The authors thank Dr. Wietske Kievit for her methodological support and comments on the manuscript.

The study is authorized by the ethics review board of the Radboud University Medical Center (#2015-1742). Subsequent approval of the executive boards from each of the participating institutes is obtained (Trial registration: Dutch Trial Registry, NTR 5475).
1. Enrolling patients in the trial/randomization
<ol>
	<li>Approach all referred patients by general practitioners, surgeons or internal medicine specialists for colonoscopy, to achieve a diverse sample.</li>
	<li>Contact all eligible patients for inclusion by the outpatient&#8217;s clinic assistant by telephone call or face-to-face contact with the patient in a protocol led manner (described below).
	<ol>
		<li>Say the following: Good morning/afternoon, you are speaking to the gastroenterology department of the trial center. You have been referred for colonoscopy, correct? We have to inform you prior to the examination. Do you have a computer/tablet/smart phone with internet access? (If not, do you have a peer who does?) We have the possibility to give you the information using an internet-based application. This is subject to our scientific research, comparing the novel method to a traditional visit of the outpatient&#8217;s clinic. If you cooperate in this trial, you will have to answer several questionnaires in the process. We also use information from your patient record. If you agree, we will randomize the method of education; either digital or nurse counseling. If no, reason for declining is noted. Negative answers are categorized in reasons to decline participation. If yes, can I have your e-mail address?</li>
	</ol>
	</li>
	<li>Randomize patients to the intervention or control group per center after obtaining permission. 
	NOTE: This is linked to the invitation that is sent out; patients are asked for their e-mail addresses, linked to their patient identification number. The automated HTML script then randomly decides which invitation is being sent (nurse visit or computer-based education). The outcome is visible to the assistant.</li>
	<li>Make sure that the patient reads the automatically sent email with instructions regarding more information on the trial. Here, digital informed consent for trial participation is obtained.</li>
</ol>
2. Baseline questionnaire
<ol>
	<li>Subject the patient to the intervention or control group after randomization. Make sure that the patient completes the first questionnaire, containing baseline characteristics, several validated tools such as the RAND-36, PAM-13, e-Health Literacy Scale and the STAI.</li>
</ol>
3. Intervention arm: patient is prepared with computer-based education
<ol>
	<li>Make sure that the patient receives the interactive CBE via e-mail. 
	NOTE: Current best practices are implemented in the design, including the use of plain language, good accessibility and obligatory interaction to engage users7. The used CBE is a web-based platform, mimicking the patient journey with specific video guided by voiceover, supported by photos, three-dimensional animation and instructive texts.</li>
	<li>Conduct a dedicated video and photo shoot specific for each separate endoscopy unit in the trial following a uniform script. (Figure 1, the CBE used in one of the trial sites is accessible via https://trials.medify.eu/cbe-colonoscopy). Divide the video in short clips, with a maximum duration of 45 seconds. Implement a mandatory mouse-click after each item to ascertain interaction in the CBE. Ensure that the tool contains all elements that are obligatory for informed consent such as risks, benefits and alternatives for colonoscopy.</li>
	<li>Have the patient complete the CBE. 
	NOTE: The following steps (under tab 3.3) are mandatory for the patient to follow in the CBE.
	<ol>
		<li>Click on the link in the email: https://trials.medify.eu/cbe-colonoscopy.</li>
		<li>Enter the main menu of the CBE. First, read the pop-up with instructions how to use the CBE.</li>
		<li>Click on the tab Explanation of colonoscopy procedure.</li>
		<li>Read the text on slide : Questionnaire &#38; Informed consent. After finishing, click Send. 
		NOTE: This module serves as a pre-sedation risk assessment. It double-checks the informed consent. After final approval by the patient the information is sent via e-mail to the endoscopy unit.</li>
		<li>Click on the tab Preparation for the colonoscopy that is now made available. Follow the steps and read all information on the use of the laxatives in the same stepwise fashion.</li>
		<li>Click on the tab Route to the department for the routing to the endoscopy unit.</li>
	</ol>
	</li>
	<li>For the trained endoscopic nurse: assess the received information sent by the patient. Use the automated protocol whereby actions are related to the answers provided by the patients. 
	NOTE: This system automatically labels responses with &#8220;green&#8221; (no action), &#8220;orange&#8221; (action might be necessary) and &#8220;red&#8221; (action is necessary). When in doubt, risk assessment will be performed by a consultant gastroenterologist.</li>
</ol>
4. Control arm: Patient is visiting the outpatient clinic
<ol>
	<li>Schedule a visit for the patient at the outpatient clinic for instruction by a trained nurse. Follow the standard operating procedure during counseling. 
	NOTE: This provides information on how to use the purgatives, dietary instructions, effects of sedation with benzodiazepines and relevant practical matters. Finally the nurse double-checks signed informed consent and files information on medical history.</li>
</ol>
5. Day of colonoscopy
<ol>
	<li>Schedule the patient approximately 2-8 weeks from baseline for the colonoscopy. Ask the patient to complete the questionnaire, containing the 10-item knowledge test, the STAI and measures for patient satisfaction prior to colonoscopy (T1).</li>
	<li>Score the bowel cleanliness during colonoscopy (T2) online and in the endoscopy report; also fill out the several relevant items regarding colonoscopy here (indication, type of sedation and analgesic, ASA classification).</li>
	<li>Ask the patient to complete the post-colonoscopy questionnaire, containing measures for patient satisfaction (T3), just prior to discharge.</li>
</ol>

