569 resultados para sociocultural factors
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Background: Critical care units are designed and resourced to save lives, yet the provision of end-of-life care is a significant component of nursing work in these settings. Limited research has investigated the actual practices of critical care nurses in the provision of end-of-life care, or the factors influencing these practices. To improve the care that patients at the end of life and their families receive, and to support nurses in the provision of this care, further research is needed. The purpose of this study was to identify critical care nurses' end-of-life care practices, the factors influencing the provision of end-of-life care and the factors associated with specific end-of-life care practices. Methods: A three-phase exploratory sequential mixed-methods design was utilised. Phase one used a qualitative approach involving interviews with a convenience sample of five intensive care nurses to identify their end-of-life care experiences and practices. In phase two, an online survey instrument was developed, based on a review of the literature and the findings of phase one. The survey instrument was reviewed by six content experts and pilot tested with a convenience sample of 28 critical care nurses (response rate 45%) enrolled in a postgraduate critical care nursing subject. The refined survey instrument was used in phase three of this study to conduct a national survey of critical care nurses. Descriptive analyses, exploratory factor analysis and univariate general linear modelling was undertaken on completed survey responses from 392 critical care nurses (response rate 25%). Results: Six end-of-life care practice areas were identified in this study: information sharing, environmental modification, emotional support, patient and family-centred decision making, symptom management and spiritual support. The items most frequently identified as always undertaken by critical care nurses in the provision of end-of-life care were from the information sharing and environmental modification practice areas. Items least frequently identified as always undertaken included items from the emotional support practice area. Eight factors influencing the provision of end-of-life care were identified: palliative values, patient and family preferences, knowledge, preparedness, organisational culture, resources, care planning, and emotional support for nurses. Strong agreement was noted with items reflecting values consistent with a palliative approach and inclusion of patient and family preferences. Variation was noted in agreement for items regarding opportunities for knowledge acquisition in the workplace and formal education, yet most respondents agreed that they felt adequately prepared. A context of nurse-led practice was identified, with variation in access to resources noted. Collegial support networks were identified as a source of emotional support for critical care nurses. Critical care nurses reporting values consistent with a palliative approach and/or those who scored higher on support for patient and family preferences were more likely to be engaged in end-of-life care practice areas identified in this study. Nurses who reported higher levels of preparedness and access to opportunities for knowledge acquisition were more likely to report engaging in interpersonal practices that supported patient and family centred decision making and emotional support of patients and their families. A negative relationship was identified between the explanatory variables of emotional support for nurses and death anxiety, and the patient and family centred decision making practice area. Contextual factors had a limited influence as explanatory variables of specific end-of-life care practice areas. Gender was identified as a significant explanatory variable in the emotional and spiritual support practice areas, with male gender associated with lower summated scores on these practice scales. Conclusions: Critical care nurses engage in practices to share control with and support inclusion of families experiencing death and dying. The most frequently identified end-of-life care practices were those that are easily implemented, practical strategies aimed at supporting the patient at the end of life and the patient's family. These practices arguably require less emotional engagement by the nurse. Critical care nurses' responses reflected values consistent with a palliative approach and a strong commitment to the inclusion of families in end-of-life care, and these factors were associated with engagement in all end-of-life care practice areas. Perceived preparedness or confidence with the provision of end-of-life care was associated with engagement in interpersonal caring practices. Critical care nurses autonomously engage in the provision of end-of-life care within the constraints of an environment designed for curative care and rely on their colleagues for emotional support. Critical care nurses must be adequately prepared and supported to provide comprehensive care in all areas of end-of-life care practice. The findings of this study raise important implications, and informed recommendations for practice, education and further research.
