Review : Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome

( Eric Shah ),( Mark Pimentel ) 대한소화기기능성질환·운동학회(구 대한소화관운동학회) 2014 Journal of Neurogastroenterology and Motility (JNM Vol.20 No.2

Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various approaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real world setting. (J Neurogastroenterol Motil 2014;20:163-170)

Estimating the Contribution of Acute Gastroenteritis to the Overall Prevalence of Irritable Bowel Syndrome

( Eric D Shah ),( Mark S Riddle ),( Christopher Chang ),( Mark Pimentel ) 대한소화기기능성질환·운동학회(구 대한소화관운동학회) 2012 Journal of Neurogastroenterology and Motility (JNM Vol.18 No.2

Background/Aims Recent studies reveal that acute gastroenteritis can precipitate irritable bowel syndrome (IBS) symptoms leading to the concept of post-infectious IBS. However, the overall contribution of gastroenteritis to the total IBS prevalence is unknown. In this exercise we try to estimate the contribution of gastroenteritis in IBS using the published literature and a longitudinal approach. Methods Existing literature was reviewed to determine the incidence of IBS after gastroenteritis, the rate of remission over time, data on rates of gastroenteritis in a given population and any patterns of resistance to these effects in human populations. This produced 3 models. The first assumed all humans were susceptible to gastroenteritis and its ability to produce IBS. The second assumed (using meta-analysis data) that 90% of humans in a given outbreak would be resistant to this effect. The third model used a high gastroenteritis exposure rate as might be seen in military deployment. Results In model 1, the prevalence was unrealistically high with an eventual steady state of 43.6% of the population affected by IBS. In a very conservative approach (model 2), steady state was achieved after 10 years to an overall prevalence of 8.9%. Interestingly, based on a high 1 year exposure rate such as military deployment, the maximum prevalence (steady state) was reached before 1 year suggesting high risk. Conclusions Although hypothetical in approach, based on conservative estimates in existing literature the contribution of gastroenteritis to the overall prevalence of IBS is substantial.

Lower and Upper Gastrointestinal Symptoms Differ Between Individuals With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation

Eric D Shah,Christopher V Almario,Brennan M R Spiegel,William D Chey 대한소화기 기능성질환∙운동학회 2018 Journal of Neurogastroenterology and Motility (JNM Vol.24 No.2

Background/Aims We evaluated the distribution of lower and upper gastrointestinal (GI) symptoms among individuals with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in a nationwide survey. Methods Individuals (≥ 18 years of age) were identified from a nationwide sample of > 70 000 United States adults. Participants completed the National Institutes of Health GI Patient Reported Outcomes Measurement Information System (NIH GI-PROMIS) questionnaire. Symptom frequency and intensity in the prior 7 days were assessed using validated PROMIS scores. Odds ratios (OR) with 95% confidence intervals (CI) were calculated to compare symptom prevalence in IBS-C vs CIC, and one-way ANOVA was used to assess differences in PROMIS scores. Regression analysis was performed to adjust for demographic variables. Results Nine hundred and seventy adults met eligibility criteria (275 with IBS-C, 734 with CIC). Demographics were similar among groups except for education, marital and employment status, and income. Adjusting for demographic differences, GI-PROMIS scores of global GI symptoms were higher in IBS-C (251.1; 95% CI, 230.0–273.1) compared to CIC (177.8; 95% CI 167.2–188.4) (P < 0.001). Abdominal pain was more prevalent (OR, 4.3; 95% CI, 2.9–6.6) and more severe (P = 0.007) in IBS-C. Constipation was more severe in IBS-C (P = 0.011). Incontinence was more common (OR, 2.9; 95% CI, 1.3–6.3) but just as severe (P = 0.389) in IBS-C versus CIC. Regarding upper GI symptoms, the prevalence of dysphagia, heartburn, and nausea were similar. However, IBS-C individuals had more severe heartburn (P = 0.001). Conclusion GI symptoms are generally more severe in IBS-C compared to CIC, however abdominal pain, bloating, and upper GI symptoms still commonly occur in CIC.

