |
All patients analysed |
All intended outcomes were reported |
moderate |
moderate ‐ high |
| Canovas 1991 |
Quote: " (...) se realizó mediante la aplicación de la tabla de numeros aleatorios (...)." Comment: probably done, table of random numbers used |
Not reported. Equal distribution of characteristics/prognostic factors stated in text, but no detailed data provided |
No blinding reported |
All patients analysed |
All intended outcomes were reported |
moderate |
moderate ‐ high |
| Cohen 1979 |
Quote: "(...) randomly received (...)" Comment: sequence generation not reported |
No concealment reported. Dissimilarities in baseline characteristics; small sample size |
No blinding reported |
Quote:"Statistical analysis was also (...) of 55 patients. All results (..) in the 46 protocol‐eligible patients were also significant for (...) 55 patients." Comment: number of withdrawals/drop‐outs balanced, reasons for exclusions described, PP and ITT performed |
Comprehensive report of outcomes |
moderate |
moderate ‐ high |
| De Serdio 1997 |
Quote: "Las tablas de azar nos suministratron (...) siguiente esquema de randomización (...)" Comment: adequate sequence generation |
No concealment reported. Detailed list of disease localisation and stage given; other patient related characteristics not reported |
No blinding reported |
All patients analysed |
All intended outcomes were reported |
Outcomes not assessed |
moderate ‐ high |
| Del Giacco 1988 |
Quote:" (...) patients were randomised between (...)" Comment: sequence generation not reported |
No concealment reported. |
No blinding reported |
Quote: "31 could be randomised (...) but only 22 are completely evaluable (the other 9 having an incomplete follow‐up (..)" Comment: 9 patients lost to follow‐up, reasons not commented, distribution between intervention and control group unclear |
Discrepancy between intended and reported outcome measures, results on quality of life were not reported, tumour response only reported in the preliminary publication |
high |
high |
| Federico 1995 |
Quote: "(...) patients were randomised (...)." Comment: sequence generation not reported |
No concealment reported. Dissimilarities in baseline prognostic factors, which were discussed by study authors as possibly having influenced the outcomes |
No blinding reported |
Equal numbers of drop‐outs/exclusions in both groups |
Comprehensive report of outcomes |
moderate ‐ high |
high |
| Gonnelli 1995 |
Quote: "(...) were randomly selected (...)" Comment: sequence generation not reported |
No concealment reported. |
No blinding reported |
4 patients inevaluable, 1 in IG, 3 in CG, reasons not stated, ITT for tumour response and rate of infection |
Intended outcomes not stated |
Outcome not assessed |
high |
| Guzman 1988 |
Quote: “(...) were randomised.” Comment: sequence generation not reported |
No concealment reported. No data on distribution of risk factors |
No blinding reported |
All patients analysed |
All intended outcomes were reported |
moderate ‐ high |
high |
| Iaffaioli 1994 |
Quote: "(...) and randomised (...)" Comment: sequence generation not reported |
No concealment reported; prognostic factors similarly distributed |
No blinding reported |
All patients analysed |
Intended outcomes were not comprehensively reported |
Outcome not assessed |
moderate |
| Luzi 1984 |
Quote: "(...) in a randomized controlled study; (...)" Comment: sequence generation not reported |
No concealment reported. Slight imbalances in patient‐related factors. Small sample size. (direction of possible risk unclear) |
No blinding reported |
Three patients with adenocarcinoma were excluded afterwards for unknown reasons, (two in IG and on in CG) |
Intended outcomes were not comprehensively reported |
moderate ‐ high |
high |
| Macchiarini 1989 |
Quote: "The randomization was performed by assigning a prerandomized sequential number to each patient (...)" Comment: probably done, table of random numbers used |
No concealment reported. Dissimilarities in disease stage. Small sample size.(possible risk of bias in favor of the intervention group) |
No blinding reported |
Two patients from the control group excluded because of death within the first 2 weeks of treatment; no ITT; (possible risk of bias concerning mortality outcomes in favor of the control group) |
All intended outcomes were reported |
high |
high |
| Mantovani 1988 |
Quote:"(...) enrolled for study and randomized (...)" Comment: sequence generation not reported |
No concealment reported. Dissimilarities in disease characteristics. Small sample size.(possible risk of bias in favour of the control group) |
No blinding reported |
All patients analysed |
All intended outcomes were reported |
high |
high |
| Mustacchi 1994 |
Quote: "(...) entering this prospective randomized multicenter trial (...)"Comment: sequence generation not reported |
Quote: "(...) were randomly allocated over the phone by the Central Office (...)"Comment: probably done (central allocation) |
No blinding reported |
Quote: "(...) 25 out of 235 patients were lost due to cancellation, ineligibility or protocol violations (..)"Comment: distribution between groups similar, outcome measure not likely to be influenced |
All intended outcomes reported |
low ‐ moderate |
moderate |
| Pavesi 1993 |
Quote: "(...) and randomly allocated (...)"Comment: sequence generation not reported |
Quote: "(...) and randomly allocated over the phone (...)"Comment: probably done (central allocation) |
No blinding reported |
Quote: "(...) in 245 fully evaluable patients (..)"Comment: 51 randomised patients not included in analysis, reasons not reported, distribution between groups unclear |
Intended outcomes were reported (only abstract publication available) |
moderate |
moderate ‐ high |
| Salvati 1984 |
“(?) hanno ricevuto a random (?)”Comment: sequence generation not reported |
No concealment reported. Distribution of possible risk factors/disease characteristics unclear. Small sample size |
No blinding reported |
Quote: "I pazienti valutabili sono stati 40 (..)"Comment: six patients not included in analysis, reasons not reported, distribution between groups unclear |
Intended outcomes were reported (but report was not very detailed) |
high |
high |
| Sanchiz 1996 |
Quote: "(...) were randomly assigned (by means of tables of random numbers) (...)"Comment: probably done, table of random numbers used |
No concealment reported. Slight imbalances in possible risk factors/disease characteristics. Small sample size |
No blinding reported |
No dropouts/withdrawals reported but unclear whether all patients were included in the analyses |
All intended outcomes were reported |
Outcome not assessed |
moderate ‐ high |
| Scher 1988 |
Quote: "Randomization was by the method of random permuted blocks (...)"Comment: probably done |
No concealment reported. Dissimilarities in prognostic factors between groups |
No blinding reported |
All randomised patients were included in the survival analysis and the reasons for the exclusion of three patients from the response analysis were reported and unlikely to introduce bias |
Outcomes comprehensively reported |
low ‐ moderate |
moderate |
| Wara 1981 |
Quote: “(?) were randomly assigned (?)"Comment: sequence generation not reported |
No concealment reported. Dissimilarities in prognostic factors. |
No blinding reported |
All but one randomised patients included in the analyses, reason for exclusion not reported |
All intended outcomes reported |
Outcome not assessed |
moderate ‐ high |
