Early rehabilitation intervention is associated with significant positive functional outcomes in traumatic brain injury: a retrospective analysis

Background: Traumatic brain injury (TBI) is a global public health problem affecting adversely health care system. While acute trauma care has been documented to improve outcomes, the impact of early rehabilitation on outcome is not well documented especially in the developing world like ours. Predicting functional outcome from admission variables helps in intervention development, and appropriate fund allocation for TBI treatment. Therefore, we accepted a challenge to do a retrospective study on TBI patients admitted in our newly established and resource limited trauma center. The aim of the study was to assess the effect of early rehabilitation on TBI patients on functional improvement and to prognosticate the improvement from early admission variables.Methods: Study was conducted at Apex Trauma Center, SGPGIMS, Lucknow analysis of prospectively maintained data. Retrospective analysis of records of patients, admitted within 48 hrs of moderate to severe injury, was done after Institute Ethic Committee approval. Statistical analysis used was regression analysis and multivariate analysis was done between possible risk factors and FIM gain.Results: There was significant FIM score improvement from admission to discharge (p<0.001). Factors associated with a higher FIM gain were admission FIM motor and cognitive scores, GCS score on admission and length of hospital stay.Conclusions: Our study strongly suggests that a dedicated rehabilitation programme, designed according to the functional needs of TBI patient, helps in improved functional outcome and recovery.

Students’ perceptions on their use of an EHR: pilot questionnaire study

IntroductionMany clinical education programmes have not incorporated the use of the electronic health record (EHR) into their curriculum. It is important to incorporate technologies that will be used in real-world settings to better prepare students for clinical practice.ObjectivesTo undertake a review of literature to identify a training evaluation framework; to conduct a self-completion survey, pretraining and post-training, to determine students’ perceptions on the benefit of using EHR training system.SettingNursing School, University, North West England, UK; University Ethic Committee Approval Received.ParticipantsRegistered nurses undertaking a validated return to practice course; 24 participants for the first cohort who completed pretraining questionnaire and 23 for the second post-training cohort.ResultsThe statistical results show that the students perceived that the training improved their capability in employing digital systems with statistically significant difference in the assessed preproficiency and post proficiency in the use of digital clinical systems (premedians and post medians are 2 and 5 on 10-point Likert scale, p=0.041). There was also an indication of an improvement in the knowledge of EHR systems although not statistically significant. Most students perceived it increased their knowledge on digital systems.ConclusionStudents perceived an increase in proficiency with the EHR. There was evidence of improvement in confidence in the use of the EHR, but this confidence would be enhanced by additional use of the system. Some desire to increase confidence further and to develop knowledge of digital systems was expressed.

Evaluation of the effect of multidisciplinary simulation-based team training on patients, staff and organisations: protocol for a stepped-wedge cluster-mixed methods study of a national, insurer-funded initiative for surgical teams in New Zealand public hospitals

IntroductionNetworkZ is a national, insurer-funded multidisciplinary simulation-based team-training programme for all New Zealand surgical teams. NetworkZ is delivered in situ, using full-body commercial simulators integrated with bespoke surgical models. Rolled out nationally over 4 years, the programme builds local capacity through instructor training and provision of simulation resources. We aim to improve surgical patient outcomes by improving teamwork through regular simulation-based multidisciplinary training in all New Zealand hospitals.Methods and analysisOur primary hypothesis is that surgical patient outcomes will improve following NetworkZ. Our secondary hypotheses are that teamwork processes will improve, and treatment injury claims will decline. In addition, we will explore factors that influence implementation and sustainability of NetworkZ and identify organisational changes following its introduction. The study uses a stepped-wedge cluster design. The intervention will roll out at yearly intervals to four cohorts of five District Health Boards. Allocation to cohort was purposive for year 1, and subsequently randomised. The primary outcome measure is Days Alive and Out of Hospital at 90 days using patient data from an existing national administrative database. Secondary outcomes measures will include analysis of postoperative complications and treatment injury claims, surveys of teamwork and safety culture, in-theatre observations and stakeholder interviews.Ethics and disseminationWe believe this is the first surgical team training intervention to be implemented on a national scale, and a unique opportunity to evaluate a nation-wide team-training intervention for healthcare teams. By using a pre-existing large administrative data set, we have the potential to demonstrate a difference to surgical patient outcomes. This will be of interest to those working in the field of healthcare teamwork, quality improvement and patient safety. New Zealand Health and Disability Ethic Committee approval (#16/NTB/143).Trial registration numberAustralian and New Zealand Clinical Trials Registry ID ACTRN12617000017325 and the Universal Trial Number is U1111-1189-3992.

Hypermetabolic activity by FDG-PET after immunogenic chemotherapy and multi-peptide immunotherapy in ovarian cancer.

