Standard Prep Research Articles

An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BackgroundPre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care.ObjectiveThe goal of this study is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (electronic PrEP, ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up.MethodsThis 2-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged between 18 and 24 years from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of black or Latino men who have sex with men. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate in dried blood spots).ResultsEnrollment will begin in May 2019, with study completion in 2022.ConclusionsThis trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small-town areas of the United States.Trial RegistrationClinicalTrials.gov NCT03729570; https://clinicaltrials.gov/ct2/show/NCT03729570 (Archived by WebCite at http://www.webcitation.org/78RE2Qizf)International Registered Report Identifier (IRRID)PRR1-10.2196/13982

Preventing Surgical Site Infection Related to Abdominal Hysterectomy: We Got This!

BACKGROUND Since the implementation of the Centers for Medicare and Medicaid Service (CMS) Hospital Value Based Purchasing (VBP) Program, much attention has been focused on prevention of total abdominal hysterectomy (TAH) related Surgical Site Infection (SSI). CMS requires that hospitals report all TAH-SSI to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN), shares individual performance measures publicly on the Hospital Compare website, and awards institutions 'bonus' incentive payments based on these performance measures. Incidence of TAH-SSI therefore not only increases patient morbidity, mortality, length of stay, and associated costs, but it is also tied to monetary penalties and reimbursement to the institution from CMS. METHODS Since SSIs are often multifactorial, they usually cannot be traced back to a single event or failure. Infection Prevention and Epidemiology (IPE) took a multidisciplinary approach to evaluate our data collection process and perform case review of each TAH-SSI to identify potential areas for improvement. IPE partnered with Obstetrics and Gynecology Service Chiefs, Surgeons, Nursing, and Antibiotic Stewardship staff to implement the following interventions: standard surgical prep and continuous education/training for staff; optimal prophylactic antibiotic selection, ordering, and timing; use of a standard closure tray; and enhanced data extraction methods. RESULTS The Standard Infection Ratio (SIR) for complex TAH-SSI decreased from 2.99 in 2013 to 0.233 in 2017. CONCLUSIONS Through collaboration with a multidisciplinary group, we were able to implement a number of process improvement measures to successfully decrease incidence of complex TAH-SSI at our institution.

A Low Residue Diet with a Split Dose Bowel Prep Is Effective in Improving Bowel Prep Adequacy in a Veteranʼs Affairs Endoscopy Unit

Introduction: To achieve an effective colon cancer screening program, it has been proposed that GI labs should have an adequate bowel prep for >85% of exams. The aim of this study is to compare the efficacy of standard prep involving 2 days of clear liquid diet (CLD) followed by polyethylene glycol (PEG) prep on the night prior to procedure with a modified prep involving a low residue diet (LRD) for 5 days leading up to the procedure followed by 1 day of CLD and a split prep with PEG. Secondary aim is to assess the impact on adequacy of bowel prep. Methods: This study has pre-post study design evaluating all colonoscopies before and after an institutional policy change in the method of bowel preparation. All patients who received outpatient colonoscopies at the Atlanta VA Medical Center during May, 2016 and May to June, 2017 were included in this study. Patients who received alternative prep instructions were excluded from this study. Procedures aborted for reasons unrelated to prep were excluded. Pre-procedure nurses queried patients about adherence to split prep instructions and adherence to LRD. The data was analyzed by a statistician using frequency tables that were produced to examine the overall distributions of gender, race, type of prep, and prep quality among the study population. Chi square tests of association were applied to cross-tabulated data to detect associations between overall prep quality and a set of relevant variables including type of prep and completion prep and consumption of LRD. Estimated odds ratios with corresponding 95% confidence intervals were considered to indicate strong association. Results: A total 506 patients met inclusion criteria. The bowel prep was adequate significantly more often in modified prep patients compared to standard prep patients (87% vs 79.7%, p=0.017). Among modified prep patients, the LRD produced an adequate prep more often than without the diet (90.1% vs 77%, p=0.005). Adequacy rates were highest in those who followed the LRD, irrespective of completing split prep instructions or not (90.2% vs 88.9%). Conclusion: Our study confirms that adherence to a split prep results in higher rates of adequate bowel prep. However, adding a LRD for 5 days leading up to the colonoscopy improves the adequacy of the bowel prep beyond split prep alone. These novel findings support adding LRD to increase bowel prep adequacy rates.1066_A Figure 1. Bowel Prep Quality based on type of prep1066_B Figure 2. Modified Bowel Prep Quality based low residue diet1066_C Figure 3. Modified Bowel Prep Quality based on type of prep and diet

