ABSTRACT
Background: We planned to compare pemetrexed maintenance with erlotinib maintenance in non squamous non Epidermal Growth Factor Receptor (EGFR) mutated non small cell lung cancer (NSCLC). The null hypothesis for this study was that there would be no difference in quality of life (QOL) between pemetrexed and erlotinib maintenance. Results: The QL2 scores at 3 months were 63.35 (SD 24.99) in pemetrexed arm and 63.01(SD 23.04) in erlotinib arm (p-0.793). Except in 1 domain, the scores were statistically similar between the 2 arms. In the domain of diarrhea, the score was higher as expected in the erlotinib arm (p-0.048). The median progression free survival was 4.5 months (95%CI 4.1-4.9 months) in pemetrexed arm versus 4.5 months (95%CI 3.8-5.2 months) in erlotinib arm (p-0.94). The median overall survival was 16.6 months (15.2-17.9 months) in pemetrexed arm versus 18.3 months (95% CI 13.75-22.91 months) in erlotinib arm (p-0.49). Methods: The study was an open label, single centre, parallel, phase 3 randomized study with 1:1 randomization between maintenance pemetrexed arm and erlotinib arm. Adult patients (age > or = 18 years), with non squamous EGFR mutation, treated with first line palliative therapy, with non progressive disease post 4-6 cycles of pemetrexed-carboplatin were randomized. Primary outcome was change in the score of QOL (Global health status {QL2}) at 3 months. We estimated that with 200 patients, the study had 80% power to detect a significant difference between the two groups in the change in the global health status score at 3 months with an alpha error of 5%, with an effect size of 0.3 SD. Conclusions: Maintenance pemetrexed post pemetrexed-platinum chemotherapy fails to improve QOL or time to event outcomes over maintenance erlotinib in EGFR mutation negative NSCLC.
ABSTRACT
OBJECTIVE: The aim of the study was to introduce and evaluate the compliance to documentation of situation, background, assessment, recommendation (SBAR) form. METHODS: Twenty nurses involved in active bedside care were selected by simple random sampling. Use of SBAR was illustrated thru self-instructional module (SIM). Content validity and reliability were established. The situation, background, assessment, recommendation (SBAR) form was disseminated for use in a clinical setting during shift handover. A retrospective audit was undertaken at 1st week (A1) and 16th week (A2), post introduction of SIM. Nurse's opinion about the SBAR form was also captured. RESULTS: Majority of nurses were females (65%) in the age group 21-30 years (80%). There was a significant association (P = 0.019) between overall audit scores and graduate nurses. Significant improvement (P = 0.043) seen in overall scores between A1 (mean: 23.20) and A2 (mean: 24.26) and also in "Situation" domain (P = 0.045) as compared to other domains. There was only a marginal improvement in documentation related to patient's allergies and relevant past history (7%) while identifying comorbidities decreased by 40%. Only 70% of nurses had documented plan of care. Most (76%) of nurses expressed that SBAR form was useful, but 24% nurses felt SBAR documentation was time-consuming. The assessment was easy (53%) to document while recommendation was the difficult (53%) part. CONCLUSIONS: SBAR technique has helped nurses to have a focused and easy communication during transition of care during handover. Importance and relevance of capturing information need to be reinforced. An audit to look for reduced number of incidents related to communication failures is essential for long-term evaluation of patient outcomes. Use of standardized SBAR in nursing practice for bedside shift handover will improve communication between nurses and thus ensure patient safety.
