scholarly journals Study protocol: an investigation of the prevalence of autism among adults admitted to acute mental health wards: a cross-sectional pilot study

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033169 ◽  
Author(s):  
Sam Tromans ◽  
Guiqing Lily Yao ◽  
Reza Kiani ◽  
Regi Alexander ◽  
Mohammed Al-Uzri ◽  
...  
Keyword(s):  
Mental Health ◽  
Pilot Study ◽  
Phase I ◽  
Diagnostic Criteria ◽  
Phase Ii ◽  
Univariate Analysis ◽  
Psychiatric Morbidity ◽  
Communication Disorders ◽  
Autism Spectrum ◽  
Study Results

IntroductionAutism spectrum disorders (ASDs) are associated with difficulties in social interaction, communication and restricted, repetitive behaviours. Much is known about their community prevalence among adults, data on adult inpatients within an acute mental health setting is lacking.This pilot study aimed to estimate the prevalence of ASDs among adults admitted to acute mental health wards and to examine the association between ASDs and psychiatric and physical comorbidities within this group.Methods and analysisA multiple-phase approach will be used. Phase I will involve testing of 200 patients and corresponding informants, using the autism quotient (AQ), the informant version of the Social Responsiveness Scale, second edition—Adult, the self and informant versions of the Adult Social Behaviour Questionnaire and the EuroQol-5D-5L. Patients with intellectual disability (ID) will bypass Phase I.Phase II will involve diagnostic testing of a subgroup of 40 patients with the Diagnostic Interview for Social and Communication Disorders, the Autism Diagnostic Observation Schedule version 2 and the ASD interview within the Schedules for Clinical Assessment in Neuropsychiatry version 3. 25±5 patients will not have ID and be selected via stratified random sampling according to AQ score; 15±5 patients will have ID. Phase II patients will be interviewed with the Physical Health Conditions and Mental Illness Diagnoses and Treatment sections of the 2014 Adult Psychiatric Morbidity Survey.Prevalence estimates will be based on the proportion of Phase II participants who satisfy the 10th revision of the International Statistical Classification of Diseases and Related Health Problems Diagnostic Criteria for Research (ICD-10-DCR) and the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for ASD, adjusting for selection and non-response. Univariate analysis will be conducted for comorbidities to identify the level of their association with an ASD diagnosis.Ethics and disseminationStudy oversight is provided by the University of Leicester. The National Health Service Health Research Authority have provided written approval. Study results will be disseminated via conference presentations and peer-reviewed publications.Trial registration numberISRCTN27739943

scholarly journals Pilot Study to Evaluate the Appropriate Management of Patients With Coexistent Bacterial Vaginosis and Cervicitis

1995 ◽  
Vol 3 (3) ◽  
pp. 119-122 ◽  
Author(s):  
Jane R. Schwebke ◽  
Mary Beth Schulien ◽  
Mark Zajackowski
Keyword(s):  
Targeted Therapy ◽  
Pilot Study ◽  
Phase I ◽  
Bacterial Vaginosis ◽  
Phase Ii ◽  
Preliminary Data ◽  
Sexually Transmitted Disease ◽  
Transmitted Disease ◽  
Vaginal Flora ◽  
Sexually Transmitted

A pilot study was performed to obtain preliminary data regarding the need for targeted therapy of bacterial vaginosis (BV) when it accompanies clinically defined cervicitis. Specifically, women attending a sexually transmitted disease (STD) clinic with clinically defined BV and cervicitis were treated in the first phase of the study with doxycycline alone. In phase II, the patients received doxycycline and concomitant intravaginal metronidazole gel. All patients were reexamined 3–4 weeks after therapy. Persistence of BV occurred in 18/19 (95%) of women in phase I vs. 1/7 (14%) of women in phase II (P < 0.001). We concluded that, in women with coexistent clinically defined cervicitis and BV, the treatment of cervicitis does not result in a normalization of the vaginal flora.