Immunomodulatory properties of stem cells and bioactive molecules for tissue engineering

Molina, Eric R.,Smith, Brandon T.,Shah, Sarita R.,Shin, Heungsoo,Mikos, Antonios G. Elsevier 2015 Journal of controlled release Vol.219 No.-

<P><B>Abstract</B></P> <P>The immune system plays a crucial role in the success of tissue engineering strategies. Failure to consider the interactions between implantable scaffolds, usually containing cells and/or bioactive molecules, and the immune system can result in rejection of the implant and devastating clinical consequences. However, recent research into mesenchymal stem cells, which are commonly used in many tissue engineering applications, indicates that they may play a beneficial role modulating the immune system. Likewise, direct delivery of bioactive molecules involved in the inflammatory process can promote the success of tissue engineering constructs. In this article, we will review the various mechanisms in which modulation of the immune system is achieved through delivered bioactive molecules and cells and contextualize this information for future strategies in tissue engineering.</P> <P><B>Graphical abstract</B></P> <P>[DISPLAY OMISSION]</P>

Treatment of Cerebral Vasospasm in an Infant Using a Modified Dotter Technique

Brian M. Snelling,Eric C. Peterson,Samir Sur,Sumedh S. Shah 대한뇌혈관외과학회 2017 Journal of Cerebrovascular and Endovascular Neuros Vol.19 No.1

An 8-month old female presented with spontaneous subarachnoid hemorrhage and was treated successfully with endovascular coil embolization of the ruptured aneurysm. Transcranial Doppler ultrasound performed four days later demonstrated middle cerebral artery (MCA) velocities greater than 350 cm/sec on the right and greater than 200 cm/sec on the left, despite medical management. The patient demonstrated no focal neurological deficits, though examination was limited by our patient's sedation and intubation. Angiography revealed severe vasospasm of the supraclinoid internal carotid and MCA territories, bilaterally. The vasospasm was refractory to the administration of intra-arterial verapamil. Balloon angioplasty was attempted, but the device could not be advanced safely due to the small size of the patient's vessels and the stiffness of the device. A microcatheter (0.0165'' diameter) was advanced over a J-shaped soft microwire (0.014'' diameter) to perform mechanical angioplasty in the internal carotid artery and MCA vessels bilaterally. Dramatic improvement was seen angiographically and on transcranial Doppler, and no complications were seen.

Home exercise program adherence strategies in vestibular rehabilitation: a systematic review

Gaikwad, Shilpa B.,Mukherjee, Tatri,Shah, Parita V.,Ambode, Oluwaseun I.,Johnsonb, Eric G.,Daher, Noha S. korean Academy of Physical Therapy Rehabilitation 2016 Physical therapy rehabilitation science Vol.5 No.2

Objective: The aim of this systematic review was to investigate for effective strategies to improve home exercise program (HEP) adherence in vestibular rehabilitation (VR). Design: Systematic review. Methods: A systematic review was conducted to identify effective strategies used to improve HEP adherence of patients in VR. Six databases, Academic Search Premier, Cochrane Library, CINAHL, PUBMED, PsycINFO, and Web of Science were searched from their inception to December 31, 2015. The keywords used for search were 'home program', 'home intervention', 'compliance', 'adherence', 'vestibular rehabilitation', 'motion sickness', and 'motion sensitivity'. Results: A total of eight studies were selected to be included in the review. There was 95.2% agreement between the two reviewers who reviewed the studies using a quality assessment tool. The overall inter-rater agreement (${\kappa}$=0.73) showed good agreement between the reviewers. Strong evidence was identified for 3 major categories of effective HEP adherence strategies, 1) providing patient with written summary of HEP; 2) asking patient to maintain a record of HEP and symptoms; and 3) providing tele-rehabilitation in form of email and/or telephone support along with in person treatment sessions. Also, based on strong evidence, computerized technology was not found to be superior to other strategies for improving patients' HEP adherence in VR. Conclusions: The effective strategies for improving HEP in VR include written summary of exercise, maintenance of log of HEP and symptoms and tele-rehabilitation along with in person treatment sessions.

Intraoperative aerosol box use: does an educational visual aid reduce contamination?

