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Prospective randomized double-blind pilot study of site-specific consensus atlas implementation for rectal cancer target volume delineation in the cooperative group setting.

ABSTRACT: Variations in target volume delineation represent a significant hurdle in clinical trials involving conformal radiotherapy. We sought to determine the effect of a consensus guideline-based visual atlas on contouring the target volumes.A representative case was contoured (Scan 1) by 14 physician observers and a reference expert with and without target volume delineation instructions derived from a proposed rectal cancer clinical trial involving conformal radiotherapy. The gross tumor volume (GTV), and two clinical target volumes (CTVA, including the internal iliac, presacral, and perirectal nodes, and CTVB, which included the external iliac nodes) were contoured. The observers were randomly assigned to receipt (Group A) or nonreceipt (Group B) of a consensus guideline and atlas for anorectal cancers and then instructed to recontour the same case/images (Scan 2). Observer variation was analyzed volumetrically using the conformation number (CN, where CN = 1 equals total agreement).Of 14 evaluable contour sets (1 expert and 7 Group A and 6 Group B observers), greater agreement was found for the GTV (mean CN, 0.75) than for the CTVs (mean CN, 0.46-0.65). Atlas exposure for Group A led to significantly increased interobserver agreement for CTVA (mean initial CN, 0.68, after atlas use, 0.76; p = .03) and increased agreement with the expert reference (initial mean CN, 0.58; after atlas use, 0.69; p = .02). For the GTV and CTVB, neither the interobserver nor the expert agreement was altered after atlas exposure.Consensus guideline atlas implementation resulted in a detectable difference in interobserver agreement and a greater approximation of expert volumes for the CTVA but not for the GTV or CTVB in the specified case. Visual atlas inclusion should be considered as a feature in future clinical trials incorporating conformal RT.

SUBMITTER: Fuller CD

PROVIDER: S-EPMC2929319 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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Prospective randomized double-blind pilot study of site-specific consensus atlas implementation for rectal cancer target volume delineation in the cooperative group setting.

Fuller Clifton D CD Nijkamp Jasper J Duppen Joop C JC Rasch Coen R N CR Thomas Charles R CR Wang Samuel J SJ Okunieff Paul P Jones William E WE Baseman Daniel D Patel Shilpen S Demandante Carlo G N CG Harris Anna M AM Smith Benjamin D BD Katz Alan W AW McGann Camille C Harper Jennifer L JL Chang Daniel T DT Smalley Stephen S Marshall David T DT Goodman Karyn A KA Papanikolaou Niko N Kachnic Lisa A LA

International journal of radiation oncology, biology, physics 20100418 2

<h4>Purpose</h4>Variations in target volume delineation represent a significant hurdle in clinical trials involving conformal radiotherapy. We sought to determine the effect of a consensus guideline-based visual atlas on contouring the target volumes.<h4>Methods and materials</h4>A representative case was contoured (Scan 1) by 14 physician observers and a reference expert with and without target volume delineation instructions derived from a proposed rectal cancer clinical trial involving confor ...[more]

