A Focus on Evaluating Major Study Limitations in Order to Apply Clinical Trials to Patient Care: Implications for the Healthcare Team.

Background: With more than a million new biomedical articles published annually, healthcare providers must stay up to date in order to provide optimal evidence-based patient care. The concise ROOTs (relevance, observe validity, obtain clinically significant results, and translate results to clinical practice) format is a valuable tool to assist with literature evaluation. Purpose: To illustrate how major study limitations found in clinical trials might inhibit the ability to adopt the findings of such studies to patient care. Methods: Examples from published clinical trials that contain major study flaws were used to illustrate, if taken at face value, would lead to erroneous assumptions, and if adopted, could potentiallly harm patients. Conclusion: When evaluating the literature, it is crucial to identify limitations in the published literature that might reduce the internal validity, affect the results, or limit the external validity of clinical trials, hence affecting the usability of literature for patient care. This article provides examples of clinical trials that contain major study limitations with potentially erroneous assumptions. These illustrations are meant to show how important it is to delve deeper into an article before conclusions are drawn.

Planning a pharmacy-led medical mission trip, part 4: an exploratory study of student experiences.

BACKGROUND: At the Gregory School of Pharmacy (GSOP), pharmacy students routinely participate in domestic and international medical mission trips. Participation can be for academic credit as part of final-year Advanced Pharmacy Practice Experiences (APPEs) or as required community service hours. These mission experiences could potentially result in both professional and personal transformations for participating students. OBJECTIVE: To evaluate data collected from GSOP pharmacy students regarding their experiences on the medical mission field in 2011 and how that participation has impacted the students professionally and personally. METHODS: GSOP students participating in an international or domestic medical mission trip in the summer of 2011 were asked to voluntarily complete pre- and posttrip surveys. RESULTS: Of the 68 final-year APPE students and student volunteers who participated in a summer 2011 GSOP medical mission trip, 36 (53%) completed pre- and posttrip surveys. The mission trips significantly impacted students' beliefs regarding better preparation to care for the medical needs of patients, identification of others' needs, understanding team dynamics, perceptions about the value of patient care, and comfort level with the provision of medical and pharmaceutical care in a foreign country. However, there were no statistically significant improvements in students' perceptions of their ability to care for the emotional needs of patients, the importance of team unity, and their level of respect for team members; their ability to lead or participate in future trips; and their belief that participating preceptors and faculty serve as effective role models of servant leaders. CONCLUSIONS: Based on the findings from this exploratory study, participation in a domestic or international medical mission trip as a student volunteer or APPE student appears to have a positive impact on some of the beliefs and perceptions of GSOP students. By continuing to follow these particular students and similar cohorts of students in the future, further insight may be gained regarding the long-term impact of medical mission experiences during pharmacy school training.

Planning a pharmacy-led medical mission trip, part 3: development and implementation of an elective medical missions advanced pharmacy practice experience (APPE) rotation.

With an increasing number of new pharmacy schools/colleges and expansion of existing ones, pharmacy schools/colleges are often in need of elective rotation experiences as part of the final year advanced pharmacy practice experience (APPE) program. Offering a medical missions elective APPE in either a domestic or international setting is a unique opportunity to expose pharmacy students to direct patient care. APPE students can be involved in triaging patients, compounding and dispensing medications, and providing patient education. As part of this APPE, pharmacy students are expected to complete projects such as formulary development, case presentations, book club discussions, journal reflections, manuscript preparations, and trip logistics planning. An elective APPE focused on medical missions facilitates the learning process and promotes the emergence of team leaders and leadership skills in general.

Planning a pharmacy-led medical mission trip, part 1: focus on medication acquisition.

Pharmacists can be involved in many functions of the medical mission team. Particularly, they can play a large role in formulary development, acquisition of medications, and organization of medications before and during the mission trip. Important factors for consideration in formulary development and logistical planning include the group's budget; importation laws and regulations of the country being visited; transportation and storage of medications and supplies; disease states anticipated; whether controlled substances will be included; whether medical or surgical procedures will be provided; age distribution and languages of the population to be treated; whether sample medications will be used; handling of unused medications and supplies after the trip; and considerations of the population's cultural beliefs. Various organizations are available to provide medications for medical mission efforts at little to no cost, and knowledge of these organizations will help to facilitate the process of medication acquisition. Additionally, pharmacists can provide insight regarding the logistical set-up and workflow considerations during the mission experience.

