Consensus definition and diagnostic criteria for neonatal encephalopathy-study protocol for a real-time modified delphi study.

BACKGROUND: 'Neonatal encephalopathy' (NE) describes a group of conditions in term infants presenting in the earliest days after birth with disturbed neurological function of cerebral origin. NE is aetiologically heterogenous; one cause is peripartum hypoxic ischaemia. Lack of uniformity in the terminology used to describe NE and its diagnostic criteria creates difficulty in the design and interpretation of research and complicates communication with families. The DEFINE study aims to use a modified Delphi approach to form a consensus definition for NE, and diagnostic criteria. METHODS: Directed by an international steering group, we will conduct a systematic review of the literature to assess the terminology used in trials of NE, and with their guidance perform an online Real-time Delphi survey to develop a consensus diagnosis and criteria for NE. A consensus meeting will be held to agree on the final terminology and criteria, and the outcome disseminated widely. DISCUSSION: A clear and consistent consensus-based definition of NE and criteria for its diagnosis, achieved by use of a modified Delphi technique, will enable more comparability of research results and improved communication among professionals and with families. IMPACT: The terms Neonatal Encephalopathy and Hypoxic Ischaemic Encephalopathy tend to be used interchangeably in the literature to describe a term newborn with signs of encephalopathy at birth. This creates difficulty in communication with families and carers, and between medical professionals and researchers, as well as creating difficulty with performance of research. The DEFINE project will use a Real-time Delphi approach to create a consensus definition for the term 'Neonatal Encephalopathy'. A definition formed by this consensus approach will be accepted and utilised by the neonatal community to improve research, outcomes, and parental experience.

Does interpersonal loss preceding panic disorder onset moderate response to psychotherapy? An exploratory study.

BACKGROUND: Little research has addressed moderators of treatment outcome for anxiety disorders, and none has considered interpersonal loss as a predictor of outcome. PURPOSE: To examine the effect of interpersonal loss events within the 6 weeks preceding panic disorder onset as a moderator of outcome in a randomized controlled trial of Panic-Focused Psychodynamic Therapy (PFPP) and Applied Relaxation Therapy (ART). Researchers hypothesized that such loss events would predict better outcome in PFPP but would not affect ART outcome. METHOD: Forty-nine subjects with panic disorder were randomly assigned to a 12-week course of PFPP or ART. Independent raters blinded to treatment condition and study hypotheses rated subjects on the Panic Disorder Severity Scale (PDSS) and Sheehan Disability Scale. Exploratory analyses assessed between-group effect size for PFPP and ART following standard moderator analytic procedures. The trial was conducted between February 2000 and January 2005. RESULTS: Three quarters of subjects reported a narrowly defined interpersonal loss (LOSS) in the 6 weeks preceding panic disorder onset. These subjects had a mean (SD) duration of panic disorder of 8.2 (9.5) years. PFPP was more efficacious than ART, but LOSS did not moderate PFPP outcome. An unexpected finding was that LOSS moderated ART outcome: subjects without LOSS showed no response to ART (PDSS mean (SD) change score = 0.00 [2.90]), whereas LOSS had a pre-post mean (SD) change score of 4.29 (5.60). Neither examination of potential confounding variables nor sensitivity analyses of assumptions regarding attrition altered these findings. CONCLUSIONS: Interpersonal loss events preceding onset of panic disorder were more common even than in prior studies. These losses moderated outcome in ART, a therapy that does not focus on such losses. Implications and the need for future research before incorporating these findings into clinical practice are discussed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00128388.