Health Care Rationing in a Just Society: The Clinical Effectiveness Model.

Representing 18% of gross domestic product, and projected to increase to 20% by 2022, health care costs in the United States are an unsustainable expense. The clinical effectiveness model of cost containment is an ethical and self-sustaining paradigm that can assist bending the health care-cost curve. As envisioned by Buyx et al, clinically effective care is aimed at making the practice of medicine more explicitly evidence based with the goals of improving clinical success, efficiency, and value. I provide a vision for applying the clinical effectiveness model to the American health care system. I illustrate its use with 2 examples from the practice of child neurology: DOC-band (helmet therapy) for the treatment of positional plagiocephaly-relatively inexpensive but ineffective, and adrenocorticotropic hormone for the treatment of infantile spasms-expensive but effective.

HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial.

BACKGROUND: In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls) aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. METHODS/DESIGN: Pragmatic randomised controlled trial (RCT) nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment). At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT); they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. DISCUSSION: HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies.Besides these health outcomes, we will be able to address several methodological questions, e.g. do participants in an RCT represent the eligible target population and do outcomes of the RCT differ from outcomes found in the nRCT? TRIAL REGISTRATION: ISRCTN18473161.