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  1. Article: Laws relating to informed consent in clinical trials.

    Craig, Kathrine J

    Nursing standard (Royal College of Nursing (Great Britain) : 1987)

    2013  Volume 27, Issue 51, Page(s) 33

    MeSH term(s) Clinical Trials as Topic/legislation & jurisprudence ; Drugs, Investigational ; Humans ; Informed Consent/legislation & jurisprudence
    Chemical Substances Drugs, Investigational
    Language English
    Publishing date 2013-08-07
    Publishing country England
    Document type Letter
    ZDB-ID 645016-7
    ISSN 2047-9018 ; 0029-6570
    ISSN (online) 2047-9018
    ISSN 0029-6570
    DOI 10.7748/ns2013.08.27.51.33.s45
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Implementation and resource needs for long-acting PrEP in low- and middle-income countries: a scoping review.

    Castor, Delivette / Heck, Craig J / Quigee, Daniela / Telrandhe, Niharika Vasant / Kui, Kiran / Wu, Jiaxin / Glickson, Elizabeth / Yohannes, Kibret / Rueda, Sergio Torres / Bozzani, Fiammetta / Meyers, Kathrine / Zucker, Jason / Deacon, Justine / Kripke, Katharine / Sobieszczyk, Magdalena E / Terris-Prestholt, Fern / Malati, Christine / Obermeyer, Chris / Dam, Anita /
    Schwartz, Katie / Forsythe, Steven

    Journal of the International AIDS Society

    2023  Volume 26 Suppl 2, Page(s) e26110

    Abstract: Introduction: Several low- and middle-income countries (LMICs) are preparing to introduce long-acting pre-exposure prophylaxis (LAP). Amid multiple pre-exposure prophylaxis (PrEP) options and constrained funding, decision-makers could benefit from ... ...

    Abstract Introduction: Several low- and middle-income countries (LMICs) are preparing to introduce long-acting pre-exposure prophylaxis (LAP). Amid multiple pre-exposure prophylaxis (PrEP) options and constrained funding, decision-makers could benefit from systematic implementation planning and aligned costs. We reviewed national costed implementation plans (CIPs) to describe relevant implementation inputs and activities (domains) for informing the costed rollout of LAP. We assessed how primary costing evidence aligned with those domains.
    Methods: We conducted a rapid review of CIPs for oral PrEP and family planning (FP) to develop a consensus of implementation domains, and a scoping review across nine electronic databases for publications on PrEP costing in LMICs between January 2010 and June 2022. We extracted cost data and assessed alignment with the implementation domains and the Global Health Costing Consortium principles.
    Results: We identified 15 implementation domains from four national PrEP plans and FP-CIP template; only six were in all sources. We included 66 full-text manuscripts, 10 reported LAP, 13 (20%) were primary cost studies-representing seven countries, and none of the 13 included LAP. The 13 primary cost studies included PrEP commodities (n = 12), human resources (n = 11), indirect costs (n = 11), other commodities (n = 10), demand creation (n = 9) and counselling (n = 9). Few studies costed integration into non-HIV services (n = 5), above site costs (n = 3), supply chains and logistics (n = 3) or policy and planning (n = 2), and none included the costs of target setting, health information system adaptations or implementation research. Cost units and outcomes were variable (e.g. average per person-year).
    Discussion: LAP planning will require updating HIV prevention policies, technical assistance for logistical and clinical support, expanding beyond HIV platforms, setting PrEP achievement targets overall and disaggregated by method, extensive supply chain and logistics planning and support, as well as updating health information systems to monitor multiple PrEP methods with different visit schedules. The 15 implementation domains were variable in reviewed studies. PrEP primary cost and budget data are necessary for new product introduction and should match implementation plans with financing.
    Conclusions: As PrEP services expand to include LAP, decision-makers need a framework, tools and a process to support countries in planning the systematic rollout and costing for LAP.
    MeSH term(s) Humans ; Developing Countries ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; Health Care Costs ; Consensus ; Databases, Factual
    Language English
    Publishing date 2023-07-13
    Publishing country Switzerland
    Document type Journal Article ; Review ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, N.I.H., Extramural
    ZDB-ID 2467110-1
    ISSN 1758-2652 ; 1758-2652
    ISSN (online) 1758-2652
    ISSN 1758-2652
    DOI 10.1002/jia2.26110
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop.

