It’s possible that I shall make an ass of myself. But in that case one can always get out of it with a little dialectic. I have, of course, so worded my proposition as to be right either way (K.Marx, Letter to F.Engels on the Indian Mutiny)
Friday, May 12, 2023
Higher mortality rate for Porton Down veterans involved in chemical weapons research
IMAGE: GAS MASK PROTECTION AGAINST A CHEMICAL ATTACKview more
CREDIT: LANCASTER UNIVERSITY
Military veterans involved in chemical warfare agent research at Porton Down faced a 6% higher mortality rate than similar veterans who were not involved.
The research from the King’s Centre for Military Health Research (KCMHR) at King’s College London, in partnership with Lancaster University, is published in the International Journal of Epidemiology.
Researchers compared the medical records of 16,721 male UK veterans who participated in the ‘Service Volunteer Programme’ from 1941-1989, comparing them with 16,228 non-Porton Down veterans, placing a particular focus on the most common causes of death and types of cancer.
They found that these military veterans had higher rates of mortality from diseases of the genitourinary systems (for example, kidney disease), as well as deaths attributable to alcohol, but found little evidence of an association between attendance at Porton Down and higher rates of overall cancer incidence.
Porton Down first opened during World War I in response to the use of chemical weapons. Since 1916, over 20,000 service personnel have exposed to low doses of chemical warfare agents and their antidotes, some of which are known to be carcinogenic. This has raised questions over the long-term impacts on the health of veterans attached to the Program.
While there was only a small increased risk overall, the researchers did find that veterans who took part in the Porton Down Volunteer Program between 1960-64 were at significantly greater risk of dying from a range of causes including cancerous tumours, diseases within the circulatory system, and smoking related deaths.
The researchers suggest that health providers need to be aware of the specific health issues connected to military veterans, and the wider population, who may have been exposed to chemical warfare agents.
Dr Tom Keegan, one of the study’s authors and a Senior Lecturer in Epidemiology from Lancaster Medical School said: “Military personnel were exposed to over four hundred different types of chemicals over the course of the programme, so we now want to investigate whether particular chemicals are associated with increased risk of poorer health.”
Dr Gemma Archer, from KCMHR, the study’s first author said: “Veterans of the Porton Down Service Volunteer Program were often exposed to small doses of chemical agents designed to be used in war. Our study followed the health of veterans for over fifty years, and we are thankful that it indicates that the large majority of veterans were unlikely to have come to harm. A small number of veterans did appear to have higher rates of death and a variety of other illnesses, and it is something that healthcare professionals need to be mindful of when treating victims of chemical exposure.”
Professor Nicola Fear, co-director of KCMHR and the study’s senior author said: “There has, for some time, been a question mark hanging over the volunteers who contributed to the research of Porton Down. While it is reassuring that our study found no evidence of increased risk of cancer in veterans who attended Porton Down, the 6% higher rate of all-cause mortality compared to veterans who didn’t attend Porton Down is not something that should be overlooked”.
IMAGE: JENNY KINDBLOM, SAHLGRENSKA ACADEMY AT THE UNIVERSITY OF GOTHENBURG.view more
CREDIT: PHOTO BY JOHAN WINGBORG/UNIVERSITY OF GOTHENBURG
A clinical study with children as participants entails extra costs often omitted in the initial budget. Clinical studies involving children are thus at risk of being undercompensated, new research shows.
Kids will be kids when they take part in clinical studies, as at other times. Sometimes they need a break to do something else for a while before the next study session can start. With children as study participants, researchers also need to involve more people — frequently two legal guardians— and this, too, boosts the time a study requires.
The person responsible for the current study is Jenny Kindblom, associate professor (docent) at the Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, and senior consultant clinical pharmacologist at Sahlgrenska University Hospital.
Kindblom and her colleagues at the Hospital’s clinical trials unit for children and adolescents had long noticed that, in budget proposals from the pharmaceutical companies to cover study activities performed at the hospital, activities in pediatric clinical studies were often undercompensated. This pattern emerged clearly when the researchers embarked on a more structured type of work, supported by a team member with expertise in budget and contract issues.
Studies costing 59 percent more
The article in Acta Paediatrica is based on ten clinical studies with children as participants, and their true costs proved to be 59 percent higher, on average, than the total initial budget in the proposal from the pharmaceutical company sponsoring the trial. The problem was that the studies were based on adults and had not been adapted to the paediatric setting.
Child studies require extensive planning and coordination with various people, including some around the child. In addition, child studies often comprise a great many investigations, with staff and resources from various units.
“In implementing the study, you need to have the child on your side. Forcing kids to participate in study activities never works. You need to adjust to what the child can cope with — and sometimes have a break and a bit of rest and recreation,” Kindblom says.
Younger children, unlike adults, may also need to be sedated during, for instance, a magnetic resonance imaging (MRI) scan or bowel examination. Anesthesia comes with a wide range of input requirements from different units, which makes the activity more time-consuming.
Budget processing important
The study’s first author is Stavros Koulizakos, the team expert in charge of budget and contractual matters for the pediatric clinical studies underway at Sahlgrenska University Hospital. He describes the major gaps between budgeted and actual costs as follows.