Doripenem: a new carbapenem antibiotic.

PURPOSE: The chemistry, pharmacology, antimicrobial activity, pharmacokinetics, pharmacodynamics, efficacy and safety in humans, and formulary considerations of doripenem are reviewed. SUMMARY: Doripenem, a member of the ß-lactam class of antibiotics, is the newest addition to the carbapenems. It exhibits concentration-independent bactericidal activity against gram-positive bacteria; enteric and nonenteric gram-negative bacteria, including extended-spectrum ß-lactamase-producing strains; and anaerobic pathogens. Doripenem was found to be noninferior to meropenem in the treatment of complicated intraabdominal infections and noninferior to levofloxacin in the treatment of complicated urinary tract infections including pyelonephritis and was granted marketing approval by the Food and Drug Administration for these two indications. Doripenem was also found to be noninferior to imipenem in the treatment of ventilator-associated pneumonia and noninferior to piperacillin-tazobactam in the treatment of hospital-acquired pneumonia. It has a favorable safety profile, with gastrointestinal complaints and headache being the most common adverse effects and allergic reactions the most serious adverse effects. Doripenem has a relatively low potential to induce seizures. The only known clinically relevant drug interaction is that coadministration with valproic acid may result in reductions of valproic acid serum concentrations. As with most renally eliminated antibiotics, the dose of doripenem should be adjusted according to kidney function. CONCLUSION: Doripenem is an injectable carbapenem antibiotic with a spectrum of activity comparable to that of imipenem and meropenem. Its safety is similar to that of other carbapenems.

Pharmacy curriculum outcomes assessment for individual student assessment and curricular evaluation.

The Pharmacy Curriculum Outcomes Assessment (PCOA) is a standardized examination for assessing academic progress of pharmacy students. Although no other national benchmarking tool is available on a national level, the PCOA has not been adopted by all colleges and schools of pharmacy. Palm Beach Atlantic University (PBAU) compared 2008-2010 PCOA results of its P1, P2, and P3 students to their current grade point average (GPA) and to results of a national cohort. The reliability coefficient of PCOA was 0.91, 0.90, and 0.93 for the 3 years, respectively. PBAU results showed a positive correlation between GPA and PCOA scale score. A comparison of subtopic results helped to identify areas of strengths and weaknesses of the curriculum. PCOA provides useful comparative data that can facilitate individual student assessment as well as programmatic evaluation. There are no other standardized assessment tools available. Despite limitations, PCOA warrants consideration by colleges and schools of pharmacy. Expanded participation could enhance its utility as a meaningful benchmark.

Clinical versus statistical significance: interpreting P values and confidence intervals related to measures of association to guide decision making.

Pharmacists need to apply outcomes from studies to reduce risk and improve patient care. Interpretation of outcomes is based on a variety of assessment tools, such as P values and confidence intervals (CIs). P values determine statistical significance of data, while CIs suggest the degree of clinical application. Many health care providers might not have the skill set required to carefully examine and interpret statistical results and then are required to assume that the researchers of the study correctly interpreted and presented the statistical results. The reluctance to examine statistical data often reflects a misconception that concepts such as P values and CIs are difficult to understand, while in reality, both can be interpreted once basic definitions and applications are understood. Measures of association such as number needed to treat can serve as effective tools for quantifying important parameters that ultimately affect patient care. A basic understanding of how to interpret and apply P values and CIs enhances one's ability to effectively assess the validity of results from the literature. An informed reader, armed with tools for critical analysis, is in the best position to evaluate studies and thereby discern which information is applicable to a specific patient care decision.

The taxonomy of professionalism: reframing the academic pursuit of professional development.

Student professionalism continues to be an elusive goal within colleges and schools of pharmacy. Several reports have described the nature of professionalism and enumerated the characteristic traits of a professional, but educational strategies for inculcating pharmacy students with attitudes of professionalism have not been reliably effective. Some authors have suggested the need for a standard definition. If the goal can be more clearly conceptualized by both faculty members and students, and the moral construct of the fiduciary relationship between pharmacist and patient better understood, the development of professional values and behaviors should be easier to achieve. This paper describes a new approach to defining professionalism that is patterned after Bloom's Taxonomy of Educational Objectives. It includes the general concept of patient care advocacy as an underlying paradigm for a new pharmacy practice model, and defines 5 behavioral elements within each of the 3 domains of professionalism: competence, connection, and character.

Assessing the clinical efficacy of sildenafil for the treatment of female sexual dysfunction.

