Larsson 2014.

Methods	Randomised trial
Participants	107 patients (total group). Mean age in intervention group 55.0 (12.3), in control group 55.8 (13.2); 45.0% male in intervention group, 44% male in control group 5 nurses Unknown number of rheumatologists
Interventions	Intervention: patients monitored by a nurse, later monitored by a rheumatologist Control: patients monitored by a rheumatologist Detailed description of the intervention: Compared and evaluated treatment outcomes at a nurse‐led rheumatology clinic and a rheumatologist‐led clinic in patients with low disease activity or in remission undergoing biological therapy. The intention was to replace one of the 2 annual rheumatologist monitoring visits by a nurse‐led rheumatology monitoring visit in patients undergoing biological therapy. Rheumatologist‐led clinic: Patients with CIA undergoing biological therapy were monitored by a rheumatologist every 6 months for 30 minutes to evaluate effects of the medication and to measure disease activity. The rheumatologist assessed disease activity by examining tender and swollen joints based on a 28‐joint count in addition to evaluating the results of laboratory tests. Nurse‐led rheumatology clinic: Patients were monitored for 30 minutes by a rheumatology nurse after 6 months, then for 30 minutes by a rheumatologist after 12 months. The nurse assessed patients' disease activity by examining tender and swollen joints based on the 28‐joint count in addition to evaluating results of laboratory tests in the same way as a rheumatologist. Drug treatment was discussed in terms of administration, adherence, side effects, and laboratory tests, as well as patients' global health. Supervision, oversight: If necessary, the nurse could contact the rheumatologist to ask for advice or to obtain a prescription.
Outcomes	Patient outcomes: Disease activity Perceived global health the previous week Physical difficulties in performing activities of daily living Pain Satisfaction with and confidence in obtaining rheumatology care Medication record Employment status Adverse events Resouce utilisation: Cortisone injections in addition to regular rheumatologist monitoring visits Blood tests Radiography Pharmacological therapy Additional telephone calls to a rheumatology nurse Additional telephone calls to a rheumatologist Additional rheumatologist visits Team rehabilitation in in‐patient settings Team rehabilitation in out‐patient settings Occupational therapist treatments Psychosocial treatments Specialist consultations Costs: total annual rheumatology care per patient
Notes	Country: Sweden Study period: 22 months Nurse role: nurse‐led rheumatology monitoring visit for patients undergoing biological therapy Nurse title: registered nurse Nurse educational background: EQF level 6 Nurse years of experience: 22 to 39 years' professional experience and 9 to 20 years' experience managing rheumatic diseases in both in‐patient and out‐patient rheumatology care Nurse additional training: Nurses had undergone special training provided by a rheumatologist and RA instructors to assess swollen and tender joints based on the 28‐joint count to make an evidence‐based assessment of disease activity. • Theoretical lecture about anatomy of the joint with pictures and about joint examination techniques – inspection, palpation, assessing range of motion and function for a half hour • Practical examination of the hand and wrist. Nurses were trained in groups of 2 to 3 by RA instructors (patient partners) who had RA themselves and were well educated. Time: 1.5 hours • Same procedure, but now foot and ankle. Time: 1.5 hours • All nurses also got a booklet about hand and wrist examination, and another about foot and ankle examination, for self‐study and training. • One week later, another 1.5‐hour lecture to repeat both hand and foot examinations in the same groups • Rheumatologist met the whole group of nurses and gave a lecture on how to examine the big joints ‐ shoulder, elbow, knee, and hip. Nurses examined an RA patient and then practiced on each other. Time: 1.5 hours • Time to ask the rheumatologist questions afterwards if needed, and to watch the rheumatologist examining other patients in the practice
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The sequence process included a random component. "Randomization took the form of sealed envelopes containing assignment to one of the two groups. The envelopes were mixed and when a patient met the inclusion criteria, an envelope was randomly picked".
Allocation concealment (selection bias)	Low risk	Patients and investigators enrolling patients could not foresee assignment. "Randomization took the form of sealed envelopes containing assignment to one of the two groups. The envelopes were mixed and when a patient met the inclusion criteria, an envelope was randomly picked".
Baseline characteristics	Unclear risk	Characteristics of patients were similar in both groups, except in those with rheumatic disease. It is unclear whether this biased trial results.
Baseline outcome measurement	Low risk	Primary outcomes were assessed before the intervention. Mean differences were used as an outcome.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information available It is unclear whether the outcome was influenced by possible lack of blinding of patients and care providers.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not performed It is unclear whether the outcome was influenced by lack of blinding of the outcome assessment. Assessment of disease activity may have been influenced by lack of blinding of the outcome assessor. "The monitoring by the rheumatology nurse (intervention group) and the rheumatologist (control group) included an assessment of the number of swollen and tender joints based on the DAS28". and "All patients were monitored by the rheumatologist at baseline and after 12 months".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up of patients > 80% "In total, 47 patients (89%) in the intervention group and 50 patients (93%) in the control group completed the 12‐month trial".
Selective reporting (reporting bias)	Unclear risk	The protocol was not available.
Contamination	Unclear risk	Not reported whether trial authors protect against contamination
Bias due to lack of power	Low risk	Sufficient power "Based on a change of 0.6 in the DAS28 score and a SD of 1.0, the power analysis demonstrated that 95 patients would be a sufficient number to detect a clinically moderate difference between groups at a 5% significance level with at least 90% power. It was decided to include 107 patients to allow for the predicted 10% dropout. The primary outcome measure was change in the DAS28 over a 12‐month period".