Preliminary Outcome Data Research Articles

P1.16-11 A Dyad-Based Mindfulness Cancer Recovery Program for Survivors and Family Members to Reduce Lung Cancer Symptoms

Although the five-year survival rate for individuals with NSCLC stages I-IIIa, is increasing, excessive symptom burden remains a distressing problem that negatively impacts quality of life. Our long-term goal is to improve clinical outcomes for survivors of localized lung cancer (NSCLC; stages I–IIIa). The study objective is to test a tailored intervention, Breathe Easier, which encompasses meditation, varying levels of yoga, and breathing exercises to evaluate feasibility and preliminary effects for survivors and family members (dyads). A community-based participatory research approach was used to adapt a mindfulness-based cancer recovery program. Using a prospective, one-group, repeated measures, mixed method design, this study collected feasibility and preliminary data to test the hypothesis that survivors and family members (dyads) who receive an 8-week intervention will demonstrate (a) less dyspnea, (b) less fatigue, (c) improved sleep quality and quantity, (d) improved exercise tolerance and (e) less stress immediately after the intervention. The intervention known as “Breathe Easier” consisted of breathing exercises, individual and partner sitting, standing and floor yoga movements, meditations and participant interaction. The outcome variables were measured pre and immediately post intervention by the FACIT Dyspnea Short Form (Parts 1 and 2), FACIT Fatigue Scale v.4. Pittsburgh Sleep Quality Index, 6-Minute Walk Test, and the Perceived Stress Scale v.4. Post-intervention qualitative interviews were conducted. Descriptive statistics were obtained for five quantitative feasibility measures (recruitment, retention, intervention dose, adherence, acceptability). Thematic analysis was used to interpret the qualitative data. In six iterations of the intervention,164 survivors were reached, and 32 dyads enrolled (62 participants; 20% recruitment and 94% retention rates). Survivors were 44% male and 62% African American. Among all, 74% were not current smokers, 22% used oxygen, and 71% completed a six-minute walk test post-intervention. Adherence was demonstrated by good attendance and exceeding expectations on home assignments for breathing exercises and meditations. All participants practiced gentle movements (yoga), meeting approximately 80% of expectations. Survivors reported completing daily home assignments slightly more than family members. All agreed that the intervention materials were easy to use, learning yoga and breathing exercises helped, and involving a family member was important. For each outcome variable, differences in survivors versus partners were calculated. Survivors had less dyspnea and perceived stress over time. Both groups had improved fatigue and sleep scores. Interview data enriched the understanding of feasibility and preliminary outcome measures. Six themes illustrated participants’ experiences: (1) Learning to Breathe Easier, (2) Enhanced Closeness with Committed Partners, (3) Stretching, Releasing Tension, and Feeling Energized, (4) Interacting with Others as Beneficial, (5) Refocused on Living, and (6) Sustainability as a Decision. Recruitment, retention, adherence, and acceptability demonstrated strong feasibility. Preliminary outcome data indicate benefits over time for both survivors and family members.

A453 Personalized, Multi-Component Interventions for Behavioral Weight Management: Yes, but How? A Hybrid Intervention of Compulsory and Personalized Elements Based in Self-Determination Theory

Bariatric surgery is the most effective treatment for severe obesity. However, with more than 40% of postoperative bariatric patients experiencing excessive weight regain (i.e., 25%+ of total lost weight) and the majority of patients regaining some weight, there is a need for individualized behavioral interventions to promote sustained, lifelong maintenance of surgical weight loss. Given the multifactorial nature of weight regain, interventions must be multicomponent and personalized. This recommendation represents best practice; however, clinicians may lack knowledge or experience for pragmatic implementation. This session will address these issues, highlighting self-determination theory (SDT) as optimal for conceptualizing personalized treatments. Emphasis will be placed on the utility of the three components of SDT – autonomy, competence, and relatedness – to inform personalized, holistic interventions for patients who have lost or are trying to lose weight. SDT-based, personalized behavioral interventions can be tailored for both surgical and non-surgical populations with obesity, and they are ideal for preventing recidivism following weight loss. A brief overview of the BOSS intervention (Bariatric Outcomes: Sustaining Success) will be provided: this is an SDT-based, multicomponent intervention for promoting sustained weight loss and preventing recidivism. Five adult case examples will highlight how the intervention is tailored across SDT domains of autonomy, competence, and relatedness. Preliminary outcome data will also be provided: all patients are actively losing weight or maintaining weight loss. The session will demonstrate the implementation and personalization of evidence-based interventions, emphasizing the need for both compulsory and individualized elements within a multi-component program for lifelong behavioral weight management.