Sa1711 Colon Irrigation Prep Outcomes, One Year in Review: an Effective, Well Tolerated Low-Risk Alternative to Standard Oral Prep

Sa1711 Colon Irrigation Prep Outcomes, One Year in Review: an Effective, Well Tolerated Low-Risk Alternative to Standard Oral Prep

Cyanoacrylate Microbial Sealant May Reduce the Prevalence of Positive Cultures in Revision Shoulder Arthroplasty

Cyanoacrylate-based, microbial sealant is an adhesive skin barrier designed to prevent bacterial contamination in surgical wounds. This type of adhesive barrier could have use in decreasing the incidence of positive cultures and subsequent infection in shoulder arthroplasty. We therefore evaluated whether cyanoacrylate microbial sealant reduced the positive intraoperative culture rates in revision shoulder arthroplasty. We retrospectively reviewed 55 patients who underwent revision shoulder arthroplasties. Intraoperative aerobic and anaerobic deep tissue culture results taken during the revisions were compared. Cultures were taken of the deep synovial tissue lining the prosthesis. Patients were divided into two groups: those who underwent standard preparations with adhesive, iodine-barrier drapes (Group SP) and those who had placement of cyanoacrylate microbial sealant in addition to the standard prep (Group MS). The prevalence of cases with positive cultures was 18% (seven of 40) in Group SP compared with 7% (one of 15) in Group MS. The prevalence of positive, anaerobic Propionibacterium acnes cultures was 13% in Group SP compared with 7% in Group MS. The prevalence of infections confirmed at revision surgery was 8% in Group SP versus 0% in Group MS. Our observations suggest application of a cyanoacrylate microbial sealant may reduce the prevalence of positive cultures and thereby subsequent infections in revision shoulder arthroplasties. Level III, retrospective cohort study. See Guidelines for Authors for a complete description of levels of evidence.

Effectiveness of a simplified “patient friendly” split dose polyethylene glycol colonoscopy prep in Veterans Health Administration patients

Adequate colon cleansing is an important factor in performing quality colonoscopy. Split dose Polyethylene Glycol (PEG) solutions have been shown to improve colon cleansing, but the effectiveness in a large clinical practice of elderly co-morbid patients has not been demonstrated. The aim of this study was to assess the efficacy of a simplified split PEG bowel prep in Veterans Health Administration (VHA) patients. Prospective pre-post study design of VHA patients undergoing routine colonoscopy. Bowel prep quality was assessed using a standardized semi-quantitative 5-point scale. "Standard" 4L PEG prep was consumed once the evening before the procedure. "Split" prep was consumed half in the early evening and half in the late evening or early morning depending on procedure time. Right colon preps were Excellent/Good in 81.4% of split preps (n=199) vs. 63% of standard preps (n=447, p<0.001). Left colon preps were Excellent/Good in 85.9% of split preps vs. 71.6% of standard preps (p<0.001). Diabetics (n=133) had significantly more right colon preps rated fair or worse compared to non-diabetics irrespective of prep (39.9% vs. 29.0%, p=0.02). Split prep in diabetics resulted in fewer right colon preps rated fair or worse compared to diabetics using standard prep (28.3% vs. 45.9%, p=0.049). Average adenomas detected per colonoscopy were 1.04 for split prep vs. 0.85 for standard prep (p=NS). Patient satisfaction was higher for split preps. System-wide implementation of a split PEG prep resulted in significantly improved bowel cleansing in VHA patients, particularly in the right colon. Improved bowel cleansing with split preps was associated with higher patient satisfaction.