<ol>
	<li>Zauber, A. G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Colonoscopic+polypectomy+and+long-term+prevention+of+colorectal-cancer+deaths.">Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths.</a> New England Journal of Medicine. 366 (8), 687-696 (2012).</li><li>Chang, C. W., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Meta-analysis:+The+effect+of+patient+education+on+bowel+preparation+for+colonoscopy.">Meta-analysis: The effect of patient education on bowel preparation for colonoscopy.</a> Endoscopy Internation Open. 3 (6), E646-E652 (2015).</li><li>Yee, R., Manoharan, S., Hall, C., Hayashi, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Optimizing+bowel+preparation+for+colonoscopy:+what+are+the+predictors+of+an+inadequate+preparation.">Optimizing bowel preparation for colonoscopy: what are the predictors of an inadequate preparation.</a> American Journal of Surgery. 209 (5), 787-792 (2015).</li><li>Abuksis, G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+patient+education+program+is+cost-effective+for+preventing+failure+of+endoscopic+procedures+in+a+gastroenterology+department.">A patient education program is cost-effective for preventing failure of endoscopic procedures in a gastroenterology department.</a> American Journal of Gastroenterology. 96 (6), 1786-1790 (2001).</li><li>Denberg, T. D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Effect+of+a+mailed+brochure+on+appointment-keeping+for+screening+colonoscopy:+a+randomized+trial.">Effect of a mailed brochure on appointment-keeping for screening colonoscopy: a randomized trial.</a> Annals of Internal Medicine. 145 (12), 895-900 (2006).</li><li>Morcom, J., Dunn, S. V., Luxford, Y. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Establishing+an+Australian+nurse+practitioner-led+colorectal+cancer+screening+clinic.">Establishing an Australian nurse practitioner-led colorectal cancer screening clinic.</a> Gastroenterology Nursing. 28 (1), 33-42 (2005).</li><li>Fox, M. P. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+systematic+review+of+the+literature+reporting+on+studies+that+examined+the+impact+of+interactive,+computer-based+patient+education+programs.">A systematic review of the literature reporting on studies that examined the impact of interactive, computer-based patient education programs.</a> Patient Education and Counseling. 77 (1), 6-13 (2009).</li><li>Veldhuijzen, G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Computer-assisted+instruction+before+colonoscopy+is+as+effective+as+nurse+counseling,+a+clinical+pilot+trial.">Computer-assisted instruction before colonoscopy is as effective as nurse counseling, a clinical pilot trial.</a> Endoscopy International Open. 5 (8), E792-E797 (2017).</li><li>Mittal, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Boston+bowel+preparation+scale:+reliable+not+only+for+colonoscopy-oriented+research+but+clinical+practice+also.">The Boston bowel preparation scale: reliable not only for colonoscopy-oriented research but clinical practice also.</a> Gastrointestinal Endoscopy. 71 (1), 221 (2010).</li><li>Lai, E. J., Calderwood, A. H., Doros, G., Fix, O. K., Jacobson, B. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Boston+bowel+preparation+scale:+a+valid+and+reliable+instrument+for+colonoscopy-oriented+research.">The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research.</a> Gastrointestinal Endoscopy. 69, 620-625 (2009).</li><li>Bouwmans, C., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+iMTA+Productivity+Cost+Questionnaire:+A+Standardized+Instrument+for+Measuring+and+Valuing+Health-Related+Productivity+Losses.">The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses.</a> Value in Health. 18 (6), 753-758 (2015).</li><li>Spielberger, C. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Manual for the State&#8208;Trait anxiety inventory (form Y). , (1987).</li><li>Krol, M. W., de Boer, D., Delnoij, D. M., Rademakers, J. J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Net+Promoter+Score+-+an+asset+to+patient+experience+surveys?.">The Net Promoter Score - an asset to patient experience surveys?.</a> Health Expectactions. 18 (6), 3099-3109 (2015).</li><li>van der Vaart, R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Validation+of+the+Dutch+functional,+communicative+and+critical+health+literacy+scales.">Validation of the Dutch functional, communicative and critical health literacy scales.</a> Patient Education and Counseling. 89 (1), 82-88 (2012).</li><li>van der Vaart, R., Drossaert, C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+of+the+Digital+Health+Literacy+Instrument:+Measuring+a+Broad+Spectrum+of+Health+1.0+and+Health+2.0+Skills.">Development of the Digital Health Literacy Instrument: Measuring a Broad Spectrum of Health 1.0 and Health 2.0 Skills.</a> Journal of Medical Internet Research. 19 (1), e27 (2017).</li><li>Rademakers, J., Nijman, J., van der Hoek, L., Heijmans, M., Rijken, M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Measuring+patient+activation+in+The+Netherlands:+translation+and+validation+of+the+American+short+form+Patient+Activation+Measure+(PAM13).">Measuring patient activation in The Netherlands: translation and validation of the American short form Patient Activation Measure (PAM13).</a> Biomed Central Public Health. 12, 577 (2012).</li><li>Ware, J. E. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=SF-36+health+survey+update.">SF-36 health survey update.</a> Spine (Phila Pa 1976). 25 (24), 3130-3139 (2000).</li><li>Rex, D. K., Imperiale, T. F., Latinovich, D. R., Bratcher, L. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Impact+of+bowel+preparation+on+efficiency+and+cost+of+colonoscopy.">Impact of bowel preparation on efficiency and cost of colonoscopy.</a> American Journal of Gastroenterology. 97 (7), 1696-1700 (2002).</li><li>Rosenfeld, G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+impact+of+patient+education+on+the+quality+of+inpatient+bowel+preparation+for+colonoscopy.">The impact of patient education on the quality of inpatient bowel preparation for colonoscopy.</a> Canadian Journal of Gastroenterology. 24 (9), 543-546 (2010).</li><li>Clark, B. T., Rustagi, T., Laine, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=What+level+of+bowel+prep+quality+requires+early+repeat+colonoscopy:+systematic+review+and+meta-analysis+of+the+impact+of+preparation+quality+on+adenoma+detection+rate.">What level of bowel prep quality requires early repeat colonoscopy: systematic review and meta-analysis of the impact of preparation quality on adenoma detection rate.</a> American Journal of Gastroenterology. 109 (11), 1714-1723 (2014).</li><li>Liu, X., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Telephone-based+re-education+on+the+day+before+colonoscopy+improves+the+quality+of+bowel+preparation+and+the+polyp+detection+rate:+a+prospective,+colonoscopist-blinded,+randomised,+controlled+study.">Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study.</a> Gut. 63 (1), 125-130 (2014).</li><li>Tae, J. W., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Impact+of+patient+education+with+cartoon+visual+aids+on+the+quality+of+bowel+preparation+for+colonoscopy.">Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy.</a> Gastrointestinal Endoscopy. 76 (4), 804-811 (2012).</li><li>Prakash, S. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Improving+the+quality+of+colonoscopy+bowel+preparation+using+an+educational+video.">Improving the quality of colonoscopy bowel preparation using an educational video.</a> Canadian Journal of Gastroenteroly. 27 (12), 696-700 (2013).</li></ol>