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Since the introduction of the National Human Papillomavirus Vaccine Program (NHPVP) in 2007, few studies have assessed women's knowledge, beliefs and attitudes towards cervical screening and human papillomavirus (HPV) vaccination in Australia. It is imperative to ascertain this, as substantial changes are anticipated to the National Cervical Screening Program (NCSP) through a process called 'the Renewal', to ensure any changes that are introduced will be acceptable and well understood by women. The objectives of this study were to describe Queensland women's current knowledge of cervical cancer/screening and HPV, their beliefs and attitudes towards Pap smears and the HPV vaccine and seek their advice on effective methods for communicating changes to the NCSP in their communities. This research was a descriptive-exploratory study that incorporated a combination of qualitative and quantitative methods within the context of the Health Belief Model (HBM). A computer-assisted telephone interview (CATI) survey of 1002 Queensland women was conducted in Phase 1 of the study. During Phase 2 of the study, 23 focus groups were conducted throughout Queensland to gather in-depth information about women's knowledge, awareness and acceptance about cervical cancer prevention strategies. This study found high levels of awareness of HPV (over 60%) and the HPV vaccine (over 86%) amongst Queensland women. However, it also identified considerable uncertainty amongst participants about perceived susceptibility to cervical cancer, especially, the link between cervical cancer, HPV and sexual activity. Women also had limited understanding of the benefit of the Pap smear as a preventative strategy, with many women thinking the main purpose of the Pap smear was for the early detection of cancer. Despite high awareness of HPV, women participating in this study also had significant knowledge deficits about their susceptibility to HPV and the severity of HPV infection. Queensland women had high levels of awareness of the HPV vaccine, which was most commonly via the media. High acceptance of the HPV vaccine was found amongst participants although awareness of the full benefits of vaccination was not evident with little acknowledgement that the quadrivalent vaccine used in the NHPVP would also prevent genital warts. Extensive barriers to having Pap smears, including physical and psychological discomfort, were identified and the most common barriers to vaccination were concerns about side effects and a lack of information upon which to make a decision about consent. Women described enablers for screening participation, such as reminder systems and practitioner characteristics, and expressed positive views towards self collected testing as an enabler, particularly for women who did not attend screening. As this study was conducted with Queensland women it may therefore not be representative of women from other parts of Australia and as participants were more likely to report they were regular screeners than Queensland women overall, these results may not be representative of women least likely to participate in cervical screening. The use of self-reported cervical screening history may also have led to over-reporting of screening status and previous abnormalities by participants. This study reveals significant gaps in Queensland women's knowledge that require effective communication strategies to address. Recommendations from this study highlight the need for increased community education to raise awareness about primary and secondary cervical cancer prevention strategies, training of cervical screening providers in sensitive examination techniques, a reduction in costs associated with screening, the exploration of alternative service models and communication plans that incorporate methods women trust and recommend for disseminating information about changes to the NCSP. This study is the first large study to explore women's perceptions of the Pap smear and barriers to screening, their knowledge about HPV and their attitudes towards the HPV vaccine in Queensland, since the introduction of the NHPVP. It highlights considerable uncertainty about many aspects of cervical cancer and primary and secondary prevention strategies available in Australia and identified many barriers to cervical screening and concerns about HPV vaccination. These knowledge gaps and barriers need to be taken into account and addressed within the context of anticipated changes to the NCSP to ensure benefits are maximised for women in future primary and secondary cervical cancer prevention strategies in the Australian context.
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Defence projects are typically undertaken within a multi-project-management environment where a common agenda of project managers is to achieve higher project efficiency. This study adopted a multi-facet qualitative approach to investigate factors contributing to or impeding project efficiency in the Defence sector. Semi-structured interviews were undertaken to identify additional factors to those compiled from the literature survey. This was followed by a three-round Delphi study to examine the perceived critical factors of project efficiency. The results showed that project efficiency in the Defence sector went beyond its traditional internally focused scope to one that is externally focused. As a result, efforts are needed on not only those factors related to individual projects but also those factors related to project inter-dependencies and external customers. The management of these factors will help to enhance the efficiency of a project within the Defence sector.
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Purpose To determine the rate of recurrence and associated risk factors following the use of mitomycin C (MMC) and/or interferon alpha-2b (IFN) for management of non-invasive ocular surface squamous neoplasia (OSSN). Design Retrospective non-comparative interventional case series. Methods Clinical practice setting of 135 patients treated consecutively with topical MMC (0.4 mg/mL) and/or IFN (1 million units/mL) for OSSN observed for clinical recurrence. Results Clinical recurrences were diagnosed in 19 of 135 (14.1%) eyes following topical treatment. The mean time to recurrence was 17.2 months (range 4 - 61) with 14 (73.7%) recurring within a two year period. There was no greater risk of recurrence identified for variables including lesion size, lesion location, gender, age, treatment type or duration. Post-hoc log-Rank pairwise comparisons revealed that lesions initially treated using surgery alone had significantly reduced time to recurrence (21.1 ± 5.6 months) compared to previous topical treatment with MMC (with or without surgery) (29.6 ± 4.7 months) (p = 0.04) and primary OSSN (23.2 ± 1.8 months) (p = 0.09). Conclusions Topical MMC and IFN are an effective treatment modality for a wide range of non-invasive OSSN. Topical therapy avoids the morbidity of excisional surgery with equivalent or reduced recurrence rates and should be considered as primary therapy.