scholarly journals Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study (Preprint)

2019 ◽  
Author(s):  
Vijay Ravindran ◽  
Monica Osgood ◽  
Vibha Sazawal ◽  
Rita Solorzano ◽  
Sinan Turnacioglu
Keyword(s):  
Virtual Reality ◽  
Pilot Study ◽  
Side Effects ◽  
Joint Attention ◽  
Autism Spectrum ◽  
Primary Objective ◽  
School Aged Children ◽  
Attention Skills ◽  
Study Results ◽  
Target Skills

BACKGROUND Advances in virtual reality (VR) technology offer new opportunities to design supports for the core behaviors associated with autism spectrum disorder (ASD) that promote progress toward optimal outcomes. Floreo has developed a novel mobile VR platform that pairs a user receiving instruction on target skills with an adult monitor. OBJECTIVE The primary objective of this pilot study was to explore the feasibility of using Floreo’s Joint Attention Module in school-aged children with autism in a special education setting. A secondary objective was to explore a novel joint attention measure designed for use with school-aged children and to observe whether there was a suggestion of change in joint attention skills from preintervention to postintervention. METHODS A total of 12 participants (age range: 9 to 16 years) received training with the Joint Attention Module for 14 sessions over 5 weeks. RESULTS No serious side effects were reported, and no participants dropped out of the study because of undesirable side effects. On the basis of monitor data, 95.4% (126/132) of the time participants tolerated the headset, 95.4% (126/132) of the time participants seemed to enjoy using Floreo’s platform, and 95.5% (128/134) of the time the VR experience was reported as valuable. In addition, scoring of the joint attention measure suggested a positive change in participant skills related to the total number of interactions, use of eye contact, and initiation of interactions. CONCLUSIONS The study results suggest that Floreo’s Joint Attention Module is safe and well tolerated by students with ASD, and preliminary data also suggest that its use is related to improvements in fundamental joint attention skills.

scholarly journals Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study

10.2196/14429 ◽  
2019 ◽  
Vol 2 (2) ◽  
pp. e14429 ◽  
Author(s):  
Vijay Ravindran ◽  
Monica Osgood ◽  
Vibha Sazawal ◽  
Rita Solorzano ◽  
Sinan Turnacioglu
Keyword(s):  
Virtual Reality ◽  
Pilot Study ◽  
Side Effects ◽  
Joint Attention ◽  
Autism Spectrum ◽  
Primary Objective ◽  
School Aged Children ◽  
Attention Skills ◽  
Study Results ◽  
Target Skills

Background Advances in virtual reality (VR) technology offer new opportunities to design supports for the core behaviors associated with autism spectrum disorder (ASD) that promote progress toward optimal outcomes. Floreo has developed a novel mobile VR platform that pairs a user receiving instruction on target skills with an adult monitor. Objective The primary objective of this pilot study was to explore the feasibility of using Floreo’s Joint Attention Module in school-aged children with autism in a special education setting. A secondary objective was to explore a novel joint attention measure designed for use with school-aged children and to observe whether there was a suggestion of change in joint attention skills from preintervention to postintervention. Methods A total of 12 participants (age range: 9 to 16 years) received training with the Joint Attention Module for 14 sessions over 5 weeks. Results No serious side effects were reported, and no participants dropped out of the study because of undesirable side effects. On the basis of monitor data, 95.4% (126/132) of the time participants tolerated the headset, 95.4% (126/132) of the time participants seemed to enjoy using Floreo’s platform, and 95.5% (128/134) of the time the VR experience was reported as valuable. In addition, scoring of the joint attention measure suggested a positive change in participant skills related to the total number of interactions, use of eye contact, and initiation of interactions. Conclusions The study results suggest that Floreo’s Joint Attention Module is safe and well tolerated by students with ASD, and preliminary data also suggest that its use is related to improvements in fundamental joint attention skills.