The E-PACO trial is an investigator-initiated trial. The authors declare that they have no competing interests.
Funding is supported by ZonMW (The Netherlands Organisation for Health Research and Development) through a grant in the programme &#8220;Actieplan eHealth&#8221;, project number 430000016. Medify (producer of the software) had no role in the funding of this trial, nor in design and conduct of the study or in the writing and submission of the manuscript.

The E-Patient Counseling (E-PACO) trial aims to study the utility, practicality, and patient-perceived usefulness of computer-based education (CBE), in comparison to conventional nurse counseling. In this manuscript the CBE is demonstrated together with the methodology used to evaluate the hypotheses.
It is established that high quality colonoscopy is the golden standard for prevention of colorectal cancer. Inadequate bowel preparation is related to the missing of neoplasm&#8217;s and increase...

A complete colonoscopy is the procedure for detection of precancerous lesions in the colon1. For adequate examination of the colon mucosa, optimal bowel cleanliness is crucial. A poorly prepared colon leads to insufficient adenoma detection rate and therefore the need for repeated procedures. In previous studies, better patient understanding of how to prepare clearly results in a higher quality of bowel preparation2. To achieve a clean colon, patients have a restricted diet for 1-2 days and use purgatives to induce diarrhea. This elicits abdominal discomfort and interrupts daily routine. In view of these barriers, inadequate bowel preparation is not infrequent3. Optimal patient compliance to the protocol enhances effective bowel preparation and subsequent efficacy of colonoscopy.
There is appreciable variation in the way information for a colonoscopy is administered to patients4. Some patients receive information directly from their health care professional during consultation, or are informed by auxiliary personnel (nurses, technicians, or administrators), while other units provide information through printed leaflets5. The effect of any information transfer is compounded by patient dependent factors such as educational level, comprehensive capacities, and cultural aspects. This results in a mixed understanding of the information that can negatively affect compliance to instructions.
A pivotal element in patient preparation is that every patient is thoroughly informed about risks and benefits of the procedure including the bowel preparation steps for colonoscopy. In addition, the routine use of sedative and analgesics requires a risk assessment of the individual patient. Many centers rely on nurse counseling to obtain informed consent before the procedure. This results in patient improved adherence to the instructions for bowel preparation. However, while effective, it is time-consuming for the nurse, repetitive, and results in patient-to-patient variability of information. More importantly, it demands an extra hospital visit for the patient, implicating absence of the patient at work6. In summary, it is an economically challenging practice in cost-conscious healthcare environments. Previous studies show that focused e-learning paths enable good comprehension and learning and enhance patients satisfaction7. Web-based education is used successfully for increasing knowledge of patients and it has become an accepted mechanism for obtaining informed consent. This has led to the development of tailored instruction programs for bowel preparation that combines the advantages of flexibility in time and environment, yet maintains consistency in delivery of information. Previously, the authors developed a tool that allows computer assisted instruction (CAI) for colonoscopy8. This tool employs a computer animation that captures the viewers&#8217; attention while adequately informing him/her of objectives for colonoscopy. Written in comprehensible language in logical order, the module educates patients on different aspects of colonoscopy. It provides basic anatomical teaching points and step-by-step instructs the patient how to perform bowel preparation. In our pilot study we showed that CAI for colonoscopy enhanced bowel preparation to the level that is comparable to nurse counseling.
The research group sought to enhance the efficacy of the developed CAI. Its limitation was that it was a unidirectional tool that delivered information but did not allow acquiring patient specific information concerning medical history and medication use. This is an important part of the nurse counseling visit, as it allows a pre-sedation risk assessment when judged by the nurse. Therefore, a dedicated questionnaire was developed, designed to collect data points for structured risk assessment. This questionnaire is completed by the patient at the end of the CAI. This eliminates the need for a face-to-face meeting with a nurse or physician at this point in time. The use of two-way communication (combining CAI with a questionnaire) is practical and provides high quality information to the patient whilst at the same time attending to the need of the endoscopist for information on sedation risks. This combined instruction and acquiring of information is known as computer based education (CBE)7.
