Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies.

OBJECTIVE: Creating an environment that supports conditions of routine clinical practice and enables an effectiveness trial design with a pre-licensed medicine is extremely challenging. Here, we summarise our experiences and achievements with engaging and mobilising community pharmacies in and around Salford, United Kingdom, in the Phase III effectiveness Salford Lung Studies (SLS). METHODS: This article provides the authors' personal experiences and viewpoints on community pharmacy involvement in the SLS. KEY FINDINGS: More than 130 community pharmacies were enabled, and >2500 pharmacy staff trained, for involvement in the SLS. Key to community pharmacy participation in the SLS was the formation of the SLS Pharmacy Steering Group (PSG), contributing to study oversight, and the development of a pharmacy standard operating procedure document, the major principle of which was to ensure minimum disruption to the normal medicine dispensing process while ensuring compliance with regulations, guidelines, good clinical practice and requirements for pharmacovigilance. The high level of commitment and collaboration of community pharmacy in the SLS demonstrated a willingness to work together and take on additional and novel roles beyond their everyday commercial functions for the benefit of patients, despite normally competing for prescription business. CONCLUSIONS: The involvement and integration of community pharmacy as a key partner in the SLS was pivotal in securing the delivery of these world-first clinical effectiveness studies. To our knowledge, this has not been previously achieved in a study of a pre-licensed maintenance therapy for a common disease in primary care.

The association between BMI and BSA-temozolomide-induced myelosuppression toxicities: a correlative analysis of NRG oncology RTOG 0525.

BACKGROUND: Fearing increased myelotoxicity, many practitioners adjust the body surface area (BSA)-calculated doses in obese patients. Regarding temozolomide (TMZ), a prior study suggested men with a BSA >2 m2 may experience increased toxicity; however, surprisingly, the inverse observation was noted in women, ie, BSA <2 m2 was associated with higher toxicity. To further clarify this issue, data derived from a large clinical trial were analyzed. METHODS: The incidence of grade 3 and 4 myelotoxicity in a newly diagnosed glioblastoma phase 3 trial (RTOG 0525) was statistically correlated with BMI and separately with BSA. All patients received radiation and TMZ followed by adjuvant standard dose TMZ vs dose-dense TMZ; dosing regimen-associated myelotoxicity and BMI/BSA were analyzed separately. Obesity was defined as a BMI ≥30. RESULTS: There was no statistically significant correlation between gender and BSA and the occurrence of myotoxicities. For the standard arm, surprisingly the incidence of grade 3/4 myotoxicities in patients with a BMI <30 was significantly higher than in patients with a BMI ≥30 (12% vs 1%, odds ratio [OR] 12.5, P < .001). There was no significant difference between obese and nonobese patients (BMI "cut-point" of 30) in the dose-dense arm (OR = 0.9, 95% confidence interval: 0.4-1.6). The grade hematological 3/4 toxicity rate was significantly higher in women vs men (14% vs 8%) P = .009 in spite of the lack of association between gender and BSA or BMI. CONCLUSION: TMZ dosing based on actual BSA is recommended with the caveat that woman are likely at higher toxicity risk.

Association between substance use and concurrent sexual relationships among urban slum dwellers in Nairobi, Kenya.

While the overall incidence and prevalence of HIV/AIDS are declining in Africa, substance use-related HIV/AIDS is on the rise. The main objectives of this study were to elicit the types of commonly used substances and to examine the association between substance use and concurrent sexual relationships among slum dwellers in Kenya. Freelisting elicitation techniques were used to identify the most commonly used substances using 53 key informants. This was followed by a self-administered, structured questionnaire using a convenience sample of 506 participants. Findings from our freelisting analysis produced 27 substances that were used in the community. Analysis of the survey data shows that participants who reported using substances in the past three months were more likely to be involved in concurrent sexual relationships than those who did not (86.2% vs. 74.0%; p = .002). In the multivariable model, the odds of ever having concurrent sexual relationships were higher among participants who used any substance in the past three months (aOR 2.46; 95% CI 1.37-4.42, p < .01). The observed association between substance use and concurrent sexual relationships may be influenced by social and economic factors such as poverty and lack of opportunity among urban slum dwellers.

