The Establishment of the GENEQOL Consortium to Investigate the Genetic Disposition of Patient-Reported Quality-of-Life Outcomes

To our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported quality-of-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary consortium, the GENEQOL Consortium, which intends to investigate the genetic disposition of patient-reported quality-of-life outcomes. We have identified five primary patient-reported quality-of-life outcomes as initial targets: negative psychological affect, positive psychological affect, self-rated physical health, pain, and fatigue. The first tangible objective of the GENEQOL Consortium is to develop a list of potential biological pathways, genes and genetic variants involved in these quality-of-life outcomes, by reviewing current genetic knowledge. The second objective is to design a research agenda to investigate and validate those genes and genetic variants of patient-reported quality-of-life outcomes, by creating large datasets. During its first meeting, the Consortium has discussed draft summary documents addressing these questions for each patient-reported quality-of-life outcome. A summary of the primary pathways and robust findings of the genetic variants involved is presented here. The research agenda outlines possible research objectives and approaches to examine these and new quality-of-life domains. Intriguing questions arising from this endeavor are discussed. Insight into the genetic versus environmental components of patient-reported quality-of-life outcomes will ultimately allow us to explore new pathways for improving patient care. If we can identify patients who are susceptible to poor quality of life, we will be able to better target specific clinical interventions to enhance their quality of life and treatment outcomes.quality of life, self-rated health, pain, fatigue, genetic disposition, Patient-Reported Quality-of-Life Outcomes

Deforestation is driven by agricultural expansion in Ghana's forest reserves

Ghana's protected forest reserves have suffered average annual deforestation rates of 0.7%, 0.5%, 0.4%, and 0.6% for the periods 1990–2000, 2000–2005, 2005–2010 and 2010–2015, respectively. The Ashanti region has recorded the second highest deforestation rates. Despite the government's efforts to maintain and protect Ghana's forest reserves, deforestation continues. We observed deforestation patterns in the Ashanti region of Ghana from 1986 to 2015 using Landsat imagery to identify the main causes of deforestation. We obtained and processed two adjacent Landsat images from the United States Geological Survey's (USGS) National Centre for Earth Resources Observation and Science at 30 m spatial resolution for 1986, 2002, and 2015. We then supported the results with findings from 291 farm household surveys in communities fringing the forest reserves. By 2015, dense forest covered 53.3% of the land area of the forest reserves, and the remaining area had been disturbed. Expansion of annual crop farms and tree crops caused 78% of the forest loss within the 29-year period. Afforestation projects are ongoing some of which employ the participation of farmers, yet agricultural expansion exerts more pressure on the remaining dense forest. Agricultural intensification on existing farmlands may reduce farm expansion into the remaining forest areas. Strengthening and enforcing forest protection laws could minimise the extent of agricultural encroachment into forests. Mixed tree-crop systems could reduce the effects of arable farming on deforestation, limit the clearance of trees from farmlands, enhance the provision of ecosystem services, and improve the soil's fertility and moisture content. A forest transition may be underway leading to more trees in agricultural systems and better protection of residual natural forests

Breaking bad news in cancer : an assessment of Maltese patients’ preferences

Purpose: It is unclear whether Maltese cancer patients wish to know their diagnosis or to what extent they want to be informed. The aim was to assess patients’ preferences for receiving a cancer diagnosis and being involved in the decision-making process, and then compare these with results from similar international studies. Methods: Two hundred fifty-two Maltese adult cancer patients were invited to complete two standardised tools: the Measure of Patients’ Perspective (MPP), assessing patients’ preferences for receiving news about their cancer, and the Control Preferences Scale (CPS), examining involvement in decision-making. Results: Maltese patients rated the ‘content’ subscale (information given; mean 4.17, SD 0.59) as significantly more important (p<0.001) than ‘support’ (offering comfort/support; mean 3.73, SD 0.68) and ‘facilitation’ (how information is given; mean 3.86, SD 0.68). Patients with higher levels of education had significantly higher scores for ‘content’ (p=0.018) and ‘facilitation’ (p<0.001) on the MPP, while lower education levels preferred a passive role (p=0.01) on the CPS. Although there is a trend towards a collaborative and even an active role in treatment decisions, patients still exhibit a paternalistic attitude towards their physician. Age, gender and medical variables had no significant influence on response. Conclusions: Maltese cancer patients want to be informed of their cancer diagnosis, its treatment and prognosis, similar to other international studies. However, 60% of Maltese patients prefer a more paternalistic approach towards their physician when compared to other studies.peer-reviewe