The goal of this trial is to test the utility, practicality, and patient-perceived usefulness of CBE off-center, in comparison to conventional nurse counseling. The hypothesis is that CBE is non-inferior to nurse counseling in achieving high quality of bowel preparation during colonoscopy. This process is independent of time and space and therefore can be viewed in the comfort of the patients&#8217; home. Accordingly, the chosen secondary outcomes are patient related outcome measures such as a short leave absence, anxiety, satisfaction and comprehension of information, as these might benefit from delivery through this digital channel. Included process measures are patient activation, health and e-health literacy to determine which patients benefit most from this tool.
Study design 
The trial is set up as an endoscopist blinded multicenter randomized controlled trial design. Inclusion criteria are adult age and a referral for elective complete colonoscopy. Exclusion criteria are illiteracy in Dutch and significant audiovisual handicaps and mental disabilities that preclude delivery of CBE. Also, patients were excluded if there is no internet access or a relative with internet access (see Table 1). Patients will be recruited by back office staff at the outpatient&#8217;s clinic in 4 large volume endoscopy centers in the Netherlands. All patients receive a split dose laxative regime based on either polyethylene glycol or sodium picosulfate. After evaluation of in- and exclusion criteria by trained staff, patients are randomized in 1:1 distribution per trial site using a randomization tool (described in the protocol below). Reasons for declining to participate are recorded. The trial flowchart is presented in Figure 2.
Outcome measures 
The primary outcome measure is the quality of bowel preparation during endoscopy. Endoscopists are trained to score the bowel preparation with the Boston Bowel Preparation Scale (BBPS). The BBPS is a cumulative score of three bowel segments, ranging from 0-1 &#8220;unsatisfactory&#8221;, 2-3 &#8220;poor&#8221;, 4-5 &#8220;fair&#8221;, 6-7 &#8220;good&#8221;, and 8-9 &#8220;excellent&#8221;. Scores of &#8805;6 are considered adequate9,10. As secondary outcomes, the focus is on sickness absence, anxiety, satisfaction and information re-call. Information is also collected on patient activation and health literacy.
The cost minimization effect of the intervention is calculated in two ways. The comparison between groups with regard to endoscopy unit costs will be done using a cost-per-visit analysis. The macroeconomic effect of sickness absence is also evaluated, as patients in the intervention group will need less hospital visits. To do so, several items are assessed: socio-economic status, work status and duration of sickness absence, using an adapted iProductivity Cost Questionnaire11.
Patients anticipating invasive medical procedures often experience anxiety that may exceed their coping mechanisms. Anxiety is assessed at T0 and T1 with the State-Trait Anxiety Inventory (STAI)12. The STAI is a widely used 20-item self-report instrument with scores ranging from 20 (absence of anxiety) to 80 (high anxiety). Patient satisfaction is scored using two different measures. Patient experience impacts future behavior and therefore &#8220;willingness to return&#8221; is assessed at T3, ranging from 1 (extremely unwilling to return) to 10 (extremely willing to return). Furthermore, the Net Promoter Score (NPS) is utilized on the question &#8220;Would you recommend this endoscopy unit to your peers?&#8221;. Patient&#8217;s scores range from 1 (Not at all likely) to 10 (Extremely likely). The NPS will be assessed at T0 and T3 and is calculated as % Promoters (scores 9-10) - % Detractors (scores 1-6)13. To evaluate patient comprehension of the information in the CBE patients are asked to reproduce elements of the instruction. The patient information re-call is assessed at T1 (before colonoscopy) using a 10-item test, with questions to be answered with &#8220;yes&#8221; or &#8220;no&#8221;. The effect of patient education in colonoscopy is influenced by the patient ability to understand medical information. The 14-item Dutch validated Health Literacy Scale is used to assess this item, divided in 3 subscales, at T014. A new 21-item questionnaire is added as a measure for e-Health Literacy15. This contains questions regarding the skill and experience of patients in handling medical information online. Patients are confronted with options every day that may have major implications for their health. Effectively managing their choices requires knowledge, skill, and confidence. To this end these elements were mapped at T0 13-item Patient Activation Measure Scale (PAM-13)16. The current health status of patients is evaluated with the Medical Outcomes Study 36-item health survey (RAND-36) at T017.
Statistical analysis 
To statistically compare both groups on the primary outcome, the relative risk for an inadequately prepared colon, defined as a BBPS &#60;6, is used. In literature, a 90% success rate (for an adequately prepared colon) is common, with a 10% non-inferiority margin as the maximum clinically acceptable difference. The non-inferiority power calculation resulted in 180 patients per group, 360 patients in total. This is required to exclude a difference in favor of the standard group of more than 10%. With a margin of &#177; 60% loss of patients before completing the protocol, based on earlier research, the target number of patients to approach is set at 1,000. In addition to the non-inferiority analyses, superiority analyses will be conducted to investigate effects on secondary outcome measures.

