Patient perceptions concerning clinical trials in oncology patients.

BACKGROUND: Clinical trials are critical to scientifically evaluate promising new therapies in oncology, but patient accrual to these studies is persistently low. Patient preference plays an important role in enrollment in these trials. We performed this survey to evaluate the perceptions of newly diagnosed oncology patients about clinical trials and the reasons why they wish to or not to participate in these trials. METHODS: Patients were given a ten question survey reflective of their attitudes regarding clinical trials as a treatment option at their initial visit. The self-directed questionnaire was scored on an ordinate scale from strongly agree [1] to strongly disagree [5]. RESULTS: Ninety three patients were surveyed in the cancer specific multispecialty clinics in an academic center. Our patients expected their providers to discuss all information relating to clinical trials and eligibility at the first visit (65.4% agree and 15.4% neutral, p < 0.0001). Patients felt their privacy and safety would be safeguarded in the University sponsored trials (56.8% agree, and 25.7% neutral, p < 0.0001). Over 80% patients showed their unwillingness to participate in randomized clinical trials (disagree 61%, neutral 19.5%, p < 0.001). Patients also showed less likelihood to participate in clinical trials as a first treatment option (48.7% disagree and 28.9% neutral, p0.0161), but were willing to consider participating in a clinical trial if the conventional treatment failed. Industry sponsored trials, phase 1 trials, investigator initiated trials with the involved tests and time commitment and altruistic reasons did not significantly deviate from the mean preference analyzed using Fisher's exact test analysis. CONCLUSIONS: Patients consider the option of clinical trials as important in their treatment, and expect to be informed by their oncologist about such trials. Newly diagnosed cancer patients perceive randomization and first line trials negatively. Since randomization data provides new standards of care and hope for improved treatment, patients and their families must be educated of their importance.

A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer.

BACKGROUND: Treatment options after first-line chemotherapy are limited in non-small cell lung cancer (NSCLC). Belagenpumatucel-L is a therapeutic vaccine comprised of 4 transforming growth factor (TGF)-ß2-antisense gene-modified, irradiated, allogeneic NSCLC cell lines that may be useful for maintenance after initial treatment. METHODS: Stage III/IV NSCLC patients who did not progress after platinum-based chemotherapy were randomised 1:1 to receive maintenance belagenpumatucel-L or placebo. Patients were eligible for randomisation between one and four months from the end of induction chemotherapy. The primary endpoint was overall survival. RESULTS: This phase III trial enrolled 270 patients in the belagenpumatucel-L arm and 262 in the control arm. Belagenpumatucel-L was well tolerated with no serious safety concerns. There was no difference in survival between the arms (median survival 20.3 versus 17.8months with belagenpumatucel-L versus placebo, respectively; hazard ratio (HR) 0.94, p=0.594). There were also no differences in progression-free survival (4.3months versus 4.0 for belagenpumatucel-L vs placebo, respectively; HR 0.99, p=0.947). A prespecified Cox regression analysis demonstrated that the time elapsed between randomisation and the end of induction chemotherapy had a significant impact on survival (p=0.002) and that prior radiation was a positive prognostic factor (median survival 28.4months with belagenpumatucel-L versus 16.0months with placebo; HR 0.61, p=0.032). CONCLUSIONS: Although the overall trial did not meet its survival endpoint, improved survival for belagenpumatucel-L is suggested in patients who were randomised within 12weeks of completion of chemotherapy and in those who had received prior radiation. Further studies of belagenpumatucel-L in NSCLC are warranted.

Pooled preventable death rates in trauma patients : Meta analysis and systematic review since 1990.