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To understand the survival status of cancer patients and influencing factors, an analysis was undertaken using data of 6450 cancer patients living in Linqu County, Shandong, diagnosed between 1993 and 1999. Survival rates were calculated using life table method with SAS 9.0 software. Overall 1-5 year survival rates for all patients were 53.16%, 28.65%, 21.57%, 18.36% and 17.87%, respectively. Cancers with a 5-year survival rate over 25% included ovarium, breast, uterus, stomach and colorectal cancers. Cancers with a 5-year survival lower than 10% were cancers on liver, cervical, lung and bones.Survival rates differed significantly across gender, age of onset, economic status, year of diagnosis and evidence of diagnosis. Patients' economic status, age of diagnosis and year of diagnosis seem to have strong effects on survival. [目的] 了解临朐县恶性肿瘤患者生存现状,探讨影响生存率的因素. [方法] 对临朐县1993~1999年发病的6450例肿瘤患者的生存资料进行分析,利用SAS9.0软件寿命表法计算生存率. [结果] 临朐县1993~1999年的恶性肿瘤患者1~5年生存率分别为53.16%、28.65%、21.57%、18.36%和17.87%,5年生存率超过25%的恶性肿瘤有卵巢癌、乳腺癌、宫体癌、胃癌、结直肠癌,5年生存率低于10%的有肝癌、宫颈癌、肺癌、骨恶性肿瘤.不同性别、发病年龄、经济状况、诊断时间和诊断依据的恶性肿瘤生存率有显著性差异. [结论] 患者经济条件、诊断年龄和诊断时间影响恶性肿瘤生存率.
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Objective: To explore the influencing factors of esophageal cancer in the trunk basin of Dawen river , Shandong province. Methods: A case- control study was carried out: 195 living cases of diagnosed esophageal cancer and 195 controls were matched by age and sex and surveyed by a unified inventory. Results: T he following items could rises the risk of esophageal cancer : hard dry diet, smoke homemade cigarettes, alcohol consumption> 500 ml/ day, relatives with tumor in history ( OR = 51850, OR = 161 158, OR = 111 513, OR = 11 827, respectively ) . While drinking tea may have protective effect against esophageal cancer ( OR = 01 311). Conclusion: The high incidence of esophageal cancer in the area is relative not only to the environment and dietary factors, but also to the family history of esophageal cancer.
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Background Substantial changing trends in women’s alcohol consumption show increased proportions women drinking at risky/ high risk levels. Not confined to the younger female population, these increases are also occurring in older female age groups (aged 35 and over), posing a set of risks differing to those of their male counterparts. However, little research investigates the influences behind these changing trends. The current research examined multiple level influences (i.e. cultural, social and psychosocial on women’s drinking across a range of age groups. Methods Semi-structured telephone interviews were conducted with thirty-five women (aged 18-55) residing in Australia. Interview development was guided by an adaptation of Bronfenbrenner’s Bioecological Model of Development to assess multiple areas of influences from cultural through to psychosocial (i.e. intra-individual). Each interview took approximately 1 hour to complete. Findings Bronfenbrenner’s Bioecological Model could account for multiple-level factors impacting women’s drinking with multidirectional influences interacting across each level. Cultural influences included gender roles and national identity. Exosystem influences (e.g. infrastructure, legislation, and media) and microsystem influences (e.g. drinking context, family, partner and peer influence) were clearly identified as impacting drinking behaviours. Finally, at the psychosocial level, attitudes and expectations around the disinhibiting effects of alcohol and social facilitation emerged as key influences. Discussion The outcomes indicated the importance of these influences as women’s alcohol-related attitudes and behaviours changed across a woman’s life span and across age cohorts. Future research will build on these initial findings in order to underpin targeted interventions of the key factors influencing women’s drinking.