<table><tbody><tr><td>Computer Based Education</td><td>Medify BV</td><td>n/a</td><td>Computer Based Education tool for patient instruction prior to colonoscopy</td></tr><tr><td>Computer / tablet</td><td>Any</td><td></td><td>A computer or tablet should be used to complete the e-learning and fill out the questionnaires</td></tr><tr><td>Medify Content Management System</td><td>Medify BV</td><td>n/a</td><td>A content management system to process the e-learning content</td></tr></tbody></table>

e-patient counseling trial (e-paco): computer based education versus nurse counseling for patients to prepare for colonoscopy

Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and perform a risk assessment for sedative use prior to a colonoscopy. The current practice in the Netherlands to achieve these goals is nurse counseling in an outpatient setting. This is costly and has disadvantages in terms of uniformity and time consumption for both the patient and the hospital. The hypothesis is that computer-based education with use of video and 3D animations may replace nurse counseling in most cases, without losing quality of bowel cleanliness during colonoscopy.
This multicenter, randomized, endoscopist blinded clinical trial evaluates a primary outcome measure (bowel preparation) during colonoscopy. Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call. The study will be performed in four endoscopy units of different levels (rural, urban, and tertiary). Inclusion criteria are adult age and referral for complete colonoscopy. Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access.
This trial aims to establish online computer-based education as tool for patient education prior to a colonoscopy. By choosing a direct comparison with the standard of care (nurse counseling), both endoscopic quality measures and patient related outcome measures can be evaluated.

The earlier mentioned pilot study compared nurse instruction to CAI using the same interactive tool as used in this protocol8. As the goals of this study were comparable to the outcomes used in this protocol, a short explanation of the results of the pilot are provided here in more detail. See also Table 28.
In this pilot study 385 patients were enrolled. The CAI g...

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E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

The aim of this trial is to establish the position of online computer-based education as a tool for patient preparation prior to a colonoscopy. Computer based education is compared with the standard of care, nurse counseling, evaluating endoscopic quality measures and patient related outcome measures.

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and ...

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8.2K Views.  Radboud University Medical Center. The aim of this trial is to establish the position of online computer-based education as a tool for patient preparation prior to a colonoscopy. Computer based education is compared with the standard of care, nurse counseling, evaluating endoscopic quality measures and patient related outcome measures.

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Simulation-Based Training of EBUS-TBNA

Systematic Endobronchial Ultrasound - The Six Landmarks Approach

Lung cancer is the leading cause of cancer mortality globally. To ensure the correct diagnosis and staging in relation to treatment options, it is crucial to obtain valid biopsies from suspected tumors and mediastinal lymph nodes and accurate identification of the mediastinal lymph nodes regarding the Tumor-Node-Metastasis (TNM)-classification. Flexible bronchoscopy combined with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is essential in the workup and diagnosis of patients suspected of lung cancer. EBUS-TBNA from mediastinal lymph nodes is a technically difficult procedure and has been identified as one of the most important procedures that should be integrated into a simulation-based training program for invasive pulmonologists. More specific guidelines that govern training in EBUS-TBNA are needed to meet this demand. We hereby propose a systematic, stepwise approach with specific attention to six landmarks that support the endoscopist when navigating through the bronchial maze. The stepwise approach relying on the six landmarks is used in the EBUS-certified training program offered by the European Respiratory Society (ERS).

Author Spotlight: Demonstrating Systematic Endobronchial Ultrasound to New Endoscopists 

Endobronchial ultrasound-guided sampling using transbronchial needle aspiration plays a key role in staging and diagnosing lung cancer. We propose a systematic stepwise approach dividing the procedure into six landmarks that should be taught to new operators.

Lung cancer is the leading cause of cancer mortality globally. To ensure the correct diagnosis and staging in relation to treatment options, it is crucial ...

