Use of selective gut decontamination in critically ill children: protocol for the Paediatric Intensive Care and Infection Control (PICnIC) pilot study.

INTRODUCTION: Healthcare-associated infections (HCAIs) are a major cause of morbidity and mortality in critically ill children. In critically ill adults, there are data that suggest the use of Selective Decontamination of the Digestive tract (SDD), alongside standard infection control measures reduce mortality and the incidence of HCAIs. SDD-enhanced infection control has not been compared directly with standard infection prevention strategies in the Paediatric Intensive Care Unit (PICU) population. The aim of this pilot study is to determine the feasibility of conducting a multicentre cluster randomised controlled trial (cRCT) in critically ill children comparing SDD with standard infection control. METHODS AND ANALYSIS: Paediatric Intensive Care and Infection Control is a parallel group pilot cRCT, with integrated mixed-methods study, comparing incorporation of SDD into infection control procedures to standard care. After a 1-week pretrial ecology surveillance period, recruitment to the cRCT will run for a period of 18 weeks, comprising: (1) baseline control period (2) pre, mid and post-trial ecology surveillance periods and (3) intervention period. Six PICUs (in England, UK) will begin with usual care in period 1, then will be randomised 1:1 by the trial statistician using computer-based randomisation, to either continue to deliver usual care or commence delivery of the intervention (SDD) in period 2. Outcomes measures include parent and healthcare professionals' views on trial feasibility, adherence to the SDD intervention, estimation of recruitment rate and understanding of potential patient-centred primary and secondary outcome measures for the definitive trial. The planned recruitment for the cRCT is 324 participants. ETHICS AND DISSEMINATION: The trial received favourable ethical opinion from West Midlands-Black Country Research Ethics Committee (reference: 20/WM/0061) and approval from the Health Research Authority (IRAS number: 239324). Informed consent is not required for SDD intervention or anonymised data collection but is sought for investigations as part of the study, any identifiable data collected and monitoring of medical records. Results will be disseminated via publications in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: ISRCTN40310490.

Family satisfaction with critical care in the UK: a multicentre cohort study.

OBJECTIVE: To assess family satisfaction with intensive care units (ICUs) in the UK using the Family Satisfaction in the Intensive Care Unit 24-item (FS-ICU-24) questionnaire, and to investigate how characteristics of patients and their family members impact on family satisfaction. DESIGN: Prospective cohort study nested within a national clinical audit database. SETTING: Stratified, random sample of 20 adult general ICUs participating in the Intensive Care National Audit & Research Centre Case Mix Programme. PARTICIPANTS: Family members of patients staying at least 24 hours in ICU were recruited between May 2013 and June 2014. INTERVENTIONS: Consenting family members were sent a postal questionnaire 3 weeks after the patient died or was discharged from ICU. Up to four family members were recruited per patient. MAIN OUTCOME MEASURES: Family satisfaction was measured using the FS-ICU-24 questionnaire. MAIN RESULTS: A total of 12 346 family members of 6380 patients were recruited and 7173 (58%) family members of 4615 patients returned a completed questionnaire. Overall and domain-specific family satisfaction scores were high (mean overall family satisfaction 80, satisfaction with care 83, satisfaction with information 76 and satisfaction with decision-making 73 out of 100) but varied significantly across adult general ICUs studied and by whether the patient survived ICU. For family members of ICU survivors, characteristics of both the family member (age, ethnicity, relationship to patient (next-of-kin and/or lived with patient) and visit frequency) and the patient (acute severity of illness and receipt of invasive mechanical ventilation) were significant determinants of family satisfaction, whereas, for family members of ICU non-survivors, only patient characteristics (age, acute severity of illness and duration of stay) were significant. CONCLUSIONS: Overall family satisfaction in UK adult general ICUs was high but varied significantly. Adjustment for differences in family member/patient characteristics is important to avoid falsely identifying ICUs as statistical outliers. TRIAL REGISTRATION NUMBER: ISRCTN47363549.

Heterogeneity of prognostic profiles in non-small cell lung cancer: too many variables but a few relevant.

OBJECTIVE: Many prognostic factors, exceeding 150, for non-small cell lung cancer (NSCLC) are mentioned in the literature. The different statistical weight of the some variables at issue, their heterogeneity and their clinical uselessness is reviewed. STUDY DESIGN AND SETTING: Survival analysis of a cohort of NSCLC operated (n = 1730, 1993-1997) was carried out utilizing different statistical approaches: Cox proportional hazard analysis (CPHA), logistic regression (LRA), and recursive partitioning (CART). RESULTS: CPHA identified 13 prognostic variables and 11 LRA. Of the 17 possible variables, 10 are coincident. CART provided five different diagnostic groups but only three differentiated survival levels. Parsimonious models were constructed including only T and N cancer staging variables. Areas under the ROC curve of 0.68 and 0.68 were found for CPHA and LGA parsimonious models respectively, and 0.72 and 0.71 for complete models. CONCLUSION: Variables with a minimal impact on the respective models and thus with little or scarce predictive clinical repercussion were identified. Differences in the prognostic profile of survival can be caused by the different methodological approaches used. No relevant differences were found between the parsimonious and complete models. Although the amount of information managed is considerable, there continues to be a large predictive gap yet to be explained.

Staging in lung cancer: is 3 cm a prognostic threshold in pathologic stage I non-small cell lung cancer? A multicenter study of 1,020 patients.

INTRODUCTION: Since 1974, a tumor size of 3 cm in diameter has been regarded as the prognostic threshold in the staging of bronchogenic carcinoma. OBJECTIVE: To study the prognostic behavior of surgical-pathologic tumor size in non-small cell lung cancer (NSCLC) with complete resection. DESIGN: Four-year multi-institutional prospective study from 1993 to 1997. PATIENTS: Consecutive cases of NSCLC in pathologic stages IA-IB (pIA-pIB) treated surgically with complete resection in hospitals belonging to the Bronchogenic Carcinoma Co-operative Group of the Spanish Society of Pneumology and Thoracic Surgery (GCCB-S). METHODS: The Schoenfeld procedure was used to identify different prognostic groups, considering 1 cm as the measurement unit. RESULTS: Based on the 1,020 cases evaluated, four prognostic groups were identified: 0 to 2 cm (group A; n = 147), 2.1 to 4 cm (group B; n = 448), 4.1 to 7 cm (group C; n = 336), and > 7 cm (group D; n = 89). At 5 years, survival was 0.63 (95% confidence interval [CI], 0.58 to 0.68), 0.56 (95% CI, 0.53 to 0.59), 0.49 (95% CI, 0.46 to 0.52), and 0.38 (95% CI, 0.32 to 0.44) for groups A, B, C, and D, respectively. Differences between paired groups (log-rank) were significant: 0.0074 between groups A and B, 0.0048 between groups B and C, and 0.0034 between groups C and D. CONCLUSIONS: In initial stages (pIA-pIB) of NSCLC, the 3-cm value was not found to behave as a prognostic threshold; in this study, four surgical-pathologic tumor size groups were identified with strong prognostic differences: from 0 to 2 cm, from 2.1 to 4 cm, from 4.1 to 7 cm, and > 7 cm.