Medicine and Health Sciences Commons^™

Development And Evaluation Of A Heart Failure Tool For Homebound Patients, Matthew Kaspar

Walden Dissertations and Doctoral Studies

With more than 700,000 new diagnoses annually, congestive heart failure (CHF) is a chronic condition that affects the chambers of the heart. When not managed correctly, the disease rapidly progresses to substantial fluid volume overload that impacts activities of daily living and the overall quality of life. The financial implications for poor CHF management cost a mean annual medical expenditure of $33,427 per patient per year. The need for a diagnostic and prognostic at-home protocol is needed in the medical community, as there is currently no such tool on the market. Donabedian's framework was used to guide the formulation and …

T-Tube Placement As A Method For Treating Penetrating Oesophageal Injuries, Roger Gill, K. M. Inam Pal, Fatima Mannan, Amber Bawa, Saulat H. Fatimi

Department of Surgery Docs

Introduction: Penetrating oesophageal injuries are extremely rare. Their timely recognition can be difficult and optimal treatment remains controversial. Early recognition of injury is possible with the help of a high index of suspicion and early radiological and endoscopic examinations. Prompt surgical intervention with primary repair of injury, should be the goal.
Presentation of cases: We describe two cases of penetrating oesophageal trauma where T-Tube placement through the oesophageal defect, was successfully employed. Both cases proved to be challenging due to time lapse after injury and anatomical location.
Discussion: Penetrating injuries to the Oesophagus are rare with a reported …

The Involvement Of Estrogen Receptors In Astrocyte Survival, Lauren M. Johnson

Theses and Dissertations

Estrogens are a class of hormones that are demonstrated to be neuroprotective. The levels of estrogen in the body decline during menopause which can cause a variety of symptoms. Hormone replacement therapy (HRT) is a treatment option for menopause, however, it has been demonstrated to have adverse side effects. Of the treatment options for adverse side effects of HRT, Selective estrogen Down-regulators do not appear to have an agonist effects on estrogen receptors while Selective estrogen receptor Modulators do. The aim of this study was to determine the role that estrogen receptors play in the survival of astrocytes when placed …

International Survey On Skin Patch Test Procedures, Attitudes And Interpretation., Luciana K. Tanno, Razvigor Darlenski, Silvia Sánchez-Garcia, Matteo Bonini, Andrea Vereda, Pavel Kolkhir, Dario Antolin-Amerigo, Vesselin Dimov, Claudia Gallego-Corella, Juan Carlos Aldave Becerra, Alexander Diaz, Virginia Bellido Linares, Leonor Villa, Lanny J. Rosenwasser, Mario Sanchez-Borges, Ignacio Ansotegui, Ruby Pawankar, Thomas Bieber, Wao Junior Members Group

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Skin patch test is the gold standard method in diagnosing contact allergy. Although used for more than 100 years, the patch test procedure is performed with variability around the world. A number of factors can influence the test results, namely the quality of reagents used, the timing of the application, the patch test series (allergens/haptens) that have been used for testing, the appropriate interpretation of the skin reactions or the evaluation of the patient's benefit.

METHODS: We performed an Internet -based survey with 38 questions covering the educational background of respondents, patch test methods and interpretation. The questionnaire was …

The Relationship Between Emotion Regulation, Social Support, And Alcohol-Related Problems Among Racially Diverse Adolescents., Briana A. Woods-Jaeger, Richard H. Nobles, Linnea Warren, Mary E. Larimer

Manuscripts, Articles, Book Chapters and Other Papers

No abstract provided.

Vague Neuroglycopenic Complaints Camouflage Diagnosis Of Adolescent Insulinoma: A Case Report., Kelsee Halpin, Ryan Mcdonough, Patria Alba, Jared Halpin, Vivekanand Singh, Yun Yan

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Insulinoma is a rare diagnosis in the general population with estimates of 1 in 250,000 people per year. Reports of these pancreatic islet cell tumors are even more unusual in children and adolescents. Chronic hypoglycemia due to an insulinoma often presents with neuroglycopenic symptoms that can easily be overlooked, especially in adolescents where nonspecific complaints are common. This may result in delayed diagnosis with prolonged periods of untreated hypoglycemia and associated complications. The rarity of pediatric insulinoma, vagueness of presenting symptoms, and challenge of tumor localization make insulinoma a true diagnostic quandary for clinicians.