1336TiP - A randomized phase Ib/II study of the selective small molecule Axl inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib (D/T) or pembrolizumab in patients with metastatic melanoma

BackgroundUpregulation of the receptor tyrosine kinase Axl has been linked with both a reduced response to immune checkpoint blockade as well as the development of therapy resistance to BRAF directed therapies in melanoma. Bemcentinib is a first-in-class orally bioavailable selective inhibitor of Axl which is currently being explored in several phase II clinical trials. BGBIL006 (NCT02872259) is an open label phase Ib/II trial designed to explore whether combinations with bemcentinib improves ORR and duration of response compared to standard of care therapies in patient (pts) with metastatic melanoma (MM). Trial designPatients are randomized 2:1 to receive D/T or pembro +/- bemcentinib, respectively, based on mutation status and tumour load. BRAF positive pts are allowed to switch D/T with pembrolizumab and vice versa upon progression. Tumour responses are assessed per investigator using RECIST v1.1. Plasma protein biomarker levels are measured using the DiscoveryMap v3.3 panel (Myriad RBM) in pts pre-dose and at C2D1. In June 2019, a formal interim analysis of clinical safety and efficacy data will be performed when at least 20 randomised patients have completed up to 12 cycles of treatment. Currently, 50 pts (92 planned) have been enrolled in the trial. Tolerability of the bemcentinib RP2D (200mg daily) in combination with either D/T or pembro, and AE profiles for either therapeutic approach alone will be reported. Protein biomarkers candidates predictive of pt benefit following treatment and pre/post treatment changes of soluble proteins will be presented. Preliminary efficacy outcome data and safety data from the first formal preplanned interim analysis will be presented together with the recommendations from the Data Monitoring Committee. Clinical trial identificationNCT02872259. Legal entity responsible for the studyThe authors. FundingResearch Council Norway. DisclosureO. Straume: Travel / Accommodation / Expenses: BerGenBio. J.B. Lorens: Shareholder / Stockholder / Stock options: BerGenBio ASA. G. Gausdal: Full / Part-time employment: BerGenBio ASA. All other authors have declared no conflicts of interest.

Pediatric partial gelfoam myringoplasty with ventilation tube placement

ObjectiveFor children with a history of persistent Eustachian tube dysfunction (ETD) or otitis media with effusion presenting with recurring tympanic membrane (TM) perforation, surgeons must often balance the treatment goals of correcting the perforation and maintaining ventilation to the middle ear to prevent future perforation formation. A partial gelfoam myringoplasty with ventilation tube placement is a previously unreported procedural option for addressing these goals. The objective of this study is to describe the partial myringoplasty technique and report preliminary outcome data for the procedure. MethodsRetrospective cohort study of 29 children <18 years old undergoing partial myringoplasty at a tertiary care children's hospital or satellite location. Size and course of initial perforation, time to tube extrusion, audiogram findings, and need for future otological procedures were studied. ResultsDuring a partial myringoplasty, a tympanostomy tube is placed in a TM perforation larger than the tube itself. The edges of the perforation are freshened, a tube is placed, and a piece of gelfoam is inserted to support the tube and to cover any remaining perforation. Out of 32 ears in 29 patients, 23 procedures were completed to correct existing perforations. The remainder were indicated in placement (n = 7) or replacement (n = 2) where the myringotomy or existing perforation was deemed too large to retain the tympanostomy tube without further support due to atelectatic or monomeric tympanic membranes. Thirteen tubes extruded within 1 year, of which 12 were Armstrong tubes and 1 was a T-tube. Out of 25 TM perforations corrected, 4 shrank in size and 2 did not close. For patients who underwent pre-surgical audiograms with findings indicating conductive hearing loss and had post-operative audiograms at follow-up, 8/10 showed improvement and 2/10 showed no change in hearing. ConclusionA partial myringoplasty is a simple procedure to close existing TM perforations while maintaining ventilation to the middle ear that can potentially improve hearing, provide ongoing ventilation, and eventually result in TM closure without the need for more complex repair. It may serve as a reasonable first line treatment for repair of perforations, reserving tympanoplasty for patients who fail this procedure.