PMID: 20400244

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Project description:Delineation of treatment volumes is a major source of uncertainties in radiotherapy (RT). This is also true for rectal cancer patients undergoing neoadjuvant RT, with a potential impact on treatment quality. We investigated the role of the digital platform Anatom-e (Anatom-e Information Sytems Ltd., Houston, Texas) in increasing the compliance to follow a specific treatment protocol in a multicentric setting.Two clinical cases of locally advanced rectal cancer were chosen. Participants were instructed to follow the 2009 Radiation Therapy Oncology Group consensus atlas and asked to manually segment clinical target volumes (CTVs), for both patient 1 and 2, on day 1 with and without the use of Anatom-e. After one week (day 2), the same radiation oncologist contoured again, with and without Anatom-e, the same CT series. Intraobserver (Intra-OV) and interobserver (Inter-OV) variability were evaluated with the Dice similarity coefficient (DSC), the Hausdorff distance (HD) and mean distance to agreement (MDA).For clinical case 1, no significant difference was found for Intra-OV and Inter-OV. For clinical case 2, no significant difference was found for Intra-OV but a statistically significant difference was found for Inter-OV in DSC when using or not the platform. Mean DCS was 0.65 (SD: ±0.64; range: 0.58-0.79) for day 1 vs reference volume without Anatom-e and 0.72 (SD: ±0.39; range: 0.67-0.77) (p?=?0.03) with it. Mean MDA was lower with Anatom-e (3.61; SD: ±1.33; range: 2.85-4.78) than without (4.14; SD: ±2.97; range: 2.18-5.21), with no statistical significance (p?=?0.21) The use of Anatom-e decreased the SD from 2.97 to 1.33. Mean HD was lower with Anatom-e (26.06; SD: ±2.05; range: 24.08-32.62), with no statistical significance (p?=?0.14) compared to that without (31.39; SD: ±1.31; range: 26.14-48.72).The use of Anatom-e decreased the Inter-OV in the CTV delineation process for locally advanced rectal cancer with complex disease presentation planned for neoadjuvant RT. This system may be potentially helpful in increasing the compliance to follow shared guidelines and protocols.

Project description:BackgroundFrail older patients are at risk of experiencing a decline in physical and cognitive function unrelated to the reason for admission. The Elder-Friendly Care (EFC) program was designed to improve the care, experiences, and outcomes of frail older adults. The project supported 8 Early Adoption Sites (EAS) in a large Canadian healthcare organization by providing multiple strategies, educational opportunities, and resources. The purpose of this study was to assess the usefulness of EFC educational materials and resources, staff practice changes and perceptions in pilot sites, and readiness for scale and spread.MethodsThe study was conducted from May 2017 to June 2018 using a mixed-methods approach incorporating the Kirkpatrick Model of Training/Evaluation. A total of 76 Direct Care Staff participated in the staff survey, which assessed their awareness of, satisfaction with, and utilization of EFC principles, resources, and practices. Additionally, 12 interviews were conducted with staff who were directly involved in site implementation of EFC.ResultsMost survey participants were aware (86%, n = 63) of the EFC program, and 85% (n = 41) indicated they or their site/unit had implemented EFC. Out of these 41 participants, the most common practice changes identified were: incorporating alternatives to restraint (81%, n = 33), decreased use of pharmacological restraint (78%, n = 32), and patient and family care planning (76%, n = 31). Participants that attended all 3 EFC Learning Workshops (LWs) were significantly more likely to recommend the EFC Toolkit to others (87% versus 40%; χ2 = 8.82, p < 0.01) compared to participants attending less than 3 EFC LWs. Interview participants indicated that the program was well structured and flexible as sites/units could adopt changes that suited their individual sites, needs, contexts, and challenges.ConclusionsThe educational materials and resources used for the EFC project are useful and appreciated by the Direct Care Staff. Further, participants perceive the EFC intervention as effective in creating positive practice change and useful in reducing hospital-related complications for older patients. Future implementation will investigate the impact of EFC on system-level outcomes in acute care.

Project description:BackgroundThis nonrandomized exploratory intervention and feasibility study examines how digital assistive technology (DAT), comprising a DFree ultrasound sensor, affects nursing care for continence support and evaluates nurses' willingness to incorporate DAT into the planning and practical implementation of care processes.ObjectiveThe relief provided by DFree in the clinical care setting and the extent to which it supports nursing care for activities of daily living pertaining to "micturition" is unclear. DAT DFree is expected to reduce nurses' workload in clinical continence-care settings and was designed as a human-technology interaction that ensures a high level of usability for the subjects (ie, the nurses) and increases user acceptance by at least one level (eg, from average to slightly above average) during the study.MethodsApproximately 45 nurses from neurology, neurosurgery, and geriatric medicine clinics and polyclinics at the University Medicine Halle will be included in the 90-day (3-month) intervention on-site in the respective wards. After the wards are equipped with digital technologies, the participating nurses will be trained to use DFree and will be able to select DFree as a possible patient-care resource if the anamnesis includes bladder dysfunction among only patients who are willing to participate. The willingness of nurse participants to use DFree in planning their care process will be assessed using the Technology Usage Inventory at 3 measurement points. The primary target values include the results of the multidimensional Technology Usage Inventory assessment that will be processed using descriptive statistics. Ten participating nurses will be invited to conduct extensive guided interviews that are intended to provide information about the device's usefulness and feasibility in the specific field of continence care and possible improvements.ResultsIt is expected that the intention to use will be confirmed by nurses, and the number of nursing problems, such as bladder dysfunction-induced bedwetting, will be reduced with a high rating of DAT usability.ConclusionsFirst, this study aims to produce multilevel innovative impacts, including practical, scientific, and societal effects. The results will provide practical solutions for workload reduction in the field of nursing support for continence care, where digital assistive technologies are becoming increasingly important. The DFree ultrasonic sensor is a new technical tool for the treatment of bladder dysfunction. Generating feedback to improve technical applications can increase the user-friendliness and usefulness of the device.Trial registrationDeutsches Register Klinischer Studien DRKS00031483; https://drks.de/search/en/trial/DRKS00031483.International registered report identifier (irrid)PRR1-10.2196/47025.

Project description:BackgroundFeasibility and pilot studies are recommended prior to embarking on large-scale costly confirmatory trials. The objectives were to determine the feasibility of conducting a cluster randomized controlled trial (C-RCT) to evaluate a complex knowledge translation (KT) intervention to improve the management of people with neck pain, and to identify challenges and potential solutions to conducting a fully powered C-RCT in the chiropractic setting.MethodsPilot C-RCT involving a nationally representative sample of chiropractors and patients. We invited 400 chiropractors and 150 patients to participate. Clinicians were randomized to receive either an online theory-based KT educational and brief action plan (BAP) intervention (intervention group) or a copy of a clinical practice guideline (control group). Study-related challenges were ascertained via mid-study phone interviews and end-of-study feedback questionnaires. Analyses focused on descriptive estimates of likely recruitment, retention, and adherence rates, and documentation of potential barriers.ResultsIn total, 47 chiropractors (12%) agreed to participate and were randomized after resampling. Fifteen withdrew from the study, leaving a total of 32 (8%) participants. Eleven chiropractors in the intervention group completed the webinars and e-learning modules, two partially completed them and three did not register. Participating chiropractors recruited a total of 29 patients. Sixty-three percent (n = 7) of intervention and 56% (n = 10) of control group patients completed all outcome measures at both baseline and 3-months follow-up, attended follow-up visits and performed home exercises. Patients in the intervention group reported significant reductions in pain (mean 1.6, 95% CI 0.26-2.94, P = 0.027) and disability scores (9.8, 95% CI 3.68-15.91, P = 0.033) from baseline to 3-month follow-up. Key barriers to participation reported by chiropractors included lack of time, difficulties in recruiting patients, problems with the administration of study questionnaires, concern that the clinician-patient relationship might be jeopardized, and lack of assistance from office staff. Over half (55%) of the respondents in the intervention group encountered some difficulty registering or completing the educational modules.ConclusionRecruitment of clinicians and patients for a trial of a complex intervention can be challenging, and retention of participants after enrolment may be low. Future trials of this nature likely require multiple recruitment strategies to achieve desired sample sizes. Moreover, time-constraint issues are perceived particularly by clinicians as a major barrier to both study enrolment before, and protocol adherence during, their actual participation in a trial.Trial registrationThe study was registered at, NCT02483091, on 17th June 2015.

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Dataset Information

Prospective randomized double-blind pilot study of site-specific consensus atlas implementation for rectal cancer target volume delineation in the cooperative group setting.

Publications

Prospective randomized double-blind pilot study of site-specific consensus atlas implementation for rectal cancer target volume delineation in the cooperative group setting.

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