Dataset Information

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

ABSTRACT: Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs.For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%).Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.

SUBMITTER: Mueller JL

PROVIDER: S-EPMC5365351 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

Mueller Jenna L JL Asma Elizabeth E Lam Christopher T CT Krieger Marlee S MS Gallagher Jennifer E JE Erkanli Alaattin A Hariprasad Roopa R Malliga J S JS Muasher Lisa C LC Mchome Bariki B Oneko Olola O Taylor Peyton P Venegas Gino G Wanyoro Anthony A Mehrotra Ravi R Schmitt John W JW Ramanujam Nimmi N

Journal of lower genital tract disease 20170401 2

<h4>Objective</h4>Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.<h4>Materials and methods</h4>There were 2 protocols, which included 44 and 18 patients. F ...[more]

PMID: 28263237

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Project description:IntroductionCurrent guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope's concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies.ResultsOur POCkeT Colposcope has comparable resolving power, color reproduction accuracy, minimal lens distortion, and illumination when compared to commercially available colposcopes. In vitro and pilot in vivo imaging results are promising with our POCkeT Colposcope capturing comparable quality images to commercial systems.ConclusionThe POCkeT Colposcope is capable of capturing images suitable for cervical lesion analysis. Our portable low cost system could potentially increase access to cervical cancer screening in limited resource settings through task shifting to community health workers.

Project description:IntroductionStreptococcal pharyngitis, which commonly occurs in children, should be treated with antibiotics. Clinical prediction rules to differentiate streptococcal pharyngitis from viral infection are not recommended in children. Rapid point-of-care (POC) antigen tests have limited sensitivity and so are not often used in Canadian paediatric emergency departments (EDs). Standard paediatric practice is to rely on laboratory-based testing, which often results in a delay before the results can be communicated to the patient; this may impede appropriate prescribing, decrease caregiver satisfaction and delay recovery. The objective of this study is to determine whether a novel rapid molecular POC assay for streptococcal pharyngitis leads to more appropriate antibiotic use in children seeking care in a paediatric ED than standard laboratory-based testing.Methods and analysisA randomised, superiority, open-label, trial with two parallel groups. Children presenting to a tertiary paediatric ED at least 3 years of age who have a throat swab ordered for diagnosis of streptococcal pharyngitis will be eligible; those who have taken antibiotics within 72 hours prior to presentation and those with additional active infections will be excluded. The primary study outcome will be appropriate antibiotic treatment at 3-5 days postenrolment. Secondary outcomes include time to symptom resolution, caregiver satisfaction, caregiver/child absenteeism, number of subsequent healthcare visits, clinician satisfaction and incremental cost-effectiveness of POC testing. A total of 352 participants will be needed.Ethics and disseminationAll study documentation has been approved by the Hamilton Integrated Research Ethics board and informed consent will be obtained from all participants. Data from this trial will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines.Trial registration numberNCT04247243.

Project description:BackgroundThe Pediatric Emergency Medicine (PEM) Point-of-care Ultrasound (POCUS) Network (P2Network) was established in 2014 to provide a platform for international collaboration among experts, including multicenter research. The objective of this study was to use expert consensus to identify and prioritize PEM POCUS topics, to inform future collaborative multicenter research.MethodsOnline surveys were administered in a two-stage, modified Delphi study. A steering committee of 16 PEM POCUS experts was identified within the P2Network, with representation from the United States, Canada, Italy, and Australia. We solicited the participation of international PEM POCUS experts through professional society mailing lists, research networks, social media, and "word of mouth." After each round, responses were refined by the steering committee before being reissued to participants to determine the ranking of all the research questions based on means and to identify the high-level consensus topics. The final stage was a modified Hanlon process of prioritization round (HPP), which emphasized relevance, impact, and feasibility.ResultsFifty-four eligible participants (16.6%) provided 191 items to Survey 1 (Round 1). These were refined and consolidated into 52 research questions by the steering committee. These were issued for rating in Survey 2 (Round 2), which had 45 participants. At the completion of Round 2, all questions were ranked with six research questions reaching high-level consensus. Thirty-one research questions with mean ratings above neutral were selected for the HPP round. Highly ranked topics included clinical applications of POCUS to evaluate and manage children with shock, cardiac arrest, thoracoabdominal trauma, suspected cardiac failure, atraumatic limp, and intussusception.ConclusionsThis consensus study has established a research agenda to inform future international multicenter PEM POCUS trials. This study has highlighted the ongoing need for high-quality evidence for PEM POCUS applications to guide clinical practice.

Project description:IntroductionVenous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU.Methods and analysisThis is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes.Ethics and disseminationEthical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberISRCTN21541209.

Project description:BackgroundThere is no single national guideline in Australia on the provision of postnatal care, which means there is potential for significant variation in the standard and quality of care. This review aimed to systematically identify, synthesise, and assess the quality of postnatal care guidelines produced for use in Australia. A second aim was to compare postnatal care recommendations in Australian guidelines to the National Institute for Health and Care Excellence's (NICE) and the World Health Organization's (WHO) postnatal care recommendations, to identify gaps and areas of disagreement. We focussed on recommendations regarding postnatal assessment of the woman or newborn, infant feeding, discharge planning, or community-based care.MethodsA scoping review was undertaken informed by the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for scoping reviews. A database search and a manual search of state and national government health departments, professional associations and research institute websites was performed to identify relevant guidelines and recommendations. Guideline quality was assessed using the AGREE II tool. Guideline recommendations from Australia were mapped to 67 NICE/WHO recommendations. Recommendations that partially agreed, were modified, or in disagreement underwent further analysis.ResultsA total of 31 Australian postnatal guidelines were identified and overall, these were of moderate- to high-quality. Of the 67 NICE/WHO recommendations, most agreed with the recommendations contained in Australian guidelines. There were five NICE/WHO recommendations with which corresponding Australian recommendations disagreed. There were 12 NICE/WHO recommendations that were commonly modified within Australia's guidelines. There were three NICE/WHO recommendations that did not appear in any Australian guideline.ConclusionsRecommendations from postnatal guidelines in Australia have a high level of agreement with corresponding NICE/WHO recommendations. The few disagreements and modifications found in guideline recommendations - both across Australia's guidelines and between Australia's and the NICE/WHO guidelines - are worrying and warrant further examination, as they may result in different standards of care across Australia. Identified gaps in guidance should be prioritised for inclusion in new or updated guidelines where appropriate.

Dataset Information

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

Publications

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

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