Sharples 2002.
| Methods | Country: United Kingdom Design: randomised controlled trial, single centre, cross‐over study. No washout phase Study objective: to assess feasibility and safety of nurse‐led outpatient clinic and to compare cost‐effectiveness of nurse‐led vs doctor‐led care Methods of analysis: paired student's t tests, means, confidence intervals Exacerbation and admission: Poisson distribution and modes of care comparison using likelihood ratios Patient satisfaction: Wilcoxon signed rank test, McNemar test Cost analysis: paired non‐parametric bootstrap analysis Clustering adjustments made: not relevant |
|
| Participants | Eligible for study: 80 Randomised: 39 nurse‐led care, 41 doctor‐led care Completed: 37 nurse‐led care, 40 doctor‐led care Age, years: nurse/doctor 63.7, doctor/nurse 53.1; mean age 58.3 ± 13.3 years Gender: male/female 25/55 Bronchiectasis diagnosis: confirmed by high‐resolution computed tomography Recruitment: outpatient clinic attendance with established management plan Comorbidities: no detail provided regarding comorbid conditions Exclusion criteria: life expectancy < 2 years, need for transplant listing within 2 years, FEV1 < 30% predicted, other significant pathology that would modify the management of bronchiectasis |
|
| Interventions | Intervention description: nurse specialist‐led care Control description: doctor‐led care Duration of intervention: two 1‐year care blocks Setting: outpatient |
|
| Outcomes | Prespecified outcomes: FEV1, FVC, exacerbation rates, hospital admissions, quality of life, cost‐effectiveness, exercise capacity, 12MWT, withdrawals and dropouts, nurse autonomy, participant and GP satisfaction; consultation: type, length, and venue; participant compliance Follow‐up period: 1 year, then cross‐over |
|
| Notes | Funding: NHS R&D Health Technology Assessment Programme | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation mentioned but methods not described |
| Allocation concealment (selection bias) | Low risk | Numbered opaque envelopes used |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding did not occur; blindness was not possible, given it is part of the intervention. Impact of knowing group assignment is unclear. Carryover effects from first year of study may have occurred when crossed‐over. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding did not occur. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | High level of completion; attrition reported with reasons |
| Selective reporting (reporting bias) | High risk | Changes between time periods were tested; however effects were observed in the economic analysis during the second time period; post hoc analyses occurred for carryover of clinical outcomes but were not reported. Selection effect cannot be ruled out, given that 6 participants did not cross‐over to nurse‐led care. |
| Other bias | Low risk | No other biases identified |
12MWT: 12‐minute walk test; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; GP: general practitioner; NHS: National Health Service; R&D: Research and Development.