“The budget items that generate the biggest discrepancies are, first, the expenses involved in clinical trials; second, the estimated time required for the study activities; and third, the costs of examinations.”
The researchers emphasize that drug companies are enormously important for driving development in the direction of new and improved medicines, for children and adolescents as well as adults. Nevertheless, the compensation for study activities must be as much as possible representative of the study costs for the Hospital and the respective companies alike.
Kindblom again:
“There’s a definite risk of fewer studies being conducted because of underfunding. An increased risk of pediatric studies not reaching completion has been observed. To an extreme extent, undercompensation can contribute to this outcome. But an even more clearcut consequence is for the health care services to engage in paediatric trials sponsored by drug companies, without getting compensation. It’s not a reasonable state of affairs,” she concludes.
IMAGE: ABPN TEA PARTY-GOVERNANCE AND DEVELOPMENT BOARDview more
CREDIT: ASSOCIATION OF BRITISH PAEDIATRIC NURSES
At a recent event to celebrate the Association’s 85th Anniversary, the Association of British Paediatric Nurses awarded Honorary Fellowships to eight children’s nurses in recognition of their outstanding contribution to the nursing care of children and young people.
The 2023 Honorary Fellows
Ann Bisbrown Lee for services to children’s nursing and for many years’ service to the Association of British Paediatric Nurses, especially in leading marketing and conference activities.
Professor Steven Campbell for services to children’s nurse education and to the Association of British Paediatric Nurses as the first Editor of the Association’s journal, the Journal of Child Health Care.
Rachel Cooke for services to children’s nursing, especially in the field of children’s palliative care and childhood bereavement services in the UK and overseas.
Norman Long for services to children’s nurse education and for many years’ service to the Association of British Paediatric Nurses as the finance officer.
Professor Bertha Ochieng for services to children’s nursing and child health, especially in the field of community empowerment and engagement of socially disadvantaged populations.
Dr Gerri Sefton for services to children’s nursing, especially in the field of paediatric intensive care and children’s nursing research.
Fiona Smith for services to children’s nursing in the UK and globally, including playing a key role in establishing the Paediatric Nursing Associations of Europe.
Clinical Associate Professor Michael Tatterton for services to children’s nursing and children’s nurse education, especially in the field of children’s palliative and community care.
Caron Eyre, ABPN Chair, said “This year’s ABPN Fellows are each of an extremely high calibre and have made inspirational improvements to the care of babies, children and young people.”
Professor Bernie Carter, President of the ABPN, said “The appointment of our Honorary Fellows acknowledges the amazing and diverse work undertaken by children’s nurses in practice, education, academia, research and leadership. We are immensely proud of their achievements and welcome them as special members of our ABPN family”.
Stress-management interventions may help individual healthcare workers for at least a year
Interventions aimed at reducing work-related stress for individual healthcare workers may lead to improvements in how people cope with stress up to a year later.
Interventions aimed at reducing work-related stress for individual healthcare workers may lead to improvements in how people cope with stress up to a year later. Findings from a Cochrane review of the latest available evidence build on the conclusions of a previous review in 2015 that found low-quality evidence that interventions, such as cognitive behavioural training (CBT), mental and physical relaxation, were better than none.
The researchers included 117 studies of the effects of different interventions on stress alleviation in the current review, of which 89 studies were new. These 89 studies were published between 2013 and 2022. A total of 11,119 healthcare workers worldwide were randomised to different interventions, and stress was assessed by questionnaires measuring stress symptoms in the short term (up to three months after an intervention ended), in the medium term (between three and 12 months) and long-term (follow-up after more than a year).
The review from Cochrane, a collaboration of independent, international experts, looked at interventions at the level of the individual healthcare worker that focused attention either on the experience of stress, or away from the experience of stress. Strategies for focusing attention on the stress included CBT, and training on assertiveness, coping and communication skills. Interventions that focus attention away from the stress included relaxation, mindfulness meditation, exercise such as yoga and tai chi, massage, acupuncture, and listening to music. The researchers wanted to see whether different types of interventions were better than no intervention in reducing stress.
The healthcare workers in the studies were experiencing low to moderate levels of stress and burnout, which can lead to physical symptoms such as headaches, muscle tension or pain, but also mental symptoms, such as depression, anxiety, impaired concentration and emotional and relationship problems.
Sietske Tamminga, assistant professor in public and occupational health at Amsterdam University Medical Centre, Amsterdam, The Netherlands, who led the research said: “Healthcare workers often deal with stressful and emotional situations in patient care, human suffering, and pressure from relationships with patients, family members and employers, as well as high work demands and long working hours.
“We found that healthcare workers might be able to reduce their stress by means of individual-level interventions such as cognitive behaviour training, exercising or listening to music. This may be beneficial for the healthcare workers themselves and it may spill over to the patients they care for, and the organisations they work for. The effect may last for up to a year and a combination of interventions may be beneficial as well, at least in the short term. Employers should not hesitate to facilitate a range of stress interventions for their employees. The long-term effects of stress management interventions remain unknown.”
The researchers say that larger, better-quality studies are needed to look at both the short- and long-term effects of individual level interventions in order to increase the certainty of the evidence.