CASE PRESENTATION: In this report, …

Reducing Overutilization Of Testing For Clostridium Difficile Infection In A Pediatric Hospital System: A Quality Improvement Initiative., J Michael Klatte, Rangaraj Selvarangan, Mary Anne Jackson, Angela Myers

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVES: Study objectives included addressing overuse of Clostridium difficile laboratory testing by decreasing submission rates of nondiarrheal stool specimens and specimens from children ≤12 months of age and determining resultant patient and laboratory cost savings associated with decreased testing.

METHODS: A multifaceted initiative was developed, and components included multiple provider education methods, computerized order entry modifications, and automatic declination from laboratory on testing stool specimens of nondiarrheal consistency and from children ≤12 months old. A run chart, demonstrating numbers of nondiarrheal plus infant stool specimens submitted over time, was developed to analyze the initiative's impact on clinicians' test-ordering practices. A …

Randomized Trial Of Late Surfactant Treatment In Ventilated Preterm Infants Receiving Inhaled Nitric Oxide., Roberta A. Ballard, Roberta L. Keller, Dennis M. Black, Philip L. Ballard, Jeffrey D. Merrill, Eric C. Eichenwald, William E Truog, Mark C. Mammel, Robin H. Steinhorn, Elizabeth E. Rogers, Rita M. Ryan, David J. Durand, Jeanette M. Asselin, Catherine M. Bendel, Ellen M. Bendel-Stenzel, Sherry E. Courtney, Ramasubbareddy Dhanireddy, Mark L. Hudak, Frances R. Koch, Dennis E. Mayock, Victor J. Mckay, T Michael O'Shea, Nicolas F. Porta, Rajan Wadhawan, Lisa Palermo, Tolsurf Study Group

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: To assess whether late surfactant treatment in extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD).

STUDY DESIGN: Extremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days were enrolled in a randomized, masked controlled trial at 25 US centers. All infants received inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation every 1-3 days to a maximum of 5 doses while intubated. The primary outcome was survival at 36 weeks postmenstrual age (PMA) without …

Locations Of Physical Activity As Assessed By Gps In Young Adolescents., Jordan A. Carlson, Jasper Schipperijn, Jacqueline Kerr, Brian E. Saelens, Loki Natarajan, Lawrence D. Frank, Karen Glanz, Terry L. Conway, Kelli L. Cain, James F. Sallis, J E. Chapman

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVES: To compare adolescents' physical activity at home, near home, at school, near school, and at other locations.

METHODS: Adolescents (N = 549) were ages 12 to 16 years (49.9% girls, 31.3% nonwhite or Hispanic) from 447 census block groups in 2 US regions. Accelerometers and Global Positioning System devices assessed minutes of and proportion of time spent in moderate to vigorous physical activity (MVPA) in each of the 5 locations. Mixed-effects regression compared MVPA across locations and demographic factors.

RESULTS: Forty-two percent of adolescents' overall MVPA occurred at school, 18.7% at home, 18.3% in other (nonhome, nonschool) locations, and …

Allergic Diseases And Internalizing Behaviors In Early Childhood., Maya K. Nanda, Grace K. Lemasters, Linda Levin, Marc E. Rothenberg, Amal H. Assa'ad, Nicholas Newman, David Bernstein, Gurjit Khurana-Hershey, James E. Lockey, Patrick H. Ryan

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND AND OBJECTIVES: The relationship between allergic diseases and internalizing disorders has not been well characterized with regard to multiple allergic diseases or longitudinal study. The objective of this study was to examine the association between multiple allergic diseases in early childhood with validated measures of internalizing disorders in the school-age years.