PURPOSE: To estimate the pooled PDRs (preventable death rates) with articles being published since 1990, and compare the differences of PDRs over time and according to the evaluation approaches to determine preventable deaths. METHODS: Articles concerning preventable deaths of trauma patients published between 1990 and 2013 were systematically reviewed, and the pooled PDRs with 95 % confidence intervals were estimated using meta-analysis. It was also observed whether the PDRs differed over time and according to the evaluation approaches employed for determining preventable deaths. RESULTS: Twenty seven articles were identified through bibliographic searches using PUBMED with the keywords of 'preventable deaths', 'the cause of deaths' and 'trauma'. Mean ages of the trauma patients in the selected articles ranged from 32.9 to 58 years old and 72 % were male on average. The pooled PDR was estimated as 0.20 with 95 % CI (0.16, 0.25) with a p-value of 0.0001, and the differences of PDRs over time and according to the employed approaches were not statistically significant with p-values of 0.06 and 0.99, respectively. However, PDRs determined by statistical approaches alone showed greater dispersion in comparison with the 'panel review approach'. CONCLUSIONS: This article provided some insights about the trauma care system by computing the pooled estimate of PDRs over the past 23 years as an indicator. The pooled PDR was estimated as approximately 20 %, with no statistical significance of differences in PDRs over time or by the evaluation methods employed. That left us still room for improvement in trauma care system despite our efforts to reduce PDRs. In addition, when 'statistical approaches' are applied alone to estimate PDRs, we recommend that statistical methods should be applied with caution when the characteristics of trauma patients are heterogeneous. The optimal approach might be to combine both statistical and panel review approaches instead of employing a single approach.

Drive cancer out: a physician-led anti-smoking program directed at teens and adolescents.

Kentucky is among the states with the highest smoking-related mortality and youth smoking rates. Drive Cancer Out is a physician-led program that assesses and attempts to influence health literacy among Kentucky adolescents. Surveys on fifth-grade students identify social risk factors for smoking initiation and propose methods to decrease the rate of smoking among teenagers.

Urinary incontinence among male veterans receiving care in primary care clinics.

BACKGROUND: Male urinary incontinence is not a well-investigated subject. OBJECTIVE: To determine the prevalence and consequences of incontinence in men. DESIGN: Cross-sectional survey. SETTING: 3 primary care clinics in a Kentucky Veterans Affairs facility. PATIENTS: 840 men with a mean age of 59.8 years (range, 25 to 93 years). MEASUREMENTS: Written survey on patient demographic information and continence, including the Incontinence Impact Questionnaire. RESULTS: Among all study patients, 32.3% reported incontinence within the past 12 months and 13.8% (43% of those who were incontinent) reported at least weekly episodes. Age did not correlate with frequency or amount of urine loss. Frequency correlated with emotional health, social relationships, physical activity, and travel. Greater amounts of lost urine had a stronger effect on emotional health, social relationships, and travel. Among men with incontinence, only 32% had discussed incontinence with their medical provider but 75% desired evaluation and treatment. CONCLUSIONS: Urinary incontinence is common among male veterans and affects all age groups. Although incontinence often has unfavorable consequences on quality of life and although men with incontinence desired treatment, they seldom discussed the problem with medical providers. Systematic screening of men for urinary incontinence may be necessary.

The quality of medical evidence in hematology-oncology.

PURPOSE: The purpose of this study was to evaluate the quality of the medical evidence available to the clinician in the practice of hematology/oncology. METHODS: We selected 14 neoplastic hematologic disorders and identified 154 clinically important patient management decision/interventions, ranging from initial treatment decisions to those made for the treatment of recurrent or refractory disease. We also performed a search of the scientific literature for the years 1966 through 1996 to identify all randomized controlled trials in hematology/oncology. RESULTS: We identified 783 randomized controlled trials (level 1 evidence) pertaining to 37 (24%) of the decision/interventions. An additional 32 (21%) of the decision/interventions were supported by evidence from single arm prospective studies (level 2 evidence). However, only retrospective or anecdotal evidence (level 3 evidence) was available to support 55% of the identified decision/interventions. In a retrospective review of the decision/interventions made in the management of 255 consecutive patients, 78% of the initial decision/interventions in the management of newly diagnosed hematologic/oncologic disorders could have been based on level 1 evidence. However, more than half (52%) of all the decision/interventions made in the management of these 255 patients were supported only by level 2 or 3 evidence. CONCLUSIONS: We conclude that level 1 evidence to support the development of practice guidelines is available primarily for initial decision/interventions of newly diagnosed diseases. Level 1 evidence to develop guidelines for the management of relapsed or refractory malignant diseases is currently lacking.