Larrey 2011.

Methods	Randomized controlled trial
Participants	The study location was Montpellier, Nimes, Bagnols/ceze, Beziers, Ales, Narbonne, Avignon, Arles, Perpignan, and Aix en Provence, France 123 participants were randomized to the intervention group and 121 participants were randomized to the control group The inclusion criteria were age 18 to 65 years; chronic infection with either genotype 2 or genotype 3 HCV; absolute neutrophil count > = 1500mm3 and platelet count > = 100,000 mm3; no prior treatment for HCV The exclusion criteria were any relevant concomitant medical condition; decompensated liver disease or cirrhosis, or other significant liver disease; human immunodeficiency virus or hepatitis B virus co‐infection; peginterferon (Peg‐IFN) or ribavirin (RBV) contraindication; a history of alcohol or illicit drug use; pregnancy/breast‐feeding
Interventions	Intervention: NURSE EDUCATION The nurse used a standardized questionnaire to evaluate the patient's understanding of the disease and the side effects of treatment. The nurse responded to any questions and informed the patient as thoroughly as possible with the means at his/her disposal, including by using explanatory texts and drawings. The nurse's goal during the consultation was to improve adherence. The following points were systematically covered: a) evaluation of the reasons for any eventual change in adherence; b) improvement of the quality of the patient‐medical team relationship; c) explanation of para‐clinical tests on therapeutic follow‐up and discussion of the positive aspects of the results; d) facilitation of the quality of the patient's relationship with his/her family and/or professional milieu; e) increasing if necessary social service support for the patient. This consultation with the nurse took place in a standardized fashion, which was set out in a document to guide the consultation. All the nurses involved in these consultations had received prior training in the field of viral hepatitis and its treatment, and on the details of this study. The consultation lasted between 30 and 45 minutes. At the end of the consultation, the nurse filled out a standardized questionnaire build for this study and comprising 34 items in 8 groups. The patient could call the nurse free‐of‐charge if necessary outside the standard consultation dates Control: USUAL CARE The control group received conventional clinical follow‐up. These patients did not receive consultation from the nurses
Outcomes	The measures of adherence were defined as the continuation of treatment as normally scheduled. Patients with early discontinuation were classified as non‐adherent. These visits were systematic at the beginning of treatment day 0, week 4, week 8, week 12, week 24, and in patients with 48 weeks of treatment at week 36 The patient outcome was sustained virologic response (SVR). SVR was evaluated at 12 and 24 weeks after the end of treatment
Notes	Substantial discontinuation of treatment. See table 3 in the article
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgment of 'Low risk' or 'High risk'
Allocation concealment (selection bias)	Unclear risk	Insufficient information about allocation concealment to permit judgment of 'Low risk' or 'High risk'
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Unclear risk	The authors noted: (pg.785) "The limitations of this study were the relatively low number of participating patients and the choice to centralize therapeutic education only to specialized nurse care. Other methods also probably would be beneficial. Multidisciplinary protocols probably would improve results even more. These avenues must be explored in controlled studies to validate the notion of multidisciplinary management."
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) INTERVIEW WITH THE NURSE ‐ Open‐label trial
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SUSTAINED VIROLOGICAL RESPONSE ‐ Objective measure
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) INTERVIEW WITH THE NURSE ‐ Open‐label trial
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) SUSTAINED VIROLOGICAL RESPONSE ‐ Objective measure
Blinding of personnel (performance bias) Adherence measure	High risk	(PRIMARY) INTERVIEW WITH THE NURSE ‐ Open‐label trial
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) SUSTAINED VIROLOGICAL RESPONSE ‐ Objective measure
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) INTERVIEW WITH THE NURSE ‐ 6 patients refused treatment in group B. Large number of discontinuations
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) SUSTAINED VIROLOGICAL RESPONSE ‐ 6 patients refused treatment in group B. Large number of discontinuations