METHODS: Children enrolled in the Cincinnati Childhood Allergy and Air Pollution Study underwent skin testing and examinations at ages 1, 2, 3, 4, and 7 years. At age 7, parents completed the Behavior Assessment System for Children, Second Edition (BASC-2), a validated measure of childhood behavior and emotion. …

Proceedings Of The Working Group Session On Fertility Preservation For Individuals With Gender And Sex Diversity., Courtney Finlayson, Emilie K. Johnson, Diane Chen, Elizabeth Dabrowski, Yasmin Gosiengfiao, Lisa Campo-Engelstein, Ilina Rosoklija, Jill Jacobson, Margarett Shnorhavorian, Mary Ellen Pavone, Molly B. Moravek, Herbert J. Bonifacio, Lisa Simons, Janella Hudson, Patricia Y. Fechner, Veronica Gomez-Lobo, Rachel Kadakia, Angela Shurba, Erin Rowell, Teresa K. Woodruff

Manuscripts, Articles, Book Chapters and Other Papers

Children and adolescents with gender and sex diversity include (1) gender-nonconforming and transgender individuals for whom gender identity or expression are incongruent with birth-assigned sex (heretofore, transgender) and (2) individuals who have differences in sex development (DSD). Although these are largely disparate groups, there is overlap in the medical expertise necessary to care for individuals with both gender and sex diversity. In addition, both groups face potential infertility or sterility as a result of desired medical and surgical therapies. The Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's) gender and sex development program (GSDP) provides specialized multidisciplinary …

Current And Upcoming Stroke Research At Baptist Health, Amy K. Starosciak

All Publications

No abstract provided.

Prevalence Of Nasal Colonization By Methicillin-Resistant Staphylococcus Aureus In Persons Using A Homeless Shelter In Kansas City, Megan Ottomeyer, Charles D. Graham, Avery D. Legg, Elizabeth S. Cooper, Chad D. Law, Mariam Molani, Karine Matevossian, Jerry Marlin, Charlott Williams, Ramon Newman, Jason A. Wasserman, Larry W. Segars, Tracey A H Taylor

Manuscripts, Articles, Book Chapters and Other Papers

Nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) plays an important role in the epidemiology and pathogenesis of disease. Situations of close-quarter contact in groups are generally regarded as a risk factor for community-acquired MRSA strains due to transmission via fomites and person-to-person contact. With these criteria for risk, homeless individuals using shelter facilities, including showers and toilets, should be considered high risk for colonization and infection. The aim of this study was to determine the prevalence of nasal colonization of MRSA in a homeless population compared to established rates of colonization within the public and a control group of subjects …

Dog Walking Among Adolescents: Correlates And Contribution To Physical Activity., Jessa K. Engelberg, Jordan A. Carlson, Terry L. Conway, Kelli L. Cain, Brian E. Saelens, Karen Glanz, Lawrence D. Frank, James F. Sallis

Manuscripts, Articles, Book Chapters and Other Papers

PURPOSE: To assess the association of dog walking with adolescents' moderate-to-vigorous physical activity (MVPA) and body mass index (BMI), and identify correlates of dog walking.

METHODS/DESIGN: Participants were 12-17year-olds (n=925) from the Baltimore, MD and Seattle, WA regions. Differences in accelerometer-assessed minutes/day of MVPA and self-reported BMI (percentile) were compared among adolescents (1) without a dog (n=441) and those with a dog who (2) did (≥1days/week, n=300) or (3) did not (n=184) walk it. Correlates of (1) dog walking (any vs. none) among adolescents with dogs (n=484), and (2) days/week of dog walking among dog walkers (n=300) were investigated. Potential …

The Arp2/3 Complex Is Essential At Multiple Stages Of Neural Development., Fu-Sheng Chou, Pei-Shan Wang

