Khoury 2018.
Methods | Randomised, individual, single‐site trial, 52 weeks | |
Participants | Denmark; 1 hospital (150 participants); psoriasis; 95 men, 55 women; mean age 47.4 years CONT, 51.5 years INT | |
Interventions | INT (n = 73): participants were able to request a consultation when needed via a telephone helpline managed by specialist nurses who could also provide advice and assistance. Laboratory tests every 12 weeks. Safety net – 1 scheduled annual appointment with dermatologist. CONT (n = 77): consultant‐led every 12–16 weeks plus laboratory tests as in INT group, emergency appointments available. |
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Outcomes | Health‐related quality of life: 52 weeks (DLQI) Psychological well‐being: 52 weeks (HADS) Satisfaction with the system: 52 weeks (3 questions on Likert scale) Appointment use due to psoriasis: 52 weeks (medical records) Treatment safety: 12–16 weeks for 52 weeks (laboratory tests) Clinical monitoring: 52 weeks (PASI, physiological clinical measurements) |
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Notes | All participants interested had a mandatory information meeting to hear about the study. Patients had to collect medication and have laboratory tests every 12 weeks (checked monthly by lead researcher). The lead researcher provided face‐to‐face information to patients on their safety and recognising difficulties/flare‐ups and access to help through the helpline. Patient adherence checked monthly. Patients who failed to attend their laboratory test or pick up medication were telephoned and encouraged along. Patients who failed to adhere > 3 times were excluded from the study. Funded by Capital region of Denmark, Johannes Foghs Fond and The Danish National Psoriasis Association. COI: C.Z. has served as a scientific consultant for AbbVie, Almirall, Pfizer, Janssen‐Cilag, Merck & Co., Inc., Eli Lilly, Takeda and Novartis, and as a clinical study investigator for AbbVie, LEO Pharma, Amgen, Eli Lilly, Merck & Co., Inc., Takeda and Novartis. L.S. has received research grants from Pfizer, Janssen‐Cilag and LEO Pharma, and served as a scientific consultant for AbbVie, Almirall, Pfizer, Janssen‐Cilag, LEO Pharma, Eli Lilly, Celgene and Novartis, and as a clinical study investigator for AbbVie, Amgen, Eli Lilly, LEO Pharma, Takeda and Novartis. Contacted authors for more information, further data provided for DLQI, HADS and satisfaction with the system. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised at an individual level by a computer‐generated algorithm, stratified according to sex and medical treatment. |
Allocation concealment (selection bias) | Unclear risk | Allocation did not appear to be concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not feasible, which may have influenced self‐reported outcomes such as DLQI and HADS. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No attempt to conceal allocation from data analysts. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Very low levels of withdrawals or missing data but no ITT attempted. |
Selective reporting (reporting bias) | High risk | Protocol suggested outcomes were to be reported at 2 years; this article was at 1 year and did not cover all the outcomes planned in the protocol. Patients who failed to adhere more than 3 times were excluded from the analysis. |
Other bias | Low risk | No obvious signs of other bias. |