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With unpredictable workloads and a need for a multitude of specialized skills, many main contractors rely heavily on subcontracting to reduce their risks (Bresnen et al., 1985; Beardsworth et al., 1988). This is especially the case In Hong Kong, where the average direct labour content accounts for only around 1% of the total contract sum (Lai, 1987). Extensive usage of subcontracting is also reported in many other countries, including the UK (Gray and Flanagan, 1989) and Japan (Bennett et al., 1987). In addition, and depending upon the scale and complexity of works, it is not uncommon for subcontractors to further sublet their works to lower tier(s) subcontractors. Richter and Mitchell (1982) argued that main contractors can obtain a higher profit margin by reducing their performance costs by subcontracting work to those who have the necessary resources to perform the work more efficiently and economically. Subcontracting is also used strategically to allow firms to employ a minimum work force under fluctuating demand (Usdiken and Sözen, 1985). Through subcontracting, the risks of main contractors are also reduced, as errors in estimating or additional costs caused by delays or extra labour requirements can be absorbed by the subcontractors involved (Woon and Ofori, 2000). Despite these benefits, the quality of work can suffer when incapable or inexperienced subcontractors are employed. Additional problems also exist in the form of bid shopping, unclear accountability, and high fragmentation (Palaneeswaran et al., 2002). A recent CIB TG 23 International Conference, October 2003, Hong Kong report produced by the Hong Kong Construction Industry Review Committee (CIRC) points to development of a framework to help distinguish between capable and incapable subcontractors (Tang, 2001). This paper describes research aims at identifying and prioritising criteria for use in such a framework.
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Purpose: The objective of the study was to assess the bioequivalence of two tablet formulations of capecitabine and to explore the effect of age, gender, body surface area and creatinine clearance on the systemic exposure to capecitabine and its metabolites. Methods: The study was designed as an open, randomized two-way crossover trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 25 patients with solid tumors. On one day, the patients received four 500-mg tablets of formulation B (test formulation) and on the other day, four 500-mg tablets of formulation A (reference formulation). The washout period between the two administrations was between 2 and 8 days. After each administration, serial blood and urine samples were collected for up to 12 and 24 h, respectively. Unchanged capecitabine and its metabolites were determined in plasma using LC/MS-MS and in urine by NMRS. Results: Based on the primary pharmacokinetic parameter, AUC(0-∞) of 5'-DFUR, equivalence was concluded for the two formulations, since the 90% confidence interval of the estimate of formulation B relative to formulation A of 97% to 107% was within the acceptance region 80% to 125%. There was no clinically significant difference between the t(max) for the two formulations (median 2.1 versus 2.0 h). The estimate for C(max) was 111% for formulation B compared to formulation A and the 90% confidence interval of 95% to 136% was within the reference region 70% to 143%. Overall, these results suggest no relevant difference between the two formulations regarding the extent to which 5'-DFUR reached the systemic circulation and the rate at which 5'-DFUR appeared in the systemic circulation. The overall urinary excretions were 86.0% and 86.5% of the dose, respectively, and the proportion recovered as each metabolite was similar for the two formulations. The majority of the dose was excreted as FBAL (61.5% and 60.3%), all other chemical species making a minor contribution. Univariate and multivariate regression analysis to explore the influence of age, gender, body surface area and creatinine clearance on the log-transformed pharmacokinetic parameters AUC(0-∞) and C(max) of capecitabine and its metabolites revealed no clinically significant effects. The only statistically significant results were obtained for AUC(0-∞) and C(max) of intact drug and for C(max) of FBAL, which were higher in females than in males. Conclusion: The bioavailability of 5'-DFUR in the systemic circulation was practically identical after administration of the two tablet formulations. Therefore, the two formulations can be regarded as bioequivalent. The variables investigated (age, gender, body surface area, and creatinine clearance) had no clinically significant effect on the pharmacokinetics of capecitabine or its metabolites.