A Computer-Based Platform for Aiding Clinicians in Eating Disorder Analysis and Diagnosis

Eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder, and other specified eating or feeding disorders) have a combined prevalence of 13% and are associated with severe physical and psychosocial problems. Early diagnosis, which is important for effective treatment and prevention of undesirable long-term health consequences, imposes problems among non-specialist clinicians unfamiliar with these patients, such as those working in primary care. Early, accurate diagnosis, particularly in primary care, allows expert interventions early enough in the disorder to facilitate positive treatment outcomes. Computer-assisted diagnostic procedures offer a possible solution to this problem by providing expertise via an algorithm that has been developed from a large number of cases that have been diagnosed in person by expert diagnosticians and expert caregivers. A web-based system for determining an accurate diagnosis for patients suspected to suffer from an eating disorder was developed based on these data. The process is automated using an algorithm that estimates the respondent's probability of having an eating disorder and the type of eating disorder the individual has. The system provides a report that works as an aid for clinicians during the diagnostic process and serves as an educational tool for new clinicians.

Diagnosing eating disorders in healthcare is challenging. Therefore, the present protocol develops an algorithm based on 949 patient responses to a questionnaire, with the diagnosis displayed on an easy-to-use web-based interface. This system facilitates the accurate diagnosis of eating disorders while excluding those believed to have an eating disorder.

Eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder, and other specified eating or feeding disorders) have a combined prevalence of ...

Behavior

Nomogram Development for Survival Prediction in MPCC Patients

Competing-Risk Nomogram for Predicting Cancer-Specific Survival in Multiple Primary Colorectal Cancer Patients after Surgery

Cancer-specific survival (CSS) in multiple primary colorectal cancer (MPCC) patients is competitively affected by death from other causes. This study aimed to investigate CSS and associated risk factors by competing risk analysis in MPCC patients. The data of this study is from the SEER database. Using univariable and multivariable analysis of the competitive risk model to weaken the impact of competitive events, it explores the risk factors of CSS and develops a nomogram model. Then, the performance of the model is verified by the ROC curve, calibration curve, and DCA. The study encompasses a total of 8931 patients, with 6255 in the training cohort and 2676 in the validation cohort. Univariable and multivariable analyses showed that sex, Tumor Node Metastasis (TNM) stage, and tumor grade are independent risk factors for cancer-specific survival in MPCC patients. Based on the risk factors, we developed a diagram model to predict CSS. ROC curve, calibration curve, and DCA also show good results. In conclusion, a nomogram is developed that serves as a valuable tool for predicting CSS in MPCC patients, providing clinicians with crucial insights for personalized treatment planning.

The study found that male gender, poor tumor grade, and advanced Tumor Node Metastasis stage were associated with poorer cancer-specific survival (CSS) in multiple primary colorectal cancer (MPCC) patients after surgery. We developed a nomogram to predict the CSS of MPCC patients and contribute to clinical treatment decision-making.

Cancer-specific survival (CSS) in multiple primary colorectal cancer (MPCC) patients is competitively affected by death from other causes. This study ...

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Limited evidence exists to precisely estimate efficacy and safety differences between parenteral nutrition (PN) prepared using olive-oil-based three-chamber bags (3CBs) and soybean-oil-based compounded bags (CoBs) in hospitalized adult patients. We designed a multicenter, randomized, prospective, open-label, noninferiority protocol to compare the efficacy, safety, and distribution of olive-oil-based 3CBs and soybean-oil-based CoB formulations in adult Chinese patients requiring PN during surgical intervention. Subjects were randomized to receive either one of the study treatments using an interactive voice or web-based recognition system in accordance with the randomization code. Randomization was further stratified based on the study site and surgical category. Both treatment groups received similar amounts of calories and protein. In addition, the two study treatments contained a similar composition of the amino-acid component. The only difference between the two PN formulations was the lipid constitution. The duration of administration of study treatments was a minimum of 5 days up to a maximum of 14 days after the surgical procedure. The primary efficacy endpoint was serum prealbumin levels on day 5 of the study. Noninferiority was proved if the anti-log of the lower bound of the 95% confidence interval (CI) of the treatment difference was at least 0.80. Other efficacy measures included treatment preparation time; duration to achieve tolerability of oral nutrition; associated infectious complications; length of hospitalization; and laboratory assessment of markers of nutrition, inflammation, metabolism, and oxidative stress. A total of 458 patients were enrolled in the study. The results showed that olive-oil-based 3CBs were non-inferior to soybean-based CoBs, besides being well tolerated. The infection rate was found to be significantly lower in the olive-oil-based 3CB group. Thus, this study may be used as a reference for future research on lipid emulsion and 3CBs.

Here, we present a protocol for a study comparing the efficacy, safety, and delivery of olive-oil-based 3CB and soybean-oil-based CoB formulations in adults requiring parenteral nutrition. The results revealed that olive-oil-based 3CBs is non-inferior and well tolerated compared to soybean formulations.

Limited evidence exists to precisely estimate efficacy and safety differences between parenteral nutrition (PN) prepared using olive-oil-based ...

