Discrepancies Between Objective and Subjective Outcomes of and Quality of Life During Molding Helmet Therapy for Cranial Deformities.

Positional skull deformities have been on the rise for decades and can be treated with molding helmets in early childhood. Parents often fear later cosmetic stigmatization, but also a reduced quality of life (QoL) during treatment. The aim of this study was to examine therapy results in our patient collection from a new perspective. Cranial vault asymmetry (CVA), cranial vault asymmetry index (CVAI), and cranial index (CI) were compared before and after molding helmet therapy. Correction was defined by a decrease in CVA <3.5 mm and CI <90%. Subjective therapy outcome, side effects and QoL from the parents' perspective were determined using a questionnaire. There were 25 patients included. Differences between pretherapeutic and posttherapeutic CVA, CVAI, and CI were significant (P<0.01). An objective correction according to the defined values was observed in only 12% of cases. However, 76% of parents stated that their child's skull shape was normal after therapy. There were 60 side effects reported in 23 cases. The QoL of 21 children was assessed as unimpaired during helmet therapy. Even though complete normalization was rarely observed, the parameters were significantly different after therapy, and subjective reduction in skull deformity was common.

[What became of Prialt®? : Observational study on the use of ziconotide in the treatment of chronic pain]. / Was wurde eigentlich aus Prialt®? : Beobachtungsstudie über den Langzeiteinsatz von Ziconotid in der Behandlung chronischer Schmerzen.

BACKGROUND: Prialt® was approved by the European Medicine Agency in February 2005. Besides morphine, it is the only analgesic approved for long-term intrathecal infusion in the treatment of chronic pain. As it does not bind to opioid receptors, its use in the treatment of chronic pain seemed to be safer and to lead to less adverse events compared with morphine. However, it is an orphan drug and studies of its long-term use are rare. QUESTIONS: What role does Prialt® play in the treatment of chronic pain compared with other analgesics given intrathecally? What impact do the initial dose and the rate of infusion have on the analgesic effect and on the incidence of side effects? MATERIAL AND METHODS: Medical reports were used to identify all patients receiving ziconotide monotherapy from February 2005 to the end of the analysis period in October 2018 in our department. Furthermore, a questionnaire was created and given to the patients to find out more about their experience with ziconotide. RESULTS: The study included 12 patients, all of whom suffered from at least one adverse event. The most common adverse events were forgetfulness and paraesthesia, each affecting 25% of the patients. One third of the patients discontinued ziconotide therapy due to severe adverse events. The mean initial dose was 1.98 µg/day. DISCUSSION: Ziconotide was used at the Jena University Hospital according to the latest guidelines. Nevertheless, morphine and other opioid analgesics are still more frequently used in the intrathecal management of chronic pain. There are various reasons for this, but the narrow therapeutic index, the high incidence of adverse events, and the difficulties in finding the right dose are among the most important.