Morfini 1976.
| Study characteristics | ||
| Methods | RCT. Cross‐over trial. Trial period: 1 year. Time unit: 3‐month cycles (A‐B‐A‐B versus B‐A‐B‐A). | |
| Participants | Country: Italy. Participants: males with haemophilia B (factor IX < 1%). Age range: 5 ‐ 45 years. Number enrolled: 10. | |
| Interventions | Two secondary prophylaxis treatment arms. Factor IX concentrate (Bebulin). Arm A: 7.5 U/kg twice weekly. Arm B: 15 U/kg weekly. Follow‐up duration: 6 months per arm. |
|
| Outcomes | Bleeding events or frequency, joint deterioration. | |
| Notes | Study involved participants of the Research Committee of the Fondazione dell’Emofilia. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information given. |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation to treatment protocols was made on the basis of random envelopes...". |
| Blinding (performance bias and detection bias) Clinical Joint Function | Low risk | The personnel involved in the orthopedic examinations was blinded. |
| Blinding (performance bias and detection bias) Bleeding | High risk | No blinding. |
| Blinding (performance bias and detection bias) Radiologic Joint Score | Low risk | Radiological examinations were carried out in a blinded fashion. |
| Blinding of outcome assessment (detection bias) Bleeding | High risk | Haematologists were aware of patients' treatment. |
| Blinding of outcome assessment (detection bias) Clinical Joint Function | Low risk | Quote: "Orthopedic and radiological examinations were carried out by staff who were unaware of the trial details." |
| Blinding of outcome assessment (detection bias) Radiologic Joint Score | Low risk | Quote: "Orthopedic and radiological examinations were carried out by staff who were unaware of the trial details." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data for primary outcome and minimal missing data for secondary outcomes. |
| Selective reporting (reporting bias) | Low risk | Protocol was not available but all expected outcomes were reported. |
| Other bias | Unclear risk | Washout period between arms was not clear. |