scholarly journals Lung Cancer–Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results

Diabetes Care ◽  
2019 ◽  
Vol 42 (9) ◽  
pp. 1708-1715 ◽  
Author(s):  
Nicolle M. Gatto ◽  
Daniel O. Koralek ◽  
Michael B. Bracken ◽  
William T. Duggan ◽  
Joanna Lem ◽  
...  
2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e028192
Author(s):  
Therese Hugoy ◽  
Anners Lerdal ◽  
Tone Rustoen ◽  
Trine Oksholm

ObjectivesDespite the negative influence of fatigue on quality of life in patients who undergo lung cancer surgery, little is known about the possible predictors of postoperative fatigue. The aim of this study was to examine demographic and clinical characteristics that might predict postoperative fatigue 5 months after lung cancer surgery.DesignA prospective longitudinal follow-up study comprising preoperative and postoperative questionnaires, including Lee Fatigue Scale, and sociodemographic and clinical data.SettingThree university hospitals in Norway (eg, Oslo University Hospital, St. Olav University Hospital and Haukeland University Hospital).ParticipantsIn total, 196 surgically treated patients who answered the questionnaires both preoperatively and at 5-month follow-up with valid fatigue scores.ResultsBivariate analyses showed that preoperative fatigue was associated with comorbidities and the symptoms of shortness of breath, cough, depression, anxiety, sleep disturbance and pain. Only cough was directly associated with preoperative fatigue in a regression model. Comorbidities and the symptoms of shortness of breath, cough, depression and sleep disturbance were associated with postoperative fatigue in the bivariate analyses, but only shortness of breath was associated with postoperative fatigue in the regression model. We did not find any significant correlations between fatigue and any treatment variable.ConclusionClinicians should pay special attention to lung symptoms and be aware that these may lead to long-term postoperative fatigue. Further research should examine whether interventions reducing lung symptoms, such as shortness of breath and coughing, may prevent development of fatigue in patients undergoing lung cancer surgery.


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