Reengineering the clinical research enterprise to involve more community clinicians

<p>Abstract</p> <p>Background</p> <p>The National Institutes of Health has called for expansion of practice-based research to improve the clinical research enterprise.</p> <p>Methods</p> <p>This paper presents a model for the reorganization of clinical research to foster long-term participation by community clinicians.</p> <p>Based on the literature and interviews with clinicians and other stakeholders, we posited a model, conducted further interviews to test the viability of the model, and further adapted it.</p> <p>Results</p> <p>We propose a three-dimensional system of checks and balances to support community clinicians using research support organizations, community outreach, a web-based registry of clinicians and studies, web-based training services, quality audits, and a feedback mechanism for clinicians engaged in research.</p> <p>Conclusions</p> <p>The proposed model is designed to offer a systemic mechanism to address current barriers that prevent clinicians from participation in research. Transparent mechanisms to guarantee the safety of patients and the integrity of the research enterprise paired with efficiencies and economies of scale are maintained by centralizing some of the functions. Assigning other responsibilities to more local levels assures flexibility with respect to the size of the clinician networks and the changing needs of researchers.</p

Measuring research impact: a large cancer research funding programme in Australia

Background: Measuring research impact is of critical interest to philanthropic and government funding agencies interested in ensuring that the research they fund is both scientifically excellent and has meaningful impact into health and other outcomes. The Beat Cancer Project (BCP) is a AUD $34 m cancer research funding scheme that commenced in 2011. It was initiated by an Australian charity (Cancer Council SA), and supported by the South Australian Government and the state’s major universities. Methods: This study applied Buxton and Hanney’s Payback Framework to assess research impact generated from the BCP after 3 years of funding. Data sources were an audit of peer-reviewed publications from January 2011 to September 2014 from Web of Knowledge and a self-report survey of investigators awarded BCP research funding during its first 3 years of implementation (2011–2013). Of the 104 surveys, 92 (88 Results: The BCP performed well across all five categories of the Payback Framework. In terms of knowledge production, 1257 peer-reviewed publications were generated and the mean impact factor of publishing journals increased annually. There were many benefits to future research with 21 respondents (23$1 that the cancer charity invested, the BCP gained an additional AUD $6.06. Five projects (5%) had informed policy and 5 (5%) informed product development, with an additional 31 (34%) and 35 (38%) projects, respectively, anticipating doing so. In terms of health and sector and broader economic benefits, 8 (9%) projects had influenced practice or behaviour of health staff and 32 (34%) would reportedly to do so in the future. Conclusions: Research impact was a priority of charity and government funders and led to a deliberate funding strategy. Emphasising research impact while maintaining rigorous, competitive processes can achieve the joint objectives of excellence in research, yielding good research impact and a high rate of leverage for philanthropic and public investment, as indicated by these early results

Herbal medicine use during pregnancy in a group of Australian women

BACKGROUND: There are limited data on the extent of women's use of herbal medicines during pregnancy, despite the fact that knowledge of the potential benefits or harms of many of these products is sparse, particularly with respect to their use in pregnancy. We aimed to measure the prevalence of herbal medicine use in a group of pregnant women attending a public tertiary maternity hospital in Melbourne, Australia. Secondary aims were to explore why women took the herbal medicine, where they received advice, what form the supplements took and if they perceived the supplements to be helpful. METHODS: Consecutive pregnant women were approached in the antenatal clinic and the birth centre at around 36–38 weeks gestation. A questionnaire was developed and self-administered in English, as well as being translated into the four most common languages of women attending the hospital: Cantonese, Vietnamese, Turkish and Arabic. Back translation into English was undertaken by different professional translators to verify accuracy of both words and concepts. Data collected included demographic information, model of pregnancy care and herbal supplement use. Descriptive statistics were used initially, with stratified and regression analysis to compare sub-groups. RESULTS: Of 705 eligible women, 588 (83%) agreed to participate. Of these, 88 (15%) completed the questionnaire in a language other than English. Thirty-six percent of women took at least one herbal supplement during the current pregnancy. The most common supplements taken were raspberry leaf (14%), ginger (12%) and chamomile (11%). Women were more likely to take herbal supplements if they were older, tertiary educated, English speaking, non-smokers and primiparous. CONCLUSION: Use of herbal supplements in pregnancy is likely to be relatively high and it is important to ascertain what supplements (if any) women are taking. Pregnancy care providers should be aware of the common herbal supplements used by women, and of the evidence regarding potential benefits or harm

