MRC Centre for Epidemiology of Child Health, Institute of Child Health, University College London, London, United Kingdom.
PLoS One. 2012;7(8):e41791. doi: 10.1371/journal.pone.0041791. Epub 2012 Aug 3.
Enrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU). We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren) comparing impregnated with standard central venous catheters (CVCs) for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia.
We recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent.
Five PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP). Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running), due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82%) and 18/35 (51%) for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child.
Co-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and patients.
将儿童纳入多项试验可以增加招募人数，并在儿科重症监护病房（PICU）更快地提供最佳护理。我们评估了 PICU 临床医生和家长在参与两项大型实用试验时的决策：CATCH 试验（比较涂有浸渍剂与标准中心静脉导管（CVC）以减少 PICU 血流感染）和 CHiP 试验（比较严格与标准控制高血糖）。
我们记录了参与 CATCH 和 CHiP 的所有 PICU 的试验重叠期，并记录了临床医生决定是否将儿童同时纳入这两项研究的原因。我们通过测量招募率和拒绝同意的原因来检查父母对共同参与的决定。
五家 PICU 在同一时期同时招募 CATCH 和 CHiP（另外四家在结束 CHiP 后开始招募 CATCH）。其中三家拒绝共同参与（一家在 CHiP 进行期间延迟招募 CATCH 择期患者），原因是担心危及 CHiP 的招募，向家长提出过多要求，需要向家长解释两次试验的大量信息，以及一项反对共同参与的政策。两家单位共同参与，以最大限度地增加两项试验的招募人数。在第一家单位，有 35 名家长同时参与了两项试验。17/35 同意参加两项试验；13/35 仅同意参加一项试验；5/35 两项都拒绝。在共同参与时，CATCH 和 CHiP 的同意率分别为 29/35（82%）和 18/35（51%），而在同一 PICU 内仅对一名家长进行单次试验的同意率分别为 78%和 51%。第二家单位没有记录方法或拒绝的相关数据，但成功共同参与了一名儿童。
共同参与似乎没有危及招募或使家长感到不知所措。需要制定寻求多项试验同意的策略，包括如何为家长和患者合并信息。