    Williams, Eloise / Craig, Kathrine / Chiu, Christopher / Davies, Hugh / Ellis, Stephanie / Emerson, Claudia / Jamrozik, Euzebiusz / Jefford, Monica / Kang, Gagandeep / Kapulu, Melissa / Kolstoe, Simon E / Littler, Katherine / Lockett, Anthony / Elena Rey / Messer, Janet / McShane, Helen / Saenz, Carla / Selgelid, Michael J / Shah, Seema /
    Smith, Peter G / Yamazaki, Naho

    Vaccine

    2022  Volume 40, Issue 26, Page(s) 3484–3489

    Abstract: This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the ... ...

    Abstract This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.
    MeSH term(s) COVID-19/prevention & control ; Ethical Review ; Ethics Committees, Research ; Humans ; Pandemics/prevention & control ; World Health Organization
    Language English
    Publishing date 2022-02-14
    Publishing country Netherlands
    Document type Clinical Conference ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2022.02.004
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Conference proceedings: Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop

    Williams, Eloise / Craig, Kathrine / Chiu, Christopher / Davies, Hugh / Ellis, Stephanie / Emerson, Claudia / Jamrozik, Euzebiusz / Jefford, Monica / Kang, Gagandeep / Kapulu, Melissa / Kolstoe, Simon E. / Littler, Katherine / Lockett, Anthony / Elena Rey / Messer, Janet / McShane, Helen / Saenz, Carla / Selgelid, Michael J. / Shah, Seema /
    Smith, Peter G. / Yamazaki, Naho

    Vaccine. 2022 Feb. 01,

    2022  

    Abstract: This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the ... ...

    Abstract This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO’s international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA’s approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.
    Keywords COVID-19 infection ; World Health Organization ; ethics ; humans ; pandemic ; vaccination ; vaccines ; United Kingdom
    Language English
    Dates of publication 2022-0201
    Publishing place Elsevier Ltd
    Document type Article ; Conference proceedings
    Note Pre-press version
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2022.02.004
    Database NAL-Catalogue (AGRICOLA)

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  5. Article ; Online: Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

    Cruz Rivera, Samantha / Aiyegbusi, Olalekan Lee / Ives, Jonathan / Draper, Heather / Mercieca-Bebber, Rebecca / Ells, Carolyn / Hunn, Amanda / Scott, Jane A / Fernandez, Conrad V / Dickens, Andrew P / Anderson, Nicola / Bhatnagar, Vishal / Bottomley, Andrew / Campbell, Lisa / Collett, Clive / Collis, Philip / Craig, Kathrine / Davies, Hugh / Golub, Robert /
    Gosden, Lesley / Gnanasakthy, Ari / Haf Davies, Elin / von Hildebrand, Maria / Lord, Janet M / Mahendraratnam, Nirosha / Miyaji, Tempei / Morel, Thomas / Monteiro, Joao / Zwisler, Ann-Dorthe Olsen / Peipert, John Devin / Roydhouse, Jessica / Stover, Angela M / Wilson, Roger / Yap, Christina / Calvert, Melanie J

    JAMA

    2022  Volume 327, Issue 19, Page(s) 1910–1919

    Abstract: Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. ... ...

    Abstract Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.
    Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.
    Evidence review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.
    Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.
    Conclusions and relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.
    MeSH term(s) Biomedical Research/ethics ; Consensus ; Delphi Technique ; Ethics, Clinical ; Humans ; Morals ; Patient Reported Outcome Measures ; Practice Guidelines as Topic ; Research Design ; Research Report
    Language English
    Publishing date 2022-05-17
    Publishing country United States
    Document type Journal Article ; Systematic Review
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2022.6421
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Enhanced surveillance and data feedback loop associated with improved malaria data in Lusaka, Zambia.