“We need more studies on interventions addressing work-related risk factors both at the individual and organisational level,” said Dr Tamminga. “It might be even more beneficial to improve working conditions themselves, instead of only helping individuals to deal better with heavy psychosocial burdens. For example, employers could address problems of understaffing, over-work and anti-social shift patterns. If you’re dedicated to change, you need to change the underlying risk factors rather than focusing on the symptoms.”
Limitations of the research include: the estimates of the effects of individual-level stress management interventions may be biased because of a lack of blinding of the participants in the included studies; many studies were small; and there were too few studies that focused on specific factors that can cause stress in the workplace.
Studies have reported that between 30% to 70% of physicians and nurses and 56% of anaesthesiologists experience burnout symptoms as a result of their work. Previous research has tended to focus on a particular type of intervention in specific groups of healthcare workers. The authors of this Cochrane review write: “To the best of our knowledge there are no up-to-date reviews that examine the effectiveness of various types of individual-level interventions aimed at reducing stress in various healthcare workers to provide a more complete overview.”
Dr Tamminga concluded: “There is already a shortage of healthcare workers due to high turnover rates, and effective prevention of stress and burnout may help to reduce this.”
Shortages of health workers such as doctors, nurses and midwifery staff are strongly associated with higher death rates, especially for certain diseases such as neglected tropical diseases and malaria, pregnancy and birth complications, diabetes and kidney diseases, finds an analysis of 172 countries and territories, published by The BMJ today.
The results show that, although inequalities in health workforces have been decreasing globally over the past 30 years, they continue to have a substantial impact on death rates globally - and the researchers say targeted action is needed to boost health workforces in these priority areas.
The term human resources for health (HRH) refers to a range of occupations, including doctors, nurses, midwives, dentists and other allied professions and support functions designed to promote or improve health.
This workforce is key to achieving the goal of universal health coverage by 2030.
Although several studies have analysed the relation between HRH density and deaths, studies on inequalities in total and specific HRH types and relations with specific causes of death from a global perspective are scarce.
To address this, researchers used data from the Global Burden of Disease Study 2019, United Nations Statistics, and Our World in Data to measure the associations between HRH and all cause and cause specific deaths in 172 countries and territories representing most of WHO’s member states. They also explored the inequalities in HRH from 1990 to 2019.
Globally, the total health workforce per 10,000 population increased, from 56 in 1990 to 142.5 in 2019.
In 2019, the total health workforce was distributed unevenly and was more concentrated among countries and territories that ranked high on the human development index (a summary measure of education, health, and income).
For example, Sweden had the highest access to HRH per capita (696.1 per 10,000 population), whereas Ethiopia and Guinea had less than one ninth of the global HRH level, with 13.9 and 15.1 workers per 10,000 population, respectively.
The all cause aged standardised death rate decreased from 995.5 per 100,000 population in 1990 to 743.8 per 100,000 in 2019. And for most of the 21 specific causes of death analysed, the number of deaths per 100,000 population declined from 1990 to 2019, except for those due to neurological and mental disorders, skin diseases, and muscle and bone disorders.
The death rate for HIV/AIDS and sexually transmitted infections increased from 2 per 100,000 population in 1990 to 3.6 per 100,000 in 2000, but then decreased steadily to 3.4 per 100,000 population in 2019.
The risk of death due to gut infections, neglected tropical diseases and malaria, diabetes and kidney diseases, and disorders of pregnancy and birth was more pronounced (between 2 and 5.5 times higher) in countries and territories with low or the lowest health worker density than in those with the highest density.
This is an observational study, so can’t establish cause, and the researchers point to several potential limitations in the data that might have influenced their results, although the associations were similar after further analysis, suggesting that the results are robust.
As such, they conclude: “Our findings highlight the importance of expanding the financing of health and developing equity oriented policies for the health workforce to reduce deaths related to an inadequate HRH.”
Association between inequalities in human resources for health and all cause and cause specific mortality in 172 countries and territories, 1990-2019: observational study
ARTICLE PUBLICATION DATE
10-May-2023
COI STATEMENT
All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the National Nature Science Foundation of China, National R and D Key project, and National Science and Technology Project on Development Assistance for Technology, Developing China-ASEAN Public Health Research and Development Collaborating Center for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Majority of nurses attribute well-being struggles to staffing shortages
FAU, Cross Country Healthcare’s third annual report shows one-third of nurses plan to leave the profession in the next two years
IMAGE: A NEW REPORT SHOWS ONE-THIRD OF NURSES PLAN TO LEAVE THE PROFESSION IN THE NEXT TWO YEARS.view more
CREDIT: ALEX DOLCE, FLORIDA ATLANTIC UNIVERSITY
Cross Country Healthcare, Inc. (NASDAQ: CCRN), a market-leading, tech-enabled workforce solutions platform and advisory firm, in collaboration with Florida Atlantic University, today announced the results of its annual survey of nursing professionals and students.
