ObjectiveThis study aimed to develop a questionnaire for measuring patient perceptions of participating in clinical trials. Development was based on earlier research on patient views of involvement in medical care and a literature review. Patients were recruited from an ongoing clinical trial focused on cardiovascular illness and from an outpatient psychiatry department. Factor analysis was conducted on a pilot version of the questionnaire in 2016 and on a revised version in 2017.ResultsA total of 53 patients were recruited for the pilot study and 55 were recruited for the main study, substantially below the goal of 100 participants. Factor analysis revealed six factors measuring aspects of patients’ perceptions of participating in clinical trials, including motivation, risks and benefits, the nature of the trial itself, and practical considerations, such as cost and convenience. Inter-scale correlations ranged between 0.06 and 0.64, indicating acceptable scale independence. Reliability scores (Cronbach’s alphas) ranged from 0.62 to 0.85. Factor analysis results were somewhat unstable, with shared variance for several items across scales. This is likely due to the small sample sizes. In larger, more diverse patient samples, this questionnaire can be useful for measuring and incorporating patients’ views into the design and execution of clinical trials.
BackgroundConflict in Iraq has displaced millions of refugee youth. Warzone exposure and forced migration have unique acute and chronic impacts on youth, yet effects of exposure may not be universal across diverse refugee groups. Understanding how youth from various refugee groups are differentially affected by stress and trauma is critical to allocate resources and implement screening measures with the goal of providing early intervention.MethodTo identify the effects of warzone exposure and forced migration, a convenience sample of 48 Iraqi refugee youth ages 6–17 was assessed within the first month of arrival to the United States. Youth provided self-reported severity of posttraumatic stress and anxiety symptoms; symptom severity was then compared with an existing sample of 135 Syrian refugee youth to explore whether refugee youth of different nationalities experience the same effects of warzone exposure and forced migration. These data are the baseline for a longitudinal developmental study of refugee health, which also includes parental data.ResultsSeverity of separation anxiety and negative alterations in cognition and mood were the greatest symptomatic concerns in Iraqi refugee youth. Thirty-eight percent of responding Iraqi youth showed possible indication of an anxiety disorder. Severity of posttraumatic stress symptoms was lower in Iraqi youth compared to Syrian youth. For both Iraqi and Syrian refugee youth, separation anxiety was the most significant concern, with more than 80% of both samples showing a possible indication of clinically significant separation anxiety.ConclusionThe present observational study indicated that Iraqi refugee youth experience a range of anxiety and posttraumatic stress symptoms following warzone exposure and forced migration; posttraumatic stress symptoms were less severe in Iraqi versus Syrian youth. Comparing refugee youth of different nationalities is of particular importance, as our results demonstrate that findings from one refugee population cannot easily be generalized to another. Clinical and research efforts should prioritize interventions to address separation anxiety in refugee youth, which was of concern in both samples.
Aripiprazole, a partial dopamine agonist has been reported to help reduce symptoms of tardive dyskinesia (TD). In a prospective, open label study of a series of cases, we examined the effectiveness of aripiprazole in reducing TD symptoms. Six clinically stable patients with schizophrenia or Schizoaffective disorder and a moderate to severe TD participated in this study. They were systematically cross-titrated from their current medication to aripiprazole and maintained for 16 weeks. The mean extra pyramidal symptom score measured by Abnormal Involuntary Movement Scale (AIMS) improved from a baseline score of 15.8 to final score of 5 (paired t-test; P=0.0009). The severity of psychiatric symptoms remained unchanged. This study supports our hypothesis that clinically stable patients with moderate tardive dyskinesia who are under treatment with other first- or second-generation antipsychotics may benefit from switching to aripiprazole with a reduction of TD symptoms but with out any significant benefit in psychiatric symptoms. The results need to be viewed with caution and not considered as indicative of a viable treatment option for TD as this is an open label study, and a small sample size.
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