Evaluation of Fibroblast Growth Factor 19 in the Diagnosis of Bile Acid Diarrhea

Introduction The prevalence of bile acid diarrhoea (BAD) is estimated to be 1%, but the condition remains under diagnosed, partly because the selenium homocholic acid taurine (SeHCAT) test is not widely available. Fibroblast Growth Factor 19 (FGF19) produced in the terminal ileum in response to bile acid absorption plays an important role as a negative regulator of bile acid synthesis and low median FGF19 levels were shown in patients with primary BAD. The aim of this study was to evaluate the relationship between fasting FGF19 levels and SeHCAT in a large prospective group of patients defined by SeHCAT results. We also compared FGF19 levels at the time of colonoscopy in order to assess the effect of bowel preparation. Methods Patients recruited with chronic diarrhoea had SeHCAT testing as part of routine workup and provided fasting blood samples. Group 1 (n=74) were diagnosed as having BAD with a SeHCAT value of less than 15% and included patients with any of the possible causes of BAD. Group 2 patients (n=63) had SeHCAT values of greater than 15%. Serum FGF19 was measured in all patients by ELISA. Data were analysed to compare the relationship between FGF19 and SeHCAT in both groups. 17 patients had additional blood samples taken before colonoscopy after a standard bowel prep. Results FGF19 and SeHCAT were positively related (r=-0.49 Spearman rank correlation). The median FGF19 values in Group 1 and Group 2 were 146 pg/ml and 242 pg/ml respectively (p Conclusion The use of SeHCAT to diagnose BAD is currently the gold standard test of choice, but has its limitations. In this large prospective group we have shown a positive correlation between SeHCAT and FGF19. Potentially FGF19, which is a simple blood test, could be utilised as an alternative diagnostic or screening test for this condition. Further development and refinement to account for factors such as obesity, timing of a sample, and the effect of bowel preparation for colonoscopy may improve the sensitivity and specificity of the test.

Abstract 4829: Massively parallel RNA sequencing analysis of micropapillary carcinomas of the breast

Abstract Micropapillary carcinomas of the breast are a special type of breast cancer that account for up to 3% of breast cancers and which have an aggressive clinical behaviour. They are preferentially of intermediate to high histological grade and consistently express oestrogen receptor (ER). Previous genomic studies have demonstrated that micropapillary carcinomas are characterized by a constellation of genetic aberrations that is distinct from that of grade and ER-matched ductal carcinomas of the breast. Akin to sarcomas and leukaemias, it has recently been demonstrated that some special types of breast cancer (e.g. secretory and adenoid cystic carcinomas) are characterised by recurrent specific chromosomal translocations leading to the formation of oncogenic fusion genes. The aim of this study was to investigate whether micropapillary carcinomas of the breast harbour novel recurrent fusion genes. A series of six pure micropapillary carcinomas and two secretory carcinomas (positive controls harbouring the ETV6-NTRK3 translocation) were subjected to paired-end massively parallel RNA sequencing (RNA-seq). cDNA libraries were prepared according to standard mRNA prep Illumina protocols and run on the GAII sequencers (read length of each mate pair = 54bp; 2 lanes per sample). Data were aligned to the genome and transcriptome using Eland and mate-pairs supporting novel chimeras identified using previously validated pipelines. Fusion genes identified were validated using reverse transcription PCR (RT-PCR), Sanger sequencing and investigated in separate cohorts of micropapillary carcinomas (n=25) and other types of breast cancer (n=163) using fluorescence in situ hybridisation and RT-PCR. The sensitivity of the approach was validated by the analysis of the two secretory carcinomas, as the ETV6-NTRK3 reciprocal fusion gene was identified using our pipeline. Analysis of micropapillary carcinomas identified four novel intra-chromosomal fusion genes. Three of the fusions; SLC2A1-FAF1, ELMO2-RAE1, BCAS4-AURKA were present in a single tumour and spanned breakpoints of amplification. A fourth, TSPAN14-DYDC2, was a copy neutral event in a separate tumour sample. We also observed that the three fusions from a single patient were also present in the lymph node metastasis. All fusions were validated with RT-PCR, Sanger sequencing and/or FISH. One of the fusion genes was shown to be recurrent (index case and a mixed micropapillary carcinoma). Our results demonstrate that a proportion of micropapillary carcinomas of the breast harbour fusion transcripts. Further investigations are being undertaken to determine the functionality of these fusion genes. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 4829. doi:10.1158/1538-7445.AM2011-4829

Environmental factors and manual manipulations during preparation influence embryo culture media osmolality

OBJECTIVE: Examine the impact of IVF lab conditions used during microdrop preparation on resulting media osmolality. DESIGN: Experimental Study. MATERIALS AND METHODS: Microdrops of P1 media + 10% SSS (10μl, 20μl, and 40μl) were prepared under a variety of laboratory conditions. Drops were pipetted directly onto a dish and covered by oil (Standard), or placed in the dish, covered with oil, removed, and replaced with fresh media (Wash-Drop). Drops were made at room temp or on a 37°C stage, and were prepared in a hood with or without airflow. This resulted in 24 experimental groups. Media osmolality was assessed at 5min and 24h. Each measurement and experiment was performed 3 times. Osmolalities were standardized by subtracting a baseline mean value of control media, as determined by averaging 3 measurements. Bivariate analysis using student's t-tests and ANOVA, as well as multivariate regression analysis, were used to assess treatment effects. RESULTS: Bivariate analysis suggested that reduced drop volume, increased temp and standard prep method were all associated with a significant increase in media osmolality at both 5mins and 24h. Hood airflow alone had no significant impact compared to no-airflow. Multivariate analysis indicated that 10 and 20μl microdrop, 37°C temperature, and standard prep method were associated with a 7.10 (p<0.0001), 2.72 (p=0.04), 5.99 (p<0.0001), and 5.86 (p<0.0001) mOsm increase in media osmolality, compared to 40μl, room temperature, and Wash-Drop method, respectively. In addition, there was a significant interaction effect between hood airflow, decreased drop volume, increased temp and standard prep method (p<0.0001) that can cause an ∼40 mOsm increase in osmolality compared to controls. There was no significant change in media osmolality over time. CONCLUSION: Method of microdrop preparation and environmental conditions in which IVF case set-up is performed results in media osmolality shifts that can impact subsequent embryo development.