The study found that although nurses are passionate about doing meaningful work and earning a good income, only one-third of nurses plan to remain in the profession for the foreseeable future, and about one-fourth plan to leave in just one to two years from now. The survey, conducted in collaboration with FAU’s Christine E. Lynn College of Nursing, found that more than half of nurses claim there is insufficient staff to meet demand, which they regard as the worst part of the profession, resulting in burnout and feeling overworked.
May is Nurse Appreciation Month and Mental Health Awareness Month, and to help address some of the mental health struggles facing our nurses today, Cross Country Healthcare is launching the Check Your Vitalsinitiative, asking nurses to check their vitals, or overall health and well-being, while offering tips and strategies for nurses on maintaining both mental and physical wellness. As part of the campaign, nurses are encouraged to wear green to show support for mental health awareness and post their green on social media using the hashtag #checkyourvitals.
“We had hoped that at this point past the pandemic, we would see improvement in the sentiment of our nurses, but that’s simply not the case,” said John A. Martins, president and CEO of Cross Country Healthcare. “The decision to choose nursing is more of a calling than a job. Nurses are tireless in their passion for quality patient care, no matter how challenging their working conditions may be. But the profession has reached a breaking point, and it is well past time that industry leaders come together to create reform to revitalize this essential profession.”
According to the survey, nurses reported experiencing symptoms of anxiety (46 percent), insomnia (35 percent), and depression (32 percent). Most employed nurses (83 percent) do not utilize mental health or well-being counseling, despite employers offering such services. The leading cause for poor mental health was staffing shortages (71 percent), followed by a lack of support resources (55 percent). The nurses’ experience with the COVID-19 pandemic has added to feelings of discontent, and nearly 2 in 5 employed nurses said it dramatically increased their desire to leave the profession.
The findings come as the United States Health Resources & Services Administration predicts a national projected shortage of 63,720 full-time registered nurses in 2030 and a projected shortage of 141,580 fulltime licensed practical nurses in 2035.
With regard to mental health in nursing students, 61 percent said their school offers mental health and well-being resources, including student assistance programs, gyms and fitness resources, counseling, food and nutrition services, and a mental health and well-being hotline. Forty-seven percent of students use the mental health offerings from their school, and 53 percent find them useful. When asked if they were satisfied with their decision to become a nurse, 93 percent of student nurses said they are.
“Despite the many challenges and stressors that have contributed to burnout and nurses being on the brink of a breaking point in their professional careers, nurses and nursing students remain overwhelming satisfied with their career choice,” said Safiya George, Ph.D., Holli Rockwell Trubinsky Eminent Dean and Professor, FAU’s Christine E. Lynn College of Nursing. “Nurses have endured and thrived over the years. The profession as a whole will need a lot more investment of human capital as well as fiscal and other supportive resources moving forward. This national survey has helped to identify innovative ways to improve quality of work and life for current and the next generation of nurses.”
The Christine E. Lynn College of Nursing offers accredited programs at all levels to prepare and train students, including Bachelor of Science in Nursing (B.S.N.), Master of Science in Nursing (M.S.N.), Doctor of Nursing Practice (DNP) and Ph.D. programs. A BSN-DNP program with a psychiatric mental health nurse practitioner concentration and post-graduate dermatology and telehealth certificate courses, and other concentrations that combine innovation and technology also are offered to address health care provider shortages.
“Nurses are struggling and have been for years now. They are overworked and understaffed, and addressing their well-being challenges must be a critical priority for health care leaders,” said Hank Drummond, Ph.D., M.Div, B.A., RN, senior vice president, and chief clinical officer. “The patient experience is only as good as the caregiver experience, so we need to ensure our caregivers are well and cared for, both physically and emotionally.”
Other survey findings include:
Nearly 1 in 5 employed nurses don’t know if they would follow the same career path if they could talk to their former selves.
Most nurses overwhelmingly believe that increased pay rates/incentives are necessary to attract and retain staff and increase flexible scheduling.
While many health care organizations offer opportunities for growth and development, 1 in 3 nurses are unaware if their employer has such opportunities, and 1 in 5 said their employer does not.
The most common well-being programs offered include employee assistance programs, hotlines, employer-paid health care, flexibility and time off.
Employed and unemployed nurses greatly believe in the value of national licensure.
To help address some of the challenges facing the nursing profession today, Cross Country Healthcare recommends five ways to revitalize the profession, including:
Create new opportunities for education:
Identify new pathways at the high school, undergraduate and postgraduate levels to expedite the supply of nurses.
Recruit more nursing faculty to educate and train the next generation of nurses.
Offer flexibility and awareness of growth opportunities:
Open every door to expedite the transition from the university to the hospital floor and offer more fluid career paths that match individual skills and ambitions to evolve and grow with the person.
Invest in retention strategies and well-being initiatives that matter:
Focus on enriching current and future nurses’ working conditions and well-being to ensure long-term satisfaction and subsequent retention.
Technological innovation will drive the future:
Use technology to understand better equitable workforce distribution, workflow management, employee satisfaction and well-being, and patient safety.
Explore innovative staffing models:
Explore innovative and flexible staffing models, including travel and per-diem nurses, to provide agility and continuity of quality patient care.
