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Journal of Lung Diseases & Treatment

ISSN: 2472-1018

Open Access

Volume 2, Issue 3 (2016)

Research Article Pages: 1 - 7

Finding the Patients for Respiratory Clinical Trials; Successful Recruitment by Adapting Trial Design

Delsing L, Jauhiainen A, Brailsford W, Buxtfeldt C, Sethi T and Betts J

DOI: 10.4172/2472-1018.1000110

There is increasing need to develop new therapeutics for respiratory diseases such as asthma and COPD, driven by the rising global prevalence, association with significant morbidity and mortality and limited current treatment options. However, recruitment of patients into respiratory trials remains challenging, time-consuming and often very costly. As a consequence, recruitment times frequently have to be extended during the trial to reach the recruitment goal. To identify key changes in trial design which could lead to improved recruitment in respiratory trials, trial recruitment between 1999 and 2012 was analyzed using data from Citeline Trialtrove. The manner by which trials met their recruitment goal was analyzed together with a more in-depth study of trials terminated due to poor recruitment. The percentage of respiratory trials found not to be recruiting to target was substantial (average 26.3%). Whilst no significant changes in recruitment to target were observed during the time period, there appeared to be a trend towards shorter recruitment times. Common features of poorly recruiting trials were very few centers and strict eligibility criteria. Recruitment is central to clinical trials and more complex trials enrolling more specific patient populations will prove increasingly challenging. Therefore, it is important to both consider by what means recruitment will be affected when making trial design decisions and to ensure that every eligibility criteria is as inclusive as possible while still maintaining selection of the right patient population.

Case Report Pages: 1 - 3

Persistent Bloodstream Infection with P. aeruginosa in a Patient with an Aortic Root Graft and a New Diagnosis of Lung Cancer

Chen X, Ramirez A and Al Achkar M

DOI: 10.4172/2472-1018.1000112

Pseudomonas aeruginosa is the third most common gram-negative pathogen causing bloodstream infection (BSI) and is associated with an elevated mortality rate of up to 42%. The primary sources of infection are the pulmonary system, indwelling catheters, urinary tract, and soft tissue. BSI caused by vascular graft infection is 1-6% depending on the location of the graft. There is increasing prevalence of resistance of P. aeruginosa to antimicrobial agents, and oral agents are usually not considered as treatment of choice for P. aeruginosa BSI. Here, we report a case of persistent BSI with P. aeruginosa with the aortic graft as the primary source of infection. Patient did not go through aortic graft extraction due to new diagnosis of end stage lung cancer but was successfully managed by oral suppression therapy after failing a prolonged course of IV antibiotic therapy.

Research Article Pages: 1 - 8

The Development and Validation of a New Questionnaire to Address theGap between the Actual and Desired States in COPD Patients

Motegi T, Takahashi T, Katsura H, Ichinose M and Nagai A

DOI: 10.4172/2472-1018.1000113

Background: Numerous quality of life (QOL) assessment tools are available for patients with chronic obstructive pulmonary disease (COPD); however, most only focus on the patient’s actual state, and very few assess the patient’s desired state. Objective: To develop a questionnaire that can assess COPD patients’ desired states and to verify the usefulness of the findings. Methods: We interviewed COPD patients to identify components that best reflected the patients’ desired movement/activities. Two types of questionnaires were created with each component intended for self-assessment by actual and desired states. The revised questionnaire included the appropriate components based on the results of the preliminary survey. A multicenter study was performed using the final questionnaire. Results: We selected 32 components of the patients’ desired movement/activity from interviews with 22 COPD patients. The final questionnaire consisted of eight components and had a sufficiently high internal consistency (Cronbach’s α > 0.8). Three hundred and sixty two COPD patients participated in the validation study. The gap score (the difference between actual and desired scores) was significantly correlated with the predicted percentage of the forced expiratory volume in 1 s, dyspnea scale, and the COPD assessment test (CAT) (p < 0.0001). Oxygen therapy and frequent exacerbations exhibited unfavorable gap scores (p < 0.001). Multiple regression analysis on actual scores identified dyspnea scale, CAT, oxygen use, unemployment, exacerbation and heart failure to be independent explanatory variables (adjusted R2=0.63). Whereas only dyspnea scale and CAT were significant predictors in gap score (adjusted R2=0.32). Conclusion: The gap and actual scores evaluate the different aspect of the patients’ state. Evaluating the gap scores in patients might be useful in the assessment of the suitability of ongoing medical interventions and in the determination of future therapeutic goals.

Research Article Pages: 1 - 6

Impact of Asthma on the Quality of Life of Adolescent Patients from Saudi Arabia

Halwani R, Al-kufeidy R, Muharib BA, Alkhashram FM, Hussain SIB, Alhenaki RS, Vazquez-Tello A, Al-Frayh A, Iqbal SM and Al-Muhsen S

DOI: 10.4172/2472-1018.1000114

Background: Bronchial asthma is a chronic inflammatory disease afflicting people worldwide without distinction of age, gender or ethnicity. The health-related quality of life (HRQL) of adolescents with asthma can be disrupted considerably and may reflect the effectiveness of symptoms management, therapy and health services provided.
Objective: To evaluate the health-related quality of life (HRQL) of Saudi Arab adolescents with documented clinical history of asthma, classified by severity.
Methods: In this cross-sectional survey, the Pediatric Asthma Quality of Life (PAQLQ) and the Mini Asthma Quality of life (Mini-AQLQ) questionnaires were applied to 135 randomly recruited asthma patients (11-to-19 years old) in the period between January and June 2012, grouped as intermitent, mild, moderate, or severe.
Results: In 9 of 27 questions, significantly impaired HRQL was perceived by severe asthmatics, relative to intermittent patients; in particular, almost all aspects of the symptoms category significantly bothered the severe asthmatics. In emotional aspects, mild and moderates feel frustrated because couldn't keep up with others, whereas in social activities, moderate and severe groups indicated worse scores in school attendance, relative to intermittent asthmatics. In physical activities, severe and moderate groups reported lowest scores. A consistent finding was related to the influence of environmental triggers: Dust, cigarette smoke and air pollution impaired HRQL of all four asthma groups, relative to intermittent asthmatics.
Conclusion: Asthma lowers the health-related quality of life of Saudi adolescent patients, in terms of physical, emotional, symptoms, and environmental triggers, impairing mainly the severe asthmatics.

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