    Chisha, Zunda / Larsen, David A / Burns, Matthew / Miller, John M / Chirwa, Jacob / Mbwili, Clara / Bridges, Daniel J / Kamuliwo, Mulakwa / Hawela, Moonga / Tan, Kathrine R / Craig, Allen S / Winters, Anna M

    Malaria journal

    2015  Volume 14, Page(s) 222

    Abstract: Background: Accurate and timely malaria data are crucial to monitor the progress towards and attainment of elimination. Lusaka, the capital city of Zambia, has reported very low malaria prevalence in Malaria Indicator Surveys. Issues of low malaria ... ...

    Abstract Background: Accurate and timely malaria data are crucial to monitor the progress towards and attainment of elimination. Lusaka, the capital city of Zambia, has reported very low malaria prevalence in Malaria Indicator Surveys. Issues of low malaria testing rates, high numbers of unconfirmed malaria cases and over consumption of anti-malarials were common at clinics within Lusaka, however. The Government of Zambia (GRZ) and its partners sought to address these issues through an enhanced surveillance and feedback programme at clinic level.
    Methods: The enhanced malaria surveillance programme began in 2011 to verify trends in reported malaria, as well as to implement a data feedback loop to improve data uptake, use, and quality. A process of monthly data collection and provision of feedback was implemented within all GRZ health clinics in Lusaka District. During clinic visits, clinic registers were accessed to record the number of reported malaria cases, malaria test positivity rate, malaria testing rate, and proportion of total suspected malaria that was confirmed with a diagnostic test.
    Results and discussion: Following the enhanced surveillance programme, the odds of receiving a diagnostic test for a suspected malaria case increased (OR = 1.54, 95 % CI = 0.96-2.49) followed by an upward monthly trend (OR = 1.05, 95 % CI = 1.01-1.09). The odds of a reported malaria case being diagnostically confirmed also increased monthly (1.09, 95 % CI 1.04-1.15). After an initial 140 % increase (95 % CI = 91-183 %), costs fell by 11 % each month (95 % CI = 5.7-10.9 %). Although the mean testing rate increased from 18.9 to 64.4 % over the time period, the proportion of reported malaria unconfirmed by diagnostic remained high at 76 %.
    Conclusions: Enhanced surveillance and implementation of a data feedback loop have substantially increased malaria testing rates and decreased the number of unconfirmed malaria cases and courses of ACT consumed in Lusaka District within just two years. Continued support of enhanced surveillance in Lusaka as well as national scale-up of the system is recommended to reinforce good case management and to ensure timely, reliable data are available to guide targeting of limited malaria prevention and control resources in Zambia.
    MeSH term(s) Child, Preschool ; Diagnostic Tests, Routine/utilization ; Epidemiological Monitoring ; Humans ; Infant ; Infant, Newborn ; Malaria/diagnosis ; Malaria/epidemiology ; Malaria/parasitology ; Prevalence ; Public Health Surveillance/methods ; Zambia/epidemiology
    Language English
    Publishing date 2015-05-29
    Publishing country England
    Document type Journal Article
    ISSN 1475-2875
    ISSN (online) 1475-2875
    DOI 10.1186/s12936-015-0735-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Evaluation of sulphadoxine-pyrimethamine for intermittent preventive treatment of malaria in pregnancy: a retrospective birth outcomes study in Mansa, Zambia.

    Mace, Kimberly E / Chalwe, Victor / Katalenich, Bonnie L / Nambozi, Michael / Mubikayi, Luamba / Mulele, Chikuli K / Wiegand, Ryan E / Filler, Scott J / Kamuliwo, Mulakwa / Craig, Allen S / Tan, Kathrine R

    Malaria journal

    2015  Volume 14, Page(s) 69

    Abstract: Background: Intermittent preventive treatment of malaria in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) decreases placental parasitaemia, thus improving birth outcomes. Zambian policy recommends monthly SP-IPTp doses given presumptively during ...