Effect of an educational pamphlet on colon cancer screening: a randomized, prospective trial

Anxious patients can cause unexpected increases in healthcare costs that are often overlooked. There are no studies examining the use of an educational pamphlet and its effects on secondary outcomes at colonoscopy. The goal of this study was to determine if the use of an educational pamphlet lowers the anxiety levels before colonoscopy, and if its use has any effect on the quality of the prep or medication or the amount of medication use during the procedure. We prospectively enrolled 121 patients having a first-time screening colonoscopy. Patients were blinded and randomized into two groups. One group received standard prep instructions only (group P), and the other group received the American Gastroenterological Association colonoscopy educational pamphlet along with their prep instructions (group I). All information was sent by mail 3 weeks before the procedure. The endoscopists were blinded as to which of their patients were in the study and of those, which were in the standard prep group or the intervention group. Anxiety was measured immediately before endoscopy using the State portion of the 'State Trait Anxiety Index'. Procedure-related information was recorded and analyzed at the end of the study using a statistical package looking at primary and secondary endpoints. Fifteen patients did not show their examination or were otherwise lost to follow-up. Of the 106 patients who completed the study, there were 55 patients in the P group and 51 in the I group. The average State Anxiety score of the P group was 45.18, and of the I group was 40.54 (P=0.014). The use of Midazolam was significantly less in the group. The use of Meperidine was lower in the I group but the difference was not statistically significant. Both the groups took the same amount of time to complete the prep, but the I group fasted longer. The I group also completed or drank more of the prep more often than the P group. The prep quality was found to be superior with less frequency of a poor prep in the I group. Most important, the I group was more likely to have a complete colonoscopy. The I group tended to have fewer questions on the day of the procedure, and less fear about what to expect on the basis of their lower anxiety scores. We found that providing the American Gastroenterological Association educational pamphlet to patients before colonoscopy lowers the overall anxiety level, provides a reduction in sedative use during the procedure, and leads to better colon preparation when given in addition to standard instructions.

PTU-013 Do we over estimate the risks of capsule endoscopy in suspected or established small bowel Crohn's disease? A comparison with completion rates and complications observed in the setting of obscure gastrointestinal bleeding

Introduction The advent of capsule endoscopy (CE) has presented new opportunities to assess and manage small bowel (SB) conditions. In obscure GI bleeding (OGIB) CE is the preferred method to examine the SB, with proven safety and efficacy. In Crohn9s disease (CD) its role has been harder to establish in part due to fear of capsule retention. The British Society of Gastroenterology (BSG) guidelines propose radiological studies of the SB in the first instance, reserving CE for those in whom strictures have been excluded and findings are equivocal. However a recent meta-analysis highlighted superior diagnostic yield for CE compared with standard radiological imaging techniques,1 and SB studies are known to lack specificity in terms of excluding strictures.2 Although safety concerns are limiting the use of CE in this field, there is little evidence comparing CE complications in CD with those in established uses of CE such as investigation of OGIB. Methods Individuals with suspected/established CD, or OGIB who had undergone CE following a standard prep regime (1 picolax±10 mg metoclopramide), were identified from a dedicated CE database established in 2006. Suspected CD was defined by the criteria in the BSG guidelines, OGIB by evidence of melaena, haematochezia, or drop in haemoglobin >2 g/dl and positive faecal occult blood test. A retrospective study design was employed. Key demographics were recorded. Studies were considered complete if the capsule was seen to pass into the caecum. Complications were recorded. Rates of completion and complication were compared between the two groups. Results 102 patients were identified. 53 (52%) had suspected/established CD, mean age 39±15 years. 16 (30%) had established CD, and in six of these CE was performed to establish recurrence post resection. 49 (48%) underwent CE for OGIB, mean age 59±13 years. Complete visualisation of the SB was achieved in 94% (50/53) of the CD group and 93% (46/49) of the OGIB group (no statistical difference). Of note completion rates were significantly lower in suspected compared to established CD; 92% (34/37) vs 100% (16/16), (p Conclusion CE is safe in both suspected and established CD with completion rates comparable to that in OGIB. Concerns regarding risk of retention may have been overestimated. Its use in regular clinical practice is likely to increase.