Manuscripts, Articles, Book Chapters and Other Papers

During development of the nervous system, radial glial cells perform self-renewing asymmetric divisions and give rise to intermediate progenitor cells (IPC) and neurons. The neuronally committed IPC subsequently undergo multiple rounds of transient amplification and migrate outwards to form cortical layers as they continue to differentiate into mature neurons. Maturing neurons extend protrusions on their cell surface to form neurites, a process called neuritogenesis. Neurite formation results in the establishment of dendrites and axons for synapse formation, which is essential for sensory and motor functions and even higher-level functioning including memory formation and cognitive function, as well as shaping of …

Improvements In Cultural Competence Through Classroom And Local Cross-Cultural Service-Learning Activities, Jason M. Denton, Shandra Esparza, David S. Fike, Jaime González, Melinda Lundquist Denton

Physical Therapy Faculty Publications

Introduction: Improving cultural competence has been proposed as a way to decrease health disparities and is a priority of physical therapist (PT) education programs. Multiple published works describe curricular design for PT education programs to promote cultural competence, but limited data support the effectiveness of classroom or local cross-cultural activities.

Subjects: Fifty-two first-year PT students participated in the study.

Methods: All participants completed an Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals-Student Version (IAPCC-SV ©) pretest for a baseline measure of cultural competence and an IAPCC-SV© posttest 1 after a classroom educational module including readings, limited lecture, …

N-Acetylcysteine Decreases Binge Eating In A Rodent Model, M. M. Hurley, Jon M. Resch, Brian Maunze, M. M. Frenkel, David A. Baker, Sujean Choi

Biomedical Sciences Faculty Research and Publications

Binge-eating behavior involves rapid consumption of highly palatable foods leading to increased weight gain. Feeding in binge disorders resembles other compulsive behaviors, many of which are responsive to N-acetylcysteine (NAC), which is a cysteine prodrug often used to promote non-vesicular glutamate release by a cystine–glutamate antiporter. To examine the potential for NAC to alter a form of compulsive eating, we examined the impact of NAC on binge eating in a rodent model. Specifically, we monitored consumption of standard chow and a high-fat, high carbohydrate western diet (WD) in a rodent limited-access binge paradigm. Before each session, rats received either …

Cb1 Receptor Antagonism Blocks Stress-Potentiated Reinstatement Of Cocaine Seeking In Rats, Jayme R. Mcreynolds, Elizabeth M. Doncheck, Oliver Vranjkovic, Geoffrey S. Ganzman, David A. Baker, Cecilia J. Hillard, John R. Mantsch

Biomedical Sciences Faculty Research and Publications

Rationale

Under some conditions, stress, rather than directly triggering cocaine seeking, potentiates reinstatement to other stimuli, including a subthreshold cocaine dose. The mechanisms responsible for stress-potentiated reinstatement are not well defined. Endocannabinoid signaling is increased by stress and regulates synaptic transmission in brain regions implicated in motivated behavior.

Objectives

The objective of this study was to test the hypothesis that cannabinoid type 1 receptor (CB1R) signaling is required for stress-potentiated reinstatement of cocaine seeking in rats.

Methods

Following i.v. cocaine self-administration (2 h access/day) and extinction in male rats, footshock stress alone does not reinstate cocaine seeking but reinstatement is …

The Level Of Nmda Receptor In The Membrane Modulates Amyloid-Β Association And Perforation, Christian Peters, Fernando J. Sepúlveda, Eduardo Fernández-Pérez, Robert W. Peoples, Luis G. Aguayo

Biomedical Sciences Faculty Research and Publications

Alzheimer’s disease is a neurodegenerative disorder that affects mostly the elderly. The main histopathological markers are the senile plaques formed by amyloid-β peptide (Aβ) aggregates that can perforate the plasma membrane of cells, increasing the intracellular calcium levels and releasing synaptic vesicles that finally lead to a delayed synaptic failure. Several membrane proteins and lipids interact with Aβ affecting its toxicity in neurons. Here, we focus on NMDA receptors (NMDARs) as proteins that could be modulating the association and neurotoxic perforation induced by Aβ on the plasma membrane. In fact, our results showed that decreasing NMDARs, using enzymatic or siRNA …

Is Acupuncture, Including Electroacupuncture, Effective In Treating Pain In Plantar Fasciitis?, Alicia Campiglia

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether the use of acupuncture, including electroacupuncture, is effective in treating pain in patients with plantar fasciitis.