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Background The incidence of malignant mesothelioma is increasing. There is the perception that survival is worse in the UK than in other countries. However, it is important to compare survival in different series based on accurate prognostic data. The European Organisation for Research and Treatment of Cancer (EORTC) and the Cancer and Leukaemia Group B (CALGB) have recently published prognostic scoring systems. We have assessed the prognostic variables, validated the EORTC and CALGB prognostic groups, and evaluated survival in a series of 142 patients. Methods Case notes of 142 consecutive patients presenting in Leicester since 1988 were reviewed. Univariate analysis of prognostic variables was performed using a Cox proportional hazards regression model. Statistically significant variables were analysed further in a forward, stepwise multivariate model. EORTC and CALGB prognostic groups were derived, Kaplan-Meier survival curves plotted, and survival rates were calculated from life tables. Results Significant poor prognostic factors in univariate analysis included male sex, older age, weight loss, chest pain, poor performance status, low haemoglobin, leukocytosis, thrombocytosis, and non-epithelial cell type (p<0.05). The prognostic significance of cell type, haemoglobin, white cell count, performance status, and sex were retained in the multivariate model. Overall median survival was 5.9 (range 0-34.3) months. One and two year survival rates were 21.3% (95% CI 13.9 to 28.7) and 3.5% (0 to 8.5), respectively. Median, one, and two year survival data within prognostic groups in Leicester were equivalent to the EORTC and CALGB series. Survival curves were successfully stratified by the prognostic groups. Conclusions This study validates the EORTC and CALGB prognostic scoring systems which should be used both in the assessment of survival data of series in different countries and in the stratification of patients into randomised clinical studies.
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Background: A recent study by Dhillon et al. [12], identified both angioinvasion and mTOR as prognostic biomarkers for poor survival in early stage NSCLC. The aim of this study was to verify the above study by examining the angioinvasion and mTOR expression profile in a cohort of early stage NSCLC patients and correlate the results to patient clinico-pathological data and survival. Methods: Angioinvasion was routinely recorded by the pathologist at the initial assessment of the tumor following resection. mTOR was evaluated in 141 early stage (IA-IIB) NSCLC patients (67 - squamous; 60 - adenocarcinoma; 14 - others) using immunohistochemistry (IHC) analysis with an immunohistochemical score (IHS) calculated (% positive cells × staining intensity). Intensity was scored as follows: 0 (negative); 1+ (weak); 2+ (moderate); 3+ (strong). The range of scores was 0-300. Based on the previous study a cut-off score of 30 was used to define positive versus negative patients. The impact of angioinvasion and mTOR expression on prognosis was then evaluated. Results: 101 of the 141 tumors studied expressed mTOR. There was no difference in mTOR expression between squamous cell carcinoma and adenocarcinoma. Angioinvasion (p= 0.024) and mTOR staining (p= 0.048) were significant univariate predictors of poor survival. Both remained significant after multivariate analysis (p= 0.037 and p= 0.020, respectively). Conclusions: Our findings verify angioinvasion and mTOR expression as new biomarkers for poor outcome in patients with early stage NSCLC. mTOR expressing patients may benefit from novel therapies targeting the mTOR survival pathway. © 2011 Elsevier Ireland Ltd.
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Neo-angiogenesis during neoplastic growth involves endothelial mitogenic and migration stimuli produced by cancer or tumour stromal cells. Although this active angiogenesis takes place in the tumour periphery, the process of vessel growth and survival in inner areas and its clinical role remain largely unexplored. The present study compared the microvessel score (MS) as well as the single endothelial cell score (ECS) in the invading edge and in inner areas of non-small cell lung carcinomas (NSCLCs). Three different patterns of vascular growth were distinguished: the edvin (edge vs. inner) type 1, where a low MS was observed in both peripheral and inner tumour areas; the edvin type 2, where a high MS was noted in the invading front but a low MS in inner areas; and the edvin type 3, where both peripheral and inner tumour areas had a high MS. The ECS was high in the invading edge in edvin type 2 and 3 cases and was sharply decreased in both types in inner areas, suggesting that endothelial cell migration is unlikely to contribute to the angiogenic process in areas away from the tumour front. Expression of the vascular endothelial growth factor (VEGF) and of thymidine phosphorylase (TP) was associated with a high MS in the invading edge. VEGF was associated with a high MS in inner areas (edvin 3), while TP expression was associated with edvin type 2, showing that VEGF (and not TP) contributes to the preservation of the inner vasculature. Both edvin type 2 and 3 cases showed an increased incidence of node metastasis, but edvin type 3 cases had a poorer prognosis, even in the N1-stage group. The present study suggests that tumour factors regulating angiogenesis and vascular survival are not identical. A possible method is reported to quantify these two parameters by comparing the MS in the invading edge and inner areas (edvin types). This observation may contribute to the evaluation of the effectiveness of different therapeutic approaches, namely vascular targeting vs. anti-angiogenesis. Copyright (C) 2000 John Wiley and Sons, Ltd.