Dose, Efficacy and Acceptability of Oral Sodium Phosphate Solution for Bowel Preparation in Children and Adolescents: A Randomized Single Blinded Study

Dose, Efficacy and Acceptability of Oral Sodium Phosphate Solution for Bowel Preparation in Children and Adolescents: A Randomized Single Blinded Study

P0790 DOSE, EFFICACY AND ACCEPTABILITY OF ORAL SODIUM PHOSPHATE SOLUTION FOR BOWEL PREPARATION: A RANDOMIZED SINGLE BLINDED STUDY

Introduction: Successful strategy for bowel preparation (prep) for colonoscopy aims at administering small–volume oral cathartics coupled with restricted solid food intake. An effective, safe, and standardized bowel preparation in children that is easily administered and acceptable has not yet been determined for children undergoing colonoscopy. Methods: This study compared the efficacy and acceptability of oral sodium phosphate (NaP) regimen 1 day prior to the examination at 1 mL/kg/day with a maximum 90 mL (2/3 dose in the morning, a maximum 45 mL, the remainder in the evening) (regimen A) to our standard prep regimen magnesium citrate 4 mL/kg/day in the morning (maximum 240 mL) for 3 days prior to, and a NaP enema the morning of the colonoscopy (regimen B). Both groups were only allowed clear liquids on prep days and nothing by mouth after midnight. After informed consent, 45 children (22 females) were randomized. Weight, vital signs, electrolytes, calcium, phosphorus and magnesium were taken at screening and on the day of the colonoscopy. Questionnaires were given to the subjects to assess acceptability and 10 possible side effects with intensity rating at none, mild, moderate or severe. An endoscopist blinded to the medication rated the bowel prep on a 4-level scale of excellent, good, fair or poor for overall quality of the colon prep and within each of its 5 segments. Results: Median [range] age (yr) and weight (kg) at screening was 13 [9–17], 53 [27–88], and 15 [8–18], 51 [28–109] in A and B, respectively. Mean weight loss of 0.88 and 1.05, SD ± 1.04 kg for A and B, respectively was not significantly different between groups. The mean increase in serum magnesium (mEq/L) was −0.01 vs 0.14 (p=0.001), and the mean increase in serum phosphorus (mg/dL) was 0.40 vs 0.33 (p=NS) in A vs B, respectively. No statistically significant difference was observed in other electrolytes between both groups. There were no serious adverse events reported from both regimens. The side effects were not statistically significant between both regimens, apart from higher nausea intensity in regimen A (p=0.012). Bowel cleansing was similar between the groups; 71% were rated excellent or good. Willingness to repeat the prep was higher in A vs B (77% vs 32%, p<0.006). Ten subjects in regimen A had prior colonoscopies using regimen B; 9 rated A better, 1 rated A the same. Conclusion: Oral NaP is safe and effective for bowel cleansing prior to colonoscopy in children and adolescents. It has a shorter prep time, comparable side effects and is more acceptable than our standard magnesium citrate regimen.

Patient Acceptance and Effectiveness of a Balanced Lavage Solution (Golytely) Versus the Standard Preparation for Colonoscopy

An oral electrolyte solution containing 125 mM/L sodium, 10 mM/L potassium, 80 mM/L sulfate, 20 mM/L bicarbonate, and 80 mM/L of polyethylene glycol, and associated with little water or electrolyte absorption from the gut was recently described in this journal. To determine the efficacy of this solution (Golytely) for colonoscopy, 20 consecutive patients were randomized to either a standard colonoscopy prep or Golytely. Both preps resulted in a feces-free colon, allowing colonoscopy to the cecum in most cases. Although Golytely produced mild cramps (3 of 12) and transient fullness (6 of 12 vs. 0 of 8 with standard prep, p less than 0.02), 11 of 12 were willing to repeat Golytely vs. 3 of 8 with the standard prep (p less than 0.02). It is concluded that Golytely is an effective prep for colonoscopy and well tolerated by patients. It is especially useful for those requiring repeated examinations because of patient acceptance and efficacy.