OBJECTIVE: To review the clinical data regarding the efficacy and safety of sildenafil for the treatment of female sexual dysfunction (FSD). DATA SOURCES: A MEDLINE search from 1950 to February 2009 was conducted using the key words sildenafil and female sexual dysfunction. Human studies and publication in English were used as primary limits. A combination of several publication-type limits was used to locate the clinical trials (eg, clinical trial, controlled clinical trial, randomized clinical trial). A bibliographic search was also performed of all located articles. STUDY SELECTION AND DATA EXTRACTION: Clinical trials involving sildenafil treatment of premenopausal and postmenopausal women with FSD and women with FSD due to concomitant medications and/or disease states were reviewed. DATA SYNTHESIS: An increasing number of clinical trials have been published regarding the treatment of FSD with sildenafil. Eight studies demonstrated a possible benefit from treatment for FSD in patients receiving sildenafil, regardless of dose, while 4 trials did not show any significant differences with treatment. It appears that sildenafil might be beneficial for women with FSD caused by diseases such as multiple sclerosis, type 1 diabetes, spinal cord injury, and use of antidepressant medications. CONCLUSIONS: Although data suggest a possible role of sildenafil for the treatment of FSD, the information should be interpreted cautiously, as many of the studies included small sample sizes, used inappropriate statistical tests, and used nonvalidated assessment tools. A better FSD classification system and consistent use of validated assessment tools might help alleviate differences among clinical trials and provide a more cohesive foundation for assessing the safety and efficacy of sildenafil for the treatment of FSD.

White coat ceremonies in US schools of pharmacy.

BACKGROUND: Pharmacy and medical schools share similar concerns regarding the need to place greater emphasis on professional socialization. Many academic institutions of both professions have elected to establish a white coat ceremony to initiate the process of inculcating professional values. However, a recent literature search revealed little published information on pharmacy white coat ceremonies. OBJECTIVE: To determine the prevalence of white coat ceremonies in US schools of pharmacy and identify commonalities between ceremonies conducted at different schools. METHODS: In April 2002, a 25-question survey was sent via E-mail to the deans of the 83 accredited schools of pharmacy in the US. The survey solicited details about the nature of each school's white coat ceremony or reasons why the school does not conduct a ceremony. RESULTS: The first ceremony in pharmacy was held at the University of Kentucky in 1995. As of May 2002, 51 of the 83 schools had already conducted a white coat ceremony and another 10 indicated plans to initiate a ceremony by the end of the year. Telephone follow-up confirmed that, as of May 2003, the number had risen to 61 schools. Most schools conduct the ceremony during the first professional year. Common features include presentation of the coat, recitation of an oath, a speech by an honored guest, a class photograph, and a reception. CONCLUSIONS: The white coat ceremony is a growing phenomenon in pharmacy education that could play a pivotal role in the quest to better achieve professional socialization among students.

Granulocyte macrophage-colony stimulating factor and oral mucositis.

OBJECTIVE: To evaluate the effect of granulocyte macrophage-colony stimulating factor (GM-CSF) in patients with oral mucositis. DATA SOURCES: Literature was accessed through MEDLINE (1966-June 2000) and bibliographic searches. DATA SYNTHESIS: Published literature assessing the use of GM-CSF to treat or prevent oral mucositis was analyzed. CONCLUSIONS: Reports of GM-CSF improving mucositis have been published; however, because of limitations in these reports, insufficient evidence confirms the benefits of GM-CSF. These preliminary studies provide a rationale to conduct well-designed, double-blind, randomized trials to evaluate the safety and efficacy of GM-CSF in the treatment and/or prevention of oral mucositis induced by chemotherapy and/or radiotherapy.

ECT During Pregnancy: Physiologic and Pharmacologic Considerations.

ECT is an accepted treatment for depression, mania, catatonia, and schizophrenia, but is usually used after other traditional drug treatments have failed. This also holds true for pregnant women who require psychiatric treatment. ECT is normally deferred until the fetus is at risk from the unstable psychiatric condition of the mother. This review examines the physiological effects of ECT, case reports of pregnant women receiving ECT, and possible complications of the medications administered before the procedure. All published case reports of ECT during all trimesters of pregnancy and the effects of ECT on the child are reviewed. The medications given before ECT (i.e., anticholinergics, muscle relaxants, and anesthetics) are examined for their teratogenic potential when administered multiple times during pregnancy.