Medicine

The Dyspepsia Educational Tool As a Novel Aid in Dyspepsia Management

Digital educational tools have a well-established role in current healthcare. In particular, disorders that are managed non-pharmacologically benefit from this development, as it enables patient engagement in self-management. Dyspepsia is a condition thought to arise from gastric and duodenal perturbations, brain-gut axis disturbances, and dietary factors. Behavioral interventions are a major part of dyspepsia treatment, hence patient engagement and motivation through education is essential. Protocols that describe the development process of such educational tools are scarce. We provide a methodology describing development of a dyspepsia educational tool. Assessment of users' needs is the first step, followed by a literature search. The content is developed based on the main themes and entered into a content management system, to build the program. Final adjustments are made after a pilot test of the tool. The presented protocol can be used as a guide for development of a digital dyspepsia educational tool or as a tool for similar situations.

This protocol describes the development process of a digital dyspepsia educational tool. Assessment of unmet needs and literature, content development, and building of the tool are presented. The methodology can be used as a guide for future development of digital educational tools.

Digital educational tools have a well-established role in current healthcare. In particular, disorders that are managed non-pharmacologically benefit from ...

A Computerized Functional Skills Assessment and Training Program Targeting Technology Based Everyday Functional Skills

Today, many functional skills are technology-based, so development of a technology-based training program has broad importance. Here we present a computerized functional skills training program that was paired in half of the participants with a commercially available cognitive training (CCT) program.
Non-impaired older individuals (NC) aged 60+ (n=45) and similarly aged individuals with mild cognitive impairment (MCI; n=50) were randomized to receive 12 weeks of twice-weekly computerized functional skills training (CFST) or 12 weeks of twice-weekly sessions split between CCT and CFST. Skills trained were use of an ATM; internet banking; ticket kiosk; telephone and internet prescription refill; medication management; and internet shopping. As with previous functional capacity assessments, we focus on completion time for each simulation.
51 participants completed the training program, either by mastering all 6 tasks (34) or completing 12 weeks of training. 44 more participants completed 4 or more training sessions so they were also analyzed for improvement up to their last training session. Completion time for all 6 tests significantly improved from the baseline assessment to the final training session in both groups of participants (all p&#60;0.001 with an average improvement in task completion time of 45%). Further, there was no differential improvement in MCI and NC in the 6 tests from baseline to end of training (all t&#60;1.66, all p&#62;0.12). Finally, combined CCT plus CFST did not differ from CSFT alone on any of the percent-change score measures (all t&#60;1.64, all p&#62;0.11).
Both NC and MCI groups evidenced substantial improvements in performance. CCT supplementation led to similar functional gains with half as many training sessions. The NC participants proceeded through the training fairly rapidly even without CCT supplementation; MCI participants required more training but learned equivalently. These findings suggest that even in cases with memory impairments, functional skills can be efficiently learned with training.

This training protocol uses computerized training to teach technology-related everyday functional skills. These skills include financial skills, travel and transit, as well as medication management.

Today, many functional skills are technology-based, so development of a technology-based training program has broad importance. Here we present a ...

Improving Constipation 

Electroacupuncture Combined with Chinese Medicine Ironing Therapy for Functional Constipation

Functional constipation (FC) is a dysfunctional gastrointestinal disease with the main clinical manifestations of complex bowel movements, incomplete bowel movements, reduced frequency of bowel movements, and dry and hard stools, which seriously affect patients' quality of life and psychology. Electroacupuncture improves constipation by performing acupuncture on specific points in the body to accelerate intestinal peristalsis. Chinese medicine ironing therapy (CMIT) can warm up the meridians, accelerate local blood circulation, promote gastrointestinal dynamics, and accelerate gastric emptying. This study elaborated on the method and steps of electroacupuncture combined with CMIT for functional constipation, including patient selection, material preparation, operation procedure, postoperative care, and precautions. The therapeutic effect of the method was also evaluated. The results of the study showed that after 4 weeks of treatment, compared with Western medicine alone, electroacupuncture combined with CMIT can improve the frequency of FC patients' voluntary bowel movements, constipation, and quality of life. There were no obvious adverse reactions.

Electroacupuncture combined with Chinese medicine ironing therapy can effectively improve patients' constipation symptoms and their quality of life. Here, we present a protocol to describe the treatment process of electroacupuncture combined with Chinese medicine ironing therapy for functional constipation.

Functional constipation (FC) is a dysfunctional gastrointestinal disease with the main clinical manifestations of complex bowel movements, incomplete ...

Training Novices in POCUS for Vascular Cannulation Using Simulation Models

Using Simulation Models to Train Clinicians in the Use of Point-of-Care Ultrasound

The use of point-of-care ultrasound (POCUS) has shown to be a beneficial non-invasive vascular access assessment method by clinicians, which can provide critical elements of visual and measurable information that proves to be useful in the context of vascular access cannulation, in combination with the practical skill of the clinician performing the cannulation. However, the use of POCUS in this context is to practically train and enable individuals who are novices in using this technique to become proficient in performing this task subsequently on patients in a careful and successful way. The simulation of these vascular conditions may be useful to help healthcare professionals learn, understand, apply, and establish such practical skills for vascular cannulation safely to achieve the desired outcomes. This project intended, through the attendance of a half-day workshop, to establish skills to use POCUS in connection with simulation models and perform specific tasks to enable clinicians to use this method in their clinical practice for vascular access cannulation in patients. A mixed-methods longitudinal study design was used to evaluate the effect of a point-of-care ultrasound workshop for peripheral intravenous cannula insertion, including specific tasks for the participants to be performed on simulation models. A total of 81 individuals participated in 11 half-day workshops through 2021 and 2022. Offering a workshop that uses simulation models in combination with various POCUS devices is useful in establishing this newly learned skill in clinicians, such as measurements of depth, caliper, and direction of a vein with POCUS prior to cannulation providing essential anatomical facts to the operator, which increases the likelihood of first-time success in cannulation.

