which adjusted for the complex survey structure of MEPS and provided national level estimates. Results: National-level prevalence of psychotropic polypharmacy among community-dwelling elderly individuals with PD was 14.7% [95% Confidence Interval (CI), 8.69% -20.71%]. Antidepressants (33.9%, 95% CI, 26.2% -41.6%) comprised the highest psychotropic medication class used followed by anti-anxiety (12.7%, 95% CI, 7.34% -18.07%), antipsychotics (8.25%, 95% CI, 3.26% -13.23%), and sedative/hypnotic (5.78%, 95% CI, 2.08% -9.46%). Individual level factors associated with psychotropic polypharmacy among community-dwelling elderly individuals with PD consisted of age, gender, race/ethnicity, education, marital status, exercise, body mass index, perceived physical and mental health status as well as chronic physical and mental health conditions. For example, elderly individuals with PD diagnosed with mental health conditions were seven times more likely (Odds Ratio -7.19; 95% CI-2.70-19.1) to receive psychotropic polypharmacy compared to those without a diagnosis of mental health condition. ConClusions: Even though the use of psychotropic polypharmacy among community-dwelling elderly individuals with PD is less compared to nursing home and home healthcare settings, close monitoring is still warranted to prevent serious adverse events in this vulnerable population.
which adjusted for the complex survey structure of MEPS and provided national level estimates. Results: National-level prevalence of psychotropic polypharmacy among community-dwelling elderly individuals with PD was 14.7% [95% Confidence Interval (CI), 8.69% -20.71%]. Antidepressants (33.9%, 95% CI, 26.2% -41.6%) comprised the highest psychotropic medication class used followed by anti-anxiety (12.7%, 95% CI, 7.34% -18.07%), antipsychotics (8.25%, 95% CI, 3.26% -13.23%), and sedative/hypnotic (5.78%, 95% CI, 2.08% -9.46%). Individual level factors associated with psychotropic polypharmacy among community-dwelling elderly individuals with PD consisted of age, gender, race/ethnicity, education, marital status, exercise, body mass index, perceived physical and mental health status as well as chronic physical and mental health conditions. For example, elderly individuals with PD diagnosed with mental health conditions were seven times more likely (Odds Ratio -7.19; 95% CI-2.70-19.1) to receive psychotropic polypharmacy compared to those without a diagnosis of mental health condition. ConClusions: Even though the use of psychotropic polypharmacy among community-dwelling elderly individuals with PD is less compared to nursing home and home healthcare settings, close monitoring is still warranted to prevent serious adverse events in this vulnerable population.
Objectives: Develop definitions for clinically meaningful 'within-subject change' on the Migraine Physical Function Impact Diary (MPFID), an instrument evaluating migraine impact on physical functioning. MethOds: Responder definitions (RDs) were developed using interim data from an observational study of episodic migraineurs (EM) who recently initiated or changed their migraine prophylaxis regimen. Subjects completed MPFID and a headache diary daily for 4 months. MPFID domain scores (Impact on Everyday Activities [ea]; Physical Impairment [Pi]) range from 0-100 (higher score= greater impact). Monthly MFPID domains were averaged daily scores across migraine and non-migraine days. Differences in MPFID domain scores between months 1 and 4 were used to estimate RDs for average within-subject change using (a) multiple external anchors/indicators of change: monthly migraine days, Patient Global Impression of Change (PGIC) in overall migraine since first visit, migraine interference with daily activities, and MPFID global impact item, and (b) distribution-based analyses. Results: The sample included 78 EM subjects. EA change scores by anchor-based groups were: -4.7 for ≥ 50% monthly migraine reduction, -4.7 for PGIC 'a little better' to -3.7 for combined 'moderately/a little better,' -3.4 for 1-2 point change in interference, and -5.5 points for ≥ 20% change on MPFID global impact. PI change scores were: -3.1 for ≥ 50% monthly migraine reduction, -3.3 for PGIC 'a little better' to -2.5 for combined 'moderately/a little better', -2.2 for 1-2 point change in interference, and -4.0 points for ≥ 20% change on MPFID global impact. Distribution-based results (0.50 SD: EA= 5.4, PI= 5.8) supported anchor-based methods. MPFID cut-points for 'within-subject change' were estimated at 4-5 points for EA and 3-5 points for PI domain scores based on this study. cOnclusiOns: Findings suggested that change of 3-5 points for MPFID EA and PI domain scores were related to clinically meaningful change as assessed by various anchors. RDs will be confirmed using additional data.
A733to show that raw and aggregated data can be transmitted remotely outside of the traditional clinical setting. This research demonstrates that data from accelerometers has value beyond the traditional sleep and activity endpoints and could be used in remote studies. Methods: Two healthy volunteers (A and B) were provided with accelerometers and hubs. The hubs were SIM enabled to allow for continuous data collection. Volunteer A wore the device for 24 hours and used a diary to identify 27 scratching events of approximately 30 seconds duration. Volunteer B wore the device for 8 hours and used a diary to identify 7 scratching events. Results: Raw 100 Hz accelerometer data was transmitted remotely via the hubs to the centralized study center, from where it was further processed and analyzed. An analytical model was developed using the data from Volunteer A to identify scratching events at a 10 second epoch level. This algorithm achieved sensitivity and specificity values of 99 and 100%, respectively for Volunteer A. The algorithm was further evaluated on unseen (from the model's point of view) Volunteer B and achieved sensitivity and specificity values of 99 and 86%, respectively. ConClusions: Accelerometerbased wearables are gaining acceptance in clinical trials as a means of generating objective endpoints for sleep and activity using validated algorithms. This study has shown that the application of suitable algorithms to raw accelerometer data has the potential to generate clinically relevant outcome measures associated with patient motor movement patterns, which can have significance in studies looking at tremor and itch and other clinical symptoms. The ability to generate and transmit raw data from a patient's home facilitates the integration of this methodology into remote and virtual trials.
A285claim date was designated as the index date. Continuous health plan enrollment 12 months pre-and post-index date was required. Patients were assigned to four monotherapy AED cohorts based on drug class: sodium channel blockers (SCs), gamma-aminobutyric acid analogs (GABAs), synaptic vesicle protein 2A binding (SV2) and multiple mechanisms (MMs). Adherence was assessed using the proportion of days covered (PDC) and persistence was defined as days to discontinuation with an allowable treatment gap of 45 days without the index AED. Logistic and Cox proportional hazards models were used to compare the results among the cohorts. RESULTS: Patients in the SC cohort had significantly lower baseline Charlson Comorbidity Index scores (1.82), indicating that they were healthier than those in the GAMA (2.08, p< 0.001) and SV2 (2.46, p< 0.001) cohorts. Patients in the SC cohort were significantly less likely to have a baseline psychiatric disorder (37.6%) than those in the GABA (63.8%, p< 0.001) and MM (52.1%, p< 0.001) cohorts. Patients treated with GABAs (OR= 0.44, p< 0.001) and MMs (OR= 0.63, p< 0.001) were significantly less likely to adhere to their medications (PDC < 80%) than those treated with SC. Furthermore, patients treated with GABAs (hazard ratio [HR]= 1.74; 95% confidence interval [CI]= 1.59-1.90) and MMs (HR= 1.18; 95% CI= 1.07-1.29) were more likely to discontinue treatment during the follow-up period compared to those in the SC cohort. CONCLUSIONS: Patients treated with Sodium channel blockers are more likely adhere to treatment and have lower discontinuation of AED monotherapy than those treated with GABAs and MMs. PND44 MeasuriNg aDhereNce aND outcoMe iN treatMeNt of MultiPle sclerosis iN the geisiNger cliNic
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