STUDY DESIGN: Review of 3 RCTs published between 2011-current, all in the English language.

DATA SOURCES: Three RCTs analyzed the effectiveness of acupuncture therapy compared to a control group using alternate analgesic therapies. All studies were found using EBSCOhost and PubMed and were selected based on relevance to the proposed clinical question.

OUTCOMES MEASURED: Each of the 3 articles analyzed the effectiveness of treating pain with acupuncture treatment in patients diagnosed with …

Are Statins An Effective Treatment In Men With Erectile Dysfunction?, Kelsey Caton

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether or not HMG-CoA Inhibitors (Statins) are an effective treatment for erectile dysfunction (ED).

STUDY DESIGN: Systematic review of three English language randomized controlled trials published between 2011-2013.

DATA SOURCES: Three randomized controlled trials published in peer-reviewed journals comparing the effects of statins on erectile function found using the PubMed database.

OUTCOMES MEASURED: The outcomes measured included erectile function, assessed using the International Index of Erectile Dysfunction Questionnaire (IIEF) in all three studies and Nocturnal Penile Tumescence (NPT) in one study, and male ED-quality of life using the MED-QoL …

Does Ivabradine Improve Quality Of Life In Cardiovascular Disease Patients?, Daniel E. Lynch

PCOM Physician Assistant Studies Student Scholarship

Objective: The objective of this review is to determine whether ivabradine therapy can improve the quality of life in cardiovascular disease patients.

Study Design: The studies included in this review are one randomized control study and two double blind randomized control studies from 2008, 2010, and 2012.

Data Source: The three studies in this review were obtained by performing a PubMed search using the keywords “ivabradine” and random control trial.” All articles were published in English and in peer-reviewed journals.

Outcomes Measured: The three studies ascertained whether there was a decrease in hospitalization events within coronary artery disease and heart …

Does Hyperbaric Oxygen Therapy Relieve Post-Concussion Symptoms And Improve Quality Of Life?, Kevin (Sung Min) Lee

PCOM Physician Assistant Studies Student Scholarship

Objective: The objective of this selective EBM review is to determine whether or not hyperbaric oxygen therapy relieves post-concussion symptoms and improve quality of life.

Study Design: Review of three randomized controlled trials published in English in peer review journals.

Data Sources: Three randomized controlled trials which evaluated the therapeutic benefits of hyperbaric oxygen therapy compared to control group that did not receive any treatment. All studies were found in PubMed database.

Outcomes Measured: All three studies analyzed the effect of hyperbaric oxygen therapy on quality of life. Rivermead Postconcussion Symptoms Questionnaire (RPQ) and EQ-VAS questionnaire were used to measure …

Does Music Therapy Reduce Anxiety Levels In End-Stage Renal Disease Patients Undergoing Hemodialysis?, Andrew C. Konopacki

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether or not music therapy reduces anxiety levels in end-stage renal disease patients undergoing hemodialysis.

STUDY DESIGN: Systematic Review of two randomized controlled trials and one crossover study published in English in 2008, 2012 and 2013, respectively.

DATA SOURCES: Two non-blind randomized controlled trials and one cross-over study were found via PubMed and EBSCOhost databases.

OUTCOMES MEASURED: Subjective Anxiety Levels were measured in ESRD patients undergoing hemodialysis pre and posttest via patient self-reporting. An anxiety level survey graded on a scale of 1-10 was used in the study by …

Is Flibanserin A Safe And Effective Treatment To Increase Sexual Desire In Premenopausal Women With Hypoactive Sexual Desire Disorder?, Rebecca Lee

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether or not Flibanserin is a safe and effective treatment to increase sexual desire in premenopausal women with Hypoactive Sexual Desire Disorder.

