Skip to main content

Table 2 Summary of the case studies

From: Recommendations for the analysis of individually randomised controlled trials with clustering in one arm – a case of continuous outcomes

Trial

Leg Ulcers

Acupuncture

CPSW

PLINY

Objective

Establish clinical effectiveness of specialist community leg ulcer clinics versus usual care provided by district nurses [15]

Determine whether a short course of traditional acupuncture improves longer-term outcomes for patients with persistent nonspecific low back pain [7]

Establish the relative cost-effectiveness of postnatal support in the community in addition to the usual care provided by community midwives [16]

Evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of health related quality of life (HRQoL) in older people [17]

Cluster

8 specialist clinics

7 acupuncturists

7 CPSW

5 volunteer facilitators

Outcome of Interest

aNumber of ulcer free weeks during 12 months follow-up

SF-36 pain dimension measured at 12 months follow-up [28]

SF-36 general health perception domain measured at 6 weeks [28]

SF-36 mental health dimension score measured at 6 months follow-up [28]

Target Difference

 

10 points

5 points

8 points

Original Analysis

Robust standard errors

No adjustment

Generalised linear model with robust standard errors with participants in the control arm treated as individual clusters of size one

  1. aThis was not the primary outcome in the main study