Interpreting and Reporting Results Based on Patient-Reported Outcomes

AbstractThis article deals with the incorporation of patient-reported outcomes (PROs) into clinical trials and focuses on issues associated with the interpretation and reporting of PRO data. The primary focus and context of this information relates to the evidentiary support and reporting for a labeling or advertising claim of a PRO benefit for a new or approved pharmaceutical product. This manuscript focuses on issues associated with assessing clinical significance and common pitfalls to avoid in presenting results related to PROs. Specifically, the questions addressed by this manuscript involve: What are the best methods to assess clinical significance for PROs? How should investigators present PRO data most effectively in a Food and Drug Administration (FDA) application? In labeling or in a scientific publication? Guidelinesfor interpreting clinical significance of PROs and for comprehensively reporting on the methods, measures and results of clinical trials that incorporate PROs are important for clinicians, regulatory agencies, and most of all to patients. Clear specifications for considering a finding on a PRO measure, as clinically meaningful, need to be determined by instrument developers and psychometricians; they need to be reported for all clinical trials involving PRO end points. Clinical trial reports need to be comprehensive, clear, and sufficient to enable any reader to understand the methods, PRO measures, statistical analysis, and results

The Mayo Clinic Manuscript Series Relative to the Discussion, Dissemination, and Operationalization of the Food and Drug Administration Guidance on Patient-Reported Outcomes

AbstractPatient-reported outcomes (PROs) have become increasingly prevalent in clinical research and practice. On February 2, 2006, the Food and Drug Administration (FDA) released a draft guidance document with respect to incorporating PROs into clinical research endeavors which include FDA involvement. Researchers at the Mayo Clinic worked with FDA personnel and experts from academia, industry, clinical research, and clinical practice to facilitate discussion, dissemination, and operationalization of the FDA guidance document. This article introduces a manuscript series that resulted from this collective effort. Basic terms are definedand a précis of each article in the manuscript series is given. The ultimate conclusion to be drawn from this series is that, while the goals of assessing and analyzing PRO elements of clinical practice and research are challenging, there now exists a scientific foundation that makes achieving these goals feasible and the results credible. This is vitally important because after all, at the heart of all healthcare endeavors is the patient

Analysis and Interpretation of Results Based on Patient-Reported Outcomes

AbstractThis article is part of a series of manuscripts dealing with the incorporation of patient-reported outcomes (PROs) into clinical trials. The issues dealt with in this manuscript concern the common pitfalls to avoid in statistical analysis and interpretation of PROs. Specifically, the questions addressed by this manuscript involve the analysis pitfalls with PRO data in clinical trials and how can they be avoided (e.g.,missing data, multiplicity, null results etc.). The manuscript provides key literature for existing resources and proposes new guidelines

Spitzer Infrared Spectrograph Observations of M, L, and T Dwarfs

We present the first mid-infrared spectra of brown dwarfs, together with observations of a low-mass star. Our targets are the M3.5 dwarf GJ 1001A, the L8 dwarf DENIS-P J0255-4700, and the T1/T6 binary system epsilon Indi Ba/Bb. As expected, the mid-infrared spectral morphology of these objects changes rapidly with spectral class due to the changes in atmospheric chemistry resulting from their differing effective temperatures and atmospheric structures. By taking advantage of the unprecedented sensitivity of the Infrared Spectrograph on the Spitzer Space Telescope we have detected the 7.8 micron methane and 10 micron ammonia bands for the first time in brown dwarf spectra.Comment: 4 pages, 2 figure

Combining Survival and Toxicity Effect Sizes from Clinical Trials: NCCTG 89-20-52 (Alliance)

Background: How can a clinician and patient incorporate survival and toxicity information into a single expression of comparative treatment benefit? Sloan et al. recently extended the ½ standard deviation concept for judging the clinical importance of findings from clinical trials to survival and tumor response endpoints. A new method using this approach to combine survival and toxicity effect sizes from clinical trials into a quality-adjusted effect size is presented.Methods: The quality-adjusted survival effect size (QASES) is calculated as survival effect size (ESS) minus the calibrated toxicity effect sizes (EST) (QASES=ESS-EST). This combined effect size can be weighted to adjust for the relative emphasis placed by the patient on survival and toxicity effects.Results: As an example, consider clinical trial NCCTG 89-20-52 which randomized patients to once-daily thoracic radiotherapy (ODTRT) versus twice-daily treatment of thoracic radiotherapy (TDRT) for the treatment of lung cancer. The ODTRT vs. TDRT arms had median survival time of 22 vs. 20 months (p=0.49) and toxicity rate of 39% vs. 54%, (p&lt;0.05). The QASES of 0.18 standard deviations translates to a quality-adjusted survival difference of 5.7 months advantage for the ODRT arm over the TDRT treatment arm (22(16.3) months), p&lt;0.05). Similar results are presented for the four possible case combinations of significant/non-significant survival and toxicity benefits using completed clinical trials.Conclusions: We used a novel approach to re-analyze clinical trial data to produce a single estimate for each treatment that combines survival and toxicity data. The QASES approach is an intuitive and mathematically simple yet robust approach