Does interhospital transfer improve outcome of acute myocardial infarction? A propensity score analysis from the Cardiovascular Cooperative Project

<p>Abstract</p> <p>Background</p> <p>Many patients suffering acute myocardial infarction (AMI) are transferred from one hospital to another during their hospitalization. There is little information about the outcomes related to interhospital transfer. The purpose of this study was to compare processes and outcomes of AMI care among patients undergoing interhospital transfer with special attention to the impact on mortality in rural hospitals.</p> <p>Methods</p> <p>National sample of Medicare patients in the Cooperative Cardiovascular Study (n = 184,295). Retrospective structured medical record review of AMI hospitalizations. Descriptive study using a retrospective propensity score analysis of clinical and administrative data for 184,295 Medicare patients admitted with clinically confirmed AMI to 4,765 hospitals between February 1994 and July 1995. Main outcome measure included: 30-day mortality, administration of aspirin, beta-blockers, ACE-inhibitors, and thrombolytic therapy.</p> <p>Results</p> <p>Overall, 51,530 (28%) patients underwent interhospital transfer. Transferred patients were significantly younger, less critically ill, and had lower comorbidity than non-transferred patients. After propensity-matching, patients who underwent interhospital transfer had better quality of care anlower mortality than non-transferred patients. Patients cared for in a rural hospital had similar mortality as patients cared for in an urban hospital.</p> <p>Conclusion</p> <p>Transferred patients were vastly different than non-transferred patients. However, even after a rigorous propensity-score analysis, transferred patients had lower mortality than non-transferred patients. Mortality was similar in rural and urban hospitals. Identifying patients who derive the greatest benefit from transfer may help physicians faced with the complex decision of whether to transfer a patient suffering an acute MI.</p

Pregnancy, prescription medicines and the potential risk of herb-drug interactions:a cross-sectional survey

Funding All funding was from institutional resource. JSM, AS are employed by the University of Aberdeen. DS is employed by the Robert Gordon University. BP and CR are employed by NHS Scotland. ARP and MAH are employed by the Hamad Medical Corporation. Qatar. NI is a postgraduate student at the University of Aberdeen.Peer reviewedPublisher PD

Bayesian versus frequentist statistical inference for investigating a one-off cancer cluster reported to a health department

Background. The problem of silent multiple comparisons is one of the most difficult statistical problems faced by scientists. It is a particular problem for investigating a one-off cancer cluster reported to a health department because any one of hundreds, or possibly thousands, of neighbourhoods, schools, or workplaces could have reported a cluster, which could have been for any one of several types of cancer or any one of several time periods. Methods. This paper contrasts the frequentist approach with a Bayesian approach for dealing with silent multiple comparisons in the context of a one-off cluster reported to a health department. Two published cluster investigations were re-analysed using the Dunn-Sidak method to adjust frequentist p-values and confidence intervals for silent multiple comparisons. Bayesian methods were based on the Gamma distribution. Results. Bayesian analysis with non-informative priors produced results similar to the frequentist analysis, and suggested that both clusters represented a statistical excess. In the frequentist framework, the statistical significance of both clusters was extremely sensitive to the number of silent multiple comparisons, which can only ever be a subjective "guesstimate". The Bayesian approach is also subjective: whether there is an apparent statistical excess depends on the specified prior. Conclusion. In cluster investigations, the frequentist approach is just as subjective as the Bayesian approach, but the Bayesian approach is less ambitious in that it treats the analysis as a synthesis of data and personal judgements (possibly poor ones), rather than objective reality. Bayesian analysis is (arguably) a useful tool to support complicated decision-making, because it makes the uncertainty associated with silent multiple comparisons explicit

Do multiple outcome measures require p-value adjustment?

BACKGROUND: Readers may question the interpretation of findings in clinical trials when multiple outcome measures are used without adjustment of the p-value. This question arises because of the increased risk of Type I errors (findings of false "significance") when multiple simultaneous hypotheses are tested at set p-values. The primary aim of this study was to estimate the need to make appropriate p-value adjustments in clinical trials to compensate for a possible increased risk in committing Type I errors when multiple outcome measures are used. DISCUSSION: The classicists believe that the chance of finding at least one test statistically significant due to chance and incorrectly declaring a difference increases as the number of comparisons increases. The rationalists have the following objections to that theory: 1) P-value adjustments are calculated based on how many tests are to be considered, and that number has been defined arbitrarily and variably; 2) P-value adjustments reduce the chance of making type I errors, but they increase the chance of making type II errors or needing to increase the sample size. SUMMARY: Readers should balance a study's statistical significance with the magnitude of effect, the quality of the study and with findings from other studies. Researchers facing multiple outcome measures might want to either select a primary outcome measure or use a global assessment measure, rather than adjusting the p-value