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Purpose: Data from two randomized phase III trials were analyzed to evaluate prognostic factors and treatment selection in the first-line management of advanced non-small cell lung cancer patients with performance status (PS) 2. Patients and Methods: Patients randomized to combination chemotherapy (carboplatin and paclitaxel) in one trial and single-agent therapy (gemcitabine or vinorelbine) in the second were included in these analyses. Both studies had identical eligibility criteria and were conducted simultaneously. Comparison of efficacy and safety was performed between the two cohorts. A regression analysis identified prognostic factors and subgroups of patients that may benefit from combination or single-agent therapy. Results: Two hundred one patients were treated with combination and 190 with single-agent therapy. Objective responses were 37 and 15%, respectively. Median time to progression was 4.6 months in the combination arm and 3.5 months in the single-agent arm (p < 0.001). Median survival imes were 8.0 and 6.6 months, and 1-year survival rates were 31 and 26%, respectively. Albumin <3.5 g, extrathoracic metastases, lactate dehydrogenase ≥200 IU, and 2 comorbid conditions predicted outcome. Patients with 0-2 risk factors had similar outcomes independent of treatment, whereas patients with 3-4 factors had a nonsignificant improvement in median survival with combination chemotherapy. Conclusion: Our results show that PS2 non-small cell lung cancer patients are a heterogeneous group who have significantly different outcomes. Patients treated with first-line combination chemotherapy had a higher response and longer time to progression, whereas overall survival did not appear significantly different. A prognostic model may be helpful in selecting PS 2 patients for either treatment strategy. © 2009 by the International Association for the Study of Lung Cancer.
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In the UK mortality from malignant mesothelioma (MM) is likely to more than double over the next 20 years and despite advances in surgery, chemotherapy and radiation treatment the overall prognosis for patients remains poor. A number of scoring systems based on assessment of clinicopathological features of patients with the disease have been developed but the search continues for further prognostic indicators. Angiogenesis, tumour necrosis (TN), epidermal growth factor receptor (EGFR) expression, cyclooxygenase-2 (COX-2) and matrix metalloproteinases (MMPs) have been linked with poor prognosis in some types of solid tumour and their relevance as prognostic factors in malignant mesothelioma is examined in this paper. © 2004 Elsevier Ireland Ltd. All rights reserved.
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The FLEX study demonstrated that the addition of cetuximab to chemotherapy significantly improved overall survival in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). In the FLEX intention to treat (ITT) population, we investigated the prognostic significance of particular baseline characteristics. Individual patient data from the treatment arms of the ITT population of the FLEX study were combined. Univariable and multivariable Cox regression models were used to investigate variables with potential prognostic value. The ITT population comprised 1125 patients. In the univariable analysis, longer median survival times were apparent for females compared with males (12.7 vs 9.3 months); patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 compared with 1 compared with 2 (13.5 vs 10.6 vs 5.9 months); never smokers compared with former smokers compared with current smokers (14.6 vs 11.1 vs 9.0); Asians compared with Caucasians (19.5 vs 9.6 months); patients with adenocarcinoma compared with squamous cell carcinoma (12.4 vs 9.3 months) and those with metastases to one site compared with two sites compared with three or more sites (12.4 months vs 9.8 months vs 6.4 months). Age (<65 vs ≥65 years), tumor stage (IIIB with pleural effusion vs IV) and percentage of tumor cells expressing EGFR (<40% vs ≥40%) were not identified as possible prognostic factors in relation to survival time. In multivariable analysis, a stepwise selection procedure identified age (<65 vs ≥65 years), gender, ECOG PS, smoking status, region, tumor histology, and number of organs involved as independent factors of prognostic value. In summary, in patients with advanced NSCLC enrolled in the FLEX study, and consistent with previous analyses, particular patient and disease characteristics at baseline were shown to be independent factors of prognostic value. The FLEX study is registered with ClinicalTrials.gov, number NCT00148798. © 2012 Elsevier Ireland Ltd.