scholarly journals Text Message Medication Adherence Reminders Automated and Delivered at Scale Across Two Institutions: Testing the Nudge System: Pilot Study

2021 ◽  
Author(s):  
Phat Luong ◽  
Thomas J. Glorioso ◽  
Gary K. Grunwald ◽  
Pamela Peterson ◽  
Larry A. Allen ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Phase I ◽  
Phase Ii ◽  
Text Messaging ◽  
Care Delivery ◽  
Text Message ◽  
Text Messages ◽  
Medication Refill ◽  
The Impact

Background: Medication refill behavior in patients with cardiovascular diseases is suboptimal. Brief behavioral interventions called Nudges may impact medication refill behavior and can be delivered at scale to patients using text messaging. Methods: Patients who were prescribed and filled at least one medication for hypertension, hyperlipidemia, diabetes, atrial fibrillation, and coronary artery disease were identified for the pilot study. Patients eligible for the pilot (N=400) were enrolled with an opportunity to opt out. In phase I of the pilot, we tested text message delivery to 60 patients. In phase II, we tested intervention feasibility by identifying those with refill gap of ≥7 days and randomized them to intervention or control arms. Patients were texted Nudges and assessed whether they refilled their medications. Results: Of 400 patients sent study invitations, 56 (14%) opted out. In phase I, we successfully delivered text messages to 58 of 60 patients and captured patient responses via text. In phase II, 207 of 286 (72.4%) patients had a medication gap ≥7 days for one or more cardiovascular medications and were randomized to intervention or control. Enrolled patients averaged 61.7 years old, were primarily male (69.1%) and White (72.5%) with hypertension being the most prevalent qualifying condition (78.7%). There was a trend towards intervention patients being more likely to refill at least 1 gapping medication (30.6% versus 18.0%; P =0.12) and all gapping medications (17.8% versus 10.0%; P =0.27). Conclusions: It is possible to set up automated processes within health care delivery systems to identify patients with gaps in medication adherence and send Nudges to facilitate medication refills. Text message Nudges could potentially be a feasible and effective method to facilitate medication refills. A large multi-site randomized trial to determine the impact of text-based Nudges on overall CVD morbidity and mortality is now underway to explore this further. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03973931.

Prevalence of Cluttering in Two European Countries: A Pilot Study

2017 ◽  
Vol 2 (17) ◽  
pp. 42-49 ◽  
Author(s):  
Yvonne Van Zaalen ◽  
Isabella Reichel
Keyword(s):  
Pilot Study ◽  
General Population ◽  
The Netherlands ◽  
Diagnostic Criteria ◽  
Screening Tool ◽  
Communication Disorders ◽  
European Countries ◽  
German Study ◽  
Speech Language Pathologist ◽  
Dutch Study

Purpose Until now, little has been known about the prevalence of “pure” cluttering in a general population. This study sheds light on the prevalence of cluttering in populations of normally developing pre-adolescents in the Netherlands and Germany who do not stutter or have other communication disorders. Method 304 adolescents (Netherlands, n=219/393; Germany, n= 85) were screened with the Predictive Cluttering Inventory-Revised (PCI-r), and when cluttering characteristics were detected, tested for cluttering, using the Fluency Assessment Battery (FAB). Results In total, a group of 13 adolescents had a PCI-r score above 23, indicating the necessity for further fluency assessment. Four adolescents met all the diagnostic criteria for cluttering. The prevalence of pure cluttering in the Dutch study was computed to be 1.1%. The prevalence of pure cluttering in the German study was computed to be 1.2%. Conclusion The PCI-r can serve as an appropriate screening tool for further fluency assessment and should be administered by a speech-language pathologist (SLP). The prevalence of cluttering in a population of normally developing adolescents who do not stutter was found to be about 1.1%.