The Impact of Integrating Physical Health into a Brief CBT Approach for Medically Ill Veterans.

The current study explored the use and preliminary outcomes of physical health treatment elements integrated into a traditional brief cognitive behavioral therapy (bCBT) approach for medically ill veterans with depression and/or anxiety. Data were collected as part of a pragmatic randomized trial examining patient outcomes of bCBT versus an enhanced usual care condition. bCBT was delivered to participants by Veterans Health Administration (VA) mental health providers in the primary care setting. Using a skill-based approach, providers and participants selected modules from a list of intervention strategies. Modules included Taking Control of Your Physical Health, Using Thoughts to Improve Wellness, Increasing Pleasant Activities, and Learning How to Relax. Skill module use and impact on treatment completion and clinical outcomes were explored for participants randomized to bCBT who received at least one skill module (n = 127). Utilization data showed that participants and providers most commonly selected the physical health module for the first skill session. Receiving the "physical health" and "thoughts" modules earlier in treatment were associated with a higher likelihood of treatment completion (defined as four or more sessions). Preliminary outcome data suggest that the physical health skill module was equally effective or superior to other bCBT skill modules. Results suggest that incorporating physical health elements with a bCBT approach hold the potential to positively impact treatment engagement/completion and may result in improved outcomes for medically ill patient populations.

Caregiving for children through conflict and displacement: a pilot study testing the feasibility of delivering and evaluating a light touch parenting intervention for caregivers in the West Bank.

A child's adjustment to wartime stress is reliant not only on individual responses and qualities, but very significantly on the availability of support that they may receive from their parent or caregivers and quality of relationships. Strengthening parental support has the potential to be valuable. A pilot two-arm randomised controlled trial investigated the feasibility of delivering and evaluating the "Caring for Children Through Conflict and Displacement" intervention with caregivers in the West Bank. Feasibility to recruit and train non-specialist staff on-the-ground to screen families for eligibility, collect outcome data, deliver the intervention and to recruit and retain families in the study were examined. Research staff and intervention facilitators were successfully appointed in the field, screened participants and delivered the intervention to 120 caregivers, collecting outcome measures pre-and post-delivery. All families completed the outcome measures, with very little missing data. This indicated that the intervention can be delivered feasibly and evaluated with families in this humanitarian context. Preliminary outcome data showed promise that the intervention may have the potential to both improve family functioning and reduce children's problem behaviour. Implications of family-focused initiatives, particularly within a conflict/post-conflict context for the prevention of several negative health and social outcomes directions, are discussed.

The middle fossa approach with self-drilling screws: a novel technique for BONEBRIDGE implantation

BackgroundBone conduction implants can be used in the treatment of conductive or mixed hearing loss. The BONEBRIDGE bone conduction implant (BB-BCI) is an active, transcutaneous device. BB-BCI implantation can be performed through either the transmastoid or retrosigmoid approach with their respective limitations. Here, we present a third, novel approach for BB-BCI implantation.ObjectiveDescribe the detailed surgical technique of BB-BCI implantation through a middle fossa approach with self-drilling screws and present preliminary audiometric outcome data following this approach.MethodsA single institution, retrospective chart review was completed for patients implanted with the BB-BCI via the middle fossa approach. Preoperative planning and modelling were performed using 3D Slicer. Audiological testing was performed pre- and post-operatively following standard audiometric techniques.ResultsForty patients underwent BB-BCI implantation using the middle fossa approach. Modelling techniques allowed for implantation through the use of external landmarks, obviating the need for intraoperative image guidance. The surgical technique was refined over time through experience and adaptation. Mean follow-up was 29 months (range 3–71 months) with no surgical complications, favourable cosmesis, and expected audiometric outcomes. An average functional gain of 39.6 dB (± 14.7 SD) was found.ConclusionThe middle fossa technique with self-drilling screws is a safe and effective option for BONEBRIDGE implantation. As a reference for other groups considering this approach, an annotated video has been included as a supplement to the study.

A feasibility study of a cross-diagnostic, CBT-based psychological intervention for acute mental health inpatients: Results, challenges, and methodological implications.