    Abstract Background: Intermittent preventive treatment of malaria in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) decreases placental parasitaemia, thus improving birth outcomes. Zambian policy recommends monthly SP-IPTp doses given presumptively during pregnancy at each antenatal examination, spaced one month apart after 16 weeks of gestation. The effectiveness of SP-IPTp was evaluated in Zambia where a recent study showed moderate prevalence of Plasmodium falciparum parasites with genetic mutations that confer SP resistance.
    Methods: HIV-negative women were enrolled at the time of delivery at two facilities in Mansa, Zambia, an area of high malaria transmission. Women were interviewed and SP exposure was determined by antenatal card documentation or self-reports. Using Poisson regression modelling, the effectiveness of SP-IPTp was evaluated for outcomes of parasitaemia (microscopic examination of maternal peripheral, cord, and placental blood films), maternal anaemia (Hb < 11 g/dl), placental infection (histopathology), and infant outcomes (low birth weight (LBW), preterm delivery, and small for gestational age) in women who took 0-4 doses of SP-IPTp.
    Results: Participants included 435 women, with a median age of 23 years (range 16-44). Thirty-four women took zero doses of SP-IPTp, while 115, 142 and 144 women took one, two, or ≥ three doses, respectively. Multivariate Poisson regression models considering age, mosquito net usage, indoor residual spraying, urban home, gravidity, facility, wet season delivery, and marital status showed that among paucigravid women ≥ two doses of SP-ITPp compared to one or less doses was associated with a protective effect on LBW (prevalence ratio (PR) 0.33, 95% confidence interval (CI) 0.12-0.91) and any infection (PR 0.76, CI 0.58-0.99). Multivariate models considering SP-IPTp as a continuous variable showed a protective dose-response association with LBW (paucigravid women: PR 0.54, CI 0.33-0.90, multigravid women: PR 0.63, CI 0.41-0.97).
    Conclusions: In Mansa, Zambia, an area of moderate SP resistance, ≥ two doses of SP-IPTp were associated with a protective effect from malaria in pregnancy, especially among paucigravid women. Each dose of SP-IPTp contributed to a 46 and 37% decrease in the frequency of LBW among paucigravid and multigravid women, respectively. SP-IPTp remains a viable strategy in this context.
    MeSH term(s) Adolescent ; Adult ; Antimalarials/therapeutic use ; Cohort Studies ; Dose-Response Relationship, Drug ; Drug Combinations ; Female ; Humans ; Malaria, Falciparum/epidemiology ; Malaria, Falciparum/parasitology ; Malaria, Falciparum/prevention & control ; Multivariate Analysis ; Poisson Distribution ; Pregnancy ; Pregnancy Complications, Parasitic/prevention & control ; Prevalence ; Pyrimethamine/therapeutic use ; Retrospective Studies ; Sulfadoxine/therapeutic use ; Treatment Outcome ; Young Adult ; Zambia/epidemiology
    Chemical Substances Antimalarials ; Drug Combinations ; fanasil, pyrimethamine drug combination (37338-39-9) ; Sulfadoxine (88463U4SM5) ; Pyrimethamine (Z3614QOX8W)
    Language English
    Publishing date 2015-02-07
    Publishing country England
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
    ISSN 1475-2875
    ISSN (online) 1475-2875
    DOI 10.1186/s12936-015-0576-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Peritoneal dialysis training: a multisensory approach.

    Neville, Alison / Jenkins, Jean / Williams, John D / Craig, Kathrine J

    Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

    2005  Volume 25 Suppl 3, Page(s) S149–51

    Abstract: Undertaking peritoneal dialysis (PD) therapy poses a challenge to all patients with renal failure. The potentially high risk of infection makes it essential that patients undertaking PD have adequate training and ongoing support. Over recent years, ... ...

    Abstract Undertaking peritoneal dialysis (PD) therapy poses a challenge to all patients with renal failure. The potentially high risk of infection makes it essential that patients undertaking PD have adequate training and ongoing support. Over recent years, increasing numbers of elderly patients, patients with significant learning disabilities, and patients with marked comorbidities have been accepted onto renal replacement therapy programs. For those undertaking PD in particular, this has posed new educational challenges. The Community Dialysis Team recognized an area of weakness in their current training program for these patient groups. The degree of literacy skills as well as the volume of written material and the amount of medical terminology used did not result in a user-friendly training program. A collaborative approach involving various members of the multidisciplinary team designed an appropriate training program for patients with learning disabilities. The new program included (1) a photographic bag-exchange procedure; (2) the provision of simple, step-by-step instructions on audiotape; (3) a new assessment sheet where words were replaced with symbols; (4) a redesigned daily record sheet (used to monitor clinical parameters); and (5) a simple contact card. The quality of the new training program was assessed by a small pilot study evaluation. The reduction of training times and the satisfactory peritonitis rates suggest that the new multisensory training program could be successfully implemented. The use of pictorial aids and more symbols, with less focus on the written word, made PD training a viable option for many individuals, including elderly patients and those with learning disabilities. The increased use of pictorial aids and symbols may also be helpful in training patients where there is a language barrier as well as the pediatric population.
    MeSH term(s) Comorbidity ; Education/methods ; Humans ; Kidney Failure, Chronic/epidemiology ; Kidney Failure, Chronic/therapy ; Learning Disabilities/epidemiology ; Patient Education as Topic ; Peritoneal Dialysis
    Language English
    Publishing date 2005-07-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 645010-6
    ISSN 0896-8608
    ISSN 0896-8608
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Rapidly adaptable automated interpretation of point-of-care COVID-19 diagnostics.

    Arumugam, Siddarth / Ma, Jiawei / Macar, Uzay / Han, Guangxing / McAulay, Kathrine / Ingram, Darrell / Ying, Alex / Chellani, Harshit Harpaldas / Chern, Terry / Reilly, Kenta / Colburn, David A M / Stanciu, Robert / Duffy, Craig / Williams, Ashley / Grys, Thomas / Chang, Shih-Fu / Sia, Samuel K

    Communications medicine

    2023  Volume 3, Issue 1, Page(s) 91

    Abstract: Background: Point-of-care diagnostic devices, such as lateral-flow assays, are becoming widely used by the public. However, efforts to ensure correct assay operation and result interpretation rely on hardware that cannot be easily scaled or image ... ...

    Abstract Background: Point-of-care diagnostic devices, such as lateral-flow assays, are becoming widely used by the public. However, efforts to ensure correct assay operation and result interpretation rely on hardware that cannot be easily scaled or image processing approaches requiring large training datasets, necessitating large numbers of tests and expert labeling with validated specimens for every new test kit format.
    Methods: We developed a software architecture called AutoAdapt POC that integrates automated membrane extraction, self-supervised learning, and few-shot learning to automate the interpretation of POC diagnostic tests using smartphone cameras in a scalable manner. A base model pre-trained on a single LFA kit is adapted to five different COVID-19 tests (three antigen, two antibody) using just 20 labeled images.
    Results: Here we show AutoAdapt POC to yield 99% to 100% accuracy over 726 tests (350 positive, 376 negative). In a COVID-19 drive-through study with 74 untrained users self-testing, 98% found image collection easy, and the rapidly adapted models achieved classification accuracies of 100% on both COVID-19 antigen and antibody test kits. Compared with traditional visual interpretation on 105 test kit results, the algorithm correctly identified 100% of images; without a false negative as interpreted by experts. Finally, compared to a traditional convolutional neural network trained on an HIV test kit, the algorithm showed high accuracy while requiring only 1/50th of the training images.
    Conclusions: The study demonstrates how rapid domain adaptation in machine learning can provide quality assurance, linkage to care, and public health tracking for untrained users across diverse POC diagnostic tests.
    Language English
    Publishing date 2023-06-23
    Publishing country England
    Document type Journal Article
    ISSN 2730-664X
    ISSN (online) 2730-664X
    DOI 10.1038/s43856-023-00312-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Efficacy of sulphadoxine-pyrimethamine for intermittent preventive treatment of malaria in pregnancy, Mansa, Zambia.

    Tan, Kathrine R / Katalenich, Bonnie L / Mace, Kimberly E / Nambozi, Michael / Taylor, Steve M / Meshnick, Steven R / Wiegand, Ryan E / Chalwe, Victor / Filler, Scott J / Kamuliwo, Mulakwa / Craig, Allen S

    Malaria journal

    2014  Volume 13, Page(s) 227

    Abstract: Background: Intermittent preventive treatment of malaria in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) decreases adverse effects of malaria during pregnancy. Zambia implemented its IPTp-SP programme in 2003. Emergence of SP-resistant ... ...

    Abstract Background: Intermittent preventive treatment of malaria in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) decreases adverse effects of malaria during pregnancy. Zambia implemented its IPTp-SP programme in 2003. Emergence of SP-resistant Plasmodium falciparum threatens this strategy. The quintuple mutant haplotype (substitutions in N51I, C59R, S108N in dhfr and A437G and K540E in dhps genes), is associated with SP treatment failure in non-pregnant patients with malaria. This study examined efficacy of IPTp-SP and presence of the quintuple mutant among pregnant women in Mansa, Zambia.
    Methods: In Mansa, an area with high malaria transmission, HIV-negative pregnant women presenting to two antenatal clinics for the 1st dose of IPTp-SP with asymptomatic parasitaemia were enrolled and microscopy for parasitaemia was done weekly for five weeks. Outcomes were parasitological failure and adequate parasitological response (no parasitaemia during follow-up). Polymerase chain reaction assays were employed to distinguish recrudescence from reinfection, and identify molecular markers of SP resistance. Survival analysis included those who had reinfection and incomplete follow-up (missed at least one follow-up).
    Results: Of the 109 women included in the study, 58 (53%) completed all follow-up, 34 (31%) had incomplete follow-up, and 17 (16%) were lost to follow-up after day 0. Of those who had complete follow-up, 15 (26%, 95% confidence interval [CI] [16-38]) had parasitological failure. For the 92 women included in the survival analysis, median age was 20 years (interquartile range [IQR] 18-22), median gestational age was 22 weeks (IQR range 20-24), and 57% were primigravid. There was no difference in time to failure in primigravid versus multigravid women. Of the 84 women with complete haplotype data for the aforementioned loci of the dhfr and dhps genes, 53 (63%, 95% CI [50-70]) had quintuple mutants (two with an additional mutation in A581G of dhps). Among women with complete follow-up and quintuple mutants, 22% had parasitological failure versus 0% without (p = 0.44).
    Conclusions: While underpowered, this study found 26% failure rates of SP given the moderate prevalence of the quintuple mutant haplotype. Despite the presence of resistance, SP retained some efficacy in clearing parasites in pregnant women, and may remain a viable option for IPTp in Zambia.
    MeSH term(s) Adolescent ; Adult ; Animals ; Antimalarials/therapeutic use ; Drug Combinations ; Drug Resistance ; Drug Therapy, Combination/methods ; Female ; Humans ; Malaria, Falciparum/prevention & control ; Mutation ; Plasmodium falciparum/drug effects ; Pregnancy ; Pregnancy Complications, Infectious/prevention & control ; Pyrimethamine/therapeutic use ; Sulfadoxine/therapeutic use ; Survival Analysis ; Treatment Failure ; Young Adult ; Zambia
    Chemical Substances Antimalarials ; Drug Combinations ; fanasil, pyrimethamine drug combination (37338-39-9) ; Sulfadoxine (88463U4SM5) ; Pyrimethamine (Z3614QOX8W)
    Language English
    Publishing date 2014-06-09
    Publishing country England
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
    ISSN 1475-2875
    ISSN (online) 1475-2875
    DOI 10.1186/1475-2875-13-227
    Database MEDical Literature Analysis and Retrieval System OnLINE

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