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. 2018 Jul 16;2018(7):CD001271. doi: 10.1002/14651858.CD001271.pub3

Ndosi 2013.

Methods Randomised trial
Participants 181 patients (total group), 91 intervention group, 90 control group; mean age in intervention group 60.2 (11.3), in control group 57.3 (12.2); 26.5% male in intervention group, 25.7% male in control group
9 nurses
10 doctors (rheumatologists)
Interventions Intervention: RA patients allocated to nurse‐led care
Control: RA patients allocated to rheumatologist care
Detailed description of the intervention:
Compared 2 groups providing care to patients with a positive diagnosis of RA
  • Nurse‐led care: included allocated 30‐minute time slots in which the nurse took history, performed physical examination, provided pain control, prescribed or recommended medication and dosage changes, administered intra‐articular or intramuscular steroid injections, provided patient education and psychosocial support, and ordered blood tests or x‐rays. Referrals for ward admission, to the rheumatologist or to other healthcare professionals, were carried out as appropriate.

  • Rheumatologist care: The usual RLC is similar to the above, except that it usually involves an allocated 15‐minute time slot.


Supervision, oversight: Rheumatology nurse‐led clinics were autonomous but were conducted alongside rheumatologist‐led clinics; therefore, a rheumatologist was available on‐site and could be consulted.
Outcomes Patient outcomes:
  • DAS28

  • Pain

  • Fatigue

  • Duration of morning stiffness

  • Quality of life

  • Disability

  • Hospital anxiety

  • Depression

  • Arthritis self‐efficacy

  • Satisfaction


Resource utilisation:
Costs: EQ5D, costs applied to units of resource use
Notes Country: UK
Study period: 4 years
Nurse role: ongoing care for patients with rheumatological arthritis
Nurse title: clinical nurse specialist
Nurse educational background: EQF level 7
Nurse years of experience: The nurse had a median experience of 10 years in their current post and had experience in running nurse‐led clinics.
Nurse additional training: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The sequence process included a random component.
"Randomisation was on a 1 : 1 basis to either NLC (experimental group) or rheumatologist‐led care (RLC) (control group), by random permuted blocks, using the stratification factors, centre and DAS28 (low disease activity DAS28 ≤ 3.2, or moderate to high disease activity DAS28 > 3.2)".
Allocation concealment (selection bias) Low risk Patients or investigators enrolling patients could not foresee assignments, because a random permuted block method was used.
Baseline characteristics Low risk Characteristics of patients were similar in both groups, except DMARD. In the analyses, trial authors corrected for DMARD.
"The demographics and baseline characteristics of patients under NLC (n = 91) were comparable to those under RLC (n = 90) except in the proportion of patients receiving biological disease‐modifying antirheumatic drugs (DMARD)".
"The baseline difference in the proportion of patients receiving biological DMARD was a result of chance (not systematic). In the follow‐up period, the proportion of patients receiving biological agents in NLC remained more or less constant while that in RLC doubled. Assuming that change onto biological agents would significantly improve DAS28, this was likely to favour RLC. Predictably, additional adjustment for baseline biological agents increased the effects on NLC".
Baseline outcome measurement Low risk Primary outcomes were assessed before the intervention.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk It is unclear whether the outcome was influenced by lack of blinding of patients and care providers.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessor was blind.
"The independent assessors, performing the joint counts for DAS28, were masked".
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Follow‐up of patients < 80%
However, intention‐to‐treat and per‐protocol analyses were performed. Differences in outcomes were reported.
"Of the 622 patients who were assessed for eligibility, 181 were eventually randomly assigned and 133 (73.5%) had complete DAS28 data for all the five visits (PP analysis)".
Selective reporting (reporting bias) Low risk The protocol was available.
Contamination Low risk One patient crossed over. It seems that the patient crossing over was registered; therefore no further contamination took place.
Bias due to lack of power Low risk Sufficient power
"Allowing for a 10% participant dropout rate, a total sample size of 180 participants (90 per treatment arm) was needed on the basis of a repeated‐measures analysis of between‐group differences averaged over four equidistant follow‐up time points given 90% power and one‐sided statistical testing with 2.5% significance level (with anticipated SD of 1.5, intraclass correlation coefficient of 0.5)".