e17079 Background: There are several reports of increased of SUV in the lymph nodes of cancer patients after immune manipulation such as the administration of vaccines and checkpoint inhibitors. However the clinical importance of these phenomena is poorly understood. The administration of two immunogenic drugs and eight peptides in HGSOC induced atypical bright zones in multiple lymph nodes and, in areas with microscopic disease where potentially we can have cancer stem cells (CSC’s). Methods: We enrolled N = 10 HGSOC after the local IRB ethic committee approval. All the patients had 3 recurrences with mPFS = 8 months of the third relapse. The last FDG-PET scan was used as basal image for the study. Blood was collected for cellular and humoral immunology analysis such as Granzyme B ELISPOT and ELISA. Tissue was used for IHC analysis for the evaluation of CD8, FOXP3, Th1, and proteins related with CSC’s. The patients received 50 mg of oxaliplatin and 30 mg of doxorubicin total dose every week four times simultaneously with multi peptide immunotherapy. A second FDG-PET scan was performed after the termination of the treatment. Results: After the treatment 100% of the patients showed intense atypical bright uptake areas in lymph nodes and in the peritoneum. There was a correlation between the brightness intensity (SUV), and the Granzyme B production (p = 0.001). We found multiple bright small lesions in the peritoneum that were not visible before treatment. We demonstrated the presence of proteins related with CSC’s in the original tumor tissue and an antibody immune response against EGFR (P = 0.005), Ape-1 (p = 0.003) and Bcl-2 (p = 0.05). Conclusions: Immunotherapy may produce hypermetabolic activity that could lead to overtreatment when evaluated by FDG-PET in HGSOC. Vaccination may activate lymph nodes and anti-cancer immune interventions may also activate CD8 and Th1 cells able to accumulate in CSC’s clusters and increased notably the SUV, which may lead to false relapse interpretation by the radiologists and oncologists.

A phase II-III, multicenter, randomized, open study evaluating the feasibility and efficacy of a supervised home-based standard physical exercise program for metastatic cancer patients receiving oral targeted therapy: The UNICANCER SdS 01 QUALIOR study (ID-RCB: 2015-A01922-47).

TPS10126 Background: Fatigue is a frequent side effect with oral targeted therapies (OTT). Physical activity has been reported to improve fatigue and quality of life (QoL). However, few studies focused on metastatic cancer patients and mainly among patients treated with chemotherapy. Furthermore, recent guidelines recommend evaluation and optimization of standardized exercise programs. The aim of our study is to evaluate home-based standard physical exercise program (SPEP) for metastatic cancer patients treated with OTT. Methods: This phase II-III study will randomize (2:1) patients starting first-line OTT for metastatic cancer between an individualized SPEP supervised by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, ECOG PS ≤2, controlled pain (VAS < 3/10), and life expectancy ≥3 months. The phase II part (120 patients) will evaluate the feasibility of a 3-month SPEP using the rate of patients performing ≥50% of SPEP (2-stage Fleming: one-sided α = 5%; β = 85%). An interim analysis is planned after the phase II. The phase III will compare the efficacy of an SPEP as opposed to recommendations to reduce fatigue and/or improve physical well-being (PWB) dimensions of QoL (evaluated with FACT-G and FACT-F questionnaires). To show a difference of ≥5 points in PWB and 2.5 for fatigue (α = 2.5%; β = 80%), 312 patients are required in the phase III trial. . Secondary objectives include: PFS, OS, other dimensions of QoL, tolerability and observance of OTT, change in body composition, physical benefits, and a medico-economic study. The SPEP was developed by specialized coaches involved in physical activity and cancer. The study has Ethic committee approval and accrual is planned in 18 French centers in April 2017, for 30 months. This is the first randomized trial dedicated to patients with metastatic cancer treated with OTT evaluating the feasibility and the efficacy of a well design home based SPEP on fatigue and physical well-being.

Randomized phase II trial of two sequential schedules of docetaxel (D) and cisplatin (C) followed by gemcitabine (G) in patients with advanced non-small cell lung cancer

18154 Background: C based doublets remain the cornerstone for first line treatment of advanced NSCLC but the role of sequential use of chemotherapy is still investigational. Aim of this study was to assess the activity and toxicity of 3 courses of C and D followed by 3 courses of single agent G, to reduce C exposure and sequentially administer 2 second generation cytotoxic drugs. The weekly D/C schedule was further investigated, to reduce toxicity. Methods: Chemotherapy naive stage IIIB or IV measurable NSCLC pts, aged 18–70 and PS 0–1, were stratified by stage (IIIB vs IV) and randomized, after local ethic committee approval and signed informed consent, to D and C (both 75 mg/m2 on day 1) q21 days for 3 cycles (Arm A), or to D and C (both 25 mg/m2 on days 1, 8, 15) q28 days for 3 (Arm B). Responding or stable pts of each arm, were treated with 3 additional cycles of G (1,200 mg/m2 on days 1, 8) q 21 days. Primary endpoint of the study was response rate (RECIST). Sample size was calculated of 42 pts per arm, considering worthy of further investigation a regimen with =14 objective responses. Results: Between May 2005 and October 2006, 88 pts were enrolled (Arm A/B: 43/45), with 69 evaluable so far (median age 63 yrs, median PS 0, and M/F ratio 53/16). Toxicity (NCI-CTG criteria) after 3 cycles, evaluable on 67 (32/35) pts, was mainly hematological, with grade 3/4 neutropenia in 17 pts (17/0), neutropenic fever in 1 (arm A), infections in 2 (arm B), grade 3/4 thrombocytopenia in 3 (1/2) and grade 3/4 anemia in 2 (arm A). Non-hematological grade 3/4 toxicity consisted of fatigue (4/1), diarrhea (4/1), pulmonary toxicity (1/4), pain (2/3), stomatitis (1/2) and alopecia (2/0). Fifty one pts (A/B: 29/22) are evaluable for response after 3 cycles, with 16 PR (55%) and 7NC in arm A and 1CR+6PR (32%) and 7NC in arm B. Objective responses after 6 cycles, available only in few pts so far, show 1CR+10PR in arm A and 2PR in arm B. At a median FU of 6.5 months, 60/85 pts are alive (33/27) and 25 are dead (8/17), with 3 pts, never treated, lost to f. up. Conclusions: From these preliminary results, CD combination appears active and manageable while the activity of G, cannot be defined yet. Data collection is continuing and analysis will be completed and mature, by the time of the meeting. [Table: see text]