Investigating the Effect of Reirradiation or Systemic Therapy in Patients With Glioblastoma After Tumor Progression: A Secondary Analysis of NRG Oncology/Radiation Therapy Oncology Group Trial 0525.

PURPOSE: To determine the impact on overall survival with different salvage therapies, including no treatment, reirradiation, systemic therapy, or radiation and systemic therapy, in participants of a phase 3 clinical trial evaluating dose-dense versus standard-dose temozolomide for patients with newly diagnosed glioblastoma. METHODS AND MATERIALS: This analysis of patients from Trial RTOG 0525 investigated the effect of reirradiation or systemic treatment after tumor progression. Survival from first progression was compared between patients receiving no therapy, systemic therapy alone, radiation alone, and both modalities. The Cox proportional hazards model was used to compare the mortality hazard, controlling for potential confounders. RESULTS: The analysis included 637 patients who progressed and had information on their management, excluding those who died less than half a month after progression. A total of 267 patients (42%) received neither reirradiation nor systemic treatment at progression, 24 (4%) received radiation alone, 282 (44%) received systemic treatment only, and 64 (10%) received both radiation and systemic therapy. Patients who received no treatment had a median survival of 4.8 months, lower than with radiation treatment alone (8.2 months), systemic therapy alone (10.6 months), and both radiation and systemic therapy (12.2 months). In survival models controlling for potential confounders, those who received radiation alone had modestly better survival (hazard ratio HR 0.74, 95% confidence interval [CI] 0.43-1.28), whereas those who underwent systemic therapy either without (HR 0.42, 95% CI 0.34-0.53) or with radiation therapy (HR 0.44, 95% CI 0.30-0.63) had better survival. There was no significant survival difference between patients who received radiation only and those who received systemic therapy (either with radiation or alone). CONCLUSIONS: Patients who received no salvage treatment had poorer survival than those who received radiation, chemotherapy, or the combination. However, patient selection for no treatment likely reflects poorer expected prognosis. There was no significant survival difference among those receiving radiation therapy, systemic therapy, or both. Ongoing clinical trials will help define the role of reirradiation after glioblastoma progression.

Sexual health promotion on social networking sites: a process evaluation of The FaceSpace Project.

PURPOSE: This article reports findings from an evaluation of reach and engagement of The FaceSpace Project, a novel sexual health promotion project delivered through social networking sites that targeted young people aged 16-29 years. METHODS: Multiple methods were used to evaluate project reach and engagement. The evaluation focussed on quantitative data (online usage statistics, online surveys), complemented by available qualitative data (project team meeting notes). RESULTS: The project reached 900 fans who were mostly between 18 and 34 years of age. The most successful ways of increasing audience reach were via Facebook advertisements and tagging photos of young people attending a music festival on the project Facebook page. Peaks in Facebook page interactions (comments and "likes") coincided with recruitment peaks and when videos were posted. However, video views varied greatly between postings. Feedback from the project team for increasing engagement in future social networking site interventions included having one centralized Facebook page and using episodic videos. CONCLUSIONS: This evaluation is among the first to assess the use of social networking sites for sexual health promotion and provides information to inform the implementation and evaluation of future projects using new media. Social networking sites offer great potential to reach and engage young people for sexual health promotion. However, further work is required to improve implementation and promote audience reach and engagement as well as to determine effectiveness of social networking sites in changing knowledge, attitudes, and behaviors.

Queer as F**k: reaching and engaging gay men in sexual health promotion through social networking sites.

