NETS²: Collaborative long-term observational studies

Background

Best practice for analysis of surgical interventions utilises the IDEAL framework[1]. This defines five stages for the assessment of complex interventions.

  • Stages 1 and 2a (Idea and Development), investigate whether the intervention can achieve a specific physical or physiological goal, what the optimal technique for achieving this goal is, and in which patient population this intervention works best. Case series and development studies are the recommended assessment methodology[2].
  • Stage 2b (Exploration), explores outcomes in more heterogeneous populations, and establishes whether equipoise exists as a pre-requisite for a definitive clinical trial. Prospective observational studies with contemporaneous comparators are used at this stage[3].
  • By stage 3 (Assessment), the procedure is relatively widespread, and its promise has been demonstrated. Comparison is made against established interventions using randomised controlled trials[4].
  • Stage 4 (Long-term study), assesses long-term outcomes, and whether there are any rare complications. Long-term observational studies or registries are recommended.

High-volume surgical specialties already incorporate the IDEAL guidelines into assessment of their clinical practice, but paediatric surgery has lagged behind. The majority of published research uses small, single-centre retrospective case series to assess stages 1 and 2a of the framework[5]. The lack of randomised controlled trials or large cohort studies assessing interventions at stages 2b, 3 and 4 of the IDEAL framework is contributing to the paucity of management guidelines for paediatric surgical conditions, and resulting in significant management variation.

Whilst the low incidence (rarity) of many paediatric surgical conditions, the complex interventions, and the ethical dilemmas encountered with paediatric research are in part responsible for the lack of controlled, prospective studies, it has been shown that these problems can be overcome by creating multi-centre research networks[6][7][8]. The aim of NETS² is therefore to expand the existing BAPS-CASS framework to allow long-term follow-up of infants with paediatric surgical conditions, and to develop international collaboration with other research networks, including the Canadian Pediatric Surgery Network. NETS² studies will help to inform generation of evidence-based management guidelines, and inform the development of future randomised controlled trials.

More information on the IDEAL collaboration

More information on the Canadian Pediatric Surgery Network

Studies

References

  1. ^ McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105-12.
  2. ^ McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ (Clinical research ed). 2013;346:f3012.
  3. ^ Patrick LE, Jeffrey SB, Peter M, Jonathan AC, Douglas GA. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ (Clinical research ed). 2013;346.
  4. ^ Patrick LE, Jeffrey SB, Peter M, Jonathan AC, Douglas GA. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ (Clinical research ed). 2013;346.
  5. ^ Allin BSR AN, Campion-Smith T, Floyd E, Kimpton J, Swarbrick K, Williams E, Knight M. . What evidence is there to support clinical practice in paediatric surgery? A systematic review describing the study designs used in paediatric surgical research. [Systematic Review]. In press 2014.
  6. ^ Jacobs JP, Jacobs ML, Maruszewski B, Lacour-Gayet FG, Clarke DR, Tchervenkov CI, et al. Current status of the European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons Congenital Heart Surgery Database. The Annals of thoracic surgery. 2005;80(6):2278-83; discussion 83-4.
  7. ^ Horbar JD, Rogowski J, Plsek PE, Delmore P, Edwards WH, Hocker J, et al. Collaborative quality improvement for neonatal intensive care. NIC/Q Project Investigators of the Vermont Oxford Network. Pediatrics. 2001;107(1):14-22
  8. ^ Lee SK, Aziz K, Singhal N, Cronin CM, James A, Lee DS, et al. Improving the quality of care for infants: a cluster randomized controlled trial. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2009;181(8):469-76.