Gratwohl 1981.
Methods | Duration
Randomization
Treatment
Median follow‐up time
|
|
Participants | Setting
Eligibility criteria
Number of patients
Age
Gender
Further inclusion criteria to define SAA
|
|
Interventions | MSD‐HSCT arm
IST arm
Haploidentical family donor arm
|
|
Outcomes | Primary outcome
Secondary outcomes
|
|
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of outcome assessor was not reported for any outcome |
Incomplete outcome data (attrition bias) All outcomes | High risk | The data for 58 of 61 consecutively recruited patients that fulfilled the eligibility criteria have been analyzed. Therefore 3 patients have dropped out. "Von den 61 überwiesenen Patienten sind 3 trotz intensivem Zellersatz und Antibiotika gestorben, bevor die spezifische Behandlung fUr die SAA begonnen werden konnte." |
Selective reporting (reporting bias) | Unclear risk | Besides overall survival, no other outcome was reported systematically |
Other bias | Unclear risk | 15% (2 of 13) patients assigned to the IST group had an HLA‐identical sibling donor and were actually eligible to be allocated to the MSD‐HSCT group. "13 Patienten hatten keinen Spender und erhielten ALG allein. Von diesen 13 Patienten in Gruppe C hatten 2 einen HLA‐identischen Spender". No other bias such as competing interest or cross‐over. The study was supported by non‐for‐profit institutions such as a Swiss National Research Foundation, a Swiss Cancer Association, and the Swiss Department for Health. |
Comparable baseline characteristics | Low risk | There were no differences of baseline characteristics between the 2 treatment groups, in particular with reference to age. "Diese drei Gruppen sind vergleichbar bezüglich Alter, Ätiologie, vorhergehender Behandlung und Schwere der SAA bei Einweisung (Tab. 2)." |
Concurrent control | Low risk | Data for the MSD‐HSCT arm were collected during the same time period as the data for the IST arm. "Dieser Bericht beschreibt alle Patienten, die dem Kantonsspital Basel zwischen Januur 1976 und Dezember 1980 wegen SAA überwiesen wurden." |
Definitions of HLA‐identical or matched bone marrow vary with time and between different studies. In this table, expressions are quoted as given in the publications. Death from secondary malignancy was not considered treatment‐related mortality in the present review.
ALG: antilymphocyte globulin
ATG: antithymocyte globulin
BMT: bone marrow transplantation
G‐CSF: granulocyte colony‐stimulating factor
GVHD: graft‐versus‐host‐disease
HSCT: hematopoietic stem cell transplantation
IST: immunosuppressive therapy
MSD: matched sibling donor
MSD‐HSCT: first‐line allogeneic hematopoietic stem cell transplantation from HLA‐matched (identical) sibling donor
PMN: polymorphonuclear neutrophils
SAA: severe aplastic anemia
VSAA: very severe aplastic anemia