Association of CTCAE v4 grading of hypertension with toxicity in patients with renal cancer receiving vascular endothelial growth factor (VEGF)-targeting agents.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 447-447 ◽  
Author(s):  
Naveed Hassan Akhtar ◽  
Irene Karpenko ◽  
Beerinder Singh ◽  
Himisha Beltran ◽  
David M. Nanus ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Individual Patient Data ◽  
Objective Response ◽  
Patient Data ◽  
Pressure Effects ◽  
Complete Evaluation ◽  
Study Results ◽  
Blood Pressure Effects ◽  
Endothelial Growth Factor

447 Background: The NCI Common Terminology Criteria for Adverse Events (CTCAE) system underwent a change to version 4 in May 2009. In addition to system re-organization, several AE categories underwent changes in grading, including hypertension (HTN). As many anti-neoplastic agents, particularly those targeting VEGF are associated with HTN, changing in the grading system may result in changes to maximum tolerated or recommended phase II doses (MTD or RP2D) in dose-escalation studies using classic trial schemas (such as 3+3 design). Methods: We reviewed individual patient data of a phase I/II trial of sorafenib plus gemcitabine and capecitabine for advanced renal cell carcinoma (RCC). The phase I portion of the study was conducted to define the dose-limiting toxicity and RP2D of the combination (Am J Clin Oncol, 2011). The phase II portion further assessed efficacy as defined by objective response rate. Initial grading of AE’s during this study used CTCAE v3. Individual patient data was reviewed and HTN AE’s were re-graded using CTCAE v4 criteria for up to 12 cycles of therapy on study. Results: Of 28 pts enrolled, 23 (82.1%) had complete source documents available for the complete evaluation of HTN. The table compares each individual’s highest CTCAE v3 versus v4 grading of HTN on study. All pts had HTN AE’s using CTCAE v4. Only 1 pt maintained grading using both versions (Gr 3), with 22 (95.7%) changing grades. Two (8.7%) moved from Gr 0 to Gr 1, fourteen 60.9(%) from Gr 0 to Gr 2, four (17.4%) from Gr 1 to Gr 2, one from Gr 1 to Gr 3, and two (8.7%) from Gr 2 to Gr 3. Conclusions: Re-classification of grading in this study demonstrates that only 4.3% maintained stable grading of HTN across systems, with 65.2% increasing by 2 grades. The change in AE reporting criteria has the potential significantly impact results of clinical trials. This may be particularly important with VEGF-targeted agents, with emerging data pointing towards HTN as a pharmacodynamic marker in pts with RCC, and may affect dosing of other drugs with blood pressure effects, including CYP17 inhibitors for prostate cancer. Clinical trial information: NCT00121251. [Table: see text]

A phase I trial of muscadine grape skin in men with biochemically recurrent prostate cancer.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 263-263
Author(s):  
Channing Judith Paller ◽  
Michelle A. Rudek ◽  
Emmanuel S. Antonarakis ◽  
Mario A. Eisenberger ◽  
Hans J. Hammers ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
High Dose ◽  
Recurrent Prostate Cancer ◽  
Grape Skin ◽  
Study Results ◽  
Patient Reported ◽  
Muscadine Grape

263 Background: New therapies are being explored as an alternative to observation in men with biochemically recurrent prostate cancer (BRPC). Muscadine Grape Skin (MPX) is comprised of ellagic acid, quercetin, and resveratrol and demonstrates preclinical activity against prostate cancer cells in vitro. Here we summarize data from a phase I dose finding trial. Methods: This phase I study assigned non-metastatic BRPC patients to increasing doses of MPX (Muscadine Naturals) in cohorts of two patients, with six patients at the highest dose, using a modified continual reassessment method. Dose selection is based on preclinical data showing the equivalent of 500 to 4,000 mg of MPX to be safe in mouse models. Our primary end point was to determine the recommended phase II dosing. We calculated changes in prostate-specific antigen (PSA) doubling time (PSADT) from at least three measurements prior to trial initiation and PSA measurements on study. Results: The cohort (n=14, 71% white, 29% black) had a median follow-up of 14.7 (6.9 to 20.7) months, median age 61, median Gleason seven, and median PSA of 5.1 ng/mL (0.2 to 153.4). Four patients had possibly related gastrointestinal symptoms, including grade 1 flatulence, grade 1 soft stools, and grade 1 burping. No other related adverse events were reported and one patient reported improvement of chronic constipation. Two of 14 patients came off study for metastatic disease. Median within-patient PSADT increased from 9.4 to 12.3 months with a PSADT difference of 3.9 months. Conclusions: These data suggest that 4,000 mg of MPX is safe, and exploratory review of change in PSADT suggests there is enough data to proceed to a phase II trial. Both low dose (500 mg) and high dose (4,000 mg) MPX are being further investigated in a multicenter, placebo-controlled, dose evaluating phase II trial. Clinical trial information: NCT01317199.

