Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial).

BACKGROUND AND PURPOSE: Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay. METHODS: According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence. The units of analysis were the patients admitted to hospital, with stroke and transient ischemic attack, over a time period of 15 months, beginning 3 months before the intervention was launched in the first province to allow for baseline data collection. The proportion of early arrivals (within 2 hours of symptom onset) was the primary outcome. Thrombolysis rate and some behavioral end points were the secondary outcomes. Data were analyzed using a fixed-effect model, adjusting for cluster and time trends. RESULTS: We enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign. The proportion of early access was nonsignificantly lower in exposed patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95% confidence interval, 0.60-1.08; P=0.15). As for secondary end points, an increase was found for stroke recognition, which approximated but did not reach statistical significance (P=0.07). CONCLUSIONS: Our campaign was not effective in reducing prehospital delay. Even if some limitations of the intervention, mainly in terms of duration, are taken into account, our study demonstrates that new communication strategies should be tested before large-scale implementation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152.

Development of an education campaign to reduce delays in pre-hospital response to stroke.

BACKGROUND: Systematic reviews call for well-designed trials with clearly described intervention components to support the effectiveness of educational campaigns to reduce patient delay in stroke presentation. We herein describe the systematic development process of a campaign aimed to increase stroke awareness and preparedness. METHODS: Campaign development followed Intervention Mapping (IM), a theory- and evidence-based tool, and was articulated in two phases: needs assessment and intervention development. In phase 1, two cross-sectional surveys were performed, one aiming to measure stroke awareness in the target population and the other to analyze the behavioral determinants of prehospital delay. In phase 2, a matrix of proximal program objectives was developed, theory-based intervention methods and practical strategies were selected and program components and materials produced. RESULTS: In phase 1, the survey on 202 citizens highlighted underestimation of symptom severity, as in only 44% of stroke situations respondents would choose to call the emergency service (EMS). In the survey on 393 consecutive patients, 55% presented over 2 hours after symptom onset; major determinants were deciding to call the general practitioner first and the reaction of the first person the patient called. In phase 2, adult individuals were identified as the target of the intervention, both as potential "patients" and witnesses of stroke. The low educational level found in the patient survey called for a narrative approach in cartoon form. The family setting was chosen for the message because 42% of patients who presented within 2 hours had been advised by a family member to call EMS. To act on people's tendency to view stroke as an untreatable disease, it was decided to avoid fear-arousal appeals and use a positive message providing instructions and hope. Focus groups were used to test educational products and identify the most suitable sites for message dissemination. CONCLUSIONS: The IM approach allowed to develop a stroke campaign integrating theories, scientific evidence and information collected from the target population, and enabled to provide clear explanations for the reasons behind key decisions during the intervention development process. TRIAL REGISTRATION: NCT01881152 . Retrospectively registered June 7 2013.

The progression of non-motor symptoms in Parkinson's disease and their contribution to motor disability and quality of life.

Non-motor symptoms are gaining relevance in Parkinson's disease (PD) management but little is known about their progression and contribution to deterioration of quality of life. We followed prospectively 707 PD patients (62 % males) for 2 years. We assessed non-motor symptoms referred to 12 different domains, each including 1-10 specific symptoms, as well as motor state (UPDRS), general cognition, and life quality. Hoehn & Yahr (H&Y) stage was used to categorize patient status (I-II mild; III moderate; IV-V severe). We found that individual non-motor symptoms had variable evolution over the 2-year follow-up with sleep, gastrointestinal, attention/memory and skin disturbances (hyperhidrosis and seborrhea) becoming more prevalent and psychiatric, cardiovascular, and respiratory disorders becoming less prevalent. Development of symptoms in the cardiovascular, apathy, urinary, psychiatric, and fatigue domains was associated with significant life-quality worsening (p < 0.0045, alpha with Bonferroni correction). During the observation period, 123 patients (17 %) worsened clinically while 584 were rated as stable. There was a fivefold greater increase in UPDRS motor score in worse compared with stable patients over 24 months (p < 0.0001 vs. baseline both in stable and worse group). The total number of reported non-motor symptoms increased over 24 months in patients with motor worsening compared to stable ones (p < 0.001). Thirty-nine patients died (3.4 % of patients evaluable at baseline) with mean age at death of 74 years. Deceased patients were older, had significantly higher H&Y stage and motor score, and reported a greater number of non-motor symptoms at baseline. In conclusion, overall non-motor symptom progression does not follow motor deterioration, is symptom-specific, and only development of specific domains negatively impacts quality of life. These results have consequences for drug studies targeting non-motor features.

Preliminary evaluation of the DDS-PC inventory: a new tool to assess impulsive-compulsive behaviours associated to dopamine replacement therapy in Parkinson's disease.

Dopaminergic medications could increase the occurrence of a set of dysregulated behaviours in Parkinson's disease (PD), including reward-seeking behaviours (pathological gambling, hypersexuality, compulsive shopping, binge eating, reckless driving), punding and compulsive medication use. We report a preliminary evaluation of a questionnaire to assess the presence of these impulsive-compulsive behaviours associated to dopamine replacement therapy in PD. We screened 38 patients and their caregivers, comparing dopamine dysregulation syndrome (DDS) patients and non-DDS patients. The questionnaire was well accepted and demonstrated a preliminary good discriminant validity (p = 0.000). In addition, clinically relevant dysregulated condition is associated with a younger age (p = 0.006), younger age at disease onset (p = 0.001), levodopa-equivalent daily dose (p = 0.029), UPDRS III (p = 0.021), increased global psychopathology (interpersonal sensitivity and psychoticism), and differences in our inventory (p = 0.000). These preliminary results suggest that the DDS-PC inventory could help to identify patients experiencing impulsive-compulsive behaviours associated to DDS.

The thrill of reckless driving in patients with Parkinson's disease: an additional behavioural phenomenon in dopamine dysregulation syndrome?

We report two male patients with Parkinson's disease who developed compulsive risk-seeking driving behaviour as a result of self-administering high doses of L-dopa despite an adequate therapeutic response at lower doses. When L-dopa reduction was feasible, it resulted in cessation of unsafe driving. We believe that this impairment in driving performance, due to deliberate overuse of dopaminergic medication, should be included as a new behavioural phenomenon in dopamine dysregulation syndrome.

Prevalence of pathological gambling in patients with Parkinson's disease.

Pathological gambling (PG) is a psychiatric disorder characterized by loss of control of gambling, which has repercussions on family, personal, and professional life. Several recent studies have reported the relationship between PG and the treatment of Parkinson's disease (PD), but no prevalence study has yet been conducted to investigate this correlation. The purpose of this study was to evaluate the prevalence of PG in Italian patients with PD on dopamine replacement therapy. The prevalence of PG in a PD sample (n = 98) and in an age- and sex-matched control group (n = 392) was obtained. The prevalence of PG results significantly higher (P = 0.00001) in PD patients than in control subjects (6.1% vs. 0.25%). Our results emphasize that PG in patients with idiopathic PD on dopamine replacement therapy is an emergent comorbidity, but probably at present the condition is not properly diagnosed because it is mostly unknown.