Azimuthal anisotropy and correlations at large transverse momenta in p+pp+p and Au+Au collisions at sNN\sqrt{s_{_{NN}}}= 200 GeV

Results on high transverse momentum charged particle emission with respect to the reaction plane are presented for Au+Au collisions at $\sqrt{s_{_{NN}}}$= 200 GeV. Two- and four-particle correlations results are presented as well as a comparison of azimuthal correlations in Au+Au collisions to those in $p+p$ at the same energy. Elliptic anisotropy, $v_2$, is found to reach its maximum at $p_t \sim 3$ GeV/c, then decrease slowly and remain significant up to $p_t\approx 7$ -- 10 GeV/c. Stronger suppression is found in the back-to-back high-$p_t$ particle correlations for particles emitted out-of-plane compared to those emitted in-plane. The centrality dependence of $v_2$ at intermediate $p_t$ is compared to simple models based on jet quenching.Comment: 4 figures. Published version as PRL 93, 252301 (2004

Perspectives and attitudes of breastfeeding women using herbal galactagogues during breastfeeding: a qualitative study

Some herbal galactagogues have gained reputation and recognition by the public and health professionals as alternative approaches to increase breast milk supply. This study explores the perspectives and attitudes of breastfeeding women towards the use of herbal galactagogues while breastfeeding, their experiences, and why and how they have chosen an alternative option over conventional treatments to enhance breastfeeding performance. This exploratory research was conducted through in-depth semi-structured interviews with women living in Perth, Western Australia, who were using one or more herbal galactagogues during breastfeeding. Purposeful and subsequent snowball sampling methods were employed to recruit participants. All interviews, facilitated by an interview guide, were audio-recorded, then transcribed verbatim. Thematic analysis was used to analyse qualitative data to construct themes and subthemes.The perspectives and attitudes of the 20 participants are classified under three main headings: i) use of herbal medicines during breastfeeding, ii) available herbal medicines resources, and iii) level of breastfeeding support received. Throughout the interviews, participants described how their perseverance and determination to breastfeed, as well as concerns over breastfed infants’ safety with conventional treatments, influenced their choice of therapy. A sense of self-efficacy and autonomy over their own health needs was seen as influential to their confidence level, supported self-empowerment and provided reassurance throughout the breastfeeding journey. There was also a desire for more evidence-based information and expectations of health professionals to provide credible and reliable information regarding the use of herbal medicines during breastfeeding. This study has enhanced our understanding of the perspectives and attitudes of breastfeeding women towards the use of herbal medicines, in particular galactagogues, while breastfeeding. The positive attitudes of breastfeeding women identified in this study highlight the need for further research into evaluating the safety and efficacy of commonly used herbal galactagogues, whilst the negative views on breastfeeding education should be taken into consideration when implementing or improving breastfeeding-related health policies

Checkpoints in a Yeast Differentiation Pathway Coordinate Signaling during Hyperosmotic Stress

All eukaryotes have the ability to detect and respond to environmental and hormonal signals. In many cases these signals evoke cellular changes that are incompatible and must therefore be orchestrated by the responding cell. In the yeast Saccharomyces cerevisiae, hyperosmotic stress and mating pheromones initiate signaling cascades that each terminate with a MAP kinase, Hog1 and Fus3, respectively. Despite sharing components, these pathways are initiated by distinct inputs and produce distinct cellular behaviors. To understand how these responses are coordinated, we monitored the pheromone response during hyperosmotic conditions. We show that hyperosmotic stress limits pheromone signaling in at least three ways. First, stress delays the expression of pheromone-induced genes. Second, stress promotes the phosphorylation of a protein kinase, Rck2, and thereby inhibits pheromone-induced protein translation. Third, stress promotes the phosphorylation of a shared pathway component, Ste50, and thereby dampens pheromone-induced MAPK activation. Whereas all three mechanisms are dependent on an increase in osmolarity, only the phosphorylation events require Hog1. These findings reveal how an environmental stress signal is able to postpone responsiveness to a competing differentiation signal, by acting on multiple pathway components, in a coordinated manner