Acute psychiatric inpatient wards are characterized by minimal provision of therapeutic activities and high readmission rates. Implementation of a comprehensive inpatient psychological intervention service has been recommended to overcome these problems; however, whether this is feasible or effective remains unclear. This non-randomized parallel cluster feasibility trial examined the feasibility of delivering and evaluating cross-diagnostic psychologically informed acute psychiatric care the Edinburgh-Acute Psychological Inpatient Therapy Service (EDAPTS) and gathered preliminary clinical outcome data. Patients able to consent and complete questionnaires were recruited from two adult acute wards (i.e., clusters) and received either EDAPTS plus TAU or TAU. Between October 2015 and October 2016, 96 inpatients were recruited. Findings suggested that there were good data completion rates for several clinical outcomes, that several EDAPTS components were successfully delivered, and that some initial effects appeared to favour the intervention, depending on outcome. However, difficulties relating to the recruitment process were also identified, as well as problems relating to adequate delivery of group therapies, participant engagement in some intervention components, and data completion at follow-up. These issues, and the feasibility of randomization and rater-blinding, have important implications for the design of future trials. Overall, this study provides an important insight into the challenges and complexities of developing and evaluating a comprehensive psychological intervention service in an acute psychiatric setting. Individual therapy sessions can be delivered in the acute environment. The EDAPTS intervention showed some promise on outcomes of distress and self-efficacy. Delivery of nurse-led groups was challenging and may need to be embedded into routine clinical practice to increase intervention and outcome reach. More parameters, for example, randomization at cluster level, should be tested before progressing to an adequately powered, single-blind, definitive cluster RCT.

1266P - Update on the randomised phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma

Abstract Background Upregulation of the receptor tyrosine kinase Axl has been linked with both a reduced response to immune checkpoint blockade as well as the development of therapy resistance to BRAF directed therapies in melanoma. Bemcentinib is a first-in-class orally bioavailable selective inhibitor of Axl which is currently being explored in several phase II clinical trials. BGBIL006 (NCT02872259) is an open label phase Ib/II trial designed to explore whether combinations with bemcentinib improves ORR and duration of response compared to standard of care therapies in patient (pts) with metastatic melanoma (MM). Trial design Patients are randomized 2:1 to receive D/T or pembro +/- bemcentinib, respectively, based on mutation status and tumour load. BRAF positive pts are allowed to switch D/T with pembrolizumab and vice versa upon progression. Tumour responses are assessed per investigator using RECIST v1.1. Plasma protein biomarker levels are measured using the DiscoveryMap v3.3 panel (Myriad RBM) in pts pre-dose and at C2D1. In June 2019, a formal interim analysis of clinical safety and efficacy data will be performed when at least 20 randomised patients have completed up to 12 cycles of treatment. Currently, 50 pts (92 planned) have been enrolled in the trial. Tolerability of the bemcentinib RP2D (200 mg daily) in combination with either D/T or pembro, and AE profiles for either therapeutic approach alone will be reported. Protein biomarkers candidates predictive of pt benefit following treatment and pre/post treatment changes of soluble proteins will be presented. Preliminary efficacy outcome data and safety data from the first formal preplanned interim analysis will be presented together with the recommendations from the Data Monitoring Committee. Clinical trial identification NCT02872259. Legal entity responsible for the study The authors. Funding Research Council Norway. Disclosure O. Straume: Travel / Accommodation / Expenses: BerGenBio. J.B. Lorens: Shareholder / Stockholder / Stock options: BerGenBio ASA. G. Gausdal: Full / Part-time employment: BerGenBio ASA. All other authors have declared no conflicts of interest.

NP30 - School Dining Redesign: Impacts on Students and Teachers in Middle and High Schools in California

Objective: The purpose of the study was to evaluate a school dining redesign in a large school district in California. Outcomes included school lunch participation, student intake of fruits and vegetables, and teacher promotion of school meals. Description: Using a quasi-experimental controlled trial design, we present results from the first year of a 2-year implementation of a 3-pronged intervention: dining room redesign, distributed points of sale of school lunch, and staff promotion of school meals. Linear regression models were used to compare changes from 2016 to 2017 in survey responses from 7th-10th grade students and teachers from 12 middle and high schools compared to 12 control schools. Models of student survey data were adjusted for race/ethnicity, gender and grade. Changes from 2016–2017 in school lunch participation were adjusted for school enrollment, free and reduced price meal enrollment, and student race/ethnicity. Evaluation: Surveys were collected from over 8,000 students and over 500 teachers. Half of students were Asian, 17% Latino, 10% White, 4% African-American. Significantly more students in intervention compared to control schools reported eating school breakfast and getting lunch from a mobile school cart. More intervention students indicated that they liked the fruit served with lunch, staff encouraged them to eat school lunch, and the school lunch was healthier than foods from elsewhere. Compared to teachers at control schools, teachers at intervention schools reported more often eating the school lunch, and eating from the healthy student vending machines as opposed to the traditional staff vending machines. No increases in the weekly frequency of students eating fruits and vegetables or in teachers promoting school meals to students were detected. Trends in school lunch participation appear promising. Conclusions and Implications: Preliminary outcome data suggest that a school dining redesign may be effective in improving student perceptions of school meals and participation in school lunch. Future analyses will include 2-year results and assessment of school meal waste. Funding: 2015-68001-23236. The following is the supplementary data to this article: Download .pdf (2.88 MB) Help with pdf files Poster