Burnett Garrett W.,Zhou George,Fried Eric A.,Shah Ronak S.,Park Chang,Katz Daniel 대한마취통증의학회 2021 Korean Journal of Anesthesiology Vol.74 No.2

Background: The aerosol box was rapidly developed and disseminated to minimize viral exposure during aerosolizing procedures during the COVID-19 pandemic, yet users may not understand how to use and clean the device. This could potentially lead to increased viral exposure to subsequent patients and practitioners. We evaluated intraoperative contamination and aerosol box decontamination and the impact of a preoperative educational visual aid. Methods: Using a double-blinded randomized design, forty-four anesthesiology trainees and faculty completed a simulated anesthetic case using an aerosol box contaminated with a fluorescent marker; half of the subjects received a visual aid prior to the simulation. Intraoperative contamination was evaluated at 10 standardized locations using an ultraviolet (UV) light. Next, subjects were instructed to clean the aerosol box for use on the next patient. Following cleaning, the box was evaluated for decontamination using an UV light. Results: Median total contamination score was significantly reduced in the experimental group (5.0 vs. 10.0, P < 0.001). The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (P = 0.009). Conclusions: The use of a visual aid significantly decreased intraoperative contamination and improved box cleaning. Despite these findings, a potentially clinically significant amount of viral exposure may exist. Thorough evaluation of the risks and benefits of the aerosol box should be completed prior to use. If an aerosol box is used, a visual aid should be considered to remind practitioners how to best use and clean the box.

Home exercise program adherence strategies in vestibular rehabilitation: a systematic review

( Shilpa Bgaikwad ),( Tatri Mukherjee ),( Parita V Shah ),( Oluwaseun I Ambode ),( Eric G Johnson ),( Noha S Daher ) 물리치료재활과학회 2016 Physical therapy rehabilitation science Vol.5 No.2

Objective: The aim of this systematic review was to investigate for effective strategies to improve home exercise program (HEP) adherence in vestibular rehabilitation (VR). Design: Systematic review. Methods: A systematic review was conducted to identify effective strategies used to improve HEP adherence of patients in VR. Six databases, Academic Search Premier, Cochrane Library, CINAHL, PUBMED, PsycINFO, and Web of Science were searched from their inception to December 31, 2015. The keywords used for search were `home program`, `home intervention`, `compliance`, `adherence`, `vestibular rehabilitation`, `motion sickness`, and `motion sensitivity`. Results: A total of eight studies were selected to be included in the review. There was 95.2% agreement between the two reviewers who reviewed the studies using a quality assessment tool. The overall inter-rater agreement (κ=0.73) showed good agreement between the reviewers. Strong evidence was identified for 3 major categories of effective HEP adherence strategies, 1) providing patient with written summary of HEP; 2) asking patient to maintain a record of HEP and symptoms; and 3) providing tele-rehabilitation in form of email and/or telephone support along with in person treatment sessions. Also, based on strong evidence, computerized technology was not found to be superior to other strategies for improving patients` HEP adherence in VR. Conclusions: The effective strategies for improving HEP in VR include written summary of exercise, maintenance of log of HEP and symptoms and tele-rehabilitation along with in person treatment sessions.

Relationships between erectile dysfunction, prostate cancer treatment type and inflatable penile prosthesis implantation

Chan Shen,Kunj Jain,Tejash Shah,Eric Schaefer,Shouhao Zhou,Dennis Fried,Drew A. Helmer,Hossein Sadeghi-Nejad 대한비뇨의학회 2022 Investigative and Clinical Urology Vol.63 No.3

Purpose: The prevalence of erectile dysfunction (ED) and the utilization of inflatable penile prosthesis (IPP) among prostate cancer patients are understudied. The aim of the study was to examine the relationships between ED, prostate cancer treatment type and IPP implantation in a national cohort. Materials and Methods: We identified a retrospective cohort of Surveillance, Epidemiology, and End Results (SEER)-Medicare patients diagnosed with locoregional prostate cancer between 2006 and 2011 and treated with surgery or radiation. Chi-square tests were used to detect significant differences in ED rates as well as use of IPP among the subset with ED. Multivariable logistic regression was used to examine factors associated with the use of IPP. Results: Among 31,233 patients in our cohort, 10,334 (33.1%) received prostatectomy and 20,899 (66.9%) received radiation. ED within 5 years was significantly more common in the prostatectomy group relative to those the radiation group (65.3% vs. 33.8%, p<0.001). In the subset of 13,812 patients with ED, the radiation group had greater median time to ED diagnosis compared to the prostatectomy group (346 vs. 133 days, p<0.001). IPP implantation was more frequent for prostatectomy patients than for radiation patients (3.6% vs. 1.4%, p<0.001). Cancer treatment type, race, and marital status were significantly associated with IPP utilization. Conclusions: ED is highly prevalent among prostate cancer patients, and IPP implantation is be underutilized. ED rates, time to ED diagnosis and utilization of IPP differed significantly by prostate cancer treatment type.