BACKGROUND: A growing number of health promotion interventions are taking advantage of the popularity and interactivity of new social media platforms to foster and engage communities for health promotion. However, few health promotion interventions using social networking sites (SNS) have been rigorously evaluated. "Queer as F**k"(QAF) began as pilot project in 2010 to deliver sexual health promotion via short "webisodes" on SNS to gay men. Now in its fifth season, QAF is among the few published examples internationally to demonstrate the sexual health promotion potential of SNS. OBJECTIVE: The objective of this evaluation is to assess reach, interactivity, and engagement generated by QAF to inform future health interventions and evaluations using SNS. METHODS: We undertook a mixed method process evaluation using an uncontrolled longitudinal study design that compared multiple measurements over time to assess changes in reach and engagement. We adapted evaluation methods from the health promotion, information systems, and creative spheres. We incorporated online usage statistics, interviews informed by user diary-scrapbooks, and user focus groups to assess intervention reach and engagement. RESULTS: During Series 1-3 (April 2010 to April 2011), 32 webisodes were posted on the QAF Facebook and YouTube pages. These webisodes attracted over 30,000 views; ranging from 124-3092 views per individual episode. By April 2011, the QAF Facebook page had 2929 predominantly male fans. Interview and focus group participants supported the balance of education and entertainment. They endorsed the narrative "soap opera" format as an effective way to deliver sexual health messages in an engaging, informative, and accessible manner that encouraged online peer discussion of sexual health and promoted community engagement. CONCLUSIONS: QAF offers a successful example of exploiting the reach, interactivity, and engagement potential of SNS; findings from this process evaluation provide a model to inform the delivery and evaluation of future health promotion interventions on SNS.

Factors associated with use of automated smoking cessation interventions: findings from the eQuit study.

The aim was to better understand structural factors associated with uptake of automated tailored interventions for smoking cessation. In a prospective randomized controlled trial with interventions only offered, not mandated, participants were randomized based on the following: web-based expert system (QuitCoach); text messaging program (onQ); both as an integrated package; the choice of using either or both; or a control condition informed of a static website (not considered here). Participants were 3530 smokers or recent quitters recruited from two sources; those seeking smoking cessation information, mostly recruited over the phone, and a cold-contacted group recruited from an Internet panel. More participants (60.1%) initially accepted the intervention they had been offered than used it (42.5%). Uptake of each intervention differed substantially by both recruitment source and modality (phone or web). onQ was a little more popular overall, especially in the information seeker sample. Highest overall intervention uptake occurred in the choice condition. A web-based intervention is most attractive if the offer to use is made by web, whereas a phone-based intervention is more likely to be used if the offer is made over the phone. Providing automated interventions on multiple platforms allows for maximal choice and greatest overall use of some form of help.

Developing health promotion interventions on social networking sites: recommendations from The FaceSpace Project.

Online social networking sites offer a novel setting for the delivery of health promotion interventions due to their potential to reach a large population and the possibility for two-way engagement. However, few have attempted to host interventions on these sites, or to use the range of interactive functions available to enhance the delivery of health-related messages. This paper presents lessons learnt from "The FaceSpace Project", a sexual health promotion intervention using social networking sites targeting two key at-risk groups. Based on our experience, we make recommendations for developing and implementing health promotion interventions on these sites. Elements crucial for developing interventions include establishing a multidisciplinary team, allowing adequate time for obtaining approvals, securing sufficient resources for building and maintaining an online presence, and developing an integrated process and impact evaluation framework. With two-way interaction an important and novel feature of health promotion interventions in this medium, we also present strategies trialled to generate interest and engagement in our intervention. Social networking sites are now an established part of the online environment; our experience in developing and implementing a health promotion intervention using this medium are of direct relevance and utility for all health organizations creating a presence in this new environment.

A systematic examination of the use of online social networking sites for sexual health promotion.