Description and Preliminary Outcomes of an In Vivo Exposure Group Treatment for Posttraumatic Stress Disorder.

Prolonged exposure (PE) therapy is traditionally delivered individually to patients. To engage more veterans in care, an in vivo exposure group treatment was developed in an urban VA medical center. This treatment represented a modification of the in vivo exposure portion of PE, with the addition of in-session, therapist-assisted in vivo exposures. Here, we describe this 12-week treatment and present preliminary outcome data. Demographics and pre- and posttreatment scores on the PTSD Checklist-Specific (PCL-S) and Beck Depression Inventory-II (BDI-II) were extracted from a program evaluation database. The sample included veterans with a diagnosis of posttraumatic stress disorder (PTSD) who participated in the in vivo exposure group between October 2010 and March 2014 and had available treatment outcome data (N = 43). The majority of participants in the sample were male (n = 41, 95.3%) and Black (n = 34, 79.1%). Participation in the in vivo group was associated with a significant decrease in PCL-S scores, with a medium-large effect size, t(42) = 5.35, p < .001, d = 0.73, and a significant decrease in BDI-II scores, with a small effect size, t(38) = 2.55, p = .015, d = 0.23. Previous participation in an evidenced-based treatment (EBT) was not associated with symptom change following the in vivo group. Findings suggest that in vivo exposure group therapy constitutes a promising intervention for individuals who decline EBTs or remain symptomatic after completing an EBT for PTSD. Further study of this treatment using a randomized controlled trial design is warranted.

Mindfulness-based resilience training to reduce health risk, stress reactivity, and aggression among law enforcement officers: A feasibility and preliminary efficacy trial

The primary objective of this study was to assess feasibility and gather preliminary outcome data on Mindfulness-Based Resilience Training (MBRT) for law enforcement officers. Participants (n = 61) were randomized to either an 8-week MBRT course or a no intervention control group. Self-report and physiological data were collected at baseline, post-training, and three months following intervention completion. Attendance, adherence, post-training participant feedback, and interventionist fidelity to protocol all demonstrated feasibility of MBRT for law enforcement officers. Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up. This initial randomized trial suggests MBRT is a feasible intervention. Outcome data suggest MBRT targets key physiological, psychological, and health risk factors in law enforcement officers, consistent with the potential to improve officer health and public safety. However, follow-up training or “booster” sessions may be needed to maintain training gains. A fully powered longitudinal randomized trial is warranted.

A pulmonary embolism response team's initial 20 month experience treating 87 patients with submassive and massive pulmonary embolism.

Pulmonary Embolism Response Teams (PERTs) have emerged to provide rapid multidisciplinary assessment and treatment of PE patients. However, descriptive institutional experience and preliminary outcomes data from such teams are sparse. PERT activations were identified through a retrospective review. Only confirmed submassive or massive PEs were included in the data analysis. In addition to baseline variables, the therapeutic intervention, length of stay (LOS), in-hospital mortality, and bleeding rate/severity were recorded. A total of 124 PERT activations occurred over 20 months: 43 in the first 10 months and 81 in the next 10. A total of 87 submassive (90.8%) and massive (9.2%) PE patients were included. The median age was 65 (51-75 IQR) years. Catheter-directed thrombolysis (CDT) was administered to 25 patients, systemic thrombolysis (ST) to six, and anticoagulation alone (AC) to 54. The median ICU stay and overall LOS were 6 (3-10 IQR) and 7 (4-14 IQR) days, respectively, with no association with any variables except a brain natriuretic peptide (BNP) >100 pg/mL ( p=0.008 ICU LOS; p=0.047 overall LOS). Twelve patients (13.7%) died in the hospital, nine of whom had metastatic or brain cancer, with a median overall LOS of 13 (11-17 IQR) days. There were five major bleeds: one in the CDT group, one in the ST group, and three in the AC group. Overall, (1) PERT activations increased after the first 10 months; (2) BNP >100 pg/mL was associated with a longer LOS; (3) rates of mortality and bleeding did not correlate with treatment; and (4) the majority of in-hospital deaths occurred in patients with advanced cancer.

