Table 1 Summary of parent trials
From: Verifying participant-reported clinical outcomes: challenges and implications
Trial | Design and comparisons | Recruitment |
|---|---|---|
The Knee Arthroplasty Trial (KAT) [10] ISRCTN45837371 NIHR Health Technology Assessment Programme | Partial factorial, pragmatic, multicentre RCT comparing three aspects of knee replacements: resurfacing the patella vs no resurfacing; mobile bearing between the tibial and femoral components vs standard designs without a mobile bearing; and metal-backed plate for the tibial component vs single high-density- polyethylene component. | July 1999 to January 2003, 2352 participants randomised: Resurfacing patella (n = 1715) Mobile bearing (n = 539) Metal backing (n = 409) 345 participants randomised in more than one comparison. |
The REFLUX trial [11] ISRCTN15517081 NIHR Health Technology Assessment Programme | Pragmatic, multi-centre RCT to evaluate the clinical effectiveness, cost effectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued, but optimised medical management amongst people with gastro-oesophageal reflux disease (with contemporaneous patient preference arms). | March 2001 to June 2004, 357 participants randomised: Surgery (n = 178) Medical management (n = 179). 453 participants entered the preference arm: Preferred surgery (n = 261) Preferred medical management (n = 192) |
The RECORD trial [12] ISRCTN51647438 UK Medical Research Council | Factorial, pragmatic, multi-centre RCT to assess whether 800 IU daily oral vitamin D3 and 1000 mg calcium, either alone or in combination, were effective in prevention of secondary fractures. | January 1999 to March 2002, 5292 participants randomised: Vitamin D and calcium (n = 1306) Vitamin D alone (n = 1343) Calcium alone (n = 1311) Placebo (n = 1332) |
The CATHETER trial [13] ISRCTN75198618 NIHR Health Technology Assessment Programme | Pragmatic, multi-centre randomised controlled trial to evaluate the clinical and cost effectiveness of three different types of urethral catheters (antiseptic-coated (silver) latex catheter, antimicrobial-impregnated (nitrofurazone) catheter or a standard PTFE-coated latex catheter) to reduce catheter-associated urinary tract infections (UTIs). | July 2007 to September 2010, 6394 participants randomised and included: Silver alloy catheter (n = 2097) Nitrofurazone catheter (n = 2153) PTFE catheter (n = 2144) |