BACKGROUND: In recent years social networking sites (SNSs) have grown rapidly in popularity. The popularity of these sites, along with their interactive functions, offer a novel environment in which to deliver health promotion messages. The aim of this paper is to examine the extent to which SNSs are currently being used for sexual health promotion and describe the breadth of these activities. METHODS: We conducted a systematic search of published scientific literature, electronic sources (general and scientific search engines, blogs) and SNSs (Facebook, MySpace) to identify existing sexual health promotion activities using SNSs. Health promotion activities were eligible for inclusion if they related to sexual health or behaviour, utilised one or more SNSs, and involved some element of health promotion. Information regarding the source and type of health promotion activity, target population and site activity were extracted. RESULTS: 178 sexual health promotion activities met the inclusion criteria and were included in the review; only one activity was identified through a traditional systematic search of the published scientific literature. Activities most commonly used one SNS, were conducted by not-for-profit organisations, targeted young people and involved information delivery. Facebook was the most commonly used SNS (used by 71% of all health promotion activities identified), followed by MySpace and Twitter. Seventy nine percent of activities on MySpace were considered inactive as there had been no online posts within the past month, compared to 22% of activities using Facebook and 14% of activities using Twitter. The number of end-users and posts in the last seven days varied greatly between health promotion activities. CONCLUSIONS: SNSs are being used for sexual health promotion, although the extent to which they are utilised varies greatly, and the vast majority of activities are unreported in the scientific literature. Future studies should examine the key factors for success among those activities attracting a large and active user base, and how success might be measured, in order to guide the development of future health promotion activities in this emerging setting.

Improvement in coronary anastomosis with cardiac surgery simulation.

OBJECTIVE: Cardiac surgery trainees might benefit from simulation training in coronary anastomosis and more advanced procedures. We evaluated distributed practice using a portable task station and experience on a beating-heart model in training coronary anastomosis. METHODS: Eight cardiothoracic surgery residents performed 2 end-to-side anastomoses with the task station, followed by 2 end-to-side anastomoses to the left anterior descending artery by using the beating-heart model at 70 beats/min. Residents took home the task station, recording practice times. At 1 week, residents performed 2 anastomoses on the task station and 2 anastomoses on the beating-heart model. Performances of the anastomosis were timed and reviewed. RESULTS: Times to completion for anastomosis on the task station decreased 20% after 1 week of practice (351 +/- 111 to 281 +/- 53 seconds, P = .07), with 2 residents showing no improvement. Times to completion for beating-heart anastomosis decreased 15% at 1 week (426 +/- 115 to 362 +/- 94 seconds, P = .03), with 2 residents demonstrating no improvement. Home practice time (90-540 minutes) did not correlate with the degree of improvement. Performance rating scores showed an improvement in all components. Eighty-eight percent of residents agreed that the task station is a good method of training, and 100% agreed that the beating-heart model is a good method of training. CONCLUSIONS: In general, distributed practice with the task station resulted in improvement in the ability to perform an anastomosis, as assessed by times to completion and performance ratings, not only with the task station but also with the beating-heart model. Not all residents improved, which is consistent with a "ceiling effect" with the simulator and a "plateau effect" with the trainee. Simulation can be useful in preparing residents for coronary anastomosis and can provide an opportunity to identify the need and methods for remediation.

Walking forward: the South Dakota Native American project.

BACKGROUND: The "Walking Forward" program is a scientific collaborative program between Rapid City Regional Hospital, the University of Wisconsin, the Mayo Clinic, and partnerships with the American Indian community in western South Dakota-3 reservations and 1 urban population. The purpose is to increase participation of health disparities populations on National Cancer Institute clinical trials as part of the Cancer Disparities Research Partnership program. Clinical practice suggests that Native American cancer patients present with more advanced stages of cancer and hence have lower cure rates and higher treatment-related morbidities. It is hypothesized that a conventional course of cancer treatment lasting 6 to 8 weeks may be a barrier. METHODS: Innovative clinical trials have been developed to shorten the course of treatment. A molecular predisposition to treatment side effects is also explored. These clinical endeavors will be performed in conjunction with a patient navigator research program. RESULTS AND CONCLUSIONS: Research metrics include analysis of process, clinical trials participation, treatment outcome, and assessment of access to cancer care at an early stage of disease.