Phase I/II study of weekly topotecan and gefitinib in patients with platinum-resistant ovarian, peritoneal, or fallopian tube cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6059-6059
Author(s):  
Anca Chelariu- Raicu ◽  
Charles F. Levenback ◽  
Brian M. Slomovitz ◽  
Diane C. Bodurka ◽  
David Marc Gershenson ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Dose Level ◽  
Fallopian Tube ◽  
Phase Ii ◽  
Response To Therapy ◽  
Clinical Activity ◽  
Study Results ◽  
Level 3

6059 Background: The epidermal growth factor receptor (EGFR) is expressed in many types of cancer. Fifty to 70% of epithelial ovarian can overexpress EGFR, and its expression has been correlated with poor prognosis features in many cases. While these tumors are chemosensitive to platinum-based therapy, chemoresistance often develops. We conducted a phase I/II trial to examine the efficacy, safety, and toxicity of gefitinib, a tyrosine kinase inhibitor, combined with topotecan in women with recurrent ovarian cancer with EGFR receptor positivity (1+ or greater). Methods: Patients with measurable, recurrent or persistent cancer after treatment with a platinum and paclitaxel-containing regimen were eligible for this study (n = 19). We first used “run-in” dose escalation, in which a conventional 3+3 algorithm was used. Initial treatment was gefitinib 250 mg oral dose daily and topotecan at a dose of 2.0 mg/m2 on days 1, 8, and 15, with cycles repeated every 28 days. Dose escalations were planned for topotecan (Dose Levels 1–3: 2, 3, 4 mg/m2) until the MTD was reached. Next, an additional 10 patients with refractory or progressive ovarian cancer were enrolled in the phase II study. Results: 19 patients received a total of 61 cycles. Median age was 60 years. Histological types of treated patients included 73% serous (n = 14), 12.5% mixed (n = 2), 12.5% transitional (n = 2) and 6.3% clear cell (n = 1). There were 3 patients treated at dose level 1, 3 patients at dose level 2, and 3 patients treated at dose level 3. The maximum tolerated dose was topotecan 4.0mg/m2 IV days 1, 8 and 15, and gefitinib 250mg p.o. QD x28 days. Therefore, dose level 3 was used for the Phase II portion of the trial. Of the 19 patients included in the phase I/II, 3 patients were inevaluable for response to therapy due to toxicity, missed therapy or decline in performance status. Of the 16 patients, 81% patients (n = 13) had progressive disease, 12.5% stable disease (n = 2), and 6% partial response (n = 1). We assessed all 19 patients for adverse events; 60% had treatment-related grade 3 events, primarily blood disorders such as anemia (n = 3, 16%), neutrophil count decrease (n = 4, 21%). Conclusions: This prospective phase I/II clinical trial failed to show sufficient clinical activity of topotecan in combination with gefitinib in patients with EGFR-positive recurrent ovarian, fallopian tube, or peritoneal cancers. The drug combination was relatively well-tolerated in this cohort. As such, the study did not proceed to the next accrual goal secondary to the lack of response. Clinical trial information: NCT00317772.

Sign in / Sign up

Export Citation Format

Share Document