scholarly journals Safety and efficacy of the new CryoPop® cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
S. Yogeshkumar ◽  
Jean Anderson ◽  
Enriquito Lu ◽  
Edward Kenyi ◽  
Margaret Mensa ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Cervical Cancer ◽  
Precancerous Lesions ◽  
Cervical Dysplasia ◽  
High Grade ◽  
Care Providers ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Abstract Background Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally takes years and provides a window of opportunity to screen for and treat precancerous lesions. Methods This study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers, and potential participants. Organized community based as well as hospital-based screening is being conducted using visual inspection with acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high-grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device. Discussion There is a need to develop an inexpensive, simple, and effective cryotherapy device for use by frontline health care providers at locations where screening and timely treatment can be given, accelerating access to cervical cancer prevention services and minimizing loss to follow-up of women with precancerous lesions who need treatment. Trial registration Clinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644. Registered on November 6, 2019.

scholarly journals Safety and Efficacy of the New CryoPop® Cryotherapy Device for Cervical Dysplasia in Low- and Middle-income Countries: Study Protocol for a Multicentre Open-label Non-inferiority Clinical Trial With Historical Controls

2021 ◽  
Author(s):  
S YogeshKumar ◽  
Jean Anderson ◽  
Enrique Lu ◽  
Edward Kenyi ◽  
Margaret Mensa ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Cervical Cancer ◽  
Precancerous Lesions ◽  
Cervical Dysplasia ◽  
High Grade ◽  
Care Providers ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Abstract Background: Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally takes years and provides a window of opportunity to screen for and treat precancerous lesions. Methods: This study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers and potential participants. Organized community based as well as hospital-based screening is being conducted using Visual Inspection with Acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device.Discussion: There is a need to develop an inexpensive, simple and effective cryotherapy device for use by frontline health care providers at locations where screening and timely treatment can be given, accelerating access to cervical cancer prevention services and minimizing loss to follow-up of women with precancerous lesions who need treatment.Trial Registration: Clinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644 on November 6, 2019. https://bit.ly/3yRQWC4

Clinical trial to implementation: Cost and effectiveness considerations for scaling up cervical cancer screening in low- and middle-income countries

2016 ◽  
Vol 7 ◽  
pp. 4-11 ◽  
Author(s):  
Sujha Subramanian ◽  
Rengaswamy Sankaranarayanan ◽  
Pulikkottil Okkuru Esmy ◽  
Jissa Vinoda Thulaseedharan ◽  
Rajaraman Swaminathan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Scaling Up ◽  
Implementation Cost ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

scholarly journals Cervical Precancer Treatment in Low- and Middle-Income Countries: A Technology Overview

2017 ◽  
Vol 3 (4) ◽  
pp. 400-408 ◽  
Author(s):  
Mauricio Maza ◽  
Celina M. Schocken ◽  
Katherine L. Bergman ◽  
Thomas C. Randall ◽  
Miriam L. Cremer
Keyword(s):  
Cervical Cancer ◽  
Early Stage ◽  
Precancerous Lesions ◽  
Low Cost ◽  
Treatment Modalities ◽  
Middle Income ◽  
Novel Technologies ◽  
Middle Income Countries ◽  
Cervical Precancer ◽  
Low And Middle Income

Cervical cancer is the fourth leading cause of cancer-related death in women worldwide, with 90% of cases occurring in low- and middle-income countries (LMICs). There has been a global effort to increase access to affordable screening in these settings; however, a corresponding increase in availability of effective and inexpensive treatment modalities for ablating or excising precancerous lesions is also needed to decrease mortality. This article reviews the current landscape of available and developing technologies for treatment of cervical precancer in LMICs. At present, the standard treatment of most precancerous lesions in LMICs is gas-based cryotherapy. This low-cost, effective technology is an expedient treatment in many areas; however, obtaining and transporting gas is often difficult, and unwieldy gas tanks are not conducive to mobile health campaigns. There are several promising ablative technologies in development that are gasless or require less gas than conventional cryotherapy. Although further evaluation of the efficacy and cost-effectiveness is needed, several of these technologies are safe and can now be implemented in LMICs. Nonsurgical therapies, such as therapeutic vaccines, antivirals, and topical applications, are also promising, but most remain in early-stage trials. The establishment of evidence-based standardized protocols for available treatments and the development and introduction of novel technologies are necessary steps in overcoming barriers to treatment in LMICs and decreasing the global burden of cervical cancer. Guidance from WHO on emerging treatment technologies is also needed.

scholarly journals Breast Cancer in Low- and Middle-Income Countries: An Emerging and Challenging Epidemic

2010 ◽  
Vol 2010 ◽  
pp. 1-5 ◽  
Author(s):  
Arafat Tfayli ◽  
Sally Temraz ◽  
Rachel Abou Mrad ◽  
Ali Shamseddine
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Low Income ◽  
Therapeutic Interventions ◽  
Low Income Countries ◽  
Middle Income ◽  
Major Health ◽  
Middle Income Countries ◽  
Low And Middle Income

Breast cancer is a major health care problem that affects more than one million women yearly. While it is traditionally thought of as a disease of the industrialized world, around 45% of breast cancer cases and 55% of breast cancer deaths occur in low and middle income countries. Managing breast cancer in low income countries poses a different set of challenges including access to screening, stage at presentation, adequacy of management and availability of therapeutic interventions. In this paper, we will review the challenges faced in the management of breast cancer in low and middle income countries.

scholarly journals An International Analysis of Dialysis Services Reimbursement

2018 ◽  
Vol 14 (1) ◽  
pp. 84-93 ◽  
Author(s):  
Arjan van der Tol ◽  
Norbert Lameire ◽  
Rachael L. Morton ◽  
Wim Van Biesen ◽  
Raymond Vanholder
Keyword(s):  
Health Care ◽  
Peritoneal Dialysis ◽  
Replacement Therapy ◽  
Gdp Per Capita ◽  
Middle Income ◽  
Middle Income Countries ◽  
Number Of Patients ◽  
Kidney Replacement Therapy ◽  
Per Capita ◽  
Low And Middle Income

Background and objectivesThe prevalence of patients with ESKD who receive extracorporeal kidney replacement therapy is rising worldwide. We compared government reimbursement for hemodialysis and peritoneal dialysis worldwide, assessed the effect on the government health care budget, and discussed strategies to reduce the cost of kidney replacement therapy.Design, setting, participants, & measurementsCross-sectional global survey of nephrologists in 90 countries to assess reimbursement for dialysis, number of patients receiving hemodialysis and peritoneal dialysis, and measures to prevent development or progression of CKD, conducted online July to December of 2016.ResultsOf the 90 survey respondents, governments from 81 countries (90%) provided reimbursement for maintenance dialysis. The prevalence of patients per million population being treated with long-term dialysis in low- and middle-income countries increased linearly with Gross Domestic Product per capita (GDP per capita), but was substantially lower in these countries compared with high-income countries where we did not observe an higher prevalence with higher GDP per capita. The absolute expenditure for dialysis by national governments showed a positive association with GDP per capita, but the percent of total health care budget spent on dialysis showed a negative association. The percentage of patients on peritoneal dialysis was low, even in countries where peritoneal dialysis is better reimbursed than hemodialysis. The so-called peritoneal dialysis–first policy without financial incentive seems to be effective in increasing the utilization of peritoneal dialysis. Few countries actively provide CKD prevention.ConclusionsIn low- and middle-income countries, reimbursement of dialysis is insufficient to treat all patients with ESKD and has a disproportionately high effect on public health expenditure. Current reimbursement policies favor conventional in-center hemodialysis.

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