STUDY DESIGN: Review of three randomized controlled trials published in 2013, 2012, and 2012; selection was based on their relevance to the clinical question and if they contained patient oriented outcomes.

DATA SOURCES: Three peer-reviewed randomized controlled trials comparing the use of Flibanserin to placebo in the treatment of Hypoactive Sexual Desire Disorder were found on PubMed.

OUTCOME(S) MEASURED: For each trial patients were divided into two …

Does Aerobic Exercise During Pregnancy Prevent Cesarean Sections?, Kait Lassen

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether or not aerobic exercise in pregnant women prevents cesarean sections (“C-sections”).

STUDY DESIGN: Review of two English articles and one English/Portuguese article, two of which were randomized control trials (RCTs) and one was a prospective study, all published after 2011.

DATA SOURCES: Two RCTs and one prospective study found via PubMed and Cochrane Database.

OUTCOMES MEASURED: The main clinical outcome in all studies measured the incidence of C-section as compared to vaginal delivery. The outcomes were measured by method of delivery which was categorized as either vaginally or …

Is Safinamide Effective As An Add-On Medication In Treating Parkinson's Disease Motor Symptoms?, Erin E. Kilonsky

PCOM Physician Assistant Studies Student Scholarship

Objective: The objective of this systematic review is to determine whether or not “Is safinamide effective as an add-on medication in treating Parkinson's disease motor symptoms?”

Study Design: Review of three randomized, controlled studies published in peer reviewed journals in English between 2012-2014.

Data Sources: The three randomized, double-blind clinical trials were found via PubMed and EBSCOhost Web. Articles were selected based on relevance, the date of publication, and whether or not they included patient outcomes.

Outcomes Measured: Among other measures, each trial measured improvement in motor symptoms using the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (motor) scores, …

How Effective Is Acupuncture In Treating Cancer-Related Fatigue In Adult Cancer Patients?, Anita Elizabeth Kurian

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether or not acupuncture is an effective course of treatment for improving cancer-related fatigue in adult cancer patients.

DESIGN: Review of three English language primary randomized controlled studies published from 2006-2012.

DATA SOURCES: Three randomized controlled trials studying the effects of acupuncture therapy on cancer-related fatigue were found using PubMed and Cochrane databases.

OUTCOMES MEASURED: Each of the three trials assessed the efficacy and clinical improvement of cancer-related fatigue after acupuncture therapy. Results were measured on the Functional Assessment of Chronic-Illness Therapy-Fatigue Subscale (FACIT-F) or the Multidimensional Fatigue Inventory …

Is Laser Therapy Effective At Relieving Pain In Adult Patients With Recurrent Aphthous Stomatitis?, Kevin Jackson

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this selective EBM review is to determine whether or not laser therapy is effective at relieving pain in adult patients with recurrent aphthous stomatitis.

STUDY DESIGN: Systematic review of three randomized controlled trials published in 2009, 2009, and 2013.

DATA SOURCES: Three randomized controlled trials were obtained using PubMed.

OUTCOMES MEASURED: The symptom of pain was measured for improvement by patient survey of visual analog pain scales.

RESULTS: Prasad et al. (2013), Tezel et al. (2009), and Zand et al. (2009) all demonstrated improvement in a majority of the subjects’ pain relief from treatment with laser …

Is A Vitamin Supplement Effective In Treatment Of Recurrent Aphthous Ulcers?, Annalyse Grayson

PCOM Physician Assistant Studies Student Scholarship

OBJECTIVE: The objective of this EBM review is to determine whether or not a daily vitamin supplement is effective treatment for recurrent aphthous ulcers.

STUDY DESIGN: A review of 3 randomized control trials. All three trials are in English between 2009-2014.

DATA SOURCES: 3 randomized double blind placebo-controlled parallel-arm single center trials were found using PubMed.

OUTCOMES MEASURED: Each of the RCTs measured the efficacy of treatment for RAU in patients with aphthous ulcer outbreaks for at least a year or at least one to three outbreaks a month. This was performed by subjects of the study reporting on efficacy …