- FAU -
About the Study
This national survey, titled, "The Future of Nursing: At the Breaking Point,” was conducted with nearly 1,500 nursing professionals and students at health care and hospital facilities. The online survey was conducted between Feb. 22 and April 14, in partnership with FAU’s Christine E. Lynn College of Nursing.
About the Christine E. Lynn College of Nursing
FAU’s Christine E. Lynn College of Nursing is nationally and internationally known for its excellence and philosophy of caring science. The College was ranked No. 11 nationwide by US News and World Report in 2021 for “Best Online Master’s in Nursing Administration Programs” and No. 32 for the “Best Online Master’s in Nursing Programs.” In 2020, FAU graduates earned a 95.9% pass rate on the National Council Licensure Examination for Registered Nurses (NCLEX-RN®) and a 100% AGNP Certification Pass Rate. The baccalaureate, master’s and DNP programs at Florida Atlantic University’s Christine E. Lynn College of Nursing are accredited by the Commission on Collegiate Nursing Education. The College is the only one in the U.S. to have all degree programs endorsed by the American Holistic Nursing Credentialing Corporation.
About Florida Atlantic University: Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University serves more than 30,000 undergraduate and graduate students across six campuses located along the southeast Florida coast. In recent years, the University has doubled its research expenditures and outpaced its peers in student achievement rates. Through the coexistence of access and excellence, FAU embodies an innovative model where traditional achievement gaps vanish. FAU is designated a Hispanic-serving institution, ranked as a top public university by U.S. News & World Report and a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. For more information, visit www.fau.edu.
About Cross Country Healthcare
Cross Country Healthcare, Inc. is a leading tech-enabled workforce solutions and advisory firm with 36 years of industry experience and insight. We solve complex labor-related challenges for customers while providing high-quality outcomes and exceptional patient care. As a multi-year Best of Staffing® award winner, we are committed to an exceptionally high level of service to our clients, our homecare, education, and clinical and non-clinical healthcare professionals. Our locum tenens line of business, Cross Country Locums, has been certified by the National Committee for Quality Assurance (NCQA), the leader in healthcare accreditation, since 2001. We are the first publicly traded staffing firm to obtain The Joint Commission Certification, which we still hold with a Letter of Distinction. Cross Country Healthcare is rated as the top staffing and recruiting employer for women by InHerSights, and Certified™ by Great Place to Work®.
For three consecutive years, Cross Country has received the Top Workplaces USA award from Energage and has also been recognized with the Top Workplaces Award for Diversity, Equity & Inclusion Practices and the Top Workplaces Awards for Innovation and Leadership. Cross Country has recently been awarded the Women Executive Leadership Elevate Award, recognizing gender diversity in our Boardroom. We have a history of investing in diversity, equality, and inclusion as a key component of the organization’s overall corporate social responsibility program, closely aligned with its core values to create a better future for its people, communities, and its stockholders.
METHOD OF RESEARCH
Survey
SUBJECT OF RESEARCH
People
ARTICLE TITLE
The Future of Nursing: At the Breaking Point
ARTICLE PUBLICATION DATE
11-May-2023
THE LANCET PUB. HEALTH: Mailing at-home HPV sampling kits nearly doubles cervical screening uptake among hard-to-reach populations, US clinical trial suggests
THE LANCET
Peer-reviewed / Randomised Controlled Trial / People
Clinical trial with 665 under-screened women in North Carolina (USA) investigated use of high-risk human papillomavirus (hrHPV) self-collection kits to increase cervical cancer screening uptake.
Screening uptake among participants sent self-collection kits and given support to attend an in-person appointment was almost double (72%) the cervical cancer screening uptake in those only given appointment support alone (37%).
More than three quarters (78%) of these underserved participants who were mailed a hrHPV kit returned a sample, suggesting effective community outreach plays a key role in increasing screening uptake among women at highest risk of cervical cancer.
The authors say their findings, together with those from previous studies, provide evidence that HPV self-collection kits have the potential to increase uptake of cervical cancer screening in under-screened women.
At-home high-risk human papillomavirus (hrHPV) sampling kits can help increase cervical cancer screening among under-screened women from low-income backgrounds, according to findings from a US-based clinical trial published in The Lancet Public Healthjournal.
The trial shows mailing kits to low-income, under-screened women and helping them book an in-person clinic appointment led to a two-fold increase in screening uptake compared to only offering assistance making an appointment.
The main cause of cervical cancer is persistent infection with a hrHPV, which puts women at risk of developing precancerous cervical lesions. Cervical cancer disproportionately affects Black and Hispanic women in the USA, with the highest incidence among Hispanic women and the highest mortality among Black women. Regular hrHPV testing in accordance with national screening guidelines reduces the risk of women developing the disease.
Current US guidelines on cervical cancer screening have several options. For women 21 years and over, a Papanicolaou (Pap) test every three years is recommended. For those 30 years and older, additional options include HPV cytology co-testing every five years or primary hrHPV testing every five years.
While previous studies have shown hrHPV self-collection kits can help increase cervical cancer screening, little research has involved under-screened women in the USA. Limited data is available on the combined effectiveness of using hrHPV self-collection kits and offering help scheduling in-person screening appointments.
