Assessing the Validity of Statistical Inferences in Public Health Research: An Evidence-Based, ‘Best-Practices’ Approach

Like many fields, public health has embraced the process of evidence-based practice to inform practice decisions and to guide policy development. Evidence-based practice is typically dependent upon generalizations made on the bases of the existing body of knowledge – assimilations of the research literature on a particular topic. The potential utility of scientific evidence for guiding policy and practice decisions is grounded in the validity of the research investigations upon which such decisions are made. However, the validity of inferences made from the extant public health research literature requires more than ascertaining the validity of the statistical methods alone; for each study, the validity of the entire research process must be critically analyzed to the greatest extent possible so that appropriate conclusions can be drawn, and that recommendations for development of sound public health policy and practice can be offered. A critical analysis of the research process should include the following: An a priori commitment to the research question; endpoints that are both appropriate for and consistent with the research question; an experimental design that is appropriate (i.e., that answers the research question[s]); study procedures that are conducted in a quality manner, that eliminate bias and ensure that the data accurately reflect the condition(s) under study; evidence that the integrity of the Type-I error – or false-positive risk – has been preserved; use of appropriate statistical methods (e.g. assumptions checked, dropouts appropriately handled, correct variance term) for the data analyzed; and accurate interpretation of the results of statistical tests conducted in the study (e.g., the robustness of conclusions relative to missing data, multiple endpoints, multiple analyses, conditions of study, generalization of results, etc.). This paper provides a framework for both researcher and practitioner so that each may assess this critical aspect of public health research

Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy

J Charles Henry1, James H Peace2, Jeanette A Stewart3,4, William C Stewart3,41Little Rock Eye Clinic, Little Rock, AR, USA; 2Diabetic Eye Medical Clinic, Inglewood, CA, USA; 3PRN Pharmaceutical Research Network, LLC, Dallas,TX, USA; 4Carolina Eye Institute, University of South Carolina, School of Medicine, Columbia, SC, USAPurpose: To evaluate the efficacy, safety and tolerability of changing to travoprost BAK-free from prior prostaglandin therapy in patients with primary open-angle glaucoma or ocular hypertension.Design: Prospective, multi-center, historical control study.Methods: Patients treated with latanoprost or bimatoprost who needed alternative therapy due to tolerability issues were enrolled. Patients were surveyed using the Ocular Surface Disease Index (OSDI) to evaluate OSD symptoms prior to changing to travoprost BAK-free dosed once every evening. Patients were re-evaluated 3 months later.Results: In 691 patients, travoprost BAK-free demonstrated improved mean OSDI scores compared to either latanoprost or bimatoprost (p < 0.0001). Patients having any baseline OSD symptoms (n = 235) demonstrated significant improvement after switching to travoprost BAK-free (p < 0.0001). In 70.2% of these patients, symptoms were reduced in severity by at least 1 level. After changing medications to travoprost BAK-free, mean intraocular pressure (IOP) was significantly decreased (p < 0.0001). Overall, 72.4% preferred travoprost BAK-free (p < 0.0001, travoprost BAK-free vs prior therapy). Travoprost BAK-free demonstrated less conjunctival hyperemia than either prior therapy (p < 0.0001).Conclusions: Patients previously treated with a BAK-preserved prostaglandin analog who are changed to travoprost BAK-free have clinically and statistically significant improvement in their OSD symptoms, decreased hyperemia, and equal or better IOP control.Keywords: glaucoma, prostaglandin analog, travoprost, latanoprost, bimatoprost, preservative, benzalkonium chloride, ocular surface diseas

The Impact of Intra-Household Gender Relations in Accessing Agricultural Extension Services for Improved Livelihoods: The Case of NAADS Beneficiary Sub-Counties in Kabale District

This study explored the influence of intra-household gender relations in access to Agricultural Extension Services (AESs) for improved livelihoods as a pathway to long term poverty reduction. The study covered the four NAADS pioneer beneficiary Sub counties of Bubare, Bukiinda, Ikumba and Maziba in Kabale district. It analysed gender based relational differences prevailing between men and women in a household (HH) in the creation and recreation of secure livelihoods through AESs. A mixed method approach with cross sectional and exploratory research designs was used to collect data through documentary review, Focus Group Discussions (FGDs), HH surveys, Key Informant (KI) interviews and observation checklist. The study sample comprised of 181 farmers’ HHs and 14 KIs.The study results revealed that intra-HH gender relations among the Bakiga people of Kabale district are situated within a patriarchal setting which exhibit men’s dominance over women’s decisions in major spheres of life which affects equal access to AESs. Although AESs have been  operational in the district for over a decade, their existence has not transformed farmers’ livelihoods in  which is majorly attributed to unequal gender relations with regard to gender roles and division of labour, resource distribution, ownership and control as well as decision making which are reinforced by the Bakiga’s patriarchal system. Extension system is “gender blind” and NAADS agents/officials pay little attention to the gender relations which are skewed in favour of men, yet women are the key actors in agriculture production and reproduction. Micro, meso and macro level extension systems and structures were also anchored onto the patriarchal power setting thus obscure how women and men access production resources in their HHs in pursuit of livelihood streams. Thus, there is need for equitable technical advice to principle HHs members and examination of the composition of AESs structure as well as deconstructing HH power and control structure in pursuit of improved livelihood. This will empower women who are the linchpin of HH production and reproduction hence creating foundational pathways for improved livelihood

Understanding how open data could impact resource allocation for poverty eradication in Kenya and Uganda

This study was carried out by Development initiatives (www.devinit.org) and Development Research and Training (www.drt-­‐ug.org)Using case studies from Uganda and Kenya, Development Research and Training (DRT) and Development Initiatives (DI) researched the evolution of the open data movement in the two countries assessing its role in the equitable allocation of financial resources for eradication of extreme and chronic poverty. The paper presents methodology and findings, and includes factors of high tech intermediaries, civil society organizations, the media, academia and think tanks. Political barriers were most often cited as the reason for government not engaging with provision of open data. Analysis of literature shows that inclusion and empowerment could be fostered by making data open

Appetitive aggression in offending youths: Contributions of callous unemotional traits and violent cognitive patterns

Appetitive aggression, marked by the derivation of positive affect from harming others has been observed mostly among youths in societies experiencing extreme violence. Perpetrators report craving violence, and find the process and actual infliction of harm relishing. Because this dimension of aggression is relatively new, studies have barely examined likely psychological correlates of this phenomenon. In this study, we considered the associations between callous-unemotional (CU) traits as well as violent cognition, with appetitive aggression in young offenders. Male youth offenders (n = 188) from 2 detention facilities in Northern and the Niger Delta regions of Nigeria completed measures of appetitive aggression, CU traits, and violent-supportive cognition. Demographic information regarding their offences were collected from official records and corroborated with self-reports. CU traits were related to the perpetration of appetitive aggression. Offenders who endorsed machismo beliefs that portrays aggression as a masculine characteristic and a fitting response to threats were more likely to report the enjoyment of aggression. There was a mediation effect of machismo thinking on the relationship between CU traits and appetitive aggression. The study finds that, like other known types of aggression, CU traits and machismo thinking are associated with appetitive aggression, and invites future studies to investigate other correlates of this pattern of aggression

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma.

Prostate cancer is the most commonly diagnosed malignancy and second leading cause of cancer death among men in the United States. In recent years, several new agents, including cancer immunotherapies, have been approved or are currently being investigated in late-stage clinical trials for the management of advanced prostate cancer. Therefore, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel, including physicians, nurses, and patient advocates, to develop consensus recommendations for the clinical application of immunotherapy for prostate cancer patients. To do so, a systematic literature search was performed to identify high-impact papers from 2006 until 2014 and was further supplemented with literature provided by the panel. Results from the consensus panel voting and discussion as well as the literature review were used to rate supporting evidence and generate recommendations for the use of immunotherapy in prostate cancer patients. Sipuleucel-T, an autologous dendritic cell vaccine, is the first and currently only immunotherapeutic agent approved for the clinical management of metastatic castrate resistant prostate cancer (mCRPC). The consensus panel utilized this model to discuss immunotherapy in the treatment of prostate cancer, issues related to patient selection, monitoring of patients during and post treatment, and sequence/combination with other anti-cancer treatments. Potential immunotherapies emerging from late-stage clinical trials are also discussed. As immunotherapy evolves as a therapeutic option for the treatment of prostate cancer, these recommendations will be updated accordingly