Foods provoking and alleviating symptoms in gastroparesis: patient experiences.

PubMed

Wytiaz, Victoria; Homko, Carol; Duffy, Frank; Schey, Ron; Parkman, Henry P

2015-04-01

Nutritional counseling for gastroparesis focuses on reduction of meal size, fiber, and fat to control symptoms. The tolerance of gastroparesis patients for particular foods is largely anecdotal. The aim of this study was to identify and characterize foods provoking or alleviating gastroparesis symptoms. Gastroparesis patients completed: (1) Demographic Questionnaire; (2) Patient Assessment of Upper GI Symptoms; (3) Food Toleration and Aversion survey asking patients about experiences when eating certain foods utilizing a scale from -3 (greatly worsening symptoms) to +3 (greatly improving symptoms). Descriptive qualities (acidic, fatty, spicy, roughage-based, bitter, salty, bland, and sweet) were assigned to foods. Forty-five gastroparesis patients participated (39 idiopathic gastroparesis). Foods worsening symptoms included: orange juice, fried chicken, cabbage, oranges, sausage, pizza, peppers, onions, tomato juice, lettuce, coffee, salsa, broccoli, bacon, and roast beef. Saltine crackers, jello, and graham crackers moderately improved symptoms. Twelve additional foods were tolerated by patients (not provoking symptoms): ginger ale, gluten-free foods, tea, sweet potatoes, pretzels, white fish, clear soup, salmon, potatoes, white rice, popsicles, and applesauce. Foods provoking symptoms were generally fatty, acidic, spicy, and roughage-based. The foods shown to be tolerable were generally bland, sweet, salty, and starchy. This study identified specific foods that worsen as well as foods that may help alleviate symptoms of gastroparesis. Foods that provoked symptoms differed in quality from foods that alleviated symptoms or were tolerable. The results of this study illustrate specific examples of foods that aggravate or improve symptoms and provide suggestions for a gastroparesis diet.

Gastroparesis Updates on Pathogenesis and Management

PubMed Central

Liu, Nanlong; Abell, Thomas

2017-01-01

Gastroparesis (Gp) is a chronic disease that presents with clinical symptoms of early satiety, bloating, nausea, vomiting, and abdominal pain. Along with these symptoms, an objective finding of delayed gastric emptying, along with a documented absence of gastric outlet obstruction, are required for diagnosis. This article focuses on updates in the pathogenesis and management of Gp. Recent studies on full thickness biopsies of Gp patients have shed light on the complex interactions of the central, autonomic, and enteric nervous systems, which all play key roles in maintaining normal gut motility. The management of Gp has evolved beyond prokinetics and antiemetics with the use of gastric electrical stimulators (GES). In addition, this review aims to introduce the concept of gastroparesis-like syndrome (GLS). GLS helps groups of patients who have the cardinal symptoms of Gp but have a normal or rapid emptying test. Recent tests have shown that patients with Gp and GLS have similar pathophysiology, benefit greatly from GES placement, and likely should be treated in a similar manner. PMID:28535580

Dietary intake and nutritional deficiencies in patients with diabetic or idiopathic gastroparesis.

PubMed

Parkman, Henry P; Yates, Katherine P; Hasler, William L; Nguyan, Linda; Pasricha, Pankaj J; Snape, William J; Farrugia, Gianrico; Calles, Jorge; Koch, Kenneth L; Abell, Thomas L; McCallum, Richard W; Petito, Dorothy; Parrish, Carol Rees; Duffy, Frank; Lee, Linda; Unalp-Arida, Aynur; Tonascia, James; Hamilton, Frank

2011-08-01

Gastroparesis can lead to food aversion, poor oral intake, and subsequent malnutrition. We characterized dietary intake and nutritional deficiencies in patients with diabetic and idiopathic gastroparesis. Patients with gastroparesis on oral intake (N = 305) were enrolled in the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Registry and completed diet questionnaires at 7 centers. Medical history, gastroparesis symptoms, answers to the Block Food Frequency Questionnaire, and gastric emptying scintigraphy results were analyzed. Caloric intake averaged 1168 ± 801 kcal/day, amounting to 58% ± 39% of daily total energy requirements (TER). A total of 194 patients (64%) reported caloric-deficient diets, defined as <60% of estimated TER. Only 5 patients (2%) followed a diet suggested for patients with gastroparesis. Deficiencies were present in several vitamins and minerals; patients with idiopathic disorders were more likely to have diets with estimated deficiencies in vitamins A, B(6), C, K, iron, potassium, and zinc than diabetic patients. Only one-third of patients were taking multivitamin supplements. More severe symptoms (bloating and constipation) were characteristic of patients who reported an energy-deficient diet. Overall, 32% of patients had nutritional consultation after the onset of gastroparesis; consultation was more likely among patients with longer duration of symptoms and more hospitalizations and patients with diabetes. Multivariable logistic regression analysis indicated that nutritional consultation increased the chances that daily TER were met (odds ratio, 1.51; P = .08). Many patients with gastroparesis have diets deficient in calories, vitamins, and minerals. Nutritional consultation is obtained infrequently but is suggested for dietary therapy and to address nutritional deficiencies. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Pyloric sphincter characteristics using EndoFLIP® in gastroparesis.

PubMed

Saadi, M; Yu, D; Malik, Z; Parkman, H P; Schey, R

2018-04-27

Pyloric sphincter abnormalities may be detected in gastroparesis. Botulinum toxin A (BoNT/A) injection into the pylorus has been used to treat gastroparesis with varying results. The aim of the present article was to assess whether pyloric sphincter characteristics using the endoscopic functional lumen imaging probe (EndoFLIP ® ) with impedance planimetry in patients with gastroparesis correlated with symptoms, gastric emptying, and therapeutic response to pyloric sphincter BoNT/A injection. EndoFLIP ® study was performed on patients undergoing gastroparesis treatment with BoNT/A. The gastroparesis cardinal symptom index (GCSI) was applied prior to treatment and at post-treatment weeks 2, 4, 8, and 12. Forty-four patients were enrolled (30 with idiopathic gastroparesis, 14 with diabetic gastroparesis). Smaller pyloric diameter, cross-sectional area (CSA), and distensibility correlated with worse vomiting and retching severity at baseline. Greater gastric retention tended to correlate with decreased CSA and pyloric distensibility. BoNT/A treatment resulted in a significant decrease in the GCSI score at 2 and 4 weeks after treatment, but not at post-treatment weeks 8 or 12. Nausea, early satiety, postprandial fullness, and upper abdominal pain improved up to 12 weeks, whereas loss of appetite, stomach fullness, and stomach visibly larger improved only up to 4 weeks. Retching and vomiting failed to improve. Greater pyloric compliance at baseline correlated with greater improvement in early satiety and náusea at 8 weeks and greater pyloric distensibility correlated with improvement in upper abdominal pain. EndoFLIP ® characteristics of the pylorus provided important pathophysiologic information in patients with gastroparesis, in relation to symptoms, gastric emptying, and predicting the response to treatment directed at the pylorus. Copyright © 2018 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Readability of Healthcare Literature for Gastroparesis and Evaluation of Medical Terminology in Reading Difficulty.

PubMed

Meillier, Andrew; Patel, Shyam

2017-02-01

Gastroparesis is a chronic condition that can be further enhanced with patient understanding. Patients' education resources on the Internet have become increasingly important in improving healthcare literacy. We evaluated the readability of online resources for gastroparesis and the influence by medical terminology. Google searches were performed for "gastroparesis", "gastroparesis patient education material" and "gastroparesis patient information". Following, all medical terminology was determined if included on Taber's Medical Dictionary 22nd Edition. The medical terminology was replaced independently with "help" and "helping". Web resources were analyzed with the Readability Studio Professional Edition (Oleander Solutions, Vandalia, OH) using 10 different readability scales. The average of the 26 patient education resources was 12.7 ± 1.8 grade levels. The edited "help" group had 6.6 ± 1.0 and "helping" group had 10.4 ± 2.1 reading levels. In comparing the three groups, the "help" and "helping" groups had significantly lower readability levels (P < 0.001). The "help" group was significantly less than the "helping" group (P < 0.001). The web resources for gastroparesis were higher than the recommended reading level by the American Medical Association. Medical terminology was shown to be the cause for this elevated readability level with all, but four resources within the recommended grade levels following word replacement.

Exploring Symptom Severity, Illness Perceptions, Coping Styles, and Well-Being in Gastroparesis Patients Using the Common Sense Model.

PubMed

Woodhouse, Sally; Hebbard, Geoff; Knowles, Simon R

2018-04-01

This study aimed to examine the relationships between gastroparesis symptom severity, illness perceptions, coping styles, quality of life (QoL), and psychological distress in patients with gastroparesis, guided by the common sense model. One hundred and seventy-nine adults with gastroparesis (165 females, 14 males; mean age 41.82 years) completed an online questionnaire. The Gastroparesis Cardinal Symptom Index was used to measure gastroparesis symptom severity, QoL was explored using the PAGI-QOL, illness perceptions were measured using the Brief Illness Perception Questionnaire, the Carver Brief COPE scale assessed coping styles, and psychological distress was investigated using the DASS21. Structural equation modeling resulted in a final model with excellent fit. Gastroparesis symptom severity directly influenced illness perceptions (β = .52, p < .001) and QoL (β = .30, p < .001). Illness perceptions directly influenced maladaptive coping (β = - .64, p < .001), psychological distress (β = - .32, p < .001), and QoL (β = .30, p = .01). Maladaptive coping directly influenced psychological distress (β = .62, p < .001), which in turn had a direct influence on QoL (β = - .38, p < .001). The final model showed that the influence of gastroparesis symptom severity on psychological distress was fully mediated by illness perceptions, while the influence on QoL was partially mediated by illness perceptions. The study provides guidance for the development of psychological interventions targeted toward improving mediating psychological factors.

Endoscopic botox injections in therapy of refractory gastroparesis

PubMed Central

Ukleja, Andrew; Tandon, Kanwarpreet; Shah, Kinchit; Alvarez, Alicia

2015-01-01

Gastroparesis (GP) is a common disease seen in gastroenterology practice particularly in western countries, and it may be underdiagnosed. The available drug therapies for this condition are quite disappointing. Botulinum toxin type A (BT) has been found to be effective therapy in various spastic disorders of smooth muscle of gastrointestinal tract. However, the benefits of BT injections in GP have been unclear. Several retrospective and open label studies have shown clinical advantages of intrapyloric Botulinum toxin type A injections, while two small randomized trials did not show positive results. Therefore, the available published studies yielded conflicting results leading to fading out of botox therapy for GP. We recognize possible clinical benefit of BT injections without any disadvantages of this treatment. We are calling for revisiting the endoscopy guided botox therapy in refractory GP. In this review we discuss important features of these studies pointing out differences in results among them. Differences in patient selection, doses and method of administration of botox toxin in the prior studies may be the cause of conflicting results. The mechanism of action, indications, efficacy and side-effects of BT are reviewed. Finally, we recognize limited evidence to recommend BT in GP and calling attention for future research in this field since no advances in drug management had been made in the last two decades. PMID:26191343

Diabetic gastroparesis-associated bezoar resolution via "cola-lysis".

PubMed

Whitson, Bryan A; Asolati, Massimo; Kandaswamy, Raja; Sutherland, David E R

2008-01-01

Phytobezoars associated with diabetic gastroparesis are often sources of diminished quality of life for patients. Poor blood sugar control has been associated with increasing gastroparesis. For recipients of pancreas transplants to correct diabetes, phytobezoar treatment post-transplant can typically be limited to invasive procedures and prokinetic agents. We present the case of an alternative treatment to phytobezoar, cola libation, i.e., "cola-lysis."

Itopride and pantoprazole outcomes in diabetic gastroparesis trial (IPOD trial).

PubMed

Venkatesh, Veena; Kulkarni, K P

2008-12-01

The most common cause of gastroparesis is diabetes mellitus. The present study was carried out to asses the combination of itopride and pantoprazole in the treatment of diabetic gastroparesis. The study was an open label, multicentre, conducted in 743 patients with diabetic gastroparesis for a period of 3 weeks. The efficacy parameters included nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and regurgitation. The patients were evaluated based on the frequency and severity of symptoms and compared with the baseline scores. There were significant improvement in severity as well as the frequency of all the symptom parameters of the disease (p<0.001). The physicians' evaluation to the therapy was rated either excellent or good.

Nausea, gastroparesis, and aerophagia.

PubMed

Hasler, William L

2005-01-01

Nausea, gastroparesis, and aerophagia are gastrointestinal phenomena that have variable impact on affected patients. The causes of nausea are varied; treatment of these conditions relates to the underlying etiology. Antiemetic agents acting on several distinct receptor subtypes produce benefits in distinct patient subsets. Gastroparesis is characterized by delays in gastric emptying, usually defined scintigraphically. Standard care of gastroparesis relies on dietary modification, antiemetic drug therapy, and initiation of medications that stimulate gastric motor activity. Recent advances include pyloric injection of botulinum toxin and surgical implantation of an electrical neurostimulator. Other surgical therapies are reserved for refractory cases. Aerophagia presents in individuals of normal and impaired cognitive function, most commonly with symptoms of overdistension or eructation. There are no pharmaceutical remedies for this condition; thus, therapy relies on behavioral treatments.

[The onset of physiological activity in the stomach in the postoperative period. A comparative study with a prokinetic preparation, Ganaton].

PubMed

Frasko, R; Maruna, P; Gürlich, R

2004-10-01

Postoperative gastroparesis decreases patient's postoperative comfort. The aim of this prospective study was to assess efficacy of the peroperatively administered prokinetic preparation Ganaton (Itopridi hydrochloridum, Abbott) on the postoperative gastroparesis. This prospective study was conducted in the Ist Surgical Clinic of the 1st Medical Faculty in Prague in 2001-2001. The total of 64 patients took part in this study. The patients underwent either a non-adjustable bandaging of the stomach via laparoscopy for a severe obesity, or a laparoscopic cholecystectomy. In the postoperative period, a subjective status of each patient, as well as objective examinations (auscultaion, gas excretion, stool excretion) and a percutaneous electrographic record were recorded. The patients after both the gastric bandaging and the laparoscopic cholecystectomy, demonstrated faster restoration of the physiological stomach contractions frequency in the group with itopride, compared with the placebo group. The prokinetic preparation was well tolerated and the authors did not record any undesirable side-effects. The preparation significantly speeded up restoration of the physiological stomach contractions frequency compared with the placebo group. Based on our results, its administration is a suitable part of the prophylaxis and treatment of the postoperative gastroparesis.

Upper Gastrointestinal Tract Motility Disorders in Women, Gastroparesis, and Gastroesophageal Reflux Disease.

PubMed

Zia, Jasmine K; Heitkemper, Margaret M

2016-06-01

This article reviews the sex differences in upper gastrointestinal (GI) motility for both healthy and common dysmotility conditions. It focuses on gastroesophageal reflux disease and other esophageal motor disorders for the esophagus and on gastroparesis and accelerated gastric emptying for the stomach. It also describes differences in upper GI motility signs and symptoms during each female hormonal stage (ie, menstrual cycle, pregnancy, perimenopause, menopause) for both healthy participants and those suffering from one of the aforementioned upper GI dysmotility conditions. More research still needs to be conducted to better understand sex differences in upper GI motility. Copyright © 2016 Elsevier Inc. All rights reserved.

Relating gastric scintigraphy and symptoms to motility capsule transit and pressure findings in suspected gastroparesis

PubMed Central

Hasler, W. L.; May, K. P.; Wilson, L. A.; Van Natta, M.; Parkman, H. P.; Pasricha, P. J.; Koch, K. L.; Abell, T. L.; McCallum, R. W.; Nguyen, L. A.; Snape, W. J.; Sarosiek, I.; Clarke, J. O.; Farrugia, G.; Calles-Escandon, J.; Grover, M.; Tonascia, J.; Lee, L. A.; Miriel, L.; Hamilton, F. A.

2018-01-01

Background Wireless motility capsule (WMC) findings are incompletely defined in suspected gastroparesis. We aimed to characterize regional WMC transit and contractility in relation to scintigraphy, etiology, and symptoms in patients undergoing gastric emptying testing. Methods A total of 209 patients with gastroparesis symptoms at NIDDK Gastroparesis Consortium centers underwent gastric scintigraphy and WMCs on separate days to measure regional transit and contractility. Validated questionnaires quantified symptoms. Key Results Solid scintigraphy and liquid scintigraphy were delayed in 68.8% and 34.8% of patients; WMC gastric emptying times (GET) were delayed in 40.3% and showed 52.8% agreement with scintigraphy; 15.5% and 33.5% had delayed small bowel (SBTT) and colon transit (CTT) times. Transit was delayed in ≥2 regions in 23.3%. Rapid transit was rarely observed. Diabetics had slower GET but more rapid SBTT versus idiopathics (P ≤ .02). GET delays related to greater scintigraphic retention, slower SBTT, and fewer gastric contractions (P ≤ .04). Overall gastroparesis symptoms and nausea/vomiting, early satiety/fullness, bloating/distention, and upper abdominal pain subscores showed no relation to WMC transit. Upper and lower abdominal pain scores (P ≤ .03) were greater with increased colon contractions. Constipation correlated with slower CTT and higher colon contractions (P = .03). Diarrhea scores were higher with delayed SBTT and CTT (P ≤ .04). Conclusions & Inferences Wireless motility capsules define gastric emptying delays similar but not identical to scintigraphy that are more severe in diabetics and relate to reduced gastric contractility. Extragastric transit delays occur in >40% with suspected gastroparesis. Gastroparesis symptoms show little association with WMC profiles, although lower symptoms relate to small bowel or colon abnormalities. PMID:28872760

[Gastroparesis and other gastrointestinal symptoms in Parkinson's disease].

PubMed

Santos-Garcia, D; de Deus, T; Tejera-Perez, C; Exposito-Ruiz, I; Suarez-Castro, E; Carpintero, P; Macias-Arribi, M

2015-09-16

Different gastrointestinal symptoms, such as excessive salivation, deterioration and other disorders affecting the teeth, dysphagia, gastroparesis, gastroesophageal reflux, constipation, difficult defecation or loss of weight are frequent events in all the stages of the development of Parkinson's disease and affect at least a third of the patients. These symptoms reflect the dysfunction of the enteric nervous system, and the stomach is one of the organs where alpha-synuclein is first deposited. Other factors, such as the dysfunction of structures in the central nervous system like the dorsal motor nucleus of the vagal nerve, hormonal factors or secondary effects deriving from the consumption of antiparkinsonian drugs, are involved in its origin. The present article offers a detailed review of the epidemiological, pathophysiological, clinical and therapeutic management aspects of the different gastrointestinal symptoms in Parkinson's disease.

Impaired insulin/IGF-1 is responsible for diabetic gastroparesis by damaging myenteric cholinergic neurones and interstitial cells of Cajal.

PubMed

Yang, Shu; Wu, Bo; Sun, Haimei; Sun, Tingyi; Han, Kai; Li, Dandan; Ji, Fengqing; Zhang, Guoquan; Zhou, Deshan

2017-10-31

Diabetic gastroparesis is a common complication of diabetes mellitus (DM) that is characterized by decreased serum insulin and insulin-like growth factor-1 (IGF-1). Despite the fact that insulin treatment not glycemic control potently accelerated gastric emptying in type 1 DM patients, the role of insulin/InsR and IGF-1/IGF-1R signaling in diabetic gastroparesis remains incompletely elucidated. In the present study, type 1 DM mice were established and treated with insulin or Voglibose for 8 weeks. The gastric emptying was delayed from DM week 4 when the gastric InsR and IGF-1R were declined. Meanwhile, the gastric choline acetyltransferase (ChAT) was significantly reduced and the myenteric cholinergic neurones and their fibers were significantly diminished. The production of stem cell factor (SCF) was dramatically repressed in the gastric smooth muscles in DM week 6. TWereafter, interstitial cells of Cajal (ICC) were clearly lost and their networks were impaired in DM week 8. Significantly, compared with Voglibose, an 8-week treatment with insulin more efficiently delayed diabetic gastroparesis development by protecting the myenteric cholinergic neurones and ICC. In conclusion, diabetic gastroparesis was an aggressive process due to the successive damages of myenteric cholinergic neurones and ICC by impairing the insulin/InsR and IGF-1/IGF-1R signaling. Insulin therapy in the early stage may delay diabetic gastroparesis. © 2017 The Author(s).

Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study

PubMed Central

Pasricha, Pankaj J.; Tonascia, James; Parkman, Henry P.; Hamilton, Frank; Herman, William H.; Basina, Marina; Buckingham, Bruce; Earle, Karen; Kirkeby, Kjersti; Hairston, Kristen; Bright, Tamis; Rothberg, Amy E.; Kraftson, Andrew T.; Siraj, Elias S.; Subauste, Angela; Lee, Linda A.; Abell, Thomas L.; McCallum, Richard W.; Sarosiek, Irene; Nguyen, Linda; Fass, Ronnie; Snape, William J.; Vaughn, Ivana A.; Miriel, Laura A.; Farrugia, Gianrico

2018-01-01

Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8% from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95% CI 0.85–1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9% to 1.8% (P<0.0001), time in euglycemia (70–180 mg/dL) increased from 44.0% to 52.0% (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2% to 7.0% (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4% to 8.3±1.3% (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P≤0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis. PMID:29652893

Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience.

PubMed

Malik, Zubair; Kataria, Rahul; Modayil, Rani; Ehrlich, Adam C; Schey, Ron; Parkman, Henry P; Stavropoulos, Stavros N

2018-02-22

Gastric per oral endoscopic myotomy (G-POEM) of the pylorus is a technique that is recently being used to treat gastroparesis. Our aim was to report our experience in performing G-POEM for refractory gastroparesis of different etiologies and determine symptom improvement. Thirteen patients undergoing G-POEM are reported. Pre- and post-procedure gastric emptying study (GES) and PAGI-SYM for symptom severity were obtained. Patients underwent G-POEM by creating a submucosal tunnel starting in the greater curvature of the distal antrum and extending it to the beginning of the duodenal bulb, followed by a full thickness pyloromyotomy. All 13 gastroparesis patients successfully underwent G-POEM (one diabetic [DGp], four idiopathic [IGp], eight postsurgical [PSGp]). Postsurgical patients included 4 s/p esophagectomy for esophageal cancer, 3 s/p Nissen fundoplication, and 1 s/p esophagectomy for achalasia. There were no procedure-related side effects. Of 11 patients completing follow-up questionnaires, eight were improved subjectively (four patients reported considerably better, four patients somewhat better, one unchanged, and two worse). Individual symptom severity scores tended to improve, particularly vomiting, retching, and loss of appetite. Of six patients that had post-G-POEM GES; GES improved in four, unchanged in one, and worsened in one). G-POEM for treatment of refractory gastroparesis appears to be a feasible and safe technique that can be successfully performed in patients with a variety of etiologies including different types of postsurgical gastroparesis. Our initial experience suggests that the majority of patients report some improvement in symptoms, particularly symptoms of vomiting, retching, and loss of appetite. Further experience is needed to determine the efficacy and safety of G-POEM and predict those who best respond to this treatment.

Some Non-FDA Approved Uses for Neuromodulation in Treating Autonomic Nervous System Disorders: A Discussion of the Preliminary Support.

PubMed

Lee, Samuel; Abd-Elsayed, Alaa

2016-12-01

Neuromodulation, including cavernous nerve stimulation, gastric electrical stimulation, deep brain stimulation, and vagus nerve stimulation, has been used with success in treating several functional disease conditions. The FDA has approved the use of neuromodulation for a few indications. We discuss in our review article the evidence of using neuromodulation for treating some important disorders involving the autonomic nervous system that are not currently FDA approved. This was a review article that included a systematic online web search for human clinical studies testing the efficacy of neuromodulation in treating erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure. Our review includes all feasibility studies, nonrandomized clinical trials, and randomized controlled trials. Our systematic literature search found 3, 4, 5, 4, 1, and 4 clinical studies relating to erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure, respectively. This review article shows preliminary support based on clinical studies that neuromodulation can be of benefit for patients with important autonomic nervous system disease conditions that are not currently approved by the FDA. All of these investigational uses are encouraging; further studies are necessary and warranted for all indications discussed in this review before achieving FDA approval. © 2016 International Neuromodulation Society.

Impaired contractile responses and altered expression and phosphorylation of Ca2+ sensitization proteins in gastric antrum smooth muscles from ob/ob mice

PubMed Central

Bhetwal, Bhupal P.; An, Changlong; Baker, Salah A.; Lyon, Kristin L.

2013-01-01

Diabetic gastroparesis is a common complication of diabetes, adversely affecting quality of life with symptoms of abdominal discomfort, nausea, and vomiting. The pathogenesis of this complex disorder is not well understood, involving abnormalities in the extrinsic and enteric nervous systems, interstitial cells of Cajal (ICCs), smooth muscles and immune cells. The ob/ob mouse model of obesity and diabetes develops delayed gastric emptying, providing an animal model for investigating how gastric smooth muscle dysfunction contributes to the pathophysiology of diabetic gastroparesis. Although ROCK2, MYPT1, and CPI-17 activities are reduced in intestinal motility disorders, their functioning has not been investigated in diabetic gastroparesis. We hypothesized that reduced expression and phosphorylation of the myosin light chain phosphatase (MLCP) inhibitory proteins MYPT1 and CPI-17 in ob/ob gastric antrum smooth muscles could contribute to the impaired antrum smooth muscle function of diabetic gastroparesis. Spontaneous and carbachol- and high K+-evoked contractions of gastric antrum smooth muscles from 7 to 12 week old male ob/ob mice were reduced compared to age- and strain-matched controls. There were no differences in spontaneous and agonist-evoked intracellular Ca2+ transients and myosin light chain kinase expression. The F-actin:G-actin ratios were similar. Rho kinase 2 (ROCK2) expression was decreased at both ages. Basal and agonist-evoked MYPT1 and myosin light chain 20 phosphorylation, but not CPI-17 phosphorylation, was reduced compared to age-matched controls. These findings suggest that reduced MLCP inhibition due to decreased ROCK2 phosphorylation of MYPT1 in gastric antrum smooth muscles contributes to the antral dysmotility of diabetic gastroparesis. PMID:23576331

Stomach Dysfunction in Diabetes Mellitus: Emerging Technology and Pharmacology

PubMed Central

Szarka, Lawrence A.; Camilleri, Michael

2010-01-01

Gastroparesis and other types of gastric dysfunction result in substantial morbidity in diabetes patients. The pathophysiology of these disorders is incompletely understood. This article reviews techniques applicable to the assessment of gastric function in diabetes patients, including the measurement of emptying, accommodation, and contractility. Available treatment options are also reviewed, including novel yet unapproved serotonin 5-HT4 agonist pharmacological treatments, as well as the role of endoscopic, surgical, and device treatments of gastroparesis. PMID:20167183

Post-pyloric feeding

PubMed Central

Niv, Eva; Fireman, Zvi; Vaisman, Nachum

2009-01-01

Postpyloric feeding is an important and promising alternative to parenteral nutrition. The indications for this kind of feeding are increasing and include a variety of clinical conditions, such as gastroparesis, acute pancreatitis, gastric outlet stenosis, hyperemesis (including gravida), recurrent aspiration, tracheoesophageal fistula and stenosis in gastroenterostomy. This review discusses the differences between pre- and postpyloric feeding, indications and contraindications, advantages and disadvantages, and provides an overview of the techniques of placement of various postpyloric devices. PMID:19294757

Gut dysfunction in Parkinson's disease

PubMed Central

Mukherjee, Adreesh; Biswas, Atanu; Das, Shyamal Kumar

2016-01-01

Early involvement of gut is observed in Parkinson’s disease (PD) and symptoms such as constipation may precede motor symptoms. α-Synuclein pathology is extensively evident in the gut and appears to follow a rostrocaudal gradient. The gut may act as the starting point of PD pathology with spread toward the central nervous system. This spread of the synuclein pathology raises the possibility of prion-like propagation in PD pathogenesis. Recently, the role of gut microbiota in PD pathogenesis has received attention and some phenotypic correlation has also been shown. The extensive involvement of the gut in PD even in its early stages has led to the evaluation of enteric α-synuclein as a possible biomarker of early PD. The clinical manifestations of gastrointestinal dysfunction in PD include malnutrition, oral and dental disorders, sialorrhea, dysphagia, gastroparesis, constipation, and defecatory dysfunction. These conditions are quite distressing for the patients and require relevant investigations and adequate management. Treatment usually involves both pharmacological and non-pharmacological measures. One important aspect of gut dysfunction is its contribution to the clinical fluctuations in PD. Dysphagia and gastroparesis lead to inadequate absorption of oral anti-PD medications. These lead to response fluctuations, particularly delayed-on and no-on, and there is significant relationship between levodopa pharmacokinetics and gastric emptying in patients with PD. Therefore, in such cases, alternative routes of administration or drug delivery systems may be required. PMID:27433087

Diabetic and Nondiabetic Gastroparesis.

PubMed

McCallum; Brown

1998-12-01

Nutritional support is essential in treating patients with gastroparesis. Initially, dietary changes should be instituted to reduce extra fat and bulk, and patients should be encouraged to eat frequent small meals with liquid supplementation. Enteral feeding should be introduced in the event of weight loss or persistent vomiting. Medical therapy is usually necessary early in treatment. Cisapride is the initial agent of choice and may be combined with an antiemetic agent, such as promethazine or chlorpromazine or, if side effects occur, ondansetron and granesitron. If cisapride is ineffective or contraindicated, metoclopramide is a reasonable option, though limited by side effects. Erythromycin is useful in the acute treatment of postoperative ileus and hospitalized gastroparetic patients, but its role is limited based on concerns about poor long-term effectiveness and antimicrobial resistance. Once domperidone becomes available in the United States, it will be useful for its promotility and antiemetic qualities. Combination therapy should be considered if monotherapy with cisapride or metoclopramide alone is ineffective. While not yet well studied, combination therapy has the potential to offer dramatic benefit for patients with refractory gastroparesis. Metoclopramide may be added to cisapride for patients with breakthrough symptoms or refractory chronic symptoms. Other combinations include metoclopramide with erythromycin, domperidone with cisapride, and domperidone with erythromycin. In the future, gastric pacing may become an effective option for patients not responding to medical therapy. Total gastrectomy should be performed only for end-stage gastroparesis when all other therapy has failed. Both procedures should be reserved for centers that specialize in severe gastric motility disorders.

Randomized Controlled Double-blind Trial Comparing Haloperidol Combined With Conventional Therapy to Conventional Therapy Alone in Patients With Symptomatic Gastroparesis.

PubMed

Roldan, Carlos J; Chambers, Kimberly A; Paniagua, Linda; Patel, Sonali; Cardenas-Turanzas, Marylou; Chathampally, Yashwant

2017-11-01

Gastroparesis is a debilitating condition that causes nausea, vomiting, and abdominal pain. Management includes analgesics and antiemetics, but symptoms are often refractory. Haloperidol has been utilized in the palliative care setting for similar symptoms. The study objective was to determine whether haloperidol as an adjunct to conventional therapy would improve symptoms in gastroparesis patients presenting to the emergency department (ED). This was a randomized, double-blind, placebo-controlled trial of adult ED patients with acute exacerbation of previously diagnosed gastroparesis. The treatment group received 5 mg of haloperidol plus conventional therapy (determined by the treating physician). The control group received a placebo plus conventional therapy. The severity of each subject's abdominal pain and nausea were assessed before intervention and every 15 minutes thereafter for 1 hour using a 10-point scale for pain and a 5-point scale for nausea. Primary outcomes were decreased pain and nausea 1 hour after treatment. Of the 33 study patients, 15 were randomized to receive haloperidol. Before treatment, the mean intensity of pain was 8.5 in the haloperidol group and 8.28 in the placebo group; mean pretreatment nausea scores were 4.53 and 4.11, respectively. One hour after therapy, the mean pain and nausea scores in the haloperidol group were 3.13 and 1.83 compared to 7.17 and 3.39 in the placebo group. The reduction in mean pain intensity therapy was 5.37 in the haloperidol group (p ≤ 0.001) compared to 1.11 in the placebo group (p = 0.11). The reduction in mean nausea score was 2.70 in the haloperidol group (p ≤ 0.001) and 0.72 in the placebo group (p = 0.05). Therefore, the reductions in symptom scores were statistically significant in the haloperidol group but not in the placebo group. No adverse events were reported. Haloperidol as an adjunctive therapy is superior to placebo for acute gastroparesis symptoms. © 2017 by the Society for Academic Emergency Medicine.

A gluten-free vegan meal for gastric emptying scintigraphy: establishment of reference values and its utilization in the evaluation of diabetic gastroparesis.

PubMed

Somasundaram, Vijay Harish; Subramanyam, Padma; Palaniswamy, Shanmuga Sundaram

2014-11-01

The aim of this study was to describe the preparation of radiolabeled idli (savory cake) meal for use as an alternate to the egg white sandwich (EWS) meal in gastric emptying scintigraphy (GES). Furthermore, the aim of this study was to establish normal emptying rates for this meal and present our experience in using it in the evaluation of diabetic gastroparesis. The meal was prepared using a universally available packaged mix labeled with 1 mCi 99mTc sulfur colloid, and the stability of labeling was tested up to 4 hours in simulated gastric fluid. One hundred thirteen healthy volunteers (aged 20-78 years; 54 women, 59 men) underwent GES study using the idli meal. Gastric retention at one-half, 1, 2, and 4 hours after ingestion of the meal was estimated, and the normal limits were set using the fifth and 95th percentile values at each period. Having established its normal emptying rates, the idli meal was further used to evaluate 70 patients suspected with diabetic gastroparesis. The idli meal, with a calorific value ≈282 kcal, has a relatively higher fat content (8% of total mass) than EWS. More than 96% of 99mTc sulfur colloid remained bound to the meal after 4 hours suspension in simulated gastric fluid. Gastric retention greater than 30% and greater than 6% at 2 hours and 4 hours, respectively, indicated delayed gastric emptying, whereas retention less than 30% at 1 hour suggested rapid emptying. Among patients suspected with diabetic gastroparesis, delayed gastric emptying was identified in 76%, and rapid emptying was seen in 4.2%. Radiolabeled idli meal is a good alternative to EWS meal for routine GES, especially among patients with specific dietary restrictions.

Novel Soy Germ Pasta Enriched in Isoflavones Ameliorates Gastroparesis in Type 2 Diabetes

PubMed Central

Setchell, Kenneth D.R.; Nardi, Elisabetta; Battezzati, Pier-Maria; Asciutti, Stefania; Castellani, Danilo; Perriello, Gabriele; Clerici, Carlo

2013-01-01

OBJECTIVE To determine the effect of soy germ pasta enriched in biologically active isoflavone aglycons on gastric emptying in type 2 diabetic patients with gastroparesis. RESEARCH DESIGN AND METHODS This randomized double-blind, placebo-controlled study compared soy germ pasta with conventional pasta for effects on gastric emptying. Patients (n = 10) with delayed gastric emptying consumed one serving per day of each pasta for 8 weeks, with a 4-week washout. Gastric emptying time (t1/2) was measured using the [13C]octanoic acid breath test at baseline and after each period, and blood glucose and insulin concentrations were determined after oral glucose load. RESULTS Soy germ pasta significantly accelerated the t1/2 in these patients (161.2 ± 17.5 min at baseline vs. 112.6 ± 11.2 min after treatment, P = 0.009). Such change differed significantly (P = 0.009) from that for conventional pasta (153.6 ± 24.2 vs. 156.2 ± 27.4 min), without affecting glucose or insulin concentrations. CONCLUSIONS These findings suggest that soy germ pasta may offer a simple dietary approach to managing diabetic gastropathy. PMID:23835688

[Influence on glycemic control of improved diabetic gastroparesis by long-term cisapride therapy].

PubMed

Ishii, K; Tanabe, S; Mitsuhashi, T; Saigenji, K

1995-10-01

To investigate the effect on glycemic control of improving diabetic gastroparesis, we evaluated symptoms (scored), gastric motor functions (solid and liquid gastric emptying studies and electrogastrography), and glycemic control in 11 patients with diabetic gastroparesis (5 men, 6 women, 50.4 +/- 4.5 years old) before and after treatment with cisapride (15 mg/day p.o., 12 weeks). None of the patients had organic abnormalities on gastrointestinal endoscopy. The dysmotility symptom score (maximum: 18) on cisapride significantly improved from 13.1 to 4.0 (p < 0.01). Retention rates at 15 and 80 minutes after ingestion improved in a solid-food gastric emptying study using a test meal of instant noodles labeled with 37 MBq (1 mCi) technetium-99m (both p < 0.05). Liquid gastric emptying, evaluated using a sulfamethizole technique, also improved but not significantly. Electrogastrography revealed no significant changes after treatment, but the postprandial rate of normal frequency waves tended to increase. Glycemic control was assessed based on HbA1C, fructosamine and M value. There were no significant changes in glycemic control after treatment with cisapride. We conclude that long-term administration of cisapride reduced dysmotility symptoms and improved solid and liquid gastric emptying without adversely affecting glycemic control.

Gastroparesis

MedlinePlus

... hours the contractile responses while the subject is fasting and eating are observed and recorded. The manometry ... Hepatitis C Inflammatory Bowel Disease Irritable Bowel Syndrome Obesity Digestive Health Topics Abdominal Pain Syndrome Belching, Bloating, ...

Liraglutide Injection

MedlinePlus

... called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when ... suicide, changes in behavior, pancreatitis (inflammation of the pancreas); severe stomach problems, including gastroparesis (slowed movement of ...

Dulaglutide Injection

MedlinePlus

... called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when ... or have ever had pancreatitis (inflammation of the pancreas); severe stomach problems, including gastroparesis (slowed movement of ...

Albiglutide Injection

MedlinePlus

... called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when ... or have ever had pancreatitis (inflammation of the pancreas); severe stomach problems, including gastroparesis (slowed movement of ...

Quality of life and symptomatic response to gastric neurostimulation for gastroparesis.

PubMed

Velanovich, Vic

2008-10-01

Gastroparesis can be a difficult problem with patients suffering from nausea, vomiting, bloating, and pain intractable to medical management. Gastric neurostimulation has been developed as an adjunctive treatment for patients with diabetic and idiopathic gastroparesis unresponsive to pharmacologic and dietary treatment. The purpose of this study is to report symptomatic and quality-of-life response to gastric neurostimulation. This study was approved by the institutional review board, and patients had informed consent. The gastric neurostimulation device (Enterra therapy, Medtronic, Inc., Minneapolis, MN, USA) is approved by the Food and Drug Administration under the Humanitarian Device Exemption. Candidates for placement were patients with either idiopathic or diabetic gastroparesis who had symptomatic failure to dietary changes and to prokinetic and antiemetic drugs. Before placement, the patients' symptoms were recorded, and patients completed the Gastrointestinal Symptom Rating Scale (GSRS, three domains: dyspeptic syndrome, indigestion syndrome, and bowel dysfunction syndrome) and the Short Form-36 (SF-36, eight domains: physical functioning, role-physical, role-emotional, bodily pain, vitality, mental health, social functioning, general health, plus a health transition item). The device was surgically placed using a hybrid laparoscopic/open technique. Patients were followed and adjustments made on the device until satisfactory symptom control was achieved. At that time, patients completed both the GSRS and SF-36, and comparisons were made to preoperative values. Forty-two patients had the device placed, 29 women, aged 41 (SD +14) years, 24 diabetic patients, 17 idiopathic patients, one postgastrectomy patient. Median follow-up was 12 months (range 1-42 months). There was a 2% immediate postoperative morbidity rate and 7% long-term morbidity rate (device extrusion). Thirty-one patients (74%) responded to gastric neurostimulation of variable degrees. Eleven patients had no response or had worsening symptoms. Of the patients who responded, there were statistically significant improvements in all three domains of the GSRS. Median scores (with interquartile ranges): dyspeptic syndrome, 9 (7-11.5) to 4 (2.5-6), p = 0.02; indigestion syndrome, 5 (2-7) to 4 (0-5), p = 0.05; bowel dysfunction syndrome, 3 (2-3) to 1 (0-1), p = 0.01. In the SF-36, there were statistically significant improvement in the health transition item, 4 (4-5) to 1.5 (1-3), p = 0.01; and social functioning domain, 25 (12.5-62.5) to 75 (50-87.5), p = 0.03. Three quarters of gastroparesis patients responded to gastric neurostimulation to variable degrees. Gastrointestinal-specific symptoms are improved in responders. Patients felt that there health and social functioning (SF) improved, although there was no significant difference in the other domains. These results are encouraging considering that these patients had intractable symptoms with no other effective treatments available.

Find a Gastroenterologist

MedlinePlus

... Province Select Country Zip/Postal Code Sort By GI Health Centers Colorectal Cancer Hepatitis C Inflammatory Bowel ... GI Symptoms Gastroparesis See All Topics (A-Z) GI Procedures Colonoscopy Colorectal Cancer Screening See All Procedures ( ...

Gastroparesis

MedlinePlus

... emptying study (using isotope labeling) Upper GI series Treatment People with diabetes should always control their blood sugar levels. Better ... digestive tract more easily (gastroenterostomy) Outlook (Prognosis) ... imbalances Malnutrition People with diabetes may have serious complications from poor blood sugar ...

Functional aerophagia in children: a frequent, atypical disorder.

PubMed

Morabito, Giuliana; Romeo, Claudia; Romano, Claudio

2014-01-01

Aerophagia is a functional gastrointestinal disorder characterized by repetitive air swallowing, abdominal distension, belching and flatulence. Pathologic aerophagia is a condition caused by the swallowing of excessive volumes of air with associated various gastrointestinal symptoms, such as burping, abdominal cramps, flatulence and a reduced appetite. It is a clinical entity that can simulate pediatric gastrointestinal motility disorders, such as gastroparesis, megacolon and intestinal pseudo-obstruction, and presents more frequently in children with mental retardation. Early recognition and diagnosis of functional aerophagia or pathologic aerophagia is required to avoid unnecessary, expensive diagnostic investigations or serious clinical complications. Functional aerophagia is frequent in the adult population, but rarely discussed in the pediatric literature. We present two pediatric clinical cases with a history of functional constipation in whom gaseous abdominal distension was the most important symptom. Mechanical intestinal obstruction, chronic intestinal pseudo-obstruction, malabsorption and congenital aganglionic megacolon were ruled out. Extensive gaseous abdominal distension was due to aerophagia, and treatment consisted of parents' reassurance and psychological counseling.

Functional Aerophagia in Children: A Frequent, Atypical Disorder

PubMed Central

Morabito, Giuliana; Romeo, Claudia; Romano, Claudio

2014-01-01

Aerophagia is a functional gastrointestinal disorder characterized by repetitive air swallowing, abdominal distension, belching and flatulence. Pathologic aerophagia is a condition caused by the swallowing of excessive volumes of air with associated various gastrointestinal symptoms, such as burping, abdominal cramps, flatulence and a reduced appetite. It is a clinical entity that can simulate pediatric gastrointestinal motility disorders, such as gastroparesis, megacolon and intestinal pseudo-obstruction, and presents more frequently in children with mental retardation. Early recognition and diagnosis of functional aerophagia or pathologic aerophagia is required to avoid unnecessary, expensive diagnostic investigations or serious clinical complications. Functional aerophagia is frequent in the adult population, but rarely discussed in the pediatric literature. We present two pediatric clinical cases with a history of functional constipation in whom gaseous abdominal distension was the most important symptom. Mechanical intestinal obstruction, chronic intestinal pseudo-obstruction, malabsorption and congenital aganglionic megacolon were ruled out. Extensive gaseous abdominal distension was due to aerophagia, and treatment consisted of parents’ reassurance and psychological counseling. PMID:24847194

Acid and non-acid reflux in patients refractory to proton pump inhibitor therapy: is gastroparesis a factor?

PubMed

Tavakkoli, Anna; Sayed, Bisma A; Talley, Nicholas J; Moshiree, Baharak

2013-10-07

To determine whether an increased number and duration of non-acid reflux events as measured using the multichannel intraluminal impedance pH (MII-pH) is linked to gastroparesis (GP). A case control study was conducted in which 42 patients undergoing clinical evaluation for continued symptoms of gastroesophageal reflux disease (both typical and atypical symptoms) despite acid suppression therapy. MII-pH technology was used over 24 h to detect reflux episodes and record patients' symptoms. Parameters evaluated in patients with documented GP and controls without GP by scintigraphy included total, upright, and supine number of acid and non-acid reflux episodes (pH < 4 and pH > 4, respectively), the duration of acid and non-acid reflux in a 24-h period, and the number of reflux episodes lasting longer than 5 min. No statistical difference was seen between the patients with GP and controls with respect to the total number or duration of acid reflux events, total number and duration of non-acid reflux events or the duration of longest reflux episodes. The number of non-acid reflux episodes with a pH > 7 was higher in subjects with GP than in controls. In addition, acid reflux episodes were more prolonged (lasting longer than 5 min) in the GP patients than in controls; however, these values did not reach statistical significance. Thirty-five patients had recorded symptoms during the 24 h study and of the 35 subjects, only 9% (n = 3) had a positive symptom association probability (SAP) for acid/non-acid reflux and 91% had a negative SAP. The evaluation of patients with a documented history of GP did not show an association between GP and more frequent episodes of non-acid reflux based on MII-pH testing.

Pilot cohort study of endoscopic botulinum neurotoxin injection in Parkinson's disease.

PubMed

Triadafilopoulos, George; Gandhy, Rita; Barlow, Carrolee

2017-11-01

Gastrointestinal symptoms, such as dysphagia, postprandial bloating, and defecatory straining are common in Parkinson's Disease (PD) and they impact quality of life. Endoscopic botulinum neurotoxin (BoNT) injection has been used in the treatment of dysphagia, gastroparesis and chronic anismus. To examine the feasibility, safety and efficacy of endoscopically delivered BoNT injection to distal esophagus, pylorus or anal canal aiming at relieving regional gastrointestinal symptoms in patients with PD. This is a retrospective open cohort pilot study to assess the clinical response to endoscopic BoNT injection on selected PD patients with symptoms and identifiable abnormalities on high-resolution manometry and wireless motility capsule, to generate early uncontrolled data on feasibility, tolerability, safety and efficacy. Baseline symptoms and response to therapy were assessed by questionnaires. Fourteen PD patients (10 M:4 F), mean age 73 (range: 62-93) were treated. Three patients had esophageal Botox for ineffective esophageal motility (IEM) (n = 1), esophago-gastric junction outlet obstruction (EGJOO) & IEM (n = 1), and diffuse esophageal spasm (DES) (n = 1). Nine patients were treated with pyloric BoNT injection for gastroparesis with mean gastric transit time of 21.2 h; range 5.2-44.2 h. Two patients received anal Botox for defecatory dyssynergia ((Type I) (n = 1) and overlap (slow-transit and dyssynergic) constipation (n = 1). Endoscopic BoNT injection (100-200 units) was well tolerated and there were no significant adverse events. Endoscopic BoNT injection to esophagus, pylorus or anal canal is safe, well-tolerated and leads to symptomatic improvement that lasts up to several months. The procedure can be repeated as needed and combined with other therapies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Relationship of gastrointestinal symptoms and psychosocial distress to gastric retention in children

USDA-ARS?s Scientific Manuscript database

Our objective was to determine whether gastrointestinal (GI) symptoms (abdominal pain, non-pain GI symptoms, nausea) and/or psychosocial distress differ between children with/without gastroparesis and whether the severity of GI symptoms and/or psychosocial distress is related to the degree of gastro...

[The use of prokinetics for the correction of motor and tonic digestive disorders].

PubMed

Maev, I V; Samsonov, A A; Karmanova, E A; Ivanchenko, E A

2009-01-01

Abnormal tonic-motor activity is a key component in pathogenesis of many digestive disorders. Secondary disturbance of tonic-motor activity of digestive organs and the accompanying symptoms are known to develop in conjunction with diseases of other organs and systems, diabetes mellitus, Parkinson's disease, myotonic muscular dystrophy, amyloidosis, hyper- and hypothyroidism, hypoparathyroidism, etc. Disturbed motor activity in the gastro-duodenal region most frequently underlies functional dyspepsia, i.e. a group of symptoms unrelated to organic, systemic and metabolic diseases. Prokinetics are an important class of medicinal products for the treatment of all clinical forms of dyspepsia. One of the new ones is itopride hdrochloride having combined mechanism of action. Clinical studies of this drug revealed its high efficiency in patients with functional dyspepsia, chronic gastritis, and diabetic gastroparesis. It is well tolerated by the patients and produces no serious side effects. Inclusion of this drug in therapy improves the outcome of the treatment of disturbed motor activity of the gastrointestinal tract.

Gastric emptying scintigraphy results in children are affected by age, anthropometric factors, and study duration

USDA-ARS?s Scientific Manuscript database

A standardized 4-hour adult-based gastric emptying scintigraphy (GES) protocol is increasingly being used in children to evaluate for gastroparesis. We sought to determine the effect of age, anthropometrics, and study duration on GES results using this protocol in children. Retrospective review of c...

Novel soy germ pasta enriched in isoflavones ameliorates gastroparesis in type 2 diabetes: a pilot study.

PubMed

Setchell, Kenneth D R; Nardi, Elisabetta; Battezzati, Pier-Maria; Asciutti, Stefania; Castellani, Danilo; Perriello, Gabriele; Clerici, Carlo

2013-11-01

To determine the effect of soy germ pasta enriched in biologically active isoflavone aglycons on gastric emptying in type 2 diabetic patients with gastroparesis. This randomized double-blind, placebo-controlled study compared soy germ pasta with conventional pasta for effects on gastric emptying. Patients (n = 10) with delayed gastric emptying consumed one serving per day of each pasta for 8 weeks, with a 4-week washout. Gastric emptying time (t1/2) was measured using the [(13)C]octanoic acid breath test at baseline and after each period, and blood glucose and insulin concentrations were determined after oral glucose load. Soy germ pasta significantly accelerated the t1/2 in these patients (161.2 ± 17.5 min at baseline vs. 112.6 ± 11.2 min after treatment, P = 0.009). Such change differed significantly (P = 0.009) from that for conventional pasta (153.6 ± 24.2 vs. 156.2 ± 27.4 min), without affecting glucose or insulin concentrations. These findings suggest that soy germ pasta may offer a simple dietary approach to managing diabetic gastropathy.

Impaired fasting pyloric compliance in gastroparesis and the therapeutic response to pyloric dilatation.

PubMed

Gourcerol, G; Tissier, F; Melchior, C; Touchais, J Y; Huet, E; Prevost, G; Leroi, A M; Ducrotte, P

2015-02-01

Pyloric pressure and compliance have never been investigated in health nor gastroparesis. We hypothesised that pyloric pressure and/or compliance may be altered in gastroparesis. Fasting pyloric pressure and compliance were investigated in 21 healthy volunteers (HV), 27 gastroparetic patients (GP) and 5 patients who had undergone oesophagectomy without pyloroplasty as positive controls. Under videofluoroscopic control, pyloric compliance and pressure were measured by the EndoFLIP technique. Gastric emptying half time (T1/2 ) using (13) C-octanoic acid breath test, as well as symptoms and quality of life (GIQLI score) were also monitored. Mean fasting pyloric compliance was measured at 25.2 ± 2.4 mm²/mmHg in HV, and was lower both in GP (16.9 ± 2.1 mm²/mmHg; P < 0.05) and patients with oesophagectomy (10.9 ± 2.9 mm²/mmHg; P < 0.05). By contrast, fasting pyloric pressure was not different among groups. Fasting pyloric compliance and pressure correlated with T1/2 in GP (R = -0.43; P = 0.04). Fasting pyloric compliance, but not pressure, correlated with symptoms and GIQLI score. Pyloric dilation in 10 GP with low fasting pyloric compliance (<10 mm²/mmHg) increased compliance from 7.4 ± 0.4 to 20.1 ± 4.9 mm²/mmHg (P < 0.01) and improved the GIQLI score from 72.5 ± 5.5 to 89.3 ± 6.1 (P = 0.04). This prospective study assessed pyloric compliance for the first time, and showed that fasting pyloric compliance is decreased in gastroparetic patients and is associated with T1/2 , symptoms and quality of life. This suggests that pyloric compliance may be a new relevant metric in gastroparetic patients, and may be useful to target patients for pyloric dilation or botulinum toxin injection. © 2014 John Wiley & Sons Ltd.

5-Amino-6-chloro-N-[(1-isobutylpiperidin-4-yl)methyl]-2-methylimidazo[1,2-alpha]pyridine-8-carboxamide (CJ-033,466), a novel and selective 5-hydroxytryptamine4 receptor partial agonist: pharmacological profile in vitro and gastroprokinetic effect in conscious dogs.

PubMed

Mikami, Tadayoshi; Ochi, Yasuo; Suzuki, Keiko; Saito, Toshiyuki; Sugie, Yutaka; Sakakibara, Minoru

2008-04-01

5-Hydroxytryptamine (5-HT) receptors and dopamine(2) (D(2)) receptor modulate gastrointestinal motility. Gastroprokinetic agents that act on several 5-HT receptor subtypes and/or D(2) receptors are used clinically. Although the 5-HT(4) receptor is known to mediate the gastroprokinetic effects of these agents, the absence of highly selective 5-HT(4) receptor agonists has made it difficult to confirm the physiological consequences of selective 5-HT(4) receptor stimulation. In this study, we report the in vitro pharmacological profiles and the in vivo gastroprokinetic effects of 5-amino-6-chloro-N-[(1-isobutylpiperidin-4-yl)methyl]-2-methylimidazo[1,2-alpha]pyridine-8-carboxamide (CJ-033,466), a novel, potent, and selective 5-HT(4) partial agonist. Compared with preceding 5-HT(4) agonists such as cisapride, mosapride, and tegaserod, CJ-033,466 had a superior in vitro profile, with nanomolar agonistic activities for the 5-HT(4) receptor and 1000-fold greater selectivity for the 5-HT(4) receptor over other 5-HT and D(2) receptors. In vivo studies in conscious dogs showed that CJ-033,466 dose-dependently stimulated gastric antral motility in both the fasted and postprandial states at the same dose range and that it was 30 times more potent than cisapride. Furthermore, CJ-033,466 accelerated the gastric emptying rate in a gastroparesis dog model at the minimally effective dose established in the gastric motility study. In conclusion, CJ-033,466 is a potent and highly selective 5-HT(4) agonist that stimulates physiologically coordinated gastric motility, and it has no activity on other 5-HT receptor subtypes and D(2) receptors. Therefore, CJ-033,466 could be used to treat gastroparesis, providing better gastroprokinetics and reduced side effects mediated by the other receptors.

Imaging acetylcholinesterase density in peripheral organs in Parkinson's disease with 11C-donepezil PET.

PubMed

Gjerløff, Trine; Fedorova, Tatyana; Knudsen, Karoline; Munk, Ole L; Nahimi, Adjmal; Jacobsen, Steen; Danielsen, Erik H; Terkelsen, Astrid J; Hansen, John; Pavese, Nicola; Brooks, David J; Borghammer, Per

2015-03-01

Parkinson's disease is associated with early parasympathetic dysfunction leading to constipation and gastroparesis. It has been suggested that pathological α-synuclein aggregations originate in the gut and ascend to the brainstem via the vagus. Our understanding of the pathogenesis and time course of parasympathetic denervation in Parkinson's disease is limited and would benefit from a validated imaging technique to visualize the integrity of parasympathetic function. The positron emission tomography tracer 5-[(11)C]-methoxy-donepezil was recently validated for imaging acetylcholinesterase density in the brain and peripheral organs. Donepezil is a high-affinity ligand for acetylcholinesterase-the enzyme that catabolizes acetylcholine in cholinergic synapses. Acetylcholinesterase histology has been used for many years for visualizing cholinergic neurons. Using 5-[(11)C]-methoxy-donepezil positron emission tomography, we studied 12 patients with early-to-moderate Parkinson's disease (three female; age 64 ± 9 years) and 12 age-matched control subjects (three female; age 62 ± 8 years). We collected clinical information about motor severity, constipation, gastroparesis, and other parameters. Heart rate variability measurements and gastric emptying scintigraphies were performed in all subjects to obtain objective measures of parasympathetic function. We detected significantly decreased (11)C-donepezil binding in the small intestine (-35%; P = 0.003) and pancreas (-22%; P = 0.001) of the patients. No correlations were found between the (11)C-donepezil signal and disease duration, severity of constipation, gastric emptying time, and heart rate variability. In Parkinson's disease, the dorsal motor nucleus of the vagus undergoes severe degeneration and pathological α-synuclein aggregations are also seen in nerve fibres innervating the gastro-intestinal tract. In contrast, the enteric nervous system displays little or no loss of cholinergic neurons. Decreases in (11)C-donepezil binding may, therefore, represent a marker of parasympathetic denervation of internal organs, but further validation studies are needed. © The Author (2014). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Per-oral endoscopic myotomy: Major advance in achalasia treatment and in endoscopic surgery

PubMed Central

Friedel, David; Modayil, Rani; Stavropoulos, Stavros N

2014-01-01

Per-oral endoscopic myotomy (POEM) represents a natural orifice endoscopic surgery (NOTES) approach to laparoscopy Heller myotomy (LHM). POEM is arguably the most successful clinical application of NOTES. The growth of POEM from a single center in 2008 to approximately 60 centers worldwide in 2014 with several thousand procedures having been performed attests to the success of POEM. Initial efficacy, safety and acid reflux data suggest at least equivalence of POEM to LHM, the previous gold standard for achalasia therapy. Adjunctive techniques used in the West include impedance planimetry for real-time intraprocedural luminal assessment and endoscopic suturing for challenging mucosal defect closures during POEM. The impact of POEM extends beyond the realm of esophageal motility disorders as it is rapidly popularizing endoscopic submucosal dissection in the West and spawning offshoots that use the submucosal tunnel technique for a host of new indications ranging from resection of tumors to pyloromyotomy for gastroparesis. PMID:25548473

Prevalence of Small Intestinal Bacterial Overgrowth among Chronic Pancreatitis Patients: A Case-Control Study

PubMed Central

Bouchard, Simon; Sidani, Sacha

2016-01-01

Background. Patients with chronic pancreatitis (CP) exhibit numerous risk factors for the development of small intestinal bacterial overgrowth (SIBO). Objective. To determine the prevalence of SIBO in patients with CP. Methods. Prospective, single-centre case-control study conducted between January and September 2013. Inclusion criteria were age 18 to 75 years and clinical and radiological diagnosis of CP. Exclusion criteria included history of gastric, pancreatic, or intestinal surgery or significant clinical gastroparesis. SIBO was detected using a standard lactulose breath test (LBT). A healthy control group also underwent LBT. Results. Thirty-one patients and 40 controls were included. The patient group was significantly older (53.8 versus 38.7 years; P < 0.01). The proportion of positive LBTs was significantly higher in CP patients (38.7 versus 2.5%: P < 0.01). A trend toward a higher proportion of positive LBTs in women compared with men was observed (66.6 versus 27.3%; P = 0.056). The subgroups with positive and negative LBTs were comparable in demographic and clinical characteristics, use of opiates, pancreatic enzymes replacement therapy (PERT), and severity of symptoms. Conclusion. The prevalence of SIBO detected using LBT was high among patients with CP. There was no association between clinical features and the risk for SIBO. PMID:27446865

Prevalence of Small Intestinal Bacterial Overgrowth among Chronic Pancreatitis Patients: A Case-Control Study.

PubMed

Therrien, Amelie; Bouchard, Simon; Sidani, Sacha; Bouin, Mickael

2016-01-01

Background. Patients with chronic pancreatitis (CP) exhibit numerous risk factors for the development of small intestinal bacterial overgrowth (SIBO). Objective. To determine the prevalence of SIBO in patients with CP. Methods. Prospective, single-centre case-control study conducted between January and September 2013. Inclusion criteria were age 18 to 75 years and clinical and radiological diagnosis of CP. Exclusion criteria included history of gastric, pancreatic, or intestinal surgery or significant clinical gastroparesis. SIBO was detected using a standard lactulose breath test (LBT). A healthy control group also underwent LBT. Results. Thirty-one patients and 40 controls were included. The patient group was significantly older (53.8 versus 38.7 years; P < 0.01). The proportion of positive LBTs was significantly higher in CP patients (38.7 versus 2.5%: P < 0.01). A trend toward a higher proportion of positive LBTs in women compared with men was observed (66.6 versus 27.3%; P = 0.056). The subgroups with positive and negative LBTs were comparable in demographic and clinical characteristics, use of opiates, pancreatic enzymes replacement therapy (PERT), and severity of symptoms. Conclusion. The prevalence of SIBO detected using LBT was high among patients with CP. There was no association between clinical features and the risk for SIBO.

New-generation 5-HT4 receptor agonists: potential for treatment of gastrointestinal motility disorders.

PubMed

Manabe, Noriaki; Wong, Banny S; Camilleri, Michael

2010-06-01

Gastrointestinal (GI) dysmotility is an important mechanism in functional GI disorders (FGIDs) including constipation, irritable bowel syndrome, functional dyspepsia, and gastroparesis. 5-hydroxytryptamine(4) (5-HT(4)) receptors are targets for the treatment of GI motility disorders. However, older 5-HT(4) receptor agonists had limited clinical success because they were associated with changes in the function of the cardiac HERG potassium channel. We conducted a PubMed search using the following key words alone or in combination: 5-HT(4), safety, toxicity, pharmacokinetics, pharmacodynamics, clinical trial, cardiac, hERG, arrhythmia, potassium current, elderly, prucalopride, ATI-7505, and velusetrag (TD-5108), to review mechanisms of action, clinical efficacy, safety and tolerability of three new-generation 5-HT(4) receptor agonists. Prucalopride, ATI-7505, and velusetrag (TD-5108) are highly selective, high-affinity 5-HT(4) receptor agonists that are devoid of action on other receptors within their therapeutic range. Their efficacy has been demonstrated in pharmacodynamic studies which demonstrate acceleration of colonic transit and, to a variable degree, in clinical trials that significantly relieve chronic constipation. Currently available evidence shows that the new 5-HT(4) receptor agonists have safe cardiac profiles. New-generation 5-HT(4) receptor agonists and future drugs targeting organ-specific splice variants are promising approaches to treat GI dysmotility, particularly colonic diseases.

ER stress and ER stress-induced apoptosis are activated in gastric SMCs in diabetic rats

PubMed Central

Chen, Xia; Fu, Xiang-Sheng; Li, Chang-Ping; Zhao, Hong-Xian

2014-01-01

AIM: To investigate the gastric muscle injury caused by endoplasmic reticulum (ER) stress in rats with diabetic gastroparesis. METHODS: Forty rats were randomly divided into two groups: a control group and a diabetic group. Diabetes was induced by intraperitoneal injection of 60 mg/kg of streptozotocin. Gastric emptying was determined at the 4th and 12th week. The ultrastructural changes in gastric smooth muscle cells (SMCs) were investigated by transmission electron microscopy. TdT-mediated dUTP nick end labeling (TUNEL) assay was performed to assess apoptosis of SMCs. Expression of the ER stress marker, glucose-regulated protein 78 (GRP78), and the ER-specific apoptosis mediator, caspase-12 protein, was determined by immunohistochemistry. RESULTS: Gastric emptying was significantly lower in the diabetic rats than in the control rats at the 12th wk (40.71% ± 2.50%, control rats vs 54.65% ± 5.22%, diabetic rats; P < 0.05). Swollen and distended ER with an irregular shape was observed in gastric SMCs in diabetic rats. Apoptosis of gastric SMCs increased in the diabetic rats in addition to increased expression of GRP78 and caspase-12 proteins. CONCLUSION: ER stress and ER stress-mediated apoptosis are activated in gastric SMCs in diabetic rats with gastroparesis. PMID:25009401

Gastrointestinal disorders associated with migraine: A comprehensive review

PubMed Central

Cámara-Lemarroy, Carlos R; Rodriguez-Gutierrez, Rene; Monreal-Robles, Roberto; Marfil-Rivera, Alejandro

2016-01-01

Migraine is a recurrent and commonly disabling primary headache disorder that affects over 17% of women and 5%-8% of men. Migraine susceptibility is multifactorial with genetic, hormonal and environmental factors all playing an important role. The physiopathology of migraine is complex and still not fully understood. Many different neuropeptides, neurotransmitters and brain pathways have been implicated. In connection with the myriad mechanisms and pathways implicated in migraine, a variety of multisystemic comorbidities (e.g., cardiovascular, psychiatric and other neurological conditions) have been found to be closely associated with migraine. Recent reports demonstrate an increased frequency of gastrointestinal (GI) disorders in patients with migraine compared with the general population. Helicobacter pylori infection, irritable bowel syndrome, gastroparesis, hepatobiliary disorders, celiac disease and alterations in the microbiota have been linked to the occurrence of migraine. Several mechanisms involving the gut-brain axis, such as a chronic inflammatory response with inflammatory and vasoactive mediators passing to the circulatory system, intestinal microbiota modulation of the enteric immunological milieu and dysfunction of the autonomic and enteric nervous system, have been postulated to explain these associations. However, the precise mechanisms and pathways related to the gut-brain axis in migraine need to be fully elucidated. In this review, we survey the available literature linking migraine with GI disorders. We discuss the possible physiopathological mechanisms, and clinical implications as well as several future areas of interest for research. PMID:27688656

Gastrointestinal disorders associated with migraine: A comprehensive review.

PubMed

Cámara-Lemarroy, Carlos R; Rodriguez-Gutierrez, Rene; Monreal-Robles, Roberto; Marfil-Rivera, Alejandro

2016-09-28

Migraine is a recurrent and commonly disabling primary headache disorder that affects over 17% of women and 5%-8% of men. Migraine susceptibility is multifactorial with genetic, hormonal and environmental factors all playing an important role. The physiopathology of migraine is complex and still not fully understood. Many different neuropeptides, neurotransmitters and brain pathways have been implicated. In connection with the myriad mechanisms and pathways implicated in migraine, a variety of multisystemic comorbidities (e.g., cardiovascular, psychiatric and other neurological conditions) have been found to be closely associated with migraine. Recent reports demonstrate an increased frequency of gastrointestinal (GI) disorders in patients with migraine compared with the general population. Helicobacter pylori infection, irritable bowel syndrome, gastroparesis, hepatobiliary disorders, celiac disease and alterations in the microbiota have been linked to the occurrence of migraine. Several mechanisms involving the gut-brain axis, such as a chronic inflammatory response with inflammatory and vasoactive mediators passing to the circulatory system, intestinal microbiota modulation of the enteric immunological milieu and dysfunction of the autonomic and enteric nervous system, have been postulated to explain these associations. However, the precise mechanisms and pathways related to the gut-brain axis in migraine need to be fully elucidated. In this review, we survey the available literature linking migraine with GI disorders. We discuss the possible physiopathological mechanisms, and clinical implications as well as several future areas of interest for research.

Gastric dysrhythmias and the current status of electrogastrography

NASA Technical Reports Server (NTRS)

Koch, K. L.

1989-01-01

Myoelectrical activity recorded simultaneously from mucosal, serosal, and cutaneous electrodes has confirmed that the 3-cpm signal from such electrodes reflects gastric slow-wave activity. Now, the observation that patients with unexplained nausea and vomiting may have very rapid slow-wave frequencies (tachygastrias) and very slow, slow-wave frequencies (bradygastrias) suggests that electrogastrography, a reliable and noninvasive technique, may be useful in the diagnosis and management of patients with upper abdominal symptoms and gastroparesis.

[Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial].

PubMed

Zhou, Q; Zuo, M H; Li, Q W; Tian, Y T; Xie, Y B; Wang, Y B; Yang, G Y; Ye, Y J; Guo, P; Liu, J P; Liu, Z L; An, C; Zhou, T; Tian, Z; Liu, C B; Hu, Y; Chi, X Y; Shen, Y; Xia, Y; Hu, K W

2017-12-23

Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard. Results: From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group ( P =0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group ( P =0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups ( P =0.244). Conclusion: Weitan Waifu patch is a safely and effectively therapeutic method for patients with PGS (cold syndrome) of gastroenterological cancer. Trial registration: International Standard Randomized Controlled Trial Number Register, ISRCTN18291857.

Relamorelin: A Novel Gastrocolokinetic Synthetic Ghrelin Agonist

PubMed Central

Camilleri, Michael; Acosta, Andres

2015-01-01

Synthetic ghrelin agonists, predominantly small molecules, are being developed as prokinetic agents that may prove useful in the treatment of gastrointestinal motility disorders. Relamorelin (RM-131) is a pentapeptide synthetic ghrelin analog that activates the growth hormone secretagogue (GHS)-1a (also called the ghrelin) receptor with approximately 6-fold greater potency than natural ghrelin. The ability of relamorelin to stimulate growth hormone (GH) release is comparable to that of native ghrelin. Relamorelin has enhanced efficacy and plasma stability compared to native ghrelin. In this review, we discuss the pharmacokinetics, pharmacodynamics and potential indications for relamorelin. Relamorelin is administered subcutaneously, dosed daily or twice daily. Relamorelin is being studied for the treatment of patients with gastrointestinal motility disorders. Phase IIA pharmacodynamic studies have demonstrated acceleration of gastric emptying in patients with type 1 diabetes mellitus (T1DM) and type 2 DM (T2DM) and upper gastrointestinal symptoms. In a phase IIA study in patients with diabetic gastroparesis, relamorelin accelerated gastric emptying and significantly improved vomiting frequency compared to placebo and improved other symptoms of gastroparesis in a pre-specified subgroup of patients with vomiting at baseline. In patients with chronic idiopathic constipation with defined transit profile at baseline, relamorelin relieved constipation and accelerated colonic transit compared to placebo. These characteristics suggest that this new ghrelin analog shows great promise to relieve patients with upper or lower gastrointestinal motility disorders. PMID:25545036

Gastric Electrical Stimulation for Abdominal Pain in Patients with Symptoms of Gastroparesis

PubMed Central

Lahr, Christopher J.; Griffith, James; Subramony, Charu; Halley, Lindsey; Adams, Kristen; Paine, Elizabeth R.; Schmieg, Robert; Islam, Saleem; Salameh, Jay; Spree, Danielle; Kothari, Truptesh; Kedar, Archana; Nikitina, Yana; Abell, Thomas

2016-01-01

Abdominal pain physiology may be better understood studying electrophysiology, histology, and symptom scores in patients with the symptoms of gastroparesis (Gp) treated with gastric electrical stimulation (GES). Ninety-five Gp patients’ symptoms were recorded at baseline and during temporary and permanent GES. Gastric-emptying times and cutaneous, mucosal, and serosal electrogastrograms were obtained. S100-stained, full-thickness gastric biopsies were compared with autopsy controls. Sixty-eight patients reported severe pain at baseline. Severe pain patients’ mean pain scores decreased with temporary GES from 3.62 to 1.29 (P < 0.001) and nonsevere pain from 1.26 to 0.67 (P = 0.01). With permanent GES, severe mean pain scores fell to 2.30 (P < 0.001); nonsevere pain changed to 1.60 (P = 0.221). Mean follow-up was 275 days. Mean cutaneous, mucosal, and serosal frequencies and frequency-to-amplitude ratios were markedly higher than literature controls. For patients with Gp overall and subdivided by etiology and severity of pain, S-100 neuronal fibers were significantly reduced in both muscularis propria layers. GES improved severe pain associated with symptoms of Gp. This severe pain is associated with abnormal electrogastrographic activity and loss of S100 neuronal fibers in the stomach’s inner and outer muscularis propria and, therefore, could be the result of gastric neuropathy. PMID:23635579

Effect of X-irradiation on the stomach of the rat

DOE Office of Scientific and Technical Information (OSTI.GOV)

Breiter, N.; Trott, K.R.; Sassy, T.

1989-10-01

A model for localized 300 kV X-irradiation of the rat stomach was developed. After irradiation with single doses, three distinct gastric disorders were observed which occurred at different latency times. Acute death 2-3 weeks after irradiation was caused by an erosive and ulcerative gastritis and occurred in all animals given 28.5 Gy without diet, in 17% of the animals given 28.5 Gy plus diet, and in 13% of the animals given 23 Gy. Subacute to chronic fatal disorders 4 weeks to 7 months after irradiation were seen as stomach dilatation and gastroparesis, associated with the replacement of the normal gastricmore » mucosa by a hyperkeratinized multilayered squamous epithelium. These disorders occurred in 40-100% of the animals after doses between 16 Gy and 28.5 Gy (+diet). An ED 50 value of 19.2 Gy (16.5-21.2 Gy, 95% confidence interval) was calculated for this gastroparesis. Late gastric obstruction exceeding 7 months after irradiation was seen in the rats because of profound changes in the gastric wall in 13-18% of the animals after doses between 23 Gy and 14 Gy. In animals surviving these three periods, an atrophic mucosa and intestinal metaplasia developed. From functional and morphohistological studies, it can be concluded that there are differences in the pathogenesis of the fatal radiation damage for each of these periods after irradiation.« less

Weight loss and decubitus duodenal ulcer in Parkinson's disease treated with levodopa-carbidopa intestinal gel infusion.

PubMed

Martino, Tommaso; Melchionda, Donato; Tonti, Paolo; De Francesco, Vincenzo; Lalla, Alessandra; Specchio, Luigi Maria; Avolio, Carlo

2016-12-01

Apparently, unexplained weight loss is a common symptom experienced by patients affected by Parkinson's disease, especially in those treated by levodopa-carbidopa infusion gel (LCIG) with a poor control of dyskinesias. Weight loss is considered part of gastrointestinal dysfunction seen in patients affected by Parkinson's disease, along with gastroparesis and reduced bowel peristalsis. In patients treated with LCIG, weight loss needs to be accurately evaluated, because of possible underlying life-threatening adverse events, like duodenum decubitus ulcer.

Growth, nutritional, and gastrointestinal aspects of focal dermal hypoplasia (Goltz-Gorlin syndrome).

PubMed

Motil, Kathleen J; Fete, Mary; Fete, Timothy J

2016-03-01

Focal dermal hypoplasia (FDH) is a rare genetic disorder caused by mutations in the PORCN gene located on the X-chromosome. In the present study, we characterized the pattern of growth, body composition, and the nutritional and gastrointestinal aspects of children and adults (n = 19) affected with this disorder using clinical anthropometry and a survey questionnaire. The mean birth length (P < 0.06) and weight (P < 0.001) z-scores of the participants were lower than the reference population. The mean head circumference (P < 0.001), height (length) (P < 0.001), weight (P < 0.01), and BMI (P < 0.05) for age z-scores of the participants were lower than the reference population. The height-for-age and weight-for-age z-scores of the participants did not differ significantly between birth and current measurements. Three-fourths of the group reported having one or more nutritional or gastrointestinal problems including short stature (65%), underweight (77%), oral motor dysfunction (41%), gastroesophageal reflux (24%), gastroparesis (35%), and constipation (35%). These observations provide novel clinical information about growth, body composition, and nutritional and gastrointestinal aspects of children and adults with FDH and underscore the importance of careful observation and early clinical intervention in the care of individuals affected with this disorder. © 2016 Wiley Periodicals, Inc.

Gastrointestinal Physiology and Function.

PubMed

Greenwood-Van Meerveld, Beverley; Johnson, Anthony C; Grundy, David

2017-01-01

The gastrointestinal (GI) system is responsible for the digestion and absorption of ingested food and liquids. Due to the complexity of the GI tract and the substantial volume of material that could be covered under the scope of GI physiology, this chapter briefly reviews the overall function of the GI tract, and discusses the major factors affecting GI physiology and function, including the intestinal microbiota, chronic stress, inflammation, and aging with a focus on the neural regulation of the GI tract and an emphasis on basic brain-gut interactions that serve to modulate the GI tract. GI diseases refer to diseases of the esophagus, stomach, small intestine, colon, and rectum. The major symptoms of common GI disorders include recurrent abdominal pain and bloating, heartburn, indigestion/dyspepsia, nausea and vomiting, diarrhea, and constipation. GI disorders rank among the most prevalent disorders, with the most common including esophageal and swallowing disorders, gastric and peptic ulcer disease, gastroparesis or delayed gastric emptying, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). Many GI disorders are difficult to diagnose and their symptoms are not effectively managed. Thus, basic research is required to drive the development of novel therapeutics which are urgently needed. One approach is to enhance our understanding of gut physiology and pathophysiology especially as it relates to gut-brain communications since they have clinical relevance to a number of GI complaints and represent a therapeutic target for the treatment of conditions including inflammatory diseases of the GI tract such as IBD and functional gut disorders such as IBS.

Gastric motor dysfunctions in Parkinson's disease: Current pre-clinical evidence.

PubMed

Pellegrini, Carolina; Antonioli, Luca; Colucci, Rocchina; Ballabeni, Vigilio; Barocelli, Elisabetta; Bernardini, Nunzia; Blandizzi, Corrado; Fornai, Matteo

2015-12-01

Parkinson's disease (PD) is associated with several non-motor symptoms, such as behavioral changes, urinary dysfunction, sleep disorders, fatigue and, above all, gastrointestinal (GI) dysfunction, including gastric dysmotility, constipation and anorectal dysfunction. Delayed gastric emptying, progressing to gastroparesis, is reported in up to 100% of patients with PD, and it occurs at all stages of the disease with severe consequences to the patient's quality of life. The presence of α-synuclein (α-syn) aggregates in myenteric neurons throughout the digestive tract, as well as morpho-functional alterations of the enteric nervous system (ENS), have been documented in PD. In particular, gastric dysmotility in PD has been associated with an impairment of the brain-gut axis, involving the efferent fibers of the vagal pathway projecting directly to the gastric myenteric plexus. The present review intends to provide an integrated overview of available knowledge on the possible role played by the ENS, considered as a semi-autonomous nervous network, in the pathophysiology of gastric dysmotility in PD. Particular attention has been paid review how translational evidence in humans and studies in pre-clinical models are allowing a better understanding of the functional, neurochemical and molecular alterations likely underlying gastric motor abnormalities occurring in PD. Copyright © 2015 Elsevier Ltd. All rights reserved.

Endoscopic placement of the small-bowel video capsule by using a capsule endoscope delivery device.

PubMed

Holden, Jeremy P; Dureja, Parul; Pfau, Patrick R; Schwartz, Darren C; Reichelderfer, Mark; Judd, Robert H; Danko, Istvan; Iyer, Lalitha V; Gopal, Deepak V

2007-05-01

Capsule endoscopy performed via the traditional peroral route is technically challenging in patients with dysphagia, gastroparesis, and/or abnormal upper-GI (UGI) anatomy. To describe the indications and outcomes of cases in which the AdvanCE capsule endoscope delivery device, which has recently been cleared by the Food and Drug Administration, was used. Retrospective, descriptive, case series. Tertiary care, university hospital. We report a case series of 16 consecutive patients in whom the AdvanCE delivery device was used. The study period was May 2005 through July 2006. Endoscopic delivery of the video capsule to the proximal small bowel by using the AdvanCE delivery device. Indications, technique, and completeness of small bowel imaging in patients who underwent endoscopic video capsule delivery. The AdvanCE delivery device was used in 16 patients ranging in age from 3 to 74 years. The primary indications for endoscopic delivery included inability to swallow the capsule (10), altered UGI anatomy (4), and gastroparesis (2). Of the 4 patients with altered UGI anatomy, 3 had dual intestinal loop anatomy (ie, Bilroth-II procedure, Whipple surgery, Roux-en-Y gastric bypass) and 1 had a failed Nissen fundoplication. In all cases, the capsule was easily deployed without complication, and complete small intestinal imaging was achieved. Small patient size. Endoscopic placement of the Given PillCam by use of the AdvanCE delivery device was safe and easily performed in patients for whom capsule endoscopy would otherwise have been contraindicated or technically challenging.

Nutritional Rehabilitation: Practical Guidelines for Refeeding the Anorectic Patient

PubMed Central

Mehler, Philip S.; Winkelman, Amy B.; Andersen, Debbie M.; Gaudiani, Jennifer L.

2010-01-01

Weight restoration is crucial for successful treatment of anorexia nervosa. Without it, patients may face serious or even fatal medical complications of severe starvation. However, the process of nutritional rehabilitation can also be risky to the patient. The refeeding syndrome, a problem of electrolyte and fluid shifts, can cause permanent disability or even death. It is essential to identify at-risk patients, to monitor them carefully, and to initiate a nutritional rehabilitation program that aims to avoid the refeeding syndrome. A judicious, slow initiation of caloric intake, requires daily management to respond to entities such as liver inflammation and hypoglycemia that can complicate the body's conversion from a catabolic to an anabolic state. In addition, nutritional rehabilitation should take into account clinical characteristics unique to these patients, such as gastroparesis and slowed colonic transit, so that measures can be taken to ameliorate the physical discomforts of weight restoration. Adjunct methods of refeeding such as the use of enteral or parenteral nutrition may play a small but important role in a select patient group who cannot tolerate oral nutritional rehabilitation alone. PMID:20798756

Ghrelin and motilin receptor agonists: time to introduce bias into drug design.

PubMed

Sanger, G J

2014-02-01

Ghrelin and motilin receptor agonists increase gastric motility and are attractive drug targets. However, 14 years after the receptors were described (18-24 years since ligands became available) the inactivity of the ghrelin agonist TZP-102 in patients with gastroparesis joins the list of unsuccessful motilin agonists. Fundamental questions must be asked. Pustovit et al., have now shown that the ghrelin agonist ulimorelin evokes prolonged increases in rat colorectal propulsion yet responses to other ghrelin agonists fade. Similarly, different motilin agonists induce short- or long-lasting effects in a cell-dependent manner. Together, these and other data create the hypothesis that the receptors can be induced to preferentially signal ('biased agonism') via particular pathways to evoke different responses with therapeutic advantages/disadvantages. Biased agonism has been demonstrated for ghrelin. Are motilin agonists which cause long-lasting facilitation of human stomach cholinergic function (compared with motilin) biased agonists (e.g., camicinal, under development for patients with gastric hypo-motility)? For ghrelin, additional complications exist because the therapeutic aims/mechanisms of action are uncertain, making it difficult to select the best (biased) agonist. Will ghrelin agonists be useful treatments of nausea and/or as suggested by Pustovit et al., chronic constipation? How does ghrelin increase gastric motility? As gastroparesis symptoms poorly correlate with delayed gastric emptying (yet gastro-prokinetic drugs can provide relief: e.g., low-dose erythromycin), would low doses of ghrelin and motilin agonists relieve symptoms simply by restoring neuromuscular rhythm? These questions on design and functions need addressing if ghrelin and motilin agonists are to reach patients as drugs. © 2014 John Wiley & Sons Ltd.

Black esophagus: Acute esophageal necrosis syndrome

PubMed Central

Gurvits, Grigoriy E

2010-01-01

Acute esophageal necrosis (AEN), commonly referred to as “black esophagus”, is a rare clinical entity arising from a combination of ischemic insult seen in hemodynamic compromise and low-flow states, corrosive injury from gastric contents in the setting of esophago-gastroparesis and gastric outlet obstruction, and decreased function of mucosal barrier systems and reparative mechanisms present in malnourished and debilitated physical states. AEN may arise in the setting of multiorgan dysfunction, hypoperfusion, vasculopathy, sepsis, diabetic ketoacidosis, alcohol intoxication, gastric volvulus, traumatic transection of the thoracic aorta, thromboembolic phenomena, and malignancy. Clinical presentation is remarkable for upper gastrointestinal bleeding. Notable symptoms may include epigastric/abdominal pain, vomiting, dysphagia, fever, nausea, and syncope. Associated laboratory findings may reflect anemia and leukocytosis. The hallmark of this syndrome is the development of diffuse circumferential black mucosal discoloration in the distal esophagus that may extend proximally to involve variable length of the organ. Classic “black esophagus” abruptly stops at the gastroesophageal junction. Biopsy is recommended but not required for the diagnosis. Histologically, necrotic debris, absence of viable squamous epithelium, and necrosis of esophageal mucosa, with possible involvement of submucosa and muscularis propria, are present. Classification of the disease spectrum is best described by a staging system. Treatment is directed at correcting coexisting clinical conditions, restoring hemodynamic stability, nil-per-os restriction, supportive red blood cell transfusion, and intravenous acid suppression with proton pump inhibitors. Complications include perforation with mediastinal infection/abscess, esophageal stricture and stenosis, superinfection, and death. A high mortality of 32% seen in the setting of AEN syndrome is usually related to the underlying medical co-morbidities and diseases. PMID:20614476

Synchronized gastric electrical stimulation improves vagotomy-induced impairment in gastric accommodation via the nitrergic pathway in dogs

PubMed Central

Chen, Jie; Koothan, Thillai; Chen, Jiande D. Z.

2009-01-01

Impaired gastric accommodation and gastric dysrhythmia are common in gastroparesis and functional dyspepsia. Recent studies have shown that synchronized gastric electrical stimulation (SGES) accelerates gastric emptying and enhances antral contractions in dogs. The aim of this study was to investigate the effects and mechanism of SGES on gastric accommodation and slow waves impaired by vagotomy in dogs. Gastric tone, compliance, and accommodation as well as slow waves with and without SGES were assessed in seven female regular dogs and seven dogs with bilateral truncal vagotomy, chronically implanted with gastric serosal electrodes and a gastric cannula. We found that 1) vagotomy impaired gastric accommodation that was normalized by SGES. The postprandial increase in gastric volume was 283.5 ± 50.6 ml in the controlled dogs, 155.2 ± 49.2 ml in the vagotomized dogs, and 304.0 ± 57.8 ml in the vagotomized dogs with SGES. The ameliorating effect of SGES was no longer observed after application of Nω-nitro-l-arginine (l-NNA); 2) vagotomy did not alter gastric compliance whereas SGES improved gastric compliance in the vagotomized dogs, and the improvement was also blocked by l-NNA; and 3) vagotomy impaired antral slow wave rhythmicity in both fasting and fed states. SGES at the proximal stomach enhanced the postprandial rhythmicity and amplitude (dominant power) of the gastric slow waves in the antrum. In conclusion, SGES with appropriate parameters restores gastric accommodation and improves gastric slow waves impaired by vagotomy. The improvement in gastric accommodation with SGES is mediated via the nitrergic pathway. Combined with previously reported findings (enhanced antral contractions and accelerated gastric emptying) and findings in this study (improved gastric accommodation and slow waves), SGES may be a viable therapy for gastroparesis. PMID:19023028

Autonomic Evaluation of Patients With Gastroparesis and Neurostimulation: Comparisons of Direct/Systemic and Indirect/Cardiac Measures

PubMed Central

Stocker, Abigail; Abell, Thomas L.; Rashed, Hani; Kedar, Archana; Boatright, Ben; Chen, Jiande

2016-01-01

Background Disorders of nausea, vomiting, abdominal pain, and related problems often are manifestations of gastrointestinal, neuromuscular, and/or autonomic dysfunction. Many of these patients respond to neurostimulation, either gastric electrical stimulation or electroacupuncture. Both of these therapeutic techniques appear to influence the autonomic nervous system which can be evaluated directly by traditional testing and indirectly by heart rate variability. Methods We studied patients undergoing gastric neuromodulation by both systemic autonomic testing (39 patients, six males and 33 females, mean age 38 years) and systemic autonomic testing and heart rate variability (35 patients, seven males and 28 females, mean age 37 years) testing before and after gastric neuromodulation. We also performed a pilot study using both systemic autonomic testing and heart rate variability in a small number of patients (five patients, all females, mean age 48.6 years) with diabetic gastroparesis at baseline to compare the two techniques at baseline. Systemic autonomic testing and heart rate variability were performed with standardized techniques and gastric electrical stimulation was performed as previously described with electrodes implanted serosally in the myenteric plexus. Results Both systemic autonomic testing and heart rate variability measures were often abnormal at baseline and showed changes after gastric neuromodulation therapy in two groups of symptomatic patients. Pilot data on a small group of similar patients with systemic automatic nervous measures and heart rate variability showed good concordance between the two techniques. Conclusions Both traditional direct autonomic measures and indirect measures such as heart rate variability were evaluated, including a pilot study of both methods in the same patient group. Both appear to be useful in evaluation of patients at baseline and after stimulation therapies; however, a future full head-to-head comparison is warranted. PMID:27785318

Vitamin C Improves Gastroparesis in Diabetic Rats: Effects on Gastric Contractile Responses and Oxidative Stress.

PubMed

Da Silva, Luisa Mota; da Silva, Rita de Cássia Melo Vilhena de Andrade Fonseca; Maria-Ferreira, Daniele; Beltrame, Olair Carlos; da Silva-Santos, José Eduardo; Werner, Maria Fernanda de Paula

2017-09-01

Diabetic gastroparesis is a common complication of diabetes mellitus, which mainly affects women. Previous studies have demonstrated that oxidative stress is involved in its onset and development. This study evaluated the role of vitamin C on diabetes-associated gastric dysmotility. Female rats with streptozotocin-induced diabetes were treated with vehicle (water, 1 mL/kg, p.o.), vitamin C (300 mg/kg/day, p.o.), or insulin (6 IU/day, s.c.). Gastric emptying, in vitro gastric contractility, and biochemistry parameters were analyzed at the end of the treatment (i.e. 8 weeks after the diabetes induction). Vitamin C reversed the delayed gastric emptying of diabetic rats to normal levels, and avoided the changes in the contractile responses to acetylcholine (0.1 nM-1 µM), but not to 5-hydroxytryptamine (0.1 nM-1 µM), in the pylorus and fundus from diabetic rats. Moreover, the contraction evoked by KCl (40 mM) in the fundus, but not in the pylorus, was intensely increased in diabetic rats treated with vitamin C. Notably, the vitamin C reestablished the reduced glutathione levels by 77% and decreased the reactive oxygen species content by 60% in the gastric tissue from diabetic rats. Despite the effects on gastric motility, vitamin C treatment did not change the fasting glycaemia or the glycated hemoglobin of diabetic rats. Unsurprisingly, insulin treatment normalized all parameters evaluated. Vitamin C exhibited a remarkable beneficial effect on gastric emptying dysfunction in diabetic rats, which was mediated by attenuation of oxidative stress and maintenance of the cholinergic contractile responses in fundus and pylorus.

Impact of gastroesophageal reflux and delayed gastric emptying on pediatric lung transplant outcomes.

PubMed

Jamie Dy, Fei; Freiberger, Dawn; Liu, Enju; Boyer, Debra; Visner, Gary; Rosen, Rachel

2017-08-01

Gastroesophageal reflux disease is thought to predispose to adverse lung allograft outcomes. However, little is known about the burden of gastroesophageal reflux (GER) and gastroparesis in pediatric patients. In this study we describe the burden of reflux and gastroparesis in children undergoing lung transplant, and evaluates their impact on allograft survival and rejection incidence. This study is a retrospective analysis of pediatric lung transplant recipients who had combined pH and multichannel intraluminal impedance testing (pH-MII) and gastric-emptying scans (GES). Hazard ratios with 95% confidence intervals (CIs) estimated from Cox proportional hazard models were used to examine the associations between reflux parameters and adverse allograft outcomes. Covariates considered in the multivariate analysis included abnormal pH-MII testing, abnormal GES and Nissen fundoplication status. Kaplan-Meier curves were created, with log-rank testing employed to assess differences between groups. Thirty lung transplant recipients, aged 1 to 21 years, were identified. Eight of 30 patients (27%) had abnormal reflux by impedance, and 12 (40%) had abnormal pH-metry. Of 19 patients tested, 5 (26.3%) had evidence of gastric dysmotility; however, the severity of GER did not trend with delays in gastric emptying. Neither reflux burden by pH-MII testing nor fundoplication status impacted survival or rejection. However, delayed gastric emptying appeared significantly linked to the development of chronic lung allograft dysfunction, independent of GER. In children, reflux burden and fundoplication status do not impact lung transplant outcomes, but gastric dysmotility may be linked to allograft dysfunction in children. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Presentation and Epidemiology of Gastroesophageal Reflux Disease.

PubMed

Richter, Joel E; Rubenstein, Joel H

2018-01-01

Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disorder in the United States, and leads to substantial morbidity, though associated mortality is rare. The prevalence of GERD symptoms appeared to increase until 1999. Risk factors for complications of GERD include advanced age, male sex, white race, abdominal obesity, and tobacco use. Most patients with GERD present with heartburn and effortless regurgitation. Coexistent dysphagia is considered an alarm symptom, prompting evaluation. There is substantial overlap between symptoms of GERD and those of eosinophilic esophagitis, functional dyspepsia, and gastroparesis, posing a challenge for patient management. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Competitive speed eating: truth and consequences.

PubMed

Levine, Marc S; Spencer, Geoffrey; Alavi, Abass; Metz, David C

2007-09-01

The purpose of our investigation was to assess the stomachs of a world-class speed-eating champion and of a control subject during a speed-eating test in our gastrointestinal fluoroscopy suite to determine how competitive speed eaters are able to eat so much so fast. Our observations suggest that successful speed eaters expand the stomach to form an enormous flaccid sac capable of accommodating huge amounts of food. We speculate that professional speed eaters eventually may develop morbid obesity, profound gastroparesis, intractable nausea and vomiting, and even the need for a gastrectomy. Despite its growing popularity, competitive speed eating is a potentially self-destructive form of behavior.

The Prokinetic Face of Ghrelin

PubMed Central

Sallam, Hanaa S.; Chen, Jiande D. Z.

2010-01-01

This review evaluated published data regarding the effects of ghrelin on GI motility using the PubMed database for English articles from 1999 to September 2009. Our strategy was to combine all available information from previous literature, in order to provide a complete structured review on the prokinetic properties of exogenous ghrelin and its potential use for treatment of various GI dysmotility ailments. We classified the literature into two major groups, depending on whether studies were done in health or in disease. We sub-classified the studies into stomach, small intestinal and colon studies, and broke them down further into studies done in vitro, in vivo (animals) and in humans. Further more, the reviewed studies were presented in a chronological order to guide the readers across the scientific advances in the field. The review shows evidences that ghrelin and its (receptor) agonists possess a strong prokinetic potential to serve in the treatment of diabetic, neurogenic or idiopathic gastroparesis and possibly, chemotherapy-associated dyspepsia, postoperative, septic or post-burn ileus, opiate-induced bowel dysfunction and chronic idiopathic constipation. Further research is necessary to close the gap in knowledge about the effect of ghrelin on the human intestines in health and disease. PMID:20721347

Gastric Electrical Stimulation

PubMed Central

2006-01-01

Executive Summary Objective The objective of this analysis was to assess the effectiveness, safety and cost-effectiveness of gastric electrical stimulation (GES) for the treatment of chronic, symptomatic refractory gastroparesis and morbid obesity. Background Gastroparesis - Epidemiology Gastroparesis (GP) broadly refers to impaired gastric emptying in the absence of obstruction. Clinically, this can range from the incidental detection of delayed gastric emptying in an asymptomatic person to patients with severe nausea, vomiting and malnutrition. Symptoms of GP are nonspecific and may mimic structural disorders such as ulcer disease, partial gastric or small bowel obstruction, gastric cancer, and pancreaticobiliary disorders. Gastroparesis may occur in association with diabetes, gastric surgery (consequence of peptic ulcer surgery and vagotomy) or for unknown reasons (idiopathic gastroparesis). Symptoms include early satiety, nausea, vomiting, abdominal pain and weight loss. The majority of patients with GP are women. The relationship between upper gastrointestinal symptoms and the rate of gastric emptying is considered to be weak. Some patients with markedly delayed gastric emptying are asymptomatic and sometimes, severe symptoms may remit spontaneously. Idiopathic GP may represent the most common form of GP. In one tertiary referral retrospective series, the etiologies in 146 GP patients were 36% idiopathic, 29% diabetic, 13% postgastric surgery, 7.5% Parkinson’s disease, 4.8% collagen vascular disorders, 4.1% intestinal pseudoobstruction and 6% miscellaneous causes. The true prevalence of digestive symptoms in patients with diabetes and the relationship of these symptoms to delayed gastric emptying are unknown. Delayed gastric emptying is present in 27% to 58% of patients with type 1 diabetes and 30% with type 2 diabetes. However, highly variable rates of gastric emptying have been reported in type 1 and 2 diabetes, suggesting that development of GP in patients with diabetes is neither universal nor inevitable. In a review of studies examining gastric emptying in patients with diabetes compared to control patients, investigators noted that in many cases the magnitude of the delay in gastric emptying is modest. GP may occur as a complication of a number of different surgical procedures. For example, vagal nerve injury may occur in 4% to 40% of patients who undergo laparoscopic fundoplication1 for gastroesophageal reflux disease. The prevalence of severe, refractory GP is scantily reported in the literature. Using data from a past study, it has been estimated that the prevalence of severe, symptomatic and refractory GP in the United States population is 0.017%. Assuming an Ontario population of 13 million, this would correspond to approximately 2,000 people in Ontario having severe, symptomatic, refractory GP. The incidence of severe refractory GP estimated by the United States Food and Drug Administration (FDA) is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year. Treatment for Gastroparesis To date, there have been no long-term studies confirming the beneficial effects of maintaining euglycemia on GP symptoms. However, it has been suggested that consistent findings of physiologic studies in healthy volunteers and diabetes patients provides an argument to strive for near-normal blood glucose levels in affected diabetes patients. Dietary measures (e.g., low fibre, low fat food), prokinetic drugs (e.g., domperidone, metoclopramide and erythromycin) and antiemetic or antinausea drugs (e.g, phenothiazines, diphenhydramine) are generally effective for symptomatic relief in the majority of patients with GP. For patients with chronic, symptomatic GP who are refractory to drug treatment, surgical options may include jejunostomy tube for feeding, gastrotomy tube for stomach decompression and pyloroplasty for gastric emptying. Few small studies examined the use of botulinum toxin injections into the pyloric sphincter. However, the contribution of excessive pyloric contraction to GP has been insufficiently defined and there have been no controlled studies of this therapy. Treatment with GES is reversible and may be a less invasive option compared to stomach surgery for the treatment of patients with chronic, drug-refractory nausea and vomiting secondary to GP. In theory, GES represents an intermediate step between treatment directed at the underlying pathophysiology, and the treatment of symptoms. It is based on studies of gastric electrical patterns in GP that have identified the presence of a variety of gastric arrhythmias. Similar to a cardiac pacemaker, it was hypothesized that GES could override the abnormal rhythms, stimulate gastric emptying and eliminate symptoms. Morbid Obesity Epidemiology Obesity is defined as a body mass index (BMI) of at last 30 kg/m2. Morbid obesity is defined as a BMI of at least 40 kg/m2 or at least 35 kg/m2 with comorbid conditions. Comorbid conditions associated with obesity include diabetes, hypertension, dyslipidemias, obstructive sleep apnea, weight-related arthropathies, and stress urinary incontinence. In the United States, the age-adjusted prevalence of extreme obesity (BMI ≥ 40 kg/m2) for adults aged 20 years and older has increased significantly in the population, from 2.9% (1988–1994) to 4.7% (1999–2000). An expert estimated that about 160,000 to 180,000 people are morbidly obese in Ontario. Treatment for Morbid Obesity Diet, exercise, and behavioural therapy are used to help people lose weight. Bariatric surgery for morbid obesity is considered an intervention of last resort for patients who have attempted first-line forms of medical management. Gastric stimulation has been investigated for the treatment of morbid obesity; the intention being to reduce appetite and induce early satiety possibly due to inhibitory effects on gastric motility and effects on the central nervous system (CNS) and hormones related to satiety and/or appetite. Possible advantages to GES for the treatment of morbid obesity include reversibility of the procedure, less invasiveness than some bariatric procedures, e.g., gastric bypass, and less side effects (e.g., dumping syndrome). The Device Electrical stimulation is delivered via an implanted system that consists of a neurostimulator and 2 leads. The surgical procedure can be performed via either an open or laparoscopic approach. An external programmer used by the physician can deliver instructions to the GES, i.e., adjust the rate and amplitude of stimulation (Figure 1). GES may be turned off by the physician at any time or may be removed. The battery life is approximately 4-5 years For treatment of GP, the GES leads are secured in the muscle of the lower stomach, 10 cm proximal to the pylorus (the opening from the stomach to the intestine), 1 cm apart and connected to an implantable battery-powered neurostimulator which is placed in a small pocket in the abdominal wall For treatment of morbid obesity, GES leads are implanted along the lesser curvature of the stomach where the vagal nerve branches spread, approximately 8 cm proximal to the pylorus. However, the implant positioning of the leads has been variably reported in the literature. Regulatory Status The Enterra Therapy System and the Transcend II Implantable Gastric Stimulation System (Medtronic Inc.) are both licensed as class 3 devices by Health Canada (license numbers 60264 and 66948 respectively). The Health Canada indications for use are: Enterra Therapy System “For use in the treatment of chronic intractable (drug-refractory) nausea and vomiting.” Transcend II Implantable Gastric Stimulation System “For use in weight reduction for obese adults with a body mass index greater than 35.” The GES device that is licensed by Health Canada for treatment of GP, produces high-frequency GES. Most clinical studies examining GES for GP have used high-frequency (4 times the intrinsic slow wave frequency, i.e., 12 cycles per minute), low energy, short duration pulses. This type of stimulation does not alter gastric muscular contraction and has no effect on slow wave dysrhythmias. The mechanism of action is unclear but it is hypothesized that high-frequency GES may act on sensory fibers directed to the CNS. The GES device licensed by Health Canada for treatment of morbid obesity produces low-frequency GES, which is close to or just above the normal/native gastric slow wave cycle (approximately 3 cycles/min.). This pacing uses low-frequency, high-energy, long-duration pulses to induce propagated slow waves that replace the spontaneous ones. Low-frequency pacing does not invoke muscular contractions. Most studies examining the use of GES for the treatment of morbid obesity use low-frequency GES. Under normal circumstances, the gastric slow wave propagates distally and determines the frequency and propagation direction of gastric peristalsis. Low-frequency GES aims to produce abnormal gastric slow waves that can induce gastric dysrhythmia, disrupt regular propagation of slow waves, cause hypomotility of the stomach, delay gastric emptying, reduce food intake, prolong satiety, and produce weight loss. In the United States, the Enterra Therapy System is a Humanitarian Use Device (HUD), meaning it is a medical device designated by the FDA for use in the treatment of medical conditions that affect fewer than 4,000 individuals per year.2 The Enterra Therapy System is indicated for “the treatment of chronic, drug- refractory nausea and vomiting secondary to GP of diabetes or idiopathic etiology” (not postsurgical etiologies). GES for morbid obesity has not been approved by the FDA and is for investigational use only in the United States. Review Strategy The Medical Advisory Secretariat systematically reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of GES to treat patients who have: a) chronic refractory symptomatic GP; or b) morbid obesity. The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases. The GRADE approach was used to systematically and explicitly make judgments about the quality of evidence and strength of recommendations. Findings As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence in Tables 1 and 2. High Further research is very unlikely to change our confidence in the estimate of effect. Moderate Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very Low Any estimate of effect is very uncertain Table 1: GRADE Quality of Studies – Gastroparesis Outcome Design Quality Consistency Directness Overall Quality Reduced vomiting & nausea(1° end point) RCT(Abell et al. 2003)Case Series LowWhy?Confounders related to diabetes.Possible Type 2 error for subgroup analyses.Subjective self-reported end point.Posthoc change in primary end point analysis.No sample size justification.Concomitant prokinetic/antiemetic therapy.Same as above. Some uncertainty.Why?Only 1 RCT (with different results for FDA and publication). Some uncertainty.Why?GES originally hypothesized to correct gastric rhythms, stimulate gastric emptying and therefore eliminate symptoms.Now hypothesized to directly act on neurons to the CNS to control symptoms.Weak correlation between symptoms and gastric emptying.Unclear whether gastric emptying is still considered an end point to investigate. Low Improved gastric emptying(2° end point) Open label portion of Abell et al. 2003&Case series LowWhy?Same limitations as above. Not a 1° end point. No intent-to-treat analysis. Wide variation in improvement.Same uncertainties as above. Same uncertainties as above. Low/VeryLow Table 2: GRADE Quality of Studies – Morbid Obesity Outcome Design Quality Consistency Directness Overall Quality Weight Loss RCT“O-01 Trial”According to Shikora (2004), considered “update of ongoing clinical trials”.Case series LowWhy?No sample size calculation.Small sample size.No ITT analysis.Lack of detail regarding dropouts.Possible Type 2 error.Sparse details about randomization/blinding.Full, final results not published.Same as above. Some uncertainty.Why?Only 1 RCT (technically grey literature). Generally direct (%EWL). Very Low Resolution of Comorbidities Case series Same as above ? Scanty data ? Scanty data Very Low Economic Analysis No formal economic analysis was identified in the literature search. The Alberta Heritage Foundation for Medical Research reported that the cost of implanting a GES in the United States for the treatment of GP is estimated to be $30,000 US. In Canada, the device costs approximately $10,700 Cdn; this does not include costs associated with the physician’s training, the implantation procedure, or device programming and maintenance. Ontario Context There is no Schedule of Benefits code for GES. There is no Canadian Classification of Health Interventions Index (CCI) procedure code for GES. Since the ICD-10 diagnosis code for gastroparesis falls under K31.8 “Other specified diseases of the stomach and duodenum”, it is impossible to determine how many patients in Ontario had discharge abstracts because of gastroparesis. In 2005, there were less than 5 out-of-country requests for GES (for either consultation only or for surgery). Gastroparesis The prevalence of severe, refractory GP is variably reported in the literature. The Alberta Heritage Foundation for Medical Research estimated that the prevalence of severe, symptomatic and medically refractory GP in the United States population was 0.017%. Assuming a total Ontario population of 13 million, this would correspond to a budget impact of approximately $23.6 M Cdn ($10,700 Cdn x 2,210 patients) for the device cost alone. The incidence of severe refractory GP estimated by the FDA is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year. This corresponds to a budget impact of approximately $107,000 Cdn to $1.6M Cdn per year for the device cost alone. Morbid Obesity An expert in the field estimated that there are 160,000 to 180,000 people in Ontario who are morbidly obese. This would correspond to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake). However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective). Conclusion As per the GRADE Working Group, overall recommendations consider 4 main factors. The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome. The quality of the evidence. Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise. Uncertainty about the baseline risk for the population of interest. The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 shows the overall trade-off between benefits and harms and incorporates any risk/uncertainty. For GP, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality, consistency and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $107,000 Cdn to $1.6M Cdn for the device cost alone, while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high-quality studies of effectiveness. Further evidence of effectiveness should be available in the future since there is a RCT underway that is examining the use of GES in patients with severe refractory GP associated with diabetes and idiopathic etiologies (ClinicalTrials.gov identifier NCT00157755). For morbid obesity, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and consistency), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake) while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high quality studies of effectiveness. However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective). Table 3: Overall GRADE and Strength of Recommendation (Including Uncertainty) Quality Estimated Prevalence in Ontario Cost-Effectiveness Cost in Ontario Risks/Burden Benefits Overall Grade & Strength of Recommendation Severe, chronic refractory GP Low Incidence ~ 20 to 150 ? Cdn $107,000 to $1.6M Removal rate ~ 5-10% of cases due to infection, stomach perforation, device migration/erosion.Cost effectiveness unknown.Ongoing/lifetime monitoring of patient.Battery change ~ 5 years.Post hoc change in end point analysis.Another RCT is underway. Uncertain short/long-term benefits (reduced frequency of vomiting/nausea; improved gastric emptying; quality of life). Weak Morbid obesity Very Low ~ 160,000 to 180,000 ? Uptake not determined in relation to other types of bariatric surgery (which are more effective). Adverse effects – stomach perforation and lead dislodgment – difficult to determine rate given mid-study changes in surgical technique.Cost effectiveness and uptake unknown.Ongoing/lifetime monitoring of patient.Battery change ~ < 5 years? Uncertain short/long-term benefits (EWL and improvement / resolution of comorbidities). Weak PMID:23074486

A single-center audit of the indications and clinical impact of prolonged ambulatory small intestinal manometry.

PubMed

Ang, D; Pannemans, J; Vanuytsel, T; Tack, J

2018-05-01

Small bowel manometry is a diagnostic test available only in a few specialized referral centers. Its exact place in the management of refractory symptoms is controversial. The records of all patients who underwent 24-hour ambulatory duodenojejunal manometry over a 6-year period were retrospectively reviewed. We studied the clinical indications for small bowel manometry, and reviewed the impact of manometric findings on the clinical outcome. One hundred and forty-six studies were performed in 137 patients (46M, 91F) with a mean age of 44.9 ± 15.7 years. Mean follow-up duration was 15.1 ± 22.6 months. Appropriate endoscopic, radiological and gastric scintigraphy studies were performed in all patients prior to small bowel manometry. Criteria for abnormal motor activity were based on Bharucha's classification. The indications for small bowel manometry were chronic abdominal pain (n = 43), slow-transit constipation (n = 17), refractory gastroparesis (n = 16), chronic diarrhea (n = 7), recurrent episodes of subocclusion (n = 16), postsurgical evaluation (n = 36), suspicion of gut involvement in systemic disease (n = 9), and unexplained nausea (n = 2). The most common finding was a normal 24-hour ambulatory small bowel manometry (n = 113). Thirty-three studies yielded abnormal findings which included extrinsic neuropathy (n = 6), intrinsic neuropathy (n = 18), intestinal myopathy (n = 2), and subocclusion (n = 7). Ambulatory small bowel manometry excluded a generalized motility disorder in 77% and had a significant impact on the subsequent clinical course in 23%. Ambulatory small bowel manometry is a useful and safe diagnostic tool to complement traditional investigative modalities in patients with severe unexplained abdominal symptoms. © 2018 John Wiley & Sons Ltd.

Peroral endoscopic myotomy

PubMed Central

Kumbhari, Vivek; Khashab, Mouen A

2015-01-01

Peroral endoscopic myotomy (POEM) incorporates concepts of natural orifice translumenal endoscopic surgery and achieves endoscopic myotomy by utilizing a submucosal tunnel as an operating space. Although intended for the palliation of symptoms of achalasia, there is mounting data to suggest it is also efficacious in the management of spastic esophageal disorders. The technique requires an understanding of the pathophysiology of esophageal motility disorders as well as knowledge of surgical anatomy of the foregut. POEM achieves short term response in 82% to 100% of patients with minimal risk of adverse events. In addition, it appears to be effective and safe even at the extremes of age and regardless of prior therapy undertaken. Although infrequent, the ability of the endoscopist to manage an intraprocedural adverse event is critical as failure to do so could result in significant morbidity. The major late adverse event is gastroesophageal reflux which appears to occur in 20% to 46% of patients. Research is being conducted to clarify the optimal technique for POEM and a personalized approach by measuring intraprocedural esophagogastric junction distensibility appears promising. In addition to esophageal disorders, POEM is being studied in the management of gastroparesis (gastric pyloromyotomy) with initial reports demonstrating technical feasibility. Although POEM represents a paradigm shift the management of esophageal motility disorders, the results of prospective randomized controlled trials with long-term follow up are eagerly awaited. PMID:25992188

Development of operationalized intravenous to oral antibiotic switch criteria.

PubMed

Akhloufi, H; Hulscher, M; Melles, D C; Prins, J M; van der Sijs, H; Verbon, A

2017-02-01

Despite huge overlap in suggested criteria for a safe intravenous (iv)-to-oral antibiotic switch, there is considerable variation in their operationalization. The objective of this study was to develop a set of measurable conditions that should be met in adult hospitalized patients for a safe iv-to-oral switch. A RAND-modified Delphi procedure was performed to develop a set of operationalized iv-to-oral switch criteria. Switch criteria and their accompanying suggested measurable conditions were extracted from the literature and appraised by a multidisciplinary expert panel during two questionnaire rounds with a face-to-face meeting between these two rounds. In a final step, the experts could approve the set of developed operationalized switch criteria. Seven switch criteria and 41 accompanying measurable conditions extracted from the literature were appraised. Sixteen measurable conditions that operationalize six switch criteria were selected: (i) stable systolic blood pressure; and the absence of (ii) fever, (iii) temperature <36°C, (iv) malabsorption syndrome, (v) short bowel syndrome, (vi) severe gastroparesis, (vii) ileus, (viii) continuous nasogastric suction, (ix) vomiting, (x) (severe) sepsis, (xi) fasciitis necroticans, (xii) CNS infection, (xiii) Staphylococcus aureus bacteraemia, and (xiv) endovascular infection. In addition, (xv) the patient should be cooperative and (xvi) adequate antimicrobial concentration should be achievable at the site of infection by oral administration. These operationalized criteria can be used in daily clinical practice. Future use of these criteria in audits and as rules in clinical decision support systems will facilitate the performance and evaluation of iv-oral switch programmes. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The effect of drugs and stimulants on gastric myoelectrical activity

PubMed Central

Kwiecień, Jarosław; Kasicka-Jonderko, Anna; Buschhaus, Magdalena

2014-01-01

Electrogastrography (EGG) is a non-invasive diagnostic method useful for the registration and analysis of gastric myoelectrical activity. Abnormalities within an electrogastrogram were found to correlate with a number of disorders and symptoms, like functional dyspepsia, diabetic gastroparesis and terminal hepatic or renal failure. The EGG is also a valuable diagnostic method enabling the evaluation of the effect of drugs on gastric myoelectrical activity, which can be intentional, as in the case of prokinetics, or can have an adverse character. Our review focuses on drugs with a proven impact on gastric myoelectrical activity and hence on the electrogastrogram. The paper assembles and discusses the results of investigations dealing with changes in the electrogastrograms evoked by various drugs. Moreover, the mechanisms of the influence on the gastric myoelectrical activity of drugs, curative substances and stimulants are presented. PMID:25097708

Refractory gastro-oesophageal reflux disease: diagnosis and management.

PubMed

Liu, Julia J; Saltzman, John R

2009-10-01

Refractory gastro-oesophageal reflux disease (GORD) is described when reflux symptoms have not responded to 4-8 weeks of proton pump inhibitor therapy and occurs in a heterogeneous mixture of patients. The causes of refractory GORD include inadequate acid suppression, non-acid gastro-oesophageal reflux, and non-reflux causes of GORD symptoms including achalasia, gastroparesis and functional heartburn. Upper gastrointestinal tract endoscopy should initially be performed to identify the presence of oesophagitis, and exclude other diagnoses including eosinophilic oesophagitis and peptic ulcer disease. Patients with refractory symptoms but with a normal upper endoscopy are more difficult to diagnose and may require ambulatory pH monitoring, impedance testing, oesophageal motility tests and gastric emptying scans. The primary goal of treatment is symptom reduction and eventual elimination, which can be achieved with proper identification of the underlying cause of the symptoms.

Medical and surgical management of esophageal and gastric motor dysfunction.

PubMed

Awad, R A

2012-09-01

he occurrence of esophageal and gastric motor dysfunctions happens, when the software of the esophagus and the stomach is injured. This is really a program previously established in the enteric nervous system as a constituent of the newly called neurogastroenterology. The enteric nervous system is composed of small aggregations of nerve cells, enteric ganglia, the neural connections between these ganglia, and nerve fibers that supply effectors tissues, including the muscle of the gut wall. The wide range of enteric neuropathies that includes esophageal achalasia and gastroparesis highlights the importance of the enteric nervous system. A classification of functional gastrointestinal disorders based on symptoms has received attention. However, a classification based solely in symptoms and consensus may lack an integral approach of disease. As an alternative to the Rome classification, an international working team in Bangkok presented a classification of motility disorders as a physiology-based diagnosis. Besides, the Chicago Classification of esophageal motility was developed to facilitate the interpretation of clinical high-resolution esophageal pressure topography studies. This review covers exclusively the medical and surgical management of the esophageal and gastric motor dysfunction using evidence from well-designed studies. Motor control of the esophagus and the stomach, motor esophageal and gastric alterations, treatment failure, side effects of PPIs, overlap of gastrointestinal symptoms, predictors of treatment, burden of GERD medical management, data related to conservative treatment vs. antireflux surgery, and postsurgical esophagus and gastric motor dysfunction are also taken into account.

Medication-induced acute esophageal necrosis: a case report.

PubMed

Pautola, Lauri; Hakala, Tapio

2016-09-29

Acute esophageal necrosis or Gurvits syndrome is a rare clinical condition characterized by necrotic esophageal mucosa with an abrupt end at the gastroesophageal junction. Its etiology is multifactorial, but mainly related to low-flow states. We describe a case in which a patient accidentally took the wrong medication, with clozapine and olanzapine most probably being the cause of his subsequent acute esophageal necrosis. This situation is, to the best of our knowledge, unprecedented in the medical literature. A 65-year-old Finnish male patient with schizoaffective disorder accidentally took another patient's medication, including clozapine 300 mg, olanzapine 30 mg, teofyllamine 200 mg, warfarin 5 mg, and potassium chloride 1 g. He arrived at our hospital for a routine examination 6 h after the incident. At hospital he started to vomit brownish liquid and had tachycardia and fever. Gastroparesis was found. An endoscopy revealed necrotic esophageal mucosa that was typical for Gurvits syndrome. A computed tomography scan showed an edematous esophagus and raised suspicion of a proximal jejunal obstruction. A laparotomy was performed but only healthy paralytic bowel was found. Our patient healed uneventfully within a week. There are analogous case reports describing ischemic colitis associated with the use of clozapine and olanzapine, but none describing the same for the other medications our patient took. We believe that in this case clozapine and olanzapine caused acute esophageal necrosis and this possibility should be taken into account when treating patients with acute ischemic enteropathy.

[Aspects of perioperative care in patients with diabetes].

PubMed

Pestel, G; Closhen, D; Zimmermann, A; Werner, C; Weber, M M

2013-01-01

Diabetes is a common disease in Germany. Due to diabetes-associated end-organ disease, such as large and small vessel disease and neuropathy, diabetic patients require more intense anesthesia care during the perioperative phase. An in-depth and comprehensive medical history focusing on hemodynamic alterations, gastroparesis, neuropathy and stiff joint syndrome is a cornerstone of perioperative care and may affect outcome of diabetes patients more than specific anesthetic medications or the anesthetic procedure. Intraoperative anesthetic care needs to focus on preservation of hemodynamic stability, perioperative infection control and maintenance of glucose homeostasis. Whereas some years ago strict glucose control by aggressive insulin therapy was adamantly advocated, the results of recent studies have put the risk of such therapeutic algorithms into perspective. Therefore, optimized perioperative care of diabetic patients consists of setting a predefined targeted blood glucose level, evidence-based therapeutic approaches to reach that goal and finally adequate and continuous monitoring and amendment of the therapeutic approach if required.

The Wireless Motility Capsule: a One-Stop Shop for the Evaluation of GI Motility Disorders.

PubMed

Saad, Richard J

2016-03-01

The wireless motility and pH capsule (WMC) provides an office-based test to simultaneously assess both regional and whole gut transit. Ingestion of this non-digestible capsule capable of measuring temperature, pH, and the pressure of its immediate surroundings allows for the measurement of gastric, small bowel, and colonic transit times in an ambulatory setting. Approved by the US Food and Drug Administration for the evaluation of suspected conditions of delayed gastric emptying and the evaluation of colonic transit in chronic idiopathic constipation, WMC should be considered in suspected gastrointestinal motility disorders as it provides a single study capable of simultaneously assessing for regional, multiregional, or generalized motility disorders. Specific indications for testing with the WMC should include the evaluation of suspect cases of gastroparesis, small bowel dysmotility, and slow transit constipation, as well as symptom syndromes suggestive of a multiregional or generalized gastrointestinal transit delay.

Complications associated with radiofrequency ablation of pulmonary veins.

PubMed

Madrid Pérez, J M; García Barquín, P M; Villanueva Marcos, A J; García Bolao, J I; Bastarrika Alemañ, G

Radiofrequency ablation is an efficacious alternative in patients with symptomatic atrial fibrillation who do not respond to or are intolerant to at least one class I or class III antiarrhythmic drug. Although radiofrequency ablation is a safe procedure, complications can occur. Depending on the location, these complications can be classified into those that affect the pulmonary veins themselves, cardiac complications, extracardiac intrathoracic complications, remote complications, and those that result from vascular access. The most common complications are hematomas, arteriovenous fistulas, and pseudoaneurysms at the puncture site. Some complications are benign and transient, such as gastroparesis or diaphragmatic elevation, whereas others are potentially fatal, such as cardiac tamponade. Radiologists must be familiar with the complications that can occur secondary to pulmonary vein ablation to ensure early diagnosis and treatment. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Gastric phytobezoars may be treated by nasogastric Coca-Cola lavage.

PubMed

Ladas, Spiros D; Triantafyllou, Konstantinos; Tzathas, Charalabos; Tassios, Pericles; Rokkas, Theodore; Raptis, Sotirios A

2002-07-01

Large gastric phytobezoars may occur in patients with gastric dysmotility disorders. Treatment options include dissolution with enzymes, endoscopic fragmentation with removal or aspiration, and surgery. We report our experience with nasogastric cola lavage therapy. Over an 8-year period, five consecutive patients were referred to our unit for endoscopic treatment of large gastric phytobezoars. They included one patient with lobectomy for lung cancer and four patients with diabetic gastroparesis. An initial attempt of endoscopic fragmentation and removal was unsuccessful. Patients were treated with 3 l of Coca-Cola nasogastric lavage over 12 h. Nasogastric lavage was very well tolerated by the patients. Complete phytobezoar dissolution was achieved in one session in all cases. There were no procedure-related complications. The dissolution of large gastric phytobezoars with cola nasogastric lavage is a safe, rapid and effective method. Patients may be treated in the medical ward, avoiding therapeutic endoscopy or surgery.

Review article: clinical implications of enteric and central D2 receptor blockade by antidopaminergic gastrointestinal prokinetics.

PubMed

Tonini, M; Cipollina, L; Poluzzi, E; Crema, F; Corazza, G R; De Ponti, F

2004-02-15

Antidopaminergic gastrointestinal prokinetics (bromopride, clebopride, domperidone, levosulpiride and metoclopramide) have been exploited clinically for the management of motor disorders of the upper gastrointestinal tract, including functional dyspepsia, gastric stasis of various origins and emesis. The prokinetic effect of these drugs is mediated through the blockade of enteric (neuronal and muscular) inhibitory D2 receptors. The pharmacological profiles of the marketed compounds differ in terms of their molecular structure, affinity at D2 receptors, ability to interact with other receptor systems [5-hydroxytryptamine-3 (5-HT3) and 5-HT4 receptors for metoclopramide; 5-HT4 receptors for levosulpiride) and ability to permeate the blood-brain barrier (compared with the other compounds, domperidone does not easily cross the barrier). It has been suggested that the serotonergic (5-HT4) component of some antidopaminergic prokinetics may enhance their therapeutic efficacy in gastrointestinal disorders, such as functional dyspepsia and diabetic gastroparesis. The antagonism of central D2 receptors may lead to both therapeutic (e.g. anti-emetic effect due to D2 receptor blockade in the area postrema) and adverse (including hyperprolactinaemia and extrapyramidal dystonic reactions) effects. As the pituitary (as well as the area postrema) is outside the blood-brain barrier, hyperprolactinaemia is a side-effect occurring with all antidopaminergic prokinetics, although to different extents. Extrapyramidal reactions are most commonly observed with compounds crossing the blood-brain barrier, although with some differences amongst the various agents. Prokinetics with a high dissociation constant compared with that of dopamine at the D2 receptor (i.e. compounds that bind loosely to D2 receptors in the nigrostriatal pathway) elicit fewer extrapyramidal signs and symptoms. A knowledge of central and peripheral D2 receptor pharmacology can help the clinician to choose between the antidopaminergic prokinetics to obtain a more favourable risk/benefit ratio.

Iterative Covariance-based Removal of Time-Synchronous Artifacts: Application to Gastrointestinal Electrical Recordings

PubMed Central

Putney, Joy; Hilbert, Douglas; Paskaranandavadivel, Niranchan; Cheng, Leo K.; O'Grady, Greg; Angeli, Timothy R.

2016-01-01

Objective The aim of this study was to develop, validate, and apply a fully automated method for reducing large temporally synchronous artifacts present in electrical recordings made from the gastrointestinal (GI) serosa, which are problematic for properly assessing slow wave dynamics. Such artifacts routinely arise in experimental and clinical settings from motion, switching behavior of medical instruments, or electrode array manipulation. Methods A novel iterative COvaraiance-Based Reduction of Artifacts (COBRA) algorithm sequentially reduced artifact waveforms using an updating across-channel median as a noise template, scaled and subtracted from each channel based on their covariance. Results Application of COBRA substantially increased the signal-to-artifact ratio (12.8±2.5 dB), while minimally attenuating the energy of the underlying source signal by 7.9% on average (-11.1±3.9 dB). Conclusion COBRA was shown to be highly effective for aiding recovery and accurate marking of slow wave events (sensitivity = 0.90±0.04; positive-predictive value = 0.74±0.08) from large segments of in vivo porcine GI electrical mapping data that would otherwise be lost due to a broad range of contaminating artifact waveforms. Significance Strongly reducing artifacts with COBRA ultimately allowed for rapid production of accurate isochronal activation maps detailing the dynamics of slow wave propagation in the porcine intestine. Such mapping studies can help characterize differences between normal and dysrhythmic events, which have been associated with GI abnormalities, such as intestinal ischemia and gastroparesis. The COBRA method may be generally applicable for removing temporally synchronous artifacts in other biosignal processing domains. PMID:26829772

Application of Pyridostigmine in Pediatric Gastrointestinal Motility Disorders: A Case Series.

PubMed

Manini, Mhd Louai; Camilleri, Michael; Grothe, Rayna; Di Lorenzo, Carlo

2018-04-01

Gastrointestinal (GI) motility disorders are common in children. Treatment is challenging with limited medical and surgical options. Pyridostigmine, an acetyl cholinesterase inhibitor, increases acetylcholine at the neuromuscular junction promoting intestinal contractions. Little is known about the role and dosing of pyridostigmine in pediatric GI motility disorders. We present a case series of children with GI dysmotility managed with oral pyridostigmine. Patients' diagnoses include chronic intestinal pseudo-obstruction, gastroparesis with delayed small bowel transit, chronic constipation with failure to thrive, and prolonged ileus after pelvic surgery with chronic opioid use. Pyridostigmine was effective and safe in all cases. Pyridostigmine decreased abdominal distention, increased bowel movement frequency, and improved enteral feeding tolerance. Effective dosing ranged between 0.25-2.0 mg/kg/day. One patient experienced cramping abdominal pain while on pyridostigmine, but pain resolved after medication was discontinued. We found oral pyridostigmine to be helpful in children with different GI motility problems. Pyridostigmine should be considered in such patients when other treatment interventions have not been beneficial.

Botulinum Toxin and Gastrointestinal Tract Disorders

PubMed Central

Weiser, Kirsten; Kennedy, Abigail

2008-01-01

The history of botulinum toxin is fascinating. First recognized as the cause of botulism nearly 200 years ago, it was originally feared as a deadly poison. Over the last 30 years, however, botulinum toxin has been transformed into a readily available medication used to treat a variety of medical disorders. Interest in the use of botulinum toxin has been particularly strong for patients with spastic smooth muscle disorders of the gastrointestinal tract. Patients with achalasia, diffuse esophageal spasm, gastroparesis, sphincter of Oddi dysfunction, and anal fissures have all been treated with botulinum toxin injections, often with impressive results. However, not all patients respond to botulinum toxin therapy, and large randomized controlled trials are lacking for many conditions commonly treated with botulinum toxin. This paper reviews the history, microbiology, and pharmacology of botulinum toxin, discusses its mechanism of action, and then presents recent evidence from the literature regarding the use of botulinum toxin for the treatment of a variety of gastrointestinal tract disorders. PMID:21960915

The mechanism of enhanced defecation caused by the ghrelin receptor agonist, ulimorelin.

PubMed

Pustovit, R V; Callaghan, B; Kosari, S; Rivera, L R; Thomas, H; Brock, J A; Furness, J B

2014-02-01

Discovery of adequate pharmacological treatments for constipation has proven elusive. Increased numbers of bowel movements were reported as a side-effect of ulimorelin treatment of gastroparesis, but there has been no investigation of the site of action. Anesthetized rats were used to investigate sites and mechanisms of action of ulimorelin. Intravenous ulimorelin (1-5 mg/kg) caused a substantial and prolonged (~1 h) increase in colorectal propulsive activity and expulsion of colonic contents. This was prevented by cutting the nerves emerging from the lumbosacral cord, by the nicotinic receptor antagonist hexamethonium and by antagonists of the ghrelin receptor. The effect of intravenous ulimorelin was mimicked by direct application of ulimorelin (5 μg) to the lumbosacral spinal cord. Ulimorelin is a potent prokinetic that causes propulsive contractions of the colorectum by activating ghrelin receptors of the lumbosacral defecation centers. Its effects are long-lasting, in contrast with other colokinetics that target ghrelin receptors. © 2013 John Wiley & Sons Ltd.

Utilization of wireless pH monitoring technologies: a summary of the proceedings from the esophageal diagnostic working group.

PubMed

Richter, J E; Pandolfino, J E; Vela, M F; Kahrilas, P J; Lacy, B E; Ganz, R; Dengler, W; Oelschlager, B K; Peters, J; DeVault, K R; Fass, R; Gyawali, C P; Conklin, J; DeMeester, T

2013-01-01

Gastroesophageal reflux disease (GERD) can be difficult to diagnose - symptoms alone are often not enough, and thus, objective testing is often required. GERD is a manifestation of pathologic levels of reflux into the esophagus of acidic, nonacidic, and/or bilious gastric content. However, in our current evidence-based knowledge approach, we only have reasonable outcome data in regards to acid reflux, as this particular type of refluxate predictably causes symptoms and mucosal damage, which improves with medical or surgical therapy. While there are data suggesting that nonacid reflux may be responsible for ongoing symptoms despite acid suppression in some patients, outcome data about this issue are limited. Therefore, this working group believes that it is essential to confirm the presence of acid reflux in patients with 'refractory' GERD symptoms or extraesophageal symptoms thought to be caused by gastroesophageal reflux before an escalation of antireflux therapy is considered. If patients do not have pathologic acid reflux off antisecretory therapy, they are unlikely to have clinically significant nonacid or bile reflux. Patients who do not have pathologic acid gastroesophageal reflux parameters on ambulatory pH monitoring then: (i) could attempt to discontinue antisecretory medications like proton pump inhibitors and H2-receptor antagonists (which are expensive and which carry risks - i.e. C. diff, etc.); (ii) may undergo further evaluation for other causes of their esophageal symptoms (e.g. functional heartburn or chest pain, eosinophilic esophagitis, gastroparesis, achalasia, other esophageal motor disorders); and (iii) can be referred to an ear, nose, and throat/pulmonary/allergy physician for assessment of non-GERD causes of their extraesophageal symptoms. © 2012 Copyright the Authors. Journal compilation © 2012, Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

Cannabis for inflammatory bowel disease.

PubMed

Naftali, Timna; Mechulam, Raphael; Lev, Lihi Bar; Konikoff, Fred M

2014-01-01

The marijuana plant Cannabis sativa has been used for centuries as a treatment for a variety of ailments. It contains over 60 different cannabinoid compounds. Studies have revealed that the endocannabinoid system is involved in almost all major immune events. Cannabinoids may, therefore, be beneficial in inflammatory disorders. In murine colitis, cannabinoids decrease histologic and microscopic inflammation. In humans, cannabis has been used to treat a plethora of gastrointestinal problems, including anorexia, emesis, abdominal pain, diarrhea, and diabetic gastroparesis. Despite anecdotal reports on medical cannabis in inflammatory bowel disease (IBD), there are few controlled studies. In an observational study in 30 patients with Crohn's disease (CD), we found that medical cannabis was associated with improvement in disease activity and reduction in the use of other medications. In a more recent placebo-controlled study in 21 chronic CD patients, we showed a decrease in the CD activity index >100 in 10 of 11 subjects on cannabis compared to 4 of 10 on placebo. Complete remission was achieved in 5 of 11 subjects in the cannabis group and 1 of 10 in the placebo group. Yet, in an additional study, low-dose cannabidiol did not have an effect on CD activity. In summary, evidence is gathering that manipulating the endocannabinoid system can have beneficial effects in IBD, but further research is required to declare cannabinoids a medicine. We need to establish the specific cannabinoids, as well as appropriate medical conditions, optimal dose, and mode of administration, to maximize the beneficial effects while avoiding any potential harmful effects of cannabinoid use. © 2014 S. Karger AG, Basel.

Therapeutic Potential of Targeting the Ghrelin Pathway.

PubMed

Colldén, Gustav; Tschöp, Matthias H; Müller, Timo D

2017-04-11

Ghrelin was discovered in 1999 as the endogenous ligand of the growth-hormone secretagogue receptor 1a (GHSR1a). Since then, ghrelin has been found to exert a plethora of physiological effects that go far beyond its initial characterization as a growth hormone (GH) secretagogue. Among the numerous well-established effects of ghrelin are the stimulation of appetite and lipid accumulation, the modulation of immunity and inflammation, the stimulation of gastric motility, the improvement of cardiac performance, the modulation of stress, anxiety, taste sensation and reward-seeking behavior, as well as the regulation of glucose metabolism and thermogenesis. Due to a variety of beneficial effects on systems' metabolism, pharmacological targeting of the endogenous ghrelin system is widely considered a valuable approach to treat metabolic complications, such as chronic inflammation, gastroparesis or cancer-associated anorexia and cachexia. The aim of this review is to discuss and highlight the broad pharmacological potential of ghrelin pathway modulation for the treatment of anorexia, cachexia, sarcopenia, cardiopathy, neurodegenerative disorders, renal and pulmonary disease, gastrointestinal (GI) disorders, inflammatory disorders and metabolic syndrome.

Therapeutic Potential of Targeting the Ghrelin Pathway

PubMed Central

Colldén, Gustav; Tschöp, Matthias H.; Müller, Timo D.

2017-01-01

Ghrelin was discovered in 1999 as the endogenous ligand of the growth-hormone secretagogue receptor 1a (GHSR1a). Since then, ghrelin has been found to exert a plethora of physiological effects that go far beyond its initial characterization as a growth hormone (GH) secretagogue. Among the numerous well-established effects of ghrelin are the stimulation of appetite and lipid accumulation, the modulation of immunity and inflammation, the stimulation of gastric motility, the improvement of cardiac performance, the modulation of stress, anxiety, taste sensation and reward-seeking behavior, as well as the regulation of glucose metabolism and thermogenesis. Due to a variety of beneficial effects on systems’ metabolism, pharmacological targeting of the endogenous ghrelin system is widely considered a valuable approach to treat metabolic complications, such as chronic inflammation, gastroparesis or cancer-associated anorexia and cachexia. The aim of this review is to discuss and highlight the broad pharmacological potential of ghrelin pathway modulation for the treatment of anorexia, cachexia, sarcopenia, cardiopathy, neurodegenerative disorders, renal and pulmonary disease, gastrointestinal (GI) disorders, inflammatory disorders and metabolic syndrome. PMID:28398233

Treatment of autonomic dysfunction in Parkinson disease and other synucleinopathies.

PubMed

Palma, Jose-Alberto; Kaufmann, Horacio

2018-03-01

Dysfunction of the autonomic nervous system afflicts most patients with Parkinson disease and other synucleinopathies such as dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure, reducing quality of life and increasing mortality. For example, gastrointestinal dysfunction can lead to impaired drug pharmacodynamics causing a worsening in motor symptoms, and neurogenic orthostatic hypotension can cause syncope, falls, and fractures. When recognized, autonomic problems can be treated, sometimes successfully. Discontinuation of potentially causative/aggravating drugs, patient education, and nonpharmacological approaches are useful and should be tried first. Pathophysiology-based pharmacological treatments that have shown efficacy in controlled trials of patients with synucleinopathies have been approved in many countries and are key to an effective management. Here, we review the treatment of autonomic dysfunction in patients with Parkinson disease and other synucleinopathies, summarize the nonpharmacological and current pharmacological therapeutic strategies including recently approved drugs, and provide practical advice and management algorithms for clinicians, with focus on neurogenic orthostatic hypotension, supine hypertension, dysphagia, sialorrhea, gastroparesis, constipation, neurogenic overactive bladder, underactive bladder, and sexual dysfunction. © 2018 International Parkinson and Movement Disorder Society. © 2018 International Parkinson and Movement Disorder Society.

A qualitative assessment of West Virginia pharmacist activities and attitude in diabetes management.

PubMed

Shatnawi, Aymen; Latif, David A

2017-06-01

The role of pharmacists in chronic disease state management has been shown to significantly improve patient health outcomes and reduce overall health care costs. The current study is designed to assess the roles and attitudes of West Virginia (WV) pharmacists toward diabetes, evaluate services provided, address pharmacist clinical understanding and training, and demonstrate the challenges that limit pharmacists ability to deliver an efficient disease state management. We invited 435 preceptors affiliated with the University of Charleston School of Pharmacy to participate in the study using Qualtrics online survey software. The survey was divided into sections related to pharmacists, practice environment, pharmacist's roles in diabetes management, and challenges faced that limit their ability to deliver effective care to diabetic patients. Data were analyzed using 1-way analysis of variance, and a P value ≤.05 was considered statistically significant. Of all eligible invited preceptors, 104 accessed the online survey based on the Qualtrics tracking tool, while 58 participated in the survey with a 56% response rate. Generally, WV pharmacists have positive attitudes regarding the provision of primary activities related to drug use and its associated problems. However, we report that WV pharmacists are less involved in providing education or recommendations regarding diabetes-associated risk factors such as nephropathy, retinopathy, foot care, and gastroparesis. In addition, the majority of pharmacists indicated that they face many challenges related to patient and the practice site environment that limit their ability to provide optimum diabetes patient care services. Despite the mounting evidence that pharmacists can improve diabetic patient outcomes while significantly reducing overall costs, WV pharmacists are less involved in providing education or counseling in a variety of areas related to disease state management. In addition, identifying pharmacist challenges provides significant information for future planning toward improving diabetic patient care. © 2016 John Wiley & Sons, Ltd.

[Functional and motor gastrointestinal disorders].

PubMed

Mearin, Fermín; Perelló, Antonia; Balboa, Agustín

2008-10-01

Functional gastrointestinal (GI) and motility disorders generate a large volume of consultations in gastroenterology and primary care offices. The present article summarizes the most interesting studies presented in the annual meeting of the American Gastroenterological Association 2008. For all functional GI disorders, studies were presented that evaluated the applicability of diagnostic criteria in clinical practice and new data were presented on physiopathology (for example, mediation by neuromodulators such as serotonin, microinflammation, alterations in intestinal microbiota, and psychological factors). More specifically, the therapeutic results of new prokinetic agents in functional dyspepsia, such as acotiamide, were presented. This agent has been demonstrated to have good efficacy in symptom control, especially in patients with postprandial distress syndrome. In irritable bowel syndrome, data were presented on several drugs that act through diverse mechanisms of action and have been shown to be more effective than placebo in symptom control. These drugs include antiinflammatory agents such as mesalazine, antibiotics such as rifaximin, probiotics with distinct bacterial strains, and prokinetic agents such as lubiprostone. Highly promising results have been obtained in the treatment of constipation with prokinetics such as prucalopride and with novel laxatives such as linaclotide, as well as with techniques that continue to be shown to be effective such as anorectal biofeedback, which is also highly useful in patients with fecal incontinence. Another disorder that is less frequent but highly difficult to treat is gastroparesis. For several years, treatment in the most severe cases has consisted of implantation of a gastric pacemaker. Although the results are far from perfect, new data were presented that allow better patient selection to achieve greater symptom control. The list of new advances, both in knowledge of the physiopathology of these disorders and on their treatments, is extensive. Consequently, 2008 has been a good year in terms of the useful information gathered for physicians interested in functional GI and motor disorders.

Diabetes and the Esophagus.

PubMed

Monreal-Robles, Roberto; Remes-Troche, José M

2017-12-01

Chronic hyperglycemia is a well-known cause of gastrointestinal motility disorders extending from the esophagus to the anorectum. Even though little attention has been paid to esophageal disorders in the context of DM, its prevalence is higher compared to gastroparesis. Heartburn, as a typical symptom of gastroesophageal reflux disease (GERD), is the most prevalent symptom and has been found in 25 to 41% of patients with DM. Furthermore, DM has recently been established as possible independent factor for the development of Barrett's esophagus. The pathophysiology of esophageal disorders in patients with DM is complex and multifactorial, and the mechanisms described include the following: hyperglycemia, autonomic neuropathy, biomechanical and sensory alterations of the esophagus, presbyesophagus, and psychiatric comorbidity. Opportune detection, together with adequate glycemic control, can delay the onset of esophageal dysfunction and slow its progression in diabetic patients. There is limited evidence on patients with DM and esophageal dysfunction, with respect to medical treatment. Lifestyle modifications, prokinetics, and proton pump inhibitors should be indicated on an individual basis in patients that present with DM and esophageal disorders. A greater number of improved studies are needed to develop new therapeutic strategies. This chapter will review esophageal disorders associated with DM and the currently available treatment options.

Gastrointestinal manifestations of mitochondrial disorders: a systematic review

PubMed Central

Finsterer, Josef; Frank, Marlies

2016-01-01

Mitochondrial disorders (MIDs) due to respiratory-chain defects or nonrespiratory chain defects are usually multisystem conditions [mitochondrial multiorgan disorder syndrome (MIMODS)] affecting the central nervous system (CNS), peripheral nervous system, eyes, ears, endocrine organs, heart, kidneys, bone marrow, lungs, arteries, and also the intestinal tract. Frequent gastrointestinal (GI) manifestations of MIDs include poor appetite, gastroesophageal sphincter dysfunction, constipation, dysphagia, vomiting, gastroparesis, GI pseudo-obstruction, diarrhea, or pancreatitis and hepatopathy. Rare GI manifestations of MIDs include dry mouth, paradontosis, tracheoesophageal fistula, stenosis of the duodeno-jejunal junction, atresia or imperforate anus, liver cysts, pancreas lipomatosis, pancreatic cysts, congenital stenosis or obstruction of the GI tract, recurrent bowel perforations with intra-abdominal abscesses, postprandial abdominal pain, diverticulosis, or pneumatosis coli. Diagnosing GI involvement in MIDs is not at variance from diagnosing GI disorders due to other causes. Treatment of mitochondrial GI disease includes noninvasive or invasive measures. Therapy is usually symptomatic. Only for myo-neuro-gastro-intestinal encephalopathy is a causal therapy with autologous stem-cell transplantation available. It is concluded that GI manifestations of MIDs are more widespread than so far anticipated and that they must be recognized as early as possible to initiate appropriate diagnostic work-up and avoid any mitochondrion-toxic treatment. PMID:28286566

Inhibitory effects of botulinum toxin on pyloric and antral smooth muscle.

PubMed

James, Arlene N; Ryan, James P; Parkman, Henry P

2003-08-01

Botulinum toxin injection into the pylorus is reported to improve gastric emptying in gastroparesis. Classically, botulinum toxin inhibits ACh release from cholinergic nerves in skeletal muscle. The aim of this study was to determine the effects of botulinum toxin on pyloric smooth muscle. Guinea pig pyloric muscle strips were studied in vitro. Botulinum toxin type A was added; electric field stimulation (EFS) was performed every 30 min for 6 h. ACh (100 microM)-induced contractile responses were determined before and after 6 h. Botulinum toxin caused a concentration-dependent decrease of pyloric contractions to EFS. At a low concentration (2 U/ml), botulinum toxin decreased pyloric contractions to EFS by 43 +/- 9% without affecting ACh-induced contractions. At higher concentrations (10 U/ml), botulinum toxin decreased pyloric contraction to EFS by 75 +/- 7% and decreased ACh-induced contraction by 79 +/- 9%. In conclusion, botulinum toxin inhibits pyloric smooth muscle contractility. At a low concentration, botulinum toxin decreases EFS-induced contractile responses without affecting ACh-induced contractions suggesting inhibition of ACh release from cholinergic nerves. At higher concentrations, botulinum toxin directly inhibits smooth muscle contractility as evidenced by the decreased contractile response to ACh.

Ranitidine Can Potentiate The Prokinetic Effect Of Itopride At Low Doses- An In Vitro Study.

PubMed

Butt, Aroosa Ishtiaq; Khan, Bushra Tayyaba; Khan, Asma; Khan, Qamar-Uz-Zaman

2017-01-01

Gastroparesis and GERD occur concomitantly in 40 percent of the cases. Prokinetic drugs and acid blockers are employed as the main treatment modality. Ranitidine is an acid blocker with additional prokinetic activity and Itopride is a known prokinetic drug. This study was designed to observe the synergistic potentiating prokinetic effect of Ranitidine on itopride on isolated duodenum of rabbits. Ranitidine (10-5-10-3) and itopride (10-6-10-5) were added in increasing concentrations to isolated duodenum of rabbits and contractions were recorded on PowerLab Data acquisition unit AHK/214. Cumulative dose response curves were constructed. The potentiating prokinetic effect of Ranitidine on itopride was seen by using a fixed dose of ranitidine and cumulatively enhancing doses of itopride on iWorx. Ranitidine and itopride produced a dose dependent reversible contraction of the isolated tissue of rabbits with ranitidine showing a max response of 0.124mV and itopride showing a maximum response of 0.131mV. Ranitidine was able to potentiate the prokinetic effect of itopride at low doses but at high dose the effect began to wane off. Ranitidine and itopride produce a statistically significant synergistic potentiating prokinetic effect at low doses in vitro.

Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors.

PubMed

Strauss, Julius; Heery, Christopher R; Schlom, Jeffrey; Madan, Ravi A; Cao, Liang; Kang, Zhigang; Lamping, Elizabeth; Marté, Jennifer L; Donahue, Renee N; Grenga, Italia; Cordes, Lisa; Christensen, Olaf; Mahnke, Lisa; Helwig, Christoph; Gulley, James L

2018-03-15

Purpose: M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein composed of a mAb against programmed death ligand 1 (PD-L1) fused to a TGFβ "trap." Experimental Design: In the 3+3 dose-escalation component of this phase I study (NCT02517398), eligible patients with advanced solid tumors received M7824 at 1, 3, 10, or 20 mg/kg once every 2 weeks until confirmed progression, unacceptable toxicity, or trial withdrawal; in addition, a cohort received an initial 0.3 mg/kg dose to evaluate pharmacokinetics/pharmacodynamics, followed by 10 mg/kg dosing. The primary objective is to determine the safety and maximum tolerated dose (MTD); secondary objectives include pharmacokinetics, immunogenicity, and best overall response. Results: Nineteen heavily pretreated patients with ECOG 0-1 have received M7824. Grade ≥3 treatment-related adverse events occurred in four patients (skin infection secondary to localized bullous pemphigoid, asymptomatic lipase increase, colitis with associated anemia, and gastroparesis with hypokalemia). The MTD was not reached. M7824 saturated peripheral PD-L1 and sequestered any released plasma TGFβ1, -β2, and -β3 throughout the dosing period at >1 mg/kg. There were signs of efficacy across all dose levels, including one ongoing confirmed complete response (cervical cancer), two durable confirmed partial responses (PR; pancreatic cancer; anal cancer), one near-PR (cervical cancer), and two cases of prolonged stable disease in patients with growing disease at study entry (pancreatic cancer; carcinoid). Conclusions: M7824 has a manageable safety profile in patients with heavily pretreated advanced solid tumors. Early signs of efficacy are encouraging, and multiple expansion cohorts are ongoing in a range of tumors. Clin Cancer Res; 24(6); 1287-95. ©2018 AACR . ©2018 American Association for Cancer Research.

[Effect of Different Stimulating Strength of Electroacupuncture on Gastrointestinal Motility and RhoA/ROCK Signaling in Gastric Antral Smooth Muscle in Diabetic Gastroparesis Rats].

PubMed

Wu, Xue-Fen; Chen, Xiao-Li; Zheng, Xue-Na; Guo, Xin; Xie, Zhi-Qiang; Liu, Li; Wei, Xin-Ran; Yue, Zeng-Hui

2018-03-25

To observe the effect of different strength of electroacupuncture (EA) stimulation on gastrointestinal motility and Ras homolog gene family member (RhoA)/Rho associated coiled-coil forming protein kinase (ROCK) signaling in diabetic gastroparesis (DGP) rats, so as to reveal the underlying mechanisms of EA for improving DGP. Sixty SD rats were randomly and equally divided into blank control, DGP model, weak EA, medium EA, and strong EA groups ( n ＝12 rats in each). The DGP model was established by intraperitoneal injection of streptozotocin (STZ, 55 mmol/kg, 2%) and high-sugar and high-fat fodder feeding for 8 weeks. EA (0.12, 0.24, 0.36 mA, 20 Hz/100 Hz) was applied to "Zusanli" (ST 36), "Sanyinjiao" (SP 6) and "Liangmen" (ST 21) for 20 min, once daily for 15 successive days. Blood glucose levels were measured weekly with blood glucose meter and blood glucose test paper. Fecal phenol red excretion method was used to display gastric emptying and small intestinal propulsion function. The expression of RhoA protein in the gastric antral smooth muscle tissue was detected by immunohistochemistry and Western blot (WB), separately, and that of ROCK, myosin phosphatase target subunit 1 (MYPT 1) and phosphorylated (p)-MYPT 1 proteins in gastric antrum detected by WB. Compared with the blank control group, the gastric emptying rate and small intestine propulsion rate of the model group were significantly decreased ( P <0.05), and the blood glucose level was remarkably increased ( P <0.05). Moreover, the expression levels of RhoA, ROCK, MYPT 1 and p-MYPT 1 proteins in the gastric antrum were significantly down-regulated relevant to the control group ( P <0.05). After administration of EA, the decreased gastric emptying rate and intestinal propulsion rate, and the down-regulated expression of RhoA, ROCK, MYPT 1 and p-MYPT 1 proteins were significantly increased in the strong, medium and weak EA stimulation groups ( P <0.05). Comparison among the 3 EA groups showed that the strong stimulation was significantly superior to weak stimulation in up-regulating the expression of RhoA, ROCK, MYPT 1 and p-MYPT 1 proteins, and obviously superior to the medium stimulation in up-regulating RhoA and MYPT 1 protein levels ( P <0.05), while the medium stimulation was significantly stronger than the weak stimulation in up-regulating the expression of ROCK, MYPT 1 and p-MYPT 1 proteins ( P <0.05). There were no significant differences among the 3 EA groups in up-regulating the gastric emptying rate and small intestinal propulsion rate, and between the strong stimulation and medium stimulation in the expression levels of ROCK and p-MYPT 1 proteins ( P >0.05). Electroacupuncture stimulation of ST 36-SP 6-ST 21 at 0.12, 0.24 and 0.36 mA can promote the gastrointestinal motility in DGP rats, which may be associated with its effects in enhancing RhoA/ROCK signaling in the gastric antral smooth muscle at different degrees.

Current Diagnosis and Management of Suspected Reflux Symptoms Refractory to Proton Pump Inhibitor Therapy

PubMed Central

2014-01-01

Suspected reflux symptoms that are refractory to proton pump inhibitors (PPIs) are rapidly becoming the most common presentation of gastroesophageal reflux disease (GERD) in patients seen in gastroenterology clinics. These patients are a heterogeneous group, differing in symptom frequency and severity, PPI dosing regimens, and responses to therapy (from partial to absent). Before testing, the physician needs to question the patient carefully about PPI compliance and the timing of drug intake in relation to meals. Switching PPIs or doubling the dose is the next step, but only 20% to 25% of the group refractory to PPIs will respond. The first diagnostic test should be upper gastrointestinal endoscopy. In more than 90% of cases, the results will be normal, but persistent esophagitis may suggest pill esophagitis, eosinophilic esophagitis, or rarer diseases, such as lichen planus, Zollinger-Ellison syndrome, or genotype variants of PPI metabolism. If the endoscopy results are normal, esophageal manometry and especially reflux testing should follow. Whether patients should be tested on or off PPI therapy is controversial. Most physicians prefer to test patients off PPIs to identify whether abnormal acid reflux is even present; if it is not, PPIs can be stopped and other diagnoses sought. Testing patients on PPI therapy allows nonacid reflux to be identified, but more than 50% of patients have a normal test result, leaving the clinician with a conundrum—whether to stop PPIs or continue them because the GERD is being treated adequately. Alternative diagnoses in patients with refractory GERD and normal reflux testing include achalasia, eosinophilic esophagitis, gastroparesis, rumination, and aerophagia. However, more than 50% will be given the diagnosis of functional heartburn, a visceral hypersensitivity syndrome. Treating patients with PPI-refractory GERD–like symptoms can be difficult and frustrating. Any of the following may help: a histamine-2 receptor antagonist at night, baclofen to decrease transient lower esophageal sphincter relaxations, pain modulators, acupuncture, or hypnotherapy. At this time, antireflux surgery should be limited to patients with abnormal acid reflux defined by pH testing and a good correlation of symptoms with acid reflux. PMID:27551249

Clopidogrel IBS Patients Have Higher Incidence of Gastrointestinal Symptoms Influenced by Age and Gender.

PubMed

Soghomonyan, Suren; Abdel-Rasoul, Mahmoud; Zuleta-Alarcon, Alix; Grants, Iveta; Davila, Victor; Yu, Jeffrey; Zhang, Cheng; Whitaker, Emmett E; Bergese, Sergio D; Stoicea, Nicoleta; Arsenescu, Razvan; Christofi, Fievos L

2017-10-01

Clopidogrel is an irreversible antagonist of P2Y 12 receptors (P2Y 12 Rs) used as an antiplatelet drug to reduce risk of thrombosis. P2Y 12 Rs are expressed in gastrointestinal (GI) tract where they might regulate GI function. To evaluate if blockade of P2Y 12 Rs by clopidogrel is associated with higher incidence of GI symptoms in patients with irritable bowel syndrome (IBS). A retrospective analysis of our institutional database was conducted for a 13-year period. IBS patients were identified, and their demographics, GI symptoms and clopidogrel therapy were collected. Logistic regression models were used to characterize symptoms in clopidogrel versus no-clopidogrel IBS-groups, adjusting for Age and Sex differences. An additional study characterized the P2Y 12 R distribution in human gut. The search identified 7217 IBS patients (6761 no-clopidogrel/456 clopidogrel). There were a higher proportion of patients with GI symptoms on clopidogrel (68%) compared to controls (60%, p = 0.0011) that were Females (70 vs. 60%, p = 0.0003) not Males (61 vs. 60%; p = 0.8312). In Females, clopidogrel was associated with higher incidence of GI symptoms (Age adjusted; p < 0.0001) for pain, constipation, gastroparesis (p ≤ 0.0001) and psychogenic pain (p = 0.0006). Age or Sex (adjusted models) influenced one or more GI symptoms (i.e., pain, p < 0.0001; constipation, p < 0.0001/p = 0.008; diarrhea, flatulence, p = 0.01). P2Y 12 R immunoreactivity was abundant in human ENS; glial-to-neuron ratio of P2Y 12 Rs expressed in Females ≫ Males. Irreversible blockade of P2Y 12 R by clopidogrel is associated with higher incidence of GI symptoms in Female IBS patients, although Age or Sex alone contributes to symptomatology. Prospective studies can determine clinical implications of P2Y 12 Rs in IBS.

Intestinal electrical stimulation improves delayed gastric emptying and vomiting induced by duodenal distension in dogs.

PubMed

Xu, J; Chen, J D Z

2008-03-01

The aim of this study was to investigate the effects of short-pulse intestinal electrical stimulation (IES) on duodenal distention-induced delayed gastric emptying and vomiting in dogs and its possible mechanisms. The study was performed in 12 dogs with jejunal electrodes and a duodenal cannula in three separate experiments to investigate the effects of IES on duodenal distension (DD)-induced delayed gastric emptying and discomfort signs, vagal efferent activity, and jejunal tone. We found that: (i) IES significantly accelerated gastric emptying of liquid delayed by distension (18.05 +/- 4.06%vs. 7.18 +/- 1.99%, P = 0.036 at 60 min). (ii) IES significantly reduced vomiting and discomfort/pain induced by distension. The average signs score was 15.33 +/- 1.37 during distension which decreased to 6.50 +/- 0.91 (P = 0.0002) with IES. (iii) IES did not change vagal afferent activity, which was assessed by the spectral analysis of the heart rate variability. (iv) IES decreased jejunal tone. In conclusion, IES with parameters commonly used in gastric electrical stimulation for nausea and vomiting associated with gastroparesis improves DD-induced delayed gastric emptying and prevents DD-induced vomiting and discomfort signs. Further studies are warranted to investigate the therapeutic potential of IES for gastrointestinal symptoms associated with disturbances in motility and sensory function in small intestine.

Assessment of gastric emptying in non-obese diabetic mice using a [13C]-octanoic acid breath test.

PubMed

Creedon, Christopher T; Verhulst, Pieter-Jan; Choi, Kyoung M; Mason, Jessica E; Linden, David R; Szurszewski, Joseph H; Gibbons, Simon J; Farrugia, Gianrico

2013-03-23

Gastric emptying studies in mice have been limited by the inability to follow gastric emptying changes in the same animal since the most commonly used techniques require killing of the animals and postmortem recovery of the meal(1,2). This approach prevents longitudinal studies to determine changes in gastric emptying with age and progression of disease. The commonly used [(13)C]-octanoic acid breath test for humans(3) has been modified for use in mice(4-6) and rats(7) and we previously showed that this test is reliable and responsive to changes in gastric emptying in response to drugs and during diabetic disease progression(8). In this video presentation the principle and practical implementation of this modified test is explained. As in the previous study, NOD LtJ mice are used, a model of type 1 diabetes(9). A proportion of these mice develop the symptoms of gastroparesis, a complication of diabetes characterized by delayed gastric emptying without mechanical obstruction of the stomach(10). This paper demonstrates how to train the mice for testing, how to prepare the test meal and obtain 4 hr gastric emptying data and how to analyze the obtained data. The carbon isotope analyzer used in the present study is suitable for the automatic sampling of the air samples from up to 12 mice at the same time. This technique allows the longitudinal follow-up of gastric emptying from larger groups of mice with diabetes or other long-standing diseases.

Plasticity of vagal brainstem circuits in the control of gastric function

PubMed Central

Browning, Kirsteen N.; Travagli, R. Alberto

2010-01-01

Background Sensory information from the viscera, including the gastrointestinal (GI) tract, is transmitted through the afferent vagus via a glutamatergic synapse to neurons of the nucleus tractus solitarius (NTS), which integrate this sensory information to regulate autonomic functions and homeostasis. The integrated response is conveyed to, amongst other nuclei, the preganglionic neurons of the dorsal motor nucleus of the vagus (DMV) using mainly GABA, glutamate and catecholamines as neurotransmitters. Despite being modulated by almost all the neurotransmitters tested so far, the glutamatergic synapse between NTS and DMV does not appear to be tonically active in the control of gastric motility and tone. Conversely, tonic inhibitory GABAergic neurotransmission from the NTS to the DMV appears critical in setting gastric tone and motility, yet, under basal conditions, this synapse appears resistant to modulation. Purpose Here, we review the available evidence suggesting that vagal efferent output to the GI tract is regulated, perhaps even controlled, in an “on-demand” and efficient manner in response to ever-changing homeostatic conditions. The focus of this review is on the plasticity induced by variations in the levels of second messengers in the brainstem neurons that form vago-vagal reflex circuits. Emphasis is placed upon the modulation of GABAergic transmission to DMV neurons and the modulation of afferent input from the GI tract by neurohormones/neurotransmitters and macronutrients. Derangement of this “on-demand” organization of brainstem vagal circuits may be one of the factors underlying the pathophysiological changes observed in functional dyspepsia or hyperglycemic gastroparesis. PMID:20804520

The stomach in health and disease

PubMed Central

Hunt, R H; Camilleri, M; Crowe, S E; El-Omar, E M; Fox, J G; Kuipers, E J; Malfertheiner, P; McColl, K E L; Pritchard, D M; Rugge, M; Sonnenberg, A; Sugano, K; Tack, J

2016-01-01

The stomach is traditionally regarded as a hollow muscular sac that initiates the second phase of digestion. Yet this simple view ignores the fact that it is the most sophisticated endocrine organ with unique physiology, biochemistry, immunology and microbiology. All ingested materials, including our nutrition, have to negotiate this organ first, and as such, the stomach is arguably the most important segment within the GI tract. The unique biological function of gastric acid secretion not only initiates the digestive process but also acts as a first line of defence against food-borne microbes. Normal gastric physiology and morphology may be disrupted by Helicobacter pylori infection, the most common chronic bacterial infection in the world and the aetiological agent for most peptic ulcers and gastric cancer. In this state-of-the-art review, the most relevant new aspects of the stomach in health and disease are addressed. Topics include gastric physiology and the role of gastric dysmotility in dyspepsia and gastroparesis; the stomach in appetite control and obesity; there is an update on the immunology of the stomach and the emerging field of the gastric microbiome. H. pylori-induced gastritis and its associated diseases including peptic ulcers and gastric cancer are addressed together with advances in diagnosis. The conclusions provide a future approach to gastric diseases underpinned by the concept that a healthy stomach is the gateway to a healthy and balanced host. This philosophy should reinforce any public health efforts designed to eradicate major gastric diseases, including stomach cancer. PMID:26342014

Interaction of insulin with prokinetic drugs in STZ-induced diabetic mice

PubMed Central

Shalaby, Mohamed A Fouad; Latif, Hekma A Abd El; Sayed, Mostafa E El

2013-01-01

AIM: To study the possible interactions of metoclopramide, domperidone and erythromycin in streptozotocin-induced diabetic mice treated with insulin by various parameters. METHODS: Effects of the individual as well as combined drugs were studied in diabetic mice via estimation of the blood glucose and serum insulin levels, small intestinal transit (SIT), gastric emptying (GE), xylose absorption and glucose tolerance tests. Groups were given insulin 2 IU/kg s.c., metoclopramide 20 mg/kg p.o., domperidone 20 mg/kg p.o. and erythromycin 6 mg/kg p.o. individually and in combination. There were also normal and diabetic control groups. The first set of experiments was carried out to investigate the subchronic effect on blood glucose and serum insulin levels in diabetic mice of one week of daily dose administration of the tested drugs individually as well as the combination of insulin with each prokinetic drug. The other five sets of experiments were carried out to investigate the acute effect of a single dose of each drug individually and in combination on blood glucose and serum insulin levels, SIT, GE, oral xylose absorption and glucose tolerance tests. RESULTS: The study included the prokinetic drugs metoclopramide (20 mg/kg), domperidone (20 mg/kg) and erythromycin (6 mg/kg), as well as insulin (2 IU/kg), which was individually effective in decreasing SIT, enhancing GE and increasing xylose absorption significantly in diabetic mice. Erythromycin tended to decrease blood glucose level and increase serum insulin level after 1 wk of daily administration in diabetic mice. Erythromycin potentiated the effect of insulin on blood glucose level and serum insulin level whereas other prokinetic agents failed to do so after repeated dose administration in diabetic mice. Metoclopramide or erythromycin in combination with insulin significantly decreased SIT, in diabetic mice, to lower levels than with insulin alone. Administration of prokinetic drugs along with insulin antagonized the action of insulin on xylose absorption. These combinations also increased the rate of glucose absorption from the gut. CONCLUSION: The present study suggests that prokinetic drugs could potentially improve glycemic control in diabetic gastroparesis by allowing a more predictable absorption of nutrients, matched to the action of exogenous insulin. The use of prokinetics, such as erythromycin, may be interesting in the clinic in decreasing the need for insulin in diabetic patients. The dose of insulin may be safely decreased with erythromycin in chronic treatments. PMID:23667771

Nurse awareness of clinical research: a survey in a Japanese University Hospital

PubMed Central

2014-01-01

Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse. Conclusions These findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research. PMID:24989623

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

PubMed Central

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-01-01

Objectives Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. Setting The setting for this research was a major academic institution in Beijing, China. Participants The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Methods Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Results Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. Conclusion These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. PMID:28928184

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

PubMed

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Decline of clinical research in academic medical centers.

PubMed

Meador, Kimford J

2015-09-29

Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge. © 2015 American Academy of Neurology.

Decline of clinical research in academic medical centers

PubMed Central

2015-01-01

Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge. PMID:26156509

[Support Team for Investigator-Initiated Clinical Research].

PubMed

Fujii, Hisako

2017-07-01

Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

A qualitative study on clinical research in Finland: fragmented governance and volume in the 2000s

PubMed Central

Hemminki, Elina; Veerus, Piret; Virtanen, Jorma; Lehto, Juhani

2013-01-01

Objectives Although concerns over clinical research have been expressed, the governance of clinical research has been little studied. The aim was to describe research policy, volume, funding and concerns over clinical research in Finland. Design A qualitative study and the data were collected from various sources, including documents, statistics and semistructured expert interviews. Setting Finland. Results We found no national policy for clinical research. Many actors were responsible for facilitating, directing, regulating and funding clinical research, but no actor had the main responsibility. Health professionals were the main drivers for clinical research. The role of the health ministry was small. The ministry distributed state money for clinical research in health services (EVO-money), but did not use it to direct research. Municipalities responsible for health services or national health insurance had little interest in clinical research. The Academy of Finland had had initiatives to promote clinical research, but they had not materialised in funding. Clinical research was common and internationally competitive, but its volume had declined relatively in the 2000s. Industry was an important private funder, mainly supporting drug trials made for licensing purposes. Drug trials without an outside sponsor (academic projects) declined between 2002 and 2010. The funding and its targeting and amount were no one's responsibility. Concerns over clinical research were similar as in other countries, but it had appeared late. Conclusions Our results suggest fragmented governance and funding in clinical research. The unsystematic research environment has not prevented clinical research from flourishing, but the public health relevance of the research carried out and its sustainability are unclear. PMID:23408074

Nature and governance of veterinary clinical research conducted in the UK.

PubMed

Fordyce, P; Mullan, S

2017-01-21

In order to quantify the amount of clinical research conducted on client-owned animals under the Veterinary Surgeons Act 1966, and the nature and extent of any ethical review of that research, a questionnaire was sent to 6 UK veterinary schools, 1 charity veterinary clinic and 12 private referral clinics. The questionnaire examined whether and how much clinical research respondents undertook, and the composition of any ethical review panels examining research proposals. The questionnaire revealed a substantial amount of clinical research was conducted in the UK, with over 200 veterinary surgeons involved in the year of the survey, with at least 170 academic papers involving clinical research published by respondents in the same year. However, it proved impossible to quantify the full extent of clinical research in the UK. All UK veterinary schools required ethical review of clinical research. The composition and working practices of their ethical review panels generally reflected skill sets in ethical review panels set-up under statute to consider the ethics of non-clinical biomedical research on animals and clinical research conducted on human patients. The process for review of clinical research in the private sector was less clear. British Veterinary Association.

How can we improve clinical research in pneumonia?

PubMed

Ramirez, Julio A

2018-05-01

The primary challenges in the field of clinical research include a lack of support within existing infrastructure, insufficient number of clinical research training programs and a paucity of qualified mentors. Most medical centers offer infrastructure support for investigators working with industry sponsors or government-funded clinical trials, yet there are a significant amount of clinical studies performed in the field of pneumonia which are observational studies. For this type of research, which is frequently unfunded, support is usually lacking. In an attempt to optimize clinical research in pneumonia, at the University of Louisville, we developed a clinical research coordinating center (CRCC). The center manages clinical studies in the field of respiratory infections, with the primary focus being pneumonia. Other activities of the CRCC include the organization of an annual clinical research training course for physicians and other healthcare workers, and the facilitation of international research mentoring by a process of connecting new pneumonia investigators with established clinical investigators. To improve clinical research in pneumonia, institutions need to have the appropriate infrastructure in place to support investigators in all aspects of the clinical research process.

Pharmacy Students' Knowledge and Attitude toward Registration Trials and Clinical Research: A Survey in a Japanese University Hospital.

PubMed

Ise, Natsuko; Takechi, Kenshi; Miyamoto, Toshiko; Ishizawa, Keisuke; Yanagawa, Hiroaki

2017-12-11

Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103) to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6%) understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.

Asking good clinical research questions and choosing the right study design.

PubMed

Bragge, P

2010-07-01

Clinicians and researchers seek answers to clinical research questions, primarily by accessing the results of clinical research studies. This paper moves the focus of research enquiry from getting answers to developing good clinical research questions. Using worked examples, the steps involved in refining questions drawn from various sources to create 'answerable' clinical research questions using the 'PICO' principle are described. Issues to consider in prioritising clinical research questions are also identified. Theoretical and practical considerations involved in choosing the right study design for a clinical research question are then discussed using the worked examples. These include: Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials.

PubMed

Fujiwara, Noriko; Ochiai, Ryota; Shirai, Yuki; Saito, Yuko; Nagamura, Fumitaka; Iwase, Satoru; Kazuma, Keiko

2017-12-01

Clinical research coordinators play a pivotal role in phase I cancer clinical trials. We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials. Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team. Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.

The influence of an elective introductory clinical research course on pharmacy student interest in pursuing research-based careers.

PubMed

Overholser, Brian R; Foster, David R; Henry, Joshua R; Plake, Kimberly S; Sowinski, Kevin M

2010-11-10

To assess the impact of an elective clinical research course on second- and third-year pharmacy students' knowledge of clinical research methods, training programs, career options, and interest in pursuing postgraduate training. A 2-credit hour elective course in clinical research was designed that included lectures, discussions, workshops, and in-class presentations related to study design and implementation, protocol synthesis, research evaluation, ethical and legal considerations, data analysis, and professional opportunities involving clinical research. Learner knowledge of these topics was assessed using several methods, including 3 assignments related to research protocol, ethical documentation, and presentation. A survey instrument designed to evaluate the effect the course had on pharmacy students' knowledge of clinical research methods and interest in pursuing postgraduate training in clinical research was administered. Students who completed the elective had a greater level of familiarity with research-related topics, training options, and career opportunities (p < 0.05) and a greater interest in pursuing a career in clinical research (p < 0.05) than did students in a matched control group. Taking a 2-credit hour elective course in clinical research increased pharmacy students' interest in pursuing a career in clinical research.

Developing future clinician scientists while supporting a research infrastructure.

PubMed

Holsti, Maija; Adelgais, Kathleen M; Willis, Leah; Jacobsen, Kammy; Clark, Edward B; Byington, Carrie L

2013-04-01

Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research. Describe an innovative undergraduate course that supports clinical research in an AMC. The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists' conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students. Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top-enrollers in multicenter clinical trials as a result of student support. The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research. © 2013 Wiley Periodicals, Inc.

Highly effective cystic fibrosis clinical research teams: critical success factors.

PubMed

Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

2014-08-01

Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

[Introduction of a Clinical Research Experience Program in Hospital Practical Training for Pharmacy Students and Its Evaluation].

PubMed

Takahashi, Katsuyuki; Suda, Yasuki; Kawaguchi, Hiroshi; Nakamura, Yasutaka; Kawabata, Shiho; Kawakami, Noriko; Nishikawa, Takeshi; Nagayama, Katsuya

2015-01-01

Long-term clinical training based on a model core curriculum was conducted to nurture highly competent pharmacists in the clinical field. Pharmacists' responsibilities are expanding, and a system has been developed to help pharmacists gain accreditation, identify specialties, and improve their training. However, this system requires research competency. Therefore clinical research should be considered a part of clinical training to encourage high competency among pharmacists. Because the model core curriculum does not include a section on clinical research. Osaka City University Hospital introduced a hands-on clinical research experience program and evaluated its usefulness. A significant improvement in the level of knowledge and awareness of clinical research was seen among students who underwent the clinical research experience program. In addition, the level of student satisfaction was higher. These findings suggest that a clinical research experience program may be useful to nurture a greater awareness of clinical research and knowledge acquisition among pharmacists.

Perspectives on Research Participation and Facilitation Among Dialysis Patients, Clinic Personnel, and Medical Providers: A Focus Group Study.

PubMed

Flythe, Jennifer E; Narendra, Julia H; Dorough, Adeline; Oberlander, Jonathan; Ordish, Antoinette; Wilkie, Caroline; Dember, Laura M

2017-12-19

Most prospective studies involving individuals receiving maintenance dialysis have been small, and many have had poor clinical translatability. Research relevance can be enhanced through stakeholder engagement. However, little is known about dialysis clinic stakeholders' perceptions of research participation and facilitation. The objective of this study was to characterize the perspectives of dialysis clinic stakeholders (patients, clinic personnel, and medical providers) on: (1) research participation by patients and (2) research facilitation by clinic personnel and medical providers. We also sought to elucidate stakeholder preferences for research communication. Qualitative study. 7 focus groups (59 participants: 8 clinic managers, 14 nurses/patient care technicians, 8 social workers/dietitians, 11 nephrologists/advanced practice providers, and 18 patients/care partners) from 7 North Carolina dialysis clinics. Clinics and participants were purposively sampled. Focus groups were recorded and transcribed. Thematic analysis. We identified 11 themes that captured barriers to and facilitators of research participation by patients and research facilitation by clinic personnel and medical providers. We collapsed these themes into 4 categories to create an organizational framework for considering stakeholder (narrow research understanding, competing personal priorities, and low patient literacy and education levels), relationship (trust, buy-in, and altruistic motivations), research design (convenience, follow-up, and patient incentives), and dialysis clinic (professional demands, teamwork, and communication) aspects that may affect stakeholder interest in participating in or facilitating research. These themes appear to shape the degree of research readiness of a dialysis clinic environment. Participants preferred short research communications delivered in multiple formats. Potential selection bias and inclusion of English-speaking participants only. Our findings revealed patient interest in participating in research and clinical personnel and medical provider interest in facilitating research. Overall, our results suggest that dialysis clinic research readiness may be enhanced through increased stakeholder research knowledge and alignment of clinical and research activities. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

The Design and Development of a Technology Based Orientation Manual for Clinical Research Coordinators

ERIC Educational Resources Information Center

Copp, Susan L.

2010-01-01

The objective of this research was to use technology to develop an on-line orientation manual for clinical research coordinators. Many clinical research coordinators begin their careers as staff nurses and have little knowledge related to clinical research. As such, when they transition to a career in clinical research they lack the knowledge…

Research leadership: should clinical directors be distinguished researchers?

PubMed

Allison, Stephen; Goodall, Amanda H; Bastiampillai, Tarun

2016-06-01

Clinical directors established research-led healthcare by combining research, teaching and clinical excellence within the teaching hospitals. This research culture created high clinical standards, which benefited patients, the workforce and healthcare organisations. The current paper explores this research leadership role for clinical directors. It reviews studies arising from the theory of expert leadership, which focuses on the relationship between a leader's core knowledge and organisational performance. More specifically, we examine the expert leader's research track record, the associations with their organisation's performance, and the influence of research activity on clinical excellence. Distinguished researchers still lead the most prestigious teaching hospitals and the most trusted departments of psychiatry in the United States where the clinical directorate structure originated. It is also known that good scholars can improve research output when appointed to leadership positions. This suggests that the clinical director's research track record should be a consideration at a time when research is being embedded in Australia's local health networks. A clinical director's leadership may influence the research performance of their department and contribute to the quality of mental healthcare. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Myosin Va Plays a Role in Nitrergic Smooth Muscle Relaxation in Gastric Fundus and Corpora Cavernosa of Penis

PubMed Central

Carew, Josephine A.; Goyal, Raj K.; Sullivan, Maryrose P.

2014-01-01

The intracellular motor protein myosin Va is involved in nitrergic neurotransmission possibly by trafficking of neuronal nitric oxide synthase (nNOS) within the nerve terminals. In this study, we examined the role of myosin Va in the stomach and penis, proto-typical smooth muscle organs in which nitric oxide (NO) mediated relaxation is critical for function. We used confocal microscopy and co-immunoprecipitation of tissue from the gastric fundus (GF) and penile corpus cavernosum (CCP) to localize myosin Va with nNOS and demonstrate their molecular interaction. We utilized in vitro mechanical studies to test whether smooth muscle relaxations during nitrergic neuromuscular neurotransmission is altered in DBA (dilute, brown, non-agouti) mice which lack functional myosin Va. Myosin Va was localized in nNOS-positive nerve terminals and was co-immunoprecipitated with nNOS in both GF and CCP. In comparison to C57BL/6J wild type (WT) mice, electrical field stimulation (EFS) of precontracted smooth muscles of GF and CCP from DBA animals showed significant impairment of nitrergic relaxation. An NO donor, Sodium nitroprusside (SNP), caused comparable levels of relaxation in smooth muscles of WT and DBA mice. These normal postjunctional responses to SNP in DBA tissues suggest that impairment of smooth muscle relaxation resulted from inhibition of NO synthesis in prejunctional nerve terminals. Our results suggest that normal physiological processes of relaxation of gastric and cavernosal smooth muscles that facilitate food accommodation and penile erection, respectively, may be disrupted under conditions of myosin Va deficiency, resulting in complications like gastroparesis and erectile dysfunction. PMID:24516539

Per rectal endoscopic myotomy for the treatment of adult Hirschsprung's disease: First human case (with video).

PubMed

Bapaye, Amol; Wagholikar, Gajanan; Jog, Sameer; Kothurkar, Aditi; Purandare, Shefali; Dubale, Nachiket; Pujari, Rajendra; Mahadik, Mahesh; Vyas, Viral; Bapaye, Jay

2016-09-01

Hirschsprung's disease (HD) is a congenital disorder characterized by the absence of intrinsic ganglion cells in submucosal and myenteric plexuses of the hindgut; and presents with constipation, intestinal obstruction and/or megacolon. HD commonly involves the rectosigmoid region (short segment HD), although shorter and longer variants of the disease are described. Standard treatment involves pull-through surgery for short segment HD or posterior anorectal myotomy in selected ultrashort segment candidates. Third space endoscopy has evolved during the past few years. Per oral endoscopic myotomy and per oral pyloromyotomy are described for treatment of achalasia cardia and refractory gastroparesis, respectively. Using the same philosophy of muscle/sphincter disruption for spastic bowel segments, per rectal endoscopic myotomy could be considered as a treatment option for short segment HD. A 24-year-old male patient presented with refractory constipation since childhood, and habituated to high-dose laxative combinations. Diagnosis was confirmed as adult short segment HD by barium enema, colonoscopic deep suction mucosal biopsies and anorectal manometry. Histopathology confirmed aganglionosis in the distal 15 cm. By implementing principles of third space endoscopy, per rectal endoscopic myotomy 20 cm in length was successfully carried out. At 24-week follow up, the patient reported significant relief of constipation and associated symptoms. Sigmoidoscopy, anorectal manometry and barium enema confirm improved rectal distensibility and reduced rectal pressures. The present case report describes the first human experience of per rectal endoscopic myotomy for successful treatment of adult short segment HD. © 2016 Japan Gastroenterological Endoscopy Society.

Keeping Clinicians in Clinical Research: The Clinical Research/Reproductive Scientist Training Program

PubMed Central

Armstrong, Alicia Y.; DeCherney, Alan; Leppert, Phyllis; Rebar, Robert; Maddox, Yvonne T.

2009-01-01

In recent years the need for translational and clinical research has increased while the number of physicians involved in clinical research has diminished. There is clearly a need for formalized academic training in the quantitative and methodological principles of clinical research in reproductive medicine. The Clinical Research/Reproductive Scientist Training Program (CREST), a program supported by the National Institute of Child Health and Human Development, the Clinical Research Training Program (CRTP) at Duke University, and the American Society for Reproductive Medicine,(ASRM) meets this existing need. In addition, this program is specifically designed for physicians in private or academic clinical practice in reproductive medicine. Innovative programs such as CREST encourage the practicing physician to engage in clinical research while maintaining an active role in clinical practice. Participants in the program receive didactic on-line training from the CRTP, attend intensive weekend seminars at the National Institutes of Health (NIH) and CREST seminars at the annual meeting of ASRM. Successful participants in the program receive a Certificate in Clinical Research from the CRTP. The program’s goal is to provide practicing physicians with the tools and research credentials that will facilitate collaborations with investigators involved in large clinical trials. PMID:19144332

NIH Clinical Research Trials and You

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Clinical studies of the Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan.

PubMed

Makino, Hirofumi; Sada, Ken-Ei

2013-10-01

In Japan, the Research Committee on Intractable Vasculitides, supported by the Ministry of Health, Labour and Welfare, has been promoting basic and clinical research on vasculitis since 1972. The present Research Committee on Intractable Vasculitides comprises 4 subcommittees under the direction of a Principal Investigator: Basic and Pathological Research Subcommittee, Clinical Research Subcommittee of Small and Medium-sized Vessel Vasculitis, Clinical Research Subcommittee of Large-sized Vessel Vasculitis, and International Cooperation Research Subcommittee. Since 2008, 9 nationwide clinical studies for vasculitis have been conducted and 8 clinical and basic studies are in progress.

The Weiland Medal: Clinical Research in Hand Surgery

PubMed Central

Chung, Kevin C.

2015-01-01

Clinical research designed to enhance the quality of healthcare has always received a great deal of national attention. Outcomes studies, clinical trials, and evidence-based research are key components of clinical research that have advanced the field of hand surgery. The purpose of the Weiland Award is to encourage innovations and progress in clinical research in hand surgery for the betterment of patients and to promote hand surgery’s visibility in American medicine. This article will highlight my efforts in clinical research through three specific research themes: (1) outcomes research, (2) economic analysis, and (3) evidence-based research and quality assessment in healthcare. PMID:20117312

Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

PubMed

Allen, David; Ripley, Elizabeth; Coe, Antoinette; Clore, John

2013-12-01

In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

Caught between a rock and a hard place: An intrinsic single case study of nurse researchers' experiences of the presence of a nursing research culture in clinical practice.

PubMed

Berthelsen, Connie Bøttcher; Hølge-Hazelton, Bibi

2018-04-01

To explore how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. Higher demands in the hospitals for increasing the quality of patient care engender a higher demand for the skills of health professionals and evidence-based practice. However, the utilisation of nursing research in clinical practice is still limited. Intrinsic single case study design underlined by a constructivist perspective. Data were produced through a focus group interview with seven nurse researchers employed in clinical practice in two university hospitals in Zealand, Denmark, to capture the intrinsic aspects of the concept of nursing research culture in the context of clinical practice. A thematic analysis was conducted based on Braun and Clarke's theoretical guideline. "Caught between a rock and a hard place" was constructed as the main theme describing how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. The main theme was supported by three subthemes: Minimal academic tradition affects nursing research; Minimal recognition from physicians affects nursing research; and Moving towards a research culture. The nurse researchers in this study did not experience the presence of a nursing research culture in clinical practice, however; they called for more attention on removing barriers against research utilisation, promotion of applied research and interdisciplinary research collaboration, and passionate management support. The results of this case study show the pressure which nurse researchers employed in clinical practice are exposed to, and give examples on how to accommodate the further development of a nursing research culture in clinical practice. © 2017 John Wiley & Sons Ltd.

Ethical aspects of clinical research with minors.

PubMed

Bos, Wendy; Tromp, Krista; Tibboel, Dick; Pinxten, Wim

2013-07-01

Over the past decades, clinical research has increasingly been subjected to ethical requirements and legal regulation. The specific focus of ethical and legal frameworks on competent adults (which serve as the paradigmatic research subject), however, has created an ambivalent attitude towards pediatric clinical research. On one hand, minors are regarded as a vulnerable population that deserves additional protection against the risks and burdens involved in clinical research. On the other hand, the population of minors should not be denied (or not get timely) access to the benefits of clinical research. In this paper, we will explore the legal regulation and ethical guidance that currently governs pediatric clinical research in the European Union and discuss the future challenges in this field. In addition, we will discuss major ethical concerns in pediatric clinical research, with a focus on the acceptability of research risks and the informed consent process. In the discussion, we will address key concerns in both regulating pediatric clinical research and implementing ethical and legal requirement in the actual pediatric research conduct.

Clinical Research Nursing: Development of a Residency Program
.

PubMed

Showalter, Brandi L; Cline, Debbie; Yungclas, Jan; Frentz, Kelly; Stafford, Susan R; Maresh, Kelly J

2017-10-01

Clinical research nurses are essential in the coordination of clinical trials and the management of research participants. Without a stable, knowledgeable research nurse workforce, the conduct of research is affected. A research nurse residency is a novel approach to preparing new graduate nurses for the oncology research nurse role. This article will describe the development and content of the research nurse residency and how this approach is being used to address a need for clinical research nurses to support burgeoning clinical trials at a National Cancer Institute-designated comprehensive cancer center.
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Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

PubMed

Nurmi, Sanna-Maria; Halkoaho, Arja; Kangasniemi, Mari; Pietilä, Anna-Maija

2017-10-25

Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research. Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research.

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

PubMed

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

Needs assessment for collaborative network in pediatric clinical research and education.

PubMed

Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro

2017-01-01

A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, <30% of the hospitals had a data manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P < 0.01). The number of education programs was significantly correlated with the number of original articles and case reports in English (r = 0.788), and the number of publications in Japanese (r = 0.648). All hospitals recognized the need for a leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

Danish research-active clinical nurses overcome barriers in research utilization.

PubMed

Adamsen, Lis; Larsen, Kristian; Bjerregaard, Lene; Madsen, Jan K

2003-03-01

The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further empirical studies, based on Giddens theory of sociological reflectivity, might see clinical nurses in a more serious light and simultaneously perceive them as producers of knowledge.

From bench to bedside and to health policies: ethics in translational research.

PubMed

Petrini, C

2011-01-01

Translation of biomedical research knowledge to effective clinical treatment is essential to the public good. The first level of translation ("from bench to bedside") corresponds to efficacy studies under controlled conditions with careful attention to internal validity (clinical research). The second level is the translation of results from clinical studies into everyday clinical practice and health decision making. The article summarises the ethical issues involved in the translation of biomedical research advances to clinical applications and to clinical practice. In particular, the article synthesizes theory from clinical ethics, operational design, and philosophy to examine the unique bioethical issues raised by the recent focus on translational research. In this framework safety of study participants and balancing of risk due to treatment with the potential benefits of the research are crucial: in clinical research there is a danger that the emphasis on advancements in scientific knowledge might prevail over the protection of the people who participate in research. These issues involve basic scientists, clinicians and bioethicists because of their application to comparative effectiveness research, clinical trials and evidence-based medicine, as well basic biomedical research.

[The Clinical Investigation Centers in France: Whatzat? What for? How does it work?].

PubMed

Montagne, O; Le Corvoisier, P

2008-01-01

For the last 15 years, French university-affiliated hospitals have dramatically modified how biomedical research is conducted in France. Multidisciplinary and technically complex research projects are increasingly difficult to conduct in clinical units. To ensure quality, good clinical practice, and security, platforms dedicated to clinical research with specific staff have been implanted. These units, called Clinical Investigation Centers (CICs), are open to academic and industrial investigators working in the medical fields involving patients and healthy volunteers. The CICs' activities are always closely related to the university hospital research programs and can also serve as a tool for locally implanted clinical and fundamental research teams (INSERM). Nowadays, clinical research requires specific tools and platforms. To enhance French university hospital research efficiency and provide a more open research environment, all investigators, on-site as well as from other institutions, are invited to use these cohesive research facilities and skills to conduct protocols that are fully adapted to their needs in optimal conditions of professional clinical research.

Evaluating Various Areas of Process Improvement in an Effort to Improve Clinical Research: Discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management Workshop

PubMed Central

Cola, Philip A.; Rosenblum, Daniel

2013-01-01

Abstract Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to “improve human health.” Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled “Learning by doing; applying evidence‐based tools to re‐engineer clinical research management” took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants. PMID:23919369

Evaluating various areas of process improvement in an effort to improve clinical research: discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management workshop.

PubMed

Strasser, Jane E; Cola, Philip A; Rosenblum, Daniel

2013-08-01

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to "improve human health." Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled "Learning by doing; applying evidence-based tools to re-engineer clinical research management" took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants. © 2013 Wiley Periodicals, Inc.

Enrolling Minority and Underserved Populations in Cancer Clinical Research

PubMed Central

Wallington, Sherrie Flynt; Dash, Chiranjeev; Sheppard, Vanessa B.; Goode, Tawara D.; Oppong, Bridget A.; Dodson, Everett E.; Hamilton, Rhonda N.; Adams-Campbell, Lucile L.

2015-01-01

Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials—a “gold standard.” Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six non-therapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients—their physical locales, cultural values, and environments in which they live—is essential to recruiting culturally and ethnically diverse population samples. PMID:26470805

National Heart, Lung, and Blood Institute

MedlinePlus

... of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites News & ...

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

PubMed Central

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research. PMID:28715491

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

PubMed

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

Clinical Research: A Globalized Network

PubMed Central

Richter, Trevor A.

2014-01-01

Clinical research has become increasingly globalized, but the extent of globalization has not been assessed. To describe the globalization of clinical research, we used all (n = 13,208) multinational trials registered at ClinicalTrials.gov to analyzed geographic connections among individual countries. Our findings indicate that 95% (n = 185) of all countries worldwide have participated in multinational clinical research. Growth in the globalization of clinical research peaked in 2009, suggesting that the global infrastructure that supports clinical research might have reached its maximum capacity. Growth in the globalization of clinical research is attributable to increased involvement of non-traditional markets, particularly in South America and Asia. Nevertheless, Europe is the most highly interconnected geographic region (60.64% of global connections), and collectively, Europe, North America, and Asia comprise more than 85% of all global connections. Therefore, while the expansion of clinical trials into non-traditional markets has increased over the last 20 years and connects countries across the globe, traditional markets still dominate multinational clinical research, which appears to have reached a maximum global capacity. PMID:25517976

Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-2-0159 TITLE: Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies PRINCIPAL INVESTIGATOR...Annual PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for...AND SUBTITLE Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT

Clinical Research Nursing: A Critical Resource in the National Research Enterprise

PubMed Central

Hastings, Clare E.; Fisher, Cheryl A.; McCabe, Margaret A.

2012-01-01

Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing. PMID:22172370

An Opportunity to Bridge the Gap Between Clinical Research and Clinical Practice: Implications for Clinical Training

PubMed Central

Hershenberg, Rachel; Drabick, Deborah A. G.; Vivian, Dina

2013-01-01

Clinical researchers and clinical practitioners share a goal of increasing the integration of research and clinical practice, which is reflected in an evidence-based practice (EBP) approach to psychology. The EBP framework involves the integration of research findings with clinical expertise and client characteristics, values, and preferences, and consequently provides an important foundation for conducting clinically relevant research, as well as empirically based and clinically sensitive practice. Given the critical role that early training can play in the integration of science and practice and in promoting the future of the field, the present article addresses predoctoral training programs as a context for adopting an EBP approach to clinical work. We address training in the three components of EBP and provide suggestions for curriculum development and practicum training that we hope will contribute to bridging the gap between research and practice. PMID:22642520

Research-active clinical nurses: against all odds.

PubMed

Siedlecki, Sandra L; Albert, Nancy M

2017-03-01

To develop a theoretical understanding of factors that impact decisions of clinical nurses to conduct a research study. Only a small percentage of all nurses are research-active and even fewer clinical nurses are research-active. Several researchers have explored barriers to research activity by clinical nurses, but few have examined why, in spite of all odds, some clinical nurses are research-active. As the purpose of this study was to develop a theoretical understanding of the research-active nurse, a grounded theory approach was used. The sample interviewed for this study consisted of registered nurses (n = 26) who worked in a hospital or ambulatory setting, had daily direct patient contact and had participated as principal investigator on at least one completed clinical nursing research study that was not in fulfilment of an educational requirement. The interviews were digitally recorded and analysed by two researchers using the constant comparative method. The findings from this study suggest that the conduct of research by clinical nurses was the direct result of a clinical trigger, characteristics and beliefs of the nurse about research and their role in generating knowledge, and the presence of support conditions, such as a research mentor. Clinical nurses can and do conduct research, in spite of constraints due to a lack of time, money and/or knowledge, if they have access to research mentors and are practising in a research-supportive environment. Nurses at the bedside are in a unique position to identify problems most in need of solutions. Findings from this study provide a foundation upon which to develop and test various programmes that seek to increase the number of clinical nurses who are research-active. © 2016 John Wiley & Sons Ltd.

How we implemented an analytical support clinic to strengthen student research capacity in Zambia.

PubMed

Andrews, Ben; Musonda, Patrick; Simuyemba, Moses; Wilson, Craig M; Nzala, Selestine; Vermund, Sten H; Michelo, Charles

2014-12-11

Abstract Background: Research outputs in sub-Saharan Africa may be limited by a scarcity of clinical research expertise. In Zambia, clinical and biomedical postgraduate students are often delayed in graduation due to challenges in completing their research dissertations. We sought to strengthen institutional research capacity by supporting student and faculty researchers through weekly epidemiology and biostatistics clinics. Methods: We instituted a weekly Analytical Support Clinic at the University of Zambia, School of Medicine. A combination of biostatisticians, clinical researchers and epidemiologists meet weekly with clients to address questions of proposal development, data management and analysis. Clinic sign-in sheets were reviewed. Results: 109 students and faculty members accounted for 197 visits to the Clinic. Nearly all clients (107/109, 98.2%) were undergraduate or postgraduate students. Reasons for attending the Clinic were primarily for proposal development (46.7%) and data management/analysis (42.1%). The most common specific reasons for seeking help were data analysis and interpretation (36.5%), development of study design and research questions (26.9%) and sample size calculation (21.8%). Conclusions: The Analytical Support Clinic is an important vehicle for strengthening postgraduate research through one-on-one and small group demand-driven interactions. The clinic approach supplements mentorship from departmental supervisors, providing specific expertise and contextual teaching.

Critical issues in clinical periodontal research.

PubMed

Preshaw, Philip M

2012-06-01

As periodontal researchers and clinicians, we are challenged every day to make decisions relating to the clinical management of our patients and about how best to conduct clinical periodontal research. This volume of Periodontology 2000 addresses some of the critical issues in contemporary clinical periodontics and periodontal research that are of direct relevance to clinicians, researchers, teachers and students. The 11 review articles in this volume of Periodontology 2000 focus on aspects of periodontal research methodology and clinical periodontology. In terms of research methodology, the articles aim to inform the reader on topics relating to randomized controlled trials in periodontal research, evidence-based dentistry, calibration of clinical examiners and statistics relevant to periodontal research. The clinical periodontology articles address issues relating to decisions on retaining periodontally compromised teeth or replacing them with implants, periodontal management in the patient with osteoporosis, surgical approaches for root coverage and the emerging science of advanced regenerative technologies, including the use of stem cells, for periodontal regeneration. It is hoped that these critical reviews will address many of the dilemmas that confront us on a regular basis and provide practical guidance to those engaged in both clinical periodontology and clinical periodontal research. © 2012 John Wiley & Sons A/S.

Key factors of clinical research network capacity building.

PubMed

Li, Guowei; Wu, Qianyu; Jin, Yanling; Vanniyasingam, Thuva; Thabane, Lehana

2018-01-01

In general, clinical research network capacity building refers to programs aimed at enhancing networks of researchers to conduct clinical research. Although in the literature there is a large body of research on how to develop and build capacity in clinical research networks, the conceptualizations and implementations remain controversial and challenging. Moreover, the experiences learnt from the past accomplishments and failures can assist in the future capacity building efforts to be more practical, effective and efficient. In this paper, we aim to provide an overview of capacity building in clinical research network by (1) identifying the key barriers to clinical research network capacity building, (2) providing insights into how to overcome those obstacles, and (3) sharing our experiences in collaborating with national and international partners to build capacity in clinical research networks. In conclusion, we have provided some insight into how to address the key factors of clinical research network capacity building and shared some empirical experiences. A successful capacity building practice requires a joint endeavor to procure sufficient resources and support from the relevant stakeholders, to ensure its efficiency, cost-effectiveness, and sustainability.

Building research capacity: through a hospital-based clinical school of nursing.

PubMed

Lee, Geraldine; Metcalf, Suzanne

2009-04-01

For clinical nurses and nursing academics wishing to participate in research, there are several logistical issues such as high workloads, lack of time and poor research skills and knowledge that can impede research being undertaken. To address these issues, La Trobe University in partnership with one of Melbourne's acute care hospitals developed a clinical school with the aim of delivering postgraduate courses and undertaking collaborative clinically focused nursing research. Clinical issues were identified jointly between university academics and clinical nursing staff. Research questions were developed to examine these issues with the clinical school staff facilitating the research process. Research has been undertaken in many specialty areas including emergency, cardiac and intensive care nursing and diabetes. The success of this collaboration is evident with many studies being undertaken and consequently dissemination of research findings published (with clinicians being the primary author on many papers), presentations at national and international conferences by clinical staff as well as an increased enrollment into masters and doctoral programmes. The presence of the clinical school at the hospital has been beneficial both to clinicians and nurse academics and resulted in developing a positive research environment. More importantly, the research has led to changes in patient care and enabled clinicians to gain research experience and further academic qualifications. The other benefit is that nurse academics have strengthened their working relationship with clinicians and ensured visible research outputs were achieved.

Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations.

PubMed

Smith, Kirsten V; Thew, Graham R

2017-09-01

The combination of clinical psychologists' therapeutic expertise and research training means that they are in an ideal position to be conducting high-quality research projects. However, despite these skills and the documented benefits of research to services and service users, research activity in practice remains low. This article aims to give an overview of the advantages of, and difficulties in conducting research in clinical practice. We reviewed the relevant literature on barriers to research and reflected on our clinical and research experiences in a range of contexts to offer practical recommendations. We considered factors involved in the planning, sourcing support, implementation, and dissemination phases of research, and outline suggestions to improve the feasibility of research projects in post-qualification roles. We suggest that research leadership is particularly important within clinical psychology to ensure the profession's continued visibility and influence within health settings. Clinical implications Emerging evidence suggests that clinical settings that foster research are associated with better patient outcomes. Suggestions to increase the feasibility of research projects in clinical settings are detailed. Limitations The present recommendations are drawn from the authors' practical experience and may need adaptation to individual practitioners' settings. This study does not attempt to assess the efficacy of the strategies suggested. © 2017 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

The Role of the Clinical and Translational Science Awards Program in Improving the Quality and Efficiency of Clinical Research

PubMed Central

Rosenblum, Daniel

2011-01-01

Recognizing the need to increase the efficiency and quality of translating basic discovery into treatment and prevention strategies for patients and the public, the National Institutes of Health (NIH) announced the Clinical and Translational Science Awards (CTSAs) in 2006. Academic health centers that competed successfully for these awards agreed to work as a consortium and in cooperation with the NIH to improve the translation process by training the next generation of investigators to work in interdisciplinary teams, developing public-private partnerships in the movement of basic discovery to preclinical and clinical studies and trials, improving clinical research management, and engaging with communities to ensure their involvement in shaping research questions and in implementing research results. The CTSAs have addressed the crucial need to improve the quality and efficiency of clinical research by (1) providing training for clinical investigators and for bench researchers to facilitate their participation in the clinical and translational research environment, (2) developing more systematic approaches to clinical research management, and (3) engaging communities as active participants in the design and conduct of clinical research studies and trials and as leaders in implementing health advances that are of high importance to them. We provide an overview of the CTSA activities with attention to these three areas, which are essential to developing efficient clinical research efforts and effective implementation of research results on a national level. PMID:21896519

Enrolling Minority and Underserved Populations in Cancer Clinical Research.

PubMed

Wallington, Sherrie F; Dash, Chiranjeev; Sheppard, Vanessa B; Goode, Tawara D; Oppong, Bridget A; Dodson, Everett E; Hamilton, Rhonda N; Adams-Campbell, Lucile L

2016-01-01

Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six nontherapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients-their physical locales, cultural values, and environments in which they live-is essential to recruiting culturally and ethnically diverse population samples. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

From Free to Free Market: Cost Recovery in Federally Funded Clinical Research

PubMed Central

McCammon, Margaret G.; Fogg, Thomas T.; Jacobsen, Lynda; Roache, John; Sampson, Royce; Bower, Cynthia L.

2012-01-01

In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation. PMID:22764204

Centralized Research Recruitment—Evolving a Local Clinical Research Recruitment Web Application to Better Meet User Needs

PubMed Central

Dwyer‐White, Molly; Doshi, Aalap; Hill, Mary; Pienta, Kenneth J.

2011-01-01

Abstract  Recruiting volunteers into clinical research remains a significant challenge for many clinical research study teams, thus the Michigan Institute for Clinical and Health Research (MICHR) at the University of Michigan developed UMClinicalStudies (http://www.UMClinicalStudies.org)—a Web application that links the community to a single gateway for clinical research. UMClinicalStudies (formerly named “Engage”) is an integral piece of MICHR’s efforts to increase clinical research participation in order to advance medical discoveries. Despite the initial success of the application, barriers to research participation remain, including the applications accessibility for potential research volunteers and study team members. In response, new initiatives were instigated to identify user needs, in order to broaden the ability to simultaneously assist researchers in recruitment activities, while also aiding potential volunteers in the exploration of and participation in clinical research opportunities. To do this, improvements to the interface and functionality were identified and implemented for both the public and the research audiences through extensive system analysis, and through the application of human computer interactivity processes, resulting in significant improvements in usability and ultimately research volunteerism, indicating that utilizing such technology is pivotal in reaching broader audiences for clinical trial participation. Clin Trans Sci 2011; Volume 4: 363–368 PMID:22029810

The value of formal clinical research training in initiating a career as a clinical investigator.

PubMed

Kapoor, Karan; Wu, Bechien U; Banks, Peter A

2011-12-01

The aim of this study was to determine whether formal clinical research training is of value in the initiation of a successful career as a clinical investigator. We conducted a retrospective review of the career choices of all 25 fellows who entered the Academic Clinical Research Track at Brigham and Women's Hospital since its inception in 1995 and examined the impact of formal clinical research training during their fellowship on their career choice. The primary measure of a successful career as a clinical investigator was the obtainment of external funding for clinical research within 3 years of completion of fellowship. Thirteen of the 25 fellows (52%) received a Master of Public Health (MPH) degree at the Harvard School of Public Health during their fellowship. Ten of these 13 fellows (77%) obtained external funding for clinical research within 3 years of completion of their fellowship. None of the 5 fellows who had already obtained an MPH degree prior to their fellowship and none of the 7 fellows who completed a 7-week summer Program in Clinical Effectiveness but did not complete an MPH degree attempted to receive external funding for clinical research within 3 years of completion of their fellowship. We conclude that formal clinical research training culminating in an MPH degree was extremely valuable in the initiation of a successful career as a clinical investigator.

The conduct of practice-based research in community clinics compared to private practices: similarities, differences, and challenges

PubMed Central

Gillette, Jane; Cunha-Cruz, Joana; Gilbert, Ann; Speed-McIntyre, Pollene; Zhou, Lingmei; DeRouen, Timothy

2013-01-01

Practice-based research should be performed in all practice settings if the results are to be applied to all settings. However, some practice settings, such as community clinics, have unique features that may make the conduct of such research more challenging. The purpose of this article is to describe and compare the similarities and unique challenges related to conducting research in community clinics compared to private practices within the Northwest Practice-Based REsearch Collaborative in Evidence-Based DENTistry (PRECEDENT) network. Information was obtained from meetings with general dentists, a survey of general dentists (N = 253), and a clinical examination and record review of a systemic random sample of patients visiting community clinics and private practices. (N = 1903)—all part of a dental practice-based research network. The processes of conducting research, the dentist and patient sociodemographic characteristics, the prevalence of oral diseases, and the dental treatments received in community clinics and private practices were compared. Both community clinics and private practices have the clinical treatment of the patients as their priority and have time constraints on research. The processes of research training, obtaining informed consent, and collecting, transmitting, and securely maintaining research data are also similar. The patient populations and treatment needs differ substantially between community clinics and private practices, with a higher prevalence of dental caries and higher restorative treatment needs in the community clinic patients. The process of study participant selection and follow-up for research and the dentist and staff work arrangements also vary between the two practice settings. Although community clinic patients and their dental healthcare providers have different research needs and challenges than their counterparts in private practice, practice-based research can be successfully PMID:25429251

A Domain Analysis Model for eIRB Systems: Addressing the Weak Link in Clinical Research Informatics

PubMed Central

He, Shan; Narus, Scott P.; Facelli, Julio C.; Lau, Lee Min; Botkin, Jefferey R.; Hurdle, John F.

2014-01-01

Institutional Review Boards (IRBs) are a critical component of clinical research and can become a significant bottleneck due to the dramatic increase, in both volume and complexity of clinical research. Despite the interest in developing clinical research informatics (CRI) systems and supporting data standards to increase clinical research efficiency and interoperability, informatics research in the IRB domain has not attracted much attention in the scientific community. The lack of standardized and structured application forms across different IRBs causes inefficient and inconsistent proposal reviews and cumbersome workflows. These issues are even more prominent in multi-institutional clinical research that is rapidly becoming the norm. This paper proposes and evaluates a domain analysis model for electronic IRB (eIRB) systems, paving the way for streamlined clinical research workflow via integration with other CRI systems and improved IRB application throughput via computer-assisted decision support. PMID:24929181

A model for integrating clinical care and basic science research, and pitfalls of performing complex research projects for addressing a clinical challenge.

PubMed

Steck, R; Epari, D R; Schuetz, M A

2010-07-01

The collaboration of clinicians with basic science researchers is crucial for addressing clinically relevant research questions. In order to initiate such mutually beneficial relationships, we propose a model where early career clinicians spend a designated time embedded in established basic science research groups, in order to pursue a postgraduate qualification. During this time, clinicians become integral members of the research team, fostering long term relationships and opening up opportunities for continuing collaboration. However, for these collaborations to be successful there are pitfalls to be avoided. Limited time and funding can lead to attempts to answer clinical challenges with highly complex research projects characterised by a large number of "clinical" factors being introduced in the hope that the research outcomes will be more clinically relevant. As a result, the complexity of such studies and variability of its outcomes may lead to difficulties in drawing scientifically justified and clinically useful conclusions. Consequently, we stress that it is the basic science researcher and the clinician's obligation to be mindful of the limitations and challenges of such multi-factorial research projects. A systematic step-by-step approach to address clinical research questions with limited, but highly targeted and well defined research projects provides the solid foundation which may lead to the development of a longer term research program for addressing more challenging clinical problems. Ultimately, we believe that it is such models, encouraging the vital collaboration between clinicians and researchers for the work on targeted, well defined research projects, which will result in answers to the important clinical challenges of today. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

PubMed

Mello, Michelle M; Clarridge, Brian R; Studdert, David M

2005-01-01

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

A European perspective--the European clinical research infrastructures network.

PubMed

Demotes-Mainard, J; Kubiak, C

2011-11-01

Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.

ClinicalCodes: an online clinical codes repository to improve the validity and reproducibility of research using electronic medical records.

PubMed

Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects.

ClinicalCodes: An Online Clinical Codes Repository to Improve the Validity and Reproducibility of Research Using Electronic Medical Records

PubMed Central

Springate, David A.; Kontopantelis, Evangelos; Ashcroft, Darren M.; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects. PMID:24941260

59th Clinical Research Division Research Day Briefing

DTIC Science & Technology

2016-10-27

59th Medical Wing a ’r’. ’ ( ~ ~ ’ ""· ~... ’ .,,,. lS! lflof!’~l. 59th Clinical Research Division Research Day Briefing Colonel Linda Steel...oversight and guidance to researchers in the development, performance, and dissemination of clinical investigations. CRD directly supports wing...Clinical Investigation Support 2. Training 3. Support of RDT&E protocols 4. Research Subject Protection • Human Subjects: IRS - Institutional

Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

PubMed

Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

2015-11-01

The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

Quality Assurance in Biobanking for Pre-Clinical Research

PubMed Central

Simeon-Dubach, Daniel; Zeisberger, Steffen M.; Hoerstrup, Simon P.

2016-01-01

It is estimated that not less than USD 28 billion are spent each year in the USA alone on irreproducible pre-clinical research, which is not only a fundamental loss of investment and resources but also a strong inhibitor of efficiency for upstream processes regarding the translation towards clinical applications and therapies. The issues and cost of irreproducibility has mainly been published on pre-clinical research. In contrast to pre-clinical research, test material is often being transferred into humans in clinical research. To protect treated human subjects and guarantee a defined quality standard in the field of clinical research, the manufacturing and processing infrastructures have to strictly follow and adhere to certain (inter-)national quality standards. It is assumed and suggested by the authors that by an implementation of certain quality standards within the area of pre-clinical research, billions of USD might be saved and the translation phase of promising pre-clinical results towards clinical applications may substantially be improved. In this review, we discuss how an implementation of a quality assurance (QA) management system might positively improve sample quality and sustainability within pre-clinically focused biobank infrastructures. Biobanks are frequently positioned at the very beginning of the biomedical research value chain, and, since almost every research material has been stored in a biobank during the investigated life cycle, biobanking seems to be of substantial importance from this perspective. The role model of a QA-regulated biobank structure can be found in biobanks within the context of clinical research organizations such as in regenerative medicine clusters. PMID:27781023

Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

PubMed

Turisco, Fran; Keogh, Diane; Stubbs, Connie; Glaser, John; Crowley, William F

2005-12-01

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

Clinical research: assessing the future in a changing environment; summary report of conference sponsored by the American Medical Association Council on Scientific Affairs, Washington, DC, March 1996.

PubMed

Meyer, M; Genel, M; Altman, R D; Williams, M A; Allen, J R

1998-03-01

Concerns about funding of clinical research underlie all other problems identified at the Council on Scientific Affairs conference. Future National Institutes of Health (NIH) budgets are likely to be constant at best, and the general public expects cost containment to be an ongoing goal; this is exacerbated by the impending Medicare Trust Fund crisis. Meanwhile, traditional financial support of clinical research in academic medical centers (AMCs) through cross-subsidization is imperiled by competitive pressures largely caused by managed care. Although managed care organizations (MCOs) are potentially rich sources of funding and other resources, and some not-for-profit companies are conducting some research, for-profit MCOs have not demonstrated an understanding of the importance of clinical research. Young physicians are being discouraged from careers as clinical researchers and established investigators are "dropping out" because of demands for clinical productivity and competition for research grants, loss of patients/research subjects to managed care, perceived lack of status and compensation, and overall uncertainty about continued financial support. Efforts to assist current and potential clinical investigators are discussed in this report. Loss of patients, denial of reimbursement, and competition with MCOs and contract research organizations (CROs) have placed AMCs under unprecedented pressure. However, research centers located in AMCs have allowed investigators to conduct clinical research by providing a "protected environment." Furthermore, many AMCs are determined to continue conducting clinical research and are addressing related problems. Although the NIH will continue to be a major source of funding for clinical research, partnerships between various private and public entities provide important opportunities to maximize the productivity of all individuals and institutions involved. Potential partnerships include MCOs, AMCs, CROs, pharmaceutical companies and other industry, the Department of Defense, the Veterans Health Administration, practice-based physicians, and private foundations and patient support groups. "Partnerships in advocacy" for clinical research will be essential. Efforts to recruit for-profit MCOs to the clinical research endeavor identified in this report include (1) emphasizing issues of interest to them (eg, outcomes research); (2) stressing the significance of some research to the marketplace; (3) developing criteria to distinguish individual MCOs on the basis of their contribution to the public interest; (4) equating money spent on research with "R&D dollars" spent in nonmedical business enterprises; and (5) educating purchasers of health care (eg, corporate health plan directors) about clinical research. Conducting clinical research in all managed care settings requires leadership, the understanding and cooperation of physicians and support staff, wise use of limited resources (ie, funding only the best research projects), sound methodology, and above all, the perception that the research will ultimately improve patient care.

Gender identity, research self-efficacy and research intention in trainee clinical psychologists in the UK.

PubMed

Wright, Anne B; Holttum, Sue

2012-01-01

This study tested, with a sample of United Kingdom (UK) trainee clinical psychologists, part of an existing model of factors that influence clinical psychologists' levels of research activity, in which gender identity is hypothesized to influence research self-efficacy and this in turn strength of intention to do research. A sample of 121 trainee clinical psychologists (56 men and 65 women) completed a measure of gender identity, research intention, and a research self-efficacy scale. Results indicated no differences in levels of research intention or research self-efficacy between the biological sexes or according to category-based gender identities (masculine and feminine). However, masculinity as a scale quantity was statistically significantly related to stronger research intention, preference for conducting quantitative research and research self-efficacy. Multiple regression analysis provided evidence that research self-efficacy may mediate between masculinity and strength of research intention. Research self-efficacy was the strongest predictor of intention to do research in the future. Findings have relevance for clinical psychology training as research activity directly impacts upon advances in the discipline of clinical psychology, implementation of research into practice, and evaluation of psychological therapies. Copyright © 2010 John Wiley & Sons, Ltd.

78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Development Officer through the Director of the Clinical Science Research and Development Service on the...

78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

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2013-08-27

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... through the Director of the Clinical Science Research and Development Service on the relevance and...

78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

...] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration... an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The...: 510-287-2739; or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109...

Development, implementation and evaluation of a clinical research engagement and leadership capacity building program in a large Australian health care service.

PubMed

Misso, Marie L; Ilic, Dragan; Haines, Terry P; Hutchinson, Alison M; East, Christine E; Teede, Helena J

2016-01-14

Health professionals need to be integrated more effectively in clinical research to ensure that research addresses clinical needs and provides practical solutions at the coal face of care. In light of limited evidence on how best to achieve this, evaluation of strategies to introduce, adapt and sustain evidence-based practices across different populations and settings is required. This project aims to address this gap through the co-design, development, implementation, evaluation, refinement and ultimately scale-up of a clinical research engagement and leadership capacity building program in a clinical setting with little to no co-ordinated approach to clinical research engagement and education. The protocol is based on principles of research capacity building and on a six-step framework, which have previously led to successful implementation and long-term sustainability. A mixed methods study design will be used. Methods will include: (1) a review of the literature about strategies that engage health professionals in research through capacity building and/or education in research methods; (2) a review of existing local research education and support elements; (3) a needs assessment in the local clinical setting, including an online cross-sectional survey and semi-structured interviews; (4) co-design and development of an educational and support program; (5) implementation of the program in the clinical environment; and (6) pre- and post-implementation evaluation and ultimately program scale-up. The evaluation focuses on research activity and knowledge, attitudes and preferences about clinical research, evidence-based practice and leadership and post implementation, about their satisfaction with the program. The investigators will evaluate the feasibility and effect of the program according to capacity building measures and will revise where appropriate prior to scale-up. It is anticipated that this clinical research engagement and leadership capacity building program will enable and enhance clinically relevant research to be led and conducted by health professionals in the health setting. This approach will also encourage identification of areas of clinical uncertainty and need that can be addressed through clinical research within the health setting.

The NCI Community Oncology Research Program: what every clinician needs to know.

PubMed

McCaskill-Stevens, Worta; Lyss, Alan P; Good, Marge; Marsland, Thomas; Lilenbaum, Rogerio

2013-01-01

Research in the community setting is essential for the translation of advances in cancer research into practice and improving cancer care for all populations. The National Cancer Institute is proposing a new community-based program, NCI Community Oncology Research Program (NCORP), which is the alignment of two existing programs, the Community Clinical Oncology Program, Minority-Based Community Clinical Oncology Program, and their Research Bases, and the National Cancer Institute's Community Cancer Centers Program. NCROP will support cancer control, prevention, treatment, and screening clinical trials and expand its research scope to include cancer care delivery research. Cancer disparities research will be integrated into studies across the continuum of NCORP research. Input from current NCI-funded community investigators provides critical insight into the challenges faced by oncology practices within various organizational structures. Furthermore, these investigators identify the resources, both administrative and clinical, that will be required in the community setting to support cancer care delivery research and to meet the requirements for a new generation of clinical research. The American Society for Clinical Oncology (ASCO) has initiated a forum to focus on the conduct of clinical research in the community setting. Resources are being developed to help practices in managing cancer care in community settings.

Testing a model of research intention among U.K. clinical psychologists: a logistic regression analysis.

PubMed

Eke, Gemma; Holttum, Sue; Hayward, Mark

2012-03-01

Previous research highlights barriers to clinical psychologists conducting research, but has rarely examined U.K. clinical psychologists. The study investigated U.K. clinical psychologists' self-reported research output and tested part of a theoretical model of factors influencing their intention to conduct research. Questionnaires were mailed to 1,300 U.K. clinical psychologists. Three hundred and seventy-four questionnaires were returned (29% response-rate). This study replicated in a U.K. sample the finding that the modal number of publications was zero, highlighted in a number of U.K. and U.S. studies. Research intention was bimodally distributed, and logistic regression classified 78% of cases successfully. Outcome expectations, perceived behavioral control and normative beliefs mediated between research training environment and intention. Further research should explore how research is negotiated in clinical roles, and this issue should be incorporated into prequalification training. © 2012 Wiley Periodicals, Inc.

Developing a clinical trial unit to advance research in an academic institution.

PubMed

Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

2015-11-01

Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

Report of the Task Force on Clinical Research in Dentistry.

ERIC Educational Resources Information Center

Journal of Dental Education, 1994

1994-01-01

A report on clinical dental research reviews current conditions and makes recommendations for increased funding, improved peer review for research proposals, establishment of a well-defined training track for clinical researchers, and better institutional integration of and support for research and teaching. Projected need for researchers is also…

[Working as a clinician-scientist in psychosomatic medicine: status, skills and research productivity].

PubMed

Hartmann, Mechthild; Wild, Beate; Herzog, Wolfgang; Nikendei, Christoph; Zipfel, Stephan; Henningsen, Peter; Löwe, Bernd

2008-06-01

Even though there is a high need of clinical research for the medical and psychotherapeutic practice in Germany, the interest in clinical research seems to be decreasing. The aim of this study was to assess the circumstances under which clinical research in psychosocial medicine is performed and to identify opportunities for improvement. n = 53 residents of the departments for Psychosomatic Medicine of the University Hospitals of Heidelberg and Tübingen and of the Technical University of Munich were asked about their research activities, their subjective research skills, and their productivity in clinical psychosocial research. In addition, objective research knowledge was investigated using a multiple-choice test. Both, subjective research skills and objective research knowledge were relatively low. The percentage of correct answers in the multiple choice test was 33 %. Subjective problems were predominately stated regarding "biostatistics" and "study design". In terms of research productivity, 33 % of residents had published as first authors of an original journal article, and 12 % had submitted a successful grant proposal. Altogether, there is a high need of training in the field of clinical psychosomatic research. We are presenting a training model that is adapted to the conditions of young clinicians and that addresses both general clinical research and specific psychosocial clinical research.

A study of clinical nursing research priorities in aged care: a Hong Kong perspective.

PubMed

Chang, Esther; Ho, Carey Kit Bing; Yuen, Anders Chi Man; Hatcher, Deborah

2003-10-01

The aim of this study was to identify clinical research priorities in aged care from the perspectives of rehabilitation aged care nurses in Hong Kong. The Delphi method was used whereby 33 registered nurses working in an aged care rehabilitation ward identified 28 research questions pertaining to areas in which nurses could take a leadership role: clinical research that is of highest value to patients and nurse specialists; clinical research which would provide improved community care; facilitate health promotion and disease prevention and be of value to the professional needs of clinical nurses. Study findings have implications and provide direction for clinical nursing research in aged care.

Database on veterinary clinical research in homeopathy.

PubMed

Clausen, Jürgen; Albrecht, Henning

2010-07-01

The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards.

PubMed

Refolo, P; Sacchini, D; Minacori, R; Daloiso, V; Spagnolo, A G

2015-01-01

Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference

PubMed Central

Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.

2013-01-01

Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335

[Cut a long story too short: Challenges in clinical research].

PubMed

Stallmach, A; Hagel, S; Bruns, T; Bauer, M

2012-03-01

Clinical research reflects a mandatory prerequisite to translate basic research into clinical practice. While a lack of available qualified doctors to fill positions in hospitals as well as in the ambulant sector has prompted political decisions to counteract, Germany has witnessed an insidious deterioration of clinical research over time and compared to other industrialized countries. Measures to prevent an increasing loss of academic profile have to tackle all aspects from undergraduate to postgraduate training to attract highly skilled doctors in sustainable structures to reflourish academic medicine. Cornerstones to achieve these goals involve establishing of structured graduate programs, acknowledgment of time spend in clinical research in residency programs, extra occupational opportunities to achieve dual qualification (e. g. Master programs in clinical research) as well as independent positions with inherent carrier perspectives in academic medicine for doctors interested in clinical and translational research. © Georg Thieme Verlag KG Stuttgart · New York.

Efficacy of ipamorelin, a ghrelin mimetic, on gastric dysmotility in a rodent model of postoperative ileus

PubMed Central

Greenwood-Van Meerveld, Beverley; Tyler, Karl; Mohammadi, Ehsan; Pietra, Claudio

2012-01-01

Background Delayed gastric emptying is a common disorder with few effective therapeutic options. The goal of this study was to investigate whether ipamorelin, a synthetic peptidomimetic that acts on the ghrelin receptor, accelerates gastric emptying in a rodent model of gastroparesis induced by abdominal surgery and intestinal manipulation. Methods Fasted adult male rats were subjected to laparotomy and intestinal manipulation. Following the surgery rats received ipamorelin (0.014–0.14 µmol/kg) or vehicle control via intravenous administration. Gastric emptying was measured by the percent of total recovered radioactivity remaining in the stomach 15 minutes after intragastric gavage of 1.5 mL of 99mTc (technicium-99m) sulfur colloid in 0.5% methylcellulose. In a separate group of rats subjected to laparotomy and intestinal manipulation, the gastric fundus was isolated and tissue segments were suspended in an organ bath to assess the effect of ipamorelin (1 µM) on gastric smooth muscle contractility induced by acetylcholine and electrical field stimulation. Results Abdominal surgery caused a delay in gastric emptying with 78% ± 5% of the meal remaining in the stomach in vehicle controls. Ipamorelin (0.014 µmol/kg intravenous) resulted in a significant acceleration (P < 0.05 vs vehicle-treated rat) of gastric emptying with 52% ± 11% of the meal remaining in the stomach compared to nonsurgical control animals with 44% ± 6%. Following abdominal surgery and intestinal manipulation, isolated preparations of gastric smooth muscle exhibited a marked inhibition of acetylcholine and electrical field stimulation-induced contractile responses, which were reversed by ipamorelin and ghrelin. Conclusion These results suggest that ipamorelin accelerates gastric emptying in a rodent model of postoperative ileus through the stimulation of gastric contractility by activating a ghrelin receptor-mediated mechanism involving cholinergic excitatory neurons. PMID:27186127

Efficacy of ipamorelin, a ghrelin mimetic, on gastric dysmotility in a rodent model of postoperative ileus.

PubMed

Greenwood-Van Meerveld, Beverley; Tyler, Karl; Mohammadi, Ehsan; Pietra, Claudio

2012-01-01

Delayed gastric emptying is a common disorder with few effective therapeutic options. The goal of this study was to investigate whether ipamorelin, a synthetic peptidomimetic that acts on the ghrelin receptor, accelerates gastric emptying in a rodent model of gastroparesis induced by abdominal surgery and intestinal manipulation. Fasted adult male rats were subjected to laparotomy and intestinal manipulation. Following the surgery rats received ipamorelin (0.014-0.14 µmol/kg) or vehicle control via intravenous administration. Gastric emptying was measured by the percent of total recovered radioactivity remaining in the stomach 15 minutes after intragastric gavage of 1.5 mL of (99m)Tc (technicium-99m) sulfur colloid in 0.5% methylcellulose. In a separate group of rats subjected to laparotomy and intestinal manipulation, the gastric fundus was isolated and tissue segments were suspended in an organ bath to assess the effect of ipamorelin (1 µM) on gastric smooth muscle contractility induced by acetylcholine and electrical field stimulation. Abdominal surgery caused a delay in gastric emptying with 78% ± 5% of the meal remaining in the stomach in vehicle controls. Ipamorelin (0.014 µmol/kg intravenous) resulted in a significant acceleration (P < 0.05 vs vehicle-treated rat) of gastric emptying with 52% ± 11% of the meal remaining in the stomach compared to nonsurgical control animals with 44% ± 6%. Following abdominal surgery and intestinal manipulation, isolated preparations of gastric smooth muscle exhibited a marked inhibition of acetylcholine and electrical field stimulation-induced contractile responses, which were reversed by ipamorelin and ghrelin. These results suggest that ipamorelin accelerates gastric emptying in a rodent model of postoperative ileus through the stimulation of gastric contractility by activating a ghrelin receptor-mediated mechanism involving cholinergic excitatory neurons.

The stomach in health and disease.

PubMed

Hunt, R H; Camilleri, M; Crowe, S E; El-Omar, E M; Fox, J G; Kuipers, E J; Malfertheiner, P; McColl, K E L; Pritchard, D M; Rugge, M; Sonnenberg, A; Sugano, K; Tack, J

2015-10-01

The stomach is traditionally regarded as a hollow muscular sac that initiates the second phase of digestion. Yet this simple view ignores the fact that it is the most sophisticated endocrine organ with unique physiology, biochemistry, immunology and microbiology. All ingested materials, including our nutrition, have to negotiate this organ first, and as such, the stomach is arguably the most important segment within the GI tract. The unique biological function of gastric acid secretion not only initiates the digestive process but also acts as a first line of defence against food-borne microbes. Normal gastric physiology and morphology may be disrupted by Helicobacter pylori infection, the most common chronic bacterial infection in the world and the aetiological agent for most peptic ulcers and gastric cancer. In this state-of-the-art review, the most relevant new aspects of the stomach in health and disease are addressed. Topics include gastric physiology and the role of gastric dysmotility in dyspepsia and gastroparesis; the stomach in appetite control and obesity; there is an update on the immunology of the stomach and the emerging field of the gastric microbiome. H. pylori-induced gastritis and its associated diseases including peptic ulcers and gastric cancer are addressed together with advances in diagnosis. The conclusions provide a future approach to gastric diseases underpinned by the concept that a healthy stomach is the gateway to a healthy and balanced host. This philosophy should reinforce any public health efforts designed to eradicate major gastric diseases, including stomach cancer. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

From ischochymia to gastroparesis: proposed mechanisms and preferred management of dyspepsia over the centuries.

PubMed

Bielefeldt, Klaus

2014-06-01

Dyspeptic symptoms are common with most patients suffering functional disorders that remain a therapeutic challenge for medical practitioners. Within the last three decades, gastric infection, altered motility, and hypersensitivity have gained and lost traction in explaining the development of functional dyspepsia. Considering these shifts, the aim of this review was to analyze changing understanding of and approaches to dyspepsia over a longer time period. Monographs, textbooks, and articles published during the last three centuries show that our understanding of normal gastric function has improved dramatically. With increased insight came new ideas about disease mechanisms, diagnostic options, and treatments. Despite shifts over time, the importance of functional abnormalities was recognized early on and explained in the context of societal influences and stressors, anxieties, and biological influences, thus resembling the contemporary biopsychosocial model of illness. Symptoms were often attributed to changes in secretion, motility, and sensation or perception with technological innovation often influencing proposed mechanisms and treatments. Many of the principles or even agents applied more than a century ago are still part of today's approach. This includes acid suppression, antiemetics, analgesics, and even non-pharmacologic therapies, such as gastric decompression or electrical stimulation of the stomach. This historical information does not only help us understand how we arrived at our current state of knowledge and standards of care, it also demonstrates that enthusiastic adoption of various competing explanatory models and the resulting treatments often did not survive the test of time. In view of the benign prognosis of dyspepsia, the data may function as a call for caution to avoid the potential harm of overly aggressive approaches or treatments with a high likelihood of adverse effects.

Age-dependent shift in macrophage polarisation causes inflammation-mediated degeneration of enteric nervous system.

PubMed

Becker, Laren; Nguyen, Linh; Gill, Jaspreet; Kulkarni, Subhash; Pasricha, Pankaj Jay; Habtezion, Aida

2018-05-01

The enteric nervous system (ENS) undergoes neuronal loss and degenerative changes with age. The cause of this neurodegeneration is poorly understood. Muscularis macrophages residing in close proximity to enteric ganglia maintain neuromuscular function via direct crosstalk with enteric neurons and have been implicated in the pathogenesis of GI motility disorders like gastroparesis and postoperative ileus. The aim of this study was to assess whether ageing causes alterations in macrophage phenotype that contributes to age-related degeneration of the ENS. Longitudinal muscle and myenteric plexus from small intestine of young, mid-aged and old mice were dissected and prepared for whole mount immunostaining, flow cytometry, Luminex immunoassays, western blot analysis, enteric neural stem cell (ENSC) isolation or conditioned media. Bone marrow derived macrophages were prepared and polarised to classic (M1) or alternative (M2) activation states. Markers for macrophage phenotype were measured using quantitative RT-PCR. Ageing causes a shift in macrophage polarisation from anti-inflammatory 'M2' to proinflammatory 'M1' that is associated with a rise in cytokines and immune cells in the ENS. This phenotypic shift is associated with a neural response to inflammatory signals, increase in apoptosis and loss of enteric neurons and ENSCs, and delayed intestinal transit. An age-dependent decrease in expression of the transcription factor FoxO3, a known longevity gene, contributes to the loss of anti-inflammatory behaviour in macrophages of old mice, and FoxO3-deficient mice demonstrate signs of premature ageing of the ENS. A shift by macrophages towards a proinflammatory phenotype with ageing causes inflammation-mediated degeneration of the ENS. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

KNOWLEDGE OF DIABETIC COMPLICATIONS IN PATIENTS WITH DIABETES MELLITUS.

PubMed

Ullah, Fahim; Afridi, Ayesha Khan; Rahim, Fawad; Ashfaq, Muhammad; Khan, Sheema; Shabbier, Ghulam; Rahman, Sadiq Ur

2015-01-01

The prevalence of diabetes mellitus has risen exponentially over the last three decades, with resultant increase in morbidity and mortality mainly due to its complications. Limited data is available regarding the awareness and knowledge about these complications in our population. This study was carried out to evaluate the knowledge of diabetic complications in patients with diabetes mellitus. This cross-sectional study was conducted in the Medical B Unit of Department of Medicine Khyber Teaching Hospital, Peshawar. All admitted diabetic patients above 15 years of age with duration of diabetes mellitus more than one year were included. Out of the 96 patients questioned, 58 were females and 38 were males. Mean age was 53.29 +/- 10.821 years while the mean duration of diabetes mellitus was 9.75 +/- 7.729 years. Of the total 76 (79.1%) of the patients were illiterate; 36 (37.50%) had good, 24 (25%) had average and 36 (37.50%) had poor knowledge about diabetic complications. Males and university graduate patients had slightly better knowledge. Between 50-60% patients were aware of different cardiac complications of diabetes mellitus. Awareness regarding other complications was foot ulcer/gangrene 70 (72.91%), poor wound healing 68 (70.83%), stroke 54 (56.25%), renal diseases 64 (66.66%), eye diseases 53 (55.20%), gastroparesis and other gastrointestinal problems 45 (46.87%), diabetic ketoacidosis 55 (57.29%), hypoglycaemia 50 (52.08%), lipid abnormalities 26 (27.08%) and symptoms of diabetic neuropathy ranging from 47-65%. Majority of diabetic patients are unaware of diabetic complications. Therefore, hospital and community based awareness programs should be launched to decrease the morbidity and mortality associated with diabetes mellitus.

Mechanisms of Electrical Activation and Conduction in the Gastrointestinal System: Lessons from Cardiac Electrophysiology

PubMed Central

Tse, Gary; Lai, Eric Tsz Him; Yeo, Jie Ming; Tse, Vivian; Wong, Sunny Hei

2016-01-01

The gastrointestinal (GI) tract is an electrically excitable organ system containing multiple cell types, which coordinate electrical activity propagating through this tract. Disruption in its normal electrophysiology is observed in a number of GI motility disorders. However, this is not well characterized and the field of GI electrophysiology is much less developed compared to the cardiac field. The aim of this article is to use the established knowledge of cardiac electrophysiology to shed light on the mechanisms of electrical activation and propagation along the GI tract, and how abnormalities in these processes lead to motility disorders and suggest better treatment options based on this improved understanding. In the first part of the article, the ionic contributions to the generation of GI slow wave and the cardiac action potential (AP) are reviewed. Propagation of these electrical signals can be described by the core conductor theory in both systems. However, specifically for the GI tract, the following unique properties are observed: changes in slow wave frequency along its length, periods of quiescence, synchronization in short distances and desynchronization over long distances. These are best described by a coupled oscillator theory. Other differences include the diminished role of gap junctions in mediating this conduction in the GI tract compared to the heart. The electrophysiology of conditions such as gastroesophageal reflux disease and gastroparesis, and functional problems such as irritable bowel syndrome are discussed in detail, with reference to ion channel abnormalities and potential therapeutic targets. A deeper understanding of the molecular basis and physiological mechanisms underlying GI motility disorders will enable the development of better diagnostic and therapeutic tools and the advancement of this field. PMID:27303305

Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine.

PubMed

Tepper, Stewart J; Johnstone, Merrilee R

2018-01-01

There is a need for fast-acting, non-oral medication options for migraine because some attacks develop rapidly and some are accompanied by nausea, vomiting, and gastroparesis, which can hinder oral medication uptake and absorption. The most commonly prescribed migraine medications are oral triptans, with sumatriptan as the most common. However, oral triptans are associated with adverse events (AEs) of atypical sensations that may be problematic for patients. Subcutaneous (SC) injectable sumatriptan and conventional liquid triptan nasal spray formulations are also available, but the frequency of atypical sensations is the highest with SC sumatriptan, and the intense bitter taste of conventional liquid triptan nasal spray discourages use. AVP-825 (ONZETRA ® Xsail ® ) is an intranasal medication delivery system containing 22 mg sumatriptan nasal powder that is now available in the USA for the acute treatment of migraine with or without aura in adults. The objective of this review is to summarize the development of AVP-825, which utilizes unique features of nasal anatomy to achieve efficient absorption and reduced systemic exposure. Literature searches for "sumatriptan nasal powder", "AVP-825", and "sumatriptan intranasal" were conducted. Review articles and pharmacokinetic, Phase II and Phase III studies were evaluated. AVP-825 demonstrates an earlier onset of efficacy and lower rate of atypical sensations than the oral standard of care, which can be attributed to its fast absorption and low systemic exposure. AEs of abnormal taste are predominantly mild. These results confirm the initial design concept for AVP-825, which aligned pharmacokinetics, anatomy, and drug presentation in a novel device to achieve optimal outcomes for the acute treatment of migraine.

The surgical treatment of chronic gastric atony following Roux-Y diversion for alkaline reflux gastritis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vogel, S.B.; Woodward, E.R.

1989-06-01

Symptoms of severe nausea, vomiting, abdominal pain, and frequent bezoars, as well as objective gastric retention, can occur following Roux-Y biliary diversion for alkaline reflux gastritis. Medical therapy and prokinetic drugs have proven ineffective. This review evaluates 37 patients who underwent further gastric resection from 1979 to 1987 to improve gastric emptying and resolve symptoms. Fifteen patients underwent perioperative radionuclide solid-food gastric emptying studies. Seventy-three per cent (27 of 37 patients) of the patients who underwent further gastric resection (70% to 95%) had a satisfactory postoperative response. Twenty patients were graded Visick 1 or 2 and 7 Visick-3 patients, althoughmore » much improved, still had some symptoms of gastroparesis. Twenty-seven per cent (10 of 37 patients) failed to improve and underwent completion total gastrectomy. Overall, 70% of this group had almost complete resolution of their symptoms. Three of 10 patients were considered ''failures'' due to postprandial pain in 1 and early vasomotor dumping in 2. Of the 10 patients who failed initial revisional surgery, 7 underwent a 70% to 80% subtotal gastric resection (STG) and 3 patients underwent 85% to 95% extensive resection (EXT.G.). Of the 15 patients who underwent perioperative radionuclide evaluation, a mean two-hour gastric retention of 61.4% +/- 4% (SEM) decreased to 25% +/- 4% following further gastric resection. Eight patients were in the STG group and seven patients were in the EXT.G group. Following STG, mean two-hour gastric retention of 58.2% +/- 3.5% decreased to 38% +/- 3% (p less than 0.05). In seven patients who underwent EXT.G, mean two-hour retention of 65% +/- 4% decreased to 10% +/- 2.5% (p less than 0.005). EXT.G resulted in normal gastric emptying and few late failures.« less

Animal Research on Nicotine Reduction: Current Evidence and Research Gaps.

PubMed

Smith, Tracy T; Rupprecht, Laura E; Denlinger-Apte, Rachel L; Weeks, Jillian J; Panas, Rachel S; Donny, Eric C; Sved, Alan F

2017-09-01

A mandated reduction in the nicotine content of cigarettes may improve public health by reducing the prevalence of smoking. Animal self-administration research is an important complement to clinical research on nicotine reduction. It can fill research gaps that may be difficult to address with clinical research, guide clinical researchers about variables that are likely to be important in their own research, and provide policy makers with converging evidence between clinical and preclinical studies about the potential impact of a nicotine reduction policy. Convergence between clinical and preclinical research is important, given the ease with which clinical trial participants can access nonstudy tobacco products in the current marketplace. Herein, we review contributions of preclinical animal research, with a focus on rodent self-administration, to the science of nicotine reduction. Throughout this review, we highlight areas where clinical and preclinical research converge and areas where the two differ. Preclinical research has provided data on many important topics such as the threshold for nicotine reinforcement, the likelihood of compensation, moderators of the impact of nicotine reduction, the impact of environmental stimuli on nicotine reduction, the impact of nonnicotine cigarette smoke constituents on nicotine reduction, and the impact of nicotine reduction on vulnerable populations. Special attention is paid to current research gaps including the dramatic rise in alternative tobacco products, including electronic nicotine delivery systems (ie, e-cigarettes). The evidence reviewed here will be critical for policy makers as well as clinical researchers interested in nicotine reduction. This review will provide policy makers and clinical researchers interested in nicotine reduction with an overview of the preclinical animal research conducted on nicotine reduction and the regulatory implications of that research. The review also highlights the utility of preclinical research for research questions related to nicotine reduction. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for research nurses to join our clinical program to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, ensuring adherence to ethical practice in the conduct of clinical trials, research protocol compliance and good clinical practice, ensuring patient comprehension of informed consent, management of care

5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

Code of Federal Regulations, 2010 CFR

2010-01-01

... clinical study involving human subjects under a clinical research protocol approved by an institutional review board. (2) Clinical research has the meaning set forth in 42 U.S.C. 284d(b). (3) Institutional... review a clinical research protocol and approve the initiation of biomedical research involving human...

42 CFR 68a.1 - What is the scope and purpose of the NIH Clinical Research Loan Repayment Program for Individuals...

Code of Federal Regulations, 2010 CFR

2010-10-01

..., INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR... to the award of educational loan payments under the NIH Clinical Research Loan Repayment Program for... relative to income, to conduct clinical research as NIH employees. ...

Clinical research: business opportunities for pharmacy-based investigational drug services.

PubMed

Marnocha, R M

1999-02-01

The application by an academic health center of business principles to the conduct of clinical research is described. Re-engineering of the infrastructure for clinical research at the University of Wisconsin and University of Wisconsin Hospital and Clinics began in 1990 with the creation of the Center for Clinical Trials (CCT) and the restructuring of the investigational drug services (IDS). Strategies to further improve the institution's clinical research activities have been continually assessed and most recently have centered on the adaptation of a business philosophy within the institution's multidisciplinary research infrastructure. Toward that end, the CCT and IDS have introduced basic business principles into operational activities. Four basic business concepts have been implemented: viewing the research protocol as a commodity, seeking payment for services rendered, tracking investments, and assessing performance. It is proposed that incorporation of these basic business concepts is not only compatible with the infrastructure for clinical research but beneficial to that infrastructure. The adaptation of a business mindset is likely to enable an academic health center to reach its clinical research goals.

The role of Clinical Trial Units in investigator- and industry-initiated research projects.

PubMed

von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

2015-01-01

Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

PubMed Central

Murphy, Shawn N.; Dubey, Anil; Embi, Peter J.; Harris, Paul A.; Richter, Brent G.; Turisco, Fran; Weber, Griffin M.; Tcheng, James E.; Keogh, Diane

2012-01-01

Abstract Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum’s IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT‐supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise‐level support at AMC’s. Clin Trans Sci 2012; Volume #: 1–4 PMID:22686207

Five-year review of an international clinical research-training program

PubMed Central

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

Five-year review of an international clinical research-training program.

PubMed

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

Considerations for planning and conducting clinic-based research in physical therapy.

PubMed

Fitzgerald, G K; Delitto, A

2001-08-01

There is growing demand to increase the volume of clinic-based research in physical therapy. Special considerations, unique to the planning and conduct of clinic-based research, need to be addressed to increase the likelihood that these studies will be completed successfully. The purposes of this perspective are to discuss factors affecting clinic-based research and to offer suggestions for addressing these problems when designing and conducting research studies in a clinical setting. This perspective discusses issues such as patient management, determining the availability of target patient populations, acquiring support from physical therapists and physicians, reporting and managing research-related injury or illness, and modifying or terminating projects. Some of the points made in this perspective are illustrated using examples from the authors' experiences in conducting clinical research.

Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research.

PubMed

Coyne, Elisabeth; Grafton, Eileen; Reid, Alayne

2016-12-01

Research conducted in the clinical area promotes the delivery of evidence-based patient care. Involving nurses as participants in research is considered essential to link patient care with evidence-based interventions. However recruitment is influenced by nurses' competing demands and understanding engagement strategies may assist future research. This reflective analysis aimed to understand influencing factors and strategies that support successful recruitment nurses in clinical research. A reflective analysis of research notes and focus group data from research with oncology nurses was completed. This research identified that gaining support from key staff, understanding work constraints and developing a rapport with nurses is important. Establishing clear relevance and benefits of the research and being flexible with research requirements enabled nurses to participate in the research. Clear information and a willingness to accommodate the demands and dynamic nature of the environment, ensures ongoing support and engagement of nurses in the clinical setting as participants in research.

An Integrative Review of Engaging Clinical Nurses in Nursing Research.

PubMed

Scala, Elizabeth; Price, Carrie; Day, Jennifer

2016-07-01

To review the literature for best practices for engaging clinical nurses in nursing research. Review of the research and nonresearch papers published between 2005 and 2015 that answered the evidence-based practice (EBP) question: what are the best practices for engaging clinical nursing staff in nursing research? PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Joanna Briggs Institute, and Cochrane were searched using a combination of controlled vocabulary and key words. Nineteen papers that answered the EBP question were selected for review. It can be difficult to involve clinical nurses in research. There are multiple factors to consider when nursing leadership looks to engage clinical nurses in nursing research. Nurse leaders can take many approaches to engage clinical nurses in research. Each organization must perform its own assessment to identify areas of opportunity. Nursing leadership can take these areas of opportunity to structure a multifaceted approach to support clinical staff in the conduct and dissemination of nursing research. The evidence from this review offers EBP recommendations as well as reports on the gaps in the literature related to best practices for engaging clinical nurses in nursing research. © 2016 Sigma Theta Tau International.

Prostate Cancer Clinical Consortium Clinical Research Site:Targeted Therapies

DTIC Science & Technology

2015-10-01

AWARD NUMBER: W81XWH-14-2-0159 TITLE: Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies PRINCIPAL INVESTIGATOR...Sep 2015 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies 5b. GRANT NUMBER... therapy resistance/sensitivity, identification of new therapeutic targets through high quality genomic analyses, providing access to the highest quality

Conceptual framework for behavioral and social science in HIV vaccine clinical research

PubMed Central

Lau, Chuen-Yen; Swann, Edith M.; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I.; Stansbury, James P.

2011-01-01

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. PMID:21821083

Conceptual framework for behavioral and social science in HIV vaccine clinical research.

PubMed

Lau, Chuen-Yen; Swann, Edith M; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I; Stansbury, James P

2011-10-13

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. Published by Elsevier Ltd.

Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

PubMed Central

Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae

2015-01-01

Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071

Clinician scientist training program: a proposal for training medical students in clinical research.

PubMed

Mark, A L; Kelch, R P

2001-11-01

There is national alarm about a decline in the number of clinician scientists. Most of the proposed solutions have focused on housestaff and junior faculty. We propose a new national program for training medical students in clinical research. This program, coined "Clinician Scientist Training Program" (CSTP), would consist of a combined degree program in medicine (MD) and clinical research (eg, masters in translational research or masters in clinical epidemiology). Students could enroll in the program at any stage during medical school. After 3 years of medical school, students would spend at least 2 years in a combined didactic and mentored clinical research training program and then complete medical school. Students could elect to pursue more prolonged clinical research training toward a combined PhD and MD. The CSTP is designed to meet six critical challenges: 1) engage students early in clinical research training; 2) provide a didactic clinical research curriculum; 3) expose students to several years of mentored clinical research training; 4) promote debt prevention by providing tuition payments during medical education and a stipend during clinical research training; 5) facilitate prolonged exposure to a community of peers and mentors in a program with national and institutional identity and respect; and 6) permit enrollment in the program as students enter medical school or at any stage during medical school. If the success of the Medical Scientist Training Program in training medical students in basic research is a guide, the CSTP could become a linchpin for training future generations of clinician scientists.

An official multi-society statement: the role of clinical research results in the practice of critical care medicine.

PubMed

Tonelli, Mark R; Curtis, J Randall; Guntupalli, Kalpalatha K; Rubenfeld, Gordon D; Arroliga, Alejandro C; Brochard, Laurent; Douglas, Ivor S; Gutterman, David D; Hall, Jesse R; Kavanagh, Brian P; Mancebo, Jordi; Misak, Cheryl J; Simpson, Steven Q; Slutsky, Arthur S; Suffredini, Anthony F; Thompson, B Taylor; Ware, Lorraine B; Wheeler, Arthur P; Levy, Mitchell M

2012-05-15

While the results of clinical research are clearly valuable in the care of critically ill patients, the limitations of such information and the role of other forms of medical knowledge for clinical decision making have not been carefully examined. The leadership of three large professional societies representing critical care practitioners convened a diverse group representing a wide variety of views regarding the role of clinical research results in clinical practice to develop a document to serve as a basis for agreement and a framework for ongoing discussion. Consensus was reached on several issues. While the results of rigorous clinical research are important in arriving at the best course of action for an individual critically ill patient, other forms of medical knowledge, including clinical experience and pathophysiologic reasoning, remain essential. No single source of knowledge is sufficient to guide clinical decisions, nor does one kind of knowledge always take precedence over others. Clinicians will find clinical research compelling for a variety of reasons that go beyond study design. While clinical practice guidelines and protocols based upon clinical research may improve care and decrease variability in practice, clinicians must be able to understand and articulate the rationale as to why a particular protocol or guideline is used or why an alternative approach is taken. Making this clinical reasoning explicit is necessary to understand practice variability. Understanding the strengths and weaknesses of different kinds of medical knowledge for clinical decision making and factors beyond study design that make clinical research compelling to clinicians can provide a framework for understanding the role of clinical research in practice.

Reforming the community research program: from Community Clinical Oncology Program to the National Cancer Institute Community Oncology Research Program.

PubMed

Zon, Robin T

2014-01-01

Community research has been an integral and influential component of the National Research Program since the late 1970s. Institutionalization of community research in the Community Clinical Oncology Program (CCOP) has resulted in successful collaborations, meaningful accrual, achievement of quality standards, and translation of research into clinical practice. Although the national clinical trial system is undergoing modernization and improvement, the success of the CCOP and minority-based CCOP in cancer treatment, prevention, and control research is being extended to include cancer care delivery research in the newly created National Cancer Institute (NCI) Community Oncology Research Program. This article briefly presents a historic perspective of community involvement in federally sponsored clinical trials and introduces the continued involvement in the newly created NCI program.

National Institutes of Health eliminates funding for national architecture linking primary care research.

PubMed

Peterson, Kevin A

2007-01-01

With the ending of the National Electronic Clinical Trial and Research Network (NECTAR) pilot programs and the abridgement of Clinical Research Associate initiative, the National Institutes of Health Roadmap presents a strategic shift for practice-based research networks from direct funding of a harmonized national infrastructure of cooperating research networks to a model of local engagement of primary care clinics performing practice-based research under the aegis of regional academic health centers through Clinical and Translational Science Awards. Although this may present important opportunities for partnering between community practices and large health centers, for primary care researchers, the promise of a transformational change that brings a unified national primary care community into the clinical research enterprise seems likely to remain unfulfilled.

[Proceedings of clinical pharmacy research with the cooperation of community and hospital pharmacist and pharmacy school].

PubMed

Hirotani, Yoshihiko

2007-11-01

The new pharmaceutical education system starts in Japan, those constructions are performed at a lot of universities aiming at the execution of a common examination and the clinical training, and the workshop for directive pharmacists have been held actively since last year. Moreover, various educational lectures, open lectures, and the training lectures for on-site pharmacist's upskilling are carried out. However, a technical training and the lecture for research approach that supports the pharmacist in a pharmaceutical clinical research are little at the chance to learn the research methods. Now, many joint researches with university initiative or a university is performed, and the institution of presentation inexperience at academic society also exists in terms of a regional element, a staff arrangement side, etc, and also when the continuation is difficult, it looks mostly. It is necessary that the teacher of pharmacy school almost arranged in the whole country support positively a clinical research by the nearby pharmacist, and also it seems that a clinical teacher's role is large in the cooperation of pharmacy school and the medical institution. Moreover, in order to elucidate the scientific basis (mechanism) of a problem suggestion in the clinical spot, basic research in a pharmacy school is also required. We always need to advance a pharmaceutical clinical research by considering the basic research by pharmacy school in medical institution, considering clinical research by medical institution in pharmacy school, while cooperating mutually. In this article, I show how to advance pharmaceutical clinical research.

76 FR 256 - Informed Consent Elements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... societies, trade organizations representing clinical research organizations, drug and device sponsors, blood banks, clinical research organizations, research hospitals, medical device manufacturers, nonprofit... Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to...

Data standards for clinical research data collection forms: current status and challenges.

PubMed

Richesson, Rachel L; Nadkarni, Prakash

2011-05-01

Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

PubMed

Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

2016-07-01

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

A plea for pragmatism in clinical research ethics.

PubMed

Brendel, David H; Miller, Franklin G

2008-04-01

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.

Dissemination of research into clinical nursing literature.

PubMed

Oermann, Marilyn H; Shaw-Kokot, Julia; Knafl, George J; Dowell, Jo

2010-12-01

The purpose of our study was to describe the dissemination of research into the clinical nursing literature. The literature provides a means of transferring knowledge from a research study through citations of the work by other authors. This was a citation analysis study to explore the dissemination of research into the clinical nursing literature, beginning with the publication of an original research study and including all of the citations to that article through 2009. The authors searched five academic nursing research journal titles, using CINAHL, for original research reports that had clinical relevance and were published between 1990-1999. The search process yielded a final data set of 28 research articles. For each of the articles, the authors searched three databases, CINAHL, Web of Science(®) and Google Scholar, to determine the citation patterns from the date of publication to August 2009. All of the research studies were cited in articles published in clinical journals although there was a wide range in the number of citations, from 3-80. The 28 research articles had a total of 759 citations; 717 (94.5%) of those citations were in articles published in clinical nursing journals. The median length of time between publication of the original study and the first citation was 1.5 years. Some of the studies were still being cited for 18 years after publication of the original work. All of the original research reports examined in this study were cited in articles in clinical journals, disseminating the research beyond the original work to reach clinicians. Clinical nursing journals keep readers up-to-date and informed about new practices in nursing and serve another important role: they disseminate research that is clinically relevant by publishing original studies and papers that cite research reports. © 2010 Blackwell Publishing Ltd.

How Can a Clinical Research Approach Contribute to Knowledge-Building for the Teaching Profession?

ERIC Educational Resources Information Center

Bulterman-Bos, Jacquelien

2017-01-01

This article explains what clinical research is and why it is necessary. The term "clinical" refers to an academic way of solving practical problems. Clinical research starts from a view of science that not only acknowledges the value of rational analysis and empirical research, but also acknowledges the need for human skills and…

[Strengthening innovation in clinical research methodology of acupuncture and moxibustion to promote internationalization process of acupuncture-moxibustion].

PubMed

Wang, Long; Zou, Wei; Chi, Qing-bin

2009-06-01

In order to explore the problems and countermeasure in the methodology of acupuncture and moxibustion clinical researches at present, clinical research literatures about acupuncture and moxibustion (Acup-Mox) published in recent years in our country were reviewed. For the urgent need of the current internationalization of Acup-Mox, the authors proposed the model of clinical research on Acup-Mox, which should strictly stick to the international standard and fully embody traditional Chinese medicine characteristics in the intervention measures of acupuncture. It is indicated that innovation of the methodology about clinical researches of Acup-Mox has great significance in improving the quality of clinical research on Acup-Mox in our country and promoting internationalization of Acup-Mox.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious

Integration of clinical research documentation in electronic health records.

PubMed

Broach, Debra

2015-04-01

Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration.

Exploring factors related to the translation of collaborative research learning experiences into clinical practice: Opportunities and tensions.

PubMed

Fletcher, Simon; Whiting, Cheryl; Boaz, Annette; Reeves, Scott

2017-07-01

Providing training opportunities to develop research skills for clinical staff has been prioritised in response to the need for improving the evidence base underpinning the delivery of care. By exploring the experiences of a number of former participants of a multidisciplinary postgraduate research course, this article explores the factors that have enabled and impeded staff to translate their learnt research skills into clinical practice. Adopting an exploratory case study approach, 16 interviews with 5 cohorts of Masters by Research in Clinical Practice (MResCP) graduates were undertaken. The interviews explored graduates' course experiences and their subsequent attempts to undertake clinical research. Analysis of the data indicated that although participants valued their interactions with colleagues from different professions and felt they gained useful research skills/knowledge, upon returning to clinical practice, they encountered a number of barriers which restricted their ability to apply their research expertise. Professional isolation, issues of hierarchy, and a lack of organisational support were key to limiting their ability to undertake clinical research. Further work is needed to explore in more depth how (i) these barriers can be overcome and (ii) how taught collaborative research skills can be more effectively translated into practice.

Manufacturing/Cell Therapy Specialist | Center for Cancer Research

Cancer.gov

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID),

Quality Control Specialist | Center for Cancer Research

Cancer.gov

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID),

Patient Care Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious

Cancer Center Clinic and Research Team Perceptions of Identity and Interactions.

PubMed

Reimer, Torsten; Lee, Simon J Craddock; Garcia, Sandra; Gill, Mary; Duncan, Tobi; Williams, Erin L; Gerber, David E

2017-12-01

Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members' perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias. Surveys were administered to research and clinic staff at a National Cancer Institute-designated comprehensive cancer center. Data were analyzed using descriptive statistics, t tests, and analyses of variance. Responses were received from 105 staff (clinic, n = 55; research, n = 50; 61% response rate). Compared with clinic staff, research staff identified more strongly with their own group ( P < .01) but less strongly with the overall cancer center ( P = .02). Both clinic staff and research staff viewed their own group's goals as clearer than those of the other group ( P < .01) and felt that members of their groups interacted and shared information within ( P < .01) and across ( P < .01) groups more than the other group did. Research staff perceived daily outcomes as more important than did clinic staff ( P = .05), specifically research-related outcomes ( P = .07). Although there are many similarities between clinic and research teams, we also identified key differences, including perceptions of goal clarity and sharing, understanding and alignment with cancer center goals, and importance of outcomes. Future studies should examine how variation in perceptions and group dynamics between clinic and research teams may impact function and processes of cancer care.

Clinical research in a hospital--from the lone rider to teamwork.

PubMed

Hannisdal, E

1996-01-01

Clinical research of high international standard is very demanding and requires clinical data of high quality, software, hardware and competence in research design and statistical treatment of data. Most busy clinicians have little time allocated for clinical research and this increases the need for a potent infrastructure. This paper describes how the Norwegian Radium Hospital, a specialized cancer hospital, has reorganized the clinical research process. This includes a new department, the Clinical Research Office, which serves the formal framework, a central Diagnosis Registry, clinical databases and multicentre studies. The department assists about 120 users, mainly clinicians. Installation of a network software package with over 10 programs has strongly provided an internal standardization, reduced the costs and saved clinicians a great deal of time. The hospital is building up about 40 diagnosis-specific clinical databases with up to 200 variables registered. These databases are shared by the treatment group and seem to be important tools for quality assurance. We conclude that the clinical research process benefits from a firm infrastructure facilitating teamwork through extensive use of modern information technology. We are now ready for the next phase, which is to work for a better external technical framework for cooperation with other institutions throughout the world.

Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

PubMed

Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

2017-01-01

The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

Altruism in clinical research: coordinators' orientation to their professional roles.

PubMed

Fisher, Jill A; Kalbaugh, Corey A

2012-01-01

Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus reshaping their professional identities. The purpose of this study was to identify how research coordinators manage role and ethical conflicts within clinical research trials. A qualitative study combining observation and 63 semistructured interviews at 25 research organizations was used. Altruism is a recurring theme in how research coordinators define and view their work. Altruism is adopted by research coordinators to: (1) Teach patient-subjects the appropriate reasons to participate in clinical research, (2) minimize the conflict between research and care, and (3) contest the undervaluation of coordinating. Altruism is a strategy used to handle the various conflicts they experience in a difficult job, and it has become part of the professional identity of clinical research coordinators. Copyright © 2012 Elsevier Inc. All rights reserved.

Altruism in Clinical Research: Coordinators’ Orientation to their Professional Roles

PubMed Central

Fisher, Jill A.; Kalbaugh, Corey A.

2011-01-01

Background Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus re-shaping their professional identities. Purpose The purpose of this study is to identify how research coordinators manage role and ethical conflicts within clinical research trials. Method A qualitative study combining observation and 63 semi-structured interviews at 25 research organizations was used. Discussion Altruism is a recurring theme in how research coordinators define and view their work. Conclusion Altruism is adopted by research coordinators: 1) to teach patient-subjects the appropriate reasons to participate in clinical research, 2) to minimize the conflict between research and care, and 3) to contest the undervaluation of coordinating. Altruism is a strategy employed to handle the various conflicts they experience in a difficult job, and it has become part of the professional identity of clinical research coordinators. PMID:22083045

The Secure Medical Research Workspace: An IT Infrastructure to Enable Secure Research on Clinical Data

PubMed Central

Owen, Phillips; Mostafa, Javed; Lamm, Brent; Wang, Xiaoshu; Schmitt, Charles P.; Ahalt, Stanley C.

2013-01-01

Abstract Clinical data have tremendous value for translational research, but only if security and privacy concerns can be addressed satisfactorily. A collaboration of clinical and informatics teams, including RENCI, NC TraCS, UNC's School of Information and Library Science, Information Technology Service's Research Computing and other partners at the University of North Carolina at Chapel Hill have developed a system called the Secure Medical Research Workspace (SMRW) that enables researchers to use clinical data securely for research. SMRW significantly minimizes the risk presented when using identified clinical data, thereby protecting patients, researchers, and institutions associated with the data. The SMRW is built on a novel combination of virtualization and data leakage protection and can be combined with other protection methodologies and scaled to production levels. PMID:23751029

Usability Evaluation of an Unstructured Clinical Document Query Tool for Researchers.

PubMed

Hultman, Gretchen; McEwan, Reed; Pakhomov, Serguei; Lindemann, Elizabeth; Skube, Steven; Melton, Genevieve B

2018-01-01

Natural Language Processing - Patient Information Extraction for Researchers (NLP-PIER) was developed for clinical researchers for self-service Natural Language Processing (NLP) queries with clinical notes. This study was to conduct a user-centered analysis with clinical researchers to gain insight into NLP-PIER's usability and to gain an understanding of the needs of clinical researchers when using an application for searching clinical notes. Clinical researcher participants (n=11) completed tasks using the system's two existing search interfaces and completed a set of surveys and an exit interview. Quantitative data including time on task, task completion rate, and survey responses were collected. Interviews were analyzed qualitatively. Survey scores, time on task and task completion proportions varied widely. Qualitative analysis indicated that participants found the system to be useful and usable in specific projects. This study identified several usability challenges and our findings will guide the improvement of NLP-PIER 's interfaces.

How to emerge from the conservatism in clinical research methodology?

PubMed

Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

2017-09-01

Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.

The Ontology of Clinical Research (OCRe): An Informatics Foundation for the Science of Clinical Research

PubMed Central

Sim, Ida; Tu, Samson W.; Carini, Simona; Lehmann, Harold P.; Pollock, Brad H.; Peleg, Mor; Wittkowski, Knut M.

2013-01-01

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes — the science of clinical research — are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. PMID:24239612

Clinical and translational research capacity building needs in minority medical and health science Hispanic institutions.

PubMed

Estapé-Garrastazu, Estela S; Noboa-Ramos, Carlamarie; De Jesús-Ojeda, Lizbelle; De Pedro-Serbiá, Zulmarie; Acosta-Pérez, Edna; Camacho-Feliciano, Delia M

2014-10-01

A preliminary needs assessment was conducted among faculty and students of three minority medical and health science institutions comprising the Puerto Rico Clinical and Translational Research Consortium (PRCTRC). The Web-based survey was focused on evaluating the training interests in the clinical and translational research core areas and competencies developed by the National Institutes of Health-Clinical and Translational Sciences Award. The survey was the result of a team effort of three PRCTRC key function's leaderships: Multidisciplinary Training and Career Development, Tracking and Evaluation and Community Research and Engagement. The questionnaire included 45 items distributed across five content areas including demographics, research training needs, training activities coordination and knowledge about the services offered by the PRCTRC. Analysis of research needs includes a sample distribution according to professor, assistant/associate professor and graduate students. The thematic area with highest response rate among the three groups was: "Identify major clinical/public health problems and relevant translational research questions," with the competency "Identify basic and preclinical studies that are potential testable clinical research hypothesis." These preliminary results will guide the training and professional development of the new generation of clinical and translational researchers needed to eliminate health disparities. © 2014 The Authors. Clinical and Translational Science Published by Wiley Periodicals, Inc.

Insights from clinical research completed during the west Africa Ebola virus disease epidemic

PubMed Central

Rojek, Amanda; Horby, Peter; Dunning, Jake

2018-01-01

The west Africa Ebola virus disease (EVD) epidemic was extraordinary in scale. Now that the epidemic has ended, it is a relevant time to examine published studies with direct relevance to clinical care and, more broadly, to examine the implications of the clinical research response mounted. Clinically relevant research includes literature detailing risk factors for and clinical manifestations of EVD, laboratory and other investigation findings in patients, experimental vaccine and therapeutic clinical trials, and analyses of survivor syndrome. In this Review, we discuss new insights from patient-oriented research completed during the west Africa epidemic, identify ongoing knowledge gaps, and suggest priorities for future research. PMID:28461209

[Clinical research outside of teaching hospitals: Current situation in north-eastern France].

PubMed

Goetz, C; Dupoux, A; Déloy, L; Hertz, C; Jeanmaire, T; Parneix, N

2015-04-01

Most clinical research in France takes place in teaching hospitals. There are, however, many advantages to developing it in other hospitals: access to innovative treatments, improvement in healthcare quality, attractiveness of hospitals, increased trial inclusion rates and reduced selection bias. The objectives of our study were to report on the current situation of clinical research outside teaching hospitals. A three-stage survey was conducted between January 2012 and May 2013 in non-teaching hospitals of north-eastern France. First, questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with members of 20 selected hospitals. The administrative and medical boards of 85 hospitals participated in the first stage of the survey; half of these hospitals were engaged in clinical research activities and for 10 the internal structuring was cross-disciplinary. Answers from 178 departments were obtained during the second stage; 47% reported a clinical research activity. Meetings with research teams in 20 hospitals allowed us to identify difficulties concerning research funding, transversal organization and sponsoring. Clinical research existed in more than half of the respondent non-teaching hospitals. Obstacles to its development can be grouped in three categories: 1) internal structuring of clinical research, 2) access to information and knowledge of how clinical research functions and to interlocutors outside the hospital and 3) access to skills necessary to sponsor clinical research. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Research fellowship programs as a pathway for training independent clinical pharmacy scientists.

PubMed

Mueller, Eric W; Bishop, Jeffrey R; Kanaan, Abir O; Kiser, Tyree H; Phan, Hanna; Yang, Katherine Y

2015-03-01

The American College of Clinical Pharmacy (ACCP) Research Affairs Committee published a commentary in 2013 on training clinical pharmacy scientists in the context of changes in economic, professional, political, and research environments. The commentary centered on the opportunities for pharmacists in clinical/translational research including strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. A postdoctoral fellowship is cited as a current training pathway, capable of producing independent and productive pharmacy researchers. However, a decline in the number of programs, decreased funding availability, and variability in fellowship program activities and research focus have brought into question the relevance of this research training pathway to meet demand and opportunities. In response to these points, this commentary examines the state of research fellowship training including the current ACCP research fellowship review process, the need for standardization of research fellowship programs, and strategies to strengthen and promote research fellowships as relevant researcher training pathways. © 2015 Pharmacotherapy Publications, Inc.

Genetics of Bone Density

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Research methodology in Dentistry: Part I – The essentials and relevance of research

PubMed Central

Krithikadatta, Jogikalmat

2012-01-01

The need for scientific evidence should be the basis of clinical practice. The field of restorative dentistry and endodontics is evolving at a rapid pace, with the introduction of several materials, instruments, and equipments. However, there is minimal information of their relevance in clinical practice. On the one hand, material and laboratory research is critical, however; its translation into clinical practice is not being substantiated enough with clinical research. This four part review series focuses on methods to improve evidence-based practice, by improving methods to integrate laboratory and clinical research. PMID:22368327

Construction of databases: advances and significance in clinical research.

PubMed

Long, Erping; Huang, Bingjie; Wang, Liming; Lin, Xiaoyu; Lin, Haotian

2015-12-01

Widely used in clinical research, the database is a new type of data management automation technology and the most efficient tool for data management. In this article, we first explain some basic concepts, such as the definition, classification, and establishment of databases. Afterward, the workflow for establishing databases, inputting data, verifying data, and managing databases is presented. Meanwhile, by discussing the application of databases in clinical research, we illuminate the important role of databases in clinical research practice. Lastly, we introduce the reanalysis of randomized controlled trials (RCTs) and cloud computing techniques, showing the most recent advancements of databases in clinical research.

The DREAMS Team: Creating Community Partnerships through Research Advocacy Training for Diverse Older Adults

ERIC Educational Resources Information Center

Hart, Ariel R.; Dillard, Rebecca; Perkins, Molly M.; Vaughan, Camille P.; Kinlaw, Kathy; McKay, J. Lucas; Waldrop-Valverde, Drenna; Hagen, Kimberley; Wincek, Ron C.; Hackney, Madeleine E.

2017-01-01

The DREAMS Team research advocacy training program helps clinical faculty and health students introduce basic clinical research concepts to diverse older adults to galvanize their active involvement in the research process. Older adults are frequently underrepresented in clinical research, due to barriers to participation including distrust,…

Role of the clinical research nurse in tissue viability.

PubMed

Hemingway, Beverley; Storey, Carron

Opportunities for nurses to be involved in clinical research have increased with the growing emphasis on research in the NHS. This article examines the experiences of two registered nurses adapting to the role of clinical research nurse in a pressure ulcer programme of research. The challenges, rewards and strategies involved are discussed.

PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India

PubMed Central

Burt, Tal; Dhillon, Savita; Sharma, Pooja; Khan, Danish; MV, Deepa; Alam, Sazid; Jain, Sarika; Alapati, Bhavana; Mittal, Sanjay; Singh, Padam

2013-01-01

Background A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. Objective To study public knowledge and perceptions of clinical research. Methods A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. Results Interviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%). Conclusions Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues. PMID:23874712

Medical research at the Albert Schweitzer Hospital.

PubMed

Issifou, Saadou; Adegnika, Ayola A; Lell, Bertrand

2010-03-01

Built in 1981, the Medical Research Unit is located at the campus of the Albert Schweitzer Hospital. The main scientific activities of this research unit lie on clinical research focusing on antimalarial drugs and vaccines, and basic studies on pathogenesis of infectious diseases. Since 2002 the Medical Research Unit has experience in organising and hosting high quality training in clinical research in collaboration with the Vienna School of Clinical Research and other partners. For the future, this unit is involved as a key partner in the Central African Network on Tuberculosis, HIV/AIDS and Malaria (CANTAM) consortium playing a central role for the excellence in clinical research in Central Africa.

Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

PubMed

Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

2015-12-01

The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

Protein Linked to Atopic Dermatitis

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Translating Alcohol Research

PubMed Central

Batman, Angela M.; Miles, Michael F.

2015-01-01

Alcohol use disorder (AUD) and its sequelae impose a major burden on the public health of the United States, and adequate long-term control of this disorder has not been achieved. Molecular and behavioral basic science research findings are providing the groundwork for understanding the mechanisms underlying AUD and have identified multiple candidate targets for ongoing clinical trials. However, the translation of basic research or clinical findings into improved therapeutic approaches for AUD must become more efficient. Translational research is a multistage process of streamlining the movement of basic biomedical research findings into clinical research and then to the clinical target populations. This process demands efficient bidirectional communication across basic, applied, and clinical science as well as with clinical practitioners. Ongoing work suggests rapid progress is being made with an evolving translational framework within the alcohol research field. This is helped by multiple interdisciplinary collaborative research structures that have been developed to advance translational work on AUD. Moreover, the integration of systems biology approaches with collaborative clinical studies may yield novel insights for future translational success. Finally, appreciation of genetic variation in pharmacological or behavioral treatment responses and optimal communication from bench to bedside and back may strengthen the success of translational research applications to AUD. PMID:26259085

Translating Alcohol Research: Opportunities and Challenges.

PubMed

Batman, Angela M; Miles, Michael F

2015-01-01

Alcohol use disorder (AUD) and its sequelae impose a major burden on the public health of the United States, and adequate long-term control of this disorder has not been achieved. Molecular and behavioral basic science research findings are providing the groundwork for understanding the mechanisms underlying AUD and have identified multiple candidate targets for ongoing clinical trials. However, the translation of basic research or clinical findings into improved therapeutic approaches for AUD must become more efficient. Translational research is a multistage process of stream-lining the movement of basic biomedical research findings into clinical research and then to the clinical target populations. This process demands efficient bidirectional communication across basic, applied, and clinical science as well as with clinical practitioners. Ongoing work suggests rapid progress is being made with an evolving translational framework within the alcohol research field. This is helped by multiple interdisciplinary collaborative research structures that have been developed to advance translational work on AUD. Moreover, the integration of systems biology approaches with collaborative clinical studies may yield novel insights for future translational success. Finally, appreciation of genetic variation in pharmacological or behavioral treatment responses and optimal communication from bench to bedside and back may strengthen the success of translational research applications to AUD.

Informed consent process: A step further towards making it meaningful!

PubMed Central

Kadam, Rashmi Ashish

2017-01-01

Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process. PMID:28828304

Comparative Effectiveness Research in Pediatric Respiratory Disease: Promise and Pitfalls.

PubMed

Ramos, Kathleen J; Somayaji, Ranjani; Nichols, David P; Goss, Christopher H

2018-02-01

Comparative effectiveness research (CER) has become increasing central to clinical research in medicine. CER seeks to conduct clinical trials that compare different commonly used interventions in real-world settings (pragmatic clinical trials) and use a multitude of sources of evidence (including registries and cohort studies) to inform clinical decision making. CER also ensures that stakeholders (patients, families, care providers, insurers) have a voice in the research process by integrating formal stakeholder engagement as part of the research. This innovative approach to clinical research has distinct benefits and pitfalls. This review first defines what CER is and then describes some of its benefits and then pitfalls. The focus is on the role of CER in pediatrics.

Translating research and into everyday clinical practice: Lessons learned from a USA national dental practice-based research network

PubMed Central

Gordan, Valeria V.

2012-01-01

Clinical studies are of paramount importance for testing and translation of the research findings to the community. Despite the existence of clinical studies, a significant delay exists between the generation of new knowledge and its application into the medical/dental community and their patients. One example is the repair of defective dental restorations. About 75% of practitioners in general dental practices do not consider the repair of dental restorations as a viable alternative to the replacement of defective restorations. Engaging and partnering with health practitioners in the field on studies addressing everyday clinical research questions may offer a solution to speed up the translation of the research findings. Practice-based research (PBR) offers a unique opportunity for practitioners to be involved in the research process, formulating clinical research questions. Additionally, PBR generates evidence-based knowledge with a broader spectrum that can be more readily generalized to the public. With PBR, clinicians are involved in the entire research process from its inception to its dissemination. Early practitioner interaction in the research process may result in ideas being more readily incorporated into practice. This paper discusses PBR as a mean to speed up the translation of research findings to clinical practice. It also reviews repair versus replacement of defective restorations as one example of the delay in the application of research findings to clinical practice. PMID:22889478

[Organization of clinical research: in a large scale department for cardiothoracic surgery].

PubMed

Sarikouch, S; Schilling, T; Haverich, A

2010-04-01

Translation of basic research results into routine patient care is delayed in parts by lack of institutionalization in clinical research. In this article the research structure and organization of our Department of Cardiac, Thoracic, Transplantation and Vascular Surgery are described.Basic research, separately directed, is accomplished in the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) and within the scope of the Excellence cluster "REBIRTH--from Regenerative Biology to Reconstructive Therapy".Clinical research is directed by heads of the subdepartments of our institution (valve and coronary surgery, aortic surgery, surgical electrophysiology, vascular surgery, thoracic surgery, cardiac assist systems, thoracic transplantation, intensive care and pediatric heart surgery).A separate subdepartment for clinical research is responsible for study coordination and accompanies clinical studies from study design and patient screening to publication. This subdepartment also serves as a constant contact to sponsors and superordinated research organizations within the Hannover Medical School.

Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

PubMed

Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E

2013-01-01

To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.

Integrating Single-System Design Research into the Clinical Practice Class

ERIC Educational Resources Information Center

Cooper, Marlene G.

2006-01-01

Clinical practice and research are generally taught separately in Master of Social Work programs by faculty with distinct areas of expertise. This paper discusses the teaching of single-subject design research methodology by clinical faculty, in the clinical practice class. Examples from student papers demonstrate the effectiveness of integrating…

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Clinical research in Finland in 2002 and 2007: quantity and type

PubMed Central

2013-01-01

Background Regardless of worries over clinical research and various initiatives to overcome problems, few quantitative data on the numbers and type of clinical research exist. This article aims to describe the volume and type of clinical research in 2002 and 2007 in Finland. Methods The research law in Finland requires all medical research to be submitted to regional ethics committees (RECs). Data from all new projects in 2002 and 2007 were collected from REC files and the characteristics of clinical projects (76% of all submissions) were analyzed. Results The number of clinical projects was large, but declining: 794 in 2002 and 762 in 2007. Drug research (mainly trials) represented 29% and 34% of the clinical projects; their total number had not declined, but those without a commercial sponsor had. The number of different principal investigators was large (630 and 581). Most projects were observational, while an experimental design was used in 43% of projects. Multi-center studies were common. In half of the projects, the main funder was health care or was done as unpaid work; 31% had industry funding as the main source. There was a clear difference in the type of research by sponsorship. Industry-funded research was largely drug research, international multi-center studies, with randomized controlled or other experimental design. The findings for the two years were similar, but a university hospital as the main research site became less common between 2002 and 2007. Conclusions Clinical research projects were common, but numbers are declining; research was largely funded by health care, with many physicians involved. Drug trials were a minority, even though most research promotion efforts and regulation concerns them. PMID:23680289

Clinical research in Finland in 2002 and 2007: quantity and type.

PubMed

Hemminki, Elina; Virtanen, Jorma; Veerus, Piret; Regushevskaya, Elena

2013-05-16

Regardless of worries over clinical research and various initiatives to overcome problems, few quantitative data on the numbers and type of clinical research exist. This article aims to describe the volume and type of clinical research in 2002 and 2007 in Finland. The research law in Finland requires all medical research to be submitted to regional ethics committees (RECs). Data from all new projects in 2002 and 2007 were collected from REC files and the characteristics of clinical projects (76% of all submissions) were analyzed. The number of clinical projects was large, but declining: 794 in 2002 and 762 in 2007. Drug research (mainly trials) represented 29% and 34% of the clinical projects; their total number had not declined, but those without a commercial sponsor had. The number of different principal investigators was large (630 and 581). Most projects were observational, while an experimental design was used in 43% of projects. Multi-center studies were common. In half of the projects, the main funder was health care or was done as unpaid work; 31% had industry funding as the main source. There was a clear difference in the type of research by sponsorship. Industry-funded research was largely drug research, international multi-center studies, with randomized controlled or other experimental design. The findings for the two years were similar, but a university hospital as the main research site became less common between 2002 and 2007. Clinical research projects were common, but numbers are declining; research was largely funded by health care, with many physicians involved. Drug trials were a minority, even though most research promotion efforts and regulation concerns them.

Understanding facilitators and barriers to reengineering the clinical research enterprise in community-based practice settings.

PubMed

Kukafka, Rita; Allegrante, John P; Khan, Sharib; Bigger, J Thomas; Johnson, Stephen B

2013-09-01

Solutions are employed to support clinical research trial tasks in community-based practice settings. Using the IT Implementation Framework (ITIF), an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use, we sought to understand the barriers and facilitators to clinical research in community-based practice settings preliminary to implementing new informatics solutions for improving clinical research infrastructure. The studies were conducted in practices within the Columbia University Clinical Trials Network. A mixed-method approach, including surveys, interviews, time-motion studies, and observations was used. The data collected, which incorporates predisposing, enabling, and reinforcing factors in IT use, were analyzed according to each phase of ITIF. Themes identified in the first phase of ITIF were 1) processes and tools to support clinical trial research and 2) clinical research peripheral to patient care processes. Not all of the problems under these themes were found to be amenable to IT solutions. Using the multi-level orientation of the ITIF, we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice-based settings. Developing strategies to target enabling and reinforcing factors, which focus on organizational factors, and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes, is most challenging. The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice settings. © 2013.

Current Research Studies

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... Success Home > Explore Research > Current Research Studies Current Research Studies Email Print + Share The Crohn’s & Colitis Foundation ... conducted online. Learn more about IBD Partners. Clinical Research Alliance The Clinical Research Alliance is a network ...

Steroid Treatments Equally Effective Against Sudden Deafness

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Vitamin D Levels Predict Multiple Sclerosis Progression

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Plain Language: Getting Started or Brushing Up

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Moral Stress and Job Burnout Among Frontline Staff Conducting Clinical Research on Affective and Anxiety Disorders

PubMed Central

Fried, Adam L.; Fisher, Celia B.

2016-01-01

There has been increased attention on job-related stress and burnout experienced by clinicians working with vulnerable and at-risk populations, including effects on personal mental health, therapeutic decision-making, and job effectiveness. Little is known, however, about the job-related stressors and symptoms of burnout experienced by clinical research staff working with similar populations, especially in terms of moral stress they may experience when adherence to scientific procedures appears to conflict with their personal commitment to address the clinical needs of their research participants or role as health care provider. In this national study, 125 frontline research workers conducting clinical research studies with individuals diagnosed with affective and anxiety disorders completed an online survey including measures assessing research work related moral stress, job burnout, organizational ethics climate and organizational research support. Results indicated that younger research workers, those whose research work was part of a graduate assistantship and perceptions of higher participant research risk were associated with higher levels of moral stress and job burnout. Supportive organizational climates were associated with lower levels of moral stress and job burnout. Recommendations for clinical research workers, supervisors and clinical training directors are discussed. PMID:28484305

Moral Stress and Job Burnout Among Frontline Staff Conducting Clinical Research on Affective and Anxiety Disorders.

PubMed

Fried, Adam L; Fisher, Celia B

2016-06-01

There has been increased attention on job-related stress and burnout experienced by clinicians working with vulnerable and at-risk populations, including effects on personal mental health, therapeutic decision-making, and job effectiveness. Little is known, however, about the job-related stressors and symptoms of burnout experienced by clinical research staff working with similar populations, especially in terms of moral stress they may experience when adherence to scientific procedures appears to conflict with their personal commitment to address the clinical needs of their research participants or role as health care provider. In this national study, 125 frontline research workers conducting clinical research studies with individuals diagnosed with affective and anxiety disorders completed an online survey including measures assessing research work related moral stress, job burnout, organizational ethics climate and organizational research support. Results indicated that younger research workers, those whose research work was part of a graduate assistantship and perceptions of higher participant research risk were associated with higher levels of moral stress and job burnout. Supportive organizational climates were associated with lower levels of moral stress and job burnout. Recommendations for clinical research workers, supervisors and clinical training directors are discussed.

'Mind the gap' between the development of therapeutic innovations and the clinical practice in oncology: A proposal of the European Organisation for Research and Treatment of Cancer (EORTC) to optimise cancer clinical research.

PubMed

Kempf, Emmanuelle; Bogaerts, Jan; Lacombe, Denis; Liu, Lifang

2017-11-01

In Europe, most of the cancer clinical research dedicated to therapeutic innovations aims primarily at regulatory approval. Once an anticancer drug enters the common market, each member state determines its real-world use based on its own criteria: pricing, reimbursement and clinical indications. Such an innovation-centred clinical research landscape might neglect patient-relevant issues in real-world setting, such as comparative effectiveness of distinct treatment options or long-term safety monitoring. The European Organisation for Research and Treatment of Cancer (EORTC) advocates reforming the current 'innovation-centred' system to a truly 'patient-centred' paradigm with systematically coordinated applied clinical research in conjunction with drug development, featuring the following strategy. Copyright © 2017 Elsevier Ltd. All rights reserved.

Clinical investigations for SUS, the Brazilian public health system.

PubMed

Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

2012-01-01

Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration.

PubMed

Chalmers, James D; Crichton, Megan; Goeminne, Pieter C; Loebinger, Michael R; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-09-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration

PubMed Central

Crichton, Megan; Goeminne, Pieter C.; Loebinger, Michael R.; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja ; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-01-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. Educational aims To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years PMID:28894479

Novel target for high-risk neuroblastoma identified in pre-clinical research | Center for Cancer Research

Cancer.gov

Pre-clinical research by investigators at the Center for Cancer Research and their colleagues have identified a number of novel epigenetic targets for high-risk neuroblastoma and validated a promising new targeted inhibitor in pre-clinical models.  Read more...

Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

PubMed

Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

2011-12-01

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. Copyright © 2011 Elsevier Ltd. All rights reserved.

Initial strides for invent-VTE: Towards global collaboration to accelerate clinical research in venous thromboembolism.

PubMed

Rodger, Marc; Langlois, Nicole; Middeldorp, Saskia; Kahn, Susan; Sandset, Per Morten; Brighton, Timothy; Huisman, Menno V; Meyer, Guy; Konstantinides, Stavros; Ageno, Walter; Morange, Pierre; Garcia, David; Kreuziger, Lisa Baumann; Young, Laura; Key, Nigel; Monreal, Manuel; Jiménez, David

2018-03-01

Venous thromboembolism (VTE) represents a major global burden of disease and requires collaborative efforts to conduct large, high-quality investigator-initiated and academically sponsored studies addressing the most relevant clinical questions. Owing to increasing regulatory requirements, the highly competitive nature of peer-reviewed funding and costs associated with conducting large, multinational clinical trials, completing practice-changing research constitutes a growing challenge for clinical investigators. As clinical trialists interested in VTE, we founded INVENT (International Network of Venous Thromboembolism Clinical Research Networks) in an effort to promote and accelerate patient-oriented, investigator-initiated, international collaborative research, to identify, prioritize and answer key clinical research questions for patients with VTE. We report on our activities to formalize the INVENT network and our accomplishments in our first year. Copyright © 2018 Elsevier Ltd. All rights reserved.

Restoring Bone Density in Women with Ovarian Disorder

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... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Protein-Based Urine Test Predicts Kidney Transplant Outcomes

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Research as a standard of care in PICU

PubMed Central

Zimmerman, Jerry J.; Anand, Kanwaljeet J. S.; Meert, Kathleen L.; Willson, Douglas F.; Newth, Christopher J. L.; Harrison, Rick; Carcillo, Joseph A.; Berger, John; Jenkins, Tammara L.; Nicholson, Carol; Dean, J. Michael

2016-01-01

Background Excellence in clinical care coupled with basic and applied research reflects the maturation of a medical subspecialty, advances that field, and provides objective data for identifying best practices. Pediatric intensive care units (PICU) are uniquely suited for conducting translational and clinical research. Moreover, multiple investigations have reported that a majority of parents are interested in their children’s participation in clinical research, even when the research offers no direct benefit to their child. However, such activity may generate ethical conflict with bedside care providers trying to acutely identify the best approach for an individual critically ill child. Ultimately, this conflict may diminish enthusiasm for the generation of scientific evidence that supports application of evidence-based medicine into PICU clinical standard work. Objective Provide an overview of current state PICU clinical research strengths, liabilities, opportunities, and barriers, and contrast this with an established pediatric hematology-oncology iterative research model that constitutes a learning healthcare system. Design Narrative review of medical literature published in English. Conclusions Currently most PICU therapy is not evidence-based. Developing a learning healthcare system in the PICU integrates clinical research into usual practice and fosters a culture of evidence-based learning and continual care improvement. As PICU mortality has significantly decreased, identification and validation of patient-centered, clinically relevant research outcome measures other than mortality is essential for future clinical trial design. Because most pediatric critical illness may be classified as rare diseases, participation in research networks will facilitate iterative, collaborative, multi-institutional investigations that over time identify best practices to improve PICU outcomes. Despite real ethical challenges, critically ill children and their families should have the opportunity to participate in translational/clinical research whenever feasible. PMID:26513203

Completed | Office of Cancer Clinical Proteomics Research

Cancer.gov

Prior to the current Clinical Proteomic Tumor Analysis Consortium (CPTAC), previously funded initiatives associated with clinical proteomics research included: Clinical Proteomic Tumor Analysis Consortium (CPTAC 2.0) Clinical Proteomic Technologies for Cancer Initiative (CPTC) Mouse Proteomic Technologies Initiative

Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials.

PubMed

Xiao, Lan; Lv, Nan; Rosas, Lisa G; Au, David; Ma, Jun

2017-02-01

To validate clinic weights in electronic health records against researcher-measured weights for outcome assessment in weight loss trials. Clinic and researcher-measured weights from a published trial (BE WELL) were compared using Lin's concordance correlation coefficient, Bland and Altman's limits of agreement, and polynomial regression model. Changes in clinic and researcher-measured weights in BE WELL and another trial, E-LITE, were analyzed using growth curve modeling. Among BE WELL (n = 330) and E-LITE (n = 241) participants, 96% and 90% had clinic weights (mean [SD] of 5.8 [6.1] and 3.7 [3.9] records) over 12 and 15 months of follow-up, respectively. The concordance correlation coefficient was 0.99, and limits of agreement plots showed no pattern between or within treatment groups, suggesting overall good agreement between researcher-measured and nearest-in-time clinic weights up to 3 months. The 95% confidence intervals for predicted percent differences fell within ±3% for clinic weights within 3 months of the researcher-measured weights. Furthermore, the growth curve slopes for clinic and researcher-measured weights by treatment group did not differ significantly, suggesting similar inferences about treatment effects over time, in both trials. Compared with researcher-measured weights, close-in-time clinic weights showed high agreement and inference validity. Clinic weights could be a valid pragmatic outcome measure in weight loss studies. © 2017 The Obesity Society.

Pseudonymisation of radiology data for research purposes

NASA Astrophysics Data System (ADS)

Noumeir, Rita; Lemay, Alain; Lina, Jean-Marc

2005-04-01

Medical image processing methods and algorithms, developed by researchers, need to be validated and tested. Test data should ideally be real clinical data especially when that clinical data is varied and exists in large volume. In nowadays, clinical data is accessible electronically and has important value for researchers. However, the usage of clinical data for research purposes should respect data confidentiality, patient right to privacy and the patient consent. In fact, clinical data is nominative given that it contains information about the patient such as name, age and identification number. Evidently, clinical data should be de-identified to be exported to research databases. However, the same patient is usually followed during a long period of time. The disease progression and the diagnostic evolution represent extremely valuable information for researchers, as well. Our objective is to build a research database from de-identified clinical data while enabling the database to be easily incremented by exporting new pseudonymous data, acquired over a long period of time. Pseudonymisation is data de-identification such that data belonging to the same individual in the clinical environment bear the same relation to each other in the de-identified research version. In this paper, we propose a software architecture that enables the implementation of a research database that can be incremented in time. We also evaluate its security and discuss its security pitfalls.

Leveraging electronic health records for clinical research.

PubMed

Raman, Sudha R; Curtis, Lesley H; Temple, Robert; Andersson, Tomas; Ezekowitz, Justin; Ford, Ian; James, Stefan; Marsolo, Keith; Mirhaji, Parsa; Rocca, Mitra; Rothman, Russell L; Sethuraman, Barathi; Stockbridge, Norman; Terry, Sharon; Wasserman, Scott M; Peterson, Eric D; Hernandez, Adrian F

2018-04-30

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper. Copyright © 2018 Elsevier, Inc. All rights reserved.

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

American Society of Clinical Oncology policy statement: oversight of clinical research.

PubMed

2003-06-15

Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public understanding of clinical research oversight. 6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system. This policy statement makes recommendations in several areas that serve as principles to support an improved system of oversight for clinical research. ASCO will work with all parties involved in the clinical research system to develop the steps necessary to implement these recommendations. Centralized Trial Review: A large percentage of oncology clinical trials are coordinated through the National Cancer Institute's (NCI) system of cooperative groups, which already incorporates centralized scientific review. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained IRB members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (CRBs) would also contribute consistency and efficiency to the process. Once successfully completed, the review would represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution. Considering the enormous size and complexity of the clinical research enterprise, ASCO envisions multiple CRBs, which could be distributed as regional review boards. Central review will use a single protocol and consent form, and monitor and evaluate adverse events (AEs) on a global basis, eliminating many of the time-consuming steps for the local IRB. Global monitoring and assessment of AEs has real potential to enhance trial participants' safety by giving local institutions more information on the overall trial and enabling them to devote more time to ongoing review of the trial onsite. Use of a CRB also has real potential to reduce the costs of clinical trial oversight by allowing local IRBs to eliminate the costs of initial review. These efficiencies will likely lead to institutions redirecting funds toward monitoring ongoing trials. Although a CRB has potential to improve the efficiency of the process, a CRB could also have tremendous ability to delay valuable trials. Checks and balances must be included in the newly devised system to ensure timely review and appeals of CRB actions. ASCO proposes the advent of a new pilot program for centralizing review of clinical trials. It requires clear engagement of all stakeholders in planning the experiment, clear articulation of the goals, and assurance of federal regulatory protection for institutions choosing to participate. If successful, this CRB pilot project could be expanded to include multi-institutional industry-sponsored research. Education and Training:Education and training are critical to the ultimate success of an improved oversight system. All members of the research team should receive comprehensive education on conducting scientifically and ethically valid clinical research. The curriculum should also include information on the prevailing local and federal regulations that pertain to the clinical trials process. IRB members should also receive ongoing education and training in the review of clinical research protocols. IRB training should pay particular attention to nonscientific members to give them the tools necessary to speak on behalf of research participants. ASCO should develop a curriculum that focuses on the proper conduct of human research and emphasize ethically sound clinical research in the context of its Annual Meeting. Informed Consent: Investigators and review boards have specific roles to play in ensuring the education of trial participants through the informed consent process, both when they are considering trial enrollment and as they participate in the trial. Review boards and investigators should focus primarily on the informed consent process, rather than the informed consent documents. Federal Oversight: The federal government has an important role to play in the oversight of clinical research. This role should be expanded to cover all research, not just that which is funded by the federal government or conducted with the oversight of the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the FDA should provide clear regulatory support and guidance for local institutions that choose to employ a CRB. In the case of the pilot CRB discussed in this policy statement, it should serve as the preferred option for the cancer cooperative group clinical trials. Ideally, the federal government should unify and streamline its regulations for the oversight of clinical research. Resources Supporting Clinical Research Infrastructure:An effective oversight process demands the highest quality scientific and ethical review and onsite monitoring of the safety of trial participants. This can only be accomplished by the involvement of an experienced IRB that receives funding, resources, and institutional support enabling it to fulfill its mandate. Critical to the integrity of research is the absence of bias in the process. ASCO strongly recommends the adoption of standards for the identification, management, and, where appropriate, elimination of conflicts of interests, whether they are actual, potential, or apparent.

Drug Improves Birth Rates for Women with Ovary Disorder

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Be a Partner in Clinical Research

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... Print this issue Be a Partner in Clinical Research Help Others, Help Yourself En español Send us ... you know that you can participate in clinical research? Whether you’re healthy or sick, young or ...

78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Science Research and Development Service on the relevance and feasibility of proposed projects and the...

The effect of the European Clinical Trials Directive on published drug research in anaesthesia.

PubMed

Walker, E; Hankins, M C; White, S M

2009-09-01

The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.

Translational nutrition research at UC-Davis – the key role of the clinical and translational science center

USDA-ARS?s Scientific Manuscript database

To better understand the facility and equipment needs for human clinical nutrition research the New York Academy of Sciences presented a symposium. This paper is the result of that symposium and provides information into how clinical nutrition research is conducted at the Clinical and Translational ...

Clinical Research Informatics for Big Data and Precision Medicine.

PubMed

Weng, C; Kahn, M G

2016-11-10

To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.

Clinical Research Informatics for Big Data and Precision Medicine

PubMed Central

Kahn, M. G.

2016-01-01

Summary Objectives To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. Methods We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. Results The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. Conclusion The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors. PMID:27830253

Prevalence of Allergies the Same, Regardless of Where You Live

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... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Gene Linked to Excess Male Hormones in Female Infertility Disorder

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... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Integrating Bioethics into Clinical and Translational Science Research: A Roadmap

PubMed Central

Shapiro, Robyn S.; Layde, Peter M.

2008-01-01

Abstract Recent initiatives to improve human health emphasize the need to effectively and appropriately translate new knowledge gleaned from basic biomedical and behavioral research to clinical and community application. To maximize the beneficial impact of scientific advances in clinical practice and community health, and to guard against potential deleterious medical and societal consequences of such advances, incorporation of bioethics at each stage of clinical and translational science research is essential. At the earliest stage, bioethics input is critical to address issues such as whether to limit certain areas of scientific inquiry. Subsequently, bioethics input is important to assure not only that human subjects trials are conducted and reported responsibly, but also that results are incorporated into clinical and community practices in a way that promotes and protects bioethical principles. At the final stage of clinical and translational science research, bioethics helps to identify the need and approach for refining clinical practices when safety or other concerns arise. The framework we present depicts how bioethics interfaces with each stage of clinical and translational science research, and suggests an important research agenda for systematically and comprehensively assuring bioethics input into clinical and translational science initiatives. PMID:20443821

Involving children and young people in clinical research through the forum of a European Young Persons' Advisory Group: needs and challenges.

PubMed

Gaillard, Segolene; Malik, Salma; Preston, Jenny; Escalera, Begonya Nafria; Dicks, Pamela; Touil, Nathalie; Mardirossian, Sandrine; Claverol-Torres, Joana; Kassaï, Behrouz

2018-02-19

Children and young people are seen as fundamental to the design and delivery of clinical research as active and reflective participants. In Europe, involvement of children and young people in clinical research is promoted extensively in order to engage young people in research as partners and to give them a voice to raise their own issues or opinions and for their involvement in planning and decision making in addition to learning research skills. Children and young people can be trained in clinical research through participation in young person advisory groups (YPAGs). Members of YPAGs assist other children and young people to learn about clinical research and share their experience and point of view with researchers, thereby possibly influencing all phases of research including the development and prioritization of research questions, design and methods, recruitment plans, and strategies for results dissemination. In the long term, the expansion of YPAGs in Europe will serve as a driving force for refining pediatric clinical research. It will help in a better definition of research projects according to the patients' needs. Furthermore, direct engagement of children and young people in research will be favorable to both researchers and young people. © 2018 Société Française de Pharmacologie et de Thérapeutique.

Clinical Trials: A Crucial Key to Human Health Research

MedlinePlus

... Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents For ... Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use human ...

NIH Study Offers Insight into Why Cancer Incidence Increases with Age

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... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

NIH Study Finds Regular Aspirin Use May Reduce Ovarian Cancer Risk

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... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Leading by Success: Impact of a Clinical & Translational Research Infrastructure Program to Address Health Inequities

PubMed Central

Shiramizu, Bruce; Shambaugh, Vicki; Petrovich, Helen; Seto, Todd B.; Ho, Tammy; Mokuau, Noreen; Hedges, Jerris R.

2016-01-01

Building research infrastructure capacity to address clinical and translational gaps has been a focus of funding agencies and foundations. Clinical and Translational Sciences Awards, Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research (RCTR) and the Institutional Development Award Infrastructure for Clinical and Translational Research funded by United States (US) government to fund clinical translational research programs have existed for over a decade to address racial and ethnic health disparities across the US. While the impact on the nation’s health can’t be made in a short period, assessment of a program’s impact could be a litmus test to gauge its effectiveness at the institution and communities. We report the success of a Pilot Project Program in the University of Hawaii RCTR Award in advancing careers of emerging investigators and community collaborators. Our findings demonstrated that the investment has a far-reaching impact on engagement with community-based research collaborators, career advancement of health disparities investigators, and favorable impacts on health policy. PMID:27797013

Team building: electronic management-clinical translational research (eM-CTR) systems.

PubMed

Cecchetti, Alfred A; Parmanto, Bambang; Vecchio, Marcella L; Ahmad, Sjarif; Buch, Shama; Zgheib, Nathalie K; Groark, Stephen J; Vemuganti, Anupama; Romkes, Marjorie; Sciurba, Frank; Donahoe, Michael P; Branch, Robert A

2009-12-01

Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.

The distribution of outcomes research papers across clinical journals.

PubMed

Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

2011-06-01

This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

Teens Using E-cigarettes May Be More Likely to Start Smoking Tobacco

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... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Statement on Public-Private Partnerships as Part of the NIH HEAL Initiative

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Does informed consent given by healthy individuals when enrolling in clinical research feel less voluntary than for ill individuals?

PubMed

Roberts, Laura; Kim, Jane Paik

2018-04-30

Clinical research is predicated ethically on the authentic voluntarism of individuals who choose to enroll in human studies. Existing literature has focused on aspects of informed consent for clinical research other than voluntarism. The objective of this study was to compare the perspectives of clinical research participants who are in good health and who are ill regarding voluntarism-related aspects of informed consent and to assess situational influences that enable voluntarism in the process of obtaining clinical research consent. A 23-item written survey, the Informed Consent Questionnaire (ICQ), was administered in a "piggyback" semi-structured interview study of ill and healthy volunteers enrolled in IRB-approved clinical research studies. A total of 150 (60 mentally ill, 43 physically ill, and 47 healthy) clinical research participants participated. Respondents expressed positive views of their experiences with the informed consent processes for their respective clinical research protocols and respondents strongly endorsed items related to voluntarism irrespective of their illness type (range of means = [3.9, 4.8]). Ill participants more highly endorsed items relating to informed consent conditions (mentally ill vs healthy: 0.54 on a 5-point scale, P value = 0.01) (physically ill vs. healthy: 0.47 on a 5-point scale, P value = 0.01). The favorable views of clinical research participants regarding their experience of giving informed consent to enroll in a study were not surprising. Contrary to our a priori hypothesis, healthy individuals did not feel as positively as their ill counterparts. Copyright © 2018 Elsevier Ltd. All rights reserved.

A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

PubMed

Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

2017-01-01

The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

A qualitative study on acceptable levels of risk for pregnant women in clinical research.

PubMed

van der Zande, Indira S E; van der Graaf, Rieke; Oudijk, Martijn A; van Delden, Johannes J M

2017-05-15

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals' individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

Promoting Bedside Nurse-Led Research Through a Dedicated Neuroscience Nursing Research Fellowship.

PubMed

Stutzman, Sonja; Olson, DaiWai; Supnet, Charlene; Harper, Caryn; Brown-Cleere, Shelley; McCulley, Becky; Goldberg, Mark

2016-12-01

We hypothesized that nurses would benefit from the fellowship model traditionally used to engage physicians in clinical research. The Neuroscience Nursing Research Center (NNRC) fellowship program was created as a model for engaging nurses at all levels of clinical practice to become active in clinical research. The NNRC was established in 2013 as a novel approach to promote bedside nurses as primary investigators in clinical research. The NNRC developed 4 pathways to nursing research success: research fellowship, student-nurse internship, didactic training, and research consultation. Fellows have enrolled more than 900 participants in 14 studies. Nurses have presented more than 20 abstracts at 12 conferences and submitted 11 manuscripts for publication. The NNRC has provided research training to more than 150 nurses. The NNRC program is successful in engaging nurses in research. It shows promise to continue to develop nursing research that is applicable to clinicians and thus improve patient care.

Clinical Investigator Development Program | Center for Cancer Research

Cancer.gov

Clinical Investigator Development Program Application Deadline:  September 30, 2018 Program Starts: July 1, 2019 The NCI Center for Cancer Research (CCR) is pleased to announce our annual call for applications for an exciting training opportunity intended for physicians interested in dedicating their careers to clinical research. Come join a vibrant, multidisciplinary research

Clinical Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

Researchers’ and Clinicians’ Perceptions of Recruiting Participants to Clinical Research: A Thematic Meta-Synthesis

PubMed Central

Newington, Lisa; Metcalfe, Alison

2014-01-01

Background Recruiting the desired number of research participants is frequently problematic with resulting financial and clinical implications. The views of individuals responsible for participant recruitment have not been previously reviewed. This systematic review and thematic meta-synthesis explores researchers’ and clinicians’ experiences and perceptions of recruiting participants to clinical research, with the aim of informing improved recruitment systems and strategies. Methods Studies published between January 1995 and May 2013 were identified from: Ovid MEDLINE, Ovid EMBASE, Ovid PSYCHINFO, ASSIA, British Nursing Index, Scopus, Web of Science, CINAHL and PubMed. Included studies were original peer reviewed research, with qualitative methodologies and an aim of exploring the views of clinicians and/or researchers on recruitment to clinical research. Studies discussing the recruitment of patients unable to give informed consent were excluded. The findings sections of the relevant studies were free coded to identify key concepts which were grouped into hierarchical themes. The quality of the identified studies was assessed and the relative contribution of each paper was checked to ensure individual studies did not dominate in any theme. Results Eighteen relevant papers were identified which examined the views of researchers and clinicians in 10 clinical specialties. Five main themes emerged: building a research community, securing resources, the nature of research, professional identities and recruitment strategies. The views of researchers and clinicians were similar, although the role of ‘researcher’ was inconsistently defined. Conclusions The general experience of recruiting participants to clinical research was one of competition and compromise. Competition arose over funding, staffing and participants, and between clinical and research responsibilities. Compromise was needed to create study designs that were acceptable to patients, clinicians and researchers. Forging relationships between clinical and research teams featured extensively, however the involvement of patients and the public within the research community was rarely discussed. PMID:24734142

What is the impact of research champions on integrating research in mental health clinical practice? A quasiexperimental study in South London, UK.

PubMed

Oduola, Sherifat; Wykes, Til; Robotham, Dan; Craig, Tom K J

2017-09-11

Key challenges for mental health healthcare professionals to implement research alongside clinical activity have been highlighted, such as insufficient time to apply research skills and lack of support and resources. We examined the impact of employing dedicated staff to promote research in community mental health clinical settings. Quasiexperiment before and after study. South London and Maudsley National Health Service Foundation Trust. 4455 patients receiving care from 15 community mental health teams between 1 December 2013 and 31 December 2014. The proportion of patients approached for research participation in clinical services where research champions were present (intervention group), and where research champions were not present (comparison group). Patients in the intervention group were nearly six times more likely to be approached for research participation (Adj. OR=5.98; 95% CI 4.96 to 7.22). Investing in staff that promote and drive research in clinical services increases opportunities for patients to hear about and engage in clinical research studies. However, investment needs to move beyond employing short-term staff. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Overview of clinical research design.

PubMed

Hartung, Daniel M; Touchette, Daniel

2009-02-15

Basic concepts and terminology of clinical research design are presented for new clinical investigators. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case-control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case-control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully.

Preparing ICUs for pandemics.

PubMed

Gabriel, Lucinda E K; Webb, Steve A R

2013-10-01

Influenza pandemics occur intermittently and represent an existential global infectious diseases threat. The purpose of this review is to describe clinical and research preparedness for future pandemics. Pandemic influenza typically results in large numbers of individuals with life-threatening pneumonia requiring treatment in ICUs. Clinical preparedness of ICUs relates to planning to provide increased 'surge' capacity to meet increased demand and requires consideration of staffing, equipment and consumables, bed-space availability and management systems. Research preparedness is also necessary, as timely clinical research has the potential to change the trajectory of a pandemic. The clinical research response during the 2009 H1N1 influenza pandemic was suboptimal. Better planning is necessary to optimize both clinical and research responses to future pandemics.

Best practice & research in anaesthesiology issue on new approaches in clinical research ethics in clinical research.

PubMed

Schwenzer, Karen J

2011-12-01

The history of ethics in clinical research parallels the history of abuse of human beings. The Nuremberg Code, Declaration of Helsinki, and the Belmont Report laid the foundations for modern research ethics. In the United States, the OHRP and the FDA provide guidelines for the ethical conduct of research. Investigators should be familiar with regulations concerning informed consent, doing research in vulnerable populations, and protection of privacy. Copyright © 2011 Elsevier Ltd. All rights reserved.

NIH Clinical Center: There’s No Other Hospital Like It | NIH MedlinePlus the Magazine

MedlinePlus

... scientists. The innovative curriculum includes courses in pharmacology, principles and practice of clinical research, and bioethics. Recently, the NIH Clinical Center launched the Sabbatical in Clinical Research Management program for clinical investigators, healthcare managers and administrators, ...

A metadata schema for data objects in clinical research.

PubMed

Canham, Steve; Ohmann, Christian

2016-11-24

A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.

Developing translational research infrastructure and capabilities associated with cancer clinical trials.

PubMed

Hall, Jacqueline A; Brown, Robert

2013-09-27

The integration of molecular information in clinical decision making is becoming a reality. These changes are shaping the way clinical research is conducted, and as reality sets in, the challenges in conducting, managing and organising multi-disciplinary research become apparent. Clinical trials provide a platform to conduct translational research (TR) within the context of high quality clinical data accrual. Integrating TR objectives in trials allows the execution of pivotal studies that provide clinical evidence for biomarker-driven treatment strategies, targeting early drug development trials to a homogeneous and well defined patient population, supports the development of companion diagnostics and provides an opportunity for deepening our understanding of cancer biology and mechanisms of drug action. To achieve these goals within a clinical trial, developing translational research infrastructure and capabilities (TRIC) plays a critical catalytic role for translating preclinical data into successful clinical research and development. TRIC represents a technical platform, dedicated resources and access to expertise promoting high quality standards, logistical and operational support and unified streamlined procedures under an appropriate governance framework. TRIC promotes integration of multiple disciplines including biobanking, laboratory analysis, molecular data, informatics, statistical analysis and dissemination of results which are all required for successful TR projects and scientific progress. Such a supporting infrastructure is absolutely essential in order to promote high quality robust research, avoid duplication and coordinate resources. Lack of such infrastructure, we would argue, is one reason for the limited effect of TR in clinical practice beyond clinical trials.

The UK clinical research network--has it been a success for dermatology clinical trials?

PubMed

Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R

2011-06-16

Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

Clinical verification of genetic results returned to research participants: findings from a Colon Cancer Family Registry.

PubMed

Laurino, Mercy Y; Truitt, Anjali R; Tenney, Lederle; Fisher, Douglass; Lindor, Noralane M; Veenstra, David; Jarvik, Gail P; Newcomb, Polly A; Fullerton, Stephanie M

2017-11-01

The extent to which participants act to clinically verify research results is largely unknown. This study examined whether participants who received Lynch syndrome (LS)-related findings pursued researchers' recommendation to clinically verify results with testing performed by a CLIA-certified laboratory. The Fred Hutchinson Cancer Research Center site of the multinational Colon Cancer Family Registry offered non-CLIA individual genetic research results to select registry participants (cases and their enrolled relatives) from 2011 to 2013. Participants who elected to receive results were counseled on the importance of verifying results at a CLIA-certified laboratory. Twenty-six (76.5%) of the 34 participants who received genetic results completed 2- and 12-month postdisclosure surveys; 42.3% of these (11/26) participated in a semistructured follow-up interview. Within 12 months of result disclosure, only 4 (15.4%) of 26 participants reported having verified their results in a CLIA-certified laboratory; of these four cases, all research and clinical results were concordant. Reasons for pursuing clinical verification included acting on the recommendation of the research team and informing future clinical care. Those who did not verify results cited lack of insurance coverage and limited perceived personal benefit of clinical verification as reasons for inaction. These findings suggest researchers will need to address barriers to seeking clinical verification in order to ensure that the intended benefits of returning genetic research results are realized. © 2017 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals, Inc.

Judging Surgical Research: How Should We Evaluate Performance and Measure Value?

PubMed Central

Souba, Wiley W.; Wilmore, Douglas W.

2000-01-01

Objective To establish criteria to evaluate performance in surgical research, and to suggest strategies to optimize research in the future. Summary Background Data Research is an integral component of the academic mission, focusing on important clinical problems, accounting for surgical advances, and providing training and mentoring for young surgeons. With constraints on healthcare resources, there is increasing pressure to generate clinical revenues at the expense of the time and effort devoted to surgical research. An approach that would assess the value of research would allow prioritization of projects. Further, alignment of high-priority research projects with clinical goals would optimize research gains and maximize the clinical enterprise. Methods The authors reviewed performance criteria applied to industrial research and modified these criteria to apply to surgical research. They reviewed several programs that align research objectives with clinical goals. Results Performance criteria were categorized along several dimensions: internal measures (quality, productivity, innovation, learning, and development), customer satisfaction, market share, and financial indices (cost and profitability). A “report card” was proposed to allow the assessment of research in an individual department or division. Conclusions The department’s business strategy can no longer be divorced from its research strategy. Alignment between research and clinical goals will maximize the department’s objectives but will create the need to modify existing hierarchical structures and reward systems. Such alignment appears to be the best way to ensure the success of surgical research in the future. PMID:10862192

How does the outcome of research training fellowships funded via the NHS compare with that from competitively funded fellowships from the MRC and other charities: a cross-sectional retrospective survey of trainees undertaking research training in the West Midlands.

PubMed

Maybury, Charlotte; Morgan, Matthew David; Smith, Russell; Harper, Lorraine

2018-01-23

This study aimed to investigate the impact of research training funded via the National Health Service (NHS) on medical trainees compared with traditional clinical research training fellowships (CRTFs). Online survey of 221 clinical trainees who had completed a period of research during their clinical training between 2009 and 2015 in the West Midlands. Research outcomes. Overall response rate was 59%, of whom 72 participants were funded by CRTFs and 51 funded by the NHS. Although participants with CRTFs were more likely to be awarded a higher degree compared with those on NHS-administered funding (66/72 CRTFs and 37/51 NHS, P=0.005), similar proportions of NHS-funded and CRTF-funded participants entered clinical lecturer posts on completing initial research training (8/51 NHS and 16/72 CRTF, P=0.37). 77% of participants had three or more publications (CRTF 57 and NHS 39, P=0.72). 57 participants had completed clinical training; similar proportions of CRTF-funded and NHS-funded trainees had research included in their consultant contract (12/22 NHS and 14/26 CRTF, P=0.96) or were appointed to academic posts (3 of 25 NHS funded and 6 of 32 CRTF, P>0.05). 95% of participants would recommend to colleagues and 82% of participants felt the research experience improved their provision of clinical care with no difference between CRTF-funded and NHS-funded participants (P=0.49). Continuing to participate in clinical work during the research reduced reports of trainee difficulty on returning to clinical work (23/108 continued clinical work vs 12/22 no clinical work, P=0.001). Research training funded by the NHS provides a quality experience and contributes to the clinical academic capacity within the UK. More needs to be done to support NHS participants to successfully achieve a higher degree. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Interventions for improving research productivity in clinical radiology.

PubMed

Akhtar, Waseem; Arain, Mubashir Aslam; Ali, Arif; Sajjad, Zafar

2012-07-01

The purpose of this study was to evaluate the effects of research promotion activities on overall quality and quantity of research output in a clinical department of a teaching tertiary care hospital. Simple research enhancing strategies including regular journal club, research hour, basic research skills training, hiring of research faculty, research awards, and annual research retreat and research board to increase research production were implemented in the Department of Radiology of a teaching hospital in Pakistan. A total of 77 papers were produced by the Department of Radiology before the intervention, which increased to 92 after the introduction of research initiatives. There was a significant increase in the overall proportion of publications in the international journals after the intervention (p < 0.001) with an increasing trend towards indexed journals (p < 0.001). The research enhancing interventions had a positive effect on increasing clinical research output by the Department of Radiology. Such interventions can also be replicated in other clinical departments to increase their research productivity.

Retooling Institutional Support Infrastructure for Clinical Research

PubMed Central

Snyder, Denise C.; Brouwer, Rebecca N.; Ennis, Cory L.; Spangler, Lindsey L.; Ainsworth, Terry L.; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

2016-01-01

Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

Physician participation in clinical research and trials: issues and approaches

PubMed Central

Rahman, Sayeeda; Majumder, Md Anwarul Azim; Shaban, Sami F; Rahman, Nuzhat; Ahmed, Moslehuddin; Abdulrahman, Khalid Bin; D’Souza, Urban JA

2011-01-01

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers. PMID:23745079

A framework to link international clinical research to the promotion of justice in global health.

PubMed

Pratt, Bridget; Loff, Bebe

2014-10-01

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The 'research for health justice' framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. © 2012 John Wiley & Sons Ltd.

[Which research is needed to support clinical decision-making on integrative medicine? Can comparative effectiveness research close the gap?].

PubMed

Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Berman, Brian M

2013-08-01

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

Data management by using R: big data clinical research series.

PubMed

Zhang, Zhongheng

2015-11-01

Electronic medical record (EMR) system has been widely used in clinical practice. Instead of traditional record system by hand writing and recording, the EMR makes big data clinical research feasible. The most important feature of big data research is its real-world setting. Furthermore, big data research can provide all aspects of information related to healthcare. However, big data research requires some skills on data management, which however, is always lacking in the curriculum of medical education. This greatly hinders doctors from testing their clinical hypothesis by using EMR. To make ends meet, a series of articles introducing data management techniques are put forward to guide clinicians to big data clinical research. The present educational article firstly introduces some basic knowledge on R language, followed by some data management skills on creating new variables, recoding variables and renaming variables. These are very basic skills and may be used in every project of big data research.

Giving Voice to Study Volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research

PubMed Central

Roberts, Laura Weiss; Kim, Jane Paik

2014-01-01

Motivation Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Methods Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Results Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy=−0.04, CI [−0.46, 0.39]; physically ill – healthy= −0.13, CI [−0.62, −.36]). Conclusions Clinical research volunteers and healthy clinical research-“naive” individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. PMID:24931849

Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

PubMed

Roberts, Laura Weiss; Kim, Jane Paik

2014-09-01

Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy = -0.04, CI [-0.46, 0.39]; physically ill - healthy = -0.13, CI [-0.62, -.36]). Clinical research volunteers and healthy clinical research-"naïve" individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of disclosing financial interests on attitudes toward clinical research.

PubMed

Weinfurt, Kevin P; Hall, Mark A; Dinan, Michaela A; DePuy, Venita; Friedman, Joëlle Y; Allsbrook, Jennifer S; Sugarman, Jeremy

2008-06-01

The effects of disclosing financial interests to potential research participants are not well understood. To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research. Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea

PubMed Central

2013-01-01

Background In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Discussion Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Summary Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered. PMID:23885908

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea.

PubMed

Laman, Moses; Pomat, William; Siba, Peter; Betuela, Inoni

2013-07-26

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered.

Building sustainable multi-functional prospective electronic clinical data systems.

PubMed

Randhawa, Gurvaneet S; Slutsky, Jean R

2012-07-01

A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

Empowering Mayo Clinic Individualized Medicine with Genomic Data Warehousing

PubMed Central

Horton, Iain; Lin, Yaxiong; Reed, Gay; Wiepert, Mathieu

2017-01-01

Individualized medicine enables better diagnoses and treatment decisions for patients and promotes research in understanding the molecular underpinnings of disease. Linking individual patient’s genomic and molecular information with their clinical phenotypes is crucial to these efforts. To address this need, the Center for Individualized Medicine at Mayo Clinic has implemented a genomic data warehouse and a workflow management system to bring data from institutional electronic health records and genomic sequencing data from both clinical and research bioinformatics sources into the warehouse. The system is the foundation for Mayo Clinic to build a suite of tools and interfaces to support various clinical and research use cases. The genomic data warehouse is positioned to play a key role in enhancing the research capabilities and advancing individualized patient care at Mayo Clinic. PMID:28829408

Empowering Mayo Clinic Individualized Medicine with Genomic Data Warehousing.

PubMed

Horton, Iain; Lin, Yaxiong; Reed, Gay; Wiepert, Mathieu; Hart, Steven

2017-08-22

Individualized medicine enables better diagnoses and treatment decisions for patients and promotes research in understanding the molecular underpinnings of disease. Linking individual patient's genomic and molecular information with their clinical phenotypes is crucial to these efforts. To address this need, the Center for Individualized Medicine at Mayo Clinic has implemented a genomic data warehouse and a workflow management system to bring data from institutional electronic health records and genomic sequencing data from both clinical and research bioinformatics sources into the warehouse. The system is the foundation for Mayo Clinic to build a suite of tools and interfaces to support various clinical and research use cases. The genomic data warehouse is positioned to play a key role in enhancing the research capabilities and advancing individualized patient care at Mayo Clinic.

Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

PubMed

Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

2011-03-01

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

Do patients and health care professionals view the communication processes of clinical research differently? A Rasch analysis from a survey.

PubMed

González-de Paz, Luis; Kostov, Belchin; Solans-Julian, Pilar; Navarro-Rubio, M Dolores; Sisó-Almirall, Antoni

2015-10-01

The increasing amount of the clinical research conducted in the primary health care has enabled extending research beyond traditional settings, but this transfer has implied some trade-offs. Health care professionals who conduct research with trusted patients require assuming the ethical standards of research and communication skills to enable patients' autonomy and freedom of choice. This study aims to measure the opinions of health professionals and patients on issues of communication in clinical research. A cross-sectional study with health care professionals and patients from primary health care centres in Barcelona (Spain). Each group completed a similar self-administered questionnaire. A Rasch model was fitted to data. After examination of goodness-of-fit, differences between groups were compared using analysis of variance, and patients' measures were calibrated to professionals' measures to compare overall mean measures. Professionals and patients found the ethical attitudes most difficult to endorse related to trust in clinical researchers and conflicts of interest. Patients' perceptions of professional ethical behaviour were significantly lower than professionals'. Different item functioning between nurses and family doctors was found in the item on seeking ethical collaboration when collaborating in clinical research. Effective knowledge of ethical norms was associated with greater perceived ethical values in clinical research and confidence in health care professionals among patients. Differences in the views of the communication process between patients and professionals could alert research boards, health care institutions and researchers to the need for greater transparency, trust and ethical instruction when patients are involved in clinical research. © 2015 John Wiley & Sons, Ltd.

Clinical research informatics and electronic health record data.

PubMed

Richesson, R L; Horvath, M M; Rusincovitch, S A

2014-08-15

The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI's key role in the infrastructure of a learning healthcare system.

Clinical Research Informatics and Electronic Health Record Data

PubMed Central

Horvath, M. M.; Rusincovitch, S. A.

2014-01-01

Summary Objectives The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. Results Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. Conclusions The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI’s key role in the infrastructure of a learning healthcare system. PMID:25123746

42 CFR 68a.12 - What will happen if an individual does not comply with the terms and conditions of participation...

Code of Federal Regulations, 2010 CFR

2010-10-01

... NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM... approved clinical research. Similarly, the research needs and priorities of the ICA and/or the NIH may... utilized in a non-clinical research assignment. Under these circumstances, the following will apply: (i...

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators.

PubMed

Jones, Carolynn Thomas; Hastings, Clare; Wilson, Lynda Law

2015-01-01

There has been limited research to document differences in roles between nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse. Copyright © 2015 Elsevier Inc. All rights reserved.

CRC Clinical Trials Management System (CTMS): An Integrated Information Management Solution for Collaborative Clinical Research

PubMed Central

Payne, Philip R.O.; Greaves, Andrew W.; Kipps, Thomas J.

2003-01-01

The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) consists of 9 geographically distributed sites conducting a program of research including both basic science and clinical components. To enable the CRC’s clinical research efforts, a system providing for real-time collaboration was required. CTMS provides such functionality, and demonstrates that the use of novel data modeling, web-application platforms, and management strategies provides for the deployment of an extensible, cost effective solution in such an environment. PMID:14728471

Exploitation of prisoners in clinical research: perceptions of study participants

PubMed Central

Christopher, Paul P.; Stein, Michael D.; Johnson, Jennifer E.; Rich, Josiah D.; Friedmann, Peter D.; Clarke, Jennifer G.; Lidz, Charles W.

2015-01-01

This paper discusses findings of a study examining whether prisoners view their participation in clinical research studies as exploitative. Perspectives of seventy prisoners who were enrolled in one of six different clinical studies were analyzed. A minority of participants agreed with statements suggestive of potential exploitation. All but one participant believed that prisoners should have greater access to research. On balance, these data provide reassurance that prisoners in this sample do not view their involvement in clinical research as inappropriately exploitative. PMID:26964404

NHS Trusts' clinical research activity and overall CQC performance - Is there a correlation?

PubMed

Jonker, L; Fisher, S J

2015-11-01

Since the late 2000's, the creation of the National Institute for Health Research (NIHR) has transformed clinical research activity in the United Kingdom. This study sought to establish if there is a link between clinical research activity and overall NHS Trust performance. Retrospective cohort study. Data for NHS Trust performance were obtained from public databases, namely the Care Quality Commission (CQC) 2013 risk rating for overall performance, and 2012-13 NIHR records for clinical research activity. Applying Spearman's rank analysis, none of the Trust categories showed a correlation with CQC risk rating: small hospitals, r = -0.062 (P = 0.76; n = 27); medium, r = -0.224 (P = 0.13; n = 47); large, r = -0.008 (P = 0.96; n = 57); academic, r = -0.18 (P = 0.41; n = 24). Similar results were observed when CQC risk rating was compared with the number of different clinical research studies conducted per Trust. The degree of NIHR National Portfolio clinical research activity is not significantly related to CQC risk rating, used as an indicator of overall NHS Trust performance. Other studies have previously shown that increased research activity correlates with improved mortality rates, one component of CQC risk rating scores. Alternative tools may have to be explored to evaluate the impact of clinical research on NHS Trusts and its patients. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Center for Prostate Disease Research

MedlinePlus

... 2017 Cancer Statistics programs Clinical Research Program Synopsis Leadership Multi-Disciplinary Clinic Staff Listing 2017 Cancer Statistics Basic Science Research Program Synopsis Leadership Gene Expression Data Research Achievements Staff Listing Lab ...

A Systematic Review on the Designs of Clinical Technology: Findings and Recommendations for Future Research

PubMed Central

PhD, Greg Alexander; Staggers, Nancy

2010-01-01

Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093

Big biomedical data and cardiovascular disease research: opportunities and challenges.

PubMed

Denaxas, Spiros C; Morley, Katherine I

2015-07-01

Electronic health records (EHRs), data generated and collected during normal clinical care, are increasingly being linked and used for translational cardiovascular disease research. Electronic health record data can be structured (e.g. coded diagnoses) or unstructured (e.g. clinical notes) and increasingly encapsulate medical imaging, genomic and patient-generated information. Large-scale EHR linkages enable researchers to conduct high-resolution observational and interventional clinical research at an unprecedented scale. A significant amount of preparatory work and research, however, is required to identify, obtain, and transform raw EHR data into research-ready variables that can be statistically analysed. This study critically reviews the opportunities and challenges that EHR data present in the field of cardiovascular disease clinical research and provides a series of recommendations for advancing and facilitating EHR research.

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees.

PubMed

Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L

2017-01-01

The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug-drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

PubMed Central

Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L.

2017-01-01

The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies. PMID:28785221

[Analysis on research projects for acupuncture and moxibustion supported by NSFC during the 11th 5-year-plan].

PubMed

Zhao, Chang-Long; Jing, Xiang-Hong; Li, Yu-Qing; Li, Liang; Rong, Pei-Jing; Wang, Chang-En

2012-08-01

In the present paper, the authors introduce the approved and finished research projects for acupuncture and moxibustion therapies supported by the National Natural Science Foundation of China (NSFC) during the 11th 5-year-plan. A total of 194 research projects were subsidized by NSFC from 2006 to 2010. These projects include 6 aspects: meridian-collaterals, acupoint theory, acupuncture analgesia, mechanisms underlying improvement of different clinical problems, clinical trials, and moxibustion therapy. The research on acupoints has been becoming a new hotspot in recent years. Majority of the research projects focus on the mechanism of acu-moxibustion underlying improvement of different clinical problems, while fewer projects on clinical trials. During the 11th 5-year-plan, 119 projects were completed; most of them involved meridian-collateral theory, acupoint theory, mechanism of acu-moxibustion underlying improvement of clinical problems and acupuncture manipulations. Following analysis of the finished research projects, we find that 1) many neurobiological methods and techniques are commonly used in the research on meridian-collateral theory; 2) the research on acupoint theory is changing from observing the local morphological structure to identifying characteristics of the regional activated receptors, particularly under the circumstances of visceral pathological conditions and efficacies of acupoints; 3) researches on the underlying mechanism of acu-moxibusiton for improving clinical disorders mainly focused on its cerebral protective effects against cerebral ischemia, in addition, researches about other diseases on clinical conditions have been also carried out, but the related mechanisms are far from understanding; 4) In many research projects, various new methods and techniques, such as fMRI, position emission tomography, genomics, proteomics, molecular biology, nerve stem cell, etc. were widely used; 5) Randomized controlled multi-center clinical trials are definitely insufficient. Only two clinical projects were finished during the 11th 5-year-plan. Moreover, it should be noted that in the subject of acu-moxibustion, independent innovation researches are fewer; the foundation of competitive ability is relatively weaker; the supporting conditions for finishing the research projects are poorer in some institutes or districts; and the interrelations among the theoretical, experimental and clinical researches are not intimately close, leading to relative lag in the subject development.

Preparing clinical pharmacy scientists for careers in clinical/translational research: can we meet the challenge?: ACCP Research Affairs Committee Commentary.

PubMed

Parker, Robert B; Ellingrod, Vicki; DiPiro, Joseph T; Bauman, Jerry L; Blouin, Robert A; Welage, Lynda S

2013-12-01

Developing clinical pharmacists' research skills and their ability to compete for extramural funding is an important component of the American College of Clinical Pharmacy's (ACCP) vision for pharmacists to play a prominent role in generating the new knowledge used to guide patient pharmacotherapy. Given the recent emphasis on clinical/translational research at the National Institutes of Health (NIH) and the key role of drug therapy in the management of many diseases, there is an unprecedented opportunity for the profession to contribute to this enterprise. A crucial question facing the profession is whether we can generate enough appropriately trained scientists to take advantage of these opportunities to generate the new knowledge to advance drug therapy. Since the 2009 publication of the ACCP Research Affairs Committee editorial recommending the Ph.D. degree (as opposed to fellowship training) as the optimal method for preparing pharmacists as clinical/translational scientists, significant changes have occurred in the economic, professional, political, and research environments. As a result, the 2012 ACCP Research Affairs Committee was charged with reexamining the college's position on training clinical pharmacy scientists in the context of these substantial environmental changes. In this commentary, the potential impact of these changes on opportunities for pharmacists in clinical/translational research are discussed as are strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. Failure of our profession to take advantage of these opportunities risks our ability to contribute substantively to the biomedical research enterprise and ultimately improve the pharmacotherapy of our patients. © 2013 Pharmacotherapy Publications, Inc.

The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

PubMed

Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

2008-11-01

This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

Indian Institute of Technology Bombay and Tata Memorial Centre Join the International Efforts in Clinical Proteogenomics Cancer Research | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute’s (NCI) Office of Cancer Clinical Proteomics Research, part of the National Institutes of Health, along with the Indian Institute of Technology Bombay (IITB) and Tata Memorial Centre (TMC) have signed a Memorandum of Understanding (MOU) on clinical proteogenomics cancer research. The MOU between NCI, IITB, and Tata Memorial Centre represents the thirtieth and thirty-first institutions and the twelfth country to join the International Cancer Proteogenome Consortium (ICPC). The purpose of the MOU is to facilitate scientific and programmatic collaborations between NCI, IITB, and TMC in basic and clinical proteogenomic studies leading to patient care and public dissemination and information sharing to the research community.

Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

PubMed

Hadi, Muhammad Abdul; José Closs, S

2016-06-01

The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the "integrity" to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of "quality" of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.

Using Computerized Clinical Nursing Data Bases for Nursing Research.

ERIC Educational Resources Information Center

Nail, Lillian M.; Lange, Linda L.

1996-01-01

Addresses the recognition of differences between clinical and research data in using computerized clinical nursing databases and the issues of privacy and confidentiality for patients whose records are involved. Describes procedures for assessing the quality and usability of these data for nursing research. (SK)

Clinical Pharmacokinetic Service and Research--Present Status and Future Goals at SUNY-Buffalo

ERIC Educational Resources Information Center

Koup, Jeffrey R.

1976-01-01

Two Clinical Pharmacokinetics Laboratories at Buffalo are described: one at the Millard Fillmore Hospital and the other at the Buffalo Children's Hospital. Their research efforts are reviewed and their scientific contributions to clinical therapeutics and pharmaceutical research are noted. (LBH)

Experience inheritance from famous specialists based on real-world clinical research paradigm of traditional Chinese medicine.

PubMed

Song, Guanli; Wang, Yinghui; Zhang, Runshun; Liu, Baoyan; Zhou, Xuezhong; Zhou, Xiaji; Zhang, Hong; Guo, Yufeng; Xue, Yanxing; Xu, Lili

2014-09-01

The current modes of experience inheritance from famous specialists in traditional Chinese medicine (TCM) include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.

The future of research in female pelvic medicine.

PubMed

Chao, Jamie; Chai, Toby C

2015-02-01

Female pelvic medicine and reconstructive surgery (FPMRS) was recently recognized as a subspecialty by the American Board of Medical Specialties (ABMS). FPMRS treats female pelvic disorders (FPD) including pelvic organ prolapse (POP), urinary incontinence (UI), fecal incontinence (FI), lower urinary tract symptoms (LUTS), lower urinary tract infections (UTI), pelvic pain, and female sexual dysfunction (FSD). These conditions affect large numbers of individuals, resulting in significant patient, societal, medical, and financial burdens. Given that treatments utilize both medical and surgical approaches, areas of research in FPD necessarily cover a gamut of topics, ranging from mechanistically driven basic science research to randomized controlled trials. While basic science research is slow to impact clinical care, transformational changes in a field occur through basic investigations. On the other hand, clinical research yields incremental changes to clinical care. Basic research intends to change understanding whereas clinical research intends to change practice. However, the best approach is to incorporate both basic and clinical research into a translational program which makes new discoveries and effects positive changes to clinical practice. This review examines current research in FPD, with focus on translational potential, and ponders the future of FPD research. With a goal of improving the care and outcomes in patients with FPD, a strategic collaboration of stakeholders (patients, advocacy groups, physicians, researchers, professional medical associations, legislators, governmental biomedical research agencies, pharmaceutical companies, and medical device companies) is an absolute requirement in order to generate funding needed for FPD translational research.

Life-science research within US academic medical centers.

PubMed

Zinner, Darren E; Campbell, Eric G

2009-09-02

Besides the generic "basic" vs "applied" labels, little information is known about the types of life-science research conducted within academic medical centers (AMCs). To determine the relative proportion, characteristics, funding, and productivity of AMC faculty by the type of research they conduct. Mailed survey conducted in 2007 of 3080 life-science faculty at the 50 universities with medical schools that received the most funding from the National Institutes of Health in 2004. Response rate was 74%. Research faculty affiliated with a medical school or teaching hospital, representing 77% of respondents (n = 1663). Type of research (basic, translational, clinical trials, health services research/clinical epidemiology, multimode, other), total funding, industry funding, publications, professional activities, patenting behavior, and industry relationships. Among AMC research faculty, 33.6% exclusively conducted basic science research as principal investigators compared with translational researchers (9.1%), clinical trial investigators (7.1%), and health services researchers/clinical epidemiologists (9.0%). While principal investigators garnered a mean of $410,755 in total annual research funding, 22.1% of all AMC research faculty were unsponsored, a proportion that ranged from 11.5% for basic science researchers to 46.8% for health services researchers (P < .001). The average AMC faculty member received $33,417 in industry-sponsored funding, with most of this money concentrated among clinical trial ($110,869) and multimode ($59,916) principal investigators. Translational (61.3%), clinical trial (67.3%), and multimode (70.9%) researchers were significantly more likely than basic science researchers (41.9%) to report a relationship with industry and that these relationships contributed to their most important scientific work (P < .05 for all comparisons). The research function of AMCs is active and diverse, incorporating a substantial proportion of faculty who are conducting research and publishing without sponsorship.

The Meta-Analysis of Clinical Judgment Project: Effects of Experience on Judgment Accuracy

ERIC Educational Resources Information Center

Spengler, Paul M.; White, Michael J.; Aegisdottir, Stefania; Maugherman, Alan S.; Anderson, Linda A.; Cook, Robert S.; Nichols, Cassandra N.; Lampropoulos, Georgios K.; Walker, Blain S.; Cohen, Genna R.; Rush, Jeffrey D.

2009-01-01

Clinical and educational experience is one of the most commonly studied variables in clinical judgment research. Contrary to clinicians' perceptions, clinical judgment researchers have generally concluded that accuracy does not improve with increased education, training, or clinical experience. In this meta-analysis, the authors synthesized…

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre.

PubMed

Adams, Mary; Caffrey, Louise; McKevitt, Christopher

2015-03-12

In the UK, the recruitment of patients into clinical research is a national health research and development policy priority. There has been limited investigation of how national level factors operate as barriers or facilitators to recruitment work, particularly from the perspective of staff undertaking patient recruitment work. The aim of this study is to identify and examine staff views of the key organisational barriers and facilitators to patient recruitment work in one clinical research group located in an NHS Academic Health Science Centre. A qualitative study utilizing in-depth, one-to-one semi-structured interviews with 11 purposively selected staff with particular responsibilities to recruit and retain patients as clinical research subjects. Thematic analysis classified interview data by recurring themes, concepts, and emergent categories for the purposes of establishing explanatory accounts. The findings highlight four key factors that staff perceived to be most significant for the successful recruitment and retention of patients in research and identify how staff located these factors within patients, studies, the research centre, the trust, and beyond the trust. Firstly, competition for research participants at an organisational and national level was perceived to undermine recruitment success. Secondly, the tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs. Thirdly, staff perceived an imbalance between personal patient burden and benefit. Ethical committee regulation, designed to protect patients, was perceived by some staff to detract from clarification and systematisation of incentivisation strategies. Finally, the structure and relationships within clinical research teams, in particular the low tacit status of recruitment skills, was seen as influential. The results of this case-study, conducted in an exemplary NHS academic research centre, highlight current systematic challenges to patient recruitment and retention in clinical studies more generally as seen from the perspective of staff at the 'sharp end' of recruiting. Staff experience is that, beyond individual clinical research design and protocol factors, wider organisational and extra-organisational norms, structures, and processes operate as significant facilitators or hindrances in the recruitment of patients as research subjects.

[Science and ethics, therapeutic misconception and mirage].

PubMed

Raymond, J; Long, H

2008-12-01

Medical practice changes constantly. Ethical imperatives are however incorrigible. How can we reconcile ethics, practice and progress? Some bioethicians argue that research and care should be disentangled to minimize the 'therapeutic misconception', a clinical propensity to believe that patients are the object of medical care, while in fact they are the subjects of a scientific experiment. On the contrary, we believe that clinical research should be an integral part of the good practice. A divorce between research and clinical practice leads to an incorrigible medicine, liable to the therapeutic mirage, that is the false belief that everything modern medicine can offer has been proved beneficial. But both therapeutic misconception and mirage are possible because of a misunderstanding of either research or clinical practice. In this essay we review ethical principles behind clinical trial methodology and attempt to reconcile ethics, science and clinical practice. Not only should clinical research be integrated to the good practice of medicine, it should also be part of training in our specialty.

[Basic research in traumatology and its contribution to routine operation].

PubMed

Hausner, T; Redl, H

2017-02-01

Basic research in traumatology supports the clinical outcome of patients in trauma care and tries to find science-based solutions for clinical problems. Furthermore, institutions for basic research in traumatology usually offer training in different skills, such as how to write a scientific paper, or practice in microsurgery or intubation. Two examples of clinically significant research topics are presented.

Center for Cancer Research hosts 10th Annual GIST Clinic | Center for Cancer Research

Cancer.gov

Patients and specialists from around the world gathered for the 10th Annual Pediatric and Wildtype GIST Clinic, which took place Wednesday, July 5 through Friday, July 7, 2017 at the NIH Clinical Center in Bethesda, Maryland. Occurring once a year, the clinic convenes clinicians, research scientists and advocates from across the country to consult with patients who have GIST.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research.

PubMed

Julé, Amélie; Furtado, Tamzin; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas-(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research

PubMed Central

Julé, Amélie; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas—(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally. PMID:28589027

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

PubMed

Crowley, William F; Sherwood, Louis; Salber, Patricia; Scheinberg, David; Slavkin, Hal; Tilson, Hugh; Reece, E Albert; Catanese, Veronica; Johnson, Stephen B; Dobs, Adrian; Genel, Myron; Korn, Allan; Reame, Nancy; Bonow, Robert; Grebb, Jack; Rimoin, David

2004-03-03

The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research

PubMed Central

Nicholls, Jacqueline; Dobbs, Christine; Sethi, Nayha; Cunningham, James; Ainsworth, John; Heaven, Martin; Peacock, Trevor; Peacock, Anthony; Jones, Kerina; Laurie, Graeme; Kalra, Dipak

2016-01-01

In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns. PMID:27329087

Promoting public awareness of randomised clinical trials using the media: the 'Get Randomised' campaign.

PubMed

Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; Macdonald, Thomas M

2010-02-01

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Recruitment is key to the success of clinical trials. * Many clinical trials fail to achieve adequate recruitment. * Public understanding and engagement in clinical research could be improved. WHAT THIS STUDY ADDS * 'Get Randomised' is the first campaign of its kind in the UK. * It is possible to improve public awareness of clinical research using the media. * Further work is needed to determine whether improved public awareness leads to increased participation in clinical research in the future. AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The 'Get Randomised' campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). 'Get Randomised' was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P < 0.01). Of those who recalled the advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign ['yes' 31.3% (28.4, 34.1) prior; 30.4% (27.6, 33.2) following; difference =-0.9%; 95% CI for difference -4.8, 3.1%; P= 0.92]. CONCLUSIONS It is possible to raise public awareness of clinical research using the media, but further efforts may be required to influence individuals' decisions to take part in clinical research.

[How to prevent hazards and to reduce risk in clinical trials?].

PubMed

Czarkowski, Marek

2008-12-01

Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

PubMed

Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J

2017-02-01

The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evaluation of Clinical Research Training Programs Using the Clinical Research Appraisal Inventory

PubMed Central

Lipira, Lauren; Jeffe, Donna B.; Krauss, Melissa; Garbutt, Jane; Piccirillo, Jay; Evanoff, Bradley; Fraser, Victoria

2010-01-01

Abstract The purpose of this study was to measure change in clinical research self‐efficacy after participating in KL2, postdoctoral and predoctoral clinical research training programs at Washington University School of Medicine. We surveyed program participants using a 76‐item version of the Clinical Research Appraisal Inventory (CRAI). Principal components analysis (PCA) examined the CRAI’s underlying factor structure; Cronbach alpha measured the internal consistency of items on each subscale and the overall CRAI. CRAI score changes from baseline to 1‐year follow‐up were assessed using repeated‐measures analysis of variance. All 29 KL2, 47 postdoctoral, and 31 TL1 scholars enrolled 2006–2009 (mean age 31.6 years, range 22–44; 59.6% female; 65.4% white) completed baseline surveys. Of these participants, 22 KL2, 17 postdoctoral, and 21 TL1 scholars completed the 1‐year follow‐up assessment. PCA resulted in a seven‐factor solution with 69 items (alphas > 0.849 for each subscale and 69‐item CRAI). Significant improvements at 1‐year follow‐up were observed across all programs for Study Design/Data Analysis (p= .016), Interpreting/Reporting/Presenting (p= .034), and overall CRAI (p= .050). Differences between programs were observed for all but one subscale (each p < .05). Clinical research self‐efficacy increased 1 year after clinical research training. Whether this short‐term outcome correlates with long‐term clinical research productivity, requires further study. Clin Trans Sci 2010; Volume 3: 243–248. PMID:21442017

Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

PubMed

Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn

2017-09-01

Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.

Improving Outcomes for Pulmonary Vascular Disease

PubMed Central

Robbins, Ivan M.; Blaisdell, Carol J.; Abman, Steven H.

2012-01-01

Recognizing the importance of improving lung health through lung disease research, the National Heart, Lung, and Blood Institute (NHLBI) convened a workshop of multidisciplinary experts for the following purpose: (1) to review the current scientific knowledge underlying the basis for treatment of adults and children with pulmonary vascular diseases (PVDs); (2) to identify gaps, barriers, and emerging scientific opportunities in translational PVD research and the means to capitalize on these opportunities; (3) to prioritize new research directions that would be expected to affect the clinical course of PVDs; and (4) to make recommendations to the NHLBI on how to fill identified gaps in adult and pediatric PVD clinical research. Workshop participants reviewed experiences from previous PVD clinical trials and ongoing clinical research networks with other lung disorders, including acute respiratory distress syndrome, chronic obstructive lung disease, and idiopathic pulmonary fibrosis, as well. Bioinformatics experts discussed strategies for applying cutting-edge health information technology to clinical studies. Participants in the workshop considered approaches in the following broad concept areas: (1) improved phenotyping to identify potential subjects for appropriate PVD clinical studies; (2) identification of potential new end points for assessing key outcomes and developing better-designed PVD clinical trials; and (3) the establishment of priorities for specific clinical research needed to advance care of patients with various subsets of PVDs from childhood through adulthood. This report provides a summary of the objectives and recommendations to the NHLBI concentrating on clinical research efforts that are needed to better diagnose and treat PVDs. PMID:22335936

Rightsizing Projects for Non-Research-Intensive Schools of Nursing via Academic-Clinical Partnerships.

PubMed

Kooken, Wendy Carter; Eckhardt, Ann L; McNutt-Dungan, Marianne; Woods, Jonathan

Most academic-clinical partnerships are described as formal agreements between schools of nursing at research-intensive universities and large teaching hospitals. This article demonstrates less formal versions of academic-clinical partnerships established between a small, private liberal arts university school of nursing and 2 regional clinical agencies. In both exemplars, students, faculty, and staff contributed to evidence-based practice projects. Schools of nursing in non-research-intensive environments can develop right-size academic-clinical partnerships that are beneficial for all parties involved.

A proposed clinical research support career pathway for noninvestigators.

PubMed

Smith, Sheree; Gullick, Janice; Ballard, Jacqueline; Perry, Lin

2018-06-01

To discuss the international experience of clinical research support for noninvestigator roles and to propose a new pathway for Australia, to promote a sustainable research support workforce capable of delivering high-quality clinical research. Noninvestigator research support roles are currently characterized by an ad hoc approach to training, with limited role delineation and perceived professional isolation with implications for study completion rates and participant safety. A focused approach to developing and implementing research support pathways has improved patient recruitment, study completion, job satisfaction, and research governance. The Queensland and New South Wales state-based Nurses' Awards, the Australian Qualifications Framework, and a University Professional (Research) Staff Award. Research nurses in the clinical environment improve study coordination, adherence to study protocol, patient safety, and clinical care. A career pathway that guides education and outlines position descriptions and skill sets would enhance development of the research support workforce. This pathway could contribute to changing the patient outcomes through coordination and study completion of high-quality research. A wide consultative approach is required to determine a cost-effective and feasible approach to implementation and evaluation of the proposed pathway. © 2018 John Wiley & Sons Australia, Ltd.

Profiles of Urine Drug Test in Clinical Pain Patients vs Pain Research Study Subjects.

PubMed

Lee, Cheng-ting; Vo, Trang T; Cohen, Abigail S; Ahmed, Shihab; Zhang, Yi; Mao, Jianren; Chen, Lucy

2016-04-01

To examine similarities and differences in urine drug test (UDT) results in clinical pain patients and pain subjects participating in pain research studies. An observational study with retrospective chart review and data analysis. We analyzed 1,874 UDT results obtained from 1) clinical pain patients (Clinical Group; n = 1,529) and 2) pain subjects consented to participate in pain research studies (Research Group; n = 345). Since several medications such as opioids used in pain management are drugs of abuse (DOA) and can result in a positive UDT, we specifically identified those cases of positive UDT due to nonprescribed DOA and designated these cases as positive UDT with DOA (PUD). We found that 1) there was a higher rate of PUD in clinical pain patients (41.3%) than in pain research study subjects (14.8%); 2) although subjects in the Research Group were informed ahead of time that UDT will be conducted as a screening test, a substantial number (14.8%) of pain research study subjects still showed PUD; 3) there were different types of DOA between clinical pain patients (cannabinoids as the top DOA) and research study subjects (cocaine as the top DOA); and 4) a common factor associated with PUD was opioid therapy in both Clinical Group and Research Group. These results support previous findings that PUD is a common finding in clinical pain patients, particularly in those prescribed opioid therapy, and we suggest that UDT be used as routine screening testing in pain research studies. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Patient participation in ERS guidelines and research projects: the EMBARC experience

PubMed Central

Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-01-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. Educational aims To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities. To understand the barriers and potential solutions to these barriers from a physician’s perspective, in order to ensure meaningful patient involvement in clinical projects. To understand the barriers and potential solutions from a patient’s perspective, in order to meaningfully involve patients in clinical projects. PMID:28894480

Patient participation in ERS guidelines and research projects: the EMBARC experience.

PubMed

Chalmers, James D; Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-09-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities.To understand the barriers and potential solutions to these barriers from a physician's perspective, in order to ensure meaningful patient involvement in clinical projects.To understand the barriers and potential solutions from a patient's perspective, in order to meaningfully involve patients in clinical projects.

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Inside information: Financial conflicts of interest for research subjects in early phase clinical trials.

PubMed

Helft, Paul R; Ratain, Mark J; Epstein, Richard A; Siegler, Mark

2004-05-05

In recent years, several research subjects have told us that they had bought or intended to buy stock in the companies sponsoring the clinical trials in which they were enrolled. This situation has led us to ask what, if any, are physician-investigators' scientific, ethical, and legal responsibilities concerning research subjects who choose to buy stock in the companies sponsoring the clinical trials in which they are participating. Although the scope of this problem is unknown and is likely to be small, this commentary examines the scientific, ethical, and legal concerns raised by such activities on the part of research subjects enrolled in early phase clinical trials. In addition, this commentary also outlines the basis for our opinion that research subjects involved in an early phase clinical trial should avoid the financial conflicts of interest created by trading stock in the company sponsoring the clinical trial.

Establishing a successful clinical research program.

PubMed

Scoglio, Daniele; Fichera, Alessandro

2014-06-01

Clinical research (CR) is a natural corollary to clinical surgery. It gives an investigator the opportunity to critically review their results and develop new strategies. This article covers the critical factors and the important components of a successful CR program. The first and most important step is to build a dedicated research team to overcome time constraints and enable a surgical practice to make CR a priority. With the research team in place, the next step is to create a program on the basis of an original idea and new clinical hypotheses. This often comes from personal experience supported by a review of the available evidence. Randomized controlled (clinical) trials are the most stringent way of determining whether a cause-effect relationship exists between the intervention and the outcome. In the proper setting, translational research may offer additional avenues allowing clinical application of basic science discoveries.

A novel approach to generating CER hypotheses based on mining clinical data.

PubMed

Zhang, Shuo; Li, Lin; Yu, Yiqin; Sun, Xingzhi; Xu, Linhao; Zhao, Wei; Teng, Xiaofei; Pan, Yue

2013-01-01

Comparative effectiveness research (CER) is a scientific method of investigating the effectiveness of alternative intervention methods. In a CER study, clinical researchers typically start with a CER hypothesis, and aim to evaluate it by applying a series of medical statistical methods. Traditionally, the CER hypotheses are defined manually by clinical researchers. This makes the task of hypothesis generation very time-consuming and the quality of hypothesis heavily dependent on the researchers' skills. Recently, with more electronic medical data being collected, it is highly promising to apply the computerized method for discovering CER hypotheses from clinical data sets. In this poster, we proposes a novel approach to automatically generating CER hypotheses based on mining clinical data, and presents a case study showing that the approach can facilitate clinical researchers to identify potentially valuable hypotheses and eventually define high quality CER studies.

Pre-clinical research in small animals using radiotherapy technology--a bidirectional translational approach.

PubMed

Tillner, Falk; Thute, Prasad; Bütof, Rebecca; Krause, Mechthild; Enghardt, Wolfgang

2014-12-01

For translational cancer research, pre-clinical in-vivo studies using small animals have become indispensable in bridging the gap between in-vitro cell experiments and clinical implementation. When setting up such small animal experiments, various biological, technical and methodical aspects have to be considered. In this work we present a comprehensive topical review based on relevant publications on irradiation techniques used for pre-clinical cancer research in mice and rats. Clinical radiotherapy treatment devices for the application of external beam radiotherapy and brachytherapy as well as dedicated research irradiation devices are feasible for small animal irradiation depending on the animal model and the experimental goals. In this work, appropriate solutions for the technological transfer of human radiation oncology to small animal radiation research are summarised. Additionally, important information concerning the experimental design is provided such that reliable and clinically relevant results can be attained. Copyright © 2014. Published by Elsevier GmbH.

Efficient design of clinical trials and epidemiological research: is it possible?

PubMed

Lauer, Michael S; Gordon, David; Wei, Gina; Pearson, Gail

2017-08-01

Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow. Thought leaders have called on the clinical research community to consider alternative, transformative business models, including those models that focus on simplicity and leveraging of digital resources. We present some examples of innovative approaches by which some investigators have successfully conducted large-scale, clinical trials at relatively low cost. These examples include randomized registry trials, cluster-randomized trials, adaptive trials, and trials that are fully embedded within digital clinical care or administrative platforms.

A laboratory medicine residency training program that includes clinical consultation and research.

PubMed

Spitzer, E D; Pierce, G F; McDonald, J M

1990-04-01

We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.

[The future of clinical research: why do we need an ecological approach?].

PubMed

Liberati, Alessandro; Moja, Lorenzo P; Moschetti, Ivan

2006-11-01

In this paper we try to define the future goals of the clinical research, with particular reference to methodological and policy issues. There is an increasing tension between the real drivers of clinical research and its scientific and ethical aims. To consumers the goal is to strengthen the relevance and usefulness of clinical research. This is possible only if consumers are empowered and actively involved. For the health care systems it is mandatory to re-engineer the process, enforcing national and international legislation. This should help to fill the research-clinical practice gap and to balance the research agenda, better reflecting health priorities. Finally the scientific community should reflect on its own conflicts of interests and analyse the causes of the ethical divide between the needs and the market. Scientists too often seem to loose sight of the original cumulative nature of research and of the idea of research as a collective good. More non-commercial research is needed, integrated with the health care systems, to support a transparent, more realistic and valid information useful for patient care, scientific information.

Research Areas - Clinical Trials

Cancer.gov

Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

Clinical Epidemiology Unit - overview of research areas

Cancer.gov

Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies

42 CFR 68a.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... composed of NIH scientific staff and co-chaired by the Associate Director for Clinical Research, NIH, and... Director, Intramural Research, NIH, and the co-chairs, and appointed by the Director, NIH. Clinical... educational loans for a prescribed period as specified in this part. Clinical researcher means an NIH employee...

Clinical and translational research in global health and emergency care: a research agenda.

PubMed

Runyon, Michael S; Sawe, Hendry R; Levine, Adam C; Pousson, Amelia; House, Darlene R; Agrawal, Pooja; Osei-Ampofo, Maxwell; Weiner, Scott G; Douglass, Katherine

2013-12-01

As policy-makers increasingly recognize emergency care to be a global health priority, the need for high-quality clinical and translational research in this area continues to grow. As part of the proceedings of the 2013 Academic Emergency Medicine consensus conference, this article discusses the importance of: 1) including clinical and translational research in the initial emergency care development plan, 2) defining the burden of acute disease and the barriers to conducting research in resource-limited settings, 3) assessing the appropriateness and effectiveness of local and global acute care guidelines within the local context, 4) studying the local research infrastructure needs to understand the best methods to build a sustainable research infrastructure, and 5) studying the long-term effects of clinical research programs on health care systems. © 2013 by the Society for Academic Emergency Medicine.

Translating research findings to clinical nursing practice.

PubMed

Curtis, Kate; Fry, Margaret; Shaban, Ramon Z; Considine, Julie

2017-03-01

To describe the importance of, and methods for, successfully conducting and translating research into clinical practice. There is universal acknowledgement that the clinical care provided to individuals should be informed on the best available evidence. Knowledge and evidence derived from robust scholarly methods should drive our clinical practice, decisions and change to improve the way we deliver care. Translating research evidence to clinical practice is essential to safe, transparent, effective and efficient healthcare provision and meeting the expectations of patients, families and society. Despite its importance, translating research into clinical practice is challenging. There are more nurses in the frontline of health care than any other healthcare profession. As such, nurse-led research is increasingly recognised as a critical pathway to practical and effective ways of improving patient outcomes. However, there are well-established barriers to the conduct and translation of research evidence into practice. This clinical practice discussion paper interprets the knowledge translation literature for clinicians interested in translating research into practice. This paper is informed by the scientific literature around knowledge translation, implementation science and clinician behaviour change, and presented from the nurse clinician perspective. We provide practical, evidence-informed suggestions to overcome the barriers and facilitate enablers of knowledge translation. Examples of nurse-led research incorporating the principles of knowledge translation in their study design that have resulted in improvements in patient outcomes are presented in conjunction with supporting evidence. Translation should be considered in research design, including the end users and an evaluation of the research implementation. The success of research implementation in health care is dependent on clinician/consumer behaviour change and it is critical that implementation strategy includes this. Translating best research evidence can make for a more transparent and sustainable healthcare service, to which nurses are central. © 2016 The Authors. Journal of Clinical Nursing Published by John Wiley & Sons Ltd.

Use of FEV1 in Cystic Fibrosis Epidemiologic Studies and Clinical Trials: A Statistical Perspective for the Clinical Researcher

PubMed Central

Szczesniak, Rhonda; Heltshe, Sonya L.; Stanojevic, Sanja; Mayer-Hamblett, Nicole

2017-01-01

Background Forced expiratory volume in 1 second (FEV1) is an established marker of cystic fibrosis (CF) disease progression that is used to capture clinical course and evaluate therapeutic efficacy. The research community has established FEV1 surveillance data through a variety of observational data sources such as patient registries, and there is a growing pipeline of new CF therapies demonstrated to be efficacious in clinical trials by establishing improvements in FEV1. Results In this review, we summarize from a statistical perspective the clinical relevance of FEV1 based on its association with morbidity and mortality in CF, its role in epidemiologic studies of disease progression and comparative effectiveness, and its utility in clinical trials. In addition, we identify opportunities to advance epidemiologic research and the clinical development pipeline through further statistical considerations. Conclusions Our understanding of CF disease course, therapeutics, and clinical care has evolved immensely in the past decades, in large part due to the thoughtful application of rigorous research methods and meaningful clinical endpoints such as FEV1. A continued commitment to conduct research that minimizes the potential for bias, maximizes the limited patient population, and harmonizes approaches to FEV1 analysis while maintaining clinical relevance, will facilitate further opportunities to advance CF care. PMID:28117136

Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research.

PubMed

Ishizaki, Junko

2017-01-01

Professors and teaching staff in the field of pharmaceutical sciences should devote themselves to staying abreast of relevant education and research. Similarly those in clinical pharmacies should contribute to the advancement of pharmaceutical research and the development of next generation pharmacists and pharmaceuticals. It is thought that those who work in clinical pharmacies should improve their own skills and expertise in problem-finding and -solving, i.e., "clinical skills". They should be keen to learn new standard treatments based on the latest drug information, and should try to be in a position where collecting clinical information is readily possible. In the case of pharmacists in hospitals and pharmacies, they are able to aim at improving their clinical skills simply through performing their pharmaceutical duties. On the other hand, when a pharmaceutical educator aims to improve clinical skills at a level comparable to those of clinical pharmacists, it is necessary to devote or set aside considerable time for pharmacist duties, in addition to teaching, which may result in a shortage of time for hands-on clinical practice and/or in a decline in the quality of education and research. This could be a nightmare for teaching staff in clinical pharmacy who aim to take part in such activities. Nonetheless, I believe that teaching staff in the clinical pharmacy area could improve his/her clinical skills through actively engaging in education and research. In this review, I would like to introduce topics on such possibilities from my own experiences.

Defining pediatric sepsis by different criteria: discrepancies in populations and implications for clinical practice.

PubMed

Weiss, Scott L; Parker, Brandon; Bullock, Maria E; Swartz, Sheila; Price, Carolynn; Wainwright, Mark S; Goodman, Denise M

2012-07-01

Pediatric patients with sepsis are identified using related but distinct criteria for clinical, research, and administrative purposes. The overlap between these criteria will affect the validity of extrapolating data across settings. We sought to quantify the extent of agreement among different criteria for pediatric severe sepsis/septic shock and to detect systematic differences between these cohorts. Observational cohort study. Forty-two bed pediatric intensive care unit at an academic medical center. A total of 1,729 patients ≤ 18 yrs-old. None. All patients were screened for severe sepsis or septic shock using consensus guidelines (research criteria), diagnosis by healthcare professionals (clinical criteria), and International Classification of Diseases, Ninth Revision, Clinical Modification codes (administrative criteria). Cohen's κ determined the level of agreement among criteria, and patient characteristics were compared between cohorts. Ninety (5.2%) patients were identified by research, 96 (5.6%) by clinical, and 103 (6.0%) by administrative criteria. The κ ± standard error for pair-wise comparisons was 0.67 ± 0.04 for research-clinical, 0.52 ± 0.05 for research-administrative, and 0.55 ± 0.04 for clinical-administrative. Of the patients in the clinical cohort, 67% met research and 58% met administrative criteria. The research cohort exhibited a higher Pediatric Index of Mortality-2 score (median, interquartile range 5.2, 1.6-13.3) than the clinical (3.6, 1.1-6.2) and administrative (3.9, 1.0-6.0) cohorts (p = .005), an increased requirement for vasoactive infusions (74%, 57%, and 45%, p < .001), and a potential bias toward an increased proportion with respiratory dysfunction compared with clinical practice. Although research, clinical, and administrative criteria yielded a similar incidence (5%-6%) for pediatric severe sepsis/septic shock, there was only a moderate level of agreement in the patients identified by different criteria. One third of patients diagnosed clinically with sepsis would not have been included in studies based on consensus guidelines or International Classification of Diseases, Ninth Revision, Clinical Modification codes. Differences in patient selection need to be considered when extrapolating data across settings.

Barriers to investigator-initiated deep brain stimulation and device research

PubMed Central

Malone, Donald; Okun, Michael S.; Booth, Joan; Machado, Andre G.

2014-01-01

The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients. PMID:24670888

Integrating research into clinical internship training bridging the science/practice gap in pediatric psychology.

PubMed

McQuaid, Elizabeth L; Spirito, Anthony

2012-03-01

Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a "capstone experience"; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the "business of science." Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists.

PROFESSIONAL INTEGRATION AND CLINICAL RESEARCH.

ERIC Educational Resources Information Center

WARD, TED W.

THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…

Legitimating Clinical Research in the Study of Organizational Culture.

ERIC Educational Resources Information Center

Schein, Edgar H.

1993-01-01

Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

AIDS--Challenges to Basic and Clinical Biomedical Research.

ERIC Educational Resources Information Center

Fauci, Anthony S.

1989-01-01

Clinical trials and access to therapeutic drugs pose dilemmas for researchers, physicians, and AIDS patients. The National Institute of Allergy and Infectious Diseases, recognizing the need for greater access to drugs by a broader spectrum of the infected population, is establishing the Community Programs for Clinical Research on AIDS. (Author/MLW)

Retrospective Review of Student Research Projects in a Canadian Master of Science in Physical Therapy Programme and the Perceived Impact on Advisors' Research Capacity, Education, Clinical Practice, Knowledge Translation, and Health Policy.

PubMed

Lacey, Courtney; Scodras, Stephanie; Ardron, Julie; Sellan, Ryan; Garbaczewska, Martyna; O'Brien, Kelly K; Salbach, Nancy M

2018-01-01

Purpose: This study's aim was to characterize the nature of students' research conducted for a Master of Science in Physical Therapy (MScPT) degree programme at a Canadian university and evaluate the lead advisors' perspectives of its impact on their research capacity, education, clinical practice, knowledge translation, and health policy. Methods: We conducted a quantitative, cross-sectional, retrospective review of research reports from 2003 to 2014 to characterize the MScPT students' research and a quantitative, cross-sectional e-survey of lead research advisors to evaluate the impact of this research. Results: Data were abstracted from reports of 201 research projects completed between 2003 and 2014. Projects were conducted primarily in university-affiliated hospitals (41.6%) or the university's physical therapy department (41.1%), and the majority (52.5%) had a clinical focus. Of the 95 lead advisors of 201 projects, 59 advisors (response rate 62.1%) of 119 projects completed the survey questionnaire. The respondents most frequently identified clinical practice (45.1%) and advisors' research capacity (31.4%) as areas positively affected by the students' research. Conclusions: The MScPT students' research projects facilitate the conduct of extensive research internally and across affiliated hospitals. This research appears to advance not only clinical practice but also the ability of lead advisors to undertake research.

Implementing Clinical Research Using Factorial Designs: A Primer.

PubMed

Baker, Timothy B; Smith, Stevens S; Bolt, Daniel M; Loh, Wei-Yin; Mermelstein, Robin; Fiore, Michael C; Piper, Megan E; Collins, Linda M

2017-07-01

Factorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers' increased and careful execution of such designs. Copyright © 2017. Published by Elsevier Ltd.

Health information exchanges--Unfulfilled promise as a data source for clinical research.

PubMed

Parker, Carol; Weiner, Michael; Reeves, Mathew

2016-03-01

To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical research outside of the evaluation of HIEs themselves, as well as the limited number of specific HIEs that are involved in generating published research. Significant barriers exist that prevent HIEs from developing into an invaluable resource for clinical research including technological infrastructure limitations, business processes limiting secondary use of data, and lack of participating provider support. Research to better understand challenges to developing the necessary infrastructure and policies to foster HIE engagement in research would be valuable as HIEs represent an opportunity to engage non-traditional health care provider research partners. Copyright © 2015. Published by Elsevier Ireland Ltd.

Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology

PubMed Central

Peppercorn, Jeffrey; Shapira, Iuliana; Collyar, Deborah; Deshields, Teresa; Lin, Nancy; Krop, Ian; Grunwald, Hans; Friedman, Paula; Partridge, Ann H.; Schilsky, Richard L.; Bertagnolli, Monica M.

2010-01-01

Clinical investigators in oncology are increasingly interested in using molecular analysis of cancer tissue to understand the biologic bases of response or resistance to novel interventions and to develop prognostic and predictive biomarkers that will guide clinical decision making. Some scientific questions of this nature can only be addressed, or may best be addressed, through the conduct of a clinical trial in which research biopsies are obtained from all participants. However, trial designs with mandatory research biopsies have raised ethical concerns related to the risk of harm to participants, the adequacy of voluntary informed consent, and the potential for misunderstanding among research participants when access to an experimental intervention is linked to the requirement to undergo a research biopsy. In consideration of the ethical and scientific issues at stake in this debate, the Cancer and Leukemia Group B Ethics Committee proposes guidelines for clinical trials involving mandatory research biopsies. Any cancer clinical trial that requires research biopsies of participants must be well designed to address the scientific question, obtain the biopsy in a way that minimizes risk, and ensure that research participants are fully informed of the risks, rationale, and requirements of the study, as well as of treatment alternatives. Further guidelines and discussions of this issue are specified in this position paper. We feel that if these principles are respected, an informed adult with cancer can both understand and voluntarily consent to participation in a clinical trial involving mandatory research biopsy for scientific end points. PMID:20406927

59 MDW/ST OVERVIEW BRIEFING 15 JUNE 2017

DTIC Science & Technology

2017-06-15

your department has told you they cannot fund your publication, the 59th Clinical Research Division may pay for your basic journal publishing charges...Simulation Training • Clinical Rehabilitative Medicine • Clinical Investigations Program • Dental & Nursing Research 5 \\I ••• • Science & Technology... Research and Evaluation • USAF Post Graduate Dental School and Clinics , JBSA-Lackland • Dental Evaluation and Consultation Service, JBSA-Fort Sam

Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

PubMed

Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

2016-09-27

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Perceptions and attitudes to clinical research participation in Qatar.

PubMed

Tohid, Hiba; Choudhury, Sopna M; Agouba, Sahar; Aden, Abdi; Ahmed, Lina H M; Omar, Omar; Chagoury, Odette; Taheri, Shahrad

2017-12-01

Recruitment into clinical research studies is a major challenge. This study was carried out to explore the perceptions and attitudes towards clinical research participation among the general public in Qatar. A population based questionnaire study was carried out at public events held in Qatar. Residents of Qatar, 18 years or above in age were surveyed, anonymously, following verbal consent. Descriptive and multivariate analyses were conducted. We administered 2517 questionnaires to examine clinical research participation, of which 2379 complete forms were analyzed. Those who had previously been approached to participate in research completed a more detailed assessment. Data showed that only 5.7% participants (n = 134) had previously been approached to participate in a clinical research study. Of these 63.4% (n = 85) had agreed to participate while 36.6% (n = 49) had declined. The main reasons for declining participation included: time constraint (47.8%, n = 11), 'fear' (13.0%, n = 3), lack of awareness about clinical research (8.7%, n = 2) and lack of interest (8.7%, n = 2). 'To help others' (31.8%, n = 27) and 'thought it might improve my access to health care' (24.7%, n = 21) were the prime motivators for participation. There was a general agreement among participants that their previous research experience was associated with positive outcomes for self and others, that the research conduct was ethical, and that opportunities for participation will be welcomed in future. More than ten years of stay within Qatar was a statistically significant determinant of willingness to participate, adjusted odds ratio 5.82 (95% CI 1.93-17.55), p = 0.002. Clinical research participation in Qatar needs improvement. Time constraints, lack of trust in and poor awareness about clinical research are main barriers to participation. Altruism, and improved health access are reported as prime motivators. Deeper insight in to the factors affecting clinical research participation is needed to devise evidence based policies for improvement in recruitment strategies.

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right

PubMed Central

Pandi-Perumal, Seithikurippu R.; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R.; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article. PMID:26042053

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right.

PubMed

Pandi-Perumal, Seithikurippu R; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK(®) of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

The research program coordinator: an example of effective management.

PubMed

Merry, Lisa; Gagnon, Anita J; Thomas, Julia

2010-01-01

Careers in clinical research management are increasingly common. Despite nurses' important role in clinical research, their status as research professionals is underrecognized. In this article, we describe the role of a "program coordinator" (PC) in the context of a complex research program on migration and reproductive health. The PC role expands beyond the usual role of a research coordinator because he or she is involved in all aspects of the program of research and his or her responsibilities include research, education, clinical, and administration components. He or she ensures optimal organization and continuity across several studies and ensures ethical and scientific standards are applied for each individual study. His or her clinical knowledge assures data are accurate and subjects are safe. In addition, he or she assists with applying for funding, the maintenance of research partnerships, and dissemination of research findings; he or she supports students' learning and completes all regulatory aspects related to the program of research. Key to the PC role is relationship building and the application of Good Clinical Practice principles. The advanced role of a PC also warrants opportunities for professional development and a competitive salary. A PC is an effective approach for research management and a natural role for professional nurse. Copyright 2010 Elsevier Inc. All rights reserved.

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

PubMed

Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-05-01

Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.

Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

PubMed

Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

2016-04-01

The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).

PubMed

Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa

2017-02-01

Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally. © 2016 John Wiley & Sons Australia, Ltd.

A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

PubMed

Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

2017-06-01

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug application studies but also to all types of research, including observational and public health studies. Our method is also adaptable to clinical data collected with CDASH at the beginning of a study in non-standard format. We believe that this tool will reduce the workload of new drug application studies and will support data sharing and reuse of clinical research data in academia. Copyright © 2017 Elsevier Inc. All rights reserved.

Best practices in social and behavioral research: report from the Enhancing Clinical Research Professional's Training and Qualifications project.

PubMed

Murphy, Susan L; Byks-Jazayeri, Christine; Calvin-Naylor, Nancy; Divecha, Vic; Anderson, Elizabeth; Eakin, Brenda; Fair, Alecia; Denton, Laura

2017-02-01

This article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research. The first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research. Although concepts underlying GCP were deemed similar across all clinical trials, not all areas were equally applicable and the ways in which GCP would be enacted differ for behavioral trials. It was determined that suitable training in best practices for social and behavioral research was lacking. Based on the training need, an e-learning course for best practices is available to all CTSA sites. Each institution is able to track outcomes for its employees to help achieve standardized competency-based best practices for social and behavioral investigators and staff.

Visualizing and Validating Metadata Traceability within the CDISC Standards.

PubMed

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information.

Visualizing and Validating Metadata Traceability within the CDISC Standards

PubMed Central

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information. PMID:28815125

Secondary Use of Clinical Data: the Vanderbilt Approach

PubMed Central

Danciu, Ioana; Cowan, James D.; Basford, Melissa; Wang, Xiaoming; Saip, Alexander; Osgood, Susan; Shirey-Rice, Jana; Kirby, Jacqueline; Harris, Paul A.

2014-01-01

The last decade has seen an exponential growth in the quantity of clinical data collected nationwide, triggering an increase in opportunities to reuse the data for biomedical research. The Vanderbilt research data warehouse framework consists of identified and de-identified clinical data repositories, fee-for-service custom services, and tools built atop the data layer to assist researchers across the enterprise. Providing resources dedicated to research initiatives benefits not only the research community, but also clinicians, patients and institutional leadership. This work provides a summary of our approach in the secondary use of clinical data for research domain, including a description of key components and a list of lessons learned, designed to assist others assembling similar services and infrastructure. PMID:24534443

An evidence-based guide to clinical instruction in audiology.

PubMed

Mormer, Elaine; Palmer, Catherine; Messick, Cheryl; Jorgensen, Lindsey

2013-05-01

A significant portion of the AuD curriculum occurs in clinical settings outside the classroom. Expert clinicians, employed within and outside of the university, are called upon to provide this clinical education. Most have had little or no formal training in clinical teaching yet face pedagogical and logistical challenges when simultaneously providing clinical service and teaching. Training to provide optimal methods and approaches to clinical instruction should be based on research evidence; however, there is a paucity of research in this area within the audiology discipline. This article provides a review of literature supplying evidence for important concepts, elements, and approaches to the clinical instruction process. Additionally, we provide readers with some practical tools with which to facilitate application of optimal clinical teaching principles. We conducted a systematic review of literature on clinical education in audiology and across a wide array of health professions. Through the use of content analysis we identified four elements of the clinical teaching process most critical in examining optimal practices. The elements identified as critical to positive clinical learning outcomes include the establishment of mutual expectations and goals; structured content and delivery of feedback; establishment of a positive instructor/student relationship; and questioning strategies that lead to the development of critical thinking skills. Many disciplines outside of audiology demonstrate robust research activity related to understanding and optimizing the clinical education process. The application of a number of evidence-based clinical teaching principles should allow us to improve student outcomes in audiology. Researchers in our field might consider if and how we should develop our own research literature in clinical education. American Academy of Audiology.

Personality: individual differences and clinical assessment.

PubMed

Butcher, J N; Rouse, S V

1996-01-01

Research in clinical personality assessment continues to be produced at a high rate. The MMPI/MMPI-2 remains the most popular instrument for both clinical application and psychopathology research. Two other clinical personality instruments, the Rorschach and TAT, continue to find a place in research and clinical assessment. Some new instruments have surfaced recently to deal with areas, such as personality disorders, that have been considered inadequately addressed. There is a growing recognition that the Five-Factor Model is too superficial for clinical assessment that requires more refined and broadened patient information. Clinical personality assessment has successfully survived a number of past challenges. The newest challenge stems from the health-care revolution, in which managed-care providers are reluctant to pay for assessment because of shrinking funds. Psychologists need to develop models for incorporating assessment information into the treatment process. The future is likely to see more extensive research and theoretical development in this endeavor.

Reflections on clinical research in sub-Saharan Africa.

PubMed

Kuepfer, Irene; Burri, Christian

2009-07-15

The urgent need for new, safe and sustainable interventions against diseases that disproportionally affect the poor is finally receiving global attention and the funding landscape for development projects has significantly improved during the past decade. For the development of new drug and vaccine candidates, clinical trials have become the most important tool to assess their safety and efficacy. Recently, there has been a seismic shift in the number of clinical trials conducted in resource-limited settings. We discuss the current framework of clinical research in sub-Saharan Africa, from building product pipelines to the capacities needed for the conduct of trials according the harmonised Good Clinical Practice (GCP) ICH E6 guideline. We place emphasis on clinical research in neglected tropical diseases which still frequently has to be conducted with limited financial, logistical and human resources. Given those short-comings we recommend minimum standards needed at the local, national and sponsor levels to provide GCP-compliant clinical research.

How can the research potential of the clinical quality databases be maximized? The Danish experience.

PubMed

Nørgaard, M; Johnsen, S P

2016-02-01

In Denmark, the need for monitoring of clinical quality and patient safety with feedback to the clinical, administrative and political systems has resulted in the establishment of a network of more than 60 publicly financed nationwide clinical quality databases. Although primarily devoted to monitoring and improving quality of care, the potential of these databases as data sources in clinical research is increasingly being recognized. In this review, we describe these databases focusing on their use as data sources for clinical research, including their strengths and weaknesses as well as future concerns and opportunities. The research potential of the clinical quality databases is substantial but has so far only been explored to a limited extent. Efforts related to technical, legal and financial challenges are needed in order to take full advantage of this potential. © 2016 The Association for the Publication of the Journal of Internal Medicine.

Increasing complexity of clinical research in gastroenterology: implications for the training of clinician-scientists.

PubMed

Scott, Frank I; McConnell, Ryan A; Lewis, Matthew E; Lewis, James D

2012-04-01

Significant advances have been made in clinical and epidemiologic research methods over the past 30 years. We sought to demonstrate the impact of these advances on published gastroenterology research from 1980 to 2010. Twenty original clinical articles were randomly selected from each of three journals from 1980, 1990, 2000, and 2010. Each article was assessed for topic, whether the outcome was clinical or physiologic, study design, sample size, number of authors and centers collaborating, reporting of various statistical methods, and external funding. From 1980 to 2010, there was a significant increase in analytic studies, clinical outcomes, number of authors per article, multicenter collaboration, sample size, and external funding. There was increased reporting of P values, confidence intervals, and power calculations, and increased use of large multicenter databases, multivariate analyses, and bioinformatics. The complexity of clinical gastroenterology and hepatology research has increased dramatically, highlighting the need for advanced training of clinical investigators.

Research information knowledge, perceived adequacy, and understanding in cancer clinical trial participants.

PubMed

Biedrzycki, Barbara A

2011-07-01

To describe the adequacy of research information among people with cancer at the time they accept or decline participation in a cancer clinical trial. Cross-sectional, descriptive. An urban, academic, National Cancer Institute-designated comprehensive cancer center. 197 patients with advanced gastrointestinal cancer. Mailed survey; self-reported data. Adequacy of research information (actual knowledge, perceived adequacy of information, and perceived understanding), cancer clinical trial participation, and satisfaction with the decision to participate. Most respondents (88%) perceived themselves as having adequate information to make an informed decision regarding cancer clinical trial participation. In addition, 35% demonstrated adequate knowledge of basic clinical research. Patients decide to accept or decline cancer clinical trials without having adequate knowledge. Nurses have an important role in educating patients regarding cancer clinical trials. The ideal teachable moment may not occur at the time of diagnosis; other less stressful opportunities may present when the patient is more receptive.

Ethics of clinical trials.

PubMed

Iyalomhe, G B S; Imomoh, P A

2007-01-01

Although clinical trials are conducted far more ethically and safer now than they were some decades ago, the elimination of gross abuses has tended to highlight more subtle ethical problems. Therefore, research in man, especially clinical drug trials, must now take into account ethical and legal requirements. This review examines the progress of clinical trial ethics, highlights the major ethical principles and challenges involved in the conduct of clinical trials, and suggests measures to ensure scientifically and ethically sound clinical trials. An internet search and a perusal of the literature on the history of clinical trials, medical ethics and good clinical practice, reveal that apart from laying a general principle, the Oath of Hippocrates did not provide a guide on the specific ethical problems involved in undertaking research, an important arm of advancement in medical knowledge. Hence, to avert continued ethical abuses of subjects during clinical research, the current reference guideliNe--the Helsinki Declaration of 1964 (revised in 1975), was adopted by the World Medical Assembly. It emphasized four major principles: autonomy, nonmaleficience, beneficence and justice. In applying these principles, the researcher must obtain a written free and well informed consent from patients who should be aware of their right to withdraw from trial at any moment. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. He must ethically monitor and assess risks and benefits of the trial throughout its duration and use a fair procedure in selecting research subjects and must respect the concept of inviolability of the human person. Ethical challenges confronting clinical trials include the appropriateness of the proposed research, obtaining free informed consent, use of medications after completion of drug trials, drug toxicities and long-term side effects as well as the release and publication of research result. To improve protection for research subjects and have ethically sound clinical trials, there is need to adhere to global standards and legislations; establish, strengthen and empower regulatory bodies; develop partnership among stakeholders; intensify public enlightenment and train research personnel.

National survey of pain clinics in Croatia: Organization and services.

PubMed

Fidahić, Mahir; Dogan, Katarina; Sapunar, Damir; Puljak, Livia

2015-01-01

To analyze organization and therapeutic procedures administered in tertiary outpatient pain clinics in Croatia. Data about organization of pain clinics, its personnel, equipment, continuing medical education, therapeutic procedures, research activities and relations with pharmaceutical industry were collected using questionnaires. Twenty-two Croatian pain clinics were included in the study. Most of the pain clinics employ exclusively anesthesiologists and nurses. The most frequently prescribed therapeutic procedures in pain clinics were pharmacotherapy, transcutaneous electrical nerve stimulation, acupuncture and trigger point injections. Almost all pain clinics provide educational material for patients. Most of the pain clinics have regular interactions with pharmaceutical companies. Prescribing decisions were based mostly on information from scientific meetings, research articles and consultations with colleagues. Information sources which are considered to be the gold standard--the systematic reviews of The Cochrane Collaboration--were used less frequently (n=12; 57%) than advertising materials from pharmaceutical companies (n=16; 76%). Few physicians and other pain clinics staff had scientific degrees or academic titles or were involved in a research project. The national study about pain clinics in Croatia pointed out that there is room for improvement of their organization and services. Pain clinics should employ health-care professionals with diverse backgrounds. They should offer treatments backed by the highest-level of scientific evidence. Since pain is a major public health issue, pain clinic staff should engage more in research to contribute to the growing field of pain research, to enhance capacities for pain research in Croatia, to incorporate scientific evidence into their daily decision-making and to enable evidence-based practice. Copyright © 2015 by Academy of Sciences and Arts of Bosnia and Herzegovina.

An ethnographic study of nurses' experience with nursing research and its integration in practice.

PubMed

Dupin, Cécile Marie; Borglin, Gunilla; Debout, Christophe; Rothan-Tondeur, Monique

2014-09-01

To report from a study aimed at illuminating how French Registered Nurses experience and engage in nursing research in clinical practice. Nursing research in France is mainly conducted by nurses working at clinical research units rather than by dedicated nurse researchers. Education, i.e. advanced degrees, in the field of nursing research is still in its infancy and not yet consistent with the international context. Outside France, the general perception is that nursing research is a unified part of professional nursing. Consequently, in-depth knowledge about how nurses in a French clinical context might experience and engage in nursing research is still lacking. The design of this study was influenced by an ethnographic approach as described by the French anthropologists Beaud and Weber. Data, participatory observations, field notes and interviews (n = 6) were collected in a teaching hospital between April-August 2012. The field consisted of a wound-care unit and clinical research units. Collected data were analysed based on Beaud and Weber's description of analysis. Three beliefs were identified: being a unified part of a research team, being an integral part of 'crosswise - across' activities and being part of research activities. Commitment to nursing research was strengthened by patient-related issues. Based on this context, nursing research would likely benefit from the support of a naturalized reciprocity between clinical practice and research. © 2014 John Wiley & Sons Ltd.

[An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

PubMed

Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

2015-06-01

Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p < .05). Participants who had participated in a long-term trial-training course earned higher importance scores for "CRN four-subthemes role responsibilities" (p <.05) and lower difficulty scores for "subject protection", "research coordination and management" (p <.005) than their short-term course peers. "Recognition of overall responsibilities" and "receiving trial training" were the significant predictors of difficulty in performing CRN role responsibilities, explaining 21.9% of the total variance. To further promote CRN as a professional career in Taiwan, the findings of this study recommend identifying the core competences of CRNs and adding CRN-related study materials into the advanced nursing curriculum. Long-term and systematic educational training may help CRNs understand the importance of their role responsibilities, better recognize their professional role, and reflect these responsibilities in clinical practice.

Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams

PubMed Central

2014-01-01

Background Recruiting the required number of participants is vital to the success of clinical research and yet many studies fail to achieve their expected recruitment rate. Increasing research participation is a key agenda within the NHS and elsewhere, but the optimal methods of improving recruitment to clinical research remain elusive. The aim of this study was to identify the factors that researchers perceive as influential in the recruitment of participants to clinically focused research. Methods Semi-structured interviews were conducted with 11 individuals from three clinical research teams based in London. Sampling was a combination of convenience and purposive. The interviews were audio recorded, transcribed verbatim and analysed using the framework method to identify key themes. Results Four themes were identified as influential to recruitment: infrastructure, nature of the research, recruiter characteristics and participant characteristics. The main reason individuals participate in clinical research was believed to be altruism, while logistical issues were considered important for those who declined. Suggestions to improve recruitment included reducing participant burden, providing support for individuals who do not speak English, and forming collaborations with primary care to improve the identification of, and access to, potentially eligible participants. Conclusions Recruiting the target number of research participants was perceived as difficult, especially for clinical trials. New and diverse strategies to ensure that all potentially eligible patients are invited to participate may be beneficial and require further exploration in different settings. Establishing integrated clinical and academic teams with shared responsibilities for recruitment may also facilitate this process. Language barriers and long journey times were considered negative influences to recruitment; although more prominent, these issues are not unique to London and are likely to be important influences in other locations. PMID:24456229

[Introduction of neuroethics: out of clinic, beyond academia in human brain research].

PubMed

Fukushi, Tamami; Sakura, Osamu

2008-11-01

Higher cognitive function in human brain is one of well-developed fields of neuroscience research in the 21st century. Especially functional magnetic resonance imaging (fMRI) and near infrared recording system have brought so many non-clinical researchers whose background is such as cognitive psychology, economics, politics, pedagogy, and so on, to the human brain mapping study. Authors have introduced the ethical issues related to incidental findings during the fMRI recording for non-clinical purpose, which is a typical problem derived from such expanded human brain research under non clinical condition, that is, neuroethics. In the present article we would introduce neuroethical issues in contexts of "out of clinic" and "beyond academia".

Challenging Assumptions About Minority Participation in US Clinical Research

PubMed Central

Kalbaugh, Corey A.

2011-01-01

Although extensive research addresses minorities’ low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities’ participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities’ distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field. PMID:22021285

United States private-sector physicians and pharmaceutical contract research: a qualitative study.

PubMed

Fisher, Jill A; Kalbaugh, Corey A

2012-01-01

There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities. We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers. Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.

United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study

PubMed Central

Fisher, Jill A.; Kalbaugh, Corey A.

2012-01-01

Background There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities. Methods and Findings We conducted a qualitative study in 2003–2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers. Conclusions Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary. PMID:22911055

Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research. PMID:22347696

Implications of the concept of minimal risk in research on informed choice in clinical practice

PubMed Central

Wada, Kyoko; Nisker, Jeff

2015-01-01

The concept of a minimal risk threshold in research, beneath which exception to informed consent and ethics review processes may occur, has been codified for over 30 years in many national research regulations and by the Council for International Organizations of Medical Sciences. Although minimal risk in research constitutes one of the criteria for allowing waiver of informed consent or modification to the consent process and a large body of literature exists, discussion of a minimal risk threshold in clinical practice has not occurred. One reason for lack of discussion may be that implicit consent is accepted for a wide range of routine clinical practices. Extending the role of minimal risk in research to clinical practice might assist clinicians in identifying circumstances for which implicit consent is indeed sufficient and circumstances in which it is not. Further, concepts from minimal risk in research might assist clinicians regarding when information provision in health promotion is required. We begin by reviewing concepts in both minimal risk in research and informed choice in clinical practice. We then explore how a clinical minimal risk concept may clarify recommendations for information provision in clinical practice and support the patient's informed choice regarding therapeutic and diagnostic procedures and also health promotion. Given that clinical practice involves a broad scope of health information, professional practice guidelines on information provision based on the application of the minimal risk threshold in research could be developed to guide clinicians in what information must be provided to their patients. PMID:26108215

Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

PubMed

Niranjan, Soumya J; Durant, Raegan W; Wenzel, Jennifer A; Cook, Elise D; Fouad, Mona N; Vickers, Selwyn M; Konety, Badrinath R; Rutland, Sarah B; Simoni, Zachary R; Martin, Michelle Y

2017-08-03

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

Center for Cancer Research hosts 10th Annual GIST Clinic | Center for Cancer Research

Cancer.gov

Patients and specialists from around the world gathered for the 10th Annual Pediatric and Wildtype GIST Clinic, which took place Wednesday, July 5 through Friday, July 7, 2017 at the NIH Clinical Center in Bethesda, Maryland. Occurring once a year, the clinic convenes clinicians, research scientists and advocates from across the country to consult with patients who have GIST. Christine Gonzales, a GIST clinic patient from New Mexico, says, “It’s been super amazing because I’ve never talked to a specialist about this cancer."

Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

PubMed

Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

2010-10-01

New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

In Defense of a Social Value Requirement for Clinical Research

PubMed Central

Wendler, David; Rid, Annette

2017-01-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present paper assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. PMID:28060427

In Defense of a Social Value Requirement for Clinical Research.

PubMed

Wendler, David; Rid, Annette

2017-02-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

[Nurturing clinician investigators is the best way to promote innovative drug development from academia].

PubMed

Fukuhara, Shunichi; Sakushima, Ken; Nishimura, Masaharu

2012-03-01

Clinical research in Japan is still lacking in quality and quantity, and that situation is worsening. One important cause of those problems is the dearth of clinician-investigators. A recent change in the system for post-graduate clinical training affected the career paths of medical residents and reduced the number of young doctors who enter graduate school. Even those who are interested in clinical research now have incentives to avoid graduate school. In Japan, 19th-century biological absolutism is still the dominant paradigm in the medical-research community. Science for public health in the 21st century will benefit from a probabilistic paradigm, which can help to restore an appropriate balance between basic sciences and clinical research. Research done by clinician-investigators should be based on clinical questions that arise in medical practice. That research includes investigation of disease and practice, exploration of associations between causes and outcomes, evaluation of diagnostic tests, and studies of the efficacy of treatments and prevention strategies. We emphasize the importance of nurturing clinician-investigators for the development of clinical research in Japan. This may not be the fastest way to promote innovative drug development from academia, but it is certainly the best.

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

PubMed

Ross, Joseph S

2016-09-20

The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.

Return of Individual Research Results & Incidental Findings: Facing the Challenges of Translational Science

PubMed Central

Wolf, Susan M.

2014-01-01

The debate over return of individual research results and incidental findings to research participants is a key frontier in research ethics and practice. Fundamentally, this is a problem of translational science, a question of when information about an individual that is generated in research should be communicated for clinical attention, as the technology itself is moving into clinical care. There is growing consensus that investigators should offer participants at least those individual findings of high clinical importance and actionability. Increasing attention to what information biobanks and secondary researchers owe people who provide data and samples offers an opportunity to treat these source individuals as research partners. Cutting-edge issues include return of results in pediatric populations and return to kin and family, including after death of the proband. Progress will require facing the continuum linking research and clinical care and developing standards and models for return. PMID:23875796

Clinical reasoning and its application to nursing: concepts and research studies.

PubMed

Banning, Maggi

2008-05-01

Clinical reasoning may be defined as "the process of applying knowledge and expertise to a clinical situation to develop a solution" [Carr, S., 2004. A framework for understanding clinical reasoning in community nursing. J. Clin. Nursing 13 (7), 850-857]. Several forms of reasoning exist each has its own merits and uses. Reasoning involves the processes of cognition or thinking and metacognition. In nursing, clinical reasoning skills are an expected component of expert and competent practise. Nurse research studies have identified concepts, processes and thinking strategies that might underpin the clinical reasoning used by pre-registration nurses and experienced nurses. Much of the available research on reasoning is based on the use of the think aloud approach. Although this is a useful method, it is dependent on ability to describe and verbalise the reasoning process. More nursing research is needed to explore the clinical reasoning process. Investment in teaching and learning methods is needed to enhance clinical reasoning skills in nurses.

The Clinical Research Landscape in Rhode Island.

PubMed

Mao, George; Ramratnam, Bharat

2017-01-06

To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

The Role of Research in Advanced Dental Education.

ERIC Educational Resources Information Center

Profitt, William R.; Vig, Peter S.

1980-01-01

Even though research is an integral part of quality advanced dental programs, many dental departments with postdoctoral programs lack faculty and other resources for research productivity. Programs to produce clinical faculty with research training are called for through the development of clinical research centers. (JSR)

Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

Offering African Americans Opportunities to Participate in Clinical Trials Research: How Social Workers Can Help

ERIC Educational Resources Information Center

Mason, Susan E.

2005-01-01

Historically, African Americans have resisted participation in clinical trials and other research projects because of distrust of the mostly white research establishment. Although there are legitimate reasons for refusing to join clinical trials, most notably the abuses of the Tuskegee Syphilis Study, African Americans may be passing up…

A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

ERIC Educational Resources Information Center

Ji, Ping; Wang, Haibo; Zhang, Chao; Liu, Min; Zhou, Liping; Xiao, Ping; Wang, Yanfang; Wu, Yangfeng

2017-01-01

Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals. Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen)…

Clinical and Research Perspectives on Nonspeech Oral Motor Treatments and Evidence-Based Practice

ERIC Educational Resources Information Center

Muttiah, Nimisha; Georges, Katie; Brackenbury, Tim

2011-01-01

Purpose: Evidence-based practice (EBP) involves the incorporation of research evidence, clinical expertise, and client values in clinical decision making. One case in which these factors conflict is the use of nonspeech oral motor treatments (NSOMTs) for children with developmental speech sound disorders. Critical reviews of the research evidence…

A change roadmap towards research paradigm in low-resource countries: retinoblastoma model in Egypt.

PubMed

Alfaar, Ahmad Samir; Nour, Radwa; Bakry, Mohamed Sabry; Kamal, Mohamed; Hassanain, Omneya; Labib, Rania M; Rashed, Wafaa M; Elzomor, Hossam; Alieldin, Adel; Taha, Hala; Zaghloul, Mohamed Saad; Ezzat, Sameera; AboElnaga, Sherif

2017-02-01

Research on childhood diseases represents a great global challenge. This challenge is maximized in both childhood cancer disciplines and developing world. In this paper, we aim at describing our institution experience in starting a structured childhood cancer research program in one of the developing countries in a short time based on philanthropic efforts. We used retinoblastoma as an example for what was conducted in this program. Starting in 2008, this program included improving clinical practice and its related supporting services besides developing new research services that both complement the clinical activities and pave the way towards creating a research foundation in the country. Results included developing hospital standard treatment protocols, developing national clinical trials, joining international consortia for childhood cancers clinical trials, developing data collection tools and real-time analytics, establishing a biobanking facility, and developing highly qualified team for conducting clinical, epidemiologic, and translational research studies. Moreover, this effort resulted in improving both clinical practice and patients' awareness nationally. This model can be used for other startup facilities that aim at finding answers for their national health problems in low-resource setting.

Insufficient recruitment and premature discontinuation of clinical trials in Switzerland: qualitative study with trialists and other stakeholders.

PubMed

Briel, Matthias; Elger, Bernice; von Elm, Erik; Satalkar, Priya

2017-11-29

Premature discontinuation occurs in about 25% of randomised clinical trials in Switzerland; it mainly affects investigator-initiated trials and is mostly due to problems with recruitment of patients. The aim of this study was to qualitatively investigate reasons for trial discontinuation due to poor patient recruitment and suggestions to address those reasons in the Swiss context. We conducted semi-structured interviews with trialists whose trials were discontinued because of recruitment problems, other experienced trialists, and stakeholders in clinical research in Switzerland. Interviews were audio-recorded, transcribed verbatim, and anonymised. We analysed the transcripts using deductive coding and built up themes that were continuously discussed within the research team. Of 65 invited Swiss trialists and stakeholders, 39 (60%) agreed to be interviewed and contributed to this analysis. We identified four main themes of reasons for poor recruitment: (1) Switzerland has a decentralised healthcare system with many small hospitals and few patients per hospital, many research regulations, no standardisation of medical records across hospitals, and a heterogeneous ethics assessment of study protocols. There is little collaboration of different stakeholders in clinical research and a lack of prioritisation of projects. (2) Limited human and financial resources, especially in the academic setting, compromise research questions and size of clinical trials. When funding is used up this typically triggers discontinuation of already delayed clinical trials. (3) Investigators face underdeveloped research networks and a limited collaborative attitude among clinical researchers. They typically embark on clinical studies with a great deal of optimism but insufficient preparation. (4) Swiss patients have universal health coverage and many treatment options. Negative media coverage of clinical research and a lack of accessible information for patients about ongoing clinical studies frequently make participation in clinical trials less attractive. More interactive structures and collaboration across stakeholders were mentioned as potential solutions to tackle the problems. Recruitment of participants into clinical trials in Switzerland is challenging because of various, often interlinked factors related to the Swiss health system, available funding, investigators, and patients. Common goals and concerted efforts by involved stakeholders appear necessary to achieve improvement.

Enhancing the Alignment of the Preclinical and Clinical Stroke Recovery Research Pipeline: Consensus-Based Core Recommendations From the Stroke Recovery and Rehabilitation Roundtable Translational Working Group.

PubMed

Corbett, Dale; Carmichael, S Thomas; Murphy, Timothy H; Jones, Theresa A; Schwab, Martin E; Jolkkonen, Jukka; Clarkson, Andrew N; Dancause, Numa; Weiloch, Tadeusz; Johansen-Berg, Heidi; Nilsson, Michael; McCullough, Louise D; Joy, Mary T

2017-08-01

Stroke recovery research involves distinct biological and clinical targets compared to the study of acute stroke. Guidelines are proposed for the pre-clinical modeling of stroke recovery and for the alignment of pre-clinical studies to clinical trials in stroke recovery.

A CTSA Agenda to Advance Methods for Comparative Effectiveness Research

PubMed Central

Helfand, Mark; Tunis, Sean; Whitlock, Evelyn P.; Pauker, Stephen G.; Basu, Anirban; Chilingerian, Jon; Harrell Jr., Frank E.; Meltzer, David O.; Montori, Victor M.; Shepard, Donald S.; Kent, David M.

2011-01-01

Abstract Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient‐centered outcomes, compare viable alternatives, and be responsive to individual patients’ preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness research (CER) fundamentally patient‐centered, challenge researchers to adopt or develop methods that improve the timeliness, relevance, and practical application of clinical studies. In this paper, we describe 10 priority areas that address 3 critical needs for research on patient‐centered outcomes (PCOR): (1) developing and testing trustworthy methods to identify and prioritize important questions for research; (2) improving the design, conduct, and analysis of clinical research studies; and (3) linking the process and outcomes of actual practice to priorities for research on patient‐centered outcomes. We argue that the National Institutes of Health, through its clinical and translational research program, should accelerate the development and refinement of methods for CER by linking a program of methods research to the broader portfolio of large, prospective clinical and health system studies it supports. Insights generated by this work should be of enormous value to PCORI and to the broad range of organizations that will be funding and implementing CER. Clin Trans Sci 2011; Volume 4: 188–198 PMID:21707950

Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

PubMed

Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

2004-08-01

The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

Learning for clinical leadership.

PubMed

Cook, Michael J; Leathard, Helen L

2004-11-01

Clinical leadership has been acclaimed widely as a major factor influencing the quality of patient care but research has revealed a paucity of preparation for this significant role. Leadership literature has rarely addressed clinical leadership specifically or referred to the difficulties in characterizing effective clinical leaders. The research informing this paper focused on clinical leadership and identified five attributes of effective clinical leaders: creativity, highlighting, influencing, respecting, and supporting. Effective clinical leaders adopted a transformational leadership style and improved care, through others, by including transformational (soft) knowledge as an integral part of their effective practice repertoire. Phronesis is introduced as practical wisdom that is gained through immersion in relevant experience, and as an essential element of preparation for clinical nursing leadership practice. It is argued, that learning to transform care requires opportunities to work within an environment that engenders and supports aspiring leaders. The paper describes the research process, elucidates the attributes through illustrative examples from the research data, and discusses an emergent educational strategy for the development of these attributes by clinicians in their practice environments. The paper also describes the application of this research through an interdisciplinary programme for staff leading teams in both health and social services sectors.

[Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

PubMed

Ruiz, Martial; Thibult, François

2014-06-01

The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

Antibacterial resistance leadership group: open for business.

PubMed

Chambers, Henry F; Bartlett, John G; Bonomo, Robert A; Chiou, Christine; Cosgrove, Sara E; Cross, Heather R; Daum, Robert S; Downing, Michele; Evans, Scott R; Knisely, Jane; Kreiswirth, Barry N; Lautenbach, Ebbing; Mickley, Brenda S; Patel, Robin; Pettigrew, Melinda M; Rodvold, Keith A; Spellberg, Brad; Fowler, Vance G

2014-06-01

Funded by the National Institute of Allergy and Infectious Diseases, the Antibacterial Resistance Leadership Group (ARLG) is tasked with developing a clinical research agenda and conducting clinical studies to address the growing public health threat of antibacterial resistance. The ARLG has identified 4 high-priority areas of research: infections caused by gram-negative bacteria, infections caused by gram-positive bacteria, antimicrobial stewardship and infection prevention, and diagnostics. The ARLG will be accepting proposals from the scientific community for clinical research that addresses 1 or more of these high-priority areas. These studies should have the potential to transform medical practice and be unlikely to occur without ARLG support. The purpose of this article is to make interested parties aware of clinical research opportunities made available by ARLG and to encourage submission of clinical research proposals that address the problem of antibacterial resistance.

Bridging the Gap: Supporting Translational Research Careers Through an Integrated Research Track Within Residency Training

PubMed Central

Arbuckle, Melissa R.; Gordon, Joshua A.; Pincus, Harold A.; Oquendo, Maria A.

2013-01-01

In the setting of traditional residency training programs, physician–scientists are often limited in their ability to pursue research training goals while meeting clinical training requirements. This creates a gap in research training at a critical developmental stage. In response, Columbia University Medical Center’s Department of Psychiatry, in partnership with the New York State Psychiatric Institute, has created a formal Research Track Program (RTP) for psychiatry residents so that interested individuals can maintain their attention on research training during formative residency years. Clinical and research training are integrated through core clinical rotations on research units. With protected research time and clear developmental milestones for each year of training, the RTP allows research track residents to meet both clinical and research training goals while maintaining a healthy work–life balance. In coordination with existing postdoctoral research fellowship programs, research track residents can effectively jump-start fellowship training with advanced course work and consistent, continuous mentorship bridging residency and fellowship years. A key element of the program is its provision of core training in research literacy and extensive research opportunities for all residents, stimulating research interest across the whole residency program. Supported by the National Institutes of Health and a private foundation, this RTP capitalizes on a unique academic–private partnership to address many of the challenges facing physician–scientists. By integrating clinical and research exposures and offering protected research time, careful mentoring, and financial resources, the program aims to further the development of those most poised to establish careers in translational research. PMID:23619070

[Assessment of innovations in clinical research: strengths and potentials for improvement of research in Germany].

PubMed

Vollmar, Horst Christian; Georgieff, Peter; Bührlen, Bernhard

2010-01-01

Clinical research is a central link in the development chain of new treatment methods; scientifically, it belongs between basic science and health services research. It spans from the first application of a new substance or device in humans to the main proofs of its efficacy and safety. Economically speaking, it absorbs almost half of the total expenditures for the research and development of a new drug and represents a significant factor in the labour market for researchers and study personnel. Also, through participation in clinical trials, patients gain early access to new treatment methods, while on the other hand they are placed at higher risk for undesired side effects. Politics have taken significant steps to strengthen clinical research, but the pharmaceutical industry continues to complain about competitive disadvantages. Despite internationally recognised and, to a large extent, legally codified guidelines there are still significant national differences in implementation. In addition, traditional practices in clinical research are challenged by novel, mainly biotechnological therapeutic methods for which our current knowledge base is rather limited and which therefore entail a higher risk for patients or trial participants. The following paper summarises a report for the Office of Technology Assessment at the German Federal Parliament (TAB). Based on current regulations, scientific literature and expert interviews, current challenges and solution strategies for clinical research will be analysed in terms of an international comparison.

Publishing descriptions of non-public clinical datasets: proposed guidance for researchers, repositories, editors and funding organisations.

PubMed

Hrynaszkiewicz, Iain; Khodiyar, Varsha; Hufton, Andrew L; Sansone, Susanna-Assunta

2016-01-01

Sharing of experimental clinical research data usually happens between individuals or research groups rather than via public repositories, in part due to the need to protect research participant privacy. This approach to data sharing makes it difficult to connect journal articles with their underlying datasets and is often insufficient for ensuring access to data in the long term. Voluntary data sharing services such as the Yale Open Data Access (YODA) and Clinical Study Data Request (CSDR) projects have increased accessibility to clinical datasets for secondary uses while protecting patient privacy and the legitimacy of secondary analyses but these resources are generally disconnected from journal articles-where researchers typically search for reliable information to inform future research. New scholarly journal and article types dedicated to increasing accessibility of research data have emerged in recent years and, in general, journals are developing stronger links with data repositories. There is a need for increased collaboration between journals, data repositories, researchers, funders, and voluntary data sharing services to increase the visibility and reliability of clinical research. Using the journal Scientific Data as a case study, we propose and show examples of changes to the format and peer-review process for journal articles to more robustly link them to data that are only available on request. We also propose additional features for data repositories to better accommodate non-public clinical datasets, including Data Use Agreements (DUAs).

Clinical genomics, big data, and electronic medical records: reconciling patient rights with research when privacy and science collide.

PubMed

Kulynych, Jennifer; Greely, Henry T

2017-04-01

Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data 'de-identified', removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic 'personalized medicine' now confront the problem of governing the secondary use of clinical genomic data as privacy risks escalate. We argue that regulators should no longer permit HIPAA-covered entities to treat dense genomic data as de-identified health information. Even with this step, the Privacy Rule would still permit disclosure of clinical genomic data for research, without consent, under a data use agreement, so we also urge that providers give patients specific notice before disclosing clinical genomic data for research, permitting (where possible) some degree of choice and control. To aid providers who offer clinical gene sequencing, we suggest both general approaches and specific actions to reconcile patients' rights and interests with genomic research.

Clinical genomics, big data, and electronic medical records: reconciling patient rights with research when privacy and science collide

PubMed Central

Greely, Henry T.

2017-01-01

Abstract Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data ‘de-identified’, removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic ‘personalized medicine’ now confront the problem of governing the secondary use of clinical genomic data as privacy risks escalate. We argue that regulators should no longer permit HIPAA-covered entities to treat dense genomic data as de-identified health information. Even with this step, the Privacy Rule would still permit disclosure of clinical genomic data for research, without consent, under a data use agreement, so we also urge that providers give patients specific notice before disclosing clinical genomic data for research, permitting (where possible) some degree of choice and control. To aid providers who offer clinical gene sequencing, we suggest both general approaches and specific actions to reconcile patients’ rights and interests with genomic research. PMID:28852559

Describing the implementation of an innovative intervention and evaluating its effectiveness in increasing research capacity of advanced clinical nurses: using the consolidated framework for implementation research.

PubMed

McKee, Gabrielle; Codd, Margaret; Dempsey, Orla; Gallagher, Paul; Comiskey, Catherine

2017-01-01

Despite advanced nursing roles having a research competency, participation in research is low. There are many barriers to participation in research and few interventions have been developed to address these. This paper aims to describe the implementation of an intervention to increase research participation in advanced clinical nursing roles and evaluate its effectiveness. The implementation of the intervention was carried out within one hospital site. The evaluation utilised a mixed methods design and a implementation science framework. All staff in advanced nursing roles were invited to take part, all those who were interested and had a project in mind could volunteer to participate in the intervention. The intervention consisted of the development of small research groups working on projects developed by the nurse participant/s and supported by an academic and a research fellow. The main evaluation was through focus groups. Output was analysed using thematic analysis. In addition, a survey questionnaire was circulated to all participants to ascertain their self-reported research skills before and after the intervention. The results of the survey were analysed using descriptive statistics. Finally an inventory of research outputs was collated. In the first year, twelve new clinical nurse-led research projects were conducted and reported in six peer reviewed papers, two non-peer reviewed papers and 20 conference presentations. The main strengths of the intervention were its promptness to complete research, to publish and to showcase clinical innovations. Main barriers identified were time, appropriate support from academics and from peers. The majority of participants had increased experience at scientific writing and data analysis. This study shows that an intervention, with minor financial resources; a top down approach; support of a hands on research fellow; peer collaboration with academics; strong clinical ownership by the clinical nurse researcher; experiential learning opportunities; focused and with needs based educational sessions, is an intervention that can both increase research outputs and capacity of clinically based nurses. Interventions to further enhance nursing research and their evaluation are crucial if we are to address the deficit of nurse-led patient-centred research in the literature.

Using information technology to improve the quality and efficiency of clinical trial research in academic medical centers.

PubMed

Hardison, C D; Schnetzer, T

1999-01-01

In the area of clinical trial research, academic medical centers (AMCs) need to create additional capacity and improve performance on vital indicators to attract more studies, as they are currently losing their share to stand-alone research sites. Through the utilization of information technology, AMCs will be in a better position to fend off the competitive threats to their clinical research dollars. Most AMCs are in an enviable position to leverage the value of information technology because of the existing people, processes, and technologies that probably already exist throughout the AMC. The challenge, then, is to deploy these resources in a different manner to support clinical trial research.