Care Coordination Services: A Description of an Alternative Service Model for At-Risk Families

ABSTRACTObjective: The objective of this article is to describe a care coordination model that includes promising practices which are supported by both practice-based and research-based evidence. This model was developed to address the gaps of other models, namely an emphasis on skill teaching with parents, the flexibility to adapt to the needs of youth with a wide variety of presenting problems, and model fidelity assessment tools to help scale up the program across multiple locations with fidelity.Method: We discuss preliminary administrative and outcome data from 898 youth served across eight locations.Results: Data suggest positive outcomes at departure from service, as well as 6 months and 12 months post case closure.Conclusion: Preliminary data indicate that youth with educational and behavioral health challenges can benefit from coordination of services that are both youth guided and family driven. As this program has been scaled up and has an established vehicle of dissemination, it is in a unique position to be tested via more highly controlled and rigorous efficacy trials.

Implementing the compassion intervention, a model for integrated care for people with advanced dementia towards the end of life in nursing homes: a naturalistic feasibility study

BackgroundMany people with dementia die in nursing homes, but quality of care may be suboptimal. We developed the theory-driven ‘Compassion Intervention’ to enhance end-of-life care in advanced dementia.ObjectivesTo (1) understand...

Creation and initial validation of a 360° Interprofessional Clinic Assessment Tool (IP-CAT) for pre- and post-licensure trainees

Abstract To better understand the effects of interprofessional training on clinical and systems outcomes, there is a need for cross-professional, competency-based assessment instruments that yield scores from which one can make valid inferences. Existing instruments have not been developed across medicine, nursing, pharmacy, and psychology for both pre- and post-licensure trainees. This paper describes our efforts to: 1) provide a crosswalk of the competency documents for these four professions, 2) create an Interprofessional Clinic Assessment Tool , focused on engagement with the team and assigned patient panel, and 3) generate initial validation evidence. Preliminary outcome data indicates the Interprofessional Clinic Assessment Tool (IP-CAT) is efficient and effective in evaluating interprofessional competencies and facilitating improved interprofessional communication/discussion. Future studies should focus on determining effectiveness in a variety of training settings.

Adapting and developing a video-feedback intervention for co-parents of infants at risk of externalising behaviour problems (VIPP-Co): A feasibility study.

Recent research on early interventions with parents of infants at risk of externalising behaviour problems indicates that focusing on co-parenting and involving fathers in treatment may enhance effectiveness. This article reports the development and preliminary evaluation of a brief intervention: video-feedback intervention to promote positive parenting and sensitive discipline for co-parents (VIPP-Co). Families who reported to be struggling with their infant's behaviour were recruited from the community and received six home-based sessions of VIPP-Co. The primary outcome was feasibility of the adapted intervention, assessed using semi-structured questionnaires and interviews post-intervention. Preliminary clinical outcome measures were also recorded. In total, five families with infants between 10 and 24 months completed the intervention. Feedback data documented high rates of acceptability and feasibility. All fathers and mothers completing the intervention reported that it positively impacted their understanding of their child's thoughts and feelings, as well as their approach to individual parenting and co-parenting. Additional preliminary outcome data indicated positive changes in parent-chid interaction and a positive trend was found for infant behaviour, parental well-being and parent relationship adjustment across the intervention. The overall results of this study are encouraging, but VIPP-Co must be evaluated with larger samples to explore its efficacy.