Author Spotlight: Evaluating Clinicians' Adoption of Ultrasound-Guided Vascular Cannulation Through Simulation Training

The present protocol describes an ideal solution to train novices in the use of point-of-care ultrasound devices for the practical clinical skill of visually assessing distinct individual anatomical vascular conditions prior to and during an intended venous vascular cannulation using point-of-care ultrasound in a patient.

The use of point-of-care ultrasound (POCUS) has shown to be a beneficial non-invasive vascular access assessment method by clinicians, which can provide ...

Chinese Herbal Retention Enema for the Treatment of Ulcerative Colitis

Ulcerative colitis (UC) is a globally prevalent and refractory disease that imposes a substantial socioeconomic burden, with no universally effective treatment currently available. Traditional Chinese medicine (TCM) demonstrated promising therapeutic potential in UC management, particularly through the application of Chinese herbal retention enema, which is gaining increasing international recognition. This method involves the rectal administration of an herbal decoction, which is retained for a designated period to ensure optimal contact with and absorption by the colonic mucosa. Compared to oral administration, this method offers distinct pharmacological advantages by bypassing hepatic first-pass metabolism, enhancing therapeutic effects, and minimizing systemic side effects. This study presents a comprehensive protocol for Chinese herbal retention enema in UC treatment, including patient assessment, material preparation, position selection, enema administration, postoperative care, and emergency management. A clinical trial was conducted with 22 UC patients divided into control and enema groups. Therapeutic outcomes were evaluated using individual symptom scores and the Inflammatory Bowel Disease Questionnaire (IBD-Q). The results indicated that Chinese herbal retention enema had a more significant advantage in improving clinical symptoms (mucopurulent bloody stools and abdominal pain) and quality of life (intestinal symptoms, systemic symptoms, and social functioning) compared to the control group (p &#60; 0.05). These findings suggest that Chinese herbal retention enema represents an effective, well-tolerated, and patient-adaptable therapeutic approach, offering a promising complementary treatment option for UC management.

This article demonstrates a Chinese herbal retention enema method for treating ulcerative colitis, which can effectively improve patients' clinical symptoms and quality of life.

Ulcerative colitis (UC) is a globally prevalent and refractory disease that imposes a substantial socioeconomic burden, with no universally effective ...

Comprehensive Breast Exam

Source: 
Alexandra Duncan, GTA, Praxis Clinical, New Haven, CT 
Tiffany Cook, GTA, Praxis Clinical, New Haven, CT 
Jaideep S. Talwalkar, MD, Internal Medicine and Pediatrics, Yale School of Medicine, New Haven, CT
Breast exams are a key part of an annual gynecological exam and are important for all patients, no matter their sex or gender expression. One out of every 8 women will be diagnosed with breast cancer; male breast cancer, though less common, has a lifetime incidence of 1 in 1000.
Breast exams can feel invasive to patients, so it is important to do everything possible to make the patients feel comfortable and empowered, rather than vulnerable. Examiners should be aware of what they are communicating, both verbally and non-verbally, and give their patients control wherever possible (for instance, always allowing them to remove their own gowns). Examiners may choose to utilize chaperones for the patients&#39; (as well as their own) comfort. Some institutions require the use of chaperones.
While it is always important to avoid overly clinical language, certain colloquial words can cross the line from caring to overly intimate in this exam. It is helpful to avoid the words &#34;touch&#34; and &#34;feel&#34; in this exam, as this language can feel sexualized. Instead, use words like &#34;assess,&#34; &#34;check,&#34; or &#34;examine.&#34;
Additionally, the best practice dictates avoiding assumptions about patients&#39; gender, as patients with female anatomy may identify as another gender (e.g., transgender, genderqueer, etc.). This video depicts the approach to patients whose history has revealed no specific complaints or risk factors related to breast health.
In order to avoid missing potential findings, the breast exam should be performed in a systematic approach and consist of three main components: visual inspection of the breast tissue, palpation of the lymph nodes, and palpation of breast tissue.
The breast tissue extends from directly under the clavicle to around the fifth rib (or bra line). Laterally, it extends from the midaxillary line to the sternal border. The breast is viewed in four quadrants; the upper outer quadrant has the most tissue and is the location of many lymph nodes, and the tail of Spence (or axillary tail) extends to the edge of the axilla, where it attaches to the chest wall (Figure 1).
<img alt="Figure 1" src="/files/ftp_upload/10118/10118fig1.jpg" /> 
Figure 1. Breast anatomical landmarks.