ObjectiveThe assessment of response to lithium maintenance treatment in bipolar disorder (BD) is complicated by variable length of treatment, unpredictable clinical course, and often inconsistent compliance. Prospective and retrospective methods of assessment of lithium response have been proposed in the literature. In this study we report the key phenotypic measures of the “Retrospective Criteria of Long-Term Treatment Response in Research Subjects with Bipolar Disorder” scale currently used in the Consortium on Lithium Genetics (ConLiGen) study.Materials and MethodsTwenty-nine ConLiGen sites took part in a two-stage case-vignette rating procedure to examine inter-rater agreement [Kappa (κ)] and reliability [intra-class correlation coefficient (ICC)] of lithium response. Annotated first-round vignettes and rating guidelines were circulated to expert research clinicians for training purposes between the two stages. Further, we analyzed the distributional properties of the treatment response scores available for 1,308 patients using mixture modeling.ResultsSubstantial and moderate agreement was shown across sites in the first and second sets of vignettes (κ = 0.66 and κ = 0.54, respectively), without significant improvement from training. However, definition of response using the A score as a quantitative trait and selecting cases with B criteria of 4 or less showed an improvement between the two stages (ICC1 = 0.71 and ICC2 = 0.75, respectively). Mixture modeling of score distribution indicated three subpopulations (full responders, partial responders, non responders).ConclusionsWe identified two definitions of lithium response, one dichotomous and the other continuous, with moderate to substantial inter-rater agreement and reliability. Accurate phenotypic measurement of lithium response is crucial for the ongoing ConLiGen pharmacogenomic study.
Objectives
The purpose of the present study was to analyze treatment outcome with a full-occlusion biofeedback (BFB) splint on sleep bruxism (SB) and TMD pain compared with treatment with an adjusted occlusal splint (AOS).
Materials and methods
Forty-one patients were randomly allocated to a test (BFB) or a control (AOS) group and monitored over a 3-month period. Output variables were frequency and duration of bruxing events (bursts) and various pain symptoms.
Results
The BFB group showed a statistically significant reduction in the frequency and duration of bursts and a statistically significant improvement in the patients’ global well-being and the facial muscle pain parameter. After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
Conclusions
The tested BFB splint is highly effective in reducing SB at the subconscious level, i.e., without waking the patient, and in achieving improvements in global pain perception. The results suggest that the BFB splint also provides a better treatment option for bruxism-related pain than an AOS. However, further research is needed, and specifically studies with a larger patient population displaying higher levels of pain at baseline.
Clinical relevance
By reducing burst duration and therefore the pathological load on the masticatory apparatus, the BFB splint reduces TMD and bruxism-related symptoms and improves patients’ physical well-being. In the long term, this could prevent damage to the TMJ. This study confirms the effectiveness and safety of this splint.
The universal trial number
U1111-1239-2450
DRKS-ID registration
DRKS00018092
Continuous glucose monitoring (CGM) systems use trend arrows to accurately display the anticipated glucose curve for the user. These are used for both “real-time” glucose monitoring and for intermittent scanning glucose monitoring. Trend arrow data are used by people with diabetes to make corrections to their glucose control. It is essential that they are correctly interpreted when adjusting insulin doses and to ensure that appropriate treatment decisions are made. The aim of this article is to provide general treatment guidance for diabetes teams and for people with diabetes using CGM in the context of trend arrows. This is based on previous recommendations for interpreting trend arrows without losing sight of the need for individual therapy adjustment.
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