Utilization of informatics for integrating biology and the bedside to access preliminary outcome data of post-operative complication of spine surgery associated with diabetes mellitus

Study Design: Retrospective Study Objective: To evaluate the utility of Informatics for Integrating Biology and the Bedside database (i2b2) of University of Missouri in comparing post-operative outcomes after spinal surgery of patients with Diabetes Mellitus (DM) to those without. Summary of background data: Studies in cardiovascular surgery, orthopedic surgery, and spine surgery have shown an association of poor preoperative hyperglycemia control with worse outcomes. However, the details of that association are not well described. Outcomes of spine surgery gleaned from nationwide databases are not universally available; some require significant costs, while others are not always available to all investigators. Informatics for Integrating Biology and the Bedside (i2b2) is a National Institutes of Health -sponsored National Center for Biomedical Computing developed for researchers to search electronic medical records for de-identified patient data to facilitate research investigations. Methods: The Informatics for Integrating Biology and the Bedside (i2b2) database of University of Missouri was queried for various spine surgeries using categories of Non-DM patients, DM patients, and complications. Results: Between Jan. 1, 2000 and Sept. 30, 2015 a total of 26009 spine surgeries were performed at University of Missouri Health Care. Diabetes Mellitus (DM) was not present in 20834, with 5175 had DM. DM patients had a twofold higher incidence of wound infection, Deep Venous Thrombosis, and Urinary Tract Infection. Pulmonary Embolism and myocardial infarction were 3 times more common in DM. Stroke rate was 3.9 more likely in DM. Overall, comorbidities were 2.4 fold higher in DM. The estimated time to acquire the above data was 8 hours. Conclusions: Informatics for Integrating Biology and the Bedside is an excellent tool to extract preliminary data to develop hypothesis, test hypothesis, and gather preliminary report in a reasonable period of time. De-identified data allows researchers to perform acquire data without IRB approval.

Developing a Deep Brain Stimulation Neuromodulation Network for Parkinson Disease, Essential Tremor, and Dystonia: Report of a Quality Improvement Project.

ObjectiveTo develop a process to improve patient outcomes from deep brain stimulation (DBS) surgery for Parkinson disease (PD), essential tremor (ET), and dystonia.MethodsWe employed standard quality improvement methodology using the Plan-Do-Study-Act process to improve patient selection, surgical DBS lead implantation, postoperative programming, and ongoing assessment of patient outcomes.ResultsThe result of this quality improvement process was the development of a neuromodulation network. The key aspect of this program is rigorous patient assessment of both motor and non-motor outcomes tracked longitudinally using a REDCap database. We describe how this information is used to identify problems and to initiate Plan-Do-Study-Act cycles to address them. Preliminary outcomes data is presented for the cohort of PD and ET patients who have received surgery since the creation of the neuromodulation network.ConclusionsCareful outcomes tracking is essential to ensure quality in a complex therapeutic endeavor like DBS surgery for movement disorders. The REDCap database system is well suited to store outcomes data for the purpose of ongoing quality assurance monitoring.

Analysis of Physical Therapy Intervention Outcomes for Urinary Incontinence in Women Older Than 65 Years in Outpatient Clinical Settings.

Conservative interventions provided by physical therapists for the treatment of bladder control problems in adult females are strongly supported in the literature and in clinical practice guidelines. However, physical therapy (PT) intervention outcomes specifically for women over the age of 65 with urinary incontinence (UI) in outpatient settings in the United States have not been extensively reported. To provide preliminary PT intervention outcome data specific to female patients over the age of 65 receiving outpatient physical therapy for urinary incontinence. Preliminary retrospective analysis of a convenience sample of women ages 65 to 93. Women over the age of 65 with UI who were referred to outpatient PT and answered "YES" to a UI screening question at intake completed 3 UI surveys (3 Incontinence Questions (3IQ), Incontinence Impact Questionnaire Short-Form (IIQ-7) and the International Consultation on Incontinence Modular Questionnaire- Urinary Incontinence (ICIQ-UI). Patients received individualized treatment provided by a physical therapist. Physical therapists were asked to administer the surveys again during and/or after treatment. Demographic, clinical, and health related quality of life (HRQoL) data were collected. Frequency of UI types, UI symptoms, and impact of QoL were analyzed. Paired samples t-test was used to evaluate the change in measures between the initial survey and a follow up survey. Surveys were collected from 62 women. Significant changes in scores on two outcome measures (ICIQ-UI and IIQ-7) indicated significant reductions in UI symptom severity and improvements in UI- related HRQoL after undergoing individualized physical therapy treatment for UI. The study population was a convenience sample. Data on treatment interventions was not collected. Individualized interventions provided by physical therapists have the potential to significantly improve symptom severity and HRQoL in women over age 65 with different types of UI.