Lead author Professor Jennifer S. Smith, University of North Carolina at Chapel Hill, US, said: “Until now, most studies of whether HPV self-collection increases cervical cancer screening have been outside the USA, in countries with national screening registries and universal health care. Our findings suggest programmes that use mailed HPV kits with effective community outreach can greatly improve screening uptake among underserved, at-risk women in the USA.” [1]
The authors conducted a randomised clinical trial involving 665 under-screened women in 22 counties in North Carolina, USA. Intensive community outreach campaigns – including printed and radio advertisements, online postings, community events and organisations and via a social assistance helpline – were used to recruit participants from underserved, under-screened groups and of racial and ethnic diversity.
The average age of participants in the trial – called My Body My Test-3 – which ran from 2016 to 2019, was 42 years, and more than half self-reported as Black or Hispanic (55%, 365/664 participants), uninsured (78%, 518/663), or unemployed (57%, 373/660). Women were only eligible for the trial if they had not received a Pap test in four years or more, or an hrHPV test in six years or more.
Participants were either sent hrHPV self-collection kits and given help booking an in-person appointment, or only given help making an appointment. The main outcome was cervical cancer screening uptake within 6 months of enrolment, defined as a negative hrHPV test result or attending an in-person screening appointment. Participants who tested positive for hrHPV by self-collection were referred to in-clinic appointment for further tests.
For participants who received mailed kits and help scheduling an appointment, cervical cancer screening uptake was almost double (72%, 317/438 participants) compared to those who received scheduling assistance only (37%, 85/227 participants). The benefits of home testing were similar regardless of participants’ age, time since last screening, race/ethnicity, insurance coverage, or level of education.
Among participants sent hrHPV kits, more than three quarters (78%, 341/438 participants) returned a sample. Valid hrHPV results were obtained for 329 participants, of whom 52 (16%) tested positive for hrHPV and were referred for follow-up appointments that 22 (42%) attended. Further tests detected CIN2+ lesions – which can progress to cervical cancer – in two (<1%) participants, who then received treatment.
Second author Dr Noel Brewer, of the University of North Carolina at Chapel Hill, said: “Government approval of at-home HPV tests would have a huge impact. We could better reach those in rural areas where cervical cancer screening is hard to come by. Also, only the people who self-test positive would need to go to a clinic for screening. For the many Americans without reliable access, cervical cancer screening from home would ensure they can get life-saving preventive care.” [1]
The authors acknowledge some limitations to their study. While the outreach approach used may oversample more motivated women and somewhat limit the study’s generalisability, it enabled recruitment of large numbers of at-risk women from the general population who do not regularly use clinic services. Mailed hrHPV kits do not meet the needs of all under-screened, hard-to-reach women. Consistent with other studies, less than half of participants with positive hrHPV results attended an in-clinic appointment, highlighting the need for further efforts to ensure continuity to care among those with positive self-test results. The trial was also conducted prior to the COVID-19 pandemic, so effects on screening uptake in the post-pandemic era could not be determined.
Writing in a linked Comment, Runzhi Wang, MD, and Jenell Coleman, MD, of Johns Hopkins University School of Medicine, who were not involved in the study, said: “This study provides the required evidence that high-risk HPV testing on self-collected samples can be an effective strategy for hard-to-reach populations.” They also call for developments to optimise the entire cervical cancer prevention process in the USA, saying: “Optimisation includes policy reforms to remove financial barriers to diagnostic tests and treatment; community outreach and education campaigns; and improved access to quality care through transportation services, expanded Medicaid eligibility, and skilled clinicians.”
NOTES TO EDITORS
This study was funded by the US National Institutes of Health. It was conducted by researchers from the University of North Carolina at Chapel Hill.
[1] Quote direct from author and cannot be found in the text of the Article.
Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial
ARTICLE PUBLICATION DATE
11-May-2023
COI STATEMENT
Investigators interested in accessing these data for the purposes of future studies can do so under the following conditions: Institutional Review Board approval has been obtained from the University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, the institution covering the investigator; data security procedures ensuring patient privacy have been shown by the investigator; and a Data Use Agreement has been filled. Final datasets for analysis will not include any identifying information.
Cervical cancer screening doubles when under-screened women are mailed testing kits
IMAGE: “MY HOPE GOING INTO THIS STUDY WAS THAT MAILING KITS FOR HOME-BASED COLLECTION MIGHT INCREASE CERVICAL CANCER SCREENING, BUT WE WERE THRILLED TO FIND A NEARLY TWO-FOLD INCREASE IN SCREENING UPTAKE,” SAID UNC LINEBERGER’S JENNIFER S. SMITH, PHD, MPH, PROFESSOR OF EPIDEMIOLOGY AT UNC’S GILLINGS AND CORRESPONDING AUTHOR OF THIS STUDY. “MANY HADN’T ENGAGED IN THE SCREENING SYSTEM FOR A WHILE AND GETTING THE KIT TO THEIR HOMES HELPED BREAK DOWN A FUNDAMENTAL BARRIER.”view more
CREDIT: UNC LINEBERGER COMPREHENSIVE CANCER CENTER
CHAPEL HILL, NC -- Researchers at the UNC Gillings School of Global Public Health and UNC Lineberger Comprehensive Cancer Center found mailing human papillomavirus (HPV) self-collection tests and offering assistance to book in-clinic screening appointments to under-screened, low-income women improved cervical cancer screening nearly two-fold compared to scheduling assistance alone. Scheduling assistance primarily consisted of helping to book an appointment for in-person screening at a clinic, regardless of whether an at-home test was offered or returned, or whether the HPV test was negative or positive.
The findings from the randomized trial appeared May 11, 2023, in Lancet Public Health.
“My hope going into this study was that mailing kits for home-based collection might increase cervical cancer screening, but we were thrilled to find a nearly two-fold increase in screening uptake,” said UNC Lineberger’s Jennifer S. Smith, PhD, MPH, professor of epidemiology at UNC’s Gillings and corresponding author of this study. “Many hadn’t engaged in the screening system for a while and getting the kit to their homes helped break down a fundamental barrier.”
An estimated 14,000 women will be diagnosed with cervical cancer in the United States this year, according to the National Cancer Institute, and the cancer will lead to more than 4,300 deaths. Cervical cancer disproportionately affects Black and Hispanic women, with Hispanic women having the highest incidence rates, and Black women having the highest mortality rates for the disease in North Carolina and in the United States. Most cervical cancers occur among under-screened women. The Centers for Disease Control and Prevention estimate 22% of eligible adults in the U.S. are overdue for screening.
The My Body, My Test-3 study recruited 665 women, ages 25 to 64, who were uninsured or enrolled in Medicaid or Medicare, from 22 counties across North Carolina. The women had low incomes and most of them lived in urban areas. None had a pap test in four years or a high-risk HPV test in six years, making them overdue for screening.
Two-thirds of the women received mailed HPV self-collection kits followed by assistance with scheduling a screening appointment at a clinic. The other third received screening scheduling assistance alone. The primary outcome was attending an in-clinic screening appointment or testing HPV-negative with self-collected samples within six months of enrollment in the trial.
Screening uptake was 72% among women who received mailed HPV kits compared to 37% for the other group of women. The investigators found that the effect of self-collection outreach on screening uptake didn’t vary across age, race/ethnicity, time since last screening, Medicaid or Medicare insurance coverage, or education.
“Home screening for cervical cancer puts women in control. Most can avoid having to go to a doctor’s appointment. These at-home kits can better reach people without access to screening, who are embarrassed by a cervical exam, or whose religious beliefs include modesty,” said study co-author Noel T. Brewer, PhD, Gillings Distinguished Professor in Public Health and UNC Lineberger member.
“We believe our results are applicable to low-income, under-screened women across the United States,” Smith said. “We’re now working with clinical partners to identify women who might be overdue for screening through electronic medical records. We hope to provide the option of either mailing them a self-collection kit to use at-home to mail back to us or hand a kit directly to them when they come into clinics for other services with the vision to eventually make self-collection a regular clinical provision.”
The UNC researchers also hope their findings, together with previous research findings, will spur the Food and Drug Administration to consider approving HPV self-collection as a primary screening test for cervical cancer in the U.S.
Authors and Disclosures
In addition to Smith and Brewer, the other authors are Peyton K. Pretsch, MPH, Lisa P. Spees, PhD, Michael G. Hudgens, PhD, Busola Sanusi, MA, Eliane Rohner, PhD, Elyse Miller, MPH, Sarah L. Jackson, MPH, and Stephanie B. Wheeler, PhD, MPH, UNC; Lynn Barclay, American Sexual Health Association, Research Triangle Park, NC; and Alicia Carter, MD, Laboratory Corporation of America Holdings, Burlington, NC.
The My Body My Test-3 trial was funded by the R01CA183891 grant from the National Cancer Institute. HPV testing reagents, media for self-collected sample preservation and liquid-based cytology media and cervical sample collection brushes were donated by Hologic, Inc. Self-collection brushes were donated by Rovers Medical Devices.
Smith has received research grants, supply donations and consultancies for Hologic, Inc., BD Diagnostics and Rovers Medical Devices in the past five years. Barclay works for the American Sexual Health Association which receives funding from Hologic. Neither Hologic, BD nor Rovers had input into the research design, analysis or interpretation of results. Wheeler receives grant support from Pfizer for unrelated projects. The other authors declared no conflicts of interest.
JOURNAL
The Lancet Public Health
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
ARTICLE PUBLICATION DATE
11-May-2023
COI STATEMENT
Jennifer Smith, Phd, has received research grants, supply donations and consultancies for Hologic, Inc., BD Diagnostics and Rovers Medical Devices in the past five years. Lynn Barclay works for the American Sexual Health Association which receives funding from Hologic. Neither Hologic, BD nor Rovers had input into the research design, analysis or interpretation of results. Stephanie Wheeler, PhD, MPH, receives grant support from Pfizer for unrelated projects. The other authors declared no conflicts of interest.
HPV self-collection kits increase screening among under-screened, under-served women in North Carolina
Jennifer S. Smith, Ph.D., led the Phase 3 controlled trial, which showed that self-collection kits and scheduling assistance are key for reaching these populations and preventing cervical cancer.
CHAPEL HILL, N.C. – Five years ago, the World Health Organization (WHO) announced a global call to eliminate cervical cancer. Because nearly all cervical cancers are caused by an initial infection with oncogenic types of human papillomavirus (HPV), screening for the virus is critical to preventing and treating the disease. However, providing HPV screening only within clinical settings may limit access to screening for many under-served women across the United States and here, in North Carolina.
Jennifer S. Smith, PhD, and other researchers in the Gillings School of Global Public Health and UNC’s School of Medicine, conducted an open-label, two-arm randomized controlled trial called “My Body, My Test-3” to see if under-screened, under-served women across North Carolina were more likely to undergo cervical cancer when mailed HPV self-collection kits and offered scheduling assistance.
Researchers found mailed HPV self-collection with scheduling assistance led to more cervical cancer screenings than scheduling assistance alone. The results from the “My Body, My Test-3” study were published in Lancet Public Health.
“We showed that under-screened women were able to take the time to complete an HPV self-collection kit, return it successfully, and found the process acceptable enough that it actually led to their re-engagement in cervical cancer screening,” said Smith, who is a professor in the Department of Epidemiology. “Our study was particularly unique because we used two levels of intervention to increase screening uptake.”
HPV is the most common sexually transmitted infection. In most cases, HPV goes away on its own in a few years and does not cause health problems. But for some, the infection can spur precancerous lesions, or abnormal cell development in the cervix. If doctors know that a patient has HPV-associated cervical lesions, they can act fast to remove the lesions and decrease one’s risk of developing cervical cancer.
The biggest risk factor for cervical cancer, according to Smith, is being overdue for cervical cancer screening, which is higher among those without medical insurance or the financial stability to cover tests or in-person clinical visit costs.
“Many of the cervical cancer cases in the United States are occurring among women who haven't been screened regularly, or at all, because of lack of insurance, barriers to transportation, or a lack of knowledge about state-wide screening programs that offer screening free of charge or at a sliding scale,” said Smith.
Mailing self-collection kits helps to break down these access barriers. The technique uses a simple collection device, such as a brush, to obtain cervico-vaginal cell samples to test for HPV infection. The HPV test itself has comparable performance to physician-collection for the detection of high-grade cervical precancerous lesions or cancer.
One of the advantages of self-collection is that it eliminates the need for an initial in-clinic pelvic examination and can be performed at home, or another location that is convenient for the patient. Those with positive HPV results are then referred to follow-up care at the clinic.
As part of the trial, 665 women were contacted and helped with booking a screening appointment at a nearby clinic. One group of the women were only offered scheduling assistance, so researchers could determine if the intervention was successful on its own.
The remaining group of the women also received an HPV self-collection kit with illustrated instructions and a self-collection brush. They were given a pre-stamped envelope to send back their samples for laboratory testing.
The idea of self-collection is not a new one. Self-collection is being used in national programs throughout the globe already, such as in Denmark and the Netherlands. But self-collection in the United States is still in under review with the Food and Drug Administration (FDA).
The researchers hope the evidence from the trial will help provide some extra momentum for the FDA’s approval of HPV self-collection. If self-collection is approved by national screening bodies, programs, and community organizations such as Medicaid, Federally Qualified Health Centers, or the Breast and Cervical Cancer Control Program, it could be used to identify under-screened people and implement HPV self-collection by mail or within the clinical setting.
For Smith, the trial was incredibly valuable in that it served as a challenging learning experience on ways to reach women overdue for cervical cancer screening. They used a variety of community-outreach methods to recruit women for the screening trial, including through social media, radio, and flyers on local buses.
Inevitably, Smith says that it is important for doctors, researchers, and programs to find interventions and screening strategies that cater to the women who need to be screened.
“We won't make an impact on reducing cervical cancer in North Carolina, or globally, until we are able to find the women who aren't being screened and ensure that they get screening," said Smith. “We need to work together with them. Our results showed that mailing HPV self-collection kits to women who had not been screened regularly doubled cervical cancer screening uptake.”
Moving forward, the researchers will be thinking about the best approaches to providing HPV self-collection outreach. For example, patients could be flagging through medical records as being overdue for screening, and kits could be delivered through the mail or offered in person as they come into the clinic for other services.
Smith believes that as more programs consider integrated self-collection as part of patient care, it is critical to consider the entire cervical cancer cascade, from increasing screening access to providing the needed follow-up care if a self-test result is positive.
“It is important to ensure that women can have access to providers if they have questions about the self-collection process or their results,” said Smith. “If they have a positive result, they need to be ensured the appropriate follow-up care for good patient care.”
Other authors on the Lancet Public Health paper are Peyton K. Pretsch, MPH, Lisa P. Spees, PhD, Noel Brewer, PhD, Michael G. Hudgens, PhD, Busola Sanusi, MA, Eliane Rohner, PhD, Elyse Miller, MPH, Sarah L. Jackson, MPH, and Stephanie B. Wheeler, PhD, MPH, UNC; Lynn Barclay, American Sexual Health Association, Research Triangle Park, NC; and Alicia Carter, MD, Laboratory